Coherus BioSciences Reports Fourth Quarter and Full Year 2016 Corporate Highlights and Financial Results
March 13 2017 - 4:01PM
Coherus BioSciences, Inc. (Nasdaq:CHRS), today reviewed corporate
events and reported financial results for the fourth quarter and
full year 2016.
Corporate Highlights for the Fourth Quarter 2016
Include:Oncology therapeutic
franchise:
- 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.
Immunology (anti-TNF) therapeutic
franchise:
- 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.
Financial Highlights for the Fourth Quarter 2016
include:
- 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.
Fourth Quarter and Full Year 2016 Financial
Results:
- 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.
2017 Guidance:Oncology therapeutic
franchise:
- 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.
Immunology (anti-TNF) therapeutic
franchise:
- 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.
Other:
- 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.
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.comPlease join the
conference call at least 10 minutes early to register. The
webcast will be archived on the Coherus website.
About Coherus BioSciences, Inc. Coherus is a
leading pure-play, global biosimilar company that develops and
commercializes high-quality therapeutics for major regulated
markets. Biosimilars are intended for use in place of existing,
branded biologics to treat a range of chronic and often
life-threatening diseases, with the potential to reduce costs and
expand patient access. Composed of a team of proven industry
veterans with world-class expertise in process science, analytical
characterization, protein production, sales & marketing and
clinical-regulatory development, Coherus is positioned as a leader
in the global biosimilar marketplace. Coherus is advancing three
late-stage clinical products towards commercialization, CHS-1701
(pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and
CHS-1420 (adalimumab biosimilar), as well as developing a robust
pipeline of future products in four therapeutic areas, oncology,
immunology (anti-TNF), ophthalmology and multiple sclerosis. For
additional information, please visit www.coherus.com.
Forward-Looking StatementsExcept for the
historical information contained herein, the matters set forth in
this press release, including statements regarding Coherus’ plans,
potential opportunities, expectations, projections, goals,
objectives, milestones, strategies, product pipeline, clinical
studies, product development, release of data and the potential
benefits of its products under development are forward-looking
statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995, including
Coherus’ ability to complete a partnering agreement and receive MAA
acceptance for CHS-1701, receive MAA acceptance for CHS-0214,
initiate a bioavailability study for CHS-0214 and receive BLA
acceptance for CHS-1420, complete a partnering agreement for its
immunology (anti-TNF) therapeutic franchise, to complete additional
studies for and partner CHS-131, to prioritize its use of cash
towards CHS-1701 commercialization activities, and to successfully
defend against the trade secret and related allegations made by
Amgen in the lawsuit filed against Coherus and other parties with
respect to CHS-1701 and to be able to launch that product on a
timely basis assuming approval of our New Drug Application by the
U.S. Food and Drug Administration. Such forward-looking statements
involve substantial risks and uncertainties that could cause our
clinical development programs, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the clinical drug development process, including the regulatory
approval process, the timing of our regulatory filings and other
matters that could affect the availability or commercial potential
of our biosimilar drug candidates, as well as possible patent
litigation. 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 December 31,
2016, filed with the Securities and Exchange Commission on March
13, 2017 and its future periodic reports to be filed with the
Securities and Exchange Commission.
Enbrel® and Neulasta® are registered trademarks of Amgen
Inc.Humira® is a registered trademark of AbbVie Inc.
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, |
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
Revenue: |
|
|
|
|
|
|
|
|
Collaboration and license revenue |
|
$ |
214 |
|
|
$ |
10,198 |
|
|
$ |
189,476 |
|
|
$ |
30,041 |
|
Other
revenue |
|
|
630 |
|
|
|
— |
|
|
|
630 |
|
|
|
— |
|
Total
revenue |
|
|
844 |
|
|
|
10,198 |
|
|
|
190,106 |
|
|
|
30,041 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
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 |
) |
Interest
expense |
|
|
(2,369 |
) |
|
|
— |
|
|
|
(7,980 |
) |
|
|
(33 |
) |
Other
expense, net |
|
|
(115 |
) |
|
|
(373 |
) |
|
|
(3,877 |
) |
|
|
(4,838 |
) |
Net
loss |
|
|
(75,944 |
) |
|
|
(52,580 |
) |
|
|
(127,788 |
) |
|
|
(223,938 |
) |
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 |
(in thousands) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2016 |
|
2015 |
|
|
|
|
|
Assets |
|
|
|
|
Cash and
cash equivalents |
|
$ |
124,947 |
|
$ |
158,226 |
|
Other
assets |
|
|
53,538 |
|
|
54,158 |
|
Total
assets |
|
$ |
178,485 |
|
$ |
212,384 |
|
Liabilities and Stockholders’ Equity
(deficit) |
|
|
|
|
Deferred
revenue |
|
|
1,561 |
|
|
94,959 |
|
Convertible notes |
|
|
75,192 |
|
|
— |
|
Convertible notes-related parties |
|
|
25,064 |
|
|
— |
|
Other
liabilities |
|
|
57,314 |
|
|
124,354 |
|
Total
stockholders' equity (deficit) |
|
|
19,354 |
|
|
(6,929 |
) |
Total
liabilities and stockholders’ equity (deficit) |
|
$ |
178,485 |
|
$ |
212,384 |
|
|
|
|
|
|
CONTACT:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527
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