On January 9, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported anticipated milestones for IPI-549, a potentially first-in-class immuno-oncology product candidate that selectively inhibits PI3K-gamma, and provided financial guidance for 2017 (Press release, Infinity Pharmaceuticals, JAN 9, 2017, View Source;p=RssLanding&cat=news&id=2234986 [SID1234517387]). During the year, Infinity expects to make substantial progress with the Phase 1 clinical study of IPI-549, which is designed to evaluate IPI-549 both as a monotherapy and in combination with Opdivo, a PD-1 immune checkpoint inhibitor. In 2017, the company also plans to report updated Phase 1 clinical data from the monotherapy dose-escalation as well as initial clinical data from the combination dose-escalation phase. Additionally, Infinity expects to complete the monotherapy and combination dose-escalation phases of the study and initiate monotherapy and combination expansion cohorts this year. The company also announced today that it has completed patient enrollment in the first dose-escalation cohort evaluating IPI-549 plus Opdivo. These updates were made in conjunction with the 35th Annual J.P. Morgan Healthcare Conference that begins today in San Francisco. Infinity’s chief executive officer, Adelene Perkins, will discuss the company’s continued execution on its corporate strategy and 2017 priorities as part of a live presentation on Thursday, January 12, at 10:30 a.m. PT (1:30 p.m. ET). The presentation will be webcast on Infinity’s website, www.infi.com.

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"We enter 2017 intensely focused on advancing IPI-549 and, having already fully enrolled the first dose-escalation cohort evaluating IPI-549 plus Opdivo, we are off to a strong start to the year. Preclinical data in two recent Nature publications provide a compelling rationale for advancing IPI-549 and show that IPI-549 in combination with immune checkpoint inhibitors may overcome resistance to checkpoint blockade," stated Adelene Perkins, Infinity’s chief executive officer. "IPI-549 represents a unique approach to targeting tumors through its effects on the tumor microenvironment, and we look forward to presenting updated monotherapy and initial combination data from our Phase 1 study this year."

The tumor microenvironment, or TME, refers to the non-cancerous cells present in the tumor. Cells within the TME, including immune-suppressive myeloid cells, can provide growth signals to tumor cells, as well as signals that inhibit an anti-tumor immune response. The presence of the supportive TME is believed to be one reason why some cancer therapies do not provide durable or effective results. Targeting the immune-suppressive myeloid cells represents an emerging approach within the field of cancer immunotherapy, and inhibition of PI3K-gamma represents a novel approach to targeting the immune-suppressive microenvironment. Preclinical data recently published in Nature suggest that IPI-549 may enhance the effects of checkpoint inhibitors and may also reverse tumor resistance to checkpoint inhibitors by targeting immune cells and altering the immune-suppressive microenvironment, promoting an anti-tumor immune response.1,2

Today Infinity also announced that on Friday, January 20, 2017, preclinical and initial clinical data from the Phase 1 study of IPI-549 will be presented at the Keystone Symposia Conference, ‘PI3K Pathways in Immunology, Growth Disorders and Cancer.’ Jeffery Kutok, M.D., Ph.D., vice president of biology and translational science at Infinity, will give the presentation, entitled "The PI3K-gamma inhibitor, IPI-549, increases antitumor immunity by targeting tumor-associated myeloid cells and overcomes immune checkpoint blockade resistance in preclinical tumor models."

"With IPI-549, we have a tremendous opportunity to potentially further improve response rates and survival for patients by overcoming resistance to immune checkpoint inhibitors," said Lawrence Bloch, M.D., J.D., president of Infinity. "We have an experienced and right-sized team that is well-resourced and fully focused on maximizing the value of IPI-549, with a cash runway into the first quarter of 2019."

