Amarin Reports Third Quarter 2011 Results
- Submitted a New Drug Application (NDA) for AMR101 for the reduction in triglycerides in patients with very high triglycerides (>500 mg/dL), including efficacy and safety data from both Phase 3 MARINE and ANCHOR pivotal studies
-
Agreement reached with
FDA on Special Protocol Assessment (SPA) for the REDUCE-IT cardiovascular outcomes study - U.S. patent applications for AMR101 increased to16 applications across 11 patent families
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Published MARINE Phase 3 clinical trial results in
The American Journal of Cardiology -
Accepted for oral presentation from each of its two pivotal Phase 3 studies, the MARINE trial and the ANCHOR trial, at the
American Heart Association's Scientific Sessions 2011 -
Cash balance at end of third quarter was
$125.9 million
Q3 2011 Financial Update
At September 30, 2011, there were 135,445,501 outstanding shares held as ADSs and an additional 315,237 ordinary shares. Also outstanding at September 30, 2011 were warrants to purchase 21,139,090 ADSs and stock options to purchase 10,778,763 ADSs.
Under U.S. Generally Accepted Accounting Principles (GAAP), the Company reported net income for Q3 2011 of
Excluding non-cash gains or losses for share-based compensation, warrant compensation and change in value of derivative, non-GAAP adjusted net loss for Q3 2011 was
In accordance with GAAP, the fair value of the derivative related to warrants issued in conjunction with the Company's 2009 equity financing was recorded at the time of issuance as a non-cash liability and this liability is re-measured at the end of each reporting period. Changes in fair value from period to period are recorded as gains or losses. Upon exercise of the warrants, the fair value of the warrants exercised is reclassified from liabilities to equity. Although these warrants are accounted for as derivatives, the number of warrants issuable remains fixed and the derivative liability is not an obligation on the cash of the Company. Excluding this non-cash derivative liability, the Company's liabilities reported as of
Regulatory Update — NDA Submitted for Very High Triglycerides Indication
In
Clinical Update - REDUCE-IT Outcomes Study
In
Once REDUCE-IT is substantially underway, the Company believes that it will have met all of the requirements to request approval of AMR101 for treating the mixed dyslipidemia patient population studied in the ANCHOR trial. AMR101 is positioned to be the first drug in its class approved for treatment of this indication.
Commercial Opportunity
The Company believes that AMR101 represents a major commercial opportunity as it is estimated approximately 4 million people with very high triglyceride levels (>500mg/dL-the triglyceride range studied in the MARINE trial) and approximately 36 million people with high triglyceride levels (>200 and <500mg/dL - the triglyceride range studied in the ANCHOR trial and a potential first in class prescription medicine for this indication). Clinical treatment guidelines include recommendations for triglyceride reductions in each of these groups and the Company believes that each group represents a multi-billion dollar market opportunity. In the top seven world markets it is estimated that the number of people with elevated triglyceride levels is at least two times that of the U.S. alone.
"In the third quarter,
Intellectual Property Update
Securing a patent is a complex process in which an active exchange with the patent office is common and there can be no assurance that patents will be granted in the form initially filed, or at all. Our policy is to not comment on the nature of our active and ongoing discussions with the respective patent offices or to comment on the interim status of individual patent applications.
Based in part on the unexpected findings we observed in our MARINE and ANCHOR Phase 3 clinical trials, we continue to believe that our arguments for patentability are strong and we will continue to vigorously prosecute our multiple patent applications to the fullest extent.
Anticipated Presentations
As part of the Company's overall program for communicating further details of its clinical results, the following are upcoming:
- Presentation of clinical trial results in peer-reviewed forums:
- ANCHOR results oral presentation at the annual meeting of the
American Heart Association inOrlando, Florida , November 16 (the first oral presentation of these results);- MARINE results oral presentation at the annual meeting of the
American Heart Association inOrlando, Florida , November 15 (including data results from of our MARINE trial which have not been previously presented);
- Publication of clinical trial results:
- ANCHOR results publication: multiple publications anticipated commencing after peer-review presentation of results
In addition,
Conference Call and Webcast Information
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.
The non-GAAP adjusted financial information is not meant to be considered in isolation or as a substitute for GAAP financials. The non-GAAP adjusted financial information provided by the Company may also differ from non-GAAP adjusted information provided by other companies.
