UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14D-9
(Rule 14d-101)
Solicitation/Recommendation Statement
Under Section 14(d)(4) of the Securities Exchange Act of 1934
ARIAD Pharmaceuticals, Inc.
(Name of Subject Company)
ARIAD Pharmaceuticals, Inc.
(Name of Person Filing Statement)
Common Stock, $0.001 par value per share
(Title of Class of Securities)
04033A100
(CUSIP Number of Class of Securities)
Paris Panayiotopoulos
President, Chief Executive Officer
ARIAD Pharmaceuticals, Inc.
125 Binney Street
Cambridge, Massachusetts 02142
(617) 494-0400
(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications
on Behalf of the Person Filing Statement)
With copies to:
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Manmeet S. Soni |
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Scott A. Barshay |
Executive Vice President, Chief Financial Officer |
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Jeffrey D. Marell |
ARIAD Pharmaceuticals, Inc. |
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Paul, Weiss, Rifkind, Wharton & Garrison LLP |
125 Binney Street |
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1285 Avenue of the Americas |
Cambridge, Massachusetts 02142 |
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New York, New York 10019 |
(617) 494-0400 |
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(212) 373-3000 |
x |
Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer. |
On January 8, 2017, ARIAD Pharmaceuticals, Inc. (the Company or we) entered into an Agreement and Plan of Merger (the Merger Agreement) with Takeda Pharmaceutical Company Limited (Parent or Takeda), a corporation organized under the laws of Japan, and Kiku Merger Co., Inc. (Merger Sub), a Delaware corporation and an indirect wholly-owned subsidiary of Parent. On January 9, 2017, the Company and the Parent issued a joint press release announcing the proposed transaction and execution of the Merger Agreement.
Pursuant to the Merger Agreement, upon the terms and subject to the conditions thereof, Merger Sub will commence a tender offer (the Offer) no later than January 24, 2017, to acquire all of the outstanding shares of common stock of the Company, $0.001 par value per share (the Shares), at a purchase price of $24 per Share (the Offer Price) in cash, net of applicable withholding taxes and without interest. The obligation of Merger Sub to purchase Shares tendered in the Offer is subject to certain conditions.
As soon as practicable following the consummation of the Offer and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Merger Sub will be merged with and into the Company (the Merger), with the Company surviving the Merger as an indirect wholly-owned subsidiary of Parent (the Surviving Corporation). The Merger will be governed by Section 251(h) of the Delaware General Corporate Law, as amended (DGCL) and effected without a vote of the Company stockholders. As a result of the Merger, each Share (other than as Shares (i) owned by Parent, Merger Sub or any other direct or indirect wholly-owned subsidiary of Parent immediately prior to the effective time of the Merger, (ii) owned by the Company or any direct or indirect wholly-owned subsidiary of the Company or held in the Companys treasury or (iii) held by a holder who is entitled to appraisal and who has properly exercised appraisal rights for such shares in accordance with Section 262 of the DGCL) will be converted automatically into the right to receive the Offer Price in cash, net of applicable withholding taxes and without interest.
This Schedule 14D-9 filing consists of the following documents relating to the proposed Offer and Merger:
(i) Joint press release, dated as of January 9, 2017, issued by ARIAD Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited relating to the proposed acquisition of ARIAD Pharmaceuticals, Inc. (Exhibit 99.1)
(ii) Press release, dated as of January 9, 2017, issued by ARIAD Pharmaceuticals, Inc. relating to the proposed acquisition of ARIAD Pharmaceuticals, Inc. (Exhibit 99.2)
(iii) Employee Letter dated January 9, 2018 from the President and Chief Executive Officer of ARIAD Pharmaceuticals, Inc. (Exhibit 99.3)
(iv) Notice issued by ARIAD Pharmaceuticals, Inc. on January 9, 2017 to holders of 3.625% Convertible Senior Notes due 2019 issued by ARIAD Pharmaceuticals, Inc. (Exhibit 99.4)
Exhibit 99.1
Takeda to Acquire ARIAD Pharmaceuticals, Inc.
Significantly Enhances Takedas Global Oncology Portfolio
Accretive to FY2018 Underlying Core Earnings
Reinforces Takedas Commitment to Developing Medicines for Patients Living with Cancer
Strategic Highlights
· Highly strategic deal which transforms global oncology portfolio and pipeline by expanding into solid tumors and reinforcing existing strength in hematology
· Accretive to Takedas Underlying Core Earnings by FY2018 and generates immediate and long-term revenue growth
· Attractive value drivers include two very innovative precision medicines, Iclusig® (ponatinib) and brigatinib, an exciting early stage pipeline and cost synergies
· Iclusig is a globally commercialized product with continued strong sales growth potential
· Brigatinib approval in the U.S. is expected in the first half of 2017, with peak sales potential over $1 billion and the potential to be the best-in-class ALK inhibitor
· Takeda will leverage ARIADs research and development capabilities and platform
· Takeda retains financial flexibility with no impact on dividend policy
Cambridge, Mass. and Osaka, Japan, January 9, 2017 Takeda Pharmaceutical Company Limited (TSE: 4502) (Takeda) and ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) (ARIAD) today announced that they have entered into a definitive agreement under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or an enterprise value of approximately $5.2 billion. The transaction has been approved unanimously by the boards of directors of both companies, and is expected to close by the end of February 2017, subject to required regulatory approvals and other customary closing conditions. Sarissa Capital, the holder of 6.6% of ARIADs common shares, as well as each of the members of ARIADs Board of Directors have agreed to tender their shares to Takeda pursuant to the offer.
The acquisition of ARIAD is a unique opportunity that will enable us to positively impact the lives of more patients worldwide, advance our strategic priorities and generate attractive returns for our shareholders, said Christophe Weber, president and chief executive officer of Takeda. This is a very exciting time for Takeda as we will broaden our hematology portfolio and transform our global solid tumor franchise through the addition of two innovative targeted therapies. Opportunities to acquire such high-quality, complementary targeted therapies do not come often, and we are very excited about the potential for this transaction to benefit patients, our shareholders and other stakeholders.
