Myogen Reports 2006 Second Quarter Results

Myogen, Inc. (Nasdaq:MYOG), a biopharmaceutical companyfocused on the discovery, development and commercialization of smallmolecule therapeutics for the treatment of cardiovascular disorders,today reported 2006 second quarter results. As of June 30, 2006, theCompany had cash, cash equivalents and investments of $188.1 million.Loss from continuing operations for the quarter ended June 30, 2006,was $18.5 million, or $0.44 per share, compared to a loss fromcontinuing operations of $21.7 million, or $0.61 per share during thesame period last year. Loss from continuing operations for the sixmonths ended June 30, 2006, was $36.1 million, or $0.85 per share,compared to a loss from continuing operations of $40.3 million, or$1.13 per share during the same period last year.

"In the second quarter, we continued to successfully execute ourstrategic plan with good progress across all aspects of the company,"said J. William Freytag, President and Chief Executive Officer ofMyogen. "The clinical trial results for ambrisentan enhance ouroptimism about the quality of the ambrisentan New Drug Application,which we expect to submit to the FDA in the fourth quarter, thusmoving us closer toward our ultimate goal of registering andcommercializing ambrisentan. With the launch of Flolan commercialoperations and with our PAH-focused sales force now fully engaged, wehave taken an important step forward in our growth as a commercialcompany. We also continued the development of darusentan with theinitiation of the first pivotal Phase 3 clinical trial in resistanthypertension. Lastly, the extension of our research and developmentcollaboration with Novartis furthers our goal of identifying diseasemodifying drugs for chronic heart failure."

Second Quarter Highlights

-- Announcement of Positive Results for Second Ambrisentan Pivotal Phase 3 Clinical Trial (ARIES-1)

-- Announcement of Positive Results for Integrated Analysis of ARIES-1 and ARIES-2 Trials

-- Presentation of ARIES-2 Results at Annual Meeting of American Thoracic Society

-- Initiation of Darusentan Phase 3 Clinical Program in Resistant Hypertension

-- Extension of Drug Discovery Collaboration with Novartis for Additional Two Years

Product Portfolio Update

Ambrisentan: Ambrisentan is a non-sulfonamide, propanoic-acidclass, type-A selective endothelin receptor antagonist that is beingevaluated as a once daily oral therapy for patients with pulmonaryarterial hypertension (PAH). Ambrisentan has been evaluated in twoplacebo-controlled Phase 3 trials (ARIES-1 & -2), two Phase 2 trials(AMB-201 and AMB-222), and seven Phase 1 trials. Both Phase 3 trialsmet the primary efficacy endpoint of improved exercise capacity forall three ambrisentan doses evaluated (2.5, 5 and 10 mg once daily).More than 720 subjects have received ambrisentan in clinical trials,including approximately 480 PAH patients. As of July 2006, nearly 400patients continue to be treated with ambrisentan, with exposures thatcurrently extend up to 3.8 years. Ambrisentan has been granted orphandrug designation for the treatment of PAH in both the United Statesand European Union and has also been granted Fast Track designation bythe U.S. Food and Drug Administration (FDA). Myogen expects to submitthe ambrisentan New Drug Application to the FDA in the fourth quarterof 2006.

Long-term data: After the initial 12-week assessment period, allpatients in the ARIES trials had the option to continue ambrisentantherapy in a long-term study. To date, more than 400 patients havebeen enrolled in this and other long-term studies. The incidence ofconfirmed serum aminotransferase test results greater than three timesthe upper limit of the normal range (3xULN) is approximately 1%.

In February 2006, the Company announced positive top line resultsof AMB-222, an open-label trial in which ambrisentan was administeredto 36 patients with PAH who had previously discontinued bosentan,sitaxsentan or both due to serum aminotransferase abnormalities.Patients in AMB-222 have continued to receive ambrisentan therapy forperiods up to 1.2 years (mean exposure of 11 months) and no furtherconfirmed occurrence of serum aminotransferase concentrations greaterthan 3xULN has been observed.

Global PAH Collaboration with GlaxoSmithKline

In March 2006, GlaxoSmithKline and Myogen entered into a two-partcollaboration involving each party's PAH therapy. Myogen licensedcommercialization rights for ambrisentan to GlaxoSmithKline in allterritories outside of the United States where Myogen retainsexclusive rights. Simultaneously, GlaxoSmithKline and Myogen enteredinto an agreement whereby Myogen will be responsible for the marketingand distribution of GSK's Flolan (epoprostenol sodium), a life-savingmedicine for many patients, used in the treatment of PAH, in theUnited States.

Myogen believes GlaxoSmithKline, one of the premier pharmaceuticalcompanies in the world, is the ideal ex-US partner for ambrisentan.GSK has been a pioneer in the treatment of PAH and, through itsdecade-long experience with Flolan, has a deep understanding of theinternational regulatory and competitive PAH market environments.Meanwhile, the Flolan distribution agreement is expected to underwritethe development of the Company's U.S. commercial organization andafford it the opportunity to establish a presence in the PAHmarketplace well in advance of the potential launch of ambrisentan.The Company believes this strategic development will acceleraterelationship building with all important customer segments, increasingthe Company's understanding of customer needs and market dynamics ingeneral.

Flolan: Myogen has developed a commercial organization dedicatedto the marketing and distribution of Flolan in the United States,including a PAH focused sales force, which began operations in May2006. The Company records Flolan sales net of the supply price paid tothe manufacturer/licensor, distribution fees paid to the specialtypharmacies and allowances for product returns, prompt pay discountsand government insurer rebates. Sales of Flolan in the United Statescommenced in April 2006. For the three months ended June 30, 2006, theCompany's Flolan net sales were $1.6 million on gross sales of $28.9million.

Darusentan: Darusentan is a non-sulfonamide, propanoic-acid class,type-A selective endothelin receptor antagonist that is beingevaluated as a once daily oral therapy for patients with resistanthypertension. In August 2005, the Company announced positive top lineresults of a Phase 2b clinical trial which evaluated darusentan inpatients with resistant systolic hypertension. Additional results fromthe Phase 2b study were presented at ACC.06, the 55th AnnualScientific Session of the American College of Cardiology, which washeld 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 treatmentof patients with resistant hypertension. DAR-311 was initiated in June2006. The Company expects to initiate DAR-312 in the second half of2006.

DAR-311

The primary objective of this Phase 3 randomized, double-blind,placebo-controlled parallel group trial is to determine if darusentanis effective in reducing systolic blood pressure in resistanthypertension patients currently treated with full doses of four ormore antihypertensive medications, one of which is a diuretic.Patients are eligible for enrollment in this trial if they have asystolic blood pressure greater than or equal to 140 mmHg and no othercompelling conditions. For patients with diabetes and chronic kidneydisease, the blood pressure inclusion criterion is a systolic bloodpressure greater than 130 mmHg. Approximately 352 patients will berandomized 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 thetrial is 14 weeks. The primary endpoint of the trial is change frombaseline to week 14 in trough sitting systolic blood pressure ascompared 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 inreducing systolic blood pressure in patients with resistanthypertension. Patients are eligible for enrollment in this trial ifthey have a systolic blood pressure greater than or equal to 140 mmHgdespite treatment with full doses of three antihypertensive drugs, oneof which is a diuretic, and no other compelling conditions. Forpatients with diabetes and chronic kidney disease, the blood pressureinclusion criterion is a systolic blood pressure greater than 130mmHg. Approximately 770 patients will be randomized to darusentan,active control (guanfacine, an antihypertensive drug that acts as acentral alpha agonist) or placebo, in a 3:3:1 ratio. The treatmentperiod for the trial is 14 weeks. The primary endpoint of the trial ischange from baseline to week 14 in trough sitting systolic bloodpressure compared to placebo and then compared to the active control.Upon completion of the 14-week assessment period, patients will beeligible to enroll in a long-term safety study.

Patients enrolled in the two long-term safety studies will betreated and followed for safety for at least six months with a meanexposure expected to be in excess of one year. The Company mayundertake additional studies in this indication for commercial andregulatory support.

Drug Discovery Research: Myogen is continuing to move forward withits drug discovery program, which is the subject of a broadcollaboration with Novartis. The program is focused on the discovery,development and commercialization of new therapeutics for thetreatment of heart muscle disease. In July 2006, the Company announcedthat Novartis had extended the collaboration for an additional twoyears.

Financial Highlights for Second Quarter 2006

Flolan net sales for the quarter ended June 30, 2006, were $1.6million. Sublicense revenues for the quarter were $737,000. Thesublicense revenue from GSK is derived from the non-refundable upfrontpayment of $20 million made by GSK in March 2006 and the milestoneachieved in April 2006, which are being recognized ratably over theexpected service period. The Company expects that sublicense revenuerelated to the GSK sublicense in subsequent quarters will be similarto the second quarter, based on milestones achieved to date.

Research and development contracts revenue from the Company'sresearch agreement with Novartis was $1.8 million for the secondquarter of 2006 compared to $1.6 million during the same period in2005.

Research and development expenses, including stock-basedcompensation expenses, decreased 31% to $14.5 million from $21.0million for the quarters ended June 30, 2006 and 2005, respectively.The decrease in expenses from 2005 was primarily due to thediscontinuation of the development of enoximone, which was partiallyoffset by growth in expenses related to darusentan and increasedstock-based compensation expense. The Company expects research anddevelopment expenses to increase in the second half relative to therate of spending in the second quarter, due to the initiation of thedarusentan Phase 3 clinical program.

Selling, general and administrative expenses, includingstock-based compensation expenses, increased 249% to $10.2 million forthe second quarter of 2006 from $2.9 million during the same period in2005. The increase was primarily due to increased stock-basedcompensation expense, increased marketing costs associated withambrisentan pre-launch activities, staffing and related recruitingcosts 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 clinicaltrial initiation timelines, enrollment rates and results, productrevenue and the potential for Myogen to enter into additionallicensing or strategic collaborations.

For the year ending December 31, 2006, the Company anticipates:

-- Total Flolan net revenue of $3.75 million to $4.5 million;

-- Total research and development contract revenue of $7.0 million to $7.2 million;

-- Total operating expenses, excluding stock-based compensation expenses, of $100 million to $115 million; and,

-- Basic net loss per share between $2.25 and $2.65.

In addition, based on current spending projections, the Companybelieves its cash, cash equivalents and investments are sufficient tofund operations through at least the end of 2007.

Conference Call

J. William Freytag, President and CEO, and other members ofMyogen's senior management will provide a company update and discussresults via webcast and conference call on Monday, August 7, 2006, at4:30 p.m. Eastern time. To access the live webcast, please log on tothe company's website at www.myogen.com and go to the InvestorRelations section. Alternatively, callers may participate in theconference call by dialing 800-218-0713 (domestic) or 303-262-2140(international). Webcast and telephone replays of the conference callwill be available approximately two hours after the completion of thecall through Friday, August 18, 2006. Callers can access the replay bydialing 800-405-2236 (domestic) or 303-590-3000 (international). Thepasscode is 11065905.

About Myogen

Myogen has two product candidates in late-stage clinicaldevelopment: ambrisentan for the treatment of patients with pulmonaryarterial hypertension (PAH) and darusentan for the treatment ofpatients with resistant hypertension. Myogen and GlaxoSmithKline haveentered into a global PAH collaboration in which Myogen has marketingand distribution rights to GlaxoSmithKline's Flolan(R) (epoprostenolsodium) for Injection in the United States and GlaxoSmithKline haslicensed ambrisentan from Myogen for all territories outside of theUnited States, where Myogen retains exclusive rights. Myogen alsoconducts a target and drug discovery research program focused on thedevelopment of disease-modifying drugs for the treatment of chronicheart failure and related cardiovascular disorders. Please visitMyogen's website at www.myogen.com.

