Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today reported financial results for the three and twelve month
periods ending December 31, 2016.
For the three months ended December 31, 2016,
the Company reported a net loss of $4.4 million, compared to net
income of $17.0 million in the three months ended December 31,
2015. For the full year ended December 31, 2016, the Company's net
loss was $61.7 million, or $0.45 per share, compared to a net loss
of $5.0 million for the year ended December 31, 2015, or $0.04 per
share. Cash, cash equivalents, marketable securities, and interest
receivable at December 31, 2016 were $392.5 million, not including
an additional $15.0 million milestone payment earned under the
Janssen collaboration in December 2016 and received in January
2017.
“Achillion has established itself as a leader in
complement alternative pathway (AP) research. With the advancement
of ACH-4471 into the clinic, we were first to report inhibition of
AP activity in humans after oral dosing, including robust
suppression of Bb levels, an in vivo marker of biologic activity of
Factor D,” commented Milind Deshpande, Ph.D., President and Chief
Executive Officer of Achillion. “I am excited about the progress we
have achieved in our portfolio of alternative pathway inhibitors
and we remain focused on developing medicines for underserved C3G,
PNH and dry AMD patients.”
Dr. Deshpande further stated, "Over the course
of 2017, we look forward to making progress against our goal to
advance ACH-4471 into phase II studies, first for treatment-naive
PNH patients during the first half of 2017, followed by treatment
of C3G patients during the second half of 2017. In addition,
multiple next-generation oral inhibitors are being assessed in
IND-enabling studies and we intend to bring at least one into
clinical development by the end of 2017. Lastly, our ophthalmology
portfolio now includes several internally discovered factor D
inhibitors that are being optimized in parallel with ocular
delivery technologies with the goal of identifying potential
treatment regimens that can be administered in a minimum of three
month intervals for dry AMD/geographic atrophy.”
Key 2017 Planned Milestones
- ACH-4471, oral factor D inhibitor
- Achillion recently initiated patient screening in a phase II
clinical trial for patients with PNH. The Company anticipates
providing an update on this PNH study and the phase I MAD study
during the first half of 2017.
- During the second half of 2017, Achillion anticipates
initiating a phase II trial with ACH-4471 for patients with C3G,
which includes dense deposit disease (DDD) and C3
glomerulonephritis (C3GN).
- Next generation oral factor D inhibitors
- By the end of 2017, Achillion expects to initiate phase I
clinical development with an oral next-generation, alternative
pathway factor D inhibitor compound.
- Factor D inhibitors for intraocular
administration
- Excessive activation of the complement alternative pathway has
been implicated in multiple therapeutic areas outside of rare
diseases including dry AMD/geographic atrophy (GA). Achillion has
discovered and initiated preclinical testing of multiple compounds
for potential clinical development for GA. The Company anticipates
selecting a lead compound for clinical development by the end of
2017.
Janssen World-wide Collaboration for
HCV
In September 2016, Achillion announced positive
interim results from the Janssen-sponsored 604 phase IIa clinical
trial of the triple combination of odalasvir, simeprevir, and
AL-335, the triple combination now referred to as JNJ-4178, which
achieved 100% 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 initiated in November 2016 a phase IIb
clinical study (OMEGA-1) in HCV patients evaluating both six- and
eight-week treatment durations.
David Apelian, M.D., Ph.D., Chief Medical
Officer of Achillion commented, “Our worldwide collaboration for
HCV with Janssen has continued to make significant progress since
its establishment in mid-2015. In November 2016, JNJ-4178, a
once-daily regimen containing odalasvir, AL-335, and simeprevir,
was advanced into a global phase IIb clinical trial, for which we
earned a $15 million clinical milestone. SVR12 results from this
phase IIb trial, in cohorts of 150 subjects receiving either 6
weeks or 8 weeks of JNJ-4178, are expected to position the program
for potential advancement in phase III in 2018.”
Fourth Quarter 2016 Financial
Results
The Company reported net loss of $4.4 million
for the three months ended December 31, 2016, compared to a net
income of $17.0 million for the three months ended December 31,
2015.
Achillion recognized $15.0 million of revenue
during the three months ended December 31, 2016 related to
achievement of the first clinical milestone in the development of
JNJ-4178 under the Janssen Agreement. In the fourth quarter of
2015, Achillion recognized $31.6 million of revenue under the
Janssen Agreement, representing a portion of the premium paid by
JJDC associated with its equity purchase of Achillion common
stock.
