Aclaris Therapeutics Reports Second Quarter 2018 Financial Results and Provides Update on Clinical and Commercial Development...
August 03 2018 - 7:00AM
Management to Host Conference Call at 8:00
AM ET today
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company focused on identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in aesthetic and medical dermatology and immunology, today
announced financial results for the second quarter of 2018 and
provided an update on its clinical development and commercial
programs.
- During the second quarter of 2018 Aclaris launched ESKATA®
(hydrogen peroxide) Topical Solution, 40% (w/w), recording $1.5
million in net product sales.
- In July, Aclaris held an end of Phase 2 meeting with the FDA
regarding A-101 45% Topical Solution (A-101 45%) for the treatment
of common warts (verruca vulgaris) and is on track to start its
planned Phase 3 program in the second half of 2018.
- Aclaris is seeing encouraging results which validate the
topical approach in the ongoing open label studies of its topical
Janus kinase (JAK) inhibitor ATI-502 in patients with Alopecia
Areata (AA) and the more severe and refractory phenotypes -
Alopecia Totalis (AT) and Alopecia Universalis (AU).
- Aclaris remains confident in the ongoing AA-201 Topical trial
of ATI-502 in patients with the less severe phenotype of patchy AA,
data from which is expected in the first half of 2019.
- Aclaris recently started a Phase 2 clinical trial of its
investigational JAK inhibitor ATI-501 oral suspension in patients
with AA, including AT and AU.
“The second quarter represents an important milestone with the
launch of ESKATA. This is an exciting time for Aclaris as we
establish ourselves as a fully integrated commercial organization
with a robust clinical-stage pipeline and drug discovery engine,”
said Dr. Neal Walker, President and Chief Executive Officer of
Aclaris.
Commercial Update: Sales Force
Activity:
- Sales force focused on driving clinical and business
integration in ESKATA accounts; ongoing in-service programs to
support successful training and product integration.
- Over 800 ESKATA accounts opened to date
- Over 40 ESKATA peer-to-peer speaker programs conducted to
date
ESKATA Campaign Highlights:
- ESKATA branded HCP journal ads introduced in major dermatology
journals
- Supported 30 conferences in the second quarter of 2018.
- Continued positive feedback from ESKATA Early Experience
Initiative (EEI) captured in physician and patient post-application
surveys.
Clinical Pipeline Update:
- A-101 45% Topical Solution
- Completed an End of Phase 2 meeting with the FDA in July and
plan to initiate a Phase 3 program for the treatment of common
warts in the second half of 2018.
- JAK Inhibitor Trials:
- AA-202 Topical –
- An ongoing Phase 2 clinical trial of ATI-502 for the topical
treatment of AA. Recently reported interim pharmacokinetic and
pharmacodynamic results for 6 of the 11 enrolled patients; two
patients have withdrawn.
- After completing the 28-day portion of the trial, patients
entered a 6-month open label extension during which all patients
will receive drug.
- Demonstrated drug levels in skin and pharmacodynamic effect as
measured by RNA sequencing.
- Evidence of hair regrowth in the open label extension portion
of this study has been observed.
- Safety results - generally well-tolerated; no treatment related
serious adverse events reported to date.
- The range of time on drug for the nine patients in the open
label extension is 6 to 20 weeks.
-
- AUATB-201 Topical – an ongoing Phase 2
open-label clinical trial of ATI-502 for the topical treatment of
AA in Australia. In this trial Aclaris is evaluating the efficacy
of ATI-502 on the regrowth of eyebrows in patients with AA,
including AT and AU. Interim update:
- 12 patients enrolled; 2 patients have withdrawn.
- Evidence of early signs of hair regrowth has been
observed.
- Safety results - generally well-tolerated; no treatment-related
serious adverse events reported to date.
- The range of time on drug for the 10 patients is 5 to 23
weeks.
-
- AA-201 Topical – an ongoing Phase 2 dose
ranging trial of ATI-502 for the topical treatment of AA. This
trial will evaluate the efficacy 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 in the first half of 2019.
- 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 efficacy 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 efficacy of ATI-502 on the
regrowth of hair in up to 24 patients with AGA and data are
expected in the first half of 2019.
- AUAT-201 Oral – an ongoing Phase 2 dose
ranging trial of ATI-501, an oral JAK inhibitor for the treatment
of AA. This trial will evaluate the efficacy of two concentrations
of ATI-501 on the regrowth of hair in a randomized, double-blinded,
parallel-group, vehicle-controlled trial in up to 80 patients with
AA. This trial will be conducted in the United States and data are
expected in the second half of 2019.
- AD-201 Topical – the first patient has been
dosed in an ongoing Phase 2 clinical trial of ATI-502 in patients
with atopic dermatitis (AD). This open label trial will evaluate
the safety, tolerability and efficacy of ATI-502 applied twice
daily to affected skin for four weeks in up to 30 adult subjects
with moderate-to-severe AD. 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
- Presented at the recent American Hair Research Society (AHRS)
and International Investigative Dermatology (IID) meetings.
- United States Patent and Trademark Office (USPTO) issued U.S.
Patent No. 9,980,983 covering methods of treating seborrheic
keratosis using a stabilized hydrogen peroxide composition.
This patent is listed in the Orange Book for ESKATA and is set to
expire in April 2035, subject to any patent term adjustment or
extension.
- Received Fast Track designation for ATI-502 for the treatment
of AA, including patchy AA, AT and AU.
- Appointed David Gordon, MB, ChB, as Chief Medical
Officer.
Financial Highlights
Second Quarter 2018 Financial Results
- For the quarter ended June 30, 2018, total net revenues were
$3.7 million, which consisted of ESKATA sales of $1.5 million,
contract research revenues of $1.1 million, and other revenue of
$1.0 million. For the six months ended June 30, 2018, total net
revenues were $4.8 million, which consisted of ESKATA sales of $1.5
million, contract research revenues of $2.3 million, and other
revenue of $1.0 million. Cost of revenues for the quarter and six
months ended June 30, 2018 were $1.2 million and $2.1 million,
respectively. There were no revenues or cost of revenues in either
prior year period.
- For the quarter ended June 30, 2018, total operating expenses
were $34.5 million, compared to $15.3 million for the second
quarter of 2017. For the six months ended June 30, 2018,
total operating expenses were $65.6 million, compared to $28.2
million for the same period in 2017.
-
- Research and development (R&D) expenses for the quarter and
six months ended June 30, 2018 were $14.0 million and $27.6
million, respectively, compared to $8.0 million and $15.7 million,
respectively, for the same periods of 2017. The increases of $6.0
million and $11.9 million, respectively, were mainly the result of
the expansion of Aclaris’ JAK inhibitor programs, as multiple Phase
2 trials of ATI-501 and ATI-502 are ongoing in 2018, as well as
medical affairs activities and drug discovery programs, both of
which were not incurred in 2017. Personnel related expenses,
including stock-based compensation, also increased due to increased
headcount to support these programs and as the result of the
acquisition of Confluence in August 2017.
- Sales and marketing (S&M) expenses for the quarter and six
months ended June 30, 2018 were $12.4 million and $23.6 million,
respectively, compared to $2.2 million and $3.6 million,
respectively, for the same periods of 2017. The increases of $10.2
million and $20.0 million, respectively, were mainly the result of
increases in direct marketing and professional fees, as well as
other commercial expenses incurred in preparation for the launch of
ESKATA, which occurred in May 2018. Personnel expenses, including
stock-based compensation, increased as Aclaris completed the hiring
of its field sales force in the first quarter of 2018.
- General and administrative (G&A) expenses for the quarter
and six months ended June 30, 2018 were $8.1 million and $14.4
million, respectively, compared to $5.1 million and $8.9 million,
respectively, for the same periods of 2017. The increases of $3.0
million and $5.5 million, respectively, were mainly the result of
higher personnel-related expenses, including stock-based
compensation, due to increased headcount to support the commercial
launch of ESKATA, and as the result of the acquisition of
Confluence in August 2017. G&A expenses for the quarter and six
months ended June 30, 2018 also included a $1.5 million payment
based on an ESKATA-related milestone, whereas the quarter and six
months ended June 30, 2017 included a $1.0 million ESKATA-related
milestone payment.
- For the quarter ended June 30, 2018, net loss was $31.2
million, or $1.01 per basic and diluted share, as compared to $14.8
million, or $0.56 per basic and diluted share, for the second
quarter of 2017. For the six months ended June 30, 2018, net loss
was $61.4 million, or $1.99 per basic and diluted share, as
compared to $27.4 million, or $1.04 per basic and diluted share,
for the same period of 2017.
Liquidity and Capital Resources
As of June 30, 2018, Aclaris had aggregate cash, cash
equivalents and marketable securities of $164.6 million compared to
$208.9 million as of December 31, 2017.
Aclaris anticipates that its cash, cash equivalents and
marketable securities as of June 30, 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.
2018 Financial Outlook
- Aclaris reiterated its expected 2018 GAAP 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
Aclaris’ early stage pipeline compounds.
