Recent Developments & Highlights | |||
Broad Clinical Development Progress for Btk Inhibitor PCI-32765 in B-cell malignancies Pharmacyclics has designed a broad Phase II Program in mantle cell lymphoma, chronic lymphocytic leukemia and diffuse large B-cell lymphoma to inform the Phase III program and regulatory path for PCI-32765. Throughout 2011 we will closely monitor these Phase II studies for confirmatory efficacy and safety signals to establish our regulatory approval strategy in a timely manner. Please refer to our website on the key trials listed below. | |||
- | Mantle Cell Lymphoma (MCL) | ||
Our Phase IA results in the MCL subset presented at the 2010 American Society of Hematology (ASH) Meeting showed promising activity. We therefore designed a Phase II program which includes 1) an evaluation of PCI-32765 as a single agent in 2 groups (cohorts) of patients with relapsed or refractory disease, those who have failed bortezomib and those who have not yet received bortezomib and 2) a safety study of PCI-32765 in combination with bortezomib. The single agent trial protocol has been developed and we expect to enroll a total of approximately 100 patients, beginning in Q1 of calendar year 2011. | |||
- | Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL) | ||
The Phase IB/II CLL/SLL program is well underway; to date we have dosed 75 patients and plan to complete enrollment by adding another 7 patients during the remainder of Q1 of calendar 2011. We are also evaluating the safety of PCI-32765 in combination with ofatumumab in a Phase IB/II study of patients with relapsed/refractory CLL/SLL. We began enrollment in this study in January of 2011 and expect to dose up to 40 patients and complete enrollment in the second half of calendar year 2011. We also plan to evaluate the safety of PCI-32765 in combination with several other common therapies in CLL and expect to begin enrollment in Q2 of calendar year 2011. | |||
- | Diffuse Large B-Cell Lymphoma (DLBCL) | ||
Research has demonstrated that there are 2 distinct molecular subtypes in diffuse large B-cell lymphoma (ABC and GCB). Activated B-cell, or ABC, is the poorer prognostic subtype and is characterized by activation of the B-cell receptor signaling pathway. Our Phase II program will evaluate 2 separate cohorts of patients with relapsed or refractory DLBCL who will receive single agent PCI-32765, those lymphoma patients with ABC and those with germinal center B-cell (GCB), the other molecular subtype. This study will evaluate safety and efficacy in approximately 60 patients. We anticipate that enrollment will begin during the first half of 2011. In parallel, we are also developing a Phase II safety trial combining PCI-32765 with chemotherapy in patients with relapsed or refractory DLBCL. | |||
Abstract submitted to the 47th Annual Meeting of the American Society of Clinical Oncology (June 3 — 7, 2011) based on the Phase IB/II study data, evaluating safety and efficacy of administering the Btk Inhibitor, PCI-32765 as a single agent in CLL/SLL patients | |||
Poster presentation at the 2011 GI Cancers Symposium of first in human Phase I results of Factor VIIa Inhibitor, PCI-27483 In the Phase I portion of the study, ascending repeated doses of PCI-27483 (dosages ranging from 0.8 to 1.5 mg/kg) were evaluated in 8 patients with pancreatic cancer receiving concomitant gemcitabine chemotherapy. Among the 5 patients in Phase I considered evaluable, all 5 had stable disease at week 12 and opted to extend treatment with PCI-27483. Three of the 5 patients have a progression free survival > / = 30 weeks (7 months). None of the patients receiving PCI-27483 experienced a thromboembolic event. We are currently in the Phase II portion of the study enrolling patients who receive either gemcitabine alone or gemcitabine plus PCI-27483 (dose at 1.2 mg/kg twice daily). We anticipate completion of enrollment in the Phase II portion during calendar year 2011. | |||
Financial Results for Second Quarter Fiscal 2011
The non-GAAP (Generally Accepted Accounting Principles) net loss reported for the fiscal quarter ended
The GAAP net loss for the fiscal quarter ended
Total revenue was
As of
Mr. Duggan stated, "Our Btk Inhibitor, our Factor VII Inhibitor and our HDAC Inhibitor are now in Phase II. We are pleased with our progress and remain focused on building shareholder value by continuing on the regulatory pathways we have set."
Conference Call and Webcast Details
The Company will hold a conference call today at
For further questions please contact Ramses Erdtmann, VP Finance at: 408-215-3325
Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, and includes operating and other expenses adjusted to exclude certain non-cash and non-recurring expenses. These measures are not in accordance with, or an alternative for generally accepted accounting principles, or GAAP, and may be different from non-GAAP financial measures used by other companies. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures that we present are: non-cash interest expense associated with the loan from an affiliate of
About
Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medial healthcare needs; and to identify promising product candidates based on scientific development expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.
