SUNNYVALE, Calif., May 1, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today reported financial results and recent developments for its three months ended March 31, 2013.
Financial Results for the Three Months Ended March 31, 2013 Non-GAAP net loss reported for the quarter ended March 31, 2013 was $28.3 million, or $0.40 loss per share compared to non-GAAP net loss of $9.3 million, or $0.14 loss per share for the quarter ended March 31, 2012. 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.
As reported on April 11, 2013, the Company earned a $50 million milestone payment obligation under its collaboration and license agreement (the "Agreement") with Janssen Biotech, Inc. and its affiliates ("Janssen") as a result of the enrollment of a fifth patient in a study using ibrutinib (PCI-32765) as a monotherapy versus chlorambucil in elderly patients with newly diagnosed chronic lymphocytic lymphoma/small lymphocytic lymphoma. The $28.3 million non-GAAP net loss for the quarter ended March 31, 2013 did not include the $50 million milestone earned on April 11, 2013. The Company will record the above milestone as revenue for the quarter ending June 30, 2013. As such, the Company expects non-GAAP net income/loss to be near break-even for the quarter ending June 30, 2013 and also for the full year ending December 31, 2013. This includes the assumption of costs by Janssen in excess of the $50 million annual cap per calendar year ("Excess Amounts") under the Agreement with Janssen.
The generally accepted accounting principles ("GAAP") net loss for the quarter ended March 31, 2013 was $51.9 million, or $0.73 loss per share. This includes stock-based compensation expense of $23.6 million. For the quarter ended March 31, 2012, GAAP net loss was $12.8 million, or $0.19 loss per share. This includes stock-based compensation expense of $3.5 million.
The increase of the stock-based compensation expense to $23.6 million for the three months ended March 31, 2013 compared to $3.5 million for the three months ended March 31, 2012 was primarily related to the timing and accounting of grants for performance-based stock options, share price appreciation and the growth in the Company's employee base. For the remainder of 2013 the Company expects stock-based compensation expense to average $18 million to $22 million per quarter.
GAAP operating expenses were $55.8 million for the quarter ended March 31, 2013, compared to $19.9 million for the quarter ended March 31, 2012. No Excess Amounts were recognized as a reduction to operating expenses for the three months ended March 31, 2013 and 2012.
As of March 31, 2013, the Company had cash, cash equivalents and marketable securities of $511.2 million, compared with $317.1 million as of December 31, 2012. As previously announced, during the three months ended March 31, 2013, the Company sold 2.2 million shares of its common stock in an underwritten public offering for net proceeds of $201.0 million. The net proceeds from the public stock offering were received during the three months ended March 31, 2013.
As previously disclosed in our earnings release for the quarter ended December 31, 2012, the Company expected to end the calendar year 2013 with cash, cash equivalents and marketable securities of more than $225 million. With net proceeds of $201 million from the underwritten public offering and additional milestones expected to be earned during the calendar year, the Company now expects to end 2013 with approximately $500 million in cash, cash equivalents, marketable securities and receivables due from our collaboration partner.
To date, the Company has earned four milestone payments under the Agreement with Janssen of $50 million each, totaling $200 million, including the $50 million milestone earned on April 11, 2013, which the Company expects to collect during the quarter ended June 30, 2013. The Company may earn up to an additional $625 million in development and regulatory milestone payments, however, clinical development entails risks and the Company has no assurance as to whether or when the milestone targets might be achieved.
The Agreement with Janssen includes a cost sharing arrangement for certain development activities. In general, Janssen is responsible for approximately 60% of development costs and the Company is responsible for 40% of development costs. The Agreement with Janssen also provides for a $50 million annual cap of the Company's share of development costs and pre-tax commercialization losses for each calendar year. As of March 31, 2013, the Company's total share of collaboration costs for the 2013 calendar year to date was approximately $24.9 million.
"This past quarter has been particularly successful for our company," said Bob Duggan, CEO and Chairman of the Board. "We completed the enrollment of our first Phase III trial and are well on track with our clinical programs. We also received the third Breakthrough Therapy Designation from the FDA. Last month at the American Association of Clinical Research we had 8 poster presentations and 1 oral presentation. There are 5 additional oral and 6 poster presentations with clinical and pre-clinical updates planned for the upcoming scientific conferences this summer, the American Society of Clinical Oncology, the European Hematology Association and the International Conference on Malignant Lymphoma. Last month we earned a milestone payment of $50 million from our collaboration partner Janssen, for the start of our front line study in CLL and on March 8th we concluded a successful equity offering netting us $201 million. Pharmacyclics remains resolute in its goal to lead in the creation of a new era of patient friendly, body harmonious, medicinal solutions, which are intended to improve the quality of life, increase duration of life and address serious, unmet medical health care needs for patients."
Conferences and Presentations in June 2013American Society of Clinical Oncology 2013 Annual Meeting May 31-June 4, 2013At the upcoming American Society of Clinical Oncology (ASCO) 2013 annual meeting the company will have one oral presentation and three poster presentations on ibrutinib. The oral presentation discusses the Phase I study of ibrutinib combined with R-CHOP in patients with CD20-Positive B-cell frontline NHL (DLBCL, MCL, FL). There will be a poster discussion on tumor genomic profiling revealing mechanisms of resistance to ibrutinib in CLL patients. From our clinical pharmacology team we will also present a poster on pharmacokinetics of dose ranging of ibrutinib in CLL, and another poster on describing safety data with the evaluation of electrocardiograms in CLL patients receiving ibrutinib.
