UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): February 14, 2018
ALKERMES PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
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Ireland |
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001-35299 |
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98-1007018 |
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(State or other jurisdiction |
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(Commission |
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(IRS Employer |
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of incorporation) |
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File Number) |
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Identification No.) |
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Connaught House, 1 Burlington Road |
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Dublin 4, Ireland |
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(Address of principal executive offices) |
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(Zip Code) |
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(Registrant's telephone number, including area code): + 353-1-772-8000
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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☐ |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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Ex-99.1 Press release issued by Alkermes plc dated February 14, 2018 announcing financial results for the three and twelve months ended December 31, 2017 and financial expectations for the twelve months ending December 31, 2018. |
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Ex-99.2 Investor presentation to be displayed by Alkermes plc on February 14, 2018. |
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Item 2.02 Results of Operations and Financial Condition.
On February 14, 2018, Alkermes plc (the “Company”) announced financial results for the three and twelve months ended December 31, 2017 and financial expectations for the twelve months ending December 31, 2018. A copy of the related press release is furnished hereto as Exhibit 99.1 and a copy of the investor presentation to be displayed during the Company’s conference call on February 14, 2018 discussing financial results for the three and twelve months ended December 31, 2017 and financial expectations for the twelve months ending December 31, 2018 is furnished hereto as Exhibit 99.2. This information, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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99.1 |
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99.2 |
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Investor presentation to be displayed by Alkermes plc on February 14, 2018. |
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ALKERMES PLC
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Date: February 14, 2018 |
By: |
/s/ James M. Frates |
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James M. Frates |
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Senior Vice President and Chief Financial Officer (Principal Financial Officer) |
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Exhibit 99.1
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Alkermes Contacts: |
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For Investors: |
Sandy Coombs +1 781 609 6377 |
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Eva Stroynowski +1 781 609 6823 |
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For Media: |
Jennifer Snyder +1 781 609 6166 |
ALKERMES PLC REPORTS FINANCIAL RESULTS FOR THE YEAR ENDED
DEC. 31, 2017 AND PROVIDES FINANCIAL EXPECTATIONS FOR 2018
— Record Revenues of $903.4 Million, GAAP Loss Per Share of $1.03 and Non-GAAP Diluted Earnings Per Share of $0.17 Reported for 2017 —
— 2017 Net Sales of Proprietary Products Grew by 42% Year-Over-Year —
— 2018 Net Sales of Proprietary Products Expected to Grow by Approximately 28%, Reflecting Continuing Growth of VIVITROL® and ARISTADA®—
— New Drug Application Recently Submitted to FDA for ALKS 5461 for Adjunctive Treatment of Major Depressive Disorder —
DUBLIN, Ireland, Feb. 14, 2018 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the twelve months ended Dec. 31, 2017 and provided financial expectations for 2018.
Quarter Ended Dec. 31, 2017 Financial Highlights
•Total revenues for the quarter were $275.4 million. This compared to $213.5 million for the same period in the prior year, representing an increase of 29%.
•Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $9.8 million, or a basic and diluted GAAP loss per share of $0.06. This compared to GAAP net loss of $21.1 million, or a basic and diluted GAAP loss per share of $0.14 for the same period in the prior year.
•Non-GAAP net income was $50.3 million, or a non-GAAP basic earnings per share of $0.33 and non-GAAP diluted earnings per share of $0.31, for the quarter. This compared to non-GAAP net income of $23.3 million, or a non-GAAP basic and diluted earnings per share of $0.15, for the same period in the prior year.
Quarter Ended Dec. 31, 2017 Financial Results
Revenues
•Net sales of VIVITROL® were $75.6 million, compared to $62.1 million for the same period in the prior year, representing an increase of 22%.
•Net sales of ARISTADA® were $28.3 million, compared to $17.3 million for the same period in the prior year, representing an increase of 64%.
•Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $78.2 million, compared to $74.0 million for the same period in the prior year.
•Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1 were $38.1 million, compared to $32.3 million for the same period in the prior year.
•Revenues from the collaboration with Biogen for BIIB098 (formerly ALKS 8700) included $28.0 million of license revenue and $2.3 million of R&D reimbursement.
Costs and Expenses
•Operating expenses were $269.5 million, compared to $237.1 million for the same period in the prior year.
•Income tax provision of $20.6 million included a $21.5 million tax charge related to the reduction in the value of our deferred tax assets due to the enactment of the Tax Cuts and Jobs Act of 2017. This compared to an income tax benefit of $3.2 million for the same period in the prior year.
Calendar Year 2017 Financial Highlights
•Total revenues increased 21% to $903.4 million in 2017, which included VIVITROL net sales of $269.3 million and ARISTADA net sales of $93.5 million. This compared to total revenues of $745.7 million for 2016, which included VIVITROL net sales of $209.0 million and ARISTADA net sales of $47.2 million. Please see the tables at the end of this press release for a detailed breakdown of the revenues from our key commercial products.
