corporate presentation october 2018 - theraclion eng€¦ · the company disclaims any obligation...

34
Corporate Presentation October 2018

Upload: others

Post on 22-May-2020

7 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Corporate PresentationOctober 2018

Page 2: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Disclaimer

• This document is prepared by THERACLION( the “Company”) only for the purpose of this presentation. The information contained in this document is confidentialand may not be reproduced or redistributed, directly or indirectly, to any person, or published, in whole or in part, for any reason, without the consent of theCompany. Neither this document nor any copy of it may be taken, transmitted into or distributed in the United States of America, Canada, Japan or Australia, normay it be distributed or redistributed to a resident of these countries. Non-compliance with these restrictions may result in the violation of legal restrictions ofthe United States of America or of other jurisdictions.

• The Company disclaims any obligation or undertaking to provide any update to this Presentation. The Company disclaims any obligation and liability for theinformation contained in this Presentation or for any use of this information. The information contained in this Presentation has not been subject to independentverification. No representation, warranty or undertaking, express or implied, is made to the readers of this Presentation by the Company. In particular, norepresentation, warranty or undertaking, express or implied, is given regarding the accuracy, completeness or reliability of the information, opinions and forward-looking information included in this Presentation.

• This document contains forward-looking statements and estimates made by the Company, including with respect to the anticipated future performance of theCompany and the market in which it operates. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on variousassumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may notprove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual results, thefinancial condition, performance or achievements of THERACLION, or industry results, may turn out to be materially different from any future results,performance or achievements expressed or implied by such statements, forecasts and estimates. Forward-looking statements, forecasts and estimates only speakas of the date of this forward-looking statement, and no representations are made as to the accuracy or fairness of such forward-looking statements, forecastsand estimates. The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’sexpectations with regard thereto, or any events, or changes in conditions or circumstances on which any such statement, forecast or estimate is based.

• This document does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any shares inthe Company, nor shall any part of it nor the fact of its distribution form part of or be relied on in connection with any contract or investment decision relatingthereto, nor does it constitute a recommendation regarding the securities of the Company. THERACLION’S securities have not been, and will not be, registeredunder the United States Securities Act of 1933, as amended (the “Securities Act”) and may not be offered or sold in the United States absent registration underthe Securities Act or an exemption from registration.

• This document is not intended to provide a complete analysis of the financial, business and prospective position of THERACLION. Other public informationregarding THERACLION, including risk factors, are available on THERACLION’s website (www.theraclion.com) and this document should be read in conjunctiontherewith.

2

Page 3: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Theraclion

3

Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S.

Company overview

Gaining market traction with upcoming catalysts

Echopulse® system – differentiated and proprietary HIFU technology

Large existing market; strong demand for non-invasive approach

Investment profile

Page 4: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Echopulse® and EPack

Echopulse®: Non-invasive HIFU technology

• Alternative to 8 M invasive or minimal invasive surgeries WW each year

• CE marked in 2012; 46 sites as of September 2018 including 7 clinical units

• Recurring revenues from disposables and service

Operations

• WW locations: Frankfurt, Hong Kong, based in Malakoff, France

• JV China with Furui Medical• 24 employees, >50% dedicated to R&D and clinical trials• Over 100 active patents within 20 patent families (on

Echopulse® system and consumable)• Listed on Paris Euronext Growth (ALTHE)

Theraclion

4

Company profile

• First Half ‘18: 371 routine clinical treatments +68% • First Half ‘18 : 45 echotherapy centers: + 41% vs June 17• First Half ‘18 : €0,9M Sales to external clients +61%• German population covered @ 15M X1,4 vs 2016• National French re-imbursement on Breast • U.S. Breast pivotal study enrolling patients 6 sites, 80%• First 5 units sold to JV China• FDA authorized IND on Metastatic Breast Cancer for

combination Echotherapy and Immunotherapy (Pembrolizumab), first inclusions

• Variscose Veins Study completed

Recent achievements

Page 5: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Large New Market : Non & Minimal Invasive TherapyShareholder Value Creation

