Revance Therapeutics Releases First Quarter 2015 Financial Results
Recent Highlights
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Completed enrollment forBELMONT Phase 2 active comparator trial. The study is evaluating the safety, efficacy and duration of effect of the company’s injectable RT002 product candidate to treat glabellar (frown) lines. -
Completed enrollment in the open-label study for the company’s topical RT001 product candidate for the treatment of lateral canthal (crow’s feet) lines. -
Prioritized cervical dystonia as the first therapeutic indication for the company’s RT002 Phase 2 clinical trial in a muscle movement disorder.
“We have made significant progress in 2015 with our neurotoxin product candidates in four unique indications,” said President and Chief Executive Officer,
“In addition, we are pleased to announce that we have selected cervical dystonia as our first therapeutic indication for injectable RT002. Cervical dystonia is characterized by excessive pulling of the muscles in the neck and shoulder and, as a result, negatively impacts functionality and quality of life. Since cervical dystonia is already an approved indication for botulinum toxin, we have a clear clinical and regulatory path to follow for approval. We believe physicians and patients alike would embrace a potentially longer-lasting botulinum toxin treatment option for this disorder. We plan to commence a Phase 2 clinical trial in the second half of 2015 and report preliminary efficacy results before year end.
“Our product candidate RT001 has the potential to be the first commercially-available, topically-applied form of botulinum toxin type A and maintains an exceptional safety profile. Our open-label study is now fully enrolled, and we anticipate reporting the outcome this quarter. Following a successful readout from the open-label study, we plan to initiate a Phase 3 Pivotal trial for crow’s feet lines this summer and report preliminary efficacy results before the end of the year. Separately, we plan to initiate an RT001 Phase 2 clinical study mid-year for the treatment of hyperhidrosis, or excessive sweating, and report preliminary efficacy results in the second half of 2015,” Browne concluded.
Summary Financial Results
Research and development expenses for the quarter ended
General and administrative expenses for the quarter ended
Total operating expenses for the quarter ended
Net loss for the quarter ended
Cash and cash equivalents as of
2015 Financial Outlook
Revance reaffirms its 2015 full-year guidance. The company expects cash burn for 2015 to be in the range of
Weighted-average number of shares outstanding for the first quarter ended
Conference Call
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RT001 and RT002 Product Candidates
Revance is currently developing two botulinum toxin type A product candidates. RT001 is a topical formulation, which has the potential to be the first commercially available non-injectable dose form. Revance is studying topical RT001 for aesthetic indications, such as crow’s feet lines (wrinkles around the eyes) and therapeutic indications such as hyperhidrosis (excessive sweating). RT002 is a novel, injectable formulation of botulinum toxin designed to be more targeted and longer lasting than currently available injectable botulinum toxin products. Revance is studying injectable RT002 for aesthetic indications, such as glabellar (frown) lines and therapeutic uses, such as muscle movement disorders. Both products would have the potential to expand into additional aesthetic and therapeutic indications in the future.
About
Revance is a specialty biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic indications. The company is leveraging its proprietary portfolio of botulinum toxin compounds combined with its patented TransMTS® peptide delivery system to address unmet needs in the large and growing neurotoxin markets. Revance’s proprietary TransMTS technology enables delivery of botulinum toxin A through two novel dose formulations, a needle-free topical form and an injectable form that may localize the drug to the site of injection resulting in a more targeted and potentially longer lasting delivery. Revance is pursuing clinical development for product candidates topical RT001 and injectable RT002 in a broad spectrum of aesthetic and therapeutic indications. The company holds worldwide rights
for all indications of RT001, RT002 and the TransMTS technology platform. More information on
“Revance Therapeutics”, TransMTS® 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 risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our product candidates; our ability to obtain funding for our operations; our plans to research, develop and commercialize our product candidates; our ability to achieve market acceptance of our 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 product candidates; our ability to successfully commercialize our product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our 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 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
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 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.
