Emisphere Technologies, Inc.
EMISPHERE TECHNOLOGIES INC (Form: 10-K, Received: 03/30/2017 16:34:47)
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 10-K

(Mark One)

 

     ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2016

OR

 

     TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                 to

Commission file number 0-17758

 

 

EMISPHERE TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   13-3306985

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

4 Becker Farm Road, Suite 103

Roseland, NJ

  07068
(Address of principal executive offices)   (Zip Code)

(973) 532-8000

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

None

Securities registered pursuant to Section 12(g) of the Act:

Common Stock — $.01 par value

Preferred Stock Purchase Rights

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ☐        No  ☑

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.    Yes  ☐        No  ☑

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that Registrant was required to file such reports) and (2) has been subject to such filing requirements for at least the past 90 days.    Yes  ☑        No  ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☑        No  ☐

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.    ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer  ☐   Accelerated filer  ☐   Non-accelerated filer  ☐   Smaller reporting company  ☑
  (Do not check if a smaller reporting company)                 

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes  ☐        No  ☑

As of June 30, 2016 (the last business day of the registrant’s most recently completed second quarter), the aggregate market value of the common stock held by non-affiliates of the Registrant (i.e. excluding shares held by executive officers, directors, and control persons) was $28,630,594 computed at the closing price on that date.

The number of shares of the Registrant’s common stock, $.01 par value, outstanding as of March 1, 2017 was 60,687,478.


Table of Contents

TABLE OF CONTENTS

 

         Page No.  

PART I

     1  

Item 1.

  Business      1  

Item 1A.

  Risk Factors      17  

Item 1B.

  Unresolved Staff Comments      25  

Item 2.

  Properties      25  

Item 3.

  Legal Proceedings      25  

Item 4.

  Mine Safety Disclosures      25  

PART II

     26  

Item 5.

  Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities      26  

Item 6.

  Selected Financial Data      27  

Item 7.

  Management’s Discussion and Analysis of Financial Condition and Results of Operations      27  

Item 7A.

  Quantitative and Qualitative Disclosures About Market Risk      41  

Item 8.

  Financial Statements and Supplementary Data      43  

Item 9.

  Changes in and Disagreements with Accountants on Accounting and Financial Disclosure      77  

Item 9A.

  Controls and Procedures      77  

Item 9B.

  Other Information      77  

PART III 

     78  

Item 10.

  Directors, Executive Officers and Corporate Governance      78  

Item 11.

  Executive Compensation      83  

Item 12.

  Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters      95  

Item 13.

  Certain Relationships, Related Transactions and Director Independence      99  

Item 14.

  Principal Accounting Fees and Services      101  

PART IV

     102  

Item 15.

  Exhibits and Financial Statement Schedules      102  

Item 16.

  Form 10-K Summary      102  
  Signatures      103  
  Exhibits Index      104  


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PART I

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K and the documents incorporated by reference herein contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. These forward-looking statements include, without limitation, statements regarding the sufficiency of our cash position; our ability to enter into strategic partnerships; our ability, and that of our partners, to develop, manufacture and commercialize products using our Eligen ® technology; the success of our commercialization initiatives; planned or expected studies and trials of oral formulations that utilize our Eligen ® Technology; the potential market size, advantages or therapeutic uses of our potential products and the sufficiency of our available capital resources to meet our funding needs. You should read this Annual Report on Form 10-K completely and with the understanding that our actual future results may be materially different from what we expect. We do not undertake any obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results or achievements to be materially different from any future results or achievements expressed or implied by such forward-looking statements. Such factors include the factors described in Part 1, Item 1A. “Risk Factors” and the other factors discussed in connection with any forward-looking statements.

 

ITEM 1. BUSINESS

Overview of Emisphere

Introduction and History

Emisphere Technologies, Inc. (“Emisphere,” “the Company,” “our,” “us,” or “we”) is a commercial stage pharmaceutical and drug delivery company. We are in partnership with global pharmaceutical companies to develop new oral formulations of existing injectable bio-pharmaceutical products, as well as new chemical entities, using our Eligen ® Technology. We launched our first prescription medical food product, oral Eligen B12™ in the U.S. in March 2015, and we are engaged in strategic business collaborations discussions to optimize its economic value in the U.S. and global markets. Beyond Eligen B12™, we utilize our proprietary Eligen ® Technology to create new oral formulations of therapeutic agents. Our product pipeline includes prescription drug and medical food product candidates that are being developed in partnership or internally.

Our core business strategy is to build new, high-value partnerships and continue to expand upon existing partnerships, optimize Eligen B12™’s economic value to shareholders, evaluate commercial opportunities for new prescription medical foods, and promote new uses for our Eligen ® Technology, a broadly applicable proprietary oral drug delivery platform which makes it possible to avoid injections for drug administration. Our development efforts are conducted internally and in collaboration with corporate development partners. Typically, the drugs that we target are at an advanced stage of development, or have already received regulatory approval, and are currently available on the market. Our website is www.emisphere.com . The contents of this website are not incorporated herein by reference. Investor related questions should be directed to info@emisphere.com .

Emisphere was originally founded as Clinical Technologies Associates, Inc. in 1986 and is listed for trading on the Over-the-Counter Bulletin Board (the “OTCBB”), an electronic quotation service maintained by the Financial Industry Regulatory Authority, and is trading under the symbol EMIS (or EMIS.OB for certain stock quote publication websites).

The Eligen ® Technology

The Eligen ® Technology is a broadly applicable proprietary oral drug delivery technology based on the use of proprietary synthetic chemical compounds known as Eligen ® delivery agents, or carriers. These carriers facilitate and enable the transport of therapeutic macromolecules (such as proteins, peptides, and polysaccharides) and poorly absorbed small molecules across biological membranes such as those of the

 

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gastrointestinal tract. These molecules are typically delivered by injection, and in many cases their benefits are limited due to poor bioavailability, slow on-set of action or variable absorption. The Eligen ® Technology facilitates absorption and may improve bioavailability. Moreover, it acts rapidly in the upper sections of the gastrointestinal tract where absorption is thought to occur. Using Eligen ® Technology, most therapeutic macromolecules reach the general circulation in less than an hour post-dose, which can limit enzymatic degradation that typically affects macromolecules and may be advantageous in cases where time to onset of action is important (i.e. analgesics). The Eligen ® technology is distinguished from competitive technologies in that absorption takes place through a transcellular pathway, as opposed to passing between cells, preserving the integrity of the tight junctions within the cell walls and reducing the likelihood of inflammatory processes and autoimmune gastrointestinal diseases. Furthermore, Eligen ® Technology carriers are rapidly absorbed, distributed, metabolized and eliminated from the body, and they do not accumulate in the organs and tissues and are considered safe at anticipated doses and dosing regimens. Drugs or nutritional supplements whose bioavailability is limited by poor membrane permeability or chemical or biological degradation, and which have a moderate-to-wide therapeutic index, appear to be the best candidates for use with the Eligen ® Technology. Drugs with a narrow therapeutic window or high molecular weight may not work favorably with the technology. The Eligen ® Technology can be applied to the oral route of administration as well as other delivery pathways, such as buccal, rectal, inhalation, intra-vaginal or transdermal. Implementing the Eligen ® Technology requires co-formulating a drug or nutritional supplement and an Eligen ® carrier to produce an effective formulation. The carrier does not alter the chemical properties of the drug nor its biological activity.

Results from two clinical studies published by F. Hoffmann-La Roche Ltd illustrate important safety characteristics of Emisphere’s Eligen ® Technology. These studies were performed with a novel oral formulation of ibandronate (a drug used to prevent and treat osteoporosis) with Emisphere’s SNAC carrier, an Eligen ® Technology compound. The first study (J Drug Del Technol 2011; 21: 521-5) showed that the SNAC carrier must be co-formulated, and not simply co-dosed, with ibandronate in order to increase ibandronate bioavailability. The second study (Arnzelmittelforschung 2011; 61:707-13) demonstrated that co-dosing of a SNAC/ibandronate formulation with metformin, a drug widely used in Type 2 Diabetes patients, did not influence the absorption of metformin. Together, these studies support the hypothesis that Eligen ® Technology facilitates oral absorption only when co-formulated with the intended active ingredient, and that co-dosing with other ingredients should not result in accidental or incidental absorption of unintended ingredients.

Another important safety characteristic of the Eligen ® Technology was demonstrated by the results of three clinical safety studies conducted by Novartis International AG with the former osteoporosis and osteoarthritis treatment candidate SMC021. SMC021 used Emisphere’s permeation enhancer 5-CNAC, an Eligen ® Technology compound, in combination with salmon calcitonin (“SCT”). These studies addressed the potential for SMC021 drug interaction with several widely used drugs and found, in each case, no evidence to indicate a safety concern for drug interaction. Scientific posters describing the results of these clinical studies were presented at the annual meeting of the American Society of Clinical Pharmacology and Therapeutics on March 17, 2012. The first study ( The effect of esomeprazole on the pharmacokinetics and pharmacodynamics of SMC021 in healthy volunteers. Choi L et al.) concluded that pre-treatment with a proton pump inhibitor, esomeprazole, decreased SCT exposure by approximately 30% without impacting the pharmacodynamic response to SCT. The second study ( Pharmacokinetic interaction assessment between SMC021 and ibuprofen and between SMC021 and acetaminophen. Choi L et al.) concluded that ibuprofen and acetaminophen did not significantly alter the pharmacokinetics of SMC021 when used jointly with either of these analgesics. The third study ( Pharmacokinetic interaction assessment between SMC021 and rosiglitazone. Choi L et al.) concluded that SMC021 did not inhibit the drug metabolizing enzyme CYP2C8 when SMC021 and rosiglitazone, a Type II diabetes drug metabolized by CYP2C8, were administered together at expected clinical doses. Together, these studies support the hypothesis that Eligen ® Technology does not pose a safety risk for drug interaction.

In May 2009, our Eligen ® carrier, monosodium N-[8-(2-hydroxybenzoyl) amino] caprylate (SNAC), following a comprehensive evaluation of research and toxicology data, SNAC was found to be safe at a dosage up to 250 mg per day when used in combination with nutrients to improve their dietary availability. In July 2009, concurrent with the publication of two papers in the July/August issue of the peer reviewed journal, International Journal of Toxicology , which describes the toxicology of SNAC, SNAC received GRAS status for its intended

 

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use in combination with nutrients added to food and dietary supplements. Since SNAC achieved GRAS status, it is exempt from pre-market approval for its intended use in combination with nutrients added to food and dietary supplements. Our partner, Novo Nordisk, is using SNAC in combination with its proprietary GLP-1 analog, semaglutide, in Phase 3 testing of an oral formulation. In connection with the development of its oral semaglutide product, Novo Nordisk has successfully concluded extensive safety testing on the SNAC molecule, alone and in combination with semaglutide.

Based on extensive study by our partners and our scientists, senior management and expert consultants, we believe that our technology can enhance overall healthcare, including patient accessibility and compliance, while benefiting the commercial pharmaceutical marketplace and driving company valuation. The application of the Eligen ® Technology is potentially broad and may provide for a number of opportunities across a spectrum of therapeutic modalities.

Emisphere Today

Mr. Alan L. Rubino, the Company’s President and Chief Executive Officer, and Mr. Timothy G. Rothwell, its Chairman of the Board of Directors, are seasoned industry executives with major and emerging pharmaceutical company experience who form the core of a leadership team that will implement the Company’s strategic plans. To that end, we have sought to expand opportunities with existing partners and will continue to work to expand and explore product development, and licensing partnerships

We conducted a limited pilot launch of oral Eligen B12™ as an Rx medical food therapeutic in March 2015 to positive physician and patient reception. From the start, we have continuously evaluated the product’s sales performance and uptake in light of our current commercial and financial resources as well as the changing CMS guidelines for medical food products and the reimbursement environment. As a result, we determined that a strategic transaction or collaboration with a third party that possesses the requisite marketing power and resources would be necessary for the product to reach its full market potential in the United States and internationally. Simultaneously, during the fourth quarter 2015, we were approached by several major pharmaceutical and consumer healthcare companies expressing interest in licensing or acquiring our now on-the-market Eligen B12™ product. As a result, we have concluded that we should evaluate strategic transactions and collaborations with these potential suitors in order to optimize shareholder value. These developments have also led to our decision to phase-out our small contract field force and re-prioritize our marketing resources towards more efficient non-field force maintenance promotion. Our core business strategy remains to continue building new, high-value partnerships and expand upon existing partnerships, optimize Eligen B12™’s economic value, evaluate commercial opportunities for new products, and promote new uses for our Eligen ® Technology.

Product Pipeline

GLP-1

Our most advanced collaborative partner, Novo Nordisk, is using our Eligen ® Technology in combination with semaglutide, one of its proprietary GLP-1 receptor agonists, and its insulins. During 2015, Novo Nordisk initiated a global Phase 3a development program with oral semaglutide, a once daily oral formulation of the long-acting GLP-1 analog for the treatment of Type 2 diabetes, using our absorption-enhancing carrier, monosodium N-[8-(2-hydroxybenzoyl) amino] caprylate (our “SNAC” carrier). Novo Nordisk initiated ten clinical trials containing approximately 9,300 patients with Type-2 diabetes in its global Phase 3a program. Novo Nordisk’s decision to initiate this global phase 3a program follows encouraging results from the proof of concept Phase 2 program and consultations with regulatory authorities. In February 2016, Novo Nordisk initiated the first Phase 3a trial or oral semaglutide, combined with our SNAC carrier. Novo Nordisk has now initiated all 10 clinical trials, including PIONEER 6 (a pre-approval long term cardiovascular outcomes trial in approximately 3,100 subjects), PIONEER 8 (an insulin add-on trial in approximately 700 subjects), PIONEER 9 (a monotherapy trial in approximately 200 subjects) and PIONEER 10 (an oral anti-diabetic combination trial in approximately 300 subjects). The advancement of oral semaglutide into Phase 3a development represents a significant milestone for our Eligen ® Technology platform and supports our belief that products developed using our carriers have the potential to overcome bioavailability challenges commonly associated with the oral administration of peptides and certain other compounds.

 

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Under the GLP-1 License Agreement, Emisphere could receive additional contingent product development and sales milestone payments and would also be entitled to receive royalties in the event Novo Nordisk commercializes products developed under such Agreement. Under the GLP-1 License Agreement, Novo Nordisk is responsible for the development and commercialization of the products.

On October 14, 2015, we also entered into a new Development and License Agreement with Novo Nordisk (the “Expansion License Agreement”) to develop and commercialize oral formulations of four classes of Novo Nordisk’s investigational molecules targeting major metabolic disorders, including diabetes and obesity, using our oral Eligen ® Technology. Under the terms of the Expansion License Agreement, we licensed to Novo Nordisk the exclusive right to develop potential product candidates in three molecule classes, and the non-exclusive right to develop potential product candidates in a fourth molecule class, using the Eligen ® Technology.

We have also collaborated with Novartis in connection with the development and testing of oral formulations of several drug candidates. Novartis has the right to evaluate the feasibility of using Emisphere’s Eligen ® carriers with two new compounds to assess the potential for new product development opportunities. Novartis is considering its options accordingly. If Novartis chooses to develop oral formulations of these new compounds using Eligen ® carriers, the parties will negotiate additional agreements. Development-stage product candidates incorporating our Eligen ® technology are in earlier or preclinical research phases, and we continue to assess them for their compatibility with our technology and market need. Our intent is to seek partnerships with pharmaceutical and biotechnology companies for certain of these products as we continue to expand our pipeline with product candidates that demonstrate significant opportunities for growth. Our focus is on molecules that meet the criteria for success based on our increased understanding of our Eligen ® Technology and prescription medical foods. Our preclinical programs focus on the development of oral formulations of potentially new treatments for diabetes and products in the areas of cardiovascular, appetite suppression and pain and on the development and potential expansion of nutritional supplement products.

We will continue to concentrate on expanding our Eligen ® drug delivery technology business by seeking applications with prescription molecules obtained through partnerships with other pharmaceutical companies for molecules where oral absorption is difficult yet substantially beneficial if proven. We are also working to generate new interest in the Eligen ® Technology with potential partners and attempting to expand our current collaborative relationships to take advantage of the critical knowledge that others have gained by working with our technology. Finally, we continue to pursue the development of product candidates developed internally. We believe that these internal candidates need to be developed with reasonable investment in an acceptable time period and with a reasonable risk-benefit profile.

We recognize, however, that further development, exploration and commercialization of our technology entails substantial risk and requires significant operational expenditures. We continue to refocus our efforts on strategic development initiatives to reduce non-strategic spending aggressively, and seek to obtain the funding necessary to implement our new corporate strategy. There can be no assurances, however, that the Company will be able to secure adequate funding to meet its current obligations and successfully pursue its strategic direction. Furthermore, despite our optimism regarding the Eligen ® Technology and the commercialization of oral Eligen B12™ Rx, even in the event that the Company is adequately funded, there is no guarantee that any of our products or product candidates will perform as hoped or that such products can be successfully commercialized. For further discussion, see Part II, Item 1A “ Risk Factors.

Oral Eligen B12™ Rx

We are evaluating potential strategic transactions and collaborations with third parties for oral Eligen B12™ Rx, which we launched in the U.S. in March 2015. Oral Eligen B12™ Rx is the first and only once-daily oral prescription medical food tablet shown to normalize B12 levels without the need for an injection. Medical foods are a distinct product category defined by the Orphan Drug Act of 1988 and an FDA regulation, and encompass foods which are formulated to be consumed or administered enterally under the supervision of a physician and which are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Eligen B12™ meets significant unmet patient and medical needs by combining vitamin B12 with our Eligen ® technology. Eligen B12™ Rx is indicated for the dietary management of patients who have a medically-diagnosed vitamin

 

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B12 deficiency, associated with a disease or condition that cannot be managed by a modification of the normal diet alone. Eligen B12™ is the first prescription product to market using an Eligen ® carrier, SNAC, to chaperone B12 through the gastric lining and directly into the bloodstream independent of intrinsic factor, a protein made in the stomach that normally facilitates B12 absorption.

During the fourth quarter of 2010, we completed a clinical trial which demonstrated that both oral Eligen B12™ Rx (1000 mcg) and injectable B12 (current standard of care) can efficiently and quickly restore normal Vitamin B12 levels in deficient individuals. The manuscript summarizing the results from that clinical trial was published in the July 2011 edition of the journal Clinical Therapeutics (Volume 22, pages 934 — 945). We also conducted market research to help assess the potential commercial opportunity for our oral Eligen B12™ Rx (1000 mcg) product.

Vitamin B12 is an important nutrient that is poorly absorbed in the oral form. In most healthy people, Vitamin B12 is absorbed in a receptor-mediated pathway in the presence of an intrinsic factor. A large number of people take oral B12 supplements, many in mega-doses, and by injection. Currently, it is estimated that at least five million people in the U.S. are taking 40 million injections of Vitamin B12 per year to treat a variety of debilitating medical conditions. Another estimated five million people are consuming more than 600 million tablets of Vitamin B12 orally. The international market is larger than the U.S. market. Many B12 deficient patients suffer from pernicious anemia and neurological disorders and many of them are infirm or elderly. Vitamin B12 deficiency can cause severe and irreversible damage, especially to the brain and nervous system. At levels only slightly lower than normal, a variety of symptoms such as fatigue, depression, and poor memory may occur.

The data from our first pharmacokinetic study of our new Vitamin B12 formulation showed mean Vitamin B12 peak blood levels were more than 10 times higher for the Eligen B12™ Rx 5mg formulation than for the 5mg commercial formulation. The mean time to reach peak concentration (T max) was reduced by over 90%, to 0.5 hours for the Eligen B12™ Rx 5mg from 6.8 hours for the commercial 5mg product. Improvement in bioavailability, the fraction of an administered dose of unchanged drug that reaches systemic circulation, was approximately 240%, with absorption time at 30 minutes and a mean bioavailability of 5%. The study was conducted with a single administration of Eligen ® B12. There were no adverse reactions, and Eligen B12™ Rx was well-tolerated.

On August 5, 2011, we received notice from the United States Patent Office that the U.S. patent application directed to the Eligen B12™ formulation was allowed. This new patent (US 8,022,048) provides intellectual property protection for Eligen B12™ \ through approximately October 2029.

Novo Nordisk Partnership

Novo Nordisk’s Phase III Programs

Novo Nordisk has recently begun Phase III clinical development of its GLP-1 analog, oral-semaglutide, for the treatment of Type-2 diabetes. Novo Nordisk’s oral semaglutide is a product candidate which uses Emisphere’s SNAC carrier to facilitate absorption. GLP-1 is a natural hormone involved in controlling blood sugar levels. It stimulates the release of insulin only when blood sugar levels become too high. GLP-1 secretion is often impaired in people with Type 2 diabetes. Emisphere had previously conducted extensive tests on native insulin and native GLP-1which demonstrated that both macromolecules can be effectively delivered using the Eligen ® Technology. With the progress that has been made in the development of second generation proteins, we concluded that a more productive pathway is to move forward with GLP-1 analogs, an oral form of which might be used to treat Type 2 diabetes and related conditions. Our research indicated that the development of oral formulations of Novo Nordisk proprietary GLP-1 receptor agonists may represent an opportunity for Emisphere. Consequently, on June 21, 2008, we entered into an exclusive Development and License Agreement with Novo Nordisk focused on the development of oral formulations of Novo Nordisk’s proprietary GLP-1 receptor agonists (the “GLP-1 License Agreement). Emisphere has received approximately $32.6 million as of December 31, 2016, under the GLP-1 License Agreement, and could receive up to an additional $60 million in contingent product development and sales milestone payments, as well as receive royalties on sales in the event Novo Nordisk commercializes products developed under the GLP-1 License Agreement. Under the terms of the

 

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agreement, Novo Nordisk is responsible for the development and commercialization of the products. On February 20, 2015, following the successful completion of its Phase 2 trials, Novo Nordisk highlighted positive Phase 2 data pertaining to OG217SC, the oral formulation of semaglutide, a long-acting human GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. OG217SC is provided in a tablet formulation with Emisphere’s absorption-enhancing excipient, SNAC. Novo Nordisk announced that it has successfully completed the phase 2 trial for OG217SC, investigating dose range, escalation, efficacy and safety of once-daily oral semaglutide compared with oral placebo or once-weekly subcutaneously administered semaglutide in around 600 people with type 2 diabetes treated for 26 weeks.

On August 26, 2015, Novo Nordisk announced that it will initiate a global Phase 3a development program with oral semaglutide, and SNAC and in February 2016, Novo Nordisk initiated the first Phase 3a trial of oral semaglutide, an oral formulation of Novo Nordisk’s long-acting GLP-1 analogue semaglutide using Emisphere Eligen ® Technology. Novo Nordisk has now initiated all clinical trials, including PIONEER 6 (a pre-approval long-term cardiovascular outcomes trial in approximately 3,100 people), PIONEER 8 (an insulin add-on trial in approximately 700 people), PIONEER 9 (a monotherapy trial I napproximately 200 Japanese people) and PIONEER 10 (an oral anti-diabetic combination trial in approximately 300 Japanese people). Novo Nordisk’s decision to initiate this global phase 3a program follows encouraging results from the proof of concept Phase 2 program and consultations with regulatory authorities. The advancement of oral semaglutide into Phase 3a development represents a significant milestone for our Eligen ® Technology platform and supports our belief that products developed using our carriers have the potential to overcome bioavailability challenges commonly associated with the oral administration of peptides and certain other compounds.

On October 14, 2015, we amended the GLP-1 License Agreement for a third time to provide for, among other things, a payment of $9.0 million to us from Novo Nordisk as prepayment of a product development milestone and in exchange for a reduction in certain future royalty payments. On April 26, 2013, we amended the GLP-1 License Agreement for a second time to provide for, among other things, for a payment of $10 million from Novo Nordisk to the Company as a prepayment for the achievement of certain development milestones that would have otherwise become payable to the Company under the Development Agreement in exchange for a reduction in the rate of potential future royalty payments as provided in the Development Agreement.

Preclinical Programs

On October 14, 2015, we entered into a new Development and License Agreement with Novo Nordisk (the “Expansion License Agreement”) to develop and commercialize oral formulations of four classes of Novo Nordisk’s investigational molecules targeting major metabolic disorders, including diabetes and obesity, using our oral Eligen ® Technology. Under the terms of the Expansion License Agreement, we licensed to Novo Nordisk the exclusive right to develop potential product candidates in three molecule classes, and the non-exclusive right to develop potential product candidates in a fourth molecule class, using the Eligen ® Technology. Pursuant to the Expansion License Agreement, we received a $5.0 million upfront licensing fee, and are eligible to receive up to $62.5 million in development and sales milestone payments for each of the three exclusively licensed molecule classes, and up to $20 million in development milestone payments for the non-exclusively licensed molecule class. Additionally, we are eligible to receive royalties on sales of each successfully commercialized product. Novo Nordisk is solely responsible for the development and commercialization of all product candidates. In addition, Emisphere granted Novo Nordisk the option to obtain exclusive and non-exclusive rights to develop and commercialize oral formulations of additional investigational molecules for the treatment of diabetes, obesity, and indications in other important therapeutic areas using the Eligen ® Technology. If Novo Nordisk exercises its option to develop and commercialize any additional investigational molecules, we would be entitled to receive an additional payment upon the exercise of each option for exclusive or non-exclusive development rights for each molecule class. We are eligible to receive up to $62.5 million in development and sales milestone payments for each additional exclusively licensed molecule class, and up to $20 million in development milestone payments for each additional non-exclusively licensed molecule class, plus royalties on sales of each commercialized product. The Expansion License Agreement remains in effect, on a country-by-country basis, for the longer of 10 years from the date of first sale of a licensed product in such country, or the date of expiration of the last-to-expire patent covered by the Expansion License Agreement in

 

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such country. Novo Nordisk may terminate the Expansion License Agreement with 90 days prior notice. We may terminate the Expansion License Agreement in the event that Novo Nordisk challenges the validity of any licensed patent under the agreement, but only with respect to the patents belonging to the patent family of the challenged patent. Either party may also terminate the Expansion License Agreement upon the other party’s material breach, if not cured within a specified period of time. Upon a termination of the Expansion License Agreement by Emisphere for Novo Nordisk’s breach, all intellectual property rights conveyed under the Expansion License Agreement shall revert back to us.

Our other product candidates in development are in earlier or preclinical research phases, and we continue to assess them for their compatibility with our technology and market need. Some of these pre-clinical projects are partnered and others were initiated and are being pursued internally by the Company. Our intent is to seek partnerships with pharmaceutical and biotechnology companies for certain of these products as we continue to expand the use of our Eligen ® Technology with product candidates that demonstrate significant opportunities for growth. Our preclinical programs focus on the development of oral formulations of potentially new treatments for diabetes and products in the areas of cardiovascular, appetite suppression and pain and on the development and potential expansion of nutritional supplement products.

Business Financing

Since our inception in 1986, we have generated significant losses from operations and we anticipate that we will continue to generate significant losses from operations for the foreseeable future. We have limited capital resources and operations to date have been funded with the proceeds from collaborative research agreements, public and private equity and debt financings and income earned on investments.

As of December 31, 2016, our accumulated deficit was approximately $564.6 million. Our loss from operations was $7.8 million, $18.1 million and $9.3 million for the years ended December 31, 2016, 2015 and 2014, respectively. Our net loss was $10.0 million, $40.4 million and $25.4 million for the years ended December 31, 2016, 2015 and 2014, respectively. Our net cash outlays from operations were $6.8 million, $2.8 million and $8.4 million for the years ended December 31, 2016, 2015 and 2014, respectively. Our stockholders’ deficit was $161.4 million and $151.9 million as of December 31, 2016 and 2015, respectively. On December 31, 2016 we had approximately $6.1 million of cash.

As of December 31, 2016, our obligations included approximately $53.0 million (face value) under our Second Amended and Restated Convertible Promissory Notes (the “Convertible Notes”), approximately $26.0 million (face value) under a loan agreement entered into on August 20, 2014 (the “Loan Agreement”), approximately $0.8 million (face value) under our Second Amended and Restated Reimbursement Notes (the “Reimbursement Notes”), and approximately $2.4 million (face value) under our Second Amended and Restated Bridge Notes (the “Bridge Notes”).

On October 26, 2015, we received a total payment of $14 million from Novo Nordisk pursuant to, and consisting of, $5 million as payment for entry into the Expansion License Agreement and $9 million as payment in connection with the third amendment to the GLP-1 License Agreement.

Under terms of its loan agreements, the Company was obligated to pre-pay certain loans and notes using 50% of any extraordinary receipts, such as the $14 million received from Novo Nordisk. On December 8, 2016, we entered into various agreements whereby, among other things, the creditors under our Loan Agreement and Convertible Notes agreed to waive any event of default resulting from our failure to satisfy specified net sales milestones for Eligen B12™ for the 2016 fiscal year and for all future periods specified in the Loan Agreement and Convertible Notes. The creditor also agreed to irrecovably waive the Company’s obligation to pre-pay $7 million of certain loans and notes resulting from the $14 million cash receipt from Novo Nordisk.

Management has concluded that due to the conditions described above, there is substantial doubt about the entity’s ability to continue as a going concern through March 30, 2018. We have evaluated the significance of the conditions in relation to our ability to meet our obligations and believe that our current cash balance will provide sufficient capital to continue operations through approximately March 2018. While our plan is to raise capital from commercial operations and/or product partnering opportunities to address our capital deficiencies and meet

 

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our operating cash requirements, there is no assurance that our plans will be successful. If we fail to generate sufficient capital from commercial operations or partnerships, we will need to seek capital from other sources and risk default under the terms of our existing loans. We cannot assure you that financing will be available on favorable terms or at all. Furthermore, despite our optimism regarding the Eligen ® Technology, even in the event that the Company is adequately funded, there is no guarantee that any of our products or product candidates will perform as hoped or that such products can be successfully commercialized. For further discussion, see Part I, Item 1A “Risk Factors.”

Overview of the Drug Delivery Industry

The drug delivery industry develops technologies for the improved administration of therapeutic molecules with the goal of expanding markets for existing products and extending drug franchises. Drug delivery companies also seek to develop products on their own that would be patent-protected by applying proprietary technologies to off-patent pharmaceutical products. Primarily, drug delivery technologies are focused on improving safety, efficacy, ease of patient use and/or patient compliance. Pharmaceutical and biotechnology companies consider improved drug delivery as a means of gaining competitive advantage over their peers.

Therapeutic macromolecules, of which proteins are the largest sub-class, are prime targets for the drug delivery industry for a number of reasons. Most therapeutic macromolecules must currently be administered by injection (most common) or other device such as an inhaler or nasal spray system. Many of these compounds address large markets for which there is an established medical need. These drugs are widely used, as physicians are familiar with them and accustomed to prescribing them. However, therapeutic macromolecules could be significantly enhanced through alternative delivery. These medicines are comprised of proteins and other large or highly charged molecules (carbohydrates, peptides, ribonucleic acids) that, if orally administered using traditional oral delivery methods, would degrade in the stomach or intestine before they are absorbed into the bloodstream. Also, these molecules are typically not absorbed following oral administration due to their poor permeability. Therefore, the vast majority are administered parenterally (other than orally or rectally). However, for many reasons, parenteral administration is undesirable, including patient discomfort, inconvenience and risk of infection. Poor patient acceptance of parenteral therapies can lead to medical complications. In addition, parenteral therapies can often require incremental costs associated with administration in hospitals or doctors’ offices.

Previously published research indicates that patient acceptance of and adherence to a dosing regimen is higher for orally delivered medications than it is for non-orally delivered medications. Our business strategy is partly based upon our belief that the development of an efficient and safe oral delivery system for therapeutic macromolecules represents a significant commercial opportunity. We believe that more patients will take orally delivered drugs more often, spurring market expansion.

Leading Current Approaches to Drug Delivery

Transdermal (via the skin) and “Needleless” Injection

The size of most macromolecules makes penetration into or through the skin inefficient or ineffective. Some peptides and proteins can be transported across the skin barrier into the bloodstream using high-pressure “needleless” injection devices. Needleless devices, which inject proteins through the skin into the body, have been in development for many years. We believe these devices have not been well accepted due to patient discomfort, relatively high cost, and the inconvenience of placing the drugs into the device.

Nasal (via the nose)

The nasal route (through the membranes of the nasal passage) of drug administration has been limited by low and variable bioavailability for proteins and peptides. As a result, penetration enhancers often are used with nasal delivery to increase bioavailability. These enhancers may cause local irritation to the nasal tissue and may result in safety concerns with long-term use. A limited number of peptides delivered nasally have been approved for marketing in the U.S., including MIACALCIN ® , developed by Novartis as an osteoporosis therapy, a therapeutic area we have targeted.

 

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Pulmonary (via the lung)

Pulmonary delivery (through the membranes of the lungs) of drugs is emerging as a delivery route for large molecules. Although local delivery of respiratory drugs to the lungs is common, the systemic delivery (i.e., delivery of the drugs to the peripheral vasculature) of macromolecular drugs is less common because it requires new formulations and delivery technologies to achieve efficient, safe and reproducible dosing. Only one protein using pulmonary delivery has been approved for marketing in the U.S., which is EXUBERA ® , an insulin product developed by Pfizer and Nektar, as a diabetes therapy, a therapeutic area we have targeted. However, after market acceptance of EXUBERA ® was demonstrated to be limited, Pfizer withdrew from further commercialization of, and terminated its license with Nektar for, EXUBERA ® .

Intraoral (via the membranes in the mouth)

Intraoral delivery is also emerging as a delivery route for large molecules. Buccal delivery (through the membrane of the cheek) and sublingual delivery (through the membrane under the tongue) are forms of intraoral delivery. Some Vitamin B12 manufacturers sell and distribute sublingual versions of their product.

Oral (via the mouth)

We believe that the oral method of administration is the most patient-friendly option, in that it offers convenience, is a familiar method of administration that enables increased compliance and, for some therapies, may be considered the most physiologically appropriate. We, and other drug delivery and pharmaceutical companies, have developed or are developing technologies for oral delivery of drugs. We believe that our Eligen ® Technology provides an important competitive advantage in the oral route of administration because it does not alter the chemical composition of the therapeutic macromolecules. We have conducted over 140,000 human dosings and have witnessed no serious adverse events that can be attributed to the EMISPHERE ® delivery agents dosed or the mechanism of action of the Eligen ® Technology.

In general, we believe that oral administration will be preferred to other methods of administration. However, such preference may be offset by possible negative attributes of orally administered drugs such as the quantity or frequency of the dosage, the physical size of the capsule or tablet being swallowed or the taste. For example, in our previous Phase III trial with heparin as an oral liquid formulation, patient compliance was hindered by patients’ distaste for the liquid being administered. In addition, patients and the marketplace will more likely respond favorably to improvements in absorption, efficacy, safety, or other attributes of therapeutic molecules. It is possible that greater convenience alone may not lead to success.

Collaborative and Commercial Agreements

We are a party to certain collaborative and commercial agreements with corporate partners to provide development and commercialization services relating to our products and technology. Our collaborative agreements are in the form of research and development collaborations and licensing agreements. Under these agreements, we have granted licenses or the rights to obtain licenses to our oral drug delivery technology. In return, we are entitled to receive certain payments upon the achievement of milestones and royalties on the sales of the products should a product ultimately be commercialized. We also are entitled to be reimbursed for certain research and development costs that we incur.

All of our collaborative agreements are subject to termination by our corporate partners, without significant financial penalty to them. Under the terms of these agreements, upon a termination we are entitled to reacquire all rights in our technology at no cost and are free to re-license the technology to other collaborative partners.

inVentiv

Contract Sales Force

During October 2013, we entered into a Master Services Agreement with inVentiv Health Inc. (the “inVentiv MSA”), which was subsequently terminated in March 2016. inVentiv MSA provided a contract sales force that promoted Eligen B12™ and related services. Under the inVentiv MSA we paid fixed monthly fee for services of a general manager, and monthly payments based on the number of individuals comprising the sales

 

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force, fixed fees for the maintenance of the sales force, and performance based fees based on the achievement by the sales force of predefined metrics.

Novo Nordisk A/S

GLP-1 Receptor Agonists Agreement

During June 2008, we entered into the GLP-1 License Agreement with Novo Nordisk, pursuant to which Novo Nordisk will develop and commercialize oral formulations of its proprietary GLP-1 receptor agonists in combination with Emisphere carriers. Under the GLP-1 License Agreement, we may receive more than $87 million in contingent product development and sales milestone payments, including a $10 million non-refundable license fee which was received in June 2008. To date, we have received a total of $32.6 million under the terms of this agreement. Emisphere would also be entitled to receive additional development and sales milestone payments and royalties on sales in the event Novo Nordisk commercializes products developed under such Agreement. Under the GLP-1 License Agreement, Novo Nordisk is responsible for the development and commercialization of the products. See “Phase III Program” above for a description of development activity conducted in connection with the GLP-1 License Agreement, and certain payments made to Emisphere as a result thereof. The agreement remains in effect, on a country-by-country basis, for the longer of 10 years from the date of first sale of a licensed product in such country, or the date of expiration of the last-to-expire patent covered by the agreement in such country, after which time Novo Nordisk will have a fully paid, exclusive license to the licensed product. Novo Nordisk may terminate this agreement with 90 days prior notice. We may terminate this agreement in the event that Novo Nordisk challenges the validity of any licensed patent under the agreement, but only with respect to the patents belonging to the patent family of the challenged patent. Either party may also terminate the agreement upon the other party’s material breach, if not cured within a specified period of time. Upon a termination of the agreement by Emisphere for Novo Nordisk’s breach, all intellectual property rights conveyed under the agreement shall revert back to us; upon a termination by Novo Nordisk for our breach, the licenses granted under the agreement shall remain in effect, subject to Novo Nordisk’s payment obligations under the agreement.

On February 20, 2015 Novo Nordisk announced positive Phase 2 data pertaining to OG217SC, the oral formulation of semaglutide, a long-acting human GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. OG217SC is provided in a tablet formulation with the absorption-enhancing excipient, SNAC. SNAC is an Eligen ® Carrier. Novo Nordisk announced that it has successfully completed the phase 2 trial for OG217SC, investigating dose range, escalation, efficacy and safety of once-daily oral semaglutide compared with oral placebo or once-weekly subcutaneously administered semaglutide in around 600 people with type 2 diabetes treated for 26 weeks. Based on these results, Novo Nordisk announced that it will initiate consultations with regulatory authorities subsequent to which a decision of whether to progress OG217SC into phase 3 development will be made.

The Phase II trial was designed to examine the dose range, escalation and efficacy of oral semaglutide dosed once daily over 26 weeks in subjects with Type 2 diabetes. Phase I development successfully completed with Oral GLP-1, OG217SC (NN9924). During January 2010, we announced that Novo Nordisk had initiated its first Phase I clinical trial with a long-acting oral GLP-1 analog (NN9924). This milestone released a $2 million payment to Emisphere. The first Phase I Trial investigated the safety, tolerability and bioavailability of NN9924 in healthy volunteers. The trial enrolled 155 individuals and was completed in May 2010. Novo Nordisk also conducted a multiple-dose Phase I trial. This multiple-dose trial investigated safety, tolerability, pharmacokinetics and pharmacodynamics of NN9924 in healthy male subjects. The trial enrolled 96 individuals and was completed in July 2011. In May of 2013, Novo Nordisk completed the last of five clinical pharmacology trials investigating the safety, tolerability as well as pharmacokinetic and pharmacodynamic profiles of oral administration of semaglutide tablets, OG217SC. The Phase I program in total comprised 400 healthy volunteers and 10 people with Type 2 diabetes. In the trials, oral semaglutide treatment appeared to be safe and was well-tolerated. The most frequent reported adverse events were mild or moderate in severity and in line with observations from other GLP-1 class treatments with Type 2 diabetes. In a 10-week multiple-dosing trial, oral administration of semaglutide was associated with a statistically significantly larger weight loss than placebo in healthy volunteers and people with Type 2 diabetes. Further, a statistically significant improvement in HbA1c

 

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was observed when compared to placebo treatment in the low number of people with Type 2 diabetes participating in the trial.

On August 26, 2015, Novo Nordisk announced that it will initiate a global Phase 3a development program with oral semaglutide, a once daily oral formulation of the long-acting GLP-1 analog for the treatment of Type 2 diabetes, using our absorption-enhancing carrier, monosodium N-[8-(2-hydroxybenzoyl) amino] caprylate (“SNAC”), which is one of our Eligen ® Technology delivery agents, or “carriers.” Novo Nordisk intends to initiate the Phase 3a program, which will consist of seven trials and approximately 9,300 patients with Type 2 diabetes. Novo Nordisk’s decision to initiate this global phase 3a program follows encouraging results from the proof of concept Phase 2 program and consultations with regulatory authorities. In February 2016, Novo Nordisk initiated the first Phase 3a trial of oral semaglutide, an oral formulation of Novo Nordisk’s long-acting GLP-1 analogue semaglutide using the Emisphere Eligen ® Technology. Novo Nordisk has now initiated all 10 clinical trials, including PIONEER 6 (a pre-approval long term cardiovascular outcomes trial in approcimately 3,100 people), PIONEER 8 (an insulin add-on trial in approximately 700 people), PIONEER 9 (a monotherapy trial in approximately 200 Japanese people) and PIONEER 10 (an oral anti-diabetic combination trial in approximately 300 Japanese people). The advancement of oral semaglutide into Phase 3a development represents a significant milestone for our Eligen ® Technology platform and supports our belief that products developed using our carriers have the potential to overcome bioavailability challenges commonly associated with the oral administration of peptides and certain other compounds.

On October 14, 2015, we amended the GLP-1 License Agreement for a third time to provide for, among other things, a payment of $9.0 million to us from Novo Nordisk as prepayment of a product development milestone and in exchange for a reduction in certain future royalty payments. On April 26, 2013, we amended the GLP-1 License Agreement for a second time to provide for, among other things, for a payment of $10 million from Novo Nordisk to the Company as a prepayment for the achievement of certain development milestones that would have otherwise become payable to the Company under the Development Agreement in exchange for a reduction in the rate of potential future royalty payments as provided in the Development Agreement.

Insulins License Agreement

During December 2010, the Company entered into an exclusive license agreement with Novo Nordisk to develop and commercialize oral formulations of Novo Nordisk’s insulins using Emisphere’s Eligen ® Technology (the “Insulins License Agreement”). The Insulins License Agreement includes $57.5 million in potential product development and sales milestone payments to Emisphere, of which $5 million was paid upon signing, as well as royalties on sales. The agreement remains in effect, on a country-by-country basis, for the longer of 10 years from the date of first sale of a licensed product in such country, or the date of expiration of the last-to-expire patent covered by the agreement in such country. Novo Nordisk may terminate this agreement with 90 days prior notice. We may terminate this agreement in the event that Novo Nordisk challenges the validity of any licensed patent under the agreement, but only with respect to the patents belonging to the patent family of the challenged patent. Either party may also terminate the agreement upon the other party’s material breach, if not cured within a specified period of time. Upon a termination of the agreement by Emisphere for Novo Nordisk’s breach, all intellectual property rights conveyed under the agreement shall revert back to us; upon a termination by Novo Nordisk for our breach, the licenses granted under the agreement shall remain in effect, subject to Novo Nordisk’s payment obligations under the agreement.

This extended partnership with Novo Nordisk has the potential to offer significant new solutions to millions of people with diabetes worldwide and it also serves to further validate our Eligen ® Technology.

Novartis Pharma AG

Oral Salmon Calcitonin Program for Osteoporosis and Osteoarthritis

We entered into a Research Collaboration and Option Agreement, dated as of December 3, 1997, as amended on October 20, 2000 (the “Salmon Calcitonin Option Agreement”) with Novartis to develop an oral form of salmon calcitonin (“sCT”) to treat osteoarthritis and osteoporosis (the “Salmon Calcitonin Program”), which is a hormone that inhibits the bone-tissue resorbing activity of specialized bone cells called osteoclasts,

 

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enabling the bone to retain more of its mass and functionality. During December 2011, Novartis informed the Company that it would not purse further clinical development of the investigational drug SNC021 (oral calcitonin) as a treatment option in osteoarthritis and for post-menopausal osteoporosis and that it would not seek regulatory submission for SMC021 in either indication. Novartis advised te Company that its decision to stop the clinical program of SMC021 in both indications was based on analysis and evaluation of data from three Phase III clinical trials (two in osteoarthritis and one in osteoporosis) conducted by Nordic Bioscience AS, which showed that SMC021 failed to meet key efficacy endpoints in all three trials, despite displaying a favorable safety profile. Although Novartis has not informed Emisphere if its intention to terminate the Salmon Calcitonin Option Agreement and the Salmon Calcitonin License Agreement, in the event that Novartis determined to terminate these agreements, we will reacquire the rights to our technology licensed to Novartis thereunder.

Oral PTH-1-34 Program

We have collaborated with Novartis in connection with the development and testing of oral formulations of PTH-1-34 (“PTH”) to treat osteoarthritis and osteoporosis (the “PTH Program”). On December 1, 2004, we entered into a Research Collaboration Option and License Agreement with Novartis whereby Novartis obtained an option to license our existing technology to develop oral forms of PTH 1-34 (the “PTH Option Agreement”). During March 2006, Novartis exercised its option to the license. During April 2010, we announced that Novartis initiated a second Phase I trial for an oral PTH-1-34 which uses Emisphere’s Eligen ® Technology, and was in development for the treatment of postmenopausal osteoporosis. During June 2011, Novartis informed Emisphere of the results of its recently completed Proof of Concept study for an oral PTH1-34 using Emisphere’s Eligen ® Technology in post-menopausal women with osteoporosis or osteopenia. Novartis informed Emisphere that, although the study confirmed that oral PTH1-34 was both safe and well-tolerated, several clinical endpoints were not met. Based on the data analyzed, Novartis terminated the study and did not anticipate further work on the oral formulation of PTH1-34. Although Novartis has not informed Emisphere of its intention to terminate the PTH Option Agreement in accordance with relevant terms thereunder, Emisphere would reacquire the rights to develop and/or commercialize the product should Novartis so terminate the Agreement.

Research and Development Costs

We have devoted substantially all of our efforts and resources to research and development conducted on our own behalf (self-funded) and in collaborations with corporate partners (partnered). Generally, research and development expenditures are allocated to specific research projects. Due to various uncertainties and risks, including those described in Part 1, Item 1A. “Risk Factors” below, relating to the progress of our product candidates through development stages, clinical trials, regulatory approval, commercialization and market acceptance, it is not possible to accurately predict future spending or time to completion by project or project category.

The following table summarizes research and development spending to date by project category:

 

     Year Ended December 31,      Cumulative
Spending
2016(1)
 
       2016      2015      2014     
     (In thousands)  

Research(2)

   $      $      $ 492      $ 52,681  

Feasibility projects

              52  

Self-funded

            29        201        14,262  

Partnered

                          4,353  

Development projects

              99,592  

Oral heparin (self-funded)

                          99,592  

Oral insulin (self-funded)

                          21,292  

Partnered

                          12,157  

Other(3)

     373        446        435        108,811  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total all projects

   $ 373      $ 475      $ 1,128      $ 313,148  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

 

(1) Cumulative spending from August 1, 1995 through December 31, 2016.

 

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(2) Research is classified as resources expended to expand the ability to create new carriers, to ascertain the mechanisms of action of carriers, and to establish computer based modeling capabilities, prototype formulations, animal models, and in vitro testing capabilities.

 

(3) Other includes indirect costs such as rent, utilities, training, standard supplies and management salaries and benefits.

Patents and Other Forms of Intellectual Property

Our success depends, in part, on our ability to obtain patents, maintain trade secret protection, and operate without infringing the proprietary rights of others (please refer to Part I, Item 1A “ Risk Factors ” for further discussion of how our business will suffer if we cannot adequately protect our patent and proprietary rights”). We seek patent protection on various aspects of our proprietary chemical and pharmaceutical delivery technologies, including the delivery agent compounds and the structures which encompass Emisphere’s delivery agents, their method of preparation, the combination of our compounds with a pharmaceutical, and use of our compounds with therapeutic molecules to treat various disease states. We have patents and patent applications in the U.S. and certain foreign countries. As of March 1, 2017, Emisphere had been granted more than 120 U.S. patents and more than 200 foreign patents. Emisphere also has more than 25 pending U.S. patent applications as well as more than 150 counterpart applications pending in foreign countries.

We intend to file additional patent applications when appropriate and to aggressively prosecute, enforce, and defend our patents and other proprietary technology.

We have five trademarks registered with the U.S. Patent and Trademark Office. They include three registrations for Emisphere ® in connection with drug delivery agents and research and development in the field of drug delivery systems, and two registrations for ELIGEN ® in connection with drug delivery agents and research and development in the field of drug delivery systems.

We also rely on trade secrets, know-how, and continuing innovation in an effort to develop and maintain our competitive position. Patent law relating to the patentability and scope of claims in the biotechnology and pharmaceutical fields is evolving and our patent rights are subject to this additional uncertainty. Others may independently develop similar product candidates or technologies or, if patents are issued to us, design around any products or processes covered by our patents. We expect to continue, when appropriate, to file product and other patent applications with respect to our inventions. However, we may not file any such applications or, if filed, the patents may not be issued. Patents issued to or licensed by us may be infringed by the products or processes of others.

Defense and enforcement of our intellectual property rights can be expensive and time consuming, even if the outcome is favorable to us. It is possible that the patents issued to or licensed to us will be successfully challenged, that a court may find that we are infringing validly issued patents of third parties, or that we may have to alter or discontinue the development of our products or pay licensing fees to take into account patent rights of third parties.

The primary raw materials used in making the delivery agents for our product candidates are readily available in large quantities from multiple sources. In the past we manufactured delivery agents internally using our own facilities on a small scale for research and development purposes and for early stage clinical supplies. We believe that our manufacturing capabilities complied with the FDA’s current Good Manufacturing Practice (“GMP”).

Currently, EMISPHERE ® delivery agents are manufactured by third parties in accordance with GMP regulations. We have identified other commercial manufacturers meeting the FDA’s GMP regulations that have the capability of producing EMISPHERE ® delivery agents and we do not rely on any particular manufacturer to supply us with needed quantities.

Competition

Our success depends in part upon maintaining a competitive position in the development of product candidates and technologies in an evolving field in which developments are expected to continue at a rapid pace.

 

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We compete with other drug delivery, biotechnology and pharmaceutical companies, research organizations, individual scientists and non-profit organizations engaged in the development of alternative drug delivery technologies or new drug research and testing, and with entities developing new drugs that may be orally active. Our product candidates compete against alternative therapies or alternative delivery systems for each of the medical conditions our product candidates address, independent of the means of delivery. Many of our competitors have substantially greater research and development capabilities, experience, marketing, financial and managerial resources than we have. In many cases we rely on our development partners to develop and market our product candidates.

Oral Diabetes Competition — Type 2 Diabetes

In diabetes, there are a number of unmet needs which amplify the need for further product development in the area. There are three main areas of drug therapy, oral anti-diabetes, insulin, and injectable in which companies are attempting to develop innovative products for the treatment of patients.

