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Form 8-K Revance Therapeutics, For: Oct 14

October 14, 2020 8:14 AM EDT

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Exhibit 99.1

 

LOGO

Revance Reports Positive Results from ASPEN-1 Phase 3 Trial of

DaxibotulinumtoxinA for Injection in Cervical Dystonia

- Trial met primary and all secondary endpoints for both 125- and 250-Unit doses with high statistical significance -

- DaxibotulinumtoxinA for Injection was effective and generally well-tolerated in reducing the signs and symptoms for cervical dystonia, delivering up to a median duration of 24 weeks -

- Results suggest DaxibotulinumtoxinA for Injection has the potential to reduce frequency of cervical dystonia treatments by up to 50% annually -

- Global market opportunity for cervical dystonia is $340M1 -

- Conference call today at 8:30 a.m.ET -

NEWARK, Calif., October 14, 2020 - Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced positive topline results from its ASPEN-1 Phase 3 randomized, double-blind, placebo-controlled, parallel group clinical trial for its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, a chronic and debilitating neurologic condition affecting the muscles of the neck.

This pivotal study enrolled a total of 301 subjects at 60 sites in the U.S., Canada and Europe. Subjects were randomized 3:3:1 to receive a single treatment of either 125 Units or 250 Units of DaxibotulinumtoxinA for Injection, or placebo and were followed for up to 36 weeks. The drug was generally safe and well-tolerated at both doses, with an encouraging safety profile.

The study met its primary efficacy endpoint at both doses, demonstrating a clinically meaningful improvement in the signs and symptoms of cervical dystonia at the average of Weeks 4 and 6. Compared to placebo, subjects treated with either 125 Units or 250 Units showed a statistically significant greater change from baseline (12.7 and 10.9 respectively vs. 4.3, p<0.0001 and p=0.0006) as measured on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score.

Median duration of effect was 24.0 and 20.3 weeks, for the 125 Unit and 250 Unit dose groups respectively, based on the median time to loss of 80% of the peak treatment effect.

“I was delighted to see both the degree and duration of relief that DaxibotulinumtoxinA for Injection provided trial subjects in ASPEN-1. Currently, most patients with cervical dystonia visit their physician 3 to 4 times a year for injections, which places a heavy burden on patients’ time and schedule. Often, the treatment effect wears


off between injections, significantly impacting the quality of their work and personal lives,” said trial investigator Dr. Joseph Jankovic, Professor of Neurology, Distinguished Chair in Movement Disorders, Founder and Director, The Parkinson’s Disease Center and Movement Disorders Clinic at Baylor College of Medicine, Houston, Texas. “If a treatment could offer longer duration of effect, thus requiring fewer trips each year for reinjection, I imagine patients would find this quite beneficial.”

“We are very pleased to report these positive results from the ASPEN-1 Phase 3 trial, as this is the company’s second successful Phase 3 program demonstrating DaxibotulinumtoxinA for Injection’s extended duration profile, now across two different treatment categories – aesthetics and therapeutics. In addition to laying the foundation for our therapeutics franchise, these results reinforce its potential in other muscle movement and pain disorders,” said Mark Foley, President and Chief Executive Officer at Revance. “A cervical dystonia treatment option with a longer duration of effect has the ability to offer patients a meaningful extension of symptom relief while also providing a compelling pharmacoeconomic profile. We look forward to continuing to leverage the differentiated performance profile of DaxibotulinumtoxinA for Injection across the $5.1B global neuromodulator market.”

The company expects results from the companion ASPEN-OLS Phase 3 open-label, long-term safety trial, which enrolled 354 subjects, in 2021.

EFFICACY RESULTS:

Positive efficacy results were seen with both DaxibotulinumtoxinA for Injection dose groups studied. The trial’s primary efficacy measurements were based on the average of the change from baseline in TWSTRS Total Score at Weeks 4 and 6. TWSTRS Total Score is a composite score evaluating features of the cervical dystonia condition, including severity, disability and pain:

 

     125 Unit Dose   250 Unit Dose   Placebo

Average Reduction from Baseline in TWSTRS Total Score
(% change from baseline, p-value vs. placebo)

   12.7 (31%, p<0.0001)   10.9 (27%, p=0.0006)   4.3 (12%)

The median duration of effect was 24.0 weeks for the 125 Unit dose, and 20.3 weeks for the 250 Unit dose, as measured by the time to loss of 80% of the peak treatment effect.

Two of the secondary endpoints measured the percentage of responders showing improvement with at least a 2-point improvement based on the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) at Week 4 or 6. Both the clinician and patient results were consistent and showed a statistically significant improvement greater than placebo (p<0.001).

SAFETY RESULTS: In both dose groups, DaxibotulinumtoxinA for Injection appeared to be generally safe and well-tolerated through Week 36. There were no serious treatment-related adverse events and no dose-dependent increase in adverse events was observed. Treatment-related adverse events were generally transient and mild to moderate in severity, with one case of neck pain reported as severe, which resolved two days after onset. The three most common treatment-related adverse events were (for 125 Units and 250 Units):

 

   

Injection site pain (7.9%, 4.7%)


   

Headache (4.7%, 4.7%)

 

   

Injection site erythema (4.7%, 2.3%)

The incidence of dysphagia (difficulty swallowing) and muscle weakness, which are considered adverse events of particular interest with botulinum toxin treatments for cervical dystonia, was encouragingly low: dysphagia (1.6%, 3.9%) and muscular weakness (4.7%, 2.3%).

ASPEN Phase 3 Clinical Program in Cervical Dystonia

In 2017, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for DaxibotulinumtoxinA for Injection to treat cervical dystonia, which provides certain developmental and financial benefits to trial sponsors.

The company’s ASPEN Phase 3 clinical program consists of two trials to evaluate the safety and efficacy of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults: 1) ASPEN-1, a randomized, double-blind, placebo-controlled, parallel group trial and; 2) ASPEN-OLS, an open-label, long-term safety trial.

Randomized Trial (ASPEN-1): Patients were randomized to a single treatment of either 125 Unit or 250 Unit dose of DaxibotulinumtoxinA for Injection, or placebo. Post-treatment, patients are followed for a maximum of 36 weeks. The primary efficacy endpoint of the trial was the mean change from baseline in the TWSTRS Total Score at the average of Week 4 and 6. Key secondary endpoints include the duration of treatment effect, measurement of treatment response on the Clinical and Patient Global Impression of Change assessments, and adverse events. Further, the trial featured exploratory efficacy assessments including the Cervical Dystonia Impact Profile (CDIP-58), a disease-specific, patient-rated questionnaire that measures quality of life.

Open-Label Study (ASPEN-OLS): Patients receive up to four sequential treatment cycles of DaxibotulinumtoxinA for Injection over the 52-week observation period. Primary endpoints of the trial are safety and immunogenicity after multiple cycles of treatment with DaxibotulinumtoxinA for Injection. Key secondary endpoints are the change from baseline in TWSTRS Total Score, and the duration of treatment effect, as well as overall treatment response based on the Clinical and Patient Global Impression of Change. The ASPEN-OLS trial enrollment is fully enrolled with a total of 354 patients at sites located in the United States, Canada, and Europe.

Additional information about the ASPEN Phase 3 program is available at www.clinicaltrials.gov.

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. Current neuromodulator treatments for cervical dystonia have a duration of effect of approximately three months. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects a few hundred thousand adults and children in the United States alone. The global market opportunity for cervical dystonia is $340 million1. Global Industry Analysts, Inc. estimates the global market for treating muscle movement disorders with botulinum toxins, including cervical dystonia, was approximately $1.1 billion in 2018.

