Hyloris reports full year results for 2022 & provides business outlook
15/03/2023 18:03
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230315:nGNE6BXL1m&default-theme=true
* Strong R&D progress & attractive commercial deals, including additional
Tranexamic Acid RTU out-licensing deals
* Potential U.S. market approval for Maxigesic® IV in H2 2023
* Promising new product candidates driving innovation and on track for a
planned acceleration towards a portfolio of 30 assets before 2025
* Revenues of €3 million, net loss decreased to €10.8 million with
increased R&D expenses
* €43 million in cash & cash equivalents, no financial debt
* Webcast at 1PM GMT / 2PM CET/ 9AM EST (register here
(https://hyloris.com/webcast))
Liège, Belgium - REGULATED INFORMATION – 15 March 2023 – 7PM CET
– Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty
biopharma company committed to addressing unmet medical needs through
reinventing existing medications, today announces its financial and
operational results for the year ending on 31 December 2022, as well as its
business outlook for 2023 and beyond.
Stijn Van Rompay, chief executive officer of Hyloris, commented: “Our
strategy is as successful as it is unique, and 2022 and early 2023 has proven
this once again. In an exceptionally difficult year for both the financial
markets and the healthcare sector, we successfully raised €15 million and
announced HY-083, a product candidate targeting idiopathic rhinitis. This was
followed in early 2023 by the in-licensing of a product candidate targeting
hypophosphatemia. Other pipeline assets progressed at a rapid pace and are
well underway to providing real solutions to unmet medical needs in the
upcoming years.”
“Several clinical trials will be conducted over the course of 2023 and our
team is paving the way to a market authorization for Maxigesic® IV in the
U.S. before year-end,” Van Rompay continued. “Our headcount grew from 21
at the end of 2021 to 39 today, nearly doubling in size and adding tremendous
amounts of expertise throughout our business. Thanks to proactive cost and
cash management and sufficient cash to support the current portfolio, Hyloris
is geared for an acceleration of its strategy with an increased focus on
repurposed products bringing more value to underserved patient populations and
Hyloris shareholders. We reviewed around 200 opportunities in 2022 and aim to
grow the portfolio to 30 product candidates and marketed products before 2025.
I am excited about the opportunities we are currently evaluating and eager to
disclose new deals to our shareholders in the near future.”
New product candidates added to the pipeline
HY-083 was announced in November 2022. This novel, proprietary formulation
will be administered intranasally to treat idiopathic rhinitis. Idiopathic
rhinitis is a medical disorder characterized by a nasal symptoms that resemble
nasal allergies and hay fever (allergic rhinitis) but are not related to a
known cause like allergens or infectious triggers.
Idiopathic rhinitis features an overexpression of TRPV1-receptors in the nasal
mucosa giving rise to nasal obstruction (a stuffy nose), rhinorrhea (a runny
nose) and sneezing, chronically affecting quality of life in patients. Our
product candidate aims to activate and depolarize these receptors in the nose.
An estimated 7% of the world population is affected by idiopathic rhinitis,
representing an estimated 19 million people in the U.S. alone. 13% of them
have moderate to severe idiopathic rhinitis, leading them to actively seek out
specialist care. Hyloris seeks to offer a new, unique, safe and approved
targeted therapy treatment option.
HY-088 was announced in January 2023, the Company in-licensed the technology
to develop development of an oral liquid targeting hypophosphatemia, a mineral
deficiency in the blood. In severe forms, this condition can be life
threatening. The condition can result in muscle and bone weakness, respiratory
or heart failure, seizures or coma amongst others.
There is a wide range of underlying conditions leading to hypophosphatemia
which could be hereditary (such as X-linked hypophosphatemia, hypophosphatemic
rickets, osteomalacia, Cushing syndrome) or acquired (anorexia nervosa,
recovery phase of diabetes-related ketoacidosis, alcohol withdrawal,
respiratory alkalosis, long term use of diuretic and phosphate binders).
Chronic hypophosphatemia can become life threatening, making direct treatment
of the hypophosphatemia desirable in cases where treating the underlying
condition does not solve the mineral deficiency.
