Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today reported financial results for the three and twelve month
periods ending December 31, 2015.
For the three months ended December 31, 2015,
the Company reported net income of $17.0 million, compared to a net
loss of $21.6 million in the three months ended December 31, 2014.
For the full year ended December 31, 2015, the Company's net loss
was $5.0 million, or $0.04 per share, compared to a net loss of
$69.0 million for the year ended December 31, 2014, or $0.70 per
share. Cash, cash equivalents, marketable securities, and interest
receivable at December 31, 2015 were $460.5 million.
“2015 was a transformational year for Achillion
that we believe positions us for future success. We established a
world-wide collaboration with Janssen, who is currently evaluating
a combination therapy with odalasvir, which we believe has the
potential to change the HCV treatment paradigm. Our strong balance
sheet enables us to advance innovative therapies, discovered by our
scientists, that could significantly improve the lives of patients
with complement-mediated diseases,” commented Milind Deshpande,
Ph.D., President and Chief Executive Officer of Achillion.
Dr. Deshpande further commented, “As a leader in
complement biology, we look forward to achieving a number of
milestones throughout 2016 with ACH-4471, our first,
orally-administered, small molecule complement factor D inhibitor
being developed as a potential treatment for PNH and other
complement-mediated rare diseases. We plan to report interim
results from the ongoing phase 1 trial in healthy volunteers that
aims to generate insights into the safety, tolerability,
pharmacokinetics and pharmacodynamics of ACH-4471 in the second
quarter. And by the end of this year, we plan to report results
from a multiple ascending dose study of ACH-4471 in healthy
volunteers, as well as initiate a phase 2 trial for patients with
PNH.”
Highlights of 2015
- Achillion and Janssen Pharmaceuticals, Inc. (Janssen), one of
the Janssen Pharmaceutical Companies of Johnson & Johnson,
established a 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. Assuming successful development and
commercialization, Achillion is eligible to receive up to $905
million in clinical, regulatory and commercialization milestone
payments. Achillion is also eligible to receive tiered royalty
percentages between mid-teens and low-twenties based upon future
worldwide sales, if any. Janssen is responsible for all development
and commercialization costs within the collaboration. Achillion
received $225 million from Johnson & Johnson Innovation – JJDC,
Inc. relating to the issuance and sale of 18,367,346 shares of
Achillion’s common stock at a price of $12.25 per share.
- Achillion nominated and made a regulatory submission for
ACH-4471, the Company’s first orally-administered small molecule
complement factor D inhibitor, as a potential treatment for PNH and
other complement-mediated diseases.
Key 2016 Planned Milestones
ACH-4471, small-molecule factor D
inhibitor
- In February 2016, Achillion initiated a phase 1
healthy-volunteer single-ascending dose (SAD) trial to explore the
safety, pharmacokinetics and pharmacodynamics of ACH-4471. Interim
results from this trial are anticipated in the second quarter of
2016.
- During the second quarter of 2016, Achillion anticipates
initiation of a phase 1a healthy-volunteer multiple-ascending dose
(MAD) trial to explore the safety, pharmacokinetics and
pharmacodynamics of ACH-4471. Interim results from this trial are
anticipated in the third quarter of 2016.
- During the third quarter of 2016, Achillion anticipates
initiation of a phase 2 trial with ACH-4471 for patients with PNH.
Interim results from this trial are anticipated during the fourth
quarter of 2016.
Dr. Joel Barrish, Chief Scientific Officer at
Achillion, commented, “Achillion has established a robust and
differentiated platform to evaluate and advance potential
complement factor D inhibitors tailored to specific indications.
Throughout 2016, we plan to continue to optimize distinct chemical
candidates with attributes suitable for alternative delivery routes
for potential use in ophthalmic indications, including dry AMD, and
for respiratory indications such as COPD.”
