Coherus BioSciences, Inc. (Nasdaq:CHRS), today reported financial
results and reviewed corporate events for the second quarter ended
June 30, 2016.
Corporate Highlights for the Second Quarter 2016
Include:
- Immunology (anti-TNF) therapeutic franchise:
- CHS-1420 (adalimumab (HUMIRA®) biosimilar)
- Received favorable decision from the Patent Trial and Review
Board (PTAB) for the United States Patent and Trademark Office
(USPTO) instituting Coherus' petition for Inter Partes Review (IPR)
of AbbVie’s U.S. patent 8,889,135 (“the ‘135 patent”), 9,017,680
and 9,073,987 (patents ‘680 and ‘987, respectively), which are all
related to the dosing regimen for AbbVie’s Humira (adalimumab) to
treat rheumatoid arthritis.
- Issued patents from the USPTO for U.S. patents 9,340,611;
9,340,612 and 9,346,880 generally concerning the formulations of
adalimumab, the active biologic ingredient in Coherus’ Humira
biosimilar.
- CHS-0214 (etanercept (Enbrel®) biosimilar)
- Completed enrollment on two Phase 1 bridging studies.
- Multiple sclerosis therapeutic franchise:
- CHS-131 (new chemical entity therapeutic)
- Reported a positive Phase 2b randomized, double-blind,
placebo-controlled clinical study.
- Demonstrated approximately a 50 percent statistically
significant decrease in the incidence of new contrast-enhancing
lesions over six months when compared to placebo.
Financial highlights for the Second Quarter 2016
include:
- Announced the pricing of an underwritten public offering
totaling 4,025,000 shares of its common stock at a price to the
public of $18.00 per share before deducting the
underwriting discount, resulting in $69.0 million to Coherus net of
all fees. All of the shares of the common stock sold in the
offering were offered by Coherus.
- Received $30.0 million milestone payment from Baxalta related
to the last patient, last visit in the global CHS-0214 Phase 3
trials.
Second Quarter and year-to-date 2016 Financial
Results
Total revenue for the second quarter of 2016
was $14.1 million, as compared to $6.9 million in the second
quarter of 2015. Total revenue for the six months ended June
30, 2016 was $26.4 million, as compared to $12.7 million for the
same period in 2015. The increase over the same period in
2015 was due to increased recognition of Baxalta collaboration
revenue as a result of receiving four development milestone
payments totaling $130.0 million since March 31, 2015.
Research and development (R&D) expenses for
the second quarter of 2016 were $65.5 million compared to $56.9
million for the same period in 2015. R&D expenses for the
six months ended June 30, 2016 were $130.9 million, as compared to
$93.4 million for the same period in 2015. Increases in
R&D expenses were mainly attributable to proceeding with
clinical activities associated with our Phase 3 clinical study in
psoriasis for CHS-1420, advances in other product candidates in our
pipeline, and hiring additional personnel to support both
late-development and early-stage activities, and were offset by a
decrease in costs related to BLA-enabling studies for CHS-1701.
General and administrative (G&A) expenses
for the second quarter of 2016 were $11.3 million,
compared to $8.8 million for the same period in 2015. G&A
expenses for the six months ended June 30, 2016 were $22.7 million,
as compared to $14.9 million for the same period in 2015.
Changes in G&A expenses were mainly attributable to
hiring employees to support legal, pre-commercial and accounting
activities, costs associated with stock options granted since the
first quarter of 2015, legal fees to support the intellectual
property strategy, and accounting fees and services related to
compliance with Section 404 of the Sarbanes-Oxley Act of
2002.
Net loss attributable to Coherus for the second
quarter of 2016 was $70.0 million, or $1.72 per share, compared to
$58.8 million, or $1.56 per share, for the same period in 2015.
Cash and cash equivalents
totaled $220.9 million as of June 30, 2016, compared to $179.6
million as of March 31, 2016. Cash used in operations was
$27.4 million in the second quarter of 2016 as compared to $76.3
million in the first quarter of 2016. Excluding the $30.0
million milestone payment received from Baxalta, cash used in
operations was approximately 25% less in the second quarter
compared to the first quarter of 2016.
Guidance for the Second Half of 2016:
- Oncology therapeutic franchise:
- CHS-1701 (pegfilgrastim (Neulasta®) biosimilar)
- Reported in July positive follow-on
pharmacokinetic/pharmacodynamic (PK/PD) study.
- Initiate commercial partnering discussions for certain ex-U.S.
territories.
- Anticipated submission of Marketing Authorization Application
(MAA) in the fourth quarter.