Paris Panayiotopoulos, president and chief executive officer of ARIAD, said, We are very pleased to combine with Takeda, which will allow us to not only accelerate our mission to discover, develop and deliver precision therapies to patients with rare cancers, but also deliver immediate and meaningful value to our shareholders through a substantial cash premium. This exciting transaction is a testament to the hard work and dedication of ARIADs talented team of employees. We have tremendous respect for Takeda, and I believe our shared commitment to innovation and research-driven cultures will provide for a smooth transition.
This transaction is a great outcome for shareholders of ARIAD and Takeda. Both ARIAD and Takeda are passionate about helping cancer patients, and I believe the talent and resources of Takeda coupled with ARIADs pipeline and people will accelerate the development of cancer treatments. I would like to extend my deepest gratitude to the management team and everyone at ARIAD for their unrelenting dedication, said Alexander J. Denner, Ph.D., Chairman of the Board of ARIAD.
Highly strategic deal which transforms global oncology portfolio and pipeline by expanding into solid tumors and reinforcing existing strength in hematology
The acquisition of ARIAD brings two innovative targeted therapies that will expand and enhance Takedas existing oncology portfolio. Brigatinib, an investigational drug product, has the potential to add a differentiated, global therapy in a genetically-defined subpopulation of non-small cell lung cancer (NSCLC). The addition of Iclusig will broaden Takedas strong hematology franchise to include chronic myeloid leukemia (CML) and a subset of acute lymphoblastic leukemia (ALL). Together, these two innovative targeted therapies will position Takeda for sustainable long-term growth in oncology.
Takedas track record of successful oncology product launches [ADCETRIS® (Brentuximab Vedotin), NINLAROTM (ixazomib) and VELCADE® (bortezomib)] means it has the experience and expertise required to deliver the successful launch of brigatinib and to ensure that it achieves global reach and share of voice thereafter.
Accretive to Takedas Underlying Core Earnings by FY2018 and generates immediate and long-term revenue growth
The transaction is a compelling opportunity for Takeda shareholders. It will provide immediate revenue, bring considerable long-term revenue potential and deliver synergy savings.
ARIAD provided calendar year 2016 revenue guidance for Iclusig of $170-180 million, and Takeda expects significant long-term revenue potential from the two lead assets.
Takeda projects the acquisition of ARIAD to be accretive to Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch.
Attractive value drivers include two very innovative medicines, Iclusig and brigatinib, an exciting early stage pipeline and cost synergies
Iclusig, a commercialized therapy with continued strong sales growth potential, delivers immediate value. Brigatinib, an investigational drug product with peak annual sales potential of over $1 billion, will generate significant long-term value for Takeda. U.S. approval is expected in the first half of 2017 with global filing thereafter. Beyond Iclusig and brigatinib, ARIADs commitment and expertise in targeted kinase inhibition linked to strong translational science generated further pipeline opportunities which provide additional long-term upside potential.
Takeda will leverage ARIADs R&D capabilities and platform, and largely absorb its R&D costs within
Takedas existing R&D budget. G&A cost synergies will be fully captured by FY2018.
Takeda retains financial flexibility with no impact on dividend policy
The transaction will be funded by up to $4.0 billion of new debt and the remainder from existing cash. FY2017 Net Debt/EBITDA is estimated at approximately 2.6x, which is expected to remain investment grade. The transaction has no impact on Takedas dividend policy.
Transaction terms
The acquisition is structured as an all cash tender offer by a subsidiary of Takeda for all of the outstanding shares of ARIAD common stock, followed by a merger in which remaining shares of ARIAD would be converted into the right to receive the same $24.00 cash per share price paid in the tender offer and ARIAD will become an indirect wholly owned subsidiary of Takeda.
The transaction is subject to the tender of a majority of the outstanding shares of ARIAD common stock as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close by the end of February 2017.
Takeda Pharmaceuticals U.S.A, a wholly owned subsidiary of Takeda, has established Kiku Merger Co., Inc. to effect the transaction.
(1) |
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Tender offeror |
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Kiku Merger Co., Inc. |
(2) |
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Target company |
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ARIAD Pharmaceuticals, Inc. |
(3) |
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Class of shares to be acquired |
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Common stock |
(4) |
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Tender offer price |
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$24.00 per share |
(5) |
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Acquisition amount |
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Approximately $5.4 billion enterprise value (estimate) * The amount is an estimated amount calculated by multiplying the number of the target companys shares (fully diluted basis) by the tender offer price per share. It does not include advisory fees. |
(6) |
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Payment |
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Cash * Funded by up to $4.0 billion of new debt and the remainder from existing cash. |
(7) |
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Period of tender offer |
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From January, 2017 to February, 2017 ** The initial period of the tender offer will commence within 10 business days following execution of the merger agreement with ARIAD [January 8, 2017 (U.S.)], and will close 20 business days after commencement. If the situation arises whereby the conditions of the tender offer are not satisfied, the period of the tender offer will be extended, but the extension period will not exceed May 2017 (or August 2017 if antitrust clearance not received). |
(8) |
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Minimum number of shares to be purchased |
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Consummation of the tender offer will occur once the majority of shares outstanding of the company have been tendered and other customary closing conditions have been satisfied. |
(9) |
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Financial advisor to Takeda |
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Evercore Partners |
(10) |
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Legal counsel to Takeda |
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Cleary Gottlieb Steen & Hamilton LLP |
(11) |
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Financial advisor to ARIAD |
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J.P. Morgan Securities LLC, Goldman, Sachs & Co., Lazard |
(12) |
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Legal counsel to ARIAD |
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Paul, Weiss, Rifkind, Wharton & Garrison LLP |
Overview of ARIAD
(1) |
Company name |
ARIAD Pharmaceuticals, Inc. | |||
(2) |
Headquarters |
125 Binney Street, Cambridge, Massachusetts 02142, USA | |||
(3) |
Representative |
Paris Panayiotopoulos, President and Chief Executive Officer | |||
(4) |
Business description |
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. | |||
(5) |
Capital |
US$1,339 million (Additional paid-in capital as of December 31, 2015) | |||
(6) |
Date of establishment |
April, 1991 | |||
(7) |
Major shareholders and percentage of shares held* |
Wellington Management Group LLP |
8.8 |
% | |
FMR LLC |
7.8 |
% | |||
Vanguard Group Inc. |
6.8 |
% | |||
Others | |||||
(8) |
Relationships between Takeda |
Capital relationship |
Not applicable |
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Personnel relationship |
Not applicable |
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Transactional relationship |
Not applicable |
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(9) |
Operating result and financial conditions for the last three years (consolidated) | ||||
Accounting period |
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Fiscal year ended |
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Fiscal year ended |
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Fiscal year ended |
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Net assets (US$ in thousands) |
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185,517 |
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80,801 |
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(103,141 |
) |
Total assets (US$ in thousands) |
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370,894 |
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603,116 |
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546,692 |
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Net assets per share (US$) |
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1.01 |
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0.43 |
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(0.55 |
) |
Revenue (US$ in thousands) |
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45,561 |
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105,412 |
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118,804 |
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Operating profit (US$ in thousands) |
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(273,566 |
) |
(160,195 |
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(217,276 |
) |
Net loss (US$ in thousands) |
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(274,158 |
) |
(162,602 |
) |
(231,156 |
) |
Net loss per share (US$) |
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(1.49 |
) |
(0.87 |
) |
(1.23 |
) |
* As reported in the 13F filings. Percentage of shares is calculated by dividing the number of shareholdings (as of the end of September 2016) by the number of total shares outstanding of the target company.
