REGULATED INFORMATION
A period of transformation with major new collaborations, advances in the clinical pipeline, important developments in the shareholder structure and establishment of a fully independent Board
GHENT, Belgium, Nov. 14, 2013 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX] today announced its non-audited business update, in compliance with the European transparency directive, summarising Ablynx's financial position for the first nine months of 2013, material events post 30 September 2013 and guidance for the full year.
Operating highlights - third quarter - to-date
- Signed an exclusive global license agreement with AbbVie, potentially worth $840 million, for the development and commercialisation of the anti-IL-6R Nanobody, ALX-0061, in RA and SLE
- Extended the relationship with Merck Serono through the signing of a major research alliance that has the potential to evolve into at least four co-development collaborations and could generate >€100M in cash inflow to Ablynx over the next 6.5 years
- Signed an exclusive license agreement with Eddingpharm to develop and commercialise the anti-RANKL Nanobody, ALX-0141, in Greater China (the mainland of the People's Republic of China, the Hong Kong and Macao Special Administrative Regions, and Taiwan), for the treatment of osteoporosis and bone metastases
- Started additional Phase I studies with the anti-RSV Nanobody, ALX-0171, with the goal to initiate a first-in-infant trial during H2 2014
- Boehringer Ingelheim started a Phase I study with a Nanobody to treat Alzheimer's disease, triggering a €5 million milestone payment to Ablynx
- Signed a second extension of the Strategic Alliance with Boehringer Ingelheim, worth €1.1 million in FTE payments
- Amended the protocol of the Phase II study with caplacizumab with the aim of improving patient recruitment
- Establishment of a fully independent Board with the appointment of Dr Peter Fellner as new Chairman and Dr Bo Jesper Hansen and Dr William Jenkins as new Independent Directors
Financial highlights - first nine months ending September 30 th 2013
- Raised €31.5 million in a private placement of new shares
- Revenues of €16.7 million (2012: €22.2 million)
- Net loss for the period of €18.9 million (2012: €22.3 million)
- Positive net cash inflow of €0.2 million, resulting in a strong financial position of €63.0 million in cash, cash equivalents, restricted cash and short-term investments
- Upfront payments as part of the collaborations with AbbVie and Merck Serono announced end September were booked in the fourth quarter and hence will contribute to the full year's cash inflow
Commenting on today's business update, Dr Edwin Moses, CEO of Ablynx, said:
"Ablynx has made tremendous progress in the last months. We signed a transformational global licensing agreement, with a $175M up-front payment, for ALX-0061 with AbbVie, which is the largest clinical asset deal this year. The commercial terms of this partnership provide further validation of the power of the Nanobody technology platform, have generated significant additional financial resources and allow us to further build our expertise and capabilities in late stage clinical development. Also in the period, we further expanded our relationship with Merck Serono through the signing of a major multi-year research alliance that enables a rapid expansion of the early stage Nanobody pipeline as well as potentially generating very significant cash inflows over the next years. This is the fourth deal with Merck Serono and builds on the success of the existing collaborations.
The last quarter of the year has already started strongly with the signing of a license agreement with Eddingpharm for our anti-RANKL asset, ALX-0141, in Greater China, which is a first step for Ablynx in the exploitation of opportunities in the emerging markets. In addition, our two collaborations with Boehringer Ingelheim saw further progress with the start of the Phase I clinical study with a Nanobody to treat Alzheimer's disease and a second extension of the Strategic Alliance.
Finally, during the period we have seen an important evolution of our shareholder base towards long-term financial institutions in an orderly process which has allowed the exit of a large proportion of our remaining venture capital shareholders. As part of this maturing of Ablynx, we have also established a fully independent Board of Directors with significant industry experience which further strengthens our position as a leading European biopharmaceutical company."
Financial review
| (€ million) | First 9 months of 2013 | First 9 months of 2012 |
| Revenues | 16.7 | 22.2 |
| R&D income | 15.7 | 21.1 |
| Grants | 0.9 | 1.1 |
| Operating expenses | (36.2) | (45.4) |
| R&D | (29.7) | (38.3) |
| G&A | (6.4) | (7.1) |
| Operating result | (19.5) | (23.2) |
| Finance income (net) | 0.6 | 1.0 |
| Net result | (18.9) | (22.3) |
| Net cash inflow/(burn) | 0.2 | (18.8) |
| Cash at 30 th September | 63.0 (1) | 65.0 (2) |
| (1) including €2.3 million in restricted cash (2) including €2.7 million in restricted cash | ||
Revenues were €16.7 million (2012: €22.2 million) and included FTE and contract income from on-going collaborations and a milestone payment from Merck Serono as Phase I development started with ALX-0761 in RA. Operating expenses decreased to €36.2 million (2012: €45.4 million) due to lower R&D costs as a result of variances in external development costs. The net loss for the period was €18.9 million (2012: €22.3 million).
Following the successful private placement completed on 28 th February 2013, the Company had a positive net cash inflow of €0.2 million (2012: cash burn of €18.8 million), and ended the period with a strong financial position of €63.0 million in cash, cash equivalents, restricted cash and short-term investments.
About Ablynx
Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies ® , a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has approximately 25 programmes in the pipeline and seven Nanobodies at clinical development stage. Ablynx has on-going research collaborations and significant partnerships with major pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Merck & Co, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com .
complete press release in pdf: http://hugin.info/137912/R/1743035/586164.pdf
Ablynx: Dr Edwin Moses Chairman and CEO t: +32 (0)9 262 00 07 m: +44 (0)7771 954 193 / +32 (0)473 39 50 68 e: Marieke Vermeersch Associate Director Investor Relations t: +32 (0)9 262 00 82 m: +32 (0)479 49 06 03 e: Follow us on Twitter @AblynxABLX Ablynx media relations Consilium Strategic Communications: Mary-Jane Elliott, Amber Bielecka, Lindsey Neville t: +44 207 920 2345 e:
