Johnson & Johnson to Participate in the Leerink Partners 7th Annual Global Healthcare Conference

On January 31, 2018 Johnson & Johnson (NYSE: JNJ) will participate in the Leerink Partners 7th Annual Global Healthcare Conference on Wednesday, Feb. 14, at Lotte New York Palace, NY (Press release, Johnson & Johnson, JAN 31, 2018, View Source [SID1234523686]). Dominic Caruso, Executive Vice President, Chief Financial Officer will represent the Company in a session scheduled at 9:30 a.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast and podcast replay will be available approximately two hours after the live webcast.

Starpharma to commence DEP® cabazitaxel phase 1/2 trial

On January 31, 2018 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that it has received regulatory and ethics approvals to commence its phase 1/2 clinical trial for DEP cabazitaxel (Press release, Starpharma, JAN 31, 2018, View Source [SID1234523642]). The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP cabazitaxel, to define a recommended phase 2 dose (RP2D), and then to determine anti-tumour efficacy of the product in select tumour types.

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The trial will be conducted at multiple sites, with Guy’s Hospital London and University College London Hospital (UCLH) in the UK being the first sites to open for recruitment. Further sites will open and commence recruitment as dose escalation progresses and the phase 2 part of the trial gets underway. Approximately 35 patients will be enrolled across the phase 1/2 trial.

DEP cabazitaxel is Starpharma’s detergent-free version of cancer drug, Jevtana, which is marketed by Sanofi Aventis to treat advanced prostate cancer, and is also under clinical development for a range of other cancer types, including testicular, ovarian, breast, bladder, and head and neck. Jevtana sales are estimated to reach approximately US$500 million this year.

DEP cabazitaxel is the second product from Starpharma’s DEP platform to enter the clinic, and follows DEP docetaxel, which delivered positive phase 1 clinical results in 2017 and recently progressed to phase 2. The reproducible benefits observed for DEP docetaxel and DEP cabazitaxel in preclinical models include decreased bone marrow toxicity and enhanced efficacy, and in both cases DEP has also allowed for a detergent-free formulation resulting in significant additional benefits for patients.

In parallel, AstraZeneca’s first DEP product, AZD0466, has been developed under licence with Starpharma and has also demonstrated preclinical improvements consistent with findings for DEP docetaxel and DEP cabazitaxel.

The phase 1/2 study for DEP cabazitaxel will enrol patients with advanced solid tumours and is an open-label study. In phase 1, DEP cabazitaxel will be administered once every three weeks at escalating doses to determine if there are any Dose Limiting Toxicities (DLTs) and to establish the Maximum Tolerated Dose (MTD). The characterisation of the safety, tolerability and PK profile of DEP cabazitaxel will help establish and characterise the RP2D.

In phase 2, the study will initially enrol up to 20 patients at the RP2D to determine the anti-tumour efficacy of DEP cabazitaxel in specific tumour types, and to further characterise the safety, tolerability and PK of the product.

The adaptive trial design employed enables Starpharma to move seamlessly from phase 1 to phase 2 and to explore efficacy as early as possible. As the trial progresses, decisions will be made as to which tumour types to focus on and any additional patients required to further characterise efficacy in specific tumour types.

Dr Jackie Fairley, Starpharma CEO, commented: "We are delighted to advance DEP cabazitaxel – our second DEP product from our internal portfolio to the clinic. DEP cabazitaxel has already delivered exciting preclinical results showing sustained efficacy and survival benefits, as well as eliminating neutropenia, which is a significant dose-limiting side effect of many anti-cancer drugs, including Jevtana.

"These benefits for DEP cabazitaxel are consistent with the recent positive phase 1 results for our lead internal DEP product, DEP docetaxel and findings in partnered DEP programs. The growing body of data from our DEP products illustrates the broad applicability of the DEP platform and the compelling commercial advantages of enhancing drug performance and reducing toxicity for patients, while extending patent life", concluded Dr Fairley.

About DEP cabazitaxel

Starpharma’s DEP platform was utilised to create DEP cabazitaxel, a detergent free version of cancer drug Jevtana. Jevtana is a leading oncology agency which is used to treat advanced prostate cancer and also under development for other cancers including breast cancer, bladder cancer and head and neck cancer. The current (non-dendrimer) formulation product has US Food and Drug Administration (FDA)-mandated ‘black box’ warnings in relation to neutropenia, which is a major dose limiting side effect, and sever hypersensitivity (e.g. anaphylaxis) resulting from the polysorbate 80 detergent used in its formulation.

