Myogen (NASDAQ:MYOG)
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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 2006 first quarter results. As of March 31, 2006, the
Company had cash, cash equivalents and investments of $193.8 million.
Loss from continuing operations for the quarter ended March 31, 2006,
was $17.6 million, or $0.42 per share, compared to a loss from
continuing operations of $18.6 million, or $0.52 per share during the
same period last year.
"We accomplished a great deal in the first quarter," said J.
William Freytag, President and Chief Executive Officer of Myogen. "The
continuous stream of positive clinical trial results for ambrisentan,
receipt of FDA Fast Track designation for ambrisentan and formation of
a PAH collaboration with GlaxoSmithKline were all key steps toward our
ultimate goal of registering and commercializing ambrisentan on a
worldwide basis. Obtaining US marketing and distribution rights to
Flolan was a positive step to assist us in our transition to a
commercial company. We also made excellent progress with the
darusentan Phase 3 clinical development program in resistant
hypertension and look forward to initiating the first Phase 3 trial in
the second quarter of this year."
First Quarter Highlights
-- Positive Results for Ambrisentan LFT Rescue Study (AMB-222)
-- Positive Results for Second Ambrisentan Pivotal Phase 3
Clinical Trial (ARIES-1)
-- Global PAH Collaboration with GlaxoSmithKline
-- Ambrisentan Fast Track Designation for the Treatment of PAH
-- Presentation of Darusentan Phase 2b Results at Annual
Scientific Session of the American College of Cardiology
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 evaluated in two
placebo-controlled Phase 3 trials (ARIES-1 & -2), two Phase 2 trials
(AMB 201 and AMB-222), and seven Phase 1 trials. More than 720
subjects have received ambrisentan in clinical trials, including
approximately 480 PAH patients. As of May 2006, nearly 400 patients
continue to be treated with ambrisentan, with exposures that currently
extend up to 3.5 years. Ambrisentan has been granted orphan drug
designation for the treatment of PAH in both the United States and
European Union and has also been granted Fast Track designation by the
U.S. Food and Drug Administration (FDA). Myogen expects to submit the
ambrisentan New Drug Application to the FDA in the fourth quarter of
2006.
ARIES-1 & -2
ARIES-1 & -2 are two pivotal Phase 3 trials that evaluated three
doses of 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 and evaluated 5 mg and
10 mg of ambrisentan dosed once daily. ARIES-2 enrolled 192 patients
primarily in Europe plus selected additional international sites and
evaluated 2.5 mg and 5 mg of ambrisentan dosed once daily. Top line
results for ARIES-2 were reported in December 2005 and top line
results for ARIES-1 were reported in April 2006. Both trials met the
primary efficacy endpoint of improved exercise capacity for all three
ambrisentan doses.
Analysis of the integrated data for ARIES-1 and ARIES-2 for the
primary efficacy endpoint, placebo-corrected mean change in six-minute
walk distance at week 12 compared to baseline, demonstrated a robust,
dose-dependent increase in exercise capacity with statistical
significance for the combined data for all doses (p less than 0.0001,
linear regression model) and for each individual dose.
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Dose Group Change in 6MWD Nominal p-value
---------- -------------- ---------------
2.5 mg (n=64) 32.3 meters 0.0219
5 mg (n=130) 44.6 meters less than 0.0001
10 mg (n=67) 51.4 meters 0.0001
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Improvement in time to clinical worsening, a key secondary
endpoint and measure of disease progression, was significant for the
combined dose analysis (p=0.0003) and for each of the three individual
ambrisentan dose groups (p less than 0.05 for each group).
All other prespecified secondary efficacy endpoints, including WHO
functional class, SF-36(R) Health Survey and Borg dyspnea index,
demonstrated statistically significant improvements for the combined
data for all dose groups and for the 5 mg and 10 mg doses (p less than
0.05 for each group).