Change in ownership before and after acquisition
(1) |
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Number of shares already acquired |
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0 shares |
(2) |
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Number of shares to be acquired |
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194,389,661 shares* |
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* Total shares outstanding |
Schedule
(1) |
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Board meeting resolution |
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January 6, 2017 |
(2) |
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Signing date |
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January 8, 2017 |
(3) |
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Commencement date and settlement date of the tender offer |
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From January, 2017 to February, 2017 |
(4) |
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Completion of acquisition |
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By the end of February, 2017 (planned)* |
* Fulfillment of the terms and conditions of the U.S. Antitrust Law and the satisfaction of certain other customary conditions are required to complete the acquisition.
Outlook
FY2016
At this stage we expect minimal impact on Underlying Revenue and Underlying Core Earnings. We do expect to incur transition and integration expenses, however, these expenses are not material to the current year result. We will incorporate the financial impact in our FY2016 consolidated earnings forecast and announce at the third quarter earnings conference in February 2017.
FY2017 and beyond
It is expected that the acquisition of ARIAD will be accretive to Takedas Underlying Core Earnings by FY2018 and broadly neutral in FY2017. Strong revenue growth and synergy savings will offset increased sales and marketing costs for the brigatinib launch. Takedas financial guidance, including EPS, for FY2017 will be announced when Takeda reports earnings for FY2016 in May 2017.
Conference Call Webcast Information
Takeda will host a media/investors conference call at 7:30 p.m. EST January 9, 2017 (9:30 a.m. JST January 10, 2017) to discuss the transaction.
You can listen to the conference call at the following link:
http://www.Takeda.com/investor-information/results/
A replay of the conference call will be available within 24 hours.
In light of this announcement, ARIAD will not be presenting today at the 35th Annual J.P. Morgan Healthcare Conference.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. Additional information about Takeda is available through its corporate website, www.Takeda.com.
Media and Investor Contacts
Takeda Investor Contact |
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ARIAD Investor Contact |
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Takeda Media outside Japan |
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ARIAD Media Contacts |
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 ARIADs 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:
· Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
· Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.
Limitations of use:
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
Based on the Phase 2 48 mo. follow-up analysis (N=449), except where noted
IMPORTANT U.S. SAFETY INFORMATION, INCLUDING THE BOXED WARNING
WARNING: ARTERIAL OCCLUSION, VENOUS THROMBOEMBOLISM, HEART FAILURE, and HEPATOTOXICITY
See full prescribing information for complete boxed warning.
· Arterial occlusion has occurred in at least 35% of Iclusig® (ponatinib)-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. Interrupt or stop Iclusig immediately for arterial occlusion. A benefit-risk consideration should guide a decision to restart Iclusig.
· Venous Thromboembolism has occurred in 6% of Iclusig-treated patients. Monitor for evidence of thromboembolism. Consider dose modification or discontinuation of Iclusig in patients who develop serious venous thromboembolism.
· Heart Failure, including fatalities occurred in 9% 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.
Warnings and Precautions
Arterial Occlusions: Arterial occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease have occurred in at least 35% of Iclusig-treated patients from the phase 1 and phase 2 trials. In the phase 2 trial, 33% (150/449) of Iclusig-treated patients experienced a cardiac vascular (21%), peripheral vascular (12%), or cerebrovascular (9%) arterial occlusive event; some patients experienced more than 1 type of event. Fatal and life-threatening events have occurred within 2 weeks of starting treatment, with doses as low as 15 mg per day. Iclusig can also cause recurrent or multi-site vascular occlusion. Patients have required revascularization procedures. The median time to onset of the first cardiac vascular, cerebrovascular, and peripheral vascular arterial occlusive events was 193, 526, and 478 days, respectively. Patients with and without cardiovascular risk factors, some age 50 years or younger, experienced these events. The most common risk factors observed with these events were hypertension, hyperlipidemia, and history of cardiac disease. Arterial occlusive events were more frequent with increasing age and in patients with a history of ischemia, hypertension, diabetes, or hyperlipidemia. In patients suspected of developing arterial occlusive events, interrupt or stop Iclusig.
Venous Thromboembolism: Venous thromboembolic events occurred in 6% (25/449) of Iclusig-treated patients with an incidence rate of 5% (13/270 CP-CML), 4% (3/85 AP-CML), 10% (6/62 BP-CML) and 9% (3/32 Ph+ ALL). Events included: deep venous thrombosis, pulmonary embolism, superficial thrombophlebitis, and retinal vein thrombosis with vision loss. Consider dose modification or discontinuation of Iclusig in patients who develop serious venous thromboembolism.
