Amryt Pharma Acquisition of Aegerion Building a Global ... · This presentation has been prepared...
Transcript of Amryt Pharma Acquisition of Aegerion Building a Global ... · This presentation has been prepared...
Amryt Pharma – Acquisition of Aegerion
Building a Global Leader in Rare and Orphan DiseasesSTRICTLY PRIVATE & CONFIDENTIAL
August/September 2019
Disclaimer
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Creating a Global Leader in Rare & Orphan Diseases
• Revenue generating rare & orphan drug company
• Strong portfolio of commercial & development assets
• Lojuxta (Juxtapid in US) in-licenced by Amryt (Dec 16) in EMEA - 2018 Sales: $16.1m
• Strong management team with unique knowledge of Aegerion assets
• Upside through clinical Epidermolysis Bullosa (‘EB’)franchise
• AP101 - potential mkt. opportunity >$1bn
• AP103 - novel gene therapy platform
• Rare & orphan disease focus with a global footprint
• Two commercial products with significant growth potential:
• Juxtapid 2018 Sales: $47.9m US & RoW (Lojuxta in Europe)
• Metreleptin 2018 Sales: $71.4m US, Europe & RoW
• Pipeline opportunities for Myaleptin PL and Juxtapid/Lojuxta in FCS
• Established US infrastructure in place
• Strong patent & regulatory exclusivity protection
Emerging global leader in rare & orphan diseases with diversified,
commercial portfolio
Delivers sustainable revenue, pipeline and market growth
Creates a rare disease business with two approved products – lomitapide(Lojuxta® / Juxtapid®) and metreleptin (Myalept® / Myalepta®)
$136.5m of 2018 built-in revenues, multiple growth opportunities, and a robust pipeline for value creation
Reunites the lomitapide franchise and transforms Amryt into a global player in the orphan disease market
Capitalizes on Amryt management’s unique knowledge of Aegerion’s assets and European commercialization capabilities
Presents the opportunity for meaningful expense synergies - $25m-$40m in 2020*
Establishes an appropriate capital structure and liquidity profile to drive growth and create value
Transaction already endorsed by 34.3% of Amryt’s shareholders and 67% of Aegerion’s bondholders
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Strong Strategic Rationale for Combination
Creating a global player in rare & orphan diseases*Directors belief based on work undertaken to date
Enhanced scale of combined group expected to drive revenue growth and future profitability
Expected to deliver meaningful operational synergies over the medium term
Amryt’s deep knowledge of Aegerion products is key to driving growth
Reunification of lomitapide brands provides potential to replicate success of Lojuxta in Europe with Juxtapid in the US
Opportunity to grow Myalepta revenues with broader reach across EU to accelerate recent launch
Delivers a ready-made commercial US infrastructure in advance of anticipated launch of AP101
Recapitalized business well-positioned to drive pipeline value
Planned short-term NASDAQ listing to drive liquidity and investor reach
Opportunity for corporate restructuring to drive additional value
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Value Creation Opportunity Driven by Execution on Plan
Delivering superior returns & driving shareholder value
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Amryt Leadership Team
Rory Nealon – COO/CFO
CFO/COO of Trinity Biotech
Oversaw the acquisition and integration of 12 companies
in 5 countries
Previously CFO of Conduit plc, an Irish telecoms company
Previously associate director within structured finance AIB
Dr Mark Sumeray – CMO
20 years’ experience in the pharmaceutical, medical
devices and biotech sectors
Chief Medical Officer at Aegerion Pharmaceuticals
Previously VP Cardiovascular Metabolics US Medical
at Bristol-Myers Squibb
Dr Helen Phillips – Head of Medical Affairs
20+ years in large pharma and small biotech
companies
Previously European VP of Medical Affairs in
Aegerion Pharmaceuticals
Dr Joe Wiley – CEO
Founded Amryt in 2015
20+ years in healthcare and private equity
Opened and led Sofinnova Ventures European office
Senior investment roles at Aberdeen Asset Managers,
Inventages Venture Capital
Previously Medical Director at Astellas Pharma
David Allmond – CCO
25 years’ experience in the pharmaceutical industry
in commercial roles
President EMEA at Aegerion Pharmaceuticals
Previously Corporate Vice President of Global
Marketing for Celgene Corporation
Kieran Rooney – VP, Strategic Alliances & Licensing
25+ years in business/corporate development
in pharmaceutical and biotech industry
Previously VP Business Development at Amakem
Therapeutics and corporate/management consultant to
multiple pharma/biotech/professional service companies including PwC
Derval O’ Carroll – Head of Regulatory Affairs
25 years in pharmaceutical regulatory affairs
companies
Previously Senior Director of Regulatory Affairs at
Retrophin Inc
11 years consulting experience in regulatory with clients
such as Daiichi Sankyo and Shionogi
Julie Eastwood – Head of HR
25 years experience in HR
Fellow CIPD
Previously HR Director at Totalmobile, TV3
Oxigen and Readymix.
