GHENT, Belgium, 11 May 2017 – Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its nonaudited
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®
o Submitted a marketing authorisation application (MAA) to the European Medicines Agency for approval
in the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).
o 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
o 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
o 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
o Continued discussions with AbbVie and other potential pharmaceutical partners to determine the best
options for advancing vobarilizumab in RA.
o 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
o 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
? 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 bispecific
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%
R&D income 9.1 27.2 67%
Grants - 0.2 -
Operating expenses (29.3) (28.1) 4%
R&D (25.7) (24.9) 3%
G&A (3.6) (3.2) 13%
Operating result (20.2) (0.7) >100%
Net financial result (1.9) 17.5 >100%
Net result (22.1) 16.8 >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 shortterm
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.
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