UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 13, 2015

ARIAD Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)

Delaware

001-36172

22-3106987

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)


 

26 Landsdowne Street, Cambridge, Massachusetts

02139

(Address of principal executive offices)

(Zip Code)


Registrant's telephone number, including area code: (617) 494-0400


Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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Forward-Looking Statements

This Form 8-K and the exhibits attached hereto and incorporated by reference herein contain forward-looking statements of ARIAD Pharmaceuticals, Inc. that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Form 8-K and the exhibits attached hereto, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about our selected estimated and unaudited financial results for year-end 2014; our key strategic objectives for 2015; the timing and results of our preclinical and clinical trials; and our plans to achieve sustained profitability.  These “forward-looking statements” are based on management’s good-faith 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 meet anticipated clinical trial commencement and completion dates for our products and product candidates and to move new development candidates into clinical trials; our ability to secure a partnership for brigatinib (AP26113);  difficulties or delays in filing for approvals and obtaining regulatory and pricing and reimbursement approvals to market our products; our ability to successfully commercialize and generate profits from sales of Iclusig®; competition from alternative therapies; our reliance on the performance of third-party manufacturers and specialty pharmacies for the distribution of Iclusig; the occurrence of adverse safety events with our products and product candidates; the ability of our regional commercialization and distribution partners to perform as required; preclinical data and early-stage clinical data that may not be replicated in later-stage clinical studies; the costs associated with our research, development, manufacturing and other activities; the enrollment, conduct, timing and results of pre-clinical and clinical studies of our product candidates; the adequacy of our capital resources and the availability of additional funding; and other factors detailed in our public filings with the U.S. Securities and Exchange Commission. The information contained in this Form 8-K and the exhibits attached hereto are believed to be current as of the date of original issue. After the date of these documents, we do not intend to update any of the forward-looking statements to conform these statements to actual results or to changes in management’s expectations, except as required by law.

ITEM 2.02      Results of Operations and Financial Condition.

On January 13, 2015, ARIAD Pharmaceuticals, Inc. (“ARIAD” or the “Company”) issued a press release in which it announced selected preliminary financial results for the fiscal year ended December 31, 2014. A copy of the press release is attached hereto as Exhibit 99.1. The information under the heading “2014 Key Financial Results” in the press release is incorporated by reference into this Item 2.02 of this Current Report on Form 8-K.

The Company has not completed its financial close process for the year. During the course of that process, the Company may identify items that would require it to make adjustments, which may be material, to the selected preliminary financial information presented in the press release. As a result, the preliminary financial estimates included in the press release constitute forward-looking information and are subject to risks and uncertainties, including possible adjustments to preliminary operating and other financial results.

ITEM 7.01       Regulation FD Disclosure.

In the press release dated January 13, 2015, the Company also announced key strategic objectives for 2015, details of which will be presented at the 33rd Annual J.P. Morgan Healthcare Conference on January 14, 2015 in San Francisco (the “J.P. Morgan Conference”).  These objectives are focused on expanded commercial, research and development, and new business development initiatives that together are expected to lead ARIAD to sustained profitability beginning in 2018 without the need for additional equity capital to fund operations.  

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These objectives include:

  • Expanding the global commercial opportunity for Iclusig through a Japan/Asia partnership with Otsuka Pharmaceutical Co., Ltd., and additional regional distributorships,
  • Leveraging its existing commercial infrastructure and investment, particularly in Europe,
  • Securing a broad co-development and co-commercialization partnership for brigatinib (AP26113) that will accelerate the study of brigatinib in earlier lines of treatment,
  • Investing in three randomized clinical trials to evaluate Iclusig in earlier lines of treatment and potentially to expand its addressable market,
  • Advancing its new development candidate, AP32788, into the clinic, and
  • Achieving sustained profitability in 2018 by reaching global product revenue of more than $400 million.

