Aclaris Therapeutics Reports First Quarter 2019 Financial Results and Provides Update on Clinical and Commercial Developments...
May 08 2019 - 4:01PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory and
dermatological diseases, today announced its financial results for
the first quarter of 2019, and provided an update on its clinical
development and commercial programs.
Highlights:
- Aclaris submitted an Investigational New Drug (IND) Application
to the U.S. Food and Drug Administration (FDA) for ATI-450, an oral
MK2 inhibitor, for the treatment of rheumatoid arthritis (RA) in
April 2019. It would be Aclaris’ first internally-developed novel
compound to enter the clinical phase of development and its first
inflammatory indication adjacent to dermatology. Aclaris expects to
begin a Phase 1 clinical trial of ATI-450, an investigational
compound, in the second half of 2019.
- In April 2019, Aclaris completed enrollment of more than 1,000
patients across two Phase 3 pivotal clinical trials (THWART-1 and
THWART-2) investigating A-101 45% Topical Solution, an
investigational drug, for the treatment of common warts, and
expects to complete enrollment of Aclaris’ open-label safety
extension trial (WART-303) evaluating the long-term safety of A-101
45% Topical Solution during the second quarter of 2019.
- During the first quarter of 2019, total net revenues were $5.0
million, which included net sales of RHOFADE® (oxymetazoline
hydrochloride) cream, 1% of $3.7 million, building on the positive
momentum from December 2018.
- In April 2019, the United States Patent and Trademark Office
issued U.S. Patent No. 10,265,258 covering methods of treating
alopecia areata (AA) using ruxolitinib or isotopic forms of
ruxolitinib. The claims in this issued patent cover the use of an
effective amount of isotopic forms of ruxolitinib, such as
deuterated ruxolitinib, to treat AA. This patent is exclusively
licensed to Aclaris. This represents the continued expansion of the
IP estate with numerous claims directed against ruxolitinib,
baricitinib, tofacitinib and decernotinib.
“Our development stage pipeline continues to advance with
multiple data read outs expected during the course of the year
across both our Phase 2 and Phase 3 clinical programs.
Additionally, we are excited to move ATI-450, our first internally
generated asset, into the clinic in the second half of this year.
Our drug discovery engine continues to be productive and we look
forward to developing small molecule therapeutics for many
inflammatory conditions that need new treatment approaches.
Finally, we are pleased with the reception to the relaunch and
continued growth of RHOFADE through the first quarter,” said Dr.
Neal Walker, President and Chief Executive Officer of Aclaris.
Clinical Pipeline Update:
- A-101 45% Topical Solution:
- Aclaris’ THWART-1 and THWART-2 trials, investigating A-101 45%
Topical Solution for the treatment of common warts, are progressing
as planned. Aclaris has completed enrollment of more than 1,000
patients across these two trials, and topline data for both trials
are expected in the second half of 2019.
- An open-label safety extension trial (WART-303) evaluating the
long-term safety of A-101 45% Topical Solution for the treatment of
common warts is also ongoing and Aclaris expects enrollment to be
completed during the second quarter of 2019.
- If the results of these trials are positive, NDA submission is
expected in the first half of 2020.
- JAK Inhibitor Trials:
- Aclaris has completed enrollment in all of the following JAK
inhibitor trials:
- AA-201 Topical – This ongoing Phase 2
randomized, double-blinded, parallel-group, vehicle-controlled
trial is evaluating the safety, efficacy, and dose response of two
concentrations of ATI-502, a topical JAK1/3 inhibitor, on the
regrowth of hair in 129 patients with AA. Data are expected during
the second quarter of 2019 and if the results from this trial are
positive, Aclaris’ next steps may include holding an end of Phase 2
meeting with the FDA, and initiating a Phase 3 trial of ATI-502 as
a topical treatment for AA in the first half of 2020.
- AGA-201 Topical – This ongoing Phase 2
open-label clinical trial is evaluating the safety and efficacy of
ATI-502, a topical JAK1/3 inhibitor, on the regrowth of hair in 31
patients with androgenetic alopecia (AGA), also known as
male/female pattern hair loss. 6-month data are expected during the
second quarter of 2019 and 12-month data are expected in the fourth
quarter of 2019. If the results from this trial are positive,
Aclaris expects to initiate an additional Phase 2 trial of ATI-502
for the topical treatment of AGA in the first half of 2020.
- VITI-201 Topical – This ongoing Phase 2
open-label clinical trial is evaluating the safety and efficacy of
ATI-502, a topical JAK1/3 inhibitor, on the repigmentation of
facial skin in 34 patients with vitiligo. 6-month interim data are
expected in mid-2019 and 12-month data are expected in the fourth
quarter of 2019.
- AD-201 Topical – This ongoing Phase 2
open-label clinical trial is evaluating the safety and efficacy of
ATI-502, a topical JAK1/3 inhibitor, in 22 adult patients with
moderate-to-severe atopic dermatitis (AD). Data are expected in
mid-2019.
