— Non-GAAP Diluted EPS of
— Following Positive Phase 3 Results, Company On Track to Submit New Drug Application for Aripiprazole Lauroxil in Third Quarter of 2014 —
— Company Reiterates Financial Expectations for 2014 —
“During the quarter, we continued to generate positive cash flow,
reflecting the strength of our commercial business and enabling us to
invest in our advancing late-stage pipeline and prepare for the launch
of aripiprazole lauroxil,” commented
“In early April, we announced the positive phase 3 data for aripiprazole
lauroxil. With these data now in hand, the company is on track to submit
the NDA in the third quarter, and we are accelerating our preparations
for commercial launch in 2015,” said Richard Pops, Chief Executive
Officer of
Quarter Ended
-
Total revenues for the quarter were
$130.2 million , compared to$163.4 million for the same period in the prior year, which included$30.0 million of intellectual property license revenue unrelated to key development programs. -
Non-GAAP net income was
$16.2 million , or a non-GAAP diluted earnings per share (EPS) of$0.11 for the quarter. This compared to non-GAAP net income of$56.3 million , or a non-GAAP diluted EPS of$0.40 , for the same period in the prior year, which included$30.0 million , or$0.21 per diluted share, of intellectual property license revenue. -
GAAP net loss was
$24.4 million , or a basic and diluted GAAP loss per share of$0.17 , for the quarter. This compared to GAAP net income of$3.0 million , or a basic and diluted GAAP EPS of$0.02 , for the same period in the prior year, which included$30.0 million , or$0.21 per diluted share, of intellectual property license revenue and one-time restructuring charges of$12.3 million , or$0.09 per diluted share. -
Free cash flow was
$10.5 million for the quarter, compared to$48.0 million for the same period in the prior year, which included$30.0 million of intellectual property license revenue.
Quarter Ended
Revenues
-
Manufacturing and royalty revenues from the company’s long-acting
atypical antipsychotic franchise, RISPERDAL® CONSTA®
and INVEGA® SUSTENNA®/XEPLION®, were
$49.6 million , compared to$45.6 million for the same period in the prior year, representing an increase of approximately 9%. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$20.6 million , compared to$24.7 million for the same period in the prior year. -
Net sales of VIVITROL® were
$17.1 million , compared to$14.6 million for the same period in the prior year, representing an increase of approximately 17%. -
Royalty revenue from BYDUREON® was
$7.7 million , compared to$4.8 million for the same period in the prior year. -
Additionally, results for the quarter ended
March 31, 2014 included RITALIN LA®/FOCALIN XR® revenues of$9.7 million , VERELAN® revenues of$4.6 million andTRICOR ® 145 revenues of$2.3 million . This compared to RITALIN LA/FOCALIN XR revenues of$10.6 million , VERELAN revenues of$6.7 million andTRICOR 145 revenues of$6.2 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$146.1 million , reflecting increased investment in the company’s rapidly advancing central nervous system (CNS) development pipeline and prelaunch activities for aripiprazole lauroxil. This compared to$144.4 million for the same period in the prior year, which included$12.3 million in one-time restructuring charges related to the Athlone,Ireland manufacturing facility. -
Income tax provision was
$3.8 million , compared to$4.9 million for the same period in the prior year.
Balance Sheet
At
Financial Expectations
Conference Call
About
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, non-GAAP diluted earnings per share and free cash flow. 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.
Management defines its non-GAAP financial measures as follows:
- Non-GAAP net income adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; non-cash tax expense; deferred revenue; and certain other one-time or non-cash items.
- Free cash flow represents non-GAAP net income less capital expenditures.
Management believes that these non-GAAP financial measures, when viewed with its results under GAAP and the accompanying reconciliations, better indicate underlying trends in ongoing operations and cash flows. However, non-GAAP net income, non-GAAP diluted earnings per share and free cash flow are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance.
