DENVER, Feb. 28 /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 year-end results. As of
December 31, 2004, the company had cash, cash equivalents and investments of
$119.6 million.
Net loss for the year ended December 31, 2004 was $57.7 million compared
to a net loss of $43.1 million in the prior year. Net loss attributable to
common stockholders for the year ended December 31, 2004 was $57.7 million, or
$2.00 per share, compared with $96.3 million, or $17.79 per share, during the
same period in 2003. The decrease in the company's net loss attributable to
common stockholders is due to there being no corresponding expense in 2004
related to the company's mandatorily redeemable convertible preferred stock,
all of which were converted to common stock upon completion of our initial
public offering in November 2003.
"Myogen made significant progress in the development of our three product
candidates in 2004," said J. William Freytag, President and Chief Executive
Officer of Myogen. "We are gratified by the enthusiasm expressed for Myogen's
development programs by our clinical trial investigators and the continued
support of our shareholders. In 2005, we expect to obtain important clinical
trial results for all three of our product candidates."
The company has three product candidates in late-stage clinical
development: enoximone capsules for the treatment of patients with advanced
chronic heart failure, ambrisentan for the treatment of patients with
pulmonary arterial hypertension (PAH) and darusentan for the treatment of
patients with resistant systolic hypertension. All three 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 disease indications.
2004 Highlights
* Initiation of ARIES-1 & -2, the two pivotal Phase III trials
evaluating ambrisentan in patients with PAH, in January.
* Reporting of preliminary results of EMOTE, a non-pivotal Phase III
trial of enoximone capsules in 201 patients with advanced chronic
heart failure who were dependent on intravenous (i.v.) inotrope
therapy, in March.
* Presentation of detailed results of the Phase II trial of ambrisentan
in PAH at the American Thoracic Society annual meeting in May.
* Completion of enrollment of 1,854 patients in ESSENTIAL I & II, the
two pivotal Phase III trials evaluating enoximone capsules in patients
with advanced chronic heart failure, in June.
* Initiation of the Phase IIb trial of darusentan in resistant systolic
hypertension in July.
* U.S. Food and Drug Administration (FDA) granting ambrisentan orphan
drug designation for the treatment of PAH in July.
* Presentation of detailed results of EMOTE at the Heart Failure Society
of America annual meeting in September.
* Completion of a $60 million financing in September.
* Completion of patient treatment in the ESSENTIAL trials in November.
Product Portfolio Update
Enoximone: Myogen is evaluating enoximone capsules in three Phase III
trials (ESSENTIAL I, ESSENTIAL II and EMPOWER) and has completed one
non-pivotal Phase III trial in February 2004 (EMOTE).
Data collection for ESSENTIAL I & II continues to progress in line with
expectations. The company expects to report preliminary results in the middle
of 2005. The ESSENTIAL trials have three co-primary endpoints: (1) time from
randomization to first cardiovascular hospitalization or all-cause mortality,
(2) submaximal exercise capacity (as measured by six-minute walk distance),
and (3) quality of life (as measured by patient global assessment). Data from
both trials will be pooled for the analysis of the primary endpoint of
cardiovascular hospitalization or all-cause mortality. The other two
co-primary endpoints will be analyzed within each individual trial. The
company believes that if the ESSENTIAL trials are successful, the results will
be adequate to support regulatory approval of enoximone capsules in the United
States and in various international markets.
EMPOWER, a non-pivotal Phase III trial designed to provide potential
marketing support if enoximone is approved for commercialization, began
enrollment in September 2003. The trial has enrolled substantially slower
than anticipated and the company expects to revise the trial protocol if the
ESSENTIAL trial results are positive.
Ambrisentan: In January 2004, Myogen announced the initiation of patient
enrollment in ARIES-1 & -2, the two pivotal Phase III trials evaluating
ambrisentan in patients with PAH. Each trial is designed to enroll
186 patients. ARIES-1 is being conducted in the United States and abroad.
ARIES-2 is being conducted outside of the United States. The company expects
to complete patient enrollment in ARIES-2 by the end of June 2005 and ARIES-1
in the fourth quarter of 2005. The company plans to report preliminary
results from each of the ARIES trials approximately six months following the
completion of enrollment in each trial. The FDA has granted orphan drug
designation to ambrisentan for the treatment of PAH.
Darusentan: In July 2004, the company initiated a Phase IIb randomized,
double-blind, placebo-controlled clinical trial to evaluate the safety and
efficacy of darusentan in patients with resistant systolic hypertension.
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. Enrollment in the trial continues to progress in line
with expectations and the company expects to complete the trial in the middle
of 2005.
The primary objective of this 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.
Drug Discovery Research: In October 2003, Myogen announced the
establishment of a drug discovery partnership with Novartis based on Myogen's
proprietary drug targets and lead compounds and focused on the discovery,
development and commercialization of new therapeutics for the treatment of
heart muscle disease. Although these programs are still at an early
preclinical stage, excellent progress was achieved in 2004.
Financial Highlights for the Year-Ended December 31, 2004
On September 29, 2004, the company closed a Private Investment in a Public
Entity (PIPE) financing, in which it issued 9,195,400 shares of common stock
and warrants exercisable for 1,839,080 shares of common stock to institutional
and accredited investors for total net proceeds of $57.1 million. The
warrants have an exercise price per share of $7.80.
Sales of Perfan(R) I.V. for the year were $3.3 million versus $2.8 million
for the same period in 2003. The increase in sales from the prior year period
was the result of a more favorable exchange rate and a 13% increase in unit
sales. The cost of goods sold, as a percentage of Perfan I.V. sales, was
32% for the year compared to 31% for 2003. Research and development contracts
revenue from our research agreement with Novartis was $6.6 million for the
year compared to $1.0 million for 2003.
