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Hyloris Reports 2021 Half-Year Results: Multiple Potential Value Inflection Points Ahead

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 On target to grow the broad product pipeline with at least 3 additional programmes before end 2021
Significant expansion of commercial footprint of non-opioid pain treatment Maxigesic® IV

Expected to start 2 clinical studies and to report the results from 2 clinical studies before year-end

€53.47 million in cash and cash equivalents to execute ambitious growth strategy

Conference call andwebcast today at 3pm CEST/9am EST (details below)

Liège, Belgium – 4 August 2021Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today reports its condensed consolidated financial results for the six-month period ending 30 June 2021, a year-to-date business update, and an outlook for the remainder of the year.

Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: On 29 June we celebrated our first anniversary as a publicly traded company on Euronext Brussels,and we would like thank all our stakeholders for their continued support. We are very pleased with the progress we have made over the past few months as we are successfully executing our business strategy and gradually moving up the value chain through our increased focus on repurposed medicines to offer meaningful improvementsfor patients, physicians, and payors.

We promised to grow our pipeline withfour new candidate products this year,and we are on track to deliver on that promise.In addition, during the next coming months we expect that two programmes will enter clinical development and to communicate theresults from two clinical studies. Finally, our commercial partners are making progresswith the roll-out ofSotalol IV in atrial fibrillation and Maxigesic® IV, a novel, potent, non-opioid pain medication, which is now licensed in more than 100 countries and launched in five countries. We look forward to updating the market as weexpect to report on multiplepotential value inflection points before the end of the year.”

FINANCIAL HIGHLIGHTS:SIX-MONTH PERIOD ENDING 30 JUNE 2021

Period ended 30 June
(in € thousand) 20212020Variance
Total revenue and other income1,1451021,023%
Revenues 838 82 922%
Other income 307 20 1,435%
Cost of sales(42)(109)(61%)
Operating expenses(9,016)(3,626)149%
Research and development expenses (1,560) (1,172) 33%
General and administration expenses (1,608) (2,454) (34%)
Other operating expenses (one-off)i (5,770) -- --
Operating result(7,913)(3,633)(118%)
Net result(8,240)(3,742)(120%)
Net cash (burn)/inflowii(10,934)66,578iii--
Cash and cash equivalents53,46566,783(20%)

i  One-off expenses related to the unwinding of the license agreements with the Alter Pharma Group
ii  For the period 1 January to 30 June
iii Including net proceeds from the IPO and issuance of convertible bonds

OPERATIONAL REVIEWYEAR-TO-DATE

Commercial products

  • Maxigesic IV, a novel, patented, potent, intravenous (IV) non-opioid treatment for post-operative pain – commercialised globally with AFT Pharmaceuticals (AFT) and local distribution partners:
    • Start of European roll-out with launches in Germany, the largest pharmaceutical market in Europe, and Austria.
    • Expansion of exclusive license and distribution agreement with Pharma Bavaria International for commercialisation in South America, thereby broadening the addressable market for Maxigesic IV in Latin America and the Caribbean to 17 countries.
    • Major partnership in the U.S. with Hikma Pharmaceuticals whereby Hyloris is eligible to a license fee and regulatory and commercial-based milestone payments of up to USD$10 million plus a share of any additional product-related income received by AFT in the U.S.
    • Significant enlargement of European footprint through multiple exclusive license agreements for commercialisation in Poland, Greece, the Nordics, Spain, Portugal, and The Netherlands.
  • Sotalol IV, a novel, patented, IV formulation of oral sotalol for the treatment of atrial fibrillation – commercialised by AltaThera in the U.S.: significant expansion of AltaThera’s sales force to accelerate commercial roll-out and inclusion in hospital drug formularies. 

R&D and regulatory update

  • Maxigesic IV:
    • Preparations to submit a new drug application (NDA) to the FDA further advanced, with filing in the U.S. expected shortly.
    • Obtained additional national marketing authorisations in Europe and Rest of the World, thereby further broadening the geographical base where Maxigesic IV is approved to 24 countries today.
    • Patents granted (exclusivity to 2035-2038) across multiple jurisdictions, including Japan, Singapore, Canada, Mexico, and the Republic of China.
  • HY-004: initiated a Phase 1 study to evaluate the pharmacokinetics (PK) and safety of HY-004 oral solution – the study also includes exploratory efficacy endpoints.
  • Pipeline expansion: signed a partnership with Purna Female Healthcare (PFH) to develop and commercialise Miconazole-Domiphen Bromide (MCZ-DB) a novel, topical, dual mode-of-action combination treatment for severe and recurrent vulvovaginal candidiasis (VVC), a debilitating vaginal fungal infection for which there is currently no effective treatment available.
  • Other: regulatory interactions ongoing to address questions raised by the FDA following the submission of the marketing applications for Tranexamic Acid RTU and HY-016.

Corporateupdate

  • Successfully renegotiated and unwound the license agreements with the Alter Pharma Group for Maxigesic IV, HY-075, HY-038, and Fusidic Acid Cream. Hyloris paid the Alter Pharma Group a total one-off lump sum of €5.25 million with an additional €0.5 million in potential earn-out payments, thereby waiving all past commitments and any further future financial obligations towards the Alter Pharma Group.
  • Rental agreement for laboratory space to perform drug formulation and analytical activities and further streamline processes and more effectively capitalise on internal resources.
  • Hyloris’ shareholders unanimously approved all resolutions at the 2021 Annual General Meeting, including the appointment of Chris Buyse to the Board of Directors.
  • Further strengthened the team and built internal capabilities with key hires in management and clinical and regulatory affairs.

OUTLOOK FOR THE REMAINDER OF 2021

Hyloris anticipates delivering on key value inflection milestones within its strategic focus areas:

  • Pipeline expansion: addition of at least three new reformulated or repurposed product candidates through in-licensing or joint ventures
  • Clinical development:
    • Study results: i) pivotal study of Atomoxetine oral solution (attention deficit hyperactive disorder); ii) Phase 1 PK/safety study of HY-004 oral solution (indication not disclosed)
    • Study starts: i) pivotal study of Atomoxetine oral solution; ii) Phase 2 dose-finding study of Miconazole Domiphen-Bromide (severe and recurrent VVC)
  • Commercial products: i) Maxigesic IV: continue roll-out in Europe and Rest of World, and submission of a new drug application to the FDA; ii) Sotalol IV: accelerate roll-out in the U.S.

With cash and cash equivalents of €53.47 million at 30 June 2021, the Company is well-capitalised to advance all current pipeline assets as planned and execute its current business plan with the expectation to expand the portfolio to 30 candidate - and marketed products by 2024.

FINANCIAL REVIEW FOR THESIX-MONTH PERIOD ENDING 30 JUNE 2021

Total revenue and other income

During the first six months of 2021, total revenue and other income increased to €1,145 thousand compared to €102 thousand in the first half-year of 2020.

Revenues increased by 922% to €838 thousand, compared to €82 thousand for the first six months of 2020. The significant growth was mainly driven by recognised income from a pre-commercial milestone payment related to Maxigesic IV, partnered with AFT Pharmaceuticals.

Other income amounted to €307 thousand compared to €20 thousand for the same period in 2020 thanks to higher R&D related incentive income from the Federal government.

Results

The Company realised a net loss of €8,240 thousand for the six-month period ending 30 June 2021, compared to a net loss of €3,742 thousand for the first half-year of 2020. The higher loss is mainly driven by the one-off lump sum of €5,250 thousand and €500 thousand future potential earn-out payments related to the successful renegotiation and unwinding of thelicenseagreements with the Alter Pharma Group for lead products, Maxigesic IV, HY-075 and HY-038, and the high-barrier generic, Fusidic Acid Cream in Canada. This transaction was recognised as other operating expenses.

Operating loss amounted to €7,913 thousand for the first half-year of 2021, compared to an operating loss of €3,633 thousand for the first half-year of 2020, mainly impacted by the successful renegotiation and unwinding of thelicenseagreements for the lead products with the Alter Pharma Group.

