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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ariad Pharmaceuticals, Inc. | NASDAQ:ARIA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 23.99 | 23.80 | 22.88 | 0 | 01:00:00 |
~Brigatinib granted Priority Review with a PDUFA date of April 29, 2017
~ Regulatory approval of Iclusig® in Japan
~ Enrollment continues in OPTIC, OPTIC-2L, ALTA-1L, AP32788 trials highlighting ARIAD's continued R&D investment for patients with rare cancers
~ U.S. product revenue of $33.6 million for the quarter (~66% growth from prior year)
~ Net loss for the quarter of $27.8 million
~Conference call scheduled today at 8:30 a.m. ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the third quarter and first nine months of 2016. The Company also provided an update on corporate developments and reaffirmed 2016 financial guidance.
“During the third quarter, ARIAD achieved several important milestones that further our commitment as a small, research-based biotechnology company to patients with rare cancers, including those with no other targeted treatment options available,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “Iclusig was approved in Japan and we received priority review from the FDA for brigatinib in crizotinib-treated ALK+ non-small cell lung cancer. We are continuing to invest heavily in R&D and to progress in enrolling in the OPTIC, OPTIC-2L and ALTA-1L trials for Iclusig and brigatinib, as well as our clinical trial for AP32788, a novel kinase inhibitor for a rare form of lung cancer involving mutations in the EGFR and HER2 genes, and for which there are currently no approved targeted treatments.”
Financial Results for the Quarter and Nine Months Ended September 30, 2016
Revenue
GAAP and Non-GAAP Net Income (Loss)
GAAP net loss for the quarter ended September 30, 2016 was $27.8 million, or $0.14 per basic and diluted share, respectively, compared to GAAP net loss of $55.5 million, or $0.29 loss per basic and diluted share, for the quarter ended September 30, 2015. GAAP net income for the nine months ended September 30, 2016 was $28.2 million, or $0.15 per basic share and $0.14 per diluted share, compared to GAAP net loss of $171.3 million, or $0.91 loss per basic and diluted share, for the nine months ended September 30, 2015. During the nine months ended September 30, 2016, the Company recorded a $129.0 million gain related to the Incyte transaction under other income (expense), net related to closing the sale of the Company’s European operations and out-license of Iclusig rights in Europe.
Non-GAAP net loss for the quarter ended September 30, 2016 was $22.5 million, or $0.12 per diluted share, compared to non-GAAP net loss of $45.5 million, or $0.24 per diluted share for the quarter ended September 30, 2015. Non-GAAP net income for the nine months ended September 30, 2016 was $47.4 million, or $0.24 per diluted share, compared to non-GAAP net loss of $142.3 million, or $0.75 per diluted share, for the nine months ended September 30, 2015.
Non-GAAP net loss excludes stock-based compensation, restructuring charges for a reduction in force in March 2016 and transaction costs for the Incyte transaction. See “Use of Non-GAAP Financial Measures” below for a description of non-GAAP financial measures and the reconciliation between GAAP and non-GAAP measures at the end of this press release.
Operating Expenses
Other income (expense), net
Cash Position
PDL Royalty Financing and Convertible Notes 2019
2016 Financial Guidance
Recent Progress and Key Objectives
Iclusig
Brigatinib
Advancing the Pipeline
Upcoming Meetings
Recent Event
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our third quarter and first nine months 2016 financial results this evening at 8:30 a.m. ET, at which we will also provide an update on corporate developments. The live webcast can be accessed by visiting the investor relations section of the Company’s website at http://investor.ariad.com. The call can be accessed by dialing 844-249-9386 (domestic) or 270-823-1534 (international) five minutes prior to the start time and providing the pass code 99997465. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.
Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel, Canada and Japan.
In the U.S., Iclusig is a kinase inhibitor indicated for the:
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.
Limitations of use:
Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY
See full prescribing information for complete boxed warning
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.
Iclusig is a registered trademark of ARIAD Pharmaceuticals, Inc.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is focused on discovering, developing and commercializing precision therapies for patients with rare cancers. ARIAD is working on new medicines to advance the treatment of rare forms of chronic and acute leukemia, lung cancer and other rare cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including costs and expenses and other expenses adjusted to exclude certain cash and 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:
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 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 at the end of this press release.
