Ablynx Guillaume Gerardi Paul Hermant Marion de Jalras

Ablynx Guillaume Gerardi Paul Hermant Marion de Jalras
Laurent Equipart Ablynx Positionnement concurrentiel selon Michael Porter

Pharmaceutiques et Biologiques
This is an independent study performed by students from the Faculté des Sciences Pharmaceutiques et Biologiques de Lille The opinions expressed are our own and not necessarily those of Ablynx

Presentation of Ablynx
Their technology Pipeline & concurrence Partnerships Financial analysis SWOT & Our opinion

Ablynx drug discovery and development company based in Ghent, Belgium
Ablynx is a spin-off of the Flanders Interuniversity Institute for Biotechnology (VIB) and the Vrije Universiteit Brussel (VUB). Ablynx is based on the research of Prof. Dr. R. Hamers, S. Muyldermans and was co-founded and seed-financed (€ 2M) by GIMV and Biotech Fund Flanders in 2001.

Ablynx Engaged in the discovery and development of Nanobodies®
25 projects in the pipeline 5 Nanobodies in clinical development : 4 Phase II & 1 Phase I Two products achieved clinical proof-of-concepts in RA Partnerships with Boehringer Ingelheim, Merck Serono, Novartis and Merck & Co >250 employees

Executive Management Dr. MOSES M. OTTEVAERE Mrs. ALLAN Mrs. HOLT
M. Menrad Chief Scientific Officer Chief Medical Officer Business Officer financial officer Chairman and Chief Executive Officer

Once upon a time… Conscientious students in Brussels in the late 1980s
Discovery of a new form of immunoglobulin

Work on camel antibodies
In the 1980s, several teams tried to miniaturize antibody to get recognition molecules more compact and solid But it is difficult: when we begin to reduce the size of molecules, undermines cohesion between the heavy chain and light chain compounds which are recognition sites. -Too large, complex, weak, difficult to produce in bacteria. -Do not lend themselves to applications in biotechnology -Immune response.  Ideally, to have molecules with antibody specificity, but without their complications Work on camel antibodies

Let’s go to Morocco… It was still necessary to verify that antibodies have an comparable efficacy than their heavier cousins. So they had to work on life camels. The first camel was stolen so researchers asked for help to Cheikh Mohammed bin Rashid Al Maktoum . The supply of blood serum of camelids was assured and discovery of the properties on “Heavy Ig”

Technology Petit rappel sur les anticorps, 2 chaines lourdes = 4 composants, 2 chaines légères = 2 composants, Les 2 parties hypervariables viennent reconnaître l’Ag; en 1993 découverte chez la famille des camilidé la presence Ac qu’avec chaine lourdre, avec ue composante qui permet de fixer l antigène de manièrer très stable, et cette composante consititue les nanobodies = utilisé par ablynx. Histoire sur le chameau

Recognising uncommon or hidden epitopes
Nanobodies recognize variable epitopes and recognised conserved epitopes inacessible to conventional Ab’s. En raison de leur petite taille, les Nanobodies peuvent reconnaître des épitopes rares sur les cibles cachées ou à l'abri des anticorps beaucoup plus conventionnels. Cette reconnaissance peut être associée à une activité biologique améliorée par rapport à des anticorps classiques dans les applications telles que la neutralisation du parasite.

Cavity binding-enzyme and receptors
Due to their unique 3-dimensional structure, Nanobodies have the potential to access cavities within molecular targets such as enzyme active sites and receptor clefts. These cavity structures are largely inaccessible to conventional antibodies but can be readily recognised by a long and protruding CDR3 loop as found in a number of Nanobodies. Importantly, while enzyme and receptor clefts are also binding sites for many small molecule drugs, these drugs typically engage such targets with a low affinity and low selectivity. This can result in unwanted side-effects and lack of potency. In contrast, Nanobodies have the potential to engage cavity structures with the same high affinity and selectivity as typically protein-protein interactions mediated by conventional antibodies. This is expected to yield highly potent molecules and minimise the likelihood of side-effects. Recepteur couplé au proteines g Because of their small size, Nanobodies are able to go places in the body that may be inaccessible to mAbs. For example, Nanobodies are able to act as inhibitors to enzymes through binding with active sites that are too small for mAbs to access. Another reason that Nanobodies can access enzymes is that the CDR3 loops (complementarity determining region 3, the part of the protein that mimics the antigen’s shape) are more flexible and can penetrate more deeply into binding sites. Because of their small size: -Nanobodies are able to act as inhibitors to enzymes through binding with active sites that are too small for mAbs to access. - Nanobodies can access enzymes is that the CDR3 loops are more flexible and can penetrate more deeply into binding sites.

