Hyloris Reports 2021 Half-Year Results: Multiple Potential Value
Inflection Points Ahead
On target to grow the broad product
pipeline with at least 3 additional programmes before end
2021Significant 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
and webcast today at 3pm
CEST/9am
EST (details
below)
Liège, Belgium – 4
August 2021 –
Hyloris 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
improvements for patients, physicians, and payors.”
“We promised to grow our pipeline with four 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 the results from two clinical studies. Finally, our
commercial partners are making progress with the roll-out of
Sotalol 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 we expect to report on multiple potential
value inflection points before the end of the year.”
FINANCIAL
HIGHLIGHTS: SIX-MONTH PERIOD
ENDING 30 JUNE 2021
|
Period ended 30 June |
|
(in € thousand) |
2021 |
2020 |
Variance |
Total revenue and other
income |
1,145 |
102 |
1,023% |
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)/inflow ii |
(10,934) |
66,578 iii |
-- |
Cash and cash equivalents |
53,465 |
66,783 |
(20%) |
i One-off expenses related to the unwinding of the license
agreements with the Alter Pharma Groupii For the period
1 January to 30 Juneiii Including net proceeds from the IPO
and issuance of convertible bonds
OPERATIONAL REVIEW
YEAR-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.
Corporate
update
- 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
THE SIX-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 the
license agreements 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 the license
agreements 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 47France
+33 1 70 700 781Netherlands
+ 31 20 795 6614United Kingdom
+44 2071 928 338United States
+1 646 741 3167
Confirmation code 2687826
A replay will be available on the events page of
the Hyloris website.
UPCOMING IR EVENTS 2021
AND PRELIMINARY FINANCIAL CALENDAR 2022
9 September
2021 Annual KBC
Securities Life Science Conference 23 October 2021
VFB Happening16 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 VermeerschVP Investor Relations and
Corporate CommunicationsM: +32 (0)479 490
603marieke.vermeersch@hyloris.com
Disclaimer and forward-looking
statementsHyloris 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 June2021 |
31 December2020 |
|
|
Non-current assets |
7,323 |
2,569 |
|
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 assets |
56,661 |
66,613 |
|
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 ASSETS |
63,984 |
69,182 |
|
|
|
|
|
EQUITY AND LIABILITIES(in €
thousand) |
30 June2021 |
31 December 2020 |
|
|
Equity |
51,080 |
59,059 |
|
Share capital |
129 |
129 |
|
Share premium |
103,693 |
103,693 |
|
Retained earnings |
(51,466) |
(43,226) |
|
Other reserves |
(1,276) |
(1,537) |
|
Liabilities |
12,904 |
10,123 |
|
Non-current liabilities |
10,301 |
7,991 |
|
Borrowings |
83 |
106 |
|
Other financial liabilities |
10,218 |
7,885 |
|
Current liabilities |
2,603 |
2,132 |
|
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 LIABILITIES |
63,984 |
69,182 |
|
CONSOLIDATED STATEMENT OF PROFIT OR LOSS
AND OTHER COMPREHENSIVE INCOME
STATEMENT OF COMPREHENSIVE INCOME(in €
thousand) |
30 June2021
|
30 June2020
|
|
|
Revenues |
838 |
82 |
|
Cost of sales |
(42) |
(109) |
|
Gross profit |
796 |
(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 Company |
Total Equity |
|
Share capital |
Share premium |
|
Other reserves |
Retained earnings |
|
(in € thousand) |
|
|
Share based payment reserve |
Cost of Capital |
Other reserves |
|
|
Balance at 31
December 2019 |
89 |
23,982 |
1,329 |
- |
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 2020 |
128 |
101,113 |
1,572 |
(3,758) |
434 |
(39,823) |
59,666 |
|
|
|
|
|
|
|
|
Balance at 31
December 2020 |
129 |
103,693 |
1,814 |
(3,827) |
476 |
(43,226) |
59,059 |
Share-based payments |
- |
- |
261 |
- |
- |
- |
261 |
Total comprehensive income |
- |
- |
|
- |
- |
(8,240) |
(8,240) |
Balance at 30
June 2021 |
129 |
103,693 |
2,075 |
(3,827) |
476 |
(51,466) |
51,080 |
CONSOLIDATED STATEMENT OF CASH
FLOWS
(in € thousand) |
|
30 June 2021 |
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 period |
|
64,399 |
205 |
|
CASH AND
CASH EQUIVALENTS at end of the period, calculated |
|
53,465 |
66,783 |
|
- 210804 Hyloris Press Release HY21_ENG_Final
Grafico Azioni Hyloris Pharmaceuticals (EU:HYL)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Hyloris Pharmaceuticals (EU:HYL)
Storico
Da Apr 2023 a Apr 2024