In the press release dated January 13, 2015, the Company also provided an update on its Iclusig, brigatinib (AP26113) and newly announced AP32788 programs, as well as information on its plan for profitability and its presentation at the J.P. Morgan Conference.  

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K, and the information contained therein, other than the information under the captions “2014 Key Financial Results” and “About Iclusig (ponatinib) tablets, ” is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.

In addition, a copy of the Company’s presentation at the J.P. Morgan Conference is attached as Exhibit 99.2 to this Current Report on Form 8-K, and the information contained therein is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.

ITEM 9.01      Financial Statements and Exhibits

(d)   The following exhibits are furnished with this report:

Exhibit
Number

Description

 
99.1 Press Release dated January 13, 2015.
 
99.2 ARIAD Pharmaceuticals, Inc. Presentation for the 33rd Annual J.P. Morgan Healthcare Conference dated January 14, 2015.



The press release contains hypertext links to information on our websites. The information on our websites is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.

The press release and investor presentation are being furnished pursuant to Items 2.02 and/or 7.01 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


ARIAD Pharmaceuticals, Inc.

 

 

 

By:  

/s/ Edward M. Fitzgerald

 

Edward M. Fitzgerald

Executive Vice President, Chief Financial Officer

 

Date:

January 13, 2015

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Exhibit 99.1

ARIAD Announces Key Strategic Objectives for 2015 Expected to Lead Company to Profitability in Three Years

Iclusig Commercial Opportunity Expected to Expand -- Three New Clinical Trials to Begin in 2015, including a Global, Randomized Trial of Iclusig vs. Nilotinib in Second-Line CML

CAMBRIDGE, Mass.--(BUSINESS WIRE)--January 13, 2015--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced its key strategic objectives for 2015, details of which will be presented at the 33rd Annual J.P. Morgan Healthcare Conference on January 14, 2015 in San Francisco, California. These objectives are focused on expanded commercial, research and development, and new business development initiatives that together are expected to lead ARIAD to sustained profitability beginning in 2018 without the need for additional equity capital to fund its operations.

“We made excellent progress over the past year to successfully re-launch Iclusig® (ponatinib) in the U.S., to expand Iclusig’s commercialization in Europe, and to better understand ponatinib’s benefit/risk profile using lower doses,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “Additionally, we secured an experienced Japanese partner for Iclusig, an important step in expanding its global commercial opportunity. We also advanced our pipeline, moving brigatinib -- our investigational ALK inhibitor -- into a pivotal trial and nominating our next internally discovered oncology drug candidate -- AP32788 -- into development. As we begin 2015, we are focusing our investment on value-driving clinical initiatives and positioning the Company for solid growth with the key objective of achieving sustained profitability in three years.”

ARIAD management will provide detail on its corporate strategy for the next several years. This new focus includes:

  • Expanding the global commercial opportunity for Iclusig through a Japan/Asia partnership with Otsuka Pharmaceutical Co., Ltd., and additional regional distributorships,
  • Leveraging its existing commercial infrastructure and investment, particularly in Europe,
  • Securing a broad co-development and co-commercialization partnership for brigatinib (AP26113) that will accelerate the study of brigatinib in earlier lines of treatment,
  • Investing in three randomized clinical trials to evaluate Iclusig in earlier lines of treatment and potentially to expand its addressable market,
  • Advancing its new development candidate, AP32788, into the clinic, and
  • Achieving sustained profitability in 2018 by reaching global product revenue of more than $400 million.

Evaluating Iclusig in Earlier Lines of Chronic Myeloid Leukemia (CML)

Three key Iclusig clinical trials will begin in 2015 including a randomized, Phase 3 trial in patients with chronic-phase CML (CP-CML) who have experienced failure after imatinib therapy. This second-line, global trial will evaluate two doses of Iclusig vs. the standard dose of nilotinib. The primary endpoint of the trial will be major molecular response (MMR) by 12 months. The trial is expected to open to patient enrollment in the second half of 2015 and will be integral to potentially expanding Iclusig into earlier lines of treatment. We expect that approximately 500 patients will be enrolled in this trial.

