Revance Releases Second Quarter 2018 Results
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing neuromodulators for use in treating aesthetic and
therapeutic conditions, today announced results for the second quarter ended June 30, 2018.
Recent Company Highlights and Upcoming Milestones for DaxibotulinumtoxinA for Injection (RT002)
- Revance expects to complete the SAKURA 3 open-label, long-term safety study of RT002 for the
treatment of glabellar (frown) lines in the fourth quarter of 2018. The Company remains on track to file its Biologics Licensing
Application (BLA) for RT002 to treat glabellar (frown) lines in first half of 2019.
- Revance initiated the ASPEN Phase 3 program with RT002 for the treatment of moderate to severe
isolated cervical dystonia for the U.S. in June of 2018. The program includes a single pivotal trial and an open-label safety
study, each to enroll approximately 300 patients across sites in the U.S., Canada and Europe.
- Announced the appointments of Susanne Fors, Vice President, Regulatory Affairs, Conor Gallagher,
Ph.D., as Head of Medical Affairs, Aesthetics, and Caryn McDowell as Senior Vice President, General Counsel & Corporate
Secretary in May of 2018.
"Our clinical body of work for RT002 injectable, including the SAKURA 1 & 2 pivotal trials for the treatment of glabellar
lines, supports the potential for this product to provide patients and physicians with unequaled, enduring performance. We look
forward to the SAKURA 3 open-label safety study readout in the fourth quarter of this year, followed by the BLA filing in the first
half of 2019," said Dan Browne, President and Chief Executive Officer at Revance. "In parallel to our pre-commercialization plans
underway in the aesthetics market, we are advancing the development of long-acting RT002 in multiple therapeutic indications. We
recently dosed the first patient in our ASPEN Phase 3 Program for RT002 for the treatment of cervical dystonia and look forward to
accomplishing additional clinical milestones in the fourth quarter, including the initiations of Phase 2 trials for the treatment
of plantar fasciitis and upper limb spasticity. With the potential for twice yearly administration, RT002 could represent a
meaningful advancement in neuromodulator treatment."
Summary Financial Results
Cash, cash equivalents and investments as of June 30, 2018 were $233.7 million.
Revenue for the three and six months ended June 30, 2018 was $0.7 million and $0.9 million compared to $0.1 million and
$0.2 million for the same periods in 2017, respectively. The revenue recognized during 2018 represents the portion of revenue
earned from the $25 million upfront payment from Mylan under the biosimilar collaboration and license agreement.
Research and development expenses for the three and six months ended June 30, 2018 were $22.9 million and
$45.1 million compared to $18.3 million and $37.7 million for the same periods in 2017, respectively. The change in research
and development expenses is primarily due to the cervical dystonia Phase 3 clinical trial implementation costs and increased costs
to support manufacturing, quality efforts and research.
General and administrative expenses for the three and six months ended June 30, 2018 were $12.7 million and $26.4
million compared to $8.6 million and $16.4 million for the same periods in 2017, respectively. The increase in general and
administrative expenses is primarily due to increased costs related to personnel, consulting and pre-commercial activities to
support future product launches.
Total operating expenses for the three and six months ended June 30, 2018 were $35.6 million and $71.5
million compared to $26.9 million and $54.1 million for the same periods in 2017, respectively. Stock-based compensation
for the three and six months ended June 30, 2018 was $4.2 million and $8.3 million, respectively. When excluding
depreciation and stock-based compensation, total operating expenses for the three and six months ended June 30,
2018 were $31.0 million and $62.3 million, respectively.
Net loss for the three and six months ended June 30, 2018 was $34.1 million and $69.1 million compared
to $26.9 million and $54.0 million for the same periods in 2017, respectively.
2018 Financial Outlook
Revance reiterates its financial guidance provided in January 2018. Revance expects cash burn for 2018 to be in the range
of $117 to $137 million. Revance expects 2018 GAAP operating expense to be in the range
of $128 to $154 million, which when excluding depreciation of $1 to $3 million and estimated
stock-based compensation of $17 to $21 million, results in projected 2018 non-GAAP operating expense
of $110 to $130 million, driven by increased research and development expenditure and launch preparation activities.
With three clinical programs and preparations to file the BLA for RT002 to treat glabellar (frown) lines all underway, Revance
anticipates 2018 GAAP research and development expense to be in the range of $84 to $101 million, which when
excluding depreciation of $1 to $2 million and estimated stock-based compensation of $7 to $9
million, results in projected 2018 non-GAAP research and development expense of $76 to $90 million.
Conference Call
Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484)
756-4301 for international callers and reference conference ID: 3480629; or from the webcast link in the investor relations section
of the company's website at: www.revance.com.
