SAN DIEGO, Nov. 12 /PRNewswire/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) today reported a net loss of $15.9 million, or $0.50 per share,
for the third quarter ended September 30, 1997, as compared to a net loss of
$3.8 million, or $0.13 per share, for the same period in 1996. Cash
equivalent and short-term investment balances increased from $38.3 million at
September 30, 1996 to $64.7 million at September 30, 1997. The Company also
announced an expansion of its pramlintide development program in insulin-using
patients with type 1 and type 2 diabetes. These program changes are designed
to improve regulatory filing packages which the Company believes will enhance
the approval process and optimize the commercial launch of pramlintide. Based
upon analysis of previously reported clinical results and discussions with its
commercial partner Johnson & Johnson, outside clinical consultants, and
regulatory authorities, these changes will alter the timing of planned
regulatory filings.
Third Quarter Results
For the nine months ended September 30, 1997, the Company posted a net
loss of $33.1 million, or $1.03 per share, as compared to a net loss of
$22.1 million, or $0.78 per share, for the nine-month period ended September
30, 1996. The increase in the net loss for the third quarter ended September
30, 1997 as compared to the same period in 1996 was due to increased operating
expenses associated with the Company's development program and decreased
collaborative revenues. The increase in the net loss for the nine months
ended September 30, 1997 as compared to the same period in 1996 was due to
increased operating expenses associated with the Company's development
program, partially offset by increased collaborative revenues.
The Company's net revenues were $9.1 million and $31.5 million for the
three-month and nine-month periods ended September 30, 1997, as compared to
$13.2 million and $23.9 million for the same periods in 1996. Revenues were
higher in the third quarter of 1996 as compared to the same period in 1997 due
to milestone and option fee payments received by the Company from Johnson &
Johnson. The revenue increase for the nine months ended September 30, 1997 as
compared to the same period in 1996 was due to an increase in Johnson &
Johnson's one-half share of collaboration development expenses and an increase
in license fee payments.
The Company's total operating expenses for the third quarter increased to
$25.3 million from $17.3 million for the same period in 1996. For the nine
months ended September 30, 1997, operating expenses increased to $65.7 million
from $47.3 million for the same period in 1996. The increase in research and
development expenses was primarily related to expanded pramlintide clinical
and product development efforts. In addition, growth in staffing and
facilities related expenses increased combined operating expenses.
Expanded Development Program
In August 1997 Amylin Pharmaceuticals announced key results from the first
two Phase III studies of its lead drug candidate, pramlintide. Since August,
the Company has held discussions with its commercial partner Johnson &
Johnson, outside clinical consultants, and regulatory authorities, with the
goal of refining the design parameters of the remaining development program.
In this regard, Amylin Pharmaceuticals has decided to expand the pramlintide
development program in the following ways:
* Extend the duration of the two ongoing US Phase III studies to 12
months to further substantiate the durability of the pramlintide drug effect
(and maintain the six-month duration of the two ongoing European Phase III
studies),
* Increase the number of patients in the two ongoing studies in type 1
diabetes by approximately 20% to increase the probability of achieving
statistical significance in certain prospectively defined subsets of patients,
which may be most relevant from a clinical point of view, and
* Accelerate the initiation of two planned clinical-practice trials in
type 1 and type 2 diabetes to evaluate the interrelationship of insulin and
pramlintide dosing in order to improve drug labeling and thus assist
physicians in optimizing patients' metabolic control when the two drugs are
used in concert.
"While we expect to have the results of the European Phase III clinical
trials in type 1 and type 2 diabetes in the fourth quarter of 1998, the
expansion of the pramlintide development program has extended the estimated
timeline for regulatory submissions by 12 to 18 months," said Richard M.
Haugen, Amylin Pharmaceuticals' President and Chief Executive Officer. "We
believe these changes are in the best interests of patients and our
shareholders. The overall program should enable us to file stronger marketing
application packages to the regulatory agencies, thus facilitating the
approval process and optimizing the commercial launch of the drug. In this
regard, we plan to submit the US and European regulatory filings during the
first half of 2000."
"There is a gap in the current treatment options for people with type 1
diabetes," said Davida Kruger, CNP, Henry Ford Health Systems and a
pramlintide study site coordinator. "Patients have a difficult time managing
post-meal glucose rises and improving overall glucose control without trading
off weight gain and an increase in hypoglycemic events. Based on our initial
clinical experience in people with type 1 diabetes, we were impressed that the
combination of pramlintide and insulin allowed improved glucose control
without a commensurate rise in hypoglycemic events or gain in body weight."
