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Nanobodies ® creating better medicines Webcast presentation 24 August 2017 2017 Half Year Results

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Page 1: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

Nanobodies®

creating better medicines

Webcast presentation – 24 August 2017

2017 Half Year Results

Page 2: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Ablynx 2017 half year results presentation

Participants on the call

Dr Robert K. Zeldin

CMO

Dr Edwin Moses

CEO

Wim Ottevaere

CFO

Page 3: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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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 including, without limitation, the

timing for completion of certain milestones in our agreements and the amount of any milestone payments

we may receive, our expected net cash burn, the progress of our key pre-clinical and clinical development

programmes, the timing of the commercialization of, and the estimated market potential and projected

peak sales for, our product candidates, the anticipated duration of the patent protection we receive for our

product candidates, and our ability to create value from the development and commercialisation of our

product candidates. 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: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Ablynx 2017 half year results presentation

Agenda

• Welcome and introduction

• Financial highlights

• Operational performance

• Outlook

• Q&A

• Conclusion

Page 5: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

Financial highlights

Half Year results 2017

Page 6: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Financial summary

Half year results 2017

€ million HY 2017 HY 2016 Change

Revenue 34.7 53.1 35%

Grant income - 0.4 100%

Total revenue and grant income 34.7 53.5 35%

R&D expenses (50.5) (49.0) 3%

G&A expenses (8.9) (6.5) 37%

Operating result (24.8) (2.0) > 100%

Financial income 3.1 28.4 89%

Financial expenses (3.7) (3.5) 6%

Profit/(loss) for the period (25.3) 22.8 > 100%

Net cash flow (30.9) (19.0) (1) 62%

Cash (4) at 30 June 204.5 (2) 288.7 (3) 29%

(1) excluding €71.4 million net proceeds from the private placement of new shares (1 June 2016)

(2) including €1.6 million in restricted cash

(3) including €1.3 million in restricted cash

(4) cash, cash equivalents, restricted cash and other financial assets at the end of the period

Following the initiation of the collaboration with Sanofi, and a review of the timing of other

milestone payments, net cash burn guidance for full year 2017 is lowered to €65-75 million

Page 7: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

Product pipeline

Important progress in key pre-clinical and clinical development

programmes

Page 8: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Broad product pipeline

>45 programmes, 7 Nanobodies® in clinical development

IndicationProduct Target

aTTP

RSV

vobarilizumab

Pre-clinical Phase I Phase II Phase III

caplacizumab vWF

ALX-0171

ALX-0141 RANKL

ALX-0761/M1095

RSV

Bone disorders Greater China

IL-17A/IL-17F

ozoralizumab TNFα

Greater China

Filing

Japan

RA

SLE

RA

Psoriasis

Immuno-Oncology

>20 wholly-owned and partnered programmes

Up to 17

programmes

IL-6R

IL-6R

TNFαRA

Various

Oncology VEGF/Ang2BI 836880

Chronic kidney

diseaseCX3CR1BI 655088

Filing in EU based on Phase II TITAN data

Phase III data

late Q3 2017

SLE Phase II

data H1 2018

Catalysts

+

ALX-1141/M6495 Osteoarthritis

Up to 8

programmesVariousImmuno-Inflammation

ADAMTS-5

Phase IIb

data H2 2018

Page 9: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Caplacizumab – anti-vWF Nanobody

First-in-class potential for the treatment of aTTP

• Estimated annual market potential ~€800M1

• Feb 2017: filed in Europe for approval

• Jul 2017: received Fast Track designation from the FDA

• Phase III HERCULES topline results expected in late Q3 2017

• Phase I results in Japanese healthy volunteers expected in Q4 2017

• 2018: anticipated first launch in Europe and BLA submission in USA

• 2019: anticipated launch in USA

• Forecast peak sales of >€400M1

• Ablynx expected to lead commercialisation in USA, Canada and

Europe

• Orphan Drug Status (EU/USA) – Patent protection up to 2035

aTTP: acquired thrombotic thrombocytopenic purpura

1 USA, Canada, Europe and Japan

Page 10: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Caplacizumab in aTTP