It is estimated hypophosphatemia affects around 5% of hospitalized patients,
and a subpopulation needs direct treatment during and/or after their hospital
stay.
Treatment protocols for patients deficient in phosphate are well-established
and have proven useful in other situations of bone mineral imbalance. Oral
administration is the preferred way of treating hypophosphatemia, although in
most countries no approved drugs exist. Currently, physicians mostly rely on
compounded drugs which have, by definition, not been submitted for regulatory
scrutiny regarding safety, efficacy, and quality.
Further commercial roll-out
Maxigesic® IV, a unique combination of paracetamol and ibuprofen used for
post-operative non-opioid pain management, is currently licensed to partners
covering over 100 countries across the globe.
During 2022 and early 2023:
* A Complete Response Letter from the United States Food and Drug
Administration (FDA) was received, stating that it was unable to complete its
review, requesting additional information relating to potential leachable and
extractable compounds expected to be present in the drug product based on the
drug product packaging. Importantly, the agency did not report any issues
related to the data generated during the clinical development program.
* Hyloris and its partners believe to be able to address the recommendations
made and resubmit Maxigesic® IV before the summer of 2023 with a potential
New Drug Application (NDA) approval by the end of 2023. The non-opioid
analgesic space and the market for post-operative pain is growing rapidly and
is forecasted to reach $1.7 billion in 2028 in the U.S., up from $745 million
in 2019.(1)
* Submissions were made in 15 countries in Asia, Africa and Latin America,
including large pharmaceutical markets such as Canada and Mexico.
* Marketing authorizations have been granted in several countries including
Italy, Norway, Indonesia, The Netherlands, Finland, Singapore and Hong Kong.
* Launches occurred in 7 countries including Denmark, Sweden, Finland, Norway
and The Netherlands. Imminent launches are expected in several additional
countries, bringing the total number of countries where Maxigesic® IV will be
available up to more than 20.
* 4 U.S. patents were granted to Hyloris, ranging in expiry between 2035 and
2039.
Sotalol IV is a novel, intravenous, patented, IV formulation of Sotalol for
the treatment of atrial fibrillation and life-threatening ventricular
arrhythmias developed for the U.S. market. In 2022 further commercial efforts
were made to accelerate commercial roll-out, inclusion in hospital drug
formularies and clinical education of hospital staff.
Other commercial highlights
Tranexamic Acid RTU
Out-licensing agreements were signed in early 2023, covering an important
European country and a major Southeast Asian country, with a combined
population of over 60 million people. Earlier agreements have been signed in
2021 for Australia, New-Zealand and Canada.
In doing so, the Company confirms its strategy to out-license near the end of
the product development and to prioritize downstream revenue of the product
candidates over upfront milestone payments. Regulatory submission in the
partnered territories is expected within 2023, and additional out-licensing
agreements are expected, going forward.
Thomas Jacobsen, chief business development officer of Hyloris, commented:
“Thanks to recent out-licensing deals, the previously untapped global
potential of tranexamic acid RTU was brought further into view. We now believe
the future sales volume for tranexamic acid RTU outside of the United States
could outpace the future sales volume within the U.S.”
Tranexamic acid RTU is an antifibrinolytic drug. By inhibiting the
fibrinolysis, tranexamic acid promotes the formation of blood clots
HY-038
In December 2022, the Company out-licensed HY-038, a generic and non-core
asset for an out-licensing fee of €1 million. In doing so, Hyloris
highlighted its increased focus on repurposed product candidates which offer a
bigger difference in patient outcomes, as well as a higher expected return on
investment.
Cardiovascular portfolio
in Q4 of 2022, Hyloris and its development partner API renegotiated specific
commercial agreements. As a consequence, no further royalties are payable on
Sotalol IV to API, except if the in-market net product sales exceed USD 100
million. As part of renegotiation of commercial terms, the Company made
prepayments of expected future royalties amounting to $0.7 million.
