TNT BIO’S SUCCESS IN ATOPIC DERMATITIS AND...
Transcript of TNT BIO’S SUCCESS IN ATOPIC DERMATITIS AND...
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TNT BIO’S SUCCESS IN ATOPIC DERMATITIS AND BEYOND
Team Go the Social Distance
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Ensuring Success for TNT Bio
Finding a market need
Maximizing profits within 15 years
Leveraging profitable
co-indications
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TNT Bio Strategy for Success
Finding a market need
Maximizing profits within 15 years
Leveraging profitable co-indications
Estimate market size by patient segment
Evaluate Markets for Co-indications and Determine Profitability
Goals
R&D and Capital Expenditure Offset by Drug Revenues
Recommendation
We recommend that TNT Bio pursue
TNT-002 for AD and other indications
Implementation
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TNT-002 Has Greater Opportunity for AD TreatmentTNT Bio’s Options
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Global Market Size:CAGR:
Atopic Dermatitis (AD) has High Potential for Market Growth
AD Patient Segments in U.S.
9.73M
18.82M
Children
Adults
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Global Market Size:CAGR:
Atopic Dermatitis (AD) has High Potential for Market Growth
Most traditional AD therapies fail to specifically target molecular mechanisms of pathogenesis
AD Patient Segments in U.S.
9.73M
18.82M
Children
Adults
1
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Global Market Size:CAGR:
Atopic Dermatitis (AD) has High Potential for Market Growth
AD Patient Segments in U.S.
9.73M
18.82M
Children
Adults
Children make up large patient segment but lack effective therapeutics for moderate-severe AD2
1
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Global Market Size:CAGR:
Atopic Dermatitis (AD) has High Potential for Market Growth
AD Patient Segments in U.S.
9.73M
18.82M
Children
Adults
2
1
Most systemic drugs have renal, hepatic, and other toxicities3
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Mild Moderate Severe
Line of Care for AD is Based on Severity of Symptoms
60% 29%
11%
Percent of AD Patients
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The Standard of Care for Severe AD is Inadequate Moderate Severe
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The Standard of Care for Severe AD is Inadequate Moderate Severe
↑ ↓
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The Standard of Care for Severe AD is Inadequate
TNT-002 TNT-013TNT Bio’s Targeted Immunotherapy Products Moderate Severe
↑ ↓
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The Standard of Care for Severe AD is Inadequate
TNT-002 TNT-013 Moderate Severe
TYK-2receptor
Receptor
Cytokines
TNT Bio’s Targeted Immunotherapy Products
multiple
IL-12, IL-13, IL-23, IFNα/β/λ
↑ ↓
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The Standard of Care for Severe AD is Inadequate
TNT-002 TNT-013
multiple single
Moderate Severe
Cytokine
TNT Bio’s Targeted Immunotherapy Products
TYK-2receptor
Receptor
Cytokines
IL-12, IL-13, IL-23, IFNα/β/λ
↑ ↓
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The Standard of Care for Severe AD is Inadequate
TNT-002 TNT-013
multiple single ↑
↓
Moderate Severe
TYK-2receptor
ReceptorCytokines
IL-12IL-13IL-23
IFNα/β/λ
Cytokine
TNT Bio’s Targeted Immunotherapy Products
TNT Bio is positioned to enter the moderate-to-severe AD market to provide effective therapies with minimal off-target effects.
