Pharmacyclics, Inc. (PCYC)

[surf1944]

Pharmacyclics Reports First Quarter 2008 Financial Results
Thursday October 25, 7:30 am ET
- Company to Host Conference Call at 4:30 p.m. EDT Today -

SUNNYVALE, Calif., Oct. 25 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC - News) today reported financial results for its first fiscal quarter ended September 30, 2007. The net loss for the first quarter of fiscal 2008, was $6.8 million, or $0.26 per share, compared to a net loss of $6.5 million, or $0.31 per share, in the first quarter of fiscal 2007.

Total operating expenses were $7.3 million in the first quarter of fiscal 2008 compared to $7.0 million for the first quarter of fiscal 2007, an increase of $0.3 million. Share-based compensation expense was $0.7 million in the first quarter of fiscal 2008 compared to $0.8 million in the first quarter of fiscal 2007. The increase in total operating expenses in the first quarter of fiscal 2008 was primarily due to increased pre-clinical and drug manufacturing expenses associated with the Company's HDAC, Factor VIIa and Btk inhibitor programs, partially offset by reduced personnel expenses due to lower headcount.

As of September 30, 2007, the company's cash, cash equivalents and marketable securities totaled $32.3 million compared to $38.8 million at June 30, 2007.

"We now have multiple investigational products across all stages of development that are rapidly moving forward in clinical and pre-clinical testing, which should lead to strong milestone momentum in the next several months," said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics.

Recent Accomplishments and Upcoming Milestones

-- Completion of FDA review of the new drug application (NDA) for Xcytrin
by December 31, 2007, the Prescription Drug User Free Act (PDUFA) date;
the company does not anticipate presenting to an FDA oncology drug
advisory committee (ODAC) meeting prior to the PDUFA date.
-- Presented preliminary results from three open-label, multi-center Phase
2 clinical trials evaluating Xcytrin as a single-agent and in
combination with chemotherapy as a second-line treatment for patients
with non-small cell lung cancer (NSCLC) who failed at least one
platinum-based chemotherapy regimen. The results support Xcytrin's
activity in lung cancer, with patients who failed previous treatment
with a platinum therapy exhibiting tumor responses and a high
proportion of stable disease following single-agent treatment with
Xcytrin. Presentations took place at the 12th World Conference on Lung
Cancer of the International Association for the Study of Lung Cancer.
-- Completed patient enrollment in three ongoing Phase 2 clinical trials
of Xcytrin in NSCLC and anticipate reporting final results in the first
half of calendar year 2008.
-- Initiated a Phase 1/2 trial evaluating our oral HDAC inhibitor in solid
tumors.
-- Presentation of abstracts on our HDAC and Factor VIIa inhibitor product
candidates at the European Organization for Research and Treatment of
Cancer (EORTC) meeting in October 2007.
-- Presentation of abstracts on our HDAC, Factor VIIa and Btk inhibitor
product candidates at the 49th Annual Meeting of the American Society
of Hematology (ASH) in December 2007.
-- Initiation of Phase 1/2 trial evaluating oral HDAC inhibitor in
hematologic malignancies in early calendar 2008.
-- Filing an investigational new drug application for the company's Factor
VIIa inhibitor in the first quarter of calendar year 2008.
-- Filing an investigational new drug application for the company's small
molecule Btk inhibitor in the second quarter of calendar year 2008.
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