DENVER, Aug. 1 /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 second quarter results. As of
June 30, 2005, the company had cash, cash equivalents and investments of
$88.4 million. Net loss for the quarter ended June 30, 2005 was $21.5
million, or $0.60 per share, compared to a net loss of $13.2 million, or
$0.50 per share in the same period last year.
"We made significant progress during the past quarter on our two late-
stage product candidates, ambrisentan and darusentan," said J. William
Freytag, President and Chief Executive Officer of Myogen. "While the results
of the ESSENTIAL trials did not support continuation of the enoximone
development program, we continue to be excited by the opportunities that our
two current product candidates present to positively impact the treatment of
significant cardiovascular disorders. We will now focus our energy and
corporate resources on these opportunities. We expect to report important
clinical trial results for darusentan in August and ambrisentan by the end of
the year."
The Company has two product candidates in late-stage clinical development:
ambrisentan for the treatment of patients with pulmonary arterial hypertension
(PAH) and darusentan for the treatment of patients with resistant systolic
hypertension. Both 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 therapeutic categories.
Product Portfolio Update
Ambrisentan: ARIES-1 & -2 are two pivotal Phase 3 trials evaluating
ambrisentan in patients with PAH. Each trial is designed to enroll 186
patients. ARIES-1 is enrolling patients primarily from North America plus
selected international sites, while ARIES-2 enrolled patients primarily in
Europe plus selected additional international sites. Patient enrollment in
ARIES-2 was completed on July 21, 2005. The Company expects to report top
line results of the trial by the end of 2005. The Company expects to
complete patient enrollment in ARIES-1 in the fourth quarter of 2005 and
report top line results approximately six months thereafter. 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 underwent
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 was achieved. The
treatment period for the study was 10 weeks. The trial concluded on July 8,
2005 and the Company expects to report top line results by the end of August.
The primary objective of this randomized, double-blind, placebo-controlled
trial was 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.
Enoximone: On June 26, 2005, the Company announced top line results of
ESSENTIAL I & II, the Company's two Phase 3 trials of enoximone capsules in
patients with advanced chronic heart failure. The trial results failed to
demonstrate a statistically significant benefit for any of the three co-
primary endpoints. The trials met the pre-specified safety endpoint by
demonstrating no significant difference in mortality between the enoximone and
placebo groups. Based on these results, the Company terminated development of
enoximone capsules.
Financial Highlights for the Quarter ended June 30, 2005
Sales of Perfan(R) I.V. for the quarter were $752,000 versus $900,000 for
the same period in 2004. The decrease in sales, in U.S. dollars, from the
prior year period was the result of the decreased euro/dollar exchange rate
and decreased unit sales overall. The cost of goods sold, as a percentage of
Perfan I.V. sales, was 36% for the quarter compared to 31% for the same
quarter in 2004. Research and development contracts revenue from the
Company's research agreement with Novartis was $1.6 million for the quarter
compared to $1.7 million for the same period in 2004.
Research and development expenses, excluding stock-based compensation
expenses, increased 66% to $20.7 million from $12.5 million for the quarters
ended June 30, 2005 and 2004, respectively. The increase in expenses for the
2005 period was primarily due to costs associated with process analysis,
analytical testing, regulatory compliance and estimated program termination
costs for enoximone capsules and costs associated with increased patient
enrollment, clinical monitoring and program management in the ARIES and
darusentan trials.
Selling, general and administrative expenses, excluding stock-based
compensation expenses, increased 46% to $3.0 million from $2.0 million for the
quarters ended June 30, 2005 and 2004, respectively. The increase was
primarily due to increased marketing costs, 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; and,
* Total research and development contracts revenue of $6.0 million to
$6.7 million.
Due to the discontinuation of the enoximone capsules development program,
operating expense and net loss per share guidance are still under revision.
The Company expects 2005 operating expenses will be lower than previous
guidance of $90 million to $100 million. The Company believes current cash,
cash equivalents and investments will fund its working capital requirements
and capital expenditures through at least the end of the third quarter of
2006.
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 Monday, August 1, 2005 at 4:30 pm 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 800-218-0204
(domestic) or 303-262-2143 (international). Webcast and telephone replays of
the conference call will be available approximately two hours after the
completion of the call through Monday, August 15, 2005. Callers can access
the replay by dialing 800-405-2236 (domestic) or 303-590-3000 (international).
The passcode is 11035698#.
About Myogen
Myogen currently markets one product (Perfan(R) I.V.) in Europe for the
treatment of acute decompensated heart failure and has two product candidates
in late-stage clinical development: 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 the
completion of enrollment and reporting of preliminary results from the
Company's pivotal Phase 3 trials of ambrisentan, 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 trials and the dissemination of the results of the clinical trials
may be affected by difficulties or delays, including difficulties or delays in
patient enrollment, 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.