Forward-Looking Statements
This press release contains forward-looking statements, each of which are qualified in their entirety by this cautionary statement. Any statements contained herein which do not describe historical facts, including, but not limited to the statements related to our financial and operational guidance, the anticipated timing of potential regulatory actions and research and clinical development plans and milestones for Iclusig and our product candidates, along with the statements made by our Chief Executive Officer and under the caption “Recent Progress and Key Objectives,” are forward-looking statements that are based on management’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, but are not limited to, our ability to successfully commercialize and generate profits from sales of our products; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for our products and product candidates and to move new development candidates into the clinic; our ability to execute on our key corporate initiatives; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products; competition from alternative therapies; our reliance on the performance of third-party manufacturers, specialty pharmacies, distributors and other collaborators for the supply, distribution, development and/or commercialization of our products and product candidates; the occurrence of adverse safety events with our products and product candidates; the costs associated with our research, development, manufacturing, commercialization and other activities; the conduct, timing and results of preclinical and clinical studies of our products and product candidates, including that preclinical data and early-stage clinical data may not be replicated in later-stage clinical studies; the adequacy of our capital resources and the availability of additional funding; the ability to satisfy our contractual obligations, including under our leases, convertible debt and royalty financing agreements; patent protection and third-party intellectual property claims; litigation and government investigations; our operations in foreign countries with or through third parties; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended Nine Months Ended In thousands, except per share data September 30, September 30, 2016 2015 2016 2015 Revenue: Product revenue, net $ 34,300 $ 27,543 $ 133,260 $ 79,262 License and other revenue 11,716 1,527 16,479 3,038 Total revenue 46,016 29,070 $ 149,739 82,300 Operating expenses: Cost of product revenue 1,131 483 2,725 1,666 Research and development 43,626 48,219 130,569 126,401 Selling, general and administrative 26,249 36,744 96,468 118,916 Transaction related cost - - 1,482 - Restructuring charge - - 3,010 - Total operating expenses 71,006 85,446 234,254 246,983 Loss from operations (24,990 ) (56,376 ) (84,515 ) (164,683 ) Other income (expense), net (5,171 ) (4,917 ) 112,421 (11,930 ) (Loss) income before benefit from income taxes (30,161 ) (61,293 ) 27,906 (176,613 ) Benefit from income taxes (2,334 ) (5,842 ) (328 ) (5,328 ) Net (loss) income $ (27,827 ) $ (55,451 ) $ 28,234 $ (171,285 ) Net (loss) income per common share: -- basic $ (0.14 ) $ (0.29 ) $ 0.15 $ (0.91 ) -- diluted $ (0.14 ) $ (0.29 ) $ 0.14 $ (0.91 ) Weighted-average number of shares of common stock outstanding: -- basic 193,225 188,921 191,677 188,456 -- diluted 193,225 188,921 195,079 188,456CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION (Unaudited) September 30, December 31, In thousands 2016 2015 Cash, cash equivalents and marketable securities $ 314,665 $ 242,295 Total assets $ 676,591 $ 546,692 Total liabilities $ 722,940 $ 649,833 Stockholders’ deficit $ (46,349 ) $ (103,141 )
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION (Unaudited) Nine Months Ended In thousands September 30, 2016 2015 Net cash used in operating activities $ (121,436 ) $ (120,658 ) Net cash provided by (used in) investing activities 103,577 (4,446 ) Net cash provided by financing activities 92,053 54,778 Effect of exchange rates on cash (44 ) (175 ) Net increase (decrease) in cash and cash equivalents $ 74,150 $ (70,501 )
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1) (Unaudited) Three Months Ended Nine Months Ended In thousands, except per share data September 30, September 30, 2016 2015 2016 2015 Reconciliation of GAAP to non-GAAP Net (loss) income: GAAP Net (loss) income $ (27,827 ) $ (55,451 ) $ 28,234 $ (171,285 ) Add: Stock-based Compensation (2) 5,282 9,931 14,659 29,009 Add: Restructuring Charges (3) - - 3,010 - Add: Transaction related cost (4) - - 1,482 - Non-GAAP Net (loss) income $ (22,545 ) $ (45,520 ) $ 47,385 $ (142,276 ) Three Months Ended Nine Months Ended September 30, September 30, 2016 2015 2016 2015 Reconciliation of GAAP to non-GAAP Net (loss) income per diluted share: GAAP Net (loss) income $ (0.14 ) $ (0.29 ) $ 0.14 $ (0.91 ) Add: Stock-based Compensation (2) 0.02 0.05 0.08 0.16 Add: Restructuring Charges (3) - - 0.01 - Add: Transaction related cost (4) - - 0.01 - Non-GAAP Net (loss) income per diluted share $ (0.12 ) $ (0.24 ) $ 0.24 $ (0.75 ) (1) This presentation includes non-GAAP measures. The Company's 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 its financial statements prepared in accordance with GAAP. (2) All stock-based compensation expenses were excluded for the non-GAAP analysis. (3) Restructuring charges associated with employee workforce reductions were excluded for the non-GAAP analysis. (4) Transaction related cost associated with the Incyte transaction were excluded for the non-GAAP analysis.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161107005374/en/
ARIAD Pharmaceuticals, Inc.For InvestorsJennifer Robinson, 617-621-2286Jennifer.Robinson@ariad.comorFor MediaLiza Heapes, 617-621-2315Liza.Heapes@ariad.com
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