R&D update
In 2022, R&D activities have progressed on all fronts, bringing our range of
14 product candidates and 3 high-barrier generic products closer to market in
different ways, following in the footsteps of 2 products which are already
marketed today. Some development timelines were impacted by the
Covid19-pandemic and the required transfer of manufacturing activities to
alternative third-party manufacturers. Multiple discussions are being held
with regulatory agencies and partners to confirm and validate development
plans.
A new and improved R&D lab is under construction at Légiapark in Liège
(Belgium), where our head office moved after the summer of 2022. This will
allow the Company to perform drug formulation and analytical activities
in-house for its growing pipeline, further streamlining processes and more
effectively deploying internal resources.
Cardiovascular portfolio
In its entirety, the cardiovascular portfolio covers a broad range of
indications in the biggest therapeutic segment globally. With products
advancing through or towards the clinical study phase, Hyloris expects to make
impactful differences in patients’ lives.
Main highlights for 2022 and expected milestones for 2023 include:
Aspirin IV: The clinical phase of the study assessing the pharmacokinetics has
been completed in 2022. Preliminary data has shown faster onset and good
tolerability of Aspirin IV with more analytical work required. An additional
clinical study is under preparation.
A strategic review led to a change in the contract manufacturing organisation
(CMO) for the manufacture of registration batches for the New Drug Application
(NDA).
Aspirin IV is an intravenous (IV) formulation of acetylsalicylic acid
(ASA). Aspirin is not available in the U.S. as an IV product.
Milrinone: Hyloris has contracted a CDMO for development and manufacturing. A
successful Type C meeting with the FDA was concluded, confirming development
plans for a novel, extended-release formulation offering convenient oral
dosing for a selected population of end-stage heart failure (HF) patients.
HY-074: The FDA has confirmed the development of the proposed formulation can
be pursued. Hyloris is preparing for the manufacturing of validation and
registration batches. Non-clinical work is expected to finish before H2 of
2023.
HY-074 is an intravenous formulation of current standard of care treatment for
acute coronary syndrome (ACS) to offer faster onset of action (and thereby
potentially reducing the risk of death), more convenient administration (more
notably in patients who are nauseated or unconscious), and dosage control. It
is currently available in oral form, which should allow for an optimal
switching strategy from the oral form to an IV.
Dofetilide IV: Both formulation development and non-clinical studies have been
successfully completed. A new CMO was contracted to ensure reliable
development and supply, hereby incurring a delay as a consequence of the
transfer.
Other Value-Added Programs
Our added-value programs are progressing well. Several discussions are ongoing
with regulatory agencies to confirm and validate development plans.
Main highlights for 2022 and expected milestones for 2023 include:
Tranexamic Acid Oral Mouth Rinse (previously HY-004): Positive Phase 1-results
showed that HY-004 was found to be well-tolerated under varied conditions with
no serious adverse events following tooth extraction. Hyloris also plans to
investigate its use for broader related indications in patients undergoing
oral surgical procedures with or without bleeding disorders that would benefit
from a locally acting antifibrinolytic agent. Recruitment for a Phase 3 study
will have started before H2 of 2023.
Miconazole/Domiphen Bromide: Recruitment for the phase 2 clinical trial is
completed and last patient last visit (LPLV) will have occurred by Q2 2023.
The results of this Phase 2 study will guide the Company for the preparation
and design of the next clinical trial.
Hyloris is co-funding the development of Miconazole/Domiphen Bromide, a
topical synergistic combination treatment for Recurrent Vulvovaginal
Candidiasis (rVVC), a chronic and debilitating vaginal infection commonly
caused by the yeast Candida albicans. This condition affects nearly 10% of
women during their lifetime. MCZ/DB has a strong scientific and business
rationale.
Alenura(TM): Multiple clinical trials are expected to start throughout 2023,
including a four-arm Phase 2, prospective, randomized, double-blind,
placebo-controlled, multi-center, single-dose, pharmacodynamic study comparing
Alenura(TM) to its 2 individual components (alkalinized lidocaine and heparin)
as well as placebo.