R&D expenditure during the first six months of 2021 amounted to €1,560 thousand, compared to €1,172 thousand for the first half-year of 2020. The increase was mainly driven by the costs related to outsourced product development activities.

Despite the further expansion of the Company’s Group Structure and key hires, general and administration expenses decreased to €1,608 thousand, compared to €2,454 thousand for the first half-year of 2020. The difference is mainly driven by the transaction costs in 2020 related to the successful IPO on Euronext Brussels and the issuance of convertible bonds.

Cash Position

Current cash and cash equivalents totalled €53,465 thousand on 30 June 2021, compared to €66,783 thousand on 31 December 2020.

A net decrease of €10,934 thousand in cash and cash equivalents was recorded for the six-month period ending 30 June 2021, compared to a net increase of €66,578 thousand during the first half-year of 2020. The net decrease was mainly driven by the net operational cash burn of €9,282 thousand, impacted by one-time other expenses, and committed milestone investments in joint ventures (net cash used in investing activities), compared to a net cash inflow for the same period in 2020 of €66,970 thousand, driven by the net proceeds from financing activities from the IPO on Euronext Brussels and the issuance of convertible bonds.

AUDIT REPORT

The statutory auditor, KPMG Bedrijfsrevisoren - Réviseurs d’Entreprises, represented by Olivier Declercq, has reviewed the condensed consolidated interim financial statements for the six-month period ended June 30, 2021. Its 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 its unqualified review report dated August 3, 2021 is attached to the 2021 half-year financial report which is available on the Hyloris website.

CONFERENCE CALL AND WEBCAST

Hyloris will host a conference call with audio webcast today at 3pm CEST/9am EST, followed by a Q&A session. The webcast may be accessed on the Events page of the company’s website or by clicking here. To participate in the Q&A session, please dial one of the following numbers, ten minutes prior to the start of the live call:

Belgium                +32 2 79 338 47
France                  +33 1 70 700 781
Netherlands           + 31 20 795 6614
United Kingdom       +44 2071 928 338
United States          +1 646 741 3167

Confirmation code 2687826

A replay will be available on the events page of the Hyloris website.

UPCOMING IR EVENTS2021 AND PRELIMINARY FINANCIAL CALENDAR 2022

9 September 2021        Annual KBC Securities Life Science Conference
23 October 2021          VFB Happening
16 March 2022            Full Year 2021 Financial Results and Business Update

About Hyloris Pharmaceuticals

Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimising existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. Hyloris has built a broad, patented portfolio of 13 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over available alternatives. Two products are currently in initial phases of commercialisation with partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. The Company’s development strategy primarily focuses on the FDA’s 505(b)2 regulatory pathway, which is specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This pathway can reduce the clinical burden required to bring a product to market, and significantly shorten the development timelines and reduce costs and risks. Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn.

For more information, please contact Hyloris Pharmaceuticals:

Marieke Vermeersch
VP Investor Relations and Corporate Communications
M: +32 (0)479 490 603
marieke.vermeersch@hyloris.com

Disclaimer and forward-looking statements
Hyloris means “high yield, lower risk”, which 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.
Certain statements in this press release are “forward-looking statements.” These forward-looking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

ASSETS
(in € thousand)

30 June
2021

31 December
2020

Non-current assets7,3232,569
Intangible assets 2,228 2,381
Property, plant and equipment 23 24
Right-of-use assets 129 152
Investments in associates and joint ventures 4,192 -
Financial assets 12 12
Other non-current assets 739 -
Current assets56,66166,613
Inventories - -
Trade and other receivables 2,082 253
Other financial assets 20 7
Other current assets 1,093 1,954
Cash and cash equivalents 53,465 64,399
TOTAL ASSETS63,98469,182
EQUITY AND LIABILITIES
(in € thousand)

