Takeda notes statement by Shire plc regarding revised proposal and extension of PUSU deadline to May 8, 2018

On April 25, 2018 Takeda Pharmaceutical Company Limited ("Takeda") reported the statement made by Shire plc ("Shire") confirming that it has received a revised proposal from Takeda regarding a possible offer for Shire (Press release, Takeda, APR 25, 2018, View Source [SID1234525760]).

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Takeda confirms that the revised proposal comprises 0.839 new Takeda shares and US$30.33 in cash for each Shire ordinary share (the "Revised Proposal").

Based on Takeda’s share price of ¥4,923 and the exchange rates of £:¥ of 1:151.51 and £:US$ of 1:1.3945 as at the close of business on April 23, 2018, the Revised Proposal implies an equivalent value of approximately £49 per Shire ordinary share, comprising the equivalent of:

£27.26 in new Takeda shares; and
£21.75 in cash.
On this basis the Revised Proposal is equivalent to a value of approximately £46 billion for the entire issued and to be issued share capital of Shire. Shire shareholders would also be entitled to any dividends announced, declared, made or paid by Shire in the ordinary course prior to completion of the possible transaction.

Takeda and its Board have remained disciplined with respect to the terms of the Revised Proposal and Takeda intends to maintain its well-established dividend policy and investment grade credit rating.

At completion, Shire shareholders would own approximately 50 percent of the enlarged Takeda and the new Takeda shares will be listed in Japan and in the US through an ADR program.

The Board of Shire has indicated to Takeda that it would be willing to recommend the Revised Proposal to Shire shareholders, subject to satisfactory resolution of the other terms of the possible offer, including completion of reciprocal due diligence by Shire on Takeda. Accordingly, the Board of Shire will engage in discussions with Takeda in relation to these terms.

The making of any firm offer by Takeda would be subject to the following matters:

agreement of certain other terms of the Revised Proposal;
satisfactory completion of a confirmatory due diligence review by Takeda;
the unanimous and unconditional recommendation of the Board of Shire; and
final approval by the Board of Takeda.
Takeda reserves the right to waive in whole or in part any of the pre-conditions to making a firm offer set out in this announcement.

With the consent of the Panel on Takeovers and Mergers (the "Takeover Panel"), the Board of Shire has agreed to an extension of the relevant deadline under Rule 2.6(c) of the Code until 5.00 p.m. (London time) on May 8, 2018 to enable the parties to conclude their ongoing discussions. This deadline may be extended further with the consent of the Takeover Panel, at Shire’s request, in accordance with Rule 2.6(c) of the Code.

Takeda reserves the following rights in respect of the Revised Proposal:

to make an offer for Shire at any time on less favorable terms or to vary the mix of consideration:
with the agreement or recommendation of the Board of Shire;
if a third party announces a firm intention to make an offer for Shire which, at the date Takeda announces a firm intention to make an offer for Shire, is valued at a lower price than contemplated by the terms of the Revised Proposal; or
following the announcement by Shire of a whitewash transaction pursuant to the Code; and
in the event that any dividend and/or other form of capital return or distribution is announced, declared, made or paid by Shire otherwise than in the ordinary course, to reduce any offer by the amount of such dividend and/or other form of capital return or distribution.
There can be no certainty that any firm offer for Shire will be made.

The Medicines Company Reports First-Quarter 2018 Results

On April 25, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended March 31, 2018 (Press release, Medicines Company, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344446 [SID1234525674]).

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Thermo Fisher Scientific (PRNewsfoto/Thermo Fisher Scientific)

First Quarter 2018 Highlights

First quarter revenue grew 23% to $5.85 billion.
First quarter GAAP diluted earnings per share (EPS) increased 2% to $1.43.
First quarter adjusted EPS increased 20% to $2.50.
Launched new products across our portfolio, including Thermo Scientific Vanquish Duo UHPLC systems for pharma QA/QC, the Thermo Scientific Chromeleon XTR Laboratory Management System and the Ion GeneStudio S5 Series of next-generation sequencing instruments.
Held first China-U.S. Precision Medicine Summit in Beijing, convening more than 400 thought leaders across government, academia and industry to promote global collaboration in the prevention, diagnosis and treatment of disease.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"We’re pleased to start the year on a very strong note, with excellent revenue and earnings growth," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our team did a great job meeting customer needs across our end markets and successfully executed our growth strategy to deliver outstanding results.

"On the innovation front, we kicked off 2018 by strengthening our leading technology platforms, including new instruments and software that help our customers to simplify workflows and better manage information in their labs. Geographically, we continued to leverage our industry-leading scale to deliver another great quarter in emerging and high-growth regions, with double-digit growth in China, India and South Korea. We also continued to demonstrate the power of our customer value proposition, especially in pharma and biotech, where we’re making great progress in integrating the capabilities we gained from the Patheon acquisition to make our offering for these customers even stronger."

Casper concluded, "We’re off to a great start in 2018, which positions us to deliver another excellent year."

First Quarter 2018

Revenue for the quarter grew 23% to $5.85 billion in 2018, versus $4.77 billion in 2017. Organic revenue growth was 7%; acquisitions increased revenue by 12% and currency translation increased revenue by 4%.

