36th jp morgan annual healthcare conference - btg plc · pdf file4 sustained value creation...
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January 2018
36th JP Morgan Annual Healthcare Conference
2Not all products and/or indications are available in all territories. For prescribing information, safety information, and/or product information, go to: btg-im.com | crofab.com | digifab.us | ekoscorp.com | galilmedical.com |
lemtrada.com | pneumrx.com | therasphere.com | varithena.com | vistogard.com | voraxaze.com | zytiga.com
Forward-looking statements
This presentation and information communicated verbally to you may contain certain projections and other
forward-looking statements with respect to the financial condition, results of operations, businesses and prospects
of BTG plc (“BTG”). These statements are based on current expectations and involve risk and uncertainty because
they relate to events and depend upon circumstances that may or may not occur in the future. There are a number
of factors which could cause actual results or developments to differ materially from those expressed or implied by
these forward-looking statements. Any of the assumptions underlying these forward-looking statements could
prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not
actually be achieved. Nothing contained in this presentation or communicated verbally should be construed as a
profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any
forward-looking statements contained herein. BTG undertakes no obligation to update or revise (publicly or
otherwise) any forward-looking statement, whether as a result of new information, future events or other
circumstances. Neither this presentation nor any verbal communication shall constitute an invitation or
inducement to any person to subscribe for or otherwise acquire securities in BTG.© 2017 BTG International Ltd. All rights reserved. “See More, Reach Further, Treat Smarter” and “Imagine where we can go.” are trademarks of BTG International Ltd. BTG and the BTG roundel logo are trademarks
and/or registered trademarks of BTG International Ltd. Bead Block, DC Bead, DC BeadM1, DC Bead LUMI, LC Bead, LC BeadM1, LC Bead LUMI, LUMI and Simplicit90Y are trademarks and/or registered trademarks
of Biocompatibles UK Ltd. EKOS is a trademark and/or registered trademark of EKOS Corporation. GALIL is a trademark and/or registered trademark of Galil Medical Ltd. PneumRx is a trademark and/or registered
trademark of PneumRx, Inc. TheraSphere is a trademark and/or registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd. Varithena is a trademark and/or registered trademark of
Provensis Ltd. CroFab and DigiFab are trademarks and/or registered trademarks of BTG International Inc. Vistogard is a trademark and/or registered trademark of Wellstat Therapeutics Corporation. Voraxaze is a
trademark and/or registered trademark of Protherics Medicines Development Ltd. SnakeBite911 is a trademark and/or registered trademark of Protherics UK Ltd. Lemtrada is a trademark and/or registered trademark
of Genzyme Corporation. Zytiga is a trademark and/or registered trademark of Johnson & Johnson. Biocompatibles UK Ltd, EKOS Corporation, Galil Medical Ltd, PneumRx, Inc., Protherics Medicines Development
Ltd, Protherics UK Ltd and Provensis Ltd are all BTG International group companies
3 1 At 2 January 2018 using £1:$1.36
BTG is building leadership positions in specialist areas of medicine. Our differentiated Interventional
Medicine products are used in the treatment of cancer, severe emphysema and vascular disorders, and
our Pharmaceutical products help patients who are overexposed to certain medications or toxins.
