IMPEL NEUROPHARMA, INC - CORPORATE PRESENTATION AUGUST 2021 - INVESTOR RELATIONS ...
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Impel NeuroPharma, Inc. Corporate Presentation August 2021 PROPRIETARY AND CONFIDENTIAL
Safe Harbor Statement
This presentation and the accompanying oral commentary by Impel NeuroPharma, Inc. (“we,” “us,” “our,” “Impel” or the “Company”) contains forward-looking statements that are based on our
management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements include all statements other than statements of historical fact
contained in this presentation, including information concerning our future financial performance, business plans and objectives, timing and success of our planned development activities, our
ability to obtain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, potential growth opportunities, competitive position, industry environment
and potential market opportunities.
Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors. It is not possible for our management to predict all risks, nor can we assess
the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking
statements we may make. These factors, together with those that may be described in greater detail in the registration statement (including a prospectus) that we have filed with the Securities
and Exchange Commission (“SEC”) for the transaction to which this presentation relates, may cause our actual results, performance or achievements to differ materially and adversely from those
anticipated or implied by our forward-looking statements.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the
date of this presentation, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not
be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are
cautioned not to unduly rely upon these statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties
in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any
specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as
required by law.
Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company’s own internal
estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as
to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of
assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has
not been verified by any independent source.
This presentation is not a prospectus and is not an offer to sell, nor a solicitation of an offer to buy, securities. A registration statement on Form S-1 (including a prospectus) relating to these
securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes
effective. The offering will be made only by means of a prospectus. When available, a copy of the preliminary prospectus may be obtained for free by visiting the SEC's website at www.sec.gov or
by contacting Cowen and Company, LLC, Attention: [ ]; or Guggenheim Securities, LLC, Attention: [ ].
PROPRIETARY AND CONFIDENTIAL 2
Late-stage biopharma focused on developing and
commercializing transformative therapies for patients
with Central Nervous System (CNS) disorders
VASCULAR-RICH TARGETED FORMULATIONS
UPPER NASAL CAVITY of well-established therapeutics DEVELOPING
is potentially an optimal designed for upper nasal cavity TRANSFORMATIVE
entry point delivery via our POD technology THERAPIES
Injection-like
Clinical Outcomes,
Achieved Non-invasively
POD technology Giving patients
designed to provide freedom and control
rapid absorption with on-demand,
and consistent drug standard of care
biodistribution therapeutics
that work rapidly
PROPRIETARY AND CONFIDENTIAL 3
Impel – The Investment Opportunity
• TRUDHESA™ - A Near-Term Commercial Opportunity
- Sept. 6th PDUFA; potential launch in Oct 2021
• Highly Targeted Go-to-Market Strategy
- Initial 60-person salesforce; targeting 8K physicians (35% of Market Rxs)
• INP105: Poised to Fill a Major Unmet Need
- Targeted for acute treatment of agitation and aggression in autism
• POD® Technology: Clinically Validated and Broad Utility
- Unique approach targeting upper nasal cavity; broad disease are
applicability