- AUAT-201 Oral – This ongoing randomized,
double-blinded, parallel-group, placebo-controlled trial is
evaluating the safety, efficacy, and dose response of three
concentrations of ATI-501, an oral JAK 1/3 inhibitor, on the
regrowth of hair in 87 patients with AA. Data are expected in the
second half of 2019.
- ATI-450 (MK2 Inhibitor) – In April, Aclaris
submitted an IND for ATI-450 for the treatment of RA. Aclaris
expects to initiate a Single Ascending Dose / Multiple Ascending
Dose Phase 1 trial in approximately 80 patients in the second half
of 2019. If the IND is allowed by the FDA, Aclaris expects to
initiate a Phase 1 trial in the second half of 2019. If Aclaris
successfully completes the Phase 1 trial, Aclaris expects to
advance ATI-450 into Phase 2 trials in patients with rheumatoid
arthritis and an additional inflammatory indication.
Commercial Update:
- Based on IQVIA Xponent® data for the rolling 4-week period
ended April 19, 2019 compared to the rolling 4-week period ended
January 25, 2019, the average weekly RHOFADE prescriptions have
increased by 20%, the average number of unique RHOFADE prescribers
has increased by 18%, and the average number of RHOFADE
prescriptions per HCP has increased by 3%.
- Total prescriptions for RHOFADE were 11% higher in March 2019
as compared to February 2019, according to the IQVIA Monthly
National Prescription Audit data.
- RHOFADE is currently covered for 85% of commercially-insured
lives and 52% of commercially-insured lives have unrestricted
access, according to Managed Markets Insight & Technology
data.
- Aclaris received approval to market ESKATA (hydrogen peroxide)
cutaneous solution, 685 mg for the treatment in adults of
seborrheic keratoses that are not pedunculated and have up to a
maximum diameter of 15 mm each under the brand name ESKATA in
Finland, Iceland, Netherlands, Norway, Belgium and Czech Republic,
and under the brand name ESKERIELE in the United Kingdom, Germany
and France. Aclaris is seeking a commercial partner or partners to
market the medicine as an aesthetic skin treatment in various
European countries.
Financial Highlights:Liquidity and
Capital Resources
As of March 31, 2019, Aclaris had aggregate cash, cash
equivalents and marketable securities of $136.8 million compared to
$168.0 million as of December 31, 2018. The $31.2 million decrease
during the quarter ended March 31, 2019 included:
- Net loss of $37.6 million, $0.8 million of net cash used in
working capital, and $0.3 million in property and equipment
purchases. These uses were offset by $4.9 million of non-cash
stock-based compensation expense and $2.2 million of non-cash
depreciation and amortization expense.
Aclaris anticipates that its cash, cash equivalents and
marketable securities as of March 31, 2019 will be sufficient to
fund its operations into the fourth quarter of 2020, without giving
effect to any potential new business development transactions or
financing activities.
First Quarter 2019 Financial Results
- Net loss was $37.6 million for the first quarter of 2019,
compared to $30.2 million for the first quarter of 2018.
- Net revenues were $5.0 million for the quarter ended March 31,
2019, which consisted of $3.7 million of net RHOFADE sales, $0.1
million of net ESKATA sales, and $1.3 million of contract research
revenues. This compared to total revenue of $1.1 million for the
quarter ended March 31, 2018, all of which was contract research
revenues. Cost of revenues (excluding amortization) was $2.8
million for the quarter ended March 31, 2019, compared to $1.0
million for the quarter ended March 31, 2018. Amortization of
definite-lived intangibles was $1.7 million for the quarter ended
March 31, 2019 and related to RHOFADE intellectual property
acquired in November 2018.
- Total operating expenses for the first quarter of 2019 were
$37.9 million, compared to $31.1 million for the first quarter of
2018.
- Research and development expenses were $19.9 million for the
first quarter of 2019, compared to $13.6 million for the first
quarter of 2018. The increase of $6.3 million was mainly the result
of the continued advancement of Aclaris’ JAK inhibitor and common
wart programs, as multiple Phase 2 trials of ATI-501 and ATI-502,
and Phase 3 trials of A-101 45% Topical Solution, were ongoing in
the first quarter of 2019, as well as the increased headcount to
support these programs. There was also an increase in preclinical
work for ATI-450, Aclaris’ MK2 inhibitor, as the company prepared
to file its IND in April 2019.
- Sales and marketing expenses were $9.8 million for the first
quarter of 2019, compared to $11.2 million for the first quarter of
2018. The decrease of $1.4 million was primarily the result of
decreases in direct marketing and professional fees, as well as
other commercial and personnel expenses that were incurred in the
first quarter of 2018 to support the commercialization and launch
of ESKATA in May 2018.
- General and administrative expenses were $8.2 million for the
first quarter of 2019, compared to $6.3 million for the first
quarter of 2018. The increase was driven by headcount increases,
professional and legal fees related to the RHOFADE acquisition in
November 2018, costs incurred under a transition services agreement
with Allergan related to RHOFADE, as well as increased medical
affairs activities.