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 above may 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; the therapeutic and commercial value of the company’s products; and expectations concerning the timing and results of clinical development activities. 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: whether clinical
development activities will be completed on time or at all and whether
the results of such activities will be predictive of real-world results
or of results in subsequent clinical trials; whether the company, and
its partners, are able to continue to successfully commercialize its
products; whether there will 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 possibility of adverse
decisions by the
VIVITROL® is a registered trademark of
1AMPYRA® (dalfampridine) Extended Release Tablets,
10 mg is developed and marketed in the U.S. by
Alkermes plc and Subsidiaries | ||||||||||
Selected Financial Information (Unaudited) | ||||||||||
Three Months | Three Months | |||||||||
Ended | Ended | |||||||||
Condensed Consolidated Statements of Operations - GAAP | March 31, | March 31, | ||||||||
(In thousands, except per share data) | 2014 | 2013 | ||||||||
Revenues: | ||||||||||
Manufacturing and royalty revenues | $ 111,280 | $ 146,919 | ||||||||
Product sales, net | 17,079 |
14,626 |
||||||||
Research and development revenues | 1,853 | 1,877 | ||||||||
Total Revenues | 130,212 | 163,422 | ||||||||
Expenses: | ||||||||||
Cost of goods manufactured and sold | 38,839 | 47,991 | ||||||||
Research and development | 52,140 | 35,800 | ||||||||
Selling, general and administrative | 42,550 | 34,679 | ||||||||
Amortization of acquired intangible assets | 12,576 | 10,322 | ||||||||
Restructuring | - | 12,300 | ||||||||
Impairment of long-lived assets | - | 3,346 | ||||||||
Total Expenses | 146,105 | 144,438 | ||||||||
Operating (Loss) Income | (15,893 | ) | 18,984 | |||||||
Other Expense, net: | ||||||||||
Interest income | 511 | 171 | ||||||||
Interest expense | (3,356 | ) | (11,473 | ) | ||||||
Other (expense) income, net | (1,850 | ) | 184 | |||||||
Total Other Expense, net | (4,695 | ) | (11,118 | ) | ||||||
(Loss) Income Before Income Taxes | (20,588 | ) | 7,866 | |||||||
Income Tax Provision | 3,766 | 4,867 | ||||||||
Net (Loss) Income — GAAP | $ (24,354 | ) | $ 2,999 | |||||||
(Loss) Earnings Per Share: | ||||||||||
GAAP (loss) earnings per share — basic and diluted | $ (0.17 | ) | $ 0.02 | |||||||
Non-GAAP earnings per share — basic | $ 0.11 | $ 0.42 | ||||||||
Non-GAAP earnings per share — diluted | $ 0.11 | $ 0.40 | ||||||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||||||
Basic — GAAP | 143,358 | 133,272 | ||||||||
Diluted — GAAP | 143,358 | 139,677 | ||||||||
Basic — Non-GAAP | 143,358 | 133,272 | ||||||||
Diluted — Non-GAAP | 153,583 | 139,677 | ||||||||
An itemized reconciliation between net (loss) income on a GAAP basis and non-GAAP net income is as follows: | ||||||||||
Net (Loss) Income — GAAP | $ (24,354 | ) | $ 2,999 | |||||||
Adjustments: | ||||||||||
Amortization expense | 12,576 | 10,322 | ||||||||
Share-based compensation expense | 13,420 | 7,881 | ||||||||
Depreciation expense | 9,977 | 7,999 | ||||||||
Non-cash net interest expense | 240 | 300 | ||||||||
Non-cash taxes | 3,622 | 4,443 | ||||||||
Deferred revenue | (965 | ) | (878 | ) | ||||||
Net loss on transactions with equity method investee | 1,635 | - | ||||||||
Loss on debt repricing | - | 7,541 | ||||||||
Restructuring | - | 12,300 | ||||||||
Impairment of long-lived assets | - | 3,346 | ||||||||
Non-GAAP Net Income | $ 16,151 | $ 56,253 | ||||||||
Capital expenditures | (5,685 | ) | (8,259 | ) | ||||||
Free Cash Flow | $ 10,466 | $ 47,994 | ||||||||
Condensed Consolidated Balance Sheets | March 31, | December 31, | ||||||
(In thousands) | 2014 | 2013 | ||||||
Cash, cash equivalents and total investments | $ 701,764 | $ 449,995 | ||||||
Receivables | 123,154 | 134,154 | ||||||
Inventory | 55,403 | 46,218 | ||||||
Prepaid expenses and other current assets | 45,941 | 27,535 | ||||||
Property, plant and equipment, net | 268,992 | 274,490 | ||||||
Intangible assets, net and goodwill | 617,729 | 630,305 | ||||||
Other assets | 22,495 | 14,891 | ||||||
Total Assets | $ 1,835,478 | $ 1,577,588 | ||||||
Long-term debt — current portion | $ 6,750 | $ 6,750 | ||||||
Other current liabilities | 86,009 | 94,147 | ||||||
Long-term debt | 355,963 | 357,543 | ||||||
Deferred revenue — long-term | 11,964 | 12,213 | ||||||
Other long-term liabilities | 35,291 | 41,749 | ||||||
Total shareholders' equity | 1,339,501 | 1,065,186 | ||||||
Total Liabilities and Shareholders' Equity | $ 1,835,478 | $ 1,577,588 | ||||||
Ordinary shares outstanding (in thousands) |
144,445 |
137,793 | ||||||
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, 2014, which the company intends to file in April 2014. |
Source:
Alkermes
For Investors:
Rebecca
Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder,
+1 781-609-6166