•GAAP net loss was $157.9 million, or a basic and diluted GAAP loss per share of $1.03, for 2017. This compared to a GAAP net loss of $208.4 million, or a basic and diluted GAAP loss per share of $1.38, for 2016.
•Non-GAAP net income was $27.8 million, or a non-GAAP basic earnings per share of $0.18 and non-GAAP diluted earnings per share of $0.17, for 2017. This compared to non-GAAP net loss of $10.3 million, or a non-GAAP basic and diluted loss per share of $0.07, for 2016.
•At Dec. 31, 2017, Alkermes recorded cash, cash equivalents and total investments of $590.7 million, compared to $619.2 million at Dec. 31, 2016. At Dec. 31, 2017, the company’s total debt outstanding was $281.4 million, compared to $283.7 million at Dec. 31, 2016.
“Our financial results in 2017 were driven by the strong year-over-year growth of our proprietary products, VIVITROL and ARISTADA, our base royalty and manufacturing business and our strategic alliance with Biogen for BIIB098. We exited the year well positioned to execute on our key strategic initiatives in 2018,” commented James Frates, Chief Financial Officer of Alkermes. “Looking ahead, 2018 will be a transformative year for Alkermes. Our financial expectations for 2018 reflect important investments that will drive future value as we advance our late-stage pipeline and prepare for the anticipated launch of ALKS 5461, with the planned expansion of our commercial organization midyear. We also expect solid growth for VIVITROL and ARISTADA, and remain committed to driving awareness and advancing the treatment paradigm for these important medicines.”
Recent Events:
•ALKS 5461: In January 2018, Alkermes submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). ALKS 5461 was granted Fast Track status by the FDA in October 2013 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.
•BIIB098: Biogen and Alkermes announced a license and collaboration agreement for the development and commercialization of BIIB098 for the treatment of relapsing forms of Multiple Sclerosis (MS). Under the terms of the agreement, Alkermes granted Biogen an exclusive, worldwide license to develop and commercialize BIIB098 and Biogen will pay Alkermes a mid-teens royalty on worldwide net sales of BIIB098. Biogen is responsible for all development and commercialization expenses, effective Jan. 1, 2018. Alkermes may also receive milestone payments for BIIB098 with a maximum aggregate value of $200 million upon certain clinical and regulatory achievements.
•ARISTADA: A NDA was filed with the FDA for Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD), a novel, investigational product designed for initiation onto ARISTADA. A target action date of June 30, 2018 was assigned to the ALNCD NDA under the Prescription Drug User Fee Act (PDUFA).
•VIVITROL: Results from the National Institute on Drug Abuse (NIDA)-funded X:BOT study, comparing extended-release naltrexone (VIVITROL) and buprenorphine-naloxone, were published in The Lancet. Data from the study demonstrated that, once treatment was initiated, both medications were equally safe and effective in preventing relapse to opioid dependence.
•ALKS 4230: Preclinical data on ALKS 4230 was presented at the Society of Immunotherapy of Cancer (SITC) Annual Meeting. The data showed that treatment with ALKS 4230 significantly delayed tumor growth and led to accumulation of tumor-killing T cells in the tumor microenvironment in individualized and humanized melanoma xenograft models of tumor immunology.
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“We are making significant progress in advancing our pipeline of late-stage CNS development candidates, highlighted by the recent submission of the ALKS 5461 NDA, the recently announced license and collaboration agreement with Biogen to develop and commercialize BIIB098, and as we near completion of enrollment in the six-month pivotal weight study for ALKS 3831,” said Richard Pops, Chief Executive Officer of Alkermes. “Alkermes has worked for many years toward this moment. With a diversified CNS business and significant news flow expected across our pipeline of development candidates in 2018, we are focused on executing on our business strategy to bring these important potential new medicines to patients and creating value for our shareholders.”
2018 Expected Milestones
The following outlines the company’s expected milestones for 2018. The following statements are forward-looking, and actual results may differ materially. Please see “Note Regarding Forward-Looking Statements” at the end of this press release for risks that could cause results to differ materially from these forward-looking statements.
•VIVITROL
oPublication and presentation of detoxification protocols for induction onto VIVITROL from recent clinical trials (H1)
•ARISTADA
oALNCD for initiation onto ARISTADA PDUFA target action date (June 30, 2018)
•ALKS 5461
oAssignment of PDUFA target action date, following NDA acceptance (Q2)
oPotential Advisory Committee meeting and FDA action (H2)
•ALKS 3831
oENLIGHTEN-2 six-month weight study enrollment completion (Q1)
oPhase 1 human metabolic study data presentation (H1)
oENLIGHTEN-2 topline results (Fall)
•BIIB098 (formerly ALKS 8700)
oPotential receipt of $50 million payment following initial data from EVOLVE-MS-2 gastrointestinal head-to-head study (mid-2018)
oPlanned NDA submission for treatment of MS (H2)
•ALKS 4230
oDose escalation data and dose expansion initiation (H2)
oPlanned submission of Investigational New Drug (IND) application for subcutaneous dosing phase 1 study (H2)
Financial Expectations for 2018
The following outlines the company’s financial expectations for 2018, which include investments in commercial infrastructure in preparation for the expected launch of ALKS 5461 and in the company’s pipeline of late-stage development candidates. The following statements are forward-looking, and actual results may differ materially. Please see “Note Regarding Forward-Looking Statements” at the end of this press release for risks that could cause results to differ materially from these forward-looking statements.
