SUNNYVALE, Calif., July 31, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (the "Company") (Nasdaq: PCYC) today reported financial results and recent developments for its quarter ended June 30, 2013.
Financial Results for the Three and Six Months Ended June 30, 2013 Non-GAAP net income reported for the quarter ended June 30, 2013 was $19.2 million, or $0.26 and $0.25 net income per basic and diluted share, respectively, compared to non-GAAP net loss of $15.1 million, or $0.22 net loss per basic and diluted share for the quarter ended June 30, 2012. Non-GAAP net loss reported for the six months ended June 30, 2013 was $9.1 million, or $0.13 net loss per share, compared to non-GAAP net loss of $24.4 million or $0.35 net loss per share for the six months ended June 30, 2012. See "Use of Non-GAAP Financial Measures" below for a description of our non-GAAP measures. Reconciliation between certain generally accepted accounting principles ("GAAP") and non-GAAP measures is provided at the end of this press release.
GAAP net income for the quarter ended June 30, 2013 was $12.4 million, or $0.17 and $0.16 net income per basic and diluted share, respectively. This includes stock-based compensation expense of $6.9 million. For the quarter ended June 30, 2012, GAAP net loss was $16.9 million, or $0.24 net loss per share. This includes stock-based compensation expense of $1.8 million. For the six months ended June 30, 2013, GAAP net loss was $39.6 million, or $0.55 net loss per basic and diluted share, compared to GAAP net loss of $29.7 million, or $0.43 loss per basic and diluted share for the six months ended June 30, 2012. Included in GAAP net loss for the six months ended June 30, 2013 and June 30, 2012 was stock-based compensation expense of $30.4 million and $5.3 million, respectively.
Revenue for the quarter ended June 30, 2013 was $54.7 million compared to $2.1 million for the quarter ended June 30, 2012. The increase in revenue was primarily due to the Company earning a $50 million milestone payment during the quarter ended June 30, 2013 under its collaboration and license agreement (the "Agreement") with Janssen Biotech, Inc. and its affiliates ("Janssen"). The $50 million milestone was earned on April 11, 2013 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 leukemia (CLL)/small lymphocytic lymphoma (SLL). Revenue for the six months ended June 30, 2013 was $57.5 million, compared to $4.1 million for the six months ended June 30, 2012.
To date, the Company has received four milestone payments from Janssen of $50 million each, totaling $200 million, under the Agreement. The Company may receive up to an additional $625 million ($50 million for development progress, $225 million for regulatory progress, and $350 million for regulatory approval) 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.
GAAP operating expenses were $42.7 million for the quarter ended June 30, 2013, compared to $19.6 million for the quarter ended June 30, 2012. During the three months ended June 30, 2013, the Company exceeded the $50 million annual cap on the Company's share of development costs and pre-tax commercialization losses by $20.4 million. The Company recognizes amounts incurred in excess of the annual cap ("Excess Amounts") as a reduction to operating expenses. For the three months ended June 30, 2013, the Company recognized $20.4 million of Excess Amounts as a $17.4 million reduction to research and development expense and a $3.0 million reduction to general and administrative expense.
GAAP operating expenses were $98.5 million for the six months ended June 30, 2013, compared to $39.5 million for the six months ended June 30, 2012. For the six months ended June 30, 2013, the Company recognized $20.4 million of Excess Amounts as a $17.4 million reduction to research and development expense and $3.0 million reduction to general and administrative expense. Under the Agreement, Janssen will fund maximum Excess Amounts of $225 million, which includes interest of $25 million. To date, the Company has recorded Excess Amounts of $38.5 million. The Company recognizes Excess Amounts as a reduction to operating expenses as the Company's repayment of Excess Amounts to Janssen is contingent and would become payable only after the third profitable calendar quarter for the product. Further, Excess Amounts shall be reimbursable only from the Company's share of pre-tax profits (if any) after the third profitable calendar quarter for the product.
As of June 30, 2013, the Company had cash, cash equivalents and marketable securities of $505.0 million, compared with $317.1 million as of December 31, 2012. As previously announced on July 10, 2013, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and CLL/SLL. Upon acceptance of such filing by the FDA, the Company would be entitled to receive from Janssen $75 million in regulatory milestone payments.