Preliminary analysis of the top line safety results demonstrated
that ambrisentan was well tolerated. The most frequent adverse event
was peripheral edema, which was primarily mild to moderate in
severity. No patients treated with ambrisentan developed serum
aminotransferase concentrations greater than three-times the upper
limit of the normal range (3xULN) at any time during the 12-week
treatment period, compared to three patients in the placebo groups
(2.3%).
After the initial 12-week assessment period, all patients in the
ARIES trials had 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.
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 patients with PAH 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 in AMB-222 have continued to receive ambrisentan therapy
for periods up to 11 months (mean exposure of 7 months) and no further
confirmed occurrence of serum aminotransferase concentrations greater
than 3xULN has been observed.
Global PAH Collaboration with GlaxoSmithKline
In March 2006, GlaxoSmithKline and Myogen entered into a two-part
collaboration involving each party's PAH therapy. Myogen licensed
commercialization rights for ambrisentan to GlaxoSmithKline in all
territories outside of the United States where Myogen retains
exclusive rights. Simultaneously, GlaxoSmithKline and Myogen entered
into an agreement whereby Myogen will be responsible for the marketing
and distribution of GSK's Flolan (epoprostenol sodium), a life-saving
medicine for many patients, used in the treatment of PAH, in the
United States. Myogen has begun building a commercial organization
dedicated to the marketing and distribution of Flolan in the United
States.
Myogen believes GlaxoSmithKline, one of the premier pharmaceutical
companies in the world, is the ideal ex-US partner for ambrisentan.
GSK has been a pioneer in the treatment of PAH and, through its
decade-long experience with Flolan, has a deep understanding of the
international regulatory and competitive PAH market environments.
Meanwhile, the Flolan distribution agreement is expected to underwrite
the development of the Company's U.S. commercial organization and
afford it the opportunity to establish a presence in the PAH
marketplace well in advance of the potential launch of ambrisentan.
The Company believes this strategic development will accelerate
building relationships with all important customer segments,
increasing the Company's understanding of customer needs and market
dynamics in general.
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. 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.
Additional results from the Phase 2b study were presented at ACC.06,
the 55th Annual Scientific Session of the American College of
Cardiology, which was held March 11-14, 2006, in Atlanta, Georgia.
Based on these results, the Company plans to conduct international
Phase 3 clinical trials, 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 primary endpoint 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 First Quarter 2006
Sublicense revenues for the quarter ended March 31, 2006, were
$2.0 million. These revenues consisted of $189,000 related to the
sublicense of ambrisentan ex-U.S rights to GSK and $1.8 million
related to the sublicense of Perfan(R) I.V. in January 2006. The
sublicense revenue from GSK is derived from the non-refundable upfront
payment of $20 million made by GSK in March 2006, which is being
recognized ratably over the expected service period. The $1.8 million
related to the Perfan(R) I.V. sublicense was recognized in January
2006, as no future service is required. The Company does not expect
any significant additional sublicense revenues related to Perfan(R)
I.V.
Research and development contracts revenue from the Company's
research agreement with Novartis was $1.8 million for the first
quarter of 2006 compared to $1.7 million during the same period in
2005.
Research and development expenses, including stock-based
compensation expenses, decreased 8% to $16.2 million from $17.7
million for the quarters ended March 31, 2006 and 2005, respectively.
The decrease in expenses for 2005 was primarily due to the
discontinuation of the development of enoximone capsules, which was
largely offset by growth in expenses related to ambrisentan.
Selling, general and administrative expenses, including
stock-based compensation expenses, increased 123% to $7.2 million for
the first quarter of 2006 from $3.2 million during the same period in
2005. 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 Financial Guidance
Financial projections 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.
For the year ending December 31, 2006, the Company anticipates:
-- Total Flolan net revenue of $3.5 million to $4.5 million
(Myogen will recognize Flolan revenue net of the transfer
price from GSK and specialty pharmacy distribution costs);
-- Total research and development contract revenue of $6.5
million to $7.2 million;
-- Total operating expenses, excluding stock-based compensation
expenses, of $110 million to $125 million; and,
-- Basic net loss per share between $2.30 and $2.75.