Phase III HERCULES and follow-up study on track

• 145 patients with aTTP recruited in just 20 months

• Last patient completed the HERCULES study in August

• Topline results expected in late Q3 2017

• >80% roll-over of eligible HERCULES patients into the 3-year follow-up study

Phase III topline data:

primary endpoint: time to confirmed platelet count normalisation

key secondary endpoints: composite efficacy endpoint; recurrence of aTTP during

study period; refractory aTTP; time to normalisation of organ damage markers

safety: summary of all (serious) adverse events

Page 11: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Caplacizumab in aTTP

Preparations for launch

• Medical Science Liasons (MSLs) already in place in Germany, France and the

UK – additional recruitment ongoing

• Multiple presentations and publications at both the international and national

level

• Numerous interactions with national bodies to enable rapid availability of

caplacizumab to patients

• Launch of Ablynx sponsored TTP website – UnderstandingTTP.com

• Selection of key service partners

Page 12: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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ALX-0171 – inhaled anti-RSV Nanobody

Potential breakthrough for the treatment of RSV infections

• Multi-billion dollar market

• No widely used therapeutic available

• ALX-0171 – administered by inhalation

• Infants – Phase IIb RESPIRE study: – started in January 2017

– first 3 safety cohorts complete (36 infants) – positive DMC

recommendation

– parallel dose part initiated (144 infants)

– results anticipated in H2 2018

• Adults – preparations underway to file for regulatory

approval to start clinical development in RSV-infected

haematopoietic stem cell transplant patients

• Patent protection up to 2037

RSV: respiratory syncytial virus; DMC: Data Monitoring Committee

Page 13: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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ALX-0171 development plan

Key potential near term milestones

2017 2018

Phase IIb – ongoing hospitalised infants with RSV (N=180)

topline results

Phase II in Japanhospitalised infants with RSV

Phase IIRSV-infected haematopoietic

stem cell transplant patients

CTN

IND / CTA

CTN: Clinical Trial Notification; IND: Investigational New Drug; CTA: Clinical Trial Application

Page 14: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Vobarilizumab – anti-IL-6R Nanobody

Potential novel treatment for RA and SLE

• Opportunity in multi-billion dollar markets

• RA:– very encouraging results from two Phase IIb RA studies

(N=~600)

– open-label extension study ongoing

• SLE– chronic multi-system inflammatory disease with large unmet

medical need

– Phase II study ongoing (N=~300); topline data in H1 2018

• We will wait for the SLE data and AbbVie’s opt-in

decision before deciding on our future strategy

RA: rheumatoid arthritis; SLE: systemic lupus erythematosus

Page 15: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Vobarilizumab in SLE

* complement score omitted due to mechanism of action of vobarilizumab

Phase II STEADY study on trackR

AN

DO

MIS

AT

ION

1:1:1:1:1

Placebo

ALX-0061 dose 1, Q4W

312 subjects

ALX-0061 dose 2, Q4W

ALX-0061 dose 2, Q2W

ALX-0061 dose 3, Q2W

Primary endpoint at Week 24:

modified (m)BICLA* response

Secondary endpoints:

(m)BICLA, (m)SRI, (m)SLEDAI-2K

and BILAG over time; patient’s and

physician’s global assessment; flare

rate; corticosteroid reduction

Other assessments:

pharmacokinetics,

pharmacodynamics,

safety/tolerability, immunogenicity

• Subjects with moderate-to-severe active, seropositive SLE

• Worldwide, randomised, double-blind, placebo-controlled 48 week dose-range finding

study

• Patient recruitment completed in December 2016; topline data expected in H1 2018

Page 16: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Vobarilizumab in SLE

Rationale for approach

Ball et al., Lupus 2013; Tackey et al., Lupus 2004; Mao et al., Clin Rheumatol. 2014; Wallace et al., Ann Rheum Dis 2017; Illei et al., Arthritis &