•Revenues: The company expects total revenues to range from $975 million to $1.025 billion, driven by continuing growth of VIVITROL and ARISTADA. Included in this total revenue expectation, Alkermes expects VIVITROL net sales to range from $300 million to $330 million, and ARISTADA net sales to range from $140 million to $160 million.
•Cost of Goods Manufactured and Sold: The company expects cost of goods manufactured and sold to range from $180 million to $190 million.
•Research and Development (R&D) Expenses: The company expects R&D expenses to range from $415 million to $445 million.
•Selling, General and Administrative (SG&A) Expenses: The company expects SG&A expenses to range from $555 million to $585 million. This increase reflects important planned investment in the
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expansion of our commercial organization in preparation for the anticipated launch of ALKS 5461.
•Amortization of Intangible Assets: The company expects amortization of intangibles to be approximately $65 million.
•Net Interest Expense: The company expects net interest expense to be approximately $10 million.
•Income Tax Expense: The company expects income tax expense of up to $10 million.
•GAAP Net Loss: The company expects GAAP net loss to range from $250 million to $280 million, or a basic and diluted loss per share of $1.61 to $1.81, based on a weighted average basic and diluted share count of approximately 155 million shares outstanding.
•Non-GAAP Net Loss: The company expects non-GAAP net loss to range from $5 million to $35 million, or a non-GAAP basic and diluted loss per share of $0.03 to $0.23, based on a weighted average basic and diluted share count of approximately 155 million shares outstanding.
•Capital Expenditures: The company expects capital expenditures to range from $80 million to $90 million.
Conference Call
Alkermes will host a conference call at 8:30 a.m. ET (1:30 p.m. GMT) on Wednesday, Feb. 14, 2018, to discuss these financial results and provide an update on the company. The conference call may be accessed by visiting Alkermes’ website or by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Wednesday, Feb. 14, 2018, through 5:00 p.m. ET (10:00 p.m. GMT) on Wednesday, Feb. 21, 2018, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. 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 generally accepted accounting principles in the U.S. (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; certain other one-time or non-cash items; and the income tax effect of these reconciling items.
The company’s management and board of directors 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 our liquidity.
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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: future financial and operating performance, business plans or prospects; the likelihood of continued revenue growth from the company’s commercial products, including the growth of VIVITROL and ARISTADA; the therapeutic and commercial value of the company’s marketed and development products and patient access to such products; expectations concerning the timing and results of clinical development activities, including the timing of the phase 3 clinical trial enrollment completion and data readout for ALKS 3831, the timing of the presentation of ALKS 3831 phase 1 metabolic study data, the phase 1 data readout and timing of development activities for ALKS 4230, the timing of data from the EVOLVE-MS-2 head-to-head gastrointestinal study and the potential $50 million option payment by Biogen, the submission of the NDA for BIIB098, the acceptance of the NDA for ALKS 5461 by the FDA, and the timing of FDA review of the NDA for ALKS 5461; and expectations concerning the timing and results of commercial activities, including the expected launch of ALKS 5461. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, 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 unfavorable outcome of litigation, including so-called “Paragraph IV” litigation and other patent litigation, related to any of our products, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings, such as clinical trial designs, conduct and methodologies; clinical development activities may not be completed on time or at all; the results of our 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 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 FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; 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 most recent Annual Report on Form 10-K 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 NanoCrystal® are registered trademarks of Alkermes Pharma Ireland Limited; RISPERDAL CONSTA®, INVEGA SUSTENNA®, XEPLION®, INVEGA TRINZA® and TREVICTA® are registered trademarks of Johnson & Johnson; AMPYRA® and FAMPYRA® are registered trademarks of Acorda Therapeutics, Inc.
1AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by Acorda Therapeutics, Inc. and outside the U.S. by Biogen Idec, under a licensing agreement with Acorda Therapeutics, as FAMPYRA® (prolonged-release fampridine tablets).
