On August 1, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), corporate highlights and reported financial results for the quarter ended June 30, 2019 (Press release, Coherus Biosciences, AUG 1, 2019, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-second-0" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-second-0" rel="nofollow">View Source [SID1234538007]).

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Second Quarter 2019 Company Highlights

Net product revenue for the second quarter of 2019 was $83.4 million and net income was $23.6 million, or $0.32 per share on a fully diluted basis. Net income was $3.6 million or $0.05 per share on a fully diluted basis for the first half of 2019. Cash flow from operations for the quarter was also positive at $12.7 million.
Uptake of UDENYCA (pegfilgrastim-cbqv) is progressing strongly across all segments (340B hospitals, non-340B hospitals and community oncology clinics), with increased uptake in the 340B segment after receiving transitional pass-through status from Centers for Medicare & Medicaid Services on April 1, 2019.
After just two quarters on the market, UDENYCA is the U.S. market leading pegfilgrastim biosimilar with greater than approximately 13% of unit market share at the end of June 2019, and it is anticipated to reach over 20% of unit market share by the end of 2019.
Second Quarter 2019 Financial Results

Net product revenue for the second quarter of 2019 was $83.4 million. Cost of goods sold for the second quarter of 2019 was $0.6 million, resulting in a gross profit margin of 99 percent for the second quarter of 2019, up from 94 percent in the first quarter of 2019.
Research and development (R&D) expense for the second quarter of 2019 was $18.9 million, as compared to $26.5 million for the same period in 2018. R&D expense for the six months ended June 30, 2019 was $37.7 million, as compared to $52.0 million for the same period in 2018. The decrease in R&D expense in both periods was primarily due to the capitalization of UDENYCA manufacturing costs in the first quarter of 2019 and a decrease in CHS-0214 development costs.
Selling, general and administrative (SG&A) expense for the second quarter of 2019 was $36.5 million, as compared to $18.4 million for the same period in 2018. SG&A expense for the six months ended June 30, 2019 was $69.1 million, as compared to $35.0 million for the same period in 2018. The increase in SG&A expense in 2019 was primarily attributable to the costs related to commercializing UDENYCA in the United States, which included personnel and third-party services costs for commercial and marketing initiatives, as well as legal costs in support of litigations.
Cash, cash equivalents and investments in marketable securities for the second quarter totaled $111.9 million at June 30, 2019, as compared to $96.4 million at March 31, 2019 and $72.4 million at December 31, 2018. Cash flow from operations was $12.7 million for the second quarter of 2019.
Net income attributable to the Company for the second quarter of 2019 was a 23.6 million, or $0.32 per share on a fully diluted basis, compared to a net loss of ($43.6) million, or ($0.68) per share on a basic and fully diluted basis for the same period in 2018.
Guidance for the Next Six Months from June 30, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)
• Continue as market leading pegfilgrastim biosimilar of choice.
• Achieve 2019 exit unit market share of 20% or greater.
• Increase penetration into all Neulasta dosage forms.
CHS-1420, biosimilar candidate to Humira (adalimumab)
• Complete certain development objectives to support BLA filing in 2020.
CHS-0214, biosimilar candidate to Enbrel (etanercept)
• Prepare for BLA supporting activities, pending legal developments.
CHS-3351, biosimilar candidate to Lucentis (ranibizumab) and CHS-2020, biosimilar candidate to Eylea (aflibercept)
• Advance the development of the ophthalmology pipeline.
CHS-131, small molecule, PPAR-g modulator drug candidate in nonalcoholic steatohepatitis ("NASH")
• Initiate clinical phase program in NASH.
Conference Call Information

When: Thursday, August 1, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 9268814
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

About UDENYCA

UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Indication

UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

Warnings and Precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Adverse Reactions

Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On August 1, 2019 Novavax, Inc. (NASDAQ: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported it will report its second quarter 2019 financial and operating results following the close of U.S. financial markets on Wednesday, August 7, 2019 (Press release, Novavax, AUG 1, 2019, http://ir.novavax.com/news-releases/news-release-details/novavax-host-conference-call-discuss-second-quarter-financial-2 [SID1234538039]).

