Amarin Reports Second Quarter 2016 Financial Results and Provides Update on Operations
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Revenue growth: Recognized
$32.8 million in net product revenue from Vascepa® (icosapent ethyl) sales in Q2 2016 compared to$17.7 million in Q2 2015, an increase of 85%;
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Prescription growth: Increased normalized prescriptions, based on data from
Symphony Health Solutions and IMS Health, by 55% and 58%, respectively, compared to Q2 2015, reflecting the tenth consecutive quarter of greater than 50% growth in normalized prescriptions over the corresponding quarter in the prior year;
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R&D progress: Amended the REDUCE-IT special protocol assessment (SPA) agreement to include a second interim efficacy analysis at approximately 80% of targeted primary events and additional pre-specified secondary and tertiary endpoints while confirming
FDA support for the key elements of the SPA agreement that were not amended;
- Research data: Presented data showing Vascepa's reduction of concentrations of potentially atherogenic lipoproteins in patients with Type 2 diabetes and persistent high triglyceride levels despite statin therapy and further characterizing the efficacy and safety of Vascepa in women;
- Secured regulatory exclusivity: Granted five-year new chemical entity (NCE) marketing exclusivity supplementing the existing patent protection of Vascepa;
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Improved cash flow: Consistent with target of becoming cash flow positive from commercial operations, excluding REDUCE-IT costs, at the start of 2017, net cash used in operating activities in Q2 2016 was lowered to approximately
$9.0 million with spending levels intentionally held relatively flat; and
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Strengthened management team: Appointed
Michael W. Kalb , previously chief financial officer and chief accounting officer at Taro Pharmaceutical Industries, as the company's new chief financial officer.
"We continued to identify areas of expanded opportunity in our core commercial business and accelerated growth during the second quarter," stated
Increases in New and Recurring Prescriptions Drive Steady Commercial Growth
During the second quarter, Amarin continued to see substantial prescription growth and steady increases in prescription omega-3 and non-statin market share, particularly among detailed physicians. Increased switching of patients to Vascepa from earlier generation triglyceride lowering therapy (i.e., generic omega-3 ethyl ester mixtures and fenofibrate products) is increasingly contributing to overall new prescription growth. Vascepa growth continues to be driven by focused message delivery, compelling supportive data and improved managed care coverage.
Normalized total Vascepa prescriptions, based on data from
Growth in both new and recurring Vascepa prescriptions resulted in increased shipment volumes to wholesalers during the quarter. While prescription growth was the foundation for reported revenue growth in Q2 2016, the growth in revenue reported in Q2 2016 compared to Q2 2015 also included the effect of increased inventory levels at wholesalers and to a smaller extent higher net product pricing.
Inventory levels at wholesalers tend to fluctuate based on seasonal factors, prescription trends and other factors. In Q1 2016, overall wholesaler inventory levels decreased from year-end 2015 calculated based on estimated days of Vascepa sales on hand. In Q2 2016, the trend was reversed and overall wholesaler inventory levels increased. Consequently, we estimate that the net overall increase in wholesaler inventory levels contributed approximately
On a quarterly basis, we estimate that the net overall increase in Q2 2016 wholesaler inventory levels from Q1 2016 added approximately
Additional Endpoints and Second Interim Efficacy Analysis Strengthen REDUCE-IT Trial
The REDUCE-IT cardiovascular outcomes trial continues on schedule towards anticipated completion in 2017 and publication of results in 2018. The results of this important trial, if successful, could lead to improved medical care for tens of millions of patients. As the trial progresses toward completion, Amarin has explored ways to mitigate regulatory risk, broaden the potential findings and accelerate the availability of final data. To this end, the company recently amended the study protocol to add more pre-specified secondary and tertiary efficacy endpoints and a second protocol-specified interim efficacy analysis. The SPA amendment does not change the primary endpoint or the overall size of the REDUCE-IT study, as confirmed with the
In an effort to more broadly characterize the potential benefits of Vascepa, particularly among key patient subgroups, the study now includes more than 30 pre-specified secondary and tertiary endpoints designed to capture multiple potential drug effects in various subpopulations. The added endpoints could result in improved patient care for specific groups within the diverse population studied in REDUCE-IT and are expected to support a variety of new publications furthering our goal to support informed medical decisions.
The first interim efficacy and safety analysis by the independent data monitoring committee (DMC) at approximately 60% of targeted primary events is expected to occur in September or
Amarin will remain blinded to the interim and ongoing results of the REDUCE-IT study as well as to any interim p-values and other statistical information until after the study is ready to be stopped, either at an interim analysis or at the final analysis.
Financial Update
Net product revenue for the three months ended
Based on year-to-date results and anticipated trends, Amarin is increasing its guidance estimate for total 2016 net product revenue to
In addition, Amarin recognized licensing revenue of
Cost of goods sold for the three months ended
Selling, general and administrative (SG&A) expenses in the six months ended
Research and development expenses in the six months ended
Under GAAP, Amarin reported a net loss applicable to common shareholders of
Under GAAP, Amarin reported a net loss applicable to common shareholders of
Excluding non-cash gains or losses for stock-based compensation, change in fair value of derivatives, and the non-cash deemed dividend, non-GAAP adjusted net loss was
Excluding non-cash gains or losses for stock-based compensation, warrant compensation, change in fair value of derivatives, and the non-cash deemed dividends, 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
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 stock-based compensation, warrant compensation, change in fair value of derivatives, and non-cash deemed dividends. Management uses these non-GAAP adjusted financial measures for internal reporting and forecasting purposes, when publicly providing its business outlook, to evaluate the company's performance and to evaluate and compensate the company's executives. The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial 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 TRx trends and wholesaler inventory levels; expectations regarding Vascepa sales, revenue, costs and other financial metrics; expectations related to Amarin's anticipated financial position and outlook in 2016 and the years that follow such as the company's potential to enter 2017 as cash flow positive from commercial operations; expectations for event rates, interim data reviews, results and related announcements with respect to Amarin's REDUCE-IT cardiovascular outcomes study; expectations related to the interim and final outcome of the REDUCE-IT study and the anticipated successful completion of the REDUCE-IT study; and statements regarding the potential efficacy, safety and therapeutic benefits of Vascepa. These forward-looking
statements are not promises or guarantees and involve substantial risks and uncertainties. In particular, as disclosed in filings with the
Important Information Regarding Prescription 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,
| CONSOLIDATED BALANCE SHEET DATA | ||||||||||||
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| Unaudited | ||||||||||||
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| (in thousands) | ||||||||||||
| ASSETS | ||||||||||||
| Current Assets: | ||||||||||||
| Cash and cash equivalents | $ | 72,491 | $ | 106,961 | ||||||||
| Restricted cash | 600 | 600 | ||||||||||
| Accounts receivable, net | 17,639 | 13,826 | ||||||||||
| Inventory | 20,306 | 18,985 | ||||||||||
| Prepaid and other current assets | 5,476 | 3,152 | ||||||||||
| Total current assets | 116,512 | 143,524 | ||||||||||
| Property, plant and equipment, net | 137 | 243 | ||||||||||
| Deferred tax assets | 21,718 | 19,872 | ||||||||||
| Other long-term assets | 174 | 174 | ||||||||||
| Intangible asset, net | 9,095 | 9,417 | ||||||||||
| TOTAL ASSETS | $ | 147,636 | $ | 173,230 | ||||||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||||||
| Current Liabilities: | ||||||||||||
| Accounts payable | $ | 14,811 | $ | 10,832 | ||||||||
| Accrued expenses and other current liabilities | 31,052 | 24,226 | ||||||||||
| Current portion of long-term debt | 30,816 | 14,742 | ||||||||||
| Deferred revenue, current | 1,172 | 923 | ||||||||||
| Total current liabilities | 77,851 | 50,723 | ||||||||||
| Long-Term Liabilities: | ||||||||||||
| Exchangeable senior notes, net of discount | 125,644 | 136,734 | ||||||||||
| Long-term debt | 90,150 | 91,512 | ||||||||||
| Long-term debt derivative liabilities | 3,610 | 8,170 | ||||||||||
| Deferred revenue, long-term | 14,529 | 13,308 | ||||||||||
| Other long-term liabilities | 268 | 335 | ||||||||||
| Total liabilities | 312,052 | 300,782 | ||||||||||
| Stockholders' Deficit: | ||||||||||||
| Preferred stock | 24,364 | 24,364 | ||||||||||
| Common stock | 151,183 | 149,978 | ||||||||||
| Additional paid-in capital | 822,013 | 816,171 | ||||||||||
| (1,197 | ) | (411 | ) | |||||||||
| Accumulated deficit | (1,160,779 | ) | (1,117,654 | ) | ||||||||
| Total stockholders' deficit | (164,416 | ) | (127,552 | ) | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $ | 147,636 | $ | 173,230 | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS DATA | ||||||||||||||||
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| Unaudited | ||||||||||||||||
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Three months ended |
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| (in thousands, except per share amounts) | (in thousands, except per share amounts) | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Product revenue, net | $ | 32,815 | $ | 17,707 | $ | 58,122 | $ | 33,265 | ||||||||
| Licensing revenue | 296 | - | 532 | 375 | ||||||||||||
| Total revenue, net | 33,111 | 17,707 | 58,654 | 33,640 | ||||||||||||
| Less: Cost of goods sold | 8,861 | 6,381 | 15,757 | 12,008 | ||||||||||||
| Gross margin | 24,250 | 11,326 | 42,897 | 21,632 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Selling, general and administrative (1) | 26,066 | 26,054 | 54,086 | 50,795 | ||||||||||||
| Research and development (1) | 12,578 | 12,009 | 26,308 | 24,623 | ||||||||||||
| Total operating expenses | 38,644 | 38,063 | 80,394 | 75,418 | ||||||||||||
| Operating loss | (14,394 | ) | (26,737 | ) | (37,497 | ) | (53,786 | ) | ||||||||
| Gain (loss) on change in fair value of derivative liabilities (2) | 5,810 | (600 | ) | 4,560 | (136 | ) | ||||||||||
| Interest expense, net | (5,616 | ) | (4,807 | ) | (11,202 | ) | (9,692 | ) | ||||||||
| Other (expense) income, net | (182 | ) | 95 | (303 | ) | (33 | ) | |||||||||
| Loss from operations before taxes | (14,382 | ) | (32,049 | ) | (44,442 | ) | (63,647 | ) | ||||||||
| Benefit from income taxes | 1,028 | 537 | 1,317 | 1,009 | ||||||||||||
| Net loss | (13,354 | ) | (31,512 | ) | (43,125 | ) | (62,638 | ) | ||||||||
| Preferred stock purchase option | - | - | - | (868 | ) | |||||||||||
| Preferred stock beneficial conversion feature | - | (31,341 | ) | - | (31,341 | ) | ||||||||||
| Net loss applicable to common shareholders | $ | (13,354 | ) | $ | (62,853 | ) | $ | (43,125 | ) | $ | (94,847 | ) | ||||
| Loss per share: | ||||||||||||||||
| Basic | $ | (0.07 | ) | $ | (0.35 | ) | $ | (0.23 | ) | $ | (0.53 | ) | ||||
| Diluted | $ | (0.07 | ) | $ | (0.35 | ) | $ | (0.23 | ) | $ | (0.53 | ) | ||||
| Weighted average shares: | ||||||||||||||||
| Basic | 184,471 | 180,464 | 184,262 | 178,036 | ||||||||||||
| Diluted | 184,471 | 180,464 | 184,262 | 178,036 | ||||||||||||
| (1) | Excluding non-cash stock-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 | |||||||||||||||||
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Three months ended |
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| (in thousands, except per share amounts) | (in thousands, except per share amounts) | ||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||||||
| Net loss for EPS1 - GAAP | $ | (13,354 | ) | $ | (62,853 | ) | $ | (43,125 | ) | $ | (94,847 | ) | |||||
| Stock-based compensation expense | 3,365 | 3,216 | 6,962 | 6,258 | |||||||||||||
| Warrant compensation income | - | - | - | (9 | ) | ||||||||||||
| (Gain) loss on change in fair value of derivatives | (5,810 | ) | 600 | (4,560 | ) | 136 | |||||||||||
| Preferred stock purchase option | - | - | - | 868 | |||||||||||||
| Preferred stock beneficial conversion feature | - | 31,341 | - | 31,341 | |||||||||||||
| Adjusted net loss for EPS1 - non GAAP | $ | (15,799 | ) | $ | (27,696 | ) | $ | (40,723 | ) | $ | (56,253 | ) | |||||
| 1basic and diluted | |||||||||||||||||
| Loss per share: | |||||||||||||||||
| Basic and diluted - non GAAP | $ | (0.09 | ) | $ | (0.15 | ) | $ | (0.22 | ) | $ | (0.32 | ) | |||||
| Weighted average shares: | |||||||||||||||||
| Basic and diluted | 184,471 | 180,464 | 184,262 | 178,036 | |||||||||||||
Amarin contact information:
Investor Relations:
Investor Relations and Corporate Communications
In
investor.relations@amarincorp.com
In
lstern@troutgroup.com
Media Inquiries:
In
Kristie.kuhl@finnpartners.com
Source:
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