00014792905/9/2024FALSE00014792902024-05-092024-05-09
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 9, 2024
Revance Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware001-3629777-0551645
(State or other jurisdiction of incorporation)(Commission File No.)(I.R.S. Employer Identification No.)
1222 Demonbreun Street, Suite 2000, Nashville, Tennessee, 37203
(Address of principal executive offices and zip code)

(615) 724-7755
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par valueRVNCNasdaq Global Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨



ITEM 2.02    RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
On May 9, 2024, Revance Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2024. The press release also provided an update regarding the commercial launch of DAXXIFY® for the treatment of cervical dystonia and other corporate developments. A copy of the press release regarding the financial results is furnished as Exhibit 99.1 to this report.

The information in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

ITEM 7.01    REGULATION FD DISCLOSURE.

On May 9, 2024, the Company issued a press release announcing the commercial launch of DAXXIFY® for the treatment of cervical dystonia. A copy of the press release is furnished as Exhibit 99.2 to this report.

The information in this Item 7.01 and in the press release furnished as Exhibit 99.2 to this report, is furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. The Company’s submission of this report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.

ITEM 8.01    OTHER EVENTS.

On May 9, 2024, the Company announced the commercial launch of DAXXIFY® for the treatment of cervical dystonia.

ITEM 9.01    FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits
NumberDescription
104
Interactive Data File (embedded within the Inline XBRL document)



SIGNATURES
    Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date:May 9, 2024Revance Therapeutics, Inc.
By:/s/ Tobin C. Schilke
Tobin C. Schilke
Chief Financial Officer


Exhibit 99.1
image1.jpg
Revance Reports First Quarter 2024 Financial Results, Provides Corporate Update

–Total net product revenue (DAXXIFY® and RHA® Collection) of $51.7 million, a YoY increase of 13%.
–DAXXIFY® net revenue of $22.1 million, after a reduction of $2.0 million related to a consumer coupon program.
–Toxin market share increased from 3.0% in Q4’23 to 3.7% in Q1’24.
–Aesthetic units sold increased 105% YoY and 7% QoQ, despite traditional seasonality.
–RHA® Collection net revenue of $29.6 million; filler market share increased from 9.1% in Q4’23 to 9.8% in Q1’24.
–Revance launches DAXXIFY for Cervical Dystonia, with coverage for 78% of commercial lives and continued positive real-world physician feedback from PrevU program.
–Revance continues to expect 2024 total net product revenue, which includes sales of DAXXIFY and the RHA Collection, to be at least $280 million.
–Conference call and webcast today at 4:30 p.m. ET.

NASHVILLE, Tenn. --(BUSINESS WIRE)-- May 9, 2024 - Revance Therapeutics, Inc. (RVNC, www.revance.com), today reported financial results for the first quarter ended March 31, 2024 and provided a corporate update.

Financial Highlights
In connection with the exit of the Fintech Platform business, the results of the Fintech Platform business are reflected as discontinued operations in our financial statements as of March 31, 2024 and December 31, 2023 and for the periods ended March 31, 2024 and 2023. Therefore, the GAAP and non-GAAP results discussed below reflect our continuing operations and exclude results of the Fintech Platform, which was presented in our financial statements as the service segment.
•Total net revenue for the first quarter ended March 31, 2024 was $51.9 million compared to $45.8 million for the same period last year, representing an increase of 13%, due to an increase in DAXXIFY sales volume. Net revenue for the first quarter ended March 31, 2024 included $29.6 million of RHA Collection revenue, $22.1 million of DAXXIFY revenue, and $0.2 million of collaboration revenue.
•Selling, general and administrative (SG&A) expenses for the first quarter ended March 31, 2024 were $68.9 million compared to $61.9 million for the same period in 2023, presented in