Oncology

Surgery

Life Savings

Neurology (Tremor, Alzheimer)Benign soft tissue: (BFA, TN)

Cardio & vascular (Peripheral)

Quality of Life

VeinsSkin

Body contour

Aesthetic

Laparoscopic: Laser – RF

Percutaneous: U/S

Drug-combined treatment

Non/mini invasive

Accurate and safe

Outside O.R. / Ambulatory care

Operator independent

Alternative to surgery

Pre- & Post-operation

Technologies

€40B Market by 2030

Access↗ – Cost↘

Light-based aestheticsAcquirer: HologicAmount $1.7B

Cynosure

CoolSculpting System® Acquirer: AllerganAmount $2.5B

ZELTIQ

Non-inv. aestheticAcquirer: Apax PartnersAmount $500M

Syneron

Academic to private office Recent M&A Activity

✓ Non-invasive ✓ Safe and accurate✓ Reproducible: different MDs✓ 20 Peered Review Publications

✓ +/-1400 treatments ✓ 42 Ecotherapy Sites✓ China Joint-Venture & FDA process✓ First Cancer trial on BCa & Immuno✓ First HIFU Veins Treatment

Endo Veinous RFAcquirer: MedtronicsAmount $0.5B

VNUS

Medical AdhesiveAcquirer: MedtronicsAmount $0.25B

Sapheon

Page 6: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Anja KleberVP Marketing, Market access & Sales (Fr)

12 years experience in marketing & market access for Siemens Medical and Accuray

4 years as of Head of Marketing / Market Access for Accuray

IT graduate of the University of Karlsruhe & theses at INSA Lyon

Extensive Experience in Med-Tech and Capital Equipment

David CaumartinChief Executive Officer

14 years of experience with GE Healthcare

Experience of sales, marketing and development of new products in the USA and EMEA at GE Healthcare

Global Head of Mammography at GE Healthcare, VP for M&A Strategy at Alstom

Michel NutaMD, Chief Medical Officer, VP Veins

Endovenous thermal ablation by radiofrequency expert

13 years in VNUS, a West Coast start-up later acquired by Covidien

MD degree and Medical management & marketing Master in ESCP

David AureganChief Financial Officer

16 years of experience in Finance with United Technology, GE Healthcare, Arthur Andersen

5 years as CFO of listed company EFESO Consulting

EDHEC Graduate & MBA from Newcastle Upon Tyne Uni

Management Team: Track Record of Success in Healthcare

Theraclion

Laurence AucoinVP Operations

25 years experience with GE Healthcare

Experience of Service Operations, Manufacturing, OTR and Service Engineering

Biomedical Engineering degree at UTC

(Université de Technologie de Compiègne)

6

Page 7: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

7

Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S.

Large existing market; strong demand for non-invasive approach

Gaining market traction with upcoming catalysts

Echopulse® system – differentiated and proprietary HIFU technology

Company overview

TheraclionInvestment profile

Page 8: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Addressing Large Global Markets

8

Replacing surgery & mini-invasive with non-invasive

1.4M surgeries/y

2.1B healthcare costs/y

<50 M Device Market

1.6M surgeries/y

4B healthcare costs/y

+/-100M Device Market

5M procedures/y

9B healthcare costs/y

>500M Device Market

Breast Fibroadenoma Thryoid nodules Varicose veins

Game changer: Vein already existing $500M Device Market & OOP payments helps rapidmarket penetration

Experience and footprint from BFA & Thyroid to quickly enter vein market

Page 9: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

0

500 000

1 000 000

1 500 000

2 000 000

EMEA USA CHINA ROW

Benign Breast Surgeries

9

Benign Breast and Thyroid indications : CE marked, CFDA & FDA upcoming

Sources : Cooper et al, Thyroid 2009, National Cancer Institute, Globocan, GER&FRA db