Heart Failure: Fatal or serious heart failure or left ventricular dysfunction occurred in 6% of Iclusig-treated patients (29/449). Nine percent of patients (39/449) experienced any grade of heart failure or left ventricular dysfunction. The most frequently reported heart failure events were congestive cardiac failure and decreased ejection fraction (14 patients each; 3%). Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig. Consider discontinuation if serious heart failure develops.
Hepatotoxicity: Iclusig can cause hepatotoxicity, including liver failure and death. Fulminant hepatic failure leading to death occurred in a patient within one week of starting Iclusig. Two additional fatal cases of acute liver failure also occurred. The fatal cases occurred in patients with BP-CML or Ph+ ALL. Severe hepatotoxicity occurred in all disease cohorts, with 11% (50/449) experiencing grade 3 or 4 hepatotoxicity. The most common forms of hepatotoxicity were elevations of AST or ALT (54% all grades, 8% grade 3 or 4, 5% not reversed at last follow-up), bilirubin, and alkaline phosphatase. Hepatotoxic events were observed in 29% of patients. The median time to onset of hepatotoxicity event was 3 months. 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 elevation of systolic or diastolic blood pressure (BP) occurred in 68% (306/449) of Iclusig-treated patients. Fifty-three patients (12%) experienced treatment-emergent symptomatic hypertension as a serious adverse reaction, including hypertensive crisis. Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. In patients with baseline systolic BP<140 mm Hg and baseline diastolic BP<90 mm Hg, 80% (229/285) experienced treatment-emergent hypertension; 44% (124/285) developed Stage 1 hypertension, 37% developed Stage 2 hypertension. In 132 patients with Stage 1 hypertension at baseline, 67% (88/132) 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. In the event of significant worsening, labile or treatment-resistant hypertension, interrupt treatment and consider evaluating for renal artery stenosis.
Pancreatitis: Pancreatitis occurred in 7% (31/449, 6% serious or grade 3/4) of Iclusig-treated patients. The incidence of treatment-emergent lipase elevation was 42% (16% grade 3 or greater). Pancreatitis resulted in discontinuation or treatment interruption in 6% of patients (26/449). The median time to onset of pancreatitis was 14 days. Twenty-three of the 31 cases of pancreatitis resolved within 2 weeks with dose interruption or reduction. 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.
Increased Toxicity in Newly Diagnosed Chronic Phase CML: In a prospective randomized clinical trial in the first-line treatment of newly diagnosed patients with chronic phase (CP) CML, single agent Iclusig 45 mg once-daily increased the risk of serious adverse reactions 2-fold compared to single agent imatinib 400 mg once-daily. The median exposure to treatment was less than 6 months. The trial was halted for safety in October 2013. Arterial and venous thrombosis and occlusions occurred at least twice as frequently in the Iclusig arm compared to the imatinib arm. Compared to imatinib-treated patients, Iclusig-treated patients exhibited a greater incidence of myelosuppression, pancreatitis, hepatotoxicity, cardiac failure, hypertension, and skin and subcutaneous tissue disorders. Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.
Neuropathy: Peripheral and cranial neuropathy have occurred in Iclusig-treated patients. Overall, 20% (90/449) of Iclusig-treated patients experienced a peripheral neuropathy event of any grade (2%, grade 3/4). The most common peripheral neuropathies reported were paresthesia (5%, 23/449), neuropathy peripheral (4%, 19/449), hypoesthesia (3%, 15/449), dysgeusia (2%, 10/449), muscular weakness (2% 10/449) and hyperesthesia (1%, 5/449). Cranial neuropathy developed in 2% (10/449) of Iclusig-treated patients (<1%, 3/449 - grade 3/4). Of the patients who developed neuropathy, 26% (23/90) 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 2% of Iclusig-treated patients. Conjunctival irritation, corneal erosion or abrasion, dry eye, conjunctivitis, conjunctival hemorrhage, hyperaemia and edema or eye pain occurred in 14% of patients. Visual blurring occurred in 6% of patients. Other ocular toxicities include cataracts, periorbital edema, blepharitis, glaucoma, eyelid edema, ocular hyperaemia, iritis, iridocyclitis, and ulcerative keratitis. Conduct comprehensive eye exams at baseline and periodically during treatment.
Hemorrhage: Serious hemorrhage events including fatalities, occurred in 6% (28/449) of patients treated with Iclusig. Hemorrhage occurred in 28% (124/449) of patients. The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML, and Ph+ ALL. Gastrointestinal hemorrhage and subdural hematoma were the most commonly reported serious bleeding events occurring in 1% (4/449) each. Most hemorrhagic events, but not all, occurred in patients with grade 4 thrombocytopenia. Interrupt Iclusig for serious or severe hemorrhage and evaluate.
Fluid Retention: Fluid retention events judged as serious occurred in 4% (18/449) of patients treated with Iclusig. One instance of brain edema was fatal. For fluid retention events occurring in >2% of the patients (treatment-emergent), serious cases included: pleural effusion (7/449, 2%), pericardial effusion (4/449, 1%), and edema peripheral (2/449, <1%).
In total, fluid retention occurred in 31% of the patients. The most common fluid retention events were peripheral edema (17%), pleural effusion (8%), pericardial effusion (4%) and peripheral swelling (3%).
Monitor patients for fluid retention and manage patients as clinically indicated. Interrupt, reduce, or discontinue Iclusig as clinically indicated.
Cardiac arrhythmias: Arrhythmias occurred in 19% (86/449) of Iclusig-treated patients, of which 7% (33/449) were grade 3 or greater. Arrhythmia of ventricular origin was reported in 3% (3/86) of all arrhythmias, with one case being grade 3 or greater. Symptomatic bradyarrhythmias that led to pacemaker implantation occurred in 1% (3/449) of Iclusig-treated patients.
Atrial fibrillation was the most common arrhythmia and occurred in 7% (31/449) of patients, approximately half of which were grade 3 or 4. Other grade 3 or 4 arrhythmia events included syncope (9 patients; 2.0%), tachycardia and bradycardia (2 patients each 0.4%), and electrocardiogram QT prolonged, atrial flutter, supraventricular tachycardia, ventricular tachycardia, atrial tachycardia, atrioventricular block complete, cardio-respiratory arrest, loss of consciousness, and sinus node dysfunction (1 patient each 0.2%). For 27 patients, the event led to hospitalization.