There are four leading classes for new product development in the area of diabetes. All four seek to take advantage of the potential to improve upon currently available products:

1.  GLP-1 Agonists

2.  Pulmonary Insulin

3.  DPP-IV Inhibitors

4.  PPAR modulators.

The objective of our collaboration with Novo Nordisk is to develop an orally available GLP-1 agonist for the treatment of Type 2 diabetes and potentially obesity. A product with the benefits of glucose control, promotion of weight loss, low risk of hypoglycemia, and other benefits is expected to significantly improve therapeutic options and can be expected to perform as well as or better than the existing competition.

Oral Vitamin B12 Competition

Emisphere’s potential competition in the Vitamin B12 market will depend on the direction the company takes in the development and commercialization of the product. In the event that Emisphere pursues the nutritional supplements market, competition would include a number of companies selling generic Vitamin B12 in a variety of dosage strengths and methods of delivery (e.g., oral, transdermal, nasal, sublingual) many of which have substantial distribution and marketing capabilities that exceed and will likely continue to exceed our own. In addition, our competition is likely to include many sellers, distributors, and others who are in the business of marketing, selling, and promoting multiple vitamins, vitamin-mineral, and specialized vitamin combinations. Many of these competitors are engaged in low cost, high volume operations that could provide substantial market barriers or other obstacles for a higher cost, potentially superior product that has no prior market history.

In order to successfully penetrate the Vitamin B12 medical food market, the Company will need to successfully demonstrate to physicians, nurse-practitioners and payers that an oral dose would be safe, efficacious, readily-accessible and improve compliance. These factors will likely require the Company to engage in a substantial educational and promotional product launch and a marketing outreach initiative, the time, cost, and outcome of which are uncertain.

Competition Summary

Although we believe that our oral formulations, if successful, will likely compete with well-established injectable versions of the same drugs, we believe that we will enjoy a competitive advantage because physicians and patients prefer orally delivered forms of products over injectable forms. Oral forms of products enable improved compliance, and for many programs, the oral form of products enable improved therapeutic regimens.

Government Regulation

Our operations and product candidates under development are subject to extensive regulation by the FDA, other governmental authorities in the U.S. and governmental authorities in other countries.

 

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The duration of the governmental approval process for marketing new pharmaceutical substances, from the commencement of pre-clinical testing to receipt of governmental approval for marketing a new product, varies with the nature of the product and with the country in which such approval is sought. The approval process for new chemical entities could take eight to ten years or more. The process for reformulations of existing drugs is typically shorter, although a combination of an existing drug with a currently unapproved carrier could require extensive testing. In either case, the procedures required to obtain governmental approval to market new drug products will be costly and time-consuming to us and our partners, requiring rigorous testing of the new drug product. Even after such time and effort, regulatory approval may not be obtained for our products.

The steps required before we can market or ship a new human pharmaceutical product commercially in the U.S. include pre-clinical testing, the filing of an Investigational New Drug Application (“IND”) with the FDA, the conduct of clinical trials and the filing with the FDA of either a New Drug Application (“NDA”) for drugs or a Biologic License Application (“BLA”) for biologics.

Prior to conducting the clinical (human) investigations necessary to obtain regulatory approval of marketing of new drugs in the U.S., we must file an IND with the FDA to permit the shipment and use of the drug for investigational purposes. The IND sets forth, in part, the results of pre-clinical (laboratory and animal) toxicology testing and the applicant’s initial Phase I plans for clinical testing. Unless notified that testing may not begin, clinical testing may commence 30 days after filing an IND.

Under FDA regulations, the clinical testing program required for marketing approval of a new drug typically involves three clinical phases. In Phase 1, safety studies are generally conducted on normal, healthy human volunteers to determine the maximum dosages and side effects associated with increasing doses of the substance being tested. Phase 2 studies are conducted on small groups of patients afflicted with a specific disease to gain preliminary evidence of efficacy, including the range of effective doses, and to determine common short-term side effects and risks associated with the substance being tested. Phase 3 involves large-scale trials conducted on disease-afflicted patients to provide statistically significant evidence of efficacy and safety and to provide an adequate basis for product labeling. Frequent reports are required in each phase and if unwarranted hazards to patients are found, the FDA may request modification or discontinuance of clinical testing until further studies have been conducted. The FDA may also require post-approval Phase 4 testing either to meet FDA requirements for additional information as a condition of approval. Our drug product candidates are and will be subjected to each step of this lengthy process from conception to market and many of those candidates are still in the early phases of testing.

Once clinical testing has been completed pursuant to an IND, the applicant files an NDA or BLA with the FDA seeking approval for marketing the drug product. The FDA reviews the NDA or BLA to determine whether the drug is safe, effective, and adequately labeled, and whether the applicant can demonstrate proper and consistent manufacture of the drug. The time required for initial FDA action on an NDA or BLA is set on the basis of user fee goals; for most NDA or BLAs the action date is 10 months from receipt of the NDA or BLA by the FDA. The initial FDA action at the end of the review period may be approval or a request for additional information that will be needed for approval depending on the characteristics of the drug and whether the FDA has concerns with the evidence submitted. Once our product candidates reach this stage, we will be subjected to these additional costs of time and money.

The FDA has different regulations and processes governing and regulating food products, including vitamin supplements and nutraceuticals. These products include “dietary supplements”, “food additives”, “dietary ingredients”, “medical foods”, and, most broadly, “food”. These foods products do not require the IND, NDA or BLA process outlined above. Medical foods, which are defined under the FDA’s 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act, are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. Medical foods are distinct from the broader category of foods for special dietary use and from traditional foods that bear a health claim. In order to be considered a medical food the product must, at a minimum:

 

   

be a food for oral ingestion or tube feeding (nasogastric tube);

 

   

be labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional requirements; and

 

   

be intended to be used under medical supervision. Medical foods require a prescription from a physician.

 

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The facilities of each company involved in the commercial manufacturing, processing, testing, control and labeling of pharmaceutical products must be registered with and approved by the FDA. Continued registration requires compliance with GMP regulations and the FDA conducts periodic establishment inspections to confirm continued compliance with its regulations. We are subject to various federal, state and local laws, regulations and recommendations relating to such matters as laboratory and manufacturing practices and the use, handling and disposal of hazardous or potentially hazardous substances used in connection with our research and development work.

While we do not currently manufacture any commercial products ourselves, if we did, we would bear additional cost of FDA compliance.

In addition, the distribution of prescription pharmaceutical products in the United States is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution and recordkeeping requirements for drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.

We are also subject to various federal and state laws pertaining to health care “fraud and abuse” issues, including anti-kickback laws and false claims laws. Anti-kickback laws make it illegal for a prescription drug manufacturer to solicit, offer, receive, or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescribing of a particular drug. False claims laws prohibit anyone from knowingly and willfully presenting, or causing to be presented for payment to the United States government, including Medicare and Medicaid, claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. We have adopted the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals, which is a voluntary industry code developed to establish standards for interactions with and communications to healthcare professionals and we have adopted processes that we believe enhance compliance with this code and applicable federal and state laws.

Employees

As of December 31, 2016, we had 6 full time employees, and a small group of insourced consultants who perform business development, project management, sales and market planning, logistics and supply chain planning, accounting, information technology, engineering, facilities maintenance, legal and regulatory, IP and administrative functions. Our employees all hold the necessary experience and degrees to the relevant functions outlined above and we are confident that our relationship with all employees is both positive and productive.

Available Information

Emisphere files annual, quarterly, and current reports, proxy statements, and other documents with the Securities and Exchange Commission, (the “SEC”) under the Securities Exchange Act of 1934 as amended (the “Exchange Act”). The public may read and copy any materials that we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. Also, the SEC maintains an internet website that contains reports, proxy and information statements, and other information regarding issuers, including Emisphere, that file electronically with the SEC. The public can obtain any documents that Emisphere files with the SEC at www.sec.gov.

We also make available free of charge on or through our internet website (www.emisphere.com) our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Section 16 filings, and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) or Section 16 of the Exchange Act as soon as reasonably practicable after we or the reporting person electronically files such material with, or furnishes it to, the SEC. Our internet website and the information contained therein or connected thereto are not intended to be incorporated into the Annual Report or this Form 10-K.

Our Board of Directors has adopted a Code of Business Conduct and Ethics which is posted on our website at http://ir.emisphere.com/documentdisplay.cfm?DocumentID=4947 .

 

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ITEM 1A. RISK FACTORS

An investment in our common stock involves a number of very significant risks. You should carefully consider the following risks and uncertainties in addition to other information in this report in evaluating our company and its business before purchasing shares of our company’s common stock. Our business, operating results and financial condition could be seriously harmed due to any of the following risks. You could lose all or part of your investment due to any of these risks.

Risks Related to the Company

We have limited capital resources and significant commitments and obligations.

We have limited capital resources and operations to date have been funded with the proceeds from collaborative research agreements, and debt financings. We anticipate that we will continue to generate significant losses from operations for the foreseeable future, and that our business will require substantial additional investment that we have not yet secured. As such, we anticipate that our existing capital resources will enable us to continue operations through approximately March 2018, or earlier if unforeseen events or circumstances arise that negatively affect our liquidity.

Moreover, as of December 31, 2016, our accumulated deficit was approximately $564.6 million, and our obligations included approximately $82.2 million (face value) under our secured debt obligations.

Management has concluded that due to the conditions described above, there is substantial doubt about the entity’s ability to continue as a going concern through March 30, 2018. We have evaluated the significance of the conditions in relation to our ability to meet our obligations and believe that our current cash balance will provide sufficient capital to continue operations through approximately March 2018. While our plan is to raise capital from commercial operations and/or product partnering opportunities to address our capital deficiencies and meet our operating cash requirements, there is no assurance that our plans will be successful. If we fail to generate sufficient capital from commercial operations or partnerships, we will need to seek capital from other sources and risk default under the terms of our existing loans. We cannot assure you that financing will be available on favorable terms or at all. Furthermore, despite our optimism regarding the Eligen ® Technology, even in the event that the Company is adequately funded, there is no guarantee that any of our products or product candidates will perform as hoped or that such products can be successfully commercialized.

We have a history of operating losses and we may never achieve profitability.

As of December 31, 2016, we had approximately $6.1 million in cash and cash equivalents, approximately $3.2 million in working capital deficiency, a stockholders’ deficit of approximately $161.4 million and an accumulated deficit of approximately $564.6 million. Our operating loss for the twelve months ended December 31, 2016 was approximately $7.8 million. Since our inception in 1986, we have generated significant losses from operations. We anticipate that we will continue to generate significant losses from operations for the foreseeable future, and that our business will require substantial additional investment that we have not yet secured. These conditions raise substantial doubt about our ability to continue as a going concern.

We anticipate that our existing capital resources will enable us to continue operations through approximately March 2018, or earlier if unforeseen events or circumstances arise that negatively affect our liquidity.

While our plan is to raise capital and/or to pursue product partnering opportunities to address our capital deficiencies, we cannot be sure how much we will need to spend in order to develop, market, and manufacture new products and technologies in the future. We expect to continue to spend substantial amounts on research and development, including amounts spent on conducting clinical trials for our product candidates. Further, we will not have sufficient resources to develop fully any new products or technologies unless we are able to raise substantial additional financing or to secure funds from new or existing partners. We cannot assure you that financing will be available when needed, or on favorable terms or at all. The current economic environment combined with a number of other factors pose additional challenges to the Company in securing adequate financing under acceptable terms. If additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities would result in dilution to our existing stockholders.

 

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Additionally, these conditions may increase the costs to raise capital. Our failure to raise capital when needed would adversely affect our business, financial condition, and results of operations, and could force us to reduce or discontinue operations.

We are highly dependent upon collaborative partners to develop and commercialize compounds using our delivery agents.

A key part of our strategy is to form collaborations with pharmaceutical companies for the licensing of our Eligen ® Technology. We currently have active collaborative agreements for products in clinical development with Novo Nordisk.

We negotiate specific ownership rights with respect to the intellectual property developed as a result of the collaboration with each partner. While ownership rights vary from program to program, in general we retain ownership rights to developments relating to our carrier and the collaborator retains rights related to the drug product developed.

Despite our existing agreements, we cannot make any assurances that:

 

   

we will be able to enter into additional collaborative arrangements to develop products utilizing our drug delivery technology;

 

   

any existing or future collaborative arrangements will be sustainable or successful;

 

   

the product candidates in collaborative arrangements will be further developed by partners in a timely fashion;

 

   

any collaborative partner will not infringe upon our intellectual property position in violation of the terms of the collaboration contract; or

 

   

milestones in collaborative agreements will be met and milestone payments will be received.

If we are unable to maintain or enter into new collaborative arrangements with partners, we may be unable to raise sufficient capital to fund our operations.

Our collaborative partners control the clinical development of the drug candidates and may terminate their efforts at will.

Our collaborative agreements with Novo Nordisk and Novartis provide that they control clinical development program and may terminate their programs at will for any reason and without any financial penalty or requirement to fund any further clinical studies. Novartis has discontinued all active clinical programs with us, and we cannot make any assurance that Novo Nordisk will continue to advance the clinical development of the drug candidates subject to collaboration.

Moreover, aside from provisions preventing the unauthorized use of our intellectual property by our collaborative partners, there is nothing in our collaborative agreements that prevent our partners from developing competing products. If one of our partners were to develop a competing product, our collaboration could be substantially jeopardized.

We cannot be sure that our plans for Eligen B12™ will be successful.

We expended substantial resources on the development of an oral dosage form of Vitamin B12 which we market as a medical food for use by B12 deficient individuals. We launched the product in March 2015 and in light of product sales levels, have determined that a strategic transaction or collaboration with a third party for oral Eligen B12™ Rx in the United States and internationally is necessary to optimize the value of the product to the Company and shareholders. Our inability to enter into such a transaction or collaboration, or, if we are unable to do so, to meet our sales targets for the B12 product could have a significant material adverse effect on our business.

 

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Moreover, our ability to meet future payment obligations under the terms of our existing indebtedness, fund continuing operations and business expansion are highly dependent upon our ability to optimize the value of the oral Eligen B12™ product in the U.S. and global markets during 2016 and in future years. We cannot assure you that we will succeed in these efforts as these involve activities (or portions of activities) that we have not previously completed and/or that are out of control. In addition, even if we continue to pursue the commercialization of the product ourselves, Vitamin B12 is available at reasonably low prices both in injections and tablet forms (as well as other forms) through a variety of distributors, sellers, and other sources. We have entered a highly competitive market with limited commercial capability. This outline of risks involved in the commercialization of our B12 product is not exhaustive, but illustrative. For example, it does not include additional competitive, intellectual property, commercial, product liability, and commercial risks involved in a launch of the B12 product candidate outside the U.S. or certain of such risks in the U.S.

We may not be able to meet covenants or financial obligations detailed in certain of our debt obligations.

Our inability to meet any of the terms or covenants contained in our debt obligations could result in increased interest rates and/or accelerated the maturity of certain of these obligations. While we recently received a waiver for, among other things, Eligen B12 sales milestones contained in certain of our credit facilities, there can be no assurance that we will receive any future waivers or that we will satisfy all or any of the terms in our debt obligations. Our debt obligations are secured by a first priority lien on substantially all of our assets, and if we default on our obligations under these obligations, our assets may be foreclosed on and we would be required to cease operations.

We cannot be certain that any product that we or a partner develop will be successfully commercialized.

To be profitable, we or a partner must successfully research, develop, obtain regulatory approval for, manufacture, introduce, market, and distribute our products under development. The time necessary to achieve these goals for any individual pharmaceutical product is long and can be uncertain. Before we or a potential partner can commercialize a pharmaceutical product, pre-clinical (animal) studies and clinical (human) trials must demonstrate that the product is safe and effective for human use for each targeted indication. We have never successfully commercialized a drug or a nonprescription candidate and we cannot be certain that we or our current or future partners will be able to begin, or continue, planned clinical trials for our product candidates, or if we are able, that the product candidates will prove to be safe and will produce their intended effects.

Even if products incorporating our technology are safe and effective, the size of the solid dosage form, taste, and frequency of dosage may impede their acceptance by patients.

A number of companies in the drug delivery, biotechnology, and pharmaceutical industries have suffered significant setbacks in clinical trials, even after showing promising results in earlier studies or trials. Only a small number of research and development programs ultimately result in commercially successful drugs. Favorable results in any pre-clinical study or early clinical trial do not imply that favorable results will ultimately be obtained in future clinical trials. We cannot make any assurance that results of limited animal and human studies are indicative of results that would be achieved in future animal studies or human clinical studies, all or some of which will be required in order for our product candidates incorporating our technology to obtain regulatory approval. Similarly, we cannot assure you that any of product candidates incorporating our technologywill be approved by the FDA. Even if clinical trials or other studies demonstrate safety and effectiveness of any of product candidates incorporating our technology for a specific disease or condition and the necessary regulatory approvals are obtained, the commercial success of any of such product candidates will depend upon their acceptance by patients, the medical community, and third-party payers and on our partners’ ability to successfully manufacture and commercialize such product candidates.

Our future business success depends heavily upon regulatory approvals, which can be difficult and expensive to obtain.

Pre-clinical studies and clinical trials of prescription drugs and biologic product candidates, as well as the manufacturing and marketing of our product candidates, are subject to extensive, costly and rigorous regulation by governmental authorities in the U.S. and other countries. The process of obtaining required approvals from the

 

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FDA and other regulatory authorities often takes many years, is expensive, and can vary significantly based on the type, complexity, and novelty of the product candidates. We cannot assure you that we, or our partners, will meet the applicable regulatory criteria in order to receive the required approvals for manufacturing and marketing any product incorporating our technology. Delays in obtaining regulatory approvals encountered by others with whom we collaborate also could adversely affect our business and prospects. Even if regulatory approval of a product is obtained, the approval may place limitations on the intended uses of the product, and may restrict the way in which we or our partner may market the product.

The regulatory approval process for our drug product candidates presents numerous risks, including:

 

   

Pre-clinical tests and clinical trials can take many years, and require the expenditure of substantial resources. The data obtained from these tests and trials can be susceptible to varying interpretation that could delay, limit or prevent regulatory approval

 

   

Delays or rejections may be encountered during any stage of the regulatory process based upon the failure of the clinical or other data to demonstrate compliance with, or upon the failure of the product to meet, a regulatory agency’s requirements for safety, efficacy, and quality or, in the case of a product seeking an orphan drug indication, because another designee received approval first

 

   

Requirements for approval may become more stringent due to changes in regulatory agency policy or the adoption of new regulations or guidelines

 

   

New guidelines can have an effect on the regulatory decisions made in previous years

 

   

The scope of any regulatory approval, when obtained, may significantly limit the indicated uses for which a product may be marketed and may impose significant limitations in the nature of warnings, precautions, and contraindications that could materially affect the profitability of the drug

 

   

Approved drugs, as well as their manufacturers, are subject to continuing and ongoing review, and discovery of problems with these products or the failure to adhere to manufacturing or quality control requirements may result in restrictions on their manufacture, sale or use or in their withdrawal from the market

 

   

Regulatory authorities and agencies may promulgate additional regulations restricting the sale of our existing and proposed products, and

 

   

Once a product receives marketing approval, the FDA will not permit that the marketing of such product for broader or different indications, or will not grant clearance with respect to separate product applications that represent extensions of our basic technology. In addition, the FDA may withdraw or modify existing clearances in a significant manner or promulgate additional regulations restricting the sale of products

Additionally, we face the risk that competitors may gain FDA approval for a product before we or our partners do. Having a competitor reach the market before us would impede the future commercial success for a product because we believe that the FDA uses heightened standards of approval for products once approval has been granted to a competing product in a particular therapeutic area. We believe that this standard generally limits new approvals to only those products that meet or exceed the standards set by the previously approved product.

We are highly dependent on third parties to manufacture, distribute, and sell our products.

We have hired expertmanufacturing, logistics and customer services vendors to support the commercialization of Eligen B12™. The success of our commercial operations is dependent upon the ability of these vendors to provide a high level of service and support at an economical price. If we fail to attract and retain such professionals or service providers at a reasonable price, or if third parties do not successfully carry out their contractual obligations, meet expected deadlines or conduct our activities in accordance with applicable law and regulatory requirements or our stated specifications, we may not be able to, or may be delayed in our efforts to, successfully execute upon our commercial strategy.

Our business will suffer if we cannot adequately protect our patent and proprietary rights.

Although we have patents covering our drug delivery technology and have applied for additional patents, there can be no assurance that patents applied for will be granted, that patents granted to or acquired by us now or in the future will be valid and enforceable and provide us with meaningful protection from competition, or that

 

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we will possess the financial resources necessary to enforce any of our patents. Also, we cannot be certain that any products that we (or a licensee) or a partner develop will not infringe upon any patent or other intellectual property right of a third party.

We also rely upon trade secrets, know-how, and continuing technological advances to develop and maintain our competitive position. We maintain a policy of requiring employees, scientific advisors, consultants, and collaborators to execute confidentiality and invention assignment agreements upon commencement of a relationship with us. We cannot assure you that these agreements will provide meaningful protection for our trade secrets in the event of unauthorized use or disclosure of such information.

Part of our strategy involves collaborative arrangements with other pharmaceutical companies for the development of new formulations of drugs developed by others and, ultimately, the receipt of royalties on sales of the new formulations of those drugs. These drugs are generally the property of the pharmaceutical companies and may be the subject of patents or patent applications and other rights of protection owned by the pharmaceutical companies. To the extent those patents or other forms of rights expire, become invalid or otherwise ineffective, or to the extent those drugs are covered by patents or other forms of protection owned by third parties, sales of those drugs by the collaborating pharmaceutical company may be restricted, limited, enjoined, or may cease. Accordingly, the potential for royalty revenues to us may be adversely affected.

We may be at risk of having to obtain a license from third parties making proprietary improvements to our technology.

There is a possibility that third parties may make improvements or innovations to our technology in a more expeditious manner than we do. Although we are not aware of any such circumstance related to our product portfolio, should such circumstances arise, we may need to obtain a license from such third party to obtain the benefit of the improvement or innovation. Royalties payable under such a license would reduce our share of total revenue. Such a license may not be available to us at all or on commercially reasonable terms. Although we currently do not know of any circumstances related to our product portfolio which would lead us to believe that a third party has developed any improvements or innovation with respect to our technology, we cannot assure you that such circumstances will not arise in the future. We cannot reasonably determine the cost to us of the effect of being unable to obtain any such license.

We are dependent on third parties to manufacture and test our products.

Currently, we have no long term manufacturing agreements in place and no manufacturing facilities for production of our carriers or any therapeutic compounds being commercialized or under consideration as products. We have no facilities for clinical testing. The success of our self-developed programs is dependent upon securing manufacturing capabilities and contracting with clinical service and other service providers.

The availability of manufacturers is limited by both the capacity of such manufacturers and their regulatory compliance. Among the conditions for FDA approval is the requirement that the prospective manufacturer’s quality control and manufacturing procedures continually conform with the FDA’s current GMP (GMP are regulations established by the FDA that govern the manufacture, processing, packing, storage and testing of drugs intended for human use). In complying with GMP, manufacturers must devote extensive time, money, and effort in the area of production and quality control and quality assurance to maintain full technical compliance. Manufacturing facilities and company records are subject to periodic inspections by the FDA to ensure compliance. If a manufacturing facility is not in substantial compliance with these requirements, regulatory enforcement action may be taken by the FDA, which may include seeking an injunction against shipment of products from the facility and recall of products previously shipped from the facility. Such actions could severely delay our ability to obtain product from that particular source.

The success of our clinical trials and our partnerships is dependent on the proposed or current partner’s capacity and ability to adequately manufacture drug products to meet the proposed demand of each respective market. Any significant delay in obtaining a supply source (which could result from, for example, an FDA determination that such manufacturer does not comply with current GMP) could harm our potential for success. Additionally, if a current manufacturer were to lose its ability to meet our supply demands during a clinical trial, the trial may be delayed or may even need to be abandoned.

 

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The availability and amount of reimbursement for oral Eligen B12™ and any future products, and the manner in which government and private payers may reimburse for our products, are uncertain.

Sales of Eligen B12™ or any of our product candidates will depend in part on the availability of reimbursement from third-party payers such as government health administration authorities, private health insurers and other organizations. The future magnitude of our revenues and profitability, should we continue to commercialize the product ourselves, may be affected by the continuing efforts of governmental and third-party payers to contain or reduce the costs of health care. We cannot predict the effect that private sector or governmental health care reforms may have on our business, and there can be no assurance that any such reforms will not have a material adverse effect on our business, financial condition and results of operations.

In addition, in both the United States and elsewhere, sales of prescription drugs are dependent in part on the availability of reimbursement to the consumer from third-party payers, such as government and private insurance plans. The ability to obtain reimbursement of our products from these parties is a critical factor in the commercial success for any of our products. Failure to obtain reimbursement could result in reduced or no sales of our products.

Third-party payers are increasingly challenging the price and cost-effectiveness of medical products and services. Significant uncertainty exists as to the reimbursement status of newly-approved health care products. There can be no assurance that our products will be considered cost-effective or that adequate third-party reimbursement will be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. Legislation and regulations affecting the pricing of pharmaceuticals may change before any of our products are approved for marketing. Adoption of such legislation could further limit reimbursement for medical products and services.

Current and future legislation may increase the difficulty and cost of commercializing oral Eligen B12™ and our products candidates, affect the prices we may obtain and limit reimbursement amounts.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could restrict or regulate post-approval activities and affect our revenues from future sales of our products.

The Medicare Modernization Act, or MMA, enacted in December 2003, has altered the way in which some physician-administered drugs and biologics are reimbursed by Medicare Part B. Under this reimbursement methodology, physicians are reimbursed based on a product’s “average sales price.” This reimbursement methodology has generally led to lower reimbursement levels. This legislation also added an outpatient prescription drug benefit to Medicare, which went into effect in January 2006. These benefits are provided primarily through private entities, which we expect will attempt to negotiate price concessions from pharmaceutical manufacturers.

