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 full-year results. As of December 31, 2005, the
Company had cash, cash equivalents and investments of $182.3
million. Net loss for the year ended December 31, 2005, was $63.0
million, or $1.68 per share, compared to a net loss of $57.7
million, or $2.00 per share last year. "2005 was an incredibly
exciting and rewarding year for Myogen and all of its constituents:
patients, physicians, investors and employees," said J. William
Freytag, President and Chief Executive Officer of Myogen. "We
reported positive results for our two late-stage product
candidates, ambrisentan and darusentan, as well as continued
progress in our discovery research program and, with the support of
the investment community, were able to secure additional funding to
continue the advancement of these programs. 2006 looks to be
another busy and potentially rewarding year with ambrisentan
ARIES-1 data expected in April, initiation of our darusentan Phase
3 program and launch of commercial operations for Flolan expected
in the second quarter and, hopefully, the submission of the
ambrisentan NDA in the fourth quarter." 2005 Highlights -- Positive
top line results of darusentan Phase 2b resistant hypertension
clinical trial -- Positive top line results of ambrisentan ARIES-2
Phase 3 pulmonary arterial hypertension clinical trial -- $125
million equity financing 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 enrolled 202
patients primarily from North America plus selected international
sites, while ARIES-2 enrolled 192 patients primarily in Europe plus
selected additional international sites. Positive top line results
for ARIES-2 were reported in December 2005. Additional results of
the trial will be presented at ATS 2006 -- San Diego, the annual
International Conference of the American Thoracic Society to be
held May 19-24, 2006, at the San Diego Convention Center in San
Diego, California. Patient enrollment in ARIES-1 was completed on
November 30, 2005, and the last patient completed the 12-week trial
on February 21, 2006. The Company expects to report top line
results of the trial in April 2006. 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 targeted 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 10 mg dose and then proceeding to
the 5 mg dose, will be used to control the Type I error for the two
comparisons. After the initial 12-week assessment period, all
patients in the ARIES trials have the option to continue
ambrisentan therapy in a long-term study. To date, more than 400
patients have been enrolled in this and other long-term studies.
The incidence of confirmed serum aminotransferase test results
greater than three times the upper limit of the normal range
(3xULN) remains less than 1%. AMB-222 In February 2006, the Company
announced positive top line results of AMB-222, an open-label trial
in which ambrisentan was administered to 36 PAH patients who had
previously discontinued bosentan, sitaxsentan or both due to serum
aminotransferase abnormalities. The primary endpoint of the trial
was the incidence of serum aminotransferase concentrations greater
than 3xULN during the 12 week evaluation period that resulted in
discontinuation of drug treatment. None of the 36 patients enrolled
in the study had a recurrence of liver function abnormalities that
resulted in discontinuation of ambrisentan during the initial
12-week evaluation period (the primary endpoint of the study). One
patient had a transient serum aminotransferase test result greater
than 3xULN at week 12 that resulted in dose reduction from 5 mg to
2.5 mg ambrisentan. This patient remains on ambrisentan therapy and
has not had a recurrence of serum aminotransferases greater than
3xULN. Patients have continued to receive ambrisentan therapy for
periods up to 10 months (mean exposure of 6 months) and no further
occurrence of serum aminotransferase concentrations greater than
3xULN has been observed. AMB-105 The Company recently completed a
Phase 1 study examining the potential for drug-drug interactions
between ambrisentan and sildenafil. The study results demonstrated
that multiple doses of ambrisentan had no significant interaction
with sildenafil. Similarly, multiple doses of sildenafil did not
alter the pharmacokinetics of ambrisentan. Full results of AMB-105
will be submitted for presentation at a future scientific
conference. AMB-106 The Company recently completed a Phase 1 study
examining the potential for drug-drug interactions between
ambrisentan and warfarin. The study results demonstrated that
multiple doses of ambrisentan had no significant effect on
prothrombin time, international normalized ratio (INR) and/or the
pharmacokinetics of warfarin. Full results of AMB-106 will be
submitted for presentation at a future scientific conference.
