DENVER, Dec. 4 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG), a
biopharmaceutical company focused on the discovery, development and
commercialization of small molecule therapeutics for the treatment of
cardiovascular disease, today reported financial results for the third quarter
of 2003. At September 30, 2003, the Company had cash, cash equivalents and
short-term investments of approximately $50.3 million.
Net loss for the quarter ended September 30, 2003 was $8.1 million,
compared with $9.5 million during this period last year. For the nine months
ended September 30, 2003, the Company reported a net loss of $28.0 million,
compared with $20.0 million for the same period in 2002.
"This has been a very productive period for Myogen," said J. William
Freytag, President and Chief Executive Officer of Myogen. "Our clinical
development and research activities continue to proceed on positive courses.
We are pleased that the investment community has been receptive to Myogen's
corporate vision, allowing us to secure additional financing to continue the
development of our three current product candidates, enoximone, ambrisentan
and darusentan, and our drug discovery program. Myogen remains focused on
addressing the major unmet therapeutic needs of cardiovascular disorders."
Business Highlights
- In June, the Company completed the in-licensing of darusentan, a
type-A selective endothelin receptor antagonist.
- In August, the Company completed the sale of additional shares of
its Series D preferred stock, raising net proceeds of $39.9 million.
- In September, the Company completed the Phase II trial of
ambrisentan in pulmonary arterial hypertension.
- In October, the Company entered into a research collaboration with
the Novartis Institutes for BioMedical Research, Inc.
- In November, the Company completed its initial public offering of
common stock, raising net proceeds of approximately $73.2 million.
Product Portfolio Update
Enoximone: ESSENTIAL I & ESSENTIAL II, the Company's pivotal Phase III
studies of enoximone capsules in patients with chronic heart failure, continue
to progress in line with expectations. EMOTE, the Company's Phase III study
of enoximone capsules in patients with the most advanced stage of chronic
heart failure, completed enrollment in July 2003 and is expected to conclude
in the first half of 2004. EMPOWER, an additional Phase III study to support
regulatory and post-approval marketing efforts, began enrollment in
September 2003.
Ambrisentan: Based upon the results of AMB-220, the Company's Phase II
trial of ambrisentan in pulmonary arterial hypertension (PAH) that concluded
earlier this year, and an end-of-Phase II meeting with the FDA, the Company is
preparing to initiate the pivotal Phase III trials, ARIES I & II.
ARIES I & II are randomized, double-blind, placebo-controlled studies of
ambrisentan in patients with PAH. The trials are identical except for the
doses of ambrisentan and the geographic locations of the investigative sites.
The Company plans to enroll 186 patients (62 patients per dose group) at
approximately 40 sites for each trial. ARIES I will evaluate ambrisentan
doses of 5.0 mg and 10.0 mg administered orally once-a-day for 12 weeks to
patients in the United States and Canada. ARIES II will evaluate ambrisentan
doses of 2.5 mg and 5.0 mg administered orally once-a-day for 12 weeks to
patients in Europe and South America. The primary efficacy endpoint is
exercise capacity, measured as the change from baseline in the six-minute walk
test distance compared to placebo. Secondary endpoints include Borg Dyspnea
Index, WHO Functional Class and a Quality of Life Assessment. The primary and
secondary endpoints are the same endpoints studied in AMB-220 (Phase II). The
Company expects to initiate ARIES I & II in the first half of 2004.
Darusentan: In 2004, the Company plans to initiate a Phase IIb dose
ranging study designed to determine the safety, efficacy and appropriate dose
of darusentan for lowering blood pressure in patients with uncontrolled, or
resistant, hypertension.
Financial Review
Three months ended September 30, 2003 and 2002:
Total Perfan I.V. sales increased 11.3% to $707,000 from $635,000 for the
three months ended September 30, 2003 and 2002, respectively. Unit sales were
consistent for both periods and the increase primarily relates to differences
in the US dollar and euro exchange rate. The cost of Perfan I.V. sold as a
percentage of sales was 31.1% and 35.4% for these two periods respectively.
The reduction in cost was primarily due to completion of the transfer of
formulation responsibilities for Perfan I.V. to a new contract manufacturer in
the second half of 2002.
Research and development expenses, excluding stock-based compensation
expenses, decreased 16.3% to $7.1 million from $8.4 million for the three
months ended September 30, 2003 and 2002, respectively. The decrease in costs
was primarily due to decreasing costs associated with one of the enoximone
Phase III trials nearing completion, reduced license fees for enoximone and
reduced discovery research expenses as a result of Small Business Innovation
Research (SBIR) funding that was received in the third quarter of 2003 that
was used to offset other expenses.
Selling, general and administrative expenses, excluding stock-based
compensation, decreased 54.6% to $663,000 from $1,460,000 for the three months
ended September 30, 2003 and 2002, respectively. The decrease was primarily
due to a $277,000 write-off in 2002 of expenses associated with a financing
that was not completed and $286,000 in foreign currency gains on inventory and
other assets purchased in euros.
