— First Quarter Revenues of $223.1 Million, Primarily Driven by
~8% Year-Over-Year Growth of Proprietary
Product Net Sales —
— Company Reports GAAP Net Loss per Share
of $0.62 and Non-GAAP Net Loss per
Share of $0.17 —
— Company Reiterating Financial
Expectations for 2019 —
DUBLIN, April 25, 2019 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today reported financial results for the first
quarter of 2019.
"Our first quarter results reflect the diversity of our
business, as the growth of VIVITROL® net sales and
royalty revenues from INVEGA SUSTENNA® offset a decline
in AMPYRA® royalties, following generic entry in the
market. As is typical, during the first quarter we saw the effect
of seasonal inventory fluctuations and deductible resets for
commercial payer plans impact net sales of our proprietary
commercial products, which decreased sequentially. In particular,
ARISTADA® net sales were impacted more than anticipated
by inventory fluctuations which masked underlying prescription
growth of approximately 5% compared to last quarter," commented
James Frates, Chief Financial
Officer of Alkermes. "Today, we are reiterating our financial
expectations for 2019, as we continue to position VIVITROL and
ARISTADA for long-term growth, invest in our development pipeline
and prepare for the potential launch of ALKS 3831."
"The first few months of 2019 were highlighted by the
presentation of important new data from large clinical trials of
both ALKS 3831 and ARISTADA at the 2019 Congress of the
Schizophrenia International Research Society. These innovative
studies demonstrated the clear antipsychotic efficacy of our
medicines along with our intended patient-focused attributes
relating to safety and tolerability. Our recently announced ALPINE
study results also provide information useful to clinicians making
treatment decisions for their patients," commented Richard Pops,
Chief Executive Officer of Alkermes. "Looking ahead, we are
focused on executing both commercially and across our development
pipeline. With the planned submission of the New Drug Application
for ALKS 3831 mid-year, expected regulatory action for diroximel
fumarate for multiple sclerosis in the fourth quarter, and
increasing momentum in the ALKS 4230 immuno-oncology program, we
have a number of key milestones ahead and look forward to updating
you on our progress throughout the year."
Quarter Ended Mar. 31, 2019
Financial Highlights
- Total revenues for the quarter were $223.1 million, compared to $225.2 million for the same period in the prior
year, reflecting the growth in our proprietary product net sales
and an offsetting decrease in AMPYRAi revenues following
generic entry into the market in 2018.
- Net loss according to generally accepted accounting principles
in the U.S. (GAAP) was $96.4 million
for the quarter, or a basic and diluted GAAP net loss per share of
$0.62. This compared to GAAP net loss
of $62.5 million, or a basic and
diluted GAAP net loss per share of $0.40 for the same period in the prior year.
- Non-GAAP net loss was $26.0
million for the quarter, or a non-GAAP basic and diluted net
loss per share of $0.17. This
compared to non-GAAP net loss of $14.2
million, or a non-GAAP basic and diluted net loss per share
of $0.09 for the same period in the
prior year.
Quarter Ended Mar. 31, 2019
Financial Results
Revenues
- Net sales of VIVITROL were $69.2
million, compared to $62.7
million for the same period in the prior year, representing
an increase of approximately 10%.
- Net sales of ARISTADAii were $30.3 million, compared to $29.2 million for the same period in the prior
year, representing an increase of approximately 4%.
- Manufacturing and royalty revenues from RISPERDAL
CONSTA®, INVEGA SUSTENNA®/XEPLION®
and INVEGA TRINZA®/TREVICTA® were
$75.6 million, compared to
$68.8 million for the same period in
the prior year.
- Manufacturing and royalty revenues from
AMPYRA/FAMPYRA® were $12.2
million, compared to $28.3
million for the same period in the prior year due to generic
competition to AMPYRA entering the market in late 2018.
- Research and development revenues from the collaboration with
Biogen for diroximel fumarate (BIIB098) were $13.9 million, compared to $17.5 million for the same period in the prior
year.
Costs and Expenses
- Operating expenses were $299.1
million, compared to $287.0
million for the same period in the prior year, primarily
reflecting increased investment in the commercialization of
VIVITROL and ARISTADA.
- Other expense during the quarter included a $22.6 million charge due to a decrease in the
fair value of contingent consideration, related to Recro Pharma,
Inc.'s receipt of a second complete response letter from
the United States (U.S.) Food and
Drug Administration (FDA) regarding the New Drug Application (NDA)
for IV Meloxicam.
Financial Expectations for 2019
Alkermes reiterates its financial expectations for 2019 set
forth in its press release dated Feb. 14,
2019.
