— Fiscal Year 2013 Revenues Grew 48% Year-Over-Year to
— Fiscal Year 2013 Non-GAAP EPS Grew to
— Announces Change in Fiscal Year-End From
“This was a remarkable year characterized by robust revenue growth,
focused investment and significant cash flows. Our portfolio of five key
commercial products is growing and generating significant revenues that
provide the financial foundation of the company. For the remainder of
calendar 2013, we expect our portfolio of five key products to grow
approximately 25% year-over-year,” commented
Highlights for Quarter Ended
-
Total revenues for the quarter were
$163.4 million and included$30.0 million of intellectual property license revenue unrelated to key development programs. This compared to total revenues of$130.5 million for the same period in the prior fiscal year. -
Revenues from the company’s five key commercial products for the
quarter grew 26% to
$89.5 million from$71.2 million for the same period in the prior fiscal year. -
Non-GAAP net income increased to
$56.3 million , or a non-GAAP diluted earnings per share (EPS) of$0.40 , for the quarter. This compared to non-GAAP net income of$16.5 million , or a non-GAAP diluted EPS of$0.12 , for the same period in the prior fiscal year. -
GAAP net income increased to
$3.0 million , or a basic and diluted GAAP EPS of$0.02 , for the quarter. This compared to a GAAP net loss of$63.4 million , or a basic and diluted GAAP net loss per share of$0.49 , for the same period in the prior fiscal year. -
Free cash flow increased to
$48.0 million for the quarter compared to$8.4 million for the same period in the prior fiscal year.
Highlights for Fiscal Year Ended
-
Total revenues increased 48% to
$575.5 million , reflecting the first full fiscal year following the completion of the merger ofAlkermes, Inc. with Elan Drug Technologies (EDT) onSept. 16, 2011 . Fiscal 2013 total revenues included$50.0 million of intellectual property license revenue unrelated to key development programs. This compared to total revenues of$390.0 million for the prior fiscal year. -
Non-GAAP net income increased to
$179.5 million , or a non-GAAP diluted EPS of$1.31 , for fiscal 2013. This compared to non-GAAP net income of$40.0 million , or a non-GAAP diluted EPS of$0.34 , for the prior fiscal year. -
GAAP net income increased to
$25.0 million , or a basic GAAP EPS of$0.19 and a diluted GAAP EPS of$0.18 , for fiscal 2013. This compared to a GAAP net loss of$113.7 million , or a basic and diluted GAAP net loss per share of$0.99 , for the prior fiscal year. -
Free cash flow increased to
$157.3 million for fiscal 2013 compared to$23.0 million for the prior fiscal year.
“Our financial results reported today reflect the financial
transformation of Alkermes. Our business is now evolving to the next
stage as our pipeline of highly differentiated candidates advances and
demonstrates its blockbuster potential,” commented Richard Pops, Chief
Executive Officer of
Financial Results for Fiscal Year Ended
Revenues
-
Manufacturing and royalty revenues from the company’s long-acting
atypical antipsychotic franchise, RISPERDAL® CONSTA®
and INVEGA® SUSTENNA®/XEPLION®, were
$197.0 million , compared to$186.3 million for fiscal 2012. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$65.0 million , compared to$24.6 million for fiscal 2012. -
Net sales of VIVITROL® were
$58.1 million , compared to$41.2 million for fiscal 2012, representing an increase of approximately 41% year-over-year. -
Royalty revenue from BYDUREON® was
$16.4 million compared to$1.5 million for fiscal 2012. -
Additionally, fiscal 2013 results included RITALIN LA®/FOCALIN
XR® revenues of
$40.3 million ,TRICOR ® 145 revenues of$37.5 million and VERELAN® revenues of$23.8 million . This compared to RITALIN LA/FOCALIN XR revenues of$23.1 million ,TRICOR 145 revenues of$27.8 million and VERELAN revenues of$14.2 million for fiscal 2012. -
Manufacturing and royalty revenues in fiscal 2013 also included
$50.0 million of intellectual property license revenue unrelated to key development programs.
Costs and Expenses
-
Operating expenses for fiscal 2013 were
$493.7 million , which included$12.3 million in one-time restructuring charges related to the Athlone,Ireland manufacturing facility. This compared to operating expenses of$478.3 million for fiscal 2012. -
Net interest expense for fiscal 2013 was
$48.2 million , including one-time charges of$19.7 million related to the refinancing and repricing of term loans secured to fund the acquisition of EDT. This compared to net interest expense of$26.6 million for fiscal 2012.
