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Coherus BioSciences Reports Fourth Quarter and Full Year 2018 Financial Results
Fourth Quarter 2018 and Recent Corporate Highlights Include:
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 FDAand European Commissionapproval.
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.
January 3, 2019, Coherus launched UDENYCA™ commercially in the U.S.
January 7, 2019, Coherus entered into a $75 millionsenior secured credit facility agreement with Healthcare Royalty Partners.
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
Selling, general and administrative (SG&A) expenses for the fourth quarter of 2018 were
Cash and cash equivalents and investments in marketable securities for the fourth quarter totaled
Net loss attributable to Coherus for the fourth quarter of 2018 was
Guidance for the Next Twelve Months from
UDENYCA™ (pegfilgrastim-cbqv), Neulasta® (pegfilgrastim) biosimilar
- Secure receipt of transitional pass-through status in 340-B hospitals in
- 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
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 3398069
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 http://investors.coherus.com.
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
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 UDENYCATM in patients with ARDS.
- Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCATM in patients with serious allergic reactions.
- Fatal sickle cell crises: Have occurred.
- Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCATM if causality is likely.
ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.
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, Coherus’ expectations regarding commercial sales of UDENYCA™ in the U.S., its reimbursement status and its ability to increase penetration of patient and provider support programs and access portals; Coherus’ ability to pursue manufacturing objectives of CHS-1420 in support of a BLA; Coherus’ plan to complete manufacturing technology transfer to support clinical and continued preclinical development of CHS-3351. 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’ Annual Report on Form 10-K for the year ended
UDENYCA™ is a trademark of
Enbrel® and Neulasta® are registered trademarks 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||Twelve Months Ended|
|December 31,||December 31,|
|Collaboration and license revenue||$||-||$||-||$||-||$||1,556|
|Research and development||26,662||31,488||110,239||162,389|
|Selling, general and administrative||33,840||14,978||94,177||71,303|
|Total operating expenses||60,502||46,466||204,416||233,692|
Loss from operations
|Other income (expense), net||340||(203||)||4,691||3,402|
|Net loss attributable to non-controlling interest||–||2||70||116|
|Net loss attributable to Coherus||$||(62,596||)||$||(49,067||)||$||(209,339||)||$||(238,170||)|
Net loss per share attributable to Coherus, basic and diluted
|Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted||68,089,486||58,343,720||65,034,827||53,133,620|
|Coherus BioSciences, Inc.|
|Condensed Consolidated Balance Sheets|
|December 31,||December 31,|
|Cash and cash equivalents||$||72,356||$||126,911|
|Liabilities and Stockholders’ Equity (deficit)|
|Convertible notes-related parties||25,773||25,204|
|Total stockholders' equity (deficit)||(38,591||)||30,535|
|Total liabilities and stockholders’ equity (deficit)||$||99,467||$||162,611|
Vice President, Investor Relations & Corporate Affairs
+1 (650) 395-0196
Source: Coherus BioSciences, Inc.