ABLYNX ANNOUNCES HALF-YEAR RESULTS FOR 2014

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Overig advies 28/08/2014 08:21
GHENT, Belgium, 28 August 2014 - Ablynx [Euronext Brussels: ABLX] today announced its results for the six-month period ending 30 June 2014, which have been prepared in accordance with the IAS 34 “Interim Financial Reporting” as adopted by the European Union. The Company’s operational highlights are also reported.
The results will be discussed during a webcast presentation today at 4pm CET, 10am EST
The webcast is accessible on the home page of Ablynx’s website at www.ablynx.com or by clicking here
To participate in the Q&A, dial +32(0)2 789 21 26 with confirmation code 6222038
Operational news
 Achieved clinical proof-of-concept with the anti-vWF Nanobody®, caplacizumab, in patients with acquired TTP. Preparations to start the Phase III study in 2015 have been initiated and exploratory discussions with potential partners are taking place
 Signed major discovery collaboration and licensing agreement in the field of cancer immunotherapy with Merck & Co, with an upfront payment of €20 million, €10.7 million in research funding and up to €1.7 billion in potential milestone payments plus royalties
 Announced positive results from two Phase I clinical inhalation studies with the anti-RSV Nanobody, ALX-0171, in healthy volunteers and subjects with hyper-reactive airways. In addition, ALX-0171 achieved in vivo proof-of-concept in an RSV animal model. Preparations continue to allow the initiation of a paediatric study with ALX-0171 in Q4 2014
 Initiated a Phase I bioavailability study with the subcutaneous formulation of the anti-IL-6R Nanobody, ALX-0061, partnered with AbbVie. Continued preparations to start Phase II studies in RA and SLE in 2015
 Ablynx’s partner, Merck Serono, completed the single ascending dose study in healthy volunteers and initiated a Phase Ib study with the bi-specific anti-IL-17A/F Nanobody, ALX-0761, in subjects with moderate to severe psoriasis
 Ablynx exercised an opt-out option for to the co-development project ALX-0751, a Nanobody in pre-clinical development against an undisclosed target in oncology. Merck Serono is now solely responsible for the research and development strategy and all costs associated with this programme while Ablynx has the potential to receive milestones and royalties
 After completing pre-clinical studies with the anti-IgE Nanobody, ALX-0962, for use in severe allergic asthma, a decision was made not to progress this programme into Phase I studies because of insufficient differentiation from the competition
 Following the termination of the Phase I study with BI 1034020 in Alzheimer’s disease, and after a full review of the programme, Boehringer Ingelheim (BI) decided not to move forward with the development of this anti-Abeta Nanobody, thereby ending the collaboration in Alzheimer’s disease that both companies entered into in January 2007
Financial news
 Raised €41.7 million in a private placement of new shares (accelerated book building procedure, ABO)
 Significant increase in cash income to €26.8 million (2013: €0.9 million)
 Revenue growth of 72% to €22.2 million (2013: €12.9 million)
 Net loss for the period reduced by 40% to €6.3 million (2013: €10.5 million)
 Net operational cash burn well-controlled at €3.9 million (2013: €21.6 million)
 Strong financial position with €196.0 million in cash, cash equivalents, restricted cash and short-term investments (cash from the ABO was received in the third quarter and hence did not contribute to the cash position for the first six months ending 30 June 2014)
Commenting on the half-year 2014 results, Dr Edwin Moses, CEO of Ablynx, said:
“We are very pleased with the progress we have made during the first six months of the year, both operationally and financially. We delivered our third clinical proof-of-concept and now have a Phase III ready asset, demonstrating an important transition for Ablynx into a late-stage clinical development company. We continued to advance the other lead clinical programmes, ALX-0171 for the treatment of RSV infection in infants and ALX-0061 for the treatment of RA and SLE. Our partner Merck Serono has further progressed ALX-0761, the bi-specific anti-IL-17A/F Nanobody, and started a Phase I/II study in patients with psoriasis.”
“We signed a second deal with Merck & Co, this time in the field of cancer immuno-therapeutics, which was a further validation of the broad applicability of our technology and more specifically the potential of the platform to produce multi-specific combinations, which may offer key advantages in developing novel drugs.”
“We successfully raised €41.7 million through an over-subscribed private placement of new shares with new and existing institutional investors both in the US and Europe, thereby further expanding and diversifying our shareholder base. The funds raised strengthen our financial position, allowing us to continue to invest in our technology platform and wholly-owned product pipeline and enabling us to make decisions on partnering of assets based on medium to long-term business considerations rather than short-term financial need.”
“Finally, we are looking forward to continuing good progress in 2014 for the >30 Nanobody programmes in research and development both as part of our wholly-owned pipeline and through our partnerships. We will also continue to invest in new product and technology programmes in line with our overall business strategy.”
Financial review
Key figures
(€ million)
H1 2014 H1 2013 % change
Revenues 22.2 12.9 72%
R&D income 21.8 12.0 82%
Grants 0.4 0.9 (56%)
Operating expenses (29.8) (23.8) 25%
R&D (24.5) (19.3) 27%
G&A (5.3) (4.5) 18%
Operating result (7.6) (10.9) 30%
Net financial result 1.3 0.4 225%
Net result (6.3) (10.5) 40%
Net operational cash burn (3.9) (21.6) (82%)
Cash at June 30th 196.0 (1) (2) 72.0 (3) 172%
(1) Not including proceeds from the private placement completed on 3 July 2014 (€41.7 million raised)
(2) Including €2.0 million in restricted cash
(3) Including €2.3 million in restricted cash and including proceeds from private placement closed on 28 February 2013 (€31.5 million raised)

