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Pharmion Corporation Reports Net Sales of $65.8 Million for Q2 2007
Record sales quarter, up nine percent over Q2 2006
GAAP net loss of $9.3 million, or $(0.27) per share
BOULDER, Colo., July 25 /PRNewswire-FirstCall/ -- Pharmion Corporation
( PHRM) today reported financial results for its quarter ended June
30, 2007. Second quarter net sales totaled $65.8 million, compared to $60.4
million in the second quarter of 2006. Worldwide sales of Vidaza(R)
(azacitidine for injection) totaled $40.5 million in the second quarter of
2007, compared to $36.1 million in the same quarter of 2006. In the U.S.,
sales of Vidaza totaled $32.5 million in the second quarter of 2007,
compared to $33.7 million in the same quarter of 2006, reflecting
relatively constant sales despite the entry of two competitive products to
the U.S. Myelodysplastic Syndromes (MDS) market during 2006. Named patient
and compassionate use sales of Vidaza in Europe and other international
markets totaled $8.0 million in the second quarter of 2007, compared to
$2.4 million in the second quarter of 2006. Sales of Thalidomide, including
named patient and compassionate use sales in Europe, totaled $20.4 million
in the second quarter of 2007, compared to $19.1 million in the same period
of 2006.
For the six months ended June 30, 2007, net sales totaled $128.5
million, compared to net sales of $117.0 million for the six months ended
June 30, 2006. Worldwide sales of Vidaza totaled $78.2 million in the first
six months of 2007, compared to $69.0 million in the same period in 2006.
U.S. sales of Vidaza totaled $63.8 million in the first six months of 2007,
compared to $65.4 million in the same period in 2006. Named patient and
compassionate use sales of Vidaza in Europe and other international markets
totaled $14.4 million in the first half of 2007, compared to $3.6 million
in the first half of 2006. Sales of Thalidomide totaled $40.5 million in
the first six months of 2007, compared to $38.6 million in the same period
in 2006.
"We are pleased with our financial results for the quarter, achieving
record sales in total and for Vidaza," said Patrick J. Mahaffy, Pharmion's
president and CEO. "Our core business is strong and growing and we see the
potential for significant revenue growth beginning in 2008 based on
European product approvals. In fact, we are currently accelerating
pre-launch activities for Thalidomide Pharmion. And, most important to our
near term growth prospects, we look forward to seeing the results from our
Vidaza survival study in higher-risk MDS, which are expected in the next
three to six weeks. In addition, we intend to initiate the Phase 3 pivotal
study for Amrubicin in second-line SCLC later this year, and follow with a
registrational program for MGCD0103 in 2008."
Q2 2007 Financial Highlights
Pharmion reported a net loss of $(9.3) million, or $(0.27) per share
for the second quarter of 2007. For the six months ended June 30, 2007, the
Company's net loss totaled $(14.9) million, or $(0.45) per share. The net
loss for the second quarter of 2006 was $(3.5) million, or $(0.11) per
share. For the six months ended June 30, 2006, the Company's net loss
totaled $(23.3) million, or $(0.73) per share. These net losses include
stock compensation expense for the second quarters of 2007 and 2006 of $1.4
million and $0.8 million, respectively, and $2.6 million and $1.6 million,
respectively, for the six months ended June 30, 2007 and 2006.
Research and development (R&D) expenses totaled $22.8 million for the
second quarter of 2007, compared to R&D expenses for the second quarter of
2006 of $18.4 million. For the six months ended June 30, 2007, research and
development costs totaled $42.9 million, compared to $33.5 million for the
six-month period ended June 30, 2006. These increases in R&D spending were
expected and were driven primarily by the expanded clinical development
activities for Amrubicin, Thalidomide, oral Azacitidine and MGCD0103 during
2007.
Selling, general and administrative expenses totaled $32.1 million for
the second quarter of 2007, compared to selling, general and administrative
expenses for the second quarter of 2006 of $26.0 million. For the first
half of 2007, selling, general and administrative expenses totaled $60.7
million, compared to $48.5 million in the first six months of 2006. These
increases in selling, general and administrative expenses are primarily due
to expanded commercial activities for Vidaza in the U.S. in response to the
expanding and more competitive U.S. MDS market and the Company's investment
in pre-approval activities in Europe for Thalidomide, Satraplatin and
Vidaza.
