Amgen Announces 2018 Fourth Quarter Dividend

On October 23, 2018 Amgen (NASDAQ:AMGN) reported that its Board of Directors declared a $1.32 per share dividend for the fourth quarter of 2018 (Press release, Amgen, OCT 23, 2018, View Source;p=RssLanding&cat=news&id=2373021 [SID1234530307]). The dividend will be paid on Dec. 7, 2018, to all stockholders of record as of the close of business on Nov. 16, 2018.

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Odonate Therapeutics Announces Financial Results for the Three and Nine Months Ended September 30, 2018

On October 23, 2018 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and nine months ended September 30, 2018 (Press release, Odonate Therapeutics, OCT 23, 2018, View Source [SID1234530066]).

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As of September 30, 2018, Odonate had $161.0 million in cash, compared to $198.1 million as of December 31, 2017. This decrease in cash resulted primarily from net cash used in operating and investing activities of $45.3 million and $1.6 million, respectively, less net cash provided by financing activities of $10.1 million, which includes $9.8 million from the exercise of the underwriters’ option to purchase additional shares of common stock in our initial public offering. Odonate’s net loss for the three and nine months ended September 30, 2018 was $23.9 million and $60.2 million, or $0.98 per share and $2.47 per share, respectively, compared to $10.4 million and $17.0 million, or $0.74 per share and $1.37 per share, for the same periods in 2017, respectively.

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. More than 500 patients have been treated with tesetaxel in clinical studies. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with HER2 negative, hormone receptor (HR) positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival, objective response rate (ORR) assessed by IRC and disease control rate assessed by IRC. To learn more, please visit www.contessastudy.com.

Varian Reports Results for Fourth Quarter and Full Fiscal Year 2018

On October 23, 2018 Varian (NYSE: VAR) reported its fourth quarter and full fiscal year 2018 results (Press release, Varian Medical Systems, OCT 23, 2018, View Source [SID1234530085]). All comparisons in this announcement are year-over-year, and all quarter and year references are fiscal unless noted otherwise.

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(1) Revenues, GAAP Net Earnings, GAAP Net Earnings per Diluted Share, Non-GAAP Net Earnings and Non-GAAP Net Earnings per Diluted Share refer only to continuing operations.
(2) Non-GAAP Net Earnings and Non-GAAP Net Earnings per Diluted Share are defined as GAAP Net Earnings and GAAP Net Earnings per Diluted Share adjusted to exclude the amortization of intangible assets, acquisition-related expenses and benefits, restructuring and impairment charges, significant litigation charges or benefits and legal costs, and significant non-recurring tax expense or benefit.

"We made tremendous progress this year toward our growth strategy and reinforced our industry leadership with record orders and revenue," said Dow Wilson, Chief Executive Officer of Varian. "We expanded our global footprint with the rollout of Halcyon and we enhanced our portfolio through meaningful organic investments as well as key acquisitions. Despite tariff headwinds, we are confident in our ability to continue to grow and deliver value-added products and services to cancer patients globally."

The company ended the quarter with $505 million in cash and cash equivalents and no debt. Net cash provided by operating activities was $108 million in the fourth quarter and a record $455 million for the year, representing growth of 14%. During the fourth quarter, the company invested $50 million to repurchase 440,000 shares of common stock.

Oncology Systems Segment

Continued innovation leadership and market execution drove strong growth worldwide in 2018. Oncology revenues totaled $756 million for the fourth quarter, up 13%, and $2.8 billion for the full year, up 14%. Operating earnings for the segment increased 8% for the quarter and 16% for the full year.

Gross orders for the fourth quarter were $1.1 billion, up 13%, and $3.1 billion for the full year, up 9%. Gross orders in the Americas were up 6% for the fourth quarter, driven by North America with 4% growth as well as strong double-digit growth in Latin America. Growth in North America was driven by large, multi-site orders and demand for radiosurgery and stereotactic body radiotherapy solutions. In EMEA, gross orders in the quarter rose 14%, the fifth consecutive quarter of double-digit growth for the region, driven by product tenders and robust performance across the geography. In APAC, gross orders increased 31% for the fourth quarter, driven by strong execution in China, Japan and Australia. "All three geographies grew in fiscal year 2018, led by the Americas and EMEA achieving record orders of $1.5 billion and $1.0 billion, respectively," said Dow Wilson.

