On May 9, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2019 (Press release, Coherus Biosciences, MAY 9, 2019, View Source [SID1234536057]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
First Quarter 2019 Company Highlights
UDENYCA (pegfilgrastim-cbqv) Launch Performance Consistent with Plan
Net product revenue for the first quarter of 2019 was $37.1 million following Coherus’ successful launch of UDENYCA in the U.S. marketplace on January 3, 2019.
Uptake of UDENYCA in 340B hospitals, non-340B hospitals and community oncology clinics is in line with the Company’s expectations.
UDENYCA launch performance validates its broad value proposition approach and the commercial strategy Coherus implemented. This comprehensive branded biosimilar approach leverages Coherus’ robust commercial infrastructure and its comprehensive support services program, Coherus Complete www.coheruscomplete.com.
The Company secured transitional pass-through status in 340B hospitals from CMS effective April 1, 2019, granted for a period of 36 months, incentivizing access to UDENYCA for Medicare patients.
The Company secured a $75 million credit financing with Healthcare Royalty Partners to accelerate the manufacturing and launch of UDENYCA.
Legal Developments
Coherus and Amgen settled the trade secret action brought by Amgen and Coherus continues to commercialize UDENYCA across all segments.
The Company announced a global settlement with AbbVie securing rights to commercialize its adalimumab biosimilar candidate, CHS-1420, affording a U.S. market entry date of December 15, 2023.
The Company announced the filing of a patent infringement suit against Amgen directed to Amgen’s Humira biosimilar formulation.
First Quarter 2019 Financial Results
Net product revenue for the first quarter of 2019 was $37.1 million. Cost of goods sold for the first quarter of 2019 was $2.2 million, resulting in a gross profit margin of 94 percent for the first quarter of 2019.
Research and development (R&D) expenses for the first quarter of 2019 were $18.8 million, as compared to $25.5 million for the same period in 2018. The decreases in R&D expenses were mainly due to the capitalization of UDENYCA manufacturing in the first quarter of 2019.
Selling, general and administrative (SG&A) expenses for the first quarter of 2019 were $32.7 million, as compared to $16.6 million for the same period in 2018. The increase in SG&A expenses in 2019, which was mainly attributable to the costs associated with commercializing UDENYCA in the U.S.
Total operating expenses decreased by $6.8 million from $60.5 million in the fourth quarter of 2019 to $53.7 million in the first quarter of 2019 primarily as a result of a reduction in UDENYCA manufacturing pre-approval activities.
Cash and cash equivalents and investments in marketable securities for the first quarter totaled $96.4 million as of March 31, 2019, as compared to $95.2 million as of March 31, 2018, and $72.4 million as of December 31, 2018.
Net loss attributable to the Company for the first quarter of 2019 was ($20.0) million, or ($0.29) per share, compared to a net loss of ($44.3) million, or ($0.74) per share, for the same period in 2018.
Guidance for the Next Nine Months from March 31, 2019
UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)
Increase the breadth and depth of adoption across all market segments.
Secure reimbursement coverage among remaining national and regional payers.
CHS-1420, biosimilar candidate to Humira (adalimumab)
Pursue manufacturing objectives in support of the anticipated filing of a 351(k) biologic license application (BLA) in the U.S.
CHS-3351, biosimilar candidate to Lucentis (ranibizumab) and CHS-2020, biosimilar candidate to Eylea (aflibercept)
Complete manufacturing technology transfer to support clinical development of CHS-3351.
Continue preclinical development of CHS-2020.
CHS-131, small molecule, PPAR-g modulator drug candidate in nonalcoholic steatohepatitis ("NASH")
Initiate clinical phase program in NASH.
Conference Call Information
When: Thursday, May 9, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (international)
Conference ID: 2969536
Webcast: View Source
You will be asked to register when you join the call. 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 (³ 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.