On August 1, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), corporate highlights and reported financial results for the quarter ended June 30, 2019 (Press release, Coherus Biosciences, AUG 1, 2019, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-second-0" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-second-0" rel="nofollow">View Source [SID1234538007]).

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Second Quarter 2019 Company Highlights

Net product revenue for the second quarter of 2019 was $83.4 million and net income was $23.6 million, or $0.32 per share on a fully diluted basis. Net income was $3.6 million or $0.05 per share on a fully diluted basis for the first half of 2019. Cash flow from operations for the quarter was also positive at $12.7 million.
Uptake of UDENYCA (pegfilgrastim-cbqv) is progressing strongly across all segments (340B hospitals, non-340B hospitals and community oncology clinics), with increased uptake in the 340B segment after receiving transitional pass-through status from Centers for Medicare & Medicaid Services on April 1, 2019.
After just two quarters on the market, UDENYCA is the U.S. market leading pegfilgrastim biosimilar with greater than approximately 13% of unit market share at the end of June 2019, and it is anticipated to reach over 20% of unit market share by the end of 2019.
Second Quarter 2019 Financial Results

Net product revenue for the second quarter of 2019 was $83.4 million. Cost of goods sold for the second quarter of 2019 was $0.6 million, resulting in a gross profit margin of 99 percent for the second quarter of 2019, up from 94 percent in the first quarter of 2019.
Research and development (R&D) expense for the second quarter of 2019 was $18.9 million, as compared to $26.5 million for the same period in 2018. R&D expense for the six months ended June 30, 2019 was $37.7 million, as compared to $52.0 million for the same period in 2018. The decrease in R&D expense in both periods was primarily due to the capitalization of UDENYCA manufacturing costs in the first quarter of 2019 and a decrease in CHS-0214 development costs.
Selling, general and administrative (SG&A) expense for the second quarter of 2019 was $36.5 million, as compared to $18.4 million for the same period in 2018. SG&A expense for the six months ended June 30, 2019 was $69.1 million, as compared to $35.0 million for the same period in 2018. The increase in SG&A expense in 2019 was primarily attributable to the costs related to commercializing UDENYCA in the United States, which included personnel and third-party services costs for commercial and marketing initiatives, as well as legal costs in support of litigations.
Cash, cash equivalents and investments in marketable securities for the second quarter totaled $111.9 million at June 30, 2019, as compared to $96.4 million at March 31, 2019 and $72.4 million at December 31, 2018. Cash flow from operations was $12.7 million for the second quarter of 2019.
Net income attributable to the Company for the second quarter of 2019 was a 23.6 million, or $0.32 per share on a fully diluted basis, compared to a net loss of ($43.6) million, or ($0.68) per share on a basic and fully diluted basis for the same period in 2018.
Guidance for the Next Six Months from June 30, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)
• Continue as market leading pegfilgrastim biosimilar of choice.
• Achieve 2019 exit unit market share of 20% or greater.
• Increase penetration into all Neulasta dosage forms.
CHS-1420, biosimilar candidate to Humira (adalimumab)
• Complete certain development objectives to support BLA filing in 2020.
CHS-0214, biosimilar candidate to Enbrel (etanercept)
• Prepare for BLA supporting activities, pending legal developments.
CHS-3351, biosimilar candidate to Lucentis (ranibizumab) and CHS-2020, biosimilar candidate to Eylea (aflibercept)
• Advance the development of the ophthalmology pipeline.
CHS-131, small molecule, PPAR-g modulator drug candidate in nonalcoholic steatohepatitis ("NASH")
• Initiate clinical phase program in NASH.
Conference Call Information

When: Thursday, August 1, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 9268814
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

About UDENYCA

UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Indication

UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

Warnings and Precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Adverse Reactions

Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.