DENVER, Nov. 3 /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 2004 third quarter results. As of
September 30, 2004, the Company had cash, cash equivalents and investments of
$132.2 million. Net loss attributable to common stockholders for the three
months ended September 30, 2004 was $13.0 million, or $0.49 per share,
compared with $52.3 million, or $50.29 per share, during the same period in
2003. Net loss attributable to common stockholders for the nine months ended
September 30, 2004 was $42.2 million, or $1.59 per share, compared with
$79.5 million, or $76.99 per share, during the same period in 2003.
"We continue to execute the development plans for our three product
candidates," said J. William Freytag, President and Chief Executive Officer of
Myogen. "We are gratified by the support and confidence the investment
community expressed in Myogen's product pipeline, management and development
plans with the completion of our $60 million financing in late September.
With patient enrollment completed in the two Phase III registration trials for
enoximone and progressing in the Phase III registration trials for ambrisentan
and the Phase IIb study of darusentan, we are looking forward to next year
when we expect to obtain important clinical trial results for all three
product candidates."
Product Portfolio Update
Enoximone:
* ESSENTIAL I & II, the two pivotal Phase III trials evaluating
enoximone capsules in patients with chronic heart failure, continue to
progress in line with expectations. In May, the Company announced the
completion of enrollment of 1,800 patients for the two trials, with
patient treatment to continue until 956 patients have had a primary
endpoint event (cardiovascular hospitalization or all-cause
mortality). The Company expects that patient treatment in both trials
will be completed by the end of this year. At that time, the mean
patient treatment period will exceed 18 months. The Company expects
to report preliminary, top-line results mid-year 2005.
* EMOTE, a non-pivotal Phase III trial of enoximone capsules in 201
patients in advanced stages of chronic heart failure who are dependent
on intravenous (i.v.) inotrope therapy, was completed in February 2004
and preliminary results were reported in March 2004. Additional
results were presented at the 8th Annual Scientific Meeting of the
Heart Failure Society of America on September 15, 2004 in Toronto,
Canada.
* EMPOWER, an additional non-pivotal Phase III trial designed to provide
potential marketing support, began enrollment in September 2003.
Trial enrollment continues to progress, but remains slower than
projected. The Company continues to monitor the viability of the
trial.
The Company believes that if the ESSENTIAL trials are successful, the
results will be adequate to support regulatory submission for enoximone
capsules in the United States as well as in certain international markets.
Although the Company does not believe that EMOTE or EMPOWER will be required
for regulatory approval, it believes these studies may assist in regulatory
and post-approval marketing efforts.
Ambrisentan: In January 2004, Myogen announced the initiation of patient
enrollment in ARIES 1 & 2, the two pivotal Phase III trials evaluating
ambrisentan in pulmonary arterial hypertension. The Company's goal is to
complete patient enrollment in the ARIES trials by the end of the first half
of 2005. In August 2004, the Company announced that it was adding additional
resources to aid enrollment rates in the trials, which were lower than
originally expected due to a number of factors, including declining numbers of
patients with PAH who are treatment naove seen at clinical trial sites as well
as competing trials. Preliminary indications suggest that the Company's
initiatives to accelerate enrollment to meet this target are having a positive
effect, although several additional months will be required in order to
provide clarity on the Company's ability to meet its enrollment timing goal.
The Company expects to report preliminary results of the trials approximately
six months after the completion of patient enrollment. The United States Food
and Drug Administration (FDA) has granted orphan drug designation to
ambrisentan for the treatment of PAH.
Darusentan: In July 2004, the Company announced the initiation of a Phase
IIb clinical trial to evaluate the safety and efficacy of darusentan in
patients with resistant systolic hypertension. Enrollment in the 105 patient
trial is progressing in line with expectations. The Company currently expects
the trial to be completed mid-year 2005.
The primary objective of the 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. Approximately
105 patients will be randomized to darusentan or placebo at approximately
30 investigative sites. 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.
2004 Third Quarter Financial Highlights
On September 29, 2004, the Company closed on a Private Investment in a
Public Entity (PIPE) financing, in which 9,195,400 of new shares of common
stock and warrants exercisable for 1,839,080 shares of common stock were
issued to institutional and accredited investors for total net proceeds of
$57.2 million. The warrants have an exercise price per share of $7.80.
