Hyloris Reports Half-Year 2020 Financial Results and Business Highlights

By | August 11, 2020

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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 € thousand June 30, 2020 June 30, 2019 December 31, 2019  
 
Revenue 82 75 91  
Research and development expenses (1,172) (819) (4,577)  
General and administration expenses (2,454) (316) (808)  
Other income/(expenses) 20 72 86  
Operating loss (3,633) (1,026) (5,274)  
Loss of the period (3,742) (1,314) (5,768)  
Net cash used in operations 95 (911) (4,562)  
Net cash inflow/(outflow) of the period 66,578 (1,539) (2,482)  
Cash and cash equivalents 66,783 1,147 205  
  • Revenue over the period corresponded to royalties due on the sales of Sotalol IV made in the US by Hyloris’ distribution partner, AltaThera.
  • Research and development expenses amounted to €1.2 million for the first half of 2020, an increase of €0.3 million compared to the same period of 2019 resulting from additional outsourced product development, pre-clinical and clinical expenses on our product candidates.
  • General and administrative expenses amounted to €2.4 million, compared to €0.3 million in H1 2019. The €2.1 million increase was mainly driven by transaction costs associated to fund raises completed in H1 2020 and, to a lesser extent, to expenses associated to the ESOP warrants and to the strengthening of the management structure of the Company.
  • Net operating cash flow was marginally up for H1 2020 (€0.1 million) compared to a cash burn of €0.9 million for H1 2019. Higher operating expenses incurred in H1 2020 were compensated by the proceeds of the sale of the rights of HY-REF-038 (in vial form) to Alter Pharma.
  • Cash and cash equivalents increased to €66.8 million on June 30, 2020 compared to €0.2 million on December 31, 2019, resulting mainly from the issuance of convertible bonds in March and April 2020 for respectively €10.8 million and €4.4 million, and from the IPO completed on June 29, 2020 for €61.8 million.

Outlook for the remainder of 2020

Management believes that Hyloris is well positioned for the remainder of 2020 and beyond. The successful financing transactions undertaken during the first half of 2020 provide the Company with the required funding for: Development of the existing product portfolio until market release, the establishment of a commercial infrastructure in the United States for the commercialization of the IV Cardiovascular Portfolio under development, and the further expansion of the pipeline, both internally and through business development opportunities.

Hyloris Management anticipates several upcoming key milestones in the near term including:

  • the commercial launch of Sotalol IV under the new extended label in the US
  • the first European regulatory approvals of Maxigesic® IV
  • FDA submission for market approval of Maxigesic® IV and Tranexamic Acid.

The Company’s operations were not materially affected by the ongoing COVID-19 pandemic.

Audit report

KPMG Réviseurs d’Entreprises represented by Olivier Declercq has reviewed the condensed consolidated interim financial statements of Hyloris SA as of and for the six-month period ended June 30, 2020. Their review was conducted in accordance with International Standard on Review Engagements 2410, “Review of Interim Financial Information Performed by the Independent Auditor of the Entity” and their unqualified review report dated August 5, 2020 is attached to the interim financial information.

Rapport du commissaire

KPMG Réviseurs d’Entreprises représentée par Olivier Declercq a effectué l’examen limité des états financiers intermédiaires consolidés résumés de Hyloris SA pour la période de 6 mois arrêtée au 30 juin 2020. Leur examen a été effectué selon la norme ISRE 2410 « Examen limité d’informations financières intermédiaires effectué par l’auditeur indépendant de l’entité » et leur rapport d’examen sans réserve daté du 5 août 2020 est fourni en annexe aux informations financières intermédiaires.

CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION

ASSETS
(in € thousand)
June 30, 2020 December 31, 2019  
 
Non-current assets 2,757 2,245  
Intangible assets 2,648 2,138  
Property, plant and equipment 28 32  
Right-of-use assets 73 66  
Financial assets 9 9  
       
Current assets 69,056 3,739  
Trade and other receivables 427 333  
Other financial assets 6  
Other current assets 1,839 3,200  
Cash and cash equivalents 66,783 205  
       
TOTAL ASSETS 71,813 5,983  
       
EQUITY AND LIABILITIES
(in € thousand)
June 30, 2020 December 31, 2019  
 
       
Equity attributable to owners of the parent 59,666 (10,188)  
Share capital 128 89  
Share premium 101,114 23,982  
Retained earnings (39,823) (36,081)  
Other reserves (1,753) 1,822  
       
Non-current liabilities 7,948 22  
Borrowings 26 22  
Other financial liabilities 7,922  
       
Current liabilities 4,198 16,149  
Borrowings 47 44  
Other financial liabilities 409 13,130  
Trade and other liabilities 3,694 2,927  
Current tax liabilities 47 47  
Total liabilities 12,147 16,171  
       
TOTAL EQUITY AND LIABILITIES 71,813 5,983  

CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME FOR THE 6-MONTH PERIOD ENDED JUNE 30

in € thousand 2020 2019
Revenue 82 75
Cost of sales (109) (37)
Gross profit (27) 38
Research and development expenses (1,172) (819)
General and administrative expenses (2,454) (316)
Other operating income 20 72
Operating profit/(loss) (3,633) (1,026)
Financial income 620 91
Financial expenses (729) (380)
Profit/(loss) before taxes (3,741) (1,314)
Income taxes (1)
PROFIT/(LOSS) FOR THE PERIOD (3,742) (1,314)
     
Other comprehensive income
     
TOTAL COMPREHENSIVE INCOME OF THE PERIOD (3,742) (1,314)
     
Profit/(loss) for the period attributable to the owners of the Company (3,742) (1,078)
Profit/(loss) for the period attributable to the non-controlling interests (237)
     