In patients with signs and symptoms suggestive of slow heart rate (fainting, dizziness) or rapid heart rate (chest pain, palpitations or dizziness), interrupt Iclusig and evaluate.
Myelosuppression: Myelosuppression was reported as an adverse reaction in 59% (266/449) of Iclusig-treated patients and grade 3/4 myelosuppression occurred in 50% (226/449) of patients. The incidence of these events was greater in patients with AP-CML, BP-CML, and Ph+ ALL than in patients with CP-CML.
Severe myelosuppression (Grade 3 or 4) was observed early in treatment, with a median onset time of 1 month (range <1-40 months). 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%, one with AP-CML and one with BP-CML) treated with Iclusig developed serious tumor lysis syndrome. Hyperuricemia occurred in 7% (31/449) of 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.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Postmarketing cases of reversible posterior leukoencephalopathy syndrome (RPLSalso known as Posterior Reversible Encephalopathy Syndrome (PRES)) have been reported in Iclusig-treated patients. RPLS is a neurological disorder that can present with signs and symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances. Hypertension is often present and diagnosis is made with supportive findings on magnetic resonance imaging (MRI) of the brain. If RPLS is diagnosed, interrupt Iclusig treatment and resume treatment only once the event is resolved and if the benefit of continued treatment outweighs the risk of RPLS.
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: Based on its mechanism of action and findings from animal studies, Iclusig can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at exposures lower than human exposures at the recommended human dose. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Iclusig and for 3 weeks after the last dose.
Most Common Adverse Reactions: Overall, the most common non-hematologic adverse reactions (>20%) were abdominal pain, rash, constipation, headache, dry skin, fatigue, hypertension, pyrexia, arthralgia, nausea, diarrhea, lipase increased, vomiting, myalgia and pain in extremity. Hematologic adverse reactions included thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia.
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning.
Iclusig is a registered trademark of ARIAD Pharmaceuticals, Inc.
Additional Information
The tender offer described in this press release has not yet commenced. This press release is provided for informational purposes only and does not constitute an offer to purchase or the solicitation of an offer to sell any securities. At the time the tender offer is commenced, Takeda and its wholly owned subsidiary, Kiku Merger Co., Inc., intend to file with the Securities and Exchange Commission (the SEC) a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and ARIAD intends to file with the SEC a Solicitation/Recommendation Statement on Schedule 14D 9 with respect to the tender offer. Takeda, Kiku Merger Co., Inc. and ARIAD intend to mail these documents to the ARIAD stockholders. Investors and shareholders should read those filings carefully when they become available as they will contain important information about the tender offer. Those documents may be obtained without charge at the SECs website at www.sec.gov. The offer to purchase and related materials may also be obtained (when available) for free by contacting the information agent for the tender offer.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking information related to Takeda, ARIAD and the proposed acquisition of ARIAD by Takeda that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements in this document include, among other things, statements about the potential benefits of the proposed acquisition, anticipated earnings accretion and growth rates, Takedas and ARIADs plans, objectives, expectations and intentions, the financial condition, results of operations and business of Takeda and ARIAD, ARIADs products, ARIADs pipeline assets, and the anticipated timing of closing of the acquisition. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions to closing the acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including uncertainties as to how many of ARIADs stockholders will tender their shares in the tender offer and the possibility that the acquisition does not close; risks related to
the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Takedas common stock and on Takedas operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; the uncertainties inherent in research and development, including the ability to sustain and increase the rate of growth in revenues for ARIADs products despite increasing competitive, reimbursement and economic challenges; whether and when any drug applications may be filed in any jurisdictions for any indications or any additional indications for ARIADs products or for ARIADs pipeline assets; whether and when the FDA or any other applicable regulatory authorities may approve any such applications, which will depend on its assessment of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by the FDA or other regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of ARIADs products and ARIADs pipeline assets; and competitive developments.
Many of these factors are beyond Takedas control. Unless otherwise required by applicable law, Takeda disclaims any intention or obligation to update forward-looking statements contained in this document as the result of new information or future events or developments.
###
Exhibit 99.2
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News Release |
FOR IMMEDIATE RELEASE
ARIAD Enters into Definitive Agreement to be Acquired by Takeda for $5.2 billion
ARIAD Stockholders to Receive $24.00 per Share in Cash
Cambridge, Mass. January 9, 2017 ARIAD Pharmaceuticals (NASDAQ:ARIA) (ARIAD) today announced it has entered into a definitive agreement to be acquired by Takeda Pharmaceutical Company Limited (TSE: 4502) (Takeda) under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or a total enterprise value of approximately $5.2 billion, representing a premium of approximately 75 percent over ARIADs closing price on January 6, 2017.
Under the terms of the agreement, ARIAD stockholders will receive $24.00 in cash for each share of ARIAD common stock they own. The transaction has been approved unanimously by the boards of directors of both companies, and is expected to close by the end of February 2017, subject to required regulatory approvals and other customary closing conditions.
Paris Panayiotopoulos, President and Chief Executive Officer of ARIAD, said, We are very pleased to combine with Takeda, which will allow us to not only accelerate our mission to discover, develop and deliver precision therapies to patients with rare cancers, but also deliver meaningful value to our shareholders through a substantial cash premium. This exciting transaction is a testament to the hard work and dedication of ARIADs talented team of employees. We have tremendous respect for Takeda, and I believe our shared commitment to innovation and research-driven cultures will provide for a smooth transition.
Alexander J. Denner, Ph.D., Chairman of the ARIAD Board of Directors, said: This transaction is a great outcome for ARIAD shareholders and brings hope to improve the lives of many cancer patients. It has been a pleasure to work with our outstanding management team and, on behalf of the board of directors, I extend our deepest gratitude to everyone at ARIAD for their unrelenting dedication.
Dr. Denner continued, The transaction also underscores the tremendous value that shareholder activism can create for shareholders, patients and society. While ARIADs stock price was collapsing and many investors were abandoning the company, Sarissa
Capital saw a company with important drugs and innovation and stepped in to become one of ARIADs largest shareholders. However, many things needed to be fixed before the value could be realized. With a new board and management team, ARIAD was able to focus on optimal capital allocation and operational excellence. As a result, the company created meaningful shareholder value and advanced the options for those suffering from rare cancers.
