ablynx financial presentation half year results 2014

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Nanobodies ® - Inspired by nature Ablynx Half-Year Results 2014 28 August 2014 Webcast presentation

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Webcast presentation Ablynx financial results for the first six months ending June 2014

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Page 1: Ablynx Financial Presentation Half Year Results 2014

Nanobodies® -

Inspired by nature

Ablynx Half-Year Results 2014

28 August 2014

Webcast presentation

Page 2: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

Participants on the call

2

Dr Dominique Tersago

Chief Medical Officer

Dr Antonin de Fougerolles

Chief Scientific Officer

Dr Edwin Moses

Chief Executive Officer

Wim Ottevaere

Chief Financial Officer

Page 3: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

Forward looking statements

Certain statements, beliefs and opinions in this presentation are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this presentation regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this presentation as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its parent or subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this presentation or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this presentation.

3

Page 4: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

H1 2014 results – agenda

Welcome and introduction

Strong first half of the year

Outlook

Q&A

Conclusion

4

Page 5: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

Significant progress during H1 2014

5

• Clinical proof-of-concept (POC) achieved with anti-

vWF Nanobody, caplacizumab, in patients with

acquired TTP

• Pre-clinical POC achieved and positive Phase I

results from 2 inhalation studies with ALX-0171 (anti-

RSV)

• Initiated bioavailability study with sc formulation of

ALX-0061 (anti-IL-6R)

• Merck Serono completed SAD Phase I study in

healthy volunteers and initiated Phase Ib study in

patients with psoriasis with the anti-IL-17A/F bi-

specific Nanobody (ALX-0761)

• Opt-out option exercised for ALX-0751; Merck Serono

now solely responsible for further development

(Ablynx to receive potential milestones and royalties)

• Development of ALX-0962 (anti-IgE) and BI 1034020

(anti-Abeta) stopped

• Signed major research collaboration and

licensing agreement with Merck & Co in

immuno-oncology with €20M upfront, €10.7M

research funding, up to €1.7bn in milestones

and royalties

• Raised €41.7M through a private placement

of new shares; Fidelity (US) became a >3%

shareholder

• Free float increased to ~90%

• Awarded €2.1M grant from IWT (in August) to

support development of novel Nanobodies for

ocular applications

• Won Transaction of the Year at the 2014

European Mediscience Awards

Partnering & Corporate Product Pipeline

Page 6: Ablynx Financial Presentation Half Year Results 2014

Nanobodies® -

Inspired by nature

Financial performance

Page 7: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

H1 2014 – financial summary

7

H1 2014 (€M) H1 2013 (€M) % change

Revenues 22.2 12.9 72%

R&D income 21.8 12.0 82%

Grants 0.4 0.9 (56%)

Operating expenses (29.8) (23.8) 25%

R&D (24.5) (19.3) 27%

G&A (5.3) (4.5) 18%

Operating result (7.6) (10.9) 30%

Net financial result 1.3 0.4 225%

Net result (6.3) (10.5) 40%

Net operational cash burn (3.9) (21.6) (82%)

Cash at 30th June 196.0 (1) (2) 72.0 (3) (4) 172%

(1) not including proceeds from private placement announced on 30th June 2014 (€41.7M raised) (2) including €2.0M restricted cash (3) including proceeds from private placement announced on 28th February 2013 (€31.5M raised) (4) including €2.3M restricted cash

Page 8: Ablynx Financial Presentation Half Year Results 2014

Nanobodies® -

Inspired by nature

Pipeline update

Page 9: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

Broad pipeline – current status

9

Immunology/

Inflammation

Fu

lly o

wn

ed

Therapeutic area Product name Target

Inflammation/

Immunology/

Infection

Haematology

Oncology

Pulmonology

Discovery

ALX-0061

Pre-clinical Phase I Phase II Phase III

IL-6R

caplacizumab vWF

ALX-0171

Various

Inflammation/

Immunology

Neurology

Various

ozoralizumab TNFα

ALX-0141 RANKL

Pulmonology

ALX-0761

NA

NA

NA

NA

NA

RSV

Co

Co

NA

NA

Various

Various

Various

Various

Fu

lly p

art

nere

d

NA

Oncology/Neurology

Immunology Potential to evolve into at least 4 co-co programmes

Bone disorders in Greater China

IL-17F/IL-17A

Various

Various

Immuno-oncology Various

Validated targets (clinic)

