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Coherus BioSciences Reports Corporate Highlights and First Quarter 2019 Financial Results
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 millionfollowing 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 Medicarepatients.
- The Company secured a
$75 millioncredit financing with Healthcare Royalty Partnersto accelerate the manufacturing and launch of UDENYCA®.
• Legal Developments
- Coherus and
Amgensettled the trade secret action brought by Amgenand Coherus continues to commercialize UDENYCA® across all segments.
- The Company announced a global settlement with
AbbViesecuring 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
Amgendirected to Amgen’s Humira® biosimilar formulation.
First Quarter 2019 Financial Results
• Net product revenue for the first quarter of 2019 was
• Research and development (R&D) expenses for the first quarter of 2019 were
• Selling, general and administrative (SG&A) expenses for the first quarter of 2019 were
• Total operating expenses decreased by
• Cash and cash equivalents and investments in marketable securities for the first quarter totaled
• Net loss attributable to the Company for the first quarter of 2019 was
Guidance for the Next Nine Months from
• 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
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (international)
Conference ID: 2969536
You will be asked to register when you join the call. The webcast will be archived on the Coherus website.
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
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
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.
Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.
To report SUSPECTED ADVERSE REACTIONS, contact
Full Prescribing Information available at www.UDENYCA.com
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, transitional pass-through status in 340B hospitals from CMS incentivizing access to UDENYCA®; being able to accelerate the manufacturing of UDENYCA®; Coherus’ expectations regarding its ability to increase the breadth and depth of UDENYCA’s adoption across all market segments and to secure reimbursement coverage among remaining national and regional payers for UDENYCA®; Coherus’ ability to pursue manufacturing objectives of CHS-1420 in support of an anticipated BLA; Coherus’ plan to complete the manufacturing technology transfer to support the clinical development of CHS-3351; Coherus’ expectation to continue the preclinical development of CHS-2020; and Coherus’ plan to initiate a clinical phase program for CHS-131 in NASH. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the three months ended
UDENYCA® is a trademark of
Neulasta® is a registered trademark of
Humira® is a registered trademark of
Lucentis® is a registered trademark of
Eylea® is a registered trademark of
|Coherus BioSciences, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended|
|Net product revenue||$||37,098||$||-|
|Cost of goods sold||2,225||-|
|Research and development||18,789||25,455|
|Selling, general and administrative||32,683||16,577|
|Total operating expenses||53,697||42,032|
|Loss from operations||(16,599||)||(42,032||)|
|Other income, net||811||138|
|Net loss attributable to non-controlling interest||-||5|
|Net loss attributable to Coherus||$||(20,004||)||$||(44,297||)|
|Net loss per share attributable to Coherus, basic and diluted||$||(0.29||)||$||(0.74||)|
|Weighted-average number of shares used in computing net
loss per share attributable to Coherus, basic and diluted
|Coherus BioSciences, Inc.|
|Condensed Consolidated Balance Sheets|
|March 31,||December 31,|
|Cash and cash equivalents||$||81,515||$||72,356|
|Investments in marketable securities - short-term||14,918||-|
|Trade receivables, net||46,476||-|
|Liabilities and Stockholders’ Deficit|
|Convertible notes - related parties||25,872||25,773|
|Total stockholders' deficit||(38,515||)||(38,591||)|
|Total liabilities and stockholders’ deficit||$||186,115||$||99,467|
VP, Investor Relations & Corporate Affairs
+1 (650) 395-0196
Source: Coherus BioSciences, Inc.