The Patient Protection and Affordable Care Act of 2010, or the PPACA, the future of which is uncertain may have a significant impact on the healthcare system. As part of this legislative initiative, Congress enacted a number of provisions that are intended to reduce or limit the growth of healthcare costs, which could significantly change the market for pharmaceuticals and biological products. The provisions of the PPACA could, among other things, increase pressure on drug pricing or make it costlier for patients to gain access to prescription drugs like our product candidates at affordable prices. This could ultimately lead to fewer prescriptions for our product candidates and could force individuals who are prescribed our products to pay significant out-of-pocket costs or pay for the prescription entirely by themselves. As a result of such initiatives, and the market acceptance and commercial success of our products, once approved, may be limited and our business may be harmed.

We may face product liability claims related to participation in clinical trials or future products.

The testing, manufacture, and marketing of products for humans utilizing our drug delivery technology may expose us to potential product liability and other claims. These may be claims directly by consumers or by pharmaceutical companies or others selling our future products. We seek to structure development programs with pharmaceutical companies that would complete the development, manufacturing and marketing of the finished product in a manner that would protect us from such liability, but the indemnity undertakings for product liability claims that we secure from the pharmaceutical companies may prove to be insufficient.

 

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We face rapid technological change and intense competition.

Our success depends, in part, upon maintaining a competitive position in the development of technologies and products in an evolving field in which developments are expected to continue at a rapid pace. We compete with other drug delivery, biotechnology and pharmaceutical companies, research organizations, individual scientists, and non-profit organizations engaged in the development of alternative drug delivery technologies or new drug research and testing, as well as with entities developing new drugs that may be orally active. Many of these competitors have greater research and development capabilities, experience, and marketing, financial, and managerial resources than we have, and, therefore, represent significant competition.

Products using our technology, when developed and marketed, may compete with existing parenteral or other versions of the same drug, some of which are well established in the marketplace and manufactured by formidable competitors, as well as other existing drugs. Moreover, our competitors may succeed in developing competing technologies or obtaining government approval for products before we do. Developments by others may render our product candidates, or the therapeutic macromolecules used in combination with product candidates incorporating our technology, noncompetitive or obsolete. At least one competitor has notified the FDA that it is developing a competing formulation of salmon calcitonin. If our products are marketed, we cannot assure you that they will be preferred to existing drugs or that they will be preferred to or available before other products in development.

If a competitor announces a successful clinical study involving a product that may be competitive with one of our product candidates or an approval by a regulatory agency of the marketing of a competitive product, such announcement may have a material adverse effect on our operations or future prospects resulting from reduced sales of future products that we may wish to bring to market or from an adverse impact on the price of our common stock or our ability to obtain regulatory approval for our product candidates.

We are dependent on our key personnel and if we cannot recruit and retain leaders in our research, development, manufacturing, and commercial organizations, our business will be harmed.

We are dependent on our executive officers. The loss of one or more members of our executive officers or key employees could have an adverse effect on our business, financial condition and results of operations, given their specific knowledge related to our proprietary technology and personal relationships with our pharmaceutical company partners. If we are not able to retain our executive officers, our business may suffer. We do not maintain “key-man” life insurance policies for any of our executive officers.

There is intense competition in the biotechnology industry for qualified scientists and managerial personnel in the development, manufacture, and commercialization of drugs. We may not be able to continue to attract and retain the qualified personnel necessary for developing our business. Additionally, because of the knowledge and experience of our scientific personnel and their specific knowledge with respect to our drug carriers the continued development of our product candidates could be adversely affected by the loss of any significant number of such personnel.

Provisions of our corporate charter documents, Delaware law, and our stockholder rights plan may dissuade potential acquirers, prevent the replacement or removal of our current management and may thereby affect the price of our common stock.

Our Board of Directors has the authority to issue up to 4,000,000 shares of preferred stock and to determine the rights, preferences and privileges of those shares without any further vote or action by our stockholders. Of these 4,000,000 shares, the Board of Directors has the authority to designate that number of shares of Series A Junior Participating Cumulative Preferred Stock (“A Preferred Stock”) as is required under our stockholders rights plan described below. Those shares of preferred stock not designated as A Preferred Stock remain available for future issuance. Rights of holders of common stock may be adversely affected by the rights of the holders of any preferred stock that may be issued in the future.

 

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Provisions of our corporate charter documents, Delaware law and financing agreements may prevent the replacement or removal of our current management and members of our Board of Directors and may thereby affect the price of our common stock.

In connection with the MHR financing transaction in 2005, and after approval by our Board of Directors, Dr. Mark H. Rachesky was appointed to the Board of Directors by MHR (the “MHR Nominee”) and Dr. Michael Weiser was appointed to the Board of Directors by both the majority of our Board of Directors and MHR (the “Mutual Director”), as contemplated by our bylaws and certificate of incorporation. Our certificate of incorporation provides that the MHR Nominee and the Mutual Director may be removed only by the affirmative vote of at least 85% of the shares of common stock outstanding and entitled to vote at an election of directors. Our certificate of incorporation also provides that the MHR Nominee may be replaced only by an individual designated by MHR unless the MHR Nominee has been removed for cause, in which case the MHR Nominee may be replaced only by an individual approved by both a majority of our Board of Directors and MHR. Furthermore, certain amendments to the bylaws and the certificate of incorporation provide that the rights granted to MHR by these amendments may not be amended or repealed without the unanimous vote or unanimous written consent of the Board of Directors or the affirmative vote of the holders of at least 85% of the shares of Common Stock outstanding and entitled to vote at the election of directors. The amendments to the bylaws and the certificate of incorporation will remain in effect as long as MHR holds at least 2% of the shares of fully diluted Common Stock. The amendments to the bylaws and the certificate of incorporation will have the effect of making it more difficult for a third party to gain control of our Board of Directors.

Additional provisions of our certificate of incorporation and bylaws could have the effect of making it more difficult for a third party to acquire a majority of our outstanding voting common stock. These include provisions that classify our Board of Directors, limit the ability of stockholders to take action by written consent, call special meetings, remove a director for cause, amend the bylaws or approve a merger with another company. We are subject to the provisions of Section 203 of the Delaware General Corporation Law which prohibits a publicly-held Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. For purposes of Section 203, a “business combination” includes a merger, asset sale or other transaction resulting in a financial benefit to the interested stockholder, and an “interested stockholder” is a person who, either alone or together with affiliates and associates, owns (or within the past three years, did own) 15% or more of the corporation’s voting stock.

Our stock price has been and may continue to be volatile.

The trading price for our common stock has been and is likely to continue to be highly volatile. The market prices for securities of drug delivery, biotechnology and pharmaceutical companies have historically been highly volatile.

Factors that could adversely affect our stock price include:

 

   

fluctuations in our operating results;

 

   

announcements of partnerships or technological collaborations and announcements of the results or further actions in respect of any partnerships or collaborations, including termination of same;

 

   

innovations or new products by us or our competitors;

 

   

governmental regulation;

 

   

developments in patent or other proprietary rights;

 

   

public concern as to the safety of drugs developed by us or others;

 

   

the results of pre-clinical testing and clinical studies or trials by us, our partners or our competitors;

 

   

litigation;

 

   

general stock market and economic conditions;

 

   

number of shares available for trading (float); and

 

   

inclusion in or dropping from stock indexes.

 

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As of December 31, 2016, our 52-week high and low closing market price for our common stock was $0.87 and $0.47, respectively.

Future sales of common stock or warrants, or the prospect of future sales, may depress our stock price.

Sales of a substantial number of shares of common stock or warrants, or the perception that sales could occur, could adversely affect the market price of our common stock. Additionally, as of December 31, 2016, there were outstanding options to purchase up to 5,180,157 shares of our common stock that are currently exercisable. As of December 31, 2016, 48,868,640 shares of our common stock were issuable upon the conversion of outstanding convertible notes. As of December 31, 2016, there were outstanding warrants to purchase 25,008,082 shares of our stock. The holders of these convertible securities have an opportunity to profit from a rise in the market price of our common stock with a resulting dilution in the interests of the other shareholders. The existence of these securities may adversely affect the terms on which we may be able to obtain additional financing. The weighted average exercise price of issued and outstanding options is $0.67 and the weighted average exercise price of warrants is $0.50, which compares to the $0.60 market price at closing on December 31, 2016. Additionally, there may be additional shares available on the market if we are required to file additional re-sale registration statements on Form S-1, including if MHR exercises its registration rights under its Registration Rights Agreement with the Company dated September 26, 2005.

Because the Company’s common stock is on the OTCQB tier of the OTC Markets, the volume of shares traded and the prices at which such shares trade may result in lower prices than might otherwise exist if our common stock was traded on a national securities exchange.

The Company’s shares are traded on the OTCQB tier of the OTC Markets. Stock traded on the OTCQB tier of the OTC Markets is often less liquid than stock traded on national securities exchanges, not only in terms of the number of shares that can be bought and sold at a given price, but also in terms of delays in the timing of transactions and reduced coverage of the Company by security analysts and media. This may result in lower prices for the Company’s common stock than might otherwise be obtained if the common stock were traded on a national securities exchange, and may also result in a larger spread between the bid and asked prices for the Company’s common stock. There is no guarantee that the Company will ever be able to re-list its common stock on the NASDAQ Capital Market or any other market.

 

ITEM 1B. UNRESOLVED STAFF COMMENTS

None.

 

ITEM 2. PROPERTIES

In November 2012, we entered into a sub-lease agreement with New American Therapeutics, Inc. to lease approximately 4,100 square feet of office space at 4 Becker Farm Road, Suite 103, Roseland, New Jersey, for use as our corporate office beginning February 1, 2013. The sub lease for this corporate office expired on June 30, 2014.

In December 2012, we entered into a lease agreement with 4 Becker SPE LLC to initially lease approximately 2,000 square feet adjacent to the sub-lease office space beginning in December 2012. Upon expiration of the above referenced sub-lease on June 30, 2014, that approximately 4,100 square feet will become “additional premises” included in this lease agreement. This lease for our corporate office is set to expire on June 30, 2017.

 

ITEM 3. LEGAL PROCEEDINGS

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

 

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PART II

 

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

The Company’s securities began trading on the OTCQB, an electronic quotation service maintained by the Financial Industry Regulatory Authority, effective with the open of business on Tuesday, June 9, 2009. The Company’s trading symbol has remained EMIS, however, it is our understanding that, for certain stock quote publication websites, and investors may be required to key EMIS.QB to obtain quotes.

The following table sets forth the range of high and low intra-day sale prices as reported by the OTCQB, electronic quotation service for each period indicated:

 

     High      Low  

2015

     

First quarter

     0.85        0.22  

Second quarter

     0.69        0.35  

Third quarter

     0.90        0.42  

Fourth quarter

     0.75        0.50  

2016

     

First quarter

     0.70        0.46  

Second quarter

     0.91        0.51

Third quarter

     0.80      0.60

Fourth quarter

     0.72        0.57  

2017

     

First quarter (through March 1, 2017)

     0.60        0.40  

As of March 1, 2017 there were 192 stockholders of record, including record owners holding shares on behalf of an indeterminate number of beneficial owners, and 60,687,478 shares of common stock outstanding. The closing price of our common stock on March 1, 2017, was $0.48. We have never paid cash dividends and do not intend to pay cash dividends in the foreseeable future. We intend to retain earnings, if any, to finance the growth of our business.

Equity Compensation Plan Information

The following table provides information as of December 31, 2016, about the common stock that may be issued upon the exercise of options granted to employees, consultants or members of our board of directors under all of our existing equity compensation plans, including the 2000 Stock Option Plan, the 2002 Broad Based Plan, the 2007 Stock Award and Incentive Plan, (collectively the “Plans”), the Stock Incentive Plan for Outside Directors, and the Directors Deferred Compensation Plan:

 

Plan Category

   (a)
Number of
Securities to be
Issued Upon
Exercise of
Outstanding
Options
     (b)
Weighted
Average
Exercise Price
of Outstanding
Options
     (c)
Number of Securities
Remaining Available for
Future Issuance Under
Equity Compensation Plans
(Excluding Securities
Reflected in Column (a))
 

Equity Compensation Plans Approved by Security Holders

        

The Plans

     6,386,833      $ 0.67        2,896,683  

Stock Incentive Plan for Outside Directors

                    
  

 

 

    

 

 

    

 

 

 

Total

     6,386,833      $ 0.67        2,896,683  

 

 

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ITEM 6. SELECTED FINANCIAL DATA

The following selected financial data for the years ended December 31, 2016, 2015, 2014, 2013, and 2012 have been derived from the financial statements of Emisphere and notes thereto, which have been audited by our independent registered public accounting firm.

 

     Year Ended December 31,  
     2016      2015      2014      2013      2012  
     (in thousands, except per share data)  

Net revenue

   $ 1,195      $ 411      $      $      $  

Cost of goods sold

     286        201                       

Write-off of slow moving inventory

     1,214        691                       
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Gross profit (loss)

     (305 )      (481 )                     

Costs and expenses

              

Research and development expenses

     373        475        1,128        836        1,867  

General and administrative expenses

     5,228        5,950        5,968        6,749        4,935  

Selling expenses

     1,923        11,176        2,194                

Other costs and expenses

     12        14        15        19        19  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total costs and expenses

     7,536        17,615        9,305        7,604        6,821  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Operating loss

     (7,841 )      (18,096 )      (9,305 )      (7,604 )      (6,821 )

Other Income

     15        12        10        81        45  

Research and development tax credit

                                  

Change in fair value of derivative instruments

     9,138        (13,916      (11,872      (8,433 )      8,110  

Interest expense related party, net

     (11,353 )      (8,966 )      (6,232 )      (4,955 )      (6,236 )
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Income (loss) before income tax benefit

     (10,041 )      (40,966 )      (27,399 )      (20,911      (4,902

Income tax benefit (expense)

            585        2,019        (28      2,974  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Net income (loss)

     (10,041 )      (40,381 )      (25,380 )      (20,939      (1,928 )

Net income (loss) per share — basic

     (0.17 )      (0.67 )      (0.42 )      (0.35      (0.03 )

Net income (loss) per share — diluted

     (0.17 )      (0.67 )      (0.42 )      (0.35      (0.03 )

 

     December 31,  
     2016      2015      2014      2013      2012  
     (In thousands)  

Balance Sheet Data:

              

Cash, cash equivalents

   $ 6,085      $ 12,898      $ 3,683      $ 4,053      $ 1,484  

Working capital (deficit)

     (3,165 )      (7,081 )      (1,694 )      (1,398 )      (34,745 )

Total assets

     6,584        15,810        5,988        4,979        2,176  

Derivative instruments

     43,194        47,966        29,920        15,909        2,089  

Long-term liabilities and deferrals

     123,411        109,788        86,172        74,146        31,614  

Accumulated deficit

     (564,561 )      (554,520 )      (514,139 )      (488,759 )      (467,820 )

Stockholders’ deficit

     (161,408 )      (151,918 )      (111,950 )      (86,801 )      (66,066 )

 

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Management’s Discussion and Analysis of Financial Conditions and Results of Operations (MD&A) is provided to supplement the accompanying financial statements and notes incorporated herein to help provide an understanding of our financial condition, changes in our financial condition and results of operations. To

 

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supplement its audited financial statements presented in accordance with US GAAP, the company is providing a comparison of operating results describing net income and operating expenses which removed certain non-cash and one-time or nonrecurring charges and receipts. The Company believes that this presentation of net income and operating expense provides useful information to both management and investors concerning the approximate impact of the items above. The Company also believes that considering the effect of these items allows management and investors to better compare the Company’s financial performance from period to period and to better compare the Company’s financial performance with that of its competitors. The presentation of this additional information is not meant to be considered in isolation of, or as a substitute for, results prepared in accordance with US GAAP.

CAUTION CONCERNING FORWARD-LOOKING STATEMENTS

The following discussion and analysis contain forward-looking statements that involve risks and uncertainties. When used in this Report, the words, “intend,” “anticipate,” “believe,” “estimate,” “plan,” “expect” and similar expressions as they relate to us are included to identify forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of factors, including those set forth under Item 1A. “Risk Factors” (above) and elsewhere in this Report. This discussion and analysis should be read in conjunction with the “Selected Financial Data” and the Financial Statements and notes thereto included in this Report.

Overview

Emisphere Technologies, Inc. is a commercial stage pharmaceutical and drug delivery company. We are in partnership with global pharmaceutical companies to develop new formulations of existing products, as well as new chemical entities, using our Eligen ® Technology. We launched our first prescription medical food product, oral Eligen B12™ in the U.S. in March 2015, and we are engaged in strategic discussions to optimize its economic value in the U.S. and global markets. Beyond Eligen B12™, we utilize our proprietary Eligen ® Technology to create new oral formulations of therapeutic agents. Our product pipeline includes prescription drug and medical food product candidates that are being developed in partnership or internally. Our core business strategy is to build new, high-value partnerships and continue to expand upon existing partnerships, optimize Eligen B12™’s economic value, evaluate commercial opportunities for new prescription medical foods, and promote new uses for our Eligen ® Technology.

Eligen ® Technology

We are continuing to develop and expand upon the unique and improved delivery of therapeutic molecules using our Eligen ® Technology. These molecules could be currently available or under development. Such molecules are usually delivered by injection; and, in many cases, their benefits are limited due to poor bioavailability, slow on-set of action or variable absorption. In those cases, our technology may increase the benefit of the therapy by improving bioavailability or absorption or by decreasing time to onset of action. The Eligen ® Technology can be applied to the oral route of administration as well as other delivery pathways, such as buccal, rectal, inhalation, intra-vaginal or transdermal. The Eligen ® Technology makes it possible to deliver certain therapeutic molecules orally without altering their chemical form or biological activity. Eligen ® delivery agents, or “carriers”, facilitate or enable the transport of therapeutic molecules across the mucous membranes of the gastrointestinal tract, to reach the tissues of the body where they can exert their intended pharmacological effect. Our development efforts are conducted internally or in collaboration with corporate development partners. Typically, the drugs that we target are at an advanced stage of development, or have already received regulatory approval, and are currently available on the market.

Eligen ® Technology License Agreements

Our most advanced collaborative partner, Novo Nordisk, is using our Eligen ® Technology in combination with semaglutide, one of its proprietary GLP-1 receptor agonists, and its insulins. During 2015, Novo Nordisk initiated a global Phase 3a development program with oral semaglutide, a once daily oral formulation of the long-acting GLP-1 analog for the treatment of Type 2 diabetes, using our absorption-enhancing carrier, monosodium

 

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N-[8-(2-hydroxybenzoyl) amino] caprylate (our “SNAC” carrier). Novo Nordisk initiated ten clinical trials containing approximately 9,300 patients with Type-2 diabetes in its global Phase 3a program. Novo Nordisk’s decision to initiate this global phase 3a program follows encouraging results from the proof of concept Phase 2 program and consultations with regulatory authorities. In February 2016, Novo Nordisk initiated the first Phase 3a trial of oral semaglutide combined with our SNAC carrier. Novo Nordisk has now initiated all 10 clinical trials, including PIONEER 6 (a pre-approval long term cardiovascular outcomes trial in approximately 3,100 subjects), PIONEER 8 (an insulin add-on trial in approximately 700 subjects), PIONEER 9 (a monotherapy trial in approximately 200 subjects) and PIONEER 10 (an oral anti-diabetic combination trial in approximately 300 subjects). The advancement of oral semaglutide into Phase 3a development represents a significant milestone for our Eligen ® Technology platform and supports our belief that products developed using our carriers have the potential to overcome bioavailability challenges commonly associated with the oral administration of peptides and certain other compounds.

In June 2008, Novo Nordisk and Emisphere entered into the GLP-1 Development and License Agreement (the “GLP-1 License Agreement”) under which Novo Nordisk acquired the right to develop and commercialize oral formulations of its GLP-1 analogs using the Eligen ® Technology. Under the GLP-1 License Agreement, we are eligible to receive product development and sales milestone payments, and royalties on sales in the event Novo Nordisk commercializes products developed under this agreement. In October 2015, we amended the GLP-1 License Agreement to provide for, among other things, a payment of $9.0 million to us from Novo Nordisk as prepayment of a product development milestone in exchange for a reduction in certain future royalty payments.

During October 2015, we also entered into a new Development and License Agreement with Novo Nordisk (the “Expansion License Agreement”) to develop and commercialize oral formulations of four classes of Novo Nordisk’s investigational molecules targeting major metabolic disorders, including diabetes and obesity, using our oral Eligen ® Technology. Under the terms of the Expansion License Agreement, we licensed to Novo Nordisk the exclusive right to develop potential product candidates in three molecule classes, and the non-exclusive right to develop potential product candidates in a fourth molecule class, using the Eligen ® Technology. Pursuant to the Expansion License Agreement, we received a $5.0 million upfront licensing fee, and are eligible to receive up to $62.5 million in development and sales milestone payments for each of the three exclusively licensed molecule classes, and up to $20 million in development milestone payments for the non-exclusively licensed molecule class. Additionally, we are eligible to receive royalties on sales of each successfully commercialized product. Novo Nordisk is solely responsible for the development and commercialization of all product candidates. In addition, Emisphere granted Novo Nordisk the option to obtain exclusive and non-exclusive rights to develop and commercialize oral formulations of additional investigational molecules for the treatment of diabetes, obesity, and indications in other important therapeutic areas using the Eligen ® Technology. If Novo Nordisk exercises its option to develop and commercialize any additional investigational molecules, we would be entitled to receive an additional payment upon the exercise of each option for exclusive or non-exclusive development rights for each molecule class. We are eligible to receive up to $62.5 million in development and sales milestone payments for each additional exclusively licensed molecule class, and up to $20 million in development milestone payments for each additional non-exclusively licensed molecule class, plus royalties on sales of each commercialized product. The agreement remains in effect, on a country-by-country basis, for the longer of 10 years from the date of first sale of a licensed product in such country, or the date of expiration of the last-to-expire patent covered by the agreement in such country. Novo Nordisk may terminate this agreement with 90 days prior notice. We may terminate this agreement in the event that Novo Nordisk challenges the validity of any licensed patent under the agreement, but only with respect to the patents belonging to the patent family of the challenged patent. Either party may also terminate the agreement upon the other party’s material breach, if not cured within a specified period of time. Upon a termination of the agreement by Emisphere for Novo Nordisk’s breach, all intellectual property rights conveyed under the agreement shall revert back to us.

During December 2010, Novo Nordisk also licensed the right to develop and commercialize oral formulations of its insulins using our Eligen ® Technology.

 

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We have also collaborated with Novartis AG in connection with the development and testing of oral formulations of several drug candidates. Novartis has the right to evaluate the feasibility of using our Eligen ® Technology with two new compounds to assess the potential for new product development opportunities. If Novartis chooses to develop oral formulations of these new compounds using the Eligen ® Technology, the parties will negotiate additional agreements. In that case, we could be entitled to receive development milestone and royalty payments in connection with the development and commercialization of these potentially new products. We will continue to concentrate on expanding our Eligen ® drug delivery technology business by seeking applications with prescription molecules obtained through partnerships with other pharmaceutical companies for molecules where oral absorption is difficult yet substantially beneficial if proven. We are also working to generate new interest in the Eligen ® Technology with potential partners and attempting to expand our current collaborative relationships to take advantage of the critical knowledge that others have gained by working with our technology. Finally, we continue to pursue commercialization of product candidates developed internally. We believe that these internal candidates need to be developed with reasonable investment in an acceptable time period and with a reasonable risk-benefit profile.

Oral Eligen B12™ Rx

We are evaluating potential strategic transactions and collaborations with third parties for oral Eligen B12™ Rx, which we launched in the U.S. in March 2015. Oral Eligen B12™ Rx is the first and only once-daily oral prescription medical food tablet shown to normalize B12 levels without the need for an injection. Medical foods are a distinct product category defined by the Orphan Drug Act of 1988 and an FDA regulation, and encompass foods which are formulated to be consumed or administered enterally under the supervision of a physician and which are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Eligen B12™ meets significant unmet patient and medical needs by combining vitamin B12 with our Eligen ® technology. Eligen B12™ Rx is indicated for the dietary management of patients who have a medically-diagnosed vitamin B12 deficiency, associated with a disease or condition that cannot be managed by a modification of the normal diet alone. Eligen B12™ is the first prescription product to market using an Eligen ® carrier, SNAC, to chaperone B12 through the gastric lining and directly into the bloodstream independent of intrinsic factor, a protein made in the stomach that normally facilitates B12 absorption.

During the fourth quarter of 2010, we completed a clinical trial which demonstrated that both oral Eligen B12™ Rx (1000 mcg) and injectable B12 (current standard of care) can efficiently and quickly restore normal Vitamin B12 levels in deficient individuals. The manuscript summarizing the results from that clinical trial was published in the July 2011 edition of the journal Clinical Therapeutics (Volume 22, pages 934 — 945). We also conducted market research to help assess the potential commercial opportunity for our oral Eligen B12™ Rx (1000 mcg) product.

Vitamin B12 is an important nutrient that is poorly absorbed in the oral form. In most healthy people, Vitamin B12 is absorbed in a receptor-mediated pathway in the presence of an intrinsic factor. A large number of people take oral B12 supplements, many in mega-doses, and by injection. Currently, it is estimated that at least five million people in the U.S. are taking 40 million injections of Vitamin B12 per year to treat a variety of debilitating medical conditions. Another estimated five million people are consuming more than 600 million tablets of Vitamin B12 orally. The international market is larger than the U.S. market. Many B12 deficient patients suffer from pernicious anemia and neurological disorders and many of them are infirm or elderly. Vitamin B12 deficiency can cause severe and irreversible damage, especially to the brain and nervous system. At levels only slightly lower than normal, a variety of symptoms such as fatigue, depression, and poor memory may occur.