Sources : Kaufman et al., American Journal of Surgery, GER&FRA db

0

500 000

1 000 000

1 500 000

2 000 000

EMEA USA CHINA ROW

Thyroid Surgeries

ECHOPULSE®Focus on Where Main Markets Are

0

500 000

1 000 000

1 500 000

2 000 000

EMEA US ROW &CHINA

Vein Treatments: Surgery, Foam, Endovascular w/o spider

Sources : Millenium VV Device Market EU & US

• FDA: 513(f) WIP

• CFDA in process

• EMEA: Direct Sales & Marketing

• CFDA in process

• FDA & CE Filing EoY

• Pre-clinical data available

• Clinical study inclusion completion exp. summer 2018

*EndovascularProcedures

Page 10: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

10

Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S.

Gaining market traction with upcoming catalysts

Company overview

Echopulse® system – differentiated and proprietary HIFU technology

Large existing market; strong demand for non-invasive approach

TheraclionInvestment profile

Page 11: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Breast fibroadenoma

Benign thyroidnodules

Brings HIFU* to Less Intensive Care Sites• Ambulatory setting• No sterile environment required

Compact, Mobile and Less Expensive

Indications Expansion in Cancer & Varicose Veins WIP

11

Non-Invasive Technology Provides Effective Alternative to Surgery and Minimally Invasive Ablative Technologies

Source: Company EstimateNote : (*) High Intensity Focused Ultrasound.

ECHOPULSE®“Surgery without Surgery”

Page 12: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

350

400 – 500

600 – 1,200

1,500

INSIGHTEC

HAIFU

EDAP

Bonemetastases

Liver/PancreasEquipment price (k€)

PHILIPS

SONACARE

THERACLION

Uterinefibroid

ThyroidProstate Breast

✓ ✓

✓ ✓

Ult

raso

un

d-G

uid

ed

Mr-

Gu

ide

d

Maintenance fee (k€)

20

30

60

200

✓✓

ECHOPULSE®Unique HIFU Solution for Thyroid and Breast Indications

12

Source: THERACLION.

Essential Tremor

Veins

Page 13: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Modifiez le style du titreSous-titreEchotherapy vs Hemithyroidectomy

13

HK University publication in Int. Journal of Hyperthermia, Prof. Lang

• 43 patients treated with a single HIFU session• compared with 103 patients with hemithyroidectomy

Results

Material & Methods

• Nodule shrinkage, symptom score, thyroid function evaluated at 6 months• Cost and length of hospital stay• Voice quality assessment

Single-session high intensity focussed ablation (HIFU) versus open cervical hemithyroidectomy for benign thyroid nodule: analysis on early efficacy, safety and voice qualityBrian H. H. LANG; Carlos K. H. WONG; Estella P. M. Ma; International Journal of Hyperthermia; March 2017

Relative to surgery, single HIFU ablation appeared efficacious and safe. This study provides a strong argument for HIFU ablation as a treatment for symptomatic benign thyroid nodule.

Conclusion

At 6 months:

• Nodule shrinkage = 51.71 ± 16.04%

• Significantly lower incidence of subclinical

hypothyroidism

• Significantly higher % of patients experiencing

“significant improvement” (67.4% vs. 38.8%, p=0.009)

• Significantly shorter length of hospital stay and cost

• Significantly better voice quality at one month

(p<0.05)

• No skin burn and no hypothyroidism (FT4<12pmol/L)1/43 vs. 21/103, p=0.008 0.3 vs. 1.0 day, p<0.0001

Page 14: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

PROVIDERS

✓ Attracts new patients

✓ Outpatient day procedure

✓ Simple-to-use

✓ Reduced treatment time versus

traditional surgery

✓ Highly mobile device allows

organizational efficiency

✓ Least expensive HIFU System

✓ Neo adjuvant to surgery

✓ Drug combination capability

PAYORS

✓ No hospitalization costs

✓ No general anesthesia

✓ Avoids post-surgical infections and

complications

✓ Avoids costly hormone

replacement medication

✓ Attractive to employers and

patients: minimal time off work

PATIENTS

✓ One simple outpatient procedure✓ NO general anesthesia✓ NO radiation✓ NO recovery time✓ NO scarring✓ Eliminates:

─ Post-surgical risks of infection─ Difficulty with breast-feeding─ Life-long levothyroxine

• Patient portal; 12k visits/month

http://www.echotherapie.com

14

EchotherapyBenefits All Three Major Stakeholders

Page 15: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

15

Gaining market traction with upcoming catalysts

Company overview

Large existing market; strong demand for non-invasive approach

Echopulse® system – differentiated and proprietary HIFU technology

Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S.

TheraclionInvestment profile

Page 16: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Worldwide Presence as of September 2018

16

S Sales : 28 R Renting : 1 P Pay per use : 10 C Clinical : 7

UK⚫ Harley Street, London ‘15

⚫ The London Endocrine Center ‘16

GERMANY⚫ Marienhospital Bottrop ‘13

⚫ Helios Klinik Schkeuditz ‘14

⚫ Drs. Hakman - Praxis für Nukmed, Paderborn‘15

⚫ BORAD, Bottrop ‘15

⚫ Bürgerhospital, Frankfurt ‘15

⚫ Zentrum für NM & PET/CT Bremen ‘15

⚫ Nukmed Praxis Seeberger, Heilbronn ‘16

⚫ Tübingen University ‘16

⚫ Regiomed Klinikum Coburg ‘16

⚫ University of Frankfurt ‘17

⚫ Sommerda Hospital ’17

⚫ Diagnostikum Berlin ‘18

TURKEY⚫ PENTA, Ankara ‘13

SWITZERLAND⚫ EOC, Bellinzona ’15⚫ Zurich ‘18

BULGARIA⚫ University of Endocrinology of Sofia ‘08

FRANCE⚫ American Hospital of Paris ‘14

⚫ Groupe Hospitalier DCSS, Paris ‘14

⚫ Hopital de la Pitié Salpêtrière, Paris ‘17

⚫ Centre d’imagerie Duroc, Paris ’16

⚫ Edap France, ‘18

SPAIN⚫ Clinica Santa Elena, Madrid ‘15⚫ Dr. Ortiz Remacha , Zaragoza ’17⚫ CMDA, Barcelona ‘18

HONG-KONG

⚫ Queen Mary Hospital University ’15

⚫ Baptiste Hospital ’17

⚫ Hong Kong Sanatorium & Hospital ’17

⚫ Dr CY Lo ‘17

TAIWAN⚫ Dermacare, Taipei ‘15

KOREA⚫ EchoHealthCare, Seoul ‘15

USA

⚫ University of Virginia ‘14⚫ Colombia, NY ‘17⚫ Montefiore, NY ‘17⚫ Bellevue NYU, NY ’17⚫ Focus Ultrasound

Foundaton, Virginia ‘17

ITALY⚫ ASL Livorno, Cecina ‘16⚫ Ospd Regina Apostolorum, Rome ‘16

S

P

C

SS

R

SS

S

S

C

S

S

S

S

SP

P

S

C

P

S

P

S

S

P

ROMANIA⚫ Terramed Bucharest ‘16S

SINGAPORE⚫ SGH ‘16S

Echotherapy 46 sites WW

CCC

S

S

PPP

SRussia

⚫ Moscow ‘17

Poland⚫ Kielce ‘17

⚫ Poland ‘17SS

Austria⚫ St Joseph University of Wien‘18C

S

Asia⚫ Other ‘18S

S

S

P

S

S

Page 17: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Prevalence 54,000,000

China: biggest commercial opportunity BFA & Thyroid

17

$2,5B Market

Sources : (1) Cooper et al, Thyroid 2009, National Cancer Institute, Globocan, bases de données sanitaires France et Allemagne

Sources : Kaufman et al., American Journal of Surgery, bases de données sanitaires France et Allemagne

