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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Revance Therapeutics Inc | NASDAQ:RVNC | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 3.77 | 3.81 | 4.07 | 16 | 12:12:39 |
- Q1 revenue for the RHA® Collection of dermal fillers of $11.6 million
- HintMD’s processing volume run-rate more than doubled to over $400 million from the prior quarter
- Over 1,500 aesthetic accounts activated across products and services at quarter-end
- Status of the U.S. Food and Drug Administration (FDA) pre-approval inspection
- Conference call and webcast today at 4:30 p.m. ET
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.
Financial Highlights
“We are very pleased with our commercial execution in the first quarter, particularly given the impact of COVID-19 and seasonality, where the first quarter is traditionally a slower time of the year for the aesthetics market. We are also encouraged by the progress we are making in our therapeutics franchise as we begin laying the groundwork for our first anticipated approval in the treatment of muscle movement disorders,” said Mark Foley, President and Chief Executive Officer. “Our FDA approval for DaxibotulinumtoxinA for Injection for glabellar lines remains under review with a deferred action due to COVID-related travel restrictions. We stand ready for the pre-approval inspection of our manufacturing facility and are actively engaging with the FDA to schedule an inspection date as soon as possible. We continue to anticipate an approval this year and, as we have noted before, the FDA did not indicate that there were any other review issues beyond the pending inspection.”
Foley continued, “We remain focused on execution for the balance of the year and believe we are well positioned for continued growth based on our targeted launch strategy, differentiated products and services and anticipated approval of our next-generation neuromodulator. When combined with our efforts in therapeutics and steady progress in our partnerships, we are encouraged by the longer-term growth opportunities that will be available to us.”
First Quarter Highlights and Subsequent Updates
Aesthetics Franchise
Therapeutics Franchise
Corporate Highlights
Near-Term Milestone Expectations
Aesthetics Franchise:
Therapeutics Franchise:
2021 Financial Outlook
Revance reiterates its financial guidance provided in February 2021. The company expects 2021 GAAP operating expenses to be $375 million to $390 million and non-GAAP operating expenses, which exclude costs of revenue, depreciation and amortization and stock-based compensation to be $270 million to $285 million. Revance expects 2021 non-GAAP research and development expense to be $95 million to $105 million. With the current cash, cash equivalents and short-term investments, management projects that the company is funded into 2024.
Conference Call
Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on May 10, 2021 to discuss the results and provide a business and pipeline update. 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: 5082423; 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 May 10, 2021 at 4:30 p.m. PT / 7:30 p.m. ET to May 11, 2021 at 4:30 p.m. PT / 7:30 p.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 5082423. 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, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA. BOTOX® is a registered trademark of Allergan, Inc.
Forward-Looking Statements
Any statements in this press release that are not statements of historical fact, including statements related to Revance’s financial outlook, milestone expectations, expected cash runway and financial performance; statements about our ability to obtain, and the timing relating to, regulatory approval and meetings with respect to our drug product candidates, including with respect to DaxibotulinumtoxinA for Injection in glabellar lines and in therapeutic indications; the timing and outcome of the FDA’s inspection of the Northern California manufacturing facility; the rate and degree of commercial acceptance, opportunity and growth potential of Teoxane’s RHA® Collection of dermal fillers and the HintMD fintech platform, and our product candidates, if approved; the growth opportunities available to the company; the ability and timing for our partner, Teoxane SA, to obtain FDA approval for RHA® 1 for perioral (lip) lines; the process and timing of, and ability to complete, the current and anticipated future clinical development of our product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies; the timing of the release of the next-generation HintMD fintech platform; development of a biosimilar to BOTOX® with our partner, Viatris; the progress of our international partnerships; statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans; and potential benefits of our drug product candidates and our technologies, including the RHA® Collection of dermal fillers and HintMD fintech platform, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including the continuing delay in the FDA’s approval of the BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of delays in the site inspection conducted of our manufacturing facility due to COVID-19-related policies and travel restrictions currently in place at the FDA, observations made by the FDA during the site inspection or other reasons; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, the safety, commercial acceptance and the market, competition, size and growth potential of the RHA® Collection of dermal fillers, the HintMD fintech platform and our drug product candidates, if approved; our ability to successfully commercialize the RHA® Collection of dermal fillers, the HintMD fintech platform and our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and our financial performance, including future revenue, expenses and capital requirements. 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 our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-K filed with the SEC on February 25, 2021 and including, without limitation, our Form 10-Q for the quarter ended March 31, 2021, expected to be filed with the SEC on May 10, 2021. The forward-looking statements in this press release speak only as of the date hereof. We disclaim 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 non-GAAP selling, general and administrative expenses, which excludes depreciation and amortization and stock-based compensation; non-GAAP R&D expense, which excludes depreciation and amortization and non-cash stock-based compensation; and total non-GAAP operating expense, which excludes costs of revenue, depreciation and amortization, stock-based compensation and in-process research and development costs. Revance excludes costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs 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.
