Amryt Pharma - Merger with Aegerion Building a Global Leader in Rare and Orphan Diseases - Amryt Pharma Plc
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Amryt Pharma - Merger with Aegerion Building a Global Leader in Rare and Orphan Diseases May 2019
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Recommended Acquisition of Aegerion - Deal Rationale
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,
rising further in 2021*
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 in excess of
67% of Aegerion’s bondholders
*Directors belief based on work undertaken to date
Creating a global player in rare & orphan diseases
3Creating a Global Leader in Rare & Orphan Diseases
• Rare & orphan disease focus with
• Revenue generating rare & a global footprint
orphan drug company
• Two commercial products with
• Strong portfolio of commercial significant growth potential:
& development assets
• Juxtapid (Lojuxta in Europe)
• Lojuxta (Juxtapid in US) in- Creating a - US & RoW 2018 Sales:
licenced by Amryt (Dec 16) in $47.9m
EMEA - 2018 Sales: $16.1m global leader in
rare & orphan • Metreleptin – US, Europe &
• Strong management team with RoW 2018 Sales: $71.4m
unique knowledge of Aegerion diseases
assets • Pipeline opportunities for Myalept
in PL (US) and Juxtapid in FCS*
• Core Epidermolysis Bullosa (US)
(‘EB’) franchise
• Established US infrastructure in
• AP101 - potential mkt. place
opportunity >$1bn
• Strong patent & regulatory
• AP103 - novel gene exclusivity protection
therapy platform
Delivers sustainable revenue, pipeline and market growth
4Transaction Highlights
Amryt has agreed to acquire Aegerion in an all-paper transaction
Pre-money implied transaction equity valuations: Amryt $120m and Aegerion $190.7m
Contingent Value Rights (“CVRs”) will be issued to 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
Amryt plans to raise $60m in equity concurrent with closing of the Transaction and 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
Aegerion’s balance sheet is to be restructured through a US Chapter 11 process prior to Amryt acquiring
Aegerion – Aegerion will continue to operate as usual during the Chapter 11 process
New loan facilities for the combined group will be put in place, and the key terms of such facilities have
been agreed - Amryt’s existing European Investment Bank facility is to be repaid
The combined group’s global HQ will be in Dublin, Ireland with its US HQ in Boston, Massachusetts
Enlarged group to be re-admitted to AIM and Euronext on closing with a planned dual-listing on NASDAQ
Transaction already endorsed by 34.3% of Amryt’s shareholders and in excess of 67% of Aegerion’s
bondholders
5
Significantly accelerates Amryt’s growth trajectoryTransaction Structure
Pre- new Post-new
$m
equity equity
Amryt valuation 120.0 38.6% 31.1%
Aegerion valuation 190.7 61.4% 49.5%
310.7 100%
Pre-money valuation 248.7
(20% discount)
New equity investment 60.0 19.4%
Post-money equity 308.7 100%
New Term Debt 81.9m
New Convertible Debt 125.0m
6
Significantly accelerates Amryt’s growth trajectoryValue Creation
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 NASDAQ listing to drive liquidity and investor reach
Opportunity for corporate restructuring to drive additional value
Delivering superior returns & driving shareholder value
7Amryt Leadership Team
Joseph Wiley – CEO David Allmond – CCO
Founded Amryt in 2015 25 years’ experience in the pharmaceutical industry
20+ years in healthcare and private equity in commercial roles
Opened and led Sofinnova Ventures European office President EMEA at Aegerion Pharmaceuticals
Senior investment roles at Aberdeen Asset Managers, Previously Corporate Vice President of Global
Inventages Venture Capital Marketing for Celgene Corporation
Previously Medical Director at Astellas Pharma
Rory Nealon – COO/CFO Dr Helen Phillips – Head of Medical Affairs
CFO/COO of Trinity Biotech 20+ years in large pharma and small biotech
Oversaw the acquisition and integration of 12 companies companies
in 5 countries Previously European VP of Medical Affairs in
Previously CFO of Conduit plc, an Irish telecoms company Aegerion Pharmaceuticals
Previously associate director within structured finance AIB
Dr Mark Sumeray – CMO Peter McMahon– Head of HR
20 years’ experience in the pharmaceutical, medical 30+ years global HR experience
devices and biotech sectors Previously senior HR positions at GE, Mostek,
Chief Medical Officer at Aegerion Pharmaceuticals Masstock, Best Foods, Bausch & Lomb
Previously VP Cardiovascular Metabolics US Medical and Trinity Biotech
at Bristol-Myers Squibb
Derval O’ Carroll – Head of Regulatory Affairs Kieran Rooney – VP, Strategic Alliances & Licensing
25 years in pharmaceutical regulatory affairs 25+ years in business/corporate development
companies in pharmaceutical and biotech industry
Previously Senior Director of Regulatory Affairs at Previously VP Business Development at Amakem
Retrophin Inc Therapeutics and corporate/management consultant to
11 years consulting experience in regulatory with clients multiple pharma/biotech/professional service companies including PwC
such as Daiichi Sankyo and Shionogi
Stephen Joyce – VP Global Marketing Gerard Gilligan – Manufacturing, Supply Chain
15+ years in the pharmaceutical industry Lead
Held multiple commercial roles, with a large focus on 25+ years on Pharmaceutical Manufacturing & Supply Chain
launch, access and commercial excellence Previously Held various role in Leo Pharma including:
Previously General Manger, Switzerland, Senior Director Area Site, Operations and Manufacturing Lead
Marketing & Market Access at Astellas Pharma Chemistry, Lean/Black Belt
Unique knowledge of Aegerion and its assets
8Amryt + Aegerion - Rich Commercial & Development Pipeline
Product Candidate Indication Preclinical Phase 1 Phase 2 Phase 3 Approved
Myalept/Myalepta GL US/EU
US/EU
Myalepta PL EUEU
Myalept PL US
Juxtapid HoFH (adult) US/LATAM
US/LATAM
Lomitapide FCS US/EU
Lojuxtaq (lomitapide)1 HoFH (adult) EU/MENA
EU/MENA
Lojuxtaq (lomitapide)1 HoFH (paediatrics) EU
9 AP101 EB (DEB/JEB) GLOBAL
AP101 SJS/TEN, Rad. Ind Derm GLOBAL
AP103 EB (RDEB) GLOBAL
AP103 Various/undisclosed GLOBAL Aegerion Joint Amryt
Augments existing pipeline and delivers growth opportunities
9Compelling Equity Story With Significant Upcoming Newsflow
2019 2020 2021 2022 2023 2024
H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2
A B C D E F G H I J K L
A. Metreleptin GL/PL Filing in Other Countries 2019
B. US PL FDA meeting 2019
C. Lojuxta top line PoC data for FCS 2019
D. AP101 top line data 2020
E. AP101 FDA approval 2021
F. AP101 EMA Approval 2021
G. AP101 Launch 2021
H. Lojuxta Phase 3 topline data for FCS 2022
I. Lojuxta EU pediatric approval for HoFH 2022
J. AP103 Clinical PoC data 2023
K. Lojuxta launch in FCS 2023
L. US PL launch 2024
M. Low Leptin NASH and CLD development [TBD]
Building a global leader in rare & orphan diseases
10Amryt + Aegerion - Global Presence
Current markets
Pending markets
Out-licensed
Geographically complementary and providing new market access
11Complementary Fit - Global Commercial Footprint
US GERMANY FRANCE ITALY SPAIN UK TURKEY MENA
++++ +++ +++ ++ +++ ++ ++++ +
+ ++ ++ +++ ++ +++ + ++++
Overlap in combined group brings significant synergies including head office.
Amryt brings additional reach and expertise in MENA, CEE and Russia
12
A perfect fit delivering a stronger combined platform for growthLomitapide - Same Drug / Different Name
Lomitapide is approved
for the treatment of
adults with HoFH
Lojuxta is the brand
name for lomitapide in
Europe
Juxtapid is the brand
name for lomitapide in
the US
Reuniting the global brands
13Lojuxta / Juxtapid
▲Reunifying the global lomitapide brands
▲Lojuxta / Juxtapid
▲ Approved in both Europe (Jul 2013) and the US (Dec 2012) to treat
adults with HoFH
What is HoFH ? ▲ Reduces LDL-C in adult HoFH patients
HoFH is a potentially ▲ Patent protection in US to mid 2027 and 2028 in EU*
life threatening ▲ 2018 Global Revenues: $64m**
disorder that impairs
the body’s ability to
remove LDL ‘bad’ ▲Amryt successfully commercializing Lojuxta in Europe since 2016
cholesterol from the
blood. Typically results ▲Market potential for adult HoFH patients in the US
in extremely high blood
LDL cholesterol levels
leading to aggressive ▲Deploy proven strategy for Lojuxta in Europe to drive Juxtapid
and premature growth in the US
blocking of arterial
blood vessels. ▲ Lifecycle opportunities in pediatric HoFH and Familial
Chylomicronemia Syndrome (‘FCS’)
*SPC Granted in 4 of 5 major markets; pending in UK. **Excluding Japan revenues; including Japan royalties
14
Demonstrable track record in commercializing Lojuxta/JuxtapidLojuxta 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 CAGR
26.7%
– Repositioned product
– Optimized market access - successfully
delivered positive reimbursement in key
markets such as UK and FR
– Broadened geographic reach
* Consensus estimates
Opportunity to replicate this success globally
15Myalept / Myalepta (metreleptin)
Myalept / Myalepta - A Significant Global Opportunity for Growth
What is Lipodystrophy? ▲Myalept / Myalepta
Lipodystrophy is a chronic ▲ Approved in the US (Feb 2014) to treat Generalized Lipodystrophy
condition associated with (‘GL’)
low leptin levels. Leptin is ▲ Approved in Europe (July 2018) to treat both GL and Partial
an important hormone Lipodystrophy (‘PL’)
for energy homeostasis ▲ Treats the complications of leptin deficiency in patients
and metabolic function.