European Hematology Association 18th Congress in Stockholm, Sweden June 13-16, 2013At the European Hematology Association (EHA) annual congress there will be four presentations; two oral and two poster presentations. The oral presentations will be from the clinical trials PCYC-1106, Pharmacyclics' Phase II study using ibrutinib as a monotherapy in patients with relapsed or refractory (R/R) ABC sub-type of diffuse large B-cell lymphoma (DLBCL) and from PCYC-1104, Pharmacyclics' Phase II study using ibrutinib as a monotherapy in R/R mantle cell lymphoma (MCL) patients. Pharmacyclics will also present non-clinical data in a poster presentation on BTK expression in multiple myeloma (MM). There will also be a poster presentation discussing the Phase I study of ibrutinib combined with R-CHOP in frontline NHL patients as reported previously at ASCO in June, 2013.
International Conference on Malignant Lymphoma in Lugano, Switzerland June 19-22, 2013At the International Conference on Malignant Lymphoma (ICML) there will be three oral presentations and three poster presentations on ibrutinib, and one oral presentation on abexinostat, Pharmacyclics' HDAC inhibitor. One oral presentation in the plenary session will show results using ibrutinib as a monotherapy in R/R CLL patients with deletion 17p as previously reported at AACR earlier this year. One oral presentation will cover the trial results using ibrutinib as a monotherapy in R/R Waldenstrom Macroglobulinemia (WM) patients. The other oral presentation will show the Phase I results using R-CHOP plus ibrutinib in frontline NHL patients similar to the data that will be presented at ASCO and EHA in June, 2013. Two posters are updates from the MD Anderson trial using ibrutinib plus rituximab in high risk CLL patients. An additional poster will show updated results from Pharmacyclics' trial PCYC-1104 with similar data from the oral presentation at EHA in June, 2013. An additional oral presentation will show trial data using the HDAC inhibitor abexinostat in patients with R/R follicular lymphoma.
Recent Developments & HighlightsThree Breakthrough Therapy Designations The U.S. Food and Drug Administration (FDA) granted three Breakthrough Therapy Designations for the investigational oral agent ibrutinib. These include ibrutinib used as a monotherapy in patients with R/R MCL, in patients with WM and in patients with CLL who have a deletion of chromosome 17p.
The Breakthrough Therapy Designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development." The designation of a drug as a Breakthrough Therapy was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act. Pharmacyclics, together with Janssen, is working with the FDA to determine the implications of this Breakthrough Therapy Designation to the ongoing and planned development and the filing requirements for the use of ibrutinib in patients. At this time Pharmacyclics is targeting to submit the MCL filing before the end of the third quarter 2013. Pharmacyclics anticipates to provide guidance prior to year end on the WM and CLL with deletion 17p filing timelines after further discussions with the FDA.
The FDA Breakthrough Therapy Designations for ibrutinib were based on data from clinical and pre-clinical studies. Ibrutinib has the potential to improve the outcome in these serious and life-threatening diseases which have a poor prognosis. The company and its collaboration partner, Janssen, have designed and are currently executing a development program for ibrutinib in each of these indications.
Comprehensive Pre-Clinical Research and Clinical Development To broaden our understanding of ibrutinib, Pharmacyclics has performed research into mechanisms of action both in its own research department, and through collaborations with leading universities and clinical centers. Over the past 3 years, Pharmacyclics' research department has established and maintained 47 collaborations with academic investigators at universities or clinical centers. This broad-reaching collaborative effort has resulted in 40 preclinical abstracts presented at scientific congresses, and 15 original peer-reviewed scientific manuscripts in leading scientific journals, plus 17 review articles and commentaries in the literature. Most recently 8 presentations were made at the American Association for Cancer Research in April, where ibrutinib was evaluated preclinically in various disease settings.
Today over 1300 patients have been dosed with ibrutinib in company sponsored trials. Together with our collaboration partner Janssen, Pharmacyclics has engaged upwards of approximately 250 clinical sites, using ibrutinib in CLL, and additionally over 100 clinical sites engaged for the use of ibrutinib in MCL. These numbers are continuously growing as new studies are being initiated within the overall clinical development program. As of today there are over 28 studies registered with the U.S. National Institutes of Health. Five of these studies are Phase III trials, which each enrolling approximately 300-600 patients. Several of the trials in our clinical program are sponsored by the National Cancer Institute or other medical centers. To date ibrutinib is being clinically advanced in over 25 countries, which include the major population regions: U.S., Europe, Asia Pacific and Latin America.