Development-stage product candidates incorporating our Eligen ® technology are in earlier or preclinical research phases, and we continue to assess them for their compatibility with our technology and market need. Our intent is to seek partnerships with pharmaceutical and biotechnology companies for certain of these products as we continue to expand our pipeline with product candidates that demonstrate significant opportunities for growth. Our focus is on molecules that meet the criteria for success based on our increased understanding of our Eligen ® Technology and prescription medical foods. Our preclinical programs focus on the development of oral

 

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formulations of potentially new treatments for diabetes and products in the areas of cardiovascular, appetite suppression and pain and on the development and potential expansion of nutritional supplement products.

To support our internal development programs, we implemented our commercialization strategy for the Eligen ® Technology. Using extensive safety data available for our carrier, we obtained GRAS (Generally Recognized as Safe) status for SNAC, and then applied the Eligen ® Technology with B12, another GRAS substance where bioavailability and absorption is difficult and improving such absorption would yield substantial benefit and value. Given sufficient time and resources, we intend to apply this strategy to develop other products. Examples of GRAS substances that may be developed into additional commercial products using this strategy include vitamins such as other B Vitamins, minerals such as iron, and other supplements such as the polyphenols and catechins, among others. We hope to expand our product portfolio globally with collaborative partners in different geographic markets.

Our website is www.emisphere.com . The contents of that website are not incorporated herein by reference. Investor related questions should be directed to info@emisphere.com .

Funding required to continue developing our product pipeline may be partially paid by income generated from license arrangements whose value tends to increase as product candidates move from pre-clinical into clinical development. It is our intention that investments that may be required to fund our research and development will be approached incrementally in order to minimize disruption or dilution. The Company also continues to focus on improving operational efficiency. Our cash burn rate to support continuing operations is less than $4 million per year. Additionally, we have accelerated the commercialization of the Eligen ® Technology in a cost effective way and to gain operational efficiencies by tapping into advanced scientific processes offered by independent contractors.

Liquidity and Capital Resources

Since our inception in 1986, we have generated significant losses from operations and we anticipate that we will continue to generate significant losses from operations for the foreseeable future.

As of December 31, 2016, our accumulated deficit was approximately $564.6 million. Our loss from operations was $7.8 million, $18.1 million and $9.3 million for the years ended December 31, 2016, 2015 and 2014, respectively. Our net loss was $10.0 million, $40.4 million and $25.4 million for the years ended December 31, 2016, 2015 and 2014, respectively. Our net cash outlays from operations were $6.8, $2.8 million and $8.4 million for the years ended December 31, 2016, 2015 and 2014, respectively. Our stockholders’ deficit was $161.4 million and $151.9 million as of December 31, 2016 and 2015, respectively. On December 31, 2016 we had approximately $6.1 million in cash.

As of December 31, 2016, the Company’s obligations included approximately $53.0 million (face value) under its Second Amended and Restated Convertible Notes (the “Convertible Notes”) issued to funds affiliated with MHR Fund Management LLC (collectively, “MHR”), approximately $26.0 million (face value) under a loan agreement entered into on August 20, 2014 (the “Loan Agreement”) with MHR, approximately $0.8 million (face value) under its Second Amended and Restated Reimbursement Notes (the “Reimbursement Notes”) issued to MHR, and approximately $2.4 million (face value) under its Second Amended and Restated Bridge Notes (the “Bridge Notes”) issued to MHR.

On October 26, 2015, we received a total payment of $14 million from Novo Nordisk pursuant to, and consisting of, $5 million as payment for entry into the Expansion License Agreement and $9 million as prepayment of a product development milestone and in exchange for a reduction in certain future royalty payments that may have become due and payable under the terms of the GLP-1 Development License Agreement.

Under terms of its loan agreements, the Company is obligated to pre-pay certain loans and notes using 50% of any extraordinary receipts, such as the $14 million received from Novo Nordisk. On December 8, 2016, we entered into various agreements whereby, among other things, MHR agreed to waive any event of default resulting from our failure to satisfy the net sales milestones for the Eligen B12™ product for the 2016 fiscal year and all future periods specified in our Loan Agreement and Convertible Notes. MHR also agreed to irrevocably

 

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waive the Company’s obligation to pre-pay $7 million of certain loans and notes resulting from the $14 million cash receipt from Novo Nordisk.

We believe that our current cash balance will provide sufficient capital to continue operations through approximately March 2018. The Company’s future capital requirements beyond March 2018 and its financial success depend largely on its ability to raise additional capital, including by leverage existing and securing new partnering opportunities for Eligen B12™ and for the Eligen technology.

While our plan is to raise capital from commercial operations and/or product partnering opportunities to address our capital deficiencies and meet our operating cash requirements, there is no assurance that our plans will be successful. If we fail to generate sufficient capital from commercial operations or partnerships, we will need to seek capital from other sources and risk default under the terms of our existing loans. We cannot assure you that financing will be available on favorable terms or at all. If we fail to generate sufficient additional capital from sales of oral Eligen B12™ or obtain substantial cash inflows from existing or new partners or other sources prior to March 2018, we could be forced to cease operations. Additionally, if additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities would result in dilution to our existing stockholders. These conditions raise substantial doubt about our ability to continue as a going concern. Consequently, the audit reports prepared by our independent registered public accounting firm relating to our financial statements for the years ended December 31, 2016, 2015 and 2014 include an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. Furthermore, despite our optimism regarding the Eligen ® Technology, even in the event that the Company is adequately funded, there is no guarantee that any of our products or product candidates will perform as hoped or that such products can be successfully commercialized.

During the year ended December 31, 2016, our cash liquidity (consisting of $6.1 million cash at December 31, 2016) decreased as follows:

Cash and Cash Equivalents:

 

     (In thousands)  

At December 31, 2015

   $ 12,900  

At December 31, 2016

     6,100  
  

 

 

 

Decrease in cash and cash equivalents

   $ 6,800  
  

 

 

 

The (decrease) increase in cash and cash equivalents is comprised of the following components for the years ended December 31, 2016 and 2015:

 

     2016      2015  
     (In thousands)  

Proceeds from loan

   $      $ 12,000  

Proceeds from collaboration, technology business tax certificate transfer program and other projects

            14,600  
  

 

 

    

 

 

 

Sources of cash and cash equivalents

            26,600  
  

 

 

    

 

 

 

Uses of cash and cash equivalents

     (6,800 )      (17,400 )
  

 

 

    

 

 

 

(Decrease) increase in cash and cash equivalents

   $ (6,800    $ 9,200  
  

 

 

    

 

 

 

 

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During the year ended December 31, 2016, our working capital deficiency decreased by $3.9 million as follows:

 

     December 31,         
     2016      2015      Change  
     (In thousands)         

Current assets

   $ 6,560      $ 15,774      $ (9,214

Current liabilities

     9,725        22,855        (13,130
  

 

 

    

 

 

    

 

 

 

Working capital (deficiency)

   $ (3,165 )    $ (7,081 )    $ 3,916  
  

 

 

    

 

 

    

 

 

 

The decrease in current assets is driven primarily by the decrease in cash of $6.8 million and the decrease in inventory of $1.3 million. The decrease in current liabilities is driven primarily by the decrease in fair value of derivative instruments of $4.6 million, the decrease of accounts payable and accrued expenses of $1.3 million and the decrease of $7.0 in the classification of current notes payables. The decrease in current notes payable is a result of the Company entering into a series of agreements with MHR on December 8, 2016 whereby, among other things, MHR waived the Company’s obligation to pre-pay $0.8 million of the Reimbursement Notes and $6.2 million of the Loans in connection with the $14 million of cash proceeds from Novo Nordisk on October 26, 2015.

Results of Operations

Year Ended December 31, 2016, Compared to Year Ended December 31, 2015

 

     Year Ended
December 31,
        
     (In thousands)         
     2016      2015      Change  

Net revenue

   $ 1,195      $ 411      $ 784  

Gross profit (loss)

   $ (305 )    $ (481 )    $ 176  

Operating expenses

   $ 7,536      $ 17,615      $ (10,079

Operating loss

   $ (7,841 )    $ (18,096 )    $ 10,255  

Change in fair value of derivative instruments

   $ 9,138      $ (13,916    $ 23,054  

Interest expense

   $ (11,353 )    $ (8,966 )    $ (2,387 )

Other non-operating income

   $ 15      $ 12      $ 3  

Income tax benefit

   $      $ 585      $ (585 )

Net loss

   $ (10,041 )    $ (40,381 )    $ 30,340  

Our principal operating costs include the following items as a percentage of total expense:

 

     Year Ended  
     December 31, 2016     December 31, 2015  

Human resource costs, including benefits

     35 %     18 %

Professional fees for legal, intellectual property, accounting and consulting

     26 %     15 %

Advertising and promotion

     18     58

Clinical costs

     4 %     2 %

Occupancy costs

     2 %     1 %

Other

     15 %     6 %

 

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Operating expenses, decreased by $10.1 million or 57% as a result of the following items:

 

     (In thousands)  

Decrease in human resource costs

   $ (483

Decrease in professional fees

     (754

Decrease in advertising and promotion

     (8,766

Decrease in clinical costs

     (149

Increase in occupancy costs

     8  

All other

     65  
  

 

 

 

Net decrease

   $ (10,079
  

 

 

 

Net revenue increased $0.8 million due to the commercial launch of Eligen B12™ product in March 2015 whereas in 2016, the Company had a full year of revenue generated from the sale of Eligen B12™ as compared to only ten months in 2015.

Gross loss was $(0.3) million for the year ended December 2016 compared to $(0.5) million for the year ended December 31, 2015. The decrease in the gross profit (loss) was primarily due to an increase in the selling price of our Eligin B12™ offset by an increase in a write-off of inventory of approximately $0.6 million due to obsolescence.

Human resource costs decreased approximately $0.5 million due primarily to a reduction in staff related to our chief financial officer, chief medical officer and other administrative staff.

Professional fees decreased approximately $0.8 million due primarily to a decrease in consulting costs including medical regulatory, regulatory and manufacturing support in connection with the introduction of oral Eligen B12 in the U.S. during March 2015.

Advertising and promotion decreased approximately $8.8 million due primarily to a reduction in sales, marketing and other commercial costs commensurate with our decision to phase out our sales field force, and reduce and reallocate marketing resources toward more efficient non-field force promotion of the oral Eligen B12 product in the U.S. during 2016.

Clinical costs decreased approximately $0.1 million primarily due to costs associated with developing and optimizing manufacturing production of oral Eligen B12™ Rx.

Occupancy costs were substantially unchanged in 2016 compared to 2015.

All other operating costs increased approximately $0.1 million primarily due to a $0.1 million forfeited deposit in connection with a commitment to purchase inventory.

As a result of the factors above, Emisphere’s operating expenses were $7.5 million for the year ended December 31, 2016, which represents a decrease of $10.1 million (57%) compared to operating expenses for the year ended December 31, 2015.

Other non-operating expense decreased by approximately $20.7 million for the year ended December 31, 2016, in comparison to the same period last year due primarily to a $23.1 million decrease in the change in the value of derivative instruments, and a $2.4 million increase in interest expense due to an increase in the principal balance of our outstanding debt. The change in the fair value of derivative instruments for 2016 and 2015 is the result of a lower fair value of the Company’s stock price and a shorter term at December 31, 2016 compared to December 31, 2015. Future gains and losses recognized in the Company’s operating results from changes in the value of the derivative instrument liability are based in part on the fair value of the Company’s common stock which is outside the control of the Company. These potential future gains and losses could be material.

As a result of the above factors, we reported a net loss of $10.0 million, which was $30.3 million (75%) lower than the net loss of $40.4 million for the year ended December 31, 2015.

 

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Year Ended December 31, 2015, Compared to Year Ended December 31, 2014

 

     Year Ended
December 31,
        
     (In thousands)         
     2015      2014      Change  

Net revenue

   $ 411      $      $ 411  

Gross profit (loss)

   $ (481    $      $ (481

Operating expenses

   $ 17,615      $ 9,305      $ 8,310  

Operating loss

   $ (18,096 )    $ (9,305 )    $ (8,791

Change in fair value of derivative instruments

   $ (13,916    $ (11,872    $ (2,044 )

Interest expense

   $ (8,966 )    $ (6,232 )    $ (2,734 )

Other non-operating income

   $ 12      $ 10      $ 2  

Income tax benefit

   $ 585      $ 2,019      $ (1,434

Net loss

   $ (40,381 )    $ (25,380 )    $ (15,001 )

Our principal operating costs include the following items as a percentage of total expense:

 

     Year Ended  
     December 31, 2015     December 31, 2014  

Human resource costs, including benefits

     18 %     32 %

Professional fees for legal, intellectual property, accounting and consulting

     15 %     34 %

Sales and marketing costs, excluding human resource costs

     58 %     16 %

Product development costs

     2 %     7 %

Occupancy costs

     1 %     2 %

Other

     6 %     9 %

Operating expenses, increased by $8.3 million or 89% as a result of the following items:

 

     (In thousands)  

Increase in human resource costs

   $ 175  

Decrease in professional and consulting fees

     (480

Increase in sales and marketing costs, excluding human resource costs

     8,690  

Increase in product development costs

     (222

Increase in occupancy costs

     3  

All other

     144  
  

 

 

 

Net increase

   $ 8,310  
  

 

 

 

Net revenue increased $0.4 million due to the commercial launch of Eligen B12™ in the U.S.

Gross profit (loss) was $(0.5) million due primarily to the write-off of approx. $0.7 million Eligen B12™ inventory due to obsolescence.

Human resource costs increased approximately $0.2 million due primarily to hiring our new Chief Medical Officer.

Professional and consulting fees decreased approximately $0.5 million due to reductions in legal fees and research costs.

Sales and marketing costs, excluding human resource costs increased $8.7 million due to the commercial launch of Eligen B12™ during March 2015.

Product development costs decreased approximately $0.2 million primarily due to costs associated with developing and optimizing manufacturing production of oral Eligen B12™ Rx.

 

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Occupancy costs were substantially unchanged in 2015 compared to 2014.

All other operating costs increased approximately $0.1 million.

As a result of the factors above, Emisphere’s operating expenses were $17.6 million for the year ended December 31, 2015, which represents an increase of $8.3 million (89%) compared to operating expenses for the year ended December 31, 2014.

Other non-operating expense increased by approximately $4.8 million for the year ended December 31, 2015, in comparison to the same period last year due primarily to a $2.0 million increase in the change in the value of derivative instruments, and a $2.7 million increase in interest expense due primarily to the additional accrued interest on the restatement of the Convertible Notes following the August 2014 restructuring described above. The change in the fair value of derivative instruments for 2015 and 2014 is the result of a higher fair value of the Company’s stock price and a higher estimated future volatility at December 31, 2015 compared to December 31, 2014. Future gains and losses recognized in the Company’s operating results from changes in value of the derivative instrument liability are based in part on the fair value of the Company’s common stock which is outside the control of the Company. These potential future gains and losses could be material.

During 2015, we recognized a state income tax benefit of approximately $0.6 million as a result of proceeds from the sale of $7.1 million of New Jersey net operating losses through the Technology Business Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority.

As a result of the above factors, we reported a net loss of $40.4 million, which was $15.0 million (59%) higher than the net loss of $25.4 million for the year ended December 31, 2014.

Critical Accounting Estimates and New Accounting Pronouncements

Critical Accounting Estimates

The preparation of financial statements in accordance with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect reported amounts and related disclosures in the financial statements. Management considers an accounting estimate to be critical if:

 

   

It requires assumptions to be made that were uncertain at the time the estimate was made, and

 

   

Changes in the estimate or different estimates that could have been selected could have a material impact on our results of operations or financial condition.

Share-Based Payments — We recognize expense for our share-based compensation in accordance with FASB ASC 718, “Compensation-Stock Compensation” , which establishes standards for share-based transactions in which an entity receives employee’s services for (a) equity instruments of the entity, such as stock options, or (b) liabilities that are based on the fair value of the entity’s equity instruments or that may be settled by the issuance of such equity instruments. FASB ASC 718 requires that companies expense the fair value of stock options and similar awards, as measured on the awards’ grant date. FASB ASC 718 applies to all awards granted after the date of adoption, and to awards modified, repurchased or cancelled after that date.

We estimate the value of stock option awards on the date of grant using the Black-Scholes-Merton (“Black-Scholes”) option-pricing model. The determination of the fair value of share-based payment awards on the date of grant is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include our expected stock price volatility over the term of the awards, expected term, risk-free interest rate, expected dividends and expected forfeiture rates.

If factors change and we employ different assumptions in the application of FASB ASC 718 in future periods, the compensation expense that we record under FASB ASC 718 may differ significantly from what we have recorded in the current period. There is a high degree of subjectivity involved when using option pricing models to estimate share-based compensation under FASB ASC 718. Consequently, there is a risk that our estimates of the fair values of our share-based compensation awards on the grant dates may bear little resemblance to the actual values realized upon the exercise, expiration, early termination or forfeiture of those share-based payments in the future. Employee stock options may expire worthless or otherwise result in zero

 

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intrinsic value as compared to the fair values originally estimated on the grant date and reported in our financial statements. Alternatively, value may be realized from these instruments that are significantly in excess of the fair values originally estimated on the grant date and reported in our financial statements. During the year ended December 31, 2016, we do not believe that reasonable changes in the projections would have had a material effect on share-based compensation expense.

Revenue Recognition — We recognize revenue in accordance with FASB ASC 605-10-S99, Revenue Recognition. We sell our Oral Eligen B12™ Rx product through drug wholesalers and retail pharmacies. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, and rebates. We accept returns of unsalable product from customers within a return period of six months prior to and 12 months following product expiration. Our Oral Eligen B12™ Rx product currently has a shelf life of 36 months from the date of manufacture. Given the limited history of our Oral Eligen B12™ Rx product, we currently cannot reliably estimate expected returns of the prescription products at the time of shipment. Accordingly, we defer recognition of revenue on prescription products until the right of return no longer exists, which occurs at the earlier of the time the Oral Eligen B12™ Rx product is dispensed through patient prescriptions or expiration of the right of return.

Revenue includes amounts earned from sales of our oral Eligen ® B12 (100 mcg) product, collaborative agreements and feasibility studies. Revenue earned from the sale of oral Eligen ® B12 (100 mcg) was recognized when the product was shipped, when all revenue recognition criteria were met in accordance with Staff Accounting Bulletin No. 104, “Revenue Recognition” (codified under ASC 605 “Revenue Recognition”). Revenue from feasibility studies, which are typically short term in nature, is recognized upon delivery of the study, provided that all other revenue recognition criteria are met. Revenue from collaboration agreements are recognized using the proportional performance method provided that we can reasonably estimate the level of effort required to complete our performance obligations under an arrangement and such performance obligations are provided on a best effort basis and based on “expected payments.” Under the proportional performance method, periodic revenue related to nonrefundable cash payments is recognized as the percentage of actual effort expended to date as of that period to the total effort expected for all of our performance obligations under the arrangement. Actual effort is generally determined based upon actual hours incurred and include research and development (“R&D”) activities performed by us and time spent for joint steering committee (“JSC”) activities. Total expected effort is generally based upon the total R&D and JSC hours incorporated into the project plan that is agreed to by both parties to the collaboration. Significant management judgments and estimates are required in determining the level of effort required under an arrangement and the period over which we expect to complete the related performance obligations. Estimates of the total expected effort included in each project plan are based on historical experience of similar efforts and expectations based on the knowledge of scientists for both the Company and its collaboration partners. The Company periodically reviews and updates the project plan for each collaborative agreement. The most recent reviews took place in January 2017. In the event that a change in estimate occurs, the change will be accounted for using the cumulative catch-up method which provides for an adjustment to revenue in the current period. Estimates of our level of effort may change in the future, resulting in a material change in the amount of revenue recognized in future periods.

Generally, under collaboration arrangements, nonrefundable payments received during the period of performance may include time- or performance-based milestones. The proportion of actual performance to total expected performance is applied to the “expected payments” in determining periodic revenue. However, revenue is limited to the sum of (1) the amount of nonrefundable cash payments received and (2) the payments that are contractually due but have not yet been paid.

With regard to revenue recognition from collaboration agreements, the Company previously interpreted expected payments to equate to total payments subject to each collaboration agreement. On a prospective basis, the Company has revised its application of expected payments to equate to a “best estimate” of payments. Under this application, expected payments typically include (i) payments already received and (ii) those milestone payments not yet received but that the Company believes are “more likely than not” of receiving. Our support for the assertion that the next milestone is likely to be met is based on the (a) project status updates discussed at JSC meetings; (b) clinical trial/development results of prior phases; (c) progress of current clinical trial/development phases; (d) directional input of collaboration partners and (e) knowledge and experience of the Company’s

 

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scientific staff. After considering the above factors, the Company believes those payments included in “expected payments” are more likely than not of being received. While this interpretation differs from that used previously by the Company, it does not result in any change to previously recognized revenues in either timing or amount for periods through December 31, 2016.

With regard to revenue recognition in connection with the Insulins License Agreement and the GLP-1 License Agreements with Novo Nordisk, such agreements include multiple deliverables including license grants, several versions of the Company’s Eligen ® Technology (or carriers), support services and manufacturing. Emisphere’s management reviewed the relevant terms of the Novo Nordisk agreements and determined such deliverables should be accounted for as a single unit of accounting in accordance with FASB ASC 605-25, “Multiple-Element Arrangements” since the delivered license and Eligen ® Technology do not have stand-alone value and Emisphere does not have objective evidence of fair value of the undelivered Eligen ® Technology or the manufacturing value of all the undelivered items. Such conclusion will be reevaluated as each item in the arrangement is delivered. Consequently, any payments received from Novo Nordisk pursuant to such agreements, including the initial $10 million upfront payment and any payments received for support services in connection with the GLP-1 License Agreement and the $5 million upfront payment from the Insulins License Agreement will be deferred and included in Deferred Revenue within our balance sheet. Management cannot currently estimate when all of such deliverables will be delivered nor can they estimate when, if ever, Emisphere will have objective evidence of the fair value for all of the undelivered items, therefore all payments from Novo Nordisk are expected to be deferred for the foreseeable future.

As of December 31, 2016, total deferred revenue from Novo Nordisk development programs was $42.6 million, consisting of: $32.6 million from the GLP-1 Development License Agreement, comprised of the $9.0 million prepayment received October 26, 2015, the $10.0 million prepayment received April 26, 2013, the $10.0 million non-refundable license fee, $2 million milestone payment and $1.6 million in support services; $5.0 million non-refundable license fee from the Insulin Development License Agreement and $5.0 million non-refundable license fee from the Expansion License Agreement.

With regard to revenue recognition in connection with Novartis’ discontinued oral salmon calcitonin program for osteoporosis and osteoarthritis, discontinued oral PTH-1-34 program for osteoporosis, and terminated oral recombinant human growth hormone program: all such agreements include(d) multiple deliverables including license grants, several versions of the Company’s Eligen ® Technology (or carriers) and support services. Emisphere’s management reviewed the relevant terms of each development license agreement with Novartis and determined such deliverables should be accounted for as a single unit of accounting in accordance with FASB ASC 605-25, “Multiple-Element Arrangements” since the delivered license and Eligen ® Technology do not have stand-alone value and Emisphere does not have objective evidence of fair value of the undelivered Eligen ® Technology. Such conclusion will be reevaluated as each item in the arrangement is delivered or the status of each agreement changes. Consequently, any payments received from Novartis pursuant to such agreements have been deferred and included in Deferred Revenue within our balance sheet.

During 2011, Novartis terminated its oral human growth hormone program and informed the Company of its intention not to continue development of its oral calcitonin and oral PTH programs involving Emisphere’s Eligen ® Technology. However, Novartis did not terminate its development license agreements in calcitonin or PTH. At such time that Novartis terminates its oral calcitonin and oral PTH agreements, , then the Company will recognize revenue in connection with past receipts of payments from Novartis derived from those agreements which are currently included in Deferred Revenue within our balance sheet. Management will pay close attention to Novartis actions and reevaluate circumstances that influence this determination in future.

As of December 31, 2016 total deferred revenue from all Novartis development license programs was approximately $13.0 million.

Warrants and Conversion Feature of Amended and Restated Convertible Note — Warrants issued in connection with various equity financings and embedded conversion feature of the Amended and Restated Convertible Notes, Bridge Notes and Reimbursement Notes described in Note 7 to the Financial Statements have been classified as liabilities due to certain provisions that may require cash settlement in certain circumstances. At each balance sheet date, we adjust the warrants to reflect their current fair value. For derivatives other than the

 

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Amended and Restated Convertible Notes, Bridge Notes, Reimbursement Notes, and June 2010 Warrants, we estimate the fair value of these instruments using the Black-Scholes model which takes into account a variety of factors, including historical stock price volatility, risk-free interest rates, remaining term and the closing price of our common stock. Changes in the assumptions used to estimate the fair value of these derivative instruments could result in a material change in the fair value of the instruments. The fair value of the embedded conversion feature of the Amended and Restated Convertible Notes, Amended and Restated June 2010 Warrants, Amended and Restated Bridge Notes and Amended and Restated Reimbursement Notes contain anti-dilution protection provisions, which are triggered by potentially dilutive events (including subsequent common share offerings meeting certain criteria). Due to these additional protective provisions within the instruments, additional value has been provided to the holders, which has not been provided to other equity investors. In order to estimate the value of this protection, the Company uses the Monte Carlo valuation model which assesses the probability of the occurrence of potential triggering events, such as the probability of the Company’s engaging in a capital or debt markets offering to calculate the value of the derivative at the reporting date. We believe the assumptions used to estimate the fair values of the warrants and convertible shares are reasonable. For a more complete discussion on the volatility in market value of derivative instruments, see Part I, Item 7A “ Quantitative and Qualitative Disclosures about Market Risk.