"The initial data from the one-year pramlintide studies exhibited a
consistent effect to improve glucose control which is strengthened by the fact
that patients generally did not gain weight or have an increase in
hypoglycemic events, both of which are expected with intensive insulin therapy
alone," noted Julio Rosenstock, M.D., a Dallas based endocrinologist and
pramlintide clinical investigator. "I am pleased to see that an additional
12-month study is planned in patients with type 2 diabetes since this is a
heterogeneous disease with many variables. In type 2 diabetes, any compound
which has the potential to improve glucose control while facilitating weight
loss would be a welcomed addition to our diabetes armamentarium."
Since 1995, Amylin Pharmaceuticals has been collaborating with Johnson &
Johnson to evaluate pramlintide's ability to improve metabolic control in
insulin-using patients with diabetes. The collaboration agreement calls for
Johnson & Johnson to provide to Amylin Pharmaceuticals a development loan
facility for use in certain circumstances to cover the Company's share of
pramlintide development expenses.
Amylin Pharmaceuticals, Inc. is focused on developing novel medicines for
treating metabolic disorders. The Company has pioneered research of the
hormone amylin, which is believed to play an important role in glucose control
and is missing or deficient in millions of people with diabetes. The Company
is collaborating with Johnson & Johnson to develop pramlintide, a synthetic
analog of human amylin, with the aim of improving metabolic control for people
with diabetes. Pramlintide administration has resulted in clinically relevant
improvement in glucose control and other indicators of metabolic control, such
as body weight and cholesterol profiles, during Phase II and initial Phase III
clinical testing when used as an adjunct to insulin therapy in people with
diabetes. Four Phase III PARADIGM clinical studies are underway and are aimed
at further demonstrating pramlintide's ability to improve metabolic control,
thereby lowering the risk of degenerative complications. The Company has
expanded its research and development pipeline within the field of metabolic
disorders by starting several new preclinical programs, including validation
of exendin and GLP-1 for diabetes and obesity, the mono-di-tert-butylphenols
for dyslipidemia, and several new drug targets for obesity. Amylin
Pharmaceuticals is headquartered in San Diego, California.
This press release contains forward-looking statements that involve risks
and uncertainties. Actual results may differ materially from those discussed
herein, due to, among other things, the research, development, and market
risks which could adversely affect the Company's timeline for clinical trials,
regulatory approval, and if such approval is received, time to market
thereafter. Additional risks and uncertainties are described in the Company's
most recently filed SEC documents, such as its Form 10-K for the fiscal year
ended December 31, 1996 and its most recent Form 10-Q.
Amylin Pharmaceuticals, Inc.
Consolidated Balance Sheets Data September 30, December 31,
(in thousands) 1997 1996
(unaudited) (audited)
Assets
Cash, cash equivalents and $64,746 $62,123
short term investments
Other current assets 1,800 3,231
Property & equipment, net 9,111 6,754
Other assets 1,664 1,425
Total assets $77,321 $73,533
Liabilities & Stockholders' Equity
Current liabilities $19,244 $18,664
Other liabilities 31,236 6,335
Stockholders' equity 26,841 48,534
Total liabilities & $77,321 $73,533
stockholders' equity
Consolidated Statements of Operations Data
(in thousands except
per share data) Three Months Ended Nine Months Ended
(unaudited) September 30, September 30,
1997 1996 1997 1996
Revenues under collaborative
agreements
from related party $9,091 $13,192 $31,462 $23,922
Expenses
Research & development 21,836 14,355 56,019 40,145
General &
administrative 3,484 2,915 9,693 7,190
Total expenses 25,320 17,270 65,712 47,335
Interest income, net 293 328 1,160 1,327
Net loss ($15,936) ($3,750) ($33,090) ($22,086)
Net loss per share ($0.50) ($0.13) ($1.03) ($0.78)
Shares used in
calculation of
net loss per share 32,187 28,261 32,095 28,143
SOURCE Amylin Pharmaceuticals, Inc.
-0- 11/12/97
/CONTACT: Richard W. Krawiec, Ph.D, Director of Corporate Communications,
619-552-2200, amylin.com
/Amylin Pharmaceuticals press releases are available through Company News
On-Call by fax, 800-758-5804, extension 100201, or at
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