GAAP Earnings Results

GAAP diluted EPS in the first quarter increased 2% to $1.43, versus $1.40 in the same quarter last year. GAAP operating income for the first quarter of 2018 grew to $0.79 billion, compared with $0.62 billion in the first quarter of 2017. GAAP operating margin increased to 13.4%, compared with 13.0% in the first quarter of 2017.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2018 increased 20% to $2.50, versus $2.08 in the first quarter of 2017. Adjusted operating income for the first quarter of 2018 grew 20% compared with the year-ago quarter. Adjusted operating margin was 22.0%, compared with 22.5% in the first quarter of 2017.

2018 Guidance Update

Thermo Fisher is raising its 2018 revenue and earnings guidance to reflect strong operational performance, a more significant impact from acquisitions and a more favorable foreign exchange environment. The company is raising its revenue guidance to a new range of $23.62 to $23.86 billion versus its previous guidance of $23.42 to $23.72 billion. This would result in 13 to 14% revenue growth over 2017. The company is raising its adjusted EPS guidance to a new range of $10.80 to $10.96, versus its previous guidance of $10.68 to $10.88, for 14 to 15% growth year over year.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

In the first quarter of 2018, Life Sciences Solutions Segment revenue grew 10% to $1.50 billion, compared with revenue of $1.36 billion in the first quarter of 2017. Segment adjusted operating margin increased to 34.5%, versus 31.8% in the 2017 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 19% to $1.26 billion in the first quarter of 2018, compared with revenue of $1.05 billion in the first quarter of 2017. Segment adjusted operating margin increased to 19.6%, versus 18.2% in the 2017 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew 9% to $0.95 billion in the first quarter of 2018, compared with revenue of $0.87 billion in the first quarter of 2017. Segment adjusted operating margin was 25.6%, versus 26.9% in the 2017 quarter.

Laboratory Products and Services Segment

Laboratory Products and Services Segment results reflect the acquisition of Patheon in late August 2017. In the first quarter of 2018, segment revenue grew 42% to $2.41 billion, compared with revenue of $1.70 billion in the first quarter of 2017. Segment adjusted operating margin was 11.6%, versus 12.7% in the 2017 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, the impact of significant tax audits or events and the results of discontinued operations. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of 3 to 20 years. In 2018, based on acquisitions closed through the end of the first quarter of 2018, our adjusted EPS will exclude approximately $3.42 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes or the estimated initial impacts of U.S. tax reform legislation), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans, the early retirement of debt and discontinued operations.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, April 25, 2018, at 8:30 a.m. Eastern time. To listen, dial (844) 579-6824 within the U.S. or (763) 488-9145 outside the U.S. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, May 11, 2018.

NanOlogy to Present Abstract on Preclinical Study of Nebulized NanoPac for Lung Cancer at 2018 ASCO Annual Meeting

On April 25, 2018 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported that it will present an abstract detailing results of a preclinical trial of a nebulized form of NanoPac (submicron particle paclitaxel) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago, June 1 – 5 (Press release, NanOlogy, APR 25, 2018, View Source [SID1234525695]).

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The abstract, "NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model," will be presented Sunday, June 3, 8 am to 11:30 am, in Hall A of the McCormick Place.

NanOlogy is currently conducting Phase 2 clinical trials of NanoPac sterile suspension for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer and pancreatic mucinous cysts.

In addition, NanOlogy and affiliate, DFB Soria, are progressing clinical trials of Soria-developed SOR007, a topical ointment form of NanoPac for cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce, (submicron particle docetaxel) are planned in 2018 pending IND approval.

The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patent-pending, stable, naked submicron particles with exponentially increased surface area and unique geometry. The technology enables delivery of concentrated doses of paclitaxel and docetaxel directly into the disease site without the serious adverse side effects associated with systemic infusions of the chemotherapy.

Adaptimmune to Report First Quarter 2018 Financial Results and Business Update on Wednesday May 9, 2018

On April 25, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will announce financial results for the First Quarter 2018 and provide a general business update before the open of the U.S. markets on Wednesday May 9, 2018 (Press release, Adaptimmune, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344498 [SID1234525678]). Following the announcement, the company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) on the same day.

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The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address.

To participate in the live conference call, if preferred, please dial (833) 652-5917 (U.S.) or (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (2967789).

NewLink Genetics Announces Presentation of Abstracts at ASCO 2018 Annual Meeting

On April 25, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) today reported that two abstracts pertaining to the company’s indoximod program will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago (Press release, NewLink Genetics, APR 25, 2018, View Source [SID1234525696]).

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Poster Discussion Session: Poster Board #204 – Abstract 4015 – Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer – to be presented during the discussion session, "Gastrointestinal (Noncolorectal) Cancer," Sunday, June 3, 2018, 4:45 PM – 6:00 PM CT

Poster Discussion Session: Poster Board #339 – Abstract 9512 – Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma – to be presented during the discussion session, "Melanoma/Skin Cancers," Monday, June 4, 2018, 4:45 PM – 6:00 PM CT

The complete text of abstracts selected for presentation at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting will be posted to the ASCO (Free ASCO Whitepaper) website on Wednesday, May 16th at 5pm ET.

"We are pleased to have the opportunity to present the results at ASCO (Free ASCO Whitepaper) from both of these Phase 2 trials of indoximod in combination therapies for patients with pancreatic cancer and advanced melanoma. We continue to gather data supporting the potential for our differentiated IDO pathway inhibitor, indoximod, in multiple combinations to improve the lives of patients with cancer," said Nicholas N. Vahanian, MD, President.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, chemotherapy, radiation and cancer vaccines across multiple indications such as melanoma, pancreatic cancer and other malignancies.