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.

On October 23, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported a business update that will be discussed in more detail on the company’s investor and analyst call to be held today at 10am Eastern Time / 7am Pacific Time (Press release, Rigel, OCT 23, 2019, View Source [SID1234542441]).

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"This is an exciting time for Rigel with significant advancements in all segments of our business," said Raul Rodriguez, Rigel’s president and CEO. "We continue to grow sales of TAVALISSE in the U.S. and are making substantial strides in expanding our pipeline. Our clinical development efforts will be led by our newly appointed chief medical officer, Dr. Wolfgang Dummer. We are excited to leverage his experience and depth of knowledge as we continue to pursue our clinical development goals."

Business Update Highlights

TAVALISSE Revenues Increase

Preliminary estimates indicate that TAVALISSE (fostamatinib disodium hexahydrate) net product sales continued to achieve double digit quarter over quarter growth, increasing 15% to $11.7 million from $10.2 million in the second quarter of 2019. This information is preliminary, has not been audited and is subject to change upon completion of Rigel’s closing procedures.

IRAK1/4 Program Shows Proof-of-Mechanism in Humans

Rigel completed a Phase 1 clinical trial of R835, an interleukin-1 receptor-associated kinase 1/4 (IRAK 1/4) inhibitor. In addition to positive tolerability and pharmacokinetic data, R835 showed consistent inhibition of cytokine production in an LPS (lipopolysaccharide) challenge which was designed to gauge the molecule’s impact on inflammatory stimulation.

New RIP1 Inhibitor Program

For the first time today, Rigel announced its new receptor-interacting protein kinase (RIP1) inhibitor program. The lead molecule, R552, has initiated a Phase 1 clinical trial. RIP1 is believed to be a key driver of necroptosis which is implicated in a broad range of key inflammatory cellular processes including cell death and cytokine production.

Appointment of Wolfgang Dummer, MD, PhD as CMO

The Company is pleased to announce the appointment of Wolfgang Dummer, MD, PhD to the role of Chief Medical Officer. Dr. Dummer has more than 20 years of clinical and drug development experience at world class institutions, as well as an extensive academic history. Most recently, he served as Chief Medical Officer at Aridis Pharmaceuticals, Inc. where he was responsible for overseeing all aspects of drug development in the field of antimicrobial immunotherapy. Prior to that, he served as Vice President of Clinical Development at BioMarin Pharmaceutical Inc., where he led the development of a deep rare disease pipeline, including the company’s leading marketed product, Vimizim (elosulfase alpha). Prior to Biomarin, Dr. Dummer served for 11 years in capacities of increasing importance in Clinical Research and Development at Genentech, Inc. (now part of Roche), overseeing numerous programs, including Rituximab. Dr. Dummer is a board-certified clinical dermatologist and allergist/immunologist. Over the course of his career, he has published more than 50 peer reviewed journal articles and has more than 40 abstracts, presentations, and book contributions.

Business Update Conference Call

As previously announced, Rigel will host a conference call today to provide a business update. Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

About ITP

In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About R8351

R835 is an oral investigational candidate that is a potent and selective inhibitor of IRAK1 and IRAK4 shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions. Dysregulation of the TLR and IL-1R pathways may be associated with a variety of inflammatory conditions including psoriasis, rheumatoid arthritis, lupus and gout (among others).

About R5521

R552 is an investigational candidate that is a receptor-interacting protein kinase (RIP1) inhibitor. RIP1 is believed to play a critical role in necroptosis, a type of regulated cell death. In necroptosis, cells rupture leading to the dispersion of cell contents, which signals an immune response and enhances inflammation. It is implicated in a broad range of key inflammatory cellular processes including cell death and cytokine production. In preclinical studies, R552 showed prevention of joint and skin inflammation in a RIP1-mediated murine model of inflammation and tissue damage.

About TAVALISSE
Indication

TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.

Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.

Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (>Grade 3), interrupt, reduce dose or discontinue TAVALISSE.

Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.

TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.

It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.

Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.

Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).

