Varian Reports Results for Third Quarter of Fiscal Year 2018

On July 25, 2018 Varian (NYSE: VAR) reported its third quarter fiscal year 2018 results (Press release, Varian Medical Systems, JUL 25, 2018, View Source [SID1234527868]). All comparisons in this announcement are year-over-year unless noted otherwise.

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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.

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, legal costs and significant effects of tax legislation.

"In the third quarter, the team continued to deliver robust results, and we strengthened our leadership in radiation therapy with strong orders and revenue performance," said Dow Wilson, Chief Executive Officer of Varian. "Investment will continue to be a key driver of our long-term growth and value creation, and we made strategic investments in the quarter in R&D, Sales, and Marketing to support the company’s future innovation and growth strategies."

The company ended the quarter with $536 million in cash and cash equivalents and $18 million of debt. Net cash provided by operating activities was $102 million. During the quarter, the company invested $39 million to repurchase 325,000 shares of common stock.

Oncology Systems Segment
In the fiscal third quarter, Oncology revenues totaled $667 million, up 18 percent in dollars and 16 percent in constant currency. Gross orders were $763 million, up 11 percent in dollars and 9 percent in constant currency. Gross orders in the Americas increased 9 percent in dollars and in constant currency, driven by North America at 9 percent. In EMEA, gross orders rose 27 percent in dollars and 21 percent in constant currency; in APAC, gross orders decreased 7 percent in dollars and 9 percent in constant currency. Operating earnings for the segment increased 20 percent.

Particle Therapy Segment
In the fiscal third quarter, Particle Therapy revenues totaled $42 million, down 39 percent. The company did not book any new ProBeam orders in the quarter.

Acquisition-Related Expenses and Impairment Charges in Q3
Varian’s GAAP net earnings include acquisition-related expenses totaling $13 million for the quarter, primarily driven by acquisition costs and the loss related to hedging the Australian dollar purchase price of Sirtex, partially offset by the breakup fee received from Sirtex in connection with the termination of the acquisition. Additionally, GAAP net earnings include an impairment charge of $11 million related to the expected refinancing of the Maryland Proton Treatment Center in Baltimore. Together, these costs, and their associated tax effects, reduced Varian’s net earnings in the third quarter of fiscal 2018 by $0.20 per diluted share on a GAAP basis, and were excluded from non-GAAP results.

FY18 Annual Guidance Updated
Considering the financial and operational performance year-to-date and the impact of currency and tariffs, fiscal year 2018 guidance is updated to the following:

Revenue growth range of 9 percent to 11 percent
Non-GAAP Operating earnings as a percentage of revenues range of 17.5 percent to 18.0 percent
Non-GAAP effective tax rate of 20 percent
Weighted average diluted shares of 93 million
Non-GAAP Net Earnings per diluted share range of $4.43 to $4.48
Cash flows from operations range of $475 million to $550 million
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 third quarter fiscal year 2018 conference call at 2:00 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 13680748. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, July 27, 2018.

Mirati Therapeutics To Present Updated Sitravatinib Clinical Data At The European Society For Medical Oncology (ESMO) 2018 Congress

On July 24, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that two abstracts highlighting data from ongoing clinical studies of sitravatinib will be presented as Proffered Papers in oral presentations at the 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany (Press release, Mirati, JUL 24, 2018, View Source [SID1234527849]).

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Title: Stage 2 enrollment complete: Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor Therapy
Presentation Topic: Proffered paper session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ID 159)
Location: Hall A2 – Room 18, ICM München, Munich, Germany
Lecture Date and Time: October 22, 2018 at 12:06 p.m. – 12:18 p.m. CEST
Presentation Number: 1129O
Presenter: Ticiana A. Leal, M.D.

Title: Sitravatinib demonstrates activity in patients with novel genetic alterations that inactivate CBL
Presentation Topic: Proffered paper session – Developmental therapeutics (ID 170)
Location: Hall B3 – Room 22, ICM München, Munich, Germany
Lecture Date and Time: October 21, 2018 at 11:00 a.m. – 11:12 a.m. CEST
Presentation Number: 408O
Presenter: Lyudmila Bazhenova, M.D.