BTG overview
Profile
• FTSE 250 company
(LSE: BTG)
• Market cap ~$3.9bn1
• Employees ~1,500
• Global business
Diversified portfolio
• Leading-edge oncology,
vascular, pulmonology
therapies
• Investing ~$130m
annually in R&D
Strong financials
• +32% 5 year product
sales CAGR
• +12% 5 year adjusted
EPS CAGR
• ~$300m cash at 9/30/17,
no debt
4
Sustained value creation through leadership in Interventional Medicine therapies
Building leadership
positions in attractive
markets
• Changing healthcare landscape favors IM therapies
• Focusing on underpenetrated markets with unmet needs
• Building our business on customer understanding
Investing to deliver sustained
value creation
Scalable business
delivering a strong
financial performance
• Built a strong portfolio, capabilities and infrastructure
• Targeting sustained double-digit product sales growth
• Strong free cash flow available for investment
Investing for sustained
shareholder value
creation
• Expanding pipeline through organic development and acquisitions
• Providing data and services to increase procedures, patient flow
• Extending sales into key global markets
5
Investing to deliver sustained growth and shareholder value
$Strong
free
cash
flow
Double-digit product
sales growth
Investments across multiple
drivers of growth
Innovation &
Development
Commercial
M&A
6
Differentiated therapies in underpenetrated markets
Therapy Indications Annual patients* Current number of
procedures p.a.*
Liver and
kidney tumours
Severe
blood clots
Severe
emphysema
Symptomatic
varicose veins
c. 25,000 with
BTG products
c. 150,000
c. 900 with
PneumRx® Coils
c. 700k
below the
knee
*Company estimates†US only
Ea
rly S
tag
eH
igh
Gro
wthc. 325,000
c. 2-3m
> 4m
c. 2.5m†
c. 800k
GSV
7
Interventional Medicine is an expanding field
Pulmonology
Neurology
Cardiology
Oncology
Peripheral/
Vascular
“At Memorial Sloan-Kettering in the past decade the number
of IRs has gone from approximately 8 to 20, we now have 13
dedicated IR suites compared with 4. We are adding an
additional 3 rooms in 2019 and will probably be at 22
faculty. Our volume has increased to over 15,000 annual
cases.”Stephen Solomon, MD
Minimally invasive therapies enable you to deliver more
quality care, less invasively, so you can:
i. Reduce the per capita cost of care
ii. Minimise risk to patient
iii. Improve health outcomes
iv. Improve the patient care experience
Royal College of Radiologists
SIR membership +60% since 2008/9, with >360% growth in
member-in-training categories
8
The benefits of minimally invasive therapies are evident
vs.
9
Interventional Radiologists (IRs):
• Apply technology to give better patient
outcomes
• Are hungry for more procedures
• Need data to drive adoption of our offering
– Products
– Procedures
– Patients
Building our business on customer understanding
10
A portfolio of leading-edge therapies
Schematic. Not to scale.
An
nu
al sa
les
Interventional Medicine
Early
StageHigh
GrowthEstablished
Varithena®
Injectable
microfoam
clinically proven
to reduce the
symptoms and
improve the
appearance of
varicose veins
PneumRx®
Coils
Shape-memory
metal coils
clinically proven
to improve
quality of life,
lung function and
exercise capacity
of patients with
severe
emphysema
Interventional
Vascular
Ultrasonic catheter
drug delivery device
used in the
treatment of severe
blood clots
Anchoring catheters
and microcatheters
offering options for
physicians in the
crossing of complex
lesions and arterial
blockages
Interventional
Oncology
Embolic, drug-
eluting beads and
radioactive
microspheres to
treat tumours in the
liver
Cryoablation
needles to treat
tumours in the
kidney
Pharmaceuticals
Acute care antidote
products offering
medication for
patients with little or
no other treatment
options
Licensing
Royalties relating to
products subject to
BTG intellectual
property and
licence agreements
Establishing new therapies Sustainable businesses Cash generation
11
A differentiated, multi-modality customer offering in Interventional Oncology
Open surgery
“remove it”
Systemic Interventional
Controlled destruction of tumour
while sparing healthy tissue
External Beam
Radiation
“irradiate it”
Targeted local delivery of
radiation
Ability to tailor dose to individual
tumour
Chemotherapy
“poison it”
Dual action embolisation and
targeted drug delivery
Ability to see precise location of
beads
12
• Insoluble radioactive glass microspheres for the treatment of liver tumors
• Microspheres deliver a high-dose of radiation using yttrium-90 via the hepatic artery into the
tumor
• Microspheres are trapped in the tumour capillaries where they emit beta radiation
• Very high concentration of radioactivity per sphere
(50x greater than direct competitor)
• Differentiated product:
– Simplicit90Y™ dosimetry software cleared
– βETA™ Radiation Safety Programme launched
– Flexible 90Y product with a range of doses that can be tailored
to each patient
TheraSphere®
13
Indication Trial description Detail End-points Timing (CY)
Hepatocellular Carcinoma Patients randomised (1:1) to
TheraSphere® followed by
sorafenib vs. sorafenib
Global Phase III trial; 520 Patients
Multicentre (up to 100 sites in N.