1st in class

Ocular NA

Oncology ALX-0751

Various

Page 10: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

Phase II programmes – caplacizumab

10

June 2014

Anti-vWF (caplacizumab) – bivalent Nanobody – wholly-owned

• Phase II proof-of-concept achieved in patients with acquired TTP

• preparations to start a Phase III study in 2015 initiated

Page 11: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com 11

Caplacizumab – Phase II TITAN design and schedule

Random

isation

Primary endpoint: time to confirmed normalisation of

platelet count

Secondary endpoints: plasma exchange frequency and volume;

relapse; exacerbations; mortality; major clinical

events (stroke, MI, organ dysfunction); recovery

from signs/symptoms.

1:1

PEX

PEX

X caplacizumab

1 year follow-up

1 year follow-up

Inclusion criteria:

subjects with

acquired TTP

requiring plasma

exchange (PEX)

Exclusion criteria:

• severe infection / sepsis

• pregnancy

• bone marrow

transplantation

• disseminated

intravascular

coagulation

• known congenital TTP

Long-term endpoints:

relapse; non focal neurological

symptoms..

Target – 110 subjects

Actual – 75 patients

placebo

30 days

30 days 30 days

30 days

Page 12: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

TITAN primary endpoint

N = 36 N = 39

Overall Hazard Rate Ratio for Caplacizumab vs. Placebo

(95% CI), N = 75 2.197 (1.278, 3.778)

Stratified Log-rank Test p-value 0.013

12

Caplacizumab Placebo

Median days to confirmed platelet response – subjects with

no prior plasma exchange (95% CI)

3.00 (2.74, 3.88)

N = 34

4.92 (3.21, 6.59)

N = 35

25th & 75th percentile 2.72 & 4.31 3.01 & 11.37

Median days to confirmed platelet response – subjects with

one prior plasma exchange (95% CI)

2.44 (1.92, 2.97)

N = 2

4.31 (2.91, 5.68)

N = 4

25th & 75th percentile 1.92 & 2.97 3.37 & 5.23

The group of patients treated with caplacizumab in conjunction with the standard of care

achieved confirmed platelet normalisation at more than twice the rate of the group

receiving the standard of care plus placebo

Page 13: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

TITAN key secondary endpoints

Caplacizumab

N = 36

Placebo

N = 39

Exacerbations up to 30 days after end of daily plasma

exchange for the complete population 3 (8%) 11 (28%)

Complete remission up to 30 days after end of daily plasma

exchange as measured by confirmed platelet response and

absence of exacerbation

29 (81%) 18 (46%)

Proportion of subjects with exacerbation and/or relapse

at 1 month follow-up after study drug treatment was completed 13 (36.1%) 13 (33.3%)

Deaths 0 2

13

These secondary endpoints illustrate the potential protective effect of caplacizumab

treatment in the acute phase of TTP

Page 14: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

Caplacizumab – next steps

Complete full analysis of TITAN study and consult with KOLs and regulatory

authorities

Complete a Phase I trial to demonstrate bioequivalence between the liquid and

lyophilised formulations

Perform market access and pricing study

Continue preparations to start a Phase III study in 2015

Continue to evaluate various partnering and commercialisation options

Potential presentation of complete Phase II data set at ASH conference

(Dec 2014)