▲ Patent protection in US to mid 2027 and orphan exclusivity in
Low leptin can result in
metabolic chaos typically Europe through 2028
resulting in fatty liver, ▲ 2018 Global Revenues: $71.4m
insatiable hunger,
chronic fatigue, diabetes ▲Recent European launch provides a significant opportunity for
often with severe insulin
resistance, and severe
Amryt to accelerate growth
hypertriglyceridemia
leading to a risk of ▲Strong fit with Amryt’s EMEA infrastructure
pancreatitis. This may
lead to life-altering organ
damage with reduced life
▲Market potential in US and ROW
expectancy in severe
forms. ▲Further growth through potential expansion of label to include PL
in the US
17
Enabling metreleptin to realize its full commercial potentialEpidermolysis Bullosa (EB) Franchise: AP101 & AP103
EB - AP101 - Lead Development Asset
▲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
What is EB ? – delivered Q1 2019
Epidermolysis
Bullosa (EB) is a rare
genetic skin disorder
▲Addressable market estimated at >$1bn*
that leads to
extremely fragile Amryt Proof of Concept Study in EB**
skin, and children
Representative photo series Primary efficacy endpoint
with the disorder are
Which half
often referred to as
epithelialized faster?
‘butterfly children’. AP101 + p < 0.01
There are currently Wound 8
RESULTS
dressing
no approved
Wound 4
treatments for EB.
dressing
0
alone
AP101 Wound Undecided
+ wound dressing
Day 0 7 14 dressing alone
*Management Estimates**Schwieger-Briel A, Dermatology Research and Practice 2017, https://doi.org/10.1155/2017/5068969
19
Strong progress achieved in advancing AP101AP101 - EASE Phase 3 Study in EB
Double blind, randomised, placebo controlled, Phase 3, Efficacy and Safety
Study of AP101 in Patients with EB*
90 day main study phase 2 year open label extension
AP101 + dressing
Randomisation 1:1 AP101 + dressing
(stratified by EB subtype) Placebo + dressing
Visit schedule Day0 D14 D30 D45 D60 D90 M3 M12 M24
Month 0
Primary Endpoint: proportion of target
wounds healed by day 45*
ü Study expected to be fully recruited H2 2019
*Excludes EB Simplex
20
Unblinded interim efficacy analysis delivered Q1 2019AP101 - EASE Timeline
Indication 2017 2018 2019 2020 2021
EB
Topline Data
(AP101)
Phase 3 EB (230 evaluable patients) MAA
CTD EMA approval
FPFV
Pediatric Rare Interim Breakthrough
Disease Efficacy Therapy PRV
Designation Analysis Designation
NDA
USA IND FDA
A approval
CTD
Ad Comm
Follow-up Study
Non-clinical studies
Phase 2b
Milestones Patient studies Non-human studies
Short & medium term value generating clinical milestones
21AP103 - Gene Therapy Platform
▲Novel non-viral gene therapy for EB
▲Platform gene therapy delivery technology using HPAE polymer
▲Benefits:
What is AP103?