Stephen Joyce – VP Global Marketing15+ years in the pharmaceutical industry
Held multiple commercial roles, with a large focus on
launch, access and commercial excellence
Previously General Manger, Switzerland, Senior Director Area
Marketing & Market Access at Astellas Pharma
Gerard Gilligan – VP Manufacturing, Supply Chain 25+ years on Pharmaceutical Manufacturing & Supply Chain
Previously Held various role in Leo Pharma including Site,
Operations and Manufacturing Lead, Chemistry and
Lean/Black Belt
Team in place to scale and grow our business
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Amryt + Aegerion - Global Presence
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Geographically complementary and providing new market access
Pending markets
Out-licensed
Current markets
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Overlap in combined group brings significant synergies including head office.Amryt brings additional reach and expertise in MENA, CEE and Russia
MENATURKEYUKSPAINITALYFRANCEGERMANY
+++++++++++++++++
++++++++++++++++++
A perfect fit delivering a stronger combined platform for growth
Complementary Fit - Global Commercial Footprint
US
+
++++
Product Candidate Indication Preclinical Phase 1 Phase 2 Phase 3 Approved
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Amryt + Aegerion - Rich Commercial & Development Pipeline
Myalept/Myalepta GL US/EU
Myalepta PL EU
Juxtapid (lomitapide) HoFH (adult) US/LATAM
Lojuxta (lomitapide) HoFH (adult) EU/MENA
AP101 EB (DEB/JEB) GLOBAL
Myalept PL US
Lomitapide FCS US/EU
AP101 SJS/TEN, Rad. Ind Derm GLOBAL
AP103 EB (RDEB) GLOBAL
AP103 Various/undisclosed GLOBAL
Lojuxta (lomitapide) HoFH (paediatrics) EU
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Augments existing pipeline and delivers growth opportunities
Aegerion Joint Amryt
US/EU
EU
US/LATAM
EU/MENA
H1H1 H1H2H1 H2H1
KJB I
H2 H2H2H1
LA C F GE HD
A. Metreleptin GL/PL Filing in Other Countries
B. US PL FDA meeting
C. Lojuxta top line PoC data for FCS
D. First Quarterly Report as Combined Company
E. AP101 top line data
F. First Annual Report as Combined Company
G. AP101 Approval (FDA & EMA) and Launch
H. Lojuxta Phase 3 topline data for FCS
I. Lojuxta EU pediatric approval for HoFH
J. AP103 Clinical PoC data
K. Lojuxta launch in FCS
L. US PL launch
2020
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2022
Building a global leader in rare & orphan diseases
2019 2021 2023 2024
2019
2019
2019
2020
2021
2021
2021
2022
2022
2023
2023
2024
H2
Note: Clinical milestones are estimates and subject to change.