We will begin patient enrollment in a dose-ranging, third-line trial of Iclusig in patients with CP-CML, who have become resistant to at least two prior tyrosine kinase inhibitors (TKIs). This global, randomized trial will evaluate three starting doses of Iclusig in patients with refractory CP-CML. The trial is expected to inform the optimal use of Iclusig in these patients and will begin by mid-2015. We expect that approximately 450 patients will be enrolled in this trial.

An early-switch trial of Iclusig in second-line CP-CML patients will also begin in the United Kingdom. This investigator-sponsored trial (SPIRIT3) will be coordinated by the Newcastle University, U.K., on behalf of the U.K. National Cancer Research Institute (NCRI) CML Working Group. It will enroll newly diagnosed patients with CP-CML, who will be randomized to either imatinib or nilotinib. Patients failing to reach an early molecular response at three months will then be switched to Iclusig in the second line. We expect the trial to inform the use of Iclusig as part of the emerging paradigm in CML for early switching of TKIs in patients with suboptimal responses. We anticipate that the trial will begin in the first half of 2015 and will enroll approximately 1,000 patients. Clinical data presentations from the trial are anticipated at various times over several years.

Securing a Broad Partnership for Brigatinib

In a major strategic shift for ARIAD, we expect to secure a broad partnership in 2015 to co-develop and co-commercialize brigatinib. In doing so, we will continue to leverage our existing infrastructure and capabilities, allowing us to accelerate the start of a randomized, first-line trial of brigatinib vs. crizotinib. A partnership will also provide for the exploration of new combination therapies in lung cancer that include brigatinib potentially with other approved and unapproved medicines.

Brigatinib received Breakthrough Therapy designation by the U.S. Food and Drug Administration in 2014 which may accelerate its regulatory approval timeline. Brigatinib is currently being evaluated in the global, Phase 2 pivotal ALTA trial that is anticipated to form the basis for its initial approval. We expect to achieve full patient enrollment in the ALTA trial in the third quarter 2015 and to file for approval of brigatinib in mid-2016.


Expanding its Pipeline

At the end of 2014, we nominated our next internally discovered development candidate, AP32788. This orally active TKI has a unique profile against a validated class of mutated targets in non-small cell lung cancer and certain other solid tumors and addresses an unmet medical need. We expect to file an investigational new drug (IND) application for AP32788 this year and to begin a Phase 1/2 proof-of-concept trial in 2016. This will be our third IND filing of an internally discovered oncology development candidate in the past eight years.

This complements our earlier discovery of ridaforolimus, which is being developed by Medinol Ltd. for use in drug-eluting stents (BioNIR) and is in global pivotal trials, and rimiducid (AP1903), which is being developed by Bellicum Pharmaceuticals, Inc. for use in novel cellular immunotherapies and is in Phase 2 clinical trials.

Path to Profitability

We expect to achieve profitability in 2018 through revenue growth and strategic partnerships over the next three years. This includes Iclusig revenue growth in the U.S. and in Europe, as well as Iclusig revenue from Japan and new geographies. We also anticipate increased cash flow from brigatinib revenue and partnership payments during this time period. We expect approval of Iclusig in Canada and Israel in 2015 and in Japan in 2016.

Strategic investments to support the long-term growth of the Company include its commercial presence in the U.S. and the 16 major European Union countries, the development of Iclusig in earlier lines of therapy, and the development of brigatinib and AP32788. Importantly, with a broad co-development and co-commercialization partnership for brigatinib, we do not anticipate a need for additional equity capital to fund operations. Based on this plan, we expect to achieve sustained profitability based on more than $400 million in anticipated product revenue in 2018.