Balance Sheet
At
Financial Expectations for Nine Months Ending
-
Revenues:
Alkermes expects total revenues to range from$395 million to $425 million for the nine months endingDec. 31, 2013 . Included in this total revenue expectation,Alkermes expects VIVITROL net sales to range from$50 million to $60 million . -
Cost of Goods Manufactured: The company expects cost of goods
manufactured to range from
$130 million to $140 million . -
Research and Development (R&D) Expenses: The company expects
R&D expenses to range from
$125 million to $135 million . -
Selling, General and Administrative (SG&A) Expenses: The
company expects SG&A expenses to range from
$95 million to $105 million . -
Amortization of Intangible Assets: The company expects
amortization of intangibles to be approximately
$40 million . -
Net Interest Expense: The company expects net interest expense
to be approximately
$10 million . -
Net Income Tax Expense: The company expects net income tax
expense to range from
$5 million to $10 million . -
GAAP Net Loss: The company expects a GAAP net loss in the range
of breakeven to a loss of
$25 million , or a basic and diluted EPS of $0 to a basic and diluted loss per share of approximately$0.19 , based on a weighted average basic and diluted share count of approximately 135 million shares outstanding. -
Non-GAAP Net Income: The company expects non-GAAP net income to
range from
$85 million to $105 million , and non-GAAP diluted EPS to range from$0.61 to $0.75 , based on a weighted average diluted share count of approximately 140 million shares outstanding. -
Capital Expenditures: The company expects capital expenditures
to be approximately
$20 million . -
Free Cash Flow: The company expects free cash flow to range
from
$65 million to $85 million .
Following the change in the company’s financial year-end, the company
expects total pro forma revenues for the calendar year ending
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 our 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, 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 our expectations concerning the timing and results of our 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 payors; 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
(tables follow)
Alkermes plc and Subsidiaries | ||||||
Selected Financial Information (Unaudited) | ||||||
Condensed Consolidated Statements of Operations - GAAP (In thousands, except per share data) |
Year Ended March 31, 2013 |
Year Ended March 31, 2012 |
||||
Revenues: | ||||||
Manufacturing and royalty revenues | $ 510,900 | $ 326,444 | ||||
Product sales, net | 58,107 | 41,184 | ||||
Research and development revenues | 6,541 | 22,349 | ||||
Total Revenues | 575,548 | 389,977 | ||||
Expenses: | ||||||
Cost of goods manufactured and sold | 170,466 | 127,578 | ||||
Research and development | 140,013 | 141,893 | ||||
Selling, general and administrative | 125,758 | 137,632 | ||||
Amortization of acquired intangible assets | 41,852 | 25,355 | ||||
Restructuring | 12,300 | - | ||||
Impairment of long-lived assets | 3,346 | 45,800 | ||||
Total Expenses | 493,735 | 478,258 | ||||
Operating Income (Loss) | 81,813 | (88,281 | ) | |||
Other Expense, net: | ||||||
Interest income | 841 | 1,516 | ||||
Interest expense | (48,994 | ) | (28,111 | ) | ||
Other income (expense), net | 1,781 | 484 | ||||
Total Other Expense, net | (46,372 | ) | (26,111 | ) | ||
Income (Loss) Before Income Taxes | 35,441 | (114,392 | ) | |||
Income Tax Provision (Benefit) | 10,458 | (714 | ) | |||
Net Income (Loss) — GAAP | $ 24,983 | $ (113,678 | ) | |||
Earnings (Loss) Per Share: | ||||||
GAAP earnings (loss) per share — basic | $ 0.19 | $ (0.99 | ) | |||
GAAP earnings (loss) per share — diluted | $ 0.18 | $ (0.99 | ) | |||
