January 04, 2018
- Reports 2017 Unaudited Year-End Cash and Investments Balance
Exceeded
- Expects to Complete RT002 SAKURA Phase 3 Program and Start RT002 Phase 3 Trial for Cervical Dystonia in 2018 -
- Plantar Fasciitis Phase 2a Interim Results by Mid-January -
"We're making rapid progress towards bringing a platform of innovative
treatments to patients who have conditions that lack sustained treatment
effect with current neuromodulators, as well as treatments for new
indications not approved by the
RT002 INJECTABLE 2017 CLINICAL MILESTONES
SAKURA Phase 3
In
With the SAKURA 3 open-label, long-term safety study fully enrolled, the
company plans to complete the safety study in the second half of 2018,
and assuming successful completion of SAKURA 3, to file its biologics
license application (BLA) with the
Phase 3 Trial for Treatment of Cervical Dystonia - Expects to Initiate Trial in Second Quarter of 2018
In May of 2017, Revance reported positive results from its Phase 2
dose-escalating clinical trial of RT002 injectable for the treatment of
cervical dystonia. In November, Revance announced the completion of its
End-of-Phase 2 meeting with the FDA and receipt of Scientific Advice
from the Europe Medicines Agency (EMA). Also in November, the
Phase 2a Proof of Concept Trial for Treatment of Plantar Fasciitis -
Expects to Report Interim Results by
In mid-January of 2018, the company expects to report interim 8-week results from its Phase 2a clinical trial of RT002 injectable for the management of plantar fasciitis. The plantar fascia is the foot's shock absorber. Repeated pressure on this tissue, whether from sport activities, aging, or obesity, can result in plantar fasciitis, characterized by inflammation accompanied by sharp, constant pain in the heel that can become highly debilitating. Several publications have reported neuromodulators may reduce the pain for patients suffering from a range of acute and chronic plantar fasciitis conditions. The company plans to complete the 16-week trial and then expects to initiate a Phase 2b trial for plantar fasciitis in the second half of 2018.
FINANCIAL OUTLOOK FOR 2018
Revance expects cash burn for 2018 to be in the range of
About
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
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 risks that interim results are not indicative of final
results and 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
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 for 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.
|
|||||||
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 | |||
View source version on businesswire.com: http://www.businesswire.com/news/home/20180104005437/en/
INVESTORS
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or
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or
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