DENVER, April 29 /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 disorders, today reported 2004 first quarter results. On March
31, 2004, the Company had cash, cash equivalents and investments of
$97.6 million. Net loss for the quarter ended March 31, 2004 was $16.0
million, or $0.60 per share, compared with $7.6 million, or $10.95 per share,
during the same period in 2003.
"This quarter we continued to make significant progress in the development
of our product candidates, enoximone, ambrisentan and darusentan, as well as
our discovery research program," said J. William Freytag, President and Chief
Executive Officer of Myogen. "In January, we announced the initiation of
patient enrollment in ARIES-1 & -2, our two Phase III pivotal trials of
ambrisentan in pulmonary arterial hypertension, and last month we announced
the preliminary results of EMOTE, our Phase III trial of enoximone in advanced
heart failure."
Product Portfolio Update
Enoximone:
* ESSENTIAL I & II, the Company's pivotal Phase III trials of enoximone
capsules in patients with chronic heart failure, continue to progress
in line with expectations. The Company expects to complete enrollment
of all 1,800 patients before the end of May and remains on target for
completing the treatment phase for both of these trials before the end
of this year.
* EMOTE, a Phase III trial of enoximone capsules in 201 patients in the
most advanced stage of chronic heart failure who are dependent on
intravenous (i.v.) inotrope therapy, was completed in February. The
study was designed to evaluate enoximone capsules as effective
treatment to wean patients off of i.v. inotrope therapy and
potentially support the two ongoing Phase III pivotal studies,
ESSENTIAL I & II. Analysis of the primary endpoint, wean success at
30 days, demonstrated a wean success rate of 61% in the enoximone-
treated group and 51% in the placebo-treated group. This difference
did not reach statistical significance. The key secondary endpoints,
which also evaluated wean from i.v. inotrope therapy, but over time
rather than at a fixed 30-day time point, were achieved, demonstrating
a therapeutic benefit over a range of time periods. The safety
results demonstrated no statistical difference in serious adverse
events or mortality between the groups receiving placebo or enoximone
capsules.
* EMPOWER, an additional Phase III study designed to provide promotional
support during marketing, began enrollment in September 2003. The
study continues to enroll more slowly than anticipated. The Company
continues to monitor the viability of the study.
The Company believes that if the ESSENTIAL trials are successful, the
results will be adequate to support United States regulatory approval as well
as approvals in certain international markets for enoximone capsules.
Although the Company does not believe that EMOTE or EMPOWER will be required
for regulatory approval, it believes these studies may assist in regulatory
and post-approval marketing efforts.
Ambrisentan: In January, Myogen announced the initiation of patient
enrollment in ARIES-1 & -2, two pivotal Phase III trials of ambrisentan in
pulmonary arterial hypertension (PAH). The Company currently expects to
complete enrollment in the two trials in the first half of 2005. This timing
is somewhat uncertain due to on-going competing trials for the same
indication. Upon completion of 12-weeks of treatment, eligible patients are
given the opportunity to enroll in an extension study.
Detailed results of AMB-220, a Phase II study of ambrisentan in PAH, will
be disclosed May 23, 2004 in an oral presentation at a mini-symposium,
Emerging Therapies for PAH, at the American Thoracic Society's 2004
International Conference in Orlando, Florida. Upon completion of AMB-220,
eligible patients were given the opportunity to enroll in an open-label
extension study, AMB-220E. AMB-220E is on going and may continue until
commercial product is available or the Company terminates the study.
Darusentan: The Company is finalizing the design of the Phase IIb trial
that will initiate Myogen's clinical evaluation of darusentan in patients with
resistant hypertension. The Company expects to begin the trial this year.
2004 First Quarter Financial Highlights
Sales of Perfan I.V. for the three months ended March 31, 2004 were
$852,000 versus $656,000 for the same period in 2003. The quarter-to-quarter
increase in sales is the result of a more favorable exchange rate and an
increase in the number of units sold. The cost of Perfan I.V. sold as a
percentage of sales was 31.8% and 31.5% for the quarters ended March 31, 2004
and 2003, respectively. For the quarter ended March 31, 2004, research and
development contract revenue from our research agreement with Novartis, which
began in October 2003 was $1.3 million.
Research and development expenses, excluding stock-based compensation
expenses, increased 130% to $14.6 million from $6.4 million for the three
months ended March 31, 2004 and 2003, respectively. The increase in expenses
for the quarter was primarily due to higher costs associated with increased
patient enrollment in the ESSENTIAL trials and the initiation of patient
enrollment in the ARIES trials.
Selling, general and administrative expenses, excluding stock-based
compensation expenses, increased 140% to $2.2 million from $932,000 for the
three months ended March 31, 2004 and 2003, respectively. The increase was
primarily associated with an increase in insurance and professional service
costs related to becoming a public company and an increase in staffing and
related recruiting costs.
