Supernus Pharmaceuticals - Corporate Overview May 2021
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Supernus
Pharmaceuticals
Corporate Overview
May 2021
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
1
Safe Harbor Statement
This presentation and other matters discussed today or answers that may be given to
questions asked include forward-looking statements within the meaning of the federal
securities laws. These statements, among other things, relate to Supernus’ business
strategy, goals and expectations concerning its product candidates, ability to integrate the
acquired portfolio into its infrastructure, future operations, prospects, plans and objectives
of management. The words “anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”,
“may”, “plan”, “predict“, “project”, “will“, and similar terms and phrases are used to identify
forward-looking statements in this presentation. Supernus’ operations involve risks and
uncertainties, many of which are outside its control, including the potential impact of
COVID-19, and any one of which, or a combination of which, could materially affect its
results of operations and whether the forward-looking statements ultimately prove to be
correct. Supernus assumes no obligation to update any forward-looking statements except
as required by applicable law.
Supernus has filed with the U.S. Securities and Exchange Commission (SEC) reports and
other documents required by Section 13 or 15(d) of the Securities Exchange Act of 1934,
as amended. Before you purchase any Supernus securities, you should read such reports
and other documents to obtain more complete information about the company’s
operations and business and the risks and uncertainties that it faces in implementing its
business plan. You may get these documents for free by visiting EDGAR on the SEC
website at http://www.sec.gov.
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
2
Proven Execution in CNS & ADHD
20+ Years of CNS experience including Four Programs in ADHD
SPN-830
2005
SPN-820
to SPN-817
Present
1997
to
2005
For several years, and prior to becoming independent in 2005, Supernus operated as Shire Laboratories, Inc., a division of Shire.
SPN-830, SPN-820, and SPN-817 are product candidates in various stages of development.
All trademarks are the property of their respective owners
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
3Revenue and Operating Earnings Performance
Total Revenues ($ Millions) Total Operating Earnings ($ Millions)
520 174
149
144
409
393
100
302
54
215
21
147
93
2013 2014 2015 2016 2017 2018 2019 2020
12 -5
2013 2014 2015 2016 2017 2018 2019 2020 -62
Year-end 2018 inventory build by distribution channel increased 2018 net sales by
approximately $10 million and negatively impacted 2019 net sales.
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
4Portfolio of Six Marketed Products⃰
Cervical Dystonia
ADHD Epilepsy Migraine Parkinson’s
Sialorrhea
* Qelbree™ to be available in the U.S market in 2Q 2021
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
5Robust Pipeline For Future Growth
Product Indication Development NDA
SPN-830 Parkinson’s 2H 20211
Qelbree™ Adult ADHD Positive Phase III Data 3Q 2021
Myobloc Neurological Disorders Phase IV
SPN-820 Depression Phase I
SPN-817 Severe Epilepsy Phase I
1Refusal to File letter received from FDA November 2020. NDA resubmission planned 2H 2021.
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
6Qelbree™
Novel Non-Stimulant ADHD Product
Approved in April 2021 for patients 6 to 17 years of age
Launch planned for 2Q 2021
‒ Sales force of approximately 175 sales representatives
Phase III clinical data point to a well-differentiated product
Building strong IP with expirations from 2029-2033
sNDA filing for adult patients targeted for 3Q 2021
Potential 6 months market exclusivity in children 4-5 years of
age following completion of post-marketing commitment
studies
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
7Trokendi XR
More Favorable Clinical Outcomes Compared to TPM-IR1
Side Effects with Trokendi XR vs. TPM-IR in Migraine Cohort (n=124)
Cognitive effect 28%
6%*
Paresthesia 12%
2%t
Somnolence 6%
1% TPM-IR Trokendi XR
Appetite decreased/weight loss 3% *pTrokendi XR
Use in Clinical Practice – A Pragmatic Assessment1
Responder Rate % of Patients
≥ 50% Reduction 55
≥ 75% Reduction 41
100% Reduction 24
* Responder Rate: percent change from pre-index migraine frequency associated with Trokendi XR treatment (n=159)
1 O’NealW et al. Pragmatic assessment of Trokendi XR (extended-release topiramate) in migraine prevention. Poster presented at 59 th Annual Scientific
Meeting of the American Headache Society, June 2017
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
9Oxtellar XR
Improved Adverse Event Profile at Double the Dose of Trileptal®
Dizziness
$17
Diplopia
$25
% of Patients Discontinuing
Headache 2400mg/d Therapy Due to AEs
$25
66.7
Somnolence
55%
Reduction
Vomiting
30
Nausea $11
Fatigue $11
Trileptal® Oxtellar XR®
Asthenia
0 10 20 30 40 50
Trileptal 1200 mg/d (n=171) SPN-804O 2400 mg/d (n=123)
Based on comparison of Oxtellar XR (SPN-804O) Phase III vs. Trileptal PI (adjunctive therapy study in adults); differences in trial design exist between the two studies.