The Company expects to end 2013 in excess of $550 million in cash, cash equivalents, marketable securities and receivables due from our collaboration partner, which includes the $75 million of milestone payments that would be earned upon acceptance of the filing by the FDA.
The Company expects non-GAAP net income/loss to be near break-even for the full year ending December 31, 2013, which includes the reduction of expenses related to the assumption of Excess Amounts by Janssen.
"Over the past five months, we have been steadily and inexorably building the commercial personnel infrastructure that ensures Pharmacyclics has highly professional and competent Marketing, Medical Affairs, Drug Safety and Clinical Sales teams. I am pleased to announce that we have completed the hiring process and we are now integrating our new team members into our culture and vision to ensure Pharmacyclics will be commercial-ready on a timely basis," said Bob Duggan, CEO & Chairman of Pharmacyclics. "We have entered into a very exciting chapter for the company and for our ibrutinib partner, Janssen, who has been a tremendous support in this process. Just 4 years ago we dosed our first patient with ibrutinib and since have explored its potential in most of the B-cell malignancies with Phase II and Phase III studies. Ibrutinib's success has been continuously evolving with three Breakthrough Therapy Designations announced earlier this year, two publications in the prestigious New England Journal of Medicine in June and the filing of our first NDA for ibrutinib with the Food and Drug Administration just a few weeks back. We are making very steady progress in our goal to advance science and drug development in the hopes of making a significant difference for the betterment of patients with serious, unmet healthcare needs."
Regulatory UpdateEarlier this month the Company submitted its first NDA to the FDA for the investigational oral BTK inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: MCL and CLL/ SLL. With this submission, Pharmacyclics has also requested Priority Review. Pharmacyclics is jointly developing ibrutinib with Janssen.
Further information on the implications of this filing for potential commercialization will be provided subsequent to the FDA rendering a decision on the filing.
Corporate UpdateOver the past months Pharmacyclics has steadily advanced the build out of its Sales, Marketing and Medical Affairs Organizations. As of today, key executives for these areas and their respective staff have been hired and have been integrated into the Company. In addition, Pharmacyclics has hired a total of 62 Sales Representatives for its US territories and is currently on-boarding and training them to be ready in the event the FDA finalizes their review of the most recently filed New Drug Application and awards a label. Our partner Janssen already has an oncology sales organization in place. The Market Access, Marketing, Business Analytics & Informatics and Public Relations organizations have also been established. Together with Janssen, we now have a commercial team with a reach across all US regions that will be launch ready. This is not to be interpreted as an indication of when or if the FDA will provide us a label.
The Medical Affairs Group has also significantly grown, with four specific functional teams now established: Medical Sciences, Medical Communications, Medical Information, Medical Science Liaisons. Pharmacyclics has also hired seasoned professionals to support post-marketing safety activities. We have also bolstered our legal affairs team, now consisting of contracts, corporate compliance, intellectual property and corporate legal to protect and advance the corporate mission. Over the past 6 months Pharmacyclics hired a total of 220 employees, and has increased the total headcount to 415 employees as of the end of June.
Recent Developments & HighlightsTwo New England Journal of Medicine Publications
In June 2013, The New England Journal of Medicine (NEJM) published results from two Phase II studies of ibrutinib: PCYC 1104-CA, a Phase II study evaluating the safety and efficacy of ibrutinib monotherapy in patients with relapsed/refractory MCL; and PCYC 1102-CA, a Phase Ib/II study examining the safety and efficacy of ibrutinib monotherapy for the treatment of patients with relapsed/refractory CLL/ SLL, some of whom had deletion of part of chromosome 17 (del 17p). These data suggested ibrutinib may be effective and generally well-tolerated in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL. Both studies were originally presented at the annual meeting of the American Society of Hematology (ASH) in December 2012. Updated results from PCYC 1104-CA were presented at the European Hematology Association (EHA) Annual Meeting in June 2013.
Conferences and Presentations in June 2013
In June, Pharmacyclics and its collaborators presented 5 oral and 6 poster presentations on ibrutinib at three annual conferences: American Society of Clinical Oncology (ASCO), EHA, and the International Conference on Malignant Lymphoma (ICML). These conferences showcased updated and expanded data in high risk CLL, relapsed or refractory MCL, and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Also at these conferences ibrutinib data in two new areas were presented: Waldenstrom's Macroglobulinemia (WM) and frontline DLBCL in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). All oral presentations made at these conferences have been filed in Form 8-K's with the SEC.