• Proven and Experienced Leadership
PROPRIETARY AND CONFIDENTIAL 4Our Pipeline
Stage of Development
Product Candidate Indication Key Anticipated Milestone(s)
NDA
Preclinical Phase 1 Phase 2 Phase 3
Submission
TRUDHESA™ Acute Treatment • Sept. 6, 2021: PDUFA target
(DHE) of Migraine action date
Acute Treatment
of Agitation and • By YE:2021: Initiate Phase 2
INP105 Aggression in proof-of-concept clinical trial
(olanzapine) Patients with • 2H:2022: Announce Phase 2
Autism Spectrum topline results
Disorder
Morning OFF
INP107 • 2022: Initiate PK study for dose
Episodes in
(carbidopa / levodopa) selection
Parkinson’s
PROPRIETARY AND CONFIDENTIAL 5The Post-Triptan Acute Migraine Treatment Landscape
Compelling
Entry Point
TRUDHESA
Recognized Standard
of Care Treatment
PROPRIETARY AND CONFIDENTIAL 6Our Goal – Bring Standard of Care DHE Efficacy to Market Rapidly
APPROVAL
Requirements Additional
Proven Drug: New Administration: MARKET-ENABLING Analyses
DHE Upper Nasal Cavity
1 2 3
Show Show SAFETY Track EFFICACY
BIOCOMPARABILITY at
lowest effective dose Acute Efficacy at Long-Term Efficacy at
PK data: 150 patients 1st Exposure 6 and 12 Months
TRUDHESA TRUDHESA 2x/month for Phase 3 PRE-POST DESIGN: CONSISTENCY OF
vs. 6 months (and STOP 301 TRUDHESA RESPONSE:
vs. last dose of existing TRUDHESA
IV DHE or Migranal 50 patients for 12 months) open label study
standard treatment
Completed Completed De facto Unique, large L/T database
End 2017 1Q 2020 placebo control >5,650 migraines treated
No placebo control required Promotable data for launch
PROPRIETARY AND CONFIDENTIAL 7TRUDHESA – Comparable to IV DHE and Surpassed
Migranal PK Levels
Treatments
TRUDHESA Delivers
Comparable Blood Levels
vs. IV DHE
• Similar blood levels
(20 mins - 48 hours) without early Cmax
spike associated with nausea & vomiting
vs. MIGRANAL
• 4x increase in Cmax
• 3x increase in AUC
• Much improved consistency
of dosing, similar to IV infusion
AUC in the First Two Hours –
Thought to Be Critical to DHE
Efficacy and Tolerability
PROPRIETARY AND CONFIDENTIAL 8TRUDHESA – Impressive Efficacy from STOP301 study
Percentage of Consistent 2 Hr Pain Freedom over 5,273 Migraines Percentage of
subjects with 2 Hr Treated subjects with 2 Hr
Pain Freedom MBS Freedom
38% 38% 52%
34% 38%
35%
First Dose Migraines 476 First Dose
2,559 1,736 502
TRUDHESA Treated TRUDHESA
1st 2nd 3rd 4th
12 weeks 12 weeks 12 weeks 12 weeks
74% of Enrolled Patients Continued Through 24 Weeks and 90% Enrolled Through 52 Week Extension
PROPRIETARY AND CONFIDENTIAL 9TRUDHESA – Impressive Migraine Relapse-Free Data
% of TRUDHESA Patients Not Requiring Rescue Med
or Recurrence of Migraine at 24 and 48 Hours
(Of Those Pain Free at 2 Hours)
0% 20% 40% 60% 80% 100% 120%
24 Hours 98%*
*by week 21-24.
48 Hours 95%
95% of patients with migraines achieved pain freedom at
2 hours and are migraine and rescue med free at 48hrs
PROPRIETARY AND CONFIDENTIAL 10TRUDHESA – Impressive Reduction in Hospital, ER and Urgent
Care Visits
Baseline Exposure Adjusted Event Rate
TRUDHESA INCIDENCE (n)
(EAER)*
2 0.6
# Hospitalizations
0 0
35 9.9
# ER Visits
5 2.6
25 7.1
# Urgent Care Visits 0 0
~73% Reduction in ER Visits
Achieving a 100% Reduction in Hospitalizations / Urgent Care Provides Tangible Economic Value to Payors
* EAER is a standardized metric used by payors to judge the effectiveness of a medication in lowering medical costs
PROPRIETARY AND CONFIDENTIAL 11TRUDHESA – Addressing Unmet Needs in Acute
Migraine Treatment
SUSTAINED EASY
AN ‘IDEAL’ CAN BE TAKEN
LONG RESPONSE to
FAST AT ANY TIME
MIGRAINE ACTING
LASTING
during
and incorporate
MEDICINE: RELIEF FEW OR NO into
migraine
SIDE EFFECTS everyday life
38% 95% NO 74% 84%
First Migraine Migraine free Treatment Completed 24 week Agreed
TRUDHESA treated pain free at 48 hours window treatment period; TRUDHESA
at 2 hours (for those pain free at limitations “easy to use”
(354 pts.) 2 hours, weeks 21-24)
90% continued
to 52 weeks
PROPRIETARY AND CONFIDENTIAL 12TRUDHESA CMC Regulatory Strategy – Set Up for Success
Drug Device
• TRUDHESA has utilized the same drug and
