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Myriad Genetics Reports Results for Third Quarter of Fiscal 2008
55% Growth in Product Revenues and 22% Reduction in Net Loss Highlight QuarterSALT LAKE CITY, UT, May 06, 2008 (MARKET WIRE via COMTEX News Network) -- Myriad Genetics, Inc. (NASDAQ: MYGN) (www.myriad.com) today reported
consolidated financial results for the third quarter of fiscal 2008
and the nine months ended March 31, 2008.
Molecular diagnostics revenue for the third quarter of fiscal 2008
was $59.0 million, compared with $38.0 million in the third quarter of
fiscal 2007, an increase of 55%. For the nine months ended March 31,
2008, molecular diagnostics revenue rose to $158.2 million, from
$103.0 million in the same period in fiscal 2007. Compared with the
second quarter of fiscal 2008, molecular diagnostics revenue achieved
a sequential quarterly increase of over 11%. Myriad believes that its
increased sales, marketing and educational efforts, including its
direct-to-consumer advertising campaign for BRACAnalysis(R) in the
Northeast region, have resulted in increased demand for its products.
Total revenues for the quarter were $61.8 million, compared to $41.0
million in the same period last year.
The molecular diagnostics cost of revenue for the third quarter was
$8.3 million, compared to $7.6 million in the third quarter of fiscal
2007. This 9% increase on 55% revenue growth is due in part to the
technology improvements and efficiency gains that the Company has made
in its molecular diagnostics laboratory.
The gross profit margin on the Company's molecular diagnostics
business was 86% for the three months ended March 31, 2008, compared
with an 80% gross profit margin from the same three month period in
2007.
Net operating income for the Company's molecular diagnostics business
increased to $27.7 million, a 47% net operating margin, in the third
quarter of fiscal 2008. This result compares to $16.2 million, a 43%
net operating margin, in the third quarter of fiscal 2007,
representing a 71% increase in net operating profit.
"We continue to see strong topline and bottom-line growth in our
molecular diagnostics business," said Peter Meldrum, President and
Chief Executive Officer of Myriad Genetics, Inc. "We are equally
pleased with the progress we are making on the therapeutic side of
the Company. We have completed the Phase 3 clinical trial of
Flurizan(R) in Alzheimer's disease and look forward to announcing the
results in the near future."
Research and development expense for the three months ended March 31,
2008 was $31.2 million, compared to $22.9 million for the same three
months in 2007. This increase was primarily due to costs associated
with the Company's ongoing clinical trials for its five drug
candidates in Alzheimer's disease, cancer and AIDS.
Selling, general and administrative expenses for the three months
ended March 31, 2008 were $30.2 million, a small decrease from the
prior quarter's selling, general and administrative expenses of $30.5
million. Selling, general and administrative expenses for the same
three months in 2007 were $19.6 million. The increase in third
quarter fiscal 2008 SG&A expense over the third quarter of fiscal
2007 is generally attributable to increased costs incurred to support
the 55% increase in molecular diagnostics revenue.
The net loss for the third quarter of fiscal 2008 was $4.6 million or
$0.10 per share, which is a 22% reduction in net loss from $5.9
million, or $0.14 loss per share, in the third quarter of fiscal
2007. The Company ended the third quarter in strong financial
condition with no debt and approximately $310 million in cash, cash
equivalents and marketable investment securities.
Launch of New Direct-To-Consumer Campaign
Myriad is pleased to announce the launch of a second regional
BRACAnalysis Direct-to-Consumer (DTC) Campaign, to be held in the
southern region of the United States, principally Texas and Florida.
This campaign area represents 18% of the United States market for
BRACAnalysis, compared with 12% for the northeast region. The
direct-to-physician phase of the campaign has already commenced with
a physician education component that precedes the DTC advertising to
consumers. The southern DTC campaign is expected to run from
September 2008 until March 2009. The estimated cost of the southern
DTC campaign will be in the same range as the northeast campaign,
approximately $8 million.