Research and development expenses, excluding stock-based compensation
expenses, increased 45% to $54.1 million from $37.4 million for the years
ended December 31, 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 111% to $9.3 million from $4.4 million for
the years ended December 31, 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.
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. The company plans on updating financial guidance
for 2005 when it releases results for each quarter or upon the announcement of
material corporate events which impact financial guidance.
For the year ending December 31, 2005, the company anticipates:
* Total Perfan I.V. sales of $2.6 million to $3.2 million;
* Total research and development contracts revenue of $6.0 million to
$6.7 million;
* Total operating expenses, excluding stock-based compensation expenses,
of $90 million to $100 million; and,
* Basic net loss per share between $2.30 and $2.60.
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 the first quarter of 2006.
2005 Milestones
Myogen is working towards several significant milestones in the coming
year, including:
* Reporting ESSENTIAL I & II preliminary results in the middle of the
year;
* Completing patient enrollment in ARIES-2 by the end of June;
* Completing the darusentan Phase IIb trial in resistant systolic
hypertension in the middle of the year;
* Completing patient enrollment in ARIES-1 during the fourth quarter;
and
* Reporting ARIES-2 preliminary results by the end of the year.
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, February 28, 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 800-218-8862
(domestic) or 303-262-2131 (international). Webcast and telephone replays of
the conference call will be available approximately two hours after the
completion of the call through Friday, March 11, 2005. Callers can access the
replay by dialing 800-405-2236 (domestic) or 303-590-3000 (international).
The passcode is 11024350#.
About Myogen
Myogen currently markets one product (Perfan(R) I.V.) 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 advanced chronic heart failure, 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
reporting of preliminary results from the company's pivotal phase III trials
of enoximone capsules and ambrisentan, completion of patient enrollment in the
company's pivotal phase III trials of ambrisentan, completion of the company's
phase IIb 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 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 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 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 the 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. 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, 2003, Myogen's Form S-3 filed on October 29, 2004
and Myogen's periodic reports on Form 10-Q and Form 8-K. Myogen is providing
the information contained in this release as of the date of the release and
does not undertake any obligation to update any forward-looking statements as
a result of new information, future events or otherwise.
MYOGEN, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
December 31,
2004 2003
ASSETS
Current assets:
Cash and cash equivalents $71,258,294 $44,337,721
Short-term investments 45,241,729 69,914,627
Accrued interest receivable 290,972 607,393
Trade accounts receivable 946,177 1,274,861
Research and development contract
amounts due within one year 300,000 1,625,000
Inventories 258,120 724,282
Prepaid expenses and other current
assets 1,679,340 1,434,174
Total current assets 119,974,632 119,918,058
Long-term investments 3,089,090 --
Property and equipment, net 2,503,579 1,304,028
Other assets 35,421 51,238
Total assets $125,602,722 $121,273,324
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $10,681,667 $7,594,935
Accrued liabilities 1,941,083 1,331,858
Current portion of deferred revenue 1,823,188 1,666,667
Current portion of deferred rent 59,456 18,256
Current portion of capital lease
obligations 59,924 37,015
Current portion of notes payable,
net of discount 1,821,806 1,639,246
Total current liabilities 16,387,124 12,287,977
Deferred revenue, net of current
portion 1,398,753 2,948,029
Deferred rent, net of current portion 217,616 --
Capital lease obligations, net of
current portion 112,728 121,617
Notes payable, net of current
portion and discount 172,100 1,993,906
Stockholders' equity:
Preferred Stock, $0.001 par value;
5,000,000 shares authorized at
December 31, 2004 and 2003, no
shares issued or outstanding -- --
Common stock, $0.001 par value;
100,000,000 shares authorized and
35,731,581 and 26,457,927 shares
issued and outstanding as of
December 31, 2004 and 2003 35,732 26,458
Additional paid-in capital 286,017,266 229,080,380
Deferred stock-based compensation (2,534,535) (6,730,195)
Other comprehensive income (42,203) 22,185
Deficit accumulated during the
development stage (176,161,859) (118,477,033)
Total stockholders' equity 107,314,401 103,921,795
Total liabilities and
stockholders' equity $125,602,722 $121,273,324
MYOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
2004 2003
Revenues:
Product sales $3,317,683 $2,845,713
Research and development contracts 6,606,498 1,010,305
9,924,181 3,856,018
Costs and expenses:
Cost of product sold 1,077,113 885,145
Research and development
(excluding stock-based compensation
expense of $1,971,080 and $2,372,888,
respectively) 54,123,711 37,364,578
Selling, general and administrative
(excluding stock-based compensation
expense of $1,976,559 and $1,819,368,
respectively) 9,259,430 4,386,635
Stock-based compensation 3,947,639 4,192,256
68,407,893 46,828,614
Loss from operations (58,483,712) (42,972,596)
Interest income (expense), net 821,271 (135,891)
Loss before income taxes (57,662,441) (43,108,487)
Income taxes 22,385 39,346
Net loss (57,684,826) (43,147,833)
Accretion of mandatorily redeemable
convertible preferred stock -- (13,187,174)
Deemed dividend related to beneficial
conversion feature of preferred stock -- (39,935,388)
Net loss attributable to common
stockholders $(57,684,826) $(96,270,395)
Basic and diluted net loss per
common share $(2.00) $(17.79)
Weighted average common shares outstanding 28,839,076 5,411,891
SOURCE Myogen, Inc.
 back to top
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.
|
