Aclaris Therapeutics Reports First Quarter 2018 Financial Results and Provides Update on Clinical and Commercial Developments...
May 08 2018 - 4:01PM
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company committed to identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in aesthetic and medical dermatology, and immunology, today
announced financial results for the first quarter 2018 and provided
an update on its clinical development and commercial
programs.
“The first quarter of 2018 was a busy one as we prepared for the
launch of ESKATA™ (hydrogen peroxide) Topical Solution, 40% (w/w),
the first and only FDA-approved topical treatment for raised
seborrheic keratosis (SK). We held the ESKATA Launch Meeting last
week, and ESKATA is now officially available for physicians and
their patients,” said Brett Fair, Chief Commercial Officer of
Aclaris.
Commercial Update:
- Successful rollout and implementation of the ESKATA Early
Experience Initiative (EEI).
- Program expanded to over 700 accounts to accommodate market
demand for ESKATA.
- Ongoing in-service programs to support successful training and
product integration.
- Positive initial ESKATA feedback from EEI program captured in
physician and patient post-application surveys.
- Aclaris sales force successful in generating a significant
number of ESKATA pre-orders from targeted accounts ahead of
official launch meeting.
- Commenced health care provider (HCP) order processing and
shipping the week of April 23, 2018.
- ESKATA Launch Campaign Highlights:
- ESKATA Launch Meeting held April 30 – May 4, 2018; Unveiled New
ESKATA Campaign; sales force trained on new tools and resources to
support a successful ESKATA launch.
- ESKATA Consumer website (www.eskata.com) launched May 1, 2018;
includes “Find A Doctor” resource for patients seeking ESKATA
treatment.
- ESKATA HCP website (www.eskatahcp.com) updated with new
campaign and downloadable tools/resources for offices.
- ESKATA Peer-to-peer Speaker Programs beginning in May
2018.
“In March, we announced positive results from the 3-month
follow-up portion of the WART-203 Phase 2 clinical trial of A-101
45% Topical Solution (A-101 45%) for the treatment of common warts
(verruca vulgaris). We are also advancing our topical Janus kinase
(JAK) inhibitor programs, with results from multiple Phase 2 trials
expected this year. As our early-stage pipeline compounds advance
towards the clinic, we continue to progress towards our goal of
becoming a vertically integrated, commercial-stage
biopharmaceutical company with a robust clinical-stage pipeline and
drug discovery engine,” said Dr. Neal Walker, President and Chief
Executive Officer of Aclaris.
Clinical Pipeline Update:
- A-101 45% Topical Solution
- In March 2018, announced positive results from the 3-month,
post-treatment, follow-up evaluation period of the twice-weekly
placebo-controlled Phase 2 trial (WART-203) of A-101 45% Topical
Solution (A-101 45%), an investigational new drug consisting of a
proprietary high-concentration stabilized hydrogen peroxide topical
solution being developed as a prescription treatment for common
warts (verruca vulgaris).
- Over the 3-month post-treatment follow-up period, clinically
and statistically significant greater improvements in common wart
reduction and clearance vs. placebo were observed among subjects
treated with A-101 45%.
- Scheduled an End of Phase 2 meeting with the FDA for mid-2018,
and plan to initiate two pivotal Phase 3 trials in the second half
of 2018.
- JAK Inhibitor Candidates
- AA-202 Topical – an ongoing Phase 2 clinical
trial of ATI-502 for the topical treatment of alopecia areata (AA).
This trial will evaluate the pharmacokinetics, pharmacodynamics and
safety of ATI-502 compared with placebo in 12 patients with AA.
This randomized, double-blind clinical trial is being conducted at
two investigational centers within the United States, and topline
data are expected in the first half of 2018. After completing the
28-day portion of the trial, patients will then enter a 6-month
open label extension during which all patients will receive
drug.
- AUATB-201 Topical – an ongoing Phase 2
open-label clinical trial of ATI-502 for the topical treatment of
AA. This trial will evaluate the effect of ATI-502 on the regrowth
of eyebrows in up to 24 patients with AA. This trial is being
conducted at two investigational centers in Sydney and Melbourne,
Australia, and topline qualitative data are expected mid-2018.
- AA-201 Topical – an ongoing Phase 2 dose
ranging trial of ATI-502 for the topical treatment of AA. This
trial will evaluate the effect of two concentrations of ATI-502 on
the regrowth of hair in a randomized, double-blinded,
parallel-group, vehicle-controlled trial in up to 120 patients with
AA. This trial is being conducted in the United States and data are
expected by year end 2018.
- VITI-201 Topical – an ongoing Phase 2
open-label clinical trial of ATI-502 for the topical treatment of
vitiligo. This trial will evaluate the effect of ATI-502 on the
repigmentation of facial skin in up to 24 patients with vitiligo
and data are expected in the first half of 2019.
- AGA-201 Topical – an ongoing Phase 2
open-label clinical trial of ATI-502 for the topical treatment of
androgenetic alopecia (AGA), also known as male/female pattern hair
loss. This trial will evaluate the effect of ATI-502 on the
regrowth of hair in up to 24 patients with AGA and data are
expected in first half of 2019.
- AUAT-201 Oral – a planned Phase 2 dose ranging
trial of ATI-501, an oral JAK inhibitor for the treatment of AA,
which is anticipated to begin in the first half of 2018. This trial
will evaluate the effect of two concentrations of ATI-501 on the
regrowth of hair in a randomized, double-blinded, parallel-group,
vehicle-controlled trial in 120 to 160 patients with AA. This trial
will be conducted in the United States and data are expected in
mid-2019.
- ATI-450 (MK-2 Inhibitor)
- Investigational New Drug application on track for submission to
the FDA in mid-2019.
Recent Corporate Highlights
- Exclusively licensed the Canadian rights to commercialize A-101
40% Topical Solution for the treatment of raised seborrheic
keratoses to Cipher Pharmaceuticals.
- Appointed Bryan Reasons as a director and Chairman of the Audit
Committee.
Financial Highlights
Liquidity and Capital Resources
As of March 31, 2018, Aclaris had aggregate cash, cash
equivalents and marketable securities of $187.0 million compared to
$208.9 million as of December 31, 2017. The $21.9 million decrease
during the quarter ended March 31, 2018 included:
- Net loss of $30.2 million, offset by $5.4 million of non-cash
stock-based compensation expense, depreciation and amortization,
$2.1 million of net cash provided by changes in operating assets
and liabilities, and $0.9 million for a non-cash expense associated
with an increase in the fair value of a contingent consideration
liability.
- $0.3 million of cash used for purchases of property and
equipment.
- $0.4 million in cash proceeds from the exercise of employee
stock options.
Aclaris anticipates that its cash, cash equivalents and
marketable securities as of March 31, 2018 will be sufficient to
fund its operations into the second half of 2019, without giving
effect to any potential new business development transactions or
financing activities.
First Quarter 2018 Financial Results
- Net loss was $30.2 million for the first quarter of 2018,
compared to $12.6 million for the first quarter of 2017.
- Revenue of $1.1 million and cost of revenue of $1.0 million for
the first quarter of 2018 related to Aclaris’s contract research
business acquired in August 2017.
- Total operating expenses for the first quarter of 2018 were
$31.1 million, compared to $12.9 million for the first quarter of
2017.
-
- Research and development expenses were $13.6 million for the
first quarter of 2018, compared to $7.8 million for the first
quarter of 2017. The increase of $5.8 million was primarily
attributable to a $2.7 million increase in expenses related to the
preclinical and clinical development of Aclaris’s JAK inhibitor
portfolio, a $1.3 million increase in medical affairs activities
and early-stage drug discovery, a $0.9 million increase in fair
value of the contingent consideration liability, a $0.8 million
increase in Aclaris’s A-101 45% topical solution program as Phase 2
clinical trials were initiated in June 2017, and a $0.6 million
increase in personnel-related expenses, including stock-based
compensation, due to increased headcount. These increases were
partially offset by a $0.5 million decrease in ESKATA development
expenses in the first quarter of 2018.
- Sales and marketing expenses were $11.2 million for the first
quarter of 2018, compared to $1.4 million for the first quarter of
2017. The $9.8 million increase is mainly due to increases in
direct marketing and professional fees, as well as other sales and
marketing expenses of $5.8 million, in preparation for the
commercial launch of ESKATA in the second quarter of 2018.
Personnel expenses, including stock-based compensation, increased
by $4.0 million as Aclaris completed the hiring of its field sales
force in the first quarter of 2018.
- General and administrative expenses were $6.3 million for the
first quarter of 2018, compared to $3.7 million for the first
quarter of 2017. The increase of $2.6 million was primarily
attributable to $1.6 million in higher personnel-related expenses,
including stock-based compensation, due to increased headcount, a
$0.4 million increase in professional and legal fees, and a $0.5
million increase in facility, support and other general and
administrative expenses.
2018 Financial Outlook
- Aclaris reiterated its expected 2018 GAAP research and
development (R&D) expenses to be in the range of $67 to $75
million, including estimated stock-based compensation of $9
million. The anticipated increase in R&D expenses in 2018 is
mainly due to the planned execution of Phase 2 clinical trials in
AA, AGA, and vitiligo, two planned pivotal Phase 3 trials in common
warts, and the development of our early stage pipeline
compounds.
- Aclaris reiterated its expected 2018 GAAP selling, general and
administrative (SG&A) expenses to be in the range of $80 to $86
million, including estimated stock-based compensation of $14
million. The anticipated increase in SG&A expenses in 2018 is
primarily the result of the deployment of Aclaris’s new sales force
in January 2018 and the additional selling, marketing and consumer
initiatives to support the commercial launch of ESKATA.
Company to Host Conference CallManagement will
conduct a conference call at 5:00 P.M. ET today to discuss Aclaris’
financial results and provide a general business update. The
conference will be webcast live over the Internet and can be
accessed by logging on to the “Investors” page of the Aclaris
Therapeutics website, www.aclaristx.com, prior to the event.
A replay of the webcast will be archived on the Aclaris
Therapeutics website for 30 days following the call.
To participate on the live call, please dial (844)
776-7782 (domestic) or (661) 378-9535 (international), and
reference conference ID 7386579 prior to the start of the
call.
About Aclaris
Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led
biopharmaceutical company committed to identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in aesthetic and medical dermatology, and immunology. Aclaris
is focused on market segments with no FDA-approved medications
or where treatment gaps exist. Aclaris is based in Wayne,
Pennsylvania and more information about the company can be
found by visiting the Aclaris website
at www.aclaristx.com.
Cautionary Note Regarding Forward-Looking
Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements may be identified by words such as
"believe", "expect", "may", "plan," "potential," "will," and
similar expressions, and are based on Aclaris' current beliefs and
expectations. These forward-looking statements include expectations
regarding Aclaris’ commercial launch of ESKATA, the clinical
development of its drug candidates, including the availability of
data from its ongoing and planned clinical trials and timing for
initiation of planned clinical trials, estimated research and
development and selling, general and administrative expenses for
2018 and its belief that its existing capital resources will be
sufficient to fund its operations into the second half of 2019.
These statements involve risks and uncertainties that could cause
actual results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials, Aclaris' reliance on third parties over which
it may not always have full control, and other risks and
uncertainties that are described in the Risk Factors section of
Aclaris' Annual Report on Form 10-K for the year ended December 31,
2017, Aclaris’ Quarterly Report on Form 10-Q for the quarter ended
March 31, 2018 and other filings Aclaris makes with the U.S.
Securities and Exchange Commission from time to time. These
documents are available under the "Financial Information" section
of the Investors page of Aclaris' website at
http://www.aclaristx.com. Any forward-looking statements speak only
as of the date of this press release and are based on information
available to Aclaris as of the date of this release, and Aclaris
assumes no obligation to, and does not intend to, update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Aclaris Contact Michael Tung, M.D. Senior Vice President
Corporate Strategy/Investor Relations 484-329-2140
mtung@aclaristx.com
|
Aclaris Therapeutics, Inc. |
Condensed Consolidated Statements of Operations |
(unaudited, in thousands, except share and per share
data) |
|
|
|
|
|
|
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|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
|
2018 |
|
|
|
|
2017 |
Revenue |
|
|
|
|
|
|
|
|
$ |
1,118 |
|
|
|
|
|
$ |
- |
|
Cost of revenue |
|
|
|
|
|
|
|
|
|
967 |
|
|
|
|
|
|
‑ |
|
Gross
profit |
|
|
|
|
|
|
|
|
|
151 |
|
|
|
|
|
|
‑ |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development (1) |
|
|
|
|
|
|
|
|
|
13,606 |
|
|
|
|
|
|
7,772 |
|
Sales and
marketing (1) |
|
|
|
|
|
|
|
|
|
11,233 |
|
|
|
|
|
|
1,438 |
|
General
and administrative (1) |
|
|
|
|
|
|
|
|
|
6,260 |
|
|
|
|
|
|
3,720 |
|
Total operating
expenses |
|
|
|
|
|
|
|
|
|
31,099 |
|
|
|
|
|
|
12,930 |
|
Loss from
operations |
|
|
|
|
|
|
|
|
|
(30,948 |
) |
|
|
|
|
|
(12,930 |
) |
Other income, net |
|
|
|
|
|
|
|
|
|
719 |
|
|
|
|
|
|
371 |
|
Net loss |
|
|
|
|
|
|
|
|
$ |
(30,229 |
) |
|
|
|
|
$ |
(12,559 |
) |
Net loss per share,
basic and diluted |
|
|
|
|
|
|
|
|
$ |
(0.98 |
) |
|
|
|
|
$ |
(0.48 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
|
|
|
|
|
|
|
30,885,928 |
|
|
|
|
|
|
26,080,806 |
|
|
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|
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|
|
|
|
|
|
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|
(1) Amounts include
stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
|
|
|
|
|
|
$ |
176 |
|
|
|
|
|
$ |
‑ |
|
Research and
development |
|
|
|
|
|
|
|
|
|
1,727 |
|
|
|
|
|
|
1,217 |
|
Sales and
marketing |
|
|
|
|
|
|
|
|
|
907 |
|
|
|
|
|
|
380 |
|
General and
administrative |
|
|
|
|
|
|
|
|
|
2,333 |
|
|
|
|
|
|
1,556 |
|
Total stock-based
compensation expense |
|
|
|
|
|
|
|
|
$ |
5,143 |
|
|
|
|
|
$ |
3,153 |
|
|
Aclaris Therapeutics, Inc. |
Selected Consolidated Balance Sheet Data |
(unaudited, in thousands) |
|
|
March 31, 2018 |
|
|
|
December 31, 2017 |
|
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
186,977 |
|
|
|
$ |
208,854 |
Total assets |
|
220,622 |
|
|
|
|
243,509 |
Total current
liabilities |
|
13,823 |
|
|
|
|
12,762 |
Total liabilities |
|
20,150 |
|
|
|
|
18,247 |
Total stockholders'
equity |
|
200,472 |
|
|
|
|
225,262 |
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