Conference Call

The company plans to host a conference call to discuss the results today at 8:30 am ET. A PDF of a slide deck covering the trial design and results will be posted to the company website at 8:05 am ET to accompany the commentary on the conference call. They can be found on the Revance website at www.revance.com within Presentations and Corporate Materials under the Events & Webcast tab. We encourage you to download the PDF prior to the call.

Individuals interested in listening to the conference call may do so by dialing 1(855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 1987683; 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 October 14, 2020 at 8:30 a.m. PT/12:30 a.m. ET to October 16, 2020 at 8:30 a.m. PT/12:30 a.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 1987683.

The live webcast can be accessed here and will be available in the investor relations section on the company’s website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Revance requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.

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 in 2020. 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 three therapeutic indications—cervical dystonia, adult upper limb spasticity and plantar fasciitis. 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 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 about DaxibotulinumtoxinA potential for the treatment of cervical dystonia; its therapeutic and commercial potential; the timing and results of the ASPEN Phase 3 clinical program; potential value for DaxibotulinumtoxinA in other muscle movement and pain disorders; the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform, constitute forward-looking statements.

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 the top-line results from the ASPEN-1 trial are based on our preliminary analysis of key efficacy and safety data, the fact that such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of the trial, and the FDA may not agree with our interpretation of such results; 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, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our reliance on third-party manufacturers; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the proper training and administration of our products by physicians and medical staff; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; 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 the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. 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 (the “SEC”), including factors described in the section entitled “Risks Factors” on our


Form 10-Q filed with the SEC on August 6, 2020. 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.

Investors

Revance Therapeutics, Inc.:

Jeanie Herbert, 714-325-3584

[email protected]

or

Gilmartin Group, LLC.:

Laurence Watts, 619-916-7620

[email protected]

Media

Revance Therapeutics, Inc.:

Sara Fahy, 949-887-4476

[email protected]

or

General Media:

Y&R:

Jenifer Slaw, 347-971-0906

[email protected]

or

Trade Media:

Nadine Tosk, 504-453-8344

[email protected]

 

  1.

SOURCE: Global Industry Analytics, Inc. Botulinum Toxin Global Market Trajectory & Analytics; September 2020”

Source: Revance Therapeutics, Inc.

Slide 1

Exhibit 99.2


Slide 2

Forward-Looking Statements Safe Harbor  /  Market Data This presentation contains forward-looking statements, including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to: DaxibotulinumtoxinA potential for the treatment of cervical dystonia; its therapeutic and commercial potential; the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational product candidates; the timing and results of the ASPEN Phase 3 clinical program, including results from the ASPEN-OLS trial; timing and outcome of regulatory determinations regarding potential approval of DaxibotulinumtoxinA and expected PDUFA date and commercial potential of our drug candidates; market size and market for our anticipated products; our business strategy, timeline and other goals and market for our anticipated products.   These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Our expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks and changes in circumstances, including but not limited to risks and uncertainties related to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that the top-line results from ASPEN-1 trial are based on our preliminary analysis of key efficacy and safety data, and the fact that such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of the trial, and the FDA may not agree with our interpretation of such results; whether the clinical trials have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the size and growth potential of the markets for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” and elsewhere in our most recent filings with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and any subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the Securities and Exchange Commission from time to time and available at www.sec.gov. These documents can be accessed on our Investor Relations page at https://investors.revance.com/ by clicking on the link titled “Financials and Filings.” The risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty.    


Slide 3

First Phase 3 readout for DaxibotulinumtoxinA for Injection in a therapeutic indication. DaxibotulinumtoxinA for Injection could represent an important advancement in cervical dystonia care for suffering patients. DaxibotulinumtoxinA for Injection treatment effect shows consistent long duration across aesthetic and therapeutic Phase 3 studies. Positive Top-Line Results from Phase 3 Clinical Trial in Cervical Dystonia For Investigational Drug Candidate DaxibotulinumtoxinA for Injection