Operating expense and cash flow projections involve a high degree of
uncertainty, including variances in future spending rates due to changes in
corporate priorities, outcomes of clinical trials, competitive developments
and the impact on expenditures and available capital from licensing and
strategic collaboration opportunities. 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. It is Myogen's policy to only update or confirm its public
guidance by issuing a press release or filing a periodic or current report
with the Securities and Exchange Commission. The Company generally plans to
provide guidance as part of its annual and quarterly earnings releases but
reserves the right to provide guidance at different intervals or to revise its
practice in future periods. Myogen undertakes no duty or obligation to update
any forward-looking statements contained in this release as a result of new
information, future events 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.
MYOGEN, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
June 30, December 31,
2005 2004
ASSETS
Current assets:
Cash and cash equivalents $51,600,642 $71,258,294
Short-term investments 32,278,832 48,330,819
Accrued interest receivable 269,566 290,972
Trade accounts receivable 900,573 946,177
Research and development contract
amounts due within one year 1,300,000 300,000
Inventories 311,158 258,120
Prepaid expenses and other
current assets 2,547,971 1,679,340
Total current assets 89,208,742 123,063,722
Long-term investments 4,552,386 --
Property and equipment, net 2,644,976 2,503,579
Other assets 27,299 35,421
Total assets $96,433,403 $125,602,722
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $21,938,161 $10,681,667
Accrued liabilities 883,831 1,941,083
Current portion of deferred revenue 1,186,954 1,823,188
Current portion of deferred rent 63,956 59,456
Current portion of capital
lease obligations 69,204 59,924
Current portion of notes
payable, net of discount 1,106,952 1,821,806
Total current liabilities 25,249,058 16,387,124
Deferred revenue, net of
current portion 2,249,146 1,398,753
Deferred rent, net of
current portion 184,138 217,616
Capital lease obligations,
net of current portion 72,163 112,728
Notes payable, net of current
portion and discount -- 172,100
Stockholders' equity:
Preferred Stock, $0.001 par
value; 5,000,000 shares
authorized at June 30, 2005
and December 31, 2004, no
shares issued or outstanding -- --
Common stock, $0.001 par
value; 100,000,000 shares
authorized and 35,781,247 and
35,731,581 shares issued and
outstanding as of June 30, 2005
and December 31, 2004,
respectively 35,781 35,732
Additional paid-in-capital 286,240,368 286,017,266
Deferred stock-based compensation (1,573,589) (2,534,535)
Accumulated other comprehensive
loss (41,193) (42,203)
Deficit accumulated during the
development stage (215,982,469) (176,161,859)
Total stockholders' equity 68,678,898 107,314,401
Total liabilities and
stockholders' equity $96,433,403 $125,602,722
MYOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended For the Six Months Ended
June 30, June 30,
2005 2004 2005 2004
Revenues:
Product sales $751,926 $899,831 $1,660,779 $1,751,478
Research and
development
contracts 1,580,044 1,663,667 3,285,842 3,003,295
2,331,970 2,563,498 4,946,621 4,754,773
Costs and expenses:
Cost of product
sold 272,525 277,574 580,640 548,704
Research and
development
(excluding
stock-based
compensation
expense of
$265,981,
$535,183,
$530,028, and
$1,151,131,
respectively) 20,691,213 12,461,672 38,096,618 27,086,108
Selling,
general and
administrative
(excluding
stock-based
compensation
expense of
$252,122,
$586,839,
$504,012 and
$1,182,745,
respectively) 2,985,300 2,046,850 6,229,068 4,282,128
Stock-based
compensation
expense 518,103 1,122,022 1,034,040 2,333,876
24,467,141 15,908,118 45,940,366 34,250,816
Loss from
operations (22,135,171) (13,344,620) (40,993,745) (29,496,043)
Interest income
(expense), net 610,766 136,762 1,173,584 308,640
Loss before
income taxes (21,524,405) (13,207,858) (39,820,161) (29,187,403)
Income taxes (5,170) 2,511 449 9,387
Net loss (21,519,235) (13,210,369) (39,820,610) (29,196,790)
Net loss
attributable
to common
stockholders $(21,519,235) $(13,210,369) $(39,820,610) $(29,196,790)
Basic and
diluted net
loss per
common share $(0.60) $(0.50) $(1.11) $(1.10)
Weighted average
common shares
outstanding 35,767,018 26,490,954 35,762,163 26,476,058
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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