In connection with the acceptance of the marketing authorization
application for Satraplatin in the E.U., the Company will pay an $8 million
milestone fee to GPC Biotech. This charge will be paid and reflected in the
Company's third quarter financial results.
As of June 30, 2007, the Company had $259.2 million in cash, cash
equivalents and short-term investments, and no outstanding debt.
2007 Milestones and Objectives
Pharmion has a number of important clinical, regulatory and development
objectives planned or underway in 2007 for each of its key products, and
made significant progress against those objectives during the second
quarter:
Thalidomide
-- The Company announced that the French regulatory authority has granted
an Autorisation Temporaire d'Utilisation (ATU), or Temporary
Authorization for Use, for Thalidomide for the treatment of untreated
multiple myeloma. An ATU is the regulatory mechanism used by the
French Health Products and Safety Agency to make non-approved drugs
available to patients in France when a genuine public health need
exists. This ATU allows Pharmion to supply Thalidomide to elderly
patients with untreated multiple myeloma on a cohort basis, and expands
the ATU previously granted for Thalidomide for the treatment of
relapsed/refractory multiple myeloma patients to include previously
untreated multiple myeloma patients.
-- Pharmion continues to work toward a potential recommendation for
approval from the European Medicines Agency (EMEA) by the end of 2007
for Thalidomide in combination with standard chemotherapy for the
treatment of untreated multiple myeloma. The Company's marketing
authorization application (MAA) was submitted in January. Based on this
progress, the Company is accelerating its pre-launch activities for
Thalidomide Pharmion.
Vidaza, MGCD0103 and oral Azacitidine
-- The Company expects to announce top line results from the Vidaza
survival study, the largest MDS study completed to date, within the
next three to six weeks. The study of 358 patients with higher-risk
MDS is expected to serve as the basis for the Company's MAA to the
European Medicines Agency (EMEA), which the Company plans to file by
the end of 2007.
-- The Company announced the initiation of a second multi-dose Phase 1
trial of oral Azacitidine, which is a multi-center, open label dose
escalation trial that will assess the maximum tolerated dose, dose
limiting toxicities and safety of a seven day, multi-cycle dosing
regimen in patients with MDS and AML. The trial will examine
pharmacokinetics and pharmacodynamic effects of orally administered
Azacitidine, as compared with the FDA-approved parenteral regimen,
which is marketed by Pharmion as Vidaza(R) (azacitidine for injection).
In addition, Pharmion announced the results of a pilot study
demonstrating the bioavailability of oral Azacitidine at the ASCO
annual meeting.
-- Pharmion and its partner MethylGene Inc. announced strong interim Phase
2 results for HDAC inhibitor MGCD0103 in Hodgkin's lymphoma at the ASCO
Annual Meeting, and the Companies are planning to initiate a pivotal
registration program in the near term for MGCD0103 either as
monotherapy or in combination with Vidaza in a hematological
malignancy.
Amrubicin
-- The Company expects to initiate a pivotal registration program for
Amrubicin in the treatment of second-line small cell lung cancer during
the second half of 2007, following the completion of a special protocol
assessment submitted to the U.S. FDA earlier this year. In parallel,
the Company is currently seeking scientific advice from European
regulators. The Company also plans to initiate a clinical program for
Amrubicin in breast cancer. Amrubicin has been approved in Japan for
the treatment of lung cancer since 2002.
Satraplatin
-- The Company submitted and has had accepted for review an MAA with
European regulatory authorities for Satraplatin in combination with
prednisone for the treatment of second-line hormone-refractory prostate
cancer (HRPC) in June which has been accepted for review. There are
currently no approved drugs for second-line use and limited
satisfaction with existing treatment options for HRPC. The MAA is
based on the progression-free survival (PFS) data and will be
supplemented with the overall survival data from the double-blind,
randomized Phase 3 registrational trial, SPARC (Satraplatin and
Prednisone Against Refractory Cancer).
