Daring To Make A Difference - Revance Therapeutics, Inc.
Transcript of Daring To Make A Difference - Revance Therapeutics, Inc.
Daring To MakeA DifferenceCOMPANY PRESENTATION NOVEMBER 2020
Daring To MakeA DifferenceCOMPANY PRESENTATION JANUARY 2021
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Forward-Looking StatementsSafe 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: our
financial outlook; annualized processing volume of the HintMD payments platform; milestone expectations; expected cash runway and financial performance; the market size and growth of the markets for
global neuromodulators, dermal fillers, aesthetics fintech platforms and aesthetic payment processors; the process and timing of, and ability to complete, current and anticipated future clinical development
of our investigational product candidates, including anticipated near-term milestones; statements about our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to
our drug product candidates and the Teoxane RHA® Collection of dermal fillers, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines; our ability to
successfully commercialize the RHA® Collection of dermal fillers, the HintMD payments platform and our drug product candidates, if approved, and the timing of commercialization activities, including for the
release of the next generation HintMD payments platform; our business strategy, timeline, other goals and market for our anti cipated products and our plans and prospects, including our commercialization
plans; the development, approval, manufacturing, market opportunity and commercialization of a biosimilar to BOTOX®; royalty and milestone payments from our commercial collaborations, including with
Viatris and Fosun; the benefits to customers of our product candidates and the HintMD payments platform, including in comparison to competitor offerings; demand for our product candidates and drivers
of demand; future features of the HintMD payments platform; potential next generation fillers and hyaluronic acid cosmeceutic al products; and potential therapeutic indications for botulinum toxins.
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 results, timing, costs, and completion of our research and development activities and regulatory approvals, including delays in the approval of our BLA for
DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of COVID-19-related policies and travel restrictions currently in place at the FDA; 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; our ability to obtain regulatory approval of our drug product candidates; whether the HintMD
acquisition and Teoxane agreement will provide the anticipated economic and other benefits; our ability to successfully compete with treatments and therapies, our ability to achieve, and the rate and
degree of commercial acceptance and the market, size and growth potential of the RHA® Collection of dermal fillers, the HintMD payments platform and our drug product candidates, if approved; our ability
to successfully commercialize the RHA® Collection of dermal fillers, the HintMD payments platform and our drug product candidates, if approved, and the timing and cost of commercialization activities; our
ability to obtain and maintain regulatory approval of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our ability to successfully
manufacture our drug product candidates; our ability to develop sales and marketing capabilities; the status of commercial co llaborations; our ability to obtain funding for our operations; our ability to
continue obtaining and maintaining intellectual property protection for our drug product candidates; the accuracy of our esti mates regarding expenses, future revenues, capital requirements and needs for
financing and our financial performance; and other risks. 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 filings with the SEC, including our Quarterly Report on Form 10-Q filed with the SEC on November 9, 2020. 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 forward-looking statements in this presentation speak only as of
the date hereof. We disclaim any obligation to update these forward-looking statements.
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NEXT-GENERATION
LONG-LASTINGNEUROMODULATOR
PRODUCTEXPECTING FDAAPPROVAL 2021
1ST FINTECH PLATFORM
ELEVATING PHYSICIANAND PATIENTEXPERIENCE
DaxibotulinumtoxinAfor Injection*
DaxibotulinumtoxinAfor Injection
Bringing a New Standard in Aesthetic and Therapeutic Offerings
FDA-APPROVED
HYALURONIC ACID DERMAL FILLERS
UNITED STATES EXCLUSIVITY
POTENTIALNEXT-GENERATION,
LONG-LASTINGNEUROMODULATOR
PRODUCT FORMUSCLE-MOVEMENT
DISORDERS
Worldwide** collaboration and license agreement, for biosimilar to BOTOX®
Rights to DaxibotulinumtoxinA for Injection in China, Hong Kong, Macau - Aesthetics & Therapeutics
REVANCE AESTHETICS REVANCE THERAPEUTICS GLOBAL PARTNERSHIPS
* Awaiting FDA approval in glabellar lines**Except JapanRHA® is a trademark of TEOXANE SA.BOTOX® is a registered trademark of Allergan, Inc.