Stock-based compensation expense was $841,000 for the three months ended
September 30, 2003, of which $501,000 was attributable to research and
development expenses and $340,000 was attributable to selling, general and
administrative expenses. For the three months ended September 30, 2002,
stock-based compensation expense was $291,000, of which $184,000 was
attributable to research and development expenses and $107,000 was
attributable to selling, general and administrative expenses.
Interest income net of interest expense was ($55,000) and $252,000 for the
three months ended September 30, 2003 and 2002, respectively. Interest income
was $95,000 and $255,000 for the respective periods. The decrease was
primarily a result of a decrease in invested cash balances and a reduction in
interest rates earned on invested cash balances. Interest expense was
$150,000 and $3,000 for the respective periods. The increase was due to the
$5.0 million term loan that was established in December 2002.
Net loss applicable to common stockholders for the quarter ended
September 30, 2003 was $52.3 million, or $50.29 per share, compared with
$13.2 million, or $12.95 per share during this period last year. The
increased net loss was primarily due to the recording of a one-time beneficial
conversion charge of approximately $39.9 million related to the sale of Series
D preferred stock. The charge is calculated as the difference between the
Series D offering price and the fair value of the common stock and limited to
the amount of proceeds from the sale of the preferred stock. For the nine
months ended September 30, 2003, the Company reported a net loss applicable to
common stockholders of $79.5 million, or $76.99 per share, compared with
$31.0 million, or $30.27 per share for the same period in 2002. The Company's
historical capital structure is not indicative of its current structure due to
the automatic conversion of all shares of the then outstanding preferred stock
into common stock concurrent with the closing of the Company's initial public
offering.
2003 Financial Guidance
For the year ending December 31, 2003, the Company anticipates:
* Total product revenues of $2.5 million to $2.7 million;
* Total operating expenses of $39 million to $42 million;
* Net loss of $37.4 million to $40.2 million; and
* Cash, cash equivalents and short-term investments at December 31, 2003
of $113 million to $117 million.
The Company plans on providing financial guidance for 2004 when it
releases full year results for 2003.
2004 Milestones
Myogen is working towards several significant milestones in the coming
year, including:
* Completion of EMOTE (enoximone Phase III) with top-line results to be
reported in the first half of the year;
* Initiation of ARIES I & II (ambrisentan Phase III) in the first half
of the year;
* Initiation of a Phase IIb trial of darusentan in uncontrolled, or
resistant, hypertension; and
* Completion of patient enrollment and drug treatment in ESSENTIAL I &
II (enoximone Phase III) by the end of the year.
Conference Call
J. William Freytag, President and CEO, and other members of Myogen's
senior management will review third quarter results via webcast and conference
call on Friday, December 5, 2003 at 9:00am ET. To access the live webcast,
please log on to the company's website at http://www.myogen.com and go to the
Investor Relations section. Alternatively, callers may participate in the
conference call by dialing 800-218-0204 (domestic) or 303-262-2140
(international). Webcast and telephone replays of the conference call will be
available approximately two hours after the completion of the call through
Friday, December 12, 2003. Callers can access the replay by dialing
800-405-2236 (domestic) or 303-590-3000 (international). The passcode is
560675#.
About Myogen
Myogen is a biopharmaceutical company focused on the discovery,
development and commercialization of small molecule therapeutics for the
treatment of cardiovascular disorders. Myogen currently markets one product
in Europe for the treatment of acute decompensated heart failure and is
developing three product candidates for three distinct cardiovascular
indications. The Company also conducts a target and drug discovery research
program focused on the development of disease-modifying drugs for the
treatment of chronic heart failure and related cardiovascular disorders.
Please visit our website at http://www.myogen.com .
Safe Harbor Statement
This press release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed in this release
and others that can be found in the "Risk Factors" section of Myogen's
Prospectus filed on October 30, 2003 and in our Form 10-Q filed on December 4,
2003. Myogen is providing this information as of the date of this release and
does not undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future events or
otherwise.
The Company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. No forward-
looking statement can be guaranteed and actual events and results may differ
materially from those projected. The Company's results may be affected by its
effectiveness at managing its financial resources, its ability to successfully
develop and market current and new products, difficulties or delays in its
clinical trials, difficulties or delays in manufacturing its products, and
regulatory developments involving current and future products. Delays in
clinical trials, whether caused by adverse events, patient enrollment rates,
regulatory issues or other factors, could adversely affect the Company's
financial position and prospects. Results from earlier clinical trials are
not necessarily predictive of future clinical results. Discovery or
identification of new product candidates cannot be guaranteed and progression
from concept to product is uncertain. Consequently, there can be no assurance
that any particular product candidate will be successful and become a
commercial product. Myogen is at an early stage of development and may not
ever have any products that generate significant revenue.
