Pharmacyclics, Inc. Reports Financial Results for Fiscal 2010 and for Fourth Quarter 2010

SUNNYVALE, Calif., Sept. 13 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today reported financial results for its fiscal year and fourth quarter which ended June 30, 2010.

During the fiscal year ended June 30, 2010, total revenue recognized under GAAP was $9.3 million. No revenue was generated in the fiscal year ended June 30, 2009. The GAAP net loss reported for the fiscal year ended June 30, 2010 was $15.0 million, or $0.31 per share. This compares to a GAAP net loss for the fiscal year ended June 30, 2009 of $23.5 million, or $0.88 per share.

The non-GAAP net loss for the fiscal year ended June 30, 2010 was $13.6 million, which compares to a non-GAAP net loss of $18.1 million for the year ended June 30, 2009. Reconciliation between GAAP and non-GAAP results is provided at the end of this press release.

Pharmacyclics also reported financial results for the fourth quarter of fiscal 2010. The company incurred a GAAP net loss of $6.8 million, or $0.13 per share and reported revenue of $2.5 million on a GAAP basis. This compares to a GAAP net loss of $5.4 million, or $0.20 per share with no revenue reported for the fourth quarter of fiscal 2009.

The non-GAAP net loss for the fourth quarter of fiscal 2010 was $4.9 million which compares to a non-GAAP net loss of $4.2 million for the fourth quarter of fiscal 2009.

Upon the signing of a drug supply agreement with Les Laboratoires Servier (“Servier”) in the quarter ended December 31, 2009, the company began recognizing revenue from its collaboration agreement with Servier, which was entered into in April 2009.

As of June 30, 2010, the company had cash, cash equivalents and marketable securities totaling $74.1 million. This compares to $16.3 million in cash, cash equivalents and marketable securities as of June 30, 2009. In June 2010, the company raised, in a registered direct offering, $50.8 million, net of approximately $1.6 million in offering costs. Pharmacyclics’ Chairman and CEO, Robert W. Duggan, participated in the offering in the amount of $7.0 million.

Fiscal 2011 Guidance

As a direct result of the success we are generating, accelerated investment for the purpose of collapsing the time required to achieve our goals is called for.

We expect net cash expenditures of approximately $32.5 million which equates to $35.0 million of operational expenses offset by $2.0 million in cash from R&D revenue and $0.5 million from the French Government in the form of a tax return. Approximately 80% of the clinical expenditures in fiscal 2011 will be Btk inhibitor related.

Financial projections involve a high level of uncertainty due to, among other factors, the variability involved in predicting requirements of early stage research programs and clinical trials, the potential for entering into partnering arrangements or strategic collaborations, the timing of U.S. Food and Drug Administration (FDA) decisions and share-based compensation expense.

Commenting on the announcement, Bob Duggan, CEO of Pharmacyclics, said, “Whether you judge by the rapid pace of patient enrollment in BTK inhibitor PCI 32765 clinical trials, broad enthusiasm over the patient outcomes to date, strengthening the balance sheet through equity capital raises, or stock price appreciation year to date, fiscal 2010 was an awesome year. Rest assured the entire Pharmacyclics team is dedicated to producing even better results in fiscal 2011.”

Dr. John Byrd, Ohio State University‘s Director of the Comprehensive Cancer Center, Division of Hematology, added, “It is always nice when pre-clinical studies such as those recently published by Pharmacyclics in PNAS translate to positive results in clinical trials of lymphoma and CLL patients that we and others are now observing. The laboratory and clinical members of the CLL and lymphoma program at OSU are very excited to be involved with the pre-clinical and clinical development of PCI32765.”

Recent and Upcoming Milestones and Program Updates

• Bruton’s Tyrosine Kinase (Btk) Inhibitor, PCI-32765, results from first in human phase I trial were presented at an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting that took place in Chicago, Illinois in June 2010. These results were also presented at the European Hematology Association in Barcelona, Spain in June 2010. The presentations reported data from the ongoing open-label, dose-escalation study of PCI-32765 in recurrent B cell malignancies.
• Trial Results as of August 31, 2010: In the first 6 dose cohorts, a total of 47 relapsed/refractory and progressing patients with a variety of B cell malignancies were enrolled. Forty-one of the enrolled patients had an on-treatment tumor assessment of therapy and are evaluable as of August 31, 2010. Twenty-one of these evaluable patients had a complete or partial response as their best response and eleven patients had stable diseases. This equates to a response rate of 51% in the evaluable patients (69% in CLL, 75% in Mantle, 42% in Follicular, 33% in Marginal and 38% in DLBCL). On an intent-to-treat (“ITT”) basis the overall response rate (“ORR”) was 45%.