Alenura(TM), is a first-line drug treatment for acute pain in interstitial
cystitis/bladder pain syndrome (IC/BPS), a condition affecting at least 6
million people in the U.S. Alenura(TM) is a patented, innovative,
clinical-stage bladder instillation product candidate that combines lidocaine
in a new alkalinized form with heparin. Thanks to the novel dual
mode-of-action, Alenura(TM) has the unique potential to i) immediately relieve
pain, and ii) augment the mucous inner layer of the bladder wall.
Plecoid Agents: The definition of the preferred formulation has progressed
significantly in anticipation of clinical trials.
These chelating agents could improve the effectiveness of existing
chemotherapy in patients with acute myeloid leukemia (AML) and small cell lung
cancer (SCLC). Previous studies suggested that elevated levels of toxic metals
are associated with inferior survival in patients with AML (160.000 patients
globally).
Atomoxetine oral liquid: An innovative taste masking strategy was deployed,
targeting a preferred taste for young patients, following FDA feedback.
Atomoxetine is used primarily for the treatment of patients with attention
deficit hyperactivity disorder (ADHD). This product candidate allows for
improved dosing (as patient specific dosing is also in part based on body
weight) and convenience. Other oral liquid products in this therapeutic
segment have captured significant market share in competition with oral
solids, underlining the need for a (novel) oral liquid formulation of
Atomoxetine.
HY-029: A successful pilot study demonstrating bioequivalence was completed in
2022. A pivotal study can be expected to start in H2 of 2023. Industrial batch
manufacturing has been conducted to demonstrate pharmaceutical quality of the
medicinal product and robustness of the manufacturing process.
HY-029 is a liquid formulation of an existing antiviral drug that is currently
only available in oral solid form.
Management & Board changes
Both the C-level executives and all board members remained in their respective
positions, providing continuity in the company's leadership.
Business Outlook
With 16 reformulated and repurposed molecules, and 3 high-barrier generics,
several clinical trials are expected to start and/or finish within 2023.
The Company aims to accelerate growth of the product pipeline, with the end
goal of reaching 30 product candidates before 2025.
Assuming continued strategic out-licensing, commercial success for Maxigesic®
IV and Sotalol IV, additional non-dilutive funding and milestone payments, the
Company believes it is sufficiently capitalized to execute the full
development of the current pipeline assets (14 product candidates, 3 generics
and 2 commercial products).
Webcast details
The Company will host a webcast conducted in English to present its 2022
annual results and 2023 Business Outlook, followed by a live Q&A session. The
webcast will start on March 16(th) 2023 at 2PM CET / 1PM GMT / 9AM EST. To
join the webcast, please register at Hyloris.com/webcast
(https://www.globenewswire.com/Tracker?data=yuXvGcH3v_Hba-kpNfWTIU54bJMcD0WmUGFg9x6DhyvidQkTBryF-DwEfFCngkhBVAq6-tc5nVpmPtZSIkrlOKiGyrkfeXl-aP7IHnG81wA=)
FINANCIAL HIGHLIGHTS 2022
Year ended 31 December
(in € thousand) 2022 2021 Variance
Revenues 2.951 3.096 -4,7%
Cost of sales (94) (107)
Research and development expenses (10,151) (5,056) 100,8%
General and administration expenses (3,517) (2,900) 21,3%
Shares’ issuance related expenses - -
Earnings/losses from Associates and joint ventures (130) (191) -31,9%
Other operating result 303 (5,381)
Operating result ( 10 , 638 ) ( 10 , 541 ) 0,9%
Net financial result (127) (741) -82,9%
Income Taxes (4) (297) -98,7%
Result for the period ( 10 , 770 ) ( 11 , 579 ) -7,0%
Net operating cash flow ( 13 , 154 ) ( 11 , 250 ) 16,9%
Cash and cash equivalents 43 , 457 50 , 012 -13,1%
Financial Review 2022
Income statement
In 2022, total revenues remained stable around €3 million, driven by
increased royalties received for Maxigesic® IV and Sotalol IV, the
out-licensing agreement of €1 million for HY-038 with QliniQ, IP and
regulatory services rendered to development partners.In 2021, most revenue was
comprised of one-time milestone payment (€1.8 million) related to
Maxigesic® IV.
Research and development expenses increased to €10.15 million in 2022 versus
€5.06 million in 2021, in line with several product candidates maturing from
early to late-stage development, as well as the expansion of the number of
product candidates and increased headcount of the research and development
team.
Total general and administrative expenses amounted to €3.52 million versus
€2.90 million last year and is mainly explained by additional communication
and legal/HR costs. The company remains focus on strong cost and cash
management.
As a result, Hyloris closed 2022 with an operating loss of €10.64 million.
This was mainly driven by increased R&D expenses for supporting the
development of the portfolio.
The net financial loss in 2022 was €0.13 million. Financial income amounted
to €0.47 million, comprising mostly a net currency gain of €0.40 million
and interest received on deposits of €0.07 million, versus €0.03 million
last year.
Financial expenses amounted to €0.59 million versus €0.77 million in 2021
and comprised mostly the impact of the interest rates renegotiation of the
shareholder loans, bank interest expenses, currency losses and bank fees. In
2022, Hyloris successfully renegotiated the terms of the shareholder loans,
resulting in lower interest rates.
As a result, net losses in 2022 decreased to €10.77 million versus €11.58
million in 2021.
Statement of financial position
The Company’s non-current assets mainly consist of (1) investments in joint
ventures of € 3.9 million at year-end 2022, (2) intangible assets of €3.6
million at year-end 2022 including capitalized development, purchased assets
and in-licensing costs, versus €2.94 million in 2021, (3) the conversion of
the loan to Pleco into shares of €1.0 million, (4) a prepayment of future
royalties to API of $0.7 million and (5) a tax credit. Hyloris does not
capitalize research and development expenses until the filing for a marketing
authorization for the applicable product candidate. Research and development
expenditures incurred during the period were accounted for as operating
expenses. When an intangible asset is acquired and capitalized, the
amortization begins when the asset is available for commercialization.
The Company’s current assets mainly consist of €43.46 million in cash and
cash equivalents on total assets of €61.86 million, and trade and other
receivables of €5.13 million which mainly consist of services rendered to
partners, milestones from AFT related to Maxigesic and out-licensing revenue
(€1.0 million) from Qliniq.
In 2022, Hyloris raised an amount of €15 million in gross proceeds via an
accelerated bookbuild, offering 967,742 new shares, the capital and share
premium increased with respectively €6 thousand and €2.83 million through
the exercise of 1,200,000 outstanding transactions warrants leading to
company’s equity amounted to €55.04 million.
By year-end all shareholder loans were repaid, making the Company free of any
financial debt on 31 December 2022. The same shareholders expressed their
conditional willingness to support the Company with a renewed shareholder loan
in the future if needed.
Cash flow statement
Net cash outflow from operating activities was €13.15 million in 2022,
compared to €11.25 million in 2021. As part of renegotiation of commercial
terms, the Company made prepayments of expected future royalties amounting to
$0.7 million to API.
Net cash outflow from investing activities was €1.24 million in 2022,
compared to €3.08 million in 2021, and mainly related to investments in
joint ventures, capital expenditure and capitalization of development
expenses.
The financing activities amounted to a net cash inflow of €7.84 million in
2022 compared to a net cash outflow of €0.06 million in 2021 mainly driven
by the net proceeds from the private placement via an accelerated bookbuild
for net proceeds of €14.34 million, proceeds from the execution of
transaction warrants for €2.83 million and the reimbursement of the
shareholder loans for €9.28 million including accumulated interest.
Consequently, the cash and cash equivalents amounted to €43.46 million end
of 2022 versus €50.01 million at the end of 2021.
