Financial highlights - first quarter 2016
-
Revenues up 94% to €27.4 million (2015: €14.1 million)
-
Investment in R&D up 49% to €24.9 million (2015: €16.7 million)
-
Operating result of -€0.7 million (2015: -€5.0 million)
-
Net cash outflow of €2.5 million (2015: €12.9 million)
-
€233.7 million in cash, cash equivalents, restricted cash and short-term investments (2015: €193.3 million)
Commenting on today`s update, Dr Edwin Moses, CEO of Ablynx, said:
"We are very pleased to report excellent progress since the beginning of the year. Our clinical product pipeline is rapidly expanding with eight programmes now in clinical development, of which two are bi-specific Nanobodies, two are Nanobodies against GPCRs and one is an inhaled product, demonstrating the broad potential of our platform to generate innovative therapeutics. With the positive outcome of the Phase I/IIa study of our wholly-owned inhaled anti-RSV Nanobody, ALX-0171, we have made an important step forward in the development of a possible breakthrough for the treatment of RSV infections in infants. This trial also illustrates the potential to use inhalation as the route of administration in the development of Nanobodies for the treatment of other important lung-based diseases."
"We look forward to continuing important developments throughout 2016."
Financial review
| (€ million) | First three months 2016 | First three months 2015 | % change |
| Total revenue and grant income | 27.4 | 14.1 | 94% |
| | R&D income | 27.2 | 13.9 | 96% |
| | Grants | 0.2 | 0.2 | - |
| Operating expenses | (28.1) | (19.1) | 47% |
| | R&D | (24.9) | (16.7) | 49% |
| | G&A | (3.2) | (2.5) | 28% |
| Operating result | (0.7) | (5.0) | 86% |
| Net financial result | 17.5 | 1.1 | >100% |
| Net result | 16.8 | (4.0) | >100% |
| Net cash flow | (2.5) | (12.9) | 81% |
| Cash at 31 March | 233.7 (1) | 193.3 (2) | 21% |
(1) including €1.3 million in restricted cash
(2) Including €2.0 million restricted cash
Revenues increased 94% to €27.4 million (2015: €14.1 million) mainly driven by higher milestones and recognition of upfront payments from on-going collaborations. As a result of the pipeline maturing with later-stage clinical assets, the operating expenses increased to €28.1 million (2015: €19.1 million) primarily due to higher external R&D costs. The net financial result increased to €17.5 million (2015: €1.1 million) mainly 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 profit of €16.8 million (2015: net loss of €4.0 million).
As of 31st March 2016, the Company had €233.7 million in cash, cash equivalents, restricted cash and short-term investments.
Financial guidance and 2016 outlook confirmed
In the third quarter of 2016, Ablynx expects to communicate top line results from the monotherapy and combination therapy studies with the anti-IL-6R Nanobody, ALX-0061, in patients with RA. Following a review of the complete RA data package, AbbVie is expected to decide, before the end of 2016, whether it intends to exercise its option to exclusively license ALX-0061 in RA, in which case Ablynx will receive a US$75 million milestone payment. AbbVie would then be responsible for providing all the resources to further develop and commercialise ALX-0061 in this indication and Ablynx would be eligible to receive regulatory and sales milestones plus double-digit royalties.
In the third quarter of 2016, the Company expects that the first patients from the Phase III HERCULES study of its wholly-owned anti-vWF Nanobody, caplacizumab, will have rolled-over into a three-year follow-up study to evaluate the long-term safety and clinical effects of the product.
In the fourth quarter 2016, Ablynx expects to start a Phase II efficacy study with the wholly-owned inhaled anti-RSV Nanobody, ALX-0171, in infants who are hospitalised as a result of an RSV infection.
The Company reiterates its net cash burn guidance for the full year 2016 of €65-75 million.
Financial calendar 2016
25 August 2016 - half-year results
23 November 2016 - Q3 results
Shareholders` clubs @ Ablynx
18 May at 5.45pm - in Dutch
14 September at 5.45pm - in Dutch
7 December at 5.45pm - in Dutch
If you would like to attend, please contact us via investors@ablynx.com.
Glossary
FDA U.S. Food and Drug Administration
GPCR G-protein coupled receptor
IL-6R receptor of interleukin-6
RA rheumatoid arthritis
RSV respiratory syncytial virus
SLE systemic lupus erythematosus
TTP 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 40 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@ablynx.com
Marieke Vermeersch
Associate Director Investor Relations
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
pdf format of the press release
This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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
HUG#2011870