– Simple & novel topical application
Exclusively licensed
HPAE Polymer – Strong efficacy seen in pre-clinical models
Technology for use as – Potential immunogenicity benefit vs viral vector products
a novel gene delivery
platform in EB which if – Potentially easier to manufacture than viral vector products
successful, could
eliminate the
▲Initial focus on Recessive Dystrophic EB (RDEB) with potential
requirement for viruses
as delivery vectors –
efficacy for other indications
and could provide a
substantial ▲2018 - $9.6M DTIF grant from Irish Government
competitive advantage
to Amryt. ▲Clinical proof of concept expected by 2023
Building an EB franchise globally
22Control C7 Negative
AP103 - Gene Therapy Platform
Images taken at 20x
Collagen VII Expression -
with a single topical application and increased post
three topical applications
Uptake Pathway of the Polyplexes 1x HPAE-C7 Topically
One Month
3x HPAE-C7 Topically
10 Weeks
Demonstrated efficacy in pre-clinical EB model
23Transaction & Summary
Summary Investment Case
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
Building a global leader in rare & orphan diseases
25Amryt + Aegerion - A Significant Player in Rare & Orphan Diseases
2018A Sales (in $M)
1,208
1,028
265 251
164 137
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Enterprise Value ($)
5.5B 6.0B 2.1B 1.2B 640M c.458M 2.6B 1.7B 2.8B 200M 63M 356M
Source: Capital IQ, Wall Street Equity Research, and Company filings as of 17/05/19
Underpins significant uplift in value for shareholders
26Indicative Transaction Timetable
Announcement of Transaction - 21 May 2019
Publication of Admission Document - Early August 2019
Shareholder Meeting - Late August 2019
Launch of the Equity Fundraise - September 2019
Scheme of Arrangement Completion - September 2019
Closing of Aegerion’s Chapter 11 process - Early Q4 2019
Completion of the Transaction and equity fundraise and re-admission -
Early Q4 2019
27
Building a global leader in rare & orphan diseasesDescription of Transaction - 1
On closing, the implied equity valuations of Amryt and Aegerion will be $120m
and $190.7m respectively.
Amryt stakeholders will also receive a Contingent Value Right (“CVR”) of up to
$85m, in cash or stock, at the election of its board, subject to certain regulatory
approval and commercialization milestones of its late-stage development
product candidate, AP101.
Amryt plans to raise $60m in new equity concurrent with the Transaction
closing at a 20% discount to the implied valuations. Certain Aegerion
bondholders have agreed to backstop this capital raise.
The proceeds from this financing will be used to continue to develop the
combined group’s pipeline, to develop potential new indications for the Amryt
Group’s late stage product candidates, and to be used for general corporate
purposes.
A unique opportunity & transformational for Amryt
28Description of Transaction - 2
Amryt, Aegerion and Aegerion’s key stakeholders have entered into a “Restructuring Support
Agreement” pursuant to which Aegerion will file for Chapter 11 in the United States and seek to
consummate the transaction through a plan of reorganization that has garnered the support of
Aegerion’s key creditors and stakeholders.
Pursuant to the plan of reorganization, upon Bankruptcy Court approval, Amryt will acquire
reorganized Aegerion in exchange for Amryt stock, which stock will be distributed, together with
other consideration in the form of new debt, to certain of Aegerion’s secured and unsecured
creditors, including Aegerion’s convertible bond holders, certain unsecured creditors and
Novelion.
As a result, Aegerion will emerge from Chapter 11 after having discharged substantial pre-
transaction liabilities and with a reorganized and streamlined capital structure that materially
reduces its debt obligations.
To facilitate a smooth entry into Chapter 11, Aegerion has arranged for financing to allow it to
operate uninterrupted during the Chapter 11 process, which financing will be repaid in cash pre-
closing or otherwise exchanged into the new $125m convertible notes referred to below.
Aegerion’s bondholders have agreed to support this transaction and oppose other potential
transactions to acquire Aegerion.
A unique opportunity & transformational for Amryt
29Description of Transaction - 3
$125 million of new 5% convertible notes will be issued. The notes will mature 5.5
years from closing and be convertible into equity of Amryt at a 20% premium to the
implied transaction valuation.
Aegerion’s existing $50 million (in principal) secured loan, held by certain funds
managed by Athyrium Capital Management and Highbridge Capital Management,
as well as Amryt’s existing €20m (in principal) secured loan, will be converted
and/or refinanced into new first-lien secured debt of the Amryt Group, which will
have a cash interest rate of 6.5% per annum and an additional 6.5% PIK interest
rate and will mature 5 years from closing.
In connection with the Transaction, it is proposed that a corporate reorganization
of Amryt will be undertaken by way of a scheme of arrangement, pursuant to
which a new Irish incorporated public company will become the new ultimate
holding company of the combined group.
A unique opportunity & transformational for Amryt
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