CONSOLIDATED STATEMENT OF FINANCIAL POSITION FOR THE YEAR ENDED DECEMBER 31
ASSETS (in thousands of euros) 31-Dec-22 31-Dec-21
Non-current assets 11 , 063 9 , 485
Intangible assets 3,607 2,944
Property, plant and equipment 176 122
Right-of-use assets 885 173
Equity accounted investments 3,948 4,079
Other investment, including derivatives 1.000 453
Trade and other receivables 1.447 1.714
Current assets 50 , 801 53 , 959
Trade and other receivables 5,127 2,321
Other investment, including derivatives 469 528
Prepayments 1,748 1,098
Cash and cash equivalents 43,457 50,012
TOTAL ASSETS 61 , 863 63 , 444
EQUITY AND LIABILITIES (in thousands of euros) 31-Dec-22 31-Dec-21
Equity 55.045 48.056
Share capital 140 129
Share premium 121,513 103,693
Retained earnings (53,476) (43,226)
Result of the period (10,770) (11,579)
Share based payment 1.621 2.391
Cost of Capital (4,460) (3,827)
Other reserves 476 476
Non-current liabilities 1.047 409
Borrowings 747 109
Other financial liabilities 300 300
Current liabilities 5 , 772 14 , 978
Borrowings 138 65
Other financial liabilities 3,212 11,815
Trade and other liabilities 2,422 2,749
Current tax liabilities - 349
TOTAL EQUITY AND LIABILITIES 61 , 863 63 , 444
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME FOR
THE YEAR ENDED DECEMBER 31
in € thousands 2022 2021
Revenue 2,951 3,096
Cost of sales (94) (107)
Gross profit 2 , 857 2 , 988
Research and development expenses (10,151) (5,056)
Selling, general and administrative expenses (3,517) (29)
Share of result of equity-accounted investees, net of tax (130) (191)
Other operating income 315 389
Other operating expenses (12) (5.770)
Operating profit/(loss) (EBIT) (10 , 638) (10 , 541)
Financial income 466 32
Financial expenses (594) (773)
Profit/(loss) before taxes (10 , 766) (11 , 282)
Income taxes (4) (297)
PROFIT/(LOSS) FOR THE PERIOD (10 , 770) (11 , 579)
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY FOR THE YEAR ENDED DECEMBER 31
(in thousands of euros) Attributable to equity holders of the Company Total Equity
Share capital Share premium Other reserves Retained earnings
Share-based payment reserve Cost of Capital Other reserves
Balance at December 31, 2021 129 103 , 693 2 , 391 (3 , 827) 476 (54 , 805) 48 , 056
Private Placement Via an Accelerated Bookbuild Offering 5 14,995 (634) 14,366
Equity Transaction via Transaction Warrants 6 2,826 (1,329) 1,329 2,832
Share-based payments 560 560
Total comprehensive income (10,770) (10,770)
Balance at December 31, 2022 140 121 , 513 1 , 622 (4 , 460) 476 (64 , 246) 55 , 045
CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE YEAR ENDED DECEMBER 31
in € thousands 2022 2021
CASH FLOW FROM OPERATING ACTIVITIES
Net result (10,770) (11,579)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation, amortisation and impairments 196 137
Share-based payment expense 560 576
Derivatives financial instruments 52 -
R&D Tax Credit (315) -
Interest expenses on shareholders loans 164 -
Loss on drecognition of shareholders loans 486 198
Equity transaction costs 29 -
Losses from Associates and joint ventures 130 191
Losses on disposal of PPE 16
Other non-cash adjustments 16 (1)
Changes in working capital:
Trade and other receivables (2,230) (2,068)
Other investment, including derivatives (27) (1,627)
Prepayments (650) 856
Trade and Other liabilities (468)
Other current and non-current liabilities - 2.063
Cash generated from operations (12 , 812) (11 , 253)
Interest paid 7 3
Income Taxes paid (349)
Net cash generated from operating activities (13 , 154) (11 , 250)
CASH FLOW FROM INVESTING ACTIVITIES
Purchases of property, plant and equipment (101) (107)
Purchases of Intangible assets (638) (954)
Proceeds from disposal of intangible assets - 219
Acquisition of Other Investments (500) (21)
Investments in associates and joint ventures - (1,270)
Repayment received from other financial assets - 216
Payment of other financial assets - (1,157)
Discontinued operations
Net cash provided by/(used in) investing activities (1 , 239) (3 , 075)
CASH FLOW FROM FINANCING ACTIVITIES
Reimbursements of borrowings and other financial liabilities (7,376)
Reimbursements of lease liabilities (79) (62)
Proceeds from other non-current liabilities 0 -
Proceeds from Private Placement via ABB 14,337 -
Proceeds from Execution Transactions Warrants 2,832 -
Interests paid (1,877) -
Net cash provided by/(used in) financing activities 7 , 838 (62)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (6 , 555) (14 , 387)
CASH AND CASH EQUIVALENTS at beginning of year 50,012 64,399
CASH AND CASH EQUIVALENTS at end of year, calculated 43,457 50,012
Audit Report
The statutory auditor, KPMG Bedrijfsrevisoren - Réviseurs d’Entreprises,
represented by Olivier Declercq, has confirmed that the audit procedures,
which have been substantially completed, have not revealed any material
misstatement in the accounting information included in the Company’s annual
announcement.
