-- Reported record sales of $67.3 million, up nine percent over Q3 2006
-- Raising 2007 sales guidance
-- Announced unprecedented Phase Three Vidaza overall survival data in higher-risk MDS
-- Full results to be presented later this year at a major medical conference
-- Planning to file for accelerated approval in Europe by year-end
-- Commenced Phase Three Amrubicin pivotal trial in second-line SCLC
-- Completed SPA with FDA and Scientific Advice with EMEA
-- Accelerated launch preparation activities for Thalidomide in Europe
-- Initiated research collaboration for development of sirtuin inhibitors
-- Initiated MGCD0103 studies in solid tumors (Phase 1) and CLL (Phase 2)
-- Granted Fast Track designation by FDA for oral Azacitidine for MDS
-- Centers open and enrolling for oral Azacitidine MTD study
BOULDER, Colo., Oct. 31 /PRNewswire-FirstCall/ -- Pharmion Corporation
(Nasdaq: PHRM) today reported financial results for its quarter ended
September 30, 2007. Third quarter net sales totaled $67.3 million, compared
to $61.6 million in the third quarter of 2006. Worldwide sales of Vidaza(R)
(azacitidine for injection) totaled $42.3 million in the third quarter of
2007, compared to $36.6 million in the same quarter of 2006. In the U.S.,
sales of Vidaza totaled $33.3 million in the third quarter of 2007, equal to
the same quarter of 2006. Named patient and compassionate use sales of Vidaza
in Europe and other international markets totaled $9.0 million in the third
quarter of 2007, compared to $3.3 million in the third quarter of 2006. Sales
of Thalidomide, including named patient and compassionate use sales in Europe,
totaled $20.2 million in the third quarter of 2007, also equal to the same
period of 2006.
For the nine months ended September 30, 2007, net sales totaled
$195.8 million, compared to net sales of $178.6 million for the nine months
ended September 30, 2006. Worldwide sales of Vidaza totaled $120.5 million in
the first nine months of 2007, compared to $105.6 million in the same period
in 2006. U.S. sales of Vidaza totaled $97.2 million in the first nine months
of 2007, compared to $98.7 million in the same period in 2006. Named patient
and compassionate use sales of Vidaza in Europe and other international
markets totaled $23.3 million in the first nine months of 2007, compared to
$6.9 million in the first nine months of 2006. Sales of Thalidomide totaled
$60.7 million in the first nine months of 2007, compared to $58.8 million in
the same period in 2006.
'We are very pleased with our operating results this quarter and our
continued progress toward what should be a transformative 2008 for Pharmion,'
said Patrick Mahaffy, Pharmion's president and CEO. 'The exceptionally strong
results of the Vidaza Survival study reported this quarter demonstrate
Vidaza's tremendous benefit in treating MDS, and clearly establish survival as
the standard by which treatment options for higher-risk MDS should now be
evaluated. We look forward to the presentation of the study results later
this year and based on these results, we are on track to file for accelerated
approval for Vidaza in Europe by year end. In addition, based on encouraging
progress with the EMEA, we are accelerating our preparation for launch in
Europe for Thalidomide. Finally, we made significant progress advancing our
pipeline; initiating a Phase Three pivotal trial for Amrubicin in
relapsed/refractory small cell lung cancer and furthering the development of
MGCD0103 in solid tumors.'
Pharmion reported a net loss of $(21.4) million, or $(0.58) per share for
the third quarter of 2007. For the nine months ended September 30, 2007, the
Company's net loss totaled $(36.4) million, or $(1.05) per share. The net
loss for the third quarter of 2006 was $(3.6) million, or $(0.11) per share.
For the nine months ended September 30, 2006, the Company's net loss totaled
$(26.8) million, or $(0.84) per share. These net losses include stock
compensation expense for the third quarters of 2007 and 2006 of $1.5 million
and $0.8 million, respectively, and $4.1 million and $2.4 million,
respectively, for the nine months ended September 30, 2007 and 2006. In
addition, the losses for the third quarter and nine months ended September 30,
2007 include a charge of $8 million for a milestone payment triggered by the
acceptance of our marketing authorization application (MAA) for Satraplatin
for the treatment of second-line hormone-refractory prostate cancer by the
European Medicines Agency (EMEA).
The Company made significant progress in the third quarter advancing its
product pipeline. Pharmion initiated several clinical studies across its
portfolio, including a Phase 3 study in small cell lung cancer for Amrubicin,
Phase 1 and Phase 2 studies in solid tumors and CLL for MGCD0103, opened
centers and began enrolling patients in the dose escalation study for oral
Azacitidine, and commenced our research program targeting sirtuin inhibitors.
Research and development (R&D) expenses totaled $29.1 million for the third
quarter of 2007, compared to $16.7 million for the third quarter of 2006.