Therapeutic Pipeline Update: Vivecon and MPC-3100
Vivecon(TM), a novel viral maturation inhibitor for the treatment of
HIV infection, is being studied in a Phase 1 clinical trial in healthy
volunteers. The drug candidate has completed several escalations of
dose in these individuals and initially appears to be well absorbed,
demonstrating good oral bioavailability. The half-life of the drug
candidate is long, which should allow for once-a-day dosing. Plasma
concentrations of Vivecon have been achieved that surpass the IC50
level required for inhibition of viral replication. No drug-related
adverse effects have been reported in the trial to date, indicating
that Vivecon appears to be well-tolerated. Subject to successful
completion of the Phase 1 trial and FDA review of the Phase 2
protocol, a Phase 2 study of multiple ascending doses in HIV
positive, treatment-naive patients is planned for fall 2008.
MPC-3100 is Myriad's drug candidate for the treatment of cancer. In
preclinical studies, it demonstrated the ability to inhibit HSP90
(heat shock protein 90), a molecular chaperone compound that ensures
proper folding of many oncogenic proteins. Mutation of oncogenes
frequently results in over-production of the protein or a gain in
function. Either of these events can lead to cancer. These mutated
genes require HSP90 to function, so inhibiting HSP90 may lead to a
reduction in concentration of the cancer-causing proteins. There are
two classes of HSP90 inhibitors currently in clinical development,
those that are semi-synthetics based on the natural product,
geldanamycin, and those, like MPC-3100, that are completely synthetic
and unrelated to geldanamycin. The geldanamycin-derived compounds are
given by infusion, cannot be administered orally, and their use is
limited by organ toxicity.
MPC-3100 is orally available, making daily dosing possible. In
preclinical studies, MPC-3100 has demonstrated good oral
bioavailability, high potency and appropriate pharmacokinetics. In
head-to-head tests with competitive HSP90 programs, MPC-3100 stopped
the tumor growth and reduced the tumor's volume in a mouse xenograft
model without sign of toxicity, while the competitive compound could
only slow the growth of the tumor with no reduction in its volume.
Myriad anticipates submitting an Investigational New Drug application
to the FDA in order to begin Phase 1 trials in humans in early 2009.
Conference Call and Webcast
A conference call with Company management will be held today,
Tuesday, May 6, 2008 at 10:00 a.m. Eastern time to discuss these
results and recent events at the Company. Callers are requested to
dial in between 9:45 a.m. and 10:00 a.m. to (800) 926-4420 or (212)
231-2905 from outside the U.S., and enter reservation number
21381718. An archived replay of the call will be available for seven
days by dialing (800) 633-8284 or (402) 977-9140, and entering the
reservation number 21381718. The conference call will also be
audiocast over the Web at: www.myriad.com
Flurizan(R), Vivecon(TM) and BRACAnalysis(R) are trademarks of Myriad
Genetics, Inc.
Myriad Genetics, Inc. is a biopharmaceutical company focused on the
development of novel healthcare products. The Company develops and
markets molecular diagnostic products, and is developing and intends
to market therapeutic products. Myriad's news and other information
are available on the Company's Web site at www.myriad.com.