Exceptional drug format
The Nanobody platform allows the ability to design modular drugs based on Nanobody building blocks combined with each other, with other protein domains or with other molecules or drugs. These can combine more than one function in the final drug format. Ablynx has combined Nanobodies in a wide range of formats, including unique multivalent (multiple Nanobodies with identical binding sites for the same antigen), biparatopic (two Nanobodies binding two different epitopes on the same antigen), bispecific (Nanobodies binding to two different antigens) and bi-functional molecules. These formats are easy to construct and the modular proteins can often be expressed at high levels in bacteria or yeast. As a result of this formatting flexibility, the range of therapeutic applications for Nanobodies appears to be beyond that possible for conventional antibodies and antibody fragments. These formats are easy to construct and the modular proteins can often be expressed at high levels in bacteria or yeast. As a result of this formatting flexibility, the range of therapeutic applications for Nanobodies appears to be beyond that possible for conventional antibodies and antibody fragments.

Alternative route of administration
Antibodies can only be administered via injection or SC anobodies are more resistant to extremes of pH and temperature and resist attack by proteases to a greater degree than conventional antibodies. Some Nanobodies have been shown to survive the harsh conditions of the stomach and remain biologically active in the gut. This creates opportunities for orally delivered Nanobodies to treat gastrointestinal disorders including Crohn’s disease and neutralization of viruses causing gastro-enteritis. Robust, high solubility, low tendency to aggregate, resistant to heat, pH, protéases Nanobodies can be administered via injection, pulmonary, intranasal, oral and should be administered via transdermal and ocular

Tailored Half Life Unmodified Nanobodies have a half-life in serum of a few hours  This is ideal for many acute indications but if a longer circulating half-life is required (e.g. for chronic diseases) Nanobodies can be modified to extend their half-life Unmodified Nanobodies have a half-life in serum of a few hours. This is ideal for many acute indications but if a longer circulating half-life is required (e.g. for chronic diseases) then Nanobodies can be modified to extend their half-life using a number of different technologies. Over the past few years we have developed a novel proprietary half-life extension technology called NExpediteTM, to add to our “tool box” of half-life extension technologies, which is based on small (<3kD) peptides specific for human serum albumin. These peptides can be easily fused to Nanobodies and provide another method by which Ablynx can increase the half-life of Nanobodies in serum. NExpedite® = based on small (<3kD) peptides specific for human serum albumin. These peptides can be easily fused to Nanobodies

Beyond antibodies and small molecules

Production To reduce the risk of immunogenicity, Ablynx routinely humanizes its Nanobodies. This is a straightforward procedure because Nanobodies already display relatively high sequence homology to human heavy chain variable domains, typically between 80% and 90% when comparing the framework regions. To reduce the risk of immunogenicity, Ablynx routinely humanizes its Nanobodies

Cheaper, shorter and more resistant
Monoclonal antibodies are produced from mammalian cells Nanobodies are made from micro-organisms (bacteria, yeasts) Nanobodies are robust to changes in temperature and pH Monoclonal antibodies are sensitive and must be used quickly

Their technology Presentation of Ablynx Pipeline & concurrence
Partnerships Financial analysis SWOT & Our opinion

Ablynx’s pipeline

Fully owned Ablynx’s pipeline

Infectiology – RSV Respiratory syncytial virus

Possible risk factor for asthma, wheezing and respiratory failure
RSV ? RNA (10 genes for 11 proteins) Replicates exclusively in the respiratory tract 60% of infants are infected during their first RSV season. Nearly all children will have been infected with the virus by 2–3 years of age. Naissances : US : 4M Fr: 0,8 Jap : 1M100 Bronchiolitis Possible risk factor for asthma, wheezing and respiratory failure US’s RSV season : early autumn to mid-spring Nature Review Drug Discovery - Respiratory syncytial virus market - Shane Storey

