powerpoint presentation ir... · • ce marked in 1997, fda approved in august 2015 • only...
TRANSCRIPT
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March 2020
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Forward Looking Statements and Regulatory Advisory
Forward Looking Statements: Certain statements in this presentation are forward-looking statements that are subject to risks and uncertainties
that could cause results to be materially different than expectations. In addition, there is uncertainty about the spread of the COVID-19 virus
and the impact it may have on the Company’s operations, the demand for the Company’s products, global supply chains and economic activity
in general. Important factors that could cause actual results to differ materially include: the advancement of Apollo products; development of
enhancements to Apollo’s existing products and technologies; market acceptance of Apollo’s products; the execution of our gross margin
improvement projects; the ability to collect future payments from ReShape; statements relating to the availability of cash for Apollo's future
operations; and Apollo’s ability to support the adoption of its products and broaden its product portfolio as well as other factors detailed in
Apollo’s periodic reports filed with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December
31, 2019. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo without charge. These forward-
looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo
disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
Product Regulatory Advisory: This presentation is intended for the investment and financial community and not for the promotion of Apollo
products or related procedures. The Apollo Intragastric Balloon products are approved in the US as a weight loss aid for adults suffering from
obesity, with a body mass index (BMI) ≥30 and ≤40 kg/m2, who have tried other weight loss programs, such as following supervised diet,
exercise, and behavior modification programs, but who were unable to lose weight and keep it off. The Overstitch is cleared for the
endoscopic placement of sutures and the approximation of soft tissue in the GI tract The Overstitch clearance does not include procedure-
specific indications for use. Although Apollo has and continues to obtain clinical data on additional uses for its products, the safety and
effectiveness of these uses has not been cleared or approved for commercial purposes by the U.S. Food and Drug Administration.
2
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$0
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
$14,000
1Q162Q163Q164Q161Q172Q173Q174Q171Q182Q183Q184Q181Q192Q193Q194Q19
CONTINUING PRODUCT REVENUE
ESS IGB
Transforming Therapeutic Endoscopy
Products • Endoscopic Suturing Systems
(ESS): OverStitch & OverStitch Sx
• Intragastric Balloon Systems (IGB):
Orbera, BIB, and Orbera365
User • Gastroenterologist
• Bariatric surgeons
Procedures • OverStitch: endolumenal surgeries
for GI tract, primary and revisional
bariatric therapies
• Orbera: interventional weight loss
Apollo Endosurgery Overview
3
CONTINUING PRODUCT
ANNUALIZED CAGR ~16%
ESS ANNUALIZED
CAGR ~38%
IGB product revenue excludes US ORBERA starter kit sales in 2016 and 2017
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Operational Priorities
ESS: Accelerate momentum
in high value endoluminal
procedures
IGB: Leverage data with
consistently >10% TBW
reduction
Drive scale in the operating
model
OverStitch Sx launch
addresses
>90%OF MARKET WITH
SINGLE-CHANNEL
SCOPES
Last two years
>40%CAGR
Increased
diverse utilization
OF ORIGINAL
DUAL-CHANNEL
OVERSTITCH
HANDLE
Strong OUS market
position supports
VOLUME GROWTH
OPPORTUNITY
Increased US clinical
interest and documentation
MEDICAL WEIGHT
LOSS
Growing revenue in
CORE PRODUCT
LINES DRIVE SCALE
Margin improvement projects expected
$3.5M ANNUAL COST REDUCTION
WHEN COMPLETED
4
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OverStitch™
5
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OverStitch™ – How It Works
6
320+ PATENTS and PATENTS PENDING
Load needle with suture Pull tissue into device -
pass needle and
suture through tissue
Grab tissue with helix Repeat as needed.
Drop needle
Deploy cinch to
complete suturing
Pull suture to
approximate tissue
1 2 3 4 5 6
Key intellectual property beyond 2030.