The acquisition of ARIAD is a unique opportunity that will enable us to positively impact the lives of more patients worldwide, advance our strategic priorities and generate attractive returns for our shareholders, said Christophe Weber, president and chief executive officer of Takeda. This is a very exciting time for Takeda as we will broaden our hematology portfolio and transform our global solid tumor franchise through the addition of two innovative targeted therapies. Opportunities to acquire such high-quality, complementary targeted therapies do not come often, and we are very excited about the potential for this transaction to benefit patients, our shareholders and other stakeholders.
Under the terms of the agreement, the acquisition is structured as an all cash tender offer for all of the outstanding shares of ARIAD common stock, followed by a merger in which remaining shares of ARIAD would be converted into the right to receive the same $24.00 cash per share price paid in the tender offer.
The transaction is subject to the tender of a majority of ARIAD common stock on a fully diluted basis as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close by the end of February 2017.
Takeda Pharmaceuticals U.S.A, a wholly owned subsidiary of Takeda, has established Kiku Merger Co., Inc. to effect the transaction.
JPMorgan, Goldman, Sachs & Co. and Lazard acted as financial advisors to ARIAD Pharmaceuticals and Paul, Weiss, Rifkind, Wharton & Garrison LLP acted as the Companys legal advisor. Cleary Gottlieb Steen & Hamilton LLP acted as legal advisor to Takeda Pharmaceutical Company Limited. Evercore Partners acted as financial advisor to Takeda Pharmaceutical Company Limited.
Takeda will host a media/investors conference call at 7:30 p.m. EST January 9, 2017 (9:30 a.m. JST January 10, 2017) to discuss the transaction. You can listen to the conference call at the following link: http://www.Takeda.com/investor-information/results/. A replay of the conference call will be available within 24 hours. In light of this announcement, ARIAD will not be presenting today at the 35th Annual J.P. Morgan Healthcare Conference.
About ARIAD Pharmaceuticals
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).
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.Takeda.com/news. Additional information about Takeda is available through its corporate website, www.Takeda.com.
ARIAD Contact
Investor.Relations@ariad.com
Additional Information
The tender offer described in this press release has not yet commenced. This press release is provided for informational purposes only and does not constitute an offer to purchase or the solicitation of an offer to sell any securities. At the time the tender offer is commenced, Takeda and Merger Sub intend to file with the Securities and Exchange Commission (the SEC) a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and ARIAD intends to file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Takeda, Merger Sub and ARIAD intend to mail these documents to ARIADs stockholders. Investors and stockholders should read those filings carefully when they become available as they will contain important information about the tender offer. Those documents may be obtained without charge at the SECs website at www.sec.gov. The offer to purchase and related
materials may also be obtained (when available) for free by contacting the information agent for the tender offer.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking information related to Takeda, ARIAD and the proposed acquisition of ARIAD by Takeda that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as believes, plans, anticipates, projects, estimates, expects, intends, strategy, future, opportunity, may, will, should, could, potential, or similar expressions. Forward-looking statements in this document include, among other things, statements about the potential benefits of the proposed acquisition, anticipated earnings accretion and growth rates, Takedas and ARIADs plans, objectives, expectations and intentions, the financial condition, results of operations and business of Takeda and ARIAD, ARIADs products, ARIADs pipeline assets and development, the acceleration of the development of cancer treatments; the expected timing of brigatinib approval in the U.S., and the anticipated timing of closing of the acquisition. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions to closing the acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including uncertainties as to how many of ARIADs stockholders will tender their shares in the tender offer and the possibility that the acquisition does not close; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Takedas common stock and on Takedas operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; the uncertainties inherent in research and development, including the ability to sustain and increase the rate of growth in revenues for ARIADs products despite increasing competitive, reimbursement and economic challenges; whether and when any drug applications may be filed in any jurisdictions for any indications or any additional indications for ARIADs products or for ARIADs pipeline assets; whether and when the FDA or any other applicable regulatory authorities may approve any such applications, which will depend on its assessment of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by the FDA or other regulatory authorities regarding labeling and
other matters that could affect the availability or commercial potential of ARIADs products and ARIADs pipeline assets; and competitive developments. Other factors that may cause actual results to differ materially include those set forth in the reports that ARIAD files from time to time with the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2015 and quarterly and current reports on Form 10-Q and 8-K, as well as the Tender Offer Statement on Schedule TO and other tender offer documents filed by Merger Sub and Parent.
Many of these factors are beyond ARIADs control. Unless otherwise required by applicable law, ARIAD disclaims any intention or obligation to update forward-looking statements contained in these documents as the result of new information or future events or developments.
Exhibit 99.3
Subject Line: CEO Message Regarding ARIAD/Takeda Transaction Announcement
January 9, 2017
Dear colleagues,
I have important news that I want to share with you directly we have just announced that ARIAD has entered into a definitive agreement to be acquired by Takeda Pharmaceuticals. This transaction not only allows us to accelerate ARIADs mission to discover, develop and deliver precision therapies to patients with rare cancers, but it also delivers immediate and meaningful value to our shareholders, many of whom are also ARIAD employees. The press release we issued is attached for your reference.
Todays announcement is a testament to your hard work and dedication which has driven our groundbreaking therapies, our extraordinary R&D platform and the strength of our company. Together, through the milestones we have achieved with Iclusig and brigatinib, as well as the exciting progress driven by our discovery engine, we have established ARIAD as a leader in precision cancer therapies. Each of us should be proud that we are delivering innovative, life-changing therapies to patients, including those with no other treatment options available, and have done so with commitment, passion and a sense of urgency for our patients. We have worked tirelessly in the interest of our patients and I am extremely honored to be part of the ARIAD team.
