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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 |
~Product revenue of $65.3 million for Q2 2016, including one-time $25.5 million from France
~U.S. product revenue of $32.6 million for Q2 2016, representing 50% growth from prior year
~Conference call scheduled today at 8:30 a.m. ET
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the second quarter and first half of 2016, including revenue from sales of Iclusig® (ponatinib). The Company also provided an update on corporate developments.
“We had a strong second quarter, during which we initiated a rolling NDA submission for brigatinib based on our data from the ALTA pivotal trial, presented four-year data from the PACE clinical trial for Iclusig, and advanced AP32788 for EGFR/HER2 exon 20 non-small cell lung cancer patients into a Phase 1/2 trial,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “We also strengthened our financial position through our agreement with Incyte and the strong sales performance of Iclusig. Our teams are focused on Iclusig growth, preparations for the potential launch of brigatinib in the U.S. and driving forward our promising pipeline.”
Financial Results for the Quarter and Six Months Ended June 30, 2016
Revenue
GAAP and Non-GAAP Net Income (Loss)
GAAP net income for the quarter ended June 30, 2016 was $109.8 million, or $0.57 and $0.56 per basic and diluted share, respectively, compared to GAAP net loss of $63.2 million, or $0.33 loss per basic and diluted share, for the quarter ended June 30, 2015. GAAP net income for the six months ended June 30, 2016 was $56.1 million, or $0.29 per basic and diluted share, compared to GAAP net loss of $115.8 million, or $0.62 loss per basic and diluted share, for the six months ended June 30, 2015. During the 2016 periods, the Company recorded $128.7 million of gain related to the Incyte transaction under other income (expense) related to closing the sale of the Company’s European operations and out-license of Iclusig rights in Europe.
Non-GAAP net income for the quarter ended June 30, 2016 was $114.1 million, or $0.59 per diluted share, compared to non-GAAP net loss of $52.5 million, or $0.28 per diluted share for the quarter ended June 30, 2015. Non-GAAP net income for the six months ended June 30, 2016 was $69.9 million, or $0.36 per diluted share, compared to non-GAAP net loss of $96.8 million, or $0.51 per diluted share, for the six months ended June 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
Recent Progress and Key Objectives
Business Development
Iclusig
Brigatinib
Advancing the Pipeline
Upcoming Medical Meetings
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our second quarter and first half 2016 financial results this morning 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 39871230. 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 and Canada.
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.
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 the anticipated timing of potential regulatory actions and research and clinical development plans and milestones for our product candidates, along with the statements made by our Chief Executive Officer, 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 Iclusig and our product candidates, if approved; competition from alternative therapies; 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; 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; 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 Six Months Ended In thousands, except per share data June 30, June 30, 2016 2015 2016 2015 Revenue: Product revenue, net $ 65,326 $ 27,818 $ 98,960 $ 51,719 License and other revenue 2,799 1,420 4,763 1,510 Total revenue 68,125 29,238 103,723 53,229 Operating expenses: Cost of product revenue 1,108 488 1,594 1,183 Research and development 42,864 38,739 86,943 78,183 Selling, general and administrative 34,242 48,622 70,219 82,172 Transaction related cost 1,482 - 1,482 - Restructuring charge 92 - 3,010 - Total operating expenses 79,788 87,849 163,248 161,538Other income (expense), net (5,399 ) (4,249 ) (11,072 ) (7,012 ) Gain related to the Incyte transaction 128,664 - 128,664 - Total other income (expense), net 123,265 (4,249 ) 117,592 (7,012 ) Provision for income taxes 1,754 300 2,006 514 Net income (loss) $ 109,848 $ (63,160 ) $ 56,061 $ (115,835 ) Net income (loss) per common share: -- basic $ 0.57 $ (0.33 ) $ 0.29 $ (0.62 ) -- diluted $ 0.56 $ (0.33 ) $ 0.29 $ (0.62 ) Weighted-average number of shares of common stock outstanding: -- basic 191,485 188,598 190,894 188,220 -- diluted 194,569 188,598 193,504 188,220
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION (Unaudited) June 30, December 31, In thousands 2016 2015 Cash, cash equivalents and marketable securities $ 278,544 $ 242,295 Total assets $ 624,367 $ 546,692 Total liabilities $ 662,256 $ 649,833 Stockholders’ deficit $ (37,889 ) $ (103,141 )
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION (Unaudited) Six Months Ended In thousands June 30, 2016 2015 Net cash used in operating activities $ (97,747 ) $ (78,617 ) Net cash provided by (used in) investing activities 113,343 (2,700 ) Net cash provided by financing activities 26,607 2,461 Effect of exchange rates on cash (44 ) 134 Net increase (decrease) in cash and cash equivalents $ 42,159 $ (78,722 )
Reconciliation of Selected GAAP Measures to Non-GAAP Measures (1) (Unaudited) Three Months Ended Six Months Ended In thousands, except per share data June 30, June 30, 2016 2015 2016 2015 Reconciliation of GAAP to non-GAAP Net income (loss): GAAP Net income (loss) $ 109,848 $ (63,160 ) $ 56,061 $ (115,835 ) Add: Stock-based Compensation (2) 2,658 10,644 9,378 19,078 Add: Restructuring Charges (3) 92 - 3,010 - Add: Transaction related cost (4) 1,482 - 1,482 - Non-GAAP Net income (loss) $ 114,080 $ (52,516 ) $ 69,931 $ (96,757 ) Three Months Ended Six Months Ended June 30, June 30, 2016 2015 2016 2015 Reconciliation of GAAP to non-GAAP Net income (loss) per diluted share: GAAP Net income (loss) $ 0.56 $ (0.33 ) $ 0.29 $ (0.62 ) Add: Stock-based Compensation (2) 0.02 0.05 0.05 0.11 Add: Restructuring Charges (3) 0.00 - 0.01 - Add: Transaction related cost (4) 0.01 - 0.01 - Non-GAAP Net income (loss) per diluted share $ 0.59 $ (0.28 ) $ 0.36 $ (0.51 )
(1) This presentation includes non-GAAP measures. The Company's non-GAAP measures are not meant to beconsidered in isolation or as a substitute for comparable GAAP measures and should be read only in conjunctionwith 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/20160728005409/en/
ARIAD Pharmaceuticals, Inc.For InvestorsManmeet Soni, 617-503-7298Manmeet.soni@ariad.comorFor MediaLiza Heapes, 617-621-2315Liza.heapes@ariad.com
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