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."

On July 30, 2019 City of Hope reported that it has been named the 11th best cancer hospital in the nation by U.S. News & World Report’s 2019-20 Best Hospitals: Specialty Ranking (Press release, City of Hope, JUL 30, 2019, View Source [SID1234537861]). This makes City of Hope the highest ranked cancer hospital in the West and marks the 13th consecutive year it has been distinguished as one of the nation’s elite cancer hospitals.

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"City of Hope is extremely honored to be recognized by U.S. News & World Report for our long-standing commitment to providing the best treatment and care to our patients," said Robert Stone, City of Hope president and CEO. "It’s a reflection of our exceptional, compassionate care and our dedication to turning powerful science into lifesaving new treatments for our patients."

"A steadfast collaboration between City of Hope scientists and physicians, our strong translational research model and our top-notch biomedical research and manufacturing facilities enable us to deliver excellent cancer care," Stone added.

This year, U.S. News & World Report added data from Hospital Consumer Assessment of Healthcare Providers and Systems, which tracks exemplary patient experience. City of Hope was fourth in the country out of the 885 hospitals surveyed.

City of Hope was also ranked "high-performing" in lung cancer surgery and colon cancer surgery.

"Although City of Hope is not driven by the accolades we receive, we know that patients and their families often turn to rankings and ratings to decide where to get their care," said Michael Caligiuri, M.D., president of City of Hope National Medical Center and the Deana and Steve Campbell Physician-in-Chief Distinguished Chair. "We are gratified to be recognized as a leading-edge cancer center where a patient’s hope can turn into reality through our innovative treatments and exemplary care."

The cancer hospital ranking is compiled based on data from 885 eligible cancer hospitals nationwide; U.S. News & World Report’s rankings cover 16 specialty areas in total. Only 12.5% of the more than 4,500 hospitals analyzed in all the specialty areas received the "Best" status. A cancer hospital’s overall score reflects performance in such areas as advanced technologies, designation as a National Cancer Institute comprehensive cancer center and survival score data.

City of Hope is one of 50 comprehensive cancer centers in the nation, the highest designation possible from the National Cancer Institute and a metric used by U.S. News & World Report. To earn this designation, a center must undergo a rigorous peer-review process, maintain a high number of cancer research projects and be heavily involved in community outreach, as well as meet other academic and public service requirements. City of Hope earned its comprehensive cancer center designation in 1998 and has maintained it since.

City of Hope is also a founding member of the National Comprehensive Cancer Network, making it a leader in advancing research and treatment protocols throughout the nation. City of Hope is currently conducting more than 500 clinical trials, enrolling more than 6,200 patients.

The American College of Surgeons Commission on Cancer recently awarded City of Hope a "Three-Year with Commendation" designation, its highest level of accreditation recognizing exceptional cancer care.

City of Hope was a pioneer in bone marrow and stem cell transplants, and continues to have one of the largest, most successful such programs of its kind in the U.S. The Center for International Blood and Marrow Transplant Research Center has ranked City of Hope as an "overperforming" transplant center, making it the only U.S. transplant center with this recognition for 14 consecutive years. Interlink COE Networks and Programs also recently designated City of Hope’s bone marrow and stem cell transplant program as No. 1 in the nation.

A leader in the CAR T field for being the first to offer CAR T trials for specific targets on glioblastoma and acute myeloid leukemia cells, City of Hope has treated more than 350 patients in CAR T trials and currently has 20 ongoing CAR T and T cell trials.

Complete lists of U.S. News’ "Best Hospitals" by specialties and their ranking methodology are available online beginning July 30 at 12:01 a.m. EDT.