- Aclaris reiterated its expected 2018 GAAP selling, general and
administrative (SG&A) expenses, which combine its Sales &
marketing, and General & administrative line items, 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’ 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 Call
Management will conduct a conference call at 8:00 AM ET today to
discuss Aclaris’ financial results and provide a general business
update. The conference call 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 8189419 prior to the start of the
call.
About Aclaris Therapeutics, Inc.Aclaris
Therapeutics, Inc. is a dermatologist-led biopharmaceutical company
focused on identifying, developing, and commercializing innovative
therapies to address significant unmet needs in aesthetic and
medical dermatology and immunology. Aclaris’ focus on market
segments with no FDA-approved medications or where treatment gaps
exist has resulted in the first FDA-approved treatment for raised
SKs and several clinical programs to develop medications for the
potential treatment of common warts, alopecia areata and vitiligo.
For additional information, please visit www.aclaristx.com and
follow Aclaris on LinkedIn.
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, timing for
initiation of planned clinical trials and timing for regulatory
submissions, 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 and other filings
Aclaris makes with the U.S. Securities and Exchange Commission from
time to time. These documents are available under the "Financial
Reporting" 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 Therapeutics,
Inc.Condensed Consolidated Statements of
Operations(unaudited, in thousands, except share and per share
data)
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenues: |
|
|
|
|
|
|
|
ESKATA product
sales, net |
$ |
1,533 |
|
|
$ |
- |
|
|
$ |
1,533 |
|
|
$ |
- |
|
Contract
research |
|
1,143 |
|
|
|
- |
|
|
|
2,261 |
|
|
|
- |
|
Other
revenue |
|
1,000 |
|
|
|
- |
|
|
|
1,000 |
|
|
|
- |
|
Total revenues,
net |
|
3,676 |
|
|
|
- |
|
|
|
4,794 |
|
|
|
- |
|
Cost of revenue |
|
1,181 |
|
|
|
‑ |
|
|
|
2,148 |
|
|
|
‑ |
|
Gross
profit |
|
2,495 |
|
|
|
‑ |
|
|
|
2,646 |
|
|
|
‑ |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development (1) |
|
13,984 |
|
|
|
7,965 |
|
|
|
27,590 |
|
|
|
15,737 |
|
Sales and
marketing (1) |
|
12,368 |
|
|
|
2,188 |
|
|
|
23,601 |
|
|
|
3,626 |
|
General and
administrative (1) |
|
8,121 |
|
|
|
5,142 |
|
|
|
14,381 |
|
|
|
8,862 |
|
Total operating
expenses |
|
34,473 |
|
|
|
15,295 |
|
|
|
65,572 |
|
|
|
28,225 |
|
Loss from
operations |
|
(31,978 |
) |
|
|
(15,295 |
) |
|
|
(62,926 |
) |
|
|
(28,225 |
) |
Other income, net |
|
760 |
|
|
|
457 |
|
|
|
1,479 |
|
|
|
828 |
|
Net loss |
$ |
(31,218 |
) |
|
$ |
(14,838 |
) |
|
$ |
(61,447 |
) |
|
$ |
(27,397 |
) |
Net loss per share,
basic and diluted |
$ |
(1.01 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.99 |
) |
|
$ |
(1.04 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
30,944,899 |
|
|
|
26,594,854 |
|
|
|
30,915,577 |
|
|
|
26,339,250 |
|
|
|
|
|
|
|
|
|
(1) Amounts include
stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
$ |
190 |
|
|
$ |
‑ |
|
|
$ |
366 |
|
|
$ |
‑ |
|
Research and
development |
|
1,756 |
|
|
|
1,304 |
|
|
|
3,483 |
|
|
|
2,521 |
|
Sales and
marketing |
|
1,020 |
|
|
|
400 |
|
|
|
1,927 |
|
|
|
780 |
|
General and
administrative |
|
2,283 |
|
|
|
1,600 |
|
|
|
4,616 |
|
|
|
3,156 |
|
Total stock-based
compensation expense |
$ |
5,249 |
|
|
$ |
3,304 |
|
|
$ |
10,392 |
|
|
$ |
6,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands)
|
|
|
|
|
|
|
June 30, 2018 |
|
December 31, 2017 |
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
164,604 |
|
$ |
208,854 |
Total assets |
|
201,819 |
|
|
243,509 |
Total current
liabilities |
|
20,069 |
|
|
12,762 |
Total liabilities |
|
27,616 |
|
|
18,247 |
Total stockholders'
equity |
|
174,203 |
|
|
225,262 |
|
|
|
|
|
|
Aclaris Contact Michael Tung, M.D. Senior Vice President
Corporate Strategy/Investor Relations 484-329-2140
mtung@aclaristx.com
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