Hyloris Reports Full Year Results for 2023 & Provides Business
Outlook
Hyloris Reports Full Year Results for
2023 & Provides Business Outlook
- Total
revenue and other income amounted to €4.4 million
- Stronger
growth expected in 2024 of both sales and gross margin, mainly
fueled by the recent launch in the U.S. of Maxigesic® IV and
Podofilox gel, the global roll out of Maxigesic IV® and commercial
deals
-
Increased operating R&D expenses while net operating cash
outflow remained stable versus 2022
-
Significant R&D progress including clinical and regulatory
achievements with multiple NDA submissions expected within the next
15 months
-
Attractive commercial deals, including an out-licensing deal for
Atomoxetine Oral Liquid in Canada
-
Promising new product candidates driving innovation, targeting a
portfolio of 30 assets by 2025
-
€30.2 million in cash & cash equivalents, no financial
debt
-
Webcast on 14 March 2024 at 1PM GMT / 2PM CET/ 9AM EST (Register
here)
Liège, Belgium – 14 March 2023 – 7AM CET
– Regulated Information
– Inside Information -
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 2023, as well as its business
outlook for 2024.
Stijn Van Rompay, Chief Executive
Officer of Hyloris, commented: “Despite a
challenging year for the global healthcare industry, 2023 proved to
be a year of significant accomplishment for Hyloris. As a company
built on the unique and successful strategy of repurposing and
reformulating existing pharmaceuticals, we achieved a major
milestone with the U.S. approval of Maxigesic® IV in partnership
with AFT Pharmaceuticals, marking a crucial step in delivering this
innovative pain management solution to American patients.
Additionally, approval was secured for
Podofilox gel, the first generic version of Condylox® Gel,
expanding access to this medication. Our unwavering commitment to
research and development yielded impressive progress across our
diverse product pipeline. These advancements solidify our position
as a leader in providing solutions to unmet medical needs in the
years to come. We are incredibly proud of our team's dedication and
resilience throughout this transformative year.
Looking ahead to 2024, Hyloris is poised for
continued growth and innovation. We plan to significantly bolster
our pipeline with the addition of several new product candidates
addressing critical unmet medical needs. Recent additions,
including treatments for Vulvar Lichen Sclerosus and Burning Mouth
Syndrome, demonstrate our commitment to expanding our portfolio and
addressing a wider range of patient needs. We remain confident in
our ability to continue delivering value to patients, shareholders,
and all stakeholders and expect continued growth beyond
2024.
Commercial Highlights
Maxigesic® IV is a patented,
unique combination, intravenous formulation for the treatment of
post-operative pain and is currently licensed to partners covering
over 100 countries across the globe.
During 2023 and early 2024:
- A marketing authorization was
granted by the United States Food and Drug Administration (FDA) in
October 2023.
- Hikma Pharmaceuticals (Hikma), a
leading supplier of complex injectable hospital products, has
launched the product in the U.S. under the tradename Combogesic®
IV. An exclusive license and distribution agreement had previously
been signed between Hyloris’ partner AFT Pharmaceuticals (AFT) and
Hikma.
- Additional submissions for marketing
authorization were made in 13 countries in the Middle East, Africa,
Latin America, and Asia.
- Additional marketing authorizations
have been granted in 8 countries including Poland, South Africa,
and Spain. In early 2024, Health Canada granted approval bringing
the total number of approvals to 50.
- Launches occurred in 14 countries
including Norway, Singapore, Belgium, The Netherlands, the Czech
Republic, and Romania. Imminent launches are expected in several
additional countries, bringing the total number of countries where
Maxigesic® IV will be available up to more than 30.
In the United States, chronic opioid usage in
patients following surgery averages around 9%, ranging from 4% to
24% among various specialties. Drug overdoses involving opioids
resulted in over 80.000 deaths in the U.S. in 2021. Patients who
experienced an opioid overdose accounted for nearly $2 billion in
annual hospital costs.
Sotalol IV is a patented,
intravenous formulation of Sotalol for the treatment of atrial
fibrillation, and life-threatening ventricular arrhythmias
developed for the U.S. Sotalol IV potentially allows to
significantly reduce the length of hospital stay and the overall
cost of care and potentially improve patient outcomes.
Hyloris is taking further steps targeting to
increase product related revenues in the future (see also: Ongoing
Legal Proceedings).
Podofilox Gel (Product
previously referenced as HY-016)
In December 2023, our partner Padagis US LLC
(Padagis) received marketing authorization for Podofilox gel 0.5%
from the FDA. Padagis launched the product in December 2023. It is
the first generic for Condylox® Gel in the U.S.
