EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a pure-play
biosimilar company focused on the global development and
commercialization of biosimilar monoclonal antibodies (mAbs), today
reported financial results for the fourth quarter and fiscal year
of 2015, and provided a business update.
“During 2015, we made significant progress on our
strategy of efficiently developing high quality biosimilars that
will allow more people globally to benefit from biologic
innovation,” stated Amit Munshi, president and chief executive
officer, EPIRUS Biopharmaceuticals. “We added new product
candidates to our pipeline, acquired the Bioceros technical
platform, completed several early launch market regulatory
submissions and, through partnerships, expanded our global
commercial network which now enables us to access over 70 markets.
EPIRUS is well positioned in the market as physicians, patients and
payers look for innovative market-based solutions to address the
problem of high drug costs.”
“We are off to a strong start in 2016 with the
initiation of UNIFORMi, the pivotal Phase 3 global registration
study for BOW015 (infliximab, reference biologic Remicade®)
designed to support our filings anticipated in 2017 for marketing
approval in Europe and North America. In 2016, we plan to continue
to increase the number of patients treated with BOW015, which we
expect will help support regulatory filings and provide valuable
in-market experience as we continue to make BOW015 available
globally. We will also focus on completing BOW050
(adalimumab, reference biologic Humira®) process lock and
initiating the global registration program, identifying our U.S.
commercialization strategy and planning for management of cost of
goods sold through efficient manufacturing and supply chain
strategies.”
Key Accomplishments
- Initiated UNIFORM, a 58-week, double-blind, one-to-one
randomized, comparator-controlled multi-center global study, to
compare efficacy, safety and immunogenicity and demonstrate
clinical equivalence of BOW015 with Remicade in active Rheumatoid
Arthritis (RA) patients
- Submitted regulatory applications for marketing authorization
of BOW015 in multiple Southeast Asian and Latin American
countries
- Advanced programs for six product candidates, including
preparing for pivotal Phase 3 global clinical study of BOW050
(adalimumab, reference biologic Humira®)
- Established distribution access to over 70 global markets
through partnerships with Polpharma Group, mAbxience, Sun Pharma
and Livzon
- Expanded biosimilar pipeline, product development capabilities
and experienced management team and staff through the acquisition
of privately-held Bioceros Holdings B.V.
Summary Financial Results
Cash and cash equivalents and marketable
securities, collectively "cash," totaled $31.5 million at
December 31, 2015. The Company is in the process of evaluating
various financing alternatives for operations, by raising
additional capital through equity or debt financings or entering
into collaboration agreements.
Fourth Quarter 2015 Financial
Highlights
Revenue totaled approximately
$285,000 for the fourth quarter of 2015, compared to $4,000 for the
fourth quarter of 2014. The revenue in 2015 related to
collaboration revenue under the Polpharma agreement of $185,000,
royalties and milestones under the Sun Pharmaceutical agreement of
$44,000, and $56,000 related to development service revenues from
the recently acquired Bioceros subsidiary in the Netherlands.
Research and development
(R&D) expenses totaled $10.6 million for the
fourth quarter of 2015, compared to $4.8 million for the fourth
quarter of 2014, an increase of $5.8 million. The increase
was driven by increased development expenses, including headcount,
related to BOW015 and BOW050.
General and administrative (G&A)
expenses totaled $5.8 million for the fourth quarter of
2015, compared to $5.4 million for the fourth quarter of 2014, an
increase of $0.4 million. The increase was primarily driven
by increased headcount and related costs, offset in part by a gain
of $0.6 million related to a change in the contingent consideration
related to the Bioceros acquisition.
Other income and tax (expense),
net totaled $0.7 million for the fourth quarter of 2015,
compared to $(0.2) million for the fourth quarter of 2014, an
increase of $0.9 million. The increase was driven by a gain
of $1.0 million related to the sale of our Canadian subsidiary,
offset in part by increased interest expense of $0.1 million.
Net loss was $15.4 million for the
fourth quarter of 2015, compared to $10.4 million for the fourth
quarter of 2014.
Fiscal 2015 Financial
Highlights
Revenue totaled $576,000 in 2015,
compared to $4,000 in 2014. The revenue in 2015 related to
collaboration revenue under the Polpharma agreement of $235,000,
royalties and milestones under the Sun Pharmaceutical agreement of
$155,000 and $186,000 related to development service revenues from
the recently acquired Bioceros subsidiary in the Netherlands.
Research and development
(R&D) expenses totaled $31.0 million in 2015,
compared to $16.3 million in 2014, an increase of $14.7
million. The increase was driven by increased development
expenses, including headcount, related to BOW015 and BOW050, as
well as an impairment charge related to the Z944 intangible asset
of $1.7 million and a one-time $1.8 million commitment charge for
commercial batches of BOW015.
General and administrative (G&A)
expenses totaled $21.9 million in 2015, compared to $23.0
million in 2014, a decrease of $1.1 million. The decrease was
primarily due to costs incurred in the third quarter of 2014
related to severance of former Zalicus employees of $1.8 million,
professional fees related to becoming a public company of $2.1
million and a gain of $0.6 million related to a change in the
contingent consideration related to the Bioceros acquisition,
offset in part by increased headcount and related costs and a
one-time settlement fee of $2.2 million related to the RLS
Settlement Agreement recorded in the second quarter of 2015.
Other income and tax (expense),
net totaled $0.1 million in 2015, compared to $(2.6)
million in 2014, an increase of $2.7 million. The
increase was primarily driven by reduced interest expense as a
result of the conversion of convertible notes in March and April
2014 of $2.4 million, a gain of $1.0 million related to the sale of
the Company’s Canadian subsidiary and an income tax benefit of $0.5
million resulting from the asset impairment and amortization of
deferred taxes partially offset in part by interest on debt entered
into in the third quarter of 2014 of $1.3 million.
Net loss was $52.2 million in
2015, compared to $41.8 million in 2014.
Pipeline Status Update
BOW015 (infliximab, reference biologic Remicade®) –
Global Phase 3 registration study initiated in February 2016 for
BOW015 in active RA patients; harmonized global filing anticipated
in 2017.
BOW050 (adalimumab, reference biologic Humira®) –
Harmonized global filing anticipated in 2018.
BOW070 (tocilizumab, reference biologic Actemra®) –
Harmonized global filing anticipated in 2019.
BOW080 (eculizumab, reference biologic Soliris®) -
Harmonized global filing anticipated in 2020.
BOW090 (ustekinumab, reference biologic STELARA®) -
Harmonized global filing anticipated in 2021.
BOW100 (golimumab, reference biologic SIMPONI®) -
Harmonized global filing anticipated in 2022.
Conference Call and WebcastEPIRUS
will hold a conference call this morning, March 15, 2016 at 8:00
a.m. ET, to discuss the financial results and provide a business
update.
Conference Call InformationWhen:
March 15, 2016, 8:00 a.m. ETDial-in: 1-855-638-3957 (United States)
or 1-224-633-1318 (International)Conference ID: 58250825Webcast:
http://ir.epirusbiopharma.com/events.cfmPlease join the conference
call at least 10 minutes early to register. The webcast will be
archived on EPIRUS' website for a period of three months.
About EPIRUS
BiopharmaceuticalsEPIRUS
Biopharmaceuticals (Nasdaq:EPRS) is a pure-play biosimilar
company focused on the global development and commercialization of
biosimilar monoclonal antibodies (mAbs). EPIRUS' goal is to improve
global patient access to important, cost-effective medicines. The
company’s current pipeline of biosimilar product candidates
includes: BOW015 (infliximab, reference biologic
Remicade®) currently marketed outside the U.S. and in an ongoing
global Phase 3 study for registration in Europe and North
America; BOW050 (adalimumab, reference biologic
Humira®); BOW070 (tocilizumab, reference biologic
Actemra®); BOW080 (eculizumab, reference biologic
Soliris®); BOW090 (ustekinumab, reference biologic
STELARA®); and BOW100 (golimumab, reference biologic
SIMPONI®)ii. The reference products for these candidates together
generated approximately $29.2 billion in global sales for
2014, according to EvaluatePharma®. EPIRUS has established multiple
partnerships to support its regulatory and commercialization
efforts in global markets.
Forward-Looking StatementsVarious
statements in this release are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. In addition, when or if used in this document, the
words “may,” “could,” “should,” “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “plan,” “predict” and similar
expressions and their variants, as they relate to EPIRUS or its
management, may identify forward-looking statements. EPIRUS
cautions that these forward-looking statements are subject to
numerous assumptions, risks, and uncertainties, such as EPIRUS’
ability to access sufficient capital resources during the next
twelve months to fund its operations, including the trials and
activities described in this press release, as to which EPIRUS can
provide no assurance. Important factors that may cause actual
results to differ materially from the results discussed in the
forward-looking statements or historical experience include risks
and uncertainties, including the risk that EPIRUS may lack the
financial resources and access to capital to fund proposed
operations; the failure by EPIRUS to secure and maintain
relationships with collaborators and single-source contract
manufacturers; risks relating to in-house cell line and process
development activities; risks relating to clinical trials; risks
relating to the commercialization, if any, of EPIRUS’ proposed
product candidates (such as marketing, regulatory, product
liability, supply, competition, and other risks); dependence on the
efforts of third parties; dependence on intellectual property;
risks related to the loss of any of EPIRUS’ key management
personnel; and other factors that are described in the “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” sections of EPIRUS’ annual
report on Form 10-K for the fiscal year ended December 31, 2014 and
quarterly reports on Form 10-Q for the quarters ended March 31,
2015, June 30, 2015 and September 30, 2015, which are on file with
the SEC and available on the SEC’s website at www.sec.gov. In
addition to the risks described above and in EPIRUS’ annual report
on Form 10-K, quarterly reports on Form 10-Q, current reports on
Form 8-K and other filings with the SEC, other unknown or
unpredictable factors also could affect EPIRUS’ results. There can
be no assurance that the actual results or developments anticipated
by EPIRUS will be realized or, even if substantially realized, that
they will have the expected consequences to, or effects on, EPIRUS.
Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements
attributable to EPIRUS or any person acting on its behalf are
expressly qualified in their entirety by the cautionary statements
contained or referred to herein. EPIRUS cautions investors not to
rely too heavily on the forward-looking statements EPIRUS makes or
that are made on its behalf. The information in this release is
provided only as of the date of this release, and EPIRUS undertakes
no obligation, and specifically declines any obligation, to update
or revise publicly any forward-looking statements, whether as a
result of new information, future events or otherwise.
i. UNIFORM Study – Understanding
BOW015 (infliximab-EPIRUS) and
reference infliximab (Remicade®) in patients with active
rheumatoid arthritis on stable
doses of methotrexate ii. Remicade is a registered
trademark of Johnson and Johnson; Humira is a registered trademark
of AbbVie; Actemra is a registered trademark of Chugai Seiyaku
Kabushiki Kaisha Corp., a member of the Roche Group; Stelara is
owned and marketed by Centocor Ortho Biotech Inc, a wholly owned
subsidiary of Johnson and Johnson; Simponi is marketed by Janssen
Biotech Inc; Soliris is a registered trademark of Alexion
Pharmaceuticals, Inc.
Financial Statements
EPIRUS Biopharmaceuticals,
Inc. |
|
Condensed Consolidated Statements of
Operations |
|
(In thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Fiscal Year Ended December 31, |
|
|
|
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
|
2014 |
|
|
Revenue,
net |
|
$ |
285 |
|
|
$ |
4 |
|
|
$ |
576 |
|
|
$ |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
10,586 |
|
|
|
4,798 |
|
|
|
30,999 |
|
|
|
16,286 |
|
|
|
General and
administrative |
|
|
5,784 |
|
|
|
5,362 |
|
|
|
21,934 |
|
|
|
22,973 |
|
|
Total
operating expenses |
|
|
16,370 |
|
|
|
10,160 |
|
|
|
52,933 |
|
|
|
39,259 |
|
|
Loss from
operations |
|
|
(16,085 |
) |
|
|
(10,156 |
) |
|
|
(52,357 |
) |
|
|
(39,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
Interest expense,
net |
|
|
(369 |
) |
|
|
(282 |
) |
|
|
(1,332 |
) |
|
|
(2,672 |
) |
|
|
Gain on sale of
subsidiary |
|
|
1,016 |
|
|
|
- |
|
|
|
1,016 |
|
|
|
- |
|
|
|
Change in fair value of
warrant liability |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(222 |
) |
|
|
Other income and tax
(expense), net |
|
|
22 |
|
|
|
38 |
|
|
|
463 |
|
|
|
305 |
|
|
|
Total other income
(expense) |
|
|
669 |
|
|
|
(244 |
) |
|
|
147 |
|
|
|
(2,589 |
) |
|
Net
loss |
|
$ |
(15,416 |
) |
|
$ |
(10,400 |
) |
|
$ |
(52,210 |
) |
|
$ |
(41,844 |
) |
|
Net loss
per share--basic and diluted |
|
$ |
(0.63 |
) |
|
$ |
(0.80 |
) |
|
$ |
(2.30 |
) |
|
$ |
(6.81 |
) |
|
Weighted-average number of common shares used in net loss per
share calculation--basic and diluted |
|
|
|
|
|
|
|
|
|
|
24,374,032 |
|
|
12,920,843 |
|
|
|
22,747,826 |
|
|
|
6,141,605 |
|
|
|
|
|
|
|
|
|
|
|
Contact Information:
For investor inquiries:
Marek Ciszewski, J.D.,
EPIRUS Biopharmaceuticals
+1-617-553-9716
mciszewski@epirusbiopharma.com
For media inquiries:
Hope Buggey,
FleishmanHillard
+1-919-336-3786
hope.buggey@fleishman.com
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