Pharmacyclics Reports Third Quarter Financial Results and Corporate Update
Conference Call Today at 4:30 p.m. EDT
SUNNYVALE, Calif., April 26, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today reported financial results for its third fiscal quarter ended March 31, 2007. The net loss for the third quarter of fiscal 2007 was $6.8 million, or $0.26 per share, compared to a net loss of $7.4 million, or $0.37 per share, in the third quarter of fiscal 2006. The net loss for the third quarter of fiscal 2007 included $0.9 million of share-based compensation expense, compared to share-based compensation expense of $1.4 million in the third quarter of fiscal 2006.
Total operating expenses were $7.4 million in the third quarter of fiscal 2007 compared to $8.0 million for the third quarter of fiscal 2006, a decrease of $0.6 million. The decrease in total operating expenses in the third quarter of fiscal 2007 was primarily due to a $0.5 million decrease in share- based compensation expense.
Pharmacyclics also reported its financial results for the nine months ended March 31, 2007. The net loss for the nine months ended March 31, 2007 was $19.2 million, or $0.82 per share, compared to a net loss of $27.5 million, or $1.38 per share, for the nine months ended March 31, 2006.
As of March 31, 2007, the company's cash, cash equivalents and marketable securities totaled $44.5 million compared to $40.5 million as of June 30, 2006. In November 2006, the company completed a public offering of 4,830,000 shares of common stock, which resulted in net proceeds to the company of approximately $21.3 million.
Recent Accomplishments
-- On April 23, 2007, we announced that the U.S. Food and Drug
Administration (FDA) had filed our New Drug Application (NDA) for
Xcytrin(R) (motexafin gadolinium) Injection for the treatment of brain
metastases from non-small cell lung cancer. The Prescription Drug User
Fee Act (PDUFA) date for completion of review by FDA is December 31,
2007.
-- After receiving a refusal to file letter from the FDA in February 2007
regarding our Xcytrin NDA, we notified FDA in April that we were
requesting that our NDA be filed over protest.
-- We and our collaborators presented data at the American Association for
Cancer Research (AACR) 2007 Annual Meeting demonstrating the promise of
Pharmacyclics' earlier-stage pipeline of product candidates beyond
Xcytrin to treat other types of cancer:
* Results from laboratory studies demonstrated that the company's
HDAC inhibitor, PCI-24781 inhibits homologous recombination, a
cellular mechanism of DNA repair. This work led to identification
of a biomarker that may be potentially used to predict efficacy
of the drug in patients.
* Results from studies of Pharmacyclics' BTK inhibitor, PCI-31523,
on a variety of B-cell receptor-expressing lymphoma cell lines
demonstrated that multiple diffuse large B-cell lymphoma lines
and follicular lymphoma lines are sensitive to the drug. These
studies support potential use in lymphoma therapy.
"In addition to pursuing approval of Xcytrin, a potentially important new treatment for a major unmet medical need, we are also aggressively developing it for other indications with several ongoing Phase 2 clinical trials," said Richard A. Miller, M.D., president and CEO of Pharmacyclics. "We continue to advance our earlier-stage pipeline of novel small molecules for treatment of cancer and autoimmune diseases."
Conference Call and Webcast Details
The Company will hold a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss third quarter 2007 financial results. To participate in the conference call, please dial 800-497-0451 for domestic callers and 706-758-3306 for international callers and reference conference passcode, 6302772. To access the live audio broadcast or the subsequent archived recording, log on to http://ir.pharmacyclics.com. The archived version of the webcast will be available on the company's website for one month.
About Pharmacyclics
Pharmacyclics is a pharmaceutical company developing innovative products to treat cancer and other serious diseases. The company is leveraging its small-molecule drug development expertise to build a pipeline in oncology and other diseases based on a wide range of targets, pathways and mechanisms. Its lead product, Xcytrin(R), has completed Phase 3 clinical trials and several ongoing Phase 1 and Phase 2 clinical trials are evaluating Xcytrin, either as a single agent or in combination with chemotherapy and/or radiation in multiple cancer types. More information about the company, its technology, and products can be found at www.pharmacyclics.com. Pharmacyclics(R), Xcytrin(R) and the "pentadentate" logo(R) are registered trademarks of Pharmacyclics, Inc.
NOTE: Other than statements of historical fact, the statements made in this press release about plans for our NDA filing, enrollment and future plans for our clinical trials, progress of and reports of results from preclinical and clinical studies, clinical development plans and product development activities are forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. The words "believe," "will," "may," "continue," "plan," "expect," "intend," "anticipate," variations of such words, and similar expressions also identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. The forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements. Factors that could affect actual results include risks associated with the possibility that the FDA declines to schedule an advisory panel meeting to review our NDA; the FDA refuses to approve our NDA; because our Phase 3 clinical trial known as the SMART (Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy) trial failed to meet its primary endpoint, the FDA may require additional data, analysis or studies before the NDA is approved by the FDA; the outcome of any discussions with the FDA; the initiation, timing, design, enrollment and cost of clinical trials; unexpected delays in clinical trials and preparation of materials for submission to the FDA as part of our NDA filing; the fact that data from preclinical studies and Phase 1 or Phase 2 clinical trials may not necessarily be indicative of future clinical trial results; our ability to obtain future financing and fund the preparation of our NDA filing and the product development of our pipeline; our ability to establish successful partnerships and collaborations with third parties; the regulatory approval process in the United States and other countries; and our future capital requirements. For further information about these risks and other factors that may affect the actual results achieved by Pharmacyclics, please see the company's reports as filed with the U.S. Securities and Exchange Commission from time to time, including but not limited to its annual report on Form 10-K for the period ended June 30, 2006 and its subsequently filed quarterly reports on Form 10-Q. Forward-looking statements contained in this announcement are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Pharmacyclics, Inc.
(a development stage enterprise)
Condensed Statements of Operations
(unaudited) (in thousands, except per share data)
Three Months Nine Months
Ended March 31, Ended March 31,
2007 2006 2007 2006
Grant revenue $-- $156 $19 $156
Operating expenses:
Research and development 5,669 5,313 15,557 19,315
General and administrative 1,705 2,685 5,315 9,756
Total operating expenses 7,374 7,998 20,872 29,071
Loss from operations (7,374) (7,842) (20,853) (28,915)
Interest and other income, net 615 467 1,626 1,449
Net loss $(6,759) $(7,375) $(19,227) $(27,466)
Basic and diluted net loss per share $(0.26) $(0.37) $(0.82) $(1.38)
Shares used to compute basic and
diluted net loss per share 25,938 19,904 23,581 19,871
Condensed Balance Sheets
(unaudited, in thousands)
March 31, June 30,
2007 2006
Assets
Cash, cash equivalents and marketable securities $44,541 $40,477
Other current assets 1,105 961
Total current assets 45,646 41,438
Property and equipment, net 868 764
Other noncurrent assets 523 527
$47,037 $42,729
Liabilities and stockholders' equity
Current liabilities $2,387 $3,339
Long-term obligations 75 70
Stockholders' equity 44,575 39,320
$47,037 $42,729
SOURCE Pharmacyclics, Inc.
Leiv Lea of Pharmacyclics, Inc., +1-408-774-0330; or Carolyn Bumgardner Wang of WeissComm Partners, +1-415-225-5050, for Pharmacyclics, Inc.
http://www.pharmacyclics.com/
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