- Within 90 Days of FDA PDUFA Action Date for
DWP-450 -
Evolus, Inc. (NASDAQ: EOLS), a company dedicated to aesthetic
medicine, today reported financial results for the third quarter
ended September 30, 2018.
Additional Third Quarter 2018 and Recent
Highlights:
- Received acceptance for resubmission of Biologics License
Application (“BLA”) from the U.S. Food and Drug Administration
(“FDA”) with an assigned February 2, 2019 PDUFA date.
- Raised total net proceeds to Evolus of approximately $67.7
million, before offering expenses, in a follow-on public offering
of Evolus' common stock including the full exercise and closing of
underwriter’s option to purchase additional shares.
- Completed hiring of corporate leadership team including VP of
Sales and direct reports.
- Remain on track for anticipated U.S. commercial launch of
DWP-450 in spring 2019.
David Moatazedi, President and Chief Executive Officer of
Evolus, stated, “During the quarter we achieved a number of key
regulatory and operational milestones that have positioned the
company for a successful commercial launch of DWP-450 in spring
2019. Most notably, we resubmitted our BLA application to the FDA
ahead of schedule and received acceptance of that resubmission from
the FDA in late August, which we believe provides a clear sightline
to commercial launch in Spring 2019. We have also continued to
position the Company for commercial launch by further enhancing our
management team and by building a strong balance sheet with
approximately $105 million in cash at quarter end to support our
near-term corporate objectives. If approved, we look forward to
introducing DWP-450 to physicians and consumers.”
Mr. Moatazedi continued, “In addition to our success in
advancing our U.S. strategy, we were also pleased to announce our
receipt of approval of DWP-450 by Health Canada in August. We see a
meaningful opportunity in Canada and look forward to our partner
Clarion Medical Technologies, Inc launching DWP-450 in the first
half of 2019. In Europe, we anticipate an opinion from the
Committee for Medicinal Product for Human use in the first half of
2019. Pending a favorable opinion, we expect approval prior to
mid-year.”
Third Quarter 2018 Financial Results
Operating expenses for the third quarter ended
September 30, 2018 were $11.5 million, as compared to $2.6
million in the third quarter ended September 30, 2017. The
increase was primarily attributable to expenses related to the
revaluation of future contingent royalties on sales of $2.3
million, stock-based compensation of $1.5 million which increased
largely due to hiring new employees including executives, and
increases in costs related to operating as a public company, offset
by a reduction in clinical trial costs associated with completion
of Evolus' Phase III clinical trials last year.
Non-GAAP operating expense for the third quarter ended
September 30, 2018 was $7.7 million and was calculated as
operating expense excluding stock-based compensation of $1.5
million and a revaluation expense of $2.3 million related to future
royalties on sales.
Net loss for the third quarter ended September 30, 2018 was
$11.8 million, or $0.48 basic and diluted net loss per share,
compared with a net loss of $2.6 million, or $0.16 basic and
diluted net loss per share, for the third quarter ended
September 30, 2017.
Total cash was $105.2 million as of September 30, 2018, an
increase of $61.6 million compared to June 30, 2018. Cash as of
September 30, 2018 includes total net proceeds of $67.7
million from Evolus' July follow-on public offering.
Conference Call Information
Management will host a conference call and webcast to discuss
Evolus' financial results today at 4:30 p.m. ET. The dial-in
numbers are (866) 916-2317 for domestic callers and (703) 925-2662
for international callers, and the conference ID is 6872988.
A replay of the call will be available following its completion
through November 12, 2018. To access the replay, dial (855)
859-2056 for domestic callers and (404) 537-3406 for international
callers and use the replay conference ID 6872988.
A live audio webcast of the call will be available on the
Investor Relations page of the Evolus, Inc. website,
https://investors.evolus.com. A replay of the webcast will be
archived on Evolus' website for 30 days following the completion of
the call.
About Evolus, Inc.
Evolus is a company dedicated to aesthetic medicine focused on
providing physicians and their patients with expanded choices in
aesthetic treatments and procedures. Evolus’ lead candidate
DWP-450, also known by the chemical name prabotulinumtoxinA, is a
900 kDa purified botulinum toxin type A complex that was approved
by Health Canada for the temporary improvement in the appearance of
moderate to severe glabellar lines in adult patients under 65 years
of age and is being evaluated for marketing approval in the United
States and other areas.
Forward-Looking Statements
Statements made in this press release that relate to future
plans, events, prospects or performance are forward-looking
statements as defined under the Private Securities Litigation
Reform Act of 1995. All statements, other than statements of
historical fact, are statements that could be deemed
forward-looking statements, including statements containing the
words “planned,” “expect,” “believes,” “strategy,” “opportunity,”
“anticipates,” “outlook,” “designed,” and similar words.
While these forward-looking statements are based on the current
expectations and beliefs of management, such forward-looking
statements are subject to a number of risks, uncertainties,
assumptions and other factors that could cause actual results to
differ materially from the expectations expressed in this press
release, including the risks and uncertainties disclosed in Evolus’
periodic filings with the Securities and Exchange Commission,
including factors described in the section entitled ”Risk Factors”
in its Annual Report on Form 10-K for the year ended December 31,
2017 and its Quarterly Report on Form 10-Q for the Quarter ended
June 30, 2018, as filed with the Securities and Exchange Commission
on March 29, 2018 and August 2, 2018, respectively, all of which
are available online at www.sec.gov. Readers are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, Evolus
undertakes no obligation to update or revise any forward-looking
statements to reflect new information, changed circumstances or
unanticipated events.
