On November 8, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported financial results for the quarter ended September 30, 2018 (Press release, Coherus Biosciences, NOV 8, 2018, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third" rel="nofollow">View Source [SID1234531695]).

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Third Quarter 2018 and Recent Corporate Highlights Include:

On September 25, 2018, the European Commission (EC) approved UDENYCA by granting marketing authorization in all European Union member states.
On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved UDENYCA (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy. UDENYCA is Coherus’ first drug to receive FDA or EC approval.
In preparation for a comprehensive launch of UDENYCA, Coherus completed the hiring of about 70 sales representatives covering seven territories as well as the hiring of other personnel for our commercial groups and teams.
Third Quarter 2018 Financial Results:
Research and development (R&D) expenses for the third quarter of 2018 were $31.6 million compared to $42.6 million for the same period in 2017. R&D expenses for the nine months ended September 30, 2018 were $83.6 million, as compared to $130.9 million for the same period in 2017. The decreases in R&D expenses were mainly due to the completion of our clinical trials and related manufacturing for the immunology biosimilar drug candidates, CHS-1420 (adalimumab (Humira) biosimilar) and CHS-0214 (etanercept (Enbrel) biosimilar). These cost decreases were partially offset by the costs associated with the manufacturing of UDENYCA.
General and administrative (G&A) expenses for the third quarter of 2018 were $25.4 million, compared to $14.0 million for the same period in 2017. G&A expenses for the nine months ended September 30, 2018 were $60.3 million, as compared to $56.3 million for the same period in 2017. The increases in G&A expenses in 2018 were mainly attributable to the costs associated with hiring a sales force and completing the commercial infrastructure to launch and sell UDENYCA in the U.S.
Net loss attributable to Coherus for the third quarter of 2018 was ($58.8) million, or ($0.87) per share, compared to a net loss of ($59.0) million, or ($1.09) per share, for the same period in 2017.
Cash and cash equivalents and investments in marketable securities – totaled $117.2 million as of September 30, 2018, compared to $159.8 million as of June 30, 2018. Cash use in operations of $42.8 million during the third quarter of 2018 was lower than guidance of $48 to $53 million.

Guidance for next twelve months from September 30, 2018:
UDENYCA (pegfilgrastim-cbqv), Neulasta biosimilar

Anticipate U.S. commercial launch in January 2019.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of the anticipated filing of a 351(k) biologic license application (BLA) in the U.S. at the end of 2019.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Complete manufacturing technology transfer and continue clinical development of CHS-3351.
Continue preclinical development of CHS-2020.
CHS-131 (small molecule drug candidate in nonalcoholic steatohepatitis "NASH")

Anticipate initiation of Phase 2 clinical trial in NASH.
Conference Call Information

When: Thursday, November 8, 2018 at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

Conference ID: 7181479

Webcast: View Source

Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.