accordance with U.S. generally accepted accounting principles (“GAAP”). The increase was primarily due to higher sales and marketing expenses related to DAXXIFY and the RHA Collection. Excluding stock-based compensation, depreciation and amortization, non-GAAP SG&A expenses were $61.0 million for the first quarter ended March 31, 2024, compared to $50.9 million for the same period in 2023.
•Research and development (R&D) expenses for the first quarter ended March 31, 2024 were $14.4 million compared to $17.5 million for the same period in 2023. The decrease was primarily due to lower clinical trial and regulatory activity. Excluding stock-based compensation, depreciation and amortization, non-GAAP R&D expenses were $12.7 million for the first quarter ended March 31, 2024, compared to $13.7 million for the same period in 2023.
•Total operating expenses for the first quarter ended March 31, 2024 were $98.8 million compared to $92.5 million for the same period in 2023. Excluding cost of product revenue (exclusive of amortization), stock-based compensation, depreciation and amortization, non-GAAP operating expenses for the first quarter ended March 31, 2024 were $73.6 million, compared to $64.5 million for the same period in 2023.
•Net loss from continuing operations for the first quarter ended March 31, 2024 was $49.5 million compared to $48.5 million for the same period in 2023.
•Cash, cash equivalents and short-term investments as of March 31, 2024 were $277.1 million.

“We are very pleased to see the DAXXIFY strategy change continue to drive the desired momentum and market share gains. Notably, we saw a healthy uptick in volume both on a year-on-year basis, where aesthetic units sold increased by 105%, and on a sequential quarterly basis where aesthetic units sold increased by 7% despite traditional Q4 to Q1 seasonality. The positive impact of our strategy change was further reflected in our market share gains where DAXXIFY’s share increased from 3.0% in Q4’23 to 3.7% in Q1’24.1 DAXXIFY’s net revenue was $22.1 million for the quarter, after a reduction of $2.0 million related to a consumer coupon program. In addition, the RHA Collection continued to outpace the market growing share from 9.1% in Q4’23 to 9.8%1 in Q1’24, against the backdrop of a soft filler market,” said Mark J. Foley, President and Chief Executive Officer. “Moving forward, our aesthetics business will be focused on expanding our DAXXIFY and RHA customer base while also driving deeper account penetration. Overall, we are pleased with the traction we are seeing with DAXXIFY and are encouraged by our ability to continue to take filler share, particularly as we kick-off a number of important initiatives designed to drive further growth. Additionally, today, we announced the commercial launch of DAXXIFY in cervical dystonia, which we believe will be an important driver of top line growth for us over time. We continue to be encouraged by the results of our CD PrevU Program, as


well as the progress we have made on reimbursement. Currently, DAXXIFY is covered by approximately 78% of commercial payors which, when combined with our government coverage, represents over 200 million lives. In sum, we remain on track to generate combined sales of DAXXIFY and the RHA Collection of at least $280 million in 2024.”

First Quarter Highlights and Subsequent Updates
•DAXXIFY continued to take share, with aesthetic units sold up 105% YoY and 7% QoQ, despite typical first quarter seasonality; DAXXIFY net product revenue was $22.1 million, after a $2.0 million reduction related to a consumer coupon program during the quarter that functioned like a rebate.
•RHA Collection also took share against the backdrop of a soft filler market and an ongoing focus on DAXXIFY; RHA Collection net product revenue was $29.6 million, representing a YoY decrease of 2%. In April, we launched RHA 3 for lip augmentation and fullness – the #1 performed filler procedure in the U.S.
•Accounts across Revance’s aesthetic portfolio totaled over 7,500 at the end of the first quarter 2024. The company ended the quarter with over 3,500 accounts that have ordered DAXXIFY.
•Expanded into the U.S. therapeutics market in May 2024 with the launch of DAXXIFY for the treatment of cervical dystonia. DAXXIFY for the treatment of cervical dystonia is the first and only peptide-formulated, long-lasting neurotoxin that offers the potential to improve duration of symptom control. Today’s launch enables the company to enter the $2.7 billion U.S. therapeutic neurotoxin market with a new and compelling treatment option.
•In February 2024, Revance received a permanent J-Code for DAXXIFY and announced the publication of DAXXIFY’s pivotal study (ASPEN-1) results in Neurology®. The assignment of a J-Code by the U.S. Centers for Medicare and Medicaid Services streamlines future reimbursement for DAXXIFY. The peer-reviewed publication in Neurology of DAXXIFY’s pivotal data in therapeutics reinforced the product’s long duration of effect and favorable safety profile.
•In March, the company successfully completed an offering of common stock for gross proceeds of $100.0 million, which further bolstered the company’s financial standing, and provides balance sheet optionality.



