"During the third quarter, we made great strides in commercializing the Eligen® technology. There were two important developments with our partner, Novo Nordisk A/S (NYSE:NVO). Novo Nordisk announced it will initiate a global phase 3a development program with oral semaglutide, a once daily Type 2 diabetes treatment utilizing SNAC, one of our Eligen technology carriers," said
YEAR TO DATE HIGHLIGHTS
- Novo Nordisk announced its decision to advance oral semaglutide (GLP-1) into a global phase 3a development program using Emisphere's absorption-enhancing excipient, SNAC. Novo Nordisk plans to initiate the PIONEER global
phase 3a program, consisting of seven trials and approximately 8,000 patients with Type 2 diabetes.
- Entered into an agreement with Novo Nordisk to develop and commercialize oral formulations of four classes of Novo Nordisk's investigational molecules targeting major metabolic disorders, including diabetes and obesity, using
Emisphere'soral Eligen technology. Emispherereceived a $5.0 millionupfront licensing fee, and is eligible to receive up to $207.5 millionin development and sales milestone payments in addition to royalties on sales of each successfully commercialized product under this agreement.
- Amended our GLP-1 License Agreement with Novo Nordisk to provide for, among other things,
a payment of
$9.0 millionas prepayment of a product development milestone and in exchange for a reduction in certain future royalty payments.
- Commercial Rollout of Eligen B12 Continues in the U.S. Emisphere recently launched Eligen B12, the first once-daily oral prescription medical food tablet shown to normalize B12 levels without the need for an injection in patients who have a medically-diagnosed vitamin B12 deficiency. Physician and patient reception has been positive and Eligen B12 is achieving excellent medical outcomes.
Emispherecontinues to refine its field force and other promotional efforts to increase awareness and drive adoption.
- Global Eligen Technology Business Development Initiatives Continuing. During the third quarter of 2015,
Emispherecontinued to focus on smaller, next-generation proteins and peptides; proven and/or approved drug compounds; and the development of new oral formulations to replace injectables.
- Grant of Waiver under Debt Facility and Convertible Notes. On
November 10, 2015, the creditor under our debt facility and convertible notes agreed to waive any event of default resulting from our failure to satisfy the net sales milestones for the Eligen B12TM product for the 2015 fiscal year specified in our credit facility and convertible notes.
THIRD QUARTER 2015 FINANCIAL RESULTS
Revenue for the third quarter ended
Total operating expense for the third quarter of 2015 was
For the third quarter ended
YEAR TO DATE FINANCIAL RESULTS
Revenue for the nine months ended
Total operating expense for the
nine months ended
For the nine months ended
Weighted average basic and diluted shares outstanding for the periods ended
Management believes that with the funding made available from an existing loan agreement, the new license agreement, and the GLP-1 Amendment, the Company will have
sufficient capital to continue to execute its Eligen B12 commercialization plans and to continue operations through approximately
CONFERENCE CALL AND WEBCAST INFORMATION
The live webcast of the conference call can be accessed through the Company's web site at www.emisphere.com. The call can also be accessed by dialing (877) 303-9483 (
ABOUT ELIGEN B12™
Eligen B12 is indicated for the dietary management of patients who have a medically-diagnosed vitamin B12 deficiency that is associated with a disease or condition that cannot be managed by a modification of the normal diet alone. Eligen B12 is designed so that patients only need to take a single oral tablet (cyanocobalamin 1000 mcg/salcaprozate sodium [SNAC] 100 mg) of B12 daily.
Eligen B12 is the first and only prescription medical food that has been shown to normalize vitamin B12 to levels that are comparable to an intramuscular (IM) injection of B12. In a study that compared the impact of Eligen B12 and IM B12 on plasma B12 levels in 50 patients with demonstrated B12 deficiency (serum B12 < 350 pg/mL), both products normalized B12 levels by Day 15 (first observation) and maintained normal levels over the duration of the study (three months). In a study that compared bioavailability in 20 healthy subjects of Eligen B12 with that of a standard oral B12 supplement, the bioavailability of Eligen B12 was 5.09 percent compared with 2.16 percent, which is more than double the bioavailability of the conventional over-the-counter oral B12 supplement formulation at the same dose.
