EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a biopharmaceutical
company focused on the global development and commercialization of
biosimilar monoclonal antibodies (mAbs), today reported financial
results for the third quarter of 2015, and provided a business
update.
“This is an exciting time for EPIRUS as we bring
monoclonal antibody biosimilars to patients worldwide and execute
our global strategy of building a robust biosimilar business,”
stated Amit Munshi, president and chief executive officer, EPIRUS
Biopharmaceuticals. "We enhanced our global commercialization
capabilities, expanded our biosimilar pipeline and in-house product
development capabilities, gained important patient exposure, filed
in several additional early launch markets, presented BOW015 data
at recent European League Against Rheumatism and American College
of Rheumatology meetings, and achieved readiness for the start of
the pivotal global Phase 3 clinical study for BOW015. We
believe that the combination of the previously completed BOW015
Phase 1 and Phase 3 studies, the global patients treated from early
launch markets, and the pivotal Phase 3, should it be successful,
form the foundation for a strong global regulatory package for
BOW015.”
Recent Key Accomplishments
- Announced multi-product, multi-region, profit-sharing
collaboration with Polpharma Group to advance biosimilar portfolio
targeting $6 billion addressable innovator market
- Acquired Bioceros, a leading provider of services for the
development of mAbs, expanding EPIRUS’ biosimilar pipeline with the
addition of three new product candidates
- Continued to increase number of patients treated with BOW015
globally:
- Approximately 750 patients have been treated with BOW015
- BOW015 was approved in India as InfimabTM and launched in late
2014
- Completed regulatory submissions for marketing authorization of
BOW015 (Infliximab) in multiple countries in Southeast Asia,
including Malaysia, Thailand and Indonesia
- Completed manufacturing readiness to support the initiation of
pivotal global Phase 3 clinical study of BOW015 (Infliximab) in Q1
2016, with harmonized global filing anticipated in 2017 for
marketing approval in Europe, US and Canada
Summary Financial Results
Cash and cash equivalents and marketable
securities, collectively "cash," totaled $44.4 million at
September 30, 2015.
Third Quarter 2015 Financial
Highlights
Revenue totaled $0.2 million
for the third quarter of 2015, compared to $0 for the third quarter
of 2014. The revenue in 2015 relates to royalties and
milestones under the Sun Pharmaceutical agreement of $41,000,
collaboration revenue related to the Polpharma agreement of $50,000
and $131,000 related to development service revenues from the
recently acquired Bioceros subsidiary in the Netherlands.
Research and development
(R&D) expenses totaled $9.2 million for the
third quarter of 2015, compared to $5.4 million for the third
quarter of 2014, an increase of $3.8 million. The increase
was driven by increased development expenses, including headcount,
related to BOW015 and BOW050 as well as an impairment charge
related to our Z944 intangible asset of $1.7 million.
General and administrative (G&A)
expenses totaled $5.1 million for the third quarter of
2015, compared to $8.5 million for the third quarter of 2014, a
decrease of $3.4 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 and professional fees
related to becoming a public company of $1.9 million.
Offsetting these decreases were slightly higher personnel
costs.
Other income and tax (expense), net totaled
$0.1 million for the third quarter of 2015, compared to $6,000 for
the third quarter of 2014, an increase of $0.1 million. This
is primarily due to an income tax benefit of $0.5 million resulting
from the asset impairment offset in part by interest on debt
entered into in the third quarter of 2014 of $0.4 million.
Net loss was $14.0 million for
the third quarter of 2015, compared to $13.9 million for the third
quarter of 2014.
Year-to-Date 2015 Financial
Highlights
Revenue totaled $0.3 million
for the nine months ended September 30, 2015, compared to $0 for
the nine months ended September 30, 2014. The revenue in 2015
relates to royalties and milestones under the Sun Pharmaceutical
agreement of $0.1 million, collaboration revenue related to the
Polpharma agreement of $0.1 million and $0.1 million related to
development service revenues from the recently acquired Bioceros
subsidiary in the Netherlands.
Research and development
(R&D) expenses totaled $20.5 million for the
nine months ended September 30, 2015, compared to $11.5 million for
the nine months ended September 30, 2014, an increase of $9.0
million. The increase was driven by increased development
expenses, including headcount, related to BOW015 and BOW050 as well
as an impairment charge related to our Z944 intangible asset of
$1.7M and a one-time $1.8 million commitment charge for commercial
batches of BOW015 included in the RLS Settlement Agreement.
General and administrative (G&A)
expenses totaled $16.0 million for the nine months ended
September 30, 2015, compared to $17.6 million for the nine months
ended September 30, 2014, a decrease of $1.4 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 and professional fees related to becoming a public company
of $2.1 million, offset in part by increased headcount 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 $0.5 million for the nine months ended
September 30, 2015, compared to $2.3 million for the nine months
ended September 30, 2014, a decrease of $1.8 million. The
decrease 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, 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 $1.0 million.Net loss
was $36.8 million for the nine months ended September 2015,
compared to $31.4 million for the nine months ended September 30,
2014.
Pipeline Status Update
BOW015 (infliximab, reference biologic
Remicade®) – Manufacturing readiness to support clinical study
achieved in November 2015; pivotal global Phase 3 clinical study
initiation planned in Q1 2016; harmonized global filing anticipated
in 2017.
BOW050 (adalimumab, reference biologic Humira®)
- Global pivotal Phase 3 clinical study planned to start in the
second half of 2016; 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,
November 16, 2015 at 8:00 a.m. ET, to discuss financial results
from the quarter ended September 30, 2015 and to provide a general
business update.
When: Monday, November 16, 2015, 8:00 a.m.
ETDial-in: 1-855-638-3957 (United States) or 1-224-633-1318
(International)Conference ID: 67401555 Webcast:
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 biopharmaceutical 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. EPIRUS' current pipeline of
biosimilar product candidates includes: BOW015 (infliximab,
reference biologic Remicade®); 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®)i. The reference products for these
candidates together generated approximately $29.2 billion in global
sales for 2014, according to EvaluatePharma®ii. EPIRUS has
established multiple partnerships to support its regulatory and
commercialization efforts in global markets. For more information
visit EPIRUS’ website at www.epirusbiopharma.com.
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, which change over time. 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 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; risks that EPIRUS
may lack the financial resources and access to capital to fund
proposed operations 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 and June 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 Remicade is a registered trademark of Johnson
and Johnson (www.jnj.com); Humira is a registered trademark of
AbbVie (www.abbvie.com); Actemra is a registered trademark of
Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group
(www.gene.com); Stelara is owned and marketed by Centocor
Ortho Biotech Inc., a wholly owned subsidiary of Johnson and
Johnson (www.jnj.com); Simponi is marketed by Janssen Biotech Inc
(www.janssenbiotech.com); Soliris is a registered trademark of
Alexion Pharmaceuticals, Inc. (www.alxn.com).
ii As reported by EvaluatePharma (data pulled
August 2015)
Financial Statements
EPIRUS Biopharmaceuticals,
Inc. |
|
Condensed Consolidated Statements of
Operations (Unaudited) |
|
(In thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
|
2014 |
|
|
Net
Revenue |
|
$ |
221 |
|
|
$ |
- |
|
|
$ |
291 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
9,172 |
|
|
|
5,397 |
|
|
|
20,526 |
|
|
|
11,488 |
|
|
|
General and
administrative |
|
|
5,091 |
|
|
|
8,532 |
|
|
|
16,037 |
|
|
|
17,612 |
|
|
Total
operating expenses |
|
|
14,263 |
|
|
|
13,929 |
|
|
|
36,563 |
|
|
|
29,100 |
|
|
Loss from
operations |
|
|
(14,042 |
) |
|
|
(13,929 |
) |
|
|
(36,272 |
) |
|
|
(29,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
Interest income
(expense) |
|
|
(368 |
) |
|
|
1 |
|
|
|
(963 |
) |
|
|
(2,390 |
) |
|
|
Other income and tax
(expense), net |
|
|
423 |
|
|
|
(7 |
) |
|
|
441 |
|
|
|
45 |
|
|
|
Total other income
(expense) |
|
|
55 |
|
|
|
(6 |
) |
|
|
(522 |
) |
|
|
(2,345 |
) |
|
Net
loss |
|
$ |
(13,987 |
) |
|
$ |
(13,935 |
) |
|
$ |
(36,794 |
) |
|
$ |
(31,445 |
) |
|
Net loss
per share--basic and diluted |
|
$ |
(0.59 |
) |
|
$ |
(1.28 |
) |
|
$ |
(1.66 |
) |
|
$ |
(8.15 |
) |
|
Weighted-average number of common shares used in net loss per share
calculation--basic and diluted |
|
|
23,750,820 |
|
|
|
10,846,655 |
|
|
|
22,199,801 |
|
|
|
3,857,027 |
|
|
Contact Information
For investor inquiries:
Tom Shea, EPIRUS Biopharmaceuticals
+1-617-600-3471
tshea@epirusbiopharma.com
For media inquiries:
Mike Devine, FleishmanHillard
+1-212-453-2324
michael.devine@fleishman.com
EPIRUS Biopharmaceuticals (CE) (USOTC:EPRSQ)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
EPIRUS Biopharmaceuticals (CE) (USOTC:EPRSQ)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024