Safe Harbor Statement

This press release contains forward-looking statements thatinvolve significant risks and uncertainties, including the statementsrelating to the design and implementation of the darusentan Phase 3development program, the submission of a New Drug Application forambrisentan, Flolan revenue projections and projections regarding thesufficiency of the Company's current cash, cash equivalents andinvestments. Actual results and events could differ materially fromthose projected and the Company cautions investors not to place unduereliance on the forward-looking statements contained in this release.

Among other things, the projected commencement of any of theCompany's clinical trials, including the projected commencement of thesecond darusentan Phase 3 trial in the second half of 2006, and theprojected submission of the ambrisentan NDA, may be affected bydifficulties or delays, including difficulties or delays caused byregulatory issues, patient enrollment, patient treatment, datacollection or data analysis. In addition, the Company's results may beaffected by its effectiveness at managing its financial resources, itsability to successfully develop and market its current products, itsability 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, andregulatory developments involving current and future products. Delaysin clinical programs, whether caused by competition, adverse events,patient enrollment rates, regulatory issues or other factors, couldadversely affect the Company's financial position and prospects. Priorclinical trial program designs and results are not necessarilypredictive of future clinical trial designs or results. For example,the positive results of the darusentan Phase 2b trial are notnecessarily predictive of the results of the Company's planned Phase 3trials of darusentan in patients with resistant hypertension as aresult of the fact that, among other things, the designs of theplanned Phase 3 clinical trials differ in material respects from thedesign of the Phase 2b program. In addition, the Company may elect, orbe required by applicable regulatory authorities, to modify thedesigns of one or more of its proposed clinical trials or to conductadditional clinical trials of its product candidates to evaluateefficacy and/or safety. Any such additional clinical trials couldadversely affect the Company's financial position and prospects.Preliminary clinical trial results may not be confirmed upon fullanalysis of the detailed results of a trial and additional informationrelating to the safety, efficacy or tolerability of the Company'sproduct candidates may be discovered upon further analysis of trialdata or analysis of new trial data or long term safety data. If theCompany's product candidates do not meet safety or efficacy endpointsin clinical evaluations, they will not receive regulatory approval andthe Company will not be able to market them. Even if the Company'sproduct candidates meet safety and efficacy endpoints, regulatoryauthorities may not approve them, or the Company may facepost-approval problems that require the withdrawal of its product fromthe market. There can be no assurance that Myogen's productcandidates, including ambrisentan, will be proven safe and effectivefor use in humans. Abnormal liver function test results have beenreported in trials of endothelin receptor antagonists, including thePhase 2 trial of ambrisentan.

Cash flow projections involve a high degree of uncertainty,including variances in future spending rates due to changes incorporate priorities, the timing of and outcomes of clinical trials,competitive developments and the impact on expenditures and availablecapital from licensing and strategic collaboration opportunities. Ifthe Company is unable to raise additional capital when required or onacceptable terms, it may have to significantly delay, scale back ordiscontinue one or more of its drug development or discovery researchprograms. Myogen may not ever have any products that generatesignificant revenue.

Additional risks and uncertainties relating to the company and itsbusiness can be found in the "Risk Factors" section of Myogen's annualreport on Form 10-K, in Myogen's periodic reports on Form 10-Q andForm 8-K and in other documents filed by Myogen with the Securitiesand Exchange Commission (SEC). It is Myogen's policy to only update orconfirm its public guidance by issuing a press release or filing aperiodic or current report with the SEC. The Company generally plansto provide guidance as part of its annual and quarterly earningsreleases but reserves the right to provide guidance at differentintervals or to revise its practice in future periods. Myogenundertakes no duty or obligation to update any forward-lookingstatements contained in this release as a result of new information,future events or changes in the Company's expectations.
MYOGEN, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share data)