14

In 2015, caplacizumab will be the first Nanobody to enter Phase III clinical

development

Page 15: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

anti-IL-6R (ALX-0061) – monovalent half-life extended

• initiated bioavailability Phase I study with subcutaneous formulation

• preparations well underway for Phase II studies in RA and SLE in 2015

Phase I programmes – key events

15

anti-RSV (ALX-0171) – inhaled trivalent

• positive results from 2 Phase I studies in healthy

volunteers and subjects with hyper-reactive airways

• encouraging results from a neonatal lamb model

April 2014 May 2014 July 2014

anti-IL-17A/F (ALX-0761) – bi-specific half-life extended

• Phase I SAD study in healthy volunteers completed by Merck Serono

• Phase Ib study initiated by Merck Serono in patients with psoriasis

anti-Abeta (BI 1034020) – biparatopic half-life extended

• programme stopped by Boehringer Ingelheim

Page 16: Ablynx Financial Presentation Half Year Results 2014

Nanobodies® -

Inspired by nature

Partnerships update

Page 17: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com 17

Broad platform exploitation and cash generation

>€330M in non-dilutive cash received from collaborators to date

~€3Bn in potential future milestones plus royalties

• Global licensing deal with AbbVie for ALX-0061 (anti-IL-6R) in RA and SLE: $175M upfront and

total potential value of $840M plus royalties

• Strategic discovery alliance with Boehringer Ingelheim (8 pre-clinical programmes on-going)

• 4 deals with Merck Serono: 10 programmes (1 Phase I) on-going in inflammation, immunology,

oncology, immuno-oncology, neurology and osteoarthritis

• 2 discovery deals with Merck & Co: ion channel deal in neurology; immune-onco deal with €20M

upfront, €10.7M research funding and total potential milestones of up to €1.7bn plus royalties

• Licensing deal with Eddingpharm in Greater China for ALX-0141 (anti-RANKL) in bone

disorders

• Target based discovery deal with Novartis

Page 18: Ablynx Financial Presentation Half Year Results 2014

Nanobodies® -

Inspired by nature

Outlook

Page 19: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

News flow in 2014

19

• Phase I results from safety

and PK studies with ALX-

0171 (anti-RSV)

• Phase II results caplacizumab

in acquired TTP

• Completion SAD Phase I in

healthy volunteers with ALX-

0761 (Merck Serono)

• Phase I results from s.c.

study with ALX-0061 (anti-IL-

6R)

• Phase I results from bio-

equivalence study with

caplacizumab (anti-vWF)

• Potential additional

collaborative deals

• Continue discussions with

potential partners in a

number of areas

• Start of Phase I study with

s.c. ALX-0061 (anti-IL-6R)

• Start of Phase Ib study with

ALX-0761 in patients with

psoriasis (Merck Serono)

• Start Phase I/II infant study

with ALX-0171 (anti-RSV)

• Start of bio-equivalence

study with caplacizumab

(anti-vWF)

• Preparation to start Phase II

in RA and SLE with ALX-0061

and Phase III with

caplacizumab in 2015

Business

development

Completion of

clinical trials

Start of

clinical trials

3 trial readouts achieved

2 readouts remaining

3 clinical trials initiated

1 clinical trial to be initiated

cash generative

partnerships

Page 20: Ablynx Financial Presentation Half Year Results 2014

www.ablynx.com

Value creation – clinical data expected from patient studies

20

ALX-0061 Phase IIb s.c. (anti-IL-6R) in subjects with RA

Licensed to AbbVie (worldwide)

ALX-0761 Phase Ib (anti-IL-17A/F) in subjects with psoriasis

Licensed to Merck Serono (worldwide)

ALX-0171 Phase I/II (anti-RSV) in infants with an RSV infection

Wholly-owned clinical asset

caplacizumab Phase II (anti-vWF) in subjects with acquired TTP

Wholly-owned clinical asset

caplacizumab Phase III (anti-vWF) in subjects with acquired TTP

Wholly-owned clinical asset

ALX-0171 Phase II (anti-RSV) in infants with an RSV infection

Wholly-owned clinical asset

ALX-0141 Phase I/II results from patient study in China

Licensed to Eddingpharm (Greater China)

Page 21: Ablynx Financial Presentation Half Year Results 2014

Nanobodies® -

Inspired by nature

Q&A

Page 22: Ablynx Financial Presentation Half Year Results 2014

Nanobodies® -

Inspired by nature

Ablynx Half-Year Results 2014

28 August 2014

Webcast presentation