0

200 000

400 000

600 000

800 000

EMEA USA CHINA ROW

Breast Surgery

EMEA USA CHINA ROW

0

200 000

400 000

600 000

800 000

1 000 000

EMEA USA CHINA ROW

Thyroid Surgery

EMEA USA CHINA ROW

1 275

750630

Top tier hospitals Average ThyroidSurgeries per Year

Average FA Surgeriesper Year

China Tier III hospitals treatments

China Hospital Data Base 2012

Market Access

• Market Access : Clinical trial per indication : 100 patients / single arm / 12 M follow-up

• Existing Regional Reimbursement of HIFU treatments

• Half dozen Chinese HIFU companies (not treating thyroid or breast)

• 5 system shipped CFDA technical tests WIP

Prevalence 1,600,000

Page 18: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

• Investigational Device Exemption – Granted Feb. 2014─ U. of Virginia (UVA) clinical trial for Safety & Efficacy data (recruitment fulfilled 20 patients)

• Single Clinical Trial Required for FDA Submission─ De Novo 513(f)(2) enrollment of 100-patient trial; Multi centre, prospective, single arm

─ 80 treatments completed to date, 6 sites all active since June 2017

─ 4 US sites: UVA, Columbia, Montefiore, Bellevue/NYU, 2 European sites: Sofia, Tubingen

─ Three co-primary endpoints: pain reduction, anxietey reduction, volume reduction

─ 12 months Follow up

• High Incidence In Specific-Patient Population─ Hispanic and Afro-American women: specific risks for Fibroadenoma, often mutli nodule

• RSNA 2017 : Theraclion Ultrasound Guided HIFU PODIUM presentation

• Reimbursement Considerations─ Surgical Medicare reimbursement around $4-5K

─ Hospital costs $8-12K in breast, $20k in thyroid*

─ Hospitals lose money operating on breast

─ Echotherapy cost effectiveness (OR vs. ambulatory)

─ Hogan & Lovell’s Reimbursement Group & Adnito to develop patient access strategy

• U.S. market access & sales set up 2H 2018─ Final results of the study will be available 1H 2019 :

─ 1 year of recruitment, 1 year of follow-up, 6 months to clean data and analyses

Dr. Kathie-Ann JosephBellevue NY

Dr. Sheldon FeldmanNYPH/Columbia

Dr. David BreninUVa/Charlottesville

18

USA Market AccessPreparing the Ground for Successful U.S. Market entry

*Otolaryngology–Head and Neck Surgery (2010) 143, 789-794

Page 19: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

19

Company overview

Large existing market; strong demand for non-invasive approach

Echopulse® system – differentiated and proprietary HIFU technology

Gaining market traction with upcoming catalysts

Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S.

TheraclionInvestment profile

Page 20: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Addressable markets roadmap

20

• Current Market: CE mark + Hong Kong & Singapore TN & BFA• Veins : CE mark submission expected EY 2018 ; USA could be EY 2018 • USA : 513(f) WIP recruitment completion expected 2018• China : JV created 2017, CFDA in progress

Note : (*) Based on the closing price on March 17, 2015 (€10.72).

Market size to increase X10 to X16 times within 24 months

PotentialFDA submissionEY 2018

Page 21: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Varicose Veins: Patient 4Female, refluxing stump + neovascularization after surgery

Important aesthetic improvement at D3 and M3

Before treatment Post-HIFU at D3 at M3

Page 22: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Different Therapeutic Options for Different Vein Topologies

$9B Healthcare Market: $500M Device w HIFU to $2B+ in 10yrs

Great saphenous vein

• 2 - 12 mm in diameter (or more)

• 30-40 cm long, from the groin to the knee

Tributaries (collecting veins)

• Smaller, superficial and more tortuous

• Partially not treated

Perforator veins

• Small veins which link deep and surperf. network

• Can in some case be related to ulcer formation

Telangiectasia

• very small and superficial

22

Stumps at the sapheno-femoral junction

• Appears after treatment of the GSV by stripping or high ligation

• 6-12 mm in diameter (or more)

• 3-6 cm long

Echotherapy potential

Surgical approach Endovenous(thermal, adhesive,

mechanical..)

