- Completed enrollment of Phase 2 clinical
trial of ACH-4471 in PNH as monotherapy -- Interim
data and strategic update planned for December 17, 2018
–- September 30, 2018 cash & securities
position of $283 million – - Mary Kay Fenton
to step down as CFO at year-end 2018 -
Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN), a
clinical-stage biopharmaceutical company focused on advancing
its oral factor D inhibitors into late-stage development and
commercialization, today reported financial results for the three
and nine months ended September 30, 2018.
“In my first full quarter as CEO, our priorities
have been to strengthen the leadership team, improve clinical
execution and create a data-driven, patient-centric portfolio
strategy. This quarter we added several experienced executives
including, Paul Firuta as Chief Operating Officer, Dr. Steven
Zelenkofske as Chief Medical Officer, Anthony Gibney as Chief
Business Officer, and Dr. Kevin Malobisky as Senior Vice President
Regulatory Affairs, Quality & Compliance. We continue to build
development capabilities and therapeutic area expertise as we
advance Achillion from a discovery and early-stage development
organization to a patient-focused, late-stage development company.
We have made these changes while reducing overall headcount and our
projected cash-burn rate for the full year 2018 to less than $65
million,” said Joe Truitt, President and Chief Executive
Officer.
“In the third quarter we completed enrollment in
our Phase 2 PNH monotherapy trial of ACH-4471, initiated ten
additional clinical trial sites to support our C3G development
program, and commenced development of a comprehensive portfolio
strategy that we plan to communicate to investors in December 2018.
We also plan to provide interim data on all open-label ACH-4471
clinical trials as well as Phase 1 safety and pharmacokinetics
interim data from the single ascending dose trials with our
second-generation factor D compounds, ACH-5228 and ACH-5548,”
Truitt noted. “We believe our innovative and differentiated factor
D inhibitors have the potential to address unmet medical needs in
patients with PNH and C3G as well as additional complement mediated
diseases, together representing significant value-creation
opportunities.”
Truitt continued, “Additionally, after 18 years
with Achillion, Mary Kay Fenton has decided to step down from
Achillion and her role as Chief Financial Officer effective year
end 2018. Mary Kay joined Achillion at its inception and during her
tenure has played a leadership role in establishing and growing the
company through business development deals and a number of capital
market transactions including Achillion’s IPO and listing on
Nasdaq. On behalf of the entire company, I would like to thank Mary
Kay for her many significant contributions. Her expertise in
finance and operations were instrumental in transforming Achillion
from a research organization into a clinical stage development
company.”
“Achillion has talented employees, a robust
balance sheet and exciting prospects in its clinical development
programs, and I look forward to its continued success,” said
Fenton. “I am also excited to explore new opportunities in
the next phase of my career.”
Third Quarter Financial
Results
For the three months ended September 30, 2018,
Achillion reported a net loss of $15.9 million compared with a net
loss of $19.3 million during the same period of 2017. Cash, cash
equivalents, marketable securities, and interest receivable as of
September 30, 2018 was $283.1 million compared with $295.8 million
as of June 30, 2018. Research and development expenses were $13.1
million for the three months ended September 30, 2018, compared
with $15.6 million for the same period of 2017. The decrease for
the three months ended September 30, 2018 was primarily due to
decreased manufacturing and formulation costs related to ACH-5228
and decreased discovery research costs related to the Company’s
intravitreal factor D inhibitors, combined with decreased personnel
costs and non-cash stock compensation. These amounts were partially
offset by increased clinical trial costs related to ACH-4471 and
preclinical costs related to ACH-5548.
For the three months ended September 30, 2018,
general and administrative expenses were $4.2 million, compared
with $4.8 million incurred during the same period in 2017. The
decrease for the three months ended September 30, 2018 was
primarily due to decreased non-cash stock compensation expense
related to the Company’s former chief executive officer combined
with fewer employees.
Non-cash stock compensation expense totaled $1.6
million for the three months ended September 30, 2018 as compared
with $2.4 million for the same period in 2017 and is included in
research and development expenses and general and administrative
expenses.
Nine Month Financial
Results
For the nine months ended September 30, 2018,
Achillion reported a net loss of $53.7 million, compared to a net
loss of $62.0 million in the same period in 2017. For the nine
months ended September 30, 2018, research and development expenses
totaled $39.3 million, compared with $49.4 million during the same
period in 2017. The decrease for the nine months ended
September 30, 2018 was primarily due to decreased
manufacturing and formulation costs related to ACH-5228 and
decreased discovery research costs related to the Company’s
intravitreal factor D inhibitors, combined with decreased personnel
costs and non-cash stock compensation due to fewer employees,
including fewer executives. These amounts were partially offset by
increased clinical trial costs related to ACH-4471 and preclinical
costs related to ACH-5548.
General and administrative expenses were $16.6
million for the nine months ended September 30, 2018, compared to
$15.9 million in the same period in 2017. The increase for the nine
months ended September 30, 2018 was primarily due to increased
personnel and non-cash stock-based compensation charges related to
the transition of the Company’s former chief executive officer,
partially offset by decreased consulting fees.
Non-cash stock compensation expense totaled $7.5
million for the nine months ended September 30, 2018 as compared
with $8.4 million for the same period in 2017 and is included in
research and development, general and administrative, and
restructuring expenses.
The Company expects that research and
development expense during the fourth quarter of 2018 will increase
slightly as a result of increased clinical trial activity, and that
general and administrative expenses during the fourth quarter of
2018 will be consistent with prior 2018 quarters. Annual total
research and development expense is expected to be in the range of
$55 to $58 million and annual total general and administrative
expense is expected to be in the range of $22 to $24 million.
Annual cash utilization, which excludes non-cash expenses, is
expected to be between approximately $62 to $65 million.