Minomic announces completion of accrual for clinical study of Miltuximab® in prostate, bladder and pancreatic cancers

On July 24, 2018 Minomic International Ltd (Minomic) is an immuno-oncology company specializing in therapeutics and diagnostics for solid tumors, including prostate, bladder and pancreas (Press release, Minomic, JUL 24, 2018, View Source [SID1234528622]). The Company reported that it has completed enrolment and dosing of all 12 patients in its pioneering clinical trial of Miltuximab, a chimeric version of Minomic’s MIL-38 anti-Glypican 1 antibody conjugated to the radioactive isotope 67Gallium.

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The Miltuximab Trial is a first-in-human study to evaluate the safety and tumor targeting of Miltuximab, in patients with metastatic prostate, bladder, and pancreatic cancer. The primary endpoint of the MILGa trial is safety and tolerability of Miltuximab. Secondary endpoints include tumor targeting, pharmacokinetics and dosimetry to determine relative accumulation of Miltuximab, in different organs.
All patients have now been dosed and we are pleased to report Miltuximab was well tolerated with patients reporting no drug related adverse events. Secondary endpoints will be reported when data analysis is completed – to date these are progressing well.

Minomic’s CEO, Dr Brad Walsh, said, "These results will inform the future development of the drug and most importantly the next step, progression to a Phase 1 trial in Australia. Each phase in this process enhances the attractiveness of the company to potential partners. "

We are grateful to the principal investigator Prof. Howard Gurney and his team at Macquarie University Hospital for their dedication to bringing new therapies to cancer patients.

Cytori Announces $6.7 Million in Expected Gross Proceeds from Recently Expired Rights Offering

On July 24, 2018 Cytori Therapeutics, Inc. (NASDAQ:CYTX) reported that its previously announced rights offering ("the Rights Offering") expired on July 20, 2018 and such rights are no longer exercisable (Press release, Cytori Therapeutics, JUL 24, 2018, View Source [SID1234529750]). Cytori accepted all valid subscriptions that were presented and estimates that the Rights Offering will result in approximately $6.7 million in gross proceeds. The results of the Rights Offering and Cytori’s estimates regarding the aggregate gross proceeds of the Rights Offering to be received by Cytori are subject to finalization and verification by Cytori and its subscription agent.

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Cytori expects the closing of the Rights Offering will occur on or about July 25, 2018 subject to satisfaction or waiver of all conditions to closing. Upon the closing, the subscription agent will distribute, by way of direct registration in book­-entry form or through the facilities of DTC, as applicable, shares of its Series C Convertible Preferred Stock and warrants to holders of rights who have validly exercised their rights and paid the subscription price in full. No physical stock or warrant certificates will be issued to such holders.

Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series C Convertible Preferred Stock with a stated value of $1,000 (and immediately convertible into common stock at a conversion price of $0.7986 per share, which is equal to 85% of the lowest daily volume weighted average price for Cytori’s common stock, as reported at the close of trading by Nasdaq, during the five trading days prior to the expiration of the Rights Offering (including the expiration date)) and 1,050 warrants. Each warrant entitles the holder to purchase one share of common stock at an exercise price of $0.7986, from the date of issuance through its expiration 30 months from the date of issuance.

Cytori engaged Maxim Group LLC as dealer-manager in the Rights Offering. Questions about the Rights Offering or requests for copies of the final prospectus may be directed to Maxim Group LLC at 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

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

Aptose To Release Second Quarter Ended June 30, 2018 Financial Results and Hold Conference Call on August 7, 2018

On July 24, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that it will release its financial results for the quarter ended June 30, 2018 on Tuesday, August 7, 2018 at 5:00 pm Eastern time (Press release, Aptose Biosciences, JUL 24, 2018, View Source;p=RssLanding&cat=news&id=2359587 [SID1234527824]).

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Conference Call & Webcast:
Tuesday, August 7, 2018 @ 5:00 pm Eastern time
Toll-Free: (844) 882-7834
International: (574) 990-9707
Passcode: 2693419
Webcast: View Source

Replays available through August 14, 2018
Toll-Free: (855) 859-2056
Replay Passcode: 2693419
The live conference call can also be accessed through a link on the Investor Relations section of Aptose’s website at ir.aptose.com. Please log onto the webcast at least 10 minutes prior to the start of the call to ensure time for any software downloads that may be required. An archived version of the webcast along with a transcript will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended June 30, 2018 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml