Urology Business Marc Jablonowski Area Managers‘ Meeting Q1 2015.

Urology Business

Marc Jablonowski

Area Managers‘ Meeting Q1 2015

Urology Business: Overview

1. An Interesting Market!?2. Our Position in the Market!?3. Lecture Dr. Gutierrez / Q&A 4. ATOMS – Success Stories from Australia5. Support Tools / Business Development

Degree of incontinence following RP

Incontinence after Prostate Surgery(German figures 2014)

75.000 prostate surgeries for BPH | 3% 23.000 rad. prostatectomies | 10%

Annual incidence:3% * 75.000 = 2.25010 % * 23.000 = 2.300

Annual market volume: 4.550

BPH = benign prostatic hyperplasia

4

Artificial Sphincters in Germany

800-900 AMS 800 150 Zephyr ZSI 375

Artificial sphincters: app. 20% of the market

5

France

1100-1200 AUS p.a. in France

6

Market Size in Europe

7

Europe: 500 mln. Inhabitants

8

Marktsize EuropeRegion / Country Inhabitants Implants / mln.

capitaImplant market

Germany 81.000.000 54.9 4450

Austria 8.500.000 41.2 350

Eurozone 335.000.000 25-35 8.375 to 11.725

EU 507.000.000 25-35 12.675 to 17.745

9

>10.000 implantsper year

€ 3000/implant >30 mln. EUR market volume

Is it an interesting market?

An Interesting Market?Boston Scientific‘s Answer is „YES“

A Positive Change in the MarketBoston Scientific acquires a part of AMS

They had a problem!

4.9%7.3%

The Time Plays for A.M.I6 Months of Uncertainty for AMS

The Time Plays for A.M.I6 Months of Uncertainty for AMS

250 employees ???

“Based in Minnetonka, Minn., the AMS Men's Health and Prostate Health businesses include approximately 800 employees worldwide, and generated 2014 sales of approximately $400 million”

March 2, 2015

UncertaintyBoston Scientific / AMS

Employees:– Who will stay in which part of AMS?– Stay in Endo: divestiture expected– Go to Boston Scientific: „Who is synergy?“– Re-organization

Customers:– Who is my future contact?– Which products might be discontinued

(especially female slings and POP)?– What about innovations?

What about Research – Product Innovations?AMS: One Research Center Two Companies

Research and DevelopmentWe are committed to developing new products and improving our current products to provide physicians and patients with better clinical outcomes through less invasive and more efficiently delivered therapies. Most of our research and development activities are conducted in our Minnesota and California facilities, although we also work with physicians, research hospitals, and universities around the world. Many of the ideas for new and improved products come from a global network of leading physicians who also work with us in evaluating new concepts and in conducting clinical trials to gain regulatory approvals. We conduct applied research in areas that we think will likely lead to product commercialization activities.

The Impact on Boston Scientific is Small

Division „Urology and Women‘s Health“ will move up to #4 in sales out of 7 divisions.

The acquisition will increase Boston Scientific turnover by 5-6%

No major impact on Boston Scientific

Is it an interesting market for you?

Overview

1. An Interesting Market!?2. Our Position in the Market!?3. Lecture Dr. Gutierrez / Q&A 4. ATOMS – Success Stories from Australia5. Support Tools / Business Development

Our Position in the Market

Just ask yourself what market share(*) ATOMS should have in your own market?

(*) ATOMS market share among all incontinence implants in your country.

What is the market size?How many ATOMS implants should be sold in your market?

Please write it down for you.

Overview

1. An Interesting Market!?2. Our Position in the Market!?3. Lecture Dr. Gutierrez / Q&A 4. ATOMS – Success Stories from Australia5. Support Tools / Business Development

Overview

1. An Interesting Market!?2. Our Position in the Market!?3. Lecture Dr. Gutierrez / Q&A 4. ATOMS – Success Stories from Australia5. Support Tools / Business Development

Overview

1. An Interesting Market!?2. Our Position in the Market!?3. Lecture Dr. Gutierrez / Q&A 4. ATOMS – Success Stories from Australia5. Support Tools / Business Development

Lecture Dr. MuehlstedtUniversity of Halle, Germany

ATOMS Lecture: University of Halle, Germany

ATOMS 4 Years Data

4 Years Data with ATOMS

53 patients Pre-operative 24 pad Test: 660 ml Irradiated patients: 37% Previous failed therapies:21%

(AMS 800, Argus, AdVance, …)

Success rate: 77% (< 25 ml in 24h)

incl. 49% dry

ATOMS in Comparison with …

MEDICAL TREATMENT SITUATION FOR

MALE URINARY INCONTINENCE IN

GERMANY

German English

HOW ARE MEN MEDICALLY TREATED IN

GERMANY AND WHAT IS THE OUTCOME?

German English

PERFORMED THERAPY

German English

FIRST RESULTS – COMPLICATIONS

German English

FIRST RESULTS - CONTINENCE

FIRST RESULTS – AMS 800 (N=73)

German English

Pads / day

FIRST RESULTS – ADVANCE (N=20)

German English

Pads / day

FIRST RESULTS – ADVANCE XP (N=63)

German English

Pads / day

FIRST RESULTS – ATOMS (N=39)

German English

Pads / day

FIRST RESULTS – ARGUS (N=20)

German English

Pads / day

POST-OPERATIVE PAIN

perineal

inguinal

German English

Very low pain scales for all implants at

max. FU

How Does the Data Compare?

