ANN ARBOR, Mich., Oct. 24 /PRNewswire-FirstCall/--
Esperion Therapeutics, Inc. (Nasdaq: ESPR), a biopharmaceutical company
focused on discovering and developing HDL-targeted therapies, today reported
financial results for the third quarter and nine months ended
September 30, 2002.
For the third quarter ended September 30, 2002, Esperion reported a net
loss of $7.0 million, or $0.24 per share, compared to a net loss of
$6.3 million, or $0.22 per share, for the third quarter of 2001. Total
operating expenses for the third quarter of 2002 were $7.1 million, compared
to $6.5 million for the third quarter of 2001, representing a 9.0% increase.
Research and development expenses represented 76% of operating expenses
during the third quarter of 2002, and these expenses increased by
approximately $514,000, or 10.5%, compared to the corresponding period in
2001. The magnitude of the Company's operating expenses on a quarterly basis
is largely dependent upon the progress, timing and size of its clinical trials
and related manufacturing activities in support of the ongoing clinical
development. The Company currently has active clinical programs for three of
its biopharmaceutical product candidates, two of which are in Phase II and the
third in Phase I.
The third quarter of 2002 was highlighted by the following events:
-- Esperion initiated its ETC-642-002 (RLT Peptide) clinical trial, which
represents a follow-on trial of the Company's Phase I escalating
single dose study in patients with stable atherosclerosis. The
002 study is looking at higher doses of single infusions of ETC-642 in
both men and women in order to determine the maximum tolerated dose.
The Company reported initial positive results from the 001 study in
early July 2002.
-- The Company continued to enroll patients in its ETC-216-002 (ApoA-I
Milano, or AIM) clinical trial. This trial utilizes intravascular
ultrasound to evaluate changes in plaque volume in the coronary
arteries of patients with acute coronary syndrome.
-- The Company also continued to enroll patients in its
ETC-588-004 (large unilamellar vesicles, or LUV) clinical trial.
Patients in this trial are being evaluated for changes in plaque
volume in their carotid arteries using magnetic resonance imaging.
-- The Company continued preparation of an IND filing on ESP 31015, its
lead candidate from the oral small molecule program.
-- The Company expanded its intellectual property estate on both the
ETC-642 (RLT Peptide) and its oral small molecule program through the
issuance of additional patents on both programs by the United States
Patent and Trademark Office.
The net loss for the nine months ended September 30, 2002 was
$22.1 million, or $0.76 per share compared to a net loss of $18.6 million, or
$0.70 per share, in the first nine months of 2001. Results for the nine
months ended September 30, 2002 include operating expenses of $21.7 million
compared to $20.7 million for the corresponding period in 2001, an increase of
5.3%.
As of September 30, 2002, Esperion had $49.7 million in cash and
short-term investments, compared with $70.3 million at December 31, 2001.
Long-term debt increased to $7.2 million at September 30, 2002 from
$5.5 million at December 31, 2001. Net cash used in operations during the
first nine months of 2002 was $20.9 million compared to $16.7 million in the
first nine months of 2001. As a development stage company, Esperion has not
reported any revenue since its inception.
Esperion Therapeutics
Esperion Therapeutics, Inc. discovers and develops pharmaceutical products
for the treatment of cardiovascular and metabolic diseases. Esperion intends
to commercialize a novel class of drugs that focuses on a new treatment
approach called "HDL Therapy," which is based on the Company's understanding
of high-density lipoprotein, or HDL, function. HDL is the primary facilitator
of the reverse lipid transport, or RLT, pathway by which excess cholesterol
and other lipids are removed from arteries and other tissues and are
transported to the liver for elimination from the body. Esperion's goal is to
develop drugs that exploit the beneficial functions of HDL within the RLT
pathway. Esperion currently has several product candidates under development
for the treatment of cardiovascular and metabolic diseases. Esperion is
listed on the Nasdaq National Market under the symbol "ESPR."
Safe Harbor Statement
The information contained in this press release includes "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements are often identified by words such
as "hope," "may," "believe," "anticipate," "plan," "expect," "intend,"
"assume," and similar expressions. Forward-looking statements speak only as of
the date of this press release, reflect management's current expectations and
involve certain factors, such as risks and uncertainties, which may cause
actual results to be far different from those suggested by the Company's
forward-looking statements. These factors include, but are not limited to,
risks associated with: management's ability to successfully execute its
business strategies; the progress and cost of development of the Company's
product candidates; the extent and timing of market acceptance of the
Company's product candidates; dependence on third parties to conduct clinical
trials for these product candidates; the extent and timing of regulatory
approval, as desired or required, for the Company's product candidates; the
Company's dependence on licensing arrangements and strategic relationships
with third parties; clinical trials; manufacturing; the Company's dependence
on patents and proprietary rights; the procurement, maintenance, enforcement
and defense of the Company's patents and proprietary rights; competitive
conditions in the industry; business cycles affecting the markets in which the
Company's products may be sold; extraordinary events and transactions; the
timing and extent of the Company's financing needs; economic conditions
generally or in various geographic areas; and other factors. These factors are
discussed in more detail in the Company's filings with the Securities and
Exchange Commission. The Company does not intend to update any of these
factors or to publicly announce the results of any revisions to any of these
forward-looking statements other than as required under the federal securities
law.
