Amarin Reports First Quarter 2013 Financial Results and Provides Update on Operations
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Launched Vascepa® (icosapent ethyl) capsules in
the United States onJanuary 28, 2013 for the MARINE indication (use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia) -
Recognized
$2.34 million in product revenue from Vascepa sales in Q1 in accordance with GAAP ($5.2 million in net value of Vascepa was sold to wholesalers in Q1, resulting in$2.9 million of deferred product revenue under GAAP in Q1) - Secured formulary access for Vascepa with over 190 million lives now covered by payors without restrictions, including 40 million converted to Tier 2 in April and May
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Received Food and Drug Administration (FDA) acceptance for review of supplemental New Drug Application (sNDA) seeking approval for the marketing and sale of Vascepa for the ANCHOR indication (use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and < 500 mg/dL) with mixed dyslipidemia) - Reported statistically significant reductions of apolipoprotein C-III (Apo C-III) of 25.1% and 19.2%, compared to placebo, as demonstrated by Vascepa in post-hoc analyses of the MARINE and ANCHOR Phase 3 clinical trials, respectively
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Received
FDA approval of two additional active pharmaceutical ingredient (API) suppliers, BASF andChemport , for the manufacture of Vascepa giving Amarin three qualified API suppliers -
Increased patents issued or allowed in
the United States to 22 (adding 11 in the first quarter alone, including 3 since our last patent announcement), all but two of which have patent terms extending into 2030, with more than 30 additional patent applications being prosecuted inthe United States alone
"On
Operational update
Commercialization update
Amarin's direct sales force, consisting of approximately 275 sales professionals, made sales calls to clinicians for two months in Q1 2013. Amarin reports that, since launch, access to clinicians has been good, and that it has yet to hear any significant negative reaction to the efficacy or safety profile of Vascepa. Amarin's sales professionals are currently targeting the limited group of clinicians who are the highest prescribers of other lipid therapies. Vascepa is being marketed for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, the initial indication for Vascepa. Amarin believes that Vascepa is well differentiated in this market based on its safety profile, which is similar to placebo, and its spectrum of demonstrated lipid benefit at 4g/day, including statistically significant reductions in triglycerides, Apo B, VLDL-C, and non-HDL-C, with no increase in LDL-C, also known as bad cholesterol.
A chart accompanying this press release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=18620
Since launching Vascepa, Amarin has:
- Witnessed steady increases in the number of clinicians prescribing Vascepa (now over 4,000), in the number of prescriptions reported (via third-party sources), in the number of bottles of Vascepa shipped from wholesalers to retail pharmacies and in the number of co-pay cards used by patients
- Witnessed monthly volume (via third-party sources, often underestimated) increase with consistency in the first months post launch with prescriptions increasing from 3,224 to 7,260 to 11,768 normalized TRx, reported in February, March, and April, respectively (normalized TRx equates to 120 capsules, or one month's supply)
- Focused on clinician education about Vascepa's clinical results and increased product awareness
- Secured early managed care coverage based on the safety and efficacy profile of Vascepa, including initial Tier 2 conversions (without restrictions) in April and May, noting that it typically takes two-to-three months of time to translate into script data
- Trained clinicians as speakers on behalf of Vascepa and conducted speaker programs for groups of healthcare professionals
- Mitigated the Tier 3 vs. Tier 2 co-payment differential for patients with an actively used co-pay discount program (a common program for a new drug until Tier 2 coverage is secured)
- Received early, but encouraging, feedback from clinicians regarding their patients' initial experiences with Vascepa
Vascepa additional indication progress
In parallel with marketing Vascepa for the MARINE indication, Amarin is pursuing approval of Vascepa for the considerably larger ANCHOR indication. In a clinical trial of the use of Vascepa in the ANCHOR indication, as previously announced, Vascepa demonstrated statistically significant reductions in a broad spectrum of lipid and inflammatory markers, on top of optimized statin therapy, including significant reduction in LDL-C. In
Vascepa supply update
In the fourth quarter of 2012, Amarin submitted two sNDAs, one each for two additional active pharmaceutical ingredient (API) suppliers for Vascepa: BASF and
Vascepa exclusivity update
Amarin continues to make significant progress in its effort to expand patent protection for Vascepa and now has 22 patents issued or allowed in
REDUCE-IT and other Vascepa-related clinical development
Amarin continues to progress patient enrollment in its REDUCE-IT cardiovascular outcomes study with more than 4,000 patients enrolled in the study to date. Amarin anticipates continuing to enroll patients in this study throughout 2013. Results of the study will not be available until a specified number of cardiovascular events have been observed, the timing of which is not expected in the near-term.
