Biotalys Reports Half-Year 2024 Financial Results and Business
Highlights
Press
release – regulated information
- Continued
progress in regulatory review of its first candidate biofungicide
EVOCA™*
- Dutch
Authority CTGB approved large scale demonstration trials with EVOCA
while allowing sale of harvest
- Commenced
field trials for second biofungicide to expand potential product
line
- Initiated an
AI project with Google DeepMind and Devoteam using
AlphaFold2
- Cash and
cash equivalents amounted to €14.7 million as of the end of June
2024
- Management
to host a conference call and live webcast at 15:00 CEST / 14:00
GMT / 09:00 AM ET today, details below
Ghent, BELGIUM, Aug. 22, 2024 (GLOBE
NEWSWIRE) -- Biotalys (Euronext - BTLS), an
Agricultural Technology (AgTech) company developing protein-based
biocontrols for sustainable crop protection, today announces its
key business achievements and consolidated financial results for
the first half of 2024, prepared in accordance with International
Accounting Standard 34 ‘Interim Financial Reporting’ as adopted by
the European Union. The complete half-year report including the
interim financial results is available here on the Biotalys
website.
Kevin Helash, Chief Executive Officer of
Biotalys, noted: “The first half of 2024 heralded key
milestones for Biotalys in our mission to transform crop
protection, such as the partnership with Novonesis for EVOCA NG and
the initiation of field trials for BioFun-6, our second
biofungicide candidate. Further to the development of EVOCA, I am
very pleased to announce we just received approval by the Dutch
regulatory authority to do large scale demonstration trials with
the product in the Netherlands. The authority has also allowed the
sale of the harvested produce for human consumption.”
Helash added: “As a result of the measures
implemented at the end of last year to control costs, we have been
able to considerably reduce our operating cash burn in the first
half of this year. We will continue to concentrate our resources on
applying the targeted approach to our research platform, as well as
on progressing our various pipeline programs. We will consider
additional financing such as through equity, newly awarded grants
and partnerships to execute our strategy to transforming crop
protection.”
Regulatory update for EVOCA
- Biotalys
continues to work closely with the EPA (Environmental Protection
Agency) in the United States and the CTGB (College voor de
Toelating van Gewasbeschermingsmiddelen en Biociden) in Europe
on EVOCA’s regulatory review.
- In the
U.S., the EPA’s review is progressing and Biotalys has not
received additional questions from the authority on the dossier in
2024. Meanwhile, Biotalys is preparing a regulatory dossier for its
next generation of the product, EVOCA NG, for submission. As EVOCA
NG has the same bioactive as EVOCA with an optimized production
process and formulation which is expected to lower production
costs, the company plans to apply for an amendment procedure, which
is anticipated to have a shorter review time compared to a standard
procedure.
- In
Europe, the rapporteur Member State is The
Netherlands where the CTGB (College voor de Toelating
Gewasbeschermingsmiddelen en Biociden) is currently reviewing the
regulatory dossier. CTGB recently requested additional information,
which the company plans to submit next week allowing the authority
to finalise its review and send its report to the European level
for peer review by EFSA and the European Member States. For EVOCA
NG, the company plans to apply at EU level for an equivalency
procedure, with a significantly shorter review timeline.
- On 21 August
2024, the same CTGB granted Biotalys the approval to test
EVOCA in large scale demonstration trials, allowing
application of the product against powdery mildew in 40 hectares of
tomatoes, 20 hectares of cucumbers and 10 hectares of strawberries.
Importantly, it will also be allowed to sell the fruits and
vegetables resulting from these trials for human consumption.**
This is an exemption to standard practices requiring crop
destruction when a product is used that has not yet received
regulatory approval. This decision reinforces Biotalys’ confidence
that the product is safe to use.
H1 2024 highlights
- Biotalys has continued to take
major steps forward on the path to commercialization of EVOCA’s
next generation version, EVOCA NG, which is
expected to be the company’s first margin-generating
product. Thereto, Biotalys and Novonesis entered
into a long-term collaboration agreement, advancing EVOCA NG to the
final stage of development.
- Leveraging its advanced
fermentation capabilities, Novonesis will serve as the
global manufacturing partner for the production of EVOCA
NG. Novonesis will have the rights to distribute and sell
EVOCA NG in select crops outside of the United States, while
Biobest will sell the product in select markets to help control the
devastating fungal disease botrytis in fruits and
vegetables. The companies are also discussing the potential of
additional collaborations such as combining the Biotalys AGROBODY™
platform with Novonesis' biosolutions technology.
- Field trials for
BioFun-6, the company’s second biofungicide
program targeting botrytis, powdery mildew and
anthracnose in high-value fruits and vegetables, are now
also underway in both Europe and the United States. Initial results
are expected later this year.
- Biotalys entered
into additional academic collaborations with leading researchers in
plant science to advance its biocontrols pipeline. Building on its
established relationships with top academics, Biotalys is
now progressing its research for BioFun-4,
targeting Phytophthora infestans, an Oomycete (water
mould) that causes late blight/potato blight, with the University
of Aberdeen, and furthering BioFun-7, its ongoing
R&D program in partnership with the Gates Foundation targeting
leafspot disease, with the University of California-Davis.
- Biotalys
continued to advance its first bioinsecticide in
collaboration with Syngenta Crop
Protection, a top producer of insecticides, to target
harmful insect pests.
- Embracing the
opportunity to apply artificial intelligence (AI)
technology to its AGROBODY™ 2.0 technology platform,
Biotalys recently initiated a collaboration with Google DeepMind
and Devoteam on AlphaFold2, an AI platform, to predict the precise
3D shapes of proteins. As the AGROBODY platform applies a targeted
approach requiring the detailed characterization of target proteins
of the fungal diseases or pests, Biotalys is leveraging AlphaFold2
to speed the validation of AGROBODY™ bioactive discoveries and
improve its R&D and go-to-market workflows.
- Biotalys’ scientific team also
recently published a scientific paper exploring
the biocontrol breakthroughs afforded by its AGROBODY platform, the
promise of biocontrols in crop protection, and EVOCA specifically
in the Journal of Plant Diseases and Protection:
https://rdcu.be/dAEEh.
- Early in 2024, Biotalys
again earned Top 100 status in Forward Fooding’s FoodTech
500 list, climbing to #62. FoodTech 500 ranks global
entrepreneurial talent at the intersection of food, technology and
sustainability. And as announced yesterday, Biotalys was granted
the 2024 AgTech Breakthrough Award for Sustainable Crop Protection
Company of the Year.
- In May, Biotalys
announced the appointment of Laura J. Meyer to its Board of
Directors, effective 25 September 2024. Her career in
agriculture spans more than 28 years in various financial roles.
Until recently, she was Vice President, Investor Relations at
Bayer, responsible for the Crop Science division. Laura Meyer will
be a great asset to Biotalys in its commercialization and growth
ambitions.
* EVOCA™: Pending Registration. This product
is not currently registered for sale or use in the United States,
the European Union, or elsewhere and is not being offered for
sale.
** Decisions of the CTGB are
subject to appeal during a period of six weeks following the
publication of the decision.
Select financial information
In € thousands |
June 30, 2024 |
June 30, 2023 |
Other operating income |
1,452 |
1,318 |
Research and development expenses |
(5,135) |
(8,661) |
General and administrative expenses |
(2,777) |
(2,771) |
Marketing expenses |
(113) |
(741) |
Operating loss |
(6,574) |
(10,855) |
Loss of the period |
(6,489) |
(10,664) |
Net cash used in operations |
(6,527) |
(8,516) |
Net cash outflow of the period |
(6,890) |
(2,208) |
Cash and cash equivalents |
14,680 |
31,886 |
-
Other operating income for the first half of 2024
amounted to €1.5 million, and mainly relates to amounts recognized
for R&D tax incentives received and grants awarded to support
ongoing R&D activities.
-
Research and development expenses amounted to €5.1
million for the first half year, a decrease of €3.5 million
compared to the same period of 2023. These decreases primarily
relate to lower costs for external R&D and material costs
(-€2.3 million), partly due to lower spending in the EVOCA project
while pending EPA approval. Other decreases include lower wages
& benefits (-€0.6 million) as the result of re-organization in
the second half of 2023, and overall decrease in other
miscellaneous operational R&D spendings.