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TNT-002 Has Greater Opportunity for AD Treatment
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FactorsMarket Size
Ease of Manufacturing
Low Risk for Off-target Effects
Competitive Landscape
Financial Justification
Co-indications
Regulatory Environment
OVERALL CHOICE
Product Comparison is Based on 7 Factors
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FactorsMarket Size
Ease of Manufacturing
Low Risk for Off-target Effects
Competitive Landscape
Financial Justification
Co-indications
Regulatory Environment
OVERALL CHOICE
Product Comparison is Based on 7 Factors
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AD Treatments and Projections
Treatment Line
TNT-002 Will Capture Larger AD Patient Segments
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AD Treatments and Projections
Treatment Line
TNT-002Topical
TNT-002 Will Capture Larger AD Patient SegmentsTargeted Immunotherapy
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AD Treatments and Projections
Treatment Line
TNT-002Topical
TNT-013Systemic
TNT-002 Will Capture Larger AD Patient SegmentsTargeted Immunotherapy
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AD Treatments and Projections
Treatment Line
TNT-002Topical
TNT-013Systemic
All patients
2018: 7.13M
2027: 14.27M
Adults only
2018: 1.88M
2027: 1.88M
TNT-002 Will Capture Larger AD Patient Segments
U.S. Market
Targeted Immunotherapy
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Factors TNT-002 TNT-013Market Size ✔
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Factors TNT-002 TNT-013Market Size ✔
Ease of Manufacturing
Low Risk for Off-target Effects
Competitive Landscape
Financial Justification
Co-indications
Regulatory Environment
OVERALL CHOICE
TNT-002 Has Greater Opportunity for AD Treatment
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TNT-002 TNT-013
TNT-002 Development is Less Costly and Complex
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✔ Less complex production●●
TNT-002 Development is Less Costly and Complex
TNT-002 TNT-013
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✔ Less complex production●●
✔ Low cost●●
TNT-002 Development is Less Costly and Complex
TNT-002 TNT-013
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✔ Less complex production●●
✔ Low cost●●
x Highly complex production●●
TNT-002 Development is Less Costly and Complex
TNT-002 TNT-013
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✔ Less complex production●●
✔ Low cost●●
x Highly complex production●●
x High cost●●
TNT-002 Development is Less Costly and Complex
TNT-002 TNT-013
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✔ Less complex production●●
✔ Low cost●●
x Highly complex production●●
x High cost●●
TNT-002 Development is Less Costly and Complex
TNT-002 TNT-013
Factors TNT-002 TNT-013Manufacturing ✔
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Factors TNT-002 TNT-013Market Size ✔
Ease of Manufacturing ✔
Low Risk for Off-target Effects
Competitive Landscape
Financial Justification
Co-indications
Regulatory Environment
OVERALL CHOICE
TNT-002 Has Greater Opportunity for AD Treatment
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x Affects multiple molecules●
●
TNT-002 Has Greater Risk for Off-Target Effects
TNT-002
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x Affects multiple molecules●
●
✔ Affects one molecule●
●
TNT-002 Has Greater Risk for Off-Target Effects
TNT-002 TNT-013
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x Affects multiple molecules●
●
●
✔ Affects one molecule●
●
TNT-002 Has Greater Risk for Off-Target Effects
TNT-002 TNT-013
Factors TNT-002 TNT-013Less Risk for Off-target Effects ✔
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Factors TNT-002 TNT-013Market Size ✔
Ease of Manufacturing ✔
Low Risk for Off-target Effects ✔
Competitive Landscape
Financial Justification
Co-indications
Regulatory Environment
OVERALL CHOICE
TNT-002 Has Greater Opportunity for AD Treatment
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TNT Bio: TNT-002
TNT-002 Has Less Competition in the AD Market
Mechanism of Action:TYK2 Inhibition (Topical)
Phase II Phase I Phase III In the Market
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TNT Bio: TNT-002
TNT-002 Has Less Competition in the AD Market
Pfizer: AbrocitinibComparable Mechanism of Action:
JAK1 Oral Inhibitor
Mechanism of Action:TYK2 Inhibition (Topical)
Phase II Phase I
Eli Lilly: OlumiantComparable Mechanism of Action:
JAK1/2 Oral Inhibitor
Phase III In the Market
Abbvie: RinvoqComparable Mechanism of Action:
JAK1 Oral Inhibitor
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TNT Bio: TNT-002
TNT-002 Has Less Competition in the AD Market
Pfizer: AbrocitinibComparable Mechanism of Action:
JAK1 Oral Inhibitor
Mechanism of Action:TYK2 Inhibition (Topical)
Phase II Phase I
Eli Lilly: OlumiantComparable Mechanism of Action:
JAK1/2 Oral Inhibitor
Phase III In the Market
Abbvie: RinvoqComparable Mechanism of Action:
JAK1 Oral Inhibitor
Competitive Advantage:Only topical inhibitor that
targets TYK2 in JAK/STAT pathway
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TNT-013 has steep competition in AD
TNT Bio: TNT-013
Phase III
Leo Pharma: Tralokinumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
Dermira: Lebrikizumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
Phase II Phase I In the Market
FDA Approved for AD: March 2017 (adults) and March 2019 (adolescents)
Comparable Mechanism of Action: Blocks IL-4 and IL-13 via IL-4Rα inhibition
Strong Sales: Revenues of over $2.2 B in 2019, with projected growth up to $10 B
Mechanism of Action: IL-13 Inhibition (Injection)
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TNT-013 has steep competition in AD
TNT Bio: TNT-013
Phase III
Leo Pharma: Tralokinumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
Dermira: Lebrikizumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
Phase II Phase I In the Market
Asana BioSciences: AsN002
FDA Approved for AD: March 2017 (adults) and March 2019 (adolescents)
Comparable Mechanism of Action: Blocks IL-4 and IL-13 via IL-4Rα inhibition
Strong Sales: Revenues of over $2.2 B in 2019, with projected growth up to $10 B
Comparable Mechanism of Action:IL-13 Inhibition (Injection)
Mechanism of Action: IL-13 Inhibition (Injection)
Factors TNT-002 TNT-013Competitive Landscape ✔
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Factors TNT-002 TNT-013Market Size ✔
Ease of Manufacturing ✔
Low Risk for Off-target Effects ✔
Competitive Landscape ✔
Financial Justification
Co-indications
Regulatory Environment
OVERALL CHOICE
TNT-002 Has Greater Opportunity for AD Treatment
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TNT-002 Will Generate Higher Revenues Faster
●
●
● TNT-013○○○
● TNT-002○○○
Model Assumptions
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TNT-002 Will Generate Higher Revenues FasterNet Income Comparison for TNT-013 and TNT-002
Mill
ion
s U
SD
●
●
● TNT-013○○○
● TNT-002○○○
Model Assumptions
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IRR Payback Period
+8.11%~4.6 Years
+8.53%~24 Years
TNT-002 Has a Shorter Payback Period
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IRR Payback Period
+8.11%~4.6 Years
+8.53%~24 Years
TNT-002 Has Shorter Payback Period
Factors TNT-002 TNT-013Financial Justification ✔
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Factors TNT-002 TNT-013Market Size ✔
Ease of Manufacturing ✔
Low Risk for Off-target Effects ✔
Competitive Landscape ✔
Financial Justification ✔
Co-indications
Regulatory Environment
OVERALL CHOICE
TNT-002 Has Greater Opportunity for AD Treatment
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TNT-002 Shows Promise for Rheumatoid Arthritis (RA)
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TNT-002 Projected Sales for Rheumatoid Arthritis
Total Market Size for Oral RA Drugs ~$9000 MM
JAK Inhibitors for RA Market Size ~$3000MM
Market Penetration for TNT-002 10%
Initial Market Size for TNT-002 ~$300 MM
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TNT-013 is a Risky Bet for Asthma
FDA Approved for Asthma: October 2018 (Adults)
Comparable Mechanism of Action: Blocks IL-4 and IL-13 via IL-4Rα inhibition
Strong Sales: Revenues of over $2.2 B in 2019, with projected growth up to $10 B
Phase II Phase I Phase III
TNT Bio: TNT-013
Mechanism of Action: IL-13 Inhibition (Injection)
Leo Pharma: Tralokinumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
Dermira: Lebrikizumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
In The Market
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TNT-013 is a Risky Bet for Asthma
FDA Approved for Asthma: October 2018 (Adults)
Comparable Mechanism of Action: Blocks IL-4 and IL-13 via IL-4Rα inhibition
Strong Sales: Revenues of over $2.2 B in 2019, with projected growth up to $10 B
Phase II Phase I Phase III
TNT Bio: TNT-013
Mechanism of Action: IL-13 Inhibition (Injection)
Leo Pharma: Tralokinumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
Dermira: Lebrikizumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
In The Market
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TNT-013 is a Risky Bet for Asthma
FDA Approved for Asthma: October 2018 (Adults)
Comparable Mechanism of Action: Blocks IL-4 and IL-13 via IL-4Rα inhibition
Strong Sales: Revenues of over $2.2 B in 2019, with projected growth up to $10 B
Phase II Phase I Phase III
TNT Bio: TNT-013
Mechanism of Action: IL-13 Inhibition (Injection)
Leo Pharma: Tralokinumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
Dermira: Lebrikizumab
Comparable Mechanism of Action: IL-13 Inhibition (Injection)
In The Market
There is high risk of failure for TNT-013 in Phase 3 trials for Asthma.