Recent Events:
- Leadership
-
- Appointed Todd Nichols to the
role of Senior Vice President of Sales and Marketing. Mr. Nichols
joins Alkermes from Celgene and his responsibilities will include
leading global commercial activities, including marketing and sales
of VIVITROL and ARISTADA, as well as developing and executing the
commercial strategy for ALKS 3831 and other development
candidates.
- ARISTADA
-
- The U.S. Department of Veterans Affairs recently added ARISTADA
and ARISTADA INITIO® to its National Formulary at parity
with other long-acting injectable atypical antipsychotics.
- Announced positive topline results from ALPINE
(Aripiprazole Lauroxil and Paliperidone
palmitate: INitiation Effectiveness), a six-month
study evaluating the efficacy, safety and tolerability of ARISTADA
and INVEGA SUSTENNA, when used to initiate patients experiencing an
acute exacerbation of schizophrenia in the hospital and maintain
treatment in an outpatient setting. Results were presented at the
2019 Congress of the Schizophrenia International Research Society
(SIRS).
- ALKS 3831
-
- Presented new data at SIRS from the phase 3 ALKS 3831
ENLIGHTEN-2 six-month weight study and interim results from the
ENLIGHTEN-2 52-week safety extension study.
- Diroximel fumarate
-
- Announced that the FDA accepted for review the NDA for
diroximel fumarate. If approved, Biogen intends to market diroximel
fumarate under the brand name VUMERITY™, which has been
conditionally accepted by the FDA and would be confirmed upon
approval.
- ALKS 4230
-
- Initiated ARTISTRY-2, a new clinical study of ALKS 4230
administered subcutaneously as monotherapy and in combination with
the PD-1 inhibitor KEYTRUDA® (pembrolizumab) in patients
with advanced solid tumors.
- Announced a research collaboration with Clovis to evaluate ALKS
4230 in combination with rucaparib, Clovis' marketed PARP
inhibitor, and lucitanib, Clovis' investigational tyrosine kinase
inhibitor.
Conference Call
Alkermes will host a conference call and webcast presentation
with accompanying slides at 8:30 a.m.
ET (1:30 p.m. BST) on
Thursday, Apr. 25, 2019, to discuss
these financial results 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
(4:00 p.m. BST) on Thursday, Apr. 25, 2019, through Thursday, May 2, 2019, 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
access code is 13690081.
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, multiple sclerosis
and oncology. 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 loss and non-GAAP basic and diluted 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 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 loss and non-GAAP basic and diluted 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 loss and
non-GAAP basic and diluted 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 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 future
financial and operating performance, business plans or prospects;
expectations concerning continued revenue growth from the company's
commercial products, including the growth of VIVITROL, ARISTADA and
ARISTADA INITIO; expectations concerning the company's continued
investment in its development pipeline and commercial capabilities
and the value that can be derived therefrom; the potential
therapeutic and commercial value of the company's marketed and
development products; expectations concerning the timing and
results of clinical development and regulatory activities,
including the planned submission of an NDA for ALKS 3831, the FDA's
anticipated action with respect to the NDA for diroximel fumarate,
and increasing momentum in the ALKS 4230 development program; and
expectations concerning investment in commercial activities,
including the potential launch of ALKS 3831. 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 or products
using our proprietary technologies, 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 for our products, including our 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 ARISTADA INITIO® are
registered trademarks of Alkermes Pharma Ireland Limited and
VUMERITY™ is a trademark of Alkermes Pharma Ireland
Limited; RISPERDAL CONSTA®, INVEGA SUSTENNA®,
XEPLION®, INVEGA TRINZA®
and TREVICTA® are registered trademarks of Johnson
& Johnson; KEYTRUDA® is a registered trademark of
Merck Sharp & Dohme Corp.; and AMPYRA® and
FAMPYRA® are registered trademarks of Acorda
Therapeutics, Inc.
(tables follow)
i AMPYRA® (dalfampridine) Extended Release
Tablets, 10 mg is developed and marketed in the U.S. by Acorda.
Biogen Inc. markets this product as FAMPYRA®
(prolonged-release fampridine tablets) outside the U.S. under a
licensing agreement with Acorda.
ii The term "ARISTADA" as used in this press release
refers to ARISTADA and ARISTADA INITIO, unless the context
indicates otherwise.
