- CHS-1701 (pegfilgrastim (Neulasta®) biosimilar candidate)
- U.S. Food and Drug Administration filing of the CHS-1701 biologics license application (BLA).
- Positive topline results from follow-on pharmacokinetic and pharmacodynamic (PK/PD) clinical study CHS-1701-05. All co-primary endpoints for PK, Cmax and Area Under the Curve (AUC), and PD, absolute neutrophil count (ANC max and ANC AUC) were achieved.
- CHS-1420 (adalimumab (Humira®) biosimilar candidate)
- Reported topline results from the ongoing Phase 3 clinical study CHS-1420-02. All primary endpoints demonstrating similarity between CHS-1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at week 12 were achieved. 95% confidence intervals for the difference between treatment groups fell well within the prespecified margin. Both CHS-1420 and Humira were similarly well tolerated with similar safety profiles in this study.
- Awarded fourth US patent, 9,382,317 on formulations excluding surfactant and polyol.
- CHS-0214 (etanercept (Enbrel®) biosimilar candidate)
- Announced regaining all development and commercial rights previously licensed for CHS-0214 in Europe, Canada, Brazil, the Middle East and other territories from Shire plc.
- As a result of the termination agreement for CHS-0214 with Shire plc, Coherus recognized $162.5 million as collaboration and license revenues from payments received in prior periods in the third quarter of 2016.
- CHS-1701 (pegfilgrastim biosimilar)
- Anticipated acceptance of Marketing Authorization Application (MAA) in the fourth quarter 2016.
- Continue commercial partnering discussions for certain ex-U.S. territories, targeting agreement in place in the first half of 2017.
- CHS-1420 (adalimumab biosimilar)
- Complete CHS-1420-02, ongoing Phase 3 confirmatory, randomized, double-blind, active-control, parallel-group, 3-part study in patients with active, moderate to severe, chronic plaque psoriasis in the fourth quarter. Expect a 351(k) BLA submission in the U.S. in the first half of 2017.
- To support registration of the auto-injector configuration: complete 1420-04, a usability study, in the fourth quarter of 2016, and 1420-05, a comparability study, in the first quarter of 2017.
- Continue to advance intellectual property strategies, supporting potential 2018 launch.
- Initiate a PK study on formulation not impacted by AbbVie US Patent 9,114,166 ('166) in the first-half of 2017.
- CHS-0214 (etanercept biosimilar)
- Review program with European regulatory authorities in the first quarter; MAA submission expected in early 2017.
- Present data from two Phase 3 studies at the American College of Rheumatology.
- Partnering discussions for the immunology (anti-TNF) therapeutic franchise are underway, targeting agreement in place in the first half of 2017.
|Coherus BioSciences, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Collaboration and license revenue||$||162,835||$||7,167||$||189,262||$||19,843|
|Research and development||64,573||68,218||195,430||161,629|
|General and administrative||13,645||10,166||36,303||25,074|
|Total operating expenses||78,218||78,384||231,733||186,703|
|Income (loss) from operations||84,617||(71,217||)||(42,471||)||(166,860||)|
|Other income (expense), net||1,647||(235||)||(3,762||)||(4,465||)|
|Net income (loss)||83,844||(71,485||)||(51,844||)||(171,358||)|
|Net loss attributable to non-controlling interest||95||151||428||489|
|Net income (loss) attributable to Coherus||$||83,939||$||(71,334||)||$||(51,416||)||$||(170,869||)|
|Net income (loss) per share attributable to Coherus:|
|Weighted-average number of shares used in computing net income (loss) per share attributable to Coherus:|
|Coherus BioSciences, Inc.|
|Condensed Consolidated Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||159,677||$||158,226|
|Liabilities and Stockholders' Equity (Deficit)|
|Total stockholders' equity (deficit)||31,722||(6,929||)|
|Total liabilities and stockholders' equity (deficit)||$||192,357||$||212,384|
CONTACT:Patrick O'BrienSenior Vice President, Investor RelationsCoherus BioSciences, Inc.firstname.lastname@example.org+1 (650) 649-3527