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Entering Attractive, Growing Markets Totaling >$6 Billion in 2019
• Neuromodulators have broad potential use in aesthetics and therapeutics4
• High consumer awareness
• 30 years of established safety profile
• Approved products are not highly differentiated
$8.1Bby 2025
$4.8B2019
GLOBAL NEUROMODULATORS
• Dermal fillers provide immediate results
• Typically used for wrinkles, nasolabial folds, marionette lines, lip lines, hallows under the eyes and cheek augmentation
• Range of offering desired to deliver appropriate results for different areas of the face
$1.9Bby 2025
$1B2019
U.S. HYALURONIC ACID DERMAL FILLERS
• Enhances and streamlines payment services and loyalty programs for aesthetic practices
• 33,0003 and growing base of U.S. aesthetic practices representing $56 billion3 annual payment processing volume opportunity
• Niche aesthetic payment vertical
$700Mby 2025
$500M2019
U.S. AESTHETICSFINTECH PLATFORM
1. December 2020 -Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2021, and August 2020 Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports- 2021,2. August 2020 Decision Resources Group Aesthetics Injectables Botulinum Toxin Reports- 2021 3. Data on File, IBIS, ISAPS, AmSpa4. Time Magazine, January 16, 2017, How BOTOX Became the Drug That’s Treating Everything
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Seasoned Leadership TeamWITH ROBUST EXPERIENCE IN BIOTECH CLINICAL AND COMMERCIAL DEVELOPMENT, AESTHETICS, THERAPEUTICS AND SOFTWARE TECHNOLOGY
Mark J. FoleyPresident and
Chief Executive Officer
Abhay JoshiChief Operating Officer,
President of R&D and Product Operations
Tobin SchilkeChief Financial Officer
Dustin SjutsChief Commercial
Officer, Aesthetics & Therapeutics
Aubrey RankinPresident,
Innovation & Technology
Azita NejadSenior Vice President, Technical
Operations
Dwight MoxieSenior Vice President,
General Counsel & Corporate Secretary
Justin FordSenior Vice President,
Human Resources and Head of People
Roman RubioSenior Vice President,
Clinical Development
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2020 Accomplishments
* Trial for investigational drug candidate DaxibotulinumtoxinA for Injection
A TRANSFORMATIVE YEAR ESTABLISHING COMMERCIAL PATH FOR OUR AESTHETIC AND THERAPEUTIC FRANCHISES
TEOXANE Dermal Filler AgreementCompleted the Acquisition of HintMD Launched RHA® Collection Dermal Fillers and HintMD PlatformBiosimilar Opt-In Decision by Viatris®
Positive Phase 2 Open-Label Study Results in Forehead Lines*Positive Phase 2 Open-Label Study Results in Crow’s Feet*Positive Phase 2 Open-Label Study Results in Upper Facial Lines*BLA Acceptance & Target PDUFA Date set for DaxibotulinumtoxinA for Injection
Positive Phase 3 Pivotal Trial Results in Cervical Dystonia*Phase 2 results in Plantar Fasciitis*
Strengthened commercial and manufacturing infrastructure Announced Revance headquarters moving to Nashville, Effective Jan 1, 2021
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Strong 2020 Preliminary Results
$12.5M - $13.0MFY 2020 RHA® Collection Revenue
$200.0MHintMD Processing Volume (Based on Annualized Run Rate)
~1,000Aesthetic Accounts Activated Across
Products and Services
WITH CASH INTO 2023 AND TOTAL AND ADJUSTED OPERATING EXPENSES IN-LINE WITH PREVIOUSLY ANNOUNCED GUIDANCE
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Entering 2021 – Building the Foundation in Aesthetics, Progressing Therapeutics Franchise
• FDA-approval and commercial launch of DaxibotulinumtoxinA for Injection in glabellar lines anticipated in 2021
• Next-generation HintMD platform, including PayFac integration expected in mid-2021
• Teoxane aims for FDA approval of RHA® 1 for perioral lines in 2H21
• Topline results from JUNPIER Phase 2 study of DaxibotulinumtoxinA for Injection in upper limb spasticity expected in Q1 2021
• Topline results from ASPEN-OLS Phase 3 study of DaxibotulinumtoxinA for Injection in cervical dystonia expected in 2H21
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DaxibotulinumtoxinA for InjectionLEAD INVESTIGATIONAL NEUROMODULATOR PRODUCT CANDIDATE
The first and only neuromodulator product with a proprietary peptide formulation
Positive Phase 3 results for both aesthetics and therapeutics in glabellar lines and cervical dystonia
Positioned to be the first and only neuromodulator product with high response rates and long duration of effect
U.S.-based manufacturing for drug substance and drug product of a botulinum toxin
DaxibotulinumtoxinA is an investigational agent that has not been approved by the FDA. FDA PDUFA date of Nov. 25, 2020 delayed due to FDA travel restrictions as a result of COVID-19.
