Revance Therapeutics Releases Second Quarter 2015 Results
Recent Pipeline Highlights
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Topical RT001 - Aesthetic Indication for the Treatment of Lateral Canthal (Crow's Feet) Lines
Announced plans to initiate a US Phase 3 pivotal study for the treatment of crow's feet lines using investigational drug product candidate RT001, a topical gel formulation of botulinum toxin type A. -
Topical RT001 - Therapeutic Indication for the Treatment of Hyperhidrosis (Excessive Sweating)
Announced plans to commence a US Phase 2 study for topical RT001 for the treatment of excessive sweating. -
Injectable RT002 - Therapeutic Indication for Cervical Dystonia
Filed an Investigational New Drug (IND) application with theU.S. Food and Drug Administration (FDA) for RT002, an injectable formulation of botulinum toxin type A, for the treatment of cervical dystonia, a muscle movement disorder. -
Injectable RT002 - Aesthetic Indication for the Treatment of Glabellar (Frown) Lines
BELMONT Phase 2 active comparator trial for the company's injectable RT002 investigational drug product candidate to treat frown lines was fully enrolled and is on schedule to report interim results before year end 2015.
"The first half of 2015 has been a pivotal and exciting time for Revance. Following the achievement of numerous milestones, we are moving forward with clinical trials in four separate indications for our investigational drug product candidates topical RT001 and injectable RT002," said
"In June, we made the decision to move ahead with two important trials for topical RT001 in
Summary Financial Results
Research and development expenses for the three and six months ended
General and administrative expenses for the three and six months ended
Total operating expenses for the three and six months ended
Net loss for the three and six months ended
Cash, cash equivalents, and investments as of
2015 Financial Outlook
Revance updated its 2015 full-year cash burn guidance from its prior guidance last provided on
Revance reaffirms its 2015 full-year guidance for total non-GAAP operating expense and non-GAAP research and development expense. Revance expects 2015 non-GAAP operating expense to be in the range of
Weighted-average number of shares outstanding for the quarter ended
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RT001 and RT002 Product Candidates
Revance is currently developing two botulinum toxin type A investigational drug product candidates. RT001 is a topical formulation, which has the potential to be the first commercially available non-injectable dose form of botulinum toxin type A. 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 type A 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 (cervical dystonia and upper limb spasticity). 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 drug product candidates, 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 drug 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
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 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
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 | ||
| (In thousands, except share and per share amounts) | ||
| (Unaudited) | ||
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| 2015 | 2014 | |
| ASSETS | ||
| CURRENT ASSETS | ||
| Cash and cash equivalents | $ 96,417 | $ 171,032 |
| Short-term investments | 38,884 | — |
| Restricted cash, current portion | 35 | 75 |
| Prepaid expenses and other current assets | 1,920 | 1,624 |
| Total current assets | 137,256 | 172,731 |
| Property and equipment, net | 19,134 | 19,274 |
| Long-term investments | 14,052 | — |
| Restricted cash, net of current portion | 400 | 435 |
| Other non-current assets | 374 | 29 |
| TOTAL ASSETS | $ 171,216 | $ 192,469 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| CURRENT LIABILITIES | ||
| Accounts payable | $ 2,211 | $ 3,149 |
| Accruals and other current liabilities | 5,040 | 4,145 |
| Financing obligation, current portion | 2,906 | 307 |
| Notes payable, current portion and net of discount | — | 2,635 |
| Total current liabilities | 10,157 | 10,236 |
| Financing obligation, net of current portion | 6,973 | 598 |