Compelling Equity Story With Significant Upcoming Newsflow
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Lojuxta / Juxtapid▲Reunifying the global lomitapide brands
▲Lojuxta / Juxtapid
▲ Approved in both Europe (Jul 2013) and the US (Dec 2012) to treat adults with HoFH
▲ Reduces LDL-C in adult HoFH patients▲ Patent protection in US to mid 2027 and 2028 in EU*
▲ 2018 Global Revenues: $64m**
▲Amryt successfully commercializing Lojuxta in Europe since 2016
▲Market potential for adult HoFH patients in the US
▲Deploy proven strategy for Lojuxta in Europe to drive Juxtapidgrowth in the US
▲ Lifecycle opportunities in pediatric HoFH and Familial Chylomicronemia Syndrome (‘FCS’)
Demonstrable track record in commercializing Lojuxta/Juxtapid
What is HoFH ? HoFH is a potentially life threatening disorder that impairs the body’s ability to remove LDL ‘bad’ cholesterol from the blood. Typically results in extremely high blood LDL cholesterol levels leading to aggressive and premature blocking of arterial blood vessels.
*SPC Granted in 4 of 5 major markets; pending in UK. **Excluding Japan revenues; including Japan royalties
Lojuxta Performance & Growth Trajectory In EMEA
23% increase in revenues in 2018
Forecast to grow a further 31% by end 2019*
Performance driven by lean & talented team
– Repositioned product
– Optimized market access - successfully
delivered positive reimbursement in key
markets such as UK and FR
– Broadened geographic reach
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Opportunity to replicate this success globally
* Consensus estimates
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Myalept / Myalepta - A Significant Global Opportunity for Growth
▲Myalept / Myalepta▲ Approved in the US (Feb 2014) to treat Generalized Lipodystrophy
(‘GL’)▲ Approved in Europe (July 2018) to treat both GL and Partial
Lipodystrophy (‘PL’)▲ Treats the complications of leptin deficiency in patients ▲ Patent protection in US to mid 2027 and orphan exclusivity in
Europe through 2028▲ 2018 Global Revenues: $71.4m
▲Recent European launch provides a significant opportunity for Amryt to accelerate growth
▲Strong fit with Amryt’s EMEA infrastructure
▲Market potential in US and ROW
▲Further growth through potential expansion of label to include PL in the US
What is Lipodystrophy? Lipodystrophy is a chronic condition associated with low leptin levels. Leptin is an important hormone for energy homeostasis and metabolic function. Low leptin can result in metabolic chaos typically resulting in fatty liver, insatiable hunger, chronic fatigue, diabetes often with severe insulin resistance, and severe hypertriglyceridemia leading to a risk of pancreatitis. This may lead to life‐altering organ damage with reduced life expectancy in severe forms.
Enabling metreleptin to realize its full commercial potential
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EB - AP101 - Lead Development Asset
Strong progress achieved in advancing AP101
What is EB ? –Epidermolysis Bullosa (EB) is a rare genetic skin disorder that leads to extremely fragile skin, and children with the disorder are often referred to as ‘butterfly children’.There are currently no approved treatments for EB.
8
0
4
AP101+ wound dressing
UndecidedWound dressing
alone
Which halfepithelialized faster?
