Pharmacyclics first quarter GAAP net loss increases to $14.5M

Pharmacyclics, Inc. (Nasdaq: PCYC) today reported financial results and recent developments for its fiscal first quarter ended September 30, 2011.

Financial Results for First Quarter Ended September 30, 2011

The non-GAAP (Generally Accepted Accounting Principles) net loss reported for the fiscal quarter ended September 30, 2011 was $12.4 million, or $0.18 per share. This compares with a non-GAAP net loss of $5.4 million, or $0.09 per share, for the fiscal quarter ended September 30, 2010. See "Use of Non-GAAP Financial Measures" below for a description of our Non-GAAP measures.  Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.

The GAAP net loss for the fiscal quarter ended September 30, 2011 was $14.5 million, or $0.21 per share. This compares with a GAAP net loss of $7.5 million, or $0.13 per share for the fiscal quarter ended September 30, 2010.

At September 30, 2011, the company had cash, cash equivalents and marketable securities of $105.2 million, which compares with $112.3 million at June 30, 2011.  

"Making a significant difference for the betterment of patients, their care givers and society is an obligation Team Pharmacyclics considers an honor. We continue to be willing to do whatever it takes, including learning from our successes as well as our mistakes as we proceed on our journey towards sustained viability in service to patients suffering from serious unmet health care needs," said Bob Duggan, CEO and Chairman of the Board.  "We are pleased with how much we have accomplished over the past few years and how well we have done it. We are well into the second quarter of our fiscal year 2012  and the future we are postulating for our stakeholders looks increasingly attainable."

Recent Developments & Highlights

Six Oral Presentations and two Poster Presentations for Btk Inhibitor, PCI-32765, have been accepted at the American Society of Hematology (ASH) Annual Meeting in San Diego, CA (Dec 10-13th, 2011).  The clinical presentations during ASH will provide significant updates regarding the efficacy and safety of PCI-32765 in chronic lymphocytic leukemia, mantle cell lymphoma, and activated B-cell subtype diffuse large B-cell lymphoma. The company will hold a conference call following the ASH presentations on December 14th, 2011. The abstracts will be published today on the ASH website at www.hematology.org at approximately 10:00 a.m. ET.

Clinical Presentations

• Mantle Cell Lymphoma Oral Presentation
  • Title: The Bruton's Tyrosine Kinase Inhibitor PCI-32765 Is Highly Active As Single-Agent Therapy in Previously-Treated Mantle Cell Lymphoma (MCL): Preliminary Results of a Phase II Trial (#442)
  • Session: Lymphoma - Therapy with Biologic Agents, excluding Pre-Clinical Models: Mantle Cell and T Cell Lymphoma - Targeted Antibody and Small Molecule Approaches
  • Date/Time: Monday, December 12, 2011; 11:15 a.m. Pacific Time
  • Location: Ballroom 20A
  • Presenter: Michael Wang, MD, University of Texas MD Anderson Cancer Center, Houston, TX

• Chronic Lymphocytic Leukemia Oral Presentation
  • Title: The Bruton's Tyrosine Kinase (BTK) Inhibitor PCI-32765 Induces Durable Responses in Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): Follow-up of a Phase Ib/II Study (#983)
  • Session: CLL - Therapy, excluding Transplantation: Relapse treatment, novel agents and treatment related complications
  • Date/Time: Tuesday, December 13, 2011; 8:30 a.m. Pacific Time 
  • Location: Ballroom 20A
  • Presenter: Susan O'Brien, MD, University of Texas MD Anderson Cancer Center, Houston, TX

• Diffuse Large B-Cell Lymphoma Poster Presentation
  • Title: The Bruton's Tyrosine Kinase (BTK) Inhibitor PCI-32765 Modulates Chronic Active BCR Signaling and Induces Tumor Regression in Relapsed/Refractory ABC DLBCL (#2716)
  • Session: Lymphoma – Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster II
  • Date/Time: Sunday, December 11, 2011; 6:00 p.m. – 8:00 p.m. Pacific Time
  • Location: Hall GH
  • Presenter: Joseph Buggy, PhD, Pharmacyclics, Inc., Sunnyvale, CA

Non-Clinical Presentations

• Multiple Myeloma and Waldenstrom Oral Presentation
• Title: Targeting Bruton's Tyrosine Kinase with PCI-32765 Blocks Growth and Survival of Multiple Myeloma and Waldenstrom Macroglobulinemia via Potent Inhibition of Osteoclastogenesis, Cytokines/Chemokine secretion, and Myeloma Stem-like Cells in the Bone Marrow Microenvironment (#883)
• Session: Myeloma - Pathophysiology and Pre-Clinical Studies, excluding Therapy: Targeting the Microenvironment
• Date/Time: Monday, December 12, 2011; 6:15 p.m. Pacific Time
• Location: Room 6A
• Presenter: Yu-Tzu Tai, PhD, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA
• Chronic Lymphocytic Leukemia Oral Presentation
  • Title: The Bruton Tyrosine Kinase Inhibitor, PCI-32765, Inhibits Activation and Proliferation of Human Chronic Lymphocytic Leukemia Cells in the NSG Xenograph Mouse Model of the Tissue Microenvironment (#596)
  • Session: Pre-Clinical – Chemotherapy and Biologic Agents: Novel targeted therapy of B-cell malignancies
  • Date/Time: Monday, December 12, 2011; 3:00 p.m. Pacific Time
  • Location: Room 31
  • Presenter: Sarah E. M. Herman, PhD, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland
• Chronic Lymphocytic Leukemia Oral Presentation
  • Title: Btk Inhibitor, PCI-32765, Delays CLL Progression in a TCL1 Adoptive Transfer Model by Impairing Migration and Cell Proliferation (#982)
  • Session: CLL - Therapy, excluding Transplantation: Relapse treatment, novel agents and treatment related complications
  • Date/Time: Tuesday, December 13, 2011; 8:15 a.m. Pacific Time
  • Location: Ballroom 20A
  • Presenter: Shih-Shih Chen, PhD, The Feinstein Institute for Medical Research, North Shore-Long Island Jewish Health System, Manhasset, NY
• Mantle Cell Lymphoma Oral Presentation
  • Title: Egress of CD19+CD5+ Cells Into Peripheral Blood Following Treatment with the Bruton Tyrosine Kinase Inhibitor, PCI-32765, in Mantle Cell Lymphoma Patients (#954)
  • Session: Non-Hodgkin Lymphoma - Biology, excluding Therapy: Clinical Determinants and Microenvironment  
  • Date/Time: Tuesday, December 13, 2011; 8:45 a.m. Pacific Time
  • Location: Room 5AB
  • Presenter: Betty Y. Chang, PhD, Pharmacyclics, Inc., Sunnyvale, CA
• Mantle Cell Lymphoma Poster Presentation
  • Title: Activity of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Mantle Cell Lymphoma (MCL) Identifies Btk As a Novel Therapeutic Target (#3688)
  • Session: Non-Hodgkin Lymphoma - Biology, excluding Therapy: Poster III
  • Date/Time: Monday, December 12, 2011, 6:00 PM - 8:00 pm Pacific Time
  • Location: San Diego Convention Center, Hall GH
  • Presenter: Jan A. Burger, MD, The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia, Houston, TX