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Conference call details are as follows:

Date: August 7, 2019
Time: 4:30 p.m. U.S. Eastern Time (ET)
Dial-in number: (877) 212-6076 (Domestic) or (707) 287-9331 (International)
Passcode: 3193866
Webcast: www.novavax.com, "Investors"/ "Events"
Conference call and webcast replay:

Dates: Starting at 7:30 p.m. ET, August 7, 2019 until
7:30 p.m. ET May 9, 2019
Dial-in number: (855) 859-2056 (Domestic) or (404) 537-3406 (International)
Passcode: 3193866
Webcast: www.novavax.com, "Investors"/ "Events", until November 7, 2019

On August 1, 2019 The National Comprehensive Cancer Network (NCCN) reported publication of a new set of recommendations focused on cancer in the small intestine (Press release, NCCN, AUG 1, 2019, View Source [SID1234538055]). The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Small Bowel Adenocarcinoma (SBA) are the first treatment guidelines in the United States (and second worldwide) to address this rare cancer type that is increasing in incidence. Small bowel cancers (of which adenocarcinomas are the most common) are responsible for about three percent of all digestive system cancers, with an estimated 10,590 new cases expected in 2019.1

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"Historically, small bowel adenocarcinoma has been managed in the same way as colorectal cancer, because SBA is rare and, therefore, difficult to study," said Katrina Pedersen, MD, MS, Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, an SBA expert and member of the NCCN Guidelines Panel for Colorectal Cancer. "The new NCCN Guidelines for Small Bowel Adenocarcinoma were created to reflect new research and biologic insights over the past several years that show optimal SBA management can differ from colorectal cancer treatments. For example, we’re incorporating a different class of drugs called taxanes into SBA treatment and deemphasizing the use of EGFR inhibitors that do not show a clear benefit. Our goal is to improve outcomes by standardizing the diagnosis, staging, and multimodal treatment possibilities for SBA patients."

"Our panels work very hard to make sure the NCCN Guidelines are up to date and inclusive for any therapeutic advances," said Al B. Benson, III, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chair, NCCN Guidelines Panel for Colon/Rectal/Anal Cancers. "We do extensive review and discussion of all existing evidence, and are constantly exploring ways to provide a more comprehensive approach for patients. In the case of intestinal cancers, which include colon, rectal, anal, and now small intestine, we’re expanding the guidelines to cover rare subsets. These efforts are also reflected in personalized treatment recommendations for patients with tumors that have certain genetic mutations or characteristics, such as microsatellite instability-high (MSI-H), BRAF mutation, or HER2 overexpression. Hereditary risk assessment and screening are also essential components in caring for patients with intestinal cancers, since many are potentially preventable."

Rates for many other gastrointestinal malignancies have been on the decline in recent years, in part as a result of increases in screening. At the same time, rates for small bowel cancers have increased 1.8 percent between 2006 and 2015.2 There is not currently a consensus on screening for SBA, since it’s located higher on the gastrointestinal tract, and therefore is not detected during a routine colonoscopy. However, it has been shown to be associated with Lynch syndrome (among other familial syndromes), Crohn’s disease, and colitis.

NCCN recently released updates to the NCCN Guidelines for Genetic/Familial Risk Assessment: Colorectal Cancer—reflecting the commitment to enhancing surveillance strategies that would increase early colorectal cancer detection rates, particularly as it relates to individuals with a personal or family history. The extensive update includes a clarified step-by-step process for the assessment of hereditary colorectal cancer syndromes, and a greater emphasis on the importance of genetic counseling.

"Many of these changes reflect the widespread adoption of multi-gene panel testing for hereditary cancer syndromes, which allows assessment for even rare causes of polyposis and other cancer syndromes," explained Heather Hampel, MS, LGC, The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, member of the NCCN Guidelines Panel for Genetic/Familial Risk Assessment: Colorectal Cancer. "We’ve added a section on the principles of cancer risk assessment and counseling, and also refined the initial approach to assessing hereditary CRC syndromes, included rare genetic causes for multiple adenomatous polyps, and updated the criteria for evaluation of Lynch syndrome."

The NCCN Guidelines for Colorectal Cancer Screening were also recently updated. The panel of experts behind those guidelines is closely following any emerging studies regarding new colorectal cancer diagnoses in younger people.

"The panel has reviewed the recent data for initiating screening of average-risk individuals before age 50," said Dawn Provenzale, MD, MS, Duke Cancer Institute, Chair, NCCN Guidelines Panel for Colorectal Cancer Screening. "Based on those data, the panel continues to endorse screening of average risk individuals at age 50. The panel will continue to review this strategy and monitor data as they emerge."

The NCCN Guidelines for SBA, Colorectal Cancer Screening, and Genetic/Familial High-Risk Assessment: Colorectal are all available free-of-charge for non-commercial use at NCCN.org, or via the Virtual Library of NCCN Guidelines App for smartphone and tablet.

