DENVER, Aug. 5 /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 second quarter results. As of
June 30, 2004, the Company had cash, cash equivalents and investments of
$85.8 million. Net loss attributable to common stockholders for the three
months ended June 30, 2004 was $13.2 million, or $0.50 per share, compared
with $15.9 million, or $15.47 per share, during the same period in 2003. Net
loss attributable to common stockholders for the six months ended June 30,
2004 was $29.2 million, or $1.10 per share, compared with $27.2 million, or
$26.41 per share, during the same period in 2003.
"Myogen continues to execute its development plan for our three product
candidates," said J. William Freytag, President and Chief Executive Officer of
Myogen. "We have completed patient enrollment in the two Phase III
registration trials for enoximone to treat chronic heart failure, initiated
the Phase IIb study of darusentan for the treatment of resistant hypertension
and our Phase III registration trials for ambrisentan to treat pulmonary
arterial hypertension are on-going. In July, we hosted our first
investor/analyst day which attracted over 40 portfolio managers and equity
research analysts with additional participants viewing the live webcast. We
are looking forward to the second half of the year and furthering the
development of enoximone, ambrisentan, darusentan and our discovery research
program."
Product Portfolio Update
Enoximone:
* ESSENTIAL I & II, the Company's two pivotal Phase III trials of
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 in ESSENTIAL I & II. The
trials will continue until there have been a total of 956 primary
endpoint events (cardiovascular hospitalization or all-cause
mortality). The Company expects that the specified number of events
will have occurred by the end of this year.
* 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.
Preliminary results were reported in March 2004. Additional results
will be 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, Myogen announced the initiation of patient
enrollment in ARIES-1 & -2, two pivotal Phase III trials of ambrisentan in
pulmonary arterial hypertension (PAH). The Company's goal is to complete
enrollment in the two trials by the end of the first half of 2005. This
timing is increasingly uncertain due to a number of factors, including the
declining numbers of patients with PAH who are treatment naive seen at
clinical trial sites as well as competing on-going trials. The Company is
committing additional resources in an effort to accelerate patient enrollment
in order to increase the likelihood of completing enrollment in the expected
time frame. Upon completion of treatment in the ARIES trials, patients are
eligible to enroll in a long-term extension study. The United States Food and
Drug Administration (FDA) has granted orphan drug designation to ambrisentan
for the treatment of PAH.
Darusentan: In July, 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. 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 Second Quarter Financial Highlights
Sales of Perfan I.V. for the three months ended June 30, 2004 were
$900,000 versus $708,000 for the same period in 2003. The increase in sales
from the prior year period was the result of a more favorable exchange rate
and a 17% increase in the number of units sold. The cost of Perfan I.V. sold
as a percentage of sales was 31% and 32% for the three months ended June 30,
2004 and 2003, respectively. For the three months ended June 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 11% to $12.5 million from $11.2 million for the three
months ended June 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 preparations to
initiate the darusentan Phase IIb trial.
Selling, general and administrative expenses, excluding stock-based
compensation expenses, increased 111% to $2.0 million from $970,000 for the
three months ended June 30, 2004 and 2003, respectively. The increase was
primarily due to an increase in insurance and professional service costs
related to becoming a public company and an increase in staffing and related
recruiting costs.
2004 Milestones
* Myogen milestones for 2004 include:
* Initiation of ARIES-1 & -2 (ambrisentan pivotal Phase III studies),
which the Company announced in January;
* Completion of EMOTE (enoximone non-pivotal Phase III study), the
preliminary results of which the Company reported in March;
* Initiation of a Phase IIb trial of darusentan in resistant
hypertension, which the Company announced in July; and
* Completion of patient enrollment, which the Company announced in May,
and drug treatment in ESSENTIAL I & II (enoximone pivotal Phase III
studies) by the end of the year.
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 second quarter, the Company is updating its
financial guidance. For the year ending December 31, 2004, the Company
presently anticipates:
* Total product sales of $2.8 million to $3.3 million, an upward
revision from previous guidance of $2.5 million to $3.0 million;
* Total operating expenses, excluding stock-based compensation expenses,
of $62 million to $75 million, a downward revision from previous
guidance of $66 million to $78 million; and,
* Basic net loss per share between $2.30 and $2.76, a reduction in
anticipated net loss compared to previous guidance of between
$2.46 and $2.92.
In addition, based on current spending projections, the Company believes
its cash, cash equivalents and investments are sufficient to fund operations
through the middle of next 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 Thursday, August 5, 2004 at 4:15 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 303-262-2075 (international). Webcast and telephone replays of
the conference call will be available approximately two hours after the
completion of the call through Friday, August 20, 2004. Callers can access
the replay by dialing 800-405-2236 (domestic) or 303-590-3000 (international).
The passcode is 11004085#.
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 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)
June 30, December 31,
2004 2003
ASSETS
Current assets:
Cash and cash equivalents $13,931,887 $44,337,721
Short-term investments 68,388,299 69,914,627
Accrued interest receivable 454,326 607,393
Trade accounts receivable 1,277,245 1,274,861
Research and development contract
amounts due within one year 2,247,000 1,625,000
Inventories 679,626 724,282
Prepaid expenses and other current assets 1,328,018 1,434,174
Total current assets 88,306,401 119,918,058
Long-term investments 3,490,523 --
Property and equipment, net 1,999,208 1,304,028
Other assets 42,798 51,238
Total assets $93,838,930 $121,273,324
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $9,034,599 $7,594,935
Accrued liabilities 972,764 1,350,114
Current portion of deferred revenue 1,666,667 1,666,667
Current portion of capital lease
obligations 41,452 37,015
Current portion of notes payable,
net of discount 1,728,295 1,639,246
Total current liabilities 13,443,777 12,287,977
Deferred revenue, net of current portion 2,114,695 2,948,029
Capital lease obligations, net of
current portion 105,616 121,617
Notes payable, net of current portion
and discount 1,106,952 1,993,906
Stockholders' equity:
Preferred Stock, $0.001 par value;
5,000,000 shares authorized at
June 30, 2004 and December 31, 2003,
no shares issued or outstanding -- --
Common stock, $0.001 par value;
100,000,000 shares authorized and
26,520,586 and 26,457,927 shares issued
and outstanding as of June 30, 2004 and
December 31, 2003, respectively 26,521 26,458
Additional paid-in-capital 228,834,480 229,080,380
Deferred stock-based compensation (4,084,705) (6,730,195)
Accumulated other comprehensive income (34,583) 22,185
Deficit accumulated during the
development stage (147,673,823) (118,477,033)
Total stockholders' equity 77,067,890 103,921,795
Total liabilities and
stockholders' equity $93,838,930 $121,273,324
MYOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended For the Six Months Ended
June 30, June 30,
2004 2003 2004 2003
Revenues:
Product sales $899,831 $708,425 $1,751,478 $1,364,810
Research and
development
contracts 1,663,667 -- 3,003,295 --
2,563,498 708,425 4,754,773 1,364,810
Costs and expenses:
Cost of product
sold 277,574 227,049 548,704 433,946
Research and
development
(excluding
stock-based
compensation
expense of
$535,183,
$304,040,
$1,151,131 and
$742,394,
respectively) 12,461,672 11,218,657 27,086,108 17,569,894
Selling,
general and
administrative
(excluding
stock-based
compensation
expense of
$586,839,
$189,196,
$1,182,745 and
$522,492,
respectively) 2,046,850 970,048 4,282,128 1,901,571
Stock-based
compensation
expense 1,122,022 493,236 2,333,876 1,264,886
15,908,118 12,908,990 34,250,816 21,170,297
Loss from
operations (13,344,620) (12,200,565) (29,496,043) (19,805,487)
Interest income
(expense), net 136,762 (35,550) 308,640 (8,254)
Loss before
income taxes (13,207,858) (12,236,115) (29,187,403) (19,813,741)
Income taxes 2,511 8,320 9,387 10,635
Net loss (13,210,369) (12,244,435) (29,196,790) (19,824,376)
Accretion of
mandatorily
redeemable
convertible
preferred stock -- (3,670,184) -- (7,340,369)
Net loss
attributable
to common
stockholders $(13,210,369) $(15,914,619) $(29,196,790) $(27,164,745)
Basic and
diluted net
loss per
common share $(0.50) $(15.47) $(1.10) $(26.41)
Weighted
average
common shares
outstanding 26,490,954 1,028,736 26,476,058 1,028,517
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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