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements relating to increased sales, marketing and
educational efforts resulting in wider acceptance of Myriad products
by the medical community and increased demand by patients for
molecular diagnostic testing, driving increased revenues; the
continuation or improvement of gross profit margins on the Company's
molecular diagnostic business; the continued exceptional growth in
our molecular diagnostic business; the announcement of results from
the Phase 3 clinical trial of Flurizan in the near future; the launch
and continuation of a second regional BRACAnalysis Direct-to-Consumer
Campaign to be held in the southern region of the US from September
2008 until March 2009; the approximate cost of the southern DTC
campaign; the planned initiation of a Phase 2 study of multiple
ascending doses in HIV positive, treatment-naive patients for Fall
2008 for Vivecon; the submission of an Investigational New Drug
application to the FDA, in order to begin Phase 1 trials in humans in
early 2009 for MPC-3100 . These forward-looking statements are based
on management's current expectations and are subject to certain risks
and uncertainties that could cause actual results to differ
materially from those set forth in or implied by forward-looking
statements. These risks and uncertainties include, but are not
limited to, our inability to further identify, develop and achieve
commercial success for new products and technologies; our ability to
discover drugs that are safer and more efficacious than our
competitors; our ability to develop molecular diagnostic products that
help assess which patients are subject to greater risk of developing
diseases and who would therefore benefit from new preventive
therapies; the possibility of delays in the research and development
necessary to select drug development candidates and delays in
clinical trials; the risk that clinical trials may not result in
marketable products; the risk that we may be unable to successfully
finance and secure regulatory approval of and market our drug
candidates, or that clinical trials will not be completed on the
timelines we have estimated; uncertainties about our ability to obtain
new corporate collaborations and acquire new technologies on
satisfactory terms, if at all; the development of competing products
and services; our ability to protect our proprietary technologies;
patent-infringement claims; risks of new, changing and competitive
technologies and regulations in the United States and
internationally; and other factors discussed under the heading "Risk
Factors" contained in Item 1A in our Annual Report on Form 10-K for
the year ended June 30, 2007, which has been filed with the
Securities and Exchange Commission, as well as any updates to those
risk factors filed from time to time in our Quarterly Reports on Form
10-Q or Current Reports on Form 8-K. All information in this press
release is as of the date of the release, and Myriad undertakes no
duty to update this information unless required by law.
Financial Charts Follow
MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(in thousands, except per share Three Months Ended Nine Months Ended
amounts) -------------------- --------------------
Mar. 31, Mar. 31, Mar. 31, Mar. 31,
2008 2007 2008 2007
--------- --------- --------- ---------
Revenues:
Molecular diagnostic revenue $ 59,023 $ 37,991 $ 158,176 $ 103,017
Research and other revenue 2,742 2,979 8,597 8,631
--------- --------- --------- ---------
Total revenues 61,765 40,970 166,773 111,648
Costs and expenses:
Molecular diagnostic cost of
revenue 8,263 7,577 23,289 23,211
Research and development
expense 31,161 22,890 84,490 73,899
Selling, general and
administrative expense 30,157 19,595 87,127 49,999
--------- --------- --------- ---------
Total costs and expenses 69,581 50,062 194,906 147,109
--------- --------- --------- ---------
Operating loss (7,816) (9,092) (28,133) (35,461)
Other income (expense):
Interest income 3,250 3,123 10,774 8,298
Other (65) 32 (337) 5
--------- --------- --------- ---------
3,185 3,155 10,437 8,303
--------- --------- --------- ---------
Net loss $ (4,631) $ (5,937) $ (17,696) $ (27,158)
========= ========= ========= =========
Basic and diluted loss per
share $ (0.10) $ (0.14) $ (0.40) $ (0.67)
========= ========= ========= =========
Basic and diluted weighted
average shares outstanding 44,448 41,503 44,035 40,329
========= ========= ========= =========
Condensed Consolidated Balance Sheets (Unaudited)
Mar. 31, Jun. 30,
(In thousands) 2008 2007
---------- ----------
Cash, cash equivalents, and marketable investment
securities $ 310,488 $ 308,312
Trade receivables, net 39,704 31,103
Other receivables 2,018 1,348
Prepaid expenses 7,032 5,972
Equipment and leasehold improvements, net 28,111 24,888
Other assets 3,604 3,917
---------- ----------
Total assets $ 390,957 $ 375,540
Accounts payable and accrued liabilities $ 35,603 $ 34,794
Deferred revenue 2,058 383
Stockholders' equity 353,296 340,363
---------- ----------
Total liabilities and stockholders' equity $ 390,957 $ 375,540
Contact:
William A. Hockett
EVP, Corporate Communications
(801) 584-3600
email: Email Contact
SOURCE: Myriad Genetics
http://www2.marketwire.com/mw/emailprcntct?id=2D47D31C0F991DF7
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