Press Release Details

Revance Releases Second Quarter 2016 Results

August 04, 2016

- Completes Enrollment of Second Cohort of Patients in RT002 Phase 2 Study for Cervical Dystonia -

- Updates 2016 Financial Outlook -

NEWARK, Calif.--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced results for the second quarter ended June 30, 2016.

Recent Highlights

  • DaxibotulinumtoxinA for Injection (RT002)
    • Completed enrollment of the second cohort of patients in a Phase 2 dose-escalating study of RT002 injectable to treat cervical dystonia, a neurological muscle movement disorder.
    • Announced the completion of pre-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) regarding RT002 injectable for the treatment of glabellar (frown) lines. Based upon the discussion with the FDA and the minutes received following the meeting, Revance plans to move forward with an Investigational New Drug (IND) submission for the Phase 3 clinical program for RT002 in glabellar lines and other supportive studies required for the Biologics License Application (BLA) filing.
  • DaxibotulinumtoxinA Topical Gel (RT001)
    • Released 28-day top-line safety and efficacy results of REALISE 1 study, a Phase 3 trial for patients with moderate to severe lateral canthal lines (crow's feet) in June 2016. Based on the REALISE 1 results, the company reported that it would discontinue its RT001 topical clinical development programs in crow's feet and axillary hyperhidrosis.
  • Acquired intellectual property portfolio consisting of more than 70 botulinum toxin-related patents and patent applications from Botulinum Toxin Research Associates, Inc. (BTRX).
  • Appointed Julian Gangolli, President, North America at GW Pharmaceuticals plc, to Revance's Board of Directors.

"We have successfully pivoted our focus to RT002 injectable and believe we remain on track to deliver the first differentiated neuromodulator in nearly 30 years," said Dan Browne, President and Chief Executive Officer at Revance. "For our aesthetics program in glabellar lines, we had productive discussions with the FDA during our recent pre-Phase 3 meeting, and anticipate the initiation of Phase 3 clinical trials of RT002 injectable in 2016. In cervical dystonia, with enrollment of patients in the second cohort of our RT002 injectable Phase 2 study completed, we expect to report interim results from the first two cohorts later this year."

Summary Financial Results

Research and development expenses for the three and six months ended June 30, 2016 were $15.2 million and $27.6 million compared to $10.3 million and $19.6 million for the same periods in 2015, respectively. The increase in research and development expenses is primarily attributable to personnel costs, ongoing clinical trials, and the acquisition of botulinum toxin-related patents and patent applications from BTRX.

General and administrative expenses for the three and six months ended June 30, 2016 were $7.0 million and $14.5 million compared to $6.4 million and $12.4 million for the same periods in 2015, respectively. The change in general and administrative expenses is primarily attributable to increases in personnel, consulting, legal and administrative costs.

Total operating expenses for the three and six months ended June 30, 2016 were $24.2 million and $44.0 million compared to $16.7 million and $31.9 million for the same periods in 2015, respectively. Stock-based compensation for the three and six months ended June 30, 2016 was $3.3 million and $6.2 million, respectively. When excluding depreciation and stock-based compensation, total operating expenses for the three and six months ended June 30, 2016 were $20.6 million and $37.1 million.

Net loss for the three and six months ended June 30, 2016 was $24.6 million and $44.5 million compared to $16.8 million and $32.2 million for the same periods in 2015, respectively.

Cash and investments as of June 30, 2016 were $216.9 million.

2016 Financial Outlook

Revance updated its 2016 full-year guidance last provided on May 9, 2016. The company now expects its cash burn for 2016 to be in the range of $90 to $100 million. Revance expects its 2016 GAAP operating expense to be in the range of $95 to $108 million, which when excluding depreciation of $2 to $3 million and estimated stock-based compensation of $13 to $15 million, results in projected 2016 non-GAAP operating expense of $80 to $90 million. Revance also anticipates 2016 GAAP research and development expense to be in the range of $66 to $74 million, which when excluding depreciation of $2 to $3 million and estimated stock-based compensation of $7 to $8 million, results in projected 2016 non-GAAP research and development expense of $57 to $63 million.

Conference Call

Individuals interested in listening to the conference call today, August 4, at 1:30pm PT/4:30pm ET, may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 46636498; or from the webcast link in the investor relations section of the Company's website at: http://investors.revance.com/index.cfm.

A replay of the call will be available beginning today at 5:00pm PT/8:00pm ET through 5:00pm PT/8:00pm ET on August 5, 2016. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 46636498. 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, a Silicon Valley-based biotechnology company, is committed to the advancement of remarkable science. The company is developing a portfolio of products for aesthetic medicine and underserved therapeutic specialties, including dermatology and neurology. Revance's science is based upon a proprietary TransMTS® peptide technology, which when combined with active drug molecules, may help address current unmet needs. Revance's initial focus is on developing daxibotulinumtoxinA, the company's highly purified botulinum toxin, for a broad spectrum of aesthetic and therapeutic indications, including facial wrinkles and muscle movement disorders. The company's lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), is currently in development for the treatment of glabellar lines and cervical dystonia and has the potential to be the first long-acting neurotoxin. The company holds worldwide rights for all indications of RT002 injectable and RT001 topical and the pharmaceutical uses of the TransMTS technology platform. More information on Revance may be found at www.revance.com.