DEP cabazitaxel significantly outperformed Jevtana in a human breast cancer model with respect to both level and duration of anti-cancer activity and survival, whilst protecting against the development of neutropenia, which is a serious side effect for Jevtana.

Alexion to Present at the Leerink Partners 7th Annual Global Healthcare Conference

On January 31, 2018 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at the Leerink Partners 7th Annual Global Healthcare Conference in New York City on Wednesday, February 14, 2018 at 11:00 a.m., ET (Press release, Alexion, JAN 31, 2018, View Source [SID1234523659]).

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2017 Results

On January 31, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the fourth quarter and full year ended December 31, 2017 (Press release, Thermo Fisher Scientific, JAN 31, 2018, View Source [SID1234523657]).

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Fourth Quarter and Full Year 2017 Highlights

Fourth quarter revenue grew 22% to $6.05 billion.

Full year revenue grew 14% to $20.92 billion.

Fourth quarter GAAP diluted earnings per share (EPS) decreased 18% to $1.30.
Full year GAAP diluted EPS increased 10% to $5.59. GAAP results include a one-time tax provision of $204 million associated with the recent enactment of tax reform legislation in the U.S.

Fourth quarter adjusted EPS increased 16% to $2.79.
Full year adjusted EPS increased 15% to $9.49.

Invested $0.9 billion in R&D during the year and launched high-impact products across all segments, highlighted by the Thermo Scientific Q-Exactive HF-X mass spectrometer, Thermo Scientific Krios G3i cryo transmission electron microscope, Applied Biosystems SeqStudio genetic analyzer and the Oncomine Dx Target Test.

Delivered strong year-over-year growth in Asia-Pacific and Emerging Markets, led by outstanding performance in China, and added new capabilities to support growth opportunities in China, South Korea and the Middle East.

Deployed $7.8 billion in 2017 on strategic acquisitions, adding leading biopharma contract development and manufacturing services through Patheon and expanding our offerings in bioproduction, cloud-based informatics, electron microscopy and transplant diagnostics.

Returned $1 billion of capital to shareholders in 2017 through stock buybacks and dividends.
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 deliver an excellent 2017, with a very strong finish in the fourth quarter that capped off another outstanding year," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our performance demonstrates the continued success of our proven growth strategy and great execution by our teams.

"Among the highlights of 2017, we launched innovative new products in our key technology platforms, and enabled breakthroughs in proteomics, genetic analysis and structural biology. We continued to leverage our industry-leading scale to deliver strong performance in high-growth emerging markets, particularly China, India and South Korea. It was also a very active year for strategic M&A. We significantly enhanced our value proposition with the addition of Patheon’s leading services offering for pharma and biotech customers."

Casper concluded, "We’re in an excellent position as we begin 2018, and we’re energized about our prospects for the future."

Fourth Quarter 2017

Revenue for the quarter grew 22% to $6.05 billion in 2017, versus $4.95 billion in 2016. Organic revenue growth was 8%; acquisitions increased revenue by 11% and currency translation increased revenue by 3%.

GAAP Earnings Results

GAAP diluted EPS in the fourth quarter decreased to $1.30, versus $1.59 in the same quarter last year, due to the one-time tax provision previously noted. GAAP operating income for the fourth quarter of 2017 grew to $0.96 billion, compared with $0.75 billion in the fourth quarter of 2016. GAAP operating margin increased to 15.8%, compared with 15.2% in the fourth quarter of 2016.

Non-GAAP Earnings Results

Adjusted EPS in the fourth quarter of 2017 increased 16% to $2.79, versus $2.41 in the fourth quarter of 2016. Adjusted operating income for the fourth quarter of 2017 grew 18% compared with the year-ago quarter. Adjusted operating margin decreased 80 basis points to 24.0%, compared with 24.8% in the fourth quarter of 2016.

Full Year 2017

Revenue for the full year grew 14% to $20.92 billion in 2017, versus $18.27 billion in 2016. Organic revenue growth was 5%; acquisitions increased revenue by 9% and currency translation increased revenue slightly.