Eligen B12 was developed as a medical food as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3) as a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is 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.
For more information, visit www.eligenb12.com.
ELIGEN B12™ IMPORTANT SAFETY INFORMATION
Those with an allergy to B12, cobalt or any ingredients of Eligen B12 should not take this product. Eligen B12 should not be taken by people who have Leber's disease, which physicians may refer to as hereditary optic nerve atrophy. Cyanocobalamin (B12) can lead to optic nerve damage (and possibly blindness) in people with Leber's disease. Note that Eligen B12 has not been studied in patients below 18 years of age.
ABOUT EMISPHERE'S ELIGEN® TECHNOLOGY
Emisphere's proprietary Eligen® technology facilitates the absorption of difficult-to-deliver small and large molecules that typically are only available as injectables, without altering their chemical form, biological integrity or pharmacological properties, making it possible to avoid injections for drug administration. Eligen technology offers improved safety, broad applicability, stand-alone delivery, versatility of formulation and ease of manufacture.
SAFE HARBOR STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
The statements in this release or oral statements made by representatives of
|CONDENSED STATEMENT OF OPERATIONS|
|For the three and nine months ended |
|(in thousands, except share and per share data)|
|For the three months ended|| For the nine months ended|
| September 30,|
|Revenue, net of discounts and allowances||$||130||$||—||$||225||$||—|
|Cost of Revenue||58||—||138||—|
|Costs and expenses:|
|Research and development||94||229||382||880|
|Selling, General and administrative expenses||4,643||1,887||13,595||5,113|
|Depreciation and amortization||3||4||10||11|
|Total costs and expenses||4,740||2,120||13,987||6,004|
|Other non-operating income (expense):|
|Other income (expense)||1||(3||)||8||8|
|Change in fair value of derivative instruments|
|Interest expense related party||(2,321||)||(1,813||)||(6,391||)||(4,722||)|
|Total other non-operating income (expense)||246||(12,253||)||(16,354||)||(21,479||)|
|Net loss before tax incentive||(4,422||)||(14,373||)||(30,254||)||(27,483||)|
|Income tax incentive||—||—||—||1,684|
|Net loss per share, basic and diluted||$||(0.07||)||$||(0.24||)||$||(0.50||)||$||(0.43||)|
|Weighted average shares outstanding, basic and diluted||60,687,478||60,687,478||60,687,478||60,687,478|
|CONDENSED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|Cash and cash equivalents||$||1,404||$||3,683|
|Prepaid expenses and other current assets||722||188|
|Total Current Assets||4,485||5,939|
|Equipment and leasehold improvements, net||15||25|
|LIABILITIES AND STOCKHOLDERS DEFICIT|
|Accounts payable and accrued expenses||$||1,672||$||1,846|
|Total current liabilities||13,001||7,633|
|Notes payable, related party, net of related discount||58,669||44,546|
|Accrued interest, related party||2,201||—|
|Deferred revenue, non-current||41,616||41,616|
|Deferred lease liability, non-current and other liabilities||12||10|
|COMMITMENTS AND CONTINGENCIES|
|Preferred stock, |
|Common stock, ||610||610|
|Common stock held in treasury, at cost; 289,732 shares||(3,952||)||(3,952||)|
|Total stockholders' deficit||(141,985||)||(111,950||)|
|Total liabilities and stockholders' deficit||$||4,524||$||5,988|
Alan L. Rubino, CEO 973.532.8000 firstname.lastname@example.org Michael R. Garone, CFO 973.532.8005 email@example.com INVESTOR CONTACTS: Susan Kim Argot Partners(212) 600-1902 firstname.lastname@example.org
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