Amarin Corporation(AMRN) - 2020 Q2 - Quarterly Report

PART I Financial Statements (unaudited) Amarin's unaudited financial statements for H1 2020 show increased assets, revenue growth to $290.3 million, a narrowed net loss, and positive operating cash flow Condensed Consolidated Balance Sheets Amarin's balance sheet as of June 30, 2020, shows total assets of $914.9 million, an increase driven by investments and inventory, while liabilities rose and equity slightly decreased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $214,007 | $644,588 | | Short-term investments | $336,273 | $0 | | Inventory | $124,844 | $76,769 | | Total current assets | $827,611 | $855,005 | | Total Assets | $914,869 | $882,209 | | Liabilities & Equity | | | | Accounts payable | $86,757 | $49,950 | | Accrued expenses and other current liabilities | $168,549 | $139,826 | | Total current liabilities | $283,467 | $242,248 | | Total Liabilities | $312,106 | $273,946 | | Total Stockholders' Equity | $602,763 | $608,263 | Condensed Consolidated Statements of Operations For H1 2020, Amarin's total revenue grew 67% to $290.3 million, narrowing the net loss to $16.1 million, driven by product sales despite rising operating expenses Condensed Consolidated Statements of Operations Highlights (in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Total revenue, net | $135,317 | $100,792 | $290,310 | $174,070 | | Gross margin | $106,520 | $78,022 | $226,706 | $134,160 | | Total operating expenses | $102,364 | $80,536 | $246,579 | $159,411 | | Operating income (loss) | $4,156 | $(2,514) | $(19,873) | $(25,251) | | Net income (loss) | $4,415 | $(1,820) | $(16,138) | $(26,251) | | Diluted EPS | $0.01 | $(0.01) | $(0.04) | $(0.08) | Condensed Consolidated Statement of Changes in Stockholders' Equity (Deficit) Total stockholders' equity decreased to $602.8 million by June 30, 2020, primarily due to a net loss and treasury stock purchases, partially offset by stock option exercises and preferred stock conversion - Total stockholders' equity decreased by $5.5 million in the first six months of 2020, from $608.3 million to $602.8 million[11][12] - A net conversion of 237,713,680 Series A Convertible Preferred Shares resulted in the issuance of 23,771,368 common shares during the six months ended June 30, 2020[11] Condensed Consolidated Statements of Cash Flows Amarin generated $5.7 million in operating cash flow for H1 2020, a positive shift, but overall cash decreased by $430.6 million due to significant investing and financing outflows Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $5,724 | $(22,180) | | Net cash used in investing activities | $(396,290) | $(801) | | Net cash used in financing activities | $(40,009) | $(4,472) | | Net Decrease in Cash | $(430,575) | $(27,453) | | Cash, End of Period | $217,920 | $223,274 | Notes to Condensed Consolidated Financial Statements The notes detail Amarin's business, accounting policies, debt, inventory commitments, equity, and significant legal proceedings, including the VASCEPA patent litigation - The company's lead product is VASCEPA®, approved to reduce triglyceride levels and, as of December 2019, to reduce persistent cardiovascular risk in select high-risk patients[18] - A U.S. District Court ruled against Amarin in a patent litigation case on March 30, 2020, potentially allowing generic competition for VASCEPA, and the company is appealing the decision[22] - As of June 30, 2020, the remaining amount to be repaid under a royalty-bearing instrument with CPPIB is $23.0 million, calculated as 10% of VASCEPA net product revenues[70] - The company has minimum purchase obligations of approximately $146.0 million over the term of its long-term supply agreements[79][81] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses Amarin's financial performance, highlighting VASCEPA's commercialization, revenue growth, the impact of patent litigation and COVID-19, and the company's liquidity position Overview Amarin's overview highlights VASCEPA's FDA approval and REDUCE-IT trial success, alongside challenges from adverse patent litigation and ongoing international expansion efforts - VASCEPA is the first and only FDA-approved drug as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high-risk patients, based on the REDUCE-IT trial[152][157] - A U.S. District Court ruled against Amarin's patents on March 30, 2020, in litigation against two generic companies, and while Amarin is appealing, generic competition could materially impact revenues[158] - The company is pursuing international expansion, with VASCEPA available in Canada, Lebanon, and the UAE, and is seeking regulatory approval in Europe, China, and the Middle East[160] Results of Operations For H1 2020, net product revenue grew 65% to $285.9 million, narrowing the net loss to $16.1 million, despite a 55% increase in operating expenses driven by sales force expansion Financial Performance Comparison (Six Months Ended June 30) | Metric (in millions) | 2020 | 2019 | % Change | | :--- | :--- | :--- | :--- | | Net Product Revenue | $285.9 | $173.1 | 65% | | Gross Margin % | 78% | 77% | +1 ppt | | SG&A Expense | $226.3 | $145.0 | 56% | | R&D Expense | $20.2 | $14.4 | 41% | | Net Loss | $(16.1) | $(26.3) | (39%) | - The increase in SG&A expense was primarily due to higher personnel costs from the sales force expansion to approximately 900 professionals and increased promotional activities for VASCEPA's new indication[233] - The COVID-19 pandemic slowed new patient prescriptions in Q2 2020 due to reduced doctor visits and lab testing, impacting revenue growth compared to Q1 2020[205][225] Liquidity and Capital Resources As of June 30, 2020, Amarin held over $600 million in liquidity, generated $5.7 million in operating cash flow, and believes its resources are sufficient for the next twelve months - Total liquidity as of June 30, 2020, exceeded $600.0 million, comprising cash, cash equivalents, restricted cash, and investments[242] - Net cash provided by operating activities was $5.7 million for the six months ended June 30, 2020, compared to a use of $22.2 million in the prior-year period[242][245] - Management believes current cash and investments are sufficient to fund projected operations for at least the next twelve months[249] Quantitative and Qualitative Disclosures about Market Risk No material changes occurred in the company's quantitative and qualitative market risk disclosures since the December 31, 2019, Annual Report on Form 10-K - There were no material changes in market risk disclosures from the last annual report[252] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2020, with no material changes to internal control over financial reporting during the quarter - As of June 30, 2020, the company's management concluded that its disclosure controls and procedures were effective at a reasonable assurance level[254] - No material changes to the company's internal control over financial reporting occurred during the quarter ended June 30, 2020[256] PART II – Other Information Legal Proceedings Amarin provides an update on its ANDA patent litigation, including an adverse U.S. District Court ruling against VASCEPA patents, an ongoing appeal, and a settlement with Apotex Inc - On March 30, 2020, a Nevada court ruled against Amarin in its ANDA patent litigation, finding relevant VASCEPA patents invalid due to obviousness[259] - The company is vigorously appealing the court's decision to the U.S. Court of Appeals for the Federal Circuit[259] - A settlement with Apotex Inc. was reached in June 2020, preventing a generic launch by Apotex until August 9, 2029, unless Amarin is unsuccessful in its pending appeal[260] Risk Factors Amarin outlines significant business risks, including potential generic competition for VASCEPA, the impact of COVID-19, supply chain dependencies, regulatory scrutiny, and challenges in international commercialization - The company is substantially dependent on VASCEPA, and a federal district court ruling in favor of generic drug companies could lead to near-term generic competition in the U.S., which would materially and adversely impact revenues[263] - The COVID-19 pandemic poses a significant threat, potentially impacting sales, supply chain, clinical trials, and regulatory processes due to social distancing, travel restrictions, and reprioritization of healthcare services[274] - The company received a civil investigative demand (CID) from the U.S. Department of Justice in June 2020 regarding an investigation into its promotional speaker programs and copayment waiver program for potential violations of the Anti-Kickback Statute and False Claims Act[296][347][379] - The company's supply of VASCEPA is dependent on third-party manufacturers, and any disruption, loss of a manufacturer, or failure to comply with cGMPs could result in lost sales and disrupt operations[387][394] Unregistered Sales of Equity Securities and Use of Proceeds During Q2 2020, the company repurchased 70,971 shares at an average price of $7.34 to satisfy employee tax withholding obligations related to equity awards Issuer Purchases of Equity Securities (Q2 2020) | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 1 – 30, 2020 | 19,328 | $8.26 | | May 1 – 31, 2020 | 32,133 | $7.16 | | June 1 – 30, 2020 | 19,510 | $6.72 | | Total | 70,971 | $7.34 | - The shares purchased were withheld to satisfy employee tax withholding obligations related to equity awards[499] Exhibits This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL taxonomy documents - Exhibits filed include CEO and CFO certifications under Sarbanes-Oxley Sections 302 and 906[501] - The filing also includes various Inline XBRL documents for financial data tagging[501]