Amgen Announces Webcast of 2018 Fourth Quarter and Full Year Financial Results

On January 24, 2019 Amgen (NASDAQ: AMGN) reported that it will report its fourth quarter and full year 2018 financial results on Tuesday, Jan. 29, 2019, after the close of the U.S. financial markets (Press release, Amgen, JAN 24, 2019, View Source [SID1234532891]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

PharmaMar receives positive opinion from EMA (COMP) for orphan drug designation of Zepsyre® (lurbinectedin) for small-cell lung cancer

On January 24, 2019 PharmaMar (PHM:MSE) reported that the Committee for Orphan Medicinal Products (COMP), from the EMA, has given its positive opinion for the approval of Orphan Drug status to Zepsyre (lurbinectedin) for the treatment of small-cell lung cancer (Press release, PharmaMar, JAN 24, 2019, View Source [SID1234532892]).

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Small-cell lung cancer is PharmaMar’s current priority research area. Zepsyre (lurbinectedin) is at the Phase III investigational stage, with its ATLANTIS study for the treatment of this type of tumour. PharmaMar finalised recruitment in July 2018, and hopes to have the final data on overall survival during the second half of 2019.

PharmaMar expects to release the Zepsyre (lurbinectedin) Phase II monotherapy data for relapsed small-cell lung cancer in the first half of 2019 and to submit it for presentation it at a future medical meeting.

Legal warning This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction

PTC Therapeutics Announces Pricing of Public Offering of Common Stock

On January 23, 2019 PTC Therapeutics, Inc. (Nasdaq: PTCT) reported the pricing of a public offering of 6,720,000 shares of its common stock at a public offering price of $30.20 per share, before underwriting discounts (Press release, PTC Therapeutics, JAN 23, 2019, View Source [SID1234532837]). All of the shares in the offering are to be sold by PTC. In addition, PTC has granted the underwriter an option for a period of 30 days to purchase up to an additional 1,008,000 shares of common stock at the public offering price, less the underwriting discount.

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RBC Capital Markets is acting as the sole book-running manager for the offering.

PTC expects to close the offering on or about January 25, 2019, subject to satisfaction of customary closing conditions.

An automatically effective shelf registration statement on Form S-3 relating to the shares of common stock offered in the public offering has been filed with the Securities and Exchange Commission (the "SEC") and is available on the SEC’s website at www.sec.gov. A final prospectus supplement relating to and describing the terms of the offering also will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Before investing in the offering, interested parties should read the prospectus supplement and the accompanying prospectus for the offering and the other documents PTC has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more complete information about PTC and the offering. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281; telephone: (877) 822-4089; email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

Varian Reports Results for First Quarter of Fiscal Year 2019

On January 23, 2019 Varian (NYSE: VAR) reported its first quarter fiscal year 2019 results (Filing, 8-K, Varian Medical Systems, JAN 23, 2019, View Source [SID1234532877]). All comparisons in this announcement are year-over-year, all quarter and year references are fiscal unless noted otherwise, and any references to orders are gross orders.

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(1)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, significant litigation charges or benefits and legal costs, significant non-recurring tax expense or benefit, and gains or losses on equity investments.

"In the first quarter, we built on the strong trajectory from last year, bringing our trailing twelve-month orders growth rate to 11%," said Dow Wilson, chief executive officer of Varian. "The team delivered exceptional performance, with accelerating software revenues and overall orders growing double-digits in each of our three geographic regions. We made progress on our strategic growth initiatives, extending our global footprint by securing Halcyon approval in China and expanding our addressable markets by signing two Noona deals with pharmaceutical companies. With a strong start to the year and tariff mitigation activities on track, we are well-positioned to deliver results within our fiscal year 2019 guidance."

The company ended the quarter with $616 million in cash and cash equivalents and no debt. Net cash provided by operating activities was $141 million, down 21% due to timing of certain accounts receivable collections and inventory build to meet demand. During the quarter, the company invested $35 million to repurchase 320,000 shares of common stock.

Oncology Systems Segment

In the first quarter, Oncology revenues totaled $702 million, up 8%. Operating earnings for the segment decreased 10%, primarily driven by the impact of tariffs.

Orders were $716 million, up 16%. Orders in the Americas increased 12%. In EMEA, orders rose 15%, the sixth consecutive quarter of double-digit growth for the region. In APAC, orders increased 25%, with accelerating growth in China.

Proton Solutions Segment

In the first quarter, Proton Solutions revenues totaled $39 million, up 32%. The company completed clinical handovers for one room each at three sites.

Non-GAAP Adjustments

Varian’s GAAP operating earnings include $22 million from the gain on the sale of the company’s equity investment in Augmenix, Inc. The company also incurred $2 million in acquisition-related expenses.

Guidance for Full Fiscal Year 2019

We are reaffirming the following guidance 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, includes the expected net impact of all tariffs effective as of the beginning of the fiscal year, and excludes any future acquisitions.

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 first quarter fiscal year 2019 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 13685671. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, January 25, 2019.

B-MoGen Biotechnologies and CytoSen Therapeutics partner on research collaboration to develop next generation Natural Killer Cells for human therapeutics

On January 23, 2019 B-MoGen Biotechnologies, Inc. and CytoSen Therapeutics reported a research collaboration to develop the next generation of gene-modified Natural Killer Cell (NK) therapies (Press release, B-MoGen Biotechnologies, JAN 23, 2019, View Source [SID1234554014]). B-MoGen will utilize its expertise in genetic design and its patented non-viral gene delivery platform in conjunction with CytoSen’s nanoparticle expansion platform to improve efficacy and reduce cost of NK cell therapeutics.

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"We are very excited and look forward to teaming up with CytoSen to utilize our scientific expertise and engineering work with CARs and TCRs to help develop NK treatments in the human therapeutics space," said Jeff Liter, President and CEO of B-MoGen. "CytoSen’s innovation, science and pioneering technology is a perfect fit with B-MoGen’s genome engineering experience and technology."

CytoSen’s CEO Dr. Trent Carrier stated, "I am thrilled to see the leveraging of the combined technologies and scientific proficiency of CytoSen and B-MoGen to produce ever more effective NK cell therapeutics. These next generation enhanced NK cells will be put forth in the fight against cancers with the highest unmet medical need."

Both companies are experiencing rapid growth by providing cutting edge science and technical know-how to help create life changing human disease therapies. This partnership looks to enable the creation and delivery of new NK cell therapies for cancer patients.