(tables follow)
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Alkermes plc and Subsidiaries |
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Selected Financial Information (Unaudited) |
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Three Months |
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Three Months |
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Ended |
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Ended |
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Condensed Consolidated Statements of Operations - GAAP |
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December 31, |
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December 31, |
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(In thousands, except per share data) |
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2017 |
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2016 |
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Revenues: |
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Manufacturing and royalty revenues |
$ |
138,700 |
$ |
133,804 |
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Product sales, net |
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103,941 |
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79,451 |
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License revenues |
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28,000 |
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— |
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Research and development revenues |
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4,729 |
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259 |
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Total Revenues |
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275,370 |
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213,514 |
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Expenses: |
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Cost of goods manufactured and sold |
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38,507 |
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34,957 |
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Research and development |
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104,490 |
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89,626 |
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Selling, general and administrative |
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110,896 |
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97,145 |
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Amortization of acquired intangible assets |
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15,642 |
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15,323 |
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Total Expenses |
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269,535 |
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237,051 |
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Operating Income (Loss) |
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5,835 |
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(23,537) |
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Other Income (Expense), net: |
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Interest income |
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1,362 |
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835 |
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Interest expense |
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(3,192) |
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(4,896) |
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Change in the fair value of contingent consideration |
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5,700 |
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4,800 |
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Other income (expense), net |
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1,081 |
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(1,515) |
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Total Other Income (Expense), net |
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4,951 |
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(776) |
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Income (Loss) Before Income Taxes |
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10,786 |
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(24,313) |
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Provision (Benefit) for Income Taxes |
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20,575 |
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(3,172) |
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Net Loss — GAAP |
$ |
(9,789) |
$ |
(21,141) |
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Net (Loss) Earnings Per Share: |
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GAAP net loss per share — basic and diluted |
$ |
(0.06) |
$ |
(0.14) |
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Non-GAAP earnings per share — basic |
$ |
0.33 |
$ |
0.15 |
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Non-GAAP earnings per share — diluted |
$ |
0.31 |
$ |
0.15 |
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Weighted Average Number of Ordinary Shares Outstanding: |
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Basic and diluted — GAAP |
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153,865 |
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152,148 |
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Basic — Non-GAAP |
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153,865 |
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152,148 |
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Diluted — Non-GAAP |
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160,036 |
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159,212 |
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An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows: |
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Net Loss — GAAP |
$ |
(9,789) |
$ |
(21,141) |
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Adjustments: |
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Share-based compensation expense |
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20,581 |
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19,783 |
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Amortization expense |
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15,642 |
