On August 27, 2015 Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] reported 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 (Press release, Ablynx, AUG 27, 2015, View Source [SID:1234507354]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 €5.7 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 €100 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."
Corporate update – 1 January 2015 to date
Wholly-owned clinical product pipeline is advancing
Caplacizumab, anti-vWF Nanobody for the treatment of acquired TTP: Process validation and stability testing are currently on-going to support filing for conditional approval of caplacizumab in Europe in 2017. The first clinical sites for the Phase III study are expected to be opened shortly with the goal to complete this trial by the end of 2017, followed by BLA submission in the United States in 2018. Ablynx intends to retain 100% ownership of caplacizumab in the USA and Europe.
ALX-0171, anti-RSV Nanobody for the treatment of RSV infection in infants: A Phase IIa study in infants is planned to deliver results in H1 2016. The study started in Europe and is now proceeding in multiple clinical sites in the Asia-Pacific region where the RSV season is currently ongoing and the trial is expected to be completed in Europe when the RSV season starts later in the year. The endpoint of the study is primarily safety with secondary endpoints focused on clinical effect (such as wheezing, feeding, respiratory rate and general appearance), PK and PD, and immunogenicity.
More than 20 pre-clinical and clinical partnered programmes are progressing with the most advanced being in multiple Phase II clinical studies:
ALX-0061, anti-IL-6R Nanobody, partnered with AbbVie: Two Phase IIb studies in patients with active RA (total target enrolment: 558 patients) are on-going with results anticipated in H2 2016. Upon achievement of pre-defined success criteria, AbbVie would exercise its option to license ALX-0061 in RA and pay Ablynx an option fee as well as development, regulatory and commercial milestones totalling up to US$665 million plus double digit tiered royalties on net sales. In addition, the first patients from the Phase IIb RA studies have now rolled-over into the open-label extension study with ALX-0061, which will run until H2 2018. A Phase II study with ALX-0061 also commenced in patients with moderate to severe, active SLE, for which results are anticipated in 2018.
ALX-0761, anti-IL-17A/F Nanobody, partnered with Merck Serono: A Phase Ib study with this bi-specific Nanobody is currently on-going and is planned to be completed before the end of 2015. Merck Serono has an exclusive license to this programme and is responsible for the development and all related costs. Ablynx will receive milestones and royalties as the programme progresses.
More than 20 pre-clinical stage programmes are on-going with Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Inc., Merck Serono and Novartis, across a wide range of disease indications including immuno-oncology, oncology, inflammation, neurology and bone related disorders. The first Phase I trial arising from the Strategic Alliance with Boehringer Ingelheim is planned for later in 2015.
New partnerships and expansion of existing partnerships:
Ablynx and Merck & Co., Inc. (known as MSD outside the US and Canada) have further strengthened their relationship by:
1) A significant expansion of the immuno-oncology agreement (originally signed in 2014) targeting immune-checkpoint inhibitors, to include up to 12 additional Nanobody programmes (total now up to 17). The expansion agreement includes a €13.0 million upfront payment as well as full reimbursement of all related FTE costs over the term of the four year collaboration. In addition, Ablynx is eligible to receive further exclusivity fees and potential development, regulatory and commercial milestone payments of up to €340 million per programme, plus tiered royalties on annual net sales.
2) An 18 month extension through to September 2016 of the research collaboration signed in 2012, targeting an ion channel which could be important in neurology.
Ablynx entered into an exclusive license agreement with Taisho Pharmaceutical Co., Ltd. for the development and commercialisation of its anti-TNFα Nanobody, ozoralizumab, in Japan, for the treatment of RA. Taisho will be responsible for development, registration and commercialisation of antiTNFα Nanobody therapeutics in Japan. Ablynx received an upfront payment of US$3 million and is entitled to receive development and commercial milestone payments plus royalties.
Ablynx entered into an exclusive research collaboration with Genzyme (a Sanofi company) to investigate Nanobodies against a target that may play an important role in multiple sclerosis (MS). Ablynx has already generated Nanobodies against this challenging target and Genzyme will have the right to evaluate these Nanobodies in MS-relevant models in return for an exclusivity fee. Upon completion of these studies, Genzyme will have the option to negotiate a license agreement with Ablynx.
Other disclosures:
On 20 May, Ablynx successfully placed €100 million of senior unsecured convertible bonds, due May 2020, with a 3.25% coupon rate and a conversion price of €12.93, representing a 26.5% premium above the reference price of €10.2219, being the VWAP ("Volume Weighted Average Price") of Ablynx’s Ordinary Shares on the Brussels Stock Exchange (Euronext Brussels) on 20 May 2015.
Ablynx further strengthened its Board of Directors with the appointment of Professor Dr Baroness Lutgart Van den Berghe as an Independent Director.
Kim Simonsen, Chief Operations Officer, has left the company.
Income statement
During the first six months of 2015, total revenue and grant income increased by 73% to €38.4 million (2014: €22.2 million), mainly driven by FTE funding and recognised income from the upfront payments received from AbbVie, Merck & Co., Inc. and Merck Serono.
Research and development expenses increased by 64% to €40.3 million (2014: €24.5 million). This increase was mainly attributable to higher external development costs which are largely related to clinical trials. General and administrative expenses were broadly in line with 2014 and amounted to €5.6 million (2014: €5.3 million).
As a result of the above, the operating loss was €7.4 million in the first half of 2015 (2014: €7.6 million).
The net financial result (-€7.7 million) comprises finance income of €1.1 million which relates to interest income and realised exchange gains, and finance costs of €8.8 million which mainly relate to the effect of the fair value calculation of the convertible bond.
As a result of the above, the net loss increased to €15.2 million during the first six months ending 30 June 2015 (2014: €6.3 million).
Balance sheet
The Company’s intangible assets include a portfolio of acquired patents which are fully amortised and technology licenses that are being amortised over 5, 18 and 20 years. The Company expenses all its research and development activities in the IFRS consolidated financial statements. 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 €1.6 million restricted cash, which is a cash pledge that the Company has provided for the lease of its building. The Company owns one llama facility (which it previously rented) and continues to invest in equipment for its research activities. Tax receivables include an R&D tax credit receivable of €13.5 million.
The Company’s current assets of €274.6 million consist mainly of trade receivables, short-term financial investments, and cash and cash equivalents.
The Company’s equity decreased from €75.5 million at the end of 2014 to €63.8 million at 30 June 2015, mainly as a result of the incorporation of the loss for the period.
Non-current liabilities relate to the senior unsecured bonds due on 27 May 2020 with a principal value of €100 million.
Current liabilities consist mainly of trade payables and deferred income related to the upfront payments received from the partners.
Cash flow statement
Cash flow from operating activities represented a net outflow of €36.5 million as compared to a net outflow of €3.9 million during the first six months ending 30 June 2014. The difference primarily relates to a higher loss for the current period and the impact in 2014 of the cash upfront received from Merck & Co., Inc. in February 2014.
Cash flow from investing activities represented a net outflow of €35.0 million as compared to a net inflow of €4.9 million during the first six months ending 30 June 2014. The net cash outflow comprises primarily the net movements in cash and cash equivalents (on deposits with a term of less than 1 month) and other short-term financial investments (on deposits with a term greater than 1 month).
Cash flow from financing activities represented a net inflow of €100.0 million compared to a net inflow of €0.1 million during the first six months of 2014. The difference primarily relates to the net proceeds from the issuance of convertible bonds and the exercise of warrants.
The Company ended the period with a total liquidity position of €268.4 million (2014: €196.0 million) which consists of cash and cash equivalents of €40.0 million, other short-term financial investments of €226.8 million and restricted cash of €1.6 million.
Outlook for the remainder of 2015
Ablynx is on track to start a Phase III study with its wholly-owned anti-vWF Nanobody, caplacizumab, during Q3 2015. In parallel, process validation activities will continue to support filing for conditional approval of caplacizumab in Europe in early 2017.
The Phase IIa study with its wholly-owned anti-RSV Nanobody, ALX-0171, will continue in clinical sites in the Asia-Pacific region and Europe with the goal to complete recruitment by the end of 2015 and to deliver results in H1 2016.
Ablynx anticipates receiving further milestone payments from on-going collaborations and continues to expect its net cash burn for 2015 to be in the €70-80 million range (excluding net proceeds from the convertible bond).