Rheumatism 2010

• IL-6 levels are elevated in patients with SLE

• Inhibition or knock-out of IL-6R in pre-clinical models had a strong impact on the

SLE phenotype

• Clinical studies targeting both IL-6 and IL-6R have shown encouraging

preliminary efficacy data in SLE, though safety appears to have presented

problems

• We have been able to learn from previous studies in designing the STEADY

trial, particularly with regard to enrollment criteria

• Vobarilizumab has shown in the RA studies that it targets IL-6R effectively and

has a favourable safety profile

Page 17: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

Strategic partnerships

>€450M cash received and >€10Bn in potential milestones

plus royalties

Page 18: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Strategic collaboration with Sanofi

*GBI research Dec 2015

Up to 8 programmes initially focused on immuno-inflammatory diseases

• Deal signed in July 2017

• Up to 8 different targets or target combinations

• €23M upfront payment received plus research funding

• Potential additional option exercise fees

• Up to €2.4Bn in potential future milestones plus royalties

+

Initial focus on immune-mediated inflammatory diseases

• Chronic disorders characterised by dysregulation of immune pathways

• Associated with significant morbidity, mortality and reduced quality of life

• Growing need for novel treatments to modify disease state

• Affect 5–7% of western populations*

• Market expected to grow to $74Bn in 2022*

IBD

RA

Psoriasis

COPD

Lupus

asthma

Page 19: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Strategic partnerships

Progress year-to-date

• Co-discovery and co-development collaboration signed in November 2011

‒ €20M upfront and €15M milestone payments received so far

• Progress year-to-date

Merck KGaA accepted the pre-clinical package prepared by Ablynx for an anti-

ADAMTS-5 Nanobody in osteoarthritis in May 2017, triggering a €15M milestone

payment

• Merck KGaA plans to start the single ascending dose part of the Phase I

study in healthy volunteers in H2 2017

• Co-discovery and co-development collaboration signed in September

2008

‒ €10M upfront and €4.5M milestone payments received so far

• Progress year-to-date

Encouraging Phase Ib data with anti-IL-17A/F bi-specific Nanobody in patients with

moderate to severe psoriasis reported

• Merck KGaA partnered with Avillion to advance a potential Phase II study

Page 20: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Strategic partnerships

Progress year-to-date

• Immuno-oncology collaboration signed in 2014 and expanded in 2015

‒ includes up to 17 programmes with a focus on multi-specific combinations

‒ €33M upfront and €6M milestone payments received to date

‒ currently ~40 FTEs fully funded at Ablynx

‒ up to €5.7Bn in potential future milestones plus royalties

• Progress year-to-date

Merck & Co., Inc., started an IND-enabling toxicology study with a bi-specific

Nanobody, triggering a €2.5M milestone payment

Merck & Co., Inc., completed a second in-vivo proof-of-concept study with a mono-

specific Nanobody

• Potential start of first clinical study in H1 2018

Page 21: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

Outlook

Potential value enhancing events

Page 22: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

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Outlook

Focus on sustainable value creation

• HERCULES Phase III data anticipated to be available in late Q3 2017

• Results from Phase I with caplacizumab in Japanese healthy volunteers planned

in Q4 2017

• Preparations for commercialisation of caplacizumab ongoing

• In Q4 2017, we expect to file for regulatory approvals

– to start a trial with ALX-0171 in Japanese infants infected with RSV

– to study the use of ALX-0171 in adults who have undergone a stem cell transplant and

have become infected with RSV

• The STEADY trial with vobarilizumab in SLE will report data in H1 2018

• The RESPIRE trial with ALX-0171 in RSV infected infants should report data in H2 2018

• Cash burn for full year 2017 is now forecast to be €65-75 million

Page 23: 2017 Half Year Results - Ablynx Ablynx 2017 half year results presentation Participants on the call Dr Robert K. Zeldin CMO Dr Edwin Moses CEO Wim Ottevaere CFO

CONTACT DETAILS

Questions

+32 9 262 00 00Investor

Relations

investors@

ablynx.comwww.ablynx.com