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Resilient Hyaluronic Acid® (RHA®) Collection of Dermal Fillers –Launched September 2020
INNOVATIVE PRESERVED NETWORK TECHNOLOGY (PNT)
Formulated to
be more like the
natural HA
in the skin1
PNT is a gentle
manufacturing
process with
few chemical
modifications
The PNT process helps
preserve the natural
structure of the HA
helping it mimic the
natural HA found in
the skin
1. RHA®2, RHA®3, RHA®4 are class III medical devices and have received FDA approval and is now being commercialized in the United States. The United States Federal law restricts these devices to sale by or on the order of a physician or license practitioner. RHA®2, RHA®3 and RHA®4 are indicated for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabialfolds (NLF), in adults aged 22 years or older. RHA®2, RHA®3, and RHA®4 are sterile gels containing cross linked hyaluronic acid in physiological buffer and 0.3% l idocaine hydrochloride to reduce pain on injection. RHA®2, RHA®3 and RHA®4 are contraindicated in patients with previous hypersensitivity to local anesthetics of the amide type, such as lidocaine.References: 1. TEOXANE SA Patents FR2945293/WO2010131175, FR2968305/WO2012077054 and FR1260145/WO2014064633. (TEOXANE SA Physician Rheology brochure, page 2)
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Broad and Balanced Pipeline in Aesthetics and Therapeutics
PRECLINICAL PHASE 1 PHASE 2 PHASE 3
Positive Phase 3 pivotal results reported in Q4 2020 with Phase 3 open-label safety study results expected in 2H 2021
Teoxane aims for FDA approval in 2H21*
PDUFA date of Nov. 25, 2020 was deferred due to
FDA COVID-19 travel restrictions affecting
inspection of manufacturing site
Positive results in all three open-
label Phase 2 studies to evaluate dosing
and injection patterns.
Partnered with Viatris, file IND 2022
AESTHETICS: DaxibotulinumtoxinA
Forehead Lines
Glabellar (Frown) Lines
Upper Facial LinesLateral Canthal Lines (Crow’s Feet)
RESILIENT HYALURONIC ACID® COLLECTIONRHA® 2, 3, 4 Dermal FillersRHA® 1 Dermal Filler(U.S. distribution rights only)
Cervical Dystonia
Upper Limb Spasticity
THERAPEUTICS: DaxibotulinumtoxinA
Biosimilar to BOTOX®
Topical
OTHER NEUROMODULATORS
*Revance has the exclusive right to commercialize RHA® 1 dermal filler in the U.S., however it is not our product candidate.RHA® is a trademark of TEOXANE SA; BOTOX® is a registered trademark of Allergan®, Inc.
Topline results in Q1 2021
FDA approved
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PDUFA target action datedeferred by FDA. Approvalanticipated in 2021.
DaxibotulinumtoxinA for Injection
GLABELLAR (FROWN) LINES
AESTHETICS CLINICAL PROGRAMS FOCUSED ON UPPER FACIAL LINES
• Clinical programs for approval completed with positive SAKURA 1, 2 & 3 P3 Results
• 4,400+ DaxibotulinumtoxinA treatments in P1, 2 & 3 glabellar line program
• At least 24 weeks observed on multiple secondary endpoints
FOREHEAD LINES
• Positive combination forehead and glabellar line P2 open-label study results issued in June 2020
• At least one of four doses demonstrated a measurable treatment effect in 100% of subjects at 4 weeks, with median duration of 27 weeks
LATERAL CANTHAL LINES (CROW’S FEET)
• Positive crow’s feet P2 open-label study results issued in June 2020
• At least one of four doses demonstrated a measurable treatment effect in 100% of subjects at 4 weeks, with median duration of 24 weeks
UPPER FACIAL LINES
• Positive combination forehead, glabellar lines and crow’s feet P2 open-label study results issued in Dec. 2020
• Efficacy of 92% at Week 4
• Median time to return to baseline in responders was at least 33 weeks
• No expected safety issues; well tolerated results in all three upper facial areas
*Delayed due to FDA COVID travel restrictions affecting inspection of manufacturing site
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Glabellar Lines - SAKURA Program Phase 3 Results
PROGRAM SUMMARY
LARGEST-EVER AESTHETIC NEUROMODULATOR CLINICAL PROGRAM COMPLETED
SAKURA 1 & 2 pivotal trials
and SAKURA 3 long-term
safety study
>3,300 patients at 65 total
sites in US and Canada
PRIMARY ENDPOINT
Proportion of subjects
who achieve ≥ 2-point
composite response2 at
max frown at 4 weeks
SAKURA 1 – 73.6%
vs. placebo at 0%
SAKURA 2 – 74.0%
vs placebo at 1%
ADVERSE EVENTS (AES)
Most common treatment-
related AEs were headache,
injection site pain and
injection site erythema
Ptosis rates - 2.2% for
pooled SAKURA 1&2,
1.3% for SAKURA
MEDIAN DURATION OF EFFECT
At least 24 weeks observed on
multiple secondary endpoints
including:
• Time to loss of none
or mild wrinkle severity
• Time to return to baseline
wrinkle severity
SAKURA 1 & 2 RESULTS PUBLISHED IN JAAD AND PRS1 SAKURA 1, 2 & 3 RESULTS PRESENTED AT ASDS 2019/20 and AAD 2020
WE
EK
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1. Published in Journal of the American Academy of Dermatology, Author: Vince Bertucci, M.D. et al , Published December 2, 2019; Plastic and Reconstructive Surgery,Author: Jean Carruthers M.D. et al. Published on October 10, 2019 1. Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) & Patient Facial Wrinkle Severity (PFWS) scales
SAKURA 3 Example
2-Point Improvement
by IGA-FWS & PFWS
at Week 4
WE
EK
16
WE
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04
BA
SE
LIN
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None or Mild Response Rates on 4-Point Investigator Assessment Over Time
KEY SECONDARY ENDPOINT
DaxibotulinumtoxinA for Injection – Glabellar Lines
1. United States Prescribing Information Phase 3 Studies in GL for each neuromodulator with data available through at least Day 120 conducted separately and presented for reference only USPI: US Package Insert.2. Jeuveau data from results published in Dermatologic Surgery March 2019. Note: In SAKURA 1 and 2 (ITT), missing data were imputed with the worst post-baseline outcome (or best outcome for Placebo arm) on
visits up to Week 24. Non-responder imputation was used for visits post Week 24. BOTOX®, Dysport® and Jeuveau® are registered trademarks of their respective companies
9698
95
88
74
54
29
14
7 3
9088
64
43
23
96
8375
51
29
16
74
80
70
48
25
79
86 86
58
38
21
0
10
20
30
40
50
60
70
80
90
100
0 4 8 12 16 20 24 28 32 36
% O
F S
UB
JEC
TS
30 60 90 120 150 180 210 240Days
Weeks
SAKURA 3 Cycle 1 (n=2380 treatments)
SAKURA 3 Cycle 2 (n=882 treatments)
SAKURA 3 Cycle 3 (n=568 treatments)
SAKURA 1 DaxibotulinumtoxinA 40U (n=201)
SAKURA 2 DaxibotulinumtoxinA 40U (n=204)
Dysport® USPI: GL-1
Dysport® USPI: GL-3
BOTOX® Cosmetic USPI
Jeuveau® : EV-001
Note:
Results drawn from multiple studies.
