Fourth Quarter Net Product Sales Increase to $56 Million SAN DIEGO,
Feb. 9 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) today reported financial results for the quarter and
year ended December 31, 2005. The Company reported total revenue of
$63.5 million for the fourth quarter, including net product sales
of $56.2 million. The net loss for the quarter ended December 31,
2005 was $67.2 million, or $0.61 per share. At December 31, 2005,
the Company held cash, cash equivalents and short-term investments
of approximately $443 million. "In 2005, Amylin transformed from a
research and development organization to a fully commercial
enterprise, achieving $87 million in net product sales. We launched
two first-in-class products, BYETTA and SYMLIN, both of which are
growing in their acceptance by health care providers, patients, and
payors," said Ginger L. Graham, Amylin's President and Chief
Executive Officer. "As we enter 2006, demand for both products
continues to accelerate, we have two compounds in late-stage
development: one for diabetes and one for obesity, and expect to
introduce two novel compounds into the clinic." Quarter ended
December 31, 2005 Net product sales of $56.2 million for the
quarter include sales of $49.7 million for BYETTA(R) (exenatide)
injection and $6.5 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 million for the quarter ended
December 31, 2005. Revenue under collaborative agreements was $7.4
million for the quarter ended December 31, 2005, compared to $6.6
million for the same period in 2004. Research and development
expenses increased to $45.3 million for the quarter ended December
31, 2005, compared to $31.3 million for the same period in 2004.
Increased costs are primarily associated with the development of
exenatide LAR, support for commercial products and the advancement
of early stage development programs. Selling, general and
administrative expenses increased to $57.1 for the quarter ended
December 31, 2005, compared to $20.2 million for the same period in
2004. The increase reflects the expansion of the Company's
commercial organization and business infrastructure to support the
launches of BYETTA and SYMLIN in the United States during 2005.
This expansion included hiring and training the Company's field
force, expanded marketing, medical education, and customer service
activities, and related administrative support. Collaborative
profit sharing, which represents Lilly's share of the gross margin
for BYETTA, was $21.3 million for the quarter ended December 31,
2005. Net loss was $67.2 million, or $0.61 per share, for the
quarter ended December 31, 2005, compared to a net loss of $46.4
million, or $0.49 per share, for the same period in 2004. Fourth
quarter highlights * Announced that positive results from a study
of BYETTA used in addition to thiazolidinediones (TZDs) in patients
with type 2 diabetes resulted in improved glucose control with over
60% of patients achieving A1C goal. Supports regulatory
applications for expanded use planned for submission mid 2006. *
Purchased a facility in Ohio for the eventual commercial
manufacturing of exenatide LAR Year ended December 31, 2005 Total
revenue for the year ended December 31, 2005 was $140.5 million.
This includes net product sales of $86.7 million, consisting of
$75.2 million for BYETTA and $11.5 million for SYMLIN. The net loss
for 2005 was $206.8 million, or $1.96 per share. Revenue under
collaborative agreements increased to $53.8 million for the year
ended December 31, 2005, compared to $34.3 million for the same
period in 2004. The increase reflects the recognition of $35
million in milestone payments from Lilly earned in connection with
the regulatory approval and commercial launch of BYETTA in the
United States, partially offset by lower cost-sharing revenues due
to lower BYETTA development expenses during 2005, as compared to
2004. Research and development expenses increased to $132.1 million
for the year ended December 31, 2005, compared to $119.6 million
for 2004. The increase primarily reflects costs associated with the
continued development of exenatide LAR and pramlintide for obesity,
as well as increased costs associated with the Company's early
stage programs, partially offset by a reduction in development
expenses for BYETTA during 2005, as compared to 2004. Selling,
general and administrative expenses increased to $171.5 million for
the year ended December 31, 2005, compared to $67.0 million for the
same period in 2004. The increase consists primarily of costs
associated with the expansion of the Company's commercial
capabilities and business infrastructure to support the launches of
BYETTA and SYMLIN in the United States. Collaborative profit
sharing was $31.4 million for the year ended December 31, 2005. Net
loss was $206.8 million, or $1.96 per share, for the year ended
December 31, 2005, compared to $157.2 million, or $1.67 per share,
for the same period in 2004. 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 fourth quarter
and 2005 financial results, and information regarding key trends
and assumptions for 2006 operations. For those without access to
the Internet, the live call may be accessed by phone by calling
(800) 638-4930 (domestic) or (617) 614-3944 (international),
passcode 86499025. 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 94895774. 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 and SYMLIN may be
affected by unexpected new data or technical 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 commence when planned; and risks inherent
in the drug development and commercialization process. Commercial
and government reimbursement and pricing decisions, the pace of
market acceptance and any issues related to manufacturing and
supply may also affect the potential for BYETTA and SYMLIN. These
and additional risks and uncertainties are described more fully in
the Company's most recently filed SEC documents, including its Form
10-Qs. Amylin disclaims any obligation to update these
forward-looking statements. Amylin disclaims any obligation to
update any forward-looking statements. AMYLIN PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per
share data) (unaudited) Three months ended Years ended December 31,
December 31, 2005 2004 2005 2004 Revenues: Net product sales
$56,189 $-- $86,713 $-- Revenues under collaborative agreements
7,351 6,597 53,761 34,268 Total revenues 63,540 6,597 140,474
34,268 Costs and expenses: Cost of goods sold 9,002 -- 14,784 --
Research and development 45,251 31,335 132,128 119,558 Selling,
general and administrative 57,072 20,173 171,520 66,958
Collaborative profit sharing 21,341 -- 31,359 -- Total operating
expenses 132,666 51,508 349,791 186,516 Operating Loss (69,126)
(44,911) (209,317) (152,248) Interest income (expense), net 1,967
(1,490) 2,485 (4,909) Net loss $(67,159) $(46,401) $(206,832)
$(157,157) Net loss per share - basic and diluted $(0.61) $(0.49)
$(1.96) $(1.67) Shares used in computing net loss per share - basic
and diluted 110,262 94,377 105,532 94,054 AMYLIN PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)
(unaudited) December 31, 2005 2004 Assets Cash and cash equivalents
$72,026 $60,583 Short-term investments 371,397 233,173 Accounts
receivable, net 26,784 -- Receivables from collaborative partners
-- 5,770 Inventories 26,750 15,676 Other current assets 17,847
9,156 Property and equipment, net 42,050 20,739 Other assets 11,192
12,703 Total assets $568,046 $357,800 Liabilities and stockholders'
equity (deficit) Accounts payable, accrued expenses and other
current liabilities $95,384 $37,651 Current portion of deferred
revenue 4,286 4,286 Other liabilities, net of current portion
12,454 7,290 Deferred revenue, net of current portion 11,658 20,943
Convertible senior notes 375,000 375,000 Stockholders' equity
(deficit) 69,264 (87,370) Total liabilities and stockholders'
equity (deficit) $568,046 $357,800 DATASOURCE: Amylin
Pharmaceuticals, Inc. CONTACT: Mark G. Foletta, 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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