ABLYNX ANNOUNCES RESULTS FOR THE FIRST NINE MONTHS OF 2016 AND A YEAR-TO-DATE BUSINESS UPDATE
(Thomson Reuters ONE) -
REGULATED INFORMATION
Strong clinical progress across our product portfolio
GHENT, Belgium, 23 November 2016 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY]
today announced its financial results, summarising the non-audited financial
position for the first nine months of 2016, a business update for the year-to-
date and the outlook for the next period.
Operational highlights year-to-date
* Caplacizumab - wholly-owned anti-vWF Nanobody® for the treatment of acquired
TTP (aTTP)
* Publication of the Phase II TITAN study results for caplacizumab in The
New England Journal of Medicine (NEJM).
* Post-hoc analyses of the TITAN study results demonstrated that
caplacizumab has a significant effect on clinically relevant endpoints
showing a 71% reduction in frequency of major thromboembolic events
(e.g. stroke) and a dramatic reduction in refractoriness to treatment;
the latter is associated with a very poor prognosis for survival of an
acute episode of aTTP.
* Initial target recruitment of 92 patients in HERCULES Phase III study of
caplacizumab already achieved, 6 months ahead of schedule. Target
enrolment increased to 132 patients with results still expected in H2
2017.
* Started 3-year follow-up study with patients who completed the HERCULES
study to evaluate the long-term safety and efficacy of caplacizumab, the
safety and efficacy of repeated use of caplacizumab and to characterise
the severity and long-term impact of aTTP.
* On track to file for conditional approval of caplacizumab in Europe in
early 2017.
* ALX-0171 - wholly-owned inhaled Nanobody for the treatment of RSV infections
* Once daily inhalation, for 3 consecutive days, of ALX-0171 in infants
hospitalised with a RSV infection was safe and well tolerated, had a
significant and immediate impact on viral replication and an encouraging
initial therapeutic effect.
* Phase IIb dose-ranging efficacy study in 180 hospitalised infants with a
RSV infection on track to start by year-end.
* Vobarilizumab - anti-IL-6R Nanobody for the treatment of RA and SLE
* Delivered excellent efficacy and safety results from the Phase IIb
monotherapy and combination therapy studies of vobarilizumab in RA;
AbbVie subsequently decided not to exercise its right to opt-in and
license vobarilizumab in this indication. Ablynx has started the process
of identifying a new partner for vobarilizumab in RA.
* Recruitment of 300 patients in SLE Phase II study ahead of schedule;
results anticipated in H1 2018.
* Three partnered Nanobody programmes began Phase I clinical development,
which triggered >?16 million in success fees to Ablynx.
* Ion channel collaboration with Merck & Co., Inc. extended for the second
time, triggering a ?1 million milestone payment to Ablynx.
* Initiated >15 new wholly-owned and partnered pre-clinical programmes
bringing the total number of active programmes in the R&D pipeline to >45.
Financial highlights - at 30 September 2016
* Successfully raised ?74 million (gross) through an oversubscribed private
placement of new shares
* Total revenues were ?68.9 million, a 29% increase compared with 2015
* Operating loss of ?13.7 million, compared with ?13.3 million in 2015
* Net profit of ?10.9 million, mainly driven by the accounting treatment of
the outstanding convertible bond
* Cash position of ?263.6 million compared to ?262.2 at 30 September 2015
* Financial guidance for the full year 2016 reiterated
Commenting on today's update, Dr Edwin Moses, CEO of Ablynx, said: "Year-to-
date, we have made tremendous progress in our R&D portfolio with excellent
results from three clinical studies, the expansion of our Nanobody clinical
pipeline with three new partnered Phase I programmes starting, and the
progression of wholly-owned and partnered early-stage programmes. Our lead
programme, caplacizumab, is advancing very well and we are on track to
commercialise this product ourselves with the first launch anticipated in Europe
in 2018. We were of course disappointed that AbbVie decided not to exercise its
right to license vobarilizumab after our Phase IIb results in RA but we remain
on track to organise the end-of-Phase II regulatory consultations with the FDA
and EMA in H1 2017. We have initiated the process to identify a new partner for
vobarilizumab in RA to help take this innovative drug candidate through Phase
III and into commercialisation. Recruitment in the Phase II SLE study with
vobarilizumab is progressing well. We further strengthened our cash position
through an oversubscribed private placement of new shares and agreed a second
extension of our ion channel collaboration with Merck & Co."
"We look forward to reporting on important developments throughout 2016 and
beyond."
