Ablynx Provides Business Update for the First Nine Months of

Ablynx Provides Business Update for the First Nine Months of 2012 
GHENT, BELGIUM -- (Marketwire) -- 11/14/12 --  
REGULATED INFORMATION 
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(R)
    (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 


 
--  EUR 22.2 million in revenues for the period, up 34% compared to 2011
--  Year-to-date net cash burn at EUR 18.8M, 40% lower than 2011
--  EUR 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 


 
                                                                            
----------------------------------------------------------------------------
                          First 9 Months   First 9 Months                   
(EUR million)             of 2012          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 EUR 2.7 million restricted cash                               
(2) including EUR 3 million restricted cash                                 

 
Total revenues for the period increased 34% to EUR 22.2 million (2011:
EUR 16.6 million) as a result of an increase in R&D income to EUR
21.1 million (2011: EUR 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 EUR 45.4 million
(2011: EUR 50.8 million), mainly driven by lower external
developments costs for a number of Ablynx-led programmes. The net
loss for the period was EUR 22.3 million (2011: EUR 33.1 million).
The net cash burn during the third quarter was EUR 11.5 million,
resulting in a net cash burn for the period January-September 2012 of
EUR 18.8 million (2011: EUR 31.2 million). Ablynx's cash, cash
equivalents, restricted cash and short term investments were EUR 65
million at 30 September 2012 (2011: EUR 84.6 million). 
For the full year 2012, Ablynx reiterated its net cash burn guidance
of EUR 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 EUR 8.5
million upfront including a EUR 2 million fee for research funding.
In addition, Ablynx will be eligible to receive up to EUR 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 Meetin
g 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(R), 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. 
press release in pdf http://hugin.info/137912/R/1657927/536355.pdf  
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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