Factors TNT-002 TNT-013Co-indications ✔
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Factors TNT-002 TNT-013Market Size ✔
Ease of Manufacturing ✔
Low Risk for Off-target Effects ✔
Competitive Landscape ✔
Financial Justification ✔
Co-indications ✔
Regulatory Environment
OVERALL CHOICE
TNT-002 Has Greater Opportunity for AD Treatment
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1
3
TNT-002 is Favored By Trends in The Payor Market
2
4
The payor market is trending towards:
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The market is moving towards transparently priced, affordable drugs
Entitlement Reform Price Control & Transparency
States are beginning to implement price transparency and price
control for drugs
Proposed budget would include cuts totaling $4.8T to programs like Medicare over the next decade
Consumer Behavior
Consumers want effective, safe, and affordable treatments
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Legal Reformatory Acts Entitlement Reform Price Control & Transparency
States are beginning to implement price transparency and price control for drugs
Proposed budget would include cuts totaling $4.8T to programs like Medicare over the next decade
Legal and consumer landscapes are shifting away from high cost pharmaceuticals towards more transparently priced, affordable options.
These changes further support the selection of TNT-002.
Factors TNT-002 TNT-013Regulatory Environment ✔
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TNT-002 Has Greater Opportunity for AD Treatment
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Factors TNT-002 TNT-013Market Size ✔
Ease of Manufacturing ✔
Low Risk for Off-target Effects ✔
Competitive Landscape ✔
Financial Justification ✔
Co-indications ✔
Regulatory Environment ✔
OVERALL CHOICE ✔✔✔✔✔✔ ✔
TNT-002 Has Greater Opportunity for AD Treatment
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TNT-002 Has Greater Opportunity for AD Treatment
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Future Considerations for TNT Bio
Regulatory LandscapeCompetitive LandscapeConsumer Landscape●
○○○○
●
●
●
●
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TNT Bio’s Impact
Finding a market need
Maximizing profits within 15 years
Leveraging profitable co-indications
Develop TNT-002 to meet market need for moderate-severe AD patient segment
Continue development of TNT-002 for RA due to proven efficacy of similar therapeutics
Goals Recommendation
We recommend that TNT Bio pursue TNT-002 for
development and sales for atopic dermatitis
Findings
Develop TNT-002 to maximize profit growth in AD and RA
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Thank You For Listening! For Questions, Please Feel Free to Reach Us Virtually
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APPENDIXFindingsAD Market SizingMarket Sizing Data ⅙Market Sizing Data ⅖Market Sizing Data 3/6Market Sizing Data 4/6Market Sizing Data ⅚ Market Sizing Data 6/6Market Sizing for RA Coindication
Financial AnalysisFinancial Pro-Forma TNT-002 (⅕)Financial Pro-Forma TNT-002 (2/5)Financial Pro-Forma TNT-002 (3/5)Financial Pro-Forma TNT-002 (4/5)Financial Pro-Forma TNT-002 (5/5)Financial Pro-Forma TNT-013 (1/5)Financial Pro-Forma TNT-013 (2/5)Financial Pro-Forma TNT-013 (3/5)Financial Pro-Forma TNT-013 (4/5)Financial Pro-Forma TNT-013 (5/5Discount Rate Analysis (½)Discount Rate Analysis (2/2))
