— RISPERDAL® CONSTA® Shows Strong Operational Growth —
— Company Updates Financial Expectations for Fiscal 2010 —
Financial highlights:
-
Quarterly revenues of
$48.2 million , driven by strong manufacturing and royalty revenues from RISPERDAL® CONSTA®. Worldwide sales of RISPERDAL CONSTA by Janssen,Division of Ortho-McNeil-Janssen Pharmaceuticals , Inc. , and Janssen-Cilag (Janssen) were approximately$353 million , growing 9.9% on an operational basis year-over-year. U.S. sales growth for the quarter endedSeptember 30, 2009 , was 9.3% while sales outside the U.S. were up 10.2% operationally driven by increased share. -
GAAP net loss of
$8.7 million and pro forma net income of$1.1 million . -
Strong financial position with cash and total investments of
$369.5 million .
Other recent highlights:
- Positive data reported for two phase 1 studies of ALKS 33, an oral opioid modulator for the potential treatment of addiction and other central nervous system disorders.
- Phase 1 clinical study initiated for ALKS 37, an oral, peripherally-restricted opioid antagonist for the treatment of opioid-induced constipation.
-
Richard Pops assumed the role of President and Chief Executive Officer
of
Alkermes while maintaining his role as Chairman of the Board.
“Our financial and operating results remain strong and serve as the
foundation for our future. Our team is now focused on taking
Key operating results for the quarter ended
-
GAAP net loss of
$8.7 million or a basic and diluted loss per share of$0.09 , including$5.6 million of share-based compensation and severance expense and$4.1 million of charges associated with the planned relocation of the company’s headquarters. For the same period in 2008, GAAP net income was$1.7 million or a basic and diluted earnings per share of$0.02 , including$3.8 million of share-based compensation expense. -
Pro forma net income was
$1.1 million or a basic and diluted earnings per share of$0.01 , compared to a pro forma net income of$5.5 million or a basic and diluted earnings per share of$0.06 for the same period in 2008.
Pro Forma | Charges Related to the | Share-Based |
Reported GAAP |
|||||||||
Diluted | Relocation of the | Compensation and |
Diluted (Loss) |
|||||||||
Earnings | Company’s | Severance Expense |
Earnings |
|||||||||
Headquarters | ||||||||||||
Q2 FY 2010 |
$0.01 |
($0.04 | ) | ($0.06 | ) | ($0.09 | ) | |||||
Q2 FY 2009 |
$0.06 |
$ -- | ($0.04 | ) | $ 0.02 | |||||||
“We are pleased to report a solid quarter, which reflects the continued
growth of RISPERDAL CONSTA in the marketplace, as well as the financial
strength of our balance sheet,” commented
Revenues
-
Total revenues for the quarter ended
September 30, 2009 , were$48.2 million , compared to$47.3 million for the same period in 2008. -
Manufacturing revenues for the quarter ended
September 30, 2009 , were$32.8 million , compared to$33.0 million for the same period in 2008. Manufacturing revenues for the quarter endedSeptember 30, 2009 , included$31.9 million related to RISPERDAL CONSTA, compared to$30.7 million for RISPERDAL CONSTA and$2.3 million for VIVITROL® for the same period in 2008. -
Royalty revenues for the quarter ended
September 30, 2009 , were$8.8 million , based on RISPERDAL CONSTA sales of$352.6 million , compared to$8.4 million , based on RISPERDAL CONSTA sales of$337.5 million for the same period in 2008. -
Net sales from VIVITROL recorded by
Alkermes for the quarter endedSeptember 30, 2009 , were$4.6 million , compared to net sales of$4.1 million recorded byCephalon, Inc. (Cephalon ) for the same period in 2008. -
Research and development (R&D) revenue under collaborative
arrangements for the quarter ended
September 30, 2009 , was$1.2 million , compared to$5.3 million for the same period in 2008. -
Net collaborative profit for the quarter ended
September 30, 2009 , was$0.7 million , compared to$0.6 million for the same period in 2008, completing the recognition of the$11.0 million payment received fromCephalon to cover its share of VIVITROL losses.