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Condensed Consolidated Balance Sheets |
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(In thousands, except share and per share amounts) |
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(Unaudited) |
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2015 |
2014 |
ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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Restricted cash, current portion |
35 |
75 |
Prepaid expenses and other current assets |
1,937 |
1,624 |
Total current assets |
155,689 |
172,731 |
Property and equipment, net |
19,390 |
19,274 |
Restricted cash, net of current portion |
400 |
435 |
Other non-current assets |
243 |
29 |
TOTAL ASSETS |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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CURRENT LIABILITIES |
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Accounts payable |
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Accruals and other current liabilities |
4,019 |
4,145 |
Financing obligation, current portion |
319 |
307 |
Notes payable, current portion and net of discount |
— |
2,635 |
Total current liabilities |
6,427 |
10,236 |
Financing obligation, net of current portion |
513 |
598 |
Derivative liabilities associated with Medicis settlement |
1,583 |
1,541 |
Deferred rent |
3,741 |
3,725 |
TOTAL LIABILITIES |
12,264 |
16,100 |
Commitments and Contingencies |
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STOCKHOLDERS’ EQUITY |
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Common stock, par value |
24 |
24 |
Additional paid-in capital |
437,633 |
435,142 |
Accumulated deficit |
(274,199) |
(258,797) |
TOTAL STOCKHOLDERS’ EQUITY |
163,458 |
176,369 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Condensed Consolidated Statement of Operations and Comprehensive Loss |
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(In thousands, except share and per share amounts) |
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(Unaudited) |
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Quarter Ended |
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2015 |
2014 |
Revenue |
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Operating expenses: |
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Research and development |
9,254 |
7,551 |
General and administrative |
5,996 |
4,093 |
Total operating expenses |
15,250 |
11,644 |
Loss from operations |
(15,175) |
(11,486) |
Interest income |
27 |
2 |
Interest expense |
(165) |
(9,841) |
Change in fair value of derivative liabilities associated with the convertible notes |
— |
4,032 |
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Changes in fair value of derivative liabilities associated with Medicis settlement |
(42) |
(416) |
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Change in fair value of common stock warrant liability |
— |
(2,151) |
Change in fair value of convertible preferred stock warrant liability |
— |
(210) |
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Loss on settlement of preferred stock warrant |
— |
(1,356) |
Other expense, net |
(47) |
— |
Net and comprehensive loss |
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Net loss attributable to common stockholders: |
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Basic |
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Diluted |
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Net loss per share attributable to common stockholders: |
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Basic |
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Diluted |
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Weighted-average number of shares used in computing net loss per share attributable to common stockholders: |
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Basic |
23,535,080 |
11,092,471 |
Diluted |
23,535,080 |
11,092,471 |
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2015 Financial Results |
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Reconciliation of GAAP Operating Expense to Non-GAAP Expense |
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(In thousands) |
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Quarter Ended |
Operating expense: |
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GAAP operating expense |
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Adjustments: |
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Stock-based compensation |
(2,317) |
Depreciation |
(531) |
Non-GAAP operating expense |
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Financial Guidance |
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Reconciliation of GAAP Operating Expense to Non-GAAP Expense |
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(In thousands) |
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Fiscal Year |
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2015 |
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Low |
High |
Operating expense: |
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GAAP operating expense |
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Adjustments: |
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Stock-based compensation |
(10,000) |
(12,000) |
Depreciation |
(2,000) |
(3,000) |
Non-GAAP operating expense |
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Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense |
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(In thousands) |
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Fiscal Year |
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2015 |
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Low |
High |
Operating expense: |
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GAAP R&D expense |
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Adjustments: |
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Stock-based compensation |
(5,000) |
(7,000) |
Depreciation |
(2,000) |
(3,000) |
Non-GAAP R&D expense |
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CONTACT: Investors:Revance Therapeutics Jeanie Herbert (714) 325-3584 jherbert@revance.comWestwicke Partners Leigh Salvo (415) 513-1281 leigh.salvo@westwicke.com Trade Media: Nadine Tosk (847) 920-9858 nadinepr@gmail.com
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