Primary efficacy endpoint
p < 0.01
Wounddressing
alone
RES
ULT
S
0 7 14
AP101 +Wound
dressing
Day
Representative photo series
▲Promotes the differentiation & migration of skin cells to accelerate wound healing
▲Largest ever Global Phase 3 (EASE) patient study for EB currently underway - unblinded interim efficacy analysis delivered Q1 2019
▲Addressable market estimated at >$1bn*
Amryt Proof of Concept Study in EB**
*Management Estimates**Schwieger-Briel A, Dermatology Research and Practice 2017, https://doi.org/10.1155/2017/5068969
Double blind, randomised, placebo controlled, Phase 3, Efficacy and Safety Study of AP101 in Patients with EB*
Placebo + dressingRandomisation 1:1(stratified by EB subtype)
AP101 + dressing
AP101 + dressing
Visit schedule Day0 D14 D30 D60 D90Month 0
M3 M12 M24
90 day main study phase 2 year open label extension
D45
Primary Endpoint: proportion of target wounds healed by day 45*
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AP101 - EASE Phase 3 Study in EB
Study expected to be fully recruited H2 2019
Unblinded interim efficacy analysis delivered Q1 2019
*Excludes EB Simplex
Milestones Patient studies Non-human studies
Phase 2b
Indication 2017 2018 2019
Phase 3 EB (230 evaluable patients)
EB(AP101)
Follow-up Study
FDA approval
NDA
CTD EMA approval
MAA
CTD
Topline Data
Interim Efficacy Analysis
Non-clinical studies
FPFVFasttrack Designation
Ad Comm
A approval
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2020
USA IND
AP101 - EASE Timeline
2021
PRV
Pediatric Rare Disease
Designation
Short & medium term value generating clinical milestones
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AP103 - Gene Therapy Platform
▲Novel non-viral gene therapy for EB
▲Platform gene therapy delivery technology using HPAE polymer
▲Benefits:
– Simple & novel topical application
– Strong efficacy seen in pre-clinical models
– Potential immunogenicity benefit vs viral vector products
– Potentially easier to manufacture than viral vector products
▲Initial focus on Recessive Dystrophic EB (RDEB) with potential
efficacy for other indications
▲2018 - $9.6M DTIF grant from Irish Government*
▲Clinical proof of concept expected by 2023
What is AP103? Exclusively licensed HPAE Polymer Technology for use as a novel gene delivery platform in EB which if successful, could eliminate the requirement for viruses as delivery vectors –and could provide a substantial competitive advantage to Amryt.
Building an EB franchise globally
* Awarded to a consortium of partners comprising Amryt, University College Dublin, Curran Scientific Limited and DEBRA Ireland
Collagen VII Expression -with a single topical application and increased post
three topical applications
20Demonstrated efficacy in pre-clinical EB model
Control C7 Negative
Imag
es
take
n a
t 2
0x
On
e M
on
th
1x HPAE-C7 Topically
3x HPAE-C7 Topically
10
We
eks
Uptake Pathway of the Polyplexes
AP103 - Gene Therapy Platform
Amryt has agreed to acquire Aegerion in an all-paper transaction
– The combined group’s global HQ will be in Dublin, Ireland with its US HQ in Boston, Massachusetts
Amryt to own ~38.6% of pro forma business based on agreed transaction equity valuations (prior to proposed $60m equity financing)
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Transaction Highlights – Key Acquisition Details
Significantly accelerates Amryt’s growth trajectory
$m Ownership
Amryt Valuation1 $120.0 38.6%
Aegerion Valuation 190.7 61.4%
Pro forma Transaction Equity Valuation1,2 310.7 100%
1. Contingent Value Rights (“CVRs”) will be issued to pre-transaction Amryt stakeholders that could result in the payment of up to an additional $85m (settled in cash or stock) based on certain AP101 milestones being achieved
2. Prior to proposed equity financing.
Amryt plans to raise $60m in equity concurrent with the Transaction close
– Certain Aegerion bondholders have agreed to backstop this equity raise
This equity raise will be placed at a 20% discount to the implied transaction equity valuation
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Transaction Highlights – Key Financing Terms
Significantly accelerates Amryt’s growth trajectory
$mOwnership
Pre-new equity
Ownership Post-new
equity
Amryt valuation $120.0 38.6% 31.1%
Aegerion valuation 190.7 61.4% 49.5%
Pro forma Transaction Equity Valuation 310.7 100%
Pre-money Equity Valuation (20% discount) 248.7
New equity investment 60.0 19.4%
Post-money Equity Valuation $308.7 100%
Pro forma company will be appropriately capitalized post-Transaction and equity financing
– New debt already negotiated with existing Aegerion stakeholders
Implied post-money enterprise valuation represents 3.4x multiple on 2018 combined built-in revenue
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Transaction Highlights – Key Acquisition Details
Significantly accelerates Amryt’s growth trajectory
$m
Post-money Equity Valuation $308.7
New Term Debt 81.9
New Convertible Debt 125.0
(Cash)1 (57.0)