America, EU and Asia)
ClinicalTrials.gov ref: NCT01556490
Primary: Overall Survival (OS)
Secondary: TTP, TTUP, TTSP,
Tumor Response, QoL, Safety
2019
Metastatic Colorectal Carcinoma Patients randomised (1:1) to
TheraSphere® + 2nd line
chemo vs. 2nd line chemo
Global Phase III trial; 420 (actual 280)
Multicentre (up to 100 sites in US,
Canada, EU, Asia)
ClinicalTrials.gov ref: NCT01483027
Primary: PFS & HPFS
Secondary: OS, TTSP,
Disease Control Rate, QoL,
Safety
2019
Dosimetry in HCC
Retrospective evaluation of
dosimetry in TheraSphere®
using Simplicit90Y™ software
Global trial; up to 300 Patients
Multicentre in N. America, EU and Asia
Primary: correlation between
dose and adverse events
Secondary: Tumor absorbed
dose, safety, OR, OS
2019
Expanding the label for TheraSphere®
14
Pre-treatment imaging
The injection of Contrast Media makes the tumor
appear brighter than the normal liver
Treatment with radiopaque bead LUMI™
24-hour post-treatment imaging
The radiopaque beads indicate the proper deposition
of the device in the tumor
Case from Dr. Dominic Yee - Presbyterian St. Lukes - Denver, Colorado
15
• Market leader in cryoablation of kidney cancer
• Ongoing studies in lung and bone metastases
• Investing to accelerate product innovation
– Ablation centre of excellence for BTG
– Several new products in the pipeline
• Systems and needle improvements
• Other ablation modalities
Going outside the liver: Galil Medical
=
16
Significant clinical development to expand use of cryoablation
Indication Trial description Detail End-points Timing (CY)
Bone metastases Single arm study to assess
efficacy of cryoablation for
palliation of painful
metastases
65 Patients; multicentre (11 sites);
ClinicalTrials.gov ref: NCT02511678
Primary: Difference in worst
pain
Secondary: Responders,
QoL, physical function,
change in analgesic use,
reduction in pain, and safety
2018
Lung metastases Single arm study to assess
safety and efficacy of
cryoablation in patients
with pulmonary metastatic
disease (tumors ≤ 3.5cm)
130 Patients/ 226 tumours, multicentre
(10 sites);
ClinicalTrials.gov ref: NCT01957787
Primary: Tumor control
Secondary: OS, TTP, QoL,
safety
2018
with 2-year
follow-up
Lung metastases Single arm study to assess
safety and efficacy of
cryoablation in patients
with pulmonary metastatic
disease (tumors ≤ 3.5cm)
Pilot Study, 40 Patients/60 tumours,
multicentre (4 sites);
ClinicalTrials.gov ref: NCT01307501
Primary: Tumor control
Secondary: OS, TTP, Safety
2018
with 5-year
follow-up
17
IO2: exploring the combination of interventional oncology and immuno-oncology to fight cancer
Society of Interventional Oncology Partnership
• Funded independent research grants with 4 leading institutions to support research
evaluating immune stimulation with our LRT
• More grants to be awarded in early 2018
Investigator Initiated Study (IIS) Programme
• Exploring the immune response with radioembolisation, chemoembolisation and
cryoablation in a broad range of tumor types
• NCT03203837 – Dr. Robert Lewandowski, Northwestern, Biomarker Analyses in
Hepatocellular Carcinoma Patients Treated with TheraSphere®
• NCT03035331 – Dr. Yi Lin, Mayo Clinic, Cryosurgery, cell therapy and pembrolizumab in
treating patients with Non-Hodgkins Lymphoma
Collaborative Research Partnerships
• Conducting basic research to optimise use of LRT in combination with immunotherapy
• Forging strategic alliances with companies to offer BTG IM expertise and be at the
forefront of therapeutic breakthrough
18
A unique method of action: EKOS® Acoustic Pulse Thrombolysis™
Features• 5.4 Fr catheter
• 106 and 135 cm
working length• 6, 12, 18, 24, 30,
40 and 50 cm treatment zones
Intelligent Drug Delivery
Catheter
Ultrasound Core Device
Fibrin withoutUltrasound
Fibrin With Ultrasound
Acoustic Streaming Drives Lytic into clot
19
Indication Trial description Detail End-points Timing (CY)
Pulmonary Embolism Retrospective and prospective
international EKOS® registry of
the treatment and clinical
outcomes of patients with PE
Multicentre in N. America (up to 75
sites), EMEA (25 sites), Asia (3sites)
1000 retrospective; 500 prospective
Primary: to understand the APT treatment
protocol used as standard-of-care and
document changes in practice
following the OPTALYSE PE results;
to describe the effects of varied APT
protocols on long-term
patient outcomes
Initial data:
Retrospective
2018
Prospective
2020
Chronic DVT / Post-thrombotic
Syndrome
Evaluate the safety and efficacy of
endovascular recanalisation,
including Acoustic Pulse
Thrombolysis®
In patients with chronic DVT
suffering from PTS
Multicentre in N. America (22 sites)
73 patients / 77 limbs
ClinicalTrials.gov ref: NCT02159521
