ABLYNX : ANNOUNCES 2013 FULL YEAR RESULTS

REGULATED INFORMATION

2013 - a transformational year for Ablynx

GHENT, Belgium, 27 February 2014 - Ablynx [Euronext Brussels: ABLX] today announced its consolidated results for 2013, which have been prepared in accordance with IFRS as adopted by the European Union.

The FY13 results will be discussed during a webcast presentation today at 4 pm CET, 10 am EST.

The webcast may be accessed on the home page of the Ablynx website at www.ablynx.com:
http://www.ablynx.com/ or by clicking here:
http://www.media-server.com/m/p/4pp3kiyz. To participate in the Q&A, please dial +32 (0) 2 620 01 38 with confirmation code 8682086.

• Announced encouraging Phase IIa results from a study in RA patients treated with the anti-IL-6R Nanobody, ALX-0061, and then agreed an exclusive global license agreement for this programme with AbbVie, worth up to $840 million plus double-digit royalties
• Initiated two Phase I studies with the anti-RSV Nanobody, ALX-0171
• Merck Serono initiated a Phase I study with ALX-0761, a bi-specific Nanobody, triggering a ?2.5 million milestone payment to Ablynx
• Boehringer Ingelheim initiated a Phase I study with BI 1034020, a Nanobody with potential application in Alzheimer's disease, triggering a ?5 million milestone payment to Ablynx
• Further expanded the relationship with Merck Serono through the signing of a multi-year research alliance that could generate >?100 million in cash-income for Ablynx over the next 6.5 years
• Exclusively licensed the anti-RANKL Nanobody, ALX-0141, to Eddingpharm for development and commercialisation in China, Macao, Taiwan and Hong Kong
• Strengthened the management team and re-organized the Board with the appointment of four new independent Directors, all with considerable, relevant industrial experience

Financial highlights

• Raised ?31.5 million in a private placement of new shares (accelerated book building procedure)
• Fourfold increase in cash-income from collaborations to ?157.6 million (2012: ?36.5 million)
• Revenue growth of 34% to ?35.9 million (2012: ?26.7 million)
• Net loss for the period reduced by 32% to ?19.5 million (2012: ?28.5 million)
• Net cash burn (excluding net cash-income from the ABO and the AbbVie upfront payment of $175 million) well controlled at ?20.0 million (2012: ?21.1 million)
• Strong financial position of ?200.4 million in cash, cash equivalents, restricted cash and short-term investments (2012: ?62.8 million)
• Successfully placed 17 million shares from venture capital investors with institutional investors in Europe and the United States. The Company's free float has increased from 53% at the end of 2012 to 85% at the end of 2013

Post year-end highlights

• Recruitment of the worldwide Phase II TITAN study with the anti-vWF Nanobody, caplacizumab, to treat acquired TTP, was stopped prior to reaching the target of 110 patients. This will allow early analysis of the clinical data which will be released mid-2014. If these results are encouraging, then planning will begin to start a Phase III study in 2015.
• Signed a major discovery collaboration and licensing agreement with Merck & Co, worth up to ?1.7 billion in upfront payments, research funding and milestones, to discover and develop Nanobody immuno-therapeutics for the treatment of various cancers.
• Obtained encouraging pre-clinical proof-of-concept data with the anti-RSV Nanobody, ALX-0171, in a neonatal lamb model, demonstrating that daily inhalation of ALX-0171 resulted in a reduction of viral titres and lung inflammation, and was effective in alleviating various clinical signs and symptoms.
• After completing pre-clinical studies with the anti-IgE Nanobody, ALX-0962, for use in severe allergic asthma, Ablynx has decided not to move forward with this programme into Phase I studies because it is now believed that there is insufficient differentiation from the competition.

Commenting on the 2013 results, Dr Edwin Moses, CEO of Ablynx, said: "This was truly a transformational year for Ablynx scientifically, operationally and at a corporate level. We continued our evolution into one of Europe's leading biopharmaceutical companies with a broad product pipeline, key partnerships, a strong cash position, a diversified investor base and a re-organised Board of Directors with four new independent Directors. During the coming year, we expect to see continued growth based on developments in our wholly-owned and partnered programmes, new collaborative deals, and further investment in our unique technology platform, whilst keeping our net cash burn under control."

Operational review

Clinical pipeline update

At the end of 2013, Ablynx had seven wholly-owned and partnered Nanobodies in the clinic, three in Phase II and four in Phase I clinical development, compared to five Nanobody-based products in the clinic at the end of 2012.  

In February, the Company reported compelling Phase IIa data for its anti-IL-6R Nanobody, ALX-0061, demonstrating that intravenous administration of ALX-0061 in patients with RA resulted in a strong therapeutic effect at week 24. The Nanobody treatment was well tolerated at all doses, there was no increase in adverse events upon extension of treatment and no anti-drug antibodies were detected.

In June, Merck Serono initiated a Phase I study with the bi-specific anti-IL-17A/F Nanobody, ALX-0761, which triggered a milestone payment of ?2.5 million to Ablynx. At the time of the start of the Phase I study, Ablynx announced that it had converted this co-discovery/co-development arrangement into a classical licensing deal with milestone payments and royalties. As such, Merck Serono now has an exclusive license to the programme and is fully responsible for its further development and commercialisation. ALX-0761 has the potential to treat inflammatory diseases.