device components throughout its development
(Pre-clinical through Phase 3)
Drug Product
• TRUDHESA utilizes the same primary container,
formulation, and manufacturer as MIGRANAL;
commercially validated, low CMC risk
• MiPharm, SPA will produce TRUDHESA’s DHE drug
product; FDA approved manufacturer with >20 years
as supplier of MIGRANAL drug product
TRUDHESA
The product has used the same device design, the
same scaled manufacturing, and the same drug
product Phase 1 through potential launch
PROPRIETARY AND CONFIDENTIAL 13TRUDHESA Market Opportunity and Launch Strategy PROPRIETARY AND CONFIDENTIAL
Migraine – Large Growing Market with Significant Unmet
Need Despite New Treatment Innovations
Triptan Non Triptan
30,000,000
27M
+15%
25,000,000 24M
+12% 28% Non Triptan Mkt
21M
Annual Prescriptions
20M +6% 18% +82% ‘20 vs ‘19
20,000,000 3% 7%
15,000,000
Triptan Mkt
+0% ‘20 vs ‘19
97% 93% 82% 72%
10,000,000
5,000,000
-
2017 2018 2019 2020
Source: Symphony Health
PROPRIETARY AND CONFIDENTIAL 15Migraine: Despite New Product Launches in the CGRP Market,
Unmet Need Continues to Exist
Nurtec ODT and Ubrelvy Patient Claims Show ~50% Of the Patient Switching Away ~35% Moved to
Therapy Abandonment 90 Day Post Start Another CGRP and ~20% Moved to Triptan
Continuing Switched Away Dropped Off 100% 3% 3%
100% 90% 12% 13%
90% 20% 80%
25% 14% 14%
80%
Percent of Patient Claims
46% 70%
56% Botox
70% 17%
26% 60% 19% Analgesic
60% 31%
50% Anticonvulsants
50% 20% 18% Other Pain Med
40%
40% Triptan
30% 30% Other CGRP
54%
20% 44% 20%
34% 33%
10% 10%
0% 0%
Nurtec Ubrelvy Nurtec Ubrelvy
Source: Symphony Health Patient Claims
PROPRIETARY AND CONFIDENTIAL 16TRUDHESA – Our Positioning and Launch Strategy
TRUDHESA demonstrates strong clinical utility for multiple patient types in the post triptan failure landscape
• Oral and injectable treatments are problematic for most patients with acute migraine
• DHE offers fast-onset efficacy, with continued protection from a single dose at any point during an attack
• Upper nasal space delivery is not limited by migraine-associated GI issues that impede oral treatments
Drive Perception
• Leverage strong, existing knowledge, experience and support of DHE
• Build TRUDHESA awareness among prescribers and patients
Focused Launch Execution
• Pre-launch market preparation supported by quality MSL team
• Deploy initial 60-person specialized, experienced sales force
Enable Early Adoption
• Targeted effort towards neurologists, high PCP prescribers & DHE loyalists (8K physicians; 35% migraine
market)
• Plan to double size of sales force and target physicians (16K physicians; 45% migraine market)
Promote Swift and Accelerated Payor Adoption at Launch
• Early introduction of Impel and TRUDHESA to payors
• Leverage existing health economic data
• Goal of Tier 2 or Tier 3 managed care coverageDisciplined Go-To-Market Approach
Concentrated prescriber base allows for high market coverage at launch
Wave 2 Increases the Number of Reps to 120 and Expands
Coverage to 16k HCPs Covering 45% of Market
Our Focus: Targeting Highest Productive Writers
Wave 1 Wave 2 Non Tgt
100%
90%
Neuro PCP
Migraine Mkt Rx Coverage
80% # Mkt Physicians Targeted Avg Avg
70% 55% Reps Coverage Yearly Yearly
65%
TRx / TRx /
60%
HCP HCP
50%
Wave 60 ~35% ~8k (4k Neuro + 4k PCP) 1,352 705
40% 10% 1 95% of Neuro Mkt
9% of PCP Mkt
30%
20% 60 Reps 120 Reps
35% ~8k High 35% ~16k High
Wave +60 ~45% ~16k (5k Neuro + 11k 1,184 411
10% Productive HCP’s Productive HCP’s
~35% Mkt ~45% Mkt Coverage 2 PCP)
0% Coverage 96% of Neuro Mkt
% of Migraine TRx (~27M) % of Migraine TRx (~27M) 25% of PCP Mkt
Wave 1 Wave 2
Source: Symphony Health
PROPRIETARY AND CONFIDENTIAL 18Case in Point – Ubrelvy and Nurtec ODT Both Showing Highly
Concentrated Prescriber Bases in Migraine
Ubrelvy: ~5.5k Writers Generate ~75% of TRx Since Launch Nurtec ODT: ~4.5k Writers Generate ~80% of TRx Since Launch
1.5k Writers Generate 50% of TRx
1k Writers Generate 50% of TRx
3.9k Writers Generate Next 24% of TRx
3.3k Writers Generate Next 28% of TRx
5.3k Writers
12% of TRx