Podofilox Gel is an antimycotic drug for the
topical treatment of external genital and perianal warts caused by
certain types of the Human Papilloma Virus (HPV). Around 1% of the
sexually active population in the U.S. presents with genital or
perianal warts.1 To date there is a vaccine for HPV but
no cure.
For the 12 months period ending December 2022,
Condylox® Gel had U.S. sales of approximately $9 million according
to IQVIA Health.
Other Commercial Highlights
Tranexamic Acid RTU
Additional out-licensing agreements were signed
for Tranexamic Acid RTU in 2023. These agreements cover a large
European country and several major Asian countries, with a combined
population of over 60 million people. Previous agreements have been
signed in 2021 for Australia, New-Zealand and Canada. In 2023, our
licensing partner for Canada submitted an application for approval
by Health Canada. Additional regulatory submissions in the
partnered territories are in progress, and more out-licensing
agreements are expected going forward. An Abbreviated New Drug
Application (ANDA) has been submitted to the U.S. FDA.
Tranexamic acid injection is an established
antifibrinolytic agent used in emergency situations with major
hemorrhages and is also used as a prophylactic agent in surgeries.
Hyloris is developing a ready-to-use (RTU) formulation for
infusion.
Atomoxetine Oral Liquid
An out-licensing agreement was signed with Kye
Pharmaceuticals (Kye) in October 2023. Kye will exclusively
commercialize the product in Canada where atomoxetine is currently
not available as an oral liquid formulation. The introduction of an
oral liquid formulation in the ADHD (Attention Deficit
Hyperactivity Disorder) medication category has historically led to
significant market share gains2. This suggests a strong
potential for Atomoxetine Oral Liquid in Canada, where an estimated
1.8 million people (or 4-6% of adults and 5-7% of children) are
diagnosed with ADHD3. ADHD is a chronic condition, with
symptoms persisting into adulthood for 60-80% of
patients4.
Under the terms of the agreement, Hyloris will
be eligible to receive attractive sales-related milestone payments
(totaling up to USD 7.5 million), and a substantial share of the
generated revenue.
New Pipeline Product
Candidates
Our business development team leverages its
expertise in existing products, real-world data, and a vast network
to identify unmet medical needs. This includes collaborating with
healthcare professionals, patient groups, insurers (payors), and
industry partners. In 2023 over 87 opportunities were screened and
3 product candidates will meet our investment criteria of €7
million5 in 7 years or less.
For product candidates which Hyloris intends to
out-license, the strategic goal is to capture a substantial part of
the net product margin realized by our commercial partners. Hyloris
aims to achieve this by partnering these assets close to regulatory
submission, except in countries where additional local clinical
trials are required. In general, we will prioritize in-market
product sales or profit-based participation over (upfront)
milestone payments.
We aim to increase our product portfolio to 30
assets by 2025, with a focus on accelerating pipeline growth in the
near future.
HY-091, a novel topical
treatment candidate for Vulvar Lichen Sclerosus (VLS) was announced
in January 2024. VLS is a chronic inflammatory condition affecting
an estimated 3% of women, causing severe pain, itching, and
discomfort, significantly impacting their quality of life. HY-091
is being developed as a convenient and user-friendly treatment
specifically designed to target these VLS symptoms.
Hyloris has partnered with AFT for
co-development, registration, and worldwide commercialization.
HY-090, a promising new
treatment candidate for Burning Mouth Syndrome (BMS) was announced
in December 2023.
BMS is a chronic condition affecting millions,
primarily postmenopausal women, causing a burning, tingling, or
scalding sensation in the mouth for months at a time. While the
mouth appears healthy, sufferers may also experience dry mouth or
taste alterations, the exact cause of BMS remains unknown. Studies
suggest that 0.7% to 5% of individuals in the U.S. might be
affected6.
Hyloris has partnered with AFT to co-develop and
commercialize the product worldwide.
HY-088 was announced in January
2023. This novel, proprietary oral formulation will be administered
to patients with hypophosphatemia – a condition where the blood
level of phosphorus is lower than 2.5mg/dL. Patients can develop
hypophosphatemia from either a genetic abnormality (such as Cushing
Syndrome or osteomalacia) or an acquired condition (like long-term
use of diuretics or phosphate binders).
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.
R&D Update
Throughout 2023, Hyloris achieved significant
advancements across the entire R&D portfolio, propelling the 18
product candidates and 3 high-barrier generics closer to
commercialization. Key milestones were met for multiple programs,
and discussions with regulatory agencies and partners are underway
to solidify development plans. As a result, Hyloris anticipates
submitting multiple INDs (Investigational New Drug applications)
and NDAs (New Drug Applications) throughout 2024 and early
2025.