Slide 4

Cervical Dystonia Landscape Cervical dystonia - (also referred to as spasmodic torticollis) – is a painful chronic condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck.1 Botulinum neurotoxins (BoNT) are the standard of care for treatment of cervical dystonia. 2 Treatment approach: dosing varies based on severity and clinical presentation. Physicians initiate treatment with a low dose and titrate up over time based on response and tolerability. 1. Dystonia Medical Research Foundation. Web Site. https://dystonia-foundation.org/what-is-dystonia/types-dystonia/cervical-dystonia/. Accessed 8/11/20​ 2.  Simpson M et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology, Neurology 2016 3. NORD Web Site https://rarediseases.org/rare-diseases/cervical-dystonia/. Accessed 8/11/20​ 4. Botulinum Toxin Global Market Trajectory & Analytics September 2020 pages 37, 64 & 77​ MARKET Market of BoNT use in cervical dystonia estimated $340M worldwide.4 Cervical dystonia is an orphan disease. Affects women approximately twice as often as men and typically affects people between 40 and 60 years of age. There are an estimated 60,000 Americans who experience cervical dystonia.3 $1B muscle movement disorder segment for BoNTs.2 $ DEFINITION


Slide 5

In a recent survey of 209 respondents with cervical dystonia, 88% reported the reappearance of pre-existing symptoms between their botulinum toxin injections.6 Significant impact on professional and personal lives. 71% of patients would like longer-lasting benefits from neuromodulator treatments.6 DURATION IS A KEY UNMET NEED Challenges Exist With Currently Available BoNTs BOTULINUM TOXINS ARE STANDARD OF CARE BoNTs are the primary and first-line treatment for cervical dystonia, with ~85% of patients receiving injections.1 Patients receiving currently approved BoNT products typically require retreatment between 12 and 14 weeks.2,3,4s) Symptom reemergence not aligned to payer reimbursed treatment intervals 5 Dysphagia (swallowing difficulty) rates between 13-19% are common after treatment with conventional BoNT products. 2,3,4refs 1. Revance® Market Research 2019: Understanding the Value of DaxibotulinumtoxinA for Injections’ Therapeutic Franchise 2. Botox ® Prescribing Information, 2020 3. Dysport ® Prescribing Information, 2020 4. Xeomin ® Prescribing Information, 2010 5. Botulinum Toxin Global Market Trajectory & Analytics September 2020 pages 37, 64 & 77 6. Comella C, et al. Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in cervical dystonia. Neurology, September 2020


Slide 6

Phase 3 Results of DaxibotulinumtoxinA for Injection in CERVICAL DYSTONIA Presented By Roman G. Rubio, MD Senior Vice President Of Clinical Development


Slide 7

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults with Cervical Dystonia


Slide 8

Phase 3 Top-Line Results Demonstrated that DaxibotulinumtoxinA for Injection, at either 125U or 250U, was an effective and generally well-tolerated treatment for reducing the signs and symptoms for cervical dystonia with up to a median duration of 24 weeks. DaxibotulinumtoxinA appeared to be generally safe and well-tolerated with adverse events rates similar to or lower than other BoNT products for the treatment of cervical dystonia Incidence of dysphagia and muscular weakness was encouragingly low The positive results reinforce the findings from the previous studies with DaxibotulinumtoxinA for Injection as a highly differentiated neuromodulator The ASPEN-1 pivotal trial demonstrates the scientific and clinical validity of a long-acting neuromodulator DaxibotulinumtoxinA met Primary and all Secondary Endpoints Highly statistically significant results achieved on TWSTRS Total Score primary endpoint at weeks 4 and 6 p<0.0001 (125 U vs. Placebo) p=0.0006 (250 U vs. Placebo) Median duration for time to reach Target TWSTRS Total Score was 24 weeks for 125U dose and 20 weeks for 250U dose Superior improvement observed on CGIC and PGIC compared with placebo at Weeks 4 and 6