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15,323 |
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Depreciation expense |
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9,575 |
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9,325 |
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Income tax charge related to 2017 income tax reform(1) |
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21,453 |
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— |
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Non-cash net interest expense |
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192 |
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194 |
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Loss on warrants and equity method investments |
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64 |
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866 |
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Income tax effect related to reconciling items |
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(1,726) |
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1,636 |
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Change in the fair value of contingent consideration |
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(5,700) |
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(4,800) |
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Loss on debt refinancing |
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— |
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2,075 |
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Non-GAAP Net Income |
$ |
50,292 |
$ |
23,261 |
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Alkermes plc and Subsidiaries |
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Selected Financial Information (Unaudited) |
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Year Ended |
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Year Ended |
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Condensed Consolidated Statements of Operations - GAAP |
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December 31, |
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December 31, |
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(In thousands, except per share data) |
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2017 |
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2016 |
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Revenues: |
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Manufacturing and royalty revenues |
$ |
505,308 |
$ |
487,247 |
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Product sales, net |
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362,834 |
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256,146 |
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License revenues |
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28,000 |
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— |
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Research and development revenues |
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7,232 |
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2,301 |
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Total Revenues |
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903,374 |
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745,694 |
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Expenses: |
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Cost of goods manufactured and sold |
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154,748 |
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132,122 |
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Research and development |
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412,889 |
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387,148 |
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Selling, general and administrative |
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421,578 |
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374,130 |
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Amortization of acquired intangible assets |
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62,059 |
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60,959 |
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Total Expenses |
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1,051,274 |
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954,359 |
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Operating Loss |
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(147,900) |
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(208,665) |
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Other Income (Expense), net: |
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|
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|
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Interest income |
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4,649 |
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3,752 |
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Interest expense |
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(12,008) |
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(14,889) |
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Change in the fair value of contingent consideration |
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21,600 |
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7,900 |
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Other expense, net |
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(9,615) |
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(2,485) |
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Total Other Income (Expense), net |
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4,626 |
|
(5,722) |
|
Loss Before Income Taxes |
|
(143,274) |
|
(214,387) |
|
Provision (Benefit) for Income Taxes |
|
14,671 |
|
(5,943) |
|
Net Loss — GAAP |
$ |
(157,945) |
$ |
(208,444) |
|
|
|
|
|
|
|
Net (Loss) Earnings Per Share: |
|
|
|
|
|
GAAP net loss per share — basic and diluted |
$ |
(1.03) |
$ |
(1.38) |
|
Non-GAAP earnings (loss) per share — basic |
$ |
0.18 |
$ |
(0.07) |
|
Non-GAAP earnings (loss) per share — diluted |
$ |
0.17 |
$ |
(0.07) |
|
|
|
|
|
|
|
Weighted Average Number of Ordinary Shares Outstanding: |
|
|
|
|
|
Basic and diluted — GAAP |
|
153,415 |
|
151,484 |
|
Basic — Non-GAAP |
|
153,415 |
|
151,484 |
|
Diluted — Non-GAAP |
|
160,062 |
|
151,484 |
|
|
|
|
|
|
|
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows: |
