DENVER, May 2 /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 2005 first quarter results. As of
March 31, 2005, the company had cash, cash equivalents and investments of
$101.6 million. Net loss for the quarter ended March 31, 2005 was
$18.3 million, or $0.51 per share, compared to a net loss of $16.0 million, or
$0.60 per share in the same period last year.
"We had a productive quarter in which we made solid progress in the
advancement of all three of our clinical development programs," said J.
William Freytag, President and Chief Executive Officer of Myogen. "We expect
to report important clinical trial results for all three of our late-stage
product candidates in the second half of this year."
The company has three product candidates in late-stage clinical
development: enoximone capsules for the treatment of patients with advanced
chronic heart failure, ambrisentan for the treatment of patients with
pulmonary arterial hypertension (PAH) and darusentan for the treatment of
patients with resistant systolic hypertension. All three of the company's
product candidates are orally administered small molecules that the company
believes have the potential to address existing unmet needs in their
respective disease indications.
Product Portfolio Update
Enoximone: ESSENTIAL I & II, Myogen's pivotal Phase 3 trials of enoximone
capsules for the treatment of advanced chronic heart failure, have completed
patient treatment. Data collection and blinded review in preparation for
database lock for the trials continue to progress in line with expectations.
The company expects to report preliminary results of the trials in July 2005.
The ESSENTIAL trials have three co-primary endpoints: (1) time from
randomization to first cardiovascular hospitalization or all-cause mortality,
(2) submaximal exercise capacity (as measured by six-minute walk distance),
and (3) quality of life (as measured by patient global assessment). Data from
both trials will be pooled for the analysis of the primary endpoint of
cardiovascular hospitalization or all-cause mortality. The other two
co-primary endpoints will be analyzed within each individual trial. Subject
to the totality of the trial data, the company believes positive results
relating to any one of the three co-primary endpoints could be sufficient to
support regulatory approval of enoximone capsules in the United States and in
various international markets.
Ambrisentan: In January 2004, Myogen announced the initiation of patient
enrollment in ARIES-1 & -2, the two pivotal Phase 3 trials evaluating
ambrisentan in patients with PAH. Each trial is designed to enroll
186 patients. ARIES-1 is being conducted in the United States and abroad.
ARIES-2 is being conducted outside of the United States. The company expects
to complete patient enrollment in ARIES-2 by the end of June 2005 and ARIES-1
in the fourth quarter of 2005. The company plans to report preliminary
results from each of the ARIES trials approximately six months following the
completion of enrollment in each trial. Ambrisentan has been granted orphan
drug designation for the treatment of PAH in both the United States and
European Union.
Darusentan: In July 2004, the company initiated a Phase 2b randomized,
double-blind, placebo-controlled clinical trial to evaluate the safety and
efficacy of darusentan in patients with resistant systolic hypertension.
Enrollment of 115 patients was completed in April 2005. Patients will undergo
forced titration every two weeks through 10, 50, 100 and 150 mg of darusentan
or placebo until the target dose of 300 mg once a day is achieved. The
treatment period for the study is 10 weeks. The trial will conclude on
July 8, 2005 and the company expects to report preliminary results one to two
months thereafter.
The primary objective of this randomized, double-blind, placebo-controlled
trial is to determine if darusentan is effective in reducing systolic blood
pressure in patients with resistant systolic hypertension. Resistant
hypertension is defined by The Seventh Report of the Joint National Committee
on Prevention, Detection, Evaluation and Treatment of High Blood Pressure
sponsored by the National Institutes of Health (JNC7) as the failure to
achieve goal blood pressure in patients who are adhering to full doses of an
appropriate three-drug regimen that includes a diuretic.
Drug Discovery Research: Myogen is continuing to make progress in its
drug discovery program, which is the subject of a broad collaboration with
Novartis. The program is focused on the discovery, development and
commercialization of new therapeutics for the treatment of heart muscle
disease.
