On July 30, 2019 Pfizer Inc. (NYSE:PFE) reported the successful completion of its acquisition of Array BioPharma Inc., advancing breakthrough science for the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need (Press release, Pfizer, JUL 30, 2019, View Source [SID1234537899]).

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As Array becomes part of Pfizer, it brings an impressive existing portfolio that includes the approved combined use of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma, with significant potential for long-term growth via expansion into additional areas of unmet need. Additionally, BRAFTOVI and MEKTOVI are being investigated as a potential first-in-class combination for the treatment of BRAF-mutant metastatic colorectal cancer (mCRC), based on compelling interim results from the pivotal Phase 3 BEACON trial, setting the stage to create a potentially industry-leading franchise for colorectal cancer alongside Pfizer’s existing expertise in breast and prostate cancers.

"We are proud to bring Array’s exceptional scientific talent and broad pipeline into Pfizer," said Mikael Dolsten, Pfizer Chief Scientific Officer and President, Worldwide Research, Development and Medical. "Combined with Pfizer’s leading research and development capabilities, today’s announcement strengthens our potential to translate advanced science and technologies into the breakthroughs that change patients’ lives."

As Array’s colleagues become part of Pfizer, the company plans to maintain Array’s operations in Cambridge, Massachusetts and Morrisville, North Carolina, as well as Boulder, Colorado, which becomes part of Pfizer’s Oncology Research & Development network in addition to La Jolla, California and Pearl River, New York.

The tender offer for all of the outstanding shares of Array expired at 6:01 p.m., Eastern Time, on July 29, 2019. Computershare Trust Company, N.A., the depository and paying agent for the tender offer, has advised Pfizer that as of the tender offer expiration, 171,905,358 shares of Array common stock were validly tendered, representing approximately 77.0% of the shares outstanding. All of the conditions of the offer have been satisfied and Pfizer and its subsidiary Arlington Acquisition Sub Inc. have accepted for payment for $48 per share in cash, without interest, subject to any required withholding taxes, all shares validly tendered and not validly withdrawn and will promptly pay for all such shares. Following its acceptance of the tendered shares, Pfizer completed its acquisition of Array through a second step merger of Arlington Acquisition Sub Inc. with and into Array. As a result of the merger, Array became a wholly owned subsidiary of Pfizer. In connection with the merger, all Array shares not validly tendered (other than shares held by Array, Pfizer, their respective subsidiaries and shareholders of Array who have perfected their statutory appraisal rights) have been cancelled and converted into the right to receive the same $48 in cash (without interest and less any applicable withholding taxes) as will be paid for all Array shares that were validly tendered and not validly withdrawn. Array common stock will cease to be traded on the Nasdaq Global Market. Pfizer expects the transaction to be dilutive to Pfizer’s Adjusted Diluted EPS by $0.04 in 2019, $0.04 -$0.05 in 2020, neutral in 2021 and accretive beginning in 2022, with additional accretion and growth anticipated thereafter. The company has updated its 2019 financial guidance based on a number of factors, including this acquisition. For information on 2019 financial guidance, please see the press release for Pfizer’s Second Quarter 2019 Results here.

On July 30, 2019 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported financial results for the quarter ended June 30, 2019 (Press release, NuVasive, JUL 30, 2019, View Source [SID1234537916]).

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Second Quarter 2019 Highlights

Revenue increased 3.7% to $292.1 million, or 4.7% on a constant currency basis;
GAAP operating profit margin of 10.3%; Non-GAAP operating profit margin of 16.3%; and
GAAP diluted earnings per share of $0.29; Non-GAAP diluted earnings per share of $0.63.
"NuVasive continued to deliver consistent revenue growth in the second quarter 2019, with a notably solid performance from the U.S. Hardware business," said J. Christopher Barry, chief executive officer of NuVasive. "We saw meaningful case volume growth driven by increased surgeon adoption of lateral single-position surgery and NuVasive’s innovative X360 system. Our strong profitability results over the first half of the year demonstrate the clear initiatives and focused execution throughout the business and are reflected in our raised full-year 2019 non-GAAP guidance for operating margin and earnings per share."

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.

Second Quarter 2019 Results
NuVasive reported second quarter 2019 total revenue of $292.1 million, a 3.7% increase compared to $281.6 million for the second quarter 2018. On a constant currency basis, second quarter 2019 total revenue increased 4.7% compared to the same period last year.

For the second quarter 2019, both GAAP and non-GAAP gross profit was $214.5 million and GAAP and non-GAAP gross margin was 73.4%. These results compared to the second quarter 2018 GAAP and non-GAAP gross profit of $204.5 million and $204.9 million, respectively, and GAAP and non-GAAP gross margin of 72.6% and 72.8%, respectively.