Atopic Dermatitis (AD)AD EpidemiologyAD MarketAD Competitive LandscapeJAKSJAK STAT Diagram (½) JAK STAT Diagory (2/2) Selected Topical JAK Inhibitors in DevelopmentAntibody vs Small MoleculesSmall Molecule vs mABGlobal Eczema Therapeutic Market Size Global Dermatitis Drugs Market ShareGlobal Market Leaders for Eczema Treatment TYK2 DiagramMolecules that target the JAK-STAT Receptors(½)Molecules that target the JAK-STAT Receptors(2/2)TYK 2 for RAGlobal Market for Antibody Drugs by Region Atopic Dermatitis Has a Large Patient Population with Unmet NeedsAtopic Dermatitis Pathogenesis is driven by IL-4 and IL-13 Signaling
Rheumatoid ArthritisRheumatoid Arthritis EpidemiologyRheumatoid Arthritis MarketRheumatoid Arthritis Revenue Market Size Rheumatoid Arthritis Cost of Care Rheumatoid Arthritis Competitive Landscape Rheumatoid Arthritis mAb MarketCytokine Signaling Pathways in RAJAK Inhibitors on the way for RAJAK Inhibitors for RAAsthma Asthma Market SizeAsthma Competitive LandscapeCompetitor LandscapeProducts in the Atopic Dermatitis Market Products in the Asthma MarketProducts in the RA MarketSample Drug Profile for RASample Drug Profile for RA II TNT013 MarketTimelineTNT002 vs TNT013 Timeline
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Market Sizing
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AD Market Sizing
~75M CHILDREN (<18 Years Old) ~258M ADULTS (>18 Years Old) 333M TOTAL U.S. POPULATION
~13% Will Be Impacted By AD ~7% Will Be Impacted By AD
9.73 MM Children Impacted By AD 18.82 MM Adults Impacted By AD
TOTAL IMPACTED ~28.55 MM Go Back to AppendixGo Back to AppendixGo Back to Appendix
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Market Sizing Data 1/6
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Market Sizing Data 2/6 (Finding the Target Population)
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Market Sizing Data 3/6 (Finding the Target Population)
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Market Sizing Data 4/6 (Market Segmentation Based on Different Treatments)
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Market Sizing Data 5/6 (Systemic Immunomodulators Market Size)
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Market Sizing Data 6/6 (Topical Immunomodulators Market Size)
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Market Sizing Coindication - Rheumatoid Arthritis
Source: https://www.belegger.nl/Forum/Upload/2018/10987448.pdf Go Back to AppendixGo Back to Appendix
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Financial Analysis
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Financial Pro-Forma TNT-002 (1/5)
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Financial Pro-Forma TNT-002 (2/5)
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Financial Pro-Forma TNT-002 (3/5)
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Financial Pro-Forma TNT-002 (4/5)
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Appendix
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Financial Pro-Forma TNT-002 (5/5)
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Financial Pro-Forma TNT-013 (1/5)
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Financial Pro-Forma TNT-013 (2/5)
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AppendixGo Back to Appendix
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Financial Pro-Forma TNT-013 (3/5)
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Financial Pro-Forma TNT-013 (4/5)
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Financial Pro-Forma TNT-013 (5/5)
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Discount Rate Analysis (½)
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Discount Rate Analysis (2/2)
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Atopic Dermatitis (AD)
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AD Epidemiology●
○
● Patient population:○○
● Patient segments:○○○
● Cost:○○
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● Global Market Size:○ CAGR:
AD Market
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Major players in JAK-STAT Inhibitors:
In phase 3 clinical trials:
AD Competitive Landscape
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JANUS KINASES (JAKS)
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JAK-STAT INHIBITION AFFECTS MANY ASPECTS OF THE IMMUNE RESPONSE
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JAK-STAT INHIBITORS AFFECT DISTINCT CYTOKINES
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Selected Topical JAK Inhibitors in Development
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Antibody vs. Small Molecules
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Small Molecule vs mABProperties Small Molecule Drugs mAb Drugs
Size Small, single molecule with low molecular weight
Large, complex with high molecular weight
Manufacturing process Chemically synthesized, combining specific chemical ingredients in an ordered process
Produced in living cell cultures
Stability Stable in all environments Unstable, sensitive to external conditions
Production cost Low cost High cost
Target Any drug-able target Extracellular proteins
Side Effects Less specific action; can inhibit multiple mechanisms
Specific action, low off-target toxicity
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Global Eczema Therapeutic Market Size Shows TNT-002 a Promising Future
● Market size: Global Eczema Therapeutics market size is estimated to grow at CAGR of over 9% with Revenue USD 3.60 billion during the forecast period 2020-2024. The YOY (year-over-year) growth rate for 2020 is estimated at 7.09% by the end of 2024.
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Global Dermatitis Drugs Market Share
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Global Market Leaders for Eczema Treatment
Competitive Landscape:
○ Global market leaders for eczema treatment: (Source)■ AbbVie Inc.■ Alliance Pharma Plc■ Bausch Health Companies Inc.■ Bayer AG■ Eli Lilly and Co.■ Encore Dermatology Inc.■ LEO Pharma AS■ Mylan NV■ Pfizer Inc.■ Sanofi
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TYK2 (Tyrosine Kinase 2) Inhibitor (Topical treatment) Diagram
Crucially, the cytokines involved in AD such as IL-4, IL-13, IL-31, and IL-22 require JAK-STAT downstream signaling for their biological function. Go Back to
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Molecules that target the JAK-STAT receptors (½) ○ Oral:
■ Tofacitinib (JAK1/3) Sold by Pfizer for AD■ Abrocitinib (JAK1) Sold by Pfizer for AD■ Baricitinib (JAK1/2) Sold by Eli Lilly/Incyte for AD■ Upadicitinib (JAK1) Sold by AbbVie for AD (Clinical trial ongoing)■ ASN002 (JAK1/2/3, TYK2, SYK) Sold by Asana Biosciences for AD
○ Topical:■ Tofacitinib (JAK1//3) Sold by Pfizer for AD■ PF-06700841 (JAK1/TYK2) Sold by Pfizer for AD (Clinical trial ongoing)■ Ruxolitinib (JAK1/2) Sold by Incyte (Clinical Trial ongoing)■ ATI-502 (JAK1/3) Sold by Aclaris ■ Delgocitinib (JAK1/2/3 Syk Tyk) Sold by Japan Tobacco Inc., Leo (Ongoing Clinical trial
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Molecules that target the JAK-STAT receptors (2/2) ■ BMS-986165 (TYK2 inhibitor)
■ Byrstol Myers Squibb ● Phase III Plaque psoriasis● Phase II Crohn's disease; Psoriatic arthritis; Systemic lupus erythematosus;
Ulcerative colitis● Phase I Autoimmune disorders; Inflammatory bowel diseases; Liver disorders
■ Similar efficacy to biologics without the effects on biomarkers associated with Janus kinase inhibitors.The selectivity against other Jak family subtypes (such as Jak2) is crucial in order to minimize the potential side effects and to maximize the desired pharmacological effects.
