ABLYNX ANNOUNCES HALF-YEAR RESULTS FOR 2015

REGULATED INFORMATION * Caplacizumab on track to enter Phase III in acquired TTP, with Ablynx committed to lead commercialisation in Europe and the USA * 4 Phase II clinical programmes progressing in RSV, RA and SLE * Significant expansion of immuno-oncology deal with Merck & Co., Inc. now up to 17 programmes * New partnerships established with Genzyme and Taisho * Revenue and grant income up 73% to EUR38...
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REGULATED INFORMATION 

  • Caplacizumab on track to enter Phase III in acquired TTP, with Ablynx committed to lead commercialisation in Europe and the USA
  • 4 Phase II clinical programmes progressing in RSV, RA and SLE
  • Significant expansion of immuno-oncology deal with Merck & Co., Inc. now up to 17 programmes
  • New partnerships established with Genzyme and Taisho
  • Revenue and grant income up 73% to EUR38.4 million
  • Successful issue of EUR100 million convertible bond, with EUR268.4 million in cash at 30 June 2015

  

Webcast presentation scheduled today at 4 pm CET (10 am EST); accessible by clicking here or on the Ablynx website at http://www.ablynx.com/news/events-presentations/
To participate in the Q&A, dial +32(0)2 402 30 92 with confirmation code 6867520

 

GHENT, Belgium, 27 August 2015 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced its business update and results for the six-month period ending 30 June 2015, which have been prepared in accordance with the IAS 34 "Interim Financial Reporting" as adopted by the European Union.

 

Dr Edwin Moses, CEO of Ablynx commented:

"We have made substantial progress on all fronts, in our own fully-owned programmes and in our partnerships with leading pharmaceutical companies. In our later stage clinical pipeline we are now running four Phase II studies and will be shortly commencing the Phase III study with our wholly-owned anti-vWF Nanobody®, caplacizumab, as a potential first-in-class treatment for the orphan blood disease acquired TTP. We intend to apply for conditional approval of this product in Europe at the beginning of 2017 and, following a review of the commercialisation options, we have concluded that this product represents a strategic opportunity in our evolution into a commercial stage company and the value is best maximised by Ablynx retaining 100% ownership of the product in the USA and Europe."

 

"We significantly expanded our presence in immuno-oncology with an extension of our collaboration with Merck & Co., Inc. in a deal which now includes up to 17 programmes and could generate up to EUR5.7 billion in milestones plus royalties. We anticipate increasing our staff by about 10% to 350 during 2015 to resource this important partnership and the other opportunities we are pursuing."

 

"Thanks to an oversubscribed convertible bond issue of EUR100 million, we have substantially expanded our stakeholder base and are now well funded to execute on our potential as we look forward to multiple key inflection points, including the release of data from our Phase IIa study with ALX-0171 in infants with RSV planned for H1 2016, the results from the Phase IIb studies with ALX-0061 in RA planned for H2 2016, and the potential launch of caplacizumab in 2018."

 

 

Key figures (in EUR million)

 

H1 2015

H1 2014

Variance

Total revenue and grant income

38.4

22.2

73%

 

R&D income

38.0

21.8

74%

 

Grants

0.4

0.4

0%

Operating expenses

(45.9)

(29.8)

54%

 

R&D

(40.3)

(24.5)

64%

 

G&A

(5.6)

(5.3)

6%

Operating result

(7.4)

(7.6)

3%

Net financial result

(7.7)

1.3

(692%)

Net result

(15.2)

(6.3)

141%

Net cash burn

(35.0) (1)

(4.4)

(695%)

Cash at 30 June*

268.4 (2)

196.0 (3)

37%

(1)     Excluding net proceeds of EUR97.2M from the convertible bonds, which raised EUR100 million, announced on 20 May 2015

(2)     Including EUR1.6 million in restricted cash and net proceeds from the convertible bonds

(3)     Including EUR2.0 million in restricted cash

* Defined as liquidity position in the cash flow statement

 

 

The complete version of this press release is available via the link at the bottom of this page.

 

 

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 30 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., Merck Serono, Novartis and Taisho Pharmaceutical. 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:  [email protected]

 

Marieke Vermeersch

Associate Director Investor Relations

t:   +32 (0)9 262 00 82

m: +32 (0)479 49 06 03

e:  [email protected]

Follow us on Twitter @AblynxABLX

 

 

Ablynx media relations Instinctif Partners:

Sue Charles, Daniel Gooch

London office

t:   +44 (0)20 7866 7905

e:  [email protected]

 

Jim Rusagara

Brussels office

t:   +32 (0)2 626 9500

e:  [email protected]

 

 



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