Actual RSV therapeutics
Symptomatic Curative Preventive Non proved efficiency on RSV Reducing the number of hospitalizations and duration Hall et al., 2009, ** in the 7 MM, ***Shi et al., 2011 Respiratory

Estimated actual market
Synagis, the only specific preventive therapy of RSV 1,451 billion $ in 2012 Global market for a curative treatment could be worth than 1 billion $ Current researchs focused on Vaccine & Efficient therapy but RSV is a RNA, single-stranded (which is higly variable)  Difficult to develop Vaccine Several targets possibilities Therapy MicroDose Therapeutx - Corporate Fact Sheet - January 2013 Nature Review Drug Discovery - Respiratory syncytial virus market - Shane Storey

ALX-0171 First inhaled Nanobody
F protein inhibitor Potential First in class Large unmet need for RSV-specific treatment & Trivalent Nanobodies A biological nebulised Without significant molecular changes or loss potency Antiviral efficacy proven in cotton rat model Intranasal instillation as mimic for nebulisation

Pre-clinical assets RSV VIRAL PEAK TITRE INFECTION ONSET OF DISEASE
DAY TREATMENT Optimal dose 48 hours after the infection Significantly reduces viral replication in lung in cotton rat model

Human trials Phase I Phase II in process complete and promising &
Less children has been hospitalised Less cost for the society Potential to adress an even market: Elderly and immuno-suppressed patients

Direct concurrence MEDI-557 MDT-637
Complete a P1 study (safety and pharmakokinetic) MEDI-557 A second P1 study is conduce to evaluate safety, tolerability, AEs, … The study is expected to be completed in late 2014. Gilead : Totally fund through Phase IIa and option to assume full responsibility for clinical development MDT : eligible for milestone payments, development fees, and royalties on future sales. MDT-637 No safety issues reported. A Phase II trial was supposed to commence before the end of 2012. Gilead, MDT and MedImmune website & press releases

Potential of ALX-0171 High market (3,6 millions children) but smooth disease Competing firms seem to be ahead on the development of their products “Fight to survive”

Orphan disease – TTP Thrombotic Thrombocytopenic Purpura

Thrombotic Thrombocytopenic Purpura (TTP)
Production of Auto-Ab against ADAMTS13 Orphan disease ( / 106)

Current therapies for TTP
Not any specific therapy Use of immunosuppresive therapies Corticosteroid Rituximab (Rituxan or MabThera)

Estimated potential market of TTP
Not any specific therapy  difficult to estimate the number of patients seeking treatment in a given year 2012 Based on prevalence : ≈11000 patients (USA + UE + JAP) Sur son site, Glenmark donne 2b$ pour le marché du TTP. Et 1b$ de CA pour un developpement d’une nouvelle molécule. USA 313m jap 127m UE 500m If similar to other orphan therapies, Ablynx will be able to charge between $75,000 and $100,000 per treatment. Potential to generate $250 million with only 33% market penetration

Caplacizumab Anti-vWF Nanobody
First in class Bivalent Nanobodies Phase I complete and promising Phase II in process & Challenges of clinical development in acquired TTP MAA: Market autorisation application BLA: biological license application Europe; North-America; Israel; Australia 40 sites participate worldwide Pivotal study for MAA in Europe [Potential launch in 2015] In-house discussion for FDA to BLA

Single dose and multiple dose Subcutaneous (SC)
Clinical trial Phase I Phase Product Population Number of subjects Regimen/dose Status I Anti-wVF Healthy volunteers 36 Single dose and multiple dose Subcutaneous (SC) 2 to 12mg Complete vWF neutralization during the treatment period Daily treatment

Clinical trial Phase II
Exclusion criteria: -Severe infection/sepsis -Pregnancy -Bone Marrow Transplantation -Know congenital TTP Inclusion criteria: Patients with acquired TTP requiring Plasma EXchange (PEX)

Possible concurrence Glenmark Pharmaceuticals But not any actual CT
GBR 600 : Monoclonal antibody “Neutralization” of overactive/over expressed vWF Preclinical studies show good tolerance in baboon But not any actual CT No information in their annual report Did they stop the development of GBR-600? Glenmark website

To conclude on Caplacizumab
« Advantages » of an orphan disease Not any specific treatment Actually, Ablynx seems to be alone on this part of the market.

