Coherus BioSciences, Inc. (Nasdaq:CHRS), a late-stage clinical
biologics platform company focused on the global biosimilar market,
today reported financial results and reviewed corporate events for
the quarter ended September 30, 2014.
Recent Business Highlights
- Received two milestone payments under existing collaboration
with Baxter Healthcare Corporation (Baxter):
- In July 2014, achieved a $15.0 million milestone for the
initiation of a CHS-0214 (etanercept (Enbrel®) biosimilar
candidate) global psoriasis phase 3 study.
- In September 2014, achieved a $10.0 million milestone for
meeting regulatory expectations for biosimilarity of CHS-0214 bulk
drug substance manufactured in Europe.
- In August 2014, met the primary endpoint in a pivotal clinical
pharmacokinetic similarity study that compared adalimumab
biosimilar candidate CHS-1420 to Humira® in healthy subjects.
- In November 2014, closed initial public offering of 6,803,702
shares of common stock at $13.50 per share, which included the
purchase of 507,402 shares of common stock by the underwriters upon
partial exercise of their over-allotment option. Net proceeds from
the offering were approximately $80.4 million, after deducting
underwriting discounts and commissions and offering expenses.
"Thanks to the successful completion of our Initial Public
Offering, we are poised to start Phase 3 clinical development for
our un-partnered CHS-1420 drug candidate in the first half of
2015," stated Denny Lanfear, President and Chief Executive Officer
of Coherus. "We are also finalizing the development plan for our
pegfilgrastim (Neulasta®) biosimilar candidate, CHS-1701, based on
feedback we received from the U.S. Food and Drug Administration
regarding our decision to transition to the 351(k) (biosimilar)
regulatory pathway."
Third Quarter 2014 Financial Results
Revenue for the third quarter 2014 totaled
$16.1 million, as compared to $0.5 million in the third quarter of
2013. Revenue for the nine months ended September 30, 2014 totaled
$24.6 million, as compared to $1.5 million for the same period in
2013. The increases over the same periods in 2013 were both due to
the recognition of Baxter collaboration revenue.
Research and development (R&D) expenses for
the third quarter 2014 were $18.5 million compared with $4.9
million for the same period in 2013. R&D expenses for the nine
months ended September 30, 2014 were $51.4 million compared with
$22.1 million for the same period in 2013. Increases in R&D
expenses were mainly attributable to an increase in program costs
associated with the advancement of Coherus' late-stage clinical
product candidates, CHS-0214 and CHS-1420, as well as increased
personnel expenses.
General and administrative (G&A) expenses
for the third quarter 2014 were $4.0 million, compared to $2.4
million for the same period in 2013. G&A expenses for the
nine months ended September 30, 2014 were $11.4 million compared
with $5.0 million for the same period in 2013. Increases in
G&A expenses were mainly attributable to increased
employee-related expenses and increased legal and accounting
services in preparation for becoming a public company.
Net loss attributable to Coherus for the third
quarter 2014 was $7.9 million, or $1.79 per share, compared to
$21.5 million, or $6.23 per share, for the same period in 2013. For
the nine months ended September 30, 2014, net loss attributable to
Coherus was $58.0 million, or $13.62 per share, compared to $39.0
million, or $12.48 per share, for the same period in 2013.
Cash and cash equivalents totaled $100.9
million as of September 30, 2014, compared to $108.9 million as of
June 30, 2014.
Anticipated Near Term Milestones
- Finalize CHS-1701 development plan based on feedback received
from the U.S. Food and Drug Administration and amend the
investigational new drug application in the first quarter of
2015.
- End the year with over $150 million in cash and cash
equivalents.
Conference Call Today
Coherus management will host a conference call today beginning
at 1:30 pm PT/4:30 pm ET to review third quarter results and
pipeline progress.
The press release and an audio-only webcast of the conference
call will be accessible through the Investors section of the
Coherus website: http://investors.coherus.com. The webcast of
the conference call will be available for replay through December
29, 2014.
Analysts and investors may participate in the conference call by
dialing 844-452-6826 for domestic callers and 765-507-2587 for
international callers using the conference ID# 47041295.