|
|
|
|
|
Net Loss — GAAP |
$ |
(157,945) |
$ |
(208,444) |
|
Adjustments: |
|
|
|
|
|
Share-based compensation expense |
|
83,917 |
|
94,396 |
|
Amortization expense |
|
62,059 |
|
60,958 |
|
Depreciation expense |
|
36,464 |
|
33,298 |
|
Income tax charge related to 2017 income tax reform(1) |
|
21,453 |
|
— |
|
Other-than-temporary impairment of equity method investment |
|
10,471 |
|
— |
|
Loss on warrants and equity method investments |
|
2,824 |
|
2,130 |
|
Non-cash net interest expense |
|
770 |
|
888 |
|
Income tax effect related to reconciling items |
|
(10,622) |
|
2,252 |
|
Change in the fair value of contingent consideration |
|
(21,600) |
|
(7,900) |
|
Upfront license option payment to Reset Therapeutics, Inc. charged to R&D expense |
|
— |
|
10,000 |
|
Loss on debt refinancing |
|
— |
|
2,075 |
|
Non-GAAP Net Income (Loss) |
$ |
27,791 |
$ |
(10,347) |
|
|
|
|
|
|
|
(1) - On December 22, 2017, the Tax Cuts and Jobs Act of 2017 was signed into law and has resulted in significant changes to the U.S. corporate income tax system including a federal corporate rate reduction from 35% to 21%. The change in tax rate and tax law is accounted for in the period of enactment. Therefore, during the period ended December 31, 2017, we recorded a $21.5 million tax expense related to our current estimate of the provisions of the Tax Cuts and Jobs Act of 2017. |
||||
|
Alkermes plc and Subsidiaries |
||||
|
Selected Financial Information (Unaudited) |
||||
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets |
|
December 31, |
|
December 31, |
|
(In thousands) |
|
2017 |
|
2016 |
|
Cash, cash equivalents and total investments |
$ |
590,716 |
$ |
619,165 |
|
Receivables |
|
233,590 |
|
191,102 |
|
Inventory |
|
93,275 |
|
62,998 |
|
Prepaid expenses and other current assets |
|
48,475 |
|
39,344 |
|
Property, plant and equipment, net |
|
284,736 |
|
264,785 |
|
Intangible assets, net and goodwill |
|
349,041 |
|
411,100 |
|
Other assets |
|
197,394 |
|
137,929 |
|
Total Assets |
$ |
1,797,227 |
$ |
1,726,423 |
|
Long-term debt — current portion |
$ |
3,000 |
$ |
3,000 |
|
Other current liabilities |
|
288,122 |
|
208,993 |
|
Long-term debt |
|
278,436 |
|
280,666 |
|
Deferred revenue — long-term |
|
5,657 |
|
7,122 |
|
Other long-term liabilities |
|
19,204 |
|
17,161 |
|
Total shareholders' equity |
|
1,202,808 |
|
1,209,481 |
|
Total Liabilities and Shareholders' Equity |
$ |
1,797,227 |
$ |
1,726,423 |
|
|
|
|
|
|
|
Ordinary shares outstanding (in thousands) |
|
154,009 |
|
152,431 |
|
|
|
|
|
|
|
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Annual Report on Form 10-K for the year ended December 31, 2017, which the company intends to file in February 2018. |
||||
|
Alkermes plc and Subsidiaries |
||||||||||
|
Revenues for Calendar Year 2017 and 2016 |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Three Months |
|
Three Months |
|
Three Months |
|
Year |
|
|
|
Ended |
|
Ended |
|
Ended |
|
Ended |
|
Ended |
|
|
|
March 31, |
|
June 30, |
|
September 30, |
|
December 31, |
|
December 31, |
|
(In thousands) |
|
2017 |
|
2017 |
|
2017 |
|
2017 |
|
2017 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
$ |
60,003 |
$ |
82,169 |
$ |
79,443 |
$ |
78,238 |
$ |
299,853 |
|
AMPYRA/FAMPYRA |
|
29,219 |
|
25,256 |
|
24,478 |
|
38,066 |
|
117,019 |
|
BYDUREON |
|
12,266 |
|
11,635 |
|
10,095 |
|
11,700 |
|
45,696 |
|
VIVITROL |
|
58,456 |
|
66,071 |
|
69,178 |
|
75,617 |
|
269,322 |
|
ARISTADA |
|
18,000 |
|
22,685 |
|
24,503 |
|
28,324 |
|
93,512 |
|
Key Commercial Product Revenues |
|
177,944 |
|
207,816 |
|
207,697 |
|
231,945 |
|
825,402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Legacy Product Revenues (2) |
|
13,191 |
|
10,192 |
|
8,661 |
|
10,696 |
|
42,740 |
|
License Revenues (3) |
|
— |
|
— |
|
— |
|
28,000 |
|
28,000 |
|
Research and Development Revenues |
|
643 |
|
833 |
|
1,027 |
|
4,729 |
|
7,232 |
|
Total Revenues |
$ |
191,778 |
$ |
218,841 |
$ |
217,385 |
$ |
275,370 |
$ |
903,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Three Months |
|
Three Months |
|
Three Months |
|
Year |
|
|
|
Ended |
|
Ended |
|
Ended |
|
Ended |
|
Ended |
|
|
|
March 31, |
|
June 30, |
|
September 30, |
|
December 31, |
|
December 31, |
|
|
|
2016 |
|
2016 |
|
2016 |
|
2016 |
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
$ |
54,667 |
$ |
69,578 |
$ |
73,251 |
$ |
73,967 |
$ |
271,463 |
|
AMPYRA/FAMPYRA |
|
28,194 |
|
40,848 |
|
12,897 |
|
32,254 |
|
114,193 |
|
BYDUREON |
|
10,533 |
|
12,303 |
|
11,554 |
|
11,256 |
|
45,646 |
|
VIVITROL |
|
43,827 |
|
47,242 |
|
55,804 |
|
62,109 |
|
208,982 |
|
ARISTADA |
|
5,547 |
|
10,277 |
|
13,998 |
|
17,342 |
|
47,164 |
|
Key Commercial Product Revenues |
|
142,768 |
|
180,248 |
|
167,504 |
|
196,928 |
|
687,448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Legacy Product Revenues (2) |
|
12,765 |
|
14,305 |
|
12,548 |
|
16,327 |
|
55,945 |
|
Research and Development Revenues |
|
1,241 |
|
612 |
|
189 |
|
259 |
|
2,301 |
|
Total Revenues |
$ |
156,774 |
$ |
195,165 |
$ |
180,241 |
$ |
213,514 |
$ |
745,694 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA. |
||||||||||
|
(2) - Includes legacy product revenues, excluding product revenues sold as part of the Gainesville transaction. |
||||||||||
|
(3) - Includes the upfront payment allocated to the license sold to Biogen in connection with the BIIB098 collaboration. |
||||||||||
|
Alkermes plc and Subsidiaries |
||||||
|
2018 Guidance — GAAP to Non-GAAP Adjustments |
||||||
|
|
|
|
|
|
|
|
|
An itemized reconciliation between projected loss per share on a GAAP basis and projected loss per share on a non-GAAP basis is as follows: |
||||||
|
|
|
|
|
|
|
|
|
(In millions, except per share data) |
|
Amount |
|
Shares |
|
Loss Per Share |
|
Projected Net Loss — GAAP |
$ |
(265.0) |
|
155 |
$ |
(1.71) |
|
Adjustments: |
|
|
|
|
|
|
|
Non-cash net interest expense |
|
1.0 |
|
|
|
|
|
Income tax effect related to reconciling items |
|
(3.5) |
|
|
|
|
|
Depreciation expense |
|
42.5 |
|
|
|
|
|
Amortization expense |
|
65.0 |
|
|
|
|
|
Share-based compensation expense |
|
140.0 |
|
|
|
|
|
Projected Net Loss — Non-GAAP |
$ |
(20.0) |
|
155 |
$ |
(0.13) |
|
|
|
|
|
|
|
|
|
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance. |
||||||
Exhibit 99.2
|
Alkermes® Patient inspired Fourth Quarter and Year-End 2017 Financial Results February 14, 2018 |
|