Clinical Trial Accrual Methodology — Clinical trial expenses represent obligations resulting from our contracts with various research organizations in connection with conducting clinical trials for our product candidates. We account for those expenses on an accrual basis according to the progress of the trial as measured by patient enrollment and the timing of the various aspects of the trial. Accruals are recorded in accordance with the following methodology: (i) the costs for period expenses, such as investigator meetings and initial start-up costs, are expensed as incurred based on management’s estimates, which are impacted by any change in the number of sites, number of patients and patient start dates; (ii) direct service costs, which are primarily on-going monitoring costs, are recognized on a straight-line basis over the life of the contract; and (iii) principal investigator expenses that are directly associated with recruitment are recognized based on actual patient recruitment. All changes to the contract amounts due to change orders are analyzed and recognized in accordance with the above methodology. Change orders are triggered by changes in the scope, time to completion and the number of sites. During the course of a trial, we adjust our rate of clinical expense recognition if actual results differ from our estimates.

New Accounting Pronouncements

In April 2015, the FASB issued ASU 2015-03, “Interest — Imputation of Interest” (“ASU 2015-03”), which requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected by the amendments in this ASU. ASU 2015-03 is effective for annual and interim periods beginning on or after December 15, 2015. The adoption of ASU 2015-03 did not have a material impact on our financial position, results of operations or cash flows.

In August 2014, the FASB issued ASU No. 2014-15, “Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”), which provides guidance on management’s responsibility in evaluating whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. ASU 2014-15 is effective for the annual period ending after December 15, 2016, and for annual and interim periods thereafter. The adoption of ASU 2014-15 did not have a material impact on our financial position, results of operations or cash flows.

In July 2015, the FASB issued ASU No. 2015-11, “Simplifying the Measurement of Inventory” (“ASU 2015-11”). ASU 2015-11 requires that inventory within the scope of the guidance be measured at the lower of cost and net realizable value. Inventory measured using last-in, first-out and retail inventory method are excluded from this new guidance. This ASU replaces the concept of market with the single measurement of net realizable value and is intended to create efficiencies for preparers and more closely aligns U.S. GAAP with IFRS. This ASU is effective for public business entities in fiscal years beginning after December 15, 2016, including interim periods within those years. Prospective application is required and early adoption is permitted

 

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as of the beginning of an interim or annual reporting period. The adoption of ASU 2015-11 is not expected to have a material impact on our financial position, results of operations or cash flows.

In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”), which requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The new guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. Adoption can occur using one of two prescribed transition methods. In 2016, the FASB issued four amendments to ASU 2014-09. We have begun a limited evaluation of the provisions of ASU 2014-09 and the impact, if any, it may have on our financial position and results of operations. Our evaluation work to date includes the training of ASU 2014-09, contract review and an assessment of the distribution model for which we recognize revenue for our Eligen B12™ products. We have a small number of contracts which require an assessment and believe we have sufficient time for the implementation of ASU 2014-09.

During January 2016, the FASB issued ASU No. 2016-01, “Financial Instruments — Overall: Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”). The standard addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. This ASU is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. Early adoption is not permitted with the exception of certain provisions related to the presentation of other comprehensive income. The adoption of ASU 2016-01 is not expected to have a material impact on our financial position, results of operations or cash flows.

During February 2016, the FASB issued ASU No. 2016-02, “Leases” (“ASU 2016-02”). The standard requires lessees to recognize a lease liability and a lease asset for all leases, including operating leases, with a term greater than 12 months on its balance sheet. The update also expands the required quantitative and qualitative disclosures surrounding leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The adoption of ASU 2016-02 is not expected to have a material impact on our financial position, results of operations or cash flows.

In March 2016, the FASB issued ASU No. 2016-06, “Contingent Put and Call Option in Debt Instruments” (“ASU 2016-06”). ASU 2016-06 is intended to simplify the analysis of embedded derivatives for debt instruments that contain contingent put or call options. The amendments in ASU 2016-06 clarify that an entity is required to assess the embedded call or put options solely in accordance with the four-step decision sequence. Consequently, when a call (put) option is contingently exercisable, an entity does not have to initially assess whether the event that triggers the ability to exercise a call (put) option is related to interest rates or credit risks. The amendments in ASU 2016-06 take effect for public business entities for financial statements issued for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. The Company does not expect the adoption of ASU 2016–01 to have a significant impact on its financial statements.

In March 2016, FASB issued ASU No. 2016-09, “Improvements to Employee Share-based Payment Accounting” (“ASU 2016-09”). ASU 2016-09 simplifies several aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. ASU 2016-09 is effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods. The adoption of ASU 2016-09 is not expected to have a material impact on our financial position, results of operations or cash flows.

In August 2016, FASB issued ASU No. 2016-15, “Classification of Certain Cash Receipts and Cash Payments” (“ASU 2016-15”). ASU 2016-15 clarifies the presentation and classification of certain cash receipts and cash payments in the statement of cash flows. ASU 2016-15 is effective for fiscal years, and interim periods within those years beginning after December 15, 2017. Early adoption is permitted. The Company does not expect the adoption of ASU No. 2016-15 to have a material impact on its financial statements.

 

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Off-Balance Sheet Arrangements

As of December 31, 2016, we had no material off-balance sheet arrangements.

In the ordinary course of business, we enter into agreements with third parties that include indemnification provisions which, in our judgment, are normal and customary for companies in our industry sector. These agreements are typically with business partners, clinical sites, and suppliers. Pursuant to these agreements, we generally agree to indemnify, hold harmless, and reimburse indemnified parties for losses suffered or incurred by the indemnified parties with respect to our product candidates, use of such product candidates, or other actions taken or omitted by us. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited. We have not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of liabilities relating to these provisions is minimal. Accordingly, we have no liabilities recorded for these provisions as of December 31, 2016.

In the normal course of business, we may be confronted with issues or events that may result in a contingent liability. These generally relate to lawsuits, claims, environmental actions or the actions of various regulatory agencies. We consult with counsel and other appropriate experts to assess the claim. If, in our opinion, we have incurred a probable loss as set forth by accounting principles generally accepted in the U.S., an estimate is made of the loss and the appropriate accounting entries are reflected in our financial statements.

Contractual Arrangements

Significant contractual obligations as of December 31, 2016 are as follows:

 

            Amount Due in  

Type of Obligation

   Total      Less than
1 Year
     1 to 3
Years
     3 to 5
Years
     More than
5 Years
 
     (In thousands)  

Notes Payable(1)

   $ 82,218      $      $ 26,004      $      $ 56,214  

Derivative liabilities(2)

     43,194        8,343                      34,851  

Operating lease obligations

     74        74                       
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 125,486      $ 8,417      $ 26,004      $      $ 91,065  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

 

(1) Amounts include both principal and related interest payments.

 

(2) We have issued warrants to purchase shares of our common stock which contain provisions requiring us to make a cash payment to the holders of the warrant for any gain that could have been realized if the holders exercise the warrants and we subsequently fail to deliver a certificate representing the shares to be issued upon such exercise by the third trading day after such warrants have been exercised. As a result, these warrants have been recorded at their fair value and are classified as current liabilities. The value and timing of the actual cash payments, if any, related to these derivative instruments could differ materially from the amounts and periods shown.

 

ITEM 7A.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Fair Value of Warrants and Derivative Liabilities.     At December 31, 2016, the value of derivative instruments was $43.2 million. We estimate the fair values of these instruments using the Black-Scholes option pricing model which takes into account a variety of factors, including historical stock price volatility, risk-free interest rates, remaining maturity and the closing price of our common stock. Furthermore, the estimated fair values of the conversion features embedded in our Convertible Notes, Bridge Notes, Reimbursement Notes, and Amended and Restated June 2010 Warrants, which contain reset provisions, were measured using the Monte Carlo valuation model. In using the Monte Carlo model, we estimate the probability and timing of potential future financing and fundamental transactions as applicable. We are required to revalue this liability each quarter. We believe that the assumption that has the greatest impact on the determination of fair value is the closing price

 

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of our common stock. The following table illustrates the potential effect of changes in the assumptions used to calculate fair value:

 

     Increase/(Decrease)  
     (In thousands)  

25% increase in stock price

   $ 8,191  

50% increase in stock price

   $ 18,368  

5% increase in assumed volatility

   $ 1,402  

25% decrease in stock price

   $ (8,572 )

50% decrease in stock price

   $ (16,847 )

5% decrease in assumed volatility

   $ (3,041 )

 

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ITEM 8.     FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

EMISPHERE TECHNOLOGIES, INC.

FINANCIAL STATEMENTS

Index

 

     Page  

Emisphere Technologies, Inc.

  

Report of Independent Registered Public Accounting Firm

     44  

Balance Sheets as of December 31, 2016 and 2015

     45  

Statements of Operations for the years ended December 31, 2016, 2015 and 2014

     46  

Statements of Cash Flows for the years ended December 31, 2016, 2015 and 2014

     47  

Statements of Stockholders’ Deficit for the years ended December 31, 2016, 2015 and 2014

     48  

Notes to the Financial Statements

     49  

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders

Emisphere Technologies, Inc.

We have audited the accompanying balance sheets of Emisphere Technologies, Inc. as of December 31, 2016 and 2015, and the related statements of operations, stockholders’ deficit, and cash flows for each of the three years in the period ended December 31, 2016. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Emisphere Technologies, Inc. as of December 31, 2016 and 2015, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2016, in conformity with U.S. generally accepted accounting principles.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations, has a working capital deficiency and a significant stockholders’ deficit, and has limited cash availability. This raises substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters also are described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s/ RSM US LLP

New York, New York

March 30, 2017

 

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EMISPHERE TECHNOLOGIES, INC.

BALANCE SHEETS

 

     December 31,  
     2016      2015  
    

(In thousands,

except share data)

 
ASSETS  

Current assets:

     

Cash and cash equivalents

   $ 6,085      $ 12,898  

Accounts receivable, net

     301        455  

Inventories

     67        1,340  

Prepaid expenses and other current assets

     107        1,081  
  

 

 

    

 

 

 

Total current assets

     6,560        15,774  

Equipment and leasehold improvements, net

            12  

Security deposit

     24        24  
  

 

 

    

 

 

 

Total assets

   $ 6,584      $ 15,810  
  

 

 

    

 

 

 
LIABILITIES AND STOCKHOLDERS’ DEFICIT  

Current liabilities:

     

Accounts payable and accrued expenses

   $ 869      $ 2,121  

Notes payable, related party

            7,000  

Deferred revenue, current portion

     513        631  

Royalty payable — related party

        208  

Derivative instruments:

     

Related party

     8,343        12,690  

Others

            205  
  

 

 

    

 

 

 

Total current liabilities

     9,725        22,855  

Notes payable, related party net of related discount

     67,589        54,172  

Derivative instruments — related party

     34,851        35,071  

Royalty payable — related party

     206         

Deferred revenue

     55,616        55,616  

Deferred lease liability and other liabilities

     5        14  
  

 

 

    

 

 

 

Total liabilities

     167,992        167,728  
  

 

 

    

 

 

 

Commitments and contingencies

     

Stockholders’ deficit:

     

Preferred stock, $.01 par value; authorized 4,000,000 shares at December 31, 2016 and 2015; issued and outstanding at December 31, 2016 and 2015 — none

             

Common stock, $.01 par value; authorized 400,000,000 shares at December 31, 2016 and 2015 issued 60,977,210 shares (60,687,478 outstanding) at December 31, 2016 and 2015

     610        610  

Additional paid-in capital

     406,495        405,944  

Accumulated deficit

     (564,561      (554,520 )

Common stock held in treasury, at cost; 289,732 shares

     (3,952      (3,952 )
  

 

 

    

 

 

 

Total stockholders’ deficit

     (161,408      (151,918 )
  

 

 

    

 

 

 

Total liabilities and stockholders’ deficit

   $ 6,584      $ 15,810  
  

 

 

    

 

 

 

(See accompanying Notes to the Financials)

 

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EMISPHERE TECHNOLOGIES, INC.

STATEMENTS OF OPERATIONS

 

     Year Ended December 31,  
     2016      2015      2014  
     (In thousands, except share and per share data)  

Net revenue

   $ 1,195      $ 411      $  

Cost of goods sold

     286        201         

Write-off of slow moving inventory

     1,214        691         
  

 

 

    

 

 

    

 

 

 

Gross loss

     (305 )      (481       
  

 

 

    

 

 

    

 

 

 

Costs and expenses:

        

Research and development

     373        475        1,128  

General and administrative

     5,228        5,950        5,968  

Selling expenses

     1,923        11,176        2,194  

Depreciation and amortization

     12        14        15  
  

 

 

    

 

 

    

 

 

 

Total costs and expenses

     7,536        17,615        9,305  
  

 

 

    

 

 

    

 

 

 

Operating loss

     (7,841 )      (18,096 )      (9,305 )
  

 

 

    

 

 

    

 

 

 

Other non-operating income (expense):

        

Investment and other income

     15        12        10  

Change in fair value of derivative instruments:

        

Related party

     8,933        (13,950      (12,172 )

Others

     205        34        300  

Interest expense — related party

     (11,353 )      (8,966      (6,232 )
  

 

 

    

 

 

    

 

 

 

Total other non-operating income (expense)

     (2,200 )      (22,870      (18,094 )
  

 

 

    

 

 

    

 

 

 

Loss before income tax benefit

     (10,041 )      (40,966      (27,399

Income tax benefit

            585        2,019  
  

 

 

    

 

 

    

 

 

 

Net loss

   $ (10,041 )    $ (40,381 )    $ (25,380
  

 

 

    

 

 

    

 

 

 

Net loss per share, basic and diluted

   $ (0.17 )    $ (0.67 )    $ (0.42
  

 

 

    

 

 

    

 

 

 

Weighted average shares outstanding, basic and diluted

     60,687,478        60,687,478        60,687,478  
  

 

 

    

 

 

    

 

 

 

(See accompanying Notes to the Financials)

 

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EMISPHERE TECHNOLOGIES, INC.

STATEMENTS OF CASH FLOWS

 

     Year Ended December 31,  
     2016      2015      2014  
     (In thousands)  

Cash flows from operating activities:

        

Net loss

   $ (10,041    $ (40,381 )    $ (25,380
  

 

 

    

 

 

    

 

 

 

Adjustments to reconcile net loss to net cash used in operating activities:

        

Depreciation and amortization

     12        14        15  

Provision for slow moving inventory

     1,214        691         

Provision for doubtful accounts

     (3      9     

Non-cash interest expense:

        

Related party

     10,782        8,756        6,007  

Changes in the fair value of derivative instruments:

        

Related party

     (8,933      13,950        12,172  

Others

     (205 )      (34 )      (300 )

Non-cash compensation

     343        413        231  

Changes in assets and liabilities excluding non-cash charges:

        

Decrease (increase) in accounts receivable

     157        (464       

Decrease (increase) inventories

     59        37        (1,361

Decrease (increase) in prepaid expenses and other current assets

     974        (893      (43

Decrease in security deposits

                   10  

(Decrease) increase in accounts payable and accrued expenses

     (1,251      274        306  

(Decrease) in other current liabilities

                   (30

Increase in royalty payable

     206        208         

(Decrease) increase in deferred revenue

     (118      14,631         

(Decrease) increase in deferred lease and other liabilities

     (9      4        3  
  

 

 

    

 

 

    

 

 

 

Total adjustments

     3,228        37,596        17,010  
  

 

 

    

 

 

    

 

 

 

Net cash used in operating activities

     (6,813      (2,785      (8,370
  

 

 

    

 

 

    

 

 

 

Cash flows from financing activities:

        

Proceeds from notes payable

            12,000        8,000  
  

 

 

    

 

 

    

 

 

 

Net cash provided by financing activities

            12,000        8,000  
  

 

 

    

 

 

    

 

 

 

Net (decrease) increase in cash and cash equivalents

     (6,813      9,215        (370

Cash and cash equivalents, beginning of year

     12,898        3,683        4,053  
  

 

 

    

 

 

    

 

 

 

Cash and cash equivalents, end of year

   $ 6,085      $ 12,898      $ 3,683  
  

 

 

    

 

 

    

 

 

 

Non-cash investing and financing activities:

        

Increase in debt discounts for new derivatives

   $ 4,365      $ 4,130      $ 2,540  

Conversion of accrued interest to notes payable

   $ 10,782      $ 8,756      $ 5,542  

Fully depreciated assets written off

   $ 593      $      $  

Forgiveness of royalty payable, related party

   $ 208      $      $  

(See accompanying Notes to the Financials)

 

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EMISPHERE TECHNOLOGIES, INC.

STATEMENTS OF STOCKHOLDERS’ DEFICIT

For the years ended December 31, 2016, 2015 and 2014

 

     Common Stock      Additional
Paid-in
Capital
     Accumulated
Deficit
    Common Stock
Held in Treasury
Shares Amount
    Total  
     Shares      Amount            
     (In thousands except share data)  

Balance, December 31, 2013

     60,977,210      $ 610      $ 405,300      $ (488,759 )     289,732      $ (3,952 )   $ (86,801 )
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Net Loss

              (25,380 )          (25,380

Stock based compensation for employees

           71               71  

Stock based compensation for directors

           160               160  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Balance, December 31, 2014

     60,977,210      $ 610      $ 405,531      $ (514,139 )     289,732      $ (3,952 )   $ (111,950 )
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Net Loss

              (40,381 )          (40,381 )

Stock based compensation for employees

           164               164  

Stock based compensation for directors

           249               249  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Balance, December 31, 2015

     60,977,210      $ 610      $ 405,944      $ (554,520 )     289,732      $ (3,952 )   $ (151,918 )
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Net Loss

              (10,041          (10,041 )

Stock based compensation for employees

           142               142  

Stock based compensation for directors

           201               201  

Forgiveness of royalty payable- related party

           208               208  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Balance, December 31, 2016

     60,977,210      $ 610      $ 406,495      $ (564,561 )     289,732      $ (3,952 )   $ (161,408 )
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

 

(See accompanying Notes to the Financials)

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS

1.    Nature of Operations, Risks and Uncertainties and Liquidity

Nature of Operations.

Emisphere Technologies, Inc. is a commercial stage pharmaceutical and drug delivery company. We are in partnership with global pharmaceutical companies to develop new formulations of existing products, as well as new chemical entities, using our Eligen ® Technology. We launched our first prescription medical food product, oral Eligen B12™ in the U.S. in March 2015, and we are engaged in multiple licensing discussions to optimize its economic value in the U.S. and global markets. Beyond Eligen B12™, we utilize our proprietary Eligen ® Technology to create new oral formulations of therapeutic agents. Our product pipeline includes prescription drug and medical food product candidates that are being developed in partnership or internally.

Our core business strategy is to build new, high-value partnerships and continue to expand upon existing partnerships, pursue the global commercialization of oral Eligen B12™ to optimize its economic value, evaluate commercial opportunities for new prescription medical foods, and promote new uses for our Eligen ® Technology, a broadly applicable proprietary oral drug delivery platform which makes it possible to avoid injections for drug administration.

Risks and Uncertainties. The Company has no prescription drug products currently approved for sale by the U.S. FDA. There can be no assurance that our research and development will be successfully completed, that any products developed which require regulatory approvals will obtain necessary approvals or that any approved products will be commercially viable. In addition, we operate in an environment of rapid change in technology and are dependent upon the continued services of our current employees, consultants and subcontractors. We are highly dependent upon the commercial success of oral Eligen B12™ Rx and cannot be sure that our plans will be successful. We have limited capital resources and significant commitments and obligations.

Since our inception in 1986, we have generated significant losses from operations and we anticipate that we will continue to generate significant losses from operations for the foreseeable future, and that in order to continue as a going concern, our business will require substantial additional investment that we have not yet secured.

As of December 31, 2016, our accumulated deficit was approximately $564.6 million. Our loss from operations was $7.8 million, $18.1 million and $9.3 million for the years ended December 31, 2016, 2015 and 2014, respectively. Our net loss was $10.0 million, $40.4 million and $25.4 million for the years ended December 31, 2016, 2015 and 2014, respectively. Our net cash provided (outlays) from operations and capital expenditures were ($6.8), ($2.8) million and ($8.4) million for the years ended December 31, 2016, 2015 and 2014, respectively. Net cash provided (outlays) include receipts of deferred revenue of ($.1) million, $14.6 million and $0.0 million for 2016, 2015, and 2014, respectively. Our stockholders’ deficit was $161.4 million and $151.9 million as of December 31, 2016 and 2015, respectively. On December 31, 2016 we had approximately $6.1 million in cash.

As of December 31, 2016, the Company’s obligations included approximately $53 million (face value) under its Second Amended and Restated Convertible Notes (the “Convertible Notes”), approximately $26 million (face value) under a loan agreement entered into on August 20, 2014 (the “Loan Agreement”), approximately $0.8 million (face value) under its Second Amended and Restated Reimbursement Notes (the “Reimbursement Notes”), and approximately $2.4 million (face value) under its Second Amended and Restated Bridge Notes (the “Bridge Notes”).

On October 26, 2015 we received a total payment of $14 million from Novo Nordisk pursuant to, and consisting of, $5 million as payment for entry into the Expansion License Agreement and $9 million as payment in connection with the third amendment to the GLP-1 License Agreement. Under terms of its loan agreements, the Company was obligated to pre-pay certain loans and notes using 50% of any extraordinary receipts, such as the $14 million received from Novo Nordisk. Under the terms of the Loan Agreement and Convertible Notes Emisphere is required to satisfy annual net sales targets of Eligen B12™. As described in Note 7 to the Financial

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

Statements, on December 8, 2016, we entered into various agreements whereby, among other things, the creditor under our Loan Agreement and Convertible Notes agreed to waive any event of default resulting from our failure to satisfy the net sales milestones for the Eligen B12™ product for the 2016 fiscal year and all future periods specified in our Loan Agreement and Convertible Notes. The creditor also agreed to irrevocably waive the Company’s obligation to pre-pay $7 million of certain loans and notes resulting from the $14 million cash receipt from Novo Nordisk.

Management has concluded that due to the conditions described above, there is substantial doubt about the entity’s ability to continue as a going concern through March 30, 2018. We have evaluated the significance of the conditions in relation to our ability to meet our obligations and believe that our current cash balance will provide sufficient capital to continue operations through approximately March 2018. While our plan is to raise capital from commercial operations and/or product partnering opportunities to address our capital deficiencies and meet our operating cash requirements, there is no assurance that our plans will be successful. If we fail to generate sufficient capital from commercial operations or partnerships, we will need to seek capital from other sources and risk default under the terms of our existing loans. We cannot assure you that financing will be available on favorable terms or at all. Additionally, if additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities would result in dilution to our existing stockholders. Furthermore, despite our optimism regarding the Eligen ® Technology, even in the event that the Company is adequately funded, there is no guarantee that any of our products or product candidates will perform as hoped or that such products can be successfully commercialized.

2.    Summary of Significant Accounting Policies

Use of Estimates.     The preparation of financial statements in accordance with accounting principles generally accepted in the U.S. involves the use of estimates and assumptions that affect the recorded amounts of assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses and performance period for revenue recognition. Actual results may differ substantially from these estimates. Significant estimates include accrued expenses, the variables and method used to calculate stock-based compensation, derivative instruments and deferred taxes.

Reclassification .    Certain prior year amounts have been reclassified to conform to current year presentation.

Concentration of Credit Risk.     Financial instruments, which potentially subject us to concentrations of credit risk, consist of cash, cash equivalents, restricted cash and investments. We invest excess funds in accordance with a policy objective seeking to preserve both liquidity and safety of principal. We generally invest our excess funds in obligations of the U.S. government and its agencies, bank deposits, money market funds, and investment grade debt securities issued by corporations and financial institutions. We hold no collateral for these financial instruments. Concentration of credit risk with respect to our trade accounts receivable from our customers is primarily limited to drug wholesalers and retail pharmacies. Credit is extended to our customers based on an evaluation of a customer’s financial condition, and collateral is not required.

Cash, Cash Equivalents, and Investments.     We consider all highly liquid, interest-bearing instruments with original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents may include demand deposits held in banks and interest bearing money market funds. Our investment policy requires that commercial paper be rated A-1, P-1 or better by either Standard and Poor’s Corporation or Moody’s Investor Services or another nationally recognized agency and that securities of issuers with a long-term credit rating must be rated at least “A” (or equivalent). As of December 31, 2016, we held no investments.

Trade Accounts Receivable and Allowance for Doubtful Accounts.     Trade accounts receivable are customer obligations due under normal trade terms. We review accounts receivable for uncollectible accounts and provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. We consider trade accounts receivable past due for more than

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

90 days to be delinquent. We write off delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers. We record recoveries of accounts previously written off when received as an increase in the allowance for doubtful accounts. To the extent data we use to calculate these estimates does not accurately reflect bad debts; adjustments to these reserves may be required. The allowance for doubtful accounts at December 31, 2016 and 2015 was $6 thousand $9 thousand, respectively.

Inventory.     Inventories are stated at the lower of cost or market determined by the first in, first out method. The Company’s inventories are analyzed for slow moving and expired items no less frequently than quarterly and the valuation allowance is adjusted as required. Provisions are recorded for excess inventory which requires management’s judgment. Conditions impacting the realizability of inventory could cause actual write-offs to be materially different than provisions for excess inventory. As of December 31, 2016 and 2015, inventory reserves amounted to $0.6 million and $0.7 million.

Impairment of Long-Lived Assets.     In accordance with FASB ASC 360-10-35, we review our long-lived assets for impairment whenever events and circumstances indicate that the carrying value of an asset might not be recoverable. An impairment loss, measured as the amount by which the carrying value exceeds the fair value, is recognized if the carrying amount exceeds estimated undiscounted future cash flows.

