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.

IDEAYA Licenses Phase 1 Compound LXS196 For The Treatment Of Cancers With GNAQ And GNA11 Mutations

On October 23, 2018 IDEAYA Biosciences, Inc., reported it has entered into an exclusive license agreement with Novartis to develop and commercialize Novartis’ LXS196, a Phase 1 protein kinase C (PKC) inhibitor for the treatment of cancers with GNAQ and GNA11 mutations (Press release, Ideaya Biosciences, OCT 23, 2018, View Source [SID1234535455]).

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LXS196, which will be recoded as IDE196 by IDEAYA for future development, is a potent small molecule inhibitor of PKC demonstrating early clinical activity and tolerability in an ongoing Phase 1 study of IDE196 for patients with metastatic uveal melanoma (MUM). IDE196 is active across multiple PKC isoforms and is highly selective relative to other kinases. MUM is an orphan disease of high unmet medical need, with median overall survival of approximately 10 months and no FDA approved therapies.

"There are no approved therapies for metastatic uveal melanoma, and continued development of promising clinical stage agents, such as IDE196, with a clear genetic biomarker rationale to treat patients that harbor GNAQ and GNA11 mutations through PKC are paramount," said Dr. Sophie Piperno‐Neumann, M.D., LXS196 Study Investigator and Medical Oncologist at Institute Curie, Paris, France.

IDEAYA will continue development in metastatic uveal melanoma and will also explore a tumor agnostic basket study of solid tumors with mutations of GNAQ and GNA11. Both GNAQ and GNA11 mutations are listed in multiple diagnostic panels, including the FoundationOne CDx NGS panel, FoundationOne Liquid Biopsy Panel, and the Guardant360 Liquid Biopsy panel, which provides a clear path towards identifying patients. IDEAYA is also evaluating the potential use of IDE196 to target various PKC fusion isoforms.

Novartis is conducting an ongoing Ph1 clinical trial, entitled "A Phase I, multi-center, open-label, study of LXS196, an oral protein kinase C inhibitor, in patients with metastatic uveal melanoma" (ClinicalTrials.gov Identifier: NCT02601378). In the ongoing trial, IDE196 is being studied as a single-agent and in combination therapy with HDM201, Novartis’ human double minute 2 (HDM2) inhibitor, an important negative regulator of the p53 tumor suppressor. Notably, approximately 90% of metastatic uveal melanoma patients harbor activating mutations in GNA11 or GNAQ.

"Targeting PKC, a pathway which is active in this disease, may result in improved clinical outcomes, and the data with IDE196 treatment thus far demonstrate objective responses, with tolerability that will enable ongoing and future monotherapy and combination trials," said Dr. Ellen Kapiteijn, M.D. Ph.D., LXS196 Study Investigator and Medical Oncologist at Leiden University Medical Center, Leiden, Netherlands.

Under the exclusive license, Novartis increased its equity ownership in IDEAYA, and is due future milestones and royalties, and Novartis will continue the ongoing IDE196 monotherapy and combination study with the Novartis HDM201 compound. IDEAYA has exclusive rights for further clinical development of IDE196, together with unrestricted rights to commercialize worldwide.

"IDE196 enhances our robust precision medicine pipeline, and we are ecstatic to develop this first-in-class therapy for cancer patients who harbor activating mutations of GNAQ and GNA11," said Yujiro Hata, Chief Executive Officer of IDEAYA. "Novartis has been an investor in IDEAYA since the Series A, so we are pleased to enter into this agreement and further enhance our strategic relationship."