On February 28, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported financial results for the quarter and full year ended December 31, 2018 (Press release, Coherus Biosciences, FEB 28, 2019, View Source [SID1234533827]).

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Fourth Quarter 2018 and Recent Corporate Highlights Include:

On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved UDENYCA (pegfilgrastim-cbqv) for patients with non-myeloid cancer receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia. UDENYCA is Coherus’ first drug to receive FDA and European Commission approval.

In November 2018, Coherus received Q-Code medical billing status for UDENYCA from the Centers for Medicare and Medicaid Services, which became effective January 1, 2019.

On January 3, 2019, Coherus launched UDENYCA commercially in the U.S.

On January 7, 2019, Coherus entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners.

In January 2019, Coherus entered into settlement and license agreements with AbbVie Inc. that grant the company global, royalty-bearing, non-exclusive license rights under AbbVie’s intellectual property to commercialize CHS-1420 (adalimumab (Humira) biosimilar).

Fourth Quarter and Full Year 2018 Financial Results:

Research and development (R&D) expenses for the fourth quarter of 2018 were $26.7 million, as compared to $31.5 million for the same period in 2017. R&D expenses for the fiscal year 2018 were $110.2 million, as compared to $162.4 million for the same period in 2017. The decreases in R&D expenses were mainly due to the completion of the clinical trials and related manufacturing for the immunology biosimilar drug candidates, CHS-0214 (etanercept (Enbrel) biosimilar) and CHS-1420. These cost decreases were partially offset by increased costs associated with the manufacturing of UDENYCA. Coherus had approximately 330,000 cumulative units of UDENYCA released as of December 31, 2018.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2018 were $33.8 million, as compared to $15.0 million for the same period in 2017. SG&A expenses for the fiscal year 2018 were $94.2 million, as compared to $71.3 million for the same period in 2017. The increases in SG&A expenses in 2018 were mainly attributable to the costs associated with hiring a sales force and completing the commercial functions and infrastructure to launch and sell UDENYCA in the U.S.

Cash and cash equivalents and investments in marketable securities for the fourth quarter totaled $72.4 million as of December 31, 2018, before receiving $73.1 million in net proceeds from the senior secured credit facility in January 2019, or a pro forma total of $145.5 million, as compared to $117.2 million as of September 30, 2018. Cash used in operations was $47.4 million during the fourth quarter of 2018, as compared to $42.8 million during the third quarter of 2018.

Net loss attributable to Coherus for the fourth quarter of 2018 was ($62.6) million, or ($0.92) per share, compared to a net loss of ($49.1) million, or ($0.84) per share, for the same period in 2017. Net loss attributable to Coherus for 2018 was ($209.3) million, or ($3.22) per share, compared to a net loss of ($238.2) million, or ($4.48) per share, for 2017.

Guidance for the Next Twelve Months from December 31, 2018:

UDENYCA (pegfilgrastim-cbqv), Neulasta (pegfilgrastim) biosimilar

Secure receipt of transitional pass-through status in 340-B hospitals in April 2019.

Increase penetration of patient and provider support programs and access portals.

Secure parity payment status with all national and local payers.

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.

CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Complete manufacturing technology transfer to support clinical development of CHS-3351.

Continue preclinical development of CHS-2020.

Conference Call Information

When: Thursday, February 28, 2019 starting at 4:30 p.m. ET

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

Conference ID: 3398069

Webcast: View Source

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

Fourth quarter and full year 2018 financial results, are posted on the Coherus website at View Source.