Caution should be used when interpreting
cross-study comparisons.
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DaxibotulinumtoxinAfor Injection*1
Molecular weight 150 kDa 900 kDa ~400 kDa 150 kDa 900 kDa
Glabellar line dose 40U 20U 50U 20U 20U
Core active ingredient amount** 0.18 ng 0.18 ng6 0.27 ng6 0.08 ng6 0.12 ng7
Free of accessory proteins ✓ ✓
Proprietary peptide excipient technology ✓
No animal-derived components ✓
No human serum albumin (HSA) ✓
Response rates (2pt composite change on primary endpoint)
74% N/A 52-60% 48-60% 67-71%
Duration of response 24 weeks** 3-4 months2 Up to 4 months3
Up to 3 months4
Only Day 30 data shown5
100% sourced and manufactured in the US
✓
No refrigeration / cold chain ✓ ✓
A HIGHLY DIFFERENTIATED NEUROMODULATOR PRODUCT
Note: Results drawn from multiple studies. Caution should be used when interpreting cross-study comparisons 1.Revance Data on file (SAKURA 1 and 2 Phase 3 Trials with
DaxibotulinumtoxinA 40 Units) 2.Full details included in BOTOX® product insert3.Full details included in Dysport product insert, FDA Dysport Summary Basis of Approval (CMC section)
7. Full details included in Canadian Nucevia Product 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 Injectionand BOTOX® have nearly identical amounts of core active ingredient, botulinum toxin type A, in respective glabellar line dosage
DaxibotulinumtoxinA for Injection
4.Full details included in Xeomin product insert. 5.Full details included in Jeuveau 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
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RHA® Collection of Dermal FillersU.S. DISTRIBUTION AGREEMENT FOR THREE FDA-APPROVED PRODUCTS & PIPELINE
BA
SE
LIN
E
1. RHA® is a trademark of TEOXANE SA. RHA®2, RHA®3, RHA®4 are products of TEOXANE SA. They are class III medical devices and have received FDA approval but are not yet commercialized in the United States. The United States Federal law restricts these devices to sale by or on the order of a physician or license practitioner. RHA®2, RHA®3 and RHA®4 are indicated for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older. RHA®2, RHA®3, and RHA®4 are sterile gels containing cross linked hyaluronic acid in physiological buffer and 0.3% lidocaine hydrochloride to reduce pain on injection. RHA®2, RHA®3 and RHA®4 are contraindicated in patients with previous hypersensitivity to local anesthetics of the amide type, such as lidocaine.
Three FDA approved TEOXANE RHA®1
Launched September 2020Teoxane aims for FDA approval of RHA® 1 for perioral lines in 2H21
Potential next-generation fillersand HA cosmeceutical line
NEW INDICATIONS
TODAY TOMORROW FUTURE
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TEOXANE Fillers Successfully Compete in the European Market
1.Top 5 European countries based on GDP. DRG Report Aesthetic Injectables | Market Insights | Europe | 2021 France, Germany, Italy, Spain, UK, Author: Diksha Garg Published: September 2020– Table 23* "Other" category includes Contura, CROMA-PHARMA, FILOGRA, and other smaller players
0 10 20 30 40 50
Top 5 European Countries
Other 5%
38%
2%
16%
29%
Teoxane SA commands 10% share in facial HA markets in
top 5 European countries without a neuromodulator bundle1
Teoxane SA is the only company in top 5 European countries without a
neuromodulator to capture competitive market share
FILLERS TOXINS
10%
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HintMD Completes Our Aesthetics Value Chain by Elevating Patient and Practice Experiences LAUNCHED SEPTEMBER 2020
• Insights & Analytics
• Subscriptions
• Installments
• Point-of-Sale (No-Touch)
• Brand Loyalty Programs *• EMR / Practice Management *• Patient Lending *• Marketing & Lead Generation *
SMART PAYMENT PLATFORM
PARTNER INTEGRATIONS
SUBSCRIPTIONS & PRACTICE LOYALTY
• Patient Wallet
• Practice Custom Loyalty *
• eCommerce Shipping *
* Future features.