On a GAAP basis, the Company reported net income of $15.0 million, or diluted earnings per share of $0.29, for the second quarter 2019 compared to a net income of $11.5 million, or diluted earnings per share of $0.22, for the second quarter 2018. On a non-GAAP basis, the Company reported net income of $32.8 million, or diluted earnings per share of $0.63 per share, for the second quarter 2019 compared to net income of $30.3 million, or diluted earnings per share of $0.58 per share, for the second quarter 2018.

The Company maintains full-year 2019 revenue guidance to be in the range of $1.14 billion to $1.16 billion, which now includes approximately $5 million in year-over-year currency headwinds compared to prior guidance of $4 million. This reflects reported growth in the range of 3.4% to 5.4%, compared with prior guidance of 3.5% to 5.5%. Revenue growth on a constant currency basis remains unchanged at 3.8% to 5.8%;
Non-GAAP diluted earnings per share in a range of $2.25 to $2.35, compared with prior guidance of $2.20 to $2.30;
Non-GAAP operating profit margin of 15.3% to 15.7%, compared with prior guidance of 15.0% to 15.5%;
EBITDA margin of 25.5% to 25.9%, compared with prior guidance of 25.2% to 25.7%; and
Non-GAAP effective tax expense rate of approximately 23%.

On July 30, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported that it has submitted a supplemental new drug application for the oral androgen receptor signaling inhibitor XTANDI (generic name: enzalutamide, "XTANDI") to add the indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC) in Japan (Press release, Astellas, JUL 30, 2019, View Source [SID1234537884]). XTANDI is currently indicated for the treatment of men castration-resistant prostate cancer (CRPC) in Japan.

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The submission is based on results from the Phase 3 ARCHES trial presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in February and published in The Journal of Clinical Oncology. The study evaluated the efficacy and safety of XTANDI plus androgen deprivation therapy (ADT) versus ADT plus placebo in men with mHSPC. The primary endpoint of radiographic progression-free survival (rPFS) was met in the study.

Additionally, the submission is supported by data from ENZAMET, an Astellas-supported, investigator-sponsored Phase 3 research study led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and sponsored by the University of Sydney. The ENZAMET trial evaluated XTANDI plus ADT versus ADT plus a standard nonsteroidal antiandrogen therapy (bicalutamide, nilutamide or flutamide) in men with mHSPC to provide an active control. The results were presented during the Plenary Session at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June and simultaneously published in the New England Journal of Medicine. The primary endpoint of overall survival (OS) was met in the ENZAMET trial. The safety analysis of the ARCHES and ENZAMET trials appear consistent with the safety profile of enzalutamide in previous clinical trials in CRPC.

Enzalutamide is currently indicated for the treatment of CRPC in the U.S. and Europe. Data from the ARCHES and ENZAMET studies have also been submitted to the European Medicines Agency (EMA) and to the U.S. Food & Drug Administration (FDA) to potentially support an indication for XTANDI that includes men with mHSPC.

On July 30, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported that it will release second quarter 2019 financial results after the market closes on Tuesday, August 6, 2019 (Press release, Xencor, JUL 30, 2019, View Source [SID1234537900]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers, and referencing conference ID number 1597118. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 30 days.

On July 30, 2019 Bexion Pharmaceuticals, Inc. an oncology-focused company reported the completion of a Type B End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) to discuss the End of Phase 1 and the design of a Phase 2 clinical trial for BXQ-350, the Company’s lead candidate, for the treatment of recurrent Glioblastoma Multiforme (rGBM) (Press release, Bexion, JUL 30, 2019, View Source [SID1234537917]).

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In the Type B meeting, the FDA provided guidance on various design aspects of Bexion’s proposed Phase 2 clinical trial. The trial is expected to enroll 55-60 patients.

"An End of Phase 1 meeting with the FDA is a significant regulatory milestone for any new clinical development program," said Dr. Richard Schwen, Regulatory Consultant for Bexion. "Such meetings are granted by the FDA only when significant data on the drug are available. Bexion’s recent meeting signals the FDA’s interest in the BXQ-350 program, and an opportunity for Bexion to obtain input to refine the remaining studies required for an FDA approval."

The Phase 2 trial is designed with learnings from the Phase 1 program, which dosed 93 patients, with 21 having rGBM. The Phase 1 program reached the highest planned dose and demonstrated a strong safety profile for BXQ-350.

Based upon the FDA’s feedback, Bexion will submit a Phase 2 clinical trial protocol and statistical analysis plan along with the requested Chemistry, Manufacturing and Controls (CMC) information to the Investigational New Drug (IND) application.

"The FDA has provided us very valuable advice on the design of the Phase 2 trial, and we are grateful for their comprehensive feedback," said Dr. Ray Takigiku, CEO of Bexion Pharmaceuticals. "Recurrent GBM remains an urgent unmet medical need, and we believe the initiation of a Phase 2 clinical trial of BXQ-350 for this devastating disease is a major milestone for both patients and Bexion. We are working diligently to incorporate the FDA’s comments into the IND, with the expectation of initiating the Phase 2 trial in the first quarter of 2020."