Slide 9

Phase 3 Study Endpoints PRIMARY ENDPOINT: * Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) SECONDARY ENDPOINTS Duration of effect, defined as time from treatment to loss of ≥ 80% of peak treatment effect achieved at Weeks 4 and 6 (i.e. target TWSTRS Total Score) Change from baseline in TWSTRS Total Score over time Percentage of subjects with at least “moderate” (a 2-point) improvement on CGIC at Week 4 or 6 Percentage of subjects with at least “moderate” (a 2-point) improvement on PGIC at Week 4 or 6 Safety - incidence of adverse events EXPLORATORY EFFICACY ENDPOINTS Change from baseline in TWSTRS subscale scores (Severity, Disability, and Pain) Average change from baseline in TWSTRS* Total Score at Weeks 4 and 6 PRIMARY ENDPOINT


Slide 10

Study Design Evaluating Subjects Over 36 Weeks Across 60 Sites In US, Canada And EU Phase 3, Single Dose, Randomized, Double Blind, Placebo-controlled Study ADULTS WITH MODERATE TO SEVERE CERVICAL DYSTONIA N = 301 18 to 80 years of age Moderate to Severe CD: TWSTRS Total ≥ 20 Toxin-naïve or experienced DaxibotulinumtoxinA 125 U (n=125) DaxibotulinumtoxinA 250 U (n=130) PLACEBO (n=46) Week 0 2 4 & 6 12 36 Single Administration Primary Endpoint Visit Every 4 Weeks U, units.


Slide 11

Placebo (n=46) 125U (n=125) 250U (n=130) Total (n=301) DEMOGRAPHICS Female (n, %) 29 (63.0) 87 (69.6) 79 (60.8) 195 (64.8) AGE (years) mean (SD) range (min, max) 56.5 (11.8) 29, 80 57.2 (13.4) 18, 80 58.6 (10.6) 30, 79 57.7 (12.0) 18, 80 RACE (n, %) White 43 (93.5) 119 (95.2) 125 (96.2) 287 (95.3) Black/African American 2 (4.3) 2 (1.6) 2 (1.5) 6 (2.0) Other* 1 (2.2) 4 (3.2) 3 (2.3) 8 (2.7) BASELINE CHARACTERISTICS Baseline TWSTRS (mean, SD) 45.3 (10.5) 43.1 (9.4) 42.6 (8.6) 43.3 (9.3) Min, Max 25.5, 71.3 20.3, 66.0 27.0, 72.0 20.3, 72.0 CD Duration years (mean, SD) 11.2 (9.5) 10.8 (8.8) 10.5 (9.6) 10.8 (9.2) Prior BoNT for CD (n, %) 37 (80.4) 108 (86.4) 109 (83.8) 254 (84.4) Demographics and Baseline Characteristics * Other includes Asian (3), American Indian or Alaska Native (1), Native Hawaiian or Other Pacific Islander (1), Other (3)


Slide 12

Primary Endpoint Met for Both 125 U and 250 U Doses AVERAGE CHANGE FROM BASELINE IN TWSTRS TOTAL SCORE AT WEEKS 4 AND 6 ∆=12% ∆=31% ∆=27% Placebo (n=46) DAXI 125 U (n=125) DAXI 250 U (n=130) Primary Analysis** p<0.0001 (125 U vs. Placebo) p=0.0006 (250 U vs. Placebo) p=0.1902 (250 U vs. 125 U) * Least Square Means. **Analysis of covariance. ∆ % Change from Baseline


Slide 13

Secondary Endpoint: Median Duration of Effect was 24 Weeks for 125 U Dose and 20 Weeks for 250 U Dose MEDIAN TIME TO LOSS OF ≥ 80% OF PEAK TREATMENT EFFECT