2014 Key Financial Results

In conjunction with the corporate strategy update, ARIAD will also highlight key financial results for full-year 2014. Estimated and unaudited financial results for full-year 2014 include:

  • Net sales of Iclusig were approximately $55 million for the year ended December 31, 2014.
  • License revenue was approximately $45 million for the year ended December 31, 2014.
  • Research and development expenses were approximately $120 million for the full-year 2014
  • Selling, general and administrative expenses were approximately $140 million for the full-year 2014.
  • As of December 31, 2014, cash and cash equivalents totaled approximately $350 million.

Presentation Reminder

As previously announced, our chairman and chief executive officer, Dr. Harvey J. Berger, will provide an overview of the Company at the 33rd Annual J.P. Morgan Healthcare Conference on January 14, 2015 in San Francisco, California, at 3:00 p.m. PT (6:00 p.m. ET), highlighting the Company’s strategic operating plan.

The ARIAD presentation will be webcast live and can be accessed by visiting the investor relations section of the Company's website at http://www.ariad.com/investor. A replay will be available on the ARIAD website approximately 24 hours after the presentation and will be archived for four weeks.

About Iclusig® (ponatinib) tablets

Iclusig is approved in the U.S., EU, Australia and Switzerland.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

  • Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
  • Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

  • Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
  • Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
  • Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Vascular Occlusion: Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in at least 27% of Iclusig-treated patients from the phase 1 and phase 2 trials. Iclusig can also cause recurrent or multi-site vascular occlusion. Overall, 20% of Iclusig-treated patients experienced an arterial occlusion and thrombosis event of any grade. Fatal and life-threatening vascular occlusion has occurred within 2 weeks of starting Iclusig treatment and in patients treated with average daily dose intensities as low as 15 mg per day. The median time to onset of the first vascular occlusion event was 5 months. Patients with and without cardiovascular risk factors have experienced vascular occlusion although these events were more frequent with increasing age and in patients with prior history of ischemia, hypertension, diabetes, or hyperlipidemia. Interrupt or stop Iclusig immediately in patients who develop vascular occlusion events.

Heart Failure: Fatal and serious heart failure or left ventricular dysfunction occurred in 5% of Iclusig-treated patients (22/449). Eight percent of patients (35/449) experienced any grade of heart failure or left ventricular dysfunction. Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig. Consider discontinuation of Iclusig in patients who develop serious heart failure.

Hepatotoxicity: Iclusig can cause hepatotoxicity, including liver failure and death. Fulminant hepatic failure leading to death occurred in an Iclusig-treated patient within one week of starting Iclusig. Two additional fatal cases of acute liver failure also occurred. The fatal cases occurred in patients with blast phase CML (BP-CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Severe hepatotoxicity occurred in all disease cohorts. Iclusig treatment may result in elevation in ALT, AST, or both. Monitor liver function tests at baseline, then at least monthly or as clinically indicated. Interrupt, reduce or discontinue Iclusig as clinically indicated.

Hypertension: Treatment-emergent hypertension (defined as systolic BP≥140 mm Hg or diastolic BP≥90 mm Hg on at least one occasion) occurred in 67% of patients (300/449). Eight patients treated with Iclusig (2%) experienced treatment-emergent symptomatic hypertension as a serious adverse reaction, including one patient (<1%) with hypertensive crisis. Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. In 131 patients with Stage 1 hypertension at baseline, 61% (80/131) developed Stage 2 hypertension. Monitor and manage blood pressure elevations during Iclusig use and treat hypertension to normalize blood pressure. Interrupt, dose reduce, or stop Iclusig if hypertension is not medically controlled.

Pancreatitis: Clinical pancreatitis occurred in 6% (28/449) of patients (5% Grade 3) treated with Iclusig. Pancreatitis resulted in discontinuation or treatment interruption in 6% of patients (25/449). The incidence of treatment-emergent lipase elevation was 41%. Check serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated. Consider additional serum lipase monitoring in patients with a history of pancreatitis or alcohol abuse. Dose interruption or reduction may be required. In cases where lipase elevations are accompanied by abdominal symptoms, interrupt treatment with Iclusig and evaluate patients for pancreatitis. Do not consider restarting Iclusig until patients have complete resolution of symptoms and lipase levels are less than 1.5 x ULN.