Alkermes plc and
Subsidiaries
|
Selected Financial
Information (Unaudited)
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations - GAAP
|
|
Three Months
Ended
|
|
Three Months
Ended
|
|
March 31,
|
|
March 31,
|
(In thousands,
except per share data)
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
Manufacturing and
royalty revenues
|
|
$
108,915
|
|
$
114,601
|
Product sales,
net
|
|
99,481
|
|
91,842
|
Research and
development revenue
|
|
14,706
|
|
18,707
|
Total
Revenues
|
|
223,102
|
|
225,150
|
Expenses:
|
|
|
|
|
Cost of goods
manufactured and sold
|
|
45,361
|
|
44,476
|
Research and
development
|
|
102,570
|
|
108,346
|
Selling, general and
administrative
|
|
141,220
|
|
118,147
|
Amortization of
acquired intangible assets
|
|
9,952
|
|
16,069
|
Total
Expenses
|
|
299,103
|
|
287,038
|
Operating
Loss
|
|
(76,001)
|
|
(61,888)
|
Other Expense,
net:
|
|
|
|
|
Interest
income
|
|
3,570
|
|
1,485
|
Interest
expense
|
|
(3,500)
|
|
(5,487)
|
Change in the fair
value of contingent consideration
|
|
(22,600)
|
|
(1,900)
|
Other expense,
net
|
|
(1,721)
|
|
792
|
Total Other Expense,
net
|
|
(24,251)
|
|
(5,110)
|
Loss Before Income
Taxes
|
|
(100,252)
|
|
(66,998)
|
Income Tax
Benefit
|
|
(3,854)
|
|
(4,493)
|
Net Loss —
GAAP
|
|
$
(96,398)
|
|
$
(62,505)
|
|
|
|
|
|
Net Loss Per
Share:
|
|
|
|
|
GAAP net loss per
share — basic and diluted
|
|
$
(0.62)
|
|
$
(0.40)
|
Non-GAAP net loss per
share — basic and diluted
|
|
$
(0.17)
|
|
$
(0.09)
|
|
|
|
|
|
Weighted Average
Number of Ordinary Shares Outstanding:
|
|
|
|
|
Basic and diluted —
GAAP and Non-GAAP
|
|
156,336
|
|
154,424
|
|
|
|
|
|
An itemized
reconciliation between net loss on a GAAP basis and non-GAAP net
loss is as follows:
|
|
|
Net Loss —
GAAP
|
|
$
(96,398)
|
|
$
(62,505)
|
Adjustments:
|
|
|
|
|
Share-based
compensation expense
|
|
24,616
|
|
20,042
|
Amortization
expense
|
|
9,952
|
|
16,069
|
Depreciation
expense
|
|
9,690
|
|
9,653
|
Change in the fair
value of contingent consideration
|
|
22,600
|
|
1,900
|
Income tax effect
related to reconciling items
|
|
2,972
|
|
(5,178)
|
Non-cash net interest
expense
|
|
169
|
|
191
|
Change in the fair
value of warrants and equity method investments
|
433
|
|
(302)
|
Restructuring
expense
|
|
—
|
|
3,598
|
Debt refinancing
charge
|
|
—
|
|
2,298
|
Non-GAAP Net
Loss
|
|
$
(25,966)
|
|
$
(14,234)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets
|
|
March 31,
|
|
December
31,
|
(In
thousands)
|
|
2019
|
|
2018
|
Cash, cash
equivalents and total investments
|
|
$
625,133
|
|
$
620,039
|
Receivables
|
|
222,811
|
|
292,223
|
Contract
assets
|
|
8,447
|
|
8,230
|
Inventory
|
|
92,861
|
|
90,196
|
Prepaid expenses and
other current assets
|
|
56,492
|
|
53,308
|
Property, plant and
equipment, net
|
|
320,004
|
|
309,987
|
Intangible assets,
net and goodwill
|
|
273,922
|
|
283,874
|
Other
assets
|
|
156,866
|
|
167,150
|
Total
Assets
|
|
$
1,756,536
|
|
$
1,825,007
|
Long-term debt —
current portion
|
|
$
2,843
|
|
$
2,843
|
Other current
liabilities
|
|
324,842
|
|
336,931
|
Long-term
debt
|
|
275,923
|
|
276,465
|
Contract liabilities
— long-term
|
|
11,342
|
|
9,525
|
Other long-term
liabilities
|
|
39,445
|
|
27,958
|
Total shareholders'
equity
|
|
1,102,141
|
|
1,171,285
|
Total Liabilities
and Shareholders' Equity
|
|
$
1,756,536
|
|
$
1,825,007
|
|
|
|
|
|
Ordinary shares
outstanding (in thousands)
|
|
156,885
|
|
155,757
|
|
|
|
|
|
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, 2019, which the company intends to file in April
2019.
|
Alkermes Contacts:
For Investors: Sandy Coombs +1 781 609 6377
For Media: Matthew
Henson +1 781 609 6637
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