In July, two Phase I studies with the inhaled anti-RSV Nanobody, ALX-0171, were initiated. The first was a safety study in subjects with hyper-responsive airways, to determine the potential occurrence and then reversibility of broncho-constriction following inhalation of ALX-0171. The second was a PK study in healthy adults to investigate the concentration of the Nanobody locally and systemically with the goal to obtain additional PK parameters for further dose selection.

In August, the study protocol for the worldwide Phase II TITAN study, using the anti-vWF Nanobody, caplacizumab to treat acquired TTP, was adapted to facilitate recruitment. At the end of 2013, some improvement in recruitment had been observed. 

In October, Boehringer Ingelheim initiated a Phase I study with BI 1034020 to treat Alzheimer's disease. The start of the study triggered a ?5 million milestone payment to Ablynx.

Partnerships update

In September, Ablynx and AbbVie entered into an exclusive, global license agreement to develop and commercialise ALX-0061 for the treatment of inflammatory diseases, including RA and SLE. Under the terms of the agreement, Ablynx received an upfront payment of $175 million of which a large portion will be spent over the next four years to execute the programme. In addition, Ablynx is eligible to receive up to $665 million in milestone payments plus tiered double-digit royalties.

Also in September, Ablynx and Merck Serono further expanded their relationship through the signing of a major research alliance to discover and develop Nanobodies against a number of disease targets that play a role in oncology, immuno-oncology, immunology and neurology. The research alliance could evolve into at least four co-discovery and co-development agreements and could generate >?100 million in cash-income for Ablynx in the next 6.5 years.

In October, Ablynx signed an exclusive license agreement with Eddingpharm for the development and commercialisation of the anti-RANKL Nanobody, ALX-0141,  in the mainland of the People's Republic of China, the Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including osteoporosis and bone metastases. Ablynx received an upfront payment of ?2 million and is eligible to receive up to 20% royalties on net sales generated by Eddingpharm. In addition, the Company will have access to the clinical data generated by Eddingpharm to support potential licensing discussions in other geographic regions. This deal represents Ablynx's first entry into the emerging markets.  

The feasibility studies with Spirogen (PBD toxin-Nanobody drug conjugates in cancer therapy) and Algeta (thorium277-Nanobody drug conjugates in cancer therapy) currently continue to move forward following AstraZeneca's acquisition of Spirogen and Bayer's acquisition of Algeta.

Corporate developments

During 2013, Ablynx further strengthened its management team with two promotions and one new appointment.

Kim Simonsen, who was previously Director of Project Management, was appointed to the newly created position of Chief Operations Officer, and Dominique Tersago, who previously held the position of Senior Medical Director, was appointed Chief Medical Officer. Tony de Fougerolles was appointed Chief Scientific Officer, joining from Moderna Therapeutics in Boston, having also worked at Alnylam and Biogen Idec. Eva-Lotta Allan (Chief Business Officer), Josi Holz (Chief Medical Officer) and Andreas Menrad (Chief Scientific Officer) left the Company during 2013.

Also during 2013, Ablynx established a re-organised Board of Directors with significant industry experience. Four new independent Directors were appointed (Dr Peter Fellner, Catherine Moukheibir, Dr William Jenkins and Dr Bo Jesper Hansen). The roles of Chairman and CEO were separated with Dr Edwin Moses remaining CEO and Dr Peter Fellner appointed as his successor as Chairman. The three remaining non-executive Directors representing the venture capital shareholders (Jim Van heusden, Denis Lucquin and Stephen Bunting) resigned, as did three independent Directors (Dr Roger Perlmutter who resigned to avoid conflicts of interest following his appointment at Merck & Co, and Mats Pettersson and Dr Geert Cauwenbergh who retired after five years on the Ablynx Board).

Approximately 17 million venture capital held shares were placed during the year with institutional investors in Europe and the United States.  At the end of 2013, only Abingworth, of all the founding venture capital shareholders, retained its holding in Ablynx stock.

Financial review
Key figures

⁽¹⁾ including ?2.3 million in restricted cash   
⁽²⁾ including ?2.7 million in restricted cash

About Ablynx

Ablynx:
http://www.ablynx.com/ is a biopharmaceutical company engaged in the discovery and development of Nanobodies^®:
http://www.ablynx.com/en/research-development/nanobody-technology/understanding-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 30 programmes in the pipeline:
http://www.ablynx.com/en/research-development/pipeline/ and seven Nanobodies in clinical development. 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:
http://www.ablynx.com/.

For more information, please contact

Ablynx:

Dr Edwin Moses
CEO
t:   +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
     +32 (0)473 39 50 68
e:  edwin.moses@ablynx.com:
mailto: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:
mailto:marieke.vermeersch@ablynx.com%20
Follow us on Twitter @AblynxABLX

Ablynx media relations Consilium Strategic Communications:

Mary-Jane Elliott, Amber Bielecka, Lindsey Neville
t:   +44 207 920 2345
e:  ablynx@consilium-comms.com:
mailto:ablynx@consilium-comms.com