2024 Financial Outlook
Revance continues to expect 2024 total net product revenue, which includes sales of DAXXIFY and the RHA Collection, to be at least $280 million. Revance continues to expect 2024 GAAP operating expenses from continuing operations to be between $460 million to $490 million and non-GAAP operating expenses from continuing operations to be between $290 million to $310 million. Revance continues to expect non-GAAP SG&A expenses from continuing operations to be between $240 million to $255 million.

With cash, cash equivalents, and short-term investments of $277.1 million as of March 31, 2024, and anticipated revenues and expenditures, management projects that the company will be funded to cash flow break-even and reach positive Adjusted EBITDA in 2025.

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 9, 2024 to discuss its financial results and provide a corporate update. Individuals interested in listening to the conference call may do so by dialing (833) 470-1428 and reference conference ID: 663066, or from the webcast link in the investor relations section of the company’s website at: www.revance.com.
A webcast replay will be available beginning May 9, 2024, at 4:30 p.m. PT / 7:30 p.m. ET to August 9, 2024, at 4:30 p.m. PT / 7:30 p.m. ET. To access the replay, please register via the webcast link on the events page. The webcast will be available in the investor relations section on the company’s website for 90 days following the completion of the call.


About Revance
Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance’s portfolio includes DAXXIFY (DaxibotulinumtoxinA-lanm) for injection and the RHA Collection of dermal fillers in the U.S. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY in China.



Revance’s global headquarters and experience center is located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn(https://www.linkedin.com/company/revance).
“Revance”, the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA are trademarks of TEOXANE SA.

Forward-Looking Statements
Any statements in this press release that are not statements of historical fact, including statements related to 2024 guidance, our expected cash flow breakeven and our ability and timing related to achieving positive Adjusted EBITDA; the potential benefits, safety, efficacy and duration (including while titrating doses) of DAXXIFY® for patients, physicians and payers; our opportunity in aesthetics and therapeutics; our growth potential and our ability to take share; the potential to set a new standard in healthcare; patient outcomes and physician experiences; development of an onobotulinumtoxinA biosimilar with our partner, Viatris; and commercialization of DAXXIFY® in China with our partner, Shanghai Fosun Pharmaceutical; 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 and the timing of events to differ materially from our expectations. These risks and uncertainties relate to, but are not limited to: our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, revenues, capital requirements, supply chain and operational efficiencies; our financial performance and the economics of DAXXIFY and the RHA Collection of dermal fillers; our ability to comply with our debt obligations; the impact of macroeconomic factors on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability to maintain approval of our products; our ability and the ability of our partners to manufacture supplies for DAXXIFY and our drug product candidates; our ability to acquire supplies of the RHA Collection of dermal fillers; the uncertain clinical development process; our ability to obtain, and the timing relating to, regulatory