Primary: reduction in Villalta score at 30
days: 35.5% reduction
Secondary: major bleeds within 72 hours:
1 bleed
Initial data 2017
2 year follow-up
Pulmonary Embolism To determine the optimum
duration and dose of r-tPA using
EKOS thrombolysis; patients
randomixed to 4 treatment arms
Multicentre in N. America (16 sites)
100 patients
ClinicalTrials.gov ref: NCT02396758
Primary: improvement in RV/LV ration
over 48 hours: 23%-26%
Secondary: major bleeds within 72 hours:
3 bleeds across 2 arms, 0 in 2 arms
Initial data 2017
2 year follow-up
Pulmonary Embolism Prospective single-arm study
evaluating ultrasound-facilitated,
low-dose fibrinolysis for acute
massive and submassive PE
Multicentre in N. America (22 sites)
150 patients
ClinicalTrials.gov ref: NCT01513759
Primary: improvement in RV/LV ratio
ours: 25% reduction
Secondary: frequency of major bleeds
within 72 hours: no intracranial
hemorrhages
2014
KNOCOUT
Investing in data to drive more patients & procedures
20
Roxwood complements the existing EKOS business
Primary strategy
Wire Escalation
$100-$200 / wire
Existing secondary strategy
CTO Crossing Device
$2,000-$3,000 / device + capital
costs to power each device
$1,200
Bridging the gap between two existing treatment
options for occlusion crossing, enabling our
customers to do more procedures
21
Reduces air trapping and hyperinflation in the
lungs of advanced emphysema patients
The PneumRx® Coil improves:
• Shortness of Breath
• Lung Function
• Quality of Life
The PneumRx® Coil is the only minimally invasive, non-surgical option for all severe emphysema patients
Fig. x-ray after bilateral Coil implantation
22
PneumRx® CoilProgress and Growth Drivers
• US PMA review progressing
– Targeting 2018 approval and
launch
• EU medical education
programme established
• Initiating ELEVATE study
– Prospective study to confirm
patient responder profile
Recent progress
• Potential US approval and launch
• EU reimbursement progress
• Adoption of patient selection
criteria
• Quantitative CT service roll-out to
support treatment planning
• ELEVATE study outcome will
support therapy adoption and
reimbursement
Growth drivers
23
Varithena®: a patient-centric treatment for symptomatic varicose veinsDedicated reimbursement codes from January 2018
% of US procedures by segmentPayment
Levels
Varithena®:
Microfoam Ablation$1,660.66*
Sclerotherapy: PCF $106.53
Stab phlebectomy $730.97*
Mechanical Ablation $1,524.55
Radiofrequency Ablation $1,523.83
Laser Ablation $1,220.07
Glue $2,138.18
Commercial impact of new codes is expected to be clearer by the end of 2018
* Average of single and multiple vein payment
Below The Knee / Tributaries
47% approx. 700k
PCF, Stab phlebectomy
GSV / Truncal
53% approx. 800k
Ablation, Glue
24
Multiple investment opportunities in Interventional Medicine therapies
Smart access
Local delivery
Enhanced safety
Value for money
Precision medicine
Patient friendly
Radiation
Embolisation
Ablation
Coil and foam technology
Enhanced drug delivery
Liver
Kidney
Lung
Bone
Neuro
Vascular
Prostate
Pain
BTG
Interventional
Medicine
Themes
Existing and
potential therapy
area targets
Technology
platforms
25
Pipeline building: R&D pipeline accelerators
Novel IV products
Immuno-oncologyExplore how BTG products synergise in combination with I-O agents
Forge strategic alliances with companies to offer BTG IM expertise
Beads /
TheraSphere®
Expanding our product range; explore indications beyond HCC and mCRC
Integrated offerings to simplify procedures and improve outcomes
AblationIndication expansion to lung and bone metastases
Product development for surgical specialties
New therapy area:
Bone
Explore opportunities to develop to an integrated bone solution
Build on data in bone metastases with spinal data and pain endpoints
Roxwood Medical acquisition to provide specialty catheters
Move towards tougher obstructions and smaller vessels
Product development in the COPD space
Long term oncology and vascular adjacencies identified
Expanding lung
expertise
26
PharmaceuticalsLife-saving therapies delivering sustained cash flows
Acute Care • SnakeBite911™ app continues to drive greater physician and patient
interactions with >7,500 downloads
• Copperhead study published in the Annals of Emergency Medicine
Oncology • Voraxaze® included in the 2017 Expert Consensus Guidelines
contained within the Annals of Emergency Medicine
27
Delivering a strong financial performance
1 2012/13 excludes non-recurring product revenue2 Adjusted EPS is not prepared in accordance with IFRS. Further detail on the adjustments to IFRS financial measures is included in the interim results announcement published on 14 November 2017.