World-wide collaboration for HCV with
Janssen
- Achillion anticipates that interim top-line results from
Janssen’s ongoing phase 2a trial of odalasvir, AL-335, and
simeprevir in patients with treatment-naïve genotype 1 HCV will be
reported during the first half of 2016.
Fourth Quarter 2015 Financial
Results
The Company reported net income of $17.0 million
for the three months ended December 31, 2015, compared to a net
loss of $21.6 million for the three months ended December 31,
2014.
Achillion recognized in the fourth quarter of
2015 revenue of $31.6 million under the Janssen Agreement,
representing a portion of the premium paid by JJDC associated with
its equity purchase of Achillion common stock which was being
recognized over the 180-day technology transfer period. No revenue
was recognized during the three months ended December 31, 2014.
Research and development expenses were $9.6
million in the fourth quarter of 2015, compared to $16.4 million
for the same period of 2014, the change primarily resulting from
increased preclinical and manufacturing costs related to
Achillion’s complement inhibitor program that were offset by
decreased clinical trial costs related to its ACH-3422 clinical
trials, its odalasvir and sofosbuvir combination trial and ACH-3422
clinical and manufacturing costs. Personnel costs and non-cash
stock-based compensation also increased.
For the three months ended December 31, 2015,
general and administrative expenses totaled $5.5 million, compared
to $5.2 million in the same period in 2014, the increase primarily
due to increased personnel and facilities costs due to the addition
of personnel, partially offset by decreased corporate legal
fees.
Year-end 2015 Financial
Results
For the year ended December 31, 2015, the
Company reported a net loss of $5.0 million, compared to a net loss
of $69.0 million in 2014. For the year ended December 31, 2015,
research and development expenses totaled $56.6 million, compared
to $53.5 million in 2014. The increase in research and development
costs from 2014 to 2015 was primarily due to increased preclinical
and manufacturing costs related to the Company’s complement
inhibitor program. These amounts were partially offset by decreased
clinical trial costs related to its ACH-3422 clinical trials,
odalasvir and sofosbuvir combination trial and ACH-2684 clinical
and manufacturing costs. Personnel and non-cash stock-based
compensation costs also increased due to the addition of personnel
in the drug development group.
General and administrative expenses were $24.7
million for the year ended December 31, 2015, compared to $15.9
million for the year ended December 31, 2014, the increase
primarily due to increased business consulting and corporate legal
fees related to the Janssen Agreement, increased corporate fees and
taxes, and increased personnel and non-cash stock-based
compensation costs due to the addition of personnel.
2016 Financial Guidance
At December 31, 2015, Achillion had cash, cash
equivalents, marketable securities and interest receivable of
approximately $460.5 million.
The Company expects that research and
development expenses during 2016 will be approximately $65-70
million and that net cash used in operating activities in 2016 will
be approximately $80 million based on current operating plans,
anticipated timelines and the estimated cost of clinical trials and
product development programs. The net loss per share for fiscal
2016 is anticipated to approximate $0.65-0.70 per share.
