On November 6, 2019 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS),reported financial results for the quarter ended September 30, 2019 (Press release, Coherus Biosciences, NOV 6, 2019, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third-0" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third-0" rel="nofollow">View Source [SID1234550452]).

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Third Quarter 2019 Company Highlights

UDENYCA (pegfilgrastim-cbqv) continues as the U.S. market-leading pegfilgrastim biosimilar, achieving approximately 19% of unit market share at the end of September 2019, delivering on the promise of biosimilars for patients, providers and payers.
Net product revenue for the third quarter of 2019 was $111.7 million, and net income was $47.0 million, or $0.63 per share on a fully diluted basis for the third quarter. Net income was $50.6 million or $0.69 per share on a fully diluted basis for the nine months ending September 30, 2019. Cash flow from operations was $55.0 million for the quarter. Cash, cash equivalents and investments in marketable securities was $170.5 million at September 30, 2019.
The company completed two business development transactions:
The Company acquired exclusive rights from Bioeq IP AG, ("Bioeq") a Swiss biopharmaceutical joint venture, to commercialize Bioeq’s Lucentis (ranibizumab) biosimilar candidate in the United States. Bioeq plans to file a Biologics License Application ("BLA") with the U.S. Food and Drug Administration ("FDA") in the fourth quarter of 2019 and Coherus plans to launch the product in the United States in 2021, applying its proficiencies and infrastructure developed for the oncology therapeutic commercial environment to the ophthalmology therapeutic commercial environment.
Coherus and Pfizer entered into a license and settlement agreement relating to Coherus’ patents and applications for patents directed to Humira (adalimumab) formulations.
The Company further advanced its internal ophthalmology product candidate, CHS-2020, a biosimilar candidate to Eylea (aflibercept).
Third Quarter 2019 Financial Results

Net product revenue for third quarter of 2019 was $111.7 million. Cost of goods sold for the third quarter of 2019 was $6.4 million, resulting in a gross profit margin of 94% for the third quarter of 2019.
Research and development (R&D) expense for the third quarter of 2019 was $21.6 million compared to $31.6 million for the same period in 2018. R&D expenses for the nine months ended September 30, 2019 were $59.2 million, as compared to $83.6 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 since the approval of UDENYCA on November 2, 2019 and a decrease in costs related to impairment loss, facilities, supplies and materials.
Selling, general and administrative (SG&A) expense for the third quarter of 2019 was $31.8 million, as compared to $25.4 million for the same period in 2018. SG&A expense for the nine months ended September 30, 2019 was $101.0 million, as compared to $60.3 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.
Cash, cash equivalents and investments in marketable securities for the third quarter totaled $170.5 million at September 30, 2019, as compared to $111.9 million at June 30, 2019 and $72.4 million at December 31, 2018.
Net income attributable to the Company for the third quarter of 2019 was $47.0 million, or $0.63 per share on a fully diluted basis, compared to a net loss of ($58.8) million, or ($0.87) per share on a basic and fully diluted basis for the same period in 2018.
Guidance for the Next Twelve Months from September 30, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)
Maintain market position as the leading pegfilgrastim biosimilar of choice, continuing the validated biosimilar-specific strategy of offering a robust value proposition across all key customer segments including ample product supply.
Achieve 2019 exit unit market share of 20% or greater and gain additional market share beyond 20% through 2020.
Continue to increase penetration against all Neulasta dosage forms.
CHS-1420, biosimilar candidate to Humira (adalimumab)
Complete certain development and regulatory objectives to support a BLA filing in 2020.
Ophthalmology pipeline
Facilitate the Bioeq filing of a BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in the United States in the fourth quarter of 2019.
Advance the development of CHS-2020, a biosimilar candidate to Eylea (aflibercept).
Conference Call Information

Date: Wednesday, November 6, 2019 starting at 4:30 p.m. ET
Connect: Dial 844.452.6826 (toll free) or 765.507.2587 (international)
Enter: Conference ID: 8589299
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.