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 2007.
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, May 8, 2006, at
8:00 a.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 800-240-2430 (domestic) or 303-205-0033 (international).
Webcast and telephone replays of the conference call will be available
approximately two hours after the completion of the call through
Friday, May 26, 2006. Callers can access the replay by dialing
800-405-2236 (domestic) or 303-590-3000 (international). The passcode
is 11058413#.
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. Myogen and GlaxoSmithKline have
entered into a global PAH collaboration in which Myogen has marketing
and distribution rights to GlaxoSmithKline's Flolan (epoprostenol
sodium) in the United States for the treatment of PAH and
GlaxoSmithKline has licensed ambrisentan from Myogen for all
territories outside of the United States, where Myogen retains
exclusive rights. Myogen 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 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 design and implementation of the darusentan phase 3
development program, the submission of a New Drug Application for
ambrisentan, Flolan revenue projections 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 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,
and the projected submission of the ambrisentan NDA, 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 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.
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MYOGEN, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share data)
March December
31, 31,
2006 2005
---------- ----------
ASSETS
Current assets:
Cash and cash equivalents $ 154,962 $ 138,380
Short-term investments 36,000 38,575
Prepaid expenses, accrued interest
receivable and other current assets 4,285 2,752
Assets of discontinued operations -- 1,289
---------- ----------
Total current assets 195,247 180,996
Long-term investments 2,878 5,362
Property and equipment, net 2,810 2,622
Other assets 53 27
---------- ----------
Total assets $ 200,988 $ 189,007
========== ==========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 14,150 $ 10,345
Accrued liabilities 867 2,797
Current portion of deferred revenue 4,201 1,187
Current portion of other liabilities 140 142
Current portion of notes payable, net of
discount -- 172
Liabilities of discontinued operations -- 264
---------- ----------
Total current liabilities 19,358 14,907
Deferred revenue, net of current portion 19,656 1,656
Other long term liabilities, net of current
portion 186 220
Stockholders' equity:
Common stock, $0.001 par value;
100,000,000 shares authorized and 42,378,130
and 41,962,587 shares issued and outstanding
as of March 31, 2006, and December 31, 2005,
respectively 42 42
Additional paid-in-capital 416,850 412,862
Deferred stock-based compensation -- (1,406)
Other comprehensive loss (105) (88)
Accumulated deficit (254,999) (239,186)
---------- ----------
Total stockholders' equity 161,788 172,224
---------- ----------
Total liabilities and stockholders' equity $ 200,988 $ 189,007
========== ==========
MYOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share and per share data)
For the Three Months Ended
March 31,
2006 2005
------------ -------------
Revenues:
Sublicense revenues $ 1,972 $ --
Research and development
contracts 1,797 1,706
------------ ------------
3,769 1,706
------------ ------------
Costs and expenses:
Research and development (including
stock-based compensation expense of
$1,230 and $264, respectively) 16,227 17,669
Selling, general and administrative
(including stock-based compensation
expense of $1,912 and $252,
respectively) 7,213 3,231
------------ ------------
23,440 20,900
------------ ------------
Loss from operations (19,671) (19,194)
Interest income, net 1,923 563
------------ ------------
Loss from continuing operations before
cumulative effect of a change in
accounting principle (17,748) (18,631)
Cumulative effect of a change in accounting
principle 172 --
------------ ------------
Loss from continuing operations (17,576) (18,631)
Gain on the sale of discontinued operations 1,763 --
Discontinued operations, net of income
taxes -- 330
------------ ------------
Net loss $ (15,813) $ (18,301)
============ ============
Basic and diluted net loss per common share
attributable to common stockholders:
Continuing operations $ (0.42) $ (0.52)
Discontinued operations, net of income
taxes 0.04 0.01
------------ ------------
$ (0.38) $ (0.51)
============ ============
Weighted average common shares outstanding 42,168,261 35,757,832
============ ============
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