Dizziness includes vertigo in Trileptal group because of change in the MedDRA system
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
10Parkinson’s Disease (PD) Market
U.S. PD market is anticipated to grow from $1.5B to $6.2B by 2026 1
Second most common chronic progressive neurodegenerative disorder,
affecting 1-2% of individuals 65 years and older2
~1M U.S. PD patients (2020), ~2.5%1 annual growth rate
PD occurs when cells in the brain, which produce dopamine, become
impaired or die
The mainstay for therapy is levodopa with effectiveness wearing off
resulting in “OFF” periods
As PD advances, patients experience more “OFF” periods
1. Global Data Parkinson’s Disease Global Drug Forecast and Market Analysis 2026
2. Saxton JM. Exercise and Chronic Disease: an Evidence-Based Approach. London, Routledge, 2011
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
11Addressing Patient Needs at Different Stages of
Parkinson’s Disease
Stage 1 Stage 1.5 Stage 2 Stage 2.5 Stage 3 Stage 4 Stage 5
Pen
SPN-830
Advanced
On‐demand continuous
Therapy treatments
L‐dopa
Adjuncts
Monotherapy
Deep Brain
Stimulation
Generic
Levodopa
Initial Symptoms
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved. All trademarks are the property of their respective owners
12APOKYN®
Apomorphine Delivered Through a Subcutaneous Injection
Acute Treatment of “OFF” Episodes in Advanced Parkinson’s Disease
▪ On average, peak response seen after UPDRS(1) Motor Score Change
20 minutes, with a meaningful clinical Time (minutes)
effect seen from 4 minutes 0 20 40 60 80 100
0
▪ At peak effect, the mean decreases from
-5
baseline in UPDRS motor scores were
Mean change from pre-dose
24.2 points for the apomorphine group
UPDRS motor score
-10
and 7.4 points for the placebo group
(pSPN-830
Novel Apomorphine Subcutaneous Injection Pump
Non‐invasive dopaminergic stimulation therapy for continuous
treatment of ON-OFF episodes in PD
Currently available options
‒ Gastro-intestinal surgically implanted levodopa/carbidopa infusion
‒ Deep Brain Stimulation
Could be eligible for Orphan Drug Designation and 7-year
exclusivity
NDA resubmission planned 2H 20211
1Refusal to File (RTF) letter received from FDA November 2020.
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
14SPN-830
Novel Apomorphine Subcutaneous Injection Pump
TOLEDO Phase III Study Results
Primary Endpoint
SPN-830 demonstrated a
2.47 hours per day
reduction in OFF time
compared to placebo (0.58);
p= 0.0025
Regina Katzenschlager et al, The Lancet Neurology. 2018;Vol 17(9):749-759
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
15SPN-820
Novel MOA for Treatment-Resistant Depression (TRD)
Joint development and option agreement with Navitor Pharmaceuticals
First-in-class selective brain mTORC1 activator
‒ Binds to and modulates sestrin, a leucine amino acid sensor
‒ Long IP runway
Early efficacy signal on HAMD-6 scale in TRD patients
‒ Rapid onset of action (signal at 2 hours)
‒ Meaningful effect sizes (>0.4 through 3 days on 1 dose)
Significant market need & revenue potential
‒ Major depressive disorder (MDD) affects approximately 17.3M U.S. adults1
‒ Approximately 7% of the U.S. adult population1
‒ ~30% of MDD patients are treatment resistant2
Initiation of Phase II clinical trial in TRD expected by the end of 2021
‒ Favorable safety/tolerability profile across broad range of potentially therapeutic doses in
completed MAD study
1- National Institute of Mental Health, 2017 National Survey on Drug Use and health
2- Rush AJ Et al.(2006) Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D
Report. The American Journal of Psychiatry,163(11), 1905-1917
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
16Positioned For
Long-Term Growth
Diversified CNS Portfolio
Qelbree™, Oxtellar XR® , Trokendi XR® , APOKYN®, MYOBLOC®, XADAGO®
Innovative Pipeline in CNS
Qelbree™ ADHD (adult)
SPN-830 Parkinson’s Disease
MYOBLOC Neurological Disorders
SPN-820 Depression
SPN-817 Severe Epilepsy
© 2021 Supernus Pharmaceuticals, Inc. All Rights Reserved.
17You can also read
