Amylin Pharmaceuticals Reports First Quarter Financial Results
April 26 2006 - 5:05PM
PR Newswire (US)
First Quarter Net Product Sales Increase to $76 Million SAN DIEGO,
April 26 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) today reported financial results for the first
quarter ended March 31, 2006. The Company reported total revenue of
$82.3 million for the first quarter, including net product sales of
$75.9 million. Net loss for the quarter ended March 31, 2006 was
$67.9 million, or $0.61 per share. Pro forma net loss for the
quarter ended March 31, 2006 was $57.0 million or $0.51 per share.
This excludes stock-based compensation expense of $10.9 million, or
$0.10 per share. At March 31, 2006, the Company held cash, cash
equivalents and short-term investments of approximately $386
million. On April 5, 2006, the Company completed a public offering
of 11.5 million shares of its common stock, generating net proceeds
of approximately $508 million. "The physician and patient demand
for our two first-in-class products, BYETTA and SYMLIN, continues
to increase, and has resulted in strong revenue growth in the first
quarter. We also initiated a clinical study of exenatide LAR and
announced further developments in our research programs," said
Ginger L. Graham, Amylin's President and Chief Executive Officer.
"The financing that was completed in April strengthened our
financial position and will enable us to focus on maximizing
opportunities to build our business for the future." Net product
sales of $75.9 million for the first quarter include $68.3 million
for BYETTA(R) (exenatide) injection and $7.6 million for SYMLIN(R)
(pramlintide acetate) injection. Net product sales consist of
shipments of BYETTA and SYMLIN to the Company's wholesale
distributors, net of allowances for prescription coupons, payor
discounts, distribution fees and returns. Cost of goods sold was
$9.7 million for the quarter ended March 31, 2006. The Company
reported revenues under collaborative agreements of $6.5 million
for the quarter ended March 31, 2006, compared to $4.3 million for
the same period in 2005. Collaborative revenue in the current
quarter consists primarily of amounts earned under the
collaboration with Eli Lilly and Company on BYETTA, including cost
sharing payments and the continued amortization of up-front
payments. Research and development expenses were $51.8 million for
the quarter ended March 31, 2006, compared to $27.5 million for the
same period in 2005. The increase reflects costs associated with
the development of the Company's long-acting release (LAR)
formulation of BYETTA, or exenatide LAR, support for the Company's
commercial products, costs associated with the acquisition of
rights to leptin and a $5.0 million expense for stock-based
compensation. Selling, general and administrative expenses for the
quarter ended March 31, 2006 were $59.9 million, compared to $20.1
million in the same period in 2005. The increase in 2006 reflects
the expansion of the Company's commercial organization and business
infrastructure to support the launches of BYETTA and SYMLIN in the
United States in 2005 and $5.8 million of stock-based compensation
expense. Collaborative profit sharing, which represents Lilly's
share of the gross margin for BYETTA, was $30.0 million for the
quarter ended March 31, 2006. First quarter highlights * Reported
positive results from a 16-week Phase 2 dose-ranging study
evaluating the safety and weight effects of pramlintide in obese
subjects. * Submitted a supplemental New Drug Application (or sNDA)
to the Food and Drug Administration (FDA) to seek approval for
expanded use of BYETTA as add-on therapy to a common class of oral
diabetes medication called thiazolidinediones (or TZDs), in people
with type 2 diabetes who are not achieving acceptable blood sugar
control. * Initiated a long-term comparator clinical study of
exenatide LAR in patients with type 2 diabetes. * Initiated public
offering of common stock, which generated net proceeds to Amylin of
approximately $508 million and closed in early April. Conference
Call Amylin will webcast its Quarterly Update Conference Call today
at 5:00 p.m. ET/2:00 p.m. PT. The call will be webcast live through
Amylin's corporate website, and a recording will be made available
following the close of the call. Ginger L. Graham, Amylin's
President and Chief Executive Officer will lead the call. During
the call, the Company plans to provide supporting details
underlying its first quarter financial results, and information
regarding key trends and assumptions for the remainder of 2006
operations. For those without access to the Internet, the live call
may be accessed by phone by calling (866) 700-7441 (domestic) or
(617) 213-8839 (international), passcode 30484755. A replay of the
call will also be available by phone for 24 hours beginning
approximately one hour after the close of the call and can be
accessed at (888) 286-8010 (domestic) or (617) 801-6888
(international), passcode 10983852. Note Regarding Use of Non-GAAP
Financial Measures The Company presents pro forma financial
information that excludes stock-based compensation expense.