Neuropathy: Peripheral and cranial neuropathy have occurred in Iclusig-treated patients. Overall, 13% (59/449) of Iclusig-treated patients experienced a peripheral neuropathy event of any grade (2%, grade 3/4). In clinical trials, the most common peripheral neuropathies reported were peripheral neuropathy (4%, 18/449), paresthesia (4%, 17/449), hypoesthesia (2%, 11/449), and hyperesthesia (1%, 5/449). Cranial neuropathy developed in 1% (6/449) of Iclusig-treated patients (<1% grade 3/4). Of the patients who developed neuropathy, 31% (20/65) developed neuropathy during the first month of treatment. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness. Consider interrupting Iclusig and evaluate if neuropathy is suspected.

Ocular Toxicity: Serious ocular toxicities leading to blindness or blurred vision have occurred in Iclusig-treated patients. Retinal toxicities including macular edema, retinal vein occlusion, and retinal hemorrhage occurred in 3% of Iclusig-treated patients. Conjunctival or corneal irritation, dry eye, or eye pain occurred in 13% of patients. Visual blurring occurred in 6% of the patients. Other ocular toxicities include cataracts, glaucoma, iritis, iridocyclitis, and ulcerative keratitis. Conduct comprehensive eye exams at baseline and periodically during treatment.

Hemorrhage: Serious bleeding events, including fatalities, occurred in 5% (22/449) of patients treated with Iclusig. Hemorrhagic events occurred in 24% of patients. The incidence of serious bleeding events was higher in patients with accelerated phase CML (AP-CML), BP-CML, and Ph+ ALL. Most hemorrhagic events, but not all occurred in patients with grade 4 thrombocytopenia. Interrupt Iclusig for serious or severe hemorrhage and evaluate.

Fluid Retention: Serious fluid retention events occurred in 3% (13/449) of patients treated with Iclusig. One instance of brain edema was fatal. In total, fluid retention occurred in 23% of the patients. The most common fluid retention events were peripheral edema (16%), pleural effusion (7%), and pericardial effusion (3%). Monitor patients for fluid retention and manage patients as clinically indicated. Interrupt, reduce, or discontinue Iclusig as clinically indicated.

Cardiac Arrhythmias: Symptomatic bradyarrhythmias that led to a requirement for pacemaker implantation occurred in 1% (3/449) of Iclusig-treated patients. Advise patients to report signs and symptoms suggestive of slow heart rate (fainting, dizziness, or chest pain). Supraventricular tachyarrhythmias occurred in 5% (25/449) of Iclusig-treated patients. Atrial fibrillation was the most common supraventricular tachyarrhythmia and occurred in 20 patients. For 13 patients, the event led to hospitalization. Advise patients to report signs and symptoms of rapid heart rate (palpitations, dizziness). Interrupt Iclusig and evaluate.

Myelosuppression: Severe (grade 3 or 4) myelosuppression occurred in 48% (215/449) of patients treated with Iclusig. The incidence of these events was greater in patients with AP-CML, BP-CML and Ph+ ALL than in patients with CP-CML. Obtain complete blood counts every 2 weeks for the first 3 months and then monthly or as clinically indicated, and adjust the dose as recommended.

Tumor Lysis Syndrome: Two patients (<1%) with advanced disease (AP-CML, BP-CML, or Ph+ ALL) treated with Iclusig developed serious tumor lysis syndrome. Hyperuricemia occurred in 7% (30/449) of patients overall; the majority had CP-CML (19 patients). Due to the potential for tumor lysis syndrome in patients with advanced disease, ensure adequate hydration and treat high uric acid levels prior to initiating therapy with Iclusig.

