Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today reported financial results for the three months ended
September 30, 2016. For the third quarter of 2016, Achillion
reported a net loss of $20.7 million or $0.15 per share, compared
with net income of $26.3 million or $0.19 per share for the third
quarter of 2015. Cash, cash equivalents, marketable securities, and
interest receivable as of September 30, 2016 were $409.5 million.
"We continue to advance ACH-4471 and our
platform of small molecule factor D inhibitors,” commented Milind
Deshpande, Ph.D., President and Chief Executive Officer of
Achillion. "Our strong balance sheet, together with our
collaboration with Janssen who is developing JNJ-4178, a
next-generation short-duration treatment regimen for HCV, enables
us to focus on the discovery and development of what could be a
game-changing approach to modulating diseases of the complement
alternative pathway.”
Third Quarter Results
For the three months ended September 30, 2016,
Achillion reported a net loss of $20.7 million compared with net
income of $26.3 million during the same period of 2015.
During the third quarter of 2015, Achillion and
Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen
Pharmaceutical Companies of Johnson & Johnson, completed the
closing of the collaboration providing Janssen with an exclusive,
worldwide license to develop and, upon regulatory approval,
commercialize HCV products and regimens containing one or more of
Achillion's HCV assets. Upon closing in 2015, Achillion received
$225 million from Johnson & Johnson Innovation — JJDC, Inc.
following the issuance of 18,367,346 shares of Achillion at a price
of $12.25 per share.
Achillion recognized in the third quarter of
2015 revenue of $33.8 million under the Janssen Agreement,
representing a portion of the premium paid by JJDC. No revenue was
recognized during the three months ended September 30, 2016.
Research and development expenses were $16.7
million for the three months ended September 30, 2016, compared
with $12.0 million for the same period of 2015. The increase for
the three months ended September 30, 2016 was primarily due to
increased manufacturing; clinical trial and consulting costs
related to ACH-4471, partially offset by decreased manufacturing,
clinical trial and consulting costs related to our HCV compounds
which were licensed to Janssen in 2015.
General and administrative expenses were $4.8
million for the three months ended September 30, 2016, compared
with $4.9 million incurred during the same period in 2015. The
decrease for the three months ended September 30, 2016 was
primarily due to decreased business development consulting fees and
corporate legal fees related to the Janssen Agreement, partially
offset by increased personnel and non-cash stock costs largely
related to the addition of personnel.
Nine Month Results
For the nine months ended September 30, 2016,
Achillion reported a net loss of $57.3 million, compared to a net
loss of $22.0 million in the same period in 2015. During the nine
months ended September 30, 2015, Achillion recognized revenue of
$34.5 million under the Janssen Agreement, representing a portion
of the premium paid by JJDC.
Research and development expenses were $44.1
million and $46.9 million for the nine months ended
September 30, 2016 and 2015, respectively. The decrease for
the nine months ended September 30, 2016 was primarily due to
decreased manufacturing, clinical trial and consulting costs
related to our HCV compounds, which were licensed to Janssen in
2015, partially offset by increased manufacturing, clinical trial
and consulting costs related to ACH-4471. Personnel costs also
increased due to the addition of personnel in our discovery and
development groups.
General and administrative expenses in the
period ending September 30, 2016 were $15.4 million, compared with
$19.2 million incurred during the same period in 2015. The decrease
for the nine months ended September 30, 2016 was primarily due
to decreased consulting fees and corporate legal fees related to
the Janssen Agreement, partially offset by increased personnel and
non-cash stock compensation costs largely related to the addition
of personnel.
Complement Factor D
Platform
“ACH-4471 is the first factor D inhibitor to
demonstrate complement alternative pathway inhibition in humans
after oral dosing,” said Dr. Deshpande. “Through pioneering
research in complement biology, and data emerging from the ACH-4471
clinical program, we are gaining important insights into PK/PD
relationships as well as in vivo biomarkers to guide development in
patients. Upcoming presentations at ASH will highlight
groundbreaking research with ACH-4471 regarding complement biology
and factor D inhibition.”
Phase I Clinical Program
In June 2016, Achillion initiated enrollment and
dosing in an ongoing phase I multiple ascending dose (MAD) study of
ACH-4471 in healthy volunteers. The goal of the MAD study is to
evaluate safety and tolerability as well as to optimize the PK/PD
profile and dosing regimens for further development in
patients.
In the three dose cohorts completed to date,
strong complement inhibition using multiple in vivo as well as ex
vivo assays was observed. The plasma trough concentrations of
ACH-4471 exceeded the range the Company anticipates for potential
treatment of patients. These current projections are based on
emerging data including the benchmarking of ACH-4471 with
eculizumab for inhibition of lysis of PNH red blood cells and the
PK/PD profile of ACH-4471 from the phase I program. In the ongoing
MAD study, Achillion is planning to assess additional dosing
regimens to maintain the projected effective trough concentrations
and safety of ACH-4471.