About Coherus BioSciences, Inc.
Coherus is a late-stage clinical biologics platform company
focused on the global biosimilar market. Headquartered in the San
Francisco Bay Area and composed of a team of industry veterans with
decades of experience in pioneering biologics companies, our goal
is to become a global leader in the biosimilar market by leveraging
our team's collective expertise in key areas such as process
science, analytical characterization, protein production and
clinical-regulatory development. Coherus' commercialization
partnerships include global pharmaceutical companies in Europe,
Asia and Latin America.
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. For additional information, please visit
www.coherus.com.
Forward-Looking Statements
Except 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' expectations regarding its ability to advance
its CHS-0214, CHS-1420 and CHS-1701 biosimilar drug candidates,
amend its IND for CHS-1701 and recruit patients in biologic license
application enabling studies for Phase 3 clinical development of
CHS-1420. 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. 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' Prospectus filed with the Securities and
Exchange Commission on November 6, 2014, Coherus' Quarterly Report
on Form 10-Q for the fiscal quarter ended September 30, 2014, filed
with the Securities and Exchange Commission on December 15, 2014
and its future periodic reports to be filed with the Securities and
Exchange Commission.
COHERUS BIOSCIENCES,
INC. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(In thousands, except share and
per share data) |
(unaudited) |
|
|
|
|
|
|
Three Months
Ended |
Nine Months
Ended |
|
September 30, |
September 30, |
|
2014 |
2013 |
2014 |
2013 |
|
|
|
|
|
Revenue: |
|
|
|
|
Collaboration and license
revenue -- related party |
$ 432 |
$ 506 |
$ 1,445 |
$ 1,519 |
Collaboration and license
revenue |
15,620 |
— |
23,168 |
— |
Total
revenue |
16,052 |
506 |
24,613 |
1,519 |
Operating expenses: |
|
|
|
|
Research and development |
18,496 |
4,934 |
51,357 |
22,057 |
General and administrative |
3,979 |
2,355 |
11,378 |
4,968 |
Total operating
expenses |
22,475 |
7,289 |
62,735 |
27,025 |
Loss from operations |
(6,423) |
(6,783) |
(38,122) |
(25,506) |
Interest expense |
(1) |
(1,992) |
(3,900) |
(1,992) |
Other expense, net |
(1,490) |
(12,698) |
(16,132) |
(11,546) |
Net loss |
(7,914) |
(21,473) |
(58,154) |
(39,044) |
Net loss attributable to non-controlling
interest |
42 |
— |
155 |
— |
Net loss attributable to Coherus |
$ (7,872) |
$ (21,473) |
$ (57,999) |
$ (39,044) |
Net loss per share attributable to Coherus,
basic and diluted |
$ (1.79) |
$ (6.23) |
$ (13.62) |
$ (12.48) |
Weighted average number of shares used
in net loss per share attributable to Coherus, basic and
diluted |
4,409,703 |
3,444,484 |
4,258,770 |
3,128,380 |
|
|
|
|
|
|
|
|
|
|
COHERUS BIOSCIENCES,
INC. |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(In thousands) |
(unaudited) |
|
|
|
|
September 30, |
December 31, |
|
2014 |
2013 |
Assets |
|
|
Cash and cash equivalents |
$ 100,875 |
$ 39,554 |
Other assets |
28,307 |
7,893 |
Total assets |
$ 129,182 |
$ 47,447 |
Liabilities, Convertible Preferred
Stock and Stockholders' Deficit |
|
|
Deferred revenue |
$ 68,702 |
$ 42,850 |
Other liabilities |
51,301 |
46,979 |
Convertible preferred stock |
161,164 |
54,695 |
Total stockholders' deficit |
(151,985) |
(97,077) |
Total liabilities, convertible preferred
stock and stockholders' equity |
$ 129,182 |
$ 47,447 |
|
|
|
CONTACT: |
Jean-Frédéric Viret, Ph.D. |
|
Chief Financial Officer |
|
Coherus BioSciences, Inc. |
|
jviret@coherus.com |
|
1 (800) 794-5434 |
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