6k Writers
17k Writers 14% of TRx
12% of TRx
12k Writers
9k Writers 7% of TRx
1% of TRx
Source: Symphony Health (Prescriber counts since launch thru Jan’2021) Source: Symphony Health (Prescriber counts since launch thru Jan’2021)
PROPRIETARY AND CONFIDENTIAL 19TRUDHESA – Strategy to Achieve Broad Access Across Payors
• Anticipate Tier 2 or Tier 3 placement based on payor market
research
• Attractive Payor Mix: ~72% of migraine prescriptions paid by
commercial payors
• Projected peak commercial access of around 70% within 3
quarters of launch
• Supported by experienced market access team in field before
launch for preapproval information exchange
• Patient-centric approach to reduce barriers in RX journey
- Invest in programs to help patients to experience TRUDHESA at
launch prior to widespread coverage
- Overcome high abandonment with traditional retail pharmacy with
alternative patient channel options (digital pharmacy and
telemedicine)
PROPRIETARY AND CONFIDENTIAL 20Focused on Key MC Payors Prior to Approval
• Clinical presentations ongoing
• Anticipate contract negotiations through Q3
and Q4
• Actual formulary approval timing of “Essential
5” will vary during first six months of approval
• Projected peak commercial access of around
70% within 3 quarters of launch
• Patient-centric approach to reduce barriers in
RX journey
- Invest in “quick-start” programs to help patients
experience TRUDHESA at launch prior to
widespread coverage
- Overcome high abandonment with traditional
retail pharmacy with alternative patient channel
options (digital pharmacy and telemedicine)
PROPRIETARY AND CONFIDENTIAL 21Comparator Pricing for Acute Migraine Treatments
Acute Migraine Treatments – Dosing Analysis
DHE Nasal Spray
TRUDHESA* (Migranal Authorized
Generic)
Strengths
1.45mg 4mg 4mg 50mg / 100mg 75mg 50mg / 100mg
Manufactured
Doses Per Pack 4 8 8 10 8 8
WAC Per Pack $600.00 $3,822.93 $3,426.84 $892.50 $892.50 $672.00
Initial
50mg, 100mg,
Recommended 1.45mg 2mg 2mg 50mg 75mg
200mg
Dose Range
% of Patients Second dose Second dose
No second dose
Who Utilize 15% not rec: No not rec: No 39% 41%
offered
Second Dose clinical benefit clinical benefit
WAC Per Lowest
$150.00 $477.87 $428.36 $89.25 $111.56 $84.00
Dose
Avg gepants price per dose = $100.41
* Represents anticipated pricing for TRUDHESA subject to approval. PROPRIETARY AND CONFIDENTIAL 22TRUDHESA – Potential Pricing Flexibility Based on
Payor Input
Potential Pricing Management Continuum: Commercial
Management
Not
Payor
Covered
$400 $450 $500 $550 $600 $650 $700 $750 $800 $850 $900 $950 $1,000 +
Target WAC Price Range
Source: DRG Research
PROPRIETARY AND CONFIDENTIAL 23Pipeline Growth
Opportunities
PROPRIETARY AND CONFIDENTIALINP105 – Potential to Provide Rapid and Non-Traumatic Acute Treatment of
Agitation and Aggression in Autism
Market Opportunity
• Rapidly growing incidences of ASD and growing unmet
needs in treatment are likely to increase the demand for
effective treatments
3.5M • Individuals with ASD have a high incidence of secondary
Children and Adults in the U.S. Living with ASD problems with mood lability, tantrums, self-injurious
behavior and aggressiveness toward others
Current Treatment Options
2M • Antipsychotics including olanzapine offer safe and
Patients Receive Drug Treatment
effective option
- Risperidone and aripiprazole are FDA approved drugs for
830K irritability associated with ASD but not considered long term
~40% of ASD Patients Exhibit Agitation solutions by KOLs
Unmet Need
At-home INP105 has
• Despite two approved therapies, 68% of ASD patients
the potential to 220k demonstrated aggression to a caregiver and 49% to a
reduce ER visits ER Visits/Year non-caregiver2
• Current options require daily dosing, tend to produce
weight gain and diabetes risk; require close monitoring
• Roberts J, Gracia Canales A, Blanthorn-Hazell S, Craciun Boldeanu A, Judge D. Characterizing the experience of agitation in patients with bipolar disorder and schizophrenia.
BMC Psychiatry. 2018;18(1):104-018-1673-3. doi:10.1186/s12888-018-1673-3.