SclerotherapyLigation or Stripping

Phlebectomy

Telangiectasia Yes

G Saphenous vein Yes Yes limited

Tributaries Yes limited Yes

Perforators Yes Yes Y Yes

Stumps Yes limited

Theraclion – Proprietary information THC902453-B

Page 23: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Example 2

23

Female, refluxing stump + neovascularization after surgery

Before treatment At M3

Stump: no more reflux at M3 Neovascularization: occluded at M3

Ulcer healed at M3.

Stump

Femoral

vein

Neovasc.

Stump Healed ulcer

Neovascularization

Page 24: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

24

Veins Medical Device MarketHIFU $1,4B estimated in 2027

74%

21%

3% 2%

endoscleroChirurgie GSVChirurgie AASVHIFU

16%

8%

1%1%

74%

$500M dominated by minimally invasive

$2Bn dominated by non invasive

2007 2027*

$9B total Heathcare Costs

2,78% CAGR

Device convertion 5% to 17%

2027* : Management estimate

Est. $186M with growingminimally invasive, based on 70MUSD

rev. of VENUS in 2008 and 2,78% annual growthin traditional methods

2017

x 2,7 x 4

62%

30%

4% 4%

Page 25: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Immunotherapy & HIFUMechanims of Action

251: High-Intensity Focused Ultrasound– and Radiation Therapy–Induced Immuno-Modulation: Comparison and Potential Opportunities Roberta Cirincione Al Ultrasound in Medicine and Biology 2017, 43

Immune Checkpoint Inhibitors restore the immune system’s effector capability by disrupting tumor-expressed protection signals

Non respondents have a non immunogenic tumor and/or a lack of effector T-cells in the tumor

Numerous preclinical data show that HIFU can improve anti-cancer immune response1

At the tumor site, combination of cavitation andablation may facilitate the release ofimmunogenic tumor components AND theaccess of effector T-lymphocytes to tumor cells

Page 26: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Therapeutic Indication

26

Clinical Indication

• Breast Cancer - Stage 4 (metastatic) & triplenegative• Future extension to other cancers, esp.Melanoma, Head & Neck,...

FDA authorized A Pilot Study of Focused Ultrasound Combined with Pembrolizumab (Merck) in Metastatic Breast Cancer

- first in the world HIFU + ICI trial -

Therapeutic approach

• Combine HIFU and Immune CheckpointInhibitors to increase the responderpopulation to ICIs

Rationale

• Breast (and other) cancer frequently escape the immune system

• Pre-clinical data show that HIFU has an immuno-modulating action that could potentiate ICIs1

• The combination therapy will potentially enlarge the responder population to such drugs (today

typ. 20-30%, pathology dependent)

1: High-Intensity Focused Ultrasound– and Radiation Therapy–Induced Immuno-Modulation: Comparison and Potential Opportunities Roberta Cirincione Al Ultrasound in Medicine and Biology 2017, 43

Page 27: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

27

HIFU triggers CD8 infiltration in the tumor.

Promising Case – great potential for combination

World Class Immuno Oncology Group

CT.gov NCT03237572 – Patient1

Preliminary Clinical Results – ongoing POC study

PDL1 is up-regulated.Before Pembrolizumab treatment.

Source : Focused Ultrasound Therapy Combined with Pembrolizumab in Metastatic BreastCancer, Patrick Dillon, Bethany J Horton, Timothy Bullock, Christiana Brenin, David R. Brenin,

University of Virginia, Charlottesville, VA, ASCO-SITC, Jan 2018

Page 28: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Market Access Germany (2M)

Additional pathologies for Echopulse®

Regulatory certifications

Singapore

Thailand

Saudi Arabia

2017 2018 2019 2020

TheraclionKey Milestones

28

2016

Russia

Middle East

Taiwan (BFA) USA (BFA)

China (TN)

Germany (15M)France (BFA)UK (BFA)JV China

Germany (20M)

BEAMOTION I

Varicose Veins

New indication

Metastatic Breast Cancer (Phase IIA 15p)

Thyroid Cancer (Treat & Excise 10+10)

Korea China (BFA)

China (TN) China (TN)

USA (BFA)

USA (Thyroid)Taiwan (TN)

Page 29: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Corporate Presentation

29

Development and commercialization strategy – Expanding in Europe and Asia; preparing for U.S.