Research and development expenses were $15.0
million in the fourth quarter of 2016, compared to $9.6 million for
the same period of 2015, the change primarily due to increased
manufacturing, clinical trial and consulting costs related to the
advancement of ACH-4471, partially offset by decreased
manufacturing, clinical trial and consulting costs related to our
HCV compounds, which were licensed to Janssen in 2015.
For the three months ended December 31, 2016,
general and administrative expenses totaled $5.3 million, compared
to $5.5 million in the same period in 2015, the decrease primarily
due to decreased business development consulting fees and corporate
legal fees that were incurred in 2015 related to the Janssen
Agreement, partially offset by increased personnel and non-cash
stock compensation largely related to the addition of
personnel.
Year-end 2016 Financial
Results
For the year ended December 31, 2016, the
Company reported a net loss of $61.7 million, compared to a net
loss of $5.0 million in 2015. For the year ended December 31, 2016,
research and development expenses totaled $59.2 million, compared
to $56.6 million in 2015. The increase was primarily due to
increased manufacturing, clinical trial and consulting costs
related to the advancement of the Company's factor D portfolio,
including ACH-4471, partially offset by decreased manufacturing,
clinical trial and consulting costs related to our HCV compounds,
which were licensed to Janssen in 2015. Personnel costs also
increased due to the addition of personnel in our discovery and
development groups.
General and administrative expenses were $20.7
million for the year ended December 31, 2016, compared to $24.7
million for the year ended December 31, 2015, the decrease
primarily due to decreased business development consulting fees and
corporate legal fees that were incurred in 2015 related to the
Janssen Agreement, partially offset by increased personnel and
non-cash stock compensation largely related to the addition of
personnel.
2017 Financial Guidance
The Company expects that research and
development expenses during 2017 will be approximately $75 - 80
million and that net cash used in operating activities in 2017 will
be approximately $70 - 75 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
2017 is anticipated to approximate $0.70 - 0.75 per share.
About the Achillion Alternative Pathway
Complement Factor D Platform
Achillion has leveraged its internal discovery
capabilities and a novel complement-related platform to develop
small molecule drug candidates that includes oral inhibitors of the
complement alternative pathway. Factor D is an essential serine
protease involved in the complement alternative 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 the alternative pathway plays a
critical role. Potential indications currently being evaluated for
these compounds include paroxysmal nocturnal hemoglobinuria (PNH),
C3 glomerulopathy (C3G), and dry age-related macular degeneration
(dry AMD)/geographic atrophy (GA).
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,”
“may,” “potential” 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 GA;
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
September 30, 2016, 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.
-- Financial Tables Attached -- |
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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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Year
Ended |
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December
31, |
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December
31, |
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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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$ |
15,000 |
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$ |
31,591 |
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$ |
15,000 |
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$ |
66,122 |
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Operating
expenses: |
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Research
and development |
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15,029 |
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9,642 |
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59,162 |
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56,553 |
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General
and administrative |
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5,260 |
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5,450 |
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20,703 |
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24,676 |
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Total
operating expenses |
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20,289 |
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15,092 |
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79,865 |
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81,229 |
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Loss from
operations |
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(5,289 |
) |
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16,499 |
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(64,865 |
) |
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(15,107 |
) |
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Other income
(expense): |
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Interest
income |
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874 |
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466 |
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3,227 |
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|
1,188 |
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Interest
expense |
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|
(14 |
) |
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(13 |
) |
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(68 |
) |
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(55 |
) |
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Other
income |
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- |
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- |
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- |
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8,944 |
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Net loss |
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$ |
(4,429 |
) |
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$ |
16,952 |
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$ |
(61,706 |
) |
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$ |
(5,030 |
) |
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Net loss per share -
basic and diluted |
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$ |
(0.03 |
) |
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$ |
0.12 |
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$ |
(0.45 |
) |
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$ |
(0.04 |
) |
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Weighted average shares
outstanding - basic and diluted |
|
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136,693 |
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136,558 |
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136,667 |
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125,592 |
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Balance Sheets |
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(Unaudited, in thousands) |
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December
31, |
|
December 31, |
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2016 |
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2015 |
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Cash, cash equivalents,
marketable securities, and interest receivable |
|
$ |
392,486 |
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$ |
460,540 |
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Working capital |
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368,564 |
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447,930 |
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Total assets |
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413,875 |
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464,525 |
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Long-term
liabilities |
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|
450 |
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231 |
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Total liabilities |
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14,421 |
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|
14,889 |
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Total stockholders'
equity |
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399,454 |
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449,636 |
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Investors & Media:
Glenn Schulman, PharmD, MPH
Executive Director, Investor Relations
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
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