Enhanced Capabilities Drive
Efficiency
Further bolstering our R&D efforts, Hyloris
officially opened its new and improved R&D lab at the Montlegia
Science Park in June 2023. This on-site facility allows Hyloris to
perform drug formulation and analytical activities in-house,
streamlining processes and optimizing resource allocation for the
expanding pipeline.
Cardiovascular Portfolio
Hyloris is actively engaged in advancing a
comprehensive portfolio dedicated to addressing a wide range of
conditions within the largest global treatment category –
cardiovascular care. These products are currently progressing
through or towards clinical trials, with the aim of significantly
enhancing the quality of life for patients.
Main highlights for 2023 and selected expected
milestones for 2024 include:
Aspirin IV: Registration
batches have been manufactured and the stability study is ongoing.
An NDA submission is planned for the U.S. as soon as all necessary
data has been collected.
Aspirin IV is an
intravenous (IV) formulation of acetylsalicylic acid (ASA) to be
used in an emergency setting. Aspirin is not available in the
U.S. as an IV product. Currently, most patients suspected of having
an emergency cardiovascular event (such as a myocardial infarction
or stroke) are immediately given oral aspirin to decrease their
risk of morbidity and mortality.
Milrinone: The optimization of
the extended-release formulation for alcohol resistance marked a
significant development milestone. Preparations for a pilot
pharmacokinetic (PK) study are in progress.
Oral milrinone is being developed as a novel,
extended-release formulation offering convenient oral dosing for a
selected population of end-stage heart failure (HF) patients who
have Left Ventricular Assist Devices (LVADs).
HY-074: All non-clinical
studies were completed in 2023. A patent
application was filed through the Patent Cooperation Treaty (PCT)
which allows an applicant to seek patent protection in several
different countries – including the U.S. Hyloris is targeting an
IND submission for Q2 2024 for the PK bridging study expected to
start at the end of 2024.
HY-074 is an intravenous formulation of current
standard of care treatment for acute coronary syndrome (ACS) to
offer faster onset of action, more convenient administration, 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 in a hospital setting.
Dofetilide IV: Registration
batches have been manufactured and the stability study is ongoing.
A CRO has been selected for the required clinical study. An NDA
submission is planned for the U.S. as soon as all necessary data
has been collected.
A pivotal clinical study to support regulatory
submission for Dofetilide IV is nearing completion, with results
expected by Q3 2024. Additional U.S. patent applications have been
filed to bolster the drug's intellectual property protection.
Other Value-Added Programs
Hyloris, in collaboration with its development
partners, is achieving consistent progress on all stages of our
value-added programs.
Main highlights for 2023 and expected milestones
for 2024 include:
Tranexamic Acid Oral Mouth Rinse
(previously HY-004): A Type A meeting with the FDA
resulted in alignment on the phase 3 study protocol. The phase 3
trial began in November 2023, enrolling the first patient in early
2024. Completion of enrollment (Last Patient Last Visit - LPLV) is
expected by year-end, with study results anticipated in the first
half of 2025.
This rinse targets patients on blood thinners
(anticoagulant therapies) undergoing dental procedures with a high
risk of excessive bleeding. Additionally, Hyloris intends to
explore the effectiveness in a wider range of related oral surgery
procedures, encompassing both patients with and without bleeding
disorders who could benefit from a localized treatment to reduce
blood clotting.
Miconazole/Domiphen Bromide:
Hyloris is co-developing Miconazole/Domiphen Bromide (MCZ/DB) with
Purna Female Healthcare, a topical cream combining miconazole and
domiphen bromide. This innovative treatment targets Recurrent
Vulvovaginal Candidiasis (rVVC), a chronic and often debilitating
vaginal yeast infection affecting nearly 1 in 10 women throughout
their lives.
The Phase 2 clinical trial, completed in late
2023 (Q4), showed promising results. The low-dose group exhibited
evidence of delayed disease recurrence at day 29. These findings
will be used to design the next clinical trial, scheduled to begin
by year-end 2024. MCZ/DB presents a strong scientific and
commercial potential for addressing rVVC.
AlenuraTM: Hyloris is
co-developing Alenura™ with Vaneltix. It is a first-in-class drug
candidate designed to bring immediate pain relief to patients
suffering from interstitial cystitis/bladder pain syndrome
(IC/BPS). This chronic condition affects at least 6 million people
in the U.S. alone.
Alenura™ stands out for its innovative dual
mode-of-action. It combines a new, alkalinized form of lidocaine
for fast pain relief with heparin to potentially aid in the
regeneration of the bladder lining. This unique approach holds
promise for providing both immediate symptom relief and long-term
benefits for IC/BPS patients.
June 2023 marked a significant milestone with
the enrollment of the first patient in the Phase 2 clinical trial
of Alenura™. This pivotal study will compare the
effectiveness of Alenura™ against its individual components
(lidocaine and heparin) as well as a placebo.
PTX-252: PTX-252 is a novel
chelating agent in development for the treatment of Acute Myeloid
Leukemia (AML). This product candidate incorporates a novel
molecular entity that is a derivative of a known established
molecule. This advancement was followed by positive news: Hyloris'
co-development partner, Pleco, secured Orphan Drug Designation from
the FDA for PTX-252 specifically for AML.
PTX-252's potential lies in its ability to
potentially improve the effectiveness of existing chemotherapy for
AML patients. This is particularly significant as AML affects
approximately 160,000 people globally. Previous research suggests a
correlation between high levels of toxic metals and lower survival
rates in AML patients.
A Pre-Investigational New Drug (PIND) meeting
with the FDA is planned.
Valacyclovir: A successful
study demonstrating bioequivalence was completed in 2023. An
additional pivotal study can be expected to start and close in H1
of 2024. Registration batches have been manufactured to demonstrate
pharmaceutical quality of the product and robustness of the
manufacturing process.
Hyloris is developing a liquid formulation of
valacyclovir which is currently only available in oral solid form.
Valayclovir is an antiviral drug commonly used to treat the Herpes
Simplex Viruses (HSV) that cause cold sores, genital herpes,
chicken pox, and shingles.
Management & Board
changes
The total headcount of the Company grew to 42
people, with several key recruitments occurring over the summer. To
enhance the development activities, only limited additional hiring
is required. Both the C-level executives and all board members
remained in their respective positions, providing continuity in the
company's leadership.
Business Outlook
With 18 reformulated and repurposed molecules,
and 3 high-barrier generics, several clinical trials are expected
to start and/or finish within 2024. The Company is actively
accelerating the growth of its product pipeline, aiming to reach 30
product candidates by 2025.
The company is expecting several clinical and
regulatory achievements in the next 15 months. Several clinical
studies will be initiated or completed. The Company is anticipating
multiple NDA submissions to the U.S. FDA and other regulatory
agencies.
Webcast Details
The Company will host a webcast conducted in
English to present its 2023 annual results and 2024 Business
Outlook, followed by a live Q&A session. The webcast will start
on March 14th 2024 at 2PM CET / 1PM GMT / 9AM EST. To
join the webcast, please register at the following link: Hyloris:
2023 Full Year Results, Outlook for 2024, and Q&A
For those unable to join via webcast, please
find dial in information below:
Phone Conference ID: 598 167 742#
Belgium: +32 4 290 22 87
France: +33 1 73 24 00 56
Netherlands: +31 20 708 1382
Switzerland: +41 43 434 66 31
United Kingdom: +44 20 7660 8327
United States: +1 347 378 4531
Japan: +81 3 4540 5088
Financial Highlights 2023
|
|
Year ended 31 December |
|
|
(in € thousand) |
2023 |
2022 Restated* |
Variance |
|
Total Revenues and Other income |
4,406 |
2,386 |
85% |
|
Revenues |
2,814 |
1,951* |
44% |
|
Other operating income |
1,592 |
4357 |
266% |
|
Operating expenses |
(20,642) |
(14,024) |
47% |
|
Cost of sales |
(93) |
(94) |
(1%) |
|
Research and development expenses |
(14,749) |
(10,272) |
44% |
|
General and administration expenses |
(5,653) |
(3,517) |
61% |
|
Share of result of equity-accounted investees, net of tax |
(147) |
(130) |
13% |
|
Other operating expenses |
- |
(12) |
|
|
Operating result (EBIT) |
(16,236) |
(11,638)* |
40% |
|
Net financial result |
474 |
(127) |
-473% |
|
Income Taxes |
- |
(4) |
|
|
Profit/(Loss) for the period |
(15,762) |
(11,770)* |
34% |
|
Net operating cash flow |
(12,726) |
(12,499)8 |
2% |
|
Other investment |
- |
10,000 |
|
|
Cash and cash equivalents |
30,196 |
33,457 |
-10% |
|
Total cash and Other investment |
30,196 |
43,457 |
|
*See Note: Restatement of the year 2022 and
Press Release dated 14th of March 2024 related to
restatement for additional information on HY-038 and HY-088.