Slide 14

Duration of Effect for DaxibotulinumtoxinA for Injection, BOTOX® and Myobloc® DaxibotulinumtoxinA for Injection Figure 2. from Comella 2005 All subjects had previous successful treatment with BoNTA, with a subjective report of at least 30% benefit. BOTOX ® AND MYOBLOC ® Note: Results drawn from multiple studies. Caution should be used when interpreting cross-study comparisons. 1Comella C. Comparison of botulinum toxin serotypes A and B for the treatment of cervical dystonia. Neurology 2005. MEDIAN TIME TO LOSS OF ≥ 80% OF PEAK TREATMENT EFFECT …… Botox ® (n=63) ____ Myobloc ® (n=59) 12.1 14.0 Opie updated ®


Slide 15

Secondary Endpoints – Clinical and Patient Global Impression of Change Consistent* at Week 4 or 6 *Response of moderately better or very much better at Weeks 4 or 6. Subjects missing response on study defined as non-responder. PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC) p<0.0001 (125 U vs. Placebo) p=0.0009 (250 U vs. Placebo) p=0. 4801 (250 U vs. 125 U) CLINICAL GLOBAL IMPRESSION OF CHANGE (CGIC) p<0.0002 (125 U vs. Placebo) p=0.0007 (250 U vs. Placebo) p=0. 6034 (250 U vs. 125 U)


Slide 16

AVERAGE CHANGE FROM BASELINE AT WEEKS 4 AND 6 TWSTRS Subscales Highly Consistent With Primary Endpoint p<0.0001 (125 U vs. Placebo) p=0.0003 (250 U vs. Placebo) p=0. 2966 (250 U vs. 125 U) p<0.0001 (125 U vs. Placebo) p=0.0016 (250 U vs. Placebo) p=0. 3367 (250 U vs. 125 U) p<0.0007 (125 U vs. Placebo) p=0.0175 (250 U vs. Placebo) p=0. 1558 (250 U vs. 125 U)


Slide 17

DaxibotulinumtoxinA for Injection Duration Achieved with Low Amount of Core Neurotoxin Product, dose Dysphagia Rate DAXI 125U 1.6% DAXI 250U 3.9% Xeomin 120U 13%3 Dysport 500U 15%4 Xeomin 240U 18%3 Botox 236U 19%2 Field, et al. AbobotulinumtoxinA (Dysport®), OnabotulinumtoxinA (Botox®), and IncobotulinumtoxinA (Xeomin®) Neurotoxin Content and Potential Implications for Duration of Response in Patients, Toxins 2018, 10(12), 535 Botox Prescribing Information, 2020 Xeomin Prescribing information, 2010 Dysport Prescribing Information, 2020 Note: Results drawn from multiple studies. Caution should be used when interpreting cross-study comparisons. DAXI 125U DAXI 250U 240U3 236U2 500U4 120U3


Slide 18

AE Summary n (%) # of Events Placebo (N=46) DAXI 125U (N=127) DAXI 250U (N=128) Total N=301) SUBJECTS WITH ANY TEAEs 18 ( 39.1) 34 74 ( 58.3) 148 64 ( 50.0) 134 156 ( 51.8) 316 SUBJECTS WITH ANY SERIOUS TEAEs* 0 5 ( 3.9) 5 3 ( 2.3) 4 8 ( 2.7) 9 SUBJECTS WITH ANY TREATMENT-RELATED TEAEs 8 ( 17.4) 11 37 ( 29.1) 54 31 ( 24.2) 49 76 ( 25.2) 114 Mild 7 ( 15.2) 10 33 ( 26.0) 48 25 ( 19.5) 43 65 ( 21.6) 101 Moderate 1 (2.2) 1 3 (2.4) 5 6 ( 4.7) 6   10 ( 3.3) 12 Severe** 0 1 ( 0.8) 1 0 1 ( 0.3) 1 *None of the SAE’s were treatment related.  There was 1 unrelated death.  **Single case of neck pain reported as severe (Onset at Day 10, duration of 2 days).  Safety: Treatment-Emergent Adverse Events (TEAEs) Overall Summary DaxibotulinumtoxinA for Injection was generally safe and well-tolerated at both doses through week 36