Forward-Looking Statements and Non-GAAP Financial Information Certain statements set forth in this presentation 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: future financial and operating performance, business plans or prospects; the likelihood of continued revenue growth from the company’s commercial products, including the growth of VIVITROL and ARISTADA; the therapeutic and commercial value of the company’s marketed and development products and patient access to such products; expectations concerning the timing and results of clinical development activities, including the timing of the phase 3 clinical trial enrollment completion and data readout for ALKS 3831, the timing of data from the EVOLVE-MS-2 head-to-head gastrointestinal study and the potential $50 million option payment by Biogen, the submission of the NDA for BIIB098, the acceptance of the NDA for ALKS 5461 by the FDA, and the timing of FDA review of the NDA for ALKS 5461; and expectations concerning the timing and results of commercial activities, including the expected launch of ALKS 5461. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, 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 unfavorable outcome of litigation, including so-called “Paragraph IV” litigation and other patent litigation, related to any of our products, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings, such as clinical trial designs, conduct and methodologies; clinical development activities may not be completed on time or at all; the results of our 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 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 U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; 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 most recent Annual Report on Form 10-K 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 presentation. Non-GAAP Financial Measures: This presentation includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income/(loss) and non-GAAP net income/(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. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the Alkermes plc Current Report on Form 8-K filed with the SEC on Feb. 14, 2018. Note Regarding Trademarks: The company is the owner of various U.S. federal trademark registrations (®) and other trademarks (TM), including ARISTADA®, VIVITROL® and NanoCrystal®. Any other trademarks referred to in this presentation are the property of their respective owners. Appearances of such other trademarks herein should not be construed as any indicator that their respective owners will not assert their rights thereto. Alkermes® © 2018 Alkermes All rights reserved. |
|
Fourth Quarter Overview and Recent Events Financial Results Q4 total revenues increased 29% year-over-year to $275.4M VIVITROL® net sales increased 22% year-over-year to $75.6M ARISTADA® net sales increased 64% year-over-year to $28.3M Recognized $28.0M upfront payment related to Biogen collaboration announced 11/27/17 GAAP net loss of $9.8M, compared to a GAAP net loss of $21.1M for Q4 2016 Non-GAAP net income of $50.3M, compared to non-GAAP net income of $23.3M for Q4 2016 Clinical / Regulatory
ALKS 5461: Submitted New Drug Application (NDA) to the U.S. Food and Drug Administration BIIB098 (formerly ALKS 8700): Biogen and Alkermes announced a license and collaboration agreement to develop and commercialize BIIB098 for the treatment of Multiple Sclerosis (MS)
ARISTADA: NDA was filed with the FDA for Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD), VIVITROL: Results from NIDA-funded X:BOT study, comparing VIVITROL and buprenorphine-naloxone, were published in The Lancet; The data demonstrated that, once treatment was initiated, both medications were equally safe and effective in the treatment of opioid dependence. ALKS 4230: Preclinical data was presented at the Society of Immunotherapy of Cancer (SITC) Annual Meeting Alkermes® © 2018 Alkermes. All rights reserved. |
|
Q4 2017 Revenue Summary Total Revenues ($M) $300 $275 $250 $225 $200 $175 $150 $125 $100 $75 $50 $25 $0 Q4 2016 $213.5 Q4 2017 $275.4 In millions, except % Q4’17 Q4’16 ∆ Q4’17 VS. Q4’16 Q3’17 ∆ Q4’17 VS. Q3’17 VIVITROL ® ARISTADA ® Manufacturing & Royalty Revenue License Revenue Total Revenue $75.6 $62.1 22% $69.2 9% $28.3 $17.3 64% $24.5 16% $138.7 $133.8 4% $122.7 13% $28.0 - - - - $275.4 $213.5 29% $217.4 27% Alkermes® © 2018 Alkermes. All rights reserved. |
|
2017 Revenue Summary Total Revenues ($M) $1,000 $800 $600 $400 $200 $0 $745.7 2016 $903.4 2017 In millions, except % VIVITROL ® ARISTADA® Manufacturing & Royalty Revenue License Revenue Total Revenue FY2017 $269.3 $93.5 $505.3 $28.0 $903.4 FY 2016
$47.2 $487.2 0 $745.7 ∆2017 VS. 2016 29% 98% 4% 0 21% Alkermes ® © 2018 Alkermes. All rights reserved |
|
Growing Revenues From Proprietary Commercial Medicines Proprietary Commercial Product Revenues ($M) $120, $100 $80 $60 $40 $20 $0 Q1’16 Q2’16 Q3’16 Q4’16 Q1’17 Q2’17 Q3’17 Q4’17 ARISTADA® aripiprazole lauroxil extended-release injectable suspension 441 mg 662 mg 882 mg 1064 mg VIVITROL® (naltrexone for extended-release injectable suspension) Alkermes® © 2018 Alkermes. All rights reserved. |
|
VIVITROL® Fourth Quarter Performance VIVITROL Quarterly Net Sales ($M) $80 $70 $60 $50 $40 $30 $20 $10 $0 Q1’15 Q2’15 Q3’15 Q4’15 Q1’16 Q2’16 Q3’16 Q4’16 Q1’17 Q2’17 Q3’17 Q4’17
Q4 year-over-year net sales
9% sequential net sales
Q4 results reflect estimated
State programs expanded from ~560 at the end of Q3’17 to
2018 financial expectations of Alkermes ® ©2018 Alkermes. All rights reserved. |
|
ARISTADA® Growing in Volume and Gaining Market Share ARISTADA Quarterly Net Sales ($M) $30 $25 $20 $15 $10 $5 $0 Q1’16 Q2’16 Q3’16 Q4’16 Q1’17 Q2’17 Q3’17 Q4’17 Sequential unit growth of 15% compared to Q3’17 41.5% gross-to-net deductions ARISTADA market share increased to 24% among new aripiprazole long-acting atypical prescriptions (months of therapy) in Q4’17, compared to 17% in Q4’161 2018 Financial expectations of $140M - $160M 1. IMS NPA Alkermes® © 2018 Alkermes. All rights reserved. |
|
Alkermes: 2018 Financial Expectations † (in millions, except per share amounts) Financial Expectations for Year Ending Dec. 31, 2018†Revenues $978 – 1,025 COGS $180 – 190 R&D Expense $415 -–445 SG&A Expense $555 - 585 Amortization of intangibles ~$65 Net Interest Expense ~$10 Income tax expense $0 – 10 GAAP Net Loss $(250) – (280) Non-GAAP Net Loss‡ $(5) – (35) GAAP Net Loss Per Share $(1.61) – (1.81) Non-GAAP Loss Per Share $(0.03) – (0.23) Revenue: VIVITROL® net revenue of $300M - $330M ARISTADA® net revenue of $140M - $160M License and R&D Revenue: $50M payment and reimbursement of BIIB098 R&D expenses from Biogen AMPYRA®/FAMPYRA® royalty & manufacturing revenue of $40M - $50M; Generic competition for AMPYRA expected in July 2018 Operating Expenses: Investment in ALKS 5461 launch (~200 reps) beginning mid-year.