2017 Program Goals for IPI-549
Infinity expects to achieve the following duvelisib milestones in 2017:

Present preclinical and clinical data from Phase 1 study at the upcoming PI3K Keystone Symposia Conference in January 2017
Report Phase 1 data from the monotherapy dose-escalation phase as well as the IPI-549 plus Opdivo dose-escalation phase in 2017
Complete the dose-escalation phase evaluating IPI-549 monotherapy in the first half of 2017
Begin enrolling patients with advanced solid tumors in the monotherapy expansion cohort during the second half of 2017
Complete the dose-escalation combination phase evaluating IPI-549 plus Opdivo in the second half of 2017
Begin enrolling patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN) in combination expansion cohorts evaluating IPI-549 plus Opdivo in the second half of 2017
Cash and Investments Outlook
Infinity ended 2016 with approximately $92.1 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2016 financial results in March. The company is providing the following financial guidance today:

Net loss: Infinity expects net loss for 2017 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2017 with a year-end cash and investments balance ranging from $40 million to $50 million.
Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities at December 31, 2016, will be adequate to satisfy the company’s capital needs into the first quarter of 2019.
The company’s financial outlook excludes additional funding or business development activities and includes expenses related to duvelisib beyond November 1, 2016, capped at $4.5 million, as well as costs related to Infinity’s 2016 restructuring. Additionally, Infinity’s updated cash runway expectation assumes receiving a $6.0 million milestone payment from Verastem for positive DUO study results.

IPI-549 Phase 1 Study Details
The ongoing Phase 1 clinical study of IPI-549 is designed to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in patients with advanced solid tumors. The study includes monotherapy and combination dose-escalation phases, in addition to expansion cohorts, and is expected to enroll approximately 175 patients.

The IPI-549 monotherapy dose-escalation phase is expected to be completed in the first half of 2017, and the monotherapy expansion phase in patients with advanced solid tumors is anticipated to begin in the second half of the year. Once the dose-escalation phase evaluating IPI-549 plus Opdivo is completed, an expansion phase is planned to evaluate the combination in patients with select solid tumors, including NSCLC, melanoma and SCCHN. Patients enrolled in expansion cohorts evaluating IPI-549 plus Opdivo represent a difficult-to-treat population, as they must have demonstrated de novo or acquired resistance to an immediately prior therapy of an inhibitor of PD-1 or PD-L1.

Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma and SCCHN, which will comprise three of the expansion cohorts in this Phase 1 study, account for more than 17 percent of all new cancer cases in the U.S.3,4

About IPI-549
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 increases antitumor immunity by targeting tumor-associated myeloid cells and overcomes immune checkpoint blockade resistance in preclinical tumor models. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors. A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing.5

IPI-549 is an investigational compound, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On January 9, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, reported that the U.S. Patent and Trade Office (USPTO) has decided to uphold Celyad’s U.S. Patent No. 9,181,527, relating to allogeneic human primary T-cells that are engineered to be TCR-deficient and express a CAR (Press release, Celyad, JAN 9, 2017, View Source [SID1234517409]).

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"We are pleased with the outcome of this re-examination of our patent related to the production of allogeneic TCR-deficient CAR-T cells. This marks the third decision by the USPTO to uphold this patent, which thus remains valid and enforceable, and provides for continued intellectual property protection for this valuable asset", said Philippe Dechamps, Chief Legal Officer of Celyad.

"Allogeneic CAR T-cells are a promising avenue to broaden the scope of application of cell based immunotherapy", said Georges Rawadi, VP Business Development and IP of Celyad. "We look forward to the further development of our own allogeneic programs and also continue to offer other parties access to this important patent to advance the field more broadly."

Celyad’s U.S. patent (No. 9,181,527), and more precisely claim 1 of the said patent, was challenged by an anonymous third party through an Ex Parte Re-examination procedure. The request for Ex Parte re-examination was filed on February 10th, 2016 and an order granting Ex Parte Re-examination of claim 1 was issued by the USPTO on March 24th, 2016. The final decision of this Ex Parte procedure that was issued on January 6th 2017 is not subject to appeal and upholds the validity of the patent.

Therefore, Celyad’s U.S. patent (No. 9,181,527), confirms continued coverage of CAR-expressing human T-cells, according to Claim 1, modified to reduce or eliminate T-cell receptor expression or function.

On January 9, 2017 ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage drug development company advancing targeted therapeutics for the treatment of patients with cancer, reported it has changed its corporate name to Sierra Oncology, Inc. and that its shares will trade on the NASDAQ under the symbol ‘SRRA’, effective on January 10th (Press release, ProNAi Therapeutics, JAN 9, 2017, View Source [SID1234517352]). The company’s new name reflects its evolution into an oncology focused company advancing an emerging pipeline of promising therapies that target the DNA Damage Response (DDR) network.