Equipment and Leasehold Improvements.     Equipment and leasehold improvements are stated at cost. Depreciation and amortization are provided on a straight-line basis over the estimated useful life of the asset. Leasehold improvements are amortized over the term of the lease or useful life of the improvements, whichever is shorter. Expenditures for maintenance and repairs that do not materially extend the useful lives of the respective assets are charged to expense as incurred. The cost and accumulated depreciation or amortization of assets retired or sold are removed from the respective accounts and any gain or loss is recognized in operations.

Deferred Lease Liability.     Our leases provide for rental holidays and escalations of the minimum rent during the lease term, as well as additional rent based upon increases in real estate taxes and common maintenance charges. We record rent expense from leases with rental holidays and escalations using the straight-line method, thereby prorating the total rental commitment over the term of the lease. Under this method, the deferred lease liability represents the difference between the minimum cash rental payments and the rent expense computed on a straight-line basis.

Revenue Recognition.     We recognize revenue in accordance with FASB ASC 605-10-S99, Revenue Recognition.

Oral Eligen B12™ Rx Product

We sell our Oral Eligen B12™ Rx product through drug wholesalers and retail pharmacies. We recognize revenue from prescription product sales, net of sales discounts, chargebacks, and rebates. We accept returns of unsalable product from customers within a return period of six months prior to and 12 months following product expiration. Our Oral Eligen B12™ Rx product currently has a shelf life of 36 months from the date of manufacture. Given the limited history of our Oral Eligen B12™ Rx product, we currently cannot reliably estimate expected returns of the prescription products at the time of shipment. Accordingly, we defer recognition of revenue on prescription products until the right of return no longer exists, which occurs at the earlier of the time the Oral Eligen B12™ Rx product is dispensed through patient prescriptions or expiration of the right of return.

Collaborative Agreements and Feasibility Studies

Revenue earned from collaborative agreements and feasibility studies is comprised of reimbursed research and development costs, as well as upfront and research and development milestone payments. Deferred revenue represents payments received which are related to future performance. Revenue from feasibility studies, which are typically short term in nature, is recognized upon delivery of the study, provided that all other revenue recognition criteria are met.

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

Revenue from collaboration agreements are recognized using the proportional performance method provided that we can reasonably estimate the level of effort required to complete our performance obligations under an arrangement and such performance obligations are provided on a best effort basis and based on “expected payments.” Under the proportional performance method, periodic revenue related to nonrefundable cash payments is recognized as the percentage of actual effort expended to date as of that period to the total effort expected for all of our performance obligations under the arrangement. Actual effort is generally determined based upon actual hours incurred and include research and development (“R&D”) activities performed by us and time spent for Joint Steering Committee (“JSC”) activities. Total expected effort is generally based upon the total R&D and JSC hours incorporated into the project plan that is agreed to by both parties to the collaboration. Significant management judgments and estimates are required in determining the level of effort required under an arrangement and the period over which we expect to complete the related performance obligations. Estimates of the total expected effort included in each project plan are based on historical experience of similar efforts and expectations based on the knowledge of scientists for both the Company and its collaboration partners. The Company periodically reviews and updates the project plan for each collaborative agreement. The most recent reviews took place in January 2017. In the event that a change in estimate occurs, the change will be accounted for using the cumulative catch-up method which provides for an adjustment to revenue in the current period. Estimates of our level of effort may change in the future, resulting in a material change in the amount of revenue recognized in future periods.

Generally, under collaboration arrangements, nonrefundable payments received during the period of performance may include time- or performance-based milestones. The proportion of actual performance to total expected performance is applied to the “expected payments” in determining periodic revenue. However, revenue is limited to the sum of (i) the amount of nonrefundable cash payments received and (ii) the payments that are contractually due but have not yet been paid.

With regard to revenue recognition in connection with development and license agreements that include multiple deliverables, Emisphere’s management reviews the relevant terms of the agreements and determines whether such deliverables should be accounted for as a single unit of accounting in accordance with FASB ASC 605-25, Multiple-Element Arrangements . If it is determined that a delivered license and Eligen ® Technology do not have stand-alone value and Emisphere does not have objective evidence of fair value of the undelivered Eligen ® Technology or the manufacturing value of all the undelivered items, then such deliverables are accounted for as a single unit of accounting and any payments received pursuant to such agreement, including any upfront or development milestone payments and any payments received for support services, will be deferred and included in deferred revenue within our balance sheet until such time as management can estimate when all of such deliverables will be delivered, if ever. Management reviews and reevaluates such conclusions as each item in the arrangement is delivered and circumstances of the development arrangement change. See Note 12 for more information about the Company’s accounting for revenue from specific development and license agreements.

Research and Development and Clinical Trial Expenses.     Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, maintenance of research equipment, costs related to research collaboration and licensing agreements, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drug for use in research, pre-clinical development, and clinical trials. All costs associated with research and development are expensed as incurred.

Clinical research expenses represent obligations resulting from our contracts with various research organizations in connection with conducting clinical trials for our product candidates. We account for those expenses on an accrual basis according to the progress of the trial as measured by patient enrollment and the timing of the various aspects of the trial. Accruals are recorded in accordance with the following methodology:

 

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(i) the costs for period expenses, such as investigator meetings and initial start-up costs, are expensed as incurred based on management’s estimates, which are impacted by any change in the number of sites, number of patients and patient start dates; (ii) direct service costs, which are primarily ongoing monitoring costs, are recognized on a straight-line basis over the life of the contract; and (iii) principal investigator expenses that are directly associated with recruitment are recognized based on actual patient recruitment. All changes to the contract amounts due to change orders are analyzed and recognized in accordance with the above methodology. Change orders are triggered by changes in the scope, time to completion and the number of sites. During the course of a trial, we adjust our rate of clinical expense recognition if actual results differ from our estimates.

Income Taxes.     Deferred tax liabilities and assets are recognized for the expected future tax consequences of events that have been included in the financial statements or tax returns. These liabilities and assets are determined based on differences between the financial reporting and tax basis of assets and liabilities measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is recognized to reduce deferred tax assets to the amount that is more likely than not to be realized. In assessing the likelihood of realization, management considered estimates of future taxable income.

Stock-Based Employee Compensation.     We recognize expense for our share-based compensation based on the fair value of the awards at the time they are granted. We estimate the value of stock option awards on the date of grant using the Black-Scholes model. The determination of the fair value of share-based payment awards on the date of grant is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include our expected stock price volatility over the term of the awards, expected term, risk-free interest rate, expected dividends and expected forfeiture rates. The forfeiture rate is estimated using historical option cancellation information, adjusted for anticipated changes in expected exercise and employment termination behavior. Our outstanding awards do not contain market or performance conditions therefore we have elected to recognize share-based employee compensation expense on a straight-line basis over the requisite service period.

Advertising Expenses.     We expense advertising costs as incurred. Advertising expense was approximately $0.3 million, $0.7 million and $0.0 million, during the years ended December 31, 2016, 2015 and 2014, respectively and is included in selling expenses on the Statement of Operations.

Fair Value of Financial Instruments.     The carrying amounts for cash, cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate fair value because of their short-term nature. At December 31, 2016, the carrying value of the Second Amended and Restated Convertible Notes, Second Amended and Restated Reimbursement Notes, Second Amended and Restated Bridge Notes and Loan Agreement was $67.6 million, which reflects its original cost plus accrued interest. See Note 7 for further discussion of the notes payable.

Derivative Instruments.     Derivative instruments consist of common stock warrants, and certain instruments embedded in certain notes payable and related agreements. These financial instruments are recorded in the balance sheets at fair value as liabilities. Changes in fair value are recognized in earnings in the period of change.

Fair Value Measurements.     The authoritative guidance for fair value measurements defines fair value as the price that would be received if an asset were to be sold or paid to transfer a liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance describes a fair value hierarchy based on the levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following:

 

   

Level 1 — Quoted prices in active markets for identical assets or liabilities

 

   

Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are

 

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observable or corroborated by observable market data for substantially the full term of the assets or liabilities

 

   

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the value of the assets or liabilities

Future Impact of Recently Issued Accounting Standards

In April 2015, the FASB issued ASU 2015-03, “Interest — Imputation of Interest” (“ASU 2015-03”), which requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected by the amendments in this ASU. ASU 2015-03 is effective for annual and interim periods beginning on or after December 15, 2015. The adoption of ASU 2015-03 did not have a material impact on our financial position, results of operations or cash flows.

In August 2014, the FASB issued ASU No. 2014-15, “Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”), which provides guidance on management’s responsibility in evaluating whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. ASU 2014-15 is effective for the annual period ending after December 15, 2016, and for annual and interim periods thereafter. The adoption of ASU 2014-15 did not have a material impact on our financial position, results of operations or cash flows.

In July 2015, the FASB issued ASU No. 2015-11, “Simplifying the Measurement of Inventory” (“ASU 2015-11”). ASU 2015-11 requires that inventory within the scope of the guidance be measured at the lower of cost and net realizable value. Inventory measured using last-in, first-out and retail inventory method are excluded from this new guidance. This ASU replaces the concept of market with the single measurement of net realizable value and is intended to create efficiencies for preparers and more closely aligns U.S. GAAP with IFRS. This ASU is effective for public business entities in fiscal years beginning after December 15, 2016, including interim periods within those years. Prospective application is required and early adoption is permitted as of the beginning of an interim or annual reporting period. The adoption of ASU 2015-11 is not expected to have a material impact on our financial position, results of operations or cash flows.

In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”), which requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. ASU 2014-09 is effective for the first interim period within an annual period beginning after December 15, 2017. The new guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. Adoption can occur using one of two prescribed transition methods. In 2016, the FASB issued four amendments to ASU 2014-09. We have begun a limited evaluation of the provisions of ASU 2014-09 and the impact, if any; it may have on our financial position and results of operations. Our evaluation work to date includes the training of ASU 2014-09, contract review and an assessment of the distribution model for which we recognize revenue for our Eligen B12™ products. We have a small number of contracts which require an assessment and believe we have sufficient time for the implementation of ASU 2014-09.

During January 2016, the FASB issued ASU No. 2016-01, “Financial Instruments — Overall: Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”). The standard addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. This ASU is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. Early adoption is not permitted with the exception of certain provisions related to the presentation of other comprehensive income. The adoption of ASU 2016-01 is not expected to have a material impact on our financial position, results of operations or cash flows.

 

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During February 2016, the FASB issued ASU No. 2016-02, “Leases” (“ASU 2016-02”). The standard requires lessees to recognize a lease liability and a lease asset for all leases, including operating leases, with a term greater than 12 months on its balance sheet. The update also expands the required quantitative and qualitative disclosures surrounding leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The adoption of ASU 2016-02 is not expected to have a material impact on our financial position, results of operations or cash flows due to an insignificant number of leases that the Company has entered into.

In March 2016, the FASB issued ASU No. 2016-06, “Contingent Put and Call Option in Debt Instruments” (“ASU 2016-06”). ASU 2016-06 is intended to simplify the analysis of embedded derivatives for debt instruments that contain contingent put or call options. The amendments in ASU 2016-06 clarify that an entity is required to assess the embedded call or put options solely in accordance with the four-step decision sequence. Consequently, when a call (put) option is contingently exercisable, an entity does not have to initially assess whether the event that triggers the ability to exercise a call (put) option is related to interest rates or credit risks. The amendments in ASU 2016-06 take effect for public business entities for financial statements issued for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. The Company does not expect the adoption of ASU 2016–01 to have a significant impact on its financial statements.

In March 2016, FASB issued ASU No. 2016-09, “Improvements to Employee Share-based Payment Accounting” (“ASU 2016-09”). ASU 2016-09 simplifies several aspects of the accounting for employee share-based payment transactions for both public and nonpublic entities, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. ASU 2016-09 is effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods. The adoption of ASU 2016-09 is not expected to have a material impact on our financial position, results of operations or cash flows.

In August 2016, FASB issued ASU No. 2016-15, “Classification of Certain Cash Receipts and Cash Payments” (“ASU 2016-15”). ASU 2016-15 clarifies the presentation and classification of certain cash receipts and cash payments in the statement of cash flows. ASU 2016-15 is effective for fiscal years, and interim periods within those years beginning after December 15, 2017. Early adoption is permitted. The Company does not expect the adoption of ASU No. 2016-15 to have a material impact on its financial statements.

Management does not believe there would have been a material effect on the accompanying financial statements had any other recently issued, but not yet effective, accounting standards been adopted in the current period.

3.    Inventory

Inventory consists of the following:

 

       December 31,  
     2016      2015  
     (In thousands)  

Raw Materials

   $      $ 558  

Finished Goods

     67        782  
  

 

 

    

 

 

 
   $ 67      $ 1,340  
  

 

 

    

 

 

 

 

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4.    Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:

 

     December 31,  
     2016      2015  
     (In thousands)  

Prepaid corporate insurance

   $ 86      $ 93  

Deposit on inventory

            184  

Prepaid expenses and other current assets

     21        804  
  

 

 

    

 

 

 
   $ 107      $ 1,081  
  

 

 

    

 

 

 

5.    Fixed Assets

Equipment and leasehold improvements, net, consists of the following:

 

     December 31,         
     Useful Lives in Years      2016      2015  
            (In thousands)  

Equipment

     3-7      $ 9      $ 601  

Leasehold improvements

     Term of lease        27        27  
     

 

 

    

 

 

 
        36        628  

Less, accumulated depreciation and amortization

        36        616  
     

 

 

    

 

 

 
      $      $ 12  
     

 

 

    

 

 

 

Depreciation expense for the years ended December 31, 2016, 2015 and 2014, was $12 thousand, $14 thousand and $15 thousand, respectively.

6.    Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consist of the following:

 

     December 31,  
     2016      2015  
     (In thousands)  

Accounts payable

   $ 638      $ 1,762  

Accrued legal, professional fees and other

     202        304  

Accrued vacation

     29        55  
  

 

 

    

 

 

 
   $ 869      $ 2,121  
  

 

 

    

 

 

 

 

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NOTES TO FINANCIAL STATEMENTS — (Continued)

 

7.    Notes Payable

Notes payable, net of related discounts, consists of the following:

 

     December 31,
2016
     2015  
     (in thousands)  

Convertible Notes

   $ 40,699      $ 37,450  

Loan Agreement

     26,004        22,801  

Reimbursement Notes

     795        755  

Bridge Notes

     91        166  
  

 

 

    

 

 

 
     67,589        61,172  

Less: Current portion

            7,000  
  

 

 

    

 

 

 

Non-current Notes payable, net of related discounts

   $ 67,589      $ 54,172  
  

 

 

    

 

 

 

Loan Agreement. On August 20, 2014, the Company entered into a series of agreements (the “Transaction Documents”) with MHR Capital Partners Master Account LP, MHR Capital Partners (100) LP, MHR Institutional Partners II LP, and MHR Institutional Partners IIA LP, (collectively, “MHR” or the “Lenders”), for a new loan facility, an extension of the Company’s existing obligations under various promissory notes previously issued to the Lenders, and for payment by the Company of certain royalties to MHR (the “Transaction”).

In 2014, we accounted for the modifications to the Company’s obligations to MHR evidenced by the MHR Notes as a troubled debt restructuring under FASC ASC 470-60. As there was only a modification of terms to the existing debt and we did not transfer any assets or equity in a settlement to MHR no gain or loss was recorded on the transaction. The change in cash outflows resulting from the modification of terms are accounted for on a prospective basis.

Additional fees paid by Emisphere in connection with the Loan Agreement, MHR Notes and the Royalty Agreement included the reimbursement of $0.3 million of MHR’s professional fees associated with the transaction, which was recorded as interest expense for the year ended December 31, 2014.

The Loan Agreement provided for, among other things, a commitment (the “Commitment”) of the Lenders to loan the Company up to $20 million to finance the development, manufacturing, marketing and sale of oral Eligen B12™ Rx (the “B12 Product”). The Loan Agreement provided for five borrowings (each, a “Borrowing”, and collectively, the “Loan”). The first Borrowing occurred on August 20, 2014 in an original principal amount of $5 million, the second occurred on November 4, 2014, in an original principal amount of $3 million, the third occurred on January 6, 2015 in an original principal amount of $5.0 million, the fourth occurred on April 6, 2015 in an original principal amount of $5.0 million, and the fifth and final borrowing occurred on July 1, 2015 in an original principal amount of $2.0 million.

The Loan will mature on the earlier of (a) December 31, 2019, and, (b) 30 days after the end of any fiscal year in which the Company’s cash (plus certain cash expenditures during such fiscal year that are unrelated to the B12 Product or related products) as of the end of such fiscal year (subject to certain permitted deductions) is more than three times the principal amount of the Loan as of the end of such fiscal year. The Loan bears interest at a rate of 13% per annum (the “Interest Rate”), compounded monthly, and will be payable in kind and in arrears on June 30 and December 31 of each year up to and including the maturity date by increasing the outstanding principal amount of the Loan by the amount of each such interest payment. So long as an event of default under the Loan Agreement (an “Event of Default”) has occurred and is continuing, at the election of MHR, interest shall accrue on the Loan at a rate equal to 2% per annum above the Interest Rate (“Default Rate”). Interest at the

 

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Default Rate shall accrue from the initial date of such Event of Default until that Event of Default is cured or waived in writing and shall be payable upon demand and, if not paid when due, shall itself bear interest at the Default Rate. The Loan Agreement provides for certain representations and warranties, affirmative and negative covenants of the Company and Events of Default.

In connection with the entry into the Loan Agreement, on August 20, 2014, the Lenders and the Company further amended and restated (i) the Convertible Notes issued by the Company to certain of the Lenders, (ii) the Bridge Notes issued by the Company to certain of the Lenders, and (iii) the Reimbursement Notes (and, together with the Convertible Notes and Bridge Notes, the “MHR Notes”). Also, in connection with the entry into the Loan Agreement and the amendment and restatement of the MHR Notes, Institutional Partners IIA and the Company have amended the Pledge and Security Agreement, dated September 26, 2005, as amended, by and between the Company and Institutional Partners IIA to, among other things, secure the Reimbursement Notes and payments due under the Loan Agreement with substantially all of the Company’s assets, and secure the payments due under the Royalty Agreement and Paid-In-Kind Royalties due under the Loan Agreement with the Company’s intellectual property relating to the B12 Products and related products. As of December 31, 2016, the principal balance of the Loan agreement was approximately $26.0 million.

Convertible Notes. On September 26, 2005, we received net proceeds of approximately $12.9 million under a $15 million secured loan agreement (the “2005 Loan Agreement”) executed with MHR. Under the 2005 Loan Agreement, MHR requested, and on May 16, 2006, we effected, the exchange of the loan from MHR for the predecessor of the Convertible Notes, which were 11% senior secured convertible notes with substantially the same terms as the 2005 Loan Agreement, except that the original Convertible Notes were convertible, at the sole discretion of MHR, into shares of our common stock at a price per share of $3.78. In connection with the original Convertible Notes exchange, the Company agreed to appoint a representative of MHR (the “MHR Nominee”) and another person (the “Mutual Director”) to the Board. Further, the Company agreed to amend, and in January 2006 did amend, its certificate of incorporation to provide for continuity of the MHR Nominee and the Mutual Nominee on the Board so long as MHR holds at least 2% of the outstanding common stock of the Company. The original Convertible Notes were amended and restated on May 7, 2013 and amended and restated a second time on August 20, 2014 as described below.

The August 20, 2014 amended and restated Convertible Notes provide for a maturity date of March 31, 2022 (subject to acceleration upon the occurrence of certain specified events of default, including the failure to meet certain sales, performance, and manufacturing milestones specified in the Convertible Notes). The interest rate is 13% per annum, compounded monthly, which interest will be payable in the form of additional Convertible Notes. The Convertible Notes are collateralized by a first priority lien in favor of the Lenders on substantially all of the Company’s assets. After all principal and interest under the Loan Agreement and Reimbursement Notes are repaid, the remaining Convertible Notes must be redeemed from time to time prior to maturity pursuant to a cash sweep of 50% of the Company’s adjusted consolidated free cash flow (75% of the Company’s adjusted consolidated free cash flow in any year in which the Company’s adjusted consolidated free cash flow exceeds $50 million) to the extent such cash sweep does not cause the Company’s cash as of the end of such year to be less than the Minimum Cash Balance. The Convertible Notes are convertible, at the option of the holders, at a conversion price of $1.25 per share of common stock, which conversion price is subject to adjustment upon the occurrence of specified events, including stock dividends, stock splits, certain fundamental corporate transactions, and certain issuances of common stock by the Company. The Convertible Notes must also be redeemed from time to time prior to maturity pursuant to (a) a cash sweep of 50% of any cash proceeds received from any third party in connection with the license, distribution or sale of any Non-B12 Product, and (b) a Royalty Match (as described below), to the extent such Royalty Match does not cause the Company’s cash as of the end of such year to be less than the Minimum Cash Balance and subject to the priority described below. If we fail to meet our obligations under the terms of the Convertible Notes, or fail to meet any of the sales, operating or manufacturing performance criteria included in the Convertible Notes, we would be in default under these notes, which would give MHR the option of foreclosing on substantially all of our assets. As of

 

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December 31, 2016, the principal balance of the Convertible Notes was approximately $53.0 million; and the Convertible Notes were convertible into 42,373,002 shares of our common stock.

The Company was required to satisfy annual net sales targets of Eligen B12™ by December 31 for each fiscal year beginning 2015 through 2019 pursuant to the terms of the Loan Agreement and Convertible Notes. Failure to satisfy the sales targets will result in an event of default under these instruments, provided that the Company is not granted a waiver. On November 10, 2015, the Lenders agreed to waive any event of default resulting from the failure to satisfy the net sales milestones for the Eligen B12™ product for the 2015 fiscal year specified in the Loan Agreement and Convertible Notes (See “December 2016 Debt Modification”, below”).

Reimbursement Notes. On June 8, 2010, the Company issued the predecessor to the Reimbursement Notes to MHR in the form of certain non-interest bearing promissory notes in the aggregate principal amount of $600,000 in reimbursement for legal expenses incurred by MHR in connection with MHR’s agreement to, among other things, waive certain rights as a senior secured party of the Company and enter into a non-disturbance agreement with the Company’s collaboration partner Novartis Pharma AG, and, if necessary, to enter into a comparable agreement in connection with another potential Company transaction. The original Reimbursement Notes were amended and restated on May 7, 2013 and amended and restated again on August 20, 2014 as described below.

The Reimbursement Notes provide for a maturity date of the earlier of (a) March 31, 2022 and (b) immediately prior to the time that any amounts outstanding under the Loan Agreement are repaid (subject to acceleration upon the occurrence of certain events of default specified in the Reimbursement Notes), and bear interest at the rate of 10% per annum, compounded monthly, which interest is payable in the form of additional Reimbursement Notes. The Reimbursement Notes are collateralized by a first priority lien in favor of the Lenders on substantially all of the Company’s assets. The Reimbursement Notes are convertible, at the option of the holders, at a conversion price of $0.50 per share of common stock, which conversion price is subject to adjustment upon the occurrence of specified events, including stock dividends, stock splits, certain fundamental corporate transactions, and certain issuances of common stock by the Company. As of December 31, 2016, the principal balance of the Reimbursement Notes was $0.8 million; and the Reimbursement Notes were convertible into 1,671,632 shares of our common stock.

Bridge Notes. On October 17, 2012, the Company issued to MHR the predecessor to the Bridge Notes in the aggregate principal amount of $1,400,000. The original Bridge Notes provided for an interest rate of 13% per annum and were payable on demand. The Bridge Notes were amended and restated on May 7, 2013 and restated again on August 20, 2014 as described below.

The Bridge Notes provide for a maturity date of March 31, 2022 (subject to acceleration upon the occurrence of certain events of default specified) and bear interest at 13% per year, compounded monthly and payable in the form of additional Bridge Notes. The Bridge Notes are collateralized by a first priority lien in favor of the Lenders on substantially all of the Company’s assets. The Bridge Notes are convertible, at the option of the holders, at a conversion price of $0.50 per share of common stock, which conversion price is subject to adjustment upon the occurrence of specified events, including stock dividends, stock splits, certain fundamental corporate transactions, and certain issuances of common stock by the Company. As of December 31, 2016, the principal balance of the Bridge Notes was approximately $2.4 million; and the Bridge Notes were convertible into 4,824,006 shares of our common stock.

Royalty Agreement. As a condition to MHR entering into the Loan Agreement and amending and restating the MHR Notes, the Company and MHR entered into a Royalty Agreement (the “Royalty Agreement”) on August 20, 2014, pursuant to which the Company agreed to pay to MHR, subject to specified terms and conditions, royalties in perpetuity (the “Royalties”), commencing as of the date of the Royalty Agreement, in an amount equal to: twenty percent (20%) of all Net Product Sales (as defined in the Royalty Agreement) and any third party payments arising in connection with the sale of the B12 Product and related products, during any fiscal year. Under certain conditions including the full settlement of the Loan Agreement, the royalty rate may reduce to 5% or 2.5%.

 

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NOTES TO FINANCIAL STATEMENTS — (Continued)

 

If the Company does not have sufficient cash in excess of the Minimum Cash Balance to pay any Royalties that become due under the Royalty Agreement in cash, such Royalties will be paid as an additional Loan under the Loan Agreement by increasing the principal amount outstanding under the Loan Agreement (any such Loan, “Paid-In-Kind Royalties”). The “Minimum Cash Balance” generally means cash on hand of at least $10 million (or $15 million, under certain circumstances beginning as early as October 1, 2015). On December 31, 2015, the Company had a $12.9 million cash balance, greater than the $10 million Minimum Cash Balance as defined under the Loan Agreement, therefore $0.2 million Royalties payable under the Royalty Agreement for 2015 were due in cash. In December 2016, the accrued Royalties for 2015 were forgiven (see below). As of December 31, 2016, the Company accrued $0.2 million of Royalties. Such Royalties will be paid in 2017 by increasing the principal amount outstanding under the Loan Agreement.