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Controlling More of the Payments Chain Strengthens HintMD’s Offering to Practices
2.87 – 4.35% avg. fee per transaction1
0.5 - 1% margin on transaction fee2
0.5 - 1% avg.margin on transaction fee3
GatewayFees
Risk ManagementFees
ProcessorFees
Card Brand Fees
IssuerFees
ResellerFees
%
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1. https://squareup.com/guides/credit-card-processing-fees-and-rates2. Data on file
3. Average HintMD transaction fee
HIN
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ha
inC
on
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nti
on
al
Va
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Ch
ain
Practice Cost
Practice Cost
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U.S. Market Opportunity – Aesthetics Payment Processing in 2019
$56BillionAnnual Payment Processing Volume Opportunity
0.5% – 1.0% Margin On PayFac Transaction Fee
$500+ Million
Revenue Opportunity in U.S. Aesthetic Payment Services1
33KAesthetics Practices in the U.S.
$1.7MAverage Annual Revenue Per Practice
Data on file, IBIS, ISAPS, AmSpa1. Includes payment processing and subscription billing revenue opportunity.
Seeking to Transform Patient Care by Providing Long-Lasting Relief to Those Suffering From Debilitating Conditions
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There are 12 Approved Therapeutic Indications for Botulinum Toxin Type A in the U.S. and hundreds of potential indications2
$2.3 Billion1
Global Therapeutics Neuromodulator
Revenues
27%SPASTICITY
37%CHRONIC MIGRAINE
3%HYPERHIDROSIS 6%
OVERACTIVE BLADDER
17%CERVICAL DYSTONIA
Revance Therapeutics
1. 2020(E) based on Decision Resources Group Therapeutic Botulinum Toxin Market Insights, 20212. Time Magazine, January 16, 2017, How BOTOX® Became the Drug That’s Treating Everything
10%OTHER
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Positive ASPEN-1 Phase 3 Pivotal results announced in Oct. ASPEN–OLS Long-Term Safety Trial Fully Enrolled. Results for ASPEN-OLS expected in 2H 2021
DaxibotulinumtoxinA for Injection – Current Therapeutic Targets
CERVICAL DYSTONIA
PURSUING MUSCLE MOVEMENT INDICATIONS IN THERAPEUTICS
~$390M Global Cervical Dystonia opportunity1 typically treated by neurologists
Modified JUNIPER Phase 2 Placebo-Controlled, Dose-Ranging Study Fully Enrolled. Topline results expected in Q1 2021
ADULT UPPER LIMB SPASTICITY
~$620M Global Spasticity opportunity1 typically treated by neurologists
1. December 2020 -Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2021
28 PROPRIETARY INFORMATION. Not for Distribution. Do not Forward, Email, Print, or Leave Behind.
Phase 3 Top-Line Results in Cervical DystoniaDaxibotulinumtoxinA for Injection
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 low
“I was delighted to see both the degree and duration of relief that DaxibotulinumtoxinA for Injection provided subjects in ASPEN-1”Dr. Joseph Jankovic, Professor of Neurology, Distinguished Chair in Movement
Disorders, Founder & Director, The Parkinson's Disease Center and Movement
Disorders Clinic at Baylor College of Medicine
Met Primary and all Secondary Endpoints
• Highly statistically significant results achieved on TWSTRS* Total Score primary endpoint at Weeks 4 and 6
• Median duration for time to reach Target TWSTRS Total Score was 24 weeks for 125U and 20 weeks for 250U
• Improvement observed on CGIC and PGIC compared with placebo at Weeks 4 and 6
AVERAGE CHANGE FROM BASELINE IN TWSTRS TOTAL SCORE AT WEEKS 4 AND 6
4.3
12.7
10.9
Re
du
ctio
n F
rom
Ba
seli
ne
TW
ST
RS
To
tal S
core
*
Primary Analysis**p<0.0001 (125 U vs. Placebo)p=0.0006 (250 U vs. Placebo)p=0.1902 (250 U vs. 125 U)
PLACEBO (n=46)
DAXI 125 U (n=125)
DAXI 250 U (n=130)
∆=12%
∆=31%
∆=27%
*Toronto Western Spasmodic Torticollis Rating Scale
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DaxibotulinumtoxinA for Injection - Cervical Dystonia LONG DURATION ACHIEVED WITH LOW AMOUNT OF CORE NEUROTOXIN & LOW DYSPHAGIA RATES
Product, doseDysphagia
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
1. 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), 5352. Botox Prescribing Information, 20203. Xeomin Prescribing information, 20204. Dysport Prescribing Information, 2020
0
0.5
1
1.5
2
2.5
3
10 12 14 16 18 20 22 24 26
AM
OU
NT
OF
CO
RE
NE
UR
OT
OX
ININ
N
AN
OG
RA
MS
1
DURATION OF TREATMENT BENEFIT IN WEEKS
DAXI 125U
DAXI 250U240U3
236U2
500U4
120U3
Note: Results drawn from multiple
studies. Caution should be used when
interpreting cross-study comparisons.