Financial Highlights for the Quarter ended March 31, 2005
Sales of Perfan(R) I.V. for the quarter were $909,000 versus $852,000 for
the same period in 2004. The increase in sales from the prior year period was
the result of a more favorable euro exchange rate. The cost of goods sold, as
a percentage of Perfan I.V. sales, was 34% for the quarter compared to 32% for
the same quarter in 2004. Research and development contracts revenue from the
company's research agreement with Novartis was $1.7 million for the quarter
compared to $1.3 million for the same period in 2004.
Research and development expenses, excluding stock-based compensation
expenses, increased 19% to $17.4 million from $14.6 million for the quarters
ended March 31, 2005 and 2004, respectively. The increase in expenses for the
2005 period was primarily due to costs associated with increased patient
enrollment, clinical monitoring and program management in the ESSENTIAL and
ARIES trials.
Selling, general and administrative expenses, excluding stock-based
compensation expenses, increased 45% to $3.2 million from $2.2 million for the
quarters ended March 31, 2005 and 2004, respectively. The increase was
primarily due to increased staffing and related recruiting costs and an
increase in professional service costs.
2005 Financial Guidance
Financial projections entail a high level of uncertainty due, among many
factors, to the variability involved in predicting clinical trial enrollment
rates and results, availability, terms and timing of additional financing
transactions and the potential for Myogen to enter into additional licensing
or strategic collaborations.
For the year ending December 31, 2005, the company anticipates:
* Total Perfan I.V. sales of $2.8 million to $3.4 million, an increase
from prior guidance of $2.6 million to $3.2 million;
* Total research and development contracts revenue of $6.0 million to
$6.7 million;
* Total operating expenses, excluding stock-based compensation expenses,
of $90 million to $100 million; and,
* Basic net loss per share between $2.30 and $2.60.
In addition, based on current spending projections, the company believes
its cash, cash equivalents and investments are sufficient to fund operations
through at least the end of the first quarter of 2006.
Corporate Communications Policy Update
Effective immediately, the company is revising its corporate
communications policy. Under the new policy, the company will continue to
provide guidance in its annual earnings press releases, teleconferences and
web casts. In addition, the company will continue to confirm or update its
annual guidance in its quarterly earnings press releases, teleconferences and
web casts. The company may also update prior guidance during a fiscal quarter
if management concludes that such guidance is no longer accurate in any
material respect. Any update of the company's prior guidance will be done in
a widely disseminated news release. The company and management will not,
however, publicly or privately confirm the company's earlier guidance during a
fiscal quarter. Rather, if asked, management will direct investors and
analysts to the company's most recently issued public guidance and indicate
the prior guidance was effective as of the date it was given and that it is
the company's policy not to update or confirm guidance except in a widely
disseminated press release. Other than as described above, the company
undertakes no duty to update any forward-looking statement to reflect
subsequent, events, actual results or changes in the company's expectations.
The company also disclaims any duty to comment upon or correct information
that may be contained in reports published by the investment community.
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 web
cast and conference call on Monday, May 2, 2005 at 4:30 pm Eastern. To access
the live web cast, 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
303-262-2131 (international). Web cast and telephone replays of the
conference call will be available approximately two hours after the completion
of the call through Friday, May 20, 2005. Callers can access the replay by
dialing 800-405-2236 (domestic) or 303-590-3000 (international). The passcode
is 11028303#.
About Myogen
Myogen currently markets one product (Perfan(R) I.V.) 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 advanced chronic heart failure, ambrisentan for the treatment of
pulmonary arterial hypertension and darusentan for the treatment of resistant
systolic hypertension. The company, in collaboration with Novartis, 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 the company's
website at http://www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve
significant risks and uncertainties, including the statements relating to
reporting of preliminary results from the company's pivotal Phase 3 trials of
enoximone capsules and ambrisentan, completion of patient enrollment in the
company's pivotal Phase 3 trials of ambrisentan, completion and subsequent
release of preliminary results of the company's Phase 2b trial of darusentan,
and projections regarding the company's product sales, research and
development contracts revenue and operating expenses. Actual results could
differ materially from those projected and the company cautions investors not
to place undue reliance on the forward-looking statements contained in this
release.
Among other things, the projected completion of any of the company's
clinical trial programs and the dissemination of the results of the clinical
trial programs may be affected by difficulties or delays, including
difficulties or delays in patient treatment, data collection or data analysis.