Gaining market traction with incremental accretive Indications

Echopulse® system – differentiated and proprietary HIFU technology

Large existing market; strong demand for non-invasive approach

Summary

Page 30: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

2018 First Half –Sales Theraclion SAExternal Sales up 61%

30[2] Sales for Theraclion SA, not consolidatiting Theraclion APAC (HK) and Theraclion China Co., Ltd

• 371 treatments in clinical routine1 in 2018 First Half + 68% vs 2017• 45 echotherapy centers: + 41% vs June 17• Completion of recruitment of 35 patients in veins clinical trial

K€ 2018 2017 % vs 2017

Echopulses sales 653 656 +0%

Echopulse rent 72 24 +202%

Consumables sales (a) 70 46 +54%

Service sales (b) 67 28 +142%

Sales Theraclion SA 862 753 +15%

Inc External Sales 680 549 +24%

Inc Sales to Theraclion SA branches 183 204 -11%

Externales Sales from branches 220 11 +1 962%

External sales Theraclion SA +

branches899 559

+61%

(a)+(b) Recurring sales 137 73 +87%

Page 31: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

2018 First Half –P&L Theraclion SAReorganization costs impact M€ 0,5 in H1 to reduce future spending by 20%

31[2] Sales for Theraclion SA, not consolidatiting Theraclion APAC (HK) and Theraclion China Co., Ltd

• Cash in hands at M€ 1.5 on 30th June 2018

In thousands of euros30 June

2018

30 June

2017Var. %

Revenue 862 753 14%

Equipment sales 653 656 0%

Equipment rental 72 24 203%

Consumables 70 46 52%

Services 67 28 139%

Subsidies 4 42 -90%

Other revenues 2 0 NA

Total operating revenue 868 795 9%

External costs 2 571 2 526 2%

Other operating expenses 2 473 2 210 12%

Operating income/(loss) -4 176 -3 940 6%

Net financial items -121 -110 10%

Net non-recurring items -24 -4 505%

Research tax credit 710 652 9%

Net income/(loss) -3 611 -3 402 6%

Average headcount (FTE) 32 35 -9%

Page 32: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Cash as of 30th June 2018

32

• Equity Raise: 0,8 M€ ; Nice & Green starting from June’18 BSAR Equity Financing of 0,3 M€ per month in place • Operations spending: run rate 739 K€ per month (756 in 2016)

Note : (*) Based on the closing price on March 17, 2015 (€10.72).

4900

1452

3544436

804

143818 150

250

1250

2250

3250

4250

5250

6250

7250

Cash at31.12.17

Equity raised Net Sublsidies(including Bpi)

Client Cashcollections

EP purchase Invest JV Spending fromoperations

Cash at30.06.18

En

K€

Page 33: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Shareholding Structure and Share Information

Stock information (September 28th, 2018)

ContactsStock price

Theraclion: David AureganDirecteur FinancierTel.: +33 (0)1 55 48 90 [email protected]

AETHER: Listing SponsorEdouard [email protected]

• Alternext Paris

• Ticker: ALTHE

• ISIN code: FR0010120402

• Stock price: 1,7 €

• Market Cap.: 13 M€

• Sell side coverage:

Shareholder structure (as of May 31st, 2018)

24,42%

15,83%60%

0,12%

Truffle Capital Furui

Public Treasury stock

33

0

1

2

3

4

5

6

Page 34: Corporate Presentation October 2018 - Theraclion ENG€¦ · The Company disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any

Modifiez le style du titreSous-titre

Thank you