2004 Milestones
Myogen milestones for 2004 include:
* Initiation of ARIES-1 & -2 (ambrisentan pivotal Phase III studies),
which the Company announced in January;
* Completion of EMOTE (enoximone non-pivotal Phase III study), the
preliminary results of which the Company reported in March;
* Initiation of a Phase IIb trial of darusentan in resistant
hypertension; and
* Completion of patient enrollment and drug treatment in ESSENTIAL
I & II (enoximone pivotal Phase III studies) by the end of the year.
2004 Financial Guidance
Financial projections entail a high level of uncertainty due, among many
factors, to the variability involved in predicting clinical trial enrollment
rates, availability, terms and timing of additional financing transactions and
the potential for Myogen to enter into additional licensing or strategic
collaborations. The Company plans on updating financial guidance for 2004
when it releases results for each quarter or upon the announcement of material
corporate events.
For the year ending December 31, 2004, the Company presently anticipates:
* Total product sales of $2.5 million to $3.0 million, an upward
revision from the Company's previous guidance of $2.3 million to
$2.8 million;
* Total operating expenses, excluding stock-based compensation
expenses, of $66 million to $78 million; and
* Basic net loss per share between $2.46 and $2.92.
In addition, the Company believes its current cash, cash equivalents and
investments are sufficient to fund operations through the middle of next year.
Conference Call
J. William Freytag, President and CEO, and other members of Myogen's
senior management will provide a company update and discuss results via
webcast and conference call on Friday, April 30, 2004 at 8:00am Eastern. 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 800-218-8862
(domestic) or 303-262-2130 (international). Webcast and telephone replays of
the conference call will be available approximately two hours after the
completion of the call through Friday, May 7, 2004. Callers can access the
replay by dialing 800-405-2236 (domestic) or 303-590-3000 (international).
The passcode is 577843#.
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 has three
product candidates in late-stage clinical development: enoximone capsules for
the treatment of chronic heart failure, ambrisentan for the treatment of
pulmonary arterial hypertension and darusentan for the treatment of resistant
hypertension. 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 Myogen's 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 Annual
Report on Form 10-K filed on March 1, 2004. 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. Preliminary results may
not be confirmed upon full analysis of the detailed results of a trial. If the
Company is unable to raise additional capital when required or on acceptable
terms, it may have to significantly delay, scale back or discontinue one or
more of its drug development or discovery research programs. Myogen is at an
early stage of development and may not ever have any products that generate
significant revenue.
MYOGEN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31,2004 December 31,2003
(Unaudited)
ASSETS
Current assets:
Cash, cash equivalents and
short-term investments 94,144,458 $114,252,348
Other current assets 6,400,826 5,665,710
Total current assets 100,545,284 119,918,058
Long-term investments 3,503,210 --
Other assets 1,523,595 1,355,266
Total assets $105,572,089 $121,273,324
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $7,894,652 $7,594,935
Other current liabilities 4,311,893 4,693,042
Total current liabilities 12,206,545 12,287,977
Other liabilities 4,200,686 5,063,552
Stockholders' equity:
Common stock and preferred stock 26,466 26,458
Additional paid-in-capital 228,919,923 229,080,380
Deferred stock-based compensation (5,348,315) (6,730,195)
Other comprehensive income 30,238 22,185
Deficit accumulated during the
development stage (134,463,454) (118,477,033)
Total stockholders' equity 89,164,858 103,921,795
Total liabilities and
stockholders' equity $105,572,089 $121,273,324
MYOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended
March 31,
2004 2003
Revenues:
Product sales $851,647 $656,385
Research and development contracts 1,339,628 --
2,191,275 656,385
Costs and expenses:
Cost of product sold 271,130 206,897
Research and development
(excluding stock-based compensation
expense of $615,948, $438,354
and $3,471,657, respectively) 14,624,436 6,351,237
Selling, general and administrative
(excluding stock-based compensation
expense of $595,906, $333,296 and
$2,665,679, respectively) 2,235,278 931,523
Stock-based compensation expense 1,211,854 771,650
18,342,698 8,261,307
Loss from operations (16,151,423) (7,604,922)
Interest income (expense), net 171,878 27,296
Loss before income taxes (15,979,545) (7,577,626)
Income taxes 6,876 2,315
Net loss (15,986,421) (7,579,941)
Accretion of mandatorily redeemable
convertible preferred stock -- (3,670,185)
Deemed dividend related to
beneficial conversion feature of
preferred stock -- --
Net loss attributable to
common stockholders $(15,986,421) $(11,250,126)
Basic and diluted net
loss per common share $(0.60) $(10.95)
Weighted average common
shares outstanding 26,461,163 1,027,618
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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