Median Technologies Announces Preliminary 2019 Unaudited Financial Results

On January 13, 2020 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company reported its preliminary full year 2019 unaudited financial results (Press release, MEDIAN Technologies, JAN 13, 2020, View Source [SID1234553111]). These results fully validate the strategy adopted in 2018 .

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In 2019, Median strengthened its Research and Development efforts on the iBiopsy imaging phenomics platform. iBiopsy is based on the most advanced technologies in AI and data sciences. Using non-invasive imaging biomarkers, the platform enables the identification of certain chronic disease signatures including cancer signatures, to dramatically enhance early detection, severity quantification and monitoring of diseases. A prototype of the platform was presented during the Radiological Society of North America (RSNA) annual meeting in early December (Chicago), to showcase the potential of the iBiopsy technology. The prototype demo created a lot of traction and interest. The company’s objective is now to finalize ongoing discussions with partners regarding collaborations to conduct iBiopsy clinical validations on large patient cohorts.

On December 19th, 2019, the company signed a €35 million finance contract with the European Investment Bank (EIB). The financing is going to further accelerate the iBiopsy investment and recruitment program for the coming years. The disbursement of the first tranche of €15 million is expected during the first semester of 2020.

2019 has been a record year for Median’s iCRO business unit, which provides imaging solutions and services for oncology trials. As of December 31st, 2019, the annual revenue was €9 million, a 41% increase compared to 2018 revenue (€6.3 million). The company experienced a steady increase in its quarterly revenues all along 2019.

Median’s iCRO activity was already operationally at its break-event point as of June 30th, 2019. Full year performance demonstrated its capacity for sustainable growth and profitability.

As of December 31st, 2019, the order backlog reached €38.3 million, representing a €7.6 million increase compared to the backlog as of June 30th, 2019 and a €14.6 million increase compared to the backlog as of December 31st, 2018 (+61.6%). At the end of 2019, Chinese business represented 56% of the total order backlog compared to 39.2% at the end of 2018. As far as Europe and the US are concerned, Median largely exceeded all expectations, thanks to a dedicated sales strategy based on recurrent business. Strategy success shows a great deal of trust in Median’s execution, competitiveness and quality. In 2019, Median’s service quality was successfully validated through 12 client audits and one Food and Drug Administration (FDA) audit on a major Phase III study, sponsored by one of the top 3 pharma companies.

Considering the company’s performance, as of December 31st, 2019, the company cash and cash equivalents was €7.6 million, compared to €7.9 million as of June 30th, 2019 and €12.7 million as of December 31st, 2018. The company cash burn rate was €0.4 million per month over the year, dropping from €0.8 million per month over the first semester down to €0.3 million per month during the second semester, excluding the Research Tax Credit positive impact.

"Our excellent iCRO performance validates the strategy adopted in 2018 and we are pleased to see that the activity is now sustainable and profitable. We anticipate keeping up this momentum in 2020. Additionally, the extent of our order backlog makes us confident about our revenues for 2020", said Fredrik Brag, Median’s co-founder and CEO. "With the finance contract signed with EIB, we are now going to accelerate our iBiopsy investment program. 2020 is going to bring us partnerships and clinical data which will enable iBiopsy validations on large cohorts of patients and for different therapeutic indications", he added.

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the year ended December 31, 2019 and are subject to revision based upon the Company’s year-end closing procedures and upon the completion and external audit of the Company’s year-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the fourth quarter or full year ended December 31, 2019, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

ViewRay Announces Preliminary Fourth Quarter and Full Year 2019 Results

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.

Alkermes plc corporate presentation.

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

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Investor Presentation dated January 14, 2020

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

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Coherus Acquires Commercial Rights for Avastin® Biosimilar in the United States

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.