Use of Non-GAAP Financial Measures
Evolus' financial results are prepared in accordance with
Generally Accepted Accounting Principles (“GAAP”). This press
release and the reconciliation tables included in the financial
schedules below include non-GAAP operating expense which is
calculated as total operating expenses, excluding: (i) the
revaluation of contingent royalty obligation payable and (ii)
stock-based compensation expense. Management believes that non-GAAP
operating expense is useful in helping to identify recurring
operation performance and enables management to consistently
analyze the period-to-period financial performance of the core
business operations. Management also believes that non-GAAP
operating expense will enable investors to assess in the same way
management assesses Evolus' current and future operations. Non-GAAP
operating expense should be considered in addition to results
prepared in accordance with GAAP, but should not be considered a
substitute for or superior to GAAP results.
For a reconciliation of non-GAAP Operating Expense to total
operating expenses, the most directly comparable GAAP financial
measure, please see “Reconciliation of GAAP Operating Expense to
Non-GAAP Operating Expense” in the financial schedules below.
Evolus Contacts:
Investor Contacts:Ashwin Agarwal, EvolusTel:
+1-949-284-4559Email: IR@Evolus.com
Brian Johnston, The Ruth GroupTel:
+1-646-536-7028Email: IR@Evolus.com
Media Contacts:Kirsten Thomas, The Ruth GroupTel:
+1-508-280-6592Email: kthomas@theruthgroup.com
Dani Shaffer, Alison Brod Marketing + CommunicationsTel:
+1-212-230-1800Email: evolus@alisonbrodmc.com
Evolus, Inc.Condensed
Statements of Operations and Comprehensive Loss(in
thousands, except net loss per share
data)(Unaudited)
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
| Research and development |
$ |
1,977 |
|
|
$ |
1,465 |
|
|
$ |
5,303 |
|
|
$ |
5,481 |
|
| General and administrative |
7,209 |
|
|
1,151 |
|
|
16,924 |
|
|
3,169 |
|
| Revaluation of contingent royalty obligation
payable |
2,300 |
|
|
— |
|
|
11,400 |
|
|
— |
|
| Depreciation and amortization |
3 |
|
|
— |
|
|
7 |
|
|
218 |
|
| Total operating expenses |
11,489 |
|
|
2,616 |
|
|
33,634 |
|
|
8,868 |
|
|
Loss from operations |
(11,489 |
) |
|
(2,616 |
) |
|
(33,634 |
) |
|
(8,868 |
) |
|
Other expense: |
|
|
|
|
|
|
|
| Interest expense, net |
322 |
|
|
2 |
|
|
750 |
|
|
4 |
|
|
Loss before taxes |
(11,811 |
) |
|
(2,618 |
) |
|
(34,384 |
) |
|
(8,872 |
) |
| Income tax expense |
19 |
|
|
16 |
|
|
41 |
|
|
56 |
|
|
Net loss and comprehensive loss |
$ |
(11,830 |
) |
|
$ |
(2,634 |
) |
|
$ |
(34,425 |
) |
|
$ |
(8,928 |
) |
|
Net loss per share, basic and diluted |
$ |
(0.48 |
) |
|
$ |
(0.16 |
) |
|
$ |
(1.47 |
) |
|
$ |
(0.54 |
) |
|
Weighted-average shares outstanding used to compute basic and
diluted net loss per share |
24,769 |
|
|
16,527 |
|
|
23,417 |
|
|
16,527 |
|
Evolus, Inc.Summary of
Balance Sheet Data(in thousands)
|
|
September 30,
2018 |
|
December 31,
2017 |
|
|
(unaudited) |
|
|
|
Balance Sheet Data: |
|
|
|
|
Cash |
$ |
105,168 |
|
|
$ |
— |
|
|
Working capital |
100,632 |
|
|
(1,237 |
) |
|
Total assets |
183,377 |
|
|
152,233 |
|
|
Total current liabilities |
5,460 |
|
|
212,748 |
|
|
Total liabilities |
88,411 |
|
|
227,776 |
|
|
Accumulated deficit |
(110,583 |
) |
|
(75,543 |
) |
|
Total stockholders’ equity (deficit) |
$ |
94,966 |
|
|
$ |
(75,543 |
) |
Evolus,
Inc.Reconciliation of GAAP Operating Expense to
Non-GAAP Operating Expense(in
thousands)
|
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
Operating expense: |
|
|
|
|
|
|
|
|
GAAP operating expense |
$ |
11,489 |
|
|
$ |
2,616 |
|
|
$ |
33,634 |
|
|
$ |
8,868 |
|
|
Adjustments: |
|
|
|
|
|
|
|
| Revaluation of contingent royalty obligation
payable |
2,300 |
|
|
— |
|
|
11,400 |
|
|
— |
|
| Stock-based compensation |
1,482 |
|
|
226 |
|
|
5,111 |
|
|
472 |
|
|
Non-GAAP operating expense |
$ |
7,707 |
|
|
$ |
2,390 |
|
|
$ |
17,123 |
|
|
$ |
8,396 |
|
Evolus (NASDAQ:EOLS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Evolus (NASDAQ:EOLS)
Historical Stock Chart
From Apr 2023 to Apr 2024