June 30, December 31,
2006 2005
------------ ------------

ASSETS

Current assets:
Cash and cash equivalents $157,941 $138,380
Short-term investments 30,112 38,575
Accounts receivable, net 10,766 --
Prepaid expenses, accrued interest
receivable and other current assets 4,522 2,752
Assets of discontinued operations -- 1,289
------------ ------------
Total current assets 203,341 180,996

Long-term investments -- 5,362
Property and equipment, net 2,950 2,622
Other assets 42 27
------------ ------------

Total assets $206,333 $189,007
============ ============

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:
Accounts payable $25,660 $10,345
Accrued liabilities 2,819 2,797
Current portion of deferred revenue 4,801 1,187
Current portion of other liabilities 161 142
Current portion of notes payable,
net of discount -- 172
Liabilities of discontinued operations -- 264
------------ ------------
Total current liabilities 33,441 14,907

Deferred revenue, net of current portion 23,293 1,656
Other long term liabilities, net of
current portion 211 220

Stockholders' equity:
Common stock, $0.001 par value;
100,000,000 shares authorized and
42,552,834 and 41,962,587 shares issued
and outstanding as of June 30, 2006,
and December 31, 2005, respectively 43 42
Additional paid-in capital 422,938 412,862
Deferred stock-based compensation -- (1,406)
Other comprehensive loss (88) (88)
Accumulated deficit (273,505) (239,186)
------------ ------------
Total stockholders' equity 149,388 172,224
------------ ------------

Total liabilities and stockholders' $206,333 $189,007
equity ============ ============
MYOGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share and per share data)



For the Three For the Six
Months Ended Months Ended
June 30, June 30,
2006 2005 2006 2005
---------- ---------- ---------- ----------
Revenues:
Research and
development
contracts $1,797 $1,580 $3,593 $3,286
Product sales, net 1,570 -- 1,570 --
Sublicense revenues 737 -- 2,709 --
---------- ---------- ---------- ----------
4,104 1,580 7,872 3,286
---------- ---------- ---------- ----------

Costs and expenses:
Research and
development
(including
stock-based
compensation expense
of $1,700, $266,
$2,930 and $530,
respectively) 14,521 20,957 30,748 38,627
Selling, general and
administrative
(including
stock-based
compensation expense
of $3,907, $252,
$5,819 and $504,
respectively) 10,245 2,935 17,457 6,166
---------- ---------- ---------- ----------
24,766 23,892 48,205 44,793
---------- ---------- ---------- ----------
Loss from operations (20,662) (22,312) (40,333) (41,507)
Interest income, net 2,156 611 4,079 1,174
---------- ---------- ---------- ----------
Loss from continuing
operations before
cumulative effect of
a change in accounting
principle (18,506) (21,701) (36,254) (40,333)
Cumulative effect of a
change in accounting
principle -- -- 172 --
---------- ---------- ---------- ----------
Loss from continuing
operations (18,506) (21,701) (36,082) (40,333)
Gain on the sale of
discontinued operations -- -- 1,763 --
Discontinued operations,
net of income taxes -- 182 -- 512
---------- ---------- ---------- ----------
Net loss $(18,506) $(21,519) $(34,319) $(39,821)
========== ========== ========== ==========

Basic and diluted net
loss per common share
attributable to common
stockholders:
Continuing operations
before cumulative
effect of a change in
accounting principle (0.44) (0.61) (0.85) (1.13)
Cumulative effect of
a change in
accounting principle 0.00 0.00 0.00 0.00
Discontinued
operations, net of
income taxes 0.00 0.01 0.04 0.02
---------- ---------- ---------- ----------
$(0.44) $(0.60) $(0.81) $(1.11)
========== ========== ========== ==========
Weighted average common
shares outstanding 42,484,853 35,767,018 42,327,432 35,762,163
========== ========== ========== ==========