Financial update
Amarin reported cash and cash equivalents of
Amarin reported net product revenues for the quarter ended
Consistent with industry practice, the net price of Vascepa in the quarter ended
Cost of goods sold during the quarter ended
Under GAAP, Amarin reported a net loss of
Excluding non-cash gains or losses for share-based compensation, warrant compensation and change in value of derivatives, non-GAAP adjusted net loss was
During the three months ended
As of
Amarin's 2013 operational priorities
Operational priorities in 2013 are:
- Increasing revenues from sales of Vascepa
- Continuing managed care migration from Tier 3 to Tier 2 coverage
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Gaining approval of the ANCHOR indication sNDA (PDUFA date of
December 20, 2013 ) - Planning for the commercialization of the ANCHOR indication
- Obtaining additional patent awards from the USPTO
- Continuing development of a fixed-dose combination of Vascepa and a leading statin
- Submitting an sNDA for a fourth API supplier
- Publishing additional data from Amarin's clinical trials
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Obtaining
FDA exclusivity determination
Conference call and webcast information
Amarin will host a conference call at 4:30 p.m. EDT (
Use of non-GAAP adjusted financial information
Included in this press release and the conference call referenced above are non-GAAP adjusted financial information as defined by U.S. Securities and Exchange Commission Regulation G. The GAAP financial measure most directly comparable to each non-GAAP adjusted financial measure used or discussed, and a reconciliation of the differences between each non-GAAP adjusted financial measure and the comparable GAAP financial measure, are included in this press release after the condensed consolidated financial statements.
Non-GAAP adjusted net loss was derived by taking GAAP net loss and adjusting it with non-cash gains or losses for share-based compensation, warrant compensation, and change in value of derivative. Management believes that these non-GAAP adjusted measures provide investors with a better understanding of the company's historical results from its core business operations.
While management believes that these non-GAAP adjusted financial measures provide useful supplemental information to investors regarding the underlying performance of the company's business operations, investors are reminded to consider these non-GAAP measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the company's results of operations as determined in accordance with GAAP. In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP measures used by other companies, and management may utilize other measures to illustrate performance in the future.
About Vascepa® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule.
Indications and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components and should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo).
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Forward-looking statements
This press release contains forward-looking statements, including statements about the commercial launch of Vascepa, including the number of total prescriptions to date and sales trends, expectations for revenue growth, product awareness, receptivity of clinicians to and patient experience with Vascepa; expectations regarding managed care migration from Tier 3 to Tier 2 coverage and continued growth in Tier 2 coverage; the pricing terms of commercial supply for Vascepa; expectations regarding gross margins and cost of goods sold (COGS); the timing of
Vascepa has been approved for use by the
Important information regarding prescriptions data and product revenue
The historical prescription data provided in this press release is based on data published by a third party as of
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CONSOLIDATED BALANCE SHEET DATA | ||||
(U.S. GAAP) | ||||
Unaudited | ||||
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(in thousands) | ||||
ASSETS | ||||
Current Assets: | ||||
Cash and cash equivalents | $ 201,780 | $ 260,242 | ||
Restricted cash | 1,400 | ----- | ||
Accounts receivable | 3,441 | ----- | ||
Inventory | 27,435 | 21,262 | ||
Deferred tax asset | 937 | 937 | ||
Other current assets | 7,051 | 3,253 | ||
Total Current Assets | $ 242,044 | $ 285,694 | ||
Property, plant and equipment, net | 766 | 811 | ||
Deferred tax asset | 11,993 | 8,044 | ||
Other non-current assets | 5,335 | 4,951 | ||
Intangible asset, net | 11,193 | 11,355 | ||
