- CHS-1701 (pegfilgrastim (Neulasta®) biosimilar candidate)- Announced that the U.S. FDA has accepted the filing of 351(k) Biologics License Application (BLA) for CHS-1701. The first FDA submission and acceptance for Coherus.- Announced acceptance of Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CHS-1701. This is the first EMA submission and acceptance for Coherus.
- CHS-1420 (adalimumab (Humira®) biosimilar candidate)- Received decision from the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office denying institution of petition for Inter Partes Review (IPR) of AbbVie's U.S. Patent 9,114,166 (the "'166 Patent") related to AbbVie's HUMIRA (adalimumab) formulation.
- CHS-0214 (etanercept (Enbrel®) biosimilar candidate)- Announced results from two pharmacokinetic (PK) studies involving CHS-0214. The CHS-0214-06 trial compared CHS-0214 vs. European Union (EU) Enbrel and achieved the primary PK BE endpoint, as the 90% confidence intervals for the geometric mean ratio for the two groups was within 80% to 125% for all PK parameters. The CHS-0214-07 trial provided additional relative bioavailability data for CHS-0214.
- On October 28, 2016, Coherus entered into a Sales Agreement with Cowen and Company, LLC to sell shares of the Company's common stock with aggregate gross sales proceeds of up to $100,000,000, from time to time, through an "at the market" equity offering program under which Cowen will act as sales agent. During the fourth quarter of 2016 and in January 2017, Coherus issued 2.2 million shares and raised $60.8 million in gross proceeds under this program at an average price per share of $28.10.
- Total revenue for the fourth quarter of 2016 was $844 thousand, as compared to $10.2 million in the fourth quarter of 2015. Total revenue for the fiscal year 2016 was $190.1 million, as compared to $30.0 million in 2015. The increase over the same period in 2015 was due to increased recognition of collaboration revenue as a result of regaining the full development and commercial rights for CHS-0214 from Shire in Europe, Canada, Brazil, the Middle East and certain other territories.
- Research and development (R&D) expenses for the fourth quarter of 2016 were $59.0 million compared to $51.4 million for the same period in 2015. R&D expenses for the fiscal year 2016 were $254.4 million, as compared to $213.1 million for the same period in 2015. The increase in R&D expenses in the fourth quarter over the same period in 2015 was mainly due to analytical studies for early stage programs and CHS-0214 programs, on-going CHS-1420 PK and Phase 3 trials, offset by completion of the CHS-1701 BLA-enabling and CHS-0214 Phase 3 clinical program. The increase in R&D expenses in the fiscal year ended 2016 over the same period in 2015 was mainly attributable to proceeding with clinical activities associated with a Phase 3 clinical study in psoriasis for CHS-1420, advances in other product candidates, and hiring additional personnel to support both late-development and early-stage activities, partially offset by a decrease in costs related to BLA-enabling studies for CHS-1701 and a decrease in costs associated with the CHS-0214 Phase 3 trials that were completed in the first half of 2016.
- General and administrative (G&A) expenses for the fourth quarter of 2016 were $15.3 million, compared to $11.0 million for the same period in 2015. G&A expenses for the fiscal year 2016 were $51.6 million, as compared to $36.0 million for the same period in 2015. Changes in G&A expenses were mainly attributable to hiring employees to support pre-commercial and accounting activities, costs associated with stock options granted since the third quarter of 2015 and legal fees to support the intellectual property strategy.
- Net loss attributable to Coherus for the fourth quarter of 2016 was ($75.9) million, or ($1.71) per share, compared to a net loss of ($52.4) million, or ($1.35) per share, for the same period in 2015. Net loss attributable to Coherus for 2016 was ($127.3) million, or ($3.04) per share, compared to a net loss of ($223.3) million, or ($6.01) per share, for 2015.
- Cash and cash equivalents totaled $124.9 million as of December 31, 2016, compared to $159.7 million as of September 30, 2016. Coherus raised an additional $120.3 million in net proceeds from a follow-on equity offering in February and March 2017.
- CHS-1701 (pegfilgrastim biosimilar)- U.S. marketing approval, anticipated on the BSUFA date of June 9, 2017.- European Marketing approval anticipated in the fourth quarter of 2017.- Continue commercial partnering discussions for certain ex-U.S. territories, targeting agreement in place in the first half of 2017.
- CHS-1420 (adalimumab biosimilar)- Anticipate a 351(k) BLA submission in the U.S. in the second quarter of 2017.- Anticipate a decision from the Patent Trial and Appeal Board of the U.S. Patent and Trademark office on the Inter Partes Review of AbbVie's U.S. Patent 8,889,135 ("the '135 Patent") by May 17, 2017.- Continue to advance intellectual property strategies, supporting potential 2018 launch.- Initiate a PK study on formulation not impacted by AbbVie US Patent 9,114,166 ('166) in the second-half of 2017, if the '135 Patent is invalidated by the Patent Trial and Appeal Board.- Institution decision on four petitions for Inter Partes Review (IPR) of AbbVie's U.S. Patent 9,085,619 in the third quarter of 2017.
- CHS-0214 (etanercept biosimilar)- Anticipate filing of Marketing Authorization Application (MAA) in the second half of 2017.
- Partnering discussions for the immunology (anti-TNF) therapeutic franchise are underway, targeting agreement in place in the first half of 2017, subject to a favorable '135 IPR decision.
- Complete additional animal studies on CHS-131 to further validate its mechanism of action, pursuant to a licensing agreement in the second half of 2017.
- Management anticipates prioritizing use of cash towards CHS-1701 commercialization activities.
|Coherus BioSciences, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Collaboration and license revenue||$||214||$||10,198||$||189,476||$||30,041|
|Research and development||59,010||51,433||254,440||213,062|
|General and administrative||15,294||10,972||51,597||36,046|
|Total operating expenses||74,304||62,405||306,037||249,108|
|Loss from operations||(73,460||)||(52,207||)||(115,931||)||(219,067||)|
|Other expense, net||(115||)||(373||)||(3,877||)||(4,838||)|
|Net loss attributable to non-controlling interest||23||189||451||678|
|Net loss attributable to Coherus||$||(75,921||)||$||(52,391||)||$||(127,337||)||$||(223,260||)|
|Net loss per share attributable to Coherus, basic and diluted||$||(1.71||)||$||(1.35||)||$||(3.04||)||$||(6.01||)|
|Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted||44,341,121||38,935,832||41,912,300||37,122,008|
|Coherus BioSciences, Inc.|
|Condensed Consolidated Balance Sheets|
|December 31,||December 31,|
|Cash and cash equivalents||$||124,947||$||158,226|
|Liabilities and Stockholders' Equity (deficit)|
|Convertible notes-related parties||25,064||—|
|Total stockholders' equity (deficit)||19,354||(6,929||)|
|Total liabilities and stockholders' equity (deficit)||$||178,485||$||212,384|
CONTACT:Patrick O'BrienSenior Vice President, Investor RelationsCoherus BioSciences, Inc.firstname.lastname@example.org+1 (650) 649-3527