>>BOULDER, Colo., April 26 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM - News) today reported financial results for its first quarter ended March 31, 2005. First quarter net sales totaled $51.7 million, compared to $15.7 million in the first quarter of 2004. Sales of Vidaza® (azacitidine for injectable suspension), launched in the U.S. on July 1, 2004, totaled $27.5 million in the first quarter. First quarter named patient and compassionate use sales of thalidomide totaled $20.3 million, compared to $12.6 million in the first quarter of 2004.
Pharmion reported net income of $4.3 million for the first quarter of 2005, or $0.13 per share, compared to a net loss of $(9.8) million, or a net loss of $(0.40) per share for the first quarter of 2004.
"While we are pleased with our increased profitability this quarter, we remain focused on growing sales, particularly for Vidaza in the U.S.," said Patrick J. Mahaffy, president and chief executive officer of Pharmion. "We are currently implementing our second wave of Vidaza marketing initiatives to complement our commercial efforts to date, focusing on educational activities designed to raise physicians' awareness of the benefit that Vidaza can provide in the treatment of MDS. We believe that this increased awareness will positively affect our sales."
First Quarter Financial Detail
Pharmion's gross margin on net sales was 73 percent in the first quarter of 2005 compared to 60 percent for the first quarter of 2004. This increase is due to the launch of Vidaza as well as improved margins on thalidomide sales following the restructuring of our thalidomide license and supply agreements in the fourth quarter of 2004. Gross margin reflects the cost of product sold as well as royalty payments made to licensors on the sales of Pharmion's products.
Operating expenses, excluding cost of sales, totaled $32.4 million in the first quarter of 2005, compared to $18.2 million in the year-ago quarter. The increase in operating expenses for the first quarter of 2005 over the comparable period in 2004 is due to the expansion of clinical, regulatory and commercial activities to support the Company's products, including Vidaza sales and marketing activities.
Income tax expense totaled $2.9 million in the first quarter of 2005, compared to $0.9 million in the year-ago quarter.
As of March 31, 2005, Pharmion had $244.5 million in cash, cash equivalents and short-term investments, compared to $245.5 million at December 31, 2004. The $1 million decrease primarily reflects cash payments for prior years' product and company acquisitions as well as capital expenditures, offset by $7.5 million in cash generated by operating activities.
Regulatory and Development Update
Pharmion has an extensive development program for Vidaza under way in 2005, including over 30 Company- and investigator-sponsored clinical studies examining the use of Vidaza in the treatment of Myelodysplastic Syndromes (MDS), other hematological malignancies and solid tumors. In addition to two large company-sponsored studies, five investigator-initiated trials are currently in the enrollment stage, and six additional trials are in the final stages of approval and should be open within the next six weeks. The remaining studies will open over the next several months.
The Pharmion-sponsored clinical trials include a survival study of 354 high-risk MDS patients. Enrollment for this study is expected to be completed by the end of 2005. In addition, Pharmion is sponsoring a study examining alternative dosing schedules for Vidaza. The Company began enrolling patients in this study during the first quarter of 2005, and enrollment is expected to be completed by early 2006, with data available in late 2006.
Pharmion's marketing applications for Vidaza were filed in the third quarter of 2004 with the European and Australian regulatory authorities, and continue to be under active review.
With respect to the European marketing approval for thalidomide, Pharmion has initiated a scientific advice procedure with the European regulatory authorities, which will determine what clinical data will be required by the regulatory authorities to support a marketing authorization for thalidomide, initially in relapsed/refractory multiple myeloma. Pharmion expects to complete the first round of meetings with the regulatory authorities in the next several days and expects to be in a position to provide a status update on the European approval process when the Company reports second quarter results. Until Pharmion receives a marketing approval, it will continue to sell thalidomide on a named patient and compassionate use basis throughout Europe and several additional international markets.
2005 Financial Outlook
For 2005, Pharmion continues to expect to report total net sales in a range of $229 to $245 million, driven primarily by anticipated Vidaza sales in the U.S. and thalidomide named patient and compassionate use sales in Europe. The Company anticipates Vidaza sales will range from $130 to $140 million, and thalidomide sales will range from $80 to $86 million. Pharmion expects 2005 earnings per share to be in a range of $0.33 to $0.48 per share.
Pharmion will hold a conference call to discuss first quarter 2005 results tomorrow, April 27, at 8:30 a.m. ET. The conference call will be simultaneously Web cast on the Company's Web site, and archived for future review.<<
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This beats earnings estimates by a ways, but revenues were actually a bit light. Don't think the thalidomide license and supply agreement restructuring would account for all the difference, but I could be wrong. With guidance steady, I'm not expecting a huge move tomorrow. I've been getting interested as the stock has gone into the mid 20s, below most insider purchases. One ting the release doesn't specifically mention is a combo trial with an HDAC inhibitor.
>>JCO Early Release, published online ahead of print Apr 25 2005
Journal of Clinical Oncology, 10.1200/JCO.2005.07.450
Received December 1, 2004
Accepted February 25, 2005
Pharmacokinetics of 5-Azacitidine Given With Phenylbutyrate in Patients With Refractory Solid Tumors or Hematologic Malignancies
Michelle A. Rudek *, Ming Zhao , Ping He , Carol Hartke , Jill Gilbert , Steven D. Gore , Michael A. Carducci , and Sharyn D. Baker
From the Divisions of Medical Oncology, Experimental Therapeutics, and Hematologic Malignancy, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
* To whom correspondence should be addressed. E-mail: mrudek2@jhmi.edu
Purpose: To characterize the pharmacokinetic behavior of 5-azacitidine (5-AC), a cytidine nucleoside analog, when given with phenylbutyrate, a histone deaceytlase inhibitor.
Patients and Methods: Pharmacokinetic data were obtained from two trials involving patients with solid tumor and hematologic malignancies. 5-AC at doses ranging from 10 to 75 mg/m2/d was administered once daily as a subcutaneous injection for 5 to 21 days in combination with phenylbutyrate administered as a continuous intravenous infusion for varying dose and duration every 28 or 35 days. Serial plasma samples were collected up to 24 hours after 5-AC administration. 5-AC was quantitated using a validated liquid chromatograph/tandem mass spectrometry method.
Results: 5-AC was rapidly absorbed with the mean Tmax occurring at 0.47 hour. Average maximum concentration (Cmax) and area under the curve (AUC0-) values increased in a dose-proportionate manner with increasing dose from 10 to 75 mg/m2/d; the mean ± SD Cmax and AUC0- at 10 mg/m2/d were 776 ± 459 nM and 1,355 ± 1,125 h*nM, respectively, and at 75 mg/m2/d were 4,871 ± 1,398 nM and 6,582 ± 2,560 h*nM, respectively. Despite a short terminal half-life of 1.5 ± 2.3 hours, inhibition of DNA methyl transferase activity in tumors of patients receiving 5-AC has been documented.
Conclusion: 5-AC is rapidly absorbed and eliminated when administered subcutaneously. Sufficient 5-AC exposure is achieved to produce pharmacodynamic effects in tumors.<<
Cheers, Tuck |
