plc (NASDAQ: ALKS) today reported financial results for its second
quarter of fiscal 2013, which ended Sept. 30, 2012, and the company
provided improved financial expectations for its fiscal year 2013, which
will be the first full fiscal year of the combined company, Alkermes plc
(Alkermes), following the completion of the merger of Alkermes, Inc.
with Elan Drug Technologies (EDT) on Sept. 16, 2011.
“We reported a very strong quarter in what is shaping up to be a very
strong year. The financial power of our commercial product portfolio is
becoming even more apparent in our improved guidance and in the recent
upgrade of our credit ratings,” commented Richard Pops, Chief Executive
Officer of Alkermes. “We are building an exciting biopharmaceutical
company characterized by a diversified portfolio of products generating
growing cash flows and a pipeline of valuable late-stage candidates.”
Second Quarter Fiscal 2013 Highlights
“Our second fiscal quarter results clearly demonstrate the financial
strength and growth potential that we envisioned when we created
Alkermes plc. Our key commercial product portfolio generated strong
revenues this quarter, and we are positioned for record financial
results this fiscal year,” commented James Frates, Chief Financial
Officer of Alkermes. “In September, we updated our expectations for
improved non-GAAP net income and free cash flow for fiscal 2013,
reflecting the impact of the successful refinancing of the term loans
used to fund the merger. Today, we are further improving our financial
expectations for fiscal 2013 based on strong operational performance in
the first six months, and we now expect Alkermes to generate between
$120 million and $140 million in non-GAAP net income this fiscal year.”
Second Quarter Fiscal 2013 Financial Results
It should be noted that comparative financial information provided below
includes 14 days of revenues and operating expenses from the former EDT
business during the second quarter of fiscal 2012.
Costs and Expenses
At Sept. 30, 2012, Alkermes recorded cash and total investments of
$208.2 million compared to $231.9 million at June 30, 2012, and $246.1
million at March 31, 2012. The reduction in cash in the second quarter
was primarily due to the use of approximately $83 million to reduce
total debt outstanding and for expenses associated with the refinancing.
At Sept. 30, 2012, the company had total debt outstanding on the balance
sheet of $370.6 million, down from $444.2 million as of June 30, 2012.
Financial Expectations for Fiscal 2013
Alkermes is improving its financial expectations for fiscal 2013,
reflecting increased revenue expectations from the company’s product
portfolio and decreased expense expectations. These factors are expected
to result in an increase in non-GAAP net income of $25 million to a
range of $120 million to $140 million. The following outlines Alkermes’
financial expectations for the fiscal year ending March 31, 2013.
Alkermes will host a conference call at 8:30 a.m. EDT (12:30 p.m. GMT)
on Thursday, Nov. 1, 2012, to discuss these financial results and
provide an update on the company. The conference call may be accessed 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 11:30
a.m. EDT (3:30 p.m. GMT) on Thursday, Nov. 1, 2012, through 5:00 p.m.
EST (10:00 p.m. GMT) on Thursday, Nov. 8, 2012, 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
that applies its scientific expertise and proprietary technologies to
develop innovative medicines that improve patient outcomes. The company
has a diversified portfolio of more than 20 commercial drug products and
a substantial clinical pipeline of product candidates that address
central nervous system (CNS) disorders such as addiction, schizophrenia
and depression. Headquartered in Dublin, Ireland, Alkermes plc has an
R&D center in Waltham, Massachusetts; a research and manufacturing
facility in Athlone, Ireland; and manufacturing facilities in
Gainesville, Georgia and Wilmington, Ohio. For more information, please
visit Alkermes’ website at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, 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; and the therapeutic value of the company’s products. These
statements are neither promises nor guarantees and are subject to a
variety of risks and uncertainties, many of which are beyond the
company's control, which could cause actual results to differ materially
from those contemplated in these forward-looking statements.
These risks and uncertainties include, among others: the commercial
markets and demand for the company’s products may not be as large as the
company anticipates; reimbursement for the company’s products may
change; the possibility of adverse decisions by the U.S. Food and Drug
Administration (FDA) or regulatory authorities outside the U.S.
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 that could cause the FDA or
regulatory authorities outside the U.S. to require post-approval studies
or removal of the company’s products from the market; and those risks
described in the company’s Annual Report on Form 10-K for the year ended
March 31, 2012, and in other filings made by the company with the
Securities and Exchange Commission (“SEC”) and which are available at
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
any forward-looking information contained in this press release.
VIVITROL® is a registered trademark of Alkermes, Inc.;
RISPERDAL® CONSTA® and INVEGA® SUSTENNA®
are registered trademarks of Janssen Pharmaceuticals, Inc.; XEPLION®
is a registered trademark of Johnson & Johnson Corporation; AMPYRA®
and FAMPYRA® are registered trademarks of Acorda
Therapeutics, Inc.; BYDUREON® is a registered trademark of
Amylin Pharmaceuticals, Inc.; TRICOR® is a registered
trademark of Fournier Industrie et Sante Corporation; and RITALIN LA®
and FOCALIN XR® are registered trademarks of Novartis AG
1As a complement to GAAP results, the company is providing
non-GAAP net income (loss) and non-GAAP diluted earnings (loss) per
share, which the company believes better indicate underlying trends in
ongoing operations and cash flows. Non-GAAP net income (loss) adjusts
for one-time and non-cash charges by excluding from GAAP results:
share-based compensation; amortization; depreciation; non-cash net
interest expense; non-cash tax expense; deferred revenue; and certain
other one-time items.
2AMPYRA® (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
Use of Non-GAAP Financial Measures
We use "non-GAAP net income" as a key indicator of the underlying
financial operating performance of Alkermes plc. Non-GAAP net income is
not a GAAP measure of performance and is defined as net income or loss
plus or minus the non-cash portion of net interest expense and provision
for or benefit from income taxes, plus depreciation and amortization of
costs, share-based compensation expense, deferred revenue and other
nonrecurring items. We feel that non-GAAP net income provides management
and investors with a better representation of the ongoing economics of
the business and reflects how we manage the business internally.
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
Alkermes plc's Quarterly Report on Form 10-Q for the three and six
months ended September 30, 2012, which the company intends to file in