Costs and Expenses
-
Cost of goods manufactured and sold for the quarter ended
September 30, 2009 , was$15.1 million , which included$12.1 million related to RISPERDAL CONSTA and$2.6 million related to VIVITROL, compared to$12.1 million for the same period in 2008, of which$8.1 million related to RISPERDAL CONSTA and$4.0 million related to VIVITROL. -
R&D expenses for the quarter ended
September 30, 2009 , were$20.7 million , compared to$19.7 million for the same period in 2008. -
Selling, general and administrative (SG&A) expenses for the quarter
ended
September 30, 2009 , were$20.6 million , compared to$11.7 million for the same period in 2008. SG&A expenses for the quarter endedSeptember 30, 2009 included$1.4 million of severance and$0.9 million of share-based compensation expense related to the resignation of the former CEO. -
Share-based compensation expense (included in the expenses above) for
the quarter ended
September 30, 2009 , was$4.2 million , of which$0.5 million related to cost of goods manufactured and sold,$0.9 million related to R&D expenses and$2.8 million related to SG&A expenses. Share-based compensation expense for the same period in 2008 was$3.8 million , of which$0.4 million related to cost of goods manufactured and sold,$1.3 million related to R&D expenses and$2.1 million related to SG&A expenses. -
Interest income for the quarter ended
September 30, 2009 , was$1.1 million , compared to$2.7 million for the same period in 2008. Interest expense for the quarter endedSeptember 30, 2009 , was$1.6 million , compared to$4.2 million for the same period in 2008.
At
Updated Financial Expectations for Fiscal 2010
-
Manufacturing Revenues: The company is adjusting its
expectation for manufacturing revenues to a range of
$105 to $111 million , revised from an expectation of$116 to $122 million , due to changes in the purchase forecasts from Janssen. These revised expectations include manufacturing revenues related to RISPERDAL CONSTA in the range of$105 to $110 million , revised from an expectation of$115 to $120 million , and manufacturing revenue related to VIVITROL for the Russian market in the range of$0 to $1 million , revised from an expectation of$1 to $2 million . -
Royalty Revenues: The company expects royalty revenues from
RISPERDAL CONSTA to remain in the range of
$36 to $38 million . -
Product Sales, Net: The company is adjusting its expectation
for net sales from VIVITROL to a range of
$20 to $25 million , revised from an expectation of$23 to $28 million , due to lower than anticipated sales in the first half of fiscal 2010. -
R&D Revenues: The company expects R&D revenues to remain in
the range of
$2 to $4 million . -
Net Collaborative Profit: The company expects net collaborative
profit to remain at
$5 million , as the company has recognized all of the funds received fromCephalon to cover its share of VIVITROL losses. -
Total Revenues: The company is adjusting its expectation for
total revenues for fiscal 2010 to a range of
$168 to $183 million , revised from an expectation of$182 to $197 million . -
Cost of Goods Manufactured and Sold: The company is adjusting
its expectation for cost of goods manufactured and sold to a range of
$47 to $56 million , revised from an expectation of$50 to $60 million . This revised expectation includes cost of goods manufactured and sold related to RISPERDAL CONSTA in the range of$38 to $42 million , revised from an expectation of$40 to $44 million , and cost of goods manufactured and sold related to VIVITROL in the range of$9 to $14 million , revised from an expectation of$10 to $16 million . -
R&D Expenses: The company expects R&D expenses to remain in
the range of
$93 to $100 million . -
SG&A Expenses: The company is adjusting its expectation for
SG&A expenses to a range of
$73 to $79 million , revised from an expectation of$69 to $77 million , largely due to expenses related to severance. -
Operating Loss: The company is adjusting its expectation for
operating loss to a range of
$45 to $52 million , revised from an expectation of$30 to $40 million . -
Other Income/Expense: The company is adjusting its expectation
for other income/expense to a net expense in the range of
$0 to $3 million , revised from an expectation of $0. - Income Taxes: The company continues to expect no income taxes payable.
-
GAAP Net Loss: The company is adjusting its expectation for net
loss to a range of
$45 to $55 million , revised from an expectation of$30 to $40 million . -
Cash Flow from Operations: The company is adjusting its
expectation for cash flow from operations to an outflow of
$10 to $15 million , revised from an expectation of an inflow of$1 to $5 million . -
SFAS 123R: The company expects share-based compensation
expense, included in the operating expenses above, to remain in the
range of
$10 to $15 million . -
Relocation of Company’s Headquarters: The company expects the
non-cash charges related to the relocation of its headquarters,
included in the operating expenses above, to remain in the range of
$18 to $23 million .