Certain non-GAAP measures included in this report were not reconciled to the comparable GAAP financial measures because the GAAP measures are not accessible on a forward-looking basis. The company is unable to reconcile these forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable efforts because the company is currently unable to predict with a reasonable degree of certainty the type and extent of certain items that would be expected to impact GAAP measures for these periods but would not impact the non-GAAP measures. Such items include costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs. The unavailable information could have a significant impact on the company’s GAAP financial results.
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
March 31,
December 31,
2021
2020
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
249,427
$
333,558
Short-term investments
137,386
102,947
Accounts and other receivables, net
5,186
1,829
Inventories
5,629
5,876
Prepaid expenses and other current assets
8,799
5,793
Total current assets
406,427
450,003
Property and equipment, net
20,766
17,499
Goodwill
146,964
146,964
Intangible assets, net
67,837
71,343
Operating lease right of use assets
28,779
29,632
Restricted cash
3,445
3,445
Other non-current assets
1,729
1,334
TOTAL ASSETS
$
675,947
$
720,220
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable
$
7,079
$
12,657
Accruals and other current liabilities
27,101
32,938
Deferred revenue, current portion
9,046
7,851
Operating lease liabilities, current portion
4,472
4,437
Derivative liability
3,140
3,081
Total current liabilities
50,838
60,964
Convertible senior notes
279,694
180,526
Deferred revenue, net of current portion
74,967
77,294
Operating lease liabilities, net of current portion
26,201
27,146
TOTAL LIABILITIES
431,700
345,930
STOCKHOLDERS’ EQUITY
Convertible preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of March 31, 2021 and December 31, 2020
—
—
Common stock, par value $0.001 per share — 95,000,000 shares authorized both as of March 31, 2021 and December 31, 2020; 71,411,389 and 69,178,666 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively
71
69
Additional paid-in capital
1,432,457
1,500,514
Accumulated deficit
(1,188,281
)
(1,126,293
)
TOTAL STOCKHOLDERS’ EQUITY
244,247
374,290
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
675,947
$
720,220
REVANCE THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended March 31,
2021
2020
Revenue:
Product revenue
$
11,647
$
—
Collaboration revenue
1,511
58
Service revenue
141
—
Total Revenue
13,299
58
Operating expenses:
Cost of product revenue (exclusive of amortization)
4,217
—
Cost of service revenue (exclusive of amortization)
—
—
Selling, general and administrative
49,005
21,224
Research and development
27,251
39,794
Amortization
2,838
—
Total operating expenses
83,311
61,018
Loss from operations
(70,012
)
(60,960
)
Interest income
97
1,491
Interest expense
(1,560
)
(2,148
)
Changes in fair value of derivative liability
(59
)
(90
)
Other expense, net
(105
)
(126
)
Loss before income taxes
(71,639
)
(61,833
)
Income tax provision
—
(100
)
Net loss
(71,639
)
(61,933
)
Unrealized gain and adjustment on securities included in net loss
—
521
Comprehensive loss
$
(71,639
)
$
(61,412
)
Basic and diluted net loss
$
(71,639
)
$
(61,933
)
Basic and diluted net loss per share
$
(1.08
)
$
(1.15
)
Basic and diluted weighted-average number of shares used in computing net loss per share
66,636,830
53,868,036
REVANCE THERAPEUTICS, INC.
Reconciliation of GAAP SG&A Expense to Non-GAAP SG&A Expense
(In thousands)
(Unaudited)
Three Months Ended
March 31, 2021
SG&A expense:
GAAP SG&A expense
$
49,005
Adjustments:
Stock-based compensation
(7,281
)
Depreciation and amortization
(932
)
Non-GAAP SG&A expense
$
40,792
REVANCE THERAPEUTICS, INC.
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense
(In thousands)
(Unaudited)
Three Months Ended
March 31, 2021
R&D expense:
GAAP R&D expense
$
27,251
Adjustments:
Stock-based compensation
(3,326)
Depreciation and amortization
(471)
Non-GAAP R&D expense
$
23,454
REVANCE THERAPEUTICS, INC.
Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense
(In thousands)
(Unaudited)
Three Months Ended
March 31, 2021
Operating expense:
GAAP operating expense
$
83,311
Adjustments:
Stock-based compensation
(10,607)
Depreciation and amortization
(4,241)
Costs of revenue (exclusive of amortization)
(4,217)
Non-GAAP operating expense
$
64,246
View source version on businesswire.com: https://www.businesswire.com/news/home/20210510005766/en/
Investors Revance Therapeutics, Inc.: Jessica Serra, 626-589-1007 Jessica.serra@revance.com or Gilmartin Group, LLC.: Laurence Watts, 619-916-7620 laurence@gilmartinir.com
Media Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476 sfahy@revance.com or General Media: Goodfuse: Jenifer Slaw, 347-971-0906 jenifer.slaw@Goodfuse.com or Trade Media: Nadine Tosk, 504-453-8344 nadinepr@gmail.com
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