†This financial guidance, provided by Alkermes plc in its Current Report on Form 8-K filed with the SEC on Feb. 14, 2018, is effective only as of such date. The company expressly disclaims any obligation to update or
‡ Non-GAAP 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; certain other Alkermes® © 2018 Alkermes. All rights reserved. |
|
VIVITROL®: Confluence of Data, Policy and Funding Being Integrated Into Response to Opioid Crisis Data underscore utility of VIVITROL for opioid dependence Results from NIDA’s X:BOT study, comparing extended-release naltrexone (VIVITROL) and buprenorphine-naloxone, were published in The Lancet Data from the study demonstrated that, once treatment was initiated, both medicines were equally safe and effective in the treatment of opioid dependence Policymakers activating to address opioid epidemic at national level Focus on implementation of Comprehensive Addiction and Recovery Act FDA taking steps to promote more widespread use of medication-assisted treatment (MAT) State and federal dollars are being allocated; funding slow to reach treatment system Federal budget passed last week included $6B to address the opioid epidemic and mental health programs Last year’s 21st Century Cures Act provided $1B; Have not yet seen that funding flow from the states into changing the treatment system Alkermes® © 2018 Alkermes. All rights reserved. |
|
ARISTADA®: Focused on Patient-Centered Treatment Options NDA submitted to FDA for Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD) for initiation onto ARISTADA PDUFA date of June 30, 2018 New initiation regimen designed to replace need for concomitant three weeks of oral aripiprazole Provides an extended-release aripiprazole lauroxil formulation having a smaller particle size than ARISTADA, enabling faster dissolution and leading to more rapid achievement of therapeutic levels of aripiprazole New phase 3b study utilizing ALNCD plus two-month ARISTADA compared to current market leader INVEGA SUSTENNA® initiated in November 2017 Two-month ARISTADA dose gaining traction 9% of total ARISTADA prescriptions in Q4 Alkermes® © 2018 Alkermes. All rights reserved. |
|
ALKS 5461 Program Investigational product for adjunctive treatment of major depressive disorder Opioid system modulator with new mechanism of action FDA Fast Track status granted Status Submitted NDA, awaiting assignment of PDUFA target action date Publication of data and comprehensive scientific education ongoing Priorities Regulatory Prepare for expected Advisory Committee meeting Preparations underway for anticipated launch Scientific education about endogenous opioid system and dysregulation within the context of MDD Planned hiring of commercial field organization in mid-2018 (~200 reps) |
|
ALKS 3831 Program Novel, oral broad-spectrum antipsychotic drug candidate for the treatment of schizophrenia Designed to provide antipsychotic efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties Status
Positive results from ENLIGHTEN-1 pivotal antipsychotic efficacy study
Nearing anticipated completion of patient enrollment for ENLIGHTEN-2, a Priorities Complete ENLIGHTEN-2 Topline data expected in Fall 2018 Share data from phase 1 translational medicine study evaluating metabolic profile of ALKS 3831 compared to olanzapine Alkermes® © 2018 Alkermes. All rights reserved. |
|
BIIB098 (Formerly ALKS 8700) Program Investigational product for the treatment of relapsing forms of multiple sclerosis License and collaboration agreement with Biogen announced in Q4 2017 Status Long-term safety study ongoing; initial data showing low rates of GI AEs presented at ECTRIMS*
Pharmacokinetic bridging studies and clinical Priorities Complete remaining clin/pharm studies for registration package Planned NDA submission in 2H 2018 Biogen License and Collaboration Agreement Granted Biogen exclusive, worldwide license to commercialize BIIB098 Mid-teens percentage royalty to Alkermes on worldwide net sales Clinical and regulatory milestones of up to $200M
Biogen responsible for all development and commercial expenses * European Committee for Treatment and Research in Multiple Sclerosis Alkermes® © 2018 Alkermes. All rights reserved. |
|
ALKS 4230 Program Novel immuno-oncology candidate Designed to selectively activate intermediate-affinity IL-2 receptors to enhance tumor-killing immune cells Status Dose-escalation stage of phase 1 study ongoing Preclinical data presented at the SITC Annual Meeting
Data showed that treatment with ALKS 4230 significantly delayed tumor growth Priorities Complete dose-escalation stage and advance into dose-expansion stage in 2018 Planned submission of Investigational New Drug (IND) application for subcutaneous dosing phase 1 study Alkermes® © 2018 Alkermes. All rights reserved. |
|
www.alkermes.com © 2018 Alkermes. All rights reserved |