About Complement Factor D
Platform
Achillion has leveraged its internal discovery
capabilities and a novel complement-related platform to develop
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 compounds that inhibit
factor D, can be orally-administered, and can potentially be used
in the treatment of immune-related diseases in which complement
plays a critical role. Potential indications being evaluated for
these compounds include paroxysmal nocturnal hemoglobinuria (PNH),
atypical hemolytic uremic syndrome (aHUS), dry age-related macular
degeneration (dry AMD), and chronic obstructive pulmonary disease
(COPD). Achillion anticipates that its platform could play a role
in addressing the needs of all PNH patients, including patients who
have suboptimal response to, or fail to respond to, the currently
available treatments, as well as for patients suffering from other
alternative pathway complement-mediated diseases. Achillion
nominated ACH-4471 for clinical development in December 2015, and
initiated clinical development in February 2016 with a phase 1
healthy volunteer trial assessing single-ascending doses of
ACH-4471. 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,”
“intend,” “plan,” “aim,” “believe,” “seek,” “ estimate,” “can,”
“focus,” “will,” “look forward,” “goal,” and “may” and similar
expressions to identify such forward-looking statements. These
forward-looking statements also include statements about: the
Company’s positioning for success in 2016 and beyond; the potential
benefits of the collaboration with Janssen for treatment of HCV and
the Company’s expectation that interim top-line results from the
ongoing phase 2a trial of odalasvir, AL-335, and simeprevir will be
reported during the first half of 2016; the potential for the
Company’s complement factor D inhibitor program to significantly
improve the lives of patients with complement-mediated diseases;
the Company’s plans to rapidly advance its complement factor D
inhibitor platform, including ACH-4471; the expected plans, timing,
data readouts and results from ongoing and planned clinical trials
of ACH-4471; the Company’s estimates with respect to research and
development expenses and net cash used in operating activities in
2016 and net loss per share for fiscal 2016;and statements
concerning the Company’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 drug candidates, including 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. 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 quarter ended September 30, 2015, and its
subsequent SEC filings.
In addition, any forward-looking statement in
this press release represents Achillion’s views only as of the date
of this press release and should not be relied upon as representing
its views as of any subsequent date. Achillion disclaims any duty
to update any forward-looking statement, except as required by
applicable law.
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ACHILLION PHARMACEUTICALS INC.
(ACHN) |
|
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|
Statements of Operations |
|
|
|
(Unaudited, in thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Year
Ended |
|
|
December
31, |
|
December
31, |
|
|
2015 |
|
2014 |
|
2015 |
|
2014 |
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
31,591 |
|
|
$ |
- |
|
|
$ |
66,122 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
9,642 |
|
|
|
16,426 |
|
|
|
56,553 |
|
|
|
53,515 |
|
|
General
and administrative |
|
5,450 |
|
|
|
5,235 |
|
|
|
24,676 |
|
|
|
15,911 |
|
|
Total
operating expenses |
|
15,092 |
|
|
|
21,661 |
|
|
|
81,229 |
|
|
|
69,426 |
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
16,499 |
|
|
|
(21,661 |
) |
|
|
(15,107 |
) |
|
|
(69,426 |
) |
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest
income |
|
466 |
|
|
|
78 |
|
|
|
1,188 |
|
|
|
455 |
|
|
Interest
expense |
|
(13 |
) |
|
|
(13 |
) |
|
|
(55 |
) |
|
|
(37 |
) |
|
Other
income |
|
- |
|
|
|
- |
|
|
|
8,944 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
16,952 |
|
|
$ |
(21,596 |
) |
|
$ |
(5,030 |
) |
|
$ |
(69,008 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
0.12 |
|
|
$ |
(0.21 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.70 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding - basic and diluted |
|
136,558 |
|
|
|
100,579 |
|
|
|
125,592 |
|
|
|
98,367 |
|
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Balance Sheets |
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|
(Unaudited, in thousands) |
|
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|
|
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|
|
|
|
|
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|
December
31, |
|
December
31, |
|
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents,
marketable securities, interest and subscriptions receivable
|
$ |
460,540 |
|
|
$ |
159,167 |
|
|
|
Working capital |
|
447,930 |
|
|
|
141,816 |
|
|
|
Total assets |
|
464,525 |
|
|
|
156,807 |
|
|
|
Long-term
liabilities |
|
231 |
|
|
|
279 |
|
|
|
Total liabilities |
|
14,889 |
|
|
|
13,338 |
|
|
|
Total stockholders'
equity |
|
449,636 |
|
|
|
143,469 |
|
|
|
|
|
|
|
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Investors:
Glenn Schulman
Senior Director, Investor Relations
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com
Media:
Liz Power
Senior Director, Public Relations
Achillion Pharmaceuticals, Inc.
Tel: (203) 752-5509
lpower@achillion.com
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