-
General and administrative expenses remain at €2.8
million for the first half of 2024, compared to €2.8 million in the
same period of 2023.
- Net cash
used in operating activities decreased by €2.0 million, to
€6.5 million for the six months ended 30 June 2024. This decrease
was primarily caused by decreases in spending on research and
development expenses.
Outlook
-
Biotalys will continue to concentrate resources on obtaining
registration for its first product candidate EVOCA
as well as on advancing the targeted approach to our research
platform.
-
Pending the regulatory decision for EVOCA, the company will
continue the development of its first
margin-generating product EVOCA NG in collaboration with
Novonesis.
-
Biotalys expects the results of initial field
trials with BioFun-6 in grapes by the end
of 2024.
-
The company will progress its pipeline programs
and expects to initiate a new R&D biofungicide program for a
new pathogen later this year.
-
Together with the cash and cash equivalents balance of €14.7
million at the end of H1 2024, the company expects the current
financial runway to extend into Q2 2025 without
considering additional financing through equity, newly awarded
grants, partnerships or other sources of financing.
Auditor statement
The condensed consolidated financial statements
for the six-months’ period ended 30 June 2024 have been prepared in
accordance with IAS 34 ‘Interim Financial Reporting’ as adopted by
the European Union. They do not include all the information
required for the full annual financial statements and should
therefore be read in conjunction with the financial statements for
the year ended 31 December 2023. The condensed consolidated
financial statements are presented in thousands of Euros (unless
stated otherwise). The condensed consolidated financial statements
have been approved for issue by the Board of Directors. The
statutory auditor, Deloitte Bedrijfsrevisoren/Reviseurs
d’Entreprises, represented by Pieter-Jan Van Durme, has performed a
limited review of the interim financial report. The interim
financial report for the first half of 2024 and the review opinion
of the auditor are available on www.biotalys.com.
Upcoming IR events
Biotalys updated its investor presentation and
published it on its website. For a list of upcoming events, please
check https://biotalys.com/media/events.
Live webcast and conference call
Company management will host a live webcast to
discuss its half-year 2024 results and recent business performance
today, 22 August 2024 at 15:00 CEST / 14:00 BST / 09:00 AM
EDT.
Webcast link:
https://edge.media-server.com/mmc/p/igtczv4g
Dial-in details: To ask questions live to the
management, please also register for the conference call via
https://register.vevent.com/register/BI369eee1a131a4309b0a6aabb088c0f6a
About Biotalys
Biotalys is an Agricultural Technology (AgTech)
company developing protein-based biocontrol solutions for the
protection of crops and aiming to provide alternatives to
conventional chemical pesticides for a more sustainable and safer
food supply. Based on its novel AGROBODY™ technology platform,
Biotalys is developing a strong and diverse pipeline of effective
product candidates with a favorable safety profile that aim to
address key crop pests and diseases across the whole value chain,
from soil to plate. Biotalys was founded in 2013 as a spin-off from
the VIB (Flanders Institute for Biotechnology) and has been listed
on Euronext Brussels since July 2021. The company is based in the
biotech cluster in Ghent, Belgium. More information can be found on
www.biotalys.com.
For further information, please
contact
Toon Musschoot, Head of IR &
Communication
T: +32 (0)9 274 54 00
E: IR@biotalys.com
Important Notice
Biotalys, its business, prospects and financial
position remain exposed and subject to risks and
uncertainties. A description of and reference to these risks
and uncertainties can be found in the 2023 annual report on the
consolidated annual accounts and the full half-year report.
This announcement contains statements which are
"forward-looking statements" or could be considered as such. These
forward-looking statements can be identified by the use of
forward-looking terminology, including the words ‘aim’, 'believe',
'estimate', 'anticipate', 'expect', 'intend', 'may', 'will',
'plan', 'continue', 'ongoing', 'possible', 'predict', 'plans',
'target', 'seek', 'would' or 'should', and contain statements made
by the company regarding the intended results of its strategy. By
their nature, forward-looking statements involve risks and
uncertainties and readers are warned that none of these
forward-looking statements offers any guarantee of future
performance. Biotalys’ actual results may differ materially from
those predicted by the forward-looking statements. Biotalys makes
no undertaking whatsoever to publish updates or adjustments to
these forward-looking statements, unless required to do so by
law.
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL
POSITION
ASSETS
(in thousands of euros)
|
Note
|
30 June
2024
|
31 December
2023
|
Non-current assets |
|
11,023 |
11,671 |
Intangible assets |
|
606 |
642 |
Property, plant and equipment |
7.8 |
4,509 |
4,863 |
Right-of-use assets |
7.8 |
3,148 |
3,571 |
Deferred tax assets |
|
19 |
18 |
Other non-current assets |
|
2,742 |
2,577 |
|
|
|
|
Current assets |
|
18,459 |
24,910 |
Receivables |
|
952 |
750 |
Other financial assets |
|
2,110 |
2,100 |
Other current assets |
7.9 |
717 |
490 |
Cash and cash equivalents |
7.10 |
14,680 |
21,570 |
|
|
|
|
TOTAL ASSETS |
|
29,482 |
36,582 |
EQUITY AND LIABILITIES
(in thousands of euros)
|
Note
|
30 June
2024
|
31 December
2023
|
Equity attributable to owners of the
parent |
|
19,576 |
25,569 |
Share capital |
7.11 |
4,755 |
46,198 |
Share premium |
7.11 |
15,588 |
15,488 |
Accumulated losses |
7.11 |
(5,103) |
(40,200) |
Other reserves |
|
4,336 |
4,082 |
|
|
|
|
Total equity |
|
19,576 |
25,569 |
|
|
|
|
Non-current liabilities |
|
5,151 |
5,467 |
Borrowings |
7.12 |
4,521 |
4,841 |
Employee benefits obligations |
|
26 |
23 |
Provisions |
|
92 |
91 |
Other non-current liabilities |
7.13 |
512 |
512 |
|
|
|
|
Current liabilities |
|
4,755 |
5,546 |
Borrowings |
7.12 |
964 |
1,232 |
Trade and other liabilities |
|
1,895 |
2,591 |
Other current liabilities |
7.13 |
1,896 |
1,723 |
Total liabilities |
|
9,905 |
11,013 |
|
|
|
|
TOTAL EQUITY AND LIABILITIES |
|
29,482 |
36,582 |
The accompanying notes are an integral part of these condensed
consolidated financial statements. Please see the full interim
report available on www.biotalys.com.
CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND
OTHER COMPREHENSIVE INCOME FOR THE 6 MONTHS
ENDED 30 JUNE
in € thousands |
Note |
2024 |
2023 |
Other operating income |
7.15 |
1,452 |
1,318 |
Research and development expenses |
7.16 |
(5,135) |
(8,661) |
General and administrative expenses |
7.16 |
(2,777) |
(2,771) |
Sales and marketing expenses |
7.16 |
(113) |
(741) |
Operating loss |
|
(6,574) |
(10,855) |
Financial income |
|
335 |
422 |
Financial expenses |
|
(161) |
(191) |
Loss before taxes |
|
(6,400) |
(10,624) |
Income taxes |
|
(89) |
(40) |
LOSS FOR THE PERIOD |
|
(6,489) |
(10,664) |
|
|
|
|
Other comprehensive income (OCI) |
|
|
|
Items of OCI that will be reclassified subsequently to profit
or loss |
|
|
|
Exchange differences on translating foreign operations |
|
7 |
(3) |
|
|
|
|
TOTAL COMPREHENSIVE LOSS OF THE PERIOD |
|
(6,482) |
(10,667) |
|
|
|
|
Basic and diluted loss per share (in €) |
7.17 |
(0.20) |
(0.34) |
|
|
|
|
Loss for the period attributable to the owners of the Company |
|
(6,489) |
(10,664) |
|
|
|
|
Total comprehensive loss for the period attributable to the owners
of the Company |
|
(6,482) |
(10,667) |
The accompanying notes are an integral part of these condensed
consolidated financial statements. Please see the full interim
report available on www.biotalys.com.