30 June
2021

31 December
2020

Equity 51,08059,059
Share capital 129 129
Share premium 103,693 103,693
Retained earnings (51,466) (43,226)
Other reserves (1,276) (1,537)
Liabilities12,90410,123
Non-current liabilities10,3017,991
Borrowings 83 106
Other financial liabilities 10,218 7,885
Current liabilities2,6032,132
Current borrowings 47 46
Other current financial liabilities 1,500 409
Trade and other liabilities 1,004 1,629
Current tax liabilities 47 47
Other current liabilities 5 -
TOTAL EQUITY AND LIABILITIES63,98469,182

CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

STATEMENT OF COMPREHENSIVE INCOME
(in € thousand)

30 June
2021

30 June
2020

Revenues 838 82
Cost of sales (42) (109)
Gross profit796(27)
Research and development expenses (1,560) (1,172)
General and administrative expenses (1,608) (2,454)
Earnings/losses from Associates and joint ventures (78) -
Other operating income 307 20
Other operating expenses (5,770) -
Operating profit/(loss) (EBIT)(7,913)(3,633)
Financial income 20 620
Financial expenses (347) (729)
Profit/(loss) before taxes(8,240)(3,741)
Income taxes - (1)
PROFIT/(LOSS) FOR THE PERIOD(8,240)(3,742)
Basic and diluted earnings/(loss) per share (in €)(0.32)(0.21)

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

Attributable to equity holders of the CompanyTotal Equity
Share capitalShare premium Other reservesRetained earnings
(in € thousand)Share based payment reserve

Cost
of Capital
Other
reserves
Balance at31 December 20198923,9821,329-493(36,081)(10,188)
Initial public offering 29 61,783 (3,656) - - 58,156
Share-based payments - - 243 - - - 243
Issuance of convertible bonds - 4,531 4,531
Conversion of convertible bonds 10 15,348 (102) (4,585) - 10,671
Amortised costs on shareholders loans - - - (5) - (5)
Total comprehensive income - - - (3,742) (3,742)
Balance at 30 June 2020128101,1131,572(3,758)434(39,823)59,666
Balance at31 December2020129103,6931,814(3,827)476(43,226)59,059
Share-based payments - - 261 - - - 261
Total comprehensive income - - - - (8,240) (8,240)
Balance at30 June2021129103,6932,075(3,827)476(51,466)51,080

CONSOLIDATED STATEMENT OF CASH FLOWS

(in € thousand)



30 June2021

30 June 2020

CASH FLOW FROM OPERATING ACTIVITIES
Operating result (8,240) (3,742)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation, amortisation and impairments 50 52
Share-based payment expense 261 243
R&D tax credit 63 -
Interest expenses on convertible bonds - 235
Interest expenses on shareholders loans 234 317
Change in maturity of shareholders loans - (381)
Change in fair value of derivative instruments - (81)
Equity transaction costs - 1,408
Income taxes - 1
Losses from associates and joint ventures 78 -
Other non-cash adjustments 99 (59)
Changes in working capital:
Trade and other receivables (1,830) (94)
Other financial assets - (6)
Other current assets 861 1,361
Other non-current assets (739) -
Trade and other lliabilities (625) 723
Other current liabilities 5 -
Other financial liabilities - 119
Other non-current liabilities 500 -
Cash generated from operations(9,282)96
Taxes paid - (1)
Net cash generated from operating activities(9,282)95
CASH FLOW FROM INVESTING ACTIVITIES
Purchases of property, plant and equipment (4) -
Purchases of Intangible assets (150) (487)
Investments in associates and joint ventures (1,270) -
Acquisition of other financial assets (13) -
Other 219 -
Net cash provided by/(used in) investing activities(1,218)(487)
CASH FLOW FROM FINANCING ACTIVITIES
Reimbursements of borrowings and other financial liabilities (409) (8,050)
Proceeds from borrowings and other financial liabilities - 3,250
Reimbursements of lease liabilities (24) (26)
Proceeds from convertible bonds - 56,803
Proceeds from IPO - 14,994
Interests paid - (1)
Net cash provided by/(used in) financing activities(434)66,970
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS(10,934)66,578
CASH AND CASH EQUIVALENTS at beginning of the period64,399205
CASH AND CASH EQUIVALENTS at end of the period, calculated53,46566,783

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