- Conference call and webcast today at
First Quarter 2019 and Subsequent Highlights/Updates
- Continued progress and update on Biologics Licensing Application (BLA) submission for DaxibotulinumtoxinA for Injection (DAXI) for the treatment of glabellar (frown) lines. Revance is in the process of compiling the largest clinical data package for an aesthetic indication. The company has been working in parallel to develop a 100-unit vial, in addition to an initial 50-unit vial. This has added additional work streams for process validation and stability. Revance now expects to submit the BLA in the fall of 2019 and is on track for a 2020 approval and launch for DAXI for the treatment of glabellar lines.
- Announced the initiation of Phase 2 clinical trials for DAXI in two
therapeutic indications. In January, Revance announced it
initiated a Phase 2 trial for the treatment of upper limb spasticity.
Upper limb spasticity is a form of movement disorder that presents as
increased tone or stiffness of the muscles, affecting a patient’s
ability to produce or control voluntary movement in the arms and
hands. Also in January, the company announced it initiated a Phase 2
study for the management of plantar fasciitis. Plantar fasciitis,
characterized by inflammation accompanied by sharp, constant pain in
the heel that can become highly debilitating, is a condition that
currently has no
FDA -approved drug treatments. Revance expects to complete enrollment for both Phase 2 trials, along with its Phase 3 trial for cervical dystonia, in the second half of 2019. - Initiated two Phase 2 clinical trials of DAXI in facial aesthetic indications. In January, Revance initiated a study in forehead lines, followed in March with one in lateral canthal lines (crow’s feet). These studies are being conducted to understand the potential dosing and injection patterns of DAXI in other areas of the upper face, in addition to the lead indication in glabellar lines. Revance expects to complete enrollment in both trials in the summer of 2019.
- Presented clinical and non-clinical data to physicians at key
medical meetings. In January, DAXI was featured in 11 podium and
poster presentations at the TOXINS 2019 conference, in
Denmark . In April, the company supported podium and poster presentations of its SAKURA 3 Phase 3 open-label, long-term safety study of DAXI for the treatment of glabellar (frown) lines at the 17thAesthetics & Anti-Aging Medical World Congress , held inMonte Carlo . - Completed a successful public offering. In January, Revance
closed an underwritten public offering. The gross proceeds to the
company from the offering, before deducting the underwriters’
discounts, commissions, and other offering costs, were approximately
$115.0 million . - Continued discussions with Mylan on proposed biosimilar to BOTOX®. Following
the February meeting with the
FDA , the companies believe a potential 351(k) biosimilar pathway is viable. - Appointed
Taryn Conway as Vice President of Marketing, andAtul R. Mahableshwarkar , MD, as Vice President of Clinical Development. In April, Revance announced the appointment ofTaryn Conway , a formerAllergan marketing veteran. Ms. Conway will be an integral architect of product launch strategies and implementation, further enhancing our commercial readiness. In March, Revance appointed Atul R. Mahableshwarkar, MD, to oversee clinical science for its therapeutic programs, including cervical dystonia, upper limb spasticity, plantar fasciitis and migraine. Prior to Revance, Dr. Mahableshwarkar held key clinical development and medical director roles atBlackThorn Thera peutics andTakeda Pharmaceutical Company Ltd.
“Concurrent with two additional studies for the upper face initiated in the first quarter, we continue to target the leading indications for neuromodulators in therapeutics, where we believe DAXI’s long-acting profile will set it apart from existing products. We are pleased to have clinical trials of DAXI underway in cervical dystonia, adult upper limb spasticity and plantar fasciitis, and anticipate completing enrollment in all three trials in the second half of 2019.”
Financial Highlights
Cash, cash equivalents and short-term investments as of
Revenue for the quarter ended
Research and development expenses for the quarter ended
General and administrative expenses for the first quarter 2019
were
Total operating expenses for the quarter ended
Net loss for the first quarter was
Near-Term Milestone Expectations
Aesthetics:
-
Submission of a Biologics Licensing Application (BLA) to the
FDA for DAXI for the treatment of glabellar (frown) lines in the fall of 2019. - Topline results from Phase 2 study of DAXI in forehead lines expected in 1H 2020.
- Topline results from Phase 2 study of DAXI in lateral canthal lines (crow’s feet) expected in 1H 2020
Therapeutics:
- Completion of patient enrollment in Phase 2 upper limb spasticity study expected in 2H 2019.
- Completion of patient enrollment in Phase 2 plantar fasciitis study expected in 2H 2019.
- Completion of patient enrollment in Phase 3 cervical dystonia study in 2H 2019.
Biosimilar:
- Revance plans to share more details on this program in the coming months.