68%

no. 1ATOMS

64%

Argus

52%

AMS 800

49%

AdVanceXP

35%

AdVance

Press Release & Lecture Translated

http://www.pressebox.com/pressrelease/ami-gmbh-agency-for-medical-innovations/ATOMS-4-Years-Results/boxid/731272

Have you heard about …

Male incontinence surgery with an implant

92.3% of patients using zero pads(completely dry – not even a safety pad)

7.7% of patients using only one pad„Following surgery, one patient who previously required two pads was able to use a single pad, which he did not wet each day; he expressed satisfaction with the operation.“

The Germans did well …

… but the Spanish did better

First experience with the ATOMS® implant, a new treatment option for male urinary incontinence

Study size: 13 patients Follow-up: 16 months Pre-OP: 14.4% failed prior incontinence implants

7.7% irradiatedall mild incontinence

Peri-OP surgery time: 86 min.1 hematoma (resolved conservatively)1 retention (resolved, catheter 1 week)3 postoperative perineal–scrotal dysesthesias, resolved spontaneously

Post-OP at max FU 3 patients needed 1 adjustment (2ml)92.3 % completely dry (0 pads)7.7% 1 safety pad

First experience with the ATOMS® implant, a new treatment option for male urinary incontinence

DISCUSSIONAstorbieta et al., in a series of 22 patients, observed full continence or improvement in 90% of the cases [10]. In our study, 92.4% of the patients were fully continent after implantation of this system – this percentage is greater than the figures reported in the aforementioned series. This may be because we only use the ATOMS adjustable implant in patients with mild to moderate UI, not in individuals with severe incontinence.We consider the adjustable systems to be the best option for patients with mild to moderate incontinence. However, considering the difficulties found in divulgating and consolidating widespread use of the Pro Act system, the new ATOMS device – which is based on the same concept since it is adjustable and allows passive continence control with no patient skill of any kind at micturition – might prove accessible to most urologists, since the surgical technique is easy and reproducible.

CONCLUSIONSThe ATOMS adjustable implant offers very good results in treating mild to moderate UI in males. The device is passive and safe, and the implantation technique is easily reproducible. We consider that the implantation of an artificial sphincter in patients of this kind could be disproportionate, considering the degree of incontinence and the cost involved.

Rising EvidenceStudy # Patients

Follow-upPre-OP- irradiated- other failed implants- urine loss

Post-OPSuccess

Comment

Seweryn et al., 2012 38 patients16.9 months [13-21]

radiation: 44.7%failed inc. therapy: 28.9 %6.78 pads/day 747 ml in 24h pad test

success: 84.2%60.5 % dry1.36 pads/day115 ml in 24h pad test

patients following external radiation equal to other patients

Primus, Hoda et al., 2012

99 patients17.8 months [12-33]

rad: 31.3%failed inc. therapy: 34.3 %7.1 pads/day 681 ml in 24h pad test

success: 92%63 % dry1.3 pads/day79.8 ml in 24h pad test

European multi-center

Hoda et al, 2012 124 patients19.1 months [12-36]

rad: 34.5%failed inc. therapy: 36.3 %8.8 pads/day 725 ml in 24h pad test

success: 93,8%61,6 % dry1.8 pads/day

stable results over a period of 3 years, German language

Krause et al., 2014 36 patients30 months [9-52]

rad: 47.2%failed inc. therapy: 30.6 %8.33 pads/day

38.9 % dry (0 or 1 pad)2.77 pads/day30.6 % explantations, therefore many late infections (why ?)

open-access journal,no peer-review, not on PubMed

Gonzalez et al., 2014 13 patients16 months [4-32]

radiation: 7.2 %failed inc. therapy: 14.4 %1.7 pads/day

success: 100%completely dry (0 pads): 92.3%1 pad/day: 7.7%

excellent results for mild incontinence, only 3 patients required 1 adjustment

Muehlstaedt et al., 2015

53 patients26,5 months [3-57]

rad: 37.2%failed inc. therapy: 21 %7.9 pads/day 660 ml in 24h pad test

success: 77 %49 % dry

published in German magazine, no peer-review, not on PubMed

FIRST RESULTS - CONTINENCE

PERFORMED THERAPY

EAU & Competition

AMIAMS

Promedon

Neomedic

ZSI

Bosten Sci.

Coloplast

Bard

Competition

AMS: – Divestiture Prostate Healt end of Q3 to Boston

Scientific– Female Business (slings, POP mesh) unresolved /

laws.

Promedon– Product recall– Customers say: all implants had to be explanted– Cushion ruptures / infections

Competition

Neomedic ZSI

Coloplast

Phorbas

Markets may be partly destroyed for Promedon– Germany– Austria– NL

When will it come back?

Will it come back? … or: what kind of product will come back?

The Two Biggest Competitors are in Trouble

A.M.I. will most likely NEVER again have such a window of opportunity:

– #1 AMS: • Struggling with implants (product recall)• Mesh lawsuits• Company for sale Boston Scientific

– #2 Promedon:• Struggling with implants (product recall)

Coming back to the question

What market share(*) should ATOMS have in your own market?

(*) ATOMS market share among all incontinence implants in your country.

What is the market size?How many ATOMS implants should be sold in your market?

Please lift the appropriate card.

Thank you!