Compromised Wound Healing and Gastrointestinal Perforation: Since Iclusig may compromise wound healing, interrupt Iclusig for at least 1 week prior to major surgery. Serious gastrointestinal perforation (fistula) occurred in one patient 38 days post-cholecystectomy.

Embryo-Fetal Toxicity: Iclusig can cause fetal harm. If Iclusig is used during pregnancy, or if the patient becomes pregnant while taking Iclusig, the patient should be apprised of the potential hazard to the fetus. Advise women to avoid pregnancy while taking Iclusig.

Most common non-hematologic adverse reactions: (≥20%) were hypertension, rash, abdominal pain, fatigue, headache, dry skin, constipation, arthralgia, nausea, and pyrexia. Hematologic adverse reactions included thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia.

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 and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat 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).

This press release contains “forward-looking statements” which are based on management's good-faith 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 meet anticipated clinical trial commencement and completion dates for our products and product candidates and to move new development candidates into the clinic; our ability to secure a partnership for AP26113; difficulties or delays in filing for approvals and obtaining regulatory and pricing and reimbursement approvals to market our products; our ability to successfully commercialize and generate profits from sales of Iclusig; competition from alternative therapies, our reliance on the performance of third-party manufacturers and specialty pharmacies for the distribution of Iclusig; the occurrence of adverse safety events with our products and product candidates; the ability of our regional commercialization and distribution partners to perform as required; preclinical data and early-stage clinical data that may not be replicated in later-stage clinical studies, the costs associated with our research, development, manufacturing and other activities, the enrollment, conduct, timing and results of pre-clinical and clinical studies of our product candidates, the adequacy of our capital resources and the availability of additional funding, and other factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. After the date of this document, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results or to changes in the Company's expectations, except as required by law.

Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc.

CONTACT:
ARIAD Pharmaceuticals, Inc.
For Investors
Kendra Adams, (617) 503-7028
Kendra.adams@ariad.com
or
For Media
Liza Heapes, (617) 620-4888
Liza.heapes@ariad.com



Exhibit 99.2

GRAPHIC Path to Value and Profitability Elsa So Non-small cell lung cancer ARIAD clinical trial patient Harvey J. Berger M.D. Chairman and Chief Executive Officer ARIAD Pharmaceuticals, Inc.


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference Some of the statements in this presentation constitute “forward looking statements” under the Private Securities Litigation Reform Act of 1995. Such statements are subject to factors, risks and uncertainties (such as those detailed in the Company’s periodic filings with the SEC) that may cause actual results to differ materially from those expressed or implied by such forward looking statements.


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference ARIAD 2014: key areas of progress Re-launched Iclusig in the U.S. with ~800 patients treated Successfully completed EMA review - Iclusig indication statement unchanged Improved understanding of benefit/risk profile of ponatinib Achieved positive P&R outcomes in key European countries Concluded consultations with FDA and EMA on Iclusig dose-ranging trial Secured experienced Japanese partner for Iclusig Advanced brigatinib (AP26113) into pivotal trial and designated as Breakthrough Therapy Nominated new development candidate (AP32788)


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference 4 ARIAD 2015: our strategic focus Expand the Iclusig global commercial opportunity Leverage existing commercial infrastructure and investment Secure a broad partnership for brigatinib Invest in randomized trials to advance Iclusig and brigatinib into earlier lines of treatment, expand addressable market Achieve sustained profitability in 2018 by reaching global product revenue of >$400M


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference 5 Iclusig: seeking to expand the global opportunity in resistant Ph+ leukemias Early-switch 2nd line 2nd line 3rd line No other options T315I


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference Iclusig: seeking to expand the global opportunity in resistant Ph+ leukemias Chronic Phase Accelerated Phase Blast Phase Ph+ ALL


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference  Iclusig: leverage existing infrastructure and investment U.S. and Europe Further expand into chronic-phase disease and earlier lines of therapy Advance to market leader in 3rd line chronic-phase CML Continue launching throughout EU28 countries* Japan Otsuka partnership in Japan and select Asian countries Commercial launch expected in 2016 Rest of World Additional regional distribution agreements in 2015 *Includes Central and Eastern Europe distributorship with CSC Pharmaceuticals, a subsidiary of Angelini Pharma.