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Strategic Partnerships For Long-term GrowthMORE THAN $90 MILLION IN UPFRONT AND MILESTONE PAYMENTS RECEIVED THUS FAR
Partnership aims to develop, manufacture & commercialize a biosimilar to BOTOX® worldwide (except Japan). Plan to file investigational new drug application (IND) in 2022
Provided guidance on expectations for development program at BIAM.* Approval could result in all 14 FDA-approved BOTOX® indications
Upfront and milestone payments received to date, with additional potential milestones and royalties
Worldwide market for BOTOX® and BOTOX® Cosmetic
BIOSIMILAR FINANCIAL ASSET
$60 Million
$3.8 Billion1
Exclusive rights to develop, commercialize & distribute DaxibotulinumtoxinA for Injection in China, Hong Kong and Macau
Upfront payments received to date, with total potential milestones of $230M + tiered royalties of low-double-digit up to high-teens
of DaxibotulinumtoxinA for Injection trials in glabellar lines and cervical dystonia now have approved INDs
First Two Trials
$31 Million
GEOGRAPHIC PARTNERSHIP
*Biosimilar Initial Advisory Meeting1. Based on 2019 Allergan financial report. BOTOX is a registered trademark of Allergan, Inc.
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Well Positioned for Continued Growth Ahead
Breakthrough Products and Services
Seasoned Management Team
Strong Growth Paths for Aesthetic and Therapeutic Franchises
Seasoned Management Team Focused on Execution
Breakthrough Portfolio of Products and Services
Strong Balance Sheet with Cash Runway Into 2023 Breakthrough
Portfolio of Products and Services
Strong Growth Paths for Aesthetics and Therapeutics Franchises
Seasoned Management Team Focused on Execution
Strong Balance Sheet with Cash Runway Into 2023
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Important Product Information
RHA® is a trademark of TEOXANE SA. RHA® 2, RHA® 3, RHA® 4 are products of TEOXANE SA. They are class III medical devices and have received FDA approval but are not yet commercialized in the United States. The United States Federal law restricts these devices to sale by or on the order of a physician or license practitioner. RHA® 2, RHA® 3 and RHA® 4 are indicated for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older. RHA® 2, RHA® 3, and RHA® 4 are sterile gels containing crosslinked hyaluronic acid in physiological buffer and 0.3% lidocaine hydrochloride to reduce pain on injection. RHA® 2, RHA® 3 and RHA® 4 are contraindicated in patients with previous hypersensitivity to local anesthetics of the amide type, such as lidocaine.
Please refer to the Instructions for Use (https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170002C.pdf). It is the practitioner’s full responsibility to read and inform the patient about contraindications, warnings, precautions, risks and benefits. RHA® 2 and RHA® 3 clinical study G140028: Study 1302: A Controlled, Randomized, Double- Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA 2 and TEOSYAL® RHA 3 versus Juvéderm® U ltra XC in the Treatment of Moderate to Severe Nasolabial Folds.