Rheumatoid arthisis

Rheumatoid arthritis ≈1% of the world’s population & Autoimmune disorder Current opinion in pharmacology ,Volume 1, Issue 3, 1 June 2001, Pages 307–313

First line : MTX ± TNFα inhibitors
Actual therapies First line : MTX ± TNFα inhibitors Small molecules (ex : Sulfasalazine IL1 & TNFα inhibitor) : Generics ++ Humira Adalimumab Biologics : Humira 9,6 enbrel 8,5 remicade 7,7 cimzia 0,6 Simponi 0,95 Cimzia Certolizumab TNFα inhibitors Remicade Infliximab Simponi Golimumab Enbrel etanercept Cours DCEM3

Estimated global market of RA
These 5 drugs : $27 billion in 2012, and the market is expected to continue to grow. Humira : the top selling drug in 2012 : $9.5 billion MTX : 150m$ Suldazalasine : 50m$ Market held by some big pharma companies Very competitive but very lucrative market Cours 4A &

ALX-0061 Pre-clinical Anti-IL6R Bivalent Nanobodies

Phase I -Rapid and dose-proportional decrease of biomarker (CRP)
-Correlation between CRP and improvement of disease activity 3mg/kg is optimal biologically active dose

Phase II

Results of the Phase II Marker of efficacy Other ACR20 100% ACR50 75%
63% No tachyphylaxis No progression All patients continued the study until week 24. Up to 75% of patients in DAS28* remission DAS28: Activité de l’arthrite rhumatoide basé sur la protéine C réactive// >5,1 haute activité de la maladie 3,2<x<5,1 modéré 3,2<x<2,6 faible activité de la RA <2,6 rémission ACR: American college of rheumatology; mesure l’amélioration de la maladie Exemple ACR20: 100% c a d 100% des patients on une amélioration d’au moins 20% de la maladie ILR: Interleukine6 receptor rôle dans le processus inflammatoire

Tocilizumab Actemra in US RoActemra in UE
Direct concurrence Tocilizumab Actemra in US RoActemra in UE FDA : January 2010 EU : January 2009 IL6-R inhibitor : The drug was approved with the support of five Phase III clinical trials. A relative success, but surely a little part of the market Roche website |

Ablynx’s should be prepare to act in a hard fight.
To conclude on ALX-0061 A very competitive market but very lucrative A « new » target An important part to establish efficacy will be to conduct a head-to-head comparison trial with Actemra Ablynx’s should be prepare to act in a hard fight.

Reminder : RA & TNFα

Beneficial to patients and minimize treatment costs.
Ozoralizumab (ATN-103) Treatment of RA Anti-TNFα Nanobody “The anti-TNFα Nanobody, ozoralizumab (ATN-103), reported good 48 week open-label extension data from a worldwide Phase II study in RA patients, which demonstrated that it could have the potential for individualised treatment - a possible new approach in TNFα-targeted therapy.” 48 weeks safety study : important competitive and differentiated position in the TNFα market. Beneficial to patients and minimize treatment costs. Ablynx’s poster : A novel individualised treatment approach […]with RA on a background of MTX & Ablynx annual report 2012

Ozoralizumab ATN-103 Anti-TNFα Nanobody
Trivalent Nanobodies 2% positive for neutralizing Anti-Drug-Antibodies (nADAs) Ablynx regained worldwide rights from Pfizer

ATN-0103 : Phase 2 trial Ablynx’s poster : A novel individualised treatment approach […]with RA on a background of MTX & Ablynx annual report 2012

All these are Anti-TNFα antibodies ≈25 b$ in 2012
Direct concurrence Humira Adalimumab All these are Anti-TNFα antibodies ≈25 b$ in 2012 Remicade Infliximab Simponi Golimumab Enbrel etanercept

To conclude on Ozoralizumab
A very competitive market but very lucrative Already targeted cytokine by highly used Mab Also in competition anti-TNFα small molecule such as sulfazalazine ? Compare Ozoralizumab head-to-head to TNFα inhibitors in trials ? Try to include Ozoralizumab into an already approved therapeutic strategy?