Slide 19

AE Summary n (%) Placebo (N=46) DAXI 125 U (N=127) DAXI 250 U (N=128) Total (N=301) SUBJECTS WITH ANY TREATMENT-RELATED TEAE 8 ( 17.4) 37 ( 29.1) 31 ( 24.2) 76 ( 25.2) Injection site pain 2 ( 4.3) 10 ( 7.9) 6 ( 4.7) 18 ( 6.0) Headache 1 ( 2.2) 6 ( 4.7) 6 ( 4.7) 13 ( 4.3) Injection site erythema 1 ( 2.2) 6 ( 4.7) 3 ( 2.3) 10 ( 3.3) Muscular weakness 0 6 ( 4.7) 3 ( 2.3) 9 ( 3.0) Musculoskeletal pain 0 3 ( 2.4) 4 ( 3.1) 7 ( 2.3) Dysphagia 0 2 ( 1.6) 5 ( 3.9) 7 ( 2.3) Safety Treatment Related Adverse Events by Preferred Term (≥ 3% in Any Group) ADVERSE EVENTS OF INTEREST IN CERVICAL DYSTONIA WERE ENCOURAGINGLY LOW


Slide 20

DaxibotulinumtoxinA for Injection*1 Molecular weight 150 kDa 900 kDa7 ~400 kDa 150 kDa Cervical Dystonia dose 125U, 250U 236U 500U 120U, 240U Core neurotoxin amount** 0.56 ng, 1.12 ng 1.96 ng6 2.69 ng6 0.484 ng6, 0.968 ng6 Free of accessory proteins ✓ ✓ Proprietary peptide excipient technology  ✓ No animal-derived components or human serum albumin (HSA) ✓ TWSTRS Total Percent decrease at primary timepoint 27-31% N/A 21-35% 23-26% Duration of response as seen in pivotal clinical trials 24 weeks, 20 weeks*** 3 months2 14 weeks3 3 months4 100% sourced and manufactured in the US ✓ Dysphagia rate 1.6%, 3.9% 19%2 15%3 13%, 18%4 A Highly Differentiated Neuromodulator Product Note: Results drawn from multiple studies. Caution should be used when interpreting cross-study comparisons References: 1. Revance Data on file (Aspen-1 Phase 3 Trial with DaxibotulinumtoxinA 125-250 Units) 2. Full details included in Botox® product insert 3. Full details included in Dysport® product insert, FDA Dysport Summary Basis of Approval (CMC section) 4. Full details included in Xeomin® product insert 6. Field, et al. AbobotulinumtoxinA (Dysport®), OnabotulinumtoxinA (Botox®), and IncobotulinumtoxinA (Xeomin®) Neurotoxin Content and Potential Implications for Duration of Response in Patients, Toxins 2018, 10(12), 535 7. Pr BOTOX COSMETIC® onabotulinumtoxinA for injection Ph. Eur. Monograph *DaxibotulinumtoxinA is an investigational product.     **Mass of 150kDa core neurotoxin contained within the glabellar line dose for each product All other trademarks referenced herein are the property of their respective owners DaxibotulinumtoxinA for Injection at 125 U has approximately 1/4th the amount of core neurotoxin as BOTOX® DaxibotulinumtoxinA for Injection


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Phase 3 Top-Line Results Demonstrated that DaxibotulinumtoxinA for Injection, at either 125U or 250U, was an effective and generally well-tolerated treatment for reducing the signs and symptoms for cervical dystonia with up to a median duration of 24 weeks. DaxibotulinumtoxinA appeared to be generally safe and well-tolerated with adverse events rates similar to or lower than other BoNT products for the treatment of cervical dystonia Incidence of dysphagia and muscular weakness was encouragingly low The positive results reinforce the findings from the previous studies with DaxibotulinumtoxinA for Injection as a highly differentiated neuromodulator The ASPEN-1 pivotal trial demonstrates the scientific and clinical validity of a long-acting neuromodulator DaxibotulinumtoxinA met Primary and all Secondary Endpoints Highly statistically significant results achieved on TWSTRS Total Score primary endpoint at weeks 4 and 6 p<0.0001 (125 U vs. Placebo) p=0.0006 (250 U vs. Placebo) Median duration for time to reach Target TWSTRS Total Score was 24 weeks for 125U dose and 20 weeks for 250U dose Superior improvement observed on CGIC and PGIC compared with placebo at Weeks 4 and 6