About Hyloris Pharmaceuticals SA
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 16 reformulated and
repurposed value-added medicines that have the potential to offer significant
advantages over available alternatives. Outside of its core strategic focus,
the Company also has 3 high barrier generic products in development and
registration phase. 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
https://hyloris.com/ and follow us on LinkedIn
(https://www.globenewswire.com/Tracker?data=Tvf7kGd6hQlNnH7N-o0oXhGc5iiedXh8dvyvLhQ9jCIcX30aTZweCfyisqghgdfVdMnrf3pHxCSCePFnWy-8kyEyDrKjwg_Eb_UCb2ZOf5twcQMQvaoeUylm6vY7wlvpgMKJFs3lbCANPYE97iuFNhrzMMNFRDLyj1Aw2yBRZFpgZog-_ENS6vpxPdNDNCIyTUowT2kXz0JIQFqVAM9veSK5mvX4PwGUQ_pcdxn28shnYBRppjOLSBPmuES_l-H3gsxJjCbja18zGiDB1cq2Ww==).
For more information, contact Hyloris Pharmaceuticals:
Stijn Van Rompay, CEO
stijn.vanrompay@hyloris.com
(https://www.globenewswire.com/Tracker?data=cZRmNYmuec2ut24bZxu_njXK3S7iHZkFpWsbm370owztdxIipx1Xqw3SR5WjOrwPbaV80HyzI6AeA5ZEVjohBA==)+32
(0)4 346 02 07
Jean-Luc Vandebroek, CFO
jean-luc.vandebroek@hyloris.com
(https://www.globenewswire.com/Tracker?data=aALq8BAagAWFQE4PbNwdiyXdCuPOzOxTIzA7QODKktEVnX3YkN45QJBR72PIBhAnhqmAjBVcvwxj8lRCOEM3zg==)+32
(0)478 27 68 42
Sven Watthy, Investor Relations & Communications manager
Sven.watthy@hyloris.com
(https://www.globenewswire.com/Tracker?data=LEx9Ng9dCDpYb_GL2z-Qx2Dg5HpSJW7T5ofEDxWbtFb0KJP7MArfgWk0yKzLocJm5iE6lX6-12EzIC-IgY2owQ==)+32
(0)499 71 15 29
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 Company 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.
(1) DelveInsight Market Research Report (2020)
Attachment
* PR Annual Results FY22 FINAL
(https://ml-eu.globenewswire.com/Resource/Download/0f3771d8-3e14-42eb-9eec-1456b9c9a99e)
Recent news on Hyloris Pharmaceuticals SA
See all newsEurope Research Roundup: Akzo Nobel, MTU Aero Engines, Symrise
Brief: Hyloris Pharmaceuticals Says It Obtains Exclusive License Rights In Europe & Turkey From Arbormed For Its Wilson's Disease Therapy
Brief: Hyloris Announces Partnership With Rosemont Pharmaceuticals For Atomoxetine Oral Solution In The U.S.
Brief: Hyloris Announces Positive Study Results For Dofetilide IV
Brief: Hyloris Pharmaceuticals SA Says HY 2024 Revenues (Royalties And Milestones) Increased To EUR 4,2 Million