24 August 2017

ABLYNX ANNOUNCES 2017 HALF YEAR RESULTS AND YEAR-TO-DATE BUSINESS UPDATE

 

Important progress in key programmes and a strategic collaboration with Sanofi

Conference call and webcast today at 4pm CET/10am ET

GHENT, Belgium, 24 August 2017 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its financial results for the six-month period ending 30 June 2017, which have been prepared in accordance with IAS 34 "Interim Financial Reporting" as adopted by the European Union, a business update for the year-to-date and the outlook for the remainder of the year.

Business highlights for the year-to-date

  • Caplacizumab - wholly-owned first-in-class anti-vWF Nanobody® for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP)
  • submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA)
  • completed recruitment of 145 patients in the Phase III HERCULES study, with topline results expected in late Q3 2017
  • received Fast Track designation for aTTP from the U.S. Food and Drug Administration (FDA)
  • ALX-0171 - wholly-owned inhaled anti-RSV Nanobody
  • completed the sequential dose escalation part of the Phase IIb RESPIRE study in 36 infants hospitalised as a result of a respiratory syncytial virus (RSV) infection and subsequently initiated the parallel dose part, with topline results expected in H2 2018
  • Vobarilizumab - anti-IL-6R Nanobody
  • held "end-of-Phase II" meetings with regulators in Europe and the USA to discuss the Phase IIb data in rheumatoid arthritis (RA) and the design of a potential Phase III programme
  • advanced the Phase II study in patients with systemic lupus erythematosus (SLE), with enrollment completed and topline results expected in H1 2018
  • after discussions with AbbVie and other potential pharmaceutical partners, decided to await the results of the SLE study, and the outcome of AbbVie's opt-in decision, before deciding on the future strategy for vobarilizumab
  • Partnerships
  • entered into a strategic research collaboration with Sanofi on up to eight new programmes, focused initially on immune-mediated inflammatory diseases, with €23 million in upfront payments and up to €2.4 billion in potential milestones plus tiered royalties
  • reported encouraging results with the bi-specific anti-IL17-A/F Nanobody in a Phase Ib study in plaque psoriasis run by our partner Merck KGaA
  • received a €15 million milestone payment from Merck KGaA for the completion of a pre-clinical package for a novel Nanobody (ALX-1141) targeting ADAMTS-5 in osteoarthritis, with Merck KGaA planning to initiate a Phase I study in H2 2017
  • received a €2.5 million milestone payment from Merck & Co., Inc. as a result of their initiation of a toxicology study with a bi-specific Nanobody as part of the immuno-oncology collaboration

Financial highlights for the first six months of 2017

  • Revenues of €34.7 million (2016: €53.1 million)
  • R&D expenditure of €50.5 million (2016: €49.0 million)
  • Operating loss of €24.8 million (2016: €2.0 million)
  • Net cash burn[1] of €30.9 million (2016: €19.0 million)
  • Cash position of €204.5 million (2016: €288.7 million)

"Completing recruitment on time of 145 patients with aTTP in the Phase III HERCULES study was a key achievement and will allow us to communicate topline results in late Q3 2017. In addition, the filing of our first MAA with the EMA for caplacizumab in aTTP was a very important step for Ablynx as was the Fast Track designation received from the FDA. In parallel, we have been further developing our commercial infrastructure in preparation for a potential first launch of caplacizumab in 2018."

"We have also made good progress with our wholly-owned, inhaled anti-RSV Nanobody (ALX-0171) as we continue the Phase IIb RESPIRE study. The three initial safety cohorts, encompassing 36 RSV-infected infants, have been satisfactorily completed and after a positive recommendation from the Data Monitoring Committee (DMC), we are now proceeding with the parallel dose exploration part of the RESPIRE study with the aim to recruit an additional 144 infants."

"During the period, we held meetings with regulators in Europe and the USA to discuss the Phase IIb data generated with vobarilizumab, our IL-6R Nanobody, in RA patients and the path to a Phase III programme. We also continued to have discussions with AbbVie and other potential pharmaceutical partners and have now decided to await the outcome of the SLE study with vobarilizumab in H1 2018, and AbbVie's subsequent decision on whether to opt-in. If AbbVie does opt-in based on the SLE results, they will pay a US$25 million milestone payment and they will have an obligation to use commercial reasonable efforts to advance the programme in RA. If AbbVie does not opt-in at that point, then all rights to vobarilizumab will revert unencumbered to us and we will decide what next steps we will take with the molecule."

"As well as achieving important milestones in our collaborations with Merck & Co., Inc. and Merck KGaA, we were also delighted to sign a new strategic collaboration with Sanofi where we will work together on up to eight Nanobody product candidates, initially in the area of immune-mediated inflammatory diseases. In total now we have received payments from our pharmaceutical partners of >€450 million with the potential still to earn >€10 billion in milestone payments plus royalties from the various partnered programmes."

"Additionally during the period, we were joined by a new Chief Business Officer, Dr Markus Ewert, who will help further strengthen our senior management team."

"This has been a good period for Ablynx and we look forward to further developments over the next months.”

Dr Edwin Moses

CEO of Ablynx

About Ablynx

Ablynx is a biopharmaceutical company engaged in the development of Nanobodies, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than 45 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie; Boehringer Ingelheim; Eddingpharm; Merck & Co., Inc., Kenilworth, New Jersey, USA; Merck KGaA; Novartis; Novo Nordisk; Sanofi and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.

For more information, please contact:

Ablynx

Dr Edwin Moses

CEO

t:   +32 (0)9 262 00 07

m: +32 (0)473 39 50 68

e:  edwin.moses@ablynx.com

 

Lies Vanneste

Director IR

t:   +32 (0)9 262 0137

m: +32 (0)498 05 35 79

e:  lies.vanneste@ablynx.com

 

@AblynxABLX

 

Disclaimer

Certain statements, beliefs and opinions in this press release 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 press release 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 press release 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 press release 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 press release.


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