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference ARIAD and Otsuka: a strategic Iclusig partnership in Japan and Asia Existing hematology sales force with CML TKI experience Exclusive commercialization by Otsuka in ten Asian countries Building major hematology/oncology business in Territory $77.5 million upfront, future milestones and substantial portion of  net product sales to ARIAD  Joint development in Territory with Otsuka funding additional agreed-upon clinical studies ARIAD rights to co-promotion in Japan and China beginning in third year of commercialization* Approval and launch of Iclusig in Japan expected in 2016 *ARIAD to bear its own cost for the co-promotion and receive a higher share of incremental sales above a baseline forecast


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference  2018: product revenues reach >$400M Revenue projections do not assume an Iclusig 2nd line indication in the U.S. or an expanded 2nd line indication in Europe during this timeframe. Global product revenue – with no change to U.S./EU Iclusig label $0 $100 $200 $300 $400 $500 $600 2015E 2016E 2017E 2018E  >$400M Sales in millions Brigatinib Iclusig


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference Iclusig: potential 2nd line indication more than doubles the Iclusig opportunity Potential annual CML patients eligible for Iclusig in 2018/2019 ~3,300 U.S. Source: Kantar Health and internal data; ROW= Rest of world Europe ~4,000 Japan ~800 ROW ~1,000


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference Brigatinib – ALK+ NSCLC AP32788 – NSCLC Lung Cancer: two distinct opportunities - Potential best-in-class orally active TKI - Highly competitive profile expected to garner significant market share - Global market approaches $2B by 2020 - Orally active TKI - Unique profile against a validated class of mutated targets - Addresses unmet medical need


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference Brigatinib: maximizing the full value Secure a broad partnership to co-develop and co-commercialize brigatinib in 2015 - Leverage existing infrastructure and capabilities - Accelerate randomized, 1st line trial against crizotinib - Explore new combination therapies - Mitigate risk ALTA trial forms basis for initial approval; filing expected mid-2016 Breakthrough therapy designation may accelerate approval timeline


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference ALK + NSCLC market: a significant opportunity 2015 annual incidence ~9,000 U.S. Europe ~5,500 Japan  ~3,500 ROW ~4,700 Sources: SEER Cancer Statistics Review 1975-2010; UpToDate; 2012 SEER Data (Cancer Statistics Review, 1975-2008); Cancer.gov; incidence reflects mid-point of range; ROW = Rest of world


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference ALK+ NSCLC market: approaching $2B in 5 years Sources: * Xalkori consensus from Thomson Cortellis (7 analysts) ** Zykadia consensus from Thomson Cortellis (4 analysts) *** Alecensa consensus from Thomson Cortellis (3 analysts) Global ALK Inhibitor Consensus Revenue Forecasts $0 $400 $800 $1,200 $1,600 $2,000 2015E 2019E ~$700M ~$1.7B Product revenue in millions Alecensa Consensus*** Zykadia Consensus** Xalkori Consensus*


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference Research & Development Key Investments J.P.


GRAPHIC 01.14.2015 Morgan Healthcare Conference Iclusig – doseranging trial in 3rd line CML Iclusig – randomized trial vs. nilotinib in 2nd line CML Iclusig – early-switch trial in 2nd line CML (SPIRIT3) Brigatinib – ALTA trial in refractory ALK+ NSCLC Brigatinib – randomized  trial vs. crizotinib  in 1st line ALK+ NSCLC AP32788 – Clinical proof-of-concept Hematology Lung Cancer Our R&D strategy: focused on six investments