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN
EQUITY FOR THE 6 MONTHS ENDED 30
JUNE
(in € thousands)
|
Attributable to equity holders of the Company |
|
|
|
Other reserves |
|
|
Share capital |
Share premium |
Share-based payment reserve |
Currency translation reserve |
Accumulated losses |
Total Equity |
Balance at
31 December 2022 |
44,548 |
10,164 |
3,035 |
29 |
(19,662) |
38,114 |
Share-based
payments |
- |
- |
723 |
- |
- |
723 |
Exercise of ESOP
Warrants |
16 |
12 |
(12) |
- |
- |
16 |
Issuance of
shares |
1,634 |
5,366 |
- |
- |
- |
7,000 |
Total comprehensive loss |
- |
- |
- |
(3) |
(10,664) |
(10,667) |
Balance at
30 June 2023 |
46,198 |
15,542 |
3,746 |
26 |
(30,326) |
35,187 |
(in € thousands)
|
Attributable to equity holders of the Company |
|
|
|
Other reserves |
|
|
Share capital |
Share premium |
Share-based payment reserve |
Currency translation reserve |
Accumulated losses |
Total Equity |
Balance at
31 December 2023 |
46,198 |
15,488 |
4,060 |
22 |
(40,200) |
25,569 |
Share-based payments |
- |
- |
347 |
- |
- |
347 |
Exercise of ESOP Warrants |
142 |
100 |
(100) |
- |
- |
142 |
Reduction of capital by absorption of losses |
(41,585) |
- |
- |
- |
41,585 |
0 |
Total comprehensive loss |
- |
- |
- |
7 |
(6,489) |
(6,482) |
Balance at
30 June 2024 |
4,755 |
15,588 |
4,307 |
29 |
(5,103) |
19,576 |
The accompanying notes are an integral part of these condensed
consolidated financial statements. Please see the full interim
report available on www.biotalys.com.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE 6 MONTHS ENDED 30 JUNE
in € thousands |
Note |
2024 |
2023 |
|
|
|
|
CASH FLOW FROM
OPERATING ACTIVITIES |
|
|
|
Operating result |
|
(6,574) |
(10,855) |
Adjustments for: |
|
|
|
Depreciation, amortization and impairments |
|
918 |
888 |
Share-based payment expense |
|
348 |
723 |
R&D tax credit |
|
(440) |
(355) |
Other |
|
9 |
(41) |
Operating cash flows before movements in working
capital |
|
(5,739) |
(9,640) |
|
|
|
|
Changes
in working capital: |
|
|
|
Receivables |
|
73 |
447 |
Other current assets |
|
(227) |
(106) |
Trade and other payables |
|
(718) |
(953) |
Other current and non-current liabilities |
|
84 |
1,861 |
Cash used in operations |
|
(6,527) |
(8,392) |
Taxes
paid |
|
0 |
(124) |
Net cash used in operating activities |
|
(6,527) |
(8,516) |
|
|
|
|
CASH FLOW FROM
INVESTING ACTIVITIES |
|
|
|
Interest received |
|
283 |
251 |
Purchases of property, plant and equipment |
7.8 |
(93) |
(224) |
Proceeds from disposal of property, plant and equipment |
|
41 |
- |
Investments in other financial assets |
|
(10) |
(8) |
|
|
|
|
Net cash provided by investing activities |
|
221 |
20 |
|
|
|
|
CASH FLOW FROM
FINANCING ACTIVITIES |
|
|
|
Repayment of borrowings |
7.12 |
(215) |
(211) |
Repayment of lease liabilities |
7.12 |
(429) |
(438) |
Interests paid |
|
(82) |
(79) |
Proceeds from issue of equity instruments of the Company |
7.11 |
142 |
7,016 |
|
|
|
|
Net cash provided by (used in) financing
activities |
|
(584) |
6,289 |
|
|
|
|
NET DECREASE IN CASH AND CASH EQUIVALENTS |
|
(6,890) |
(2,208) |
|
|
|
|
CASH AND CASH EQUIVALENTS at beginning of period |
|
21,570 |
34,096 |
Effect of foreign exchange rates |
|
0 |
(2) |
CASH
AND CASH EQUIVALENTS at end of period |
|
14,680 |
31,886 |
The accompanying notes are an integral part of these condensed
consolidated financial statements. Please see the full interim
report available on www.biotalys.com.
- Biotalys Reports HY 24 Financial Results and Business
Highlights_22 August 2024
- Persbericht Financiële Resultaten en Bedrijfshoogtepunten_22
augustus 2024
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