Amarin Reports First Quarter 2016 Financial Results and Provides Update on Operations
-
Revenue growth: Recognized
$25.3 million in net product revenue from Vascepa® sales in Q1 2016 compared to$15.6 million in Q1 2015, an increase of approximately 63%;
- Gross margin: Gross margin on product sales increased to 73% in Q1 2016 compared to 64% in Q1 2015 primarily reflecting lower cost of inventory purchases due to expanded supplier network and higher purchasing volumes;
-
Prescription growth: Increased normalized prescriptions, based on data from
Symphony Health Solutions and IMS Health, by 55% and 56%, respectively, compared to Q1 2015, reflecting its ninth consecutive quarter of greater than 50% growth in normalized prescriptions over the corresponding quarter in the prior year;
-
Expanded marketing: Agreement reached with
FDA andU.S. government allowing Amarin to engage in promotion of ANCHOR Phase 3 clinical trial results and other related truthful and non-misleading information relating to Vascepa;
-
REDUCE-IT R&D progress: REDUCE-IT cardiovascular outcomes study, designed to provide data to support a significantly expanded market opportunity for Vascepa, reached target enrollment of approximately 8,000 patients and the onset of approximately 60% of the target aggregate number of primary cardiovascular events within the study has triggered preparation for a protocol pre-specified interim efficacy analysis by the independent Data Monitoring Committee (DMC) expected to be conducted in September or
October 2016 ; and
-
International commercialization: With Amarin's support,
Eddingpharm , the company's partner, completed submissions toChina Food and Drug Administration needed to better define the clinical and regulatory pathway to Vascepa approval inChina .
"Amarin's passionate field organization and managed care teams leveraged the strong underlying data that differentiates Vascepa's clinical profile from its omega-3 competitors to increase managed care coverage and drive greater utilization, resulting in our strongest first quarter yet," commented
Commercial Update
Amarin's continued year-over-year revenue growth resulted primarily from increased volume of Vascepa prescribed, with the number of physicians prescribing Vascepa and rate at which they do so both increasing.
Normalized prescriptions (estimated) for the first quarter of 2016, based on data from
REDUCE-IT Cardiovascular Outcomes Study Achieves Target Enrollment
During the first quarter of 2016, Amarin's REDUCE-IT cardiovascular outcomes study reached its target enrollment and now has over 8,000 patients enrolled in this study evaluating the effectiveness of Vascepa in preventing the occurrence of a first major cardiovascular event in a population of patients at high residual risk despite statin therapy. This is the first prospective double-blinded cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels. Unlike outcomes studies for many drugs that are designed to validate a currently approved drug indication, a positive result in REDUCE-IT could potentially expand the market opportunity for Vascepa, reflecting a potential market opportunity comparable in size to cholesterol management therapy.
The cardiovascular event rate in this events-driven study continues to track to prior estimates. Late in the first quarter, the onset of approximately 60% of the target aggregate number of primary cardiovascular events triggered formal preparation for a protocol pre-specified interim efficacy and safety analysis by the independent Data Monitoring Committee (DMC). The interim analysis is anticipated to occur in September or
Financial Update
Net product revenue for the three months ended
Cost of goods sold during the three months ended
Selling, general and administrative, or SG&A, expense in the three months ended
Research and development expense in the three months ended
Under GAAP, Amarin reported a net loss of
Excluding non-cash gains or losses for share-based compensation, warrant compensation, change in fair value of derivatives, and the non-cash deemed dividend, non-GAAP adjusted net loss was
Amarin reported cash and cash equivalents of
As of
Conference Call and Webcast Information
Amarin will host a conference call at 8:00 a.m. ET today, May 5, 2016. The conference call can be heard live on 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 are a single-molecule prescription product consisting of 1 gram of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex
- 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
Forward-looking statements
This press release contains forward-looking statements, including statements about the future commercialization of Vascepa; expectations regarding Vascepa sales, revenue, expense and other financial metrics for the quarter ended
Important Information Regarding Prescription Data and Product Revenue
The historical prescription data provided in this press release are 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 | ||||||||||||
|
( |
||||||||||||
| Unaudited | ||||||||||||
|
|
|
|||||||||||
| (in thousands) | ||||||||||||
| ASSETS | ||||||||||||
| Current Assets: | ||||||||||||
| Cash and cash equivalents | $ | 81,363 | $ | 106,961 | ||||||||
| Restricted cash | 600 | 600 | ||||||||||
| Accounts receivable, net | 15,019 | 13,826 | ||||||||||
| Inventory | 21,344 | 18,985 | ||||||||||
| Prepaid and other current assets | 6,105 | 3,152 | ||||||||||
| Total current assets | 124,431 | 143,524 | ||||||||||
| Property, plant and equipment, net | 172 | 243 | ||||||||||
| Deferred tax assets | 18,679 | 18,233 | ||||||||||
| Other long-term assets | 174 | 174 | ||||||||||
| Intangible asset, net | 9,256 | 9,417 | ||||||||||
| TOTAL ASSETS | $ | 152,712 | $ | 171,591 | ||||||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||||||
| Current Liabilities: | ||||||||||||
| Accounts payable | $ | 15,137 | $ | 10,832 | ||||||||
| Current portion of long-term debt | 12,727 | 14,742 | ||||||||||
| Deferred revenue, current | 1,172 | 923 | ||||||||||
| Accrued expenses and other current liabilities | 24,551 | 24,226 | ||||||||||
| Total current liabilities | 53,587 | 50,723 | ||||||||||
| Long-Term Liabilities: | ||||||||||||
| Exchangeable senior notes, net of discount | 138,703 | 136,734 | ||||||||||
| Long-term debt | 92,016 | 91,512 | ||||||||||
| Long-term debt derivative liabilities | 9,420 | 8,170 | ||||||||||
| Deferred revenue, long-term | 14,822 | 13,308 | ||||||||||
| Other long-term liabilities | 300 | 335 | ||||||||||
| Total liabilities | 308,848 | 300,782 | ||||||||||
| Stockholders' Deficit: | ||||||||||||
| Preferred stock | 24,364 | 24,364 | ||||||||||
| Common stock | 151,078 | 149,978 | ||||||||||
| Additional paid-in capital | 818,591 | 816,171 | ||||||||||
| (1,105 | ) | (411 | ) | |||||||||
| Accumulated deficit | (1,149,064 | ) | (1,119,293 | ) | ||||||||
| Total stockholders' deficit | (156,136 | ) | (129,191 | ) | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $ | 152,712 | $ | 171,591 | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS DATA | ||||||||
|
( |
||||||||
| Unaudited | ||||||||
| Three months ended March 31, | ||||||||
| (in thousands, except per share amounts) | ||||||||
| 2016 | 2015 | |||||||
| Product revenue, net | $ | 25,307 | $ | 15,558 | ||||
| Licensing revenue | 236 | 375 | ||||||
| Total revenue, net | 25,543 | 15,933 | ||||||
| Less: Cost of goods sold | 6,896 | 5,627 | ||||||
| Gross margin | 18,647 | 10,306 | ||||||
| Operating expenses: | ||||||||
| Selling, general and administrative (1) | 28,020 | 24,741 | ||||||
| Research and development (1) | 13,730 | 12,614 | ||||||
| Total operating expenses | 41,750 | 37,355 | ||||||
| Operating loss | (23,103 | ) | (27,049 | ) | ||||
| (Loss) gain on change in fair value of derivative liabilities (2) | (1,250 | ) | 464 | |||||
| Interest expense, net | (5,586 | ) | (4,885 | ) | ||||
| Other expense, net | (121 | ) | (128 | ) | ||||
| Loss from operations before taxes | (30,060 | ) | (31,598 | ) | ||||
| Benefit from income taxes | 289 | 472 | ||||||
| Net loss | (29,771 | ) | (31,126 | ) | ||||
| Preferred stock purchase option | - | (868 | ) | |||||
| Net loss applicable to common shareholders | $ | (29,771 | ) | $ | (31,994 | ) | ||
| Loss per share: | ||||||||
| Basic | $ | (0.16 | ) | $ | (0.18 | ) | ||
| Diluted | $ | (0.16 | ) | $ | (0.18 | ) | ||
| Weighted average shares: | ||||||||
| Basic | 184,052 | 175,582 | ||||||
| Diluted | 184,052 | 175,582 | ||||||
| (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 March 31, | |||||||||
| (in thousands, except per share amounts) | |||||||||
| 2016 | 2015 | ||||||||
| Net loss for EPS1 - GAAP | $ | (29,771 | ) | $ | (31,994 | ) | |||
| Share-based compensation expense | 3,597 | 3,042 | |||||||
| Warrant compensation income | - | (9 | ) | ||||||
| Loss (gain) on change in fair value of derivatives | 1,250 | (464 | ) | ||||||
| Preferred stock purchase option | - | 868 | |||||||
| Adjusted net loss for EPS1 - non GAAP | $ | (24,924 | ) | $ | (28,557 | ) | |||
| 1basic and diluted | |||||||||
| Loss per share: | |||||||||
| Basic and diluted - non GAAP | $ | (0.14 | ) | $ | (0.16 | ) | |||
| Weighted average shares: | |||||||||
| Basic and diluted | 184,052 | 175,582 | |||||||
| CONSOLIDATED CASH FLOWS DATA | ||||||||||
|
( |
||||||||||
| Unaudited | ||||||||||
| Three months ended March 31, | ||||||||||
| (in thousands, except per share amounts) | ||||||||||
| 2016 | 2015 | |||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||||
| Net loss | $ | (29,771 | ) | $ | (31,126 | ) | ||||
| Adjustments to reconcile loss to net cash used in operating activities: | ||||||||||
| Depreciation and amortization | 44 | 42 | ||||||||
| Loss on sale of fixed assets | 48 | - | ||||||||
| Stock-based compensation | 3,597 | 3,042 | ||||||||
| Stock-based compensation-warrants | - | (9 | ) | |||||||
| Excess tax provision on stock-based awards | 94 | 552 | ||||||||
| Amortization of debt discount and debt issuance costs | 2,473 | 1,811 | ||||||||
| Amortization of intangible asset | 161 | 161 | ||||||||
| Loss (gain) on change in fair value of derivative liabilities | 1,250 | (464 | ) | |||||||
| Deferred income taxes | (446 | ) | (95 | ) | ||||||
| Changes in assets and liabilities: | ||||||||||
| Accounts receivable | (1,193 | ) | (703 | ) | ||||||
| Inventories | (2,359 | ) | (2,450 | ) | ||||||
| Prepaid and other current assets | (2,953 | ) | 340 | |||||||
| Other non-current assets | - | 129 | ||||||||
| Accrued interest payable | (2,015 | ) | (1,292 | ) | ||||||
| Deferred revenue | 1,763 | 14,625 | ||||||||
| Accounts payable and other current liabilities | 4,531 | 2,549 | ||||||||
| Other non-current liabilities | (35 | ) | 245 | |||||||
| Net cash used in operating activities | (24,811 | ) | (12,643 | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||||
| Purchase of equipment | (21 | ) | - | |||||||
| Net cash used in investing activities | (21 | ) | - | |||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||||
| Proceeds from issuance of preferred stock, net of transaction costs | - | 52,253 | ||||||||
| Proceeds from exercise of stock options, net of transaction costs | 22 | 4 | ||||||||
| Proceeds from exercise of warrants, net of transaction costs | - | 2,713 | ||||||||
| Excess tax provision on stock-based awards | (94 | ) | (552 | ) | ||||||
| Acquisition of treasury stock | (694 | ) | (117 | ) | ||||||
| Payments under capital leases | - | (2 | ) | |||||||
| Net cash (used in) provided by financing activities | (766 | ) | 54,299 | |||||||
| NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (25,598 | ) | 41,656 | |||||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 106,961 | 119,539 | ||||||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 81,363 | $ | 161,195 | ||||||
| Supplemental disclosure of cash flow information: | ||||||||||
| Cash paid during the year for: | ||||||||||
| Interest | $ | 5,138 | $ | 4,273 | ||||||
| Income taxes | $ | 267 | $ | 17 | ||||||
| Non-cash transactions: | ||||||||||
| Transfer of preferred stock purchase option derivative liability to equity | $ | - | $ | 868 | ||||||
Amarin Contact Information:
Investor Relations:
Kathryn McNeil
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Trout Group
In U.S.: +1 (646) 378-2992
lstern@troutgroup.com
Media Inquiries:
In U.S.: +1 (212) 583-2791
Kristie.kuhl@finnpartners.com
Source:
News Provided by Acquire Media