Non-GAAP earnings per share — basic | $ 1.36 | $ 0.35 | ||||
Non-GAAP earnings per share — diluted | $ 1.31 | $ 0.34 | ||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||
Basic — GAAP | 131,713 | 114,702 | ||||
Diluted — GAAP | 137,100 | 114,702 | ||||
Basic — Non-GAAP | 131,713 | 114,702 | ||||
Diluted — Non-GAAP | 137,100 | 119,069 | ||||
An itemized reconciliation between net income (loss) on a GAAP basis and non-GAAP net income is as follows: | ||||||
Net Income (Loss) — GAAP | $ 24,983 | $ (113,678 | ) | |||
Adjustments: | ||||||
Non-cash net interest expense | 4,416 | 6,453 | ||||
Non-cash taxes | 6,825 | (10,782 | ) | |||
Depreciation expense | 31,899 | 22,529 | ||||
Amortization expense | 41,852 | 25,355 | ||||
Share-based compensation expense | 34,716 | 28,826 | ||||
Deferred revenue | 474 | 4,784 | ||||
Loss on debt refinancing and repricing | 19,670 | - | ||||
Restructuring | 12,300 | - | ||||
Impairment of long-lived assets | 3,346 | 45,800 | ||||
Change in method of revenue recognition for VIVITROL product sales, net | (1,013 | ) | - | |||
Merger-related costs | - | 29,073 | ||||
Severance costs | - | 1,624 | ||||
Non-GAAP Net Income | $ 179,468 | $ 39,984 | ||||
Condensed Consolidated Statements of Operations - GAAP (In thousands, except per share data) |
Three Months |
Three Months |
||||
Revenues: | ||||||
Manufacturing and royalty revenues | $ 146,919 | $ 110,685 | ||||
Product sales, net | 14,626 | 11,014 | ||||
Research and development revenues | 1,877 | 8,774 | ||||
Total Revenues | 163,422 | 130,473 | ||||
Expenses: | ||||||
Cost of goods manufactured and sold | 47,991 | 51,077 | ||||
Research and development | 35,800 | 45,190 | ||||
Selling, general and administrative | 34,679 | 34,432 | ||||
Amortization of acquired intangible assets | 10,322 | 11,642 | ||||
Restructuring | 12,300 | - | ||||
Impairment of long-lived assets | 3,346 | 45,800 | ||||
Total Expenses | 144,438 | 188,141 | ||||
Operating Income (Loss) | 18,984 | (57,668 | ) | |||
Other Expense, net: | ||||||
Interest income | 171 | 281 | ||||
Interest expense | (11,473 | ) | (10,092 | ) | ||
Other income (expense), net | 184 | (286 | ) | |||
Total Other Expense, net | (11,118 | ) | (10,097 | ) | ||
Income (Loss) Before Income Taxes | 7,866 | (67,765 | ) | |||
Income Tax Provision (Benefit) | 4,867 | (4,408 | ) | |||
Net Income (Loss) — GAAP | $ 2,999 | $ (63,357 | ) | |||
Earnings (Loss) Per Share: | ||||||
GAAP earnings (loss) per share — basic | $ 0.02 | $ (0.49 | ) | |||
GAAP earnings (loss) per share — diluted | $ 0.02 | $ (0.49 | ) | |||
Non-GAAP earnings per share — basic | $ 0.42 | $ 0.13 | ||||
Non-GAAP earnings per share — diluted | $ 0.40 | $ 0.12 | ||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||
Basic — GAAP | 133,272 | 129,986 | ||||
Diluted — GAAP | 139,677 | 129,986 | ||||
Basic — Non-GAAP | 133,272 | 129,986 | ||||
Diluted — Non-GAAP | 139,677 | 135,143 | ||||
An itemized reconciliation between net income (loss) on a GAAP basis and non-GAAP net income is as follows: | ||||||
Net Income (Loss) — GAAP | $ 2,999 | $ (63,357 | ) | |||
Adjustments: | ||||||
Non-cash net interest expense | 300 | 1,916 | ||||
Non-cash taxes | 4,443 | (4,406 | ) | |||
Depreciation expense | 7,999 | 8,991 | ||||
Amortization expense | 10,322 | 11,642 | ||||
Share-based compensation expense | 7,881 | 7,083 | ||||
Deferred revenue | (878 | ) | 4,843 | |||
Loss on debt repricing | 7,541 | - | ||||
Restructuring | 12,300 | - | ||||
Impairment of long-lived assets | 3,346 | 45,800 | ||||
Merger-related costs | - | 2,355 | ||||
Severance costs | - | 1,624 | ||||
Non-GAAP Net Income | $ 56,253 | $ 16,491 | ||||
Condensed Consolidated Balance Sheets (In thousands) |
March 31, 2013 |
March 31, 2012 |
||||
Cash, cash equivalents and total investments | $ 304,179 | $ 246,138 | ||||
Receivables | 124,620 | 96,381 | ||||
Inventory | 43,483 | 39,759 | ||||
Prepaid expenses and other current assets | 19,133 | 12,566 | ||||
Property, plant and equipment, net | 288,435 | 302,995 | ||||
Intangible assets, net and goodwill | 668,733 | 710,585 | ||||
Other assets | 21,708 | 26,793 | ||||
Total Assets | $1,470,291 | $1,435,217 | ||||
Long-term debt — current portion | $ 6,750 | $ 3,100 | ||||
Other current liabilities | 79,180 | 86,064 | ||||
Long-term debt | 362,258 | 441,360 | ||||
Deferred revenue — long-term | 8,866 | 7,578 | ||||
Other long-term liabilities | 60,863 | 43,263 | ||||
Total shareholders' equity | 952,374 | 853,852 | ||||
Total Liabilities and Shareholders' Equity | $1,470,291 | $1,435,217 | ||||
Common shares outstanding (in thousands) | 133,752 | 130,177 | ||||
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
Three Months Ended |
Year Ended |
||||||||||||||
June 30, |
September 30, |
December 31, |
March 31, |
March 31, |
|||||||||||
(In thousands, except per share data) | |||||||||||||||
Revenues: | |||||||||||||||
Manufacturing and royalty revenues |
|
$ 138,380 |
|
$ 107,327 |
|
$ 118,274 |
|
$ 146,919 |
|
$ 510,900 |
|||||
Product sales, net | 12,372 | 15,192 | 15,917 | 14,626 | 58,107 | ||||||||||
Research and development revenues | 1,487 | 1,459 | 1,718 | 1,877 | 6,541 | ||||||||||
Total Revenues | 152,239 | 123,978 | 135,909 | 163,422 | 575,548 | ||||||||||
Expenses: | |||||||||||||||
Cost of goods manufactured and sold | 42,070 | 41,491 | 38,914 | 47,991 | 170,466 | ||||||||||
Research and development | 37,806 | 35,088 | 31,319 | 35,800 | 140,013 | ||||||||||
Selling, general and administrative | 29,784 | 31,428 | 29,867 | 34,679 | 125,758 | ||||||||||
Amortization of acquired intangible assets | 10,434 | 10,547 | 10,549 | 10,322 | 41,852 | ||||||||||
Restructuring | - | - | - | 12,300 | 12,300 | ||||||||||
Impairment of long-lived assets | - | - | - | 3,346 | 3,346 | ||||||||||
Total Expenses | 120,094 | 118,554 | 110,649 | 144,438 | 493,735 | ||||||||||
Operating Income | 32,145 | 5,424 | 25,260 | 18,984 | 81,813 | ||||||||||
Other Expense, net | (8,948 | ) | (21,709 | ) | (4,597 | ) | (11,118 | ) | (46,372 | ) | |||||
Income (Loss) Before Income Taxes | 23,197 | (16,285 | ) | 20,663 | 7,866 | 35,441 | |||||||||
Income Tax Provision | 764 | 422 | 4,405 | 4,867 | 10,458 | ||||||||||
Net Income (Loss) |
|
$ 22,433 |
|
$ (16,707 |
) |
|
$ 16,258 |
|
$ 2,999 |
|
$ 24,983 |
||||
Basic Earnings (Loss) Per Share |
|
$ 0.17 |
|
$ (0.13 |
) |
|
$ 0.12 |
|
$ 0.02 |
|
$ 0.19 |
||||
Diluted Earnings (Loss) Per Share |
|
$ 0.17 |
|
$ (0.13 |
) |
|
$ 0.12 |
|
$ 0.02 |
|
$ 0.18 |
||||
Weighted Average Number of Ordinary | |||||||||||||||
Shares Outstanding | |||||||||||||||
Basic | 130,434 | 131,067 | 132,097 | 133,272 | 131,713 | ||||||||||
Diluted | 134,945 | 131,067 | 137,497 | 139,677 | 137,100 |
Alkermes plc and Subsidiaries | ||||||||
Guidance — GAAP to Non-GAAP Adjustments | ||||||||
An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings per share |
||||||||
on a non-GAAP basis is as follows: | ||||||||
(Loss)/Earnings | ||||||||
(In millions, except per share data) | Amount | Shares | Per Share | |||||
Projected Net Loss — GAAP | $ (12.5 | ) | 135 | $ (0.09 | ) | |||
Adjustments: | ||||||||
Non-cash net interest expense | 1.0 | |||||||
Non-cash taxes | 4.0 | |||||||
Depreciation expense | 32.5 | |||||||
Amortization expense | 40.0 | |||||||
Share-based compensation expense | 32.5 | |||||||
Deferred revenue | (2.5 | ) | ||||||
Projected Non-GAAP Net Income | $ 95.0 | 140 | $ 0.68 | |||||
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance. |
Source:
Alkermes Contacts:
For Investors:
Rebecca
Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder,
+1 781-609-6166