On August 8, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2018 (Press release, Coherus Biosciences, AUG 8, 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=2362846 [SID1234528753]).

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Second Quarter 2018 Corporate Highlights Include:

UDENYCA (pegfilgrastim-cbqv), biosimilar candidate to Neulasta
On May 3, 2018, Coherus announced the re-submission of its biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) under the 351(k) pathway.
On May 14, 2018, Coherus announced the FDA accepted and acknowledged for review the resubmission of this BLA.
On May 28, 2018, Coherus submitted its day-181 responses to the European Medicines Agency’s day-180 questions regarding its marketing authorization application in Europe.
On July 26, 2018, Coherus received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

On May 10, 2018, Coherus announced the appointment of Samuel Nussbaum, M.D. to its Board of Directors. From 2000 until 2016, Dr. Nussbaum served as Executive Vice President, Clinical Health Policy, and Chief Medical Officer for Anthem. In that role, he was the key spokesperson and policy advocate and oversaw clinical strategy and corporate medical and pharmacy policy. He currently serves as a Strategic Consultant to EBG Advisors, consulting arm for Epstein Becker and Green, where he advises life science companies, health care systems and provider organizations. In May 2018, Coherus completed an underwritten public offering of 5,948,274 shares of its common stock at a price to the public of $14.50 per share, which includes the closing of the full exercise of the underwriters’ option to purchase an additional 775,861 shares of common stock. Coherus received net proceeds of $80.8 million from the offering.
Second Quarter 2018 Financial Results:

Research and development (R&D) expenses for the second quarter of 2018 were $26.5 million compared to $34.5 million for the same period in 2017. R&D expenses for the six months ended June 30, 2018 were $52.0 million, as compared to $88.3 million for the same period in 2017. The decreases in R&D expenses were 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 UDENYCA. General and administrative (G&A) expenses for the second quarter of 2018 were $18.4 million, compared to $23.5 million for the same period in 2017. G&A expenses for the six months ended June 30, 2018 were $35.0 million, as compared to $42.3 million for the same period in 2017. The decreases in G&A expenses in 2018 were 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 second quarter of 2018 was ($43.6) million, or ($0.68) per share, compared to a net loss of ($55.3) million, or ($1.08) per share, for the same period in 2017. Cash and cash equivalents and investments in marketable securities – totaled $159.8 million as of June 30, 2018, compared to $95.2 million as of March 31, 2018.
Guidance for 2018:
UDENYCA (pegfilgrastim-cbqv), biosimilar candidate to Neulasta

FDA action date is set for November 3, 2018. Anticipate regulatory approval for UDENYCA from the European Commission on or before October 1, 2018. Commercial partnering discussions are projected to continue for certain ex-U.S. territories. Anticipate U.S. commercial launch directly following the FDA action date, dependent on regulatory review and approval timing.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of a BLA. Continue to develop partnering options for ex-U.S. territories.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Initiate clinical development of CHS-3351. Continue preclinical development of CHS-2020.
Cash flow

Anticipate cash use in operations of approximately $48 to $53 million for the third quarter of 2018.
Conference Call Information
When: Wednesday, August 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 4562488
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.