Common adverse reactions (>5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

On October 23, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Wednesday, November 6, 2019 following release of its third quarter 2019 financial results (Press release, Puma Biotechnology, OCT 23, 2019, https://investor.pumabiotechnology.com/press-release/featured-release/puma-biotechnology-host-conference-call-discuss-third-quarter-financi [SID1234542440]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

On October 23, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that an abstract containing data from the Company’s Phase 2 clinical trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC) has been selected for oral presentation at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), which will be held October 26-30, 2019 at the Hynes Convention Center in Boston (Press release, Kura Oncology, OCT 23, 2019, View Source [SID1234542439]).

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Nearly 500 abstracts were considered for this year’s program and just 10 were selected as short-talks by the Scientific Committee Cochairs. As a result of the selection, the previously announced poster presentation related to the Phase 2 clinical trial of tipifarnib in HRAS mutant HNSCC has been rescheduled to take place following the oral presentation. Details of the oral and poster presentations, entitled "Preliminary results from a phase 2 trial of tipifarnib in squamous cell carcinomas (SCCs) with HRAS mutations" (abstract A087), are as follows:

Oral Presentation
Session Title: Spotlight on Proffered Papers 3: Targeting RAS Mutant Cancers
Session Date: Tuesday, October 29, 2019
Session Start Time: 11:50 a.m. ET
Session End Time: 12:30 p.m. ET
Location: Level 3 – Ballroom AB

Poster Presentation
Session Title: Poster Session C: Clinical Trials 2
Session Date: Tuesday, October 29, 2019
Session Start Time: 12:30 p.m. ET
Session End Time: 4:00 p.m. ET
Location: Level 2 – Hall D

The data are embargoed until the beginning of the Spotlight on Proffered Papers 3: Targeting RAS Mutant Cancers session at 11:50 a.m. ET on Tuesday, October 29, 2019. A copy of the oral and poster presentations will be available at www.kuraoncology.com following presentation at the meeting.

On October 23, 2019 Elicio Therapeutics, a next generation immuno-oncology company, reported that Christopher Haqq M.D., Ph.D. has joined Elicio as Executive Vice President, Head of Research and Development, and Chief Medical Officer (Press release, Elicio Therapeutics, OCT 23, 2019, View Source [SID1234542438]).

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"Chris is an accomplished physician-scientist who brings to Elicio over 20 years of translational drug development and leadership in large and small biotechnology companies across T cell immunotherapy, biologic, and small molecule modalities," commented Elicio CEO Robert Connelly. "We expect Chris’ knowledge of the impact of T-cell expansion, persistence and trafficking in immuno-oncology will dovetail with the unique lymph node targeting ability of Elicio’s Amphiphile platform."

Before joining Elicio, Dr. Haqq was the first employee and Chief Medical Officer of Atara Biotherapeutics, and later its Chief Scientific Officer, where he was the architect for an innovative pipeline including EBV specific T-cell product candidates for oncology and autoimmune disease, and a next generation off the shelf CAR-T cells for solid tumors. Earlier at Cougar Biotechnology and Janssen, Dr. Haqq was the lead clinician for a pivotal prostate cancer study leading to market approval for Zytiga (abiraterone acetate) and he led early development studies at Amgen.

Dr. Haqq has served as medical monitor for numerous oncology clinical trials working closely with global regulatory agencies. His teams have made successful filings for investigational new drug applications, breakthrough therapy, priority medicines, special protocol assessments and marketing approval and he has authored multiple patents and publications. Dr. Haqq initially practiced as a medical oncologist and led a translational science laboratory as an Assistant Professor in the Division of Hematology/Oncology at the University of California, San Francisco following post-graduate training as an Intern and Resident in Internal Medicine, Fellow in Medical Oncology and Fellow in Molecular Medicine. Dr. Haqq completed his M.D. and Ph.D. in Genetics at Harvard Medical School and his undergraduate training at Stanford University and the University of British Columbia.

"I am excited to lead Elicio’s strong R&D team during the transition from the lab bench to the bedside for its promising lymph node targeted immunotherapies where preclinical monotherapy and CAR-T combination show unique potential," said Dr. Haqq. "And as my family has experienced the unmet need for an effective mKRAS therapy, I am looking forward to evaluate ELI-002’s safety and efficacy in mKRAS bearing pancreatic, colorectal and lung cancers."

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.