Income statement
During the first six months of 2014, revenues increased by 72% to €22.2 million (2013: €12.9 million), driven by FTE funding and recognised income from the upfront payments received from AbbVie, Merck Serono, Merck & Co and Eddingpharm.
During the first half of 2014, research and development expenses increased by 27% to €24.5 million (2013: €19.3 million). This increase was mainly attributable to higher external development costs which are largely related to clinical trials expenditure. General and administrative expenses were €5.3 million (2013: €4.5 million).
As a result of the foregoing, the loss from continuing operations, before tax and net financial result, decreased to €7.6 million during the first half of 2014 (2013: €10.9 million).
The net financial result (€1.3 million) primarily comprises €0.7 million interest income from bank deposits and floating and fixed rate notes, the positive impact of discounting the tax credit (€0.3 million) and €0.3 million net realised and unrealised exchange gains.
The net loss decreased to €6.3 million during the first six months ending 30 June 2014 (2013: €10.5 million).
Balance sheet
The Company’s intangible assets include a portfolio of acquired patents which are being amortised over approximately 12 years, and technology licenses that are being amortised over 5, 18 and 20 years. The Company has not capitalised any other patents and it expenses all its research and development activities. The intangible assets also include software licenses.
The Company’s non-current tangible assets include the Company’s laboratory and office equipment, the investments in its facilities, tax receivables and €2.0 million restricted cash, which is related to a cash pledge that the Company has provided in respect of the service agreement with its landlord, NV Bio-Versneller. The Company does not own any real estate, but continues to invest in equipment for its research activities. Tax receivables include a tax credit of € 9.9 million, which increased with €1.9 million compared to 2013 as a result of continued R&D expenditures.
The Company’s current assets consist mainly of other short-term investments, and cash and cash equivalents.
The Company’s equity decreased from €46.2 million to €41.2 million mainly as a result of the incorporation of the loss for the period.
The Company’s current liabilities primarily relate to deferred income from collaborative agreements and trade payables.
Cash flow statement
Cash flow from operating activities represented a net outflow of €3.9 million as compared to a net outflow of €21.6 million during the first six months ending 30 June 2013. The difference primarily relates to the lower net loss and the cash upfront of €20 million received from Merck & Co.
Cash flow from investing activities represented a net inflow of €4.9 million as compared to a net outflow of €7.4 million during the first six months ending 30 June 2013. The variance relates to net movements in the sale of short-term financial investments (monies placed on term deposits with banks with an initial term between 3 and 12 months).
Cash flow from financing activities represented a net inflow of €0.1 million compared to a net inflow of €31 million during the first six months of 2013. The difference is primarily related to the proceeds from the private placement on 28 February 2013, which raised €31.5 million, and the exercise of warrants.
At 30 June 2014, the Company had €196.0 million in cash, cash equivalents, restricted cash and short-term investments.
Events and updates after 30 June 2014
The proceeds from the private placement of new shares announced on 30 June were received on 3 July.
On 15 July, Ablynx announced the launch of Spotlight Options on its shares (option trading symbol: ABY). The options are available on the derivatives market of Euronext Brussels.
During the Extraordinary General Shareholders’ Meeting of 24 April 2014, the issuance of a maximum number of 725,000 warrants was approved and 286,724 warrants have subsequently been issued on 17 July 2014 (133,556 warrants at €8.85/warrant for employees and 153,168 warrants at €9.09/warrant for consultants).
On 18 July, Ablynx announced the issuance of an additional 10,000 common shares in exchange for €64,197.57 as the result of the exercise of warrants by some employees and consultants of the Company. As a result of this transaction, Ablynx now has 54,001,659 shares outstanding.
On 13 August, Ablynx announced that it was awarded a €2.1 million grant by the Flemish Agency for Innovation by Science and Technology (IWT) to help advance a wholly-owned programme, which will explore a novel approach to the treatment of diseases of the eye by utilising some of the unique characteristics of Nanobodies. The grant is available over a period of three years and will allow the development and subsequent testing of Nanobody leads in relevant pre-clinical disease models.
Outlook for the remainder of 2014
A bioavailability study with the anti-IL-6R Nanobody, ALX-0061, partnered with AbbVie, is currently on-going with the results expected in Q4 2014.
The preparations to start a first-in-infant study with the anti-RSV Nanobody, ALX-0171, are progressing well, with the start of paediatric development expected in Q4 2014.
A Phase I bioequivalence study with the anti-vWF Nanobody, caplacizumab, is currently on-going and results are expected in Q4 2014. Subject to acceptance of the abstract, the complete data set from the TITAN Phase II study with caplacizumab in patients with acquired TTP will be presented at the American Society of Hematology (ASH) Annual Conference, taking place from 6-9 December 2014 in San Francisco, USA.
Commercial discussions with potential partners will continue on a number of topics as part of the normal course of business.
Good cash management will remain a key priority for the Company and guidance for the net ccash burn for the full year 2014, excluding the proceeds of the private placement, remains €30-35 million



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