Bone loss

Bone loss Khaler C = Calcium R = Renal failure A = Anemia
B = Bone lesions

Actual therapie for bone loss
Biphosphonate Estrogen Estrogen + Progesterone SERMs PTH Calcitonins Monoclonal Antibodies

Estimated actual market of bone loss
Zometa : cancer Reclast : osteopor Prolia (after prostate ablation) = Xgeva (metastasis) Sur ces 13 molécules : 9b$ en 2012 donc 11-12% de part pour AMGEN et son Desomachin Risedronate : environ 1B$ avec Actonel Atelvia Benet Boniva : Ibandronate = 500M$ (Bondronat : 150m) Fosamax : tout seul

Anti-RANKL Nanobody ALX-0141
Bivalent Nanobodies Pre-clinical models ALX-0141 performed well compared to denosumab

Phase I results Decrease the bone biomarker CTX-1 Well tolerated
No serious adverse events Decrease the bone biomarker CTX-1 CTX-1 is a biomarker for the bone resorption

Controlled vs Denosumab
Phase II Osteoporosis Patients with bone metastases Patients with RA and joint replacement Randomized Controlled vs Denosumab First skeletal event 400 patients WW study (6 years) Open label Progression of metastasis 60 patients EU study (18 months) Open label Join healing stability 20 patients EU study (18 months)

Phase I results ALX-0141 well tolerated and no serious adverse events
CTX is an abbreviation for urinary or serum collagen type 1 cross-linked C-telopeptide (CTX). C-telopeptides cross-links of bone Type I collagen are sensitive markers of bone resorption in osteolytic diseases such as osteoporosis and osteoarthritis. High levels of CTX and NTX indicate excessive bone turnover and is a sign of osteoporosis. Levels of CXT and NT decrease with bisphosphonates therapy. Very low levels may indicate over-aggressive treatment of osteoporosis with bisphosphonates. Women with high serum CTX (T score greater than 2) have a 25% probability of fracture over 5 years. Women with low BMD and high CTX have 54% probability of fracture over 5 years. For a 90% specificity to predict a positive BMD response (+3%), cut-offs, expressed as a percentage decrease from baseline, are as follows: -Urine NTX and urine CTX, -45% to –65% - Serum CTX, -35% to –55% A change of greater than 30% is significant. ALX-0141 well tolerated and no serious adverse events Following a single dose of 1mg/kg Suppression of the bone biomarker CTX-1 at 9 months

With a relatively high success
Direct concurrence Denosumab ; Anti-RANKL antibody As Prolia : June 2010 (post menopausal) AS Xgeva : November 2010 (cancer related) Prolia (after prostate ablation) = Xgeva (metastasis) Sur ces 12 molécules : 8,329b$ en 2012 donc 14% de part pour AMGEN et son Desomachin (donc bon médoc)… With a relatively high success Amgen website & evaluatepharma.com

To conclude on bone loss
A very competitive market A market which interest and held by some big pharma firms So… In 2009, global osteoporosis market was 8 billion $and is expected to reach 11,4 billion $ by 2015 An important part of establishing efficacy will be to conduct a head-to-head comparison trial with Xgeva Ablynx should seek to a new partner for this program

To resume on Ablynx pipeline
Product Disease Target Phase Efficacy Competitive firms Our opinion on this product Caplacizumab TTP vWF 2  Glenmark ?  ALX-0171 RSV F protein 1 MedImmune Gilead Microdose Thx  ALX-0061 RA IL6-R 2 Roche Ozoralizumab TNFα  Abbott J&J Pfizer Amgen  ALX-0141 Bone loss RANKL

To resume on Ablynx pipeline
Product Disease Target Phase Efficacy Competitive firms Our opinion on this product Caplacizumab TTP vWF 2  Glenmark ?  ALX-0061 RA IL6-R 2 Roche Ozoralizumab TNFα  Abbott J&J Pfizer Amgen  ALX-0141 Bone loss RANKL 

Ablynx’s business strategy
to generate revenue through collaborations with large pharmaceutical partners relating to the development of novel Nanobodies To allow the company to manage the risks associated with such programs. In parallel, Ablynx continues to advance its own Nanobody therapeutic programmes with the goal of building a unique proprietary pipeline.