submissions and approvals with respect to our drug product candidates and third-party manufacturers; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, duration, commercial acceptance, market, competition and/or size and growth potential of DAXXIFY, the RHA Collection of dermal fillers, and our drug product candidates, if approved; our ability to successfully commercialize DAXXIFY and to continue to successfully commercialize the RHA Collection of dermal fillers; the timing and cost of commercialization activities; securing or maintaining adequate coverage or reimbursement by third-party payers for DAXXIFY; the proper training and administration of our products by physicians and medical staff; our ability to maintain and gain acceptance from injectors and physicians in the use of DAXXIFY for aesthetic and therapeutic indications; our ability to strengthen professional partnerships; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with laws and regulations; our ability to continue obtaining and maintaining intellectual property protection for our products; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; our ability to limit or mitigate cybersecurity incidents; the volatility of our stock price; 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 our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risk Factors" in our Form 10-K filed with the SEC on February 28, 2024, and including, without limitation, our Form 10-Q for the quarter ended March 31, 2024 expected to be filed with the SEC on May 9, 2024. 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 preliminary and unaudited non-GAAP financial measures and forward-looking non-GAAP financial measures in this release, including non-GAAP SG&A expenses, non-GAAP R&D expenses, non-GAAP OPEX; and Adjusted EBITDA. As discussed above, the non-GAAP results discussed below reflect our continuing operations and exclude results of the service segment. Non-GAAP SG&A expense and non-GAAP R&D expense exclude depreciation, amortization and stock-based compensation; and non-GAAP OPEX excludes cost of product revenue (exclusive of amortization), depreciation, amortization and stock-based compensation. Adjusted EBITDA is defined as earnings before interest, taxes, depreciation and amortization and stock-based compensation. The company excludes cost of product revenue (exclusive of amortization), depreciation, amortization and stock-


based compensation because management believes the exclusion of these items is helpful to investors to evaluate the company’s recurring operational performance. Company management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an ongoing 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 is unable to reconcile forward-looking non-GAAP OPEX, non-GAAP SG&A expenses or Adjusted EBITDA to the most directly comparable GAAP measure because the items that are being excluded from the non-GAAP financial measure are difficult to predict and a reconciliation or a range of results could lead to disclosure that would be imprecise or potentially misleading. Material changes to any one of the exclusions could have a significant effect on our forward-looking estimates and GAAP results. Such items include costs of revenue (exclusive of amortization), depreciation, amortization and stock-based compensation.

Sources
1.Guidepoint Qsight® Aesthetics Sales Measurement data






REVANCE THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
 March 31, 2024December 31,
 20242023
ASSETS
CURRENT ASSETS
Cash and cash equivalents$132,609 $137,329 
Restricted cash, current550 550 
Short-term investments144,463 116,586 
Accounts receivable, net29,887 27,660 
Inventories50,280 45,579 
Prepaid expenses and other current assets9,287 9,308 
Current assets of discontinued operations2,610 1,853 
Total current assets369,686 338,865 
Property and equipment, net17,505 17,225 
Intangible assets, net8,725 9,270 
Operating lease right-of-use assets70,245 53,167 
Finance lease right-of-use asset— 19,815 
Restricted cash, non-current5,895 5,995 
Finance lease prepaid expense35,846 32,383 
Other non-current assets217 321 
Non-current assets of discontinued operations— 1,413 
TOTAL ASSETS$508,119 $478,454 
LIABILITIES AND STOCKHOLDERS’ DEFICIT
CURRENT LIABILITIES
Accounts payable$5,276 $13,554 
Accruals and other current liabilities40,311 52,863 
Deferred revenue, current9,784 10,737 
Operating lease liabilities, current7,126 5,703 
Finance lease liability, current— 2,651 
Debt, current5,000 2,500 
Current liabilities of discontinued operations1,406 1,216 
Total current liabilities68,903 89,224 
Debt, non-current424,838 426,595 
Deferred revenue, non-current71,403 70,419 
Operating lease liabilities, non-current38,813 40,985 
Other non-current liabilities2,835 2,835 
TOTAL LIABILITIES606,792 630,058 
STOCKHOLDERS’ EQUITY (DEFICIT)
Preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of March 31, 2024 and December 31, 2023
— — 
Common stock, par value $0.001 per share — 190,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 104,409,798 and 87,962,765 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively
104 88 
Additional paid-in capital2,032,760 1,926,654 
Accumulated other comprehensive gain (loss)(25)14 
Accumulated deficit(2,131,512)(2,078,360)
TOTAL STOCKHOLDERS’ DEFICIT(98,673)(151,604)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT$508,119 $478,454 



