Recent Launch of Eligen B12™
Management to Host Conference Call Today at
"Eligen B12™ is the first oral prescription tablet proven to normalize B12 levels without the need for injection, and the U.S. launch earlier this month and commencement of commercial operations are transformational milestones for
2014 AND RECENT HIGHLIGHTS
Launched Eligen B12 in the U.S.: In
March 2015, Emisphereannounced the U.S. commercial availability of Eligen B12, the first and only once-daily oral prescription medical food tablet shown to normalize B12 levels without the need for an injection. Eligen B12 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 product to market using Emisphere'sadvanced Eligen Technology, which utilizes a carrier, salcaprozate sodium (SNAC), to chaperone B12 through the gastric lining and directly into the bloodstream even in the absence of intrinsic factor, a protein made in the stomach that normally facilitates B12 absorption.
Highlighted Positive Phase 2 Data From Eligen Licensee Novo Nordisk: In
February 2015, Emispherehighlighted positive Phase 2 data from Eligen licensee Novo Nordisk pertaining to OG217SC, the oral formulation of semaglutide, a long-acting human GLP-1 analogue. In a press release dated February 20, 2015, 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. Results of the study are available on Novo Nordisk's website. 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. Under Emisphere's GLP-1 License Agreement, Emispherecould 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 this Agreement.
$20 Millionin Financing to Launch Eligen B12: In August 2014, Emisphereentered into an agreement with MHR Fund Management LLC(MHR), and certain of its affiliate funds, to finance the launch of Eligen B12 in the U.S. through a new loan facility. Under the terms of the new loan facility, Emispheremay borrow, at specified times and based on the attainment of specified performance milestones, up to an aggregate of $20 millionto finance the development, manufacturing, marketing and sales of the B12 Product. To date, the Company has borrowed approximately $13 millionunder this loan facility.
Global Eligen Technology Business Development Initiatives Underway: During 2014,
Emispherelaunched a comprehensive business development initiative designed to identify and secure new Eligen Technology partnerships. Eligen Technology is a proven delivery system technology that is applicable to a broad range of chemical entities and has been shown to increase the benefit of the therapy by improving bioavailability or absorption or by decreasing time to onset of action. The Company currently owns rights to an extensive portfolio of carriers with strong patent protection. The current focus of the business development initiative is on next generation, smaller proteins and peptides, proven and/or approved drug compounds, and the development of new oral formulations to replace injectables.
FOURTH QUARTER 2014 FINANCIAL RESULTS
The Company reported an operating loss of
Total operating expenses were
FULL YEAR 2014 FINANCIAL RESULTS
Total operating expenses were
Other expense for the year ended
Weighted average basic and diluted shares outstanding for the years ended
Under the terms of the Loan Agreement,
Management believes that with the funding made available through the Loan Agreement, assuming attainment of the milestones, the Company will have sufficient capital to support the commercial launch of oral Eligen B12 in the U.S. market and to continue operations through the end of 2015. The Company's future capital requirements beyond 2015 and financial success depend largely on the commercial success of the oral Eligen B12 prescription product and the Company's ability to leverage existing partnerships and secure new partnering opportunities.
The Company is pursuing several courses of action to obtain additional capital resources including the global commercialization of Eligen B12, seeking new partnerships, seeking new product development opportunities, and leveraging existing partnerships.
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, 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 levels 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 is classified by the
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.
SAFE HARBOR STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
The statements in this release or oral statements made by representatives of
|STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Revenue||$ —||$ —||$ —|
|Cost of goods sold||—||—||—|
|Costs and expenses:|
|Research and development||1,128||836||1,867|
|General and administrative||8,162||6,749||4,935|
|Loss (gain) on disposal of fixed assets||—||10||(10)|
|Depreciation and amortization||15||9||29|
|Total costs and expenses||9,305||7,604||6,821|
|Other non-operating income (expense):|
|Investment and other income||10||81||45|
|Change in fair value of derivative instruments:|
|Interest expense - related party||(6,232)||(4,955)||(6,236)|
|Total other non-operating income (expense)||(18,094)||(13,307)||1,919|
|Loss before income tax benefit (expense)||(27,399)||(20,911)||(4,902)|
|Income tax benefit (expense)||2,019||(28)||2,974|
|Net loss||$ (25,380)||$ (20,939)||$ (1,928)|
|Net loss per share, basic||$ (0.42)||$ (0.35)||$ (0.03)|
|Net loss per share, diluted||$ (0.42)||$ (0.35)||$ (0.03)|
|Weighted average shares outstanding, basic||60,687,478||60,687,478||60,687,478|
|Weighted average shares outstanding, diluted||60,687,478||60,687,478||60,687,478|
|except share data)|
|Cash and cash equivalents||$ 3,683||$ 4,053|
|Prepaid expenses and other current assets||188||622|
|Total current assets||5,939||4,905|
|Equipment and leasehold improvements, net||25||40|
|Total assets||$ 5,988||$ 4,979|
|LIABILITIES AND STOCKHOLDERS' DEFICIT|
|Notes payable, related party, net of related discount||$ —||
|Accounts payable and accrued expenses||1,846||1,539|
|Other current liabilities||—||30|
|Total current liabilities||7,633||6,303|
|Notes payable, related party net of related discount||44,546||32,523|
|Derivative instruments - Related party||24,133||11,331|
|Deferred lease liability and other liabilities||10||7|
|Commitments and contingencies||—||—|
Preferred stock, $.01 par value; authorized 4,000,000 shares at
Common stock, $.01 par value; authorized 400,000,000 shares at
|Additional paid-in capital||405,531||405,300|
|Common stock held in treasury, at cost; 289,732 shares||(3,952)||(3,952)|
|Total stockholders' deficit||(111,950)||(86,801)|
|Total liabilities and stockholders' deficit||$ 5,988||$ 4,979|
CONTACT: COMPANY CONTACTS:
Alan L. Rubino, CEO 973.532.8000 firstname.lastname@example.org Michael R. Garone, CFO 973.532.8005 email@example.com INVESTOR CONTACTS: Matthew Haines/ Susie Kim Argot Partners(212) 600-1902 firstname.lastname@example.org email@example.com
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