DENVER, Nov. 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 third quarter results. As of
September 30, 2005, the Company had cash, cash equivalents and investments of
$193.7 million. Net loss for the quarter ended September 30, 2005 was
$7.9 million, or $0.22 per share, compared to a net loss of $13.0 million, or
$0.49 per share in the same period last year.
"We made significant progress during the past quarter with the advancement
of our two late-stage product candidates, ambrisentan and darusentan, as well
as our discovery research program," said J. William Freytag, President and
Chief Executive Officer of Myogen. "We are gratified by the support and
confidence the investment community expressed in us in connection with our
$125 million financing in September. We are looking forward to the remainder
of this year with ambrisentan ARIES-2 data expected in December and completion
of patient enrollment in ARIES-1 expected before the end of the year."
Product Portfolio Update
Ambrisentan: Ambrisentan is a non-sulfonamide, propanoic-acid class,
type-A selective endothelin receptor antagonist that is being evaluated as a
once daily oral therapy for patients with pulmonary arterial hypertension
(PAH). Ambrisentan has been granted orphan drug designation for the treatment
of PAH in both the United States and European Union.
ARIES-1 & -2
ARIES-1 & -2 are two pivotal Phase 3 trials evaluating ambrisentan in
patients with PAH. Each trial was designed to enroll 186 patients. ARIES-1
is enrolling patients primarily from North America plus selected international
sites, while ARIES-2 enrolled 192 patients primarily in Europe plus selected
additional international sites.
Patient enrollment in ARIES-2 was completed on August 4, 2005 and the last
patient completed the 12-week trial on October 24, 2005. The Company expects
to report top line results of the trial in December 2005. The primary
efficacy endpoint of this trial is the change from baseline in the six-minute
walk distance evaluated after 12 weeks of therapy compared to placebo. With a
sample size of 62 patients per arm, the trial has approximately 90% power to
detect a placebo-corrected treatment effect of 35 meters for each dose group.
A fixed-sequence approach for analysis, starting with the 5 mg dose and then
proceeding to the 2.5 mg dose, will be used to control the Type I error for
the two comparisons.
The Company expects to complete patient enrollment in ARIES-1 by the end
of 2005 and report top line results approximately six months thereafter.
AMB-222
In May 2005, the Company announced the initiation of an open-label trial
in which ambrisentan is administered to PAH patients who have previously
discontinued bosentan and/or sitaxsentan treatment due to serum
aminotransferase abnormalities. The primary endpoint of the trial is the
incidence of serum aminotransferase concentrations greater than three times
the upper limit of the normal range during the 12 week trial.
The Company recently closed screening in this trial after surpassing the
enrollment target of thirty patients. Thirty-six patients were enrolled in
the trial, 92% of whom had discontinued bosentan and 11% of whom had
discontinued sitaxsentan due to serum aminotransferase abnormalities. These
percentages sum to greater than 100% since some patients had been treated
sequentially with bosentan and sitaxsentan but had to discontinue both due to
elevated serum aminotransferase levels. The last patient enrolled in this
trial will reach the 12-week endpoint evaluation in January 2006.
Darusentan: Darusentan is a non-sulfonamide, propanoic-acid class, type-A
selective endothelin receptor antagonist which is being evaluated as a once
daily oral therapy for patients with resistant hypertension.
In August 2005, the Company announced the top line results of a Phase 2b
randomized, double-blind, placebo-controlled clinical trial designed 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.
Results of the trial demonstrated that 300 mg of darusentan dosed once
daily provided statistically significant, placebo-corrected reductions of
11.6 mmHg (p=0.02) in systolic blood pressure and 5.8 mmHg (p=0.004) in
diastolic blood pressure. Clinically meaningful reductions in systolic and
diastolic blood pressure were also observed at earlier time points at lower
doses. Trial results also demonstrated darusentan was generally well
tolerated suggesting a favorable safety profile. There was no difference in
the incidence of premature discontinuations in the darusentan arm compared to
the placebo arm. Furthermore, there were no observed serum aminotransferase
concentrations above two times the upper limit of the normal range.
Based on these results, the Company plans to move forward with Phase 3
clinical development of darusentan for the treatment of patients with
resistant hypertension. The Company recently participated in an End-of-Phase
2 meeting with the U.S. Food and Drug Administration (FDA). Over the next
several months the Company expects to continue discussions regarding the
design of the Phase 3 clinical development program with the FDA and begin
discussions with the European Medicines Agency (EMEA). Additional guidance on
the darusentan Phase 3 development program will be provided when the plan is
finalized.
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 September 30, 2005
Sales of Perfan(R) I.V. for the quarter were $738,000 versus $783,000 for
the same period in 2004. The decrease in sales, in U.S. dollars, from the
prior year period was the result of decreased sales volume. The cost of goods
sold, as a percentage of Perfan I.V. sales, was 32% 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 $1.8 million
for the quarter compared to $1.7 million for the same period in 2004.
Research and development expenses, excluding stock-based compensation
expenses, decreased 51% to $6.0 million from $12.3 million for the quarters
ended September 30, 2005 and 2004, respectively. The decrease in expenses for
the 2005 period was primarily due to the termination of the development of
enoximone capsules.