2019 Financial Outlook
- Aclaris reiterated its 2019 expected GAAP research and
development (R&D) expenses to be in the range of $61 to $64
million, including estimated stock-based compensation of $7
million. This expense guidance for R&D in 2019 contemplates the
completion of Aclaris’ Phase 2 clinical trials in AA, open-label
trials in AGA, vitiligo and AD, and two pivotal Phase 3 trials in
common warts, as well as the further advancement of Aclaris’
preclinical pipeline compounds, including ATI-450 and
ATI-1777.
- Aclaris reiterated 2019 expected GAAP sales and marketing
(S&M) expenses to be in the range of $37 to $40 million,
including estimated stock-based compensation of $4 million. This
expense guidance for S&M in 2019 contemplates all sales force
costs and the selling and marketing initiatives to support Aclaris’
marketed products.
- Aclaris reiterated 2019 expected GAAP general and
administrative (G&A) expenses to be in the range of $29 to $31
million, including estimated stock-based compensation of $10
million. This expense guidance for G&A in 2019 contemplates
additional medical affairs, legal and compliance activities to
support Aclaris’ marketed products.
Company to Host Conference CallManagement will
conduct a conference call at 5:00 PM 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
5737199 prior to the start of the
call.
About Aclaris Therapeutics, Inc.Aclaris
Therapeutics, Inc. is a physician-led biopharmaceutical company
committed to addressing the needs of people with
immuno-inflammatory and dermatological diseases who lack
satisfactory treatment options. The company’s diverse and
multi-stage portfolio includes two FDA-approved medicines, one
late-stage investigational medicine, and a pipeline powered by a
robust R&D engine exploring protein kinase regulation. Aclaris
Therapeutics’ active development programs focus on areas where
significant treatment gaps exist, such as common warts, alopecia
areata, and vitiligo. For additional information, please visit
www.aclaristx.com and follow Aclaris on LinkedIn or Twitter
@aclaristx.
Cautionary Note Regarding Forward-Looking
StatementsAny 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 the commercialization of
Aclaris’ marketed products, the clinical development of Aclaris’
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, sales, marketing and general
and administrative expenses for 2019, and its belief that its
existing cash, cash equivalents and marketable securities will be
sufficient to fund its operations into the fourth quarter of 2020.
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 and in commercialization of products, 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, 2018, and other filings Aclaris makes
with the U.S. Securities and Exchange Commission from time to time.
These documents are available under the "SEC filings” 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.Consolidated Statements of Operations(unaudited, in
thousands, except share and per share data)
|
|
Three Months Ended |
|
|
March 31, |
|
|
2019 |
|
2018 |
Revenues: |
|
|
|
|
|
|
Product sales, net |
|
$ |
3,778 |
|
|
$ |
- |
|
Contract research |
|
|
1,263 |
|
|
|
1,118 |
|
Total revenues, net |
|
|
5,041 |
|
|
|
1,118 |
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
Cost of revenues (excludes amortization) (1) |
|
|
2,777 |
|
|
|
967 |
|
Research and development (1) |
|
|
19,919 |
|
|
|
13,606 |
|
Sales and marketing (1) |
|
|
9,828 |
|
|
|
11,233 |
|
General and administrative (1) |
|
|
8,193 |
|
|
|
6,260 |
|
Amortization of definite-lived intangible assets |
|
|
1,659 |
|
|
|
- |
|
Total costs and expenses |
|
|
42,376 |
|
|
|
32,066 |
|
Loss from operations |
|
|
(37,335 |
) |
|
|
(30,948 |
) |
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(230 |
) |
|
|
719 |
|
Net loss |
|
$ |
(37,565 |
) |
|
$ |
(30,229 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ |
(0.91 |
) |
|
$ |
(0.98 |
) |
Weighted average common shares outstanding, basic and
diluted |
|
|
41,248,663 |
|
|
|
30,885,928 |
|
|
|
|
|
|
|
|
(1) Amounts include stock-based
compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
206 |
|
|
$ |
176 |
|
Research and development |
|
|
1,594 |
|
|
|
1,727 |
|
Sales and marketing |
|
|
590 |
|
|
|
907 |
|
General and administrative |
|
|
2,472 |
|
|
|
2,333 |
|
Total stock-based compensation expense |
|
$ |
4,862 |
|
|
$ |
5,143 |
|
|
|
|
|
|
|
|
|
|
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
March 31, 2019 |
|
December 31, 2018 |
Cash, cash equivalents and
marketable securities |
|
$ |
136,755 |
|
$ |
167,972 |
Total assets |
|
|
253,183 |
|
|
275,566 |
Total current liabilities |
|
|
36,228 |
|
|
27,342 |
Total liabilities |
|
|
70,930 |
|
|
60,442 |
Total stockholders' equity |
|
|
182,253 |
|
|
215,124 |
|
|
|
|
|
|
|
Aclaris ContactMichael Tung, M.D. Senior Vice PresidentCorporate
Strategy/Investor Relations 484-329-2140 mtung@aclaristx.com
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