Total Revenue and Other
Income
In 2023, total revenue and other income
increased to €4,406 thousand compared to €2,386 thousand in 2022,
which is 85% higher compared to last year. The strong growth is
mainly driven by increase of royalties of the 3 early-stage
commercialized products, services provided to external partners and
non-dilutive funding which we received from a US State Government
and the Walloon region in Belgium.
Results
The Company realized a net loss of €15,762
thousand in 2023, compared to a net loss of €11,770 thousand last
year. The net loss is mainly resulting from the increase in R&D
expenditure and G&A expenses for supporting the development of
the Company. R&D expenditure during 2023 amounted to €14,749
thousand, compared to €10,272 thousand in 2022. The increase was
mainly driven by the progressive shift from early to late-stage
development of several product candidates as well as the increased
headcount of the research and development team leading to
additional costs.
General and administrative expenses increased to
€5,653 thousand in 2023 versus €3,517 thousand in 2022, mainly
driven by higher legal costs related to the AltaThera’s litigation
compared to last year.
The net financial income in 2023 was €474
thousand compared to a net financial loss of €127 thousand in 2022.
The positive evolution of the financial result is mainly due to the
impact of an active cash management strategy in a context of high
short term interest rates both in EURO and USD.
As a result, net losses in 2023 increased to
€15,762 thousand versus €11,770 thousand in the same period of
2022.
Balance Sheet
The Company’s non-current assets mainly consist
of (1) investments in joint ventures of € 3,801 thousand, (2)
intangible assets of €3,828 thousand including capitalized
development, purchased assets and in-licensing costs, versus €3,600
thousand in 2022, (3) Right of use assets related to the leasing of
the office, lab and cars, (4) shares in Pleco of €1,000 thousand,
(5) a prepayment of future royalties to a third party of $700
thousand and (6) 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 €30,196 thousand
in cash and cash equivalents on total assets of €47.61 million, and
trade and other receivables of €4.1 million.
The increase in Right-of-use assets and
borrowings is due to the start of the lease for the new lab. The
Company received an advance payment related to a government grant
from the Walloon region. €43 thousand of this advance is a
financial liability and €37 thousand is part of Trade and other
liabilities.
Cash Position and cash flow
The Company maintains its strong cash position,
with a current cash and cash equivalents totaled €30,196 thousand
at the end of 2023, compared to €43,457 thousand at the end of 2022
(which includes a deposit for an amount of €10 million which has
been reclassified to Other investment in 2022).
Net cash outflow generated from operating
activities was €12,726 thousand in 2023, compared to a net
operating cash outflow of €12,499 thousand in 2022. The stable net
operating cash outflow is attributed to an internal control system
implemented to oversee expenditure and cash flow, which includes
effective management of working capital.
CONSOLIDATED STATEMENT OF FINANCIAL POSITION FOR THE
YEAR ENDED DECEMBER 31
ASSETS
(in thousands of euros)
|
31-Dec-23
|
31-Dec-22 Restated*
|
|
| |
|
Non-current assets |
12,336 |
11,063 |
|
|
Intangible assets |
3,828 |
3,607 |
|
|
Property, plant and equipment |
429 |
176 |
|
|
Right-of-use assets |
1,724 |
885 |
|
|
Equity accounted investments |
3,801 |
3,948 |
|
|
Other investment, including derivatives |
1,000 |
1,000 |
|
|
Trade and other receivables |
1.554 |
1.447 |
|
|
Current assets |
35,276 |
49,801 |
|
|
Trade and other receivables |
4,100 |
4,127 |
|
|
Other investment, including derivatives |
499 |
10,4699 |
|
|
Prepayments |
481 |
1,748 |
|
|
Cash and cash equivalents |
30,196 |
33,4579 |
|
|
TOTAL ASSETS |
47,612 |
60,864 |
|
| |
|
|
|
EQUITY AND LIABILITIES
(in thousands of euros)
|
31-Dec-23
|
31-Dec-22 Restated*
|
|
| |
|
Equity |
38.822 |
54.045 |
|
|
Share capital |
140 |
140 |
|
|
Share premium |
121,513 |
121,513 |
|
|
Retained earnings, excluding profit (loss) for the reporting
period |
(65,246) |
(53,476) |
|
|
Result of the period, profit (loss) for the reporting period |
(15,762) |
(11,770) |
|
|
Share based payment |
2.161 |
1,621 |
|
|
Cost of Capital |
(4,460) |
(4,460) |
|
|
Other reserves |
476 |
476 |
|
|
Non-current liabilities |
1.853 |
1,047 |
|
|
Borrowings |
1,510 |
747 |
|
|
Other financial liabilities |
344 |
300 |
|
|
Current liabilities |
6,937 |
5,772 |
|
|
Borrowings |
241 |
138 |
|
|
Other financial liabilities |
3,200 |
3,212 |
|
|
Trade and other liabilities |
3,496 |
2,422 |
|
|
Current tax liabilities |
- |
- |
|
|
TOTAL EQUITY AND LIABILITIES |
47,612 |
60,864 |
|
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER
COMPREHENSIVE INCOME FOR THE YEAR ENDED DECEMBER 31
|
in € thousands |
2023 |
2022 restated* |
Variance |
|
Revenue |
2,814 |
1,951 |
47% |
|
Other operating income |
1,592 |
4353 |
252% |
|
Operating income |
4,406 |
2,386 |
85% |
|
Cost of sales |
(93) |
(94) |
(1%) |
|
Research and development expenses |
(14,749) |
(10,272)10 |
44% |
|
Selling, general and administrative expenses |
(5,653) |
(3,517) |
61% |
|
Share of result of equity-accounted investees, net of tax |
(147) |
(130) |
13% |
|
Other operating expenses |
- |
(12) |
|
|
Operating expenses |
(20,642) |
(14,024) |
47% |
|
Operating profit/(loss) (EBIT) |
(16,236) |
(11,638) |
40% |
|
Financial income |
867 |
466 |
86% |
|
Financial expenses |
(393) |
(594) |
-34% |
|
Profit/(loss) before taxes |
(15,762) |
(11,766) |
34% |
|
Income taxes |
- |
(4) |
|
|
PROFIT/(LOSS) FOR THE PERIOD |
(15,762) |
(11,770) |
34% |
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY FOR THE YEAR
ENDED DECEMBER 31 2023
(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 |
|
|
|
|
|
(11,770) |
(11,770) |
|
Balance at December 31, 2022 |
140 |
121,513 |
1,622 |
(4,460) |
476 |
(65,246) |
54,045 |
| Share-based
payments |
|
|
539 |
|
|
|
539 |
| Total
comprehensive income |
|
|
|
|
|
(15,762) |
(15,762) |
|
Balance at December 31, 2023 |
140 |
121,513 |
2,161 |
(4,460) |
476 |
(81,008) |
38,822 |
CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE YEAR ENDED
DECEMBER 31 2023
|
in € thousands |
2023 |
2022 Restated* |
|
| CASH
FLOW FROM OPERATING ACTIVITIES |
|
|
|
| Net result |
(15,762) |
(11,770) |
|
|
Adjustments to reconcile net loss to net cash provided by
operating activities: |
|
| Depreciation,
amortisation and impairments |
349 |
196 |
|
|
|
| Share-based
payment expense |
539 |
560 |
|
|
|
| Derivatives
financial instruments |
(52) |
52 |
|
|
|
| Interest income
on deposits and current accounts |
- |
164 |
|
|
|
| Net finance
result |
(474) |
- |
|
|
|
| Change in fair
value of financial assets |
311 |
- |
|
|
|
| Loss on
derecognition of shareholders loans |
- |
486 |
|
|
|
| Equity
transaction costs |
- |
29 |
|
|
|
| Share of profit
of equity-accounted investees, net of tax |
147 |
130 |
|
|
|
| Losses on
disposal of PPE |
- |
16 |
|
|
|
| Other non-cash
adjustments |
(17) |
16 |
|
|
|
| |
|
|
|
|
|
| Changes in
working capital: |
|
|
|
|
|
| Trade and other
receivables |
(293) |
(921) |
|
|
|
| Other
investment, including derivatives |
(31) |
4 |
|
|
|
|
Prepayments |
1,268 |
(650) |
|
|
|
| Trade and Other
liabilities |
1,236 |
(468) |
|
|
|
| Cash
generated from operations |
(12,779) |
(12,157) |
|
|
|
| Interest
paid |
52 |
7 |
|
|
|
| Income Taxes
paid |
- |
(349) |
|
|
|
|
Net cash generated from operating activities |
(12,726) |
(12,499) |
|
|
|
| CASH
FLOW FROM INVESTING ACTIVITIES |
|
|
|
|
|
| Interest
received |
403 |
|
|
|
|
| Purchases of
property, plant and equipment |
(298) |
(101) |
|
|
|
| Purchases of
Intangible assets |
(425) |
(638) |
|
|
|
| Acquisition of
Other Investments |
(0) |
(500) |
|
|
|
| Loans made to
third parties |
- |
(655) |
|
|
|
| Deposits |
10,000 |
(10,000) |