GAAP Earnings Results

GAAP diluted EPS for the full year increased to $5.59, versus $5.09 in 2016. GAAP diluted EPS in 2017 reflects the one-time tax provision. GAAP operating income for 2017 grew to $2.97 billion, compared with $2.45 billion a year ago. GAAP operating margin was 14.2% in 2017, compared with 13.4% in 2016.

Non-GAAP Earnings Results

Adjusted EPS for the full year rose 15% to $9.49, versus $8.27 in 2016. Adjusted operating income for 2017 grew 15% compared with 2016, and adjusted operating margin expanded 10 basis points to 23.2%, compared with 23.1% a year ago.

Annual Guidance for 2018

The company will provide 2018 financial guidance on its earnings conference call this morning at 8:30 a.m. Eastern time.

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 fourth quarter of 2017, Life Sciences Solutions Segment revenue grew 11% to $1.58 billion, compared with revenue of $1.42 billion in the fourth quarter of 2016. Segment adjusted operating margin increased to 35.6%, versus 32.9% in the 2016 quarter.

For the full year 2017, Life Sciences Solutions Segment revenue rose 8% to $5.73 billion, compared with revenue of $5.32 billion in 2016. Segment adjusted operating margin increased to 33.1% in 2017, compared with 30.0% a year ago.

Analytical Instruments Segment

Results for the Analytical Instruments Segment reflect the acquisition of FEI Company in September 2016. Segment revenue grew 16% to $1.41 billion in the fourth quarter of 2017, compared with revenue of $1.22 billion in the fourth quarter of 2016. Segment adjusted operating margin was flat at 24.5%.

For the full year 2017, Analytical Instruments Segment revenue rose 31% to $4.82 billion, compared with revenue of $3.67 billion in 2016. Segment adjusted operating margin grew to 21.3%, versus 20.3% in 2016.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew 10% to $0.91 billion in the fourth quarter of 2017, compared with revenue of $0.83 billion in the fourth quarter of 2016. Segment adjusted operating margin was 26.5%, versus 27.2% in the 2016 quarter.

For the full year 2017, Specialty Diagnostics Segment revenue grew 4% to $3.49 billion, compared with revenue of $3.34 billion in 2016. Segment adjusted operating margin was 26.7%, versus 2016 results of 27.2%.

Laboratory Products and Services Segment

Laboratory Products and Services Segment results reflect the acquisition of Patheon in late August 2017. In the fourth quarter of 2017, segment revenue grew 43% to $2.40 billion, compared with revenue of $1.68 billion in the fourth quarter of 2016. Segment adjusted operating margin was 12.5%, versus 14.0% in the 2016 quarter.

For the full year 2017, Laboratory Products and Services Segment revenue grew 16% to $7.83 billion, compared with revenue of $6.72 billion in 2016. Segment adjusted operating margin was 12.9%, versus 14.4% in 2016.

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, benefits from tax credit carryforwards, 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 5 to 20 years. In 2018, based on acquisitions closed through the end of 2017, our adjusted EPS will exclude approximately $3.25 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, benefits from tax credit carryforwards and the impact of significant tax audits or events (such as the effect on deferred tax balances of enacted changes in tax rates or, in 2017, the incremental impact of tax reform legislation in the U.S.), 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, January 31, 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, February 16, 2018.

Protagonist Therapeutics to Participate in the Leerink Partners 7th Annual Global Healthcare Conference

On January 31, 2018 Protagonist Therapeutics, Inc. (NASDAQ: PTGX) reported that Dinesh V. Patel, Ph.D., the company’s President and Chief Executive Officer, will provide a corporate overview at the Leerink Partners 7th Annual Global Healthcare Conference taking place on February 14-15 at the Lotte New York Palace in New York, NY (Press release, Protagonist, JAN 31, 2018, View Source;p=RssLanding&cat=news&id=2329405 [SID1234523656]).

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The Protagonist Therapeutics presentation is scheduled for Wednesday, February 14 at 9:30 am Eastern Time.

A live audio webcast of the presentation may be accessed by visiting the Investors page of Protagonist Therapeutics corporate website at View Source A replay of the presentation will be available for 30 days following the presentation.