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference Iclusig: dose-ranging 3rd line CML trial Trial to open by mid-2015 Adult CP-CML patients resistant to ≥ 2 TKIs, N=450 Primary endpoint: MCyR by 12 months Minimum follow-up of 2 years 1:1:1 Randomization Dose reduction to 15 mg upon achievement of MCyR Ponatinib 15 mg Ponatinib 30 mg Ponatinib 45 mg


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference Iclusig: randomized phase 3 trial in 2nd line CML Global trial evaluating two doses of ponatinib vs. nilotinib; N=~500 Key Features CML patients resistant to imatinib Population Primary endpoint of  MMR by 12 months Efficacy Focus on arterial thrombotic events Safety Trial to open 2H 2015


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference  Iclusig: early-switch trial in 2nd line CML (SPIRIT3) EMR = early molecular  response (MR 10) Trial to open 1H 2015 Patients failing to reach EMR at 3 months switch to ponatinib Reduce dose in patients in MMR for ≥ 2 years; stop treatment if MMR maintained 1:1 Randomization Newly diagnosed CP-CML patients in the UK; N = 1,000 Primary endpoint: MMR at 3 years Imatinib 400 mg Nilotinib 300 mg BID Imatinib 400 mg Ponatinib 30 mg Ponatinib 30 mg  Nilotinib 300 mg BID


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference  Brigatinib: pivotal ALTA trial in refractory LK+ NSCLC Primary endpoint = ORR Non-comparative trial Full patient enrollment expected in Q3 2015 Brigatinib 90 mg All Patients Global Trial N= 220 patients Includes patients with brain metastases Randomized 1:1 1 Week Continue on 90 mg 110 patients Increase to 180 mg 110 patients


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference 2015 2016 2017 Iclusig • Start of 3 CML trials • Data presented from ISTs • Early data from dose-ranging trial Data presented from ISTs  Approval in Japan Full patient enrollment  in 2nd line trial Additional data from dose-ranging trial brigatinib Full patient enrollment in ALTA trial Early data from ALTA trial U.S. filing and approval in refractory ALK+ NSCLC 1st line trial enrolling U.S. launch EU filing in refractory ALK+ NSCLC AP32788 IND filing Start of Phase 1/2 trial Pre-clinical data presented Phase 1/2 Proof of Concept data Key R&D milestones: next 3 years


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference Marcele Wilson Chronic myeloid leukemia ARIAD clinical trial patient Achieving Profitability in 2018


GRAPHIC 01.14.2015 J.P. Morgan 01.14.2015 Healthcare Conference  Revenue – product and license $100 Selling, general and administrative expenses $140 Research and development expenses $120 Cash and cash equivalents as of 12/31/14 $350 2014 Key financial results *All amounts presented are unaudited estimates; revenue includes product revenue from sales of Iclusig and license revenue including revenue related to the revised license agreement with Bellicum Estimated FY 2014 financials* (dollars in millions)


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference  Path to sustained profitability 2015 2016 2017 2018 Revenue growth and partnerships drive increased cash flow Iclusig revenue growth in U.S. and Europe from current label Iclusig revenue from Japan and new geographies Brigatinib revenue and partnership payments Sustained profitability achieved on >$400M revenues in 2018 Strategic investment to support long-term growth Commercial presence in U.S. and Europe Iclusig development in earlier lines of therapy Brigatinib and AP32788 development No requirement for additional equity capital Broad co-development and co-commercialization partnership for brigatinib


GRAPHIC 01.14.2015 J.P. Morgan Healthcare Conference  ARIAD 2015: key catalysts Accelerate Iclusig sales in U.S. and Europe Initiate key Iclusig trials Dose-ranging trial Randomized 2nd line trial vs. nilotinib Early- switch 2nd line trial (SPIRIT3) Secure broad partnership for brigatinib Present early data from brigatinib pivotal ALTA trial File for approval of Iclusig in Japan with Otsuka File IND for new development candidate AP32788


GRAPHIC ARIAD®

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