ABLYNX PROVIDES BUSINESS UPDATE FOR THE FIRST NINE MONTHS OF 2012

Wed Nov 14, 2012 12:02pm EST

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REGULATED INFORMATION

GHENT, Belgium, 14 November 2012 - 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 2012, material events post 30 September 2012, and the guidance for the full year 2012.

Operating Highlights

  • Novartis initiated a Phase I trial with the anti-DR5 Nanobody® (TAS266)
  • Ablynx successfully completed a first Phase I study with the inhaled anti-RSV Nanobody (ALX-0171)
  • Ablynx and Merck Serono advanced a new Nanobody candidate into pre-clinical development (ALX-0751)
  • Proposed strengthening of the Board with two important new appointments

Financial Highlights

  • €22.2 million in revenues for the period, up 34% compared to 2011
  • Year-to-date net cash burn at €18.8M, 40% lower than 2011
  • €65 million in cash, cash equivalents, restricted cash and short term investments at the end of the period

Commenting on the results for the first nine months of 2012, Dr Edwin Moses, Chairman and CEO of Ablynx, said:

"Ablynx has had an excellent third quarter both financially and with the delivery of significant clinical and corporate news flow. We have continued to generate positive clinical data from our own pipeline, we have advanced partnered programmes and continued to see the benefits of strong cash generation combined with prudent cost management. Recent positive clinical data with our first inhaled anti-RSV Nanobody has demonstrated additional advantages of Nanobodies over conventional antibody approaches. The proposed new Board appointments are a testament to the high quality of our Nanobody platform and strong product pipeline. These appointments will help us to successfully take Ablynx to the next stage of development."

Financial review

 (€ million) First 9 Months of 2012 First 9 Months of 2011 % change
Revenues 22.2 16.6 34%
R&D income 21.1 15.3 38%
                        Grants 1.1 1.3 (15%)
Operating expenses (45.4) (50.8) (11%)
                       R&D (38.3) (43.1) (11%)
                       G&A (7.1) (7.7) (8%)
Finance income (net) 1.0 1.2 (17%)
Net result (22.3) (33.1) 33%
Cash burn 18.8 31.2 (40%)
Cash at 30 September 65.0 (1) 84.6 (2) (23%)
(1) including €2.7 million restricted cash       (2) including €3 million restricted cash


Total revenues for the period increased 34% to €22.2 million (2011: €16.6 million) as a result of an increase in R&D income to €21.1 million (2011: €15.3 million). This was mainly a result of the extension of the Strategic Alliance with Boehringer Ingelheim and revenues related to the third deal signed with Merck Serono at the end of 2011. Total operating expenses decreased to €45.4 million (2011: €50.8 million), mainly driven by lower external developments costs for a number of Ablynx-led programmes. The net loss for the period was €22.3 million (2011: €33.1 million). The net cash burn during the third quarter was €11.5 million, resulting in a net cash burn for the period January-September 2012 of €18.8 million (2011: €31.2 million). Ablynx's cash, cash equivalents, restricted cash and short term investments were €65 million at 30 September 2012 (2011: €84.6 million).

For the full year 2012, Ablynx reiterated its net cash burn guidance of €20-25 million.

Operational review

During the third quarter, Ablynx announced positive results from the Phase I study with its own inhaled Nanobody, ALX-0171, that has the potential to be a first-in-class therapeutic for RSV infections. In addition, Ablynx and its partner, Merck Serono, further advanced their collaboration with the start of pre-clinical development with ALX-0751 in oncology. Finally, Ablynx announced the strengthening of its Board of Directors with the proposed appointment of Dr Russell Greig (ex-GSK) and Dr Roger Perlmutter (ex-Amgen).

Events after 30 September 2012

On 2nd October 2012, Ablynx announced that it has entered into a collaboration with Merck & Co to develop and commercialise Nanobody candidates directed towards a voltage-gated ion channel. Under the terms of the agreement, Merck gains exclusive global rights to Nanobodies against the selected target, with an option for similar rights to a second target. Upon signing, Merck paid Ablynx a €8.5 million upfront including a €2 million fee for research funding. In addition, Ablynx will be eligible to receive up to €448 million in research, development and commercial milestone payments associated with the progress of multiple Nanobodies as well as tiered royalties on any products derived from the collaboration.

On 4th October 2012, Ablynx announced that its anti-IL-6R Nanobody, ALX-0061, met the efficacy endpoint of a significant improvement in key indicators of disease activity at the 12-week interim analysis of the Phase I/II study in patients with moderate to severe active rheumatoid arthritis (RA) on a stable background of methotrexate. These interim results demonstrate that ALX-0061 has the potential to become a best-in-class IL-6R inhibitor in RA. The Nanobody has a strong efficacy profile based on a 80% ACR20 response, a 60% DAS28-CRP remission rate, and a fast onset of DAS28-CRP remission. Furthermore, it has an excellent safety profile as no serious infections, no decrease in neutrophils, no clinically significant increases in liver enzymes and no increases in lipid levels (cholesterol and LDL) were observed.

The Extraordinary Shareholders Meeting on 6th November approved the proposed appointments of Dr Russell Greig and Dr Roger Perlmutter as independent Directors of the Company for a term of 4 years.

 
Financial Calendar 2013

27 February - Full year results 2012
31 March - Online publication annual report 2012
15 May - Q1 2013 results
21 August - Half year 2013 results
14 November - Q3 2013 results


Glossary

ACR: score that measures improvement in tender or swollen joint counts and improvement in three of five other disease-activity measures; ACR20 measures % of patients with 20% improvement; ACR50 measures % of patients with 50% improvement and ACR70 measures % of patients with 70% improvement

DAS28: RA disease activity score based on C-reactive protein (CRP), tender and swollen joint counts of 28 defined joints and physician's global health assessment; a total score of >5.1 is associated with high disease activity, moderate from 3.2 to 5.1, low disease activity from 2.6, and remission of disease if <2.6

DMARDs: disease modifying anti-rheumatoid arthritis drugs

IL-6R: receptor of interleukin-6 - a cytokine involved in a wide range of biological activities

RA: rheumatoid arthritis - autoimmune disease that causes chronic inflammation of the joints, the tissue around the joints, as well as other organs in the body

RSV: respiratory syncytial virus - virus that infects the lungs and respiratory tract


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 ongoing research collaborations and significant partnerships with major pharmaceutical companies including Boehringer Ingelheim, Merck KGaA, Novartis and Merck & Co. 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
Chairman and 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

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

M:Communications:
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t:   +44 207 920 2330
e:  ablynx@mcomgroup.com





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