I could not be happier about the partner we have found in Takeda. From a culture perspective, we are a great fit. I have had the pleasure of getting to know Takedas leadership team and can say with confidence that Takeda shares our commitment to innovation and research and our patient-focused approach. Takeda is a research and development-driven pharmaceutical company operating on a global scale, with more than 30,000 employees working in 70 countries around the world. While based in Japan, Takeda has offices in the United States, including right here in Cambridge where Takeda has its Global development center. Takedas R&D is focused on oncology, gastroenterology and central nervous system therapeutic areas, and vaccines, and Takeda is committed to bringing better health and a brighter future to patients by translating science into life-changing medicines.
ARIADs very complementary portfolio of therapies positions Takeda for accelerated growth, enhancing their strong position in hematology and transforming their global solid tumor franchise through the addition of Iclusig and brigatinib. I have a deep appreciation for Takedas global organization and track record of innovation, discovery and commercialization, as well as Takeda Oncologys strong message we aspire to cure cancer, which closely aligns with our own mission. In fact, it is Takedas scale, resources and proven capabilities in achieving global access for oncology therapies that will help us achieve our goals with Iclusig, brigatinib, our pipeline compounds and discovery efforts even more quickly and more broadly. I am confident that you will be as impressed as I have been with the Takeda organization, capabilities, leadership and culture as we plan our bright future ahead as part of Takeda.
We will hold a Company Exchange today at 9:30 A.M. ET at our headquarters. If you are unable to attend in person, you can listen to a live broadcast by dialing 1-855-244-8681 and entering passcode 730 207 472.
I understand you may have questions about what todays announcement means for you. We will do our best to answer what we can now and we are committed to keeping you updated on important developments throughout the process. While this announcement is exciting and significant for all of us, there is still work to be done and details to be worked out. For now, on behalf of the patients who need our medicines, I ask that you stay focused on our critical priorities and day-to-day responsibilities through the continued discovery and development efforts, selling and promotion of Iclusig and final preparations for a successful launch of brigatinib in the coming weeks.
The transaction is subject to regulatory approvals and other customary closing conditions. Until the transaction closes, which we expect to happen by end of February 2017, ARIAD and Takeda will continue
to operate as two separate companies. We look forward to working closely with Takeda to ensure a smooth integration and transition for our teams.
Todays announcement may generate interest from the media and other third parties. If you receive any outside inquiries, please do not discuss any information with them, but instead refer them to Manmeet Soni at Manmeet.Soni@ariad.com.
As I communicated going into the holidays, 2016 was a transformative year for our company and 2017 will bring more change and greater opportunities. I want to thank you all once again for your unprecedented level of dedication and achievements in building ARIAD to the company it is today. I am extremely grateful to work with such a talented and committed team.
Sincerely,
Paris
Additional Information
The tender offer described in this letter has not yet commenced. This letter is provided for informational purposes only and does not constitute an offer to purchase or the solicitation of an offer to sell any securities. At the time the tender offer is commenced, Takeda and Merger Sub intend to file with the Securities and Exchange Commission (the SEC) a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and ARIAD intends to file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Takeda, Merger Sub and ARIAD intend to mail these documents to ARIADs stockholders. Investors and stockholders should read those filings carefully when they become available as they will contain important information about the tender offer. Those documents may be obtained without charge at the SECs website at www.sec.gov. The offer to purchase and related materials may also be obtained (when available) for free by contacting the information agent for the tender offer.
Cautionary Statement Regarding Forward-Looking Statements
This letter contains forward-looking information related to Takeda, ARIAD and the proposed acquisition of ARIAD by Takeda that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as believes, plans, anticipates, projects, estimates, expects, intends, strategy, future, opportunity, may, will, should, could, potential, or similar expressions. Forward-looking statements in this document include, among other things, statements about the potential benefits of the proposed acquisition, anticipated earnings accretion and growth rates, Takedas and ARIADs plans, objectives, expectations and intentions, the financial condition, results of operations and business of Takeda and ARIAD, ARIADs products, ARIADs pipeline assets, and the anticipated timing of closing of the acquisition. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions to closing the acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including uncertainties as to how many of ARIADs stockholders will tender their shares in the tender offer and the possibility that the acquisition does not close; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational
relationships; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Takedas common stock and on Takedas operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; the uncertainties inherent in research and development, including the ability to sustain and increase the rate of growth in revenues for ARIADs products despite increasing competitive, reimbursement and economic challenges; whether and when any drug applications may be filed in any jurisdictions for any indications or any additional indications for ARIADs products or for ARIADs pipeline assets; whether and when the FDA or any other applicable regulatory authorities may approve any such applications, which will depend on its assessment of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by the FDA or other regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of ARIADs products and ARIADs pipeline assets; and competitive developments. Other factors that may cause actual results to differ materially include those set forth in the reports that ARIAD files from time to time with the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2015 and quarterly and current reports on Form 10-Q and 8-K, as well as the Tender Offer Statement on Schedule TO and other tender offer documents filed by Merger Sub and Parent.
Many of these factors are beyond ARIADs control. Unless otherwise required by applicable law, ARIAD disclaims any intention or obligation to update forward-looking statements contained in these documents as the result of new information or future events or developments.
Exhibit 99.4
ARIAD Pharmaceuticals, Inc.
125 Binney Street
Cambridge, Massachusetts 02142
January 9, 2017
To: Wells Fargo Bank, National Association
150 E. 42nd St., 40th Floor,
New York, NY 10017,
Attention: Corporate Trust Services Administrator for ARIAD Pharmaceuticals, Inc.
To: Holders of 3.625% Convertible Senior Notes due 2019 (the Notes) issued by ARIAD Pharmaceuticals, Inc.; CUSIP: 04033AAA8.
Re: Notice of Conversion Right
Dear Noteholder, Trustee and Conversion Agent:
Pursuant to Section 15.01(b)(iii) and Section 15.03(b) of the Indenture, dated as of June 17, 2014, between ARIAD Pharmaceuticals, Inc. (the Company or we) and Wells Fargo Bank, National Association, as Trustee (the Indenture), the Company hereby notifies you that, on January 8, 2017, the Company entered into an Agreement and Plan of Merger (the Merger Agreement) with Takeda Pharmaceutical Company Limited, (Parent), a corporation organized under the laws of Japan, and Kiku Merger Co., Inc. (Merger Sub), a Delaware corporation and an indirect wholly-owned subsidiary of Parent.
Capitalized terms used but not otherwise defined herein shall have their respective meanings set forth in the Indenture.
Pursuant to the Merger Agreement, upon the terms and subject to the conditions thereof:
· Merger Sub will commence a tender offer (the Offer) no later than January 24, 2017, to acquire all of the outstanding shares of common stock of the Company (the Shares), $0.001 par value per share, at a purchase price of $24 per share (the Offer Price) in cash, net of applicable withholding taxes and without interest;
· As soon as practicable following the completion of the Offer, Merger Sub will be merged with and into the Company (the Merger), with the Company surviving the Merger as an indirect wholly owned subsidiary of Parent;
· The Merger will be governed by Section 251(h) of the Delaware General Corporation Law, as amended (DGCL), and effected without a vote of the Company stockholders.
· As a result of the Merger, each Share (other than as Shares (i) owned by Parent, Merger Sub or any other direct or indirect wholly-owned subsidiary of Parent immediately prior to the Effective Time , (ii) owned by the Company or any direct or indirect wholly-owned subsidiary of the Company or held in the Companys treasury or (iii) held by a holder who is entitled to appraisal and who has properly exercised appraisal rights for such shares in accordance with Section 262 of the DGCL, or as otherwise provided with respect to the Company equity awards) will be converted automatically into the right to receive the Offer Price in cash, net of applicable withholding taxes and without interest;
· Pursuant to the Merger Agreement, Merger Sub is required to commence the Offer as promptly as practicable (but in no event later than 10 business days) after the date of the Merger Agreement; the Offer will remain open for a minimum of 20 business days, but may be extended under
specified circumstances. If the Offer is not extended, the Company expects the Effective Date to occur on February 15, 2017. The Company is providing this notice of an anticipated Effective Date solely to comply with its obligations under Section 15.03(b) of the Indenture. Consummation of the Merger, however, remains subject to the satisfaction of certain specified conditions under the Merger Agreement. As the actual Effective Date cannot yet be determined, the Company shall provide a supplemental notice as soon as reasonably practicable following the Companys determination of the actual Effective Date.
Pursuant to Section 15.01(b) of the Indenture, the Notes are currently convertible at a Conversion Rate of 107.5095 shares of Common Stock per $1,000 principal amount of Notes (which is equal to a Conversion Price of approximately $9.30 per share of Common Stock).
The closing of the Offer will constitute both a Fundamental Change and a Make-Whole Fundamental Change under the terms of the Indenture. Upon the occurrence of the Fundamental Change, the Company shall offer to repurchase the Notes from each Noteholder for cash at a repurchase price equal to 100% of the principal amount of the Notes, together with accrued and unpaid interest thereon to, but excluding, the Fundamental Change Repurchase Date.
In addition, as a result of the Make-Whole Fundamental Change, the Conversion Rate of the Notes is expected to temporarily increase. The Conversion Rate increase will be calculated by straight-line interpolation using the Make-Whole Conversion Rate Adjustment Table set forth in Section 15.03 of the Indenture, taking into account the Offer Price and the closing date of the Offer.
The temporarily increased Conversion Rate of the Notes will only be available if the Notes are surrendered for conversion between (a) the closing of the Offer and (b) on or before the Business Day immediately prior to the Fundamental Change Repurchase Date.
If you have any additional questions about the impact of the transactions contemplated by the Merger Agreement on your outstanding Notes, please contact Manmeet Soni of the Company, at 617-503-7298 or Manmeet.soni@ariad.com.
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Sincerely, |
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/s/ Paris Panayiotopoulos |
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Name: Paris Panayiotopoulos |
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Title: President and CEO |
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cc: Raymond Delli Colli |
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Wells Fargo Bank, National Association |
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Additional Information
The Offer referred to in this notice has not yet commenced. This notice does not constitute an offer to purchase or the solicitation of an offer to sell any securities. At the time the Offer is commenced, Takeda and its wholly owned subsidiary, Merger Sub, intend to file with the SEC a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and the Company intends to file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the Offer. Takeda, Merger Sub and the Company intend to mail these documents to the Companys stockholders. Investors and stockholders should read those filings carefully when they become available as they will contain important information about the tender offer. Those documents may be obtained without charge at the SECs website at www.sec.gov. The offer to purchase and related materials may also be obtained (when available) for free by contacting the information agent for the tender offer.
Cautionary Statement Regarding Forward-Looking Statements
This notice contains forward-looking information related to Takeda, the Company and the proposed acquisition of the Company by Takeda that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as believes, plans, anticipates, projects, estimates, expects, intends, strategy, future, opportunity, may, will, should, could, potential, or similar expressions. Forward-looking statements in this document include, among other things, statements about the potential benefits of the proposed acquisition, anticipated earnings accretion and growth rates, Takedas and the Companys plans, objectives, expectations and intentions, the financial condition, results of operations and business of Takeda and the Company, the Companys products, the Companys pipeline assets, and the anticipated timing of closing of the acquisition. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions to closing the acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including uncertainties as to how many of the Companys stockholders will tender their shares in the tender offer and the possibility that the acquisition does not close; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Takedas common stock and on Takedas operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; the uncertainties inherent in research and development, including the ability to sustain and increase the rate of growth in revenues for the Companys products despite increasing competitive, reimbursement and economic challenges; whether and when any drug applications may be filed in any jurisdictions for any indications or any additional indications for the Companys products or for the Companys pipeline assets; whether and when the FDA or any other applicable regulatory authorities may approve any such applications, which will depend on its assessment of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by the FDA or other regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of the Companys products and the Companys pipeline assets; and competitive developments. Other factors that may cause actual results to differ materially include those set forth in the reports that the Company files from time to time with the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2015 and quarterly and current reports on Form 10-Q and 8-K, as well as the Tender Offer Statement on Schedule TO and other tender offer documents filed by Parent and Merger Sub. Many of these factors are beyond Takedas and the Companys control. Unless otherwise required by applicable law, the Company disclaims any intention or obligation to update forward-looking statements contained in this document as the result of new information or future events or developments.