In addition, the company's results may be affected by its effectiveness at
managing its financial resources, its ability to successfully develop and
market its current products, difficulties or delays in manufacturing its
products, and regulatory developments involving current and future products.
Delays in clinical trials, whether caused by competition, 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's product candidates do not meet safety or
efficacy endpoints in clinical evaluations, they will not receive regulatory
approval and the company will not be able to market them. Even if the
company's product candidates meet safety and efficacy endpoints, regulatory
authorities may not approve them, or the company may face post-approval
problems that require the withdrawal of its product from the market. 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.
Additional risks and uncertainties relating to the company and its
business can be found in the "Risk Factors" section of Myogen's Form 10-K for
the year ended December 31, 2004 and Myogen's periodic reports on Form 10-Q
and Form 8-K. Myogen is providing the information contained in this release
as of the date of the release and does not undertake any obligation to update
any forward-looking statements as a result of new information, future events
or otherwise.
MYOGEN, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31, December 31,
2005 2004
ASSETS
Current assets:
Cash and cash equivalents $55,052,621 $71,258,294
Short-term investments 45,097,749 48,330,819
Accrued interest receivable 333,352 290,972
Trade accounts receivable 1,105,095 946,177
Research and development contract
amounts due within one year 1,550,000 300,000
Inventories 230,803 258,120
Prepaid expenses and other current
assets 1,282,665 1,679,340
Total current assets 104,652,285 123,063,722
Long-term investments 1,498,181 --
Property and equipment, net 2,725,730 2,503,579
Other assets 27,299 35,421
Total assets $108,903,495 $125,602,722
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $13,520,176 $10,681,667
Accrued liabilities 1,013,825 1,941,083
Current portion of deferred revenue 1,823,188 1,823,188
Current portion of deferred rent 61,706 59,456
Current portion of capital lease
obligations 67,610 59,924
Current portion of notes payable,
net of discount 1,556,271 1,821,806
Total current liabilities 18,042,776 16,387,124
Deferred revenue, net of current portion 942,956 1,398,753
Deferred rent, net of current portion 200,877 217,616
Capital lease obligations, net of
current portion 90,074 112,728
Notes payable, net of current portion
and discount -- 172,100
Stockholders' equity:
Preferred Stock, $0.001 par value;
5,000,000 shares authorized at
March 31, 2005 and December 31, 2004,
no shares issued or outstanding -- --
Common stock, $0.001 par value;
100,000,000 shares authorized and
35,766,892 and 35,731,581 shares
issued and outstanding as of
March 31, 2005 and December 31, 2004,
respectively 35,767 35,732
Additional paid-in-capital 286,219,616 286,017,266
Deferred stock-based compensation (2,089,120) (2,534,535)
Accumulated other comprehensive loss (76,217) (42,203)
Deficit accumulated during the
development stage (194,463,234) (176,161,859)
Total stockholders' equity 89,626,812 107,314,401
Total liabilities and stockholders'
equity $108,903,495 $125,602,722
MYOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended
March 31,
2005 2004
Revenues:
Product sales $908,853 $851,647
Research and development contracts 1,705,797 1,339,628
2,614,650 2,191,275
Costs and expenses:
Cost of product sold 308,115 271,130
Research and development (excluding
stock-based compensation expense of
$264,047 and $615,948, respectively) 17,405,405 14,624,436
Selling, general and administrative
(excluding stock-based compensation
expense of $251,890 and $595,906,
respectively) 3,243,768 2,235,278
Stock-based compensation expense 515,937 1,211,854
21,473,225 18,342,698
Loss from operations (18,858,575) (16,151,423)
Interest income, net 562,818 171,878
Loss before income taxes (18,295,757) (15,979,545)
Income taxes 5,618 6,876
Net loss (18,301,375) (15,986,421)
Net loss attributable to common
stockholders $(18,301,375) $(15,986,421)
Basic and diluted net loss per
common share $(0.51) $(0.60)
Weighted average common shares
outstanding 35,757,832 26,461,163
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations
of Myogen, Inc., +1-303-464-3986, derek.cole@myogen.com
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