|
|
|
|
|
|
|
|
|
|
| Discontinued
operations |
|
|
|
|
|
|
Net cash provided by/(used in) investing
activities |
9,654 |
(11,894) |
|
|
|
| |
|
|
|
|
|
| CASH
FLOW FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
Reimbursements of borrowings and other financial liabilities |
(12) |
(7,376) |
|
|
|
| Proceeds from
borrowings and other financial liabilities |
44 |
- |
|
|
|
| Reimbursements
of lease liabilities |
(222) |
(79) |
|
|
|
|
Modifications/terminations Right of Use Assets |
2 |
- |
|
|
|
| Proceeds from
Private Placement via Accelerated Book Building |
- |
14,337 |
|
|
|
| Proceeds from
Execution Transactions Warrants |
- |
2,832 |
|
|
|
| Interests
paid |
- |
(1,877) |
|
|
|
|
Net cash provided by/(used in) financing
activities |
(188) |
7,838 |
|
|
|
| |
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS |
(3,261) |
(16,555) |
|
|
|
| |
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS at beginning of year |
33,457 |
50,012 |
|
|
|
|
CASH AND CASH EQUIVALENTS at end of year,
calculated |
30,196 |
33,457* |
|
|
|
RESTATEMENT OF THE YEAR 2022 and
HALF-YEAR 2023
Accounting treatment of the transactions
with Qliniq
Hyloris initially recognized (a) €1 million in
revenue in 2022 from the divestment of HY-038, and (b) € 1 million
in R&D expenses and € 0,2 million in intangible assets in H1
2023 for the purchase of HY-088. A reassessment determined that
both transactions qualify as a non-monetary exchange because
negotiations and valuations occurred simultaneously. Due to the
development stage of the products exchanged, the fair value of
neither the asset received, nor the asset given up can be reliably
determined. As a result of this reassessment, the restated
financials for 2022 will reverse the €1 million revenue from the
divestment of HY-038. This adjustment will also affect the
half-year 2023 financial statements, resulting in a reversal of €1
million in R&D expenses for HY-088. These expenses are offset
against the €1 million received by Hyloris for HY-038.
(See Press Release dated 14th of
March 2024 on the restatement for more information)
The following tables summarize the impact of the
restatement on the consolidated financial statements.
Consolidated statement of financial
position
Per 31 December 2022
(in € thousands)
|
Impact of correction of error |
|
As previously reported |
Adjustment |
As restated |
|
Current assets |
50.801 |
-1.000 |
49.801 |
|
Trade and other receivables |
5.127 |
-1.000 |
4.127 |
|
Total assets |
61.864 |
-1.000 |
60.864 |
|
|
|
|
|
|
Equity |
55.045 |
-1.000 |
54.045 |
|
Result of the period |
(10.770) |
-1.000 |
(11.770) |
|
Total equity and liabilities |
61.864 |
-1.000 |
60.864 |
Consolidated statement of profit or loss and
other comprehensive income
For the year ended 31 December 2022
(in € thousands)
|
Impact of correction of error |
|
As previously reported |
Adjustment |
As restated |
|
Revenues |
2.951 |
-1.000 |
1.951 |
|
Gross profit |
2.857 |
-1.000 |
1.857 |
|
Operating profit/(loss) (EBIT) |
(10.638) |
-1.000 |
(11.638) |
|
Profit (loss) before taxes |
(10.766) |
-1.000 |
(11.766) |
|
PROFIT (LOSS) FOR THE PERIOD |
(10.770) |
-1.000 |
(11.770) |
|
TOTAL COMPREHENSIVE INCOME FOR THE PERIOD |
(10.770) |
-1.000 |
(11.770) |
For the year ended 31 December 2022
(in €)
|
Impact of correction of error |
|
As previously reported |
Adjustment |
As restated |
|
Basic/diluted earnings/(loss) per share |
(0.380) |
(0.035) |
(0.435) |
Consolidated statement of cash
flows
Even though there was an actual cash inflow of
EUR 1 million from the out-licensing of HY-038 and a cash outflow
of EUR 1.2 million resulting from the in-licensing of HY-088, the
transactions are presented in the consolidated statement of cash
flows for the year ended per December 31, 2023 (i.e., EUR 200k
prepaid expenses), as this most faithfully presents the substance
of the transactions. There is no impact on the consolidated
statement of cash flows for the year ended per December 31, 2022,
as no cash inflow occurred yet.