Total comprehensive income for the period attributable to the owners of the Company (3,742) (1,078)
Total comprehensive income for the period attributable to the non-controlling interests (237)
     
Basic and diluted earnings/(loss) per share (in €) (0.21) (0.07)

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY FOR THE 6-MONTH PERIOD ENDED JUNE 30, 2020

in € thousand Attributable to equity holders of the Company Equity attributable to owners of the parent Non-controlling interests Total Equity
  Share capital Share premium Other reserves Retained earnings      
Share-based payment reserve Cost of Capital Other reserves
Balance at December 31, 2018 89 23,982 1,329 450 (28,097) (2,246) (2,216) (4,462)
Issuance of shares
Contribution by shareholder 28 28 28
Total comprehensive income   (1,078) (1,078) (237) (1,314)
Balance at June 30, 2019 89 23,982 1,329 478 (29,175) (3,296) (2,453) (5,748)
                   
Balance at December 31, 2019 89 23,982 1,329 493 (36,081) (10,188) (10,188)
Initial Public Offering 29 61,784 (3,656) 58,156 58,156
Issuance of convertible bonds         4,531   4,531   4,531
Conversion of convertible bonds 10 15,347 (102) (4,585) 10,671 10,671
Amortized costs on shareholders loans (5) (5) (5)
Share-based payments 243 243 243
Total comprehensive income (3,742) (3,742) (3,742)
Balance at June 30, 2020 128 101,113 1,572 (3,758) 434 (39,823) 59,666 59,666

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE 6-MONTH PERIOD ENDED JUNE 30

in € thousand 2020 2019
     
CASH FLOW FROM OPERATING ACTIVITIES    
Net result for the period (3,742) (1,314)
Adjustments for:    
Depreciation, amortization and impairments 52 51
Equity-settled share-based payment expense 243
Interest expenses on Convertible Bonds 235
Interest expenses on shareholders loans 317 193
Change in maturity of shareholders loans (381)
Change in fair value of derivative instruments (81)
Equity transaction costs 1,408
Income taxes 1
Other non-cash adjustments (59) 28
     
Changes in working capital:    
Trade and other receivables (94) 558
Other financial assets (6) 3
Other current assets 1,361 (1)
Trade and Other Payables 723 (976)
Other current liabilities 1
Other financial liabilities 119 549
Cash generated from operations 96 (911)
     
Taxes paid (1)
     
Net cash generated from operating activities 95 (911)
     
CASH FLOW FROM INVESTING ACTIVITIES    
Purchases of property, plant and equipment
Purchases of Intangible assets (487) (603)
Proceeds from other financial assets
     
Net cash provided by/(used in) investing activities (487) (603)
     
CASH FLOW FROM FINANCING ACTIVITIES    
Reimbursements of shareholders loans (8,050)
Proceeds from shareholders loans 3,250
Reimbursements of borrowings (26) (26)
Net proceeds from the Initial Public Offering 56,803
Net proceeds from the Convertible Bonds 14,994
Interests paid (1) (1)
     
Net cash provided by/(used in) financing activities 66,970 (26)
     
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 66,578 (1,539)
     
CASH AND CASH EQUIVALENTS at beginning of the period 205 2,687
CASH AND CASH EQUIVALENTS at end of the period 66,783 1,147

Conference Call Details

Hyloris will host a conference call on Thursday, 6 August at 2:00pm CEST accessible through the following numbers:

Event Plus Passcode:                      2533728

Belgium, Brussels                             02 793 3847
Belgium                                                0800 48 471
United States, New York              1 646 741 3167
United States                                    1 877 870 9135
United Kingdom                               08 444 819 752
France                                                  08 0510 1465
Netherlands                                       0800 023 5015

               
To ensure a timely connection, it is recommended that users register at least 10 minutes prior the scheduled start timing.

-Ends-

For more information, please contact:

Hyloris Pharmaceuticals
Stijn Van Rompay, CEO
+32 (0)4 346 02 07
[email protected]  

Consilium Strategic Communications
Amber Fennell, Chris Welsh, Ashley Tapp Lucy Featherstone, Taiana De Ruyck Soares
+44 20 3709 5700
[email protected] 

About Hyloris Pharmaceuticals SA
Based in Liège, Belgium, Hyloris is an early-stage innovative specialty pharmaceutical company focused on adding value to the healthcare system by reformulating well-known pharmaceuticals. Hyloris develops proprietary products it believes offer significant advantages compared to currently available alternatives, with the aim to address the underserved medical needs of patients, hospitals, physicians, payors and other stakeholders in the healthcare system. Hyloris’ portfolio spans three areas of focus: IV Cardiovascular, Other Reformulations and Established Market (high-barrier generics). Hyloris currently has two early commercial-stage products, Sotalol IV for the treatment of atrial fibrillation, commercialized through its partner AltaThera, and Maxigesic® IV, a non-opioid analgesic product for the treatment of pain, developed with the Company’s partner, AFT Pharmaceuticals. Additionally, Hyloris has 12 product candidates in various stages of development across the Company’s wider portfolio. Read more at www.hyloris.com. Hyloris stands for “high yield, lower risk” and relates to the 505(b)(2) regulatory pathway for product approval on which the Issuer focuses, but in no way relates or applies to an investment in the Shares.


1 IV stands for intravenous

2 Maxigesic® IV is a novel combination of paracetamol (also called acetaminophen in the United States) and ibuprofen in an intravenous form

3 Hyloris and Alter Pharma have some common shareholders which don’t have a controlling interest in Alter Pharma

4 Abbreviated New drug Application; application for a US generic drug approval for an existing licensed medication or approved drug

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