Selected Clinical Trials Initiated with Ibrutinib Over the Last 18 MonthsCLL/SLL
Conference CallThe Company will hold a conference call today at 4:30 p.m. EDT. To participate in the conference call, please dial 1-877-303-7908 for domestic callers and 1-678-373-0875 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 1-855-859-2056 domestic callers and 1-404-537-3406 for international callers and use the conference ID number: 23863642. 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 is an investigational agent designed to provide potent and sustained inhibition of an enzyme called Bruton's tyrosine kinase (BTK). By inhibiting BTK, ibrutinib blocks B-cell receptor signaling. BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulation of apoptosis, adhesion, and cell migration and homing. Through these multiple signals, BTK regulation helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a micro-environment necessary for survival.
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, Waldenstrom's macroglobulinemia and multiple myeloma. To date, 7 Phase III trials have been initiated with ibrutinib and a total of 31 trials are currently registered on www.clinicaltrials.gov. Janssen and Pharmacyclics entered into 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.
Pharmacyclics 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 or future 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)Jun. 30,Dec. 31,20132012AssetsCash, cash equivalents and marketable securities 1$ 504,984$ 317,114Other current assets 248,16829,378Total current assets553,152346,492Property and equipment, net14,2176,403Other assets3,2762,234Total assets$ 570,645$ 355,129Liabilities and Stockholders' EquityDeferred revenue - current portion$
8,139Other current liabilities44,69721,118Total current liabilities52,37729,257Deferred revenue - non-current portion55,60562,562Deferred rent800784Total liabilities108,78292,603Stockholders' equity461,863262,526Total liabilities and stockholders' equity$ 570,645$ 355,1291Marketable securities$ 10,830$
9,6812As of June 30, 2013 and December 31, 2012, Other current assets includes $37.3 million and $26.6 million, respectively, due to the Company from Janssen under the collaboration and license agreement. Pharmacyclics, Inc.Condensed Consolidated Statements of Operations(unaudited; in thousands, except per share data) Three Months EndedSix Months EndedJun. 30, Jun. 30, Jun. 30, Jun. 30, 2013201220132012Revenue: License and milestone revenue$ 50,000$
- Collaboration services revenue4,6842,1237,5304,050Total revenue54,6842,12357,5304,050Operating expenses*: Research and Development45,30015,38581,08431,213 Less: Excess amounts related to Research and Development(17,377)-(17,377)-Research and Development, net27,92315,38563,70731,213 General and Administrative17,7364,22037,7628,281 Less: Excess amounts related to General and Administrative(3,006)-(3,006)-General and Administrative, net14,7304,22034,7568,281Total operating expenses42,65319,60598,46339,494Income (loss) from operations12,031(17,482)(40,933)(35,444)Interest and other income (expense), net(23)4756103Income (loss) before income taxes12,008(17,435)(40,877)(35,341)Income tax benefit3435291,3175,612Net income (loss)$ 12,351$ (16,906)$ (39,560)$ (29,729)Net income (loss) per share:Basic$
(0.43)Weighted average shares used to computenet income (loss) per share:Basic72,95369,08171,94868,965Diluted77,19469,08171,94868,965* Includes share-based compensation as follows:Research and development$
3,708General and administrative3,10183515,4991,625$
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1)(unaudited; in thousands, except per share data)Three Months EndedSix Months EndedJun. 30,Jun. 30,Jun. 30,Jun. 30,2013201220132012GAAP net income (loss)$ 12,351$ (16,906)$ (39,560)$ (29,729)Adjustments:Research and Development share-based compensation (2)
3,7601,01314,9403,708General and Administrative share-based compensation (2)
3,10183515,4991,6256,8611,84830,4395,333Non-GAAP net income (loss)$ 19,212$ (15,058)$ (9,121)$ (24,396)GAAP net income (loss) per share - basic$
(0.43)Share-based compensation expense
.020.420.08Non-GAAP net income (loss) per share - basic$
(0.35)GAAP net income (loss) per share - diluted$
(0.43)Share-based compensation expense
0.090.020.420.08Non-GAAP net income (loss) per share - diluted$
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.The non-GAAP net income/loss guidance of near break-even for the full year ending December 31, 2013 does not include projected share-based compensation expense for such period.
|SOURCE Pharmacyclics, Inc.|
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