On January 13, 2020 ViewRay, Inc. (NASDAQ: VRAY) reported preliminary results for the fourth quarter and full fiscal year ended December 31, 2019 (Press release, ViewRay, JAN 13, 2020, View Source [SID1234553128]). The preliminary results have not been audited and are subject to change .

Selected Fourth Quarter and Full Year 2019 Preliminary Results:

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Total revenue of approximately $17 million in the fourth quarter of 2019, primarily from three revenue units including one system upgrade, compared to total revenue of $21 million, primarily from four revenue units including one system upgrade, in the fourth quarter of 2018.
Received four new orders for MRIdian systems totaling approximately $21 million in the fourth quarter of 2019, compared to eight new orders totaling approximately $49 million in the fourth quarter of 2018.
Full year 2019 revenue of approximately $88 million, primarily from 15 revenue units, including two system upgrades, compared to 2018 revenue of approximately $81 million, primarily from 15 revenue units, including two system upgrades.
Total backlog was approximately $227 million as of December 31, 2019.
Cash and cash equivalents were approximately $227 million as of December 31, 2019. Cash burn in the fourth quarter of 2019, excluding the impact of the December 2019 financing, was approximately $3 million.
Chief Commercial Officer Jim Alecxih will be leaving the company effective January 17, 2020. At this time the company does not intend to backfill the Chief Commercial Officer role.
"In 2019 we built significant organizational expertise, made progress on our innovation and clinical pipelines, and fortified our balance sheet," said Scott Drake, President and CEO. "We are now better positioned than ever to improve the treatment paradigm for cancer patients. Today we also announced that Jim Alecxih, our Chief Commercial Officer, will be leaving the company to pursue other opportunities. We thank Jim for his service."

Financial guidance for 2020 will be provided on the company’s fourth quarter earnings conference call later this year.

On January 13, 2020 Alkermes Presented the corporate presentation (Presentation, Alkermes, JAN 13, 2020, View Source [SID1234553151]).

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On January 31, 2020 G1 Therapeutics Presented the corporate presentation (Presentation, G1 Therapeutics, JAN 13, 2020, View Source [SID1234553063]).

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On January 13, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported the Company has entered into a licensing agreement with Innovent Biologics, (Suzhou) Co., Ltd., ("Innovent"), a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin (bevacizumab) in the United States and Canada (Press release, Coherus Biosciences, JAN 13, 2020, View Source [SID1234553079]). Coherus plans to file a Biologics License Application ("BLA") with the U.S. Food and Drug Administration ("FDA") in late 2020 or early 2021 depending on FDA interaction timing, and to launch directly upon approval. The Company anticipates completing a single dose pharmacokinetic clinical study and certain analytical/bioanalytical exercises to support the U.S. filing. Innovent’s Avastin biosimilar successfully completed a large Phase 3 safety and efficacy study in China, and the application was filed for approval and was accepted by the National Medical Products Administration ("NMPA") in China in January 2019, and subsequently granted priority review status. Also, under the terms of the agreement, Coherus acquired an option to commercialize Innovent’s biosimilar to Rituxan (rituximab) in the United States and Canada. Innovent’s Rituxan biosimilar was filed for approval and accepted by the NMPA in China in June 2019, and subsequently granted priority review status.

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The agreement furthers the Company’s previously-stated strategic objective to expand its oncology franchise and leverage its commercial infrastructure in the United States. Coherus expects to apply its biosimilar regulatory expertise to convert the Chinese regulatory filing into a FDA biologics application.

"We are excited to enter into a strategic collaboration with one of the premier Chinese biologics companies," said Denny Lanfear, Chairman and Chief Executive of Coherus. "Innovent is an impressive fully-integrated organization delivering substantial benefits to the healthcare system and patients in China with their first approved and successfully commercialized PD-1. Its oncology therapeutics complement UDENYCA and advance our core mission to expand choice, improve patient access and lower healthcare costs in the United States."

"UDENYCA has been the most successful biosimilar launch in the United States and has made Coherus the obvious partner of choice," said Michael Yu, Ph.D., Founder, Chairman and CEO of Innovent. "Coherus and Innovent share a very similar mission, vision and set of values. We are pleased and proud to be working together."

Oncology is one of three focus areas for the Company along with ophthalmology and immunology. In the fourth quarter of 2019, Coherus announced it had acquired rights to commercialize BioEq’s Lucentis biosimilar in the United States, the lead asset in Coherus’ ophthalmology franchise.

According to the terms of the agreement with Innovent, Coherus will pay up to $45 million in milestones, including the upfront, for its Avastin biosimilar upon achieving certain regulatory and commercialization goals, as well as customary double-digit royalty payments. Financial terms for Innovent’s Rituxan biosimilar will be the same when optioned.

On January 13, 2020 EUSA Pharma (EUSA) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) reported that they have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT (siltuximab) and QARZIBA▼ (dinutuximab beta) in Greater China (Press release, EUSA Pharma, JAN 13, 2020, View Source [SID1234553096]).

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Under the terms of the agreement, EUSA has granted BeiGene exclusive rights to SYLVANT in Greater China and to QARZIBA▼in mainland China. Under the agreement, BeiGene will fund and undertake all clinical development and regulatory submissions in the territories, and will launch and commercialize both products once approved. EUSA will receive an upfront payment and be eligible to receive payments upon the achievement of regulatory and commercial milestones up to a total of $160 million. EUSA will also be eligible to receive tiered royalties on future product sales.

"Our teams are excited to work with EUSA to commercialize SYLVANT and QARZIBA, two important biologics which are already available to patients with rare diseases outside of China," said Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "This collaboration further demonstrates our commitment to bringing high quality therapies to people in China and around the world."

Lee Morley, Chief Executive Officer of EUSA Pharma, said, "This exclusive agreement with BeiGene represents an important milestone for EUSA as we deliver on our promise to bring our innovative cancer and rare disease therapies to patients around the world. BeiGene brings to our collaboration exceptional development and commercialization capabilities in China and a clear focus on delivering innovative, targeted oncology medicines. We look forward to working together over the coming months to ensure these important orphan products are made available to Chinese patients."

SYLVANT is currently approved in more than 40 countries worldwide for the treatment of idiopathic multicentric Castleman’s disease (iMCD), a rare, life-threatening and debilitating orphan condition of the lymph nodes and related tissues. QARZIBA▼ is the only EMA approved targeted immunotherapy for the treatment of high-risk neuroblastoma, an aggressive neoplasm and the most common childhood solid tumor that originates outside of the brain. Both products have been listed for fast-track approval in China by the National Medical Products Administration (NMPA) via its Review and Approval Procedures for Urgently-Needed Pharmaceutical Drugs Developed Overseas.

Jefferies International Limited acted as exclusive advisor to EUSA on the transaction.

About QARZIBA▼ (dinutuximab beta)

QARZIBA▼ is a monoclonal antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells. Dinutuximab beta was approved by the European Commission in 2017 and is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2).

About SYLVANT (siltuximab)

SYLVANT is a monoclonal antibody that blocks the action of interleukin-6 (IL-6), a multifunctional cytokine detected at elevated levels in iMCD patients. SYLVANT is approved in a number of jurisdictions and indicated for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. iMCD is a rare, life-threatening and debilitating lymphoproliferative disorder, which causes abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma.