- Announces collaboration and license agreement with Mylan for proposed biosimilar to BOTOX® -
-Cash and investments of approximately
Recent Company Highlights and Upcoming Milestones for DaxibotulinumtoxinA for Injection (RT002)
Today announced a collaboration and license agreement with Mylan N.V.
on a biosimilar to BOTOX® that will provide an upfront payment of
$25 millionto Revance, with contingent payments upon achievement of additional clinical, regulatory and sales milestones, plus sales royalties worldwide (except Japan).
- Reported positive Phase 3 results from SAKURA 1 and SAKURA 2 pivotal trials of RT002 for the treatment of glabellar (frown) lines, which met all primary and secondary endpoints, and achieved 6-month duration in multiple secondary measurements. Revance expects to complete the SAKURA 3 open-label safety study in the second half of 2018.
Received Orphan Drug Designation for RT002 from the
FDAfor the treatment of cervical dystonia.
Completed an End-of-Phase 2 meeting with the
FDAand received Scientific Advice from the Europe Medicines Agency(EMA) on its clinical program for RT002 in the treatment of moderate to severe isolated cervical dystonia. Revance plans to commence a Phase 3 program for the U.S.in the second quarter of 2018.
- Reported interim Phase 2a results for RT002 in treating plantar fasciitis. Revance plans to initiate a second Phase 2 trial in plantar fasciitis with a modified design in the second half of 2018.
"As a company, our goal is to be innovative pioneers in neuromodulators.
In 2017, our clinical trials demonstrated RT002's ability to provide
patients long-acting performance and duration of effect, with
potentially just two treatments a year in both glabellar lines and
cervical dystonia. We believe that RT002 has the potential to
meaningfully enhance the quality of life for patients suffering from a
wide array of diseases," said
"Looking ahead, we are preparing for a 2019
Summary Financial Results
Cash and investments as of December 31, 2017 were $282.9 million.
Research and development expenses for the fourth quarter and full year ended December 31, 2017 were $21.0 million and $80.4 million, respectively, compared to $12.5 million and $50.4 million for the same periods in 2016, respectively. The change in research and development expenses is primarily due to the ongoing clinical trials for RT002 for the treatment of glabellar lines, cervical dystonia, and plantar fasciitis and increased costs to support manufacturing, quality efforts and research.
General and administrative expenses for the fourth quarter and full year ended December 31, 2017 were $11.9 million and $37.4 million, respectively, compared to $7.1 million and $29.1 million for the same periods in 2016, respectively. The increase in general and administrative expenses is primarily due to increased costs related to personnel and consulting costs and pre-commercial activities to support future product launches.
Total operating expenses for the fourth quarter and full year ended December 31, 2017 were $35.8 million and $120.7 million, respectively, compared to $26.7 million and $88.5 million for the same periods in 2016, respectively. Stock-based compensation for the fourth quarter and full year ended December 31, 2017 was $3.4 million and $13.2 million, respectively. When excluding depreciation and stock-based compensation, total operating expenses for the fourth quarter and year ended December 31, 2017 were $32.0 million and $106.0 million, respectively.
Net loss for the fourth quarter and full year ended December 31, 2017 was $35.9 million and $120.6 million, respectively, compared to $26.8 million and $89.3 million for the same periods in 2016, respectively.
2018 Financial Outlook
Revance reiterates its financial guidance provided in
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: 5054928; 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 February 28,
2018 at 4:30pm PT/7:30pm ET to March 1, 2018 at 4:30pm PT/
"Revance Therapeutics" and the Revance logo are registered trademarks of
BOTOX® is a registered trademark of
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
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.
|Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)|
|Cash and cash equivalents||$||282,896||$||63,502|
|Prepaid expenses and other current assets||2,315||7,167|
|Total current assets||285,211||192,695|
|Property and equipment, net||9,250||10,585|
|Other non-current assets||658||500|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accruals and other current liabilities||12,225||12,418|
|Financing obligations, current portion||1,872||3,475|
|Total current liabilities||20,902||19,647|
|Financing obligations, net of current portion||—||1,872|
|Derivative liabilities associated with Medicis settlement||2,613||2,022|
|Other non-current liabilities||—||100|
|Commitments and Contingencies|
Common stock, par value
authorized both as of
28,648,954 shares issued and outstanding as of
|Additional paid-in capital||810,975||598,630|
|Accumulated other comprehensive loss||—||(45||)|
|TOTAL STOCKHOLDERS' EQUITY||268,845||177,071|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||$||295,699||$||204,360|
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
|Research and development||21,004||12,530||80,361||50,381|
|General and administrative||11,887||7,100||37,398||29,075|
|Loss on impairment||2,927||7,111||2,927||9,059|
|Total operating expenses||35,818||26,741||120,686||88,515|
|Loss from operations||(35,781||)||(26,666||)||(120,424||)||(88,215||)|
|Changes in fair value of derivative liabilities associated with the Medicis settlement||(380||)||(13||)||(591||)||(608||)|
|Other expense, net||(138||)||(128||)||(525||)||(535||)|
|Unrealized gain (loss) and adjustment on securities included in net loss||42||(61||)||45||(5||)|
|Basic and Diluted net loss attributable to common stockholders||$||(35,906||)||$||(26,802||)||$||(120,587||)||$||(89,270||)|
|Basic and Diluted net loss per share attributable to common stockholders||$||(1.14||)||$||(0.95||)||$||(4.01||)||$||(3.18||)|
|Basic and Diluted weighted-average number of shares used in computing net loss per share attributable to common stockholders||31,580,146||28,201,880||30,101,125||28,114,784|
2017 Financial Results
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense
|GAAP operating expense||$||35,818||$||120,686|
|Non-GAAP operating expense||$||32,036||$||105,988|
|2018 Financial Guidance|
|Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense|
|GAAP operating expense||$||128,000||$||154,000|
|Non-GAAP operating expense||$||110,000||$||130,000|
|Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense|
|GAAP R&D expense||$||84,000||$||101,000|
|Non-GAAP R&D expense||$||76,000||$||90,000|
News Provided by Acquire Media