REGULATED INFORMATION
Significant progress in key pre-clinical and clinical development programmes
Conference call and webcast today at 4pm CET/10am ET
GHENT, Belgium, 23 February 2017 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its financial results for the year ended 31 st December 2016, which have been prepared in accordance with IFRS as adopted by the European Union, business highlights year-to-date and the outlook for the remainder of the year.
- Total revenues of €85.2 million (+10%); cash position of €235.4 million, strengthened by the successful private placement of new shares via an accelerated book building procedure that raised €74.2 million
- Net cash burn [1] of €72.2 million, in line with the previously guided range of €65-75 million
- R&D highlights:
- strong recruitment of patients with acquired thrombotic thrombocytopenic purpura (aTTP) in the Phase III HERCULES study with caplacizumab
- successful completion of two Phase IIb studies in rheumatoid arthritis (RA) with vobarilizumab in approximately 600 patients
- completed recruitment of 312 patients with systemic lupus erythematosus (SLE) in Phase II study of vobarilizumab
- positive topline results for the anti-respiratory syncytial virus (RSV) Nanobody® (ALX-0171) in 53 hospitalised infants
- three Phase I trials started in partnered programmes
- initiated 19 new discovery programmes both proprietary and as part of collaborations
- extended one pharmaceutical partnership and received four milestone payments from partners
- Post-period highlights :
- initiated the global Phase IIb RESPIRE study of ALX-0171 in 180 infants hospitalised as a result of a RSV infection
- encouraging Phase Ib data in the Merck KGaA partnered anti-IL-17A/F programme in psoriasis
- submitted an application in Europe for regulatory approval of caplacizumab for the treatment of aTTP
- Additional significant clinical and regulatory catalysts anticipated in 2017 :
- topline results from the Phase III HERCULES study of caplacizumab in aTTP patients expected in H2 2017
- initiation of the first clinical trial of a Nanobody developed as part of the immuno-oncology collaboration with Merck & Co., Inc.
- dependent on establishing a new pharmaceutical partnership, initiation of a Phase III programme in RA with vobarilizumab
- at least one additional Phase I start in a partnered programme
- completion of the ~300 patient systemic lupus erythematosus (SLE) study with vobarilizumab, with topline data expected in early 2018
"We have made significant progress across a number of our key clinical programmes during 2016 and continue to advance our growing pipeline of products which now has more than 45 proprietary and partnered programmes" said Dr Edwin Moses, CEO of Ablynx. "We are approaching a key inflection point with our filing for regulatory approval of caplacizumab in Europe, results from our Phase III trial expected in H2 2017 and commercial preparations well underway for the first launch of the product expected in 2018. We remain focused on delivering sustainable value to all our stakeholders and look forward to an exciting year with multiple catalysts across our extensive pipeline."
Financial highlights
| (€ million) | FY 2016 | FY 2015 | Variance | |
| Total revenue and grant income | 85.2 | 77.5 | 10% | |
| R&D income | 84.8 | 76.8 | 10% | |
| Grants | 0.4 | 0.7 | (43%) | |
| Operating expenses | (113.8) | (94.5) | 20% | |
| R&D | (100.3) | (83.1) | 21% | |
| G&A | (13.5) | (11.4) | 18% | |
| Operating result | (28.6) | (17.0) | (68%) | |
| Net financial result | 27.5 | (37.6) | > 100% | |
| Net result | (1.1) | (54.5) | 98% | |
| Net cash flow | (72.2) (1) | (67.2) (3) | (7%) | |
| Cash* at 31 December | 235.4 (2) | 236.2 (2) | - | |
(1) excluding €71.4 million net proceeds from the private placement (which raised €74.2 million, announced on 1 June 2016) (2) including €1.6 million in restricted cash (3) excluding €97.2 million net proceeds from the convertible bonds (which raised €100 million, announced on 20 May 2015) * defined as liquidity position in the cash flow statement
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 approximately 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., Merck KGaA, Novartis, Novo Nordisk 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
Marieke Vermeersch Director IR & Corporate Communications t: +32 (0)9 262 00 82 m: +32 (0)479 49 06 03 e: marieke.vermeersch@ablynx.com Follow us on Twitter @AblynxABLX
Ablynx media relations: FTI Consulting: Julia Phillips, Brett Pollard, Mo Noonan, Matthew Moss t: +44 20 3727 1000 e: ablynx@fticonsulting.com
[1] Net cash burn is the difference between the cash position of the current and the previous year minus the proceeds (net of issue costs) from the issuance of ordinary shares and/or the issue of convertible bonds
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