Biotalys Reports Full Year 2021 Financial Results and Business
Highlights
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regulated information – inside
information
Biotalys Reports
Full Year 2021
Financial Results and
Business Highlights
-
IPO – Initial Public Offering providing a strong
financial runway to further exploit the potential of the company’s
proprietary AGROBODY Foundry™ platform
-
EVOCA™ – First protein-based biocontrol Evoca on
track for expected market calibration in the U.S. in 2022
- PRODUCT
PIPELINE – Breakthrough increase in production level of
Evoca’s active ingredient triggers adjustment of the company’s
pipeline
-
PARTNERSHIPS – Strategic partnerships with Bill
& Melinda Gates Foundation, Biobest, Olon and Kwizda Agro
-
CASH – Year-end cash and cash equivalents amounted
to €56.1 million
Conference call and live webcast today at 15:00
CET / 14:00 GMT / 09:00 EST, details below
Ghent, BELGIUM – 11
March 2022,
07:00 CET – Biotalys (Euronext - BTLS),
an Agricultural Technology (AgTech) company protecting crops and
food with protein-based biocontrol solutions, today announces its
business highlights and consolidated financial results for 2021,
prepared in accordance with IFRS as adopted by the European Union,
as well as selected post period events and an outlook for the
remainder of 2022. The annual report, including the full financial
report, is available on the company’s website.
Patrice Sellès, Chief Executive Officer
of Biotalys, commented: "2021 has been a historic year for
Biotalys where we have made outstanding progress in many areas.
Guided by new leadership in the Board of Directors, our Initial
Public Offering on Euronext Brussels has significantly increased
the global visibility of the company with partners, growers and
investors.”
“Our first protein-based biocontrol Evoca is
expected to receive EPA regulatory approval in H2 2022, which
should be one of the key milestones for our company this year. The
product is on track for market calibration in selected states in
the U.S. later this year. The product demonstrated strong
performance in independent field trials by renowned public
institutions in the U.S.”
“Recently, our strain engineering and
manufacturing teams have achieved a breakthrough in protein
expression of the bioactive ingredient of Evoca, using our
state-of-the-art biotech toolbox. This unprecedented achievement
creates an opportunity to bring a next generation of the product to
the market in 2026 at competitive efficacy and cost to growers. To
leverage this opportunity, we have decided to adapt our pipeline of
product candidates to focus our internal efforts on capturing
market share as rapidly as possible with the next generation of
Evoca products. We will therefore merge the current BioFun-5 and
BioFun-6 programs to consolidate efforts in the biofungicide space
and focus on providing growers a complementary and differentiated
biocontrol solution by 2028.”
2021
Operational
Highlights (including
post-period)
Evoca™ is a
protein-based biofungicide that aims to provide fruit and vegetable
growers with a new rotation partner in integrated pest management
(IPM) programs. It helps control diseases such as Botrytis and
powdery mildew, thus reducing the dependency on chemical pesticides
with corresponding residues in harvested produce while offering a
distinctive new tool to manage pathogen resistance development.
- Following the
submission to the Environmental Protection Agency (EPA) in the
United States in December 2020, Biotalys passed both the provided
completeness check and the preliminary technical screening in 2021.
Biotalys also submitted for approval in California in April 2021,
as this State performs its own in-depth review. In the European
Union, Biotalys received confirmation from the European Food Safety
Authority (EFSA) and the Dutch Board for the Authorisation of Plant
Protection Products and Biocides (Ctgb) that the registration
dossier submitted in March 2021 for the active substance of Evoca
was admissible for review.
The company expects to receive EPA approval in
H2 2022 which will be one of the key milestones for this year and
will also pave the way for the regulatory assessment of our product
pipeline in the future.
- Biotalys expects
to initiate a stepwise market calibration of Evoca in selected
states in the U.S. starting in late 2022, conditional upon
regulatory approval. In December 2021, Biotalys appointed Biobest,
a global leader in biocontrol and pollination, as exclusive
distributor of Evoca in the U.S. for all crops and
applications.
- Evoca
demonstrated strong performance both in the company’s own field
trial program as in independent field trials conducted by highly
reputed public institutions in the U.S. In 2021, more than 200
additional field and greenhouse trials were performed for Evoca
product development and positioning, leading to Biotalys’ ongoing
global fruit and vegetable trial program reaching over 500 trials
across multiple regions, pathogens and crops. These field trials
provide Biotalys with a tremendous amount of data points on
Evoca.
Biotalys’ pipeline of product
candidates includes programs in biofungicides,
biobactericides and bio-insecticides.
- Building on the
Biotalys’ AGROBODY Foundry™ technology platform, the company
achieved end of 2021 a breakthrough in protein expression of the
bioactive ingredient of Evoca. By using its state-of-the-art
protein expression toolbox, the strain engineering and
manufacturing teams have accomplished more than 500% increase in
production, representing an unprecedented achievement for the
active protein of Evoca in the yeast Pichia pastoris. If confirmed
in large scale production, the achieved production increase will
significantly lower the production costs of the protein as active
ingredient of the end products.
While Evoca is positioned as a tool to calibrate
the market, the company now believes that a next generation of the
product – based on the same bioactive – has the potential to
provide commercial value at competitive efficacy and cost to
growers.