Audit Report
The statutory auditor, KPMG Bedrijfsrevisoren -
Réviseurs d’Entreprises, represented by Olivier Declercq, has
informed us that the audit procedures were not yet completed.
ONGOING LEGAL PROCEEDINGS
In August 2022, AltaThera Pharmaceuticals LLC
filed a complaint before the District Court for the Northern
District of Illinois against Academic Pharmaceuticals Inc, Dr.
Somberg and Hyloris Pharmaceuticals, for (a.o.) alleged
misappropriation of AltaThera’s trade secrets and confidential
information, improper inventorship, and breach of contract, which
seeks (punitive) damages and termination of the agreement whereby
Hyloris licenses Sotalol IV to AltaThera (the “Litigation”).
Hyloris moved to dismiss the complaint for improper service of
process and lack of jurisdiction. Further, in November 2022,
Hyloris initiated an arbitration against AltaThera for breach of
the same licensing agreement between Hyloris and AltaThera in
relation to Sotalol IV, including the failure of AltaThera to use
commercially reasonable efforts in selling Sotalol IV as required
under the licensing agreement, which seeks damages and termination
of the licensing agreement (the “Arbitration”). AltaThera responded
and counter-demanded, reasserting its claims from the
Litigation.
At the end of August 2023, all parties agreed to
stipulate to the dismissal of the Litigation and to consolidate the
Litigation and the Arbitration before the American Arbitration
Association (“AAA”) in New York.
Hyloris contests the claims asserted by
AltaThera and, based upon Hyloris’ assessment of the documents and
expert reports put forward to date by AltaThera to support its
claims, Hyloris is of the view that there is no convincing evidence
supporting AltaThera’s claims for liability or damages. On the
other hand, Hyloris believes strongly in the merits of its claims
against AltaThera, and that its position is well supported by its
expert reports and other documents and evidence submitted to the
arbitration panel.
Arbitration hearings are scheduled in April 2024
with a final decision expected by the end of H1 2024. Hyloris
remains fully confident about the outcome of this litigation in its
favor. Hyloris however cannot guarantee that the outcome of the
litigation, even if in its favor, may not have a negative impact on
future sales of Sotalol IV.
About Hyloris Pharmaceuticals
SA
Hyloris is a specialty biopharma company focused
on innovating, reinventing, and optimizing existing medications to
address important healthcare needs and deliver relevant
improvements for patients, healthcare professionals and payors.
The Company’s development strategy primarily
focuses on leveraging established regulatory pathways, such as the
FDA’s 505(b)2 pathway in the U.S or equivalent regulatory
frameworks in other regions which are specifically designed for
pharmaceuticals for which safety and efficacy of the molecule have
already been established. This approach can reduce the clinical
burden required for market entry, and significantly shorten the
development timelines, leading to reduced costs and risks.
Hyloris has built a broad, patented portfolio of
18 reformulated and repurposed value-added medicines that have the
potential to offer significant advantages over existing
alternatives. Two products are currently in early phases of
commercialization in collaboration with commercial partners:
Sotalol IV for the treatment of atrial fibrillation, and Maxigesic®
IV, a non-opioid post-operative pain treatment. In addition to its
core strategic focus, the Company has 1 approved high barrier
generic product launched in the U.S. and 2 high barrier generic
products in development.
Hyloris is based in Liège, Belgium. For more
information, visit www.hyloris.com and follow-us
on LinkedIn.
For more information, contact Hyloris
Pharmaceuticals:
Stijn Van Rompay, CEO
stijn.vanrompay@hyloris.com
+32 (0)4 346 02 07
Jean-Luc Vandebroek, CFO
jean-luc.vandebroek@hyloris.com
+32 (0)478 27 68 42
Jessica McHargue
jessica.mchargue@hyloris.com
+1 919 451 4740
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 https://www.aafp.org/pubs/afp/issues/2010/1115/p1209.html
2 IQVIA
3 https://caddac.ca/about-adhd/
4 https://journals.sagepub.com/doi/10.1177/1060028013510699
5 Not adjusted for inflation
6 Based on combination of different sources: population-based
study, clinical based study and key opinion leaders' estimation
7 Reclassification of the withholding tax on R&D salaries.
(payroll tax rebates)
8 Reclassification of the loan to third-party from Operating to
Investing activities in the Cash flow statement
9 Reclassification of deposit from Cash and cash equivalents to
Other investment including derivatives for an amount of €10 million
in 2022
10 Reclassification of the withholding tax on R&D salaries.
(payroll tax rebates) for an amount of €120k
- 20240314 Full Year Results 2023 ENG
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