A replay of the call will be available beginning August 2, 2018 at 4:30pm PT/7:30pm ET to August 3,
2018 at 4:30pm PT/7:30pm ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID:
3480629. The webcast will be available in the investor relations section on the company's website for 30 days following the
completion of the call.
About Revance Therapeutics, Inc.
Revance Therapeutics is an emerging Silicon Valley biotechnology leader developing neuromodulators for the treatment of
aesthetic and therapeutic conditions. Revance uses a unique proprietary, stabilizing excipient peptide technology to create novel,
differentiated therapies. The company’s lead compound, DaxibotulinumtoxinA for Injection (RT002), is in clinical development for a
broad range of aesthetic and therapeutic indications, including glabellar lines, cervical dystonia, plantar fasciitis, upper limb
spasticity and chronic migraine. RT002 has the potential to be the first long-acting neuromodulator. The company is advancing a
robust pipeline of injectable and topical formulations of DaxibotulinumtoxinA. More information on Revance may be found at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to Revance Therapeutics' long-term
financial outlook, expected cash burn and other financial performance, the process and timing of, and ability to complete, current
and anticipated future clinical development of our investigational drug product candidates, including but not limited to initiation
and design of clinical studies for current and future indications, including the timing and results of the SAKURA 3 study of RT002
and ASPEN Phase 3 program, related results and reporting of such results; statements about our business strategy, timeline and
other goals and market for our anticipated products, plans and prospects; including our pre-commercialization plans; and statements
about our ability to obtain regulatory approval, including the timing of potential BLA filing for RT002 to treat glabellar (frown)
lines; and potential benefits of our drug product candidates and our technologies.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from
our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product
development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may
not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug
product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug
product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in
research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and
growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product
candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates;
our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital
requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our
drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially
from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with
the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risk Factors" of
our quarterly report on Form 10-Q filed May 9, 2018. These forward-looking statements speak only as of the date hereof.
Revance disclaims any obligation to update these forward-looking statements.
Use of Non-GAAP Financial Measures
Revance has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included
herein include total non-GAAP operating expense and non-GAAP R&D expense, both of which exclude depreciation and stock-based
compensation. Revance excludes depreciation costs and stock-based compensation expense because management believes the exclusion of
these items is helpful to investors to evaluate Revance's recurring operational performance. Revance management uses these non-GAAP
financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating,
budgeting and financial planning purposes. The non-GAAP financial measures 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.
| |
|
Revance Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
|
| |
|
|
June 30, |
|
December 31, |
|
|
2018 |
|
2017 |
| ASSETS |
| CURRENT ASSETS |
|
|
|
|
| Cash and cash equivalents |
|
$ |
39,282 |
|
|
$ |
282,896 |
|
| Short-term investments |
|
194,452 |
|
|
— |
|
| Prepaid expenses and other current assets |
|
9,148 |
|
|
2,315 |
|
| Total current assets |
|
242,882 |
|
|
285,211 |
|
| Property and equipment, net |
|
12,196 |
|
|
9,250 |
|
| Restricted cash |
|
730 |
|
|
580 |
|
| Other non-current assets |
|
3,315 |
|
|
658 |
|
| TOTAL ASSETS |
|
$ |
259,123 |
|
|
$ |
295,699 |
|
| LIABILITIES AND STOCKHOLDERS’ EQUITY |
| CURRENT LIABILITIES |
|
|
|
|
| Accounts payable |
|
$ |
5,435 |
|
|
$ |
6,805 |
|
| Accruals and other current liabilities |
|
13,569 |
|
|