Sales of Perfan I.V. for the three months ended September 30, 2004 were
$783,000 versus $707,000 for the same period in 2003. The increase in sales
from the prior year period was the result of a more favorable exchange rate.
The cost of Perfan I.V. sold as a percentage of sales was 31% for both the
three months ended September 30, 2004 and 2003. For the three months ended
September 30, 2004, research and development contracts revenue from our
research agreement with Novartis was $1.7 million.
Research and development expenses, excluding stock-based compensation
expenses, increased 75% to $12.3 million from $7.1 million for the three
months ended September 30, 2004 and 2003, respectively. The increase in
expenses for the period was primarily due to costs associated with increased
patient enrollment in the ESSENTIAL and ARIES trials and costs for initiation
of the darusentan Phase IIb trial.
Selling, general and administrative expenses, excluding stock-based
compensation expenses, increased 215% to $2.1 million from $663,000 for the
three months ended September 30, 2004 and 2003, respectively. The increase
was primarily due to an increase in insurance and professional service costs
related to being a public company during the current year period and an
increase in staffing and related recruiting costs.
2004 Financial Guidance
Financial projections entail a high level of uncertainty due, among many
factors, to the variability involved in predicting clinical trial enrollment
rates, availability, terms and timing of additional financing transactions and
the potential for Myogen to enter into additional licensing or strategic
collaborations. The Company plans on updating financial guidance for
2004 when it releases results for each quarter or upon the announcement of
material corporate events.
Based upon results through the third quarter, the Company is updating its
financial guidance. For the year ending December 31, 2004, the Company
presently anticipates:
* Total product sales of $3.1 million to $3.3 million, an upward
revision from previous guidance of $2.8 million to $3.3 million;
* Total operating expenses, excluding stock-based compensation expenses,
of $62 million to $65 million, a downward revision from previous
guidance of $62 million to $75 million; and,
* Basic net loss per share between $2.10 and $2.30, a reduction in
anticipated net loss compared to previous guidance of between $2.30
and $2.76.
In addition, based on current spending projections, the Company believes
its cash, cash equivalents and investments are sufficient to fund operations
at least through the end of 2005.
2005 Milestones
Myogen is working towards several significant milestones in the coming
year, including:
* Completion of ESSENTIAL I & II (enoximone pivotal Phase III) with
preliminary, top-line results to be reported mid-year 2005;
* Completion of the Phase IIb trial of darusentan in resistant systolic
hypertension;
* Completion of patient enrollment in ARIES-1 & 2 (ambrisentan pivotal
Phase III) by the end of first half of the year; and
* Completion of ARIES trials with top-line results to be reported
approximately six months after completion of patient enrollment.
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 3, 2004 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 800-366-7417
(domestic) or 303-275-2170 (international). Webcast and telephone replays of
the conference call will be available approximately two hours after the
completion of the call through Friday, November 19, 2004. Callers can access
the replay by dialing 800-405-2236 (domestic) or 303-590-3000 (international).
The passcode is 11013200#.
About Myogen
Myogen is a biopharmaceutical company focused on the discovery,
development and commercialization of small molecule therapeutics for the
treatment of cardiovascular disorders. Myogen currently markets one product
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 chronic heart failure, ambrisentan for the treatment of
pulmonary arterial hypertension and darusentan for the treatment of resistant
hypertension. The Company 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 http://www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed in this release
and others that can be found in the "Risk Factors" section of Myogen's Annual
Report on Form 10-K for the year ended December 31, 2003, Myogen's Form S-3
filed on October 29, 2004 and in Myogen's periodic reports on Form 10-Q and
Form 8-K. Myogen is providing this information as of the date of this release
and does not undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future events or
otherwise.
The Company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. No
forward-looking statement can be guaranteed and actual events and results may
differ materially from those projected. The Company's results may be affected
by its effectiveness at managing its financial resources, its ability to
successfully develop and market current and new products, difficulties or
delays in its clinical trials, difficulties or delays in manufacturing its
products, and regulatory developments involving current and future products.
