ABLYNX ANNOUNCES 2016 HALF-YEAR RESULTS AND YEAR-TO-DATE BUSINESS UPDATE
(Thomson Reuters ONE) -
REGULATED INFORMATION
Very important clinical pipeline developments and a successful financing
Conference call and webcast today at 4pm CET/10am ET
GHENT, Belgium, 25 August 2016 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY]
today announced its financial results for the six-month period ending 30 June
2016, which have been prepared in accordance with the IAS 34 "Interim Financial
Reporting" as adopted by the European Union, a business update for the year-to-
date and the outlook for the next period.
R&D highlights year-to-date
* Delivered compelling efficacy and safety results from both Phase IIb RA
monotherapy and combination therapy studies of vobarilizumab
* Reported encouraging data from the Phase I/IIa study of inhaled ALX-0171 in
infants hospitalised with an RSV infection
* Good progress in the recruitment of patients in the Phase III HERCULES study
with caplacizumab in acquired TTP
* Three partnered Nanobody® programmes began Phase I clinical development
* Initiated >15 new wholly-owned and partnered pre-clinical programmes
bringing the total active programmes in the R&D pipeline to >45
Financial highlights first six months of 2016
* Total revenues were ?53.5 million, a 39% increase compared with 2015
* Operating loss reduced to ?2.0 million, compared with ?7.4 million in 2015
* Net profit of ?22.8 million, mainly driven by the accounting treatment of
the convertible bond
* Cash position of ?288.7 million, strengthened by the successful private
placement of new shares (raising ?71.4 million in net proceeds)
* Outlook for the remainder of the year confirmed
"It has been a hugely productive year so far for us," said Dr Edwin Moses, CEO
of Ablynx. "We successfully completed three clinical trials in RSV and RA and
the results provide an excellent platform for the continued development of both
ALX-0171 and vobarilizumab. With ALX-0171, we are now preparing for a worldwide
Phase II efficacy study in hospitalised infants with an RSV infection which is
expected to start before the end of the year. The Phase IIb data for
vobarilizumab give us great confidence that the molecule should move into Phase
III development as soon as possible. We are now preparing the complete data
package from the Phase IIb vobarilizumab studies for AbbVie and we expect them
to decide before the end of the year if they wish to opt-in and license the
product for RA. In parallel, we are starting preparations for a Phase III
programme with vobarilizumab in RA and we plan to move forward with this in the
event AbbVie do not opt-in, while then at the same exploring new relationships
which will allow us to maximize the potential of this exciting drug candidate."
"We continued to make good progress in our most advanced clinical programme,
where we are developing caplacizumab for the treatment of acquired TTP, and are
on track to file the dossier for conditional approval in Europe early next year.
Recruitment for the HERCULES Phase III trial with caplacizumab in acquired TTP
patients is proceeding well and we now intend to increase the power of the key
secondary efficacy endpoint by recruiting about 40% more patients than
originally planned while still aiming to meet our original goal to report the
study results before the end of 2017."
"Our R&D pipeline is developing very encouragingly and now includes more than
45 proprietary and partnered programmes. Three new programmes entered clinical
development with our partners and >15 new wholly-owned and partnered discovery
programmes have been initiated since the beginning of the year, demonstrating
our commitment to continue to fuel our product pipeline."
"In June, we further strengthened our cash position through a ?74.2 million
(gross) oversubscribed private placement of new shares with existing and new
investors, and we remain focused on delivering sustainable value to all our
stakeholders."
Financial review - 1 January 2016 to 30 June 2016
Key figures
+-------------------------+---------------------+---------------------+--------+
|(? million) |First six months 2016|First six months 2015|% change|
+-------------------------+---------------------+---------------------+--------+
|Total revenue and grant| 53.5 | 38.4 | 39% |
|income | | | |
+-------------------------+---------------------+---------------------+--------+
| R&D income | 53.1 | 38.0 | 40% |
+-------------------------+---------------------+---------------------+--------+
| Grants | 0.4 | 0.4 | - |
+-------------------------+---------------------+---------------------+--------+
|Operating expenses | (55.5) | (45.9) | 21% |
+-------------------------+---------------------+---------------------+--------+
| R&D | (49.0) | (40.3) | 22% |
+-------------------------+---------------------+---------------------+--------+
| G&A | (6.5) | (5.6) | 16% |
+-------------------------+---------------------+---------------------+--------+
|Operating result | (2.0) | (7.4) | 73% |
+-------------------------+---------------------+---------------------+--------+
|Net financial result | 24.9 | (7.7) | >100% |
+-------------------------+---------------------+---------------------+--------+
|Net result | 22.8 | (15.2) | >100% |
+-------------------------+---------------------+---------------------+--------+
|Net operational cash flow| (19.0)( (1)) | (35.1)( (2)) | 46% |
+-------------------------+---------------------+---------------------+--------+
|Cash at 30 June* | 288.7 ((3)) | 268.4 ((4)) | 8% |
+-------------------------+---------------------+---------------------+--------+
((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
* 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 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/2037074/758947.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: 25.08.2016 - 07:00 Uhr
Sprache: Deutsch
News-ID 491015
Anzahl Zeichen: 9399
contact information:
Town:
Ghent/Zwijnaarde
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 244 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"ABLYNX ANNOUNCES 2016 HALF-YEAR RESULTS AND YEAR-TO-DATE BUSINESS UPDATE"
steht unter der journalistisch-redaktionellen Verantwortung von
Ablynx (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