• Primary market research completed by ZS Pharma on behalf of Impel NeuroPharma, n = 65 autism specialists
2. Kanne SM et al. 25
PROPRIETARY AND CONFIDENTIAL 25INP105 – Acute Treatment of Agitation and Aggression in Autism
INP105 - SIMILAR PK TO OLANZAPINE INJECTION, BUT FASTER TO PEAK BLOOD LEVELS
Target Product Profile Clinical Development to Date – Phase 1B
RAPID ONSET Rapid Tmax, Cmax and AUC of INP105 INP105 ACES (agitation scale)
Faster to peak blood matches 5mg olanzapine change matches IM
level than IM
ACES (Max Change from Baseline)
WELL-TOLERATED
Plasma Concentration
4
Olanzapine (ng/mL)
20
Minimal syncope
3
POD DELIVERY Olanzapine IM 5 mg (N=20)
INP105 POD 5 mg (N=10)
Non-invasive delivery 10 2
administered by self or caregiver
1
TARGETS UNMET NEED
Currently no approved therapies for 0
0 1 2 3 4 0
Olanzapine IM INP105 Placebo
acute agitation in autism Time (hr) 5 mg (N=20) 5 mg (N=10) (N=10)
INP105 Has Potential To Significantly Reduce Emergency Room
Visits for Patients with Autism Spectrum Disorder
*Nominal times used for mean plot PROPRIETARY AND CONFIDENTIAL 26Parkinson’s Disease – Large & Emerging Market
•
•
Global Parkinson’s Disease
• Market Expected Worth of $8.4B by 20261
1M
~1M
PATIENTS
PATIENTS
•
•
•
Parkinson's Disease Therapeutics Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2017-2025, Transparency Market Research.
(1): Global Parkinson’s Disease Drugs Market: By Drug Class: MAO-B Inhibitors, Levodopa, COMT Inhibitors, Dopamine Agonists, Others; By Route of Administration; By Distribution Channel;
By End Use; Regional Analysis; Historical Market and Forecast (2016-2026); Market Dynamics; Competitive Landscape; Industry Events and Developments, Expert Market Research.
PROPRIETARY AND CONFIDENTIAL 27INP107 – Designed to Provide Treatment of Morning OFF Episodes
350K PARKINSON’S DISEASE PATIENTS EXPERIENCE DAILY OFF EPISODES
AND NEED RAPID RETURN TO ON
Target Product Profile INP107 Clinical Development
RAPID ONSET INP107 (CARBIDOPA/LEVODOPA)
Fast to peak blood level • Encouraging consistency and levels of uptake of levodopa
WELL-TOLERATED with carbidopa / levodopa formulation in Phase 2a study in
No significant AEs noted Parkinson’s disease population
• Next step in development is identifying dose and ratio to
POD DELIVERY achieve rapid therapeutic blood levels
Ease of administration by self or caregiver and does not
require patient coordination or inhalation
• IP filed on nasal and pulmonary administration of INP107
INP107 Has Potential to Treat OFF Episodes (Nearly 65% of
Patients Are Off for Two or More Hours Per Day)
PROPRIETARY AND CONFIDENTIAL 28Impel – Recent and Upcoming Milestones
• INP104 NDA Acceptance for Review January 2021
• Successful $80M IPO April 2021
• Successful $50M Debt Financing July 2021
• INP104 PDUFA Date September 6, 2021
• Planned TRUDHESA Launch October 2021
• Initiation of INP105 PoC Study Qtr4 2021
Focused Execution Towards Transformation
PROPRIETARY AND CONFIDENTIAL 29The Impel Investment Opportunity
TRUDHESA: A Near-Term
Commercial Opportunity
Proven Leadership Highly Targeted
and Investors Go-to-Market Strategy
POD Technology: Clinically INP105: Poised to Fill a
Validated and Broad Utility Major Unmet Need
PROPRIETARY AND CONFIDENTIAL 30Appendix PROPRIETARY AND CONFIDENTIAL
Experienced Management Team
ADRIAN ADAMS
Board Chairman &
Chief Executive Officer
JOHN LEAMAN, MD LEN PAOLILLO
Chief Financial Officer Chief Commercial Officer
JOHN HOEKMAN, STEPHEN
PhD SHREWSBURY, MD
Co-Founder &
Chief Medical Officer
Chief Scientific Officer
LYNN GOLD SHEENA AURORA, MD NEUROSCIENCE
INSTITUTE
Senior Vice President, VP Medical Affairs, HEADACHE CENTER
Regulatory Affairs Migraine
JENNIFER BERMAN JERRY PENN
Vice President, Vice President, Market Access &
Marketing Trade
PROPRIETARY AND CONFIDENTIAL 32You can also read