| Derivative liabilities associated with Medicis settlement | 1,494 | 1,541 |
| Deferred rent | 3,751 | 3,725 |
| TOTAL LIABILITIES | 22,375 | 16,100 |
| Commitments and Contingencies | ||
| STOCKHOLDERS' EQUITY | ||
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Common stock, par value |
24 | 24 |
| Additional paid-in capital | 439,833 | 435,142 |
| Accumulated other comprehensive loss | (12) | — |
| Accumulated deficit | (291,004) | (258,797) |
| TOTAL STOCKHOLDERS' EQUITY | 148,841 | 176,369 |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 171,216 | $ 192,469 |
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| Condensed Consolidated Statement of Operations and Comprehensive Loss | ||||
| (In thousands, except share and per share amounts) | ||||
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| Three Months Ended | Six Months Ended | |||
| June 30, | June 30, | |||
| 2015 | 2014 | 2015 | 2014 | |
| Revenue | $ 75 | $ 75 | $ 150 | $ 233 |
| Operating expenses: | ||||
| Research and development | 10,303 | 8,110 | 19,557 | 15,661 |
| General and administrative | 6,360 | 4,857 | 12,356 | 8,950 |
| Total operating expenses | 16,663 | 12,967 | 31,913 | 24,611 |
| Loss from operations | (16,588) | (12,892) | (31,763) | (24,378) |
| Interest income | 49 | 1 | 76 | 4 |
| Interest expense | (279) | (267) | (444) | (10,108) |
| Change in fair value of derivative liabilities associated with the convertible notes | — | — | — | 4,032 |
| Changes in fair value of derivative liabilities associated with Medicis settlement | 89 | (76) | 47 | (493) |
| Change in fair value of common stock warrant liability | — | — | — | (2,151) |
| Change in fair value of convertible preferred stock warrant liability | — | — | — | (210) |
| Loss on settlement of preferred stock warrant | — | — | — | (1,356) |
| Other expense, net | (76) | (68) | (123) | (68) |
| Net loss | (16,805) | (13,302) | (32,207) | (34,728) |
| Unrealized loss on available for sale securities | (12) | — | (12) | — |
| Comprehensive loss |
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| Net loss attributable to common stockholders: | ||||
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| Diluted |
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| Net loss per share attributable to common stockholders: | ||||
| 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: | ||||
| Basic | 23,584,910 | 19,380,934 | 23,560,133 | 15,361,215 |
| Diluted | 23,584,910 | 19,380,934 | 23,560,133 | 15,361,215 |
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| 2015 Financial Results | ||
| (Unaudited) | ||
| Reconciliation of GAAP Operating Expense to Non-GAAP Expense | ||
| (In thousands) | ||
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Three Months Ended |
Six Months Ended |
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| Operating expense: | ||
| GAAP operating expense | $ 16,663 | $ 31,913 |
| Adjustments: | ||
| Stock-based compensation | (2,407) | (4,724) |
| Depreciation | (544) | (1,075) |
| Non-GAAP operating expense | $ 13,712 | $ 26,114 |
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| Non-GAAP Financial Measures Reconciliation for Forward-Looking Outlook | ||
| Reconciliation of GAAP Operating Expense to Non-GAAP Expense | ||
| (In thousands) | ||
| Fiscal Year | ||
| 2015 | ||
| Low | High | |
| Operating expense: | ||
| GAAP operating expense | $ 84,000 | $ 95,000 |
| Adjustments: | ||
| Stock-based compensation | (10,000) | (12,000) |
| Depreciation | (2,000) | (3,000) |
| Non-GAAP operating expense | $ 72,000 | $ 80,000 |
| Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense | ||
| (In thousands) | ||
| Fiscal Year | ||
| 2015 | ||
| Low | High | |
| Operating expense: | ||
| GAAP R&D expense | $ 59,000 | $ 70,000 |
| Adjustments: | ||
| Stock-based compensation | (5,000) | (7,000) |
| Depreciation | (2,000) | (3,000) |
| Non-GAAP R&D expense | $ 52,000 | $ 60,000 |
CONTACT: Investors:
Revance Therapeutics Jeanie Herbert
(714) 325-3584
jherbert@revance.com
Westwicke Partners Leigh Salvo
(415) 513-1281
leigh.salvo@westwicke.com
Trade Media:
Nadine Tosk
(847) 920-9858
nadinepr@gmail.com
Source:
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