Shire to announce first quarter 2018 results

On April 18, 2018 Shire plc (LSE: SHP, NASDAQ: SHPG), reported that it will announce first quarter 2018 earnings on Thursday April 26, 2018 (Press release, Shire, APR 18, 2018, View Source [SID1234525511]).

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Results press release will be issued at:

12:00 BST / 07:00 EDT

Investor conference call time:

14:00 BST / 09:00 EDT

Live conference call for investors:
Flemming Ornskov, MD, M.P.H., Chief Executive Officer and Thomas Dittrich, Chief Financial Officer will host the investor and analyst conference call at 9:00 am EDT / 14:00 BST.

The details of the conference call are as follows:

UK dial in:

0800 358 9473 or +44 333 300 0804

US dial in:

1 855 857 0686 or 1 631 913 1422

International Access Numbers:

Click here

Password/Conf ID:

83293759 #

Live Webcast:

Click here

Replay:
A replay of the presentation will be available for two weeks by phone and by webcast for three months. Replay information can be found on the Investor Relations section of Shire’s website at View Source

For further information please contact:
Investor Relations

Christoph Brackmann [email protected] +41 795 432 359
Sun Kim [email protected] +1 617 588 8175
Robert Coates [email protected] +44 203 549 0874
Media
Katie Joyce [email protected] +1 781 482 2779

AbbVie to Present at the Deutsche Bank’s 43rd Annual Health Care Conference

On April 18, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the Deutsche Bank’s 43rd Annual Health Care Conference on Wednesday, May 9, 2018 (Press release, AbbVie, APR 18, 2018, View Source [SID1234525494]). Bill Chase, executive vice president and chief financial officer, will present at 7 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

TG Therapeutics, Inc. Announces Preclinical Data Presentation on the Company’s BET Inhibitor, TG-1601, at the 2018 American Association for Cancer Research (AACR) Annual Meeting

On April 18, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX), reported preclinical data for TG-1601, the Company’s novel BET inhibitor at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, taking place this week in Chicago, Illinois, at McCormick Place North/South (Press release, TG Therapeutics, APR 18, 2018, View Source [SID1234525512]). The Company’s poster is available for viewing today from 8:00am to 12:00pm CT, during the Experimental and Molecular Therapeutics/ Canonical Targets 2 Session in Exhibit Hall A.

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Highlights from this poster include:

Title: TG-1601 is a novel BET inhibitor with strong binding affinity and long-lasting effect in pre-clinical models (Abstract Number 5790)
— TG-1601 is a novel and potent BET inhibitor that specifically inhibits the binding of the BET sub-family of bromodomain-containing protein family;
— TG-1601 potently inhibits cell growth of various multiple myeloma and lymphoma cell lines in vitro, but does not affect the growth of normal cell lines;
— TG-1601 inhibits MYC and Bcl-2 expression in preclinical models;
— TG-1601 showed combinatorial effects in an in vivo model with anti-PD-1 antibodies. Clinical trials will be focused on a potential synergism between TG-1601 and other drugs in the TG pipeline.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are encouraged by the preclinical data presented today for TG-1601 which we believe to be a potent BET inhibitor that could have activity in a number of hematological malignancies. Importantly, by inhibiting c-Myc and Bcl-2 protein expression, TG-1601 may provide complimentary and/or synergistic effects when combined with our other products under development to potentially create best-in-class combinations. We look forward to continuing our research and advancing this compound into the clinic later this year."

PRESENTATION DETAILS

A copy of the above referenced poster is available on the Company’s website at www.tgtherapeutics.com, located on the Publications Page

Seres Therapeutics Presents New Preclinical Data Supporting the Development of Microbiome Therapeutics for Immuno-Oncology at the 2018 American Association for Cancer Research Annual Meeting

On April 17, 2018 Seres Therapeutics, Inc. (NASDAQ:MCRB) reported that new preclinical data supporting the development of microbiome therapeutics for immuno-oncology (leveraging gut microbiota to impact tumor immunotherapy)1 will be presented today by Sceneay et al in the late breaking poster session at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) in Chicago (Press release, Seres Therapeutics, APR 17, 2018, View Source [SID1234530893]). The data presented provide new insights on the potential mechanism by which Seres’ microbiome therapies could improve the outcomes of cancer patients treated with immune checkpoint inhibitors.