- Immunology (anti-TNF) therapeutic franchise:
- CHS-0214 (etanercept biosimilar)
- Complete two Phase 1 bridging studies.
- Expect MAA acceptance in conjunction with partner Baxalta (now
part of Shire) in late 2016.
- CHS-1420 (adalimumab biosimilar)
- Reported in August positive interim Phase 3 clinical trial in
psoriasis at 16-weeks.
- Complete Phase 3 clinical trial in psoriasis in Q4 2016.
- Expect a 351(k) BLA acceptance in the U.S. late Q4/Q1
2017.
- Continue to advance intellectual property strategy.
- Partnering discussions for the immunology (anti-TNF)
therapeutic franchise have begun, targeting an agreement in the
first half of 2017.
- File one investigational new drug (IND) application for a
second wave biosimilar candidate.
Conference Call Information
When: Tuesday, August 9, 2016 at 4:30 p.m. ETDial-in: (844)
452-6826 (toll free) or (765) 507-2587 (International) Conference
ID: 46774291Webcast: http://investors.coherus.com
Please join the conference call at least 10 minutes early to
register. The webcast will be archived on the Coherus website
for one year.
About Coherus BioSciences, Inc. Coherus is a
leading global biosimilar platform 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 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 initiate and complete partnering discussions
and receive MAA acceptance for CHS-1701, complete bridging studies
and MAA acceptance for CHS-0214, complete trials and receive BLA
acceptance, and complete a partnering agreement for 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, 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’ Quarterly
Report on Form 10-Q for the quarter ended March 31, 2016, filed
with the Securities and Exchange Commission on May 9, 2016 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 |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(unaudited) |
|
(unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
Collaboration and license revenue |
$ |
14,068 |
|
|
$ |
6,866 |
|
|
$ |
26,427 |
|
|
$ |
12,676 |
|
|
Total
revenue |
|
14,068 |
|
|
|
6,866 |
|
|
|
26,427 |
|
|
|
12,676 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
65,544 |
|
|
|
56,944 |
|
|
|
130,857 |
|
|
|
93,411 |
|
|
General
and administrative |
|
11,260 |
|
|
|
8,817 |
|
|
|
22,658 |
|
|
|
14,908 |
|
|
Total
operating expenses |
|
76,804 |
|
|
|
65,761 |
|
|
|
153,515 |
|
|
|
108,319 |
|
|
Loss from
operations |
|
(62,736 |
) |
|
|
(58,895 |
) |
|
|
(127,088 |
) |
|
|
(95,643 |
) |
|
Interest expense |
|
(2,354 |
) |
|
|
— |
|
|
|
(3,191 |
) |
|
|
— |
|
|
Other expense, net |
|
(5,060 |
) |
|
|
(139 |
) |
|
|
(5,409 |
) |
|
|
(4,230 |
) |
|
Net loss |
|
(70,150 |
) |
|
|
(59,034 |
) |
|
|
(135,688 |
) |
|
|
(99,873 |
) |
|
Net loss attributable
to non-controlling interest |
|
183 |
|
|
|
224 |
|
|
|
333 |
|
|
|
338 |
|
|
Net loss attributable
to Coherus |
$ |
(69,967 |
) |
|
$ |
(58,810 |
) |
|
$ |
(135,355 |
) |
|
$ |
(99,535 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to Coherus, basic and diluted |
$ |
(1.72 |
) |
|
$ |
(1.56 |
) |
|
$ |
(3.39 |
) |
|
$ |
(2.80 |
) |
|
Weighted-average number
of shares used in computing net loss per share attributable to
Coherus, basic and diluted |
|
40,698,309 |
|
|
|
37,672,748 |
|
|
|
39,897,142 |
|
|
|
35,536,889 |
|
|
|
|
|
|
|
|
|
|
|
Coherus
BioSciences, Inc. |
|
Condensed
Consolidated Balance Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
(unaudited) |
|
|
|
Assets |
|
|
|
|
Cash and cash
equivalents |
$ |
220,916 |
|
|
$ |
158,226 |
|
|
Other assets |
|
30,185 |
|
|
|
54,158 |
|
|
Total assets |
$ |
251,101 |
|
|
$ |
212,384 |
|
|
Liabilities and
Stockholders’ Deficit |
|
|
|
|
Deferred revenue |
|
88,050 |
|
|
|
94,959 |
|
|
Convertible notes |
|
99,627 |
|
|
|
— |
|
|
Other liabilities |
|
125,372 |
|
|
|
124,354 |
|
|
Total stockholders'
deficit |
|
(61,948 |
) |
|
|
(6,929 |
) |
|
Total liabilities and
stockholders’ deficit |
$ |
251,101 |
|
|
$ |
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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