FibroGen Announces First Patient Dosed in LAPIS, a Phase 3 Clinical Trial of Pamrevlumab for the Treatment of Patients With Locally Advanced Pancreatic Cancer

On October 23, 2019 FibroGen, Inc. (NASDAQ: FGEN), reported the dosing of the first patient in the LAPIS Phase 3 clinical study of pamrevlumab in patients with unresectable locally advanced pancreatic cancer (LAPC) (Press release, FibroGen, OCT 23, 2019, View Source [SID1234542448]).

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"Patients with unresectable locally advanced pancreatic cancer face a dire prognosis. The use of pamrevlumab, a novel anti-fibrotic used as neoadjuvant therapy, may change tumor status from unresectable to resectable thus potentially improving the prognosis of the patient", said Pascal Hammel, MD, PhD a gastroenterologist, oncologist, Hôpital Beaujon, Clichy France. "If this pivotal phase 3 trial is successful, I believe this type of treatment will be highly valued by the physician community treating LAPC."

"With this announcement of dosing of the first patient in our LAPIS study, we are excited to further advance late-stage development of pamrevlumab as a treatment for locally-advanced pancreatic cancer," said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, and Drug Safety and Pharmacovigilance, with FibroGen. "We are grateful for the opportunity to build on supportive data from our previous Phase 2 studies, as we continue to explore the potential of pamrevlumab as an important treatment option for patients with LAPC."

In LAPC patients who undergo resection, median survival and five-year survival rates are higher than for unresectable LAPC patients who did not undergo resection. Therefore, achieving surgical resection in this patient population is a meaningful treatment goal.

LAPIS is a multinational randomized, double-blind, placebo-controlled Phase 3 study that will evaluate neoadjuvant pamrevlumab therapy in combination with gemcitabine and nab-paclitaxel. The design of this study is similar to FibroGen’s prior Phase 2 trials. In these studies, a higher percentage of patients treated with the pamrevlumab combination achieved surgical resection and had a statistically significant median survival rate. LAPIS is expected to enroll approximately 260 patients. The primary endpoint of the study is overall survival. The resection rate is a surrogate endpoint, and, should the resection rates favor the pamrevlumab combination, FibroGen plans to request a meeting with the FDA to discuss a marketing application under the provisions of accelerated approval.

For more information regarding this study please visit www.clinicaltrials.gov (NCT03941093).

About Locally Advanced Pancreatic Cancer
In locally advanced pancreatic cancer (LAPC), the patient’s tumor typically involves structures, particularly blood vessels that are closely associated with the pancreas such as the superior mesenteric artery and superior mesenteric vein. Involvement of the cancer around these blood vessels precludes surgical removal of the tumor. Patients with unresectable LAPC have a median survival of 6 to 10 months, only slightly better than patients with metastatic pancreatic cancer, and only 20 percent of newly diagnosed patients are classified as having resectable disease. Patients who have their tumor surgically removed have a much better prognosis with median survival of approximately 23 months with some patients being cured.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD). The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) to pamrevlumab for the treatment of patients with IPF, LAPC, and DMD. Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and LAPC. Across all clinical studies, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

Verastem Oncology Announces COPIKTRA™ (Duvelisib) Presentations at the Lymphoma & Myeloma 2019 International Congress

On October 23, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that five posters highlighting clinical data for COPIKTRA (duvelisib) will be presented at the Lymphoma & Myeloma 2019 International Congress taking place October 23-26, 2019, in New York City (Press release, Verastem, OCT 23, 2019, View Source [SID1234542447]). The presented abstracts focus on clinical data from the Phase 3 DUO study, including evaluation of COPIKTRA efficacy and safety in high-risk patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), dose modification data and results from a post-hoc analysis evaluating the effect of COPIKTRA on lymphocytosis in patients. Other presented data include the characterization of duvelisib in patients with refractory Marginal Zone Lymphoma from the Phase 2 DYNAMO study, and an update on the safety profile and management of adverse events in heavily pre-treated patients with advanced hematological malignancies.

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"Findings from the DUO study demonstrated that patients taking duvelisib who have received two or more prior therapies experienced improved clinical outcomes and a manageable safety profile," states Matthew S. Davids, MD, Associate Director, Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute. "These results with duvelisib are important for this patient population, which is in need of targeted therapies to control their disease."

"The data presented at this year’s Lymphoma & Myeloma Congress reflect the utility of duvelisib in patients with relapsed or refractory CLL/SLL after at least two prior therapies, including in patients with advanced disease or at high-risk of recurrence," commented Hagop Youssoufian, MSc, M.D., Head of Medical Strategy at Verastem Oncology. "Further, the research supports the approach to management of adverse events through dose interruptions or dose reductions without an impact on the patient’s response, which could allow patients who are benefitting to stay on therapy longer."

