— First Quarter Revenues Increased 22%
Year-Over-Year to $191.8 Million, GAAP Loss per Share of $0.45 and
Non-GAAP Loss per Share of $0.18 —
— VIVITROL® Net Sales Grew by 33%
Year-Over-Year to $58.5 Million —
— ARISTADA® Gaining Traction in Growing
Long-Acting Antipsychotic Market; Preparing for Launch of Two-Month
Dose Following June 5, 2017 PDUFA Date —
Alkermes plc (NASDAQ: ALKS) today reported financial results for
the first quarter of 2017.
“Our results this quarter reflect solid year-over-year growth of
our commercial portfolio, driven by our proprietary products,
VIVITROL® and ARISTADA®. Looking ahead to the remainder of the
year, we remain focused on making these important medicines
available to patients and driving growth,” commented James Frates,
Chief Financial Officer of Alkermes. “With our strong financial
position and growing commercial portfolio, we are well positioned
to invest in our advancing late-stage pipeline and our commercial
organization to support Alkermes’ expanding portfolio of
proprietary products. Today, we are reiterating our financial
expectations for 2017 that we provided in February.”
“The strength of the Alkermes business is grounded in our
diversified portfolio of proprietary commercial products and
late-stage development candidates, each of which represent a
potential blockbuster opportunity in major CNS disease categories,”
said Richard Pops, Chief Executive Officer of Alkermes. “Our
late-stage pipeline continues to advance rapidly in 2017 with the
planned New Drug Application submission for ALKS 5461 for the
adjunctive treatment of major depressive disorder, data from the
pivotal antipsychotic efficacy study for ALKS 3831 in schizophrenia
and completion of the clinical registration requirements for ALKS
8700 in multiple sclerosis expected before year-end.”
Quarter Ended March 31, 2017
Highlights
- Total revenues for the quarter were
$191.8 million. This compared to $156.8 million for the same period
in the prior year.
- Net loss according to generally
accepted accounting principles in the U.S. (GAAP) was $68.9
million, or a basic and diluted GAAP loss per share of $0.45, for
the quarter and reflected increased investment in the company’s
advancing late-stage pipeline and commercial infrastructure. This
compared to GAAP net loss of $77.4 million, or a basic and diluted
GAAP loss per share of $0.51 for the same period in the prior
year.
- Non-GAAP net loss was $27.9 million, or
a non-GAAP basic and diluted loss per share of $0.18 for the
quarter. This compared to non-GAAP net loss of $17.9 million, or a
non-GAAP diluted loss per share of $0.12, for the same period in
the prior year.
Quarter Ended March 31, 2017 Financial
Results
Revenues
- Net sales of VIVITROL were $58.5
million, compared to $43.8 million for the same period in the prior
year, representing an increase of approximately 33.4%.
- Net sales of ARISTADA were $18.0
million, compared to $5.5 million for the same period in the prior
year.
- Manufacturing and royalty revenues from
RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA
TRINZA®/TREVICTA® were $60.0 million, compared to $54.7 million for
the same period in the prior year.
- Manufacturing and royalty revenues from
AMPYRA®/FAMPYRA®1 were $29.2 million, compared to $28.2 million for
the same period in the prior year.
- Royalty revenue from BYDUREON® was
$12.3 million, compared to $10.5 million for the same period in the
prior year.
Costs and Expenses
- Operating expenses were $262.6 million,
compared to $233.7 million for the same period in the prior year,
reflecting increased investment in the company’s commercial
infrastructure and higher cost of goods manufactured and sold
reflecting increased manufacturing activity at our site in
Ohio.
Balance SheetAt March 31, 2017,
Alkermes had cash and total investments of $589.4 million, compared
to $619.2 million at December 31, 2016. At March 31, 2017, the
company’s total debt outstanding was $283.1 million.
Financial ExpectationsAlkermes
reiterates its financial expectations for 2017 set forth in its
press release dated Feb. 15, 2017.
Conference CallAlkermes will
host a conference call at 8:30 a.m. ET (1:30 p.m. BST) on Thursday,
April 27, 2017, 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.
BST) on Thursday, April 27, 2017 through 5:00 p.m. ET (10:00 p.m.