On August 1, 2019 ImCheck Therapeutics, a biotech company on the cutting edge of the next wave of immunotherapies against cancer and autoimmune diseases, reported the award of €2 million from Bpifrance to contribute to the development of its most advanced novel cancer immunotherapy program. With this additional financing, ImCheck has obtained a total of €3.7 million in non-dilutive funding since its €20 million Series A in 2017 (Press release, ImCheck Therapeutics, AUG 1, 2019, View Source [SID1234537964]).

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The financing is part of the ‘Deeptech’ fund from Bpifrance and represents both grants and a reimbursement loan. The support will be dedicated to conducting initial clinical studies of ICT01, a novel therapeutic anti-BTN3A activating monoclonal antibody designed to promote an anti-tumor response by γ9δ2 T cells. To date, ICT01 has demonstrated activity in a range of in vitro and in vivo tumor models.

ImCheck Therapeutics plans on completing all preclinical confirmatory studies before the end of the year to enable the start of clinical development of ICT01 during the first quarter of 2020. The first study will be a Phase I dose escalation trial using the anti-BTN3A antibody as a single agent in solid and hematologic malignancies, followed by a combination study with anti-PD-1/L1 antibodies.

"With the Deeptech program, Bpifrance supports companies in the research and development phase of a breakthrough innovation closely linked to public/private research with high barriers to entry and highly differentiated, before its industrial and commercial launch. Bpifrance supports several companies in the highly-innovative and highly-competitive field of immuno-oncology. We view ImCheck’s projects as unique and very well-positioned and we are pleased to continue to support ICT01’s development and its entry in the clinic. This €2m grant follows a first €1m funding awarded by Bpifrance in July 2017 as part of our Award for Innovation Development program," said Françoise Marchand, Project Innovation Officer at Bpifrance.

"This new financial support from Bpifrance is a validation of the potential of our pipeline and recognition of the progress we have achieved in rapidly advancing our first antibody candidate toward clinical evaluation. We remain on target to begin the trial at the start of 2020. Benefiting from the "Deeptech" fund is also an important step for ImCheck as it underlines our innovative position in immuno-oncology," concluded Pierre d’Epenoux, CEO of ImCheck Therapeutics.

On August 1, 2019 (the "Effective Date"), AVEO Pharmaceuticals, Inc. ("AVEO") reported that it has entered into an amendment (the "Amendment") to the license agreement dated December 21, 2006 (the "KKC Agreement") with Kyowa Kirin Co., Ltd. (formerly Kirin Brewery Co., Ltd.) ("KKC") (Filing, 8-K, AVEO, AUG 1, 2019, View Source [SID1234537983]). Under the KKC Agreement, KKC granted AVEO an exclusive license to research, develop, manufacture and commercialize tivozanib in all human diseases and conditions in the territory licensed to AVEO, which covers all territories in the world except for Asia and the Middle East (the "AVEO Territory"). Pursuant to the Amendment, KKC repurchased the non-oncology rights to tivozanib in the AVEO Territory, excluding the rights AVEO sublicensed to EUSA Pharma (UK) Limited ("EUSA") under the license agreement between AVEO and EUSA dated December 18, 2015.

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In consideration for KKC’s repurchase of the non-oncology rights to tivozanib in the AVEO Territory, KKC has upfront, milestone and royalty payment obligations to AVEO under the Amendment. The Amendment provides that KKC (a) will make an upfront payment of $25.0 million within thirty (30) days after the Effective Date, (b) waives a one-time milestone payment of $18.0 million otherwise payable by AVEO upon AVEO obtaining marketing approval for tivozanib in the U.S., (c) will make milestone payments to AVEO of up to an aggregate of $390.7 million upon the successful achievement of certain development and sales milestones of tivozanib in non-oncology indications, and (d) will make tiered royalty payments to AVEO on net sales of tivozanib in non-oncology indications in the AVEO Territory, which range from high single digit to low double digits as a percentage of net sales. The royalty rate escalates within this range based on increasing tivozanib sales, subject to certain adjustments. KKC’s royalty payment obligations in a particular country in the AVEO Territory begin on the date of the first commercial sale of tivozanib in that country, and end on the later of the expiration date of the last valid claim of a patent application or patent owned by KKC covering tivozanib or 10 years after the date of first commercial sale of tivozanib in non-oncology indications in that country. If KKC sublicenses any of its non-oncology rights to tivozanib to a third party, KKC is required to pay AVEO a percentage of amounts KKC receives from its sublicensees related to the AVEO Territory, including upfront license fees, milestone payments and royalties, but excluding amounts KKC receives in respect of research and development reimbursement payments or equity investments, subject to certain limitations.

The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by the full text of the Amendment, a copy of which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.