2007 Financial Outlook
Updating its financial guidance announced in April, Pharmion expects to
report total net sales for 2007 in a range of $250 to $260 million, up from
the previous guidance of $245 to $255 million. Research and development
expenses for 2007 are expected to total approximately $85 to $95 million,
adjusted from the previous guidance of $90 to $100 million. Selling,
general and administrative expense for 2007 is expected to total
approximately $120 million, up from a range of $115 to $120 million. The
Company expects to record a charge of $8 million for acquired in-process
research in the third quarter of 2007 for the payment of a regulatory
milestone to GPC Biotech upon the acceptance of the filing of the MAA in
the EU for Satraplatin. Finally, the Company expects to end 2007 with
approximately $225 to $235 million of cash, cash equivalents and short-term
investments, an increase from previous guidance of $80 to $90 million. This
increase is primarily due to the addition of the $130 million in net
proceeds from the Company's equity offering completed in June 2007.
Pharmion will hold a conference call to discuss second quarter 2007
results later this afternoon, July 25, at 5:00 p.m. ET. The conference call
will be simultaneously webcast on the Company's web site at
http://www.pharmion.com, and archived for future review. Dial-in numbers
for the conference call for institutional investors and analysts are as
follows: participants from the U.S. 866.713.8564, International
participants 617.597.5312, passcode: 71816892.
About Pharmion
Pharmion is a leading global oncology company focused on acquiring,
developing and commercializing innovative products for the treatment of
hematology and oncology patients in the U.S., Europe and additional
international markets. Pharmion has a number of products on the market
including the world's first approved epigenetic drug, Vidaza(R), a DNA
demethylating agent. For additional information about Pharmion, please
visit the company's website at http://www.pharmion.com.
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995: This release contains forward-looking statements, which
express the current beliefs and expectations of management, including
Pharmion's plans for clinical development and regulatory submissions of
Pharmion's products and product candidates, and Pharmion's anticipated
financial results for 2006. Such statements are based on current
expectations and involve a number of known and unknown risks and
uncertainties that could cause Pharmion's future results, performance or
achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such differences
include the outcome of ongoing clinical trials, the status and timing or
regulatory approvals for Pharmion's product candidates; the impact of
competition from other products under development by Pharmion's
competitors; the regulatory environment and changes in the health policies
and structure of various countries; uncertainties regarding market
acceptance of products newly launched, currently being sold or in
development; Pharmion's ability to successfully acquire rights to, develop
and commercialize additional pharmaceutical products; failure of
third-party manufacturers to produce the product volumes required on a
timely basis, fluctuations in currency exchange rates, and other factors
that are discussed in Pharmion's filings with the U.S. Securities and
Exchange Commission. Forward-looking statements speak only as of the date
on which they are made, and Pharmion undertakes no obligation to update
publicly or revise any forward-looking statement, whether as a result of
new information, future developments or otherwise.
PHARMION CORPORATION
CONSOLIDATED FINANCIAL RESULTS
(In thousands, except for per share amounts)
Unaudited
Three Months Ended Six Months Ended
June 30, June 30,
2007 2006 2007 2006
Net sales $65,838 $60,366 $128,519 $116,960
Operating expenses:
Cost of sales, inclusive of
royalties, exclusive of
product rights amortization 18,167 16,672 35,105 31,885
Research and development 22,838 18,386 42,874 33,519
Acquired in-process research -- -- -- 20,480
Selling, general and administrative 32,086 25,986 60,652 48,498
Product rights amortization 2,470 2,451 4,932 4,890
Total operating expenses 75,561 63,495 143,563 139,272
Operating loss (9,723) (3,129) (15,044) (22,312)
Interest and other income, net 2,249 1,755 3,457 3,416
Loss before taxes (7,474) (1,374) (11,587) (18,896)
Income tax expense 1,814 2,140 3,357 4,354
Net loss $(9,288) $(3,514) $(14,944) $(23,250)
Net loss per common share:
Basic and Diluted $(0.27) $(0.11) $(0.45) $(0.73)
Weighted average number of common
and common equivalent shares used to
calculate net loss per common share:
Basic and Diluted 34,339 32,007 33,241 31,963
CONSOLIDATED BALANCE SHEET DATA
June 30, 2007 December 31, 2006
Cash, cash equivalents and short-term
investments $259,245 $136,213
Total assets 451,413 326,732
Total liabilities 58,831 53,650
Total stockholders' equity 392,582 273,082
SOURCE Pharmion Corporation













