Varian Reports Results for Fourth Quarter and Full Fiscal Year 2019; Appoints New President of Interventional Oncology Solutions and New Chief Financial Officer

On October 23, 2019 Varian Reported the Results for Fourth Quarter and Full Fiscal Year 2019 (Press release, Varian Medical Systems, OCT 23, 2019, View Source [SID1234542442]).

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Fourth Quarter 2019 Summary

Oncology Systems gross orders grew 7% in dollars and 7% in constant currency; North America gross orders grew 10%; 17 Ethos orders received in Europe and Australia
Total company revenues grew 10% in dollars, or 11% in constant currency, to $879 million
GAAP operating earnings declined 3% representing 14.7% of revenues; Non-GAAP operating earnings grew 13% representing 18.1% of revenues
GAAP net earnings per diluted share of $0.97; Non-GAAP net earnings per diluted share of $1.21
Tariff exclusions had a $21 million benefit to revenues, a $4 million benefit to cost of revenues and a $2 million expense triggered by receiving the exclusion, with a net benefit to Non-GAAP operating earnings of $23 million
Fiscal Year 2019 Summary

Oncology Systems gross orders grew 9% in dollars, or 11% in constant currency
Total company revenues grew 10% in dollars, or 12% in constant currency, to $3.2 billion
Organic revenues, which excludes the year over year impact of FX and growth from the acquisitions of CTSI, Endocare, Alicon and the Boston Scientific bead portfolio, grew 11%
GAAP operating earnings declined 7% representing 12.6% of revenues; Non-GAAP operating earnings grew 6% representing 16.8% of revenues
GAAP net earnings per diluted share of $3.38; Non-GAAP net earnings per diluted share of $4.63
New President of Interventional Oncology and New Chief Financial Officer

Effective December 1, 2019, Gary E. Bischoping, Jr., currently senior vice president, Finance & chief finance officer, will take on a new role as president, Interventional Oncology Solutions; J. Michael Bruff, currently senior vice president, Finance and Investor Relations, will succeed Bischoping as senior vice president, Finance & chief finance officer
Varian (NYSE: VAR) reported its fourth quarter and full fiscal year 2019 results and new appointments to key leadership roles.

"This is the second consecutive fiscal year we have reported double-digit revenue growth and 9 percent Oncology orders growth; our core business is strong and being powered by our continuous innovation cycle, and our acquisitions are delivering on growth expectations," said Dow Wilson, Chief Executive Officer of Varian. "While we have more work to do in sharpening our execution, our order and revenue growth has us looking forward to the next fiscal year. We have strong momentum exiting our fourth quarter and our long-term growth and value creation strategy is delivering for patients, clinicians and our shareholders."

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 and inventory step-up, acquisition-related expenses and in-process research and development, impairment charges, significant litigation charges or benefits and legal costs, gains and losses on equity investments, and significant non-recurring tax expense or benefit.

The company ended the quarter with $531 million in cash and cash equivalents and $412 million in debt. Net cash provided by operating activities was $118 million, up 9%. Cash Flows from operations were $372 million for the fiscal year, down 18% due to higher working capital to support product transition and growth. During the quarter, the company invested $32 million to repurchase 279,000 shares of common stock.

Oncology Systems Segment

Continued leadership in innovation and market execution drove strong worldwide growth in 2019. Oncology revenues totaled $820 million for the fourth quarter, up 8%, and $3.1 billion for the full year, up 11%. Operating earnings for the segment increased 3% for the quarter and were flat for the full year.

Gross orders for the fourth quarter were $1.1 billion, up 7%, and $3.4 billion for the full year, up 9%. Gross orders in the Americas were up 11% for the fourth quarter. In EMEA, gross orders in the quarter rose 10%, driven in part by orders for 13 TrueBeam systems as a part of the Tata Trusts framework agreement. In APAC, gross orders decreased 9% with a challenging quarter in Japan that was partially offset by growth in China and South East Asia and Korea.

Proton Solutions Segment

Proton Solutions revenues totaled $42 million for the fourth quarter, down 9%, and $144 million for the full year, down 3%. We took one new order at Ohio State University in the fourth quarter for a total of four proton orders in the full year.

Other Segment

Revenues for our Other segment were $17 million in the fourth quarter. The Other segment is comprised of our interventional oncology business, including cryoablation, embolic microspheres, and microwave ablation, as well as our cardiac radioablation assets.

Tariff Exclusion

The company received two tariff exclusions in the fourth quarter. The exclusions had a $21 million benefit to revenues, a $4 million benefit to cost of revenues and triggered a $2 million expense due to receiving the exclusion in China. The net benefit to operating earnings was $23 million, or $0.19 on a Non-GAAP earnings per share basis. The net benefit was mostly offset by an increase in tax rate driven by updates to the estimated impact of the Global Intangible Low Tax Income (GILTI) and Base Erosion and Anti-Abuse Tax (BEAT) provisions of the Tax Cuts and Jobs Act, and expenses related to annual discretionary contributions to US-based foundations that independently fund research and training. Additionally, operational spend in our core businesses came in above expectations although this higher spend was partially offset by early momentum in our recent acquisitions.

Incrementally, the company did not record approximately $11 million of potential tariff refund in the fourth quarter due to timing of recognition. We expect to recognize this benefit in fiscal year 2020.

Guidance for Full Fiscal Year 2020

Our guidance continues to consider the projected market growth and momentum of our products and solutions in the market.

Our fiscal year 2020 guidance considers the recently announced tariff exclusions from both China and the United States Trade Representative. Expecting to continue our strong operational performance, the company plans to invest in our growth initiatives including: driving core business growth in China, fueling growth of our recent acquisitions by building out global sales and distribution capacity, and touching more patients by ramping research and development investments in technology-enabled services, FLASH technology, our Noona patient reported outcome offering, and cloud-based software. Continuing to invest in meaningful innovation, go-to-market capabilities, and scalable infrastructure is aligned with our commitment to drive long-term growth for shareholders.

Organic growth excludes the year over year impact of FX and growth from the acquisitions of CTSI, Endocare, Alicon and the Boston Scientific bead portfolio.

(2)

These values are presented on a non-GAAP basis. We have not provided a reconciliation of non-GAAP guidance measures to the corresponding GAAP measures on a forward-looking basis due to potential significant variability and limited visibility of the excluded items.

The guidance assumes a Non-GAAP effective tax rate of 22.5% to 23.5% and a weighted average diluted share count of 92 million. The guidance also assumes currency rates as of the beginning of fiscal year 2020, includes acquisitions announced to date, and includes the expected impact of all currently enacted tariffs.

Varian Appoints New President of Interventional Oncology; New Chief Financial Officer

Effective Dec. 1, 2019, Gary E. Bischoping, Jr., currently senior vice president, Finance & chief finance officer, will take on a new role as president, Interventional Oncology Solutions. J. Michael Bruff, currently senior vice president, Finance and Investor Relations, will succeed Bischoping as senior vice president, Finance & chief finance officer. Both executives will report directly to Dow Wilson, Varian CEO.

Earlier this year, we combined the recently acquired businesses of Endocare, Alicon and the microsphere and bland embolic bead assets from Boston Scientific to create our Interventional Oncology Solutions business under the Chief Growth Office, reporting to Kolleen Kennedy, president, Proton Solutions and chief growth officer. Based on the success of the integration and the robust early performance by our Interventional Oncology Solutions business, it is the right time to move this new business from the incubation stage under the Chief Growth Office, and it will now report directly to Bischoping in his new role as president of Interventional Oncology Solutions. Kennedy will continue in her role as president, Proton Solutions and chief growth officer, in which capacity she will focus on incubating emerging technologies, including FLASH therapy and cardiac radioablation, as well as leading our acquisition integration office.

"These moves will optimally position Varian for continued growth and are the result of our strong succession planning process," said Wilson. "During his tenure as CFO, Gary reset resource and capital allocation to invest in organic and inorganic opportunities focused on driving long-term growth and value creation. In addition, he led a successful initiative to build and strengthen the broader CFO organization’s capabilities. Gary will leverage his keen business expertise to further build Varian’s Interventional Oncology Solutions’ go-to-market organization, product portfolio and business management system to take advantage of the exciting opportunities we see in the interventional oncology space."

Mike Bruff joined Varian two years ago with extensive finance, accounting and operational experience. Since then, he has built a robust investor relations strategy and enhanced the company’s financial planning and business partnership functions. Prior to joining Varian, Bruff held a series of senior international and domestic roles, including business segment CFO, and roles in financial planning, accounting and internal audit at Dell Technologies. He also held leadership positions in corporate reporting at MCI Telecommunications and served as vice president, Services Accounting and Finance at CA, Inc. Bruff began his career in accounting and auditing at Deloitte and Touche in Washington, D.C.

"Mike understands the Varian processes and strategy, and he has the right background and experience to help navigate Varian through the next growth stages," said Wilson. "As Varian continues to evolve and grow, our deep bench of leadership capabilities across the organization will help propel our business to success in the near- and long-term."

Unless otherwise stated in this release, all growth rates are year-over-year, any references to orders are gross orders, and all periods referred to are fiscal periods. 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 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 13694509. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, October 25, 2019.

Envisagenics wins another SBIR grant from the National Cancer Institute to enhance their AI/ML platform for Immunotherapy development

On October 23, 2019 Envisagenics, Inc., a New York-based biotechnology company leveraging artificial intelligence (AI) and RNA-splicing analytics for discovery and development of disease specific therapeutics, reported that it was awarded a Small Business Innovation Research (SBIR) Phase I grant from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) (Press release, Envisagenics, OCT 23, 2019, View Source [SID1234542459]). This grant will provide $300,000 over 1 year to expand Envisagenics’ proprietary drug discovery platform, SpliceCore, for the discovery of novel targets for immuno-oncology (IO) therapeutic development.