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"We believe there is a significant opportunity for therapeutics that target the DDR network to have broad potential in the treatment of cancer, and that by successfully advancing our new drug candidates in this field we may generate substantial long-term value for our company," said Dr. Nick Glover, President and CEO of Sierra Oncology.

"Our new name, Sierra Oncology, reflects our focus on this approach and the commitment of our management team to charting innovative paths for developing novel therapeutics against cancer."

Dr. Glover will be presenting an update on Sierra Oncology at the BIOTECH Showcase being held in San Francisco on January 11th. The presentation, entitled ‘Beyond PARP – Next Generation DDR Therapeutics", is scheduled for 8:00 am (PST) on Wednesday, January 11th. A live audio webcast and archive of the presentation will be accessible through the Sierra Oncology website at www.sierraoncology.com.

On January 9, 2017 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update, which will be detailed as part of the company presentation at the 35th Annual J.P. Morgan Healthcare Conference on Wednesday, January 11th at 7:30 am PT (Press release, PTC Therapeutics, JAN 9, 2017, View Source [SID1234517388]). Stuart W. Peltz, Ph.D., PTC’s Chief Executive Officer, will present the company’s 2017 strategic priorities, preliminary 2016 financial results and 2017 financial guidance. The presentation will be webcast live and available with the related slide deck on the Events and Presentations page under the investors section of PTC Therapeutics’ website at www.ptcbio.com.

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Commercial Highlights, Preliminary 2016 Unaudited Financial Results, and 2017 Guidance

PTC expects to report Translarna (ataluren) net sales for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) of approximately $81 million for 2016, an increase of 140% over the prior year and achieving the upper-end of guidance. This strong performance reflects rapid uptake, sustainable pricing, and high ( > 90%) compliance to treatment.
PTC expects to report year-end 2016 cash and cash equivalents of approximately $230 million.
For 2017, PTC expects to achieve ex-U.S. Translarna nmDMD net sales of between $105 and $125 million, assuming current exchange rates, representing continued strong growth year-over-year of its sustainable DMD business. This is driven by both increased penetration into the over 25 countries where Translarna is currently available as well as continued geographic expansion into new territories.
Non-GAAP operating expenses for 2017 are expected to be between $190 and $200 million excluding estimated non-cash stock-based compensation expense of approximately $35 million, for total operating expenses of approximately $225 to $235 million.
PTC expects to finish 2017 with approximately $160 million of cash and cash equivalents.
Clinical and Regulatory Highlights

Following multiple interactions with U.S. FDA officials and PTC’s advisors, PTC plans to file the Translarna New Drug Application (NDA) for nmDMD over protest with the U.S. FDA in the first quarter of 2017. Feedback indicated this process, rather than continued appeal, is the best path forward for the current Translarna NDA to receive a full and fair review. Filing over protest is a procedural path permitted by U.S. FDA regulations that allows a company to have its NDA filed and reviewed when there is a disagreement with regulators over the acceptability of the NDA submission. PTC plans to supplement the current NDA with additional efficacy analyses utilized by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in their recent renewal recommendation.
The EMA’s CHMP recommended the renewal of the conditional marketing authorization for Translarna (ataluren) for the treatment of nmDMD based on a continued positive benefit-risk assessment. As a specific obligation of the renewal, PTC will conduct an additional trial of Translarna in nmDMD.
Top-line results of ACT CF are anticipated late in the first quarter of 2017. ACT CF is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial that is evaluating the absolute change in percent predicted forced expiratory volume in one second (FEV1) in patients with nonsense mutation cystic fibrosis (nmCF).
The spinal muscular atrophy (SMA) program, a joint collaboration with Roche and the SMA Foundation, is expected to advance into two pivotal studies in 2017. SUNFISH and FIREFISH are both two part studies in childhood onset (Type 2/3) and infant onset (Type 1) SMA patients, respectively. Both studies are enrolling the initial dose escalation part of the study which will then transition to the pivotal part of the study evaluating efficacy. Commencement of the pivotal portion of either study will trigger a $20 million milestone payment to PTC from Roche. RG7916 was recently granted orphan-drug designation by the U.S. FDA.
Pipeline Highlights:

Phase 2 proof-of-concept studies of Translarna in additional rare disease indications, including aniridia, MPS I, and Dravet/CDKL5, continue to progress. Proof-of-concept from these studies would further validate Translarna’s potential as a precision medicine for a number of rare genetic disorders caused by a nonsense mutation.
Clinical development of PTC596 is expected to progress into additional clinical studies in 2017. PTC596 is a novel, oral investigational drug that reduces the levels of BMI1, a protein required for cancer stem cell survival. An ongoing Phase 1 dose escalating study confirms that PTC596 is generally well tolerated at doses that achieved or exceed plasma concentrations in preclinical models.
PTC’s genetic disorders research organization is actively advancing lead optimization programs from its splicing platform focused on Huntington’s disease and Familial Dysautonomia.

On January 9, 2017 Takeda Pharmaceutical Company Limited (TSE:4502) ("Takeda") and ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) ("ARIAD") reported 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 (Press release, Ariad, JAN 9, 2017, View Source;p=RssLanding&cat=news&id=2234958 [SID1234517324]). 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 ARIAD’s common shares, as well as each of the members of ARIAD’s Board of Directors have agreed to tender their shares to Takeda pursuant to the offer.

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"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 ARIAD’s 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 ARIAD’s 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 Takeda’s 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 Takeda’s 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.

Takeda’s 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 Takeda’s 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, ARIAD’s 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 ARIAD’s R&D capabilities and platform, and largely absorb its R&D costs within Takeda’s 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 Takeda’s 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) Tender offeror Kiku Merger Co., Inc.
(2) Target company ARIAD Pharmaceuticals, Inc.
(3) Class of shares to be acquired Common stock
(4) Tender offer price $24.00 per share
(5) Acquisition amount
(Aggregate tender offer price)
Approximately $5.4 billion (estimate)
* The amount is an estimated amount calculated by multiplying the number of the target company’s shares (fully diluted basis) by the tender offer price per share. It does not include advisory fees.
(6) Payment Cash
* Funded by up to $4.0 billion of new debt and the remainder from existing cash.
(7) Period of tender offer 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) Minimum number of shares to be purchased 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) Financial advisor to Takeda Evercore Partners
(10) Legal counsel to Takeda Cleary Gottlieb Steen & Hamilton LLP
(11) Financial advisor to ARIAD J.P. Morgan Securities LLC, Goldman, Sachs & Co., Lazard
(12) Legal counsel to ARIAD 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$1,339 million (Additional paid-in capital as of December 31, 2015)
(6) Date of establishment April, 1991
(7) Major shareholders
and percentage of
shares held*
Wellington Management Group LLP 8.8%
FMR LLC 7.8%
Vanguard Group Inc. 6.8%
Others
(8) Relationships between Takeda Capital relationship Not applicable
Personnel relationship Not applicable
Transactional relationship Not applicable
(9) Operating result and financial conditions for the last three years (consolidated)
Accounting period Fiscal year ended December 31, 2013 Fiscal year ended December 31, 2014 Fiscal year ended December 31, 2015
Net assets
(US$ in thousands)
185,517 80,801 (103,141)
Total assets
(US$ in thousands)
370,894 603,116 546,692
Net assets per share
(US$)
1.01 0.43 (0.55)
Revenue
(US$ in thousands)
45,561 105,412 118,804
Operating profit
(US$ in thousands)
(273,566) (160,195) (217,276)
Net loss
(US$ in thousands)
(274,158) (162,602) (231,156)
Net loss per share
(US$)
(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) Number of shares already acquired 0 shares
Percentage of voting rights: 0%
(2) Number of shares to be acquired 194,389,661 shares*
Percentage of voting rights: 100% (planned)
* Total shares outstanding

Schedule

(1) Board meeting resolution January 6, 2017
(2) Signing date January 8, 2017
(3) Commencement date and settlement date of the tender offer 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 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).
(4) Completion of acquisition 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 Takeda’s 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. Takeda’s financial guidance, including EPS, for FY2017 will be announced when Takeda reports earnings for FY2016 in May 2017.