Slide 22

Thank You to Patients, Investigators, CROs & Revance Team


Slide 23

REVANCE THERAPEUTICS


Slide 24

Both physicians and patients consider duration a critically important factor with botulinum toxin treatment.1 1. Timothy Corcoran Flynn , Examining Duration of Effect in Facial Aesthetic Applications , Am J Clin Dermatol 2010; . DaxibotulinumtoxinA For Injection Has Demonstrated Long Duration in Thousands of Patients Globally Including two Phase 3 Aesthetic and Therapeutic Programs Long duration of effect could reduce payer and patient burden of care and provide favorable pharmacoeconomics First true innovation in the neuromodulator market in over 30 years


Slide 25

Market of BoNT use in Cervical Dystonia estimated $340M worldwide.1 There are 12 Approved Therapeutic Indications for Botulinum Toxin Type A in the U.S. and hundreds of potential indications3   $2.3 Billion2  Global Therapeutics Neuromodulator Revenues 29% CHRONIC MIGRAINE 51% MUSCLE MOVEMENT/ PAIN 1% OTHER 7% AXILLARY  HYPERHIDROSIS 12% OVERACTIVE BLADDER Results reinforce the potential for DaxibotulinumtoxinA for Injection in other muscle movement and pain disorders Botulinum Toxin Global Market Trajectory & Analytics September 2020 pages 37, 64 & 77​ 2019 (E) based on Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2019, November 2018 and Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports, December 2019 and December 2020  Time Magazine, January 16, 2017, How BOTOX® Became the Drug That’s Treating Everything THERAPEUTIC OPPORTUNITY


Slide 26

Cervical Dystonia Is One of Three Muscle Movement and Pain Indications In Therapeutics Revance is Currently Pursuing ADULT UPPER LIMB SPASTICITY PLANTAR FASCIITIS ~$391M Global Spasticity Opportunity1 Typically treated by neurologists. Phase 2 Placebo-Controlled Study Fully Enrolled.  Topline results expected in November 2020.                                            ~$284M US Plantar Fasciitis Treatment Market2 Typically treated by podiatrists, physiatrists & orthopedic surgeons. Modified JUNIPER Phase 2 Placebo-Controlled, Dose-Ranging Study Fully Enrolled. Topline results expected in early 2021. 1.  UBS Specialty Pharmaceuticals Handbook  April 2018; page 54, figure #49 2. https://heelthatpain.com/15-plantar-fasciitis-facts/  ASPEN–OLS Long-Term Safety Trial Fully Enrolled. Results for ASPEN-OLS expected in 2021.  CERVICAL DYSTONIA ~$340M Global Cervical Dystonia opportunity1 typically treated by neurologists


Slide 27

Entering Attractive, Growing Markets Totaling >$6 Billion Today $8.5B by 2025 $5.1B1 today GLOBAL NEUROMODULATORS $2B by 2025 $1.1B2 today U.S. HYALURONIC ACID DERMAL FILLERS $700M by 2025 $ 500M3 today U.S. AESTHETICS FINTECH PLATFORM Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2019, November 2018 and Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports, December 2019 and December 2020 Medical Insight, Inc. | Global Facial Injectables Market Study | December 2018 – Table 29 Data on File, IBIS, ISAPS, AmSpa Worldwide collaboration and license agreement, for biosimilar to BOTOX® Rights to DaxibotulinumtoxinA for Injection in China, Hong Kong, Macau - Aesthetics & Therapeutics PARTNERSHIPS


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7555 Gateway Boulevard Newark, California 94560 +1 (510) 742-3400 Thank You.



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