Presently,
The Company is headquartered in
NOTE: This announcement may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations and beliefs regarding our future results or performance. Because these statements apply to future events, they are subject to risks and uncertainties. When used in this announcement, the words "anticipate", "believe", "estimate", "expect", "expectation", "should", "would", "project", "plan", "predict", "intend" and similar expressions are intended to identify such forward-looking statements. Our actual results could differ materially from those projected in the forward-looking statements. Additionally, you should not consider past results to be an indication of our future performance. For a
discussion of the risk factors and other factors that may affect our results, please see the Risk Factors section of our filings with the
Pharmacyclics, Inc. (a development stage enterprise) Condensed Consolidated Balance Sheets (unaudited; in thousands) | ||||
December 31, 2010 | June 30, 2010 | |||
ASSETS | ||||
Cash, cash equivalents and marketable securities* | $ 61,610 | $ 74,149 | ||
Other current assets | 1,751 | 1,896 | ||
Total current assets | 63,361 | 76,045 | ||
Property and equipment, net | 536 | 459 | ||
Other assets | 315 | 316 | ||
Total assets | $ 64,212 | $ 76,820 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Deferred revenue | $ 2,368 | $ 6,099 | ||
Other current liabilities | 4,483 | 3,910 | ||
Total current liabilities | 6,851 | 10,009 | ||
Deferred rent | 36 | 50 | ||
Total liabilities | 6,887 | 10,059 | ||
Stockholders' equity | 57,325 | 66,761 | ||
Total liabilities and stockholders' equity | $ 64,212 | $ 76,820 | ||
* Marketable securities | $ 43,771 | $ 22,950 | ||
Pharmacyclics, Inc. (a development stage enterprise) Condensed Consolidated Statements of Operations (unaudited; in thousands, except per share data) | ||||||||
Three Months Ended December 31, | Six Months Ended December 31, | |||||||
2010 | 2009 | 2010 | 2009 | |||||
Revenues: | ||||||||
License and milestone revenues | $ 2,824 | $ 4,702 | $ 4,788 | $ 4,702 | ||||
Total revenues | 2,824 | 4,702 | 4,788 | 4,702 | ||||
Operating expenses: | ||||||||
Research and development | 8,256 | 3,723 | 15,958 | 7,011 | ||||
General and administrative | 2,093 | 1,765 | 3,927 | 3,298 | ||||
Total operating expenses | 10,349 | 5,488 | 19,885 | 10,309 | ||||
Loss from operations | (7,525) | (786) | (15,097) | (5,607) | ||||
Interest and other income (expense), net | 26 | 18 | 75 | (6) | ||||
Loss before provision for income tax | (7,499) | (768) | (15,022) | (5,613) | ||||
Benefit from income tax | - | 550 | - | 550 | ||||
Net loss | $ (7,499) | $ (218) | $ (15,022) | $ (5,063) | ||||
Basic and diluted net loss per share | $ (0.13) | $ (0.00) | $ (0.25) | $ (0.11) | ||||
Shares used to compute basic and | ||||||||
diluted net loss per share | 59,715 | 50,076 | 59,497 | 45,535 | ||||
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1) (unaudited; in thousands, except per share data) | ||||
Three Months Ended December 31, | ||||
2010 | 2009 | |||
GAAP net loss | $ (7,499) | $ (218) | ||
Adjustments: | ||||
Research & development share-based compensation(2) | 1,267 | 216 | ||
General & administrative share-based compensation(2) | 671 | 356 | ||
Income tax adjustment(3) | - | (550) | ||
Therapeutic discovery project tax grant, net(4) | (586) | - | ||
1,352 | 22 | |||
License and collaboration revenues(5) | - | (1,211) | ||
- | (1,211) | |||
Non-GAAP net loss | $ (6,147) | $ (1,407) | ||
Non-GAAP net loss per share | $ (0.10) | $ (0.03) | ||
(1) This presentation includes non-GAAP measures. Our non-GAAP measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read only in conjunction with our financial statements prepared in accordance with GAAP. (2) All share-based compensation was excluded for the non-GAAP analysis. (3) Represents a reclaiming of paid French Withholding Tax of $550 thousand for the $11 million upfront payment from Servier. (4) Represents the therapeutic discovery project tax grant, net of related expenses. (5) Represents the pro-rata portion of services performed under the Servier Collaboration arrangement prior to fiscal year 2010. | |
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1) (unaudited; in thousands, except per share data) | ||||
Six Months Ended December 31, | ||||
2010 | 2009 | |||
GAAP net loss | $ (15,022) | $ (5,063) | ||
Adjustments: | ||||
Research & development share-based compensation(2) | 2,961 | 374 | ||
General & administrative share-based compensation(2) | 1,149 | 446 | ||
Interest adjustment for related party loan(3) | - | 21 | ||
Income tax adjustment(4) | - | (550) | ||
Therapeutic discovery project tax grant, net(5) | (586) | - | ||
3,524 | 291 | |||
License and collaboration revenues(6) | - | (1,211) | ||
- | (1,211) | |||
Non-GAAP net loss | $ (11,498) | $ (5,983) | ||
Non-GAAP net loss per share | $ (0.19) | $ (0.13) | ||
(1) This presentation includes non-GAAP measures. Our non-GAAP measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read only in conjunction with our financial statements prepared in accordance with GAAP. | |
(2) All share-based compensation was excluded for the non-GAAP analysis. | |
(3) Due to the below market interest rate of the related party loan, total GAAP interest expense includes non-cash interest expense of $21 for the six months ended December 31, 2009. | |
(4) Represents a reclaiming of paid French Withholding Tax of $550 thousand for the $11 million upfront payment from Servier. | |
(5) Represents the therapeutic discovery project tax grant, net of related expenses. | |
(6) Represents the pro-rata portion of services performed under the Servier Collaboration arrangement prior to fiscal year 2010. | |
SOURCE
News Provided by Acquire Media