December 2016 Debt Modifications . On October 26, 2015, the Company received a total payment of $14 million from Novo Nordisk pursuant to, and consisting of, $5 million as payment for entry into the Expansion License Agreement and $9 million as payment in connection with the third amendment to the GLP-1 License Agreement. Under the terms of our loan agreements with MHR, we were obligated to pre-pay certain loans and notes using 50% of any such extraordinary receipts. On December 8, 2016, the Company entered a series of agreements with MHR pursuant to which MHR agreed to (1) waive the Company’s obligation to pre-pay $0.8 million of the Reimbursement Notes and $6.2 million of the Loans in connection with the $14 million of cash proceeds from Novo Nordisk, (2) waive any and all rights to the Royalties for the year ended December 31, 2015, (3) waive the cash sweep of 50% of any cash proceeds received from any third party in connection with the license, distribution or sale of any of the Company’s products other than B12 Product or related products if such proceeds are actually received by the Company prior to the earlier of (i) October 31, 2018 and (ii) the date immediately following the date that the Company actually receives such proceeds during any consecutive twelve month period in excess of $5 million in the aggregate, (4) waive any events of default as a result of the Company’s failure to meet the Eligen B12™ net sales targets that have already occurred or may occur in the future, (5) forgive an amount equal to $7 million of the outstanding principal of the Loan Agreement upon the first commercial sale in the United States or European Union (including the United Kingdom) of a Licensed product under the GLP-1 License Agreement with Novo Nordisk.

In consideration of the above modifications, the Company granted to MHR, among other things, a portion of any royalties payable under the terms of the GLP-1 Agreement equal to 0.5% of net sales for any licensed product subject to the GLP -1 Agreement. The GLP-1 Agreement was amended to provide that, among other things, Novo Nordisk will pay such 0.5% royalties directly to MHR.

The above debt modifications were accounted for as a troubled debt restructuring under FASC ASC 470-60. As there was only a modification of terms to the existing debt and we did not transfer any assets or equity in a settlement to MHR no gain or loss was recorded on the transaction. The change in cash outflows resulting from the modification of terms are accounted for on a prospective basis.

Direct costs incurred by Emisphere in connection with the above modifications were $0.4 million which was recorded as interest expense for the year ended December 13, 2016. As MHR is a related party, the forgiveness of the 2015 royalty accrual of $0.2 million was recorded in additional paid-in capital as a capital contribution.

 

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NOTES TO FINANCIAL STATEMENTS — (Continued)

 

The carrying value of the MHR Obligations is comprised of the following:

 

     December 31,  
     2016      2015  
     (in thousands)  

Amended and Restated Convertible Notes

   $ 52,966      $ 46,542  

Loan Agreement

     26,004        22,801  

Amended and Restated Reimbursement Notes

     836        755  

Amended and Restated Bridge Notes

     2,412        2,155  

Unamortized discounts

     (14,629 )      (11,041
  

 

 

    

 

 

 
   $ 67,589      $ 61,172  
  

 

 

    

 

 

 

8.    Derivative Instruments

Derivative instruments consist of the following:

 

     December 31,  
     2016      2015  
     (in thousands)  

Convertible Notes

   $ 30,559      $ 30,823  

Reimbursement Notes

     1,105        1,118  

Bridge Notes

     3,187        3,130  

Amended and Restated August 2009 Warrants

     1,412        2,142  

Amended and Restated June 2010 MHR Warrants

     344        552  

Amended and Restated August 2010 Warrants

     993        1,507  

Amended and Restated August 2010 MHR Waiver Warrants

     369        560  

Amended and Restated July 2011 Warrants

     1,139        1,729  

July 2011 Investor Warrants*

            205  

Amended and Restated July 2011 MHR Waiver Warrants

     301        456  

May 2013 MHR Modification Warrants

     3,785        5,744  
  

 

 

    

 

 

 
   $ 43,194      $ 47,966  
  

 

 

    

 

 

 

 

* Expired in July of 2016

Some of the Company’s outstanding derivative instruments have an exercise price reset feature. The estimated fair value of warrants and embedded conversion features that have an exercise price reset feature is estimated using the Monte Carlo valuation model. The estimated fair value of warrants that do not contain an exercise price reset feature is measured using the Black-Scholes valuation model. Inherent in both of these models are assumptions related to expected volatility, remaining life, risk-free rate and expected dividend yield. For the Monte Carlo model, we estimate the probability and timing of potential future financing and fundamental transactions as applicable.

Embedded Conversion Feature of MHR Notes. The Convertible Notes, the Reimbursement Notes, and the Bridge Notes (collectively, the “MHR Notes”) contain a provision whereby the conversion price is adjustable upon the occurrence of certain events, including the issuance by Emisphere of common stock or common stock equivalents at a price which is lower than the current conversion price of each of the MHR Notes and lower than the then-current market price. Under FASB ASC 815-40-15-5, the embedded conversion feature of the MHR Notes is not considered indexed to the Company’s own stock and, therefore, does not meet the scope exception in

 

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NOTES TO FINANCIAL STATEMENTS — (Continued)

 

FASB ASC 815-10-15 and thus needs to be accounted for as a derivative liability. The liability associated with the MHR Notes has been presented as a non-current liability as of December 31, 2016 and 2015 to correspond to their host contract.

Convertible Notes . In addition to the foregoing, the adjustment provision of the Convertible Notes does not become effective unless and until the Company were to raise $10 million through the issuance of common stock or common stock equivalents during any consecutive 24-month period. The fair value of the embedded conversion feature of the Convertible Notes is estimated at the end of each quarterly reporting period using the Monte Carlo model. The assumptions used in computing the fair values as December 31, 2016 and 2015 are as follows:

 

     December 31,
2016
    December 31,
2015
 

Closing stock price

   $ 0.60     $ 0.68  

Conversion price

   $ 1.25     $ 1.25  

Expected volatility

     146     143

Remaining term (years)

     5.25       6.25  

Risk-free rate

     1.95     1.95

Expected dividend yield

     0     0

The fair value of the embedded conversion feature of the Convertible Notes decreased $4.3 million for the year ended December 31, 2016 and increased $5.7 million and $8.9 million for the years ended December 31, 2015 and 2014, respectively, which amounts have been recognized in the accompanying statements of operations.

Reimbursement Notes . The fair value of the embedded conversion feature of the Reimbursement Notes is estimated at the end of each quarterly reporting period using the Monte Carlo model. The assumptions used in computing the fair value as of December 31, 2016 and 2015 are as follows:

 

     December 31,
2016
    December 31,
2015
 

Closing stock price

   $ 0.60     $ 0.68  

Conversion price

   $ 0.50     $ 0.50  

Expected volatility

     146     143

Remaining term (years)

     5.25       6.25  

Risk-free rate

     1.95     1.95

Expected dividend yield

     0     0

The fair value of the embedded conversion of the Reimbursement Notes decreased $0.1 million for the year ended December 31, 2016 and increased $0.3 and $0.7 million for the years ended December 31, 2016 and 2015, respectively, which has been recognized in the accompanying statements of operations.

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

Bridge Notes . The fair value of the embedded conversion feature of the Bridge Notes is estimated at the end of each quarterly reporting period using the Monte Carlo model. The assumptions used in computing the fair value as of December 31, 2016 and 2015 are as follows:

 

     December 31,
2016
    December 31,
2015
 

Closing stock price

   $ 0.60     $ 0.68  

Conversion price

   $ 0.50     $ 0.50  

Expected volatility

     146     143

Remaining term (years)

     5.25       6.25  

Risk-free rate

     1.95     1.95

Expected dividend yield

     0     0

The fair value of the embedded conversion feature of the Bridge Notes decreased $0.2 million for the year ended December 31, 2016 and increased $0.8 million and $0.7 million for the years ended December 31, 2015 and 2014, respectively, which has been recognized in the accompanying statements of operations.

Amended and Restated June 2010 Warrants. In June 2010, the Company granted MHR warrants to purchase 865,000 shares of its common stock (the “June 2010 Warrants”). In connection with the Restructuring, on May 7, 2013, the Company amended and restated the Original Warrants such that the expiration date of the Original Warrant was extended to July 8, 2019, and the exercise price was reduced to $0.50 per share (as amended and restated, the “Amended and Restated August 2010 Warrants”). The exercise price of the Amended and Restated June 2010 Warrants is adjustable upon the occurrence of certain events, including the issuance by Emisphere of common stock or common stock equivalents at a price which is lower than the current exercise price of these warrants and lower than the current market price. However, the adjustment provision does not become effective unless the Company were to raise $10 million through the issuance of common stock or common stock equivalents at a price which is lower than the current conversion price of these warrants and lower than the current market price during any consecutive 24-month period. The fair value of the Amended and Restated June 2010 Warrants is estimated at the end of each quarterly reporting period using the Monte Carlo model. The assumptions used in computing the fair value of the Amended and Restated June 2010 Warrants as of December 31, 2016 and 2015, are as follows:

 

     December 31,
2016
    December 31,
2015
 

Closing stock price

   $ 0.60     $ 0.68  

Conversion price

   $ 0.50     $ 0.50  

Expected volatility

     103     136

Remaining term (years)

     2.52       3.52  

Risk-free rate

     1.33     1.42

Expected dividend yield

     0     0

The fair value of the Amended and Restated June 2010 MHR Warrants decreased $0.2 million for the year ended December 31, 2016 and increased $.3 million and $32 thousand for the years ended December 31, 2015 and 2014, respectively. These fluctuations have been recognized in the accompanying statements of operations.

Amended and Restated Warrants. Prior to the Restructuring, the Company issued to MHR warrants to purchase varying amounts of its common stocks at various times from 2009 through 2011, as described more fully below (the August 2009 Warrants, August 2010 Warrants, August 2010 MHR Waiver Warrants, July 2011 Warrants, July 2011 MHR Waiver Warrants, and collectively, the “Original Warrants”). In connection with the Restructuring, on May 7, 2013, the Company amended and restated each of the Original Warrants such that the expiration date of each Original Warrant was extended to July 8, 2019, and the exercise price was reduced to

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

$0.50 per share (as amended and restated, the “Amended and Restated August 2009 Warrants”, “Amended and Restated August 2010 Warrants”, “Amended and Restated August 2010 MHR Waiver Warrants”, “Amended and Restated July 2011 Warrants”, “Amended and Restated July 2011 MHR Waiver Warrants”, and collectively, the “Amended and Restated Warrants”) . Under the terms of each of the Amended and Restated Warrants, as well as the August 2010 Investor Warrants, July 2011 Investor Warrants and 2013 Restructuring Warrants (collectively, the Investor Warrants, and together with the Original Warrants, the “Warrants”), the Company has an obligation to make a cash payment to the holders of each of the Warrants for any gain that could have been realized if such holder exercised the warrants and we subsequently failed to deliver a certificate representing the shares to be issued upon such exercise by the third trading day after the Warrants were exercised. Accordingly, the Warrants have been accounted for as a liability. The fair value of each of the Warrants is estimated, at the end of each quarterly reporting period, using the Black-Scholes model. The assumptions used in computing the fair value of the Original Warrants as of December 31, 2016 and 2015, are as follows:

 

     December 31,
2016
    December 31,
2015
 

Closing stock price

   $ 0.60     $ 0.68  

Conversion price

   $ 0.50     $ 0.50  

Expected volatility

     103     141

Remaining term (years)

     2.52       3.52  

Risk-free rate

     1.47     1.31

Expected dividend yield

     0     0

The fair value of the Original Warrants decreased $2.2 million for the year ended December 31, 2016 and increased $3.8 million and $1.0 million for the years ended December 31, 2015 and 2014, respectively. These fluctuations have been recognized in the accompanying statements of operations.

August 2010 Investor Warrants . Also in connection with the August 2010 Financing, Emisphere sold warrants to purchase 2.6 million shares of common stock to unrelated investors (the “August 2010 Warrants”). On January 12, 2011, one of the unrelated investors notified the Company of its intention to exercise 0.2 million warrants. On August 26, 2015, the remaining August 2010 Warrants expired. The fair value of the August 2010 Investor Warrants decreased $29 thousand for the period January 1, 2015 through their expiration on August 26, 2015, which has been recognized in the accompanying statements of operations.

July 2011 Investor Warrants. Also in connection with the July 2011 Financing, Emisphere sold warrants to purchase 3.01 million shares of common stock to unrelated investors (the “July 2011 Warrants”). The July 2011 Warrants are exercisable at $1.09 per share and expired July 6, 2016. The assumptions used in computing the fair value of the July 2011 Warrants as of December 31, 2015, are as follows:

 

     December 31,
2015
 

Closing stock price

   $ 0.68  

Conversion price

   $ 1.09  

Expected volatility

     88

Remaining term (years)

     0.51  

Risk-free rate

     0.49

Expected dividend yield

     0

The fair value of the July 2011 Investor Warrants decreased $0.2 million for the period from January 1, 2016 through their expiration on July 6, 2016 and decreased $5 thousand and $0.2 million for the years ended December 31, 2015 and 2014, respectively, which has been recognized in the accompanying statements of operations.

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

2013 Restructuring Warrants . The Company issued to MHR warrants to purchase 10 million shares of its common stock (the “2013 Restructuring Warrants”) as part of the Restructuring. The assumptions used in computing the fair value of the 2013 Restructuring Warrants as of December 31, 2016 and 2015, are as follows:

 

     December 31,
2016
    December 31,
2015
 

Closing stock price

   $ 0.60     $ 0.68  

Conversion price

   $ 0.50     $ 0.50  

Expected volatility

     103     141

Remaining term (years)

     2.52       3.52  

Risk-free rate

     1.47     1.31

Expected dividend yield

     0     0

The fair value of the 2013 Restructuring Warrants decreased $2 million for the year ended December 31, 2016 and increased $3.3 million and $0.9 for the years ended December 31, 2015 and 2014, respectively, which has been recognized in the accompanying statements of operations.

9.    Income Taxes

The components of our income tax benefit in 2016 and 2015 are as follows:

 

         2016              2015      

Current Tax Benefit

     

Federal

   $      $  

State

            (585
  

 

 

    

 

 

 
            (585
  

 

 

    

 

 

 

Deferred Tax Expense (Benefit)

     

Federal

             

State

             
  

 

 

    

 

 

 
             
  

 

 

    

 

 

 

Total Tax Benefit

   $      $ (585
  

 

 

    

 

 

 

As of December 31, 2016, we have available unused federal net operating loss (NOL) carry-forwards of $366 million, which will expire in various years from 2018 to 2036. We have New York NOL carry-forwards of $306 with the remainder expiring in various years from 2018 through 2036. We have New Jersey NOL carry-forwards of $10 million, which will expire in various years from 2020 through 2023.

As of December 31, 2016, we have Research and Development tax credit carryforwards of $11 million which will expire in various years from 2018 to 2032.

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

The effective rate differs from the statutory rate of 34% for 2016, 2015 and 2014 primarily due to the following:

 

     2016     2015     2014  

Statutory Rate on pre-tax book loss

     (34.00 %)      (34.00 %)      (34.00 %) 

Stock option issuance

     0.48     0.14     0.09

Sale of NJ NOL’s

     0.00     1.05     2.51

Disallowed interest

     2.63     0.10     0.51

Derivatives

     (30.94 %)      11.72     14.75

Expired net operating losses and credits

     0.00     0.00     2.74

State Tax benefit of Sale of NJ NOL

     0.00     (1.45 %)      (7.37 %) 

State Tax benefit — other

     (10.80 %)      (3.85 %)      (2.82 %) 

True-ups and adjustments

     2.62     (0.57 %)      0.02

Change in federal valuation allowance

     70.01     25.42     16.22
  

 

 

   

 

 

   

 

 

 
     0.00     (1.44 %)      (7.35 %) 
  

 

 

   

 

 

   

 

 

 

The tax effect of temporary differences, net operating loss carry-forwards, and research and experimental tax credit carryforwards as of December 31, 2016 and 2015 is as follows:

Deferred tax assets and valuation allowance:

 

     December 31,  
     2016      2015  
     (in thousands)  

Current deferred tax asset:

     

Accrued liabilities

   $ 97      $ 111  

Inventory reserve

     225         

Valuation allowance

     (322      (111
  

 

 

    

 

 

 

Net current deferred tax asset

             
  

 

 

    

 

 

 

Non-current deferred tax assets:

     

Fixed and intangible assets

     13        11  

Net operation loss carry-forwards

     124,945        122,205  

AMT credit carry-forwards

     74        74  

Capital loss and charitable carry-forwards

     14        13  

Research and experimental tax credits

     11,021        11,021  

Stock compensation

     665        586  

Deferred revenue

     22,213        22,213  

Interest

     10,866        6,870  

Valuation allowance

   $ (169,811    $ (162,993
  

 

 

    

 

 

 

Net non-current deferred tax asset

             
  

 

 

    

 

 

 

Future ownership changes may limit the future utilization of these net operating loss and research and development tax credit carry-forwards as defined by the Internal Revenue Code. We performed an in-depth analysis and determined that the net operating losses and research and development expenses are not limited

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

under Section 382. The net deferred tax asset has been fully offset by a valuation allowance due to our history of taxable losses and uncertainty regarding our ability to generate sufficient taxable income in the future to utilize these deferred tax assets.

We apply the provisions of ASC 740-10-25 which provides recognition criteria and a related measurement model for uncertain tax positions taken or expected to be taken in income tax returns. ASC 740-10-25 requires that a position taken or expected to be taken in a tax return be recognized in the financial statements when it is more likely than not that the position would be sustained upon examination by tax authorities. Tax positions that meet the more likely than not threshold are then measured using a probability weighted approach recognizing the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement. The Company had no tax positions relating to open income tax returns that were considered to be uncertain. Accordingly, we have not recorded a liability for unrecognized tax benefits upon adoption of ASC 740-10-25. There continues to be no liability related to unrecognized tax benefits at December 31, 2016.

The Company’s 2013, 2014 and 2015 Federal, New York and New Jersey tax returns remain subject to examination by the respective taxing authorities. In addition, net operating losses and research tax credits arising from prior years are also subject to examination at the time that they are utilized in future years. Neither the Company’s federal or state tax returns are currently under examination.

10.    Stockholders’ Deficit

Our certificate of incorporation provides for the issuance of 4,000,000 shares of preferred stock with the rights, preferences, qualifications, and terms to be determined by our Board of Directors. As of December 31, 2016 and 2015, there were no shares of preferred stock outstanding.

On June 5, 2014, the Company filed with the Secretary of the State of Delaware a Certificate of Amendment (the “Certificate of Amendment”) to its Amended and Restated Certificate of Incorporation, increasing the number of authorized shares of common stock from 200,000,000 to 400,000,000 shares and increasing the number of authorized shares of preferred stock from 2,000,000 to 4,000,000 shares.

11.    Stock-Based Compensation Plans

Total compensation expense recorded during the years ended December 31, 2016, 2015 and 2014 for share-based payment awards was $0.3 million, $0.4 million and $0.2 million, respectively. At December 31, 2016, total unrecognized estimated compensation expense related to non-vested stock options granted prior to that date was approximately $0.4 million, which is expected to be recognized over a weighted-average period of 1.53 years. No tax benefit was realized due to a continued pattern of operating losses. We have a policy of issuing new shares to satisfy share option exercises. No options were exercised during the years ended December 31, 2016 and 2015.

During the year ended December 31, 2015, the Company granted 1,785,000 options which included: 40,000 options to Michael Garone, former Chief Financial Officer (valued on the grant date of January 14, 2015 at $0.34 using the Black Scholes pricing model); 175,000 options to Timothy Rothwell, Chairman of the Board, 75,000 options to each of the Company’s outside directors, 300,000 options to Alan L. Rubino, President and Chief Executive Officer, 150,000 options to Carl Sailer, Vice President, Sales and Marketing, and an additional 40,000 options to Michael Garone, former Chief Financial Officer (valued on the grant date of March 3, 2015 at $0.55 using the Black Scholes pricing model); 250,000 options to non-executive employees and consultants (valued on the grant date of March 6, 2015 at $0.59 using the Black Scholes pricing model); an additional 40,000 options to each of the Company’s outside directors (valued on the grant date of May 20, 2015, at $0.50); an additional 175,000 options to Timothy Rothwell, Chairman of the Board, (valued on the grant date of September 14, 2015 at $0.60 using the Black Scholes pricing model); and an additional 40,000 options to Carl Sailer, Vice President, Sales and Marketing, (valued on the grant date of October 15, 2015 at $0.59 using the Black Scholes pricing model).

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

During the year ended December 31, 2016, the Company granted 40,000 options to Mr. Michael Garone (valued on the grant date of January 14, 2016 at $0.61 using the Black Scholes pricing model). Mr. Garone resigned from Emisphere and his official last day of employment was June 24, 2016 (“Separation Date”). His unexercised, vested options were due to expire on September 25, 2016 (90 days from separation). On September 20, 2016 the Company entered into a separation agreement with Michael Garone. The Company agreed to extend the period of time during which any and all of his unexpired, vested and unexercised stock options may be exercisable to March 21, 2017 (a six-month extension). The Company calculated the incremental fair value equal to the difference between the fair value of the modified award and the fair value of the original award. The incremental fair value of $7 thousand was expensed immediately. In addition, the Company granted 240,000 options which included 40,000 options to each of the Company’s outside directors (valued on the grant date of May 25, 2016, at $0.73 using the Black Scholes pricing model).

Using the Black-Scholes model, we have estimated our stock price volatility using the historical volatility in the market price of our common stock for the expected term of the option. The risk-free interest rate is based on the yield curve of U.S. Treasury STRIP securities for the expected term of the option. We have never paid cash dividends and do not intend to pay cash dividends in the foreseeable future. Accordingly, we assumed a 0% dividend yield. The forfeiture rate is estimated using historical option cancellation information, adjusted for anticipated changes in expected exercise and employment termination behavior. Forfeiture rates and the expected term of options are estimated separately for groups of employees that have similar historical exercise behavior. The ranges presented below are the result of certain groups of employees displaying different behavior.

The following weighted-average assumptions were used for grants made under the stock option plans for the years ended December 31, 2016, 2015 and 2014:

 

     2016  
       Directors     Executives     Employees  

Expected volatility

     143.91     145.82 %      

Expected term

     6.8 years       6.8 years        

Risk-free interest rate

     1.69     1.87 %    

Dividend yield

     0     0 %      

Annual forfeiture rate

     14.5     14.5 %      

 

     2015  
     Directors     Executives     Employees  

Expected volatility

     147.57-148.95 %     145.87-148.05 %     148.06 %

Expected term

     6.8 years       6.8 years       6.8 years  

Risk-free interest rate

     1.83-1.93 %     1.58-1.90 %     1.99 %

Dividend yield

     0 %     0 %     0 %

Annual forfeiture rate

     14.5 %     14.5 %     14.5 %

 

     2014  
       Directors     Executives     Employees  

Expected volatility

     143.09-145.11 %     142.69 %     145.03 %

Expected term

     6.8 years       6.8 years       6.8 years  

Risk-free interest rate

     1.97-2.20     2.22 %     1.75 %

Dividend yield

     0     0 %     0 %

Annual forfeiture rate

     14.5     14.5 %     14.5 %

 

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EMISPHERE TECHNOLOGIES, INC.

NOTES TO FINANCIAL STATEMENTS — (Continued)

 

Stock Option Plans.     On April 20, 2007, the stockholders approved the 2007 Stock Award and Incentive Plan (the “2007 Plan”). The 2007 Plan provides for grants of options, stock appreciation rights, restricted stock, deferred stock, bonus stock and awards in lieu of obligations, dividend equivalents, other stock based awards and performance awards to executive officers and other employees of the Company, and non-employee directors, consultants and others who provide substantial service to us. The 2007 Plan provides for the issuance of 9,259,476 shares as follows: 7,500,000 new shares, 1,358,406 shares remaining and transferred from the Company’s 2000 Stock Option Plan (the “2000 Plan”) (which was then replaced by the 2007 Plan) and 401,070 shares remaining and transferred from the Company’s Stock Option Plan for Outside Directors (the “Directors Stock Plan”). In addition, shares cancelled, expired, forfeited, settled in cash, settled by delivery of fewer shares than the number underlying the award, or otherwise terminated under the 2000 Plan will become available for issuance under the 2007 Plan, once registered. As of December 31, 2016, 2,896,683 shares remain available for issuance under the 2007 Plan. Generally, the options vest at the rate of 20% per year and expire within a five-to-ten-year period, as determined by the compensation committee of the Board of Directors and as defined by the Plans.

The Company also has grants outstanding under its expired and terminated 2000 Stock Option Plan (the “2000 Plan”). Under our 2000 Plan a maximum of 1,945,236 shares of our common stock were available for issuance. The 2000 Plan was available to employees, directors and consultants. The 2000 Plan provides for the grant of either ISOs, as defined by the Internal Revenue Code, or non-qualified stock options, which do not qualify as ISOs. Generally, the options vest at the rate of 20% per year and expire within a five- to ten-year period, as determined by the compensation committee of the Board of Directors and as defined by the Plans. As of December 31, 2016, 50,000 options remained outstanding under the 2000 Plan.

Transactions involving stock options awarded under the Plans described above during the years ended December 31, 2016, 2015 and 2014 are summarized as follows:

 

     Number of
Shares
     Weighted
Average
Exercise
Price
     Weighted
Average
Remaining
Contractual
Term in Years
     Aggregate
Intrinsic
Value
 
                          (In thousands)  

Outstanding at December 31, 2013

     4,340,750      $ 0.90        7.8      $ 56  

Granted

     495,000      $ 0.31        

Expired

     (2,000 )    $ 5.20        

Forfeited

     (13,000 )    $ 0.67