Boehringer Ingelheim Collaborations
The most important for Ablynx : 11 programs January 2007 First collaboration for the development of nanobody therapeutics alzheimer’s disease September 2007 Second agreement : strategic alliance to discover develop and commercialize up to 10 nanobody therapy programs March 2012 The strategic alliance with BI has been extended through September of 2014. More than € 79 million since 2007

Merck Serono Collaboration
co-discovery and co-development partner since September 2008 2008 Two disease targets, one in immunology and one in oncology €10 million ($13 million) upfront payment to Ablynx The first pre-clinical candidate : ALX-0761, the treatment of autoimmune diseases. €1 million ($1.3 million) milestone payment to Ablynx.

Merck Serono Collaboration
2010 New partnership to include Nanobodies against an inflammatory disease target. 2011 Third collaboration agreement : Two targets in osteoarthritis Selection of a second pre-clinical candidate : ALX in oncology 2012

Novartis Collaboration
2008 Collaboration agreement The deal includes R&D payments, licence fees, milestones and royalties. July 2010 license, development and commercialization agreements were signed for two targets €1 million in upfront fees and license payments to Ablynx. contre un certain nombre de cibles(d'objectifs) de maladie pour une gamme de zones(domaines) de maladie incluant les cibles(objectifs) qui sont difficiles d'adresser(aborder) avec des anticorps conventionnels April 2012 TAS266 (anti-Death Receptor 5), entered Phase I clinical development in cancer patients. receipt of a €400,000

€6.5 million upfront payment and a €2 million fee for research funding
Merck and co October 2012 Develop and commercialize Nanobody candidates against a voltage- gated ion channel, with the option to develop Nanobodies against a second non-disclosed target €6.5 million upfront payment and a €2 million fee for research funding Ablynx : discovery of Nanobody candidates Merck : research, development, manufacturing and commercialisation of any Nanobody product resulting from the collaboration. In October 2012, Ablynx entered into a collaboration with Merck & Co., Inc., through a subsidiary, to develop and commercialise Nanobody candidates directed towards a voltage gated ion channel with the option to develop and commercialise a Nanobody to a second target. Under the terms of the agreement, Merck gains exclusive global rights to Nanobodies against the selected target, with an option for similar rights to a second target. Upon signing, Merck will pay Ablynx a €6.5 million upfront payment and a €2 million fee for research funding. In addition, Ablynx will be eligible to receive up to €448 million in research, regulatory and commercial milestone payments associated with the progress of multiple candidates as well as tiered royalties on any products derived from the collaboration. Ablynx will be responsible for the discovery of Nanobody candidates and Merck will be responsible for the research, development, manufacturing and commercialisation of any Nanobody product resulting from the collaboration.

Pfizer November 2006 exclusive research and license agreement announced with Wyeth (acquired by Pfizer in 2009) Pfizer obtained global exclusive rights to develop and commercialise Nanobodies against TNFα November 2011 As reported above, Pfizer demonstrated proof-of-concept for ATN-103, an anti-TNFα Nanobody, in a Phase II study in patients with RA. Ablynx subsequently regained all rights from Pfizer to Nanobodies targeting TNFα, including ATN-103. Ablynx regains worldwide rights from Pfizer to develop and commercialise anti-TNFα Nanobodies