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"The data presented at AACR (Free AACR Whitepaper) provide important new models and mechanistic insights that inform our planned development efforts to evaluate the ability of microbiome therapy to augment immune checkpoint inhibitors," said David Cook, Ph.D., Chief Scientific Officer and Executive Vice President of Research at Seres. "The insights described in this presentation will guide the continued development of SER-401, which we expect to enter clinical development later this year. Our objective is to use our microbiome therapeutic approach to improve the efficacy of immunotherapy in patients with life-threatening cancers."

Seres presented results from preclinical studies designed to evaluate the impact of various consortia of bacterial species on the anti-tumor immune response in murine models following treatment with an anti-PD-1 checkpoint inhibitor. Results demonstrated that both germ-free mice lacking a microbiome and antibiotics-treated mice with a dysbiotic microbiome, failed to mount an effective anti-tumor response following treatment with an anti-PD-1 checkpoint inhibitor. The response to anti-PD-1 was restored in germ-free as well as antibiotics-treated mice by introducing a diverse microbiome, and was driven by increased entry of tumor-infiltrating lymphocytes into the tumor; specifically, CD8+ T effector cells. Current pre-clinical efforts are focused on optimizing specific microbiome compositions based on functional and phylogenetic information to inform the development of therapeutic candidates.

Seres is developing SER-401, a preclinical stage oral microbiome therapy comprising a consortium of live bacteria to improve the efficacy and safety of immunotherapy. Through a collaboration with The University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy, Seres plans to initiate a clinical study in patients with advanced metastatic melanoma later this year. In a 2017 study published in Science, the MD Anderson research team, led by Dr. Jennifer Wargo, described a microbiome signature associated with response to checkpoint inhibitor therapy. A planned clinical trial will evaluate the impact of an anti-PD-1 checkpoint inhibitor with adjunctive microbiome therapy on patient outcomes.

Johnson & Johnson Reports 2018 First-Quarter Results:

On April 17, 2018 Johnson & Johnson (NYSE: JNJ) reported sales of $20.0 billion for the first quarter of 2018, an increase of 12.6% as compared to the first quarter of 2017 (Press release, Johnson & Johnson, APR 17, 2018, View Source [SID1234525423]).

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Operational sales results increased 8.4% and the positive impact of currency was 4.2%. Domestic sales increased 6.1%. International sales increased 19.9%, reflecting operational growth of 10.9% and a positive currency impact of 9.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 4.3%, domestic sales increased 1.3% and international sales increased 7.6%.*

Net earnings and diluted earnings per share for the first quarter of 2018 were $4.4 billion and $1.60, respectively. First-quarter 2018 net earnings included after-tax intangible amortization expense of approximately $1.0 billion and a charge for after-tax special items of approximately $0.3 billion. First-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.4 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.6 billion and adjusted diluted earnings per share were $2.06, representing increases of 11.8% and 12.6%, respectively, as compared to the same period in 2017.* On an operational basis, adjusted diluted earnings per share also increased 5.5%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

"We are pleased with the strong and consistent performance delivered by our colleagues around the world, demonstrated by our sales and EPS growth in the first quarter," said Alex Gorsky, Chairman and Chief Executive Officer. "Our Pharmaceutical business continues to deliver robust growth and we are pleased with the improvement in our Consumer business. In our Medical Devices businesses, we have areas of leadership and continue to make investments and portfolio choices to improve performance."
Mr. Gorsky continued, "The U.S. tax legislation passed late last year is creating the opportunity for us to invest more than $30 billion in R&D and capital investments in the U.S. over the next four years, which is an increase of 15%."
The Company increased its sales guidance for the full-year 2018 to a range of $81.0 to $81.8 billion, reflecting expected operational growth in the range of 4.0% to 5.0%. Additionally, the Company reaffirmed its adjusted earnings guidance for full-year 2018 to a range of $8.00 to $8.20 per share, reflecting expected operational growth in the range of 6.8% to 9.6%.