MYOGEN, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, December 31,
2003 2002
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $7,239,045 $6,993,146
Short-term investments 43,062,015 26,804,619
Accounts receivable 1,240,418 741,852
Inventories, net 833,552 860,200
Prepaid expenses and other current assets 616,144 1,018,353
Total current assets 52,991,174 36,418,170
Property and equipment, net 1,255,298 1,691,931
Other assets 34,290 33,590
Total assets $54,280,762 $38,143,691
LIABILITIES, MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable $5,419,441 $2,748,647
Accrued liabilities 1,023,625 938,102
Current portion of
capital lease obligations 35,762 25,968
Current portion of notes payable,
net of discount 1,733,943 954,004
Total current liabilities 8,212,771 4,666,721
Capital lease obligations,
net of current portion 130,877 106,870
Notes payable, net of
current portion and discount 2,287,525 3,633,152
Commitments and contingencies
Mandatorily redeemable
convertible preferred stock 158,084,965 106,565,591
Stockholders' deficit:
Series B convertible preferred stock,
$0.001 par value, 810,000 shares
authorized and 803,606 shares issued
and outstanding as of December 31, 2002
and September 30, 2003; aggregate
liquidation preference of $1,104,958
as of December 31, 2002 and
September 30, 2003 804 804
Common stock, $0.001 par value;
17,375,000 and 24,221,913 shares
authorized and 1,024,361 and
1,055,294 shares issued and outstanding
as of December 31, 2002 and
September 30, 2003, respectively 1,057 1,025
Deferred stock-based compensation (8,676,149) (1,726,692)
Other comprehensive income 23,357 225,420
Deficit accumulated during
the development stage (105,784,445) (75,329,200)
Total stockholders' deficit (114,435,376) (76,828,643)
Total liabilities, mandatorily
redeemable convertible preferred
stock and stockholders' deficit $54,280,762 $38,143,691
MYOGEN, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended
September 30,
2002 2003
Sales $635,229 $707,013
Cost of product sold 224,783 220,192
Gross profit 410,446 486,821
Operating expenses:
Research and development
(excluding stock-based
compensation expense of
$184,176, $501,467,
$207,201, $1,243,861 and
$1,726,682, respectively) 8,421,399 7,052,067
Selling, general and
administrative (excluding
stock-based compensation
expense of $106,970, $339,949,
$106,970, $862,441 and $1,112,846,
respectively) 1,460,212 662,738
Stock-based compensation
expense 291,146 841,416
Total operating expenses 10,172,757 8,556,221
Loss from operations (9,762,311) (8,069,400)
Interest income
(expense), net 251,589 (55,125)
Loss before income taxes (9,510,722) (8,124,525)
Income taxes 7,199 5,530
Net loss (9,517,921) (8,130,055)
Accretion of mandatorily
redeemable convertible
preferred stock (3,670,935) (4,243,618)
Deemed dividend related to
beneficial conversion
feature of preferred stock -- (39,935,388)
Net loss attributable to
common stockholders $(13,188,856) $(52,309,061)
Basic and diluted net loss
per common share $(12.95) $(50.29)
Weighted average common
shares outstanding 1,018,718 1,040,108
Cumulative
Period from
For the Nine Months Ended June 10, 1996
September 30, (Inception) to
2002 2003 September 30, 2003
Sales $1,657,128 $2,071,823 $6,649,824
Cost of product sold 661,001 654,138 2,455,679
Gross profit 996,127 1,417,685 4,194,145
Operating expenses:
Research and development
(excluding stock-based
compensation expense of
$184,176, $501,467,
$207,201, $1,243,861
and $1,726,682,
respectively) 17,698,708 24,621,961 75,977,053
Selling, general and
administrative (excluding
stock-based compensation
expense of $106,970,
$339,949, $106,970,
$862,441 and $1,112,846,
respectively) 3,706,544 2,564,309 16,016,423
Stock-based compensation
expense 314,171 2,106,302 2,839,528
Total operating expenses 21,719,423 29,292,572 94,833,004
Loss from operations (20,723,296) (27,874,887) (90,638,859)
Interest income
(expense), net 744,103 (63,379) 2,472,507
Loss before income taxes (19,979,193) (27,938,266) (88,166,352)
Income taxes 10,779 16,165 37,616
Net loss (19,989,972) (27,954,431) (88,203,966)
Accretion of mandatorily
redeemable convertible
preferred stock (11,012,805) (11,583,987) (30,896,369)
Deemed dividend related to
beneficial conversion
feature of preferred stock -- (39,935,388) (39,935,388)
Net loss attributable to
common stockholders $(31,002,777) $(79,473,806) $(159,035,723)
Basic and diluted net
loss per common share $(30.27) $(76.99)
Weighted average common
shares outstanding 1,024,361 1,032,200
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations,
+1-303-464-3986, derek.cole@myogen.com, or Joseph L. Turner,
Chief Financial Officer, +1-303-464-5222, joe.turner@myogen.com,
both of Myogen, Inc.
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