- CHS-1701 (pegfilgrastim (Neulasta®) biosimilar candidate)• Announced completion of initial phases of the Biologic Price Competition and Innovation Act patent exchange with Amgen.• Announced receipt of complete response letter from U.S. Food and Drug Administration for CHS-1701's biologic license application ("BLA").
- CHS-1420 (adalimumab (Humira®) biosimilar candidate)• Received decisions from the Patent Trial and Appeal Board of the United States Patent and Trademark Office ("PTAB") in favor of Coherus' petition for Inter Partes Review invalidating all of the claims of AbbVie's U.S. Patents 8,889,135; 9,017,680 and 9,073,987.
- Cash used in operations was $55.6 million in the second quarter and was down 24% from the $73.3 million used in the first quarter of 2017.
- Total revenue for the second quarter of 2017 was $1.4 million, as compared to $14.1 million in the second quarter of 2016. Total revenue for the six months ended June 30, 2017 was $1.6 million, as compared to $26.4 million for the same period in 2016. The decrease in revenue from the same period in 2016 was mainly attributable to the termination of an agreement for CHS-0214 (etanercept (Enbrel) biosimilar candidate) with Shire plc (whereupon Coherus regained rights to CHS-0214) in the third quarter of 2016.
- Research and development (R&D) expenses for the second quarter of 2017 were $34.5 million, as compared to $65.5 million for the same period in 2016. R&D expenses for the six months ended June 30, 2017 were $88.3 million, as compared to $130.9 million for the same period in 2016. Decreases in R&D expenses were mainly attributable to the completion of Phase 3 and Phase 1 clinical studies for CHS-0214 and CHS-1420 in 2016 and a decrease in other development costs for our pipeline products.
- General and administrative (G&A) expenses for the second quarter of 2017 were $23.5 million, as compared to $11.3 million for the same period in 2016. G&A expenses for the six months ended June 30, 2017 were $42.3 million, as compared to $22.7 million for the same period in 2016. Changes in G&A expenses were mainly attributable to legal and other professional fees to support the intellectual property strategy, as well as personnel related costs to support CHS-1701 pre-commercial activities in the first six months of 2017.
- Net loss attributable to Coherus for the second quarter of 2017 was ($55.3) million, or ($1.08) per share, as compared to ($70.0) million, or ($1.72) per share, for the same period in 2016.
- Cash , cash equivalents and investments in marketable securities - short term totaled $118.3 million as of June 30, 2017, as compared to $174.8 million as of March 31, 2017.
- CHS-1701 (pegfilgrastim biosimilar)• Anticipate resubmitting the BLA in the U.S. at the end of the fourth quarter of 2017.
- Anticipate European positive opinion in the first half of 2018, such timing being dependent upon data requests.• Commercial partnering discussions are underway for certain ex-U.S. territories.
- CHS-1420 (adalimumab biosimilar)• Anticipate a decision from the PTAB on the petition for Inter Partes Review of AbbVie's U.S. Patent 9,085,619 no later than September 12, 2017.• Continue to advance intellectual property strategies, supporting potential 2019 launch.• Initiate a pharmacokinetic study with a formulation not impacted by AbbVie's U.S. Patent 9,114,166 in the second half of 2017.• Anticipate a BLA submission in the U.S. during the first half of 2018.
- CHS-0214 (etanercept biosimilar)• Focus on US legal and regulatory issues through the first half of 2018.• Provide revised guidance on filing of the marketing authorization application in Europe after CHS-1701 U.S. BLA resubmission.
- Targeting immunology (anti-TNF) partnering therapeutic franchise agreement with discussions ongoing.
- CHS-131 central nervous system anti-inflammatory asset• Completing additional animal studies on CHS-131 to further validate its mechanism of action and address drug-derived metabolites. Licensing agreement to follow subject to results.
- Management anticipates cash usage of approximately $40 - $45 million per quarter in the second half of 2017 and $30 - $35 million per quarter in the first half of 2018.
|Coherus BioSciences, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Collaboration and license revenue||$||1,395||$||14,068||$||1,556||$||26,427|
|Research and development||34,500||65,544||88,275||130,857|
|General and administrative||23,533||11,260||42,336||22,658|
|Total operating expenses||58,033||76,804||130,611||153,515|
|Loss from operations||(56,638||)||(62,736||)||(129,055||)||(127,088||)|
|Other income (expense), net||3,620||(5,060||)||3,591||(5,409||)|
|Net loss attributable to non-controlling interest||66||183||110||333|
|Net loss attributable to Coherus||$||(55,336||)||$||(69,967||)||$||(130,114||)||$||(135,355||)|
|Net loss per share attributable to Coherus, basic and diluted||$||(1.08||)||$||(1.72||)||$||(2.60||)||$||(3.39||)|
|Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted||51,291,787||40,698,309||50,008,999||39,897,142|
|Coherus BioSciences, Inc.|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Cash and cash equivalents||$||73,352||$||124,947|
|Investments in marketable securities - short-term||44,980||-|
|Liabilities and Stockholders' Equity|
|Convertible notes-related parties||25,229||25,064|
|Total stockholders' equity||30,857||19,354|
|Total liabilities and stockholders' equity||$||172,251||$||178,485|
CONTACT:Patrick O'BrienSenior Vice President, Investor RelationsCoherus BioSciences, Inc.email@example.com+1 (650) 649-3527