NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, today announced results for the fourth quarter and full year ended December 31, 2017.
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 million to 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 FDA for the treatment of cervical dystonia.
- Completed an End-of-Phase 2 meeting with the FDA and 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 Dan Browne, President and Chief Executive Officer at Revance. "As we announced today, we are not only pursuing development and commercialization of our premium, long-acting RT002 neuromodulator, we are also leveraging our capabilities to produce a biosimilar to BOTOX in collaboration with Mylan.
"Looking ahead, we are preparing for a 2019 Biologics Licensing Application (BLA) filing for RT002 to treat glabellar lines, while increasing our pre-commercial initiatives as part of the Revance Product Launch Velocity Plan in facial aesthetics. In the clinic, we plan to focus on accelerating development efforts of RT002 for therapeutic indications. Down the road, we expect RT002 to drive meaningful growth in the approximately $4 billion global neuromodulator market."
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 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 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.
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/7:30pm ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 5054928. 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 a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, including muscle movement disorders and pain. The company’s lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), is currently in development for the treatment of glabellar lines, cervical dystonia and plantar fasciitis, with the potential to be the first long-acting neuromodulator. Revance has developed a proprietary, stabilizing excipient peptide technology designed to create novel, differentiated therapies. The company has a comprehensive pipeline based upon its peptide technology, including 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.
BOTOX® is a registered trademark of Allergan, Inc.
This press release contains forward-looking statements, including statements related to Revance Therapeutics' 2018 Financial Outlook 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, 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; and statements about our ability to obtain regulatory approval; 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 November 3, 2017. 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.
|Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)|
|As of December 31,|
|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 $0.001 per share — 95,000,000 shares|
|authorized both as of December 31, 2017 and 2016; 36,516,075 and|
|28,648,954 shares issued and outstanding as of December 31, 2017 and|
|Additional paid-in capital||810,975||598,630|
|Accumulated other comprehensive loss||—||(45||)|
|TOTAL STOCKHOLDERS’ EQUITY||268,845||177,071|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||295,699||$||204,360|
REVANCE THERAPEUTICS, INC.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
|Quarter Ended December 31,||Year Ended December 31,|
|Research and development||21,004||12,530||80,361||50,381|
|General and administrative||11,887||7,100||37,398||29,075|
|Loss on impairment||2,927||7,111||2,927||9,059|
|Total operating expenses||35,818||26,741||120,686||88,515|
|Loss from operations||(35,781||)||(26,666||)||(120,424||)||(88,215||)|
|Changes in fair value of derivative liabilities associated with the Medicis settlement||(380||)||(13||)||(591||)||(608||)|
|Other expense, net||(138||)||(128||)||(525||)||(535||)|
|Unrealized gain (loss) and adjustment on securities included in net loss||42||(61||)||45||(5||)|
|Basic and Diluted net loss attributable to common stockholders||$||(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||)||$||(3.18||)|
|Basic and Diluted weighted-average number of shares used in computing net loss per share attributable to common stockholders||31,580,146||28,201,880||30,101,125||28,114,784|
|Revance Therapeutics, Inc.|
2017 Financial Results
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense
|GAAP operating expense||$||35,818||$||120,686|
|Non-GAAP operating expense||$||32,036||$||105,988|
|Revance Therapeutics, Inc.|
|2018 Financial Guidance|
|Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense|
|GAAP operating expense||$||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|