COPIKTRA, a targeted oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, received approval as monotherapy from the U.S. Food and Drug Administration (FDA) in September 2018 for the treatment of patients with relapsed or refractory CLL/SLL after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Continued approval in FL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Details for the poster presentations are as follows:

Title: An improved benefit-risk profile of duvelisib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who received ≥2 prior therapies
Lead author: Matt Davids, M.D., Dana-Farber Cancer Institute, Boston, MA
Presentation ID: P-012

Title: Effect of dose modifications on response to duvelisib in patients with relapsed or refractory CLL/SLL in the DUO trial
Lead author: Nicole Lamanna, Columbia University Medical Center
Presentation ID: P-030

Title: Patterns of duvelisib-induced lymphocytosis in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, including those with high-risk factors treated in the DUO trial
Lead author: Jacqueline Barrientos, Zucker School of Medicine at Hofstra/Northwell
Presentation ID: P-015

Title: Characterization of duvelisib in patients with refractory marginal zone lymphoma: data from the phase 2 DYNAMO trial
Lead author: Eric Jacobsen, Dana-Farber Cancer Institute, Boston, MA
Presentation ID: P-029

Title: Safety Profile and Management of Adverse Events Associated with Duvelisib in Patients with Advanced Hematologic Malignancies
Lead author: Karen Francoeur, Verastem Oncology
Presentation ID: P-031

PDF copies of these poster presentations will be available here after the meeting.

COPIKTRA includes a Boxed Warning for fatal and serious toxicities including infections, diarrhea or colitis, cutaneous reactions and pneumonitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

SELECT IMPORTANT SAFETY INFORMATION

This does not include all information needed to use COPIKTRA (duvelisib) safely and effectively. See full Prescribing Information.

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See full Prescribing Information for complete boxed warning
Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate and continued approval may be contingent upon confirmatory trials
WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at 1-877-7RXVSTM (1-877-779-8786).

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status and Orphan Drug Designation, and is being investigated in combination with other agents through investigator-sponsored studies.4 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

BioInvent Signs Manufacturing Agreement With Cancer Research UK Expected to Generate Approximately SEK 30 Million (~$3 Million)

On October 23, 2019 BioInvent International AB (publ) (OMXS: BINV) reported it has concluded a production agreement with Cancer Research UK, the world’s largest independent funder of cancer research, for the production of Hummingbird Bioscience’s anti-HER3 antibody drug HMBD-001 for use within a clinical partnership formed between Cancer Research UK and Hummingbird Bioscience to test the agent in a phase I trial (Press release, BioInvent, OCT 23, 2019, View Source [SID1234542445]).

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Under the agreement, which is expected to generate revenue of approximately SEK 30 million (~$3 million), mostly in 2020, BioInvent will provide HMBD-001 to Cancer Research UK. It includes process, analytical and formulation development, process scale up and manufacturing of toxicology and clinical grade material in 200- and 1,000-liters scale.

"We are very pleased to have concluded an agreement to provide this service to Cancer Research UK and are looking forward to producing Hummingbird’s drug candidate for clinical trials. The fact that BioInvent has its own production facility gives us added flexibility, meaning we can develop our proprietary immuno-oncology programs more efficiently, and also generate revenue from our services to help fund our pipeline," says Martin Welschof, CEO of BioInvent.

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, says: "We are delighted to be partnering with BioInvent who will produce Hummingbird Bioscience’s anti-HER3 antibody, ready to be tested in clinical trials. Our clinical development partnerships fast track promising new treatments like this through one of the most difficult stages of drug development, benefitting people with cancer much sooner."

Cancer Research UK’s Centre for Drug Development entered into a partnership with Hummingbird Bioscience to manufacture clinical grade anti-HER3 antibody and conduct a Phase I clinical trial to evaluate drug safety, toxicity and efficacy. HMBD-001 is the only anti-HER3 antibody in development that binds to the most critical region involved in HER3 activation, turning off this signal completely. If successful, this new antibody could be used in the treatment of multiple cancers and be effective against drug resistant cancers.

BioInvent’s manufacturing capabilities
The BioInvent manufacturing facility is compliant with Current Good Manufacturing Practice (cGMP) regulations and is fully based on disposable technology and can produce batches in sizes from 40 L to 1,000 L. The platform process ensures rapid and efficient process development and spans everything from cell line development to final release of drug substance for clinical trials. BioInvent offers a range of cell line development options that include a royalty free GS knocked CHO K1 cell line.

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

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.