Amarin Reports Fourth Quarter and Year-End 2015 Financial Results
and Provides Update on Operations
and Provides Update on Operations
-
Revenue growth: Recognized
$26.4 million in net product revenue from Vascepa sales and$26.6 million in total revenue in Q4 2015, reflecting a 24% increase over Q3 2015 net product sales and 60% increase over Q4 2014 net product sales, and leading to full-year net product revenue of$81.0 million and full year total revenue of$81.8 million , increases of 49% and 51%, respectively, over 2014; -
Prescription growth: Increased normalized prescriptions, based on data from
Symphony Health Solutions and IMS Health, by 14% and 15%, respectively, compared to Q3 2015, representing an increase of approximately 52% and 55%, respectively, compared to Q4 2014; - Gross margins: Achieved gross margin on product sales of 68% during Q4 2015, the highest to date in any quarterly period, and full-year gross margin of 66% driven by ongoing improvements in product costs;
- R&D progress: Exceeded 99% enrollment in REDUCE-IT cardiovascular outcomes study with the cumulative primary cardiovascular event rate tracking to expectation and independent research further increasing the company's confidence in the success of this important study; and
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Strengthened management team: Appointed
Craig Granowitz , M.D., Ph.D., former senior vice president and head of global medical affairs, global human health at Merck, to newly created position of chief medical officer; and hired a new head of managed care team to support expanded commercial growth and further prepare for REDUCE-IT success.
"Throughout 2015, Amarin remained focused on strengthening its commercial operations and driving revenue growth while investing in research critical to improving care for patients with persistently high triglycerides and increased cardiovascular risk," commented
Commercial Operations
Amarin's strong revenue growth in both the fourth quarter and year ended
Normalized prescriptions (estimated) for the fourth quarter of 2015, based on prescription data from
Introducing healthcare professionals to additional information regarding Vascepa and its unique single active ingredient ethyl-eicosapentaenoic acid (EPA) favorably impacted Vascepa prescriptions in the fourth quarter of 2015. In particular, in
The increase in Vascepa revenues during 2015 also reflects the efficiency, high level of engagement, low turnover and increased productivity of Amarin's sales force supported by expanded managed care coverage and reports of positive patient experience when treated with the therapy. Sales and marketing of Vascepa by Amarin's co-promotion partner,
REDUCE-IT Nearing Enrollment Completion and on Target for 60% of Primary Events
The REDUCE-IT cardiovascular outcomes trial continues to track to prior estimates, supporting onset of the predefined target (1,612th) cumulative event in 2017 and publication of results in 2018. The results of this important trial could lead to new treatment options and improved medical care for tens of millions of patients. While cholesterol management with statins has been shown to significantly reduce cardiovascular risk, significant residual cardiovascular risk remains. REDUCE-IT is designed to test the hypothesis that Vascepa, when added to statin therapy, significantly reduces cardiovascular risk compared to statins alone in high-risk patients with above normal triglyceride levels.
Thus far, over 99% of the approximately 8,000 patients targeted for enrollment in the event-driven REDUCE-IT study have been enrolled and Amarin has pre-notified all clinical trial sites in the REDUCE-IT study of its intention to cease further patient accrual. Approximately 20,000 patient years of study experience have been accumulated in REDUCE-IT since enrollment commenced in 2011.
Based on historical event rates in the study, Amarin expects to attain 60% of the target aggregate number of primary cardiovascular events during the first half of 2016, triggering a pre-specified interim review by the independent data monitoring committee (DMC) of the trial's efficacy and safety results. After the 60% target has been achieved, additional time is required by the contract research organizations to finish collecting and preparing data for transfer to and analysis by the DMC. As is typical for large-scale, multi-national studies, this data preparation and transfer process is expected to take several months, independent of the robustness of the underlying safety and efficacy data.
Given the high thresholds of overwhelming efficacy and safety required prior to an independent DMC recommending an early stop to a cardiovascular outcomes trial like REDUCE-IT, management continues to expect that the DMC's interim analysis will result in a recommendation to continue the REDUCE-IT study as planned.
While clinical, epidemiological, and genetic data has historically supported the hypothesis of Amarin's on-going REDUCE-IT study, the body of research exploring the potential benefits of EPA continues to grow, adding to Amarin's excitement regarding the potential for REDUCE-IT success. Research in 2015, both sponsored by Amarin and independently by the international scientific community, continues to explore unique attributes of pure EPA that could play important roles in support of cardiovascular health. This research has generated increased interest in Vascepa in the scientific community.
"With the residual risk of cardiovascular disease in excess of 60% despite statin therapy, tens of millions of statin-treated patients with persistently high triglycerides remain in need of additional therapeutic options to further reduce that risk and improve their cardiovascular health," continued
Financial Results and 2016 Guidance
Net product revenue for the three months ended
Amarin anticipates that its expanded ability to promote Vascepa will continue to drive increases in Vascepa revenues in 2016. Based on 2015 growth and anticipated trends, the company reiterates its guidance estimate of total 2016 net product revenue of between
Cost of goods sold for the three months ended
Selling, general and administrative (SG&A) expenses for the three months ended
Research and development expenses for the three months ended
Under GAAP, Amarin reported a net loss of
Under GAAP, Amarin reported a net loss of
Excluding non-cash gains or losses for share-based compensation, change in fair value of derivatives, and gain on extinguishment of debt, non-GAAP adjusted net loss was
Excluding non-cash gains or losses for share-based compensation, warrant compensation, change in fair value of derivatives, gain on extinguishment of debt, and the non-cash deemed dividends, non-GAAP adjusted net loss was
Amarin reported cash and cash equivalents of
As previously reported, in
As of
Conference Call and Webcast Information
Amarin will host a conference call at 8:00 a.m. ET today, February 25, 2016. The conference call can be heard live through the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 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
Non-GAAP adjusted net loss was derived by taking GAAP net loss and adjusting it for non-cash gains or losses for share-based compensation, warrant compensation, change in value of derivatives, gain on extinguishment of debt and preferred stock purchase option and beneficial conversion features. 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 Amarin
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.
- Use 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). There was no reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
- Adverse events and product complaints may be reported by calling
1-855-VASCEPA or the FDA at 1-800-FDA -1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
Forward-looking statements
This press release contains forward-looking statements, including statements about the future commercialization of Vascepa; expectations regarding Vascepa sales, revenue, costs and other financial metrics for the year ended
Important Information Regarding Prescriptions Data and Product Revenue
The historical prescription data provided in this press release is based on data published by third parties. References to normalized prescriptions equate to 120 capsules or one month's supply. Although Amarin believes these data are prepared on a period to period basis in a manner that is generally consistent and that such results are indicative of current prescription trends, these data are based on estimates and should not be relied upon as definitive. These data may overstate or understate actual prescriptions. Based on other data available to Amarin and the history of such third-party prescription estimates in similar stages of launch of other pharmaceutical products, Amarin believes that the trends provided by this information can be useful to gauge current prescription levels. There is a limited amount of information available to determine the actual number of total
prescriptions for prescription products like Vascepa. Amarin believes that investors should view these data with caution, as data for this single and limited period may not be representative of a trend consistent with the results presented or otherwise predictive of future results. Seasonal fluctuations in pharmaceutical sales may affect future prescription trends of Vascepa on a monthly and quarterly basis, for example, as could changes in prescriber sentiment and other factors. Amarin believes investors should consider its results during this quarter together with its results over several future quarters, or longer, and in light of seasonal fluctuations before making an assessment about potential future performance. The commercialization and co-promotion of a new pharmaceutical product are complex undertakings, and Amarin's ability to effectively and profitably commercialize Vascepa
will depend in part on its ability to continue to generate market demand for Vascepa through education, marketing and sales activities, its ability to achieve market acceptance of Vascepa, its ability to generate product revenue and its ability to receive adequate levels of reimbursement from third-party payers and its ability to benefit from continued contributions of its Vascepa co-promotion partner,
Availability of Other Information about Amarin
Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
| CONSOLIDATED BALANCE SHEET DATA | ||||||||||||
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( |
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| Unaudited | ||||||||||||
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| (in thousands) | ||||||||||||
| ASSETS | ||||||||||||
| Current Assets: | ||||||||||||
| Cash and cash equivalents | $ | 106,961 | $ | 119,539 | ||||||||
| Restricted cash | 600 | 600 | ||||||||||
| Accounts receivable, net | 13,826 | 7,842 | ||||||||||
| Inventory | 18,985 | 13,733 | ||||||||||
| Deferred tax assets, current | - | 934 | ||||||||||
| Prepaid and other current assets | 3,152 | 2,633 | ||||||||||
| Total current assets | $ | 143,524 | $ | 145,281 | ||||||||
| Property, plant and equipment, net | 243 | 381 | ||||||||||
| Deferred tax assets, long-term | 18,233 | 12,556 | ||||||||||
| Other long-term assets | 2,045 | 2,826 | ||||||||||
| Intangible asset, net | 9,417 | 10,063 | ||||||||||
| TOTAL ASSETS | $ | 173,462 | $ | 171,107 | ||||||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||||||
| Current Liabilities: | ||||||||||||
| Accounts payable | $ | 10,832 | $ | 8,525 | ||||||||
| Current portion of long-term debt | 14,742 | 15,394 | ||||||||||
| Deferred revenue, current | 923 | - | ||||||||||
| Accrued expenses and other current liabilities | 24,226 | 16,387 | ||||||||||
| Total current liabilities | $ | 50,723 | $ | 40,306 | ||||||||
| Long-Term Liabilities: | ||||||||||||
| Exchangeable senior notes, net of discount | 138,605 | 121,846 | ||||||||||
| Long-term debt | 91,512 | 89,617 | ||||||||||
| Long-term debt derivative liabilities | 8,170 | 7,400 | ||||||||||
| Deferred revenue, long-term | 13,308 | - | ||||||||||
| Other long-term liabilities | 335 | 386 | ||||||||||
| Total liabilities | $ | 302,653 | $ | 259,555 | ||||||||
| Stockholders' Deficit: | ||||||||||||
| Preferred stock | 24,364 | - | ||||||||||
| Common stock | 149,978 | 143,113 | ||||||||||
| Additional paid-in capital | 816,171 | 738,890 | ||||||||||
| (411 | ) | (217 | ) | |||||||||
| Accumulated deficit | (1,119,293 | ) | (970,234 | ) | ||||||||
| Total stockholders' deficit | $ | (129,191 | ) | $ | (88,448 | ) | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $ | 173,462 | $ | 171,107 | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS DATA | ||||||||||||||||||||
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( |
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| Unaudited | ||||||||||||||||||||
| Three months ended December 31, |
Years ended |
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| (in thousands, except per share amounts) | (in thousands, except per share amounts) | |||||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||||||