Three-pronged approach to balancing risk and reward
Fully Funded + Milestones and Royalties Co-discovery/Co-development Fully Funded + Milestones and Royalties Co-discovery/ Co-development Wholly-owned clinical assets TNFa (ozoralizumab) – Ph II vWF (caplacizumab) – Ph II IL-6R (ALX-0061) – Ph II RANKL (ALX-0141) – Ph II RSV (ALX-0171) – Ph I Wholly-owned clinical assets with large pharmaceutical partners relating to the development of novel Nanobodies. The Company has pursued three different types of collaboration deals. The first is out-licensing of assets to a partner for development, which was the structure of the 2006 deal in which Ablynx partnered with Wyeth for the development of anti-TNFα Nanobodies. The company is seeking to out-license anti- TNFα and anti-RANKL Nanobodies in this fashion. The second type of collaboration is that in which Ablynx agrees to work with a partner for the co-development of certain Nanobody assets starting at the identification of target stage but in which there is a risk and profit sharing mechanism. The well-established partnerships with Merck Serono fit this model. The third type of collaboration Ablynx has pursued also start very early at the target stage but are fully-funded partnerships, which also include milestone payments plus royalties. The Company’s relationships with Novartis and Boehringer Ingelheim fall into the third model. These collaborations have so far yielded a total of 18 clinical development candidates and have provided more than €160 million ($208 million) in revenue for the Company. €160M in non-dilutive cash from collaborators received to date and 18 Nanobody candidates selected

Future collaboration ? Ablynx and Spirogen
25 Février 2013 Ablynx and Spirogen collaboration to evaluate the potential of novel toxin-Nanobody drug conjugates in cancer Spirogen's proprietary cytotoxic drugs, pyrrolobenzodiazepines (PBD) Nanobodies generated using Ablynx’s proprietary technology platform

Balance sheet overview
Structure financière d’une biotech classique Ressources suffisantes pour couvrir leur bien courant Peu de bien stable, logique dans une biotech mm s’ils investissent dans le mobilier

BFR & FRNG Fond de roulement élevé : bien ; bcp de sous, investissement, peu de frais fixes. BFR négatif ; signifie que le cycle d’exploitation induit des ressources précédant les emplois FRNG = equity attribuable – non current assets BFR = FRNG – tréso ( cash + cash equivalent restrict + cash + short time investissement ) Structure parfaite pour une biotech Peu de BFR à part les employés à payer, pas grand chose en frais fixes + investissements sur le long terme (achat de machine, etc...) Plus de RFR ( a determiner) FRNG >0 car : a) Capitaux / b) Actifs stables / c) Tréso positive WCR & GNWC : Working capital requirement et Global Net Working Capital

Les revenues diminuent en 2011 alors que les dépenses augmentent encore et toujours.
On remrque que les principales entrées et sorties sont concentrées sur la R&D ce qui est logique pour une biotech….

LoY & YeC Perte de l’année en constante augmentation alors que la trésorerie diminue. Si ça continue ainsi on peut estimer que d’ici environ 2 ans ils n’auront plus suffisamment de trésorerie pour financer leur activité

Put on sale of new shares
NYSE euronext End of the collaboration with Pfizer NYSE euronext est un groupe mondial d’entreprise de marché financier (assure la gestiond’1 ou plusieurs marché financier) Regroupement en 2007 entre New york stock exchange et Euronext (Paris, amsterdam, bruxelle, lisbonne) Avec animation rend bien. Petite histoire avec l’euronext bien expliqué sur wikipedia. 48 millions of shares Put on sale of new shares 48M x 7,20 = 284,680,000 x 2/3 = 230,400,000€

Their technology Presentation of Ablynx Pipeline & concurrence
Partnerships Financial analysis SWOT & Our opinion

- S - - W - - O - - T - Technology > Mab Low cost
Wide range of therapeutic’s target New way of administration for biologics Financial power (partnerships) P1 trial : Good results - W - Pharmacokinetics difficulties Proprietary pipeline No P2 trials fully finished Financially dependent There making economies on R&D research - O - New markets opened 2 products potentially first-in-class New ways of administrations - T - Pharmacokinetic unpredictable Lack of experience with these kind of products (AE, Immunogenicity,…) Loss of partnerships (ex: Pfizer) Loss of Patent ! Too much explored areas

Our opinion

Merci de votre attention
Guillaume Gerardi Paul Hermant Marion de Jalras Laurent Equipart

Ablynx Guillaume Gerardi Paul Hermant Marion de Jalras

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