2019 Financial Outlook
Revance reiterates its financial guidance provided in
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: 5753548; 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
About
“Revance Therapeutics” and the Revance logo are registered trademarks of
BOTOX® is a registered trademark of
Forward-Looking Statements
This press release contains forward-looking statements, including
statements related to
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 of our annual
report on Form 10-K filed
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, stock-based compensation, and non-recurring milestone costs. Revance excludes depreciation, stock-based compensation, and non-recurring milestone costs 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) |
||||||||
| March 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 65,269 | $ | 73,256 | ||||
| Short-term investments | 205,719 | 102,556 | ||||||
| Accounts receivable | — | 27,000 | ||||||
| Prepaid expenses and other current assets | 6,128 | 5,110 | ||||||
| Total current assets | 277,116 | 207,922 | ||||||
| Property and equipment, net | 15,378 | 14,449 | ||||||
| Operating lease right of use assets | 28,105 | — | ||||||
| Restricted cash | 730 | 730 | ||||||
| Other non-current assets | 3,146 | 3,247 | ||||||
| TOTAL ASSETS | 324,475 | $ | 226,348 | |||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 4,486 | $ | 8,434 | ||||
| Accruals and other current liabilities | 13,521 | 14,948 | ||||||
| Deferred revenue, current portion | 13,054 | 8,588 | ||||||
| Operating lease liabilities, current portion | 3,009 | — | ||||||
| Total current liabilities | 34,070 | 31,970 | ||||||
| Derivative liability associated with the Medicis settlement | 2,845 | 2,753 | ||||||
| Deferred revenue, net of current portion | 37,940 | 42,684 | ||||||
| Operating lease liabilities, net of current portion | 28,517 | — | ||||||
| Deferred rent | — | 3,319 | ||||||
| TOTAL LIABILITIES | 103,372 | 80,726 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Convertible preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of March 31, 2019 and December 31, 2018 | — | — | ||||||
| Common stock, par value $0.001 per share — 95,000,000 shares authorized as of March 31, 2019 and December 31, 2018; 44,004,658 and 36,975,203 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 44 | 37 | ||||||
| Additional paid-in capital | 941,068 | 830,368 | ||||||
| Accumulated other comprehensive income (loss) | 70 | (8 | ) | |||||
| Accumulated deficit | (720,079 | ) | (684,775 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 221,103 | 145,622 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 324,475 | $ | 226,348 | ||||
|
REVANCE THERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) |
||||||||
| Three Months Ended March 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenue | $ | 278 | $ | 193 | ||||
| Operating expenses: | ||||||||
| Research and development | 23,995 | 22,239 | ||||||
| General and administrative | 12,910 | 13,616 | ||||||
| Total operating expenses | 36,905 | 35,855 | ||||||
| Loss from operations | (36,627 | ) | (35,662 | ) | ||||
| Interest income | 1,570 | 1,022 | ||||||
| Interest expense | — | (44 | ) | |||||
| Change in fair value of derivative liability associated with the Medicis settlement | (92 | ) | (34 | ) | ||||
| Other expense, net | (155 | ) | (319 | ) | ||||
| Net loss | (35,304 | ) | (35,037 | ) | ||||
| Unrealized gain (loss) and adjustment on securities included in net loss | 78 | (276 | ) | |||||
| Comprehensive loss | $ | (35,226 | ) | $ | (35,313 | ) | ||
| Basic and diluted net loss attributable to common stockholders | $ | (35,304 | ) | $ | (35,037 | ) | ||
| Basic and diluted net loss per share attributable to common stockholders | $ | (0.85 | ) | $ | (0.97 | ) | ||
| Basic and diluted weighted-average number of shares used in computing net loss per share attributable to common stockholders | 41,598,919 | 35,950,593 | ||||||
|
REVANCE THERAPEUTICS, INC. Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense (In thousands) (Unaudited) |
||||
|
Three Months Ended |
||||
| Operating expense: | ||||
| GAAP operating expense | $ | 36,905 | ||
| Adjustments: | ||||
| Stock-based compensation | (4,159 | ) | ||
| Depreciation | (628 | ) | ||
| Non-GAAP operating expense | $ | 32,118 | ||
|
REVANCE THERAPEUTICS, INC. Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense (In thousands) (Unaudited) |
||||
|
Three Months Ended |
||||
| R&D expense | ||||
| GAAP R&D expense | $ | 23,995 | ||
| Adjustments: | ||||
| Stock-based compensation | (2,079 | ) | ||
| Depreciation | (461 | ) | ||
| Non-GAAP R&D expense | $ | 21,455 | ||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190508005698/en/
Source:
INVESTORS
Revance Therapeutics, Inc.:
Jeanie Herbert,
714-325-3584
jherbert@revance.com
or
Gilmartin
Group, LLC.:
Laurence Watts, 619-916-7620
laurence@gilmartinir.com
MEDIA
General Media:
Y&R:
Jenifer Slaw
347-971-0906
jenifer.slaw@YR.com
or
Trade
Media:
Nadine Tosk, 504-453-8344
nadinepr@gmail.com