To date in the MAD study, ACH-4471 has been
generally well tolerated across three dose cohorts (200 mg, 500 mg
or 800 mg given every 12 hours) with no treatment-related SAEs
reported. Two cases of self-limited, ALT elevations (Grade 3 and 4)
were observed post-treatment in the mid- and high dose groups,
respectively, with neither subject exhibiting signs or symptoms of
hepatic decompensation. Both subjects’ ALT levels normalized
without intervention during follow up. Further, no
treatment-associated fever or infections were observed.Achillion
anticipates announcing interim results from this phase I study in
the first half of 2017.
Upcoming Presentations at the 2016
Meeting of the American Society of
Hematology
Today, the American Society of Hematology
announced the titles of two ACH-4471 related posters to be
presented at the 58th annual meeting in San Diego on December 3-6,
2016.
- ‘Effect of complement inhibition by anti-C5 (eculizumab) or a
small molecule inhibitor of Factor D (ACH-4471) on survival of
meningococci in blood from vaccinated adults.’ These data will be
presented by Dr. Dan M. Granoff, UCSF Benioff Children’s Hospital,
a world expert on meningococcal infections.
- ‘Evaluation of bacteria-mediated potential “Bystander”
hemolysis of PNH red cells in vitro: No evidence of significant
complement classical or lectin pathway-mediated hemolysis induced
by microorganisms.’ These data will be presented by Dr. Xuan Yuan
from the laboratory of Dr. Robert Brodsky, Johns Hopkins
University, a leading PNH expert.
In addition, Achillion recently presented a
poster at the XXVIth International Complement Workshop in
Kanazawa, Ishikawa, Japan, demonstrating that ACH-4471 does not
affect bacterial killing via lysis or opsonophagocytosis using E.
coli as a test pathogen.
These data expand Achillion's understanding of
complement biology and demonstrate the potential advantages of
inhibition of factor D in treatment of complement-mediated
diseases.
Ophthalmology
Achillion’s leading research in medicinal
chemistry and structural biology has led to the development of
factor D inhibitors which also have properties appropriate for
ocular delivery. The company is now advancing small molecule
candidates with characteristics appropriate for treatment of dry
AMD. Preclinical studies have demonstrated ocular safety and
desirable tissue distribution. Achillion is working on approaches
that could be used to deliver its small molecule factor D
inhibitors to the eye less frequently than other treatments in
development.
Janssen Collaboration
In September 2016, Achillion announced positive
interim results from the Janssen-sponsored 604 phase IIa clinical
trial of the triple combination of simeprevir, AL-335 and
odalasvir, the combination now referred to as JNJ-4178, which
achieved 100 percent SVR12, or sustained viral response 12
weeks after the completion of treatment, for both 8-week and 6-week
treatment durations in HCV genotype 1 infected patients . Based on
these positive results, Janssen plans to advance the triple
combination in a phase IIb clinical study (OMEGA-1) in HCV patients
along with the expanded 604 study. Janssen recently announced that
enrollment in the phase IIb study is targeted to begin in the
fourth quarter of 2016.
About the Achillion Complement Factor D
Platform
Achillion has leveraged its internal discovery
capabilities and a novel complement-related platform to develop
small molecule drug candidates that are oral inhibitors of
complement factor D. Factor D is an essential serine protease
involved in the complement pathway, a part of the innate immune
system. Achillion's complement platform is focused on seeking to
advance small molecule compounds that inhibit factor D and can
potentially be used in the treatment of immune-related diseases in
which complement alternative pathway plays a critical role.
Potential indications being evaluated for these compounds include
paroxysmal nocturnal hemoglobinuria (PNH), C3 glomerulopathy (C3G),
and dry age-related macular degeneration (dry AMD).
About HCV
Globally, HCV infection is a leading cause of
liver disease and liver related mortality. It is currently
estimated that more than 150 million people are infected with HCV
worldwide including approximately 3 million people in the United
States. Three-quarters of the HCV patient population is
undiagnosed; it is a silent epidemic and a major global health
threat. Chronic hepatitis, if left untreated, can lead to permanent
liver damage that can result in the development of liver cancer,
liver failure or death. Despite available treatments, there remains
a significant unmet need for many patients infected with HCV.
About Achillion
Pharmaceuticals
Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) is
a science-driven, patient-focused company seeking to leverage its
strengths across the continuum from discovery to commercialization
in its goal of providing better treatments for people with serious
diseases. The company employs a highly-disciplined discovery and
development approach that has allowed it to pursue best-in-class
oral antiviral therapy for chronic hepatitis C (HCV) and build a
platform of potent and specific complement inhibitors. Achillion is
rapidly advancing its efforts to become a fully-integrated
pharmaceutical company with a goal of bringing life-saving
medicines to patients with rare diseases. More information is
available at http://www.achillion.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are subject to risks, uncertainties and
other important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements.
