XYREM(R) Sales Reach Record $12.4 Million PALO ALTO, Calif., Aug. 7
PALO ALTO, Calif., Aug. 7 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals,
Inc. (Nasdaq: JAZZ) today announced financial results for the quarter ended
June 30, 2008.
Total revenues for the quarter ended June 30, 2008 were $15.5 million,
compared to $14.3 million for the quarter ended June 30, 2007. XYREM(R)
(sodium oxybate oral solution) net sales for the second quarter of 2008
increased 29 percent to $12.4 million, compared with $9.6 million for the
second quarter of 2007.
The quarter ended June 30, 2008 also included the first net sales of LUVOX
CR(R) (fluvoxamine maleate) Extended-Release Capsules, which was launched in
April 2008. Net sales during the quarter were $0.7 million.
"The response from physicians and patients to this important new treatment
option for obsessive compulsive disorder and social anxiety disorder has been
very positive," said Robert Myers, President of Jazz Pharmaceuticals. "We are
continuing to expand awareness of LUVOX CR and expect significant prescription
growth in the second half of 2008."
Research and development expenses for the second quarter of 2008 were
$21.9 million, compared to $17.4 million for the second quarter of 2007. The
increase primarily reflected expenses associated with the clinical development
of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.
"We expect to report top-line data from the first of two Phase III
clinical trials of JZP-6 in the fourth quarter of 2008, and to submit a New
Drug Application to the U.S. Food and Drug Administration by the end of 2009,"
said Samuel Saks, M.D., Chief Executive Officer.
Selling, general and administrative expenses for the second quarter of
2008 were $34.1 million, compared to $18.2 million for the second quarter of
2007. The increase was primarily due to spending in connection with the
launch of LUVOX CR, increased headcount and higher expenses to support the
company's larger sales force.
Net loss for the second quarter of 2008 was $51.9 million, compared to
$39.9 million in the second quarter of 2007.
During the quarter ended June 30, 2008, net cash used in operating
activities was $44.6 million. Jazz Pharmaceuticals' cash, cash equivalents
and marketable securities balance was $54.7 million as of June 30, 2008.
Approximately $40 million in cash was raised through three transactions
completed subsequent to June 30, 2008.
Recent Highlights
-- In June 2008, enrollment was closed with 550 subjects in the first of
two Phase III clinical trials of JZP-6 in fibromyalgia. Top-line results for
this trial are expected in the fourth quarter of 2008. Enrollment is more
than 50 percent complete in the second Phase III clinical trial of JZP-6 at
clinical sites in the U.S. and Europe.
-- On June 11, 2008, Jazz Pharmaceuticals announced a reduction in
early-stage research and development activities, and delays in the timelines
for two clinical development programs, in order to reduce its research and
development expenses. The company implemented a workforce reduction of 33
employees to align the organization with its revised strategic goals.
-- On June 12, 2008, Harvey Moldofsky, M.D., University of Toronto, and
Sarah Alvarez-Horine of Jazz Pharmaceuticals presented abstracts on
"Disordered Sleep and Sleep-related Daytime Functioning in Fibromyalgia
Syndrome (FMS)" and "Effects of Sodium Oxybate on Sleep Physiology and
Sleep-related Symptoms in Fibromyalgia" at the EULAR (European League Against
Rheumatism) meeting in Paris, France.
-- On July 21, 2008, Jazz Pharmaceuticals closed a registered direct
offering of common stock and warrants with approximately $24.5 million in net
proceeds.
-- On July 23, 2008, Jazz Pharmaceuticals and UCB Pharma Limited signed an
amendment to the XYREM license and distribution agreement between the
companies under which Jazz Pharmaceuticals received a $10.0 million payment
from UCB.
-- On August 1, 2008, Jazz Pharmaceuticals divested its Antizol(R) and
Antizol-Vet(R) products in a sale to Paladin Labs. Jazz Pharmaceuticals
received a cash payment of approximately $5.5 million in connection with the
sale, and is entitled to receive additional payments based on product sales
during the next three years if sales of the products exceed certain levels.