Proton Solutions Segment
In the fourth quarter, Proton Solutions revenues totaled $46 million, down 12%. The company completed clinical handovers for one room each at three sites, representing an important future recurring revenue stream for our proton business. These clinical handovers took place at the Georgia Proton Treatment Center, Danish Center for Particle Therapy, and the Christie Proton Beam Therapy Center. The company did not book any new ProBeam orders in the quarter.

Guidance for Full Fiscal Year 2019

We expect the following for fiscal year 2019:

·Revenue range of $3.06 billion to $3.15 billion, representing growth of 5% to 8%

·Non-GAAP operating earnings as a percentage of revenues range of 17.0% to 18.0%

·Non-GAAP net earnings per diluted share range of $4.60 to $4.75

·Cash flows from operations range of $460 million to $510 million

The guidance assumes a Non-GAAP effective tax rate of 21% to 22% and a weighted average diluted share count of 92 million. The guidance also assumes currency rates as of the beginning of fiscal year 2019, excludes any future acquisitions, and includes the expected impact of all currently enacted tariffs.

Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call

Varian Medical Systems is scheduled to conduct its fourth quarter fiscal year 2018 conference call at 1:30 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on our website at www.varian.com/investors. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering conference ID 13682642. The teleconference replay will be available through 5:00 p.m. Pacific Time, Thursday, October 25, 2018.

BioCryst to Report Third Quarter 2018 Financial Results on November 6

On October 23, 2018 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported that the company will report its third quarter 2018 financial results on Tuesday, November 6, 2018 (Press release, BioCryst Pharmaceuticals, OCT 23, 2018, View Source [SID1234530138]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 9090479. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 9090479.

NextCure Initiates Clinical Development for NC318, a Siglec-15 Targeting Antibody, for Solid Tumors

On October 23, 2018 NextCure, Inc., a privately-held biopharmaceutical company discovering and developing next generation immunomedicines for cancer and other diseases, reported the initiation of a Phase 1/2 clinical trial for NC318, a Siglec-15 (S15) antibody (Press release, NextCure, OCT 23, 2018, View Source [SID1234530067]).

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The Phase 1 dose-escalation portion of this open-label trial will evaluate the safety and tolerability of NC318 in patients with advanced or metastatic solid tumors and determine its pharmacologically active and/or maximum tolerated dose. After a recommended dose for the Phase 2 portion of the trial is determined, the efficacy of NC318 will be evaluated in select tumor types. The trial is being conducted at five clinical sites in the United States. Details can be found at clinicaltrials.gov – NCT03665285.

"NC318 is the first antibody drug candidate developed at NextCure to enter clinical trials, marking an exciting milestone for our company," says Michael Richman, CEO of NextCure. "The trial marks a major advancement in our plan to develop our pipeline of next generation immunomedicines for cancer patients who do not respond to currently approved therapies."

S15 is a novel immunomodulatory target expressed on a restricted set of myeloid cells in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. Preclinical research shows that S15 promotes the survival and differentiation of suppressive myeloid cells and negatively regulates T cell function, allowing cancer growth. In preclinical studies, NC318 blocks the negative effects of S15. NC318 is a first-in-class immunomedicine that has the potential to treat multiple cancer types.

"Immunotherapies targeting T cell function have significantly improved patient outcomes; however, a substantial proportion of patients do not respond to currently approved PD-1 or PD-L1 antibody therapies," said Kevin N. Heller, M.D., CMO of NextCure. "Laboratory studies demonstrate that Siglec-15 modulates immune suppression in a manner independent of the PD-1/PD-L1 pathway, suggesting that NC318 may have the potential to be used in patients who do not express PD-L1. Blocking S15 with NC318 is expected to diminish immunosuppression and normalize the immune response, resulting in a clinically relevant anti-tumor immune response. A goal of our trial is to test that hypothesis."

The immune regulatory function of S15 was initially discovered in the lab of Lieping Chen, M.D., Ph.D., Founder of NextCure and United Technologies Endowed Professor of Cancer Research, Professor of Immunobiology, Dermatology, and Medicine at the Yale University School of Medicine. Dr. Chen is a renowned leader in immuno-oncology and has discovered many novel immune-related targets, including the PD-1/PD-L1 pathway. "The discoveries made by our group and others have paved the way for the first generation of immunotherapies, leading to major breakthroughs in cancer treatment. Building upon these early discoveries, and in collaboration with NextCure, we continue our research to identify new targets for modulating the immune system," stated Dr. Chen. "We expect that S15, one of the first new targets identified, will be the first in a series of next generation immunomedicines. Through a comprehensive and streamlined process, NextCure has efficiently brought NC318 to the clinic."