Enables physicians to perform endolumenal procedures that previously could not be
Overstitch has broad current and future applications – upper and lower GI tract
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OverStitch™ – Large Addressable Markets for Endolumenal Surgery
7 * See Product Regulatory Advisory, slide 2
Bariatrics
$4.8BUpper GI
$150MGLOBAL
ADDRESSABLE
MARKET
GLOBAL
ADDRESSABLE
MARKET
• Primary (ESG)
• Revisions • Stent Fixation
• ESD or EMR site closure
• POEM
• Fistula and other defect closure
IN MARKET
Reflux
• Primary
• Altered Anatomies
Lower GI
• Colorectal
IN DEVELOPMENT
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ESS Market
$9,188
$16,481
$23,380
$28,309
$0
$5,000
$10,000
$15,000
$20,000
$25,000
$30,000
2016 2017 2018 2019
• Product innovation that removes capital equipment barriers
• Medical education reach to new users
• Procedure and clinical data development
• Expand OUS footprint and procedure mix
GROWTH DRIVERS
8* See Product Regulatory Advisory, slide 2
** Advanced GI includes: ESD, EMR, POEM, and other defect closure
Advanced GI**
Bariatric Revision
Stent Fixation
ESG
US ESS Revenue OUS ESS Revenue
REVENUE $ MILLIONS PROCEDURE MIX
9%
2%
22%
67%
19%
16%
42%
24%
US OUS
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2%**1%
18%
0%
5%
10%
15%
20%
MULTICENTER STUDY(2) SINGLE CENTER STUDY(3)
SURGICAL BARIATRIC PROCEDURES
Outcomes for Patients – ESG for Primary Obesity1
9
* % TBWL was statistically consistent between the three centers (using three different
techniques and patient population)
** most associated with reducing the fundus, which is no longer part of the standard technique
ESG uses suturing to reduce the volume of the stomach, but without the invasiveness of surgery or removal of part of the stomach
Demonstrates significant weight loss, with low adverse events, and repeatable across various centers
% TOTAL BODY WEIGHT LOSS
AT 24 MONTHS
% SERIOUS ADVERSE EVENTS
AT 24 MONTHS
18.6%*
20.9%
0%
5%
10%
15%
20%
MULTICENTER STUDY(2) SINGLE CENTER STUDY(3)
(1) See Product Regulatory Advisory, Slide 2
(2) Gontrand Lopez-Nava, Reem Z. Sharaiha, Eric J. Vargas, Fateh Bazerbach, Galvao Neto Manoel & Inmaculada Bautista-Castaño, Andres Acosta, Mark D. Topazian, Manpreet S. Mundi, Nikhil Kumta, Michel Kahaleh, Andrea Marie
Herr, Alpana Shukla, Louis Aronne, Christopher J. Gostout , Barham K. Abu Dayyeh ; OBES SURG DOI 10.1007/s11695-017-2693-7, Volume 27, Number 5
(3) Reem Z. Sharaiha, Nikhil A. Kumta, Monica Saumoy, Amit P. Desai, Alex M. Sarkisian, Andrea Benevenuto, Amy Tyberg, Rekha Kumar, Leon Igel, Elizabeth C. Verna, Robert Schwartz, Christina Frissora, Alpana Shukla, Louis J.
Aronne, and Micheal Kahaleh, Clinical Gastroenterology and Hepatology 2017
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OverStitch™ Sx – Expanded Market Reach
Commercial launch in February 2019
• Removes requirement for account to purchase specific endoscopic capital equipment
• Provides an additional working channel for better suction, insufflation, or additional instrumentation
• Improves maneuverability and visualization
ENDOLUMENAL LEAK PRESSURE*
COMPATIBLE SINGLE CHANNEL SCOPES
* Kohei Takizawa, MD, Mary A. Knipschield, Elizabeth Rajan MD; Closure of full thickness defects by endoluminal suturing: leak pressure study in an ex vivo porcine model10
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Orbera®
11
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How Orbera® Works – #1 Gastric Balloon in the World
12
1 2 3 4
INSERTED THROUGH MOUTH INFLATED WITH SALINE ENCOURAGES PORTION
CONTROL AND DELAYS
GASTRIC EMPTYING
DEFLATED AND REMOVED
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IGB Addressable Markets
(1) ASMBS bariatric procedure data published June 2018
(2) American Society of Plastics Surgeons: 2018 National Plastic Surgery Statistics
* See Product Regulatory Advisory, Slide 213
Aesthetic Weight Loss
• 228,000 U.S. bariatric
procedures annually(1)
• 1.8 million U.S.
cosmetic surgical
procedures annually(2)
• Diverse sites for
aesthetic services:
• Plastic surgery centers
• Bariatric clinics
• Endo-bariatric (GI)
clinics
IN MARKET
Medical Weight Loss
• Non-cirrhotic NASH with
fibrosis
• Bridge to Orthopedics or
General Surgery
• Solid Organ
Transplantation
IN DEVELOPMENT
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Orbera® (IGB) Revenue
ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee. Journal of Gastrointestinal Endoscopy. 2015 Sep; Epub 2015 Jul 29. 14
• CE marked in 1997, FDA approved in August 2015
• Only balloon currently meeting ASGE’s threshold standards(1) for safety and efficacy
• More than 230 peer reviewed publications reporting weight loss results consistently >10% TBW
• Completed Orbera FDA Post Approval Study 4Q 2019
$-
$500
$1,000
$1,500
$2,000
$2,500
$3,000
$3,500
$4,000
1Q16 2Q16 3Q16 4Q16 1Q17 2Q17 3Q17 4Q17 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 3Q19 4Q19
US OUS
IGB product revenue excludes US ORBERA starter kit sales in 2016 and 2017
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Medical Relevance of 10% weight loss on Liver Disease
(1) Manuel Romero-Gomez, Shira Zelber-Sagi, Michael Trenell - Treatment of NAFLD with diet, physical activity and exercise; graphic included as modified from Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, Torres-Gonzalez A,
GraOramas B, Gonzalez-Fabian L, et al. Weight loss through lifestyle modification significantly reduces features of nonalcoholic steatohepatitis. Gastroenterology 2015;149:367–378, [Quiz e314–e365].15
% WEIGHT LOSS (WL)
Results over a 52-Week Period
of Lifestyle Intervention (1)
<5%> <7%> <10%>
NASH – Resolution 10% 26% 64% 90%
Fibrosis Regression 45% 38% 50% 81%
Steatosis Improvement 35% 65% 76% 100%
% of Patients Achieving WL 70% 12% 9% 10%But patients experience a
low success rate in meeting
the meaningful weight loss
thresholds
Highest rates of
NASH resolution,
Fibrosis regression,
and reduction in
liver fat occur with
>10% TBWL
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2020 Clinical Data Programs
16
• MERIT RCT Trial for ESG
• AGA Endoscopic Suturing Registry
• European Bariatric Registry
• European GI Registry
• Various Investigator Initiated Studies
• European Post Market Study for Orbera365
• Various Investigator Initiated Studies
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Ongoing Gross Margin Programs
17
Helix
Transfer
complete Q3 2017
Orbera
Delivery system
complete Q3 2018
Suture
Anchor needle production
complete Q3 2017
Cinch
Transfer
complete Q3 2018
* Estimate based on 2018 production volumes; effects will phase in over time following project completion
Suture
Suture anchor assembly
complete Q3 2019
EXPECTED IMPACT OF COMPLETED PROJECTS
$3.25 million per year*
reduction in material and
purchased goods cost
8% improvement in Gross
Margin on Endo-bariatric
products*
FDA approved suture-anchor assembly September 2019 expected to reduce suture cost by ~50%
$2.5 million* additional ESS cost savings
CURRENT PROJECTS
COMPLETED PROJECTS
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Operational Priorities
ESS: Accelerate momentum
in high value endoluminal
procedures
IGB: Leverage data with
consistently >10% TBW
reduction
Drive scale in the operating
model
OverStitch Sx launch
addresses
>90%OF MARKET WITH
SINGLE-CHANNEL
SCOPES
Last two years
>40%CAGR
Increased
diverse utilization
OF ORIGINAL
DUAL-CHANNEL
OVERSTITCH
HANDLE
Strong OUS market
position supports
VOLUME GROWTH
OPPORTUNITY
Increased US clinical
interest and documentation
MEDICAL WEIGHT
LOSS
Growing revenue in
CORE PRODUCT
LINES DRIVE SCALE
Margin improvement projects expected
$3.5M ANNUAL COST REDUCTION
WHEN COMPLETED
18
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Leading Products in Minimally Invasive Therapies
Stefanie Cavanaugh
Chief Financial Officer
Matt Kreps
Darrow Associates Investor Relations