0
60
120
180
240
300
360
420
2012/13 2013/14 2014/15 2015/16 2016/17
(£m
)
Product sales: 32% CAGR1
0
5
10
15
20
25
2012/13 2013/14 2014/15 2015/16 2016/17
(GB
p)
Adjusted EPS2: 12% CAGR
Targeting sustainable double-digit product sales growth
28
Sustained value creation through leadership in Interventional Medicine therapies
Delivering strong financial performance
Scalable platform delivering growth
Excellent strategic position
Well placed to achieve additional growth through investment in organic development
and M&A
29
Appendix
30
Double-digit product sales and adjusted operating profit growth
1 Constant exchange rate (“CER”) growth is computed by restating 2017/18 results using 2016/17 foreign exchange rates for the relevant period.2 Further detail on the adjustments to IFRS financial measures is included in the interim results announcement. 30
H1 17/18 (£m) H1 16/17 (£m) Growth Growth at
CER1
Product Sales 239.7 193.2 +24% +17%
Licensing 101.6 92.2 +10% +4%
Revenues 341.3 285.4 +20% +13%
Adjusted Operating Profit2 99.1 78.8 +26% +15%
Adjusted Operating Profit Margin 29% 28% +1ppts
Adjusted Basic EPS2 21.0p 13.9p +51%
Free Cash Flow2 75.2 55.7 +35%
31
Strong product sales growth driven by IO, IV and Pharmaceuticals
31
H1 17/18
(£m)
Growth at CER Drivers of H1 17/18 performance
High Growth
Interventional Oncology (IO) 76.6 +15%Strong TheraSphere® performance and expansion of GALIL™
cryotherapy
Interventional Vascular (IV) 35.4 +18% Continued US penetration of EKOS® products
Early Stage
PneumRx® Coils 4.0 (23%) Fewer procedures in Germany
Varithena® 2.8 +57% Continued progress ahead of finalised CPT codes
Total IM 118.8 +15%
Pharmaceuticals 120.9 +20%High bite season for CroFab®, with good DigiFab® growth and
increased oncology sales
Product Sales 239.7 +17%
32
Licensing royalties benefit from good Zytiga® performance and Lemtrada™ back-royalties
32
H1 17/18
(£m)
H1 16/17
(£m)
Growth Growth
at CER
Zytiga® 71.0 65.8 +8% +3%
Lemtrada™ 21.6 17.0 +27% +17%
Other royalties 9.0 9.4 (4%) (10%)
Licensing 101.6 92.2 +10% +4%
• Lemtrada™ royalties ceased in H1 17/18 due to licence expiration, with final back-royalties
of £11m included in the half
• Continued good contribution from Zytiga®, with a strong last quarter
– No generic entrant expected in the US before October 2018
– No generic entrant expected in Europe before September 2021
33
• Investment in IM commercial capabilities ahead of anticipated growth
• Spec Pharma continues to provide strong financial underpin
• Contribution from Licensing to gradually decline as royalties drop off
Revenue mix reflected in H1 margins
33
All £m Interventional
Medicine
Pharmaceuticals Licensing Total
Revenues 118.8 120.9 101.6 341.3
Adjusted gross profit1 83.9 106.4 46.9 237.2
Gross margin 71% 88% 46% 69%
Adjusted SG&A1 63.2 16.9 13.1 93.2
Contribution1 20.7 89.5 33.8 144.0
Contribution margin 17% 74% 33% 42%
R&D 46.1
Adjusted operating profit1,2 99.1
Operating margin 29%
1 Further detail on the adjustments to IFRS financial measures is included in the interim results announcement.2 Includes £1.2m from FX and other operating income.
34
Adjusted to IFRS earnings H1 17/18
34
+72%
Growth
>100%
Growth
Adjusted
EPS
21.0p
IFRS
EPS
13.8p(3.7)(8.5) (0.9) 6.9 (1.0)-
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