GHENT, Belgium, 11 May 2017 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its non-audited financial results for the first three months of 2017, a business update for the year-to-date and the outlook for the next period.
Operational highlights year-to-date
- Caplacizumab - wholly-owned first-in-class anti-vWF Nanobody®
- Submitted a marketing authorisation application (MAA) to the European Medicines Agency for approval in the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).
- Completed patient recruitment in the multi-national, double-blind, placebo-controlled Phase III HERCULES study. A total of 145 patients with aTTP have been enrolled. The study is on track to report topline results in H2 2017.
- ALX-0171 - wholly-owned inhaled anti-RSV Nanobody
- Initiated the global Phase IIb RESPIRE dose-ranging efficacy study in 180 infants hospitalised as a result of a respiratory syncytial virus (RSV) infection. Patient recruitment is currently on track to enable reporting of topline results in H2 2018.
- Vobarilizumab - anti-IL-6R Nanobody
- Received scientific advice and 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.
- Continued discussions with AbbVie and other potential pharmaceutical partners to determine the best options for advancing vobarilizumab in RA.
- Advanced the Phase II study in patients with systemic lupus erythematosus (SLE), with topline results expected to be reported in H1 2018.
- ALX-0761 - anti-IL17A/F Nanobody
- Promising results reported by our partner Merck KGaA with the bi-specific Nanobody anti-IL-17A/F in patients with moderate-to-severe chronic plaque psoriasis. Data from the Phase Ib study demonstrated very encouraging efficacy and a favourable safety and tolerability profile. Merck KGaA subsequently partnered with Avillion to advance a potential Phase II study with the bi-specific Nanobody in plaque psoriasis.
- Good progress in multiple additional proprietary and partnered programmes.
Financial highlights - first quarter 2017
- Revenues were €9.1 million (2016: €27.4 million)
- Investment in R&D was €25.7 million (2016: €24.9 million)
- Operating result of -€20.2 million (2016: -€0.7 million)
- Net cash outflow of €26.2 million (2016: €2.5 million)
- €209.2 million in cash, cash equivalents, restricted cash and short-term investments (2016: €233.7 million)
Commenting on today's update, Dr Edwin Moses, CEO of Ablynx, said:
"We have had a positive start to the year. Filing for regulatory approval of caplacizumab in Europe to treat aTTP was a very important milestone for the Company, as was completion of patient recruitment in the Phase III HERCULES study. We are now establishing a commercial infrastructure to launch caplacizumab and are committed to making it accessible to patients as soon as possible.
Initial recruitment for the Phase IIb study of our anti-RSV Nanobody in infants is progressing as planned and we continue to prepare for a trial of this Nanobody in patients who have undergone a stem cell transplantation and have become infected with RSV.
Discussions with regulatory authorities on our Phase IIb data in RA with vobarilizumab and the design of a potential Phase III programme have been informative in our evaluation of how to move the molecule forward in this indication. We still expect to report data from our 300 patient study in SLE with vobarilizumab in H1 2018.
Our partners have also made good progress in developing Nanobodies that we have jointly discovered. In particular in this period, Merck KGaA's results from a Phase Ib study in psoriasis with our anti-IL-17A/F bi-specific Nanobody were very exciting.
With now more than 45 R&D proprietary and partnered R&D programmes, of which 8 are in clinical development, we look forward to important progress throughout 2017."
|(€ million)||First three months 2017||First three months 2016||% change|
|Total revenue and grant income||9.1||27.4||67%|
|Net financial result||(1.9)||17.5||>100%|
|Net cash flow||(26.2)||(2.5)||>100%|
|Cash at 31 March||209.2 (1)||233.7 (2)||10%|
(1) including €1.6 million in restricted cash
(2) including €1.3 million in restricted cash
Revenues decreased to €9.1 million (2016: €27.4 million) mainly driven by lower recognition of upfront payments from the ongoing collaboration with AbbVie and by milestone payments received in the first quarter of 2016. As a result of the pipeline maturing with later-stage clinical assets, operating expenses increased to €29.3 million (2016: €28.1 million) primarily due to higher external R&D costs. The net financial result was -€1.9 million (2016: €17.5 million) principally relating to the effect of the fair value calculation of the Convertible Bond. As a result of the above, the Company ended the period with a net loss of €22.1 million (2016: net profit of €16.8 million).
As of 31st March 2017, the Company had €209.2 million in cash, cash equivalents, restricted cash and short-term investments. The cash burn of €26.2 million is higher than last year due to a delay in a €5.5 million payment which was not received until the beginning of Q2 2017 and also as a result of the higher number of milestone and upfront payments received during Q1 2016.
Financial guidance and 2017 outlook confirmed
Ablynx expects to communicate topline results from the Phase III HERCULES study of caplacizumab in aTTP in the second half of 2017. These data are expected to be used to support the recently submitted MAA in Europe and the planned Biologics License Application filing in the USA in 2018.
During 2017, the Company plans to start clinical development in Japan with both caplacizumab and its anti-RSV Nanobody (ALX-0171). There are also two potential Phase I starts with partnered programmes which would trigger associated milestone payments.
The Company reiterates its net cash burn guidance for the full-year 2017 to be in the range of €75-85 million.
Financial calendar 2017
24 August - half year results 2017
16 November - Q3 results 2017
2017 shareholders' clubs at Ablynx (Dutch language only)
24 May at 5.30pm
13 September at 5.30pm
6 December at 5.30pm
To attend an event, please register via email: email@example.com , stating your name and preferred day.
aTTP acquired thrombotic thrombocytopenic purpura
IL-6R receptor of interleukin-6
IL-17A/F interleukin 17A/F
MAA marketing authorisation application
RA rheumatoid arthritis
RSV respiratory syncytial virus
SLE systemic lupus erythematosus
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
Dr Edwin Moses
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68
Director Investor Relations
t: +32 (0)9 262 01 37
m: +32 (0)498 05 35 79
Follow us on Twitter @AblynxABLX
Ablynx media/analyst relations
Julia Phillips, Brett Pollard, Mo Noonan
t: +44 20 3727 1000