Phase II / III / IV Clinical Trials Initiated with Ibrutinib Over the Last 12 Months
Conference Call and further Corporate UpdatesThe Company will hold a conference call today at 4:30 p.m. EDT. To participate in the conference call, please dial 1-877-407-0778 for domestic callers and 1-201-689-8565 for international callers. To access the live audio broadcast or the subsequent archived recording, log on to http://ir.pharmacyclics.com/events.cfm. To access a replay of the call please dial 1-877-660-6853 domestic callers and 1-201-612-7415 for international callers and use the conference ID number: 413317. The archived version of the webcast and conference call will be available for 30 days on the Investor Relations section of the company's Web site at http://www.pharmacyclics.com.
About IbrutinibIbrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulation of apoptosis, cell adhesion, and cell migration and homing.
The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Waldenström's macroglobulinemia and multiple myeloma. To date 5 Phase III trials have been initiated with ibrutinib and a total of 28 trials are currently registered on www.clinicaltrials.gov. Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib.
About PharmacyclicsPharmacyclics 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 medical healthcare needs; and to identify promising product candidates based on scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.
Presently, Pharmacyclics has three product candidates in clinical development and several preclinical molecules in lead optimization. The Company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to viable commercialization.
The Company is headquartered in Sunnyvale, California and is listed on NASDAQ under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit us at http://www.pharmacyclics.com.
Use of Non-GAAP Financial MeasuresThis press release contains non-GAAP financial measures, including operating expenses and other expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with, or an alternative to, 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 for the periods presented in this press release are employee related non-cash expenses. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding various financial and business trends relating to our financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of our ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating operational performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. To the extent this release contains historical non-GAAP financial measures, the Company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP measures is provided below.
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, among others, relating to our future capital requirements, including our expected liquidity position and timing of the receipt of certain milestone payments, and the sufficiency of our current assets to meet these requirements, our future results of operations, our expectations for and timing of ongoing or future clinical trials and regulatory approvals for any of our product candidates, and our plans, objectives, expectations and intentions. 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", "goal", "should", "would", "project", "plan", "predict", "intend", "target" and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to us and are subject to a number of risks, uncertainties and other factors that could cause our actual results, performance, expected liquidity or achievements to differ materially from those projected in, or implied by, these forward-looking statements. Factors that may cause such a difference include, without limitation, our need for substantial additional financing and the availability and terms of any such financing, the safety and/or efficacy results of clinical trials of our product candidates, our failure to obtain regulatory approvals or comply with ongoing governmental regulation, our ability to commercialize, manufacture and achieve market acceptance of any of our product candidates, for which we rely heavily on collaboration with third parties, and our ability to protect and enforce our intellectual property rights and to operate without infringing upon the proprietary rights of third parties. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance or achievements and no assurance can be given that the actual results will be consistent with these forward-looking statements. For more information about the risks and uncertainties that may affect our results, please see the Risk Factors section of our filings with the Securities and Exchange Commission, including our transition report on Form 10-K for the six month period ended December 31, 2012 and quarterly reports on Form 10-Q. We do not intend to update any of the forward-looking statements after the date of this announcement to conform these statements to actual results, to changes in management's expectations or otherwise, except as may be required by law.
Pharmacyclics, Inc.Condensed Consolidated Balance Sheets(unaudited; in thousands)Mar. 31,Dec. 31,20132012AssetsCash, cash equivalents and marketable securities 1
317,114Other current assets 2
21,41629,378Total current assets
532,663346,492Property and equipment, net
355,129Liabilities and Stockholders' EquityDeferred revenue - current portion
8,139Other current liabilities
39,35321,118Total current liabilities
47,38929,257Deferred revenue - non-current portion
437,110262,526Total liabilities and stockholders' equity
355,1291 Marketable securities
$ Pharmacyclics, Inc.Condensed Consolidated Statements of Operations
9,6812 As of March 31, 2013 and December 31, 2012, Other current assets includes $17.1 million and $26.6 million, respectively, due to the Company from Janssen under the collaboration and license agreement.
(unaudited; in thousands, except per share data)
Pharmacyclics, Inc.Condensed Consolidated Statements of Operations
- Collaboration services revenue
2,8461,927Operating expenses*: Research and Development
35,78415,828 General and Administrative
20,0264,061Total operating expenses
55,81019,889Loss from operations
(52,964)(17,962)Interest and other income, net
7956Loss before income taxes
(52,885)(17,906)Income tax benefit
(12,823)Net loss per share:Basic
(0.19)Weighted average shares used to computenet loss per share:Basic
70,93368,848* Includes stock-based compensation as follows:Research and development
2,695General and administrative
3,485 Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1)(unaudited; in thousands, except per share data)Three Months EndedMar. 31,Mar. 31,20132012GAAP net loss$
(12,823)Adjustments:Research and Development stock-based compensation (2)
11,1802,695General and Administrative stock-based compensation (2)
12,39879023,5783,485Non-GAAP net loss$
(9,338)GAAP net loss per share - basic$
(0.19)Stock-based compensation expense
0.330.05Non-GAAP net loss per share - basic$
(0.14)GAAP net loss per share - diluted$
(0.19)Stock-based compensation expense
0.330.05Non-GAAP net loss per share - diluted$
(0.14)(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 stock-based compensation was excluded for the non-GAAP analysis.
|SOURCE Pharmacyclics, Inc.|
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