Pro-forma information is used by management to evaluate, assess and
benchmark the Company's operating results, and the Company believes
that pro-forma reporting represents relevant and useful information
that is widely used by analysts, investors and other interested
parties in its industry. The Company uses pro forma financial
information excluding stock-based compensation expense, as it is
not an expense that requires or will require any cash payments by
the Company. The Company adopted Statement of Financial Accounting
Standards No. 123R (FAS 123R), "Share-Based Payment" on January 1,
2006 and recorded $10.9 million, or $0.10 per share, of stock-based
compensation expense for the quarter ended March 31, 2006. About
Amylin Amylin Pharmaceuticals is a biopharmaceutical company
committed to improving lives through the discovery, development and
commercialization of innovative medicines. This press release
contains forward-looking statements about Amylin, which involve
risks and uncertainties. The Company's actual results could differ
materially from those discussed herein due to a number of risks and
uncertainties, including risks that BYETTA or SYMLIN may be
affected by unexpected new data, technical issues, or manufacturing
and supply issues; risks that our financial results may fluctuate
significantly from quarter to quarter and may not meet market
expectations; risks that our clinical trials will not be completed
when planned; risks that the FDA may not approve the Company's sNDA
and risks inherent in the drug development and commercialization
process. Commercial and government reimbursement and pricing
decisions and the pace of market acceptance may also affect the
potential for BYETTA or SYMLIN. These and additional risks and
uncertainties are described more fully in the Company's recently
filed prospectus supplement. Amylin disclaims any obligation to
update these forward-looking statements. AMYLIN PHARMACEUTICALS,
INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except
per share data) (unaudited) Quarter Ended March 31, 2006 2005
Revenues: Net product sales $75,872 $-- Revenue under collaborative
agreements 6,474 4,262 Total revenues 82,346 4,262 Costs and
expenses: Cost of goods sold 9,744 -- Selling, general and
administrative 59,863 20,071 Research and development 51,774 27,468
Collaborative profit sharing 29,970 -- Total costs and expenses
151,351 47,539 Operating loss (69,005) (43,277) Interest income
(expense), net 1,104 (327) Net loss $(67,901) $(43,604) Net loss
per share -- basic and diluted $(0.61) $ (0.43) Shares used in
computing net loss per share -- basic and diluted 111,285 101,332
The following table presents a reconciliation of pro forma
financial information to the Company's reported GAAP results for
the quarter ended March 31, 2006: Quarter ended March 31, 2006
Stock-based compensation Reported Pro forma expense GAAP results
Net Loss $(57,023) $(10,878) $(67,901) Net loss per share -- basic
and diluted $(0.51) $(0.10) $(0.61) Selling, general and
administrative expenses $54,024 $5,839 $59,863 Research and
development expenses $46,735 $5,039 $51,774 AMYLIN PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)
(unaudited) March 31, December 31, 2006 2005 Assets Cash, cash
equivalents and short-term investments (1) $386,357 $443,423
Accounts receivable, net 41,893 26,725 Inventories 34,115 26,750
Other current assets 17,773 17,847 Property and equipment, net
49,599 42,050 Other assets 10,689 11,192 Total assets $540,426
$567,987 Liabilities and stockholders' equity Current liabilities
$109,467 $99,611 Other liabilities, net of current portion 24,373
24,112 Convertible senior notes 375,000 375,000 Stockholders'
equity 31,586 69,264 Total liabilities and stockholders' equity
$540,426 $567,987 (1) Balance at March 31, 2006 does not reflect
approximately $508 million in net proceeds from public offering of
11.5 million shares of common stock completed in early April.
DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT: Mark Foletta,
Senior Vice President, Finance and Chief Financial Officer of
Amylin Pharmaceuticals, Inc., +1-858-552-2200 Web site:
http://www.amylin.com/
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