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This is Envisagenics’ third SBIR grant and the first from the NCI. Envisagenics was previously awarded Phase I and Phase II grants from the National Institute of General Medical Sciences (NIGMS, NIH) to develop the SpliceCore software platform. SpliceCore generates actionable insights using AI to drive development of splicing-based therapeutics. Using the SpliceCore platform, Envisagenics developed its first therapeutic asset pipeline for triple negative breast cancer (TNBC). Its lead compound targets a novel isoform that is present in 65% of TNBC patients and is currently undergoing pre-clinical studies at Envisagenics’ laboratory located at Johnson & Johnson Innovation, JLABS at New York City (JLABS @ NYC).

"What makes SpliceCore truly unique is its exon-centric view of the transcriptome. While mainstream transcriptomics is all about genes, we focus on exons because they are the minimal and most powerful informative unit for RNA-therapeutics development. This grant proposal aims to extend the value of SpliceCore for the identification of tumor-associated ectodomains (TAEs), which are small protein domains encoded by three exons or less," said Martin Akerman, co-founder and CTO of Envisagenics. TAEs are peptides present on cell membranes that can elicit an immune response. They may serve as novel targets for IO therapeutics or diagnostic biomarkers. IO therapies represent a major advancement in the treatment of cancers. However, existing IO treatments remain ineffective for a significant number of patients. Current methods to detect TAEs utilize antibody- and/or proteomic-based techniques, which are costly and time-consuming approaches that rely on previous domain knowledge and are limited in their ability to identify novel TAEs. Envisagenics’ RNA-based approach utilizes high-throughput sequencing data from patient samples and takes advantage of the high sensitivity of RNA-seq data to uncover novel TAE isoforms. Isoform viability and immunogenicity is then predicted using a set of machine learning algorithms.

Envisagenics will be collaborating in this research with Dr. Omar Abdel-Wahab, an expert in the field of splicing and hematologic malignancies. Dr. Abdel-Wahab is currently an Associate Member in Human Oncology and Pathogenesis Program (HOPP) and an Associate Attending Physician on the Leukemia Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSKCC). "I am excited to collaborate on this grant," said Dr. Abdel-Wahab. "This software represents an opportunity for cancer and immunology research, allowing for the discovery and profiling of transmembrane proteins using RNA-seq data instead of lower throughput proteomics methods."

"This is a very exciting moment for Envisagenics. While we focus on developing our TNBC assets, this grant will allow us to further explore and develop innovative applications of our platform for therapeutic development, with the ultimate goal of helping patients in need," said Maria Luisa Pineda, co-founder and CEO.

Amyris to Announce Third Quarter Financial Results on Thursday, November 7, 2019

On October 23, 2019 Amyris, Inc. (Nasdaq:AMRS) reported that it will report financial results for the third quarter ended September 30, 2019 after market close on Thursday, November 7, 2019 (Press release, Amyris Biotechnologies, OCT 23, 2019, View Source [SID1234542460]).

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The company will hold its quarterly conference call to discuss these results, as well as provide an update on the company’s business and outlook, at 4:30 p.m. ET (1:30 p.m. PT) on Thursday, November 7, 2019.

Conference Call:
Thursday, November 7, 2019, 4:30 p.m. ET/1:30 p.m. PT

Dial-in Number:
(877) 870-4263 (U.S. & International)

Participants should ask to be joined to the Amyris, Inc. call.

Audio Webcast:
A live webcast of the call will be available online on the Amyris website. To listen via live webcast, please visit: View Source A replay of the webcast will be available on the Investor Relations section of the company’s website approximately two hours after the conclusion of the call.

AIM ImmunoTech to Present at the Dawson James Securities 5th Annual Small Cap Growth Conference

On October 23, 2019 AIM ImmunoTech Inc. (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, reported that it will be presenting at the Dawson James Securities 5th Annual Small Cap Growth Conference being held on October 28-29, 2019 at the Wyndham Grand Hotel in Jupiter, Florida (Press release, AIM ImmunoTech, OCT 23, 2019, View Source;id=184460&p=2170068&I=1206939-c7Z3G6f3m8 [SID1234542444]).

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Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, is scheduled to present on Tuesday, October 29th at 1:10 p.m. Eastern Time, in Track 2 – Preserve Ballroom B, with one-on-one meetings to be held throughout the conference.

About Dawson James Securities

Dawson James Securities, Inc., a member of FINRA/SIPC, is a full-service investment bank headquartered in Boca Raton, FL. View Source

Insmed to Host Third Quarter 2019 Financial Results Conference Call on Wednesday, October 30, 2019

On October 23, 2019 Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its third quarter 2019 financial results on Wednesday, October 30, 2019 (Press release, Insmed, OCT 23, 2019, View Source [SID1234542462]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Wednesday, October 30, 2019 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (888) 317-6003 (domestic) or (412) 317-6061 (international) and referencing conference ID number 6042526. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately one hour after its completion through November 6, 2019 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and referencing replay access code 10136134. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.