Coherus BioSciences Q4 and FY16 Highlights

 

On 13th March, 2017, Coherus BioSciences, Inc. (NASDAQ:CHRS) reported Q4 and full year financial results.

Operations highlights for Q4

Oncology therapeutic franchise:

  • CHS-1701, the biosimilar candidate of pegfilgrastim (Amgen’s Neulasta ®) was confirmed that FDA has accepted the filing of 351 (k) Biologics License Application (BLA) for it.
  • Confirmation of acceptance of Marketing Authorization Application (MAA) to European Medicines Agency (EMA) for CHS-1701. This marked as a first EMA submission and acceptance for Coherus.
  • Management expects to use cash towards commercial activities of CHS-1701

Immunology (anti-TNF) therapeutic franchise:

  • CHS-1420, the biosimilar candidate of adalimumab (Humira®), received decision from the PTAB (Patent Trial and Appeal Board) of the US Patent and Trademark office denying institution of petition for Inter Partes Review (IPR) of AbbVie’s U.S Patent 9,114,166 (“166 Patent) releated to AbbVie’s Humira formulation.
  • CHS-0214, the biosimilar of Amgen’s Enbrel ® (etanercept), released results from two PK studies.
  • The trial CHS-0214-06 trial compared CHS-0214 vs EU Enbrel, which resulted in achieving the primary PK BE endpoint. The trial, CHS-0214-07 provided additional relative bioavailability data for CHS-0214 candidate. Anticipate filing of Marketing Authorization Application (MAA) in 2H 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 patent IPR decision.

Others:

  • CHS-131; completion of additional animal studies on the candidate to validate its mechanism of action, with licensing agreement locked down for 2H of 2017

 

Financial Summary for Q4:

  • On 28th October  2016, Coherus BioSciences Inc (NASDAQ:CHRS) entered into a Sales Agreement with Cowen and Company LLC to act as a sales agent for executing the sale of CHRS’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.
  • During the Q4 and in January 2017, CHRS issues 2.2 million shares, which raised $60.8 million in gross proceeds under the “at the market” program, with an average price of $28.10 per share price.

Q4 and FY’16 Financial Results:

Research and Development (R&D):

  • Expenses for Q4:16 were $59.0million v $51.4million for Q4:15.
    • The jump in the Q4:16 compare to Q4:15 was largely due to analytical studies for early stage programs (phase I studies) and CHS-0214 programs, on-going CHS-1420 PK and Phase 3 trials for the biosims. This was offset by completion of CHS-1701 BLA-enabling and CHS-0214 phase 3 clinical program.
  • R&D for FY’16 were $254.4million v $213.1million for FY’15.
    • The surge in FY’16 expense compare to FY’15 was mainly because of proceedings on clinical programs associated with Phase 3 clinical study in psoriasis for CHS-1420, along with hiring of additional personnel to support both early-stage and late-developments programs. This increase was 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 1H of 2016.

General and administration (G&A):

  • Q4:16 expenses were $15.3m v $11m from Q4:15 (Q/Q 39.9% increase).
  • G&A expense for FY’16 were $51.6m v FY’15 $36.0m (Y/Y 43.33%)
    • The surge in these expenses were mainly contributed by hiring of personnel to support pre-commercial and accounting activities, stock options costs- which was granted since Q3:15 and legal fees to support the IP strategy.

Net loss:

  • Q4:16 ($75.9)m (or $1.71 per share) v ($52.4)m or ($1.35 per share) during Q4:15.
  • FY’16 ($127.3)m (or $3.04 per share) v FY’15 ($223.3)m (or $6.01 per share)

Cash and Cash equivalents:

  • $124.9m cash total for Q4:16 v $159.7m Q3:16 along with additional raise of $120milion in net proceeds from equity offerings in February and March 2017.

Total Revenue:

  • Q4:16 figures stood at $844 thousand, as compared to $10.2m in Q4:15. While the total revenue for FY’16 was $190.1m v $30.0m in FY’15.
    • The increase over the same period was due to increased recognition of collaboration revenue as a result of regaining the full development & commercial rights of CHS-0214 from shire in Europe, Canada, Brazil, the Middle East and other territories.

 

 

Conference Call InformationWhen: Monday, March 13, 2017 at 4:30 p.m. ETDial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International) Conference ID: 66529524Webcast:  http://investors.coherus.com The webcast will be archived on the Coherus website.

Leave a comment