Delays in clinical trials, whether caused by 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 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.
MYOGEN, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, December 31,
2004 2003
ASSETS
Current assets:
Cash and cash equivalents $84,758,241 $44,337,721
Short-term investments 43,909,654 69,914,627
Accrued interest receivable 302,855 607,393
Trade accounts receivable 1,119,867 1,274,861
Research and development contract
amounts due within one year 1,000,000 1,625,000
Inventories 360,910 724,282
Prepaid expenses and other current assets 1,224,118 1,434,174
Total current assets 132,675,645 119,918,058
Long-term investments 3,493,384 --
Property and equipment, net 2,280,294 1,304,028
Other assets 38,847 51,238
Total assets $138,488,170 $121,273,324
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $9,153,377 $7,594,935
Accrued liabilities 1,135,858 1,350,114
Current portion of deferred revenue 1,666,667 1,666,667
Current portion of capital lease
obligations 49,936 37,015
Current portion of notes payable,
net of discount 1,774,479 1,639,246
Total current liabilities 13,780,317 12,287,977
Deferred revenue, net of current portion 1,698,029 2,948,029
Capital lease obligations, net of
current portion 109,487 121,617
Notes payable, net of current portion
and discount 645,661 1,993,906
Stockholders' equity:
Preferred Stock, $0.001 par value;
5,000,000 shares authorized at
September 30, 2004 and December 31,
2003, no shares issued or outstanding -- --
Common stock, $0.001 par value;
100,000,000 shares authorized and
35,722,358 and 26,457,927 shares
issued and outstanding as of
September 30, 2004 and December 31,
2003, respectively 35,722 26,458
Additional paid-in-capital 286,106,160 229,080,380
Deferred stock-based compensation (3,207,096) (6,730,195)
Accumulated other comprehensive (loss)
income (3,723) 22,185
Deficit accumulated during the
development stage (160,676,387) (118,477,033)
Total stockholders' equity 122,254,676 103,921,795
Total liabilities and stockholders'
equity $138,488,170 $121,273,324
MYOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended For the Nine Months Ended
September 30, September 30,
2004 2003 2004 2003
Revenues:
Product sales $783,235 $707,013 $2,534,713 $2,071,823
Research and
development
contracts 1,666,667 -- 4,669,962 --
2,449,902 707,013 7,204,675 2,071,823
Costs and
expenses:
Cost of
product
sold 239,917 220,192 788,621 654,138
Research and
development
(excluding
stock-based
compensation
expense of
$470,155,
$501,467,
$1,621,286
and
$1,243,861,
respectively) 12,334,697 7,052,067 39,420,805 24,621,961
Selling,
general and
administrative
(excluding
stock-based
compensation
expense of
$473,161,
$339,949,
$1,655,906
and
$862,441,
respectively) 2,085,914 662,738 6,368,042 2,564,309
Stock-based
compensation
expense 943,316 841,416 3,277,192 2,106,302
15,603,844 8,776,413 49,854,660 29,946,710
Loss from
operations (13,153,942) (8,069,400) (42,649,985) (27,874,887)
Interest
income
(expense),
net 156,412 (55,125) 465,052 (63,379)
Loss before
income taxes (12,997,530) (8,124,525) (42,184,933) (27,938,266)
Income taxes 5,034 5,530 14,421 16,165
Net loss (13,002,564) (8,130,055) (42,199,354) (27,954,431)
Accretion of
mandatorily
redeemable
convertible
preferred
stock -- (4,243,618) -- (11,583,987)
Deemed dividend
related to
beneficial
conversion
feature of
preferred
stock -- (39,935,388) -- (39,935,388)
Net loss
attributable
to common
stockholders $(13,002,564) $(52,309,061) $(42,199,354) $(79,473,806)
Basic and
diluted
net loss
per common
share $(0.49) $(50.29) $(1.59) $(76.99)
Weighted
average common
shares
outstanding 26,623,208 1,040,108 26,525,466 1,032,200
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations,
+1-303-464-3986, derek.cole@myogen.com, or Joseph L. Turner,
Chief Financial Officer, +1-303-464-5222, joe.turner@myogen.com,
both of Myogen, Inc.
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