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,
 20242023
Revenue:
Product revenue, net$51,719 $45,658 
Collaboration revenue217 116 
Total revenue, net51,936 45,774 
Operating expenses:
Cost of product revenue (exclusive of amortization)14,911 12,487 
Selling, general and administrative68,914 61,920 
Research and development14,393 17,532 
Amortization545 545 
Total operating expenses98,763 92,484 
Loss from continuing operations(46,827)(46,710)
Interest income2,996 2,970 
Interest expense(5,256)(4,497)
Other expense, net(438)(234)
Net loss from continuing operations(49,525)(48,471)
Net loss from discontinued operations(3,627)(11,322)
Total net loss(53,152)(59,793)
Unrealized gain (loss)(39)249 
Comprehensive loss$(53,191)$(59,544)
Basic and diluted net loss per share:
Continuing operations$(0.54)$(0.60)
Discontinued operations(0.04)(0.14)
Total net loss per basic and diluted share$(0.58)$(0.74)
Basic and diluted weighted-average number of shares used in computing net loss per share91,919,018 81,134,111 



REVANCE THERAPEUTICS, INC.

Product Revenue Breakdown (Unaudited)
Three Months Ended March 31,
(in thousands)20242023
Product:
RHA Collection of dermal fillers$29,570 $30,280 
DAXXIFY22,149 15,378 
Total product revenue, net$51,719 $45,658 


Reconciliation of GAAP SG&A Expense from Continuing Operations to Non-GAAP SG&A Expense from Continuing Operations (Unaudited)

Three Months Ended March 31,
(in thousands)20242023
SG&A expense from continuing operations
$68,914 $61,920 
Adjustments:
Stock-based compensation(7,384)(9,555)
Depreciation and amortization(554)(1,498)
Non-GAAP SG&A expense from continuing operations
$60,976 $50,867 

Reconciliation of GAAP R&D Expense from Continuing Operations to Non-GAAP R&D Expense from Continuing Operations (Unaudited)

Three Months Ended March 31,
(in thousands)20242023
R&D expense from continuing operations
$14,393 $17,532 
Adjustments:
Stock-based compensation(1,379)(1,397)
Depreciation and amortization(344)(2,473)
Non-GAAP R&D expense from continuing operations
$12,670 $13,662 


Reconciliation of GAAP Operating Expenses from Continuing Operations to Non-GAAP Operating Expenses from Continuing Operations (Unaudited)
Three Months Ended March 31,
(in thousands)20242023
Total operating expenses from continuing operations
$98,763 $92,484 
Adjustments:
Cost of product revenue (exclusive of amortization)(14,911)(12,487)
Stock-based compensation(8,763)(10,952)
Depreciation and amortization(1,443)(4,516)
Non-GAAP operating expenses from continuing operations
$73,646 $64,529 

Investors
Laurence Watts, 619-916-7620
laurence@newstreetir.com

Media
Revance@evolvemkd.com

Exhibit 99.2

image.jpg
Revance Expands into the U.S. Therapeutics Market with the Launch of DAXXIFY® for the Treatment of Cervical Dystonia
–DAXXIFY® for the treatment of cervical dystonia is the first and only peptide-formulated, long-lasting neurotoxin that offers the potential to improve duration of symptom control1

–Revance has received a Permanent J-Code and has already secured coverage for 78% of commercial lives with top health plans, while also launching patient affordability programs

–Today’s launch provides first entry into the $2.7 billion U.S. therapeutic neurotoxin market with a new and compelling treatment option2

NASHVILLE, Tenn. — (BUSINESS WIRE) — May 9, 2024 - (NASDAQ: RVNC), today announced the commercial launch of DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia, providing patients and physicians with a compelling new treatment option for a painful and disabling chronic condition. The launch marks Revance’s entry into the large and growing U.S. therapeutics neurotoxin market.

“DAXXIFY provides a significant opportunity for Revance and marks the culmination of our decades-long mission to bring true innovation to the therapeutics market. Between DAXXIFY’s differentiated clinical profile, compelling value proposition and safety profile, DAXXIFY has the potential to address the unmet needs of all stakeholders, including patients, physicians and payers,” said President and Chief Executive Officer, Mark J. Foley.

Following the FDA’s approval of DAXXIFY for cervical dystonia in August 2023, Revance launched the DAXXIFY cervical dystonia PrevU early experience program with the objective of optimizing treatment outcomes for patients and ensuring smooth practice integration. Revance subsequently established its commercial infrastructure in preparation for launch, received a permanent J-Code for DAXXIFY from the U.S. Centers for Medicare & Medicaid Services (CMS) (which streamlines the reimbursement pathway for providers), operationalized reimbursement support services to minimize potential hurdles to adoption, and launched patient affordability programs to support patients with out-of-pocket costs.

“One of our primary goals has been to minimize barriers and ensure access to DAXXIFY for the large number of CD patients who have early symptom re-emergence and are not adequately controlled on current toxin treatments,” said David. A. Hollander, M.D., MBA, Chief Medical Officer and Global Therapeutics Franchise Lead.

Peter McAllister, M.D., co-founder and medical director of the New England Institute for Neurology and Headache, added: “As an investigator in the ASPEN program, and a participating physician in PrevU, I have seen firsthand the potential for DAXXIFY to address a significant unmet need in the treatment of cervical dystonia. Many patients struggle with pain and discomfort coming back between injections with current treatment options, but with DAXXIFY my patients have experienced long lasting symptom relief. Further, DAXXIFY’s safety profile continues to be encouraging over a broad range of doses. As patients


can currently only access treatment every 12 weeks based on product labeling and reimbursement guidelines, I’m excited to offer my patients a new therapy that offers sustained symptom control.”

For more information on DAXXIFY® access and availability, visit HCP.DAXXIFYCervicalDystonia.com
DAXXIFY® (daxibotulinumtoxinA-lanm) injection IMPORTANT SAFETY INFORMATION INDICATIONS
DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients and for the treatment of cervical dystonia in adults.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.
IMPORTANT SAFETY INFORMATION
Contraindications
DAXXIFY® contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).
Warnings and Precautions
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
The potency units of DAXXIFY® are not interchangeable with preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.
Adverse Reactions
The most commonly observed adverse reactions are:
Glabellar lines (≥1%): headache (6%), eyelid ptosis (2%) and facial paresis (1%).
Cervical dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%).
Drug Interactions
Co-administration of DAXXIFY® and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DAXXIFY® may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY® is unknown.
Use in Specific Populations
DAXXIFY® is not recommended for use in children or pregnant women.


Please see DAXXIFY® full Prescribing Information (https://www.revance.com/wp-content/uploads/2023/08/daxi-pi-and-med-guide.pdf), including Boxed Warning and Medication Guide (https://www.revance.com/wp-content/uploads/2023/08/daxi-pi-and-med-guide.pdf).
To report side effects associated with DAXXIFY®, please visit safety.revance.com, or call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .
About DAXXIFY
DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting, peptide formulated neuromodulator product with approved indications in the U.S. for the temporary improvement of glabellar lines (frown lines) and for the treatment of cervical dystonia in adults. DAXXIFY is powered by Peptide Exchange Technology™, Revance's proprietary, synthetic, 35-amino-acid stabilizing excipient, and is developed free of human serum albumin or animal-based components. Manufactured in the U.S., DAXXIFY is the first true innovation in neuromodulator product formulation in over 30 years.
Please see DAXXIFY important safety information below and full Prescribing Information, including Boxed Warning and Medication Guide (https://revance.com/wp-content/themes/allen-larson-theme/files/daxi-pi-and-med-guide.pdf).
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, cervical dystonia is a painful condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck. The movements may be sustained (tonic), jerky (clonic), or a combination. Cervical dystonia (also referred to as spasmodic torticollis) may be primary (meaning that it is the only apparent neurological disorder, with or without a family history) or may be the result of secondary causes (such as physical trauma).
First-line treatment for cervical dystonia is usually neuromodulator (botulinum toxin) injections, but additional treatments can include oral medications, surgery, and complementary therapies. Neuromodulators block the communication between the nerve and the muscle, relaxing the muscle, which alleviates abnormal involuntary movements and postures. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects roughly 60,000 people in the United States.