Selling, general and administrative expenses, excluding stock-based
compensation expenses, increased 67% to $3.5 million for the quarter ended
September 30, 2005 from $2.1 million for the same quarter of 2004. The
increase was primarily due to increased marketing costs associated with
ambrisentan pre-launch activities, 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 $3.0 million to $3.2 million;
* Total research and development contracts revenue of $6.7 million to
$6.9 million, an upward revision from previous guidance of $6.0 million
to $6.8 million;
* Total operating expenses, excluding stock-based compensation expenses
of $67 million to $73 million; and
* Basic net loss per share between $1.81 and $2.00.
In addition, based on current spending projections, we believe our cash,
cash equivalents and investments are sufficient to fund operations for at
least 18 months.
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 Wednesday, November 2, 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 800-257-1927
(domestic) or 303-205-0066 (international). Webcast and telephone replays of
the conference call will be available approximately two hours after the
completion of the call through Wednesday, November 16, 2005. Callers can
access the replay by dialing 800-405-2236 (domestic) or 303-590-3000
(international). The passcode is 11042459#.
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 patients
with pulmonary arterial hypertension and darusentan for the treatment of
patients with resistant 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, statements relating to the
design and implementation of the darusentan phase 3 development program, 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 commencement and 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 caused by regulatory issues, 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 programs, whether caused by competition, adverse events, patient
enrollment rates, regulatory issues or other factors, could adversely affect
the Company's financial position and prospects. Prior clinical trial program
designs and results are not necessarily predictive of future clinical trial
designs or results. Preliminary clinical trial 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, the timing of and 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, in Myogen's reports on Form 10-Q and
Form 8-K and in other documents filed by Myogen with the Securities and
Exchange Commission (SEC). 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 SEC. 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)
September 30, December 31,
2005 2004
ASSETS
Current assets:
Cash and cash equivalents $164,268,946 $71,258,294
Short-term investments 23,425,687 48,330,819
Accrued interest receivable 242,118 290,972
Trade accounts receivable 699,126 946,177
Research and development contract
amounts due within one year -- 300,000
Inventories 218,214 258,120
Prepaid expenses and other current assets 853,295 1,679,340
Total current assets 189,707,386 123,063,722
Long-term investments 6,003,029 --
Property and equipment, net 2,589,850 2,503,579
Other assets 27,299 35,421
Total assets $198,327,564 $125,602,722
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $12,779,823 $10,681,667
Accrued liabilities 1,462,274 1,941,083
Current portion of deferred revenue 1,272,531 1,823,188
Current portion of deferred rent 66,206 59,456
Current portion of capital lease
obligations 69,579 59,924
Current portion of notes payable, net of
discount 645,661 1,821,806
Total current liabilities 16,296,074 16,387,124
Deferred revenue, net of current portion 1,952,408 1,398,753
Deferred rent, net of current portion 167,399 217,616
Capital lease obligations, net of current
portion 55,088 112,728
Notes payable, net of current portion and
discount -- 172,100
Stockholders' equity:
Preferred Stock, $0.001 par value;
5,000,000 shares authorized at
September 30, 2005 and December 31, 2004,
no shares issued or outstanding -- --
Common stock, $0.001 par value;
100,000,000 shares authorized and
41,403,726 and 35,731,581 shares issued
and outstanding as of September 30, 2005
and December 31, 2004, respectively 41,404 35,732
Additional paid-in-capital 409,872,187 286,017,266
Deferred stock-based compensation (6,144,368) (2,534,535)
Accumulated other comprehensive loss (64,171) (42,203)
Deficit accumulated during the
development stage (223,848,457) (176,161,859)
Total stockholders' equity 179,856,595 107,314,401
Total liabilities and stockholders'
equity $198,327,564 $125,602,722
MYOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months For the Nine Months
Ended Ended
September 30, September 30,
2005 2004 2005 2004
Revenues:
Product sales $738,337 $783,235 $2,399,116 $2,534,713
Research and
development
contracts 1,779,065 1,666,667 5,064,907 4,669,962
2,517,402 2,449,902 7,464,023 7,204,675
Costs and expenses:
Cost of product
sold 235,406 239,917 816,046 788,621
Research and
development
(excluding
stock-based
compensation
expense of
$406,965,
$470,155,
$936,993, and
$1,621,286,
respectively) 6,030,698 12,334,697 44,127,316 39,420,805
Selling, general
and
administrative
(excluding
stock-based
compensation
expense of
$860,337,
$473,161,
$1,364,349, and
$1,655,906,
respectively) 3,475,977 2,085,914 9,705,045 6,368,042
Stock-based
compensation
expense 1,267,302 943,316 2,301,342 3,277,192
11,009,383 15,603,844 56,949,749 49,854,660
Loss from
operations (8,491,981) (13,153,942) (49,485,726) (42,649,985)
Interest income
(expense), net 644,611 156,412 1,818,195 465,052
Loss before
income taxes (7,847,370) (12,997,530) (47,667,531) (42,184,933)
Income taxes 18,619 5,034 19,068 14,421
Net loss (7,865,989) (13,002,564) (47,686,599) (42,199,354)
Net loss
attributable
to common
stockholders $(7,865,989) $(13,002,564) $(47,686,599) $(42,199,354)
Basic and
diluted net
loss per
common share $(0.22) $(0.49) $(1.32) $(1.59)
Weighted average
common shares
outstanding 36,479,355 26,623,208 36,006,524 26,525,466
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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