"Revance Therapeutics", TransMTS®, "Remarkable Science Changes Everything", and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

Forward Looking Statements

This press release contains forward-looking statements, including statements related to Revance Therapeutics' 2016 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 May 10, 2016. 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.
 
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
 
  June 30,   December 31,
2016 2015
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 52,651 $ 201,615
Short-term investments 164,293 50,688
Restricted cash, current portion 35
Prepaid expenses and other current assets 1,613   1,625  
Total current assets 218,557 253,963
Property and equipment, net 17,658 19,708
Long-term investments 1,751
Restricted cash, net of current portion 580 400
Other non-current assets 214    
TOTAL ASSETS $ 237,009   $ 275,822  
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable $ 2,982 $ 2,657
Accruals and other current liabilities 5,622 6,245
Financing obligations, current portion 3,314   3,135  

Total current liabilities

11,918 12,037
Financing obligations, net of current portion 3,659 5,346
Derivative liability associated with Medicis settlement 1,842 1,414
Deferred rent 3,714 3,773
Other non-current liabilities 100    
TOTAL LIABILITIES 21,233   22,570  
Commitments and Contingencies
STOCKHOLDERS' EQUITY

Preferred stock, par value $0.001 per share — 5,000,000 shares authorized both as of
June 30, 2016 and December 31, 2015; no shares issued and outstanding both as of
June 30, 2016 and December 31, 2015.

Common stock, par value $0.001 per share — 95,000,000 shares authorized both as of
June 30, 2016 and December 31, 2015; 28,481,172 and 28,288,464 shares issued
and outstanding as of June 30, 2016 and December 31, 2015, respectively

28 28
Additional paid-in capital 592,362 585,537
Accumulated other comprehensive income (loss) 148 (40 )
Accumulated deficit (376,762 ) (332,273 )
TOTAL STOCKHOLDERS' EQUITY 215,776   253,252  
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 237,009   $ 275,822  
 
 
REVANCE THERAPEUTICS, INC.
 
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
   

Three Months Ended
June 30,

Six Months Ended
June 30,

2016   2015 2016   2015
Revenue $ 75 $ 75 $ 150 $ 150
Operating expenses:
Research and development 15,192 10,303 27,556 19,557
General and administrative 7,018 6,360 14,473 12,356
Loss on impairment 1,949     1,949    
Total operating expenses 24,159   16,663   43,978   31,913  
Loss from operations (24,084 ) (16,588 ) (43,828 ) (31,763 )
Interest income 324 49 635 76
Interest expense (286 ) (279 ) (601 ) (444 )

Change in fair value of derivative liability associated with
Medicis settlement

(413 ) 89 (428 ) 47
Other expense, net (143 ) (76 ) (268 ) (123 )
Net loss (24,602 ) (16,805 ) (44,490 ) (32,207 )
Unrealized gain/(loss) on available for sale securities (38 ) (12 ) 188   (12 )
Comprehensive loss $ (24,640 ) $ (16,817 ) $ (44,302 ) $ (32,219 )
Net loss attributable to common stockholders:
Basic $ (24,602 ) $ (16,805 ) $ (44,490 ) $ (32,207 )
Diluted $ (24,602 ) $ (16,805 ) $ (44,490 ) $ (32,207 )
Net loss per share attributable to common stockholders:
Basic $ (0.88 ) $ (0.71 ) $ (1.59 ) $ (1.37 )
Diluted $ (0.88 ) $ (0.71 ) $ (1.59 ) $ (1.37 )

Weighted-average number of shares used in computing net
loss per share attributable to common stockholders:

Basic 28,089,731   23,584,910   28,047,671   23,560,133  
Diluted 28,089,731   23,584,910   28,047,671   23,560,133  
 
 
Revance Therapeutics, Inc.
2016 Financial Results
(Unaudited)
 
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense
(In thousands)
 
 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

Operating expense:
GAAP operating expense $ 24,159 $ 43,978
Adjustments:
Stock-based compensation (3,252 ) (6,229 )
Depreciation (355 ) (699 )
Non-GAAP operating expense $ 20,552   $ 37,050  
 
 
Revance Therapeutics, Inc.
2016 Financial Guidance
 
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense
(In thousands)
 
Fiscal Year
2016
Low   High
Operating expense:
GAAP operating expense $ 95,000 $ 108,000
Adjustments:
Stock-based compensation (13,000 ) (15,000 )
Depreciation (2,000 ) (3,000 )
Non-GAAP operating expense $ 80,000   $ 90,000  
 
 

Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense

(In thousands)
 
  Fiscal Year
2016
Low   High
R&D expense:
GAAP R&D expense $ 66,000 $ 74,000
Adjustments:
Stock-based compensation (7,000 ) (8,000 )
Depreciation (2,000 ) (3,000 )
Non-GAAP R&D expense $ 57,000   $ 63,000  

Investors:
Revance Therapeutics
Jeanie Herbert, (714) 325-3584
jherbert@revance.com
or
Burns McClellan
Ami Bavishi, (212) 213-0006
abavishi@burnsmc.com
or
Trade Media:
Nadine Tosk, (504) 453-8344
nadinepr@gmail.com

Source: Revance Therapeutics, Inc.

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