- In view of the
recent breakthrough in protein expression, the company has
decided to adapt its pipeline to
consolidate its efforts in biofungicides on capturing market share
as rapidly as possible with the next generation of Evoca products
by 2026. As the subsequent BioFun-5 program was also positioned to
deliver a commercial product by 2026, and would therefore compete
for resources with the next generation of Evoca, BioFun-5 will now
be merged into BioFun-6 to focus on providing growers a
differentiated biocontrol solution by 2028 as planned.
By consequence, Biotalys’ pipeline of
protein-based biocontrols can today be presented as follows:
- The expected
timelines and addressable market for the respective pipeline
programs remain as previously communicated. Biotalys pipeline of
product candidates can be summarised as follows:
-
Evoca remains the key product for market calibration in the US
through an exclusive distribution partnership with Biobest.
-
The second generation of Evoca (containing the same protein
bioactive, with enhanced manufacturing and formulation) is
currently in the development stage. The product will be submitted
to the EPA in the US and the European Food Safety Authority (EFSA)
in the EU for rapid follow-on registration to replace Evoca in the
US and enter into the European market as of 2024, allowing Biotalys
to make a significant step towards cost reduction as compared to
the original investment plan.
-
The third generation of Evoca (containing the same protein
bioactive, with optimized manufacturing and formulation) has
progressed into the development stage. It is expected to enter both
the US and the EU markets by 2026, and expected to provide
commercial value at a faster pace than anticipated for the BioFun-5
program that it will therefore replace in terms of crops,
geographies and partnership potential.
-
BioFun-6 is progressing according to plan, allowing Biotalys to
focus on the throughput and selection capacity, increasing the
probability of success and a differentiating offer in the field of
fruit and vegetables protection by 2028. The acquired knowledge,
assays, processes and lead candidate from the previous BioFun-5
program are fully incorporated into the frame of the BioFun-6
program. With this change, Biotalys is enhancing its focus on the
most value generating program, decreasing the risk while securing a
strong IP position on recent achievements.
-
The other pipeline programs (BioFun-2, BioFun-4, BioFun-7, BioBac-1
and BioIns-1) are expected to provide valuable IP and know-how
strengthening the company’s AGROBODY Foundry platform and could
form the basis of further R&D collaborations.
Biotalys also entered into several
strategic partnerships in
R&D, distribution,
manufacturing and formulation
throughout the course of 2021.
- In October 2021,
Biotalys was awarded a multi-year grant by the Bill & Melinda
Gates Foundation to develop new biological solutions for cowpea and
other legumes (BioFun-7). During the course of the four-year
project that has started beginning 2022, Biotalys is receiving a
grant of close to USD 6 million in installments to achieve, by the
end of 2025, proof-of-concept of effective on
planta protection of the cowpea crop from leaf spot by an
AGROBODY™ bioactive.
- In December
2021, Biotalys announced a strategic partnership with Biobest under
which Biobest is granted access to five protein-based biocontrol
solutions developed by Biotalys on its AGROBODY Foundry technology
platform for Biobest’s global offer in covered crops and
berries. For each of the product candidates being promoted to
the development stage, the companies will negotiate a tailored
global distribution agreement and associated fees (for the
technology and product) taking into account the spectrum, potency
and crop applicability of the bio-fungicide, bio-insecticide or
bio- bactericide solution involved.
- In January 2022,
Biotalys announced the appointment of Olon, a world-leading
contract development and manufacturing organization, as
manufacturer of its products. Olon will produce the active
ingredient of Evoca at its world-class biotech manufacturing sites
in Italy, in batches of up to 112m³. This upscaling signifies a
major step forward in terms of production efficiency and
scalability of protein-based biocontrols.
- Biotalys also
announced in January 2022 an agreement with Kwizda Agro to act as
the formulator of the protein-based biocontrol products developed
by Biotalys. This agreement forms a critical step in the set-up of
the production process for Biotalys’ unique products, starting with
its first biofungicide Evoca planned for market calibration in the
United States. The partnerships with Olon and Kwizda Agro enable
the market calibration of Evoca.
Biotalys earned recognition for its products and
innovation in several awards in 2021:
- In May 2021:
Finalist in Fast Company’s 2021 World Changing Ideas, an awards
program showcasing some of the world’s most inventive companies
that are pursuing innovation for the good of society and the
planet.
- In October 2021:
Finalist for the Scale-up of the Year 2021 Award of the Flemish
Government, recognising its recent progress as fast-growing company
with international ambitions.
- In December
2021: SEAL Award, recognising companies from all over the world
that show Sustainable and Environmental Leadership. Biotalys won in
the category Sustainable Innovation.
Biotalys continues to strengthen its
patent portfolio to protect its science and
products. In 2021, seven patents were granted to the Company as
follows: in the U.S. related to certain VHH polypeptides; in Japan
and Australia (x2) related to certain compositions; in Canada
related to a seed treatment composition; and in Canada and Brazil
related to a targeting agent.
At the beginning of 2021, Biotalys moved to its
new facility located at
Buchtenstraat 11, Ghent (Belgium), comprising offices, state-of-the
art laboratories (including growth chambers) and technical spaces,
totaling approximately 2,600 m². This new facility operates as the
Company’s headquarters and accommodates the in-house R&D as
well as the majority of the Company’s managerial and support
functions. On 9 September 2021, Mrs. Hilde Crevits, Flemish
Minister of Agriculture, Science and Innovation, officially
inaugurated the new facilities.
2021
Corporate
Highlights
In July 2021 Biotalys successfully listed on
Euronext Brussels with the support of local and international
investors, raising a total of €52.8 million. The IPO provided the
company with a strong financial runway to further exploit the
potential of its proprietary AGROBