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Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 Alkermes plc Reports Third Quarter 2020 Financial Results and Raises 2020 Financial Expectations - Company Reports Thi

Key Takeaway: Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 Alkermes plc Reports Third Quarter 2020 Financial Results and Raises 2020 Financial Expectations - Company Reports Third Quarter Revenues of $265.0 Million, GAAP Net Loss

Full Press Release Details

Alkermes Contacts:
For Investors: Sandy Coombs +1 781 609 6377
For Media: Katie Joyce +1 781 249 8927
Alkermes plc Reports Third Quarter 2020 Financial Results and
Raises 2020 Financial Expectations
- Company Reports Third Quarter Revenues of $265.0 Million, GAAP Net Loss per Share of $0.00 and Basic and Diluted Non-GAAP Earnings per Share of $0.26 -
- ARISTADA Net Sales of $62.4 Million Reflect 16% Year-Over-Year Growth -
- VIVITROL Net Sales Increased 12% Sequentially to $80.3 Million -
DUBLIN, Ireland, Oct. 29, 2020 - Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2020 and provided updated financial expectations for full-year 2020.
"Over the past several months, we achieved a number of important milestones in our development programs against the backdrop of strong commercial execution and disciplined management of our expenses. The positive outcome of the ALKS 3831 FDA Advisory Committee meeting and the presentation of accumulating data for ALKS 4230, including monotherapy responses observed in melanoma, were significant achievements that underscore the potential value of these investigational medicines," said Richard Pops, Chief Executive Officer of Alkermes. "As we look ahead, we will continue to focus on our strategic imperatives: commercial execution, including preparations for the potential launch of ALKS 3831, aggressive development of our pipeline candidates, and efficient management of our operating cost structure, as we position the company for long-term value creation."
Quarter Ended Sept. 30, 2020 Financial Highlights
Quarter Ended Sept. 30, 2020 Financial Results
"Our third quarter results reflect strong commercial execution, with the sequential growth of both VIVITROL and ARISTADA net sales within a complex and dynamic COVID-19 market environment. Today, we are pleased to be raising our financial guidance for 2020 to reflect this solid performance. Importantly, expectations for 2020 non-GAAP net income are back in line with the expectations provided in February prior to the impact of COVID-19, primarily due to disciplined management of our expenses," commented James Frates, Chief Financial Officer of Alkermes. "As we approach the end of 2020, we believe we are well-positioned to execute on our strategic imperatives to drive long-term profitability and growth."
Financial Expectations for 2020
The following financial expectations for 2020 are based on recent trends and assume that treatment provider practices and patient access to the company's commercial products continue to normalize. New COVID-19-related restrictions or a resurgence of COVID-19 could impact the company's ability to meet these expectations. All line items are according to GAAP, except as otherwise noted.
In millions (except per share amounts) Current 2020 Expectation (Provided 10/29/20) Previous Expectation (Provided 7/29/20)
Total Revenue $1,010 - $1,035 $965 - $1,005
VIVITROL Net Sales $305 - $315 $270 - $300
ARISTADA Net Sales $230 - $240 $220 - $235
Cost of Goods Sold $180 - $190 $180 - $190
R&D Expenses $375 - $390 $370 - $395
SG&A Expenses $530 - $545 $525 - $550
Amortization of Intangible Assets ~$40 ~$40
Other Income, Net ~$30 $10 - $15
Income Tax Expense $10 - $15 $10 - $15
GAAP Net Loss ($95) - ($115) ($145) - ($175)
GAAP Net Loss per Share ($0.60) - ($0.72) ($0.91) - ($1.10)
Non-GAAP Net Income $50 - $70 $0 - $30
Non-GAAP Diluted EPS $0.31 - $0.43 $0.00 - $0.19
Capital Expenditures ~$35 ~$35
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (12:00 p.m. GMT) on Thursday, Oct. 29, 2020, to discuss these financial results, financial expectations, and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (3:00 p.m. GMT) on Thursday, Oct. 29, 2020, through Thursday, Nov. 5, 2020, and may be accessed by visiting Alkermes' website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13712082.
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.
Non-GAAP Financial Measures
This press release includes information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.
Non-GAAP net income (loss) adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; changes in the fair value of the contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.
The company's management and the Board utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share are not measures of financial performance under GAAP
and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share should not be considered measures of the company's liquidity.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning future financial and operating performance, business plans or prospects, including the anticipated ongoing impacts of COVID-19 on the company's business and financial performance, the company's assumptions with respect to continued normalization of patient and healthcare provider practices, and the company's ability to drive long-term value creation and profitability; the potential therapeutic and commercial value of the company's marketed and development products; the company's expectations concerning future development activities for the company's development candidates; the company's expectations regarding the FDA's review of the ALKS 3831 NDA, including the FDA's PDUFA target action date for the NDA; and expectations concerning the company's commercial activities, including the potential launch of ALKS 3831. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition, including: impacts on the vendors or distribution channels in its supply chain, and the company's ability to continue to manufacture its products; impacts on its ability to continue its discovery activities; impacts on the conduct of its clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites and monitoring of data; impacts on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia and on patient and healthcare provider access to the company's medicines; impacts on the regulatory agencies with which the company interacts in the development, review, approval and commercialization of its medicines; impacts on reimbursement for the company's products, including its Medicaid rebate liability, and for services related to the use of its products; and impacts on the U.S., Irish and/or global economies more broadly; the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of the company's products or products using the company's proprietary technologies, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company's clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products, such as decisions not to approve the company's NDAs, including the NDA for ALKS 3831; data from clinical trials may be interpreted by the FDA in different ways than the company or an advisory committee interprets it; the FDA may not agree with the company's regulatory approval strategies or components of its ALKS 3831 NDA or other regulatory filings, including the company's clinical trial designs, conduct and methodologies, manufacturing processes and facilities, and the adequacy of the data and other information included in its filings to meet the FDA's requirements for approval, including the risk/benefit profile of the company's product candidates; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K
for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
VIVITROL is a registered trademark of Alkermes, Inc.; ARISTADA and ARISTADA INITIO are registered trademarks of Alkermes Pharma Ireland Limited; and RISPERDAL CONSTA , INVEGA SUSTENNA , XEPLION , INVEGA TRINZA and TREVICTA are registered trademarks of Johnson & Johnson.
Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Statements of Operations - GAAP Three Months Ended Three Months Ended
(In thousands, except per share data) September 30, 2020 September 30, 2019
Revenues:
Product sales, net $ 142,658 $ 138,774
Manufacturing and royalty revenues 120,351 103,783
Research and development revenue 953 12,686
License revenue 1,050 -
Total Revenues 265,012 255,243
Expenses:
Cost of goods manufactured and sold 43,129 42,319
Research and development 94,980 107,671
Selling, general and administrative 127,653 148,701
Amortization of acquired intangible assets 9,917 10,173
Total Expenses 275,679 308,864
Operating Loss (10,667 ) (53,621 )
Other Income (Expense), net:
Interest income 1,376 3,509
Interest expense (1,811 ) (3,385 )
Change in the fair value of contingent consideration 3,926 1,300
Other income (expense), net 9,368 (1,664 )
Total Other Income (Expense), net 12,859 (240 )
Income (Loss) Before Income Taxes 2,192 (53,861 )
Provision (Benefit) for Income Taxes 2,326 (983 )
Net Loss - GAAP $ (134 ) $ (52,878 )
(Loss) Earnings Per Share:
GAAP loss per share - basic and diluted $ (0.00 ) $ (0.34 )
Non-GAAP earnings (loss) per share - basic and diluted $ 0.26 $ (0.04 )
Weighted Average Number of Ordinary Shares Outstanding:
Basic and diluted - GAAP 159,062 157,199
Basic - Non-GAAP 159,062 157,199
Diluted - Non-GAAP 160,335 157,199
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows:
Net Loss - GAAP $ (134 ) $ (52,878 )
Adjustments:
Share-based compensation expense 22,618 26,729
Depreciation expense 10,663 10,173
Amortization expense 9,917 10,173
Income tax effect related to reconciling items 2,174 155
Non-cash net interest expense 166 168
Change in the fair value of contingent consideration (3,926 ) (1,300 )
Change in the fair value of warrants - (206 )
Non-GAAP Net Income (Loss) $ 41,478 $ (6,986 )
Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Statements of Operations - GAAP Nine Months Ended Nine Months Ended
(In thousands, except per share data) September 30, 2020 September 30, 2019
Revenues:
Product sales, net $ 402,799 $ 374,890
Manufacturing and royalty revenues 353,107 340,595
Research and development revenue 1,805 41,732
License Revenue 1,050 1,000
Total Revenues 758,761 758,217
Expenses:
Cost of goods manufactured and sold 135,394 133,903
Research and development 282,481 314,676
Selling, general and administrative 393,049 444,996
Amortization of acquired intangible assets 29,535 30,187
Total Expenses 840,459 923,762
Operating Loss (81,698 ) (165,545 )
Other Income (Expense), net:
Interest income 5,924 10,785
Interest expense (6,790 ) (10,405 )
Change in the fair value of contingent consideration 16,626 (27,800 )
Other income (expense), net 11,047 (1,534 )
Total Other Income (Expense), net 26,807 (28,954 )
Loss Before Income Taxes (54,891 ) (194,499 )
Provision (Benefit) for Income Taxes 13,328 (3,233 )
Net Loss - GAAP $ (68,219 ) $ (191,266 )
(Loss) Earnings Per Share:
GAAP loss per share - basic and diluted $ (0.43 ) $ (1.22 )
Non-GAAP earnings (loss) per share - basic and diluted $ 0.33 $ (0.12 )
Weighted Average Number of Ordinary Shares Outstanding:
Basic and diluted - GAAP 158,685 156,845
Basic - Non-GAAP 158,685 156,845
Diluted - Non-GAAP 159,467 156,845
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows:
Net Loss - GAAP $ (68,219 ) $ (191,266 )
Adjustments:
Share-based compensation expense 65,277 79,590
Depreciation expense 31,991 29,715
Amortization expense 29,535 30,187
Income tax effect related to reconciling items 8,971 5,170
Non-cash net interest expense 500 505
Change in the fair value of contingent consideration (16,626 ) 27,800
Acquisition of IPR&D 674 -
Change in the fair value of warrants - (907 )
Non-GAAP Net Income (Loss) $ 52,103 $ (19,206 )
Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Balance Sheets September 30, December 31,
(In thousands) 2020 2019
Cash, cash equivalents and total investments $ 597,156 $ 614,370
Receivables 265,644 257,086
Contract assets 14,395 8,386
Inventory 122,823 101,803
Prepaid expenses and other current assets 52,697 59,716
Property, plant and equipment, net 355,215 362,168
Intangible assets, net and goodwill 213,981 243,516
Other assets 254,909 158,358
Total Assets $ 1,876,820 $ 1,805,403
Long-term debt - current portion $ 2,843 $ 2,843
Other current liabilities 375,308 388,269
Long-term debt 272,663 274,295
Contract liabilities - long-term 18,635 22,068
Other long-term liabilities 123,013 32,486
Total shareholders' equity 1,084,357 1,085,442
Total Liabilities and Shareholders' Equity $ 1,876,820 $ 1,805,403
Ordinary shares outstanding (in thousands) 159,105 157,779
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020, which the company intends to file in October 2020.
Alkermes plc and Subsidiaries
2020 Guidance - GAAP to Non-GAAP Adjustments
An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings per share on a non-GAAP basis is as follows:
(In millions, except per share data) Amount Shares (Loss) Earnings Per Share
Projected Net Loss - GAAP $ (105.0 ) 159 $ (0.66 )
Adjustments:
Share-based compensation expense 92.5
Depreciation expense 42.5
Amortization expense 40.0
Income tax effect related to reconciling items 6.5
Non-cash net interest expense 1.0
Change in the fair value of contingent consideration (17.5 )
Projected Net Income - Non-GAAP $ 60.0 161 $ 0.37
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.
Last updated: Oct 29, 2020