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TYK2 for RA
● TYK2 is involved in the signaling cascade of IL-12, IL-23, type-I IFN as well as IL-6 and IL-10
● A specific TYK2 inhibitor would have less broad immunosuppression and, therefore, could be safely used for diseases such as psoriasis or inflammatory bowel disease for which inhibition of IL-12 and IL-23 is proving quite successful. Go Back to
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Global Market for Antibody Drugs by Region
• Antibody drugs have grown at CAGR of 12.2% in the global market
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Atopic Dermatitis Has a Large Patient Population With Unmet Needs
• Symptoms of AD include skin pruritis (itchiness), loss of skin barrier function, and increased skin infections
• Around 6.5 million American adults have severe AD, incurring an economic burden of ~$5.37 Billion in 2016
• Treatments for severe AD include topical anti-inflammatory creams (i.e.,topical corticosteroid and topical calcineurin inhibitors)
• Systemic agents are effective as a last line treatment, but have moderate to severe side effects, including immunosupression
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Atopic Dermatitis pathogenesis is driven by IL-4 and IL-13 Signaling
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mAb-Based Therapeutics Directly Target Pathogenic Protein Interactions
• Aberrant protein-protein interactions are central in disease pathogenesis
• Monoclonal antibodies bind a specific region of a protein to prevent pathogenic interactions
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Selective inhibition of TYK2 can provide pharmacological benefits in the treatment of many diseases
● Psoriasis● Systemic lupus erythematosus (SLE)● Inflammatory bowel disease (IBD)● Rheumatoid arthritis (RA)● Cancer● Diabetes
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Reference Timeline for Dupilumab
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TNT-013 has steep competition in AD
FDA Approved for AD: March 2017 (adults) and March 2019 (adolescents)
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2020 2021 20232022 2024 2025 2026 2027
TNT-002 and TNT-013 Have Similar Clinical Trial Timelines
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TNT-013 has steep competition in AD
FDA Approved for AD: March 2017 (adults) and March 2019 (adolescents)
Comparable Mechanism of Action: Blocks IL-4 and IL-13 via IL-4Rα inhibition
© 2019 Sanofi and Regeneron Pharmaceuticals, Inc
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TNT-013 has steep competition in AD
FDA Approved for AD: March 2017 (adults) and March 2019 (adolescents)
Comparable Mechanism of Action: Blocks IL-4 and IL-13 via IL-4Rα inhibition
Strong Sales: Revenues of over $2.2 B in 2019, with projected growth up to $10 B
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Rheumatoid Arthritis (RA)
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Rheumatoid Arthritis Epidemiology
●
○
● Patient population:○
● Patient segments:○
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Rheumatoid Arthritis Market
● Global Market Size: ○ CAGR:
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Corticosteroids
Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
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Rheumatoid Arthritis Size
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Rheumatoid Arthritis Cost of Care
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Rheumatoid Arthritis Competitive LandscapeGlobal Market Shares for Key Competitors of
Small Molecules Therapies for RA, 2017
Major players in JAK-STAT Inhibitors:
In phase 3 clinical trials:
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Rheumatoid Arthritis mAb Market, 2017-2022
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Cytokine Signaling Pathways in RA
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JAK Inhibitors on the Way for RA and Other Indications
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JAK Inhibitors For RA
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JAK Inhibitors For RA
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Asthma
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Asthma Market Size