About AMR101
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), that
About
Disclosure Notice
This press release contains forward-looking statements, including statements about the efficacy and safety of the Company's product candidates, clinical trial results, the timing of initiating, enrolling and completing a planned cardiovascular outcomes study, the timing of data publication and presentation, clinical importance of AMR101, regulatory submissions and approvals, patent approvals, the commercial opportunity and competitive positioning for AMR101and the ability of Company to achieve current operating priorities. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: anticipated operating losses and the likely need for additional capital to fund future operations and the planned
cardiovascular outcomes study; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; risks associated with qualifying new contract manufacturers prior to commercial launch; the risk that SPAs are not a guarantee that
| CONSOLIDATED BALANCE SHEET DATA | |||
| (U.S. GAAP) | |||
| Unaudited | |||
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| (in thousands) | |||
| ASSETS | |||
| Cash and cash equivalents |
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| Total Assets |
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| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |||
| Liabilities (excluding warrant derivative liability) |
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| Total shareholders' (deficit) equity | $(30,335) |
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| CONSOLIDATED STATEMENTS OF OPERATIONS DATA | ||||
| (U.S. GAAP) | ||||
| Unaudited | ||||
|
Three Months Ended |
Nine Months Ended |
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|
(in thousands, except share and per share amounts) |
(in thousands, except share and per share amounts) |
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| 2011 | 2010 | 2011 | 2010 | |
| Revenues | $ -- | $ -- | $ -- | $ -- |
| OPERATING EXPENSES: | ||||
| Research and development(1) | 6,013 | 7,642 | 15,651 | 20,565 |
| Marketing, general and administrative(1) | 3,433 | 2,134 | 16,185 | 7,205 |
| Total operating expenses | 9,446 | 9,776 | 31,836 | 27,770 |
| Operating loss | (9,446) | (9,776) | (31,836) | (27,770) |
| Gain (loss) on change in fair value of derivative liability(2) | 106,614 | (1,370) | (53,403) | (33,402) |
| Interest income (expense), net | 3 | 30 | 97 | 15 |
| Other income (expense), net | (59) | 15 | 30 | (478) |
| Income (loss) from operations before taxes | 97,112 | (11,101) | (85,112) | (61,635) |
| Provision for income taxes | (767) | (108) | (2,352) | (142) |
| Net and comprehensive income (loss) |
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| Income (loss) per share: | ||||
| Basic |
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$ (0.62) |
| Diluted | 0.62 | (0.11) | (0.68) | (0.62) |
| Weighted average shares: | ||||
| Basic | 133,238 | 100,150 | 128,377 | 99,284 |
| Diluted | 155,975 | 100,150 | 128,377 | 99,284 |
(1) A substantial portion of the Company's marketing, general and administrative costs represents non-cash warrant based compensation to former employees. 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 the Company to describe the Company's financial results determined in accordance with
| RECONCILIATION OF NON-GAAP NET INCOME / (LOSS) | ||||
| Unaudited | ||||
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Three Months Ended |
Nine Months Ended |
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(in thousands, except share and per share amounts) |
(in thousands, except share and per share amounts) |
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| 2011 | 2010 | 2011 | 2010 | |
| Net income/(loss) for EPS1 — GAAP |
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| Share based compensation expense | (2,662) | (759) | (6,022) | (2,010) |
| Warrant compensation income (expense) | 3,352 | (36) | (1,004) | (858) |
| Gain/(loss) on change in fair value of derivative | 106,614 | (1,370) | (53,403) | (33,402) |
| Adjusted net loss for EPS1 — non GAAP | (10,959) | (9,044) | (27,035) | (25,507) |
| 1 basic and diluted | ||||
| Loss per share: | ||||
| Basic and diluted — non GAAP |
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| Weighted average shares: | ||||
| Basic and diluted | 133,238 | 100,150 | 128,377 | 99,284 |
CONTACT: Investor Contact Information:
Stephen D. Schultz
Senior Director Investor Relations and
Corporate Communications
In U.S.: +1 (860) 572-4979 Ext.292
investor.relations@amarincorp.com
Lee M. Stern The Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com
Media Contact Information:
David Schull or Martina Schwarzkopf , Ph.D.
Russo Partners
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)
david.schull@russopartnersllc.com
martina.schwarzkopf@russopartnersllc.com
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