Jazz Pharmaceuticals will host an investor conference call and live audio
webcast to discuss its financial results and financial guidance and provide an
update on its commercial and development activities on August 7, 2008
commencing at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The live webcast
may be accessed on Jazz Pharmaceuticals' website at
http://www.JazzPharmaceuticals.com. Please connect to the website prior to
the start of the conference call to ensure adequate time for any software
downloads that may be necessary. An archived version of the webcast will be
available through August 21, 2008. Investors may participate in the
conference call by dialing 866-831-6270 in the U.S., or 617-213-8858 outside
the U.S., and entering passcode 59360987. A replay of this call will be
available until August 21, 2008 at 888-286-8010 or 617-801-6888
(international), using the passcode 27421347.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company focused on
identifying, developing and commercializing innovative products to meet unmet
medical needs in neurology and psychiatry. For further information see
http://www.JazzPharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act
of 1995
This press release contains forward-looking statements, including, but not
limited to, statements related to future sales of LUVOX CR, the continued
development of Jazz Pharmaceuticals' JZP-6 product candidate for the treatment
of fibromyalgia and the timing of the release of clinical results and
submission of a New Drug Application to the U.S. Food and Drug Administration.
These forward-looking statements are based on the company's current
expectations and inherently involve significant risks and uncertainties. Jazz
Pharmaceuticals' actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, without limitation,
risks related to the launch and sales of LUVOX CR; the development of Jazz
Pharmaceuticals' JZP-6 product candidate, including the risk that clinical
trial results may require Jazz Pharmaceuticals to discontinue the development
of that product candidate; the need for additional funds; and manufacturing,
regulatory requirements and competition. These and other risk factors are
discussed under "Risk Factors" in Jazz Pharmaceuticals' prospectus supplement
filed with the Securities and Exchange Commission under Rule 424(b)(5) on July
16, 2008. Jazz Pharmaceuticals undertakes no duty or obligation to update any
forward-looking statements contained in this release as a result of new
information, future events or changes in its expectations.
JAZZ PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30,June 30,
2008 2007 2008 2007
Revenues:
Product sales, net $14,751 $13,615 $28,735 $25,240
Royalties, net 503 360 868 571
Contract revenues285 289 569 2,541
Total revenues 15,53914,26430,17228,352
Operating expenses:
Cost of product sales
(excluding amortization
of acquired developed
technology) 2,796 1,679 5,094 3,682
Research and development 21,88217,40743,12532,274
Selling, general and
administrative 34,10918,17566,88932,514
Amortization of intangible assets 3,846 2,287 5,966 4,649
Provision for government
settlement - 17,469 - 17,469
Total operating expenses62,63357,017 121,07490,588
Loss from operations (47,094) (42,753) (90,902) (62,236)
Interest income 450 1,300 1,347 2,391
Interest expense (5,235) (3,314) (9,021) (6,582)
Other (expense) income, net (1)4,904 (13)1,835
Gain on sale of product rights - - - 5,145
Net loss $(51,880) $(39,863) $(98,589) $(59,447)
Net loss per share, basic and
diluted$(2.17) $(5.27) $(4.14) $(15.59)
Weighted-average common shares
used in computing net loss
per share, basic and diluted 23,858 7,56123,800 3,813
JAZZ PHARMACEUTICALS, INC.
SUMMARY OF PRODUCT SALES, NET
(In thousands) (Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007
Xyrem $12,405$9,628 $23,746 $18,252
Antizol 1,632 3,987 4,275 6,623
Luvox CR714 - 714 -
Cystadane - - - 365
Total $14,751 $13,615 $28,735 $25,240
JAZZ PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands) (Unaudited)
June 30, December 31,
2008 2007
ASSETS
Current assets:
Cash and cash equivalents$51,202 $102,945
Restricted cash1,998 1,939
Marketable securities 1,500 -
Accounts receivable5,221 5,389
Inventories6,219 2,213
Prepaid expenses 3,680 3,224
Other current assets 376 381
Total current assets70,196 116,091
Property and equipment, net 4,260 3,941
Intangible assets, net 71,07436,040
Goodwill38,21338,213
Long-term restricted cash and investments - 12,000
Other long-term assets 2,848 1,269
Total assets $186,591 $207,554
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Line of credit$6,099$3,459
Accounts payable 8,522 2,856
Accrued liabilities 31,25229,047
Purchased product rights liability21,000 -
Deferred revenue 3,430 1,494
Total current liabilities 70,30336,856
Non-current portion of deferred revenue 11,89912,468
Liability under government settlement 13,06314,881
Senior secured notes 113,70475,116
Common stock subject to repurchase 13,24113,241
Stockholders' equity (deficit) (35,619) 54,992
Total liabilities and
stockholders' equity (deficit) $186,591 $207,554
SOURCE Jazz Pharmaceuticals, Inc.
