Amarin Reports Fourth Quarter and Year-End 2012 Financial Results and Provides Update on Operations
-
Launched Vascepa® (icosapent ethyl) capsules in
the United States onJanuary 28, 2013 for the MARINE indication (use as an adjunct to diet to lower triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia) - Hired and trained U.S. sales team, including 275 sales representatives with extensive cardiovascular selling experience and relationships with healthcare professionals targeted for Vascepa along with key sales and marketing hires for Amarin's commercial team
- Stocked Vascepa at wholesalers and leading pharmacies
- Achieved > 160 million lives covered by payors
-
Submitted sNDA (supplemental New Drug Application) seeking approval in
the United States of Vascepa for use in a second indication (ANCHOR) -
Submitted two sNDAs for additional active pharmaceutical ingredient (API) suppliers:
Chemport and BASF -
Strengthened supply chain with an exclusive agreement entered into by a consortium of companies, led by
Slanmhor Pharmaceuticals, Inc. , to be Amarin's fourth Vascepa API supplier -
Increased patents issued or allowed to 18 in
the United States , a majority of which have patent terms extending into 2030, with more than 30 additional U.S. patent applications being prosecuted - Completed dosing of a fixed-dose combination study with Vascepa and a leading statin
-
Publication of MARINE and ANCHOR Phase 3 trial results in The
American Journal of Cardiovascular Drugs -
Strengthened balance sheet through successful completion of a
$100M non-dilutive, hybrid debt financing resulting in a year-end cash balance of$260.2 million
"In 2012, Amarin received
Operational update
Commercialization update
Amarin believes that Vascepa is well positioned to compete in the triglyceride lowering market. This is a large market which, based on market research, Amarin believes is currently underpenetrated due to limitations of existing therapies. Amarin's market research further suggests that clinicians value the data supporting Vascepa in the MARINE indication: in patients with very high (≥500 mg/dL) triglyceride levels, Vascepa has been shown to lower triglycerides without increasing bad cholesterol (low-density lipoprotein cholesterol, or LDL-C) and with a tolerability and safety profile similar to placebo. Amarin formally launched Vascepa in
- More than 160 million lives covered by managed care plans and insurance payors and has begun migrating these plans from Tier-3 to Tier-2 coverage
- Implemented robust early physician awareness and speaker programs
- Implemented a co-pay reduction program that offers Vascepa to patients for a co-pay cost equivalent to competitors
- Realized strong initial wholesale stocking of Vascepa to help ensure that prescriptions can be filled promptly
- Developed and launched a robust digital and print media campaign to support direct sales force efforts to educate various customer segments, including clinicians, about Vascepa
- Received early, but encouraging, feedback from physicians regarding Vascepa and results
Vascepa regulatory progress
On
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 18 patents issued or allowed with over 30 additional patent applications being prosecuted in
REDUCE-IT and other Vascepa-related clinical development
In 2012, Amarin's REDUCE-IT cardiovascular outcomes study efforts were primarily focused on clinical site activation and patient enrollment. The REDUCE-IT study seeks to evaluate the rate of cardiovascular events in at-risk patients treated with statins plus Vascepa compared to patients treated with statins plus placebo. The study is currently estimated to be completed in approximately six years and designed to enroll approximately 8,000 patients. Amarin anticipates 2013 to be an important year for REDUCE-IT as it continues to support the clinical sites and their patients that are currently active in the study while continuing progress in enrolling additional patients needed to complete trial enrollment.
Financial update
Amarin reported cash and cash equivalents of
During the three months ended December 31, 2012, cash outflows from operating activities were approximately
Cash used for operating activities during the twelve months ended December 31, 2012 was approximately
Under U.S. Generally Accepted Accounting Principles (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
As of December 31, 2012, Amarin had approximately 150.3 million ADSs outstanding as well as approximately 9.9 million, 10.9 million, and 0.5 million equivalent shares underlying warrants, stock options, and restricted stock units, respectively, at average exercise prices of
Amarin's 2013 operational priorities
Operational priorities in the upcoming year include the following:
- Increasing revenues from Vascepa
- Approval of the ANCHOR indication sNDA
- Additional patent awards from the USPTO
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FDA approval of additional API suppliers - Managed care migration from Tier-3 to Tier-2 coverage
- Continued publication of data from Amarin's clinical trials
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FDA exclusivity determination
Conference call and webcast information
Amarin will host a conference call at 4:30 p.m. EST (8:30 p.m. UTC/GMT) today, February 28, 2013. To participate in the call, please dial (877) 407-8033 within