12,225 |
|
| Deferred revenue, current portion |
|
9,320 |
|
|
— |
|
| Financing obligations |
|
— |
|
|
1,872 |
|
| Total current liabilities |
|
28,324 |
|
|
20,902 |
|
| Derivative liability associated with Medicis settlement |
|
2,717 |
|
|
2,613 |
|
| Deferred revenue, net of current portion |
|
14,800 |
|
|
— |
|
| Deferred rent |
|
3,427 |
|
|
3,339 |
|
| TOTAL LIABILITIES |
|
49,268 |
|
|
26,854 |
|
| Commitments and Contingencies |
|
|
|
|
| STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Common stock, par value $0.001 per share — 95,000,000 shares authorized as of June 30, 2018 and
December 31, 2017; 36,917,723 and 36,516,075 shares issued and outstanding as of June 30, 2018 and December 31, 2017,
respectively
|
|
37 |
|
|
37 |
|
| Additional paid-in capital |
|
821,326 |
|
|
810,975 |
|
| Accumulated other comprehensive loss |
|
(224 |
) |
|
— |
|
| Accumulated deficit |
|
(611,284 |
) |
|
(542,167 |
) |
| TOTAL STOCKHOLDERS’ EQUITY |
|
209,855 |
|
|
268,845 |
|
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
259,123 |
|
|
$ |
295,699 |
|
|
|
|
|
|
|
|
|
|
| |
|
Revance Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
|
| |
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
| Revenue |
|
$ |
686 |
|
|
$ |
75 |
|
|
$ |
880 |
|
|
$ |
150 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
| Research and development |
|
22,871 |
|
|
18,307 |
|
|
45,111 |
|
|
37,714 |
|
| General and administrative |
|
12,734 |
|
|
8,609 |
|
|
26,350 |
|
|
16,363 |
|
| Total operating expenses |
|
35,605 |
|
|
26,916 |
|
|
71,461 |
|
|
54,077 |
|
| Loss from operations |
|
(34,919 |
) |
|
(26,841 |
) |
|
(70,581 |
) |
|
(53,927 |
) |
| Interest income |
|
1,081 |
|
|
347 |
|
|
2,103 |
|
|
658 |
|
| Interest expense |
|
— |
|
|
(141 |
) |
|
(44 |
) |
|
(335 |
) |
| Change in fair value of derivative liability associated with Medicis settlement |
|
(70 |
) |
|
(107 |
) |
|
(104 |
) |
|
(167 |
) |
| Other expense, net |
|
(172 |
) |
|
(132 |
) |
|
(492 |
) |
|
(258 |
) |
| Net loss |
|
(34,080 |
) |
|
(26,874 |
) |
|
(69,118 |
) |
|
(54,029 |
) |
| Unrealized gain (loss) on available for sale securities |
|
52 |
|
|
(17 |
) |
|
(224 |
) |
|
(69 |
) |
| Comprehensive loss |
|
$ |
(34,028 |
) |
|
$ |
(26,891 |
) |
|
$ |
(69,342 |
) |
|
$ |
(54,098 |
) |
| Basic and Diluted net loss attributable to common stockholders |
|
$ |
(34,080 |
) |
|
$ |
(26,874 |
) |
|
$ |
(69,118 |
) |
|
$ |
(54,029 |
) |
| Basic and Diluted net loss per share attributable to common stockholders |
|
$ |
(0.94 |
) |
|
$ |
(0.90 |
) |
|
$ |
(1.92 |
) |
|
$ |
(1.84 |
) |
| Basic and Diluted weighted-average number of shares used in computing net
loss per share attributable to common stockholders |
|
36,123,659 |
|
|
29,776,893 |
|
|
36,037,604 |
|
|
29,295,220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Revance Therapeutics, Inc.
2018 Financial Results
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense
(In thousands)
|
| |
|
|
Three Months
Ended June 30, 2018
|
|
Six Months
Ended June 30, 2018
|
| Operating expense: |
|
|
|
|
| GAAP operating expense |
|
$ |
35,605 |
|
|
$ |
71,461 |
|
| Adjustments: |
|
|
|
|
| Stock-based compensation |
|
(4,172 |
) |
|
(8,330 |
) |
| Depreciation |
|
(417 |
) |
|
(807 |
) |
| Non-GAAP operating expense |
|
$ |
31,016 |
|
|
$ |
62,324 |
|
|
|
|
|
|
|
|
|
|
| |
|
Revance Therapeutics, Inc.
2018 Financial Guidance
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense
(In thousands)
|
| |
|
|
Fiscal Year |
|
|
2018 |
|
|
Low |
|
High |
| Operating expense: |
|
|
|
|
| GAAP operating expense |
|
$ |
128,000 |
|
|
$ |
154,000 |
|
| Adjustments: |
|
|
|
|
| Stock-based compensation |
|
(17,000 |
) |
|
(21,000 |
) |
| Depreciation |
|
(1,000 |
) |
|
(3,000 |
) |
| Non-GAAP operating expense |
|
$ |
110,000 |
|
|
$ |
130,000 |
|
|
|
|
|
|
|
|
|
|
| |
|
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense
(In thousands)
|
| |
|
|
Fiscal Year |
|
|
2018 |
|
|
Low |
|
High |
| R&D expense: |
|
|
|
|
| GAAP R&D expense |
|
$ |
84,000 |
|
|
$ |
101,000 |
|
| Adjustments: |
|
|
|
|
| Stock-based compensation |
|
(7,000 |
) |
|
(9,000 |
) |
| Depreciation |
|
(1,000 |
) |
|
(2,000 |
) |
| Non-GAAP R&D expense |
|
$ |
76,000 |
|
|
$ |
90,000 |
|
|
|
|
|
|
|
|
|
|
INVESTORS
Revance Therapeutics, Inc.:
Jeanie Herbert, 714-325-3584
jherbert@revance.com
or
Burns McClellan, Inc.:
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
MEDIA
General Media:
TOGORUN:
Mariann Caprino, 917-242-1087
m.caprino@togorun.com
or
Trade Media:
Nadine Tosk, 504-453-8344
nadinepr@gmail.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20180802005791/en/