Post-money Enterprise Valuation $458.5
1. Assumes $60 million gross proceeds, net of backstop fee. Does not include potential impact of placement fees.
1,208
1,028
301 265 251 164 137 91 51 32 18 1
2018A Sales (in $M)
Amryt + Aegerion - A Significant Player in Rare & Orphan Diseases
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Underpins significant uplift in value for shareholders
5.6B 6.0B 9.4B 2.7B 1.4B 609M c.458M 2.3B 3.0B 193M 54M 480M
Enterprise Value ($)
Source: Capital IQ, Wall Street Equity Research, and Company filings as of 12/08/19
Accelerates creation of a global leader in rare & orphan diseases
Highly experienced management with proven track record &
unique knowledge of assets
Delivering sustainable revenue, pipeline & market growth
Enhanced scale and significant operating synergies will drive
superior returns & shareholder value
Re-capitalized business with financial flexibility to develop and
launch its own pipeline programs
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Summary Investment Case
Building a global leader in rare & orphan diseases
Announcement of Transaction - 21 May 2019
Publication of Admission Document - 27 August 2019
Launch of the $60m Equity Fundraise - August 2019
Aegerion Chapter 11 confirmation order – 5 September 2019
Amryt Shareholder Meeting – 19 September 2019
Scheme of Arrangement Completion – 23 September 2019
Acquisition Completion & $60m Fundraise completion – 24 September 2019
Nasdaq listing – expected Q4 2019
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Indicative Transaction Timetable
Building a global leader in rare & orphan diseases
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Momentum Building - Accelerated & Disciplined Growth
Building a track record of successful execution
2015 2016 2017 2018 2019 +
• Amryt formed
• 1st two acquisitions agreed
• Episalvan (AP101) approved by EMA
• IPO on AIM• €20m EIB
debt facility agreed
• Lojuxta in-licensed
• Largest Global EB Phase III study (EASE) started
• €15m equity fund raise
• Lojuxta-territorial growth & expansion
• AP101 –EASE protocol refined & enhanced
• AP103 Gene therapy platform in-licensed
• EASE Interim efficacy analysis announced Q1
• Announced planned acquisition of Aegerion
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Lojuxta - Italian Real World Data Demonstrates Significant Efficacy
308
234
620
508470
168
267
843
551
726
242266
212
459
516
69 54 3975
144
25
104
44 41 45
134
231
44
157
280
0
100
200
300
400
500
600
700
800
900
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Patient ID
On standard therapy, before addingLojuxta
Lowest level achieved with Lojuxta
• The addition of Lojuxta at the average dosage of 19 mg/day lowered LDL-C levels at the nadir by 76.5 ± 16.7%.
• At their last visit, 60% of patients showed LDL-C<100 mg/dL and 47% <70 mg/dL (more stringent target with cardiovascular disease)
LDL-
C m
g/d
L
A highly effective and clinically proven treatment for HoFH
Target
Source : D’Erasmo et al, “Efficacy of Lomitapide in the Treatment of Familial Homozygous Hypercholesterolemia : Results of a Real World Clinical Experience in Italy” 2017
31
AP103 - Protein Production From RDEB Cells Treated With AP103
• Approximately 5-fold more hCol7 protein is expressed in RDEB keratinocytes after a single AP103 delivery compared with normal keratinocyte endogenous levels of hCol7 protein. These levels are comparable to those delivered by viral methods
• RDEB fibroblasts express approximately 3.5-fold more hCol7 protein compared with normal fibroblast levels
• AP103 delivers between 50 and 70 fold increased mRNA expression of hCol7 compared to normal cells
Proof-of-concept expression of hCol7
AP103 application produced type VII collagen at levels exceeding previously tested non-viral methods, and similar to those following delivery using viral vectors
Treated RDEB cells produced much higher amounts of type VII collagen then seen in healthy cells
No indication of cellular toxicity was seen after treatment with AP103
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AP103 – Confirmation of Expression & Delivery of hCol7
AP103 confirmation of proof-of-concept