On May 10, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS),reported financial results for the quarter ended March 31, 2018 (Press release, Coherus Biosciences, MAY 10, 2018, View Source/phoenix.zhtml?c=253655&" target="_blank" title="View Source/phoenix.zhtml?c=253655&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2348541 [SID1234526475]).
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First Quarter 2018 Corporate Highlights Include:
Oncology therapeutic franchise:
CHS-1701 (pegfilgrastim (Neulasta) biosimilar candidate)
Announced on March 26, 2018, that Judge Stark of the United States District Court for the District of Delaware adopted Magistrate Judge Burke’s Report and Recommendation to grant the motion of Coherus BioSciences, Inc. to dismiss with prejudice the patent infringement complaint alleging infringement of U.S. Patent No. 8,273,707 filed by Amgen Inc.
First Quarter 2018 Financial Results:
Research and development (R&D) expenses for the first quarter of 2018 were $25.5 million compared to $53.8 million for the same period in 2017. The decrease in R&D expenses in the first quarter over the same period in 2017 was mainly due to the completion of our clinical trials for the immunology biosimilar drug candidates, CHS-1420 (adalimumab (Humira) biosimilar) and CHS-0214 (etanercept (Enbrel) biosimilar), and the reprioritization of resources to advance CHS-1701. General and administrative (G&A) expenses for the first quarter of 2018 were $16.6 million, compared to $18.8 million for the same period in 2017. The decrease in G&A expenses in 2018 was mainly attributable to a decrease in personnel and in certain legal and consulting services as a result of cost control steps taken since June 2017. Net loss attributable to Coherus for the first quarter of 2018 was ($44.3) million, or ($0.74) per share, compared to a net loss of ($74.8) million, or ($1.54) per share, for the same period in 2017. Cash and cash equivalents and investments in marketable securities – totaled $95.2 million as of March 31, 2018, compared to $126.9 million as of December 31, 2017.
Guidance for 2018:
CHS-1701 (pegfilgrastim (Neulasta) biosimilar)
Anticipate acceptance of the biologics license application (BLA) on or before June 3, 2018 and a U.S. Food and Drug Administration (FDA) action date of November 3, 2018. Anticipate European approval opinion on or before June 28, 2018. Commercial partnering discussions are projected to continue for certain ex-U.S. territories. Anticipate U.S. commercial launch directly following the potential FDA action date, dependent on regulatory review and approval timing.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)
Initiate clinical development of CHS-3351. Continue preclinical development of CHS-2020.
CHS-1420 (adalimumab (Humira) biosimilar)
Pursue manufacturing objectives in support of a BLA. Continue to develop partnering options pursuant to a 2022 launch.
Cash flow
Anticipate cash use in operations of approximately $32 to $37 million for the second quarter of 2018.
Conference Call Information
When: Thursday, May 10, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 2767588
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.