Conference Call
About
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 business and operating results; the successful manufacture and
commercialization of VIVITROL and RISPERDAL CONSTA; continued revenue
growth from RISPERDAL CONSTA; and the successful continuation of
development activities for the company's programs. 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 the
company's business is subject to significant risk and uncertainties, and
there can be no assurance that its actual results will not differ
materially from its expectations. These risks and uncertainties include,
among others: whether the company will achieve the financial
expectations provided; whether the company can continue to manufacture
RISPERDAL CONSTA and VIVITROL on a commercial scale, economically or in
sufficient quantities to supply the market; whether VIVITROL will be
commercialized successfully by
VIVITROL® is a registered trademark of
(tables follow)
Alkermes, Inc. and Subsidiaries | ||||||
Selected Financial Information (Unaudited) | ||||||
Three Months | Three Months | |||||
Ended | Ended | |||||
Condensed Consolidated Statements of Operations | September 30, | September 30, | ||||
(In thousands, except per share data) | 2009 | 2008 | ||||
Revenues: | ||||||
Manufacturing revenues | $ 32,835 | $ 33,039 | ||||
Royalty revenues | 8,818 | 8,439 | ||||
Product sales, net | 4,643 | - | ||||
Research and development revenue under collaborative arrangements | 1,174 | 5,252 | ||||
Net collaborative profit | 687 | 581 | ||||
Total Revenues | 48,157 | 47,311 | ||||
Expenses: | ||||||
Cost of goods manufactured and sold | 15,092 | 12,071 | ||||
Research and development | 20,664 | 19,710 | ||||
Selling, general and administrative | 20,625 | 11,679 | ||||
Total Expenses | 56,381 | 43,460 | ||||
Operating (Loss) Income | (8,224 | ) | 3,851 | |||
Other Expense, net: | ||||||
Interest income | 1,088 | 2,693 | ||||
Interest expense | (1,566 | ) | (4,243 | ) | ||
Other expense, net | (67 | ) | (666 | ) | ||
Total Other Expense, net | (545 | ) | (2,216 | ) | ||
(Loss) Income Before Income Taxes | (8,769 | ) | 1,635 | |||
Income tax benefit | (60 | ) | (63 | ) | ||
Net (Loss) Income | $ (8,709 | ) | $ 1,698 | |||
(Loss) Earnings per Common Share: | ||||||
Basic | $ (0.09 | ) | $ 0.02 | |||
Diluted | $ (0.09 | ) | $ 0.02 | |||
Weighted Average Number of Common Shares Outstanding (GAAP): | ||||||
Basic | 94,886 | 95,637 | ||||
Diluted | 94,886 | 97,356 | ||||
Pro Forma Reconciliation: | ||||||
Net (Loss) Income - GAAP | $ (8,709 | ) | $ 1,698 | |||
Share-based compensation expense | 4,208 | 3,814 | ||||
Costs incurred related to the move of corporate headquarters | 4,149 | - | ||||
Severance charges | 1,406 | - | ||||
Net Income - Pro Forma | $ 1,054 | $ 5,512 | ||||
Pro Forma Earnings per Common Share: | ||||||
Basic | $ 0.01 | $ 0.06 | ||||
Diluted | $ 0.01 | $ 0.06 | ||||
Weighted Average Number of Common Shares Outstanding (Pro Forma): | ||||||
Basic | 94,886 | 95,637 | ||||
Diluted | 95,969 | 97,356 | ||||
Condensed Consolidated Balance Sheets | September 30, | March 31, | ||||
(In thousands) | 2009 | 2009 | ||||
Cash, cash equivalents and total investments | $ 369,525 | $ 404,482 | ||||
Receivables | 33,699 | 24,588 | ||||
Inventory | 18,524 | 20,297 | ||||
Prepaid expenses and other current assets | 7,856 | 7,500 | ||||
Property, plant and equipment, net | 94,467 | 106,461 | ||||
Other assets | 3,206 | 3,158 | ||||
Total Assets | $ 527,277 | $ 566,486 | ||||
Non-recourse RISPERDAL CONSTA secured 7% Notes - current | $ 25,667 | $ 25,667 | ||||
Other current liabilities | 30,152 | 43,323 | ||||
Non-recourse RISPERDAL CONSTA secured 7% Notes - long-term | 37,862 | 50,221 | ||||
Deferred revenue - long-term | 5,115 | 5,238 | ||||
Other long-term liabilities | 6,450 | 7,149 | ||||
Total shareholders' equity | 422,031 | 434,888 | ||||
Total Liabilities and Shareholders' Equity | $ 527,277 | $ 566,486 | ||||
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in the company's Annual Report on Form 10-K for the year ended March 31, 2009, and the company's report on Form 10-Q for the three months ended September 30, 2009, which the company intends to file in November 2009. |
Source:
Alkermes, Inc.
For Investors:
Rebecca Peterson, 617-583-6378
or
For
Media:
Jennifer Snyder, 617-583-6166