Achillion may use words such as “expect,” “anticipate,” “project,”
“target,” “intend,” “plan,” “aim,” “believe,” “seek,” “ estimate,”
“can,” “could” “focus,” “will,” “look forward,” “goal,” and “may”
and similar expressions to identify such forward-looking
statements. These forward-looking statements also include
statements about: Achillion’s expected plans, timing, data readouts
and results from ongoing and planned clinical trials of both
ACH-4471 and HCV development candidates being advanced by Janssen
under Achillion’s collaboration with Janssen; the planned
advancement of Achillion’s other small molecule factor D
inhibitors, including those for the treatment of dry AMD; and
statements concerning Achillion’s strategic goals, milestone plans,
and prospects. Among the important factors that could cause actual
results to differ materially from those indicated by such
forward-looking statements are risks relating to, among other
things Achillion’s ability to: advance the preclinical and clinical
development of its complement factor D inhibitors under the
timelines it projects in current and future preclinical studies and
clinical trials; obtain and maintain patent protection for its drug
candidates and the freedom to operate under third party
intellectual property; demonstrate in any current and future
clinical trials the requisite safety, efficacy and combinability of
its drug candidates; obtain and maintain necessary regulatory
approvals; establish commercial manufacturing arrangements;
identify, enter into and maintain collaboration agreements with
third-parties, including the current collaboration with Janssen;
compete successfully in the markets in which it seeks to develop
and commercialize its product candidates and future products;
manage expenses; manage litigation; raise the substantial
additional capital needed to achieve its business objectives; and
successfully execute on its business strategies. Furthermore,
because Janssen is solely responsible for the development and
commercialization of Achillion’s HCV assets under the exclusive
worldwide license Achillion granted to it and has the deciding vote
on all collaboration matters, Janssen generally has full discretion
over all development plans and strategies and may not advance the
HCV programs in the time frames Achillion or Janssen projects, or
at all, including with regard to the planned phase IIb combination
trial that include Achillion’s licensed drug candidates. These and
other risks are described in the reports filed by Achillion with
the U.S. Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the fiscal quarter ended June 30,
2016, and its subsequent SEC filings.
-- Financial Tables Attached
--
ACHILLION PHARMACEUTICALS INC. (ACHN) |
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Statements of
Operations |
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(Unaudited, in thousands, except per share
amounts) |
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Three Months
Ended |
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Nine Months
Ended |
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September
30, |
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September
30, |
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2016 |
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2015 |
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2016 |
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2015 |
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Revenue |
$ |
- |
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|
$ |
33,820 |
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$ |
- |
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$ |
34,531 |
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Operating
expenses: |
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Research
and development |
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16,701 |
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11,983 |
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44,133 |
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46,912 |
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General
and administrative |
|
4,848 |
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|
4,856 |
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15,443 |
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19,226 |
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Total
operating expenses |
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21,549 |
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16,839 |
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59,576 |
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|
66,138 |
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Loss from
operations |
|
(21,549 |
) |
|
|
16,981 |
|
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|
(59,576 |
) |
|
|
(31,607 |
) |
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Other income
(expense): |
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Interest
income |
|
846 |
|
|
|
346 |
|
|
|
2,353 |
|
|
|
723 |
|
|
Interest
expense |
|
(27 |
) |
|
|
(12 |
) |
|
|
(54 |
) |
|
|
(42 |
) |
|
Other
Income |
|
- |
|
|
|
8,944 |
|
|
|
- |
|
|
|
8,944 |
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NetIncome (loss) |
$ |
(20,730 |
) |
|
$ |
26,259 |
|
|
$ |
(57,277 |
) |
|
$ |
(21,982 |
) |
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Net income (loss) per
share - basic |
$ |
(0.15 |
) |
|
$ |
0.19 |
|
|
$ |
(0.42 |
) |
|
$ |
(0.18 |
) |
|
Net income (loss) per
share - diluted |
$ |
(0.15 |
) |
|
$ |
0.19 |
|
|
$ |
(0.42 |
) |
|
$ |
(0.18 |
) |
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Weighted average shares
outstanding - basic |
|
136,681 |
|
|
|
136,439 |
|
|
|
136,647 |
|
|
|
121,896 |
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|
Weighted average shares
outstanding - diluted |
|
136,681 |
|
|
|
140,024 |
|
|
|
136,647 |
|
|
|
121,896 |
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Balance Sheets |
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(Unaudited, in thousands) |
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September
30, |
|
December
31, |
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|
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|
2016 |
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|
2015 |
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Cash, cash equivalents,
marketable securities and interest and subscriptions
receivable |
$ |
409,550 |
|
|
$ |
460,540 |
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|
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Working capital |
|
398,082 |
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|
|
447,930 |
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Total assets |
|
415,193 |
|
|
|
464,525 |
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Long-term
liabilities |
|
221 |
|
|
|
231 |
|
|
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Total liabilities |
|
13,982 |
|
|
|
14,889 |
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Total stockholders'
equity |
|
401,211 |
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|
449,636 |
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Investors:
Glenn Schulman, PharmD, MPH
Executive Director, Investor Relations
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Media:
Liz Power
Senior Director, Public Relations
Achillion Pharmaceuticals, Inc.
Tel: (203) 752-5509
lpower@achillion.com
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