BST) on Thursday, May 4, 2017, 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 plcAlkermes
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
MeasuresThis 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 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, better indicate
underlying trends in ongoing operations. However, non-GAAP net
income (loss) and non-GAAP 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 diluted earnings (loss) per share should not be
considered measures of our 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
StatementsCertain 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
products; and expectations concerning the timing and results of
clinical development activities, including the NDA submission for
ALKS 5461, data from a pivotal efficacy study for ALKS 3831, the
launch of the two-month dose of ARISTADA, and completion of the
pivotal registration requirements for ALKS 8700. 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 U.S. Food and Drug Administration (“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; 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 partners, may not be able to continue to successfully
commercialize its 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 Annual Report on Form 10-K
for the year ended Dec. 31, 2016 and Quarterly Report on Form 10-Q
for the quarter ended Mar. 31, 2017 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 they are made. The information contained in this press
release is provided by the company as of the date hereof, and,
except as required by law, the company disclaims any intention or
responsibility for updating or revising any forward-looking
information contained in this press release.
VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®
is a registered trademark 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.; BYDUREON® is a registered trademark of Amylin
Pharmaceuticals, LLC.
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)
Alkermes plc and Subsidiaries Selected Financial
Information (Unaudited)
Three MonthsEndedMarch 31,2017
Three MonthsEndedMarch 31,2016
Condensed Consolidated Statements of Operations - GAAP
(In thousands, except per share data) Revenues:
Manufacturing and royalty revenues $ 114,679 $ 106,159 Product
sales, net 76,456 49,374 Research and development revenues 643
1,241 Total Revenues 191,778 156,774 Expenses: Cost of goods
manufactured and sold 40,412 27,711 Research and development
104,835 101,072 Selling, general and administrative 102,099 89,719
Amortization of acquired intangible assets 15,302 15,156 Total
Expenses 262,648 233,658 Operating Loss (70,870) (76,884) Other
Expense, net: Interest income 943 1,011 Interest expense (2,764)
(3,295) Increase in the fair value of contingent consideration
1,600 1,900 Other (expense) income, net (1,499) 249 Total Other
Expense, net (1,720) (135) Loss Before Income Taxes (72,590)
(77,019) Income Tax (Benefit) Provision (3,709) 404
Net Loss —
GAAP $ (68,881) $ (77,423)
Loss Per Share: GAAP
loss per share — basic and diluted $ (0.45) $ (0.51) Non-GAAP loss
per share — basic and diluted $ (0.18) $ (0.12)
Weighted
Average Number of Ordinary Shares Outstanding: Basic and
Diluted — GAAP and Non-GAAP 152,704 150,825 An itemized
reconciliation between net loss on a GAAP basis and non-GAAP net
loss is as follows:
Net Loss — GAAP $ (68,881) $ (77,423)
Adjustments: Share-based compensation expense 21,169 24,256
Amortization expense 15,302 15,156 Depreciation expense 8,461 7,548
Loss on warrants and equity method investment 1,452 870 Non-cash
net interest expense 193 232 Increase in the fair value of
contingent consideration (1,600) (1,900) Income tax effect related
to reconciling items (3,950) 3,340 Upfront license option payment
to Reset Therapeutics, Inc. charged to R&D expense - 10,000
Non-GAAP Net Loss $ (27,854) $ (17,921)
Alkermes
plc and Subsidiaries Selected Financial Information
(Unaudited)
Condensed Consolidated Balance Sheets March 31, December 31,
(In thousands) 2017 2016 Cash, cash equivalents and total
investments $ 589,373 $ 619,165 Receivables 176,487 191,102
Inventory 63,666 62,998 Prepaid expenses and other current assets
42,279 39,344 Property, plant and equipment, net 264,915 264,785
Intangible assets, net and goodwill 395,798 411,100 Other assets
197,309 137,929
Total Assets $ 1,729,827 $ 1,726,423
Long-term debt — current portion $ 3,000 $ 3,000 Other current
liabilities 207,742 208,993 Long-term debt 280,109 280,666 Deferred
revenue — long-term 6,522 7,122 Other long-term liabilities 15,750
17,161 Total shareholders' equity 1,216,704 1,209,481
Total
Liabilities and Shareholders' Equity $ 1,729,827 $ 1,726,423
Ordinary shares outstanding (in thousands) 153,123 152,431
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 months ended March 31, 2017, which the company
intends to file in April 2017.
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Alkermes plcFor Investors:Sandy Coombs, +1-781-609-6377orEva
Stroynowski, +1-781-609-6823orFor Media:Jennifer Snyder,
+1-781-609-6166
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