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Asthma Competitive Landscape
● Competitive landscape○ Fasenra (Benralizumab) IL 5 receptor○ Nucala (Mepolizumab) IL 5
● IL 13 Inhibition for Asthma○ Dupilumab (IL 4/13 inhibition via IL4ra) is effective○ Tralokinumab (IL-13 inhibition), while initially promising, has MIXED results
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Competitor Landscape
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Products in the Atopic Dermatitis MarketCompany Drug Name Mechanism of Action
(Application)Status Sales
Regeneron and Sanofi Dupilumab (Dupixent) Il-4Ra inhibition, for IL-4 and IL-13 inhibition(injection)
Approved and Sold for Eczema, Nasal Polyps, and Asthma
1.871B in US, 2.3B Global, eventual sales of 10B projected (at margins approaching ~30%)
Lilly Olumiant (Baricitinib) JAK1/2 oral inhibitor Phase III for AD, Sold for RA
AbbVie Rinvoq (upadacitinib) JAK-1 oral inhibitor Phase III for AD
Pfizer Xeljanz (tofacitinib) JAK1/3 inhibitor that Inhibits IL-14 and other molecules(topical/oral)
Phase 3 trials almost done for AD. Sold for adults with moderately to severely RA, Psoriatic arthritis, and ulcerative colitis
n/a
Pfizer Abrocitinib JAK1 inhibitor Phase 3 trials almost done n/a
Dermira (Eli Lilly) Lebrikizumab IL-13 Inhibition (Injection) Phase 3 trials underway n/a
Leo Pharma Tralokinumab IL-13 Inhibition (Injection) Phase 3 Trials Wrapping Up n/a
Asana Biosciences AsN002 JAK/SYK Inhibitor Phase II Go Back to Appendix
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Products in the Asthma MarketCompany Drug Name Mechanism of Action Status Sales
Regeneron and Sanofi Dupixent(Dupilumab)
Il-4Ra inhibition, for IL-4 and IL-13 inhibition
Approved and Sold for Adult Eczema, Nasal Polyps, and Asthma
On track for approval for eosinophilic esophagitis (EOE), Pediatric Asthma, Pediatric AD
1.871B in US, 2.3B Global, eventual sales of 10B projected
30% of these sales are from Asthma
REGN - Stock Business Line Segments
Dermira (Eli Lilly) Lebrikizumab IL-13 Inhibition Abandoned for lack of efficacy n/a
Leo Pharma Tralokinumab IL-13 Inhibition Lack of efficacy n/a
MedImmune (Astra Zeneca) Fasenra (Benralizumab) IL-5R Inhibition Approved in 2017 by FDA for severe eosinophilic asthma
2019 for eosinophilic oesophagitis
~$297 Million in its first year of sales for Asthma
GSK Nucala (Mepolizumab) IL-5 Inhibition Approved by FDA for Severe Asthma for patients 6 and older
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Products in the Rheumatoid Arthritis MarketCompany Drug Name Mechanism of Action Status Sales
Pfizer Xeljanz (tofacitinib) JAK1/3 inhibitor that decreases IL-4 (Oral)
Sold for adults with moderately to severely RA, Psoriatic arthritis, and ulcerative colitis
2.24Bn global sales (Consider this sale number includes other indications other than RA)
PFE Stock Business Revenue Segments
Eli Lilly Olumiant (baricitinib) JAK1/2 inhibitor(oral)
Approved for RA adult patients with moderately to severely active RA who have had an inadequate response to TNF antagonists. Being tested for AD
426.9Mn in 2019 Global sales
AbbVie Rinvoq (upadacitinib) (oral) JAK1 inhibitor Approved for RA. Phase 3 trials for atopic dermatitis, psoriatic arthritis, Crohn's disease, and ulcerative colitis
Aug-Dec sales in 2019 = 47M (approved for sale in August)
Gilead Sciences, Inc. Filgotinib JAK1 inhibitor Being investigated, clinical trials underway
n/a
Company Drug Name Mechanism of Action Status Sales
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Sample Drug for RA: Xeljanz (tofacitinib)
Approved:● Pfizer’s Xeljanz (tofacitinib), a pan-JAK inhibitor
○ Approved Nov 2012○ Oral intake○ Accounts for 4% of the total RA market○ Protected against biosimilar competition until 2025○ Sales of more than $1.6bn/year
● Price of topical tofacitinib: 320$/bottle, lasts 90 days.○ $2,326.53, 28% off the average retail price of $3,270.55 for 30 tablets
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Sample Drug for RA: Xeljanz (tofacitinib)
Revenue Growth Market Share GrowthGo Back to Appendix
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IL-13 Inhibition Is Ineffective for Asthma
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