Financial review - 1(st) January 2016 to 30(th) September 2016
+-------------------------+---------------------+---------------------+--------+
|(? million) | First nine months | First nine months |% change|
| | 2016 | 2015 | |
+-------------------------+---------------------+---------------------+--------+
|Total revenue and grant| 68.9 | 53.6 | 29% |
|income | | | |
+-------------------------+---------------------+---------------------+--------+
| R&D income | 68.5 | 53.1 | 29% |
+-------------------------+---------------------+---------------------+--------+
| Grants | 0.4 | 0.5 | (20%) |
+-------------------------+---------------------+---------------------+--------+
|Operating expenses | (82.6) | (66.9) | 23% |
+-------------------------+---------------------+---------------------+--------+
| R&D | (72.8) | (58.5) | 25% |
+-------------------------+---------------------+---------------------+--------+
| G&A | (9.8) | (8.4) | 17% |
+-------------------------+---------------------+---------------------+--------+
|Operating result | (13.6) | (13.3) | 2% |
+-------------------------+---------------------+---------------------+--------+
|Net financial result | 24.5 | (8.4) | >100% |
+-------------------------+---------------------+---------------------+--------+
|Net result | 10.9 | (21.7) | >100% |
+-------------------------+---------------------+---------------------+--------+
|Net operational cash flow| (44.1)( (1)) | (41.3)( (2)) | 7% |
+-------------------------+---------------------+---------------------+--------+
|Cash at 30 September | 263.6 ((3)) | 262.2 ((4)) | 0.5% |
+-------------------------+---------------------+---------------------+--------+
((1) ) Excluding ?71.4 million net proceeds from the private placement of new
shares (1 June 2016)
((2) ) Excluding ?97.2 million net proceeds from the convertible bond (20 May
2015)
((3) ) Including ?1.3 million in restricted cash
((4) ) Including ?1.6 million restricted cash
Revenues increased 29% to ?68.9 million (2015: ?53.6 million) mainly driven by
milestone payments received from Boehringer Ingelheim and recognised income from
the upfront payments received from Merck & Co., Inc. and Novo Nordisk. As a
result of the pipeline maturing with later-stage clinical assets, the operating
expenses increased to ?82.6 million (2015: ?66.9 million), primarily driven by
higher R&D expenses attributable to investment in personnel and external
development costs. As a result of the above, the operating loss was ?13.6
million during the first nine months of 2016 (2015: ?13.3 million).
The net financial result of ?24.5 million primarily relates to the fair value
impact (mainly non-cash) of the convertible bond (driven by the lower share
price on 30 September 2016 as compared to 31 December 2015).
As a result of the above, the Company ended the first nine months of 2016 with a
profit of ?10.9 million (2015: loss of ?21.7 million).
Following the successful private placement of new shares, raising ?71.4 million
in net proceeds, the Company had a positive net cash inflow of ?27.4 million for
the first nine months of 2016 and ended the period with ?263.6 million in cash,
cash equivalents, restricted cash and short-term investments.
2016 outlook and financial guidance confirmed
Ablynx will attend the annual American Society of Hematology (ASH) meeting being
held on 3-6 December 2016, in San Diego, USA. Prior to the start of the
conference, a HERCULES investigator meeting will be hosted by Ablynx and the
first global aTTP workshop with key physicians in TTP will be held.
Before year-end, Ablynx expects to start a Phase IIb dose-ranging efficacy study
with inhaled ALX-0171 in 180 infants who have been hospitalised as a result of a
RSV infection. The results from this study are anticipated in the second half of
2018.
The Company reiterates its net cash burn guidance for the full year 2016 of ?65-
75 million, not including the net proceeds from the private placement of new
shares announced on the 1(st) of June 2016.
Financial calendar 2017
23 February 2017 - full year results 2016
27 April 2017 - Annual General Meeting
11 May 2017 - Q1 results 2017
24 August 2017 - half year results 2017
16 November 2017 - Q3 results 2017
Shareholders' clubs (at) Ablynx
7 December 2016 at 5.45pm - in Dutch
8 March 2017 at 5.45pm - in Dutch
If you would like to attend, please contact us via investors(at)ablynx.com.
Glossary
EMA European Medicines Agency
FDA U.S. Food and Drug Administration
IL-6R receptor of interleukin-6
RA rheumatoid arthritis
RSV respiratory syncytial virus
SLE systemic lupus erythematosus
aTTP acquired thrombotic thrombocytopenic purpura
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, Genzyme, 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(at)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(at)ablynx.com
Follow us on Twitter (at)AblynxABLX
Ablynx media/analyst relations
FTI Consulting:
Julia Phillips, Brett Pollard, Mo Noonan, Matthew Moss
t: +44 20 3727 1000
e: ablynx(at)fticonsulting.com
pdf format of the press release:
http://hugin.info/137912/R/2058673/771555.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Ablynx via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 23.11.2016 - 07:00 Uhr
Sprache: Deutsch
News-ID 508730
Anzahl Zeichen: 13711
contact information:
Town:
Ghent/Zwijnaarde
Kategorie:
Business News
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