Segment Sales Performance
Worldwide Consumer sales of $3.4 billion for the first quarter 2018 represented an increase of 5.3% versus the prior year, consisting of an operational increase of 1.3% and a positive impact from currency of 4.0%. Domestic sales increased 1.6%, international sales increased 8.2%, which reflected an operational increase of 1.2% and a positive currency impact of 7.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 2.0%, domestic sales increased 1.6% and international sales increased 2.3%*.
Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by beauty products primarily NEUTROGENA, AVEENO, and Dr. Ci Labo, and international analgesics in over-the-counter products, partially offset by the negative impact of domestic baby care products.
Worldwide Pharmaceutical sales of $9.8 billion for the first quarter 2018 represented an increase of 19.4% versus the prior year with an operational increase of 15.1% and a positive impact from currency of 4.3%. Domestic sales increased 9.9%; international sales increased 33.1%, which reflected an operational increase of 22.5% and a positive currency impact of 10.6%. Sales included the impact of Actelion Ltd which contributed 7.6%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 7.5%, domestic sales increased 2.2% and international sales increased 15.3%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by new products and the strength of core products. Strong growth in new products include DARZALEX (daratumumab), for the treatment of patients with multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer and TREMFYA (guselkumab), for the treatment of adults living with moderate to severe plaque psoriasis. Additional contributors to operational sales growth included ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer, STELARA (ustekinumab) and international SIMPONI/SIMPONI ARIA (golimumab), biologics for the treatment of a number of immune-mediated inflammatory diseases, XARELTO (rivaroxaban), an oral anticoagulant, and INVEGA SUSTENNA/XEPLION/TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.

During the quarter, the U.S. Food and Drug Administration (FDA) approved an additional indication for ZYTIGA (abiraterone acetate), in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer and ERLEADA (apalutamide) an oral androgen receptor inhibitor for the treatment of patients with non-metastatic castration-resistant prostate cancer. In addition, the Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization for JULUCA (rilpivirine and dolutegravir), the first, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 infection.

Also in the quarter, a marketing authorization application was submitted to the European Medicines Agency for apalutamide, an oral androgen receptor inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer.

Worldwide Medical Devices sales of $6.8 billion for the first quarter 2018 represented an increase of 7.5% versus the prior year consisting of an operational increase of 3.2% and a positive currency impact of 4.3%. Domestic sales increased 2.2%; international sales increased 12.7%, which reflected an operational increase of 4.2% and a positive currency impact of 8.5%. Sales included the partial quarter impact of the recently acquired surgical vision business which contributed 3.1%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.1%, domestic sales decreased 0.2% and international sales increased 2.4%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by ACUVUE contact lenses in the Vision Care business; electrophysiology products in the Interventional Solutions business; endocutters in the Advanced Surgery business; and trauma products in the Orthopaedics business, partially offset by declines in the Diabetes Care business and spine products in the Orthopaedics business.
During the quarter, the acquisition of Orthotaxy S.A.S., a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery was completed. In addition, the Company announced a binding offer from Platinum Equity, a private investment firm, to acquire its LifeScan business for approximately $2.1 billion, subject to customary adjustments.

Subsequent to the quarter, ACUVUE OASYS with Transitions received 510(k) clearance from the FDA and is indicated for vision correction and the attenuation of bright light.
Additionally, Johnson & Johnson plans to implement actions across its global supply chain that are intended to enable the company to focus resources and increase investments in critical capabilities, technologies and solutions necessary to manufacture and supply its product portfolio of the future, enhance agility and drive growth. The Company expects these supply chain actions will include expanding our use of strategic collaborations, and bolstering our initiatives to reduce complexity, improving cost-competitiveness, enhancing capabilities and optimizing our network. Discussions regarding specific future actions are ongoing and are subject to all relevant consultation requirements before they are finalized.

In total, the Company expects these actions to generate approximately $0.6 to $0.8 billion in annual pre-tax cost savings that will be substantially delivered by 2022. The Company expects to record pre-tax restructuring charges of approximately $1.9 to $2.3 billion, which will be treated as a special item.