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ABLYNX ANNOUNCES 2017 FULL YEAR RESULTSREGULATED INFORMATION A year of many momentous moments GHENT, Belgium, 22 February 2018 - Ablynx [Euronext Brussels and Nasdaq: ABLX] today announced its financial results for the year ended 31st December 2017, which have been prepared in accordance with IFRS as issued by the IASB and adopted by the European Union, business highlights year-to-date and the outlook for the remainder of the year. 2017 Highlights
Dr Edwin Moses, CEO of Ablynx said: "We are also pleased with the progress made with our anti-RSV Nanobody, ALX-0171, that is delivered via nebulisation, a technique with potential in other pulmonary diseases, and we look forward to the results from our Phase IIb RESPIRE study which should be available before the end of this year." "The offer made by Sanofi on 29th January 2018 to acquire Ablynx for €3.9 billion represents compelling value for shareholders and builds on a successful existing partnership. We strongly believe that Sanofi's global infrastructure, commitment to innovation and commercial capabilities will accelerate Ablynx's therapeutic programmes and maximise the potential of our pipeline and unique Nanobody technology platform to the benefit of all stakeholders." Operational review R&D update In January, Ablynx's partner, Merck KGaA, reported encouraging results from their Phase Ib study of the bi-specific anti-IL-17A/F Nanobody, in patients with moderate to severe psoriasis. In February, Ablynx submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for caplacizumab, its wholly-owned anti-vWF-Nanobody, caplacizumab, for the treatment of aTTP, including data from the Phase II TITAN study. In November, the MAA was further updated with the positive results of the Phase III HERCULES study that were announced in October. In May, Ablynx received a €15 million milestone payment from Merck KGaA for the completion of a pre-clinical package for a novel Nanobody (ALX-1141) targeting ADAMTS-5 in osteoarthritis, with Merck KGaA subsequently starting a Phase I study. In June, Ablynx achieved a second milestone in the immuno-oncology collaboration with Merck & Co., Inc., (known as MSD outside the USA and Canada) triggering a €2.5 million payment to Ablynx. In July, Ablynx received Fast Track designation from the FDA for caplacizumab for the treatment of aTTP. In August, Ablynx announced the completion of the sequential dose escalation part of the Phase IIb RESPIRE study in 36 infants hospitalised as a result of a RSV infection and the initiation of the parallel dose part in 144 infants with ALX-0171, the Company's inhaled anti-RSV Nanobody. Results from this Phase IIb study are expected in Q4 2018. In October, Ablynx announced positive topline results from the Phase III HERCULES study of caplacizumab, in 145 patients with aTTP. The study met its primary and two key secondary endpoints and reported a favourable safety profile. In December, Ablynx reported additional clinically important benefits of caplacizumab from its Phase III HERCULES study in aTTP at the 59th Annual Meeting of the American Society of Hematology (ASH) as part of the late-breaking abstracts session. Also in December, Ablynx announced positive data from a single and multiple dose Phase I study of caplacizumab, demonstrating comparable pharmacokinetics in 60 healthy Japanese and Caucasian subjects. Corporate developments In July, Ablynx announced a research collaboration and global exclusive licensing agreement with Sanofi to develop up to eight Nanobody product candidates initially focused on immune-mediated inflammatory diseases. Ablynx received an upfront payment of €23 million plus research funding for the initially selected targets and is eligible to receive further option exercise fees from additional targets and up to €2.4 billion in potential future milestone payments and royalties on the net sales of any products originating from the collaboration. In October, following the positive Phase III data of caplacizumab, Ablynx completed its initial US public offering, raising $230 million in gross proceeds from the sale of 13,144,500 ordinary shares in the form of ADSs, including the full exercise of the underwriters' option, at a price of $17.50 per ADS. The US public offering was nearly three times oversubscribed and was upsized from the $175 million initially targeted. Also in October, Ablynx established Ablynx, Inc., its subsidiary in the USA and appointed Mr Daniel Schneider as the General Manager to lead the commercialisation of caplacizumab in North America. Post-period highlights In January 2018, Ablynx annouced the appointment of Robert Friesen, PhD, as Chief Scientific Officer, effective 1st March 2018. Dr Friesen will lead the Company's scientific, research and technology activities and become a member of the Executive Committee. In January and February 2018, Ablynx announced changes to its Board of Directors with the departures of Dr Peter Fellner and Dr Bo Jesper Hansen respectively. Dr Russell G. Greig, who has been a non-executive Director of Ablynx since 2012, is now the new Chairman of the Board. On 16th February 2018, Ablynx announced that as part of the research collaboration signed in July 2017, Sanofi has exercised its options for two additional multi-specific Nanobody product candidates, triggering the payment to Ablynx of €13 million in exercise fees. On 1st March 2018, Piet Houwen will join Ablynx as Chief Operating Officer. Mr Houwen will be responsible for the support of Ablynx's business and R&D processes and become a member of the Executive Committee. Outlook for the remainder of 2018 During H1 2018, a BLA will be submitted for caplacizumab in the USA. In Europe, the Company has the potential to receive marketing authorisation for caplacizumab in aTTP in Q3 2018 followed by potential first commercial sales in Germany. For ALX-0171, a Phase II study in Japanese infants, hospitalised as a result of a RSV infection, and a global Phase II study in hematopoietic stem cell transplant patients who become infected with RSV, are expected to be initiated in H1 2018. Results from the ongoing Phase IIb study in RSV-infected hospitalised infants are expected in Q4 2018. The Phase II study results for vobarilizumab (anti-IL6R Nanobody) in 312 systemic lupus erythematosus (SLE) patients are expected in H1 2018 followed by AbbVie's decision on whether to opt-in and license the compound. The Company expects up to three Nanobodies to enter Phase I studies from our collaborative programmes during the year. Detailed financial review
(1) excluding €179.3 million net proceeds from Nasdaq IPO * Net cash burn is the difference between the cash position of the current year and the previous year minus the proceeds (net of issue costs) from the issue of ordinary shares Income statement Total revenues and grant income decreased by 35% to €55.5 million (2016: €85.2 million), mainly driven by lower recognition of upfront payments from the ongoing collaborations with AbbVie and Merck & Co., Inc. Total research and development costs decreased to €90.9 million (2016: €100.3 million) in line with the decrease in external development costs, largely related to lower clinical trials expenditure for vobarilizumab. General and administrative costs increased to €18.8 million (2016: €13.5 million), related to expenditure for consultancies and staff, including pre-commercialisation costs for caplacizumab and costs related to the IPO on Nasdaq completed in October 2017. As a result of the above, the operating loss was €54.2 million (2016: €28.6 million). The net financial loss of €54.3 million comprises finance expenses of €46.6 million resulting from an increase in the fair value of the derivative associated with the convertible bond (following an increase in the Ablynx share price at year-end compared to that at the end of 2016), and finance costs of €7.4 million (mainly related to the amortisation of the debt component of the convertible bond). As a result, the net loss for 2017 increased to €108.5 million (2016: net loss of €1.1 million). Balance sheet The Company's non-current assets of €78.5 million are €53.9 million higher than at 31 December 2016, mainly driven by the purchase of Interest Structured Notes with a maturity of two years and higher receivables for research and development incentives. Ablynx's current assets of €311.3 million consist mainly of cash and cash equivalents and other financial assets. Cash and cash equivalents consist of cash and deposits held on call with several banks. The Company also places cash in term accounts with maturities limited to a maximum of one year. Shareholders' equity increased from €103.1 million at the end of 2016 to €179.9 million at the end of 2017, mainly as a result of the €179.3 million net proceeds from the IPO on Nasdaq and the incorporation of the €108.5 million 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 partners. Cash flow statement Net cash outflow from operating activities was €57.8 million as compared to a net outflow of €66.6million in 2016. The difference primarily relates to lower operating expenses for the current period. Cash flow from investing activities resulted in a net outflow of €160.0 million as compared to a net inflow of €45.9 million in 2016. The net cash outflow primarily relates to the movements from deposits with a term of less than 1 month to deposits with a term greater than 1 month. Cash flow from financing activities represented a net inflow of €179.5 million compared to a net inflow of €70.4 million in 2016. The difference primarily relates to higher net proceeds from the issue of new shares on Nasdaq in 2017 compared to the net proceeds raised via an accelerated book building procedure in 2016. The Company ended the period with a total liquidity position of €354.3 million (2016: €235.4 million) which consists of cash and cash equivalents of €14.9 million, other financial assets of €337.8 million and restricted cash of €1.6 million. Investor Conference Call and Webcast In light of the pending transaction with Sanofi, Ablynx will not be hosting a conference call to discuss its 2017 full year results. Next financial events 27 March 2018 - online publication Annual Report 2017 Glossary of terms 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 45 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; Merck & Co., Inc., Kenilworth, New Jersey, USA; Merck KGaA; Novo Nordisk; Sanofi and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com. For more information, please contact Lies Vanneste Follow us on Twitter @AblynxABLX Ablynx media relations: Joele Frank, Wilkinson Brimmer Katcher Disclaimer Additional Information for US Investors At the time the tender offer is commenced, Sanofi will file, or cause to be filed, a tender offer statement on Schedule TO with the SEC and thereafter, Ablynx will file a solicitation/recommendation statement on Schedule 14D-9. Holders of Securities are urged to carefully review the documents that will be filed by Sanofi and Ablynx with the SEC because these documents will contain important information, including the terms and conditions of the tender offer. The offer to purchase, the related letter of transmittal and certain other tender offer documents, as well as the solicitation/recommendation statement, are available to all holders of Securities of Ablynx at no expense to them. These documents are available for free at the SEC's website at www.sec.gov. Additional copies may be obtained for free by contacting Sanofi at [email protected] or on Sanofi's website at https://en.Sanofi.com/investors. You should read the filings made by Sanofi and Ablynx with the SEC carefully before making a decision concerning the U.S. Offer. [1] Net cash burn is the difference between the cash position of the current year and the previous year minus the proceeds (net of issue costs) from the issue of ordinary shares Attachments: //www.globenewswire.com/NewsRoom/AttachmentNg/2d4f2974-6e82-4d3d-9220-4d622bf87dcf |