Darusentan: Darusentan 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 resistant
hypertension. DAR-201 In August 2005, the Company announced
positive 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 in systolic and 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.
Additional results from the Phase 2b study will be presented at
ACC.06, the 55th Annual Scientific Session of the American College
of Cardiology, which will be held March 11-14, 2006, in Atlanta,
Georgia. Based on these results, the Company plans to conduct an
international Phase 3 clinical program (DAR-311 and DAR-312) to
further evaluate darusentan for the treatment of patients with
resistant hypertension. The Company expects to initiate the Phase 3
program in the second quarter of 2006. DAR-311 The primary
objective of this Phase 3 randomized, double-blind,
placebo-controlled parallel group trial is to determine if
darusentan is effective in reducing systolic blood pressure in
resistant hypertension patients currently treated with full doses
of four or more antihypertensive medications, one of which is a
diuretic. Patients are eligible for enrollment in this trial if
they have a systolic blood pressure greater than or equal to 140
mmHg and no other compelling conditions. For patients with diabetes
and chronic kidney disease, the blood pressure inclusion criterion
is a systolic blood pressure greater than 130 mmHg. Approximately
352 patients will be randomized to one of three doses of darusentan
(50, 100, or 300 mg qd) versus placebo in a ratio of 7:7:7:11. The
treatment period for the trial is 14 weeks. The primary endpoint of
the trial is change from baseline to week 14 in trough sitting
systolic blood pressure as compared to placebo. Upon completion of
the 14-week assessment period, patients will be eligible to enroll
in a long-term safety study. DAR-312 The primary objective of this
Phase 3 randomized, double-blind, placebo-controlled trial is to
determine if darusentan is effective in reducing systolic blood
pressure in patients with resistant hypertension. Patients are
eligible for enrollment in this trial if they have a systolic blood
pressure greater than or equal to 140 mmHg despite treatment with
full doses of three antihypertensive drugs, one of which is a
diuretic, and no other compelling conditions. For patients with
diabetes and chronic kidney disease, the blood pressure inclusion
criterion is a systolic blood pressure greater than 130 mmHg.
Approximately 770 patients will be randomized to darusentan, active
control (guanfacine, an antihypertensive drug that acts as a
central alpha agonist) or placebo, in a 3:3:1 ratio. The treatment
period for the trial is 14 weeks. The efficacy analysis of the
trial is change from baseline to week 14 in trough sitting systolic
blood pressure compared to placebo and then compared to the active
control. Upon completion of the 14-week assessment period, patients
will be eligible to enroll in a long-term safety study. Patients
enrolled in the two long-term studies will be treated and followed
for safety for at least six months with a mean exposure expected to
be in excess of one year. The Company may undertake additional
studies in this indication for commercial and regulatory support.
Drug Discovery Research: Myogen is continuing to move forward with
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
2005 In January 2006, the Company completed the sale of Myogen GmbH
and the sub-license of the Perfan(R) I.V. rights, excluding the
United States and Canada, for a total cash consideration of $6.1
million plus ongoing royalties. Accordingly, the assets,
liabilities and results of operations pertaining to Myogen GmbH and
Perfan(R) I.V. have been reclassified as "Discontinued Operations"
in the attached summary financial statements. Sales of Perfan(R)
I.V. for the year were $3.2 million versus $3.3 million in 2004.