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 SEC 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. The company's 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 patented, 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.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM
The
Forward-looking statements
This press release contains forward-looking statements, including statements about the timing of
Vascepa has been approved for use by the
| CONSOLIDATED BALANCE SHEET DATA | ||||
| (U.S. GAAP) | ||||
| Unaudited | ||||
|
|
||||
| 2012 | 2011 | |||
| (in thousands) | ||||
| ASSETS | ||||
| Current Assets | ||||
| Cash and cash equivalents | $ 260,242 | $ 116,602 | ||
| Deferred tax asset | 937 | 533 | ||
| Inventory | 21,262 | -- | ||
| Other current assets | 3,253 | 1,837 | ||
| Total Current Assets | $ 285,694 | $ 118,972 | ||
| Property, plant and equipment, net | 811 | 432 | ||
| Deferred tax asset | 8,044 | 4,734 | ||
| Other non-current assets | 4,951 | 2,241 | ||
| Intangible asset, net | 11,355 | -- | ||
| Total Assets | $ 310,855 | $ 126,379 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||
| Current Liabilities: | ||||
| Accounts payable | $ 17,458 | $ 4,419 | ||
| Accrued interest payable | 2,520 | -- | ||
| Accrued expenses and other liabilities | 5,224 | 4,033 | ||
| Total current liabilities | $ 25,202 | $ 8,452 | ||
| Long Term Liabilities | ||||
| Warrant derivative liability | 54,854 | 123,125 | ||
| Long term debt redemption feature | 14,577 | -- | ||
| Exchangeable senior notes | 134,250 | -- | ||
| Long term debt | 85,153 | -- | ||
| Other long term liabilities | 816 | 764 | ||
| Total liabilities | $ 314,852 | $ 132,341 | ||
| Stockholders' Deficit | ||||
| Common stock | 124,597 | 113,321 | ||
| Additional paid-in capital | 619,266 | 449,393 | ||
| Treasury stock | (217) | (217) | ||
| Accumulated deficit | (747,643) | (568,459) | ||
| Total stockholders' deficit | $ (3,997) | $ (5,962) | ||
| Total Liabilities and Stockholders' Deficit | $ 310,855 | $ 126,379 | ||
| CONSOLIDATED STATEMENTS OF OPERATIONS DATA | ||||
| (U.S. GAAP) | ||||
| Unaudited | ||||
|
Three Months Ended |
Twelve Months Ended |
|||
|
(in thousands, except share and per share amounts) |
(in thousands, except share and per share amounts) |
|||
| 2012 | 2011 | 2012 | 2011 | |
| Revenues | $ -- | $ -- | $ -- | $ -- |
| OPERATING EXPENSES: | ||||
| Research and development(1) | 19,221 | 5,951 | 58,956 | 21,602 |
| Marketing, general and administrative(1) | 16,735 | 6,374 | 57,794 | 22,559 |
| Total operating expenses | 35,956 | 12,325 | 116,750 | 44,161 |
| Operating loss | (35,956) | (12,325) | (116,750) | (44,161) |
| Gain (loss) on change in fair value of derivative liabilities(2) | 33,342 | 30,734 | (35,344) | (22,669) |
| Interest income (expense), net | (4,709) | 133 | (17,547) | 230 |
| Other income (expense), net | (17) | (40) | (427) | (10) |
| Income (loss) from operations before taxes | (7,340) | 18,502 | (170,068) | (66,610) |
| Provision for income taxes | (3,229) | (164) | (9,116) | (2,516) |
| Net and comprehensive income (loss) | $ (10,569) | $ 18,338 | $ (179,184) | $ (69,126) |
| Income (loss) per share: | ||||
| Basic | $ (0.07) | $ 0.14 | $ (1.24) | $ (0.53) |
| Diluted |
|
$ 0.12 | $ (1.24) | $ (0.53) |
| Weighted average shares oustanding: | ||||
| Basic | 150,184 | 135,797 | 144,017 | 130,247 |
| Diluted | 150,184 | 156,630 | 144,017 | 130,247 |
|
(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, research and development expenses were |
||||
| (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 | ||
|
|
||
| 2012 | 2011 | |
| (in thousands) | ||
| Current Liabilities: | ||
| Accounts payable | $ 17,458 | $ 4,419 |
| Accrued interest payable | 2,520 | -- |
| Accrued expenses and other liabilities | 5,224 | 4,033 |
| Total current liabilities | $ 25,202 | $ 8,452 |
| Long-Term Liabilities | ||
| Warrant derivative liability | 54,854 | 123,125 |
| Long term debt redemption feature | 14,577 | -- |
| Exchangeable senior notes | 134,250 | -- |
| Long-term debt | 85,153 | -- |
| Other long-term liabilities | 816 | 764 |
| Total liabilities — GAAP | $ 314,852 | $ 132,341 |
| Warrant derivative liability | (54,854) | (123,125) |
| Total liabilities — non GAAP | $ 259,998 | $ 9,216 |
| RECONCILIATION OF NON-GAAP NET INCOME / (LOSS) | ||||
| Unaudited | ||||
|
Three Months Ended |
Twelve Months Ended |
|||
| 2012 | 2011 | 2012 | 2011 | |
| (In thousands, except share and per share amounts) | ||||
| Net income/(loss) for EPS1 — GAAP | $ (10,569) | $ 18,338 | $ (179,184) | $ (69,126) |
| Share based compensation expense | (4,731) | (3,272) | (18,075) | (9,294) |
| Warrant compensation income (expense) | 2,790 | 1,100 | (247) | 96 |
| Gain/(loss) on change in fair value of derivatives | 33,342 | 30,734 | (35,344) | (22,669) |
| Adjusted net loss for EPS1 — non GAAP | $ (41,970) | $ (10,224) | $ (125,518) | $ (37,259) |
| 1Basic and diluted | ||||
| Loss per share: | ||||
| Basic and diluted — non GAAP | $ (0.28) | $ (0.08) | $ (0.87) | $ (0.29) |
| Weighted average shares oustanding: | ||||
| Basic and diluted | 150,184 | 135,797 | 144,017 | 130,247 |
CONTACT:Stephen Schultz orJoseph Bruno Senior Director, Investor Relations and Corporate CommunicationsAmarin Corporation plc In U.S.: +1 (908) 719-1315 investor.relations@amarincorp.com
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