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Hyloris Reports Half-Year 2020 Financial Results and Business Highlights

Hyloris Reports Half-Year 2020 Financial Results and Business Highlights

Successfully raised €80 million through public listing on Euronext Brussels and private placement

Funding of all development portfolio secured up until launch

Funding available for business development opportunities

Management to host a conference call at 2:00pm CEST today

Liège, Belgium – 6 August 2020 – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) (“Hyloris” and/or the “Company”), an early-stage innovative specialty pharmaceutical company focused on adding value to the healthcare system by reformulating well-known pharmaceuticals, today provides a business update and its consolidated financial results for the first half of 2020, prepared in accordance with IFRS as adopted by the European Union, and an outlook for the second half of 2020. The full interim condensed financial report is available on the Company’s website.

Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “Having successfully completed our public listing on Euronext Brussels, we are well positioned to deliver our goal to bring reformulated drugs with added value to the healthcare system to market as quickly as possible. We have a clear strategic vision to accomplish this and look forward to making progress through the development of our existing portfolio of product candidates, the establishment of a commercial team in the United States for our IV Cardiovascular portfolio and the potential organic or acquisition-driven expansion of our pipeline.”

First half 2020 operational highlights and relevant post-period events

Hyloris continued to successfully develop its product portfolio over the first six months of 2020. The following elements were identified as key highlights:

IV1 Cardiovascular portfolio

  • In March, the US FDA approved a Sotalol IV label expansion to include rapid loading of patients starting on sotalol. The commercialization of this new label expansion in the United States will start in H2 2020.
    • Oral Sotalol is a commonly used drug for the maintenance of sinus rhythm in patients with atrial fibrillation with a black box warning requiring patients to be continuously monitored for a period of days when initiating the therapy.
    • This novel Sotalol IV loading indication can decrease the length of hospital admission and potentially significantly decrease overall cost of care, while improving patient satisfaction and safety.

Other Reformulation portfolio

  • Maxigesic® IV2 was launched in Australia, New Zealand and the UAE in June 2020 by Hyloris’ partner AFT Pharmaceuticals (“AFT”).
    • Hyloris will receive a part of the margin generated in all countries were Maxigesic® IV will be commercialized except in Australia and New Zealand. 
    • Launch should support additional market approvals in the coming months.  
  • June – AFT signed an exclusive distribution agreement for the commercialization of Maxigesic® IV in four western European countries (Germany, France, Italy and Austria) with Austria’s Ever Pharma.
    • Commercialization could start in late 2020 in Germany and Austria.  
  • July – Completion of the enrolment of the open-label, multiple-dose, single arm exposure clinical Phase III trial of Maxigesic® IV in 232 patients with acute pain following orthopedic, general or plastic surgery.
    • This second Phase III study was undertaken in New Zealand and the United States and aims at determining the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure.
    • An earlier Phase III clinical trial conducted in 276 patients (for the treatment of acute postoperative pain after foot surgery (bunionectomy)) found that Maxigesic® IV provided significantly better pain relief than either Paracetamol IV (acetaminophen) or Ibuprofen IV alone at the same doses.
  • July – AFT signed a license and supply agreement for the commercialization of Maxigesic® for Bulgaria, Cyprus, the Czech Republic, Hungary, Romania and Slovakia with the Cyprus based multinational pharmaceutical company Medochemie.
    • Commercialization in these countries is expected to start in 2021

Established Market portfolio

  • February - Hyloris sold all rights, titles and interest in the product HY-REF-038 in vial form to Alter Pharma3, while retaining all rights to the Prefilled Syringe, for a consideration (of the transferred intellectual property rights) of € 1.4 million. The generic vial form is currently already commercially available in the United States.  
  • During the first quarter the ANDA4 application for HY-EMP-016 was submitted by Hyloris’ partner Perrigo at the FDA. Approval is expected in 2021.

Corporate highlights

  • Hyloris successfully raised €79.54 million gross proceeds.
    • In March and April, the Company issued convertible bonds totaling €15.15 million.
    • On June 29, the Company completed an Initial Public Offering on Euronext Brussels, raising a total of €61.81 million.
    • All bonds were converted into equity on June 30, at a 30% discount of the IPO price.
    • On July 30, the Company received an additional €2.58 million from the exercise of the over-allotment option, bringing the total gross proceeds of the IPO to €64.39 million.
  • Hyloris expanded its senior management team with the recruitment of an experienced Chief Legal Officer and Chief Financial Officer, who both bring extensive industry expertise in strategic legal, finance and business development planning and execution.
  • The Company also expanded its Board of directors with the addition of Leon Van Rompay and three independent directors, namely Carolyn Myers, James Gale and Marc Foidart.

Selected financial information

In € thousandJune 30, 2020June 30, 2019December 31, 2019 
Research and development expenses(1,172)(819)(4,577) 
General and administration expenses(2,454)(316)(808) 
Other income/(expenses)207286 
Operating loss(3,633)(1,026)(5,274) 
Loss of the period(3,742)(1,314)(5,768) 
Net cash used in operations95 (911)(4,562) 
Net cash inflow/(outflow) of the period66,578(1,539)(2,482) 

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