| Product revenue, net | $ | 26,402 | $ | 16,480 | $ | 80,987 | $ | 54,202 | ||||||||||||
| Licensing revenue | 231 | - | 769 | - | ||||||||||||||||
| Total revenue, net | 26,633 | 16,480 | 81,756 | 54,202 | ||||||||||||||||
| Less: Cost of goods sold | 8,389 | 5,848 | 27,875 | 20,485 | ||||||||||||||||
| Gross margin | 18,244 | 10,632 | 53,881 | 33,717 | ||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Selling, general and administrative (1) | 23,519 | 18,397 | 101,041 | 79,346 | ||||||||||||||||
| Research and development (1) | 13,347 | 12,435 | 51,062 | 50,326 | ||||||||||||||||
| Total operating expenses | 36,866 | 30,832 | 152,103 | 129,672 | ||||||||||||||||
| Operating loss | (18,622 | ) | (20,200 | ) | (98,222 | ) | (95,955 | ) | ||||||||||||
| (Loss) gain on change in fair value of derivative liabilities (2) | (740 | ) | 1,602 | (1,106 | ) | 13,472 | ||||||||||||||
| Gain on extinguishment of debt | 1,314 | - | 1,314 | 38,034 | ||||||||||||||||
| Interest expense, net | (5,295 | ) | (4,914 | ) | (20,048 | ) | (18,479 | ) | ||||||||||||
| Other (expense) income, net | (93 | ) | (267 | ) | (228 | ) | 3,727 | |||||||||||||
| Loss from operations before taxes | (23,436 | ) | (23,779 | ) | (118,290 | ) | (59,201 | ) | ||||||||||||
| Benefit from income taxes | 1,545 | 4,122 | 3,086 | 2,837 | ||||||||||||||||
| Net loss | (21,891 | ) | (19,657 | ) | (115,204 | ) | (56,364 | ) | ||||||||||||
| Preferred stock purchase option | - | - | (868 | ) | - | |||||||||||||||
| Preferred stock beneficial conversion features | - | - | (32,987 | ) | - | |||||||||||||||
| Net loss applicable to common shareholders | $ | (21,891 | ) | $ | (19,657 | ) | $ | (149,059 | ) | $ | (56,364 | ) | ||||||||
| Loss per share: | ||||||||||||||||||||
| Basic | $ | (0.12 | ) | $ | (0.11 | ) | $ | (0.83 | ) | $ | (0.32 | ) | ||||||||
| Diluted | $ | (0.12 | ) | $ | (0.11 | ) | $ | (0.83 | ) | $ | (0.36 | ) | ||||||||
| Weighted average shares: | ||||||||||||||||||||
| Basic | 183,313 | 174,590 | 180,654 | 173,719 | ||||||||||||||||
| Diluted | 183,313 | 174,590 | 180,654 | 173,824 | ||||||||||||||||
| (1) | Excluding non-cash stock- and warrant-based compensation, selling, general and administrative expenses were |
|
| (2) | Non-cash gains and losses result from changes in the fair value of a warrant derivative liability, long-term debt derivative liabilities, and a preferred stock purchase option derivative liability. | |
| RECONCILIATION OF NON-GAAP NET LOSS | ||||||||||||||||||
| Unaudited | ||||||||||||||||||
| Three months ended December 31, |
Years ended |
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| (in thousands, except per share amounts) | (in thousands, except per share amounts) | |||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||||
| Net loss for EPS1 - GAAP | $ | (21,891 | ) | $ | (19,657 | ) | $ | (149,059 | ) | $ | (56,364 | ) | ||||||
| Share based compensation expense | 3,712 | 2,749 | 13,889 | 9,022 | ||||||||||||||
| Warrant compensation income | - | - | (9 | ) | (503 | ) | ||||||||||||
| Loss (gain) on change in fair value of derivatives | 740 | (1,602 | ) | 1,106 | (13,472 | ) | ||||||||||||
| Gain on extinguishment of debt | (1,314 | ) | - | (1,314 | ) | (38,034 | ) | |||||||||||
| Preferred stock purchase option | - | - | 868 | - | ||||||||||||||
| Preferred stock beneficial conversion features | - | - | 32,987 | - | ||||||||||||||
| Adjusted net loss for EPS1 - non GAAP | $ | (18,753 | ) | $ | (18,510 | ) | $ | (101,532 | ) | $ | (99,351 | ) | ||||||
| 1basic and diluted | ||||||||||||||||||
| Loss per share: | ||||||||||||||||||
| Basic and diluted - non GAAP | $ | (0.10 | ) | $ | (0.11 | ) | $ | (0.56 | ) | $ | (0.57 | ) | ||||||
| Weighted average shares: | ||||||||||||||||||
| Basic and diluted | 183,313 | 174,590 | 180,654 | 173,719 | ||||||||||||||
Amarin contact information:
Investor Inquiries
Investor Relations and Corporate Communications
In
investor.relations@amarincorp.com
Trout Group
In
gmorrell@troutgroup.com
Media Inquiries
In
Kristie.kuhl@finnpartners.com
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