Total Assets | $ 271,331 | $ 310,855 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||
Current Liabilities: | ||||
Accounts payable | $ 22,945 | $ 17,458 | ||
Accrued interest payable | 4,646 | 2,520 | ||
Deferred revenue | 2,865 | ----- | ||
Accrued expenses and other liabilities | 11,935 | 5,224 | ||
Total current liabilities | $ 42,391 | $ 25,202 | ||
Long Term Liabilities: | ||||
Warrant derivative liability | 49,011 | 54,854 | ||
Exchangeable senior notes | 137,735 | 134,250 | ||
Long term debt | 85,873 | 85,153 | ||
Long term debt redemption feature | 15,600 | 14,577 | ||
Other long term liabilities | 807 | 816 | ||
Total liabilities | $ 331,417 | $ 314,852 | ||
Stockholders' Deficit: | ||||
Common stock | 124,846 | 124,597 | ||
Additional paid-in capital | 625,086 | 619,266 | ||
Treasury stock | (217) | (217) | ||
Accumulated deficit | (809,801) | (747,643) | ||
Total stockholders' deficit | $ (60,086) | $ (3,997) | ||
Total Liabilities and Stockholders' Deficit | $ 271,331 | $ 310,855 |
CONSOLIDATED STATEMENTS OF OPERATIONS DATA | ||
(U.S. GAAP) | ||
Unaudited | ||
Three Months Ended |
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(in thousands, except share and per share amounts) | ||
2013 | 2012 | |
Product Revenues | $ 2,341 | $ ----- |
Operating Expenses: | ||
Cost of goods sold | 1,287 | ----- |
Marketing, general and administrative(1) | 39,267 | 14,027 |
Research and development(1) | 21,838 | 4,756 |
Total operating expenses | 62,392 | 18,783 |
Operating loss | (60,051) | (18,783) |
Gain (loss) on change in fair value of derivative liabilities(2) | 3,620 | (66,209) |
Interest expense, net | (8,860) | (3,951) |
Other (expense) income, net | (124) | 68 |
Loss from operations before taxes | (65,415) | (88,875) |
Benefit for income taxes | 3,257 | 590 |
Net and comprehensive loss | $ (62,158) | $ (88,285) |
Loss per share: | ||
Basic and diluted | $ (0.41) | $ (0.65) |
Weighted average shares outstanding: | ||
Basic and diluted | 150,430 | 136,011 |
(1) Amarin's costs include non-cash stock based compensation as well as warrant based compensation to former officers. Excluding non-cash stock and warrant based compensation, for 2013 and 2012 marketing, general and administrative expenses were |
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(2) Non-cash charges result from changes in the fair value of the warrant derivative liability. This liability is revalued at each reporting period and, upon exercise of warrants, is reclassified at fair value from liability to stockholders' equity. These warrants are valued using the Black-Scholes option pricing model, they are classified for accounting purposes as financial derivatives because, under certain circumstances, the exercise price of the warrants could increase. |
The following is a reconciliation of the non-GAAP financial measures used by Amarin to describe its financial results determined in accordance with
RECONCILIATION OF NON-GAAP LIABILITIES | ||
Unaudited | ||
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(in thousands) | ||
Current Liabilities: | ||
Accounts payable | $ 22,945 | $ 17,458 |
Accrued interest payable | 4,646 | 2,520 |
Deferred revenue | 2,865 | ----- |
Accrued expenses and other liabilities | 11,935 | 5,224 |
Total current liabilities | $ 42,391 | $ 25,202 |
Long-Term Liabilities: | ||
Warrant derivative liability | 49,011 | 54,854 |
Exchangeable senior notes | 137,735 | 134,250 |
Long-term debt | 85,873 | 85,153 |
Long term debt redemption feature | 15,600 | 14,577 |
Other long-term liabilities | 807 | 816 |
Total liabilities — GAAP | $ 331,417 | $ 314,852 |
Warrant derivative liability | (49,011) | (54,854) |
Total liabilities — non GAAP | $ 282,406 | $ 259,998 |
RECONCILIATION OF NON-GAAP NET LOSS | ||
Unaudited | ||
Three Months Ended |
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2013 | 2012 | |
Net loss for EPS1 — GAAP | $ (62,158) | $ (88,285) |
Share based compensation expense | (4,874) | (3,874) |
Warrant compensation income (expense) | 451 | (2,374) |
Gain/(loss) on change in fair value of derivatives | 3,620 | (66,209) |
Adjusted net loss for EPS1 — non GAAP | $ (61,355) | $ (15,828) |
1Basic and diluted | ||
Loss per share: | ||
Basic and diluted — non GAAP | $ (0.41) | $ (0.12) |
Weighted average shares outstanding: | ||
Basic and diluted | 150,430 | 136,011 |
CONTACT: Amarin Contact Information:Source:Joseph Bruno Director, Investor Relations andCorporate Communications Amarin Corporation plc In U.S.: +1 (908) 719-1315 investor.relations@amarincorp.com
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