Research and development contracts revenue from the Company's
research agreement with Novartis was $7.0 million for the year
compared to $6.6 million in 2004. Research and development
expenses, excluding stock-based compensation expenses, decreased 3%
to $52.6 million from $54.1 million for the years ended December
31, 2005 and 2004, respectively. The decrease in expenses for 2005
was primarily due to the discontinuation of the development of
enoximone capsules. Selling, general and administrative expenses,
excluding stock-based compensation expenses, increased 57% to $13.1
million for 2005 from $8.4 million in 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. 2006
Milestones Myogen is working towards several significant milestones
in the coming year, including: -- Reporting ARIES-1 top line
results in April; -- Initiating the darusentan Phase 3 clinical
program during the second quarter; -- Launching commercial
operations for Flolan in the second quarter; and -- Submitting the
ambrisentan New Drug Application during the fourth quarter, should
the ARIES-1 results support such a submission. 2006 Financial
Guidance The darusentan development program outlined above has only
recently been finalized and the detailed costs and timelines are
still under review and revision. Similarly, the partnership with
GlaxoSmithKline announced earlier today will impact both our costs
and potential revenues. Consequently, we are not providing detailed
financial guidance at this time. However, we believe our cash, cash
equivalents and investments, together with expected licensing
proceeds, will be sufficient to fund operations until at least the
end of 2007. Financial projections such as this one entail a high
level of uncertainty due, among many factors, to the variability
involved in predicting clinical trial initiation timelines,
enrollment rates and results, product revenue and the potential for
Myogen to enter into additional licensing or strategic
collaborations. Commercial Operations Management With the
successful partnering of ambrisentan, John Julian, Senior Vice
President, Commercial Development, announced that he will be
retiring effective the end of May 2006. Robert Caspari, M.D., joins
Myogen as Senior Vice President, Commercial Operations. Dr. Caspari
has over 25 years' experience in the pharmaceutical, biotechnology
and medical fields at Schering Plough, Boehringer Mannheim
Corporation, Lederle Laboratories, Somatogen, Baxter International,
Neorx Corporation and Novo Nordisk Pharmaceuticals, Inc. Dr.
Caspari is trained as an internist and has devoted much of his
career to launching and supporting pharmaceutical products. Most
recently, Dr. Caspari was Vice President and General Manager of
Novo Nordisk's US Biopharmaceuticals Business Unit. During the
overlap of Mr. Julian and Dr. Caspari, Mr. Julian will serve as a
senior advisor to the Company. Subsequent to the end of May, Mr.
Julian will remain a consultant to the Company, providing strategic
advice in the field of commercial development. The Company wishes
to thank John for his six years of devoted service to Myogen and
for all the contributions he has made. 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, March 6, 2006, at 4:30 p.m.
Eastern. To access the live webcast, please log on to the company's
website at 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 303-262-2068 (international).
Webcast and telephone replays of the conference call will be
available approximately two hours after the completion of the call
through Friday, March 31, 2006. Callers can access the replay by
dialing 800-405-2236 (domestic) or 303-590-3000 (international).
The passcode is 11052811#. About Myogen Myogen 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
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 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 reporting of top line results from the
Company's ARIES-1 pivotal Phase 3 trial of ambrisentan, the design
and implementation of the darusentan phase 3 development program,
the submission of a New Drug Application for ambrisentan, and
projections regarding the sufficiency of the Company's current
cash, cash equivalents and investments. Actual results and events
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 timing of the release of results of clinical
trials, including the Company's projected release of top line
results from the ARIES-1 trial in April 2006, and the projected
commencement of any of the Company's clinical trials, including the
projected commencement of the darusentan Phase 3 development
program in the second quarter of 2006, 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, its ability to obtain and enforce patent
protection for its products, competition from other biotechnology
or pharmaceutical companies, difficulties or delays in
manufacturing the Company's 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. For example, the positive
top line results of the darusentan Phase 2b trial are not
necessarily predictive of the results of the Company's planned
Phase 3 trials of darusentan in patients with resistant
hypertension as a result of the fact that among other things, the
designs of the planned Phase 3 clinical trials differ in material
respects from the design of the Phase 2b program. In addition, the
Company may elect to, or be required by applicable regulatory
authorities, to modify the designs of one or more of its proposed
clinical trials or to conduct additional clinical trials of its
product candidates to evaluate efficacy and/or safety. Any such
additional clinical trials could adversely affect the Company's
financial position and prospects. Preliminary clinical trial
results may not be confirmed upon full analysis of the detailed
results of a trial and additional information relating to the
safety, efficacy or tolerability of the Company's product
candidates may be discovered upon further analysis of trial data or
analysis of new trial data or long term safety data. 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. There can be no assurance that
Myogen's product candidates, including ambrisentan, will be proven
safe and effective for use in humans. Abnormal liver function test
results have been reported in trials of other endothelin receptor
antagonists. 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 annual report on Form
10-K, in Myogen's periodic 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. -0- *T MYOGEN, INC. CONSOLIDATED
BALANCE SHEETS (Unaudited) (In thousands, except share data)
December 31, ------------------- 2005 2004 --------- ---------
ASSETS Current assets: Cash and cash
equivalents........................ $138,380 $70,669 Short-term
investments........................... 38,575 48,331 Research and
development contract amounts due within one
year................................. -- 300 Prepaid expenses,
accrued interest receivable and other current
assets............................ 2,752 1,772 Assets of
discontinued operations................ 1,289 2,052 ---------
--------- Total current assets............................ 180,996
123,124 Long-term investments............................. 5,362 --
Property and equipment, net....................... 2,622 2,452
Other assets...................................... 27 27 ---------
--------- Total assets.................................... $189,007
$125,603 ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities: Accounts
payable................................. $10,345 $10,510 Accrued
liabilities.............................. 2,797 1,893 Current
portion of deferred revenue.............. 1,187 1,823 Current
portion of other liabilities............. 142 119 Current portion
of notes payable, net of discount 172 1,822 Liabilities of
discontinued operations........... 264 220 --------- ---------
Total current liabilities....................... 14,907 16,387
Deferred revenue, net of current portion.......... 1,656 1,399
Other long-term liabilities, net of current
portion.......................................... 220 331 Notes
payable, net of current portion and
discount......................................... -- 172
Commitments and contingencies Stockholders' equity: Common stock,
$0.001 par value; 100,000,000 shares authorized and 41,962,587 and
35,731,581 shares issued and outstanding as of December 31, 2005
and 2004, respectively..................... 42 36 Additional
paid-in capital........................ 412,862 286,017 Deferred
stock-based compensation................. (1,406) (2,535) Other
comprehensive loss.......................... (88) (42) Deficit
accumulated during the development
stage............................................ (239,186)
(176,162) --------- --------- Total stockholders'
equity...................... 172,224 107,314 --------- ---------
Total liabilities and stockholders' equity...... $189,007 $125,603
========= ========= *T -0- *T MYOGEN, INC. CONSOLIDATED STATEMENTS
OF OPERATIONS (Unaudited) (In thousands, except share and per share
data) 2005 2004 ----------- ----------- Revenues - research and
development contracts.................................... $6,963
$6,606 ----------- ----------- Costs and expenses: Research and
development (excluding stock- based compensation expense of $4,111
and $1,971, respectively)....................... 52,602 54,124
Selling, general and administrative (excluding stock-based
compensation expense of $4,776 and $1,977,
respectively).................... 13,141 8,358 Stock-based
compensation...................... 8,887 3,948 -----------
----------- 74,630 66,430 ----------- ----------- Loss from
operations.......................... (67,667) (59,824) Interest
income (expense), net................ 3,661 821 -----------
----------- Loss from continuing operations............... (64,006)
(59,003) Discontinued operations, net of income
taxes........................................ 982 1,318 -----------
----------- Net loss attributable to common
stockholders................................. $(63,024) $(57,685)
=========== =========== Basic and diluted net loss per common share
attributable to common stockholders: Continuing
operations..................... $(1.71) $(2.05) Discontinued
operations, net of tax....... 0.03 0.05 ----------- -----------
$(1.68) $(2.00) =========== =========== Weighted average common
shares outstanding.... 37,416,368 28,839,076 ===========
=========== *T
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