About Revance
Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance’s portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection and the RHA® Collection of dermal fillers in the U.S. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY® in China.

Revance’s global headquarters and experience center is located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn(https://www.linkedin.com/company/revance).

“Revance”, the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA are trademarks of TEOXANE SA.



Forward-Looking Statements

Any statements in this press release that are not statements of historical fact, including statements related to the potential benefits, safety, efficacy and duration of DAXXIFY® for the treatment of Cervical Dystonia; our opportunity in therapeutics; the U.S. therapeutics neurotoxin market; patient, physician and payor outcomes and experiences; our ability to set a new standard in healthcare; development of an onobotulinumtoxinA biosimilar with our partner, Viatris; and commercialization of DAXXIFY® in China with our partner, Shanghai Fosun Pharmaceutical; 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 and the timing of events to differ materially from our expectations. These risks and uncertainties relate to, but are not limited to: our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, revenues, capital requirements, cost savings related to the divestiture of the OPUL payments business and supply chain and operational efficiencies; our financial performance and the economics of DAXXIFY and the RHA Collection of dermal fillers; the extent of future impairment charges; our ability to comply with our debt obligations; the impact of macroeconomic factors on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability to maintain approval of our products; our ability and the ability of our partners to manufacture supplies for DAXXIFY and our drug product candidates; our ability to acquire supplies of the RHA Collection of dermal fillers; the uncertain clinical development process; our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to our drug product candidates and third-party manufacturers; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, duration, commercial acceptance, market, competition and/or size and growth potential of DAXXIFY, the RHA Collection of dermal fillers, and our drug product candidates, if approved; our ability to successfully commercialize DAXXIFY and to continue to successfully commercialize the RHA Collection of dermal fillers; the timing and cost of commercialization activities; securing or maintaining adequate coverage or reimbursement by third-party payers for DAXXIFY; the proper training and administration of our products by physicians and medical staff; our ability to maintain and gain acceptance from injectors and physicians in the use of DAXXIFY for aesthetic and therapeutic indications; our ability to strengthen professional partnerships; our ability to expand sales and marketing capabilities; the status of commercial collaborations; our ability to effectively manage the exit of the OPUL payments business; changes in and failures to comply with laws and regulations; our ability to continue obtaining and maintaining intellectual property protection for our products; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; our ability to limit or mitigate cybersecurity incidents; the volatility of our stock price; 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 our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risk Factors" in our Form 10-K filed with the SEC on February 28, 2024,


and including, without limitation, our Form 10-Q for the quarter ended March 31, 2024, expected to be filed with the SEC on May 9, 2024. 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.
SOURCES
1.Data on File. ASPEN-1 Rollover and ASPEN OLS TWSTRS. Newark, CA: Revance Therapeutics, Inc.
2.Market size as of 2023. CAGRs represent projected estimates. Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2024.

Investors
Laurence Watts, 619-916-7620
laurence@newstreetir.com

Media
Revance@evolvemkd.com




v3.24.1.u1
Cover Page Document
May 09, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date May 09, 2024
Entity Registrant Name Revance Therapeutics, Inc.
Entity Incorporation, State or Country Code DE
Entity File Number 001-36297
Entity Tax Identification Number 77-0551645
Entity Address, Address Line One 1222 Demonbreun Street, Suite 2000
Entity Address, City or Town Nashville
Entity Address, State or Province TN
Entity Address, Postal Zip Code 37203
City Area Code 615
Local Phone Number 724-7755
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.001 par value
Trading Symbol RVNC
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001479290
Amendment Flag false
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