ESPERION THERAPEUTICS, INC. AND SUBSIDIARIES
(A Company in the Development Stage)
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
in thousands 2002 2001
Assets: (Unaudited)
Current assets:
Cash and cash equivalents $41,386 $70,286
Short-term investments 8,360 0
Prepaid expenses and other 753 1,000
Total current assets 50,499 71,286
Property and equipment, net 3,436 3,313
Goodwill, net 3,108 3,108
Deposits and other assets 44 633
Total assets $57,087 $78,340
Liabilities and Stockholders' Equity:
Current liabilities:
Current portion of long-term debt $975 $863
Accounts payable 1,489 2,925
Accrued liabilities 2,341 2,572
Total current liabilities 4,805 6,360
Long-term debt, less current portion 7,221 5,482
Stockholders' equity:
Common stock 29 29
Additional paid-in capital 133,195 133,143
Notes receivable (6) (15)
Accumulated deficit during the
development stage (87,427) (65,320)
Deferred stock compensation (749) (1,476)
Accumulated other comprehensive
income (loss) 19 137
Total stockholders' equity 45,061 66,498
Total liabilities and stockholders'
equity $57,087 $78,340
ESPERION THERAPEUTICS, INC. AND SUBSIDIARIES
(A Company in the Development Stage)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended
September 30,
2002 2001
in thousands except share and per
share data
Operating expenses:
Research and development $5,416 $4,902
General and administrative 1,677 1,395
Goodwill amortization 0 210
Purchased in-process R&D 0 0
Total operating expenses 7,093 6,507
Loss from Operations (7,093) (6,507)
Other income (expense):
Interest income 258 679
Interest expense (289) (228)
Other, net 144 (225)
Total other income (expense) 113 226
Loss before income taxes (6,980) (6,281)
Provision for income taxes 0 0
Net loss ($6,980) ($6,281)
Basic and diluted net loss per
share ($0.24) ($0.22)
Shares used in computing
basic and diluted loss per share 29,268,023 28,177,102
ESPERION THERAPEUTICS, INC. AND SUBSIDIARIES
(A Company in the Development Stage)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Nine Months Ended Inception to
September 30, September 30,
2002 2001 2002
in thousands except share and per
share data
Operating expenses:
Research and development $16,999 $16,303 $71,456
General and administrative 4,750 3,732 15,911
Goodwill amortization 0 630 1,089
Purchased in-process R&D 0 0 4,000
Total operating expenses 21,749 20,665 92,456
Loss from Operations (21,749) (20,665) (92,456)
Other income (expense):
Interest income 862 2,351 6,989
Interest expense (819) (540) (2,085)
Other, net (401) 267 125
Total other income (expense) (358) 2,078 5,029
Loss before income taxes (22,107) (18,587) (87,427)
Provision for income taxes 0 0 0
Net loss ($22,107) ($18,587) ($87,427)
Basic and diluted net
loss per share ($0.76) ($0.70)
Shares used in computing
basic and diluted loss
per share 29,234,243 26,675,598
ESPERION THERAPEUTICS, INC. AND SUBSIDIARIES
(A Company in the Development Stage)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine Months Ended Inception to
September 30, September 30,
in thousands 2002 2001 2002
Cash flows from operating
activities:
Net loss ($22,107) ($18,587) ($87,427)
Adjustments to reconcile net loss
to net cash
used in operating activities:
Purchased in-process research and
development 0 0 4,000
Depreciation and amortization 1,021 2,209 4,543
Stock-based compensation expense 611 0 3,490
Decrease in notes receivable 9 49 120
Loss on sale of plant and
equipment 170 22 192
Non-cash interest included in
long-term debt 277 171 680
Changes in assets and
liabilities:
Prepaid expenses and other 724 (320) (1,110)
Other assets (15) (7) (94)
Accounts payable (1,431) (1,130) 1,767
Accrued liabilities (208) 860 2,392
Net cash used in operating
activities (20,949) (16,733) (71,447)
Cash flows from investing
activities:
Purchases of property and
equipment (715) (1,641) (7,063)
Acquisition of Talaria
Therapeutics, Inc. 0 0 (233)
Proceeds from sale of property and
equipment 29 2 31
Purchases of short-term
investments (34,221) 0 (34,221)
Maturities of short-term
investments 25,861 0 25,861
Net cash used in investing
activities (9,046) (1,639) (15,625)
Cash flows from financing
activities:
Net proceeds from issuance of
convertible preferred stock 0 0 42,200
Proceeds from the issuance of
common stock 168 22,481 78,895
Proceeds from long-term debt 1,834 3,409 9,873
Repayments of long-term debt (885) (689) (2,607)
Net cash provided by financing
activities 1,117 25,201 128,361
Effect of exchange rate changes on
cash (22) (72) 97
Net increase (decrease) in cash and
cash equivalents (28,900) 6,757 41,386
Cash and cash equivalents at
beginning of period 70,286 70,228 0
Cash and cash equivalents at end of
period $41,386 $76,985 $41,386
Supplemental disclosures of cash
flow information:
Cash paid during the period for
interest $524 $362
The accompanying notes are an integral part of these condensed
consolidated financial statements.
Checks - net income
Checks - ending cash
SOURCE Esperion Therapeutics, Inc.
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Related links:
http://www.esperion.com
CONTACT:
Frank Thomas, Vice President, Finance and
Investor Relations of Esperion Therapeutics, Inc.,
+1-734-222-1831, or Jacqueline Franchetti, of JFCI,
+1-516-365-2091, for Esperion Therapeutics, Inc.
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