ACH-4471, Complement Factor D Inhibitor
for PNH and C3G
Achillion’s first generation oral factor D
inhibitor, ACH-4471 is being evaluated for safety and efficacy with
Phase 2 clinical programs in both paroxysmal nocturnal
hemoglobinuria (PNH) and C3 glomerulopathy (C3G).
The PNH program consists of two trials: A Phase
2 clinical trial in untreated PNH patients where ACH-4471 is being
assessed as a monotherapy; the second trial is Phase 2 clinical
trial evaluating ACH-4471 in patients who are inadequately
controlled or sub-optimally responding to eculizumab, which is a
therapy for patients with PNH.
The C3G program consists of three currently
recruiting Phase 2 clinical trials: a 14-day biomarker study, a
six-month blinded, placebo-controlled study, and a 12-month open
label study.
More information is available at
http://www.achillion.com/patients-and-clinicians/
ACH-5228 and ACH-5548, Complement Factor
D Inhibitors
ACH-5228 and ACH-5548 are next-generation oral
factor D inhibitors currently in Phase 1 clinical trials. In
preclinical studies, these compounds demonstrated enhanced potency
as well as improved pharmacokinetic properties that may allow for a
reduced dosing frequency.
Achillion plans to provide interim data on all
open-label ACH-4471 clinical trials as well as Phase 1 safety and
pharmacokinetics interim data from the single ascending dose trials
of its next-generation factor D compounds, ACH-5228 and ACH-5548,
on December 17, 2018, more details to follow.
About Achillion
Pharmaceuticals
Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN)
is a clinical-stage biopharmaceutical company focused on
advancing its oral factor D inhibitors into late-stage
development and commercialization. Factor D is an essential
serine protease involved in the alternative pathway of the
complement system, a part of the innate immune system. Achillion is
initially focusing its drug development activities on alternative
pathway-mediated diseases where there are no approved therapies or
where existing therapies are inadequate for patients. Potential
indications being evaluated for its compounds include paroxysmal
nocturnal hemoglobinuria (PNH), C3 glomerulopathy (C3G), and immune
complex mediated membranoproliferative glomerulonephritis
(IC-MPGN). Each of the product candidates in the Company’s oral
factor D portfolio was discovered in its laboratories and is wholly
owned. To advance its investigational product candidates into
Phase 3 clinical trials and commercialization, the Company plans to
work closely with key stakeholders including patients, payors,
regulators and healthcare professionals. 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: the potential benefits of factor D
inhibition as a treatment for complement-mediated diseases;
the potential benefits of, and indications for, Achillion’s
compounds that inhibit factor D, including ACH-4471, ACH-5228 and
ACH-5548; Achillion’s belief that its portfolio of compounds
could expand factor D portfolio opportunities, provide strategic
optionality or create significant value; Achillion’s expectations
regarding the advancement of, and timeline for reporting results
from, clinical trials of its product candidates as well as its
ability to advance additional compounds; and other statements
concerning Achillion’s strategic goals, efforts, 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: demonstrate in any current and
future clinical trials the requisite safety, efficacy and
combinability of its product candidates; 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 product candidates and the freedom to operate under third
party intellectual property; obtain and maintain necessary
regulatory approvals, and the granting of orphan designation does
not alter the standard regulatory requirements and process for
obtaining such approval; establish commercial manufacturing
arrangements; identify, enter into and maintain collaboration and
other commercial agreements with third-parties; 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 fiscal quarter ended June 30, 2018, and any
other SEC filings that Achillion makes from time to time.
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.
|
Investors & Media:Brian
Di DonatoVice President, Investor Relations and Corporate
CommunicationsAchillion Pharmaceuticals, Inc.Tel. (215)
709-3032bdidonato@achillion.com |
-- Financial Tables Attached
--
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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 |
|
Nine Months
Ended |
|
September
30, |
|
September
30, |
|
|
|
|
|
|
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
Revenue |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
13,137 |
|
|
|
15,620 |
|
|
|
39,279 |
|
|
|
49,368 |
|
General
and administrative |
|
4,152 |
|
|
|
4,843 |
|
|
|
16,560 |
|
|
|
15,853 |
|
Restructuring charges |
|
75 |
|
|
|
- |
|
|
|
1,900 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Total
operating expenses |
|
17,364 |
|
|
|
20,463 |
|
|
|
57,739 |
|
|
|
65,221 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(17,364 |
) |
|
|
(20,463 |
) |
|
|
(57,739 |
) |
|
|
(65,221 |
) |
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
Interest
income |
|
1,484 |
|
|
|
1,133 |
|
|
|
4,093 |
|
|
|
3,225 |
|
Interest
expense |
|
(4 |
) |
|
|
(8 |
) |
|
|
(25 |
) |
|
|
(37 |
) |
|
|
|
|
|
|
|
|
Net loss |
|
(15,884 |
) |
|
|
(19,338 |
) |
|
|
(53,671 |
) |
|
|
(62,033 |
) |
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
(0.12 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.45 |
) |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding - basic and diluted |
|
138,586 |
|
|
|
137,375 |
|
|
|
138,344 |
|
|
|
136,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets |
|
|
|
|
|
|
|
(Unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents,
marketable securities and interest receivable |
$ |
283,138 |
|
|
$ |
331,845 |
|
|
|
|
Working capital |
|
277,810 |
|
|
|
291,054 |
|
|
|
|
Total assets |
|
289,177 |
|
|
|
337,613 |
|
|
|
|
Long-term
liabilities |
|
47 |
|
|
|
214 |
|
|
|
|
Total liabilities |
|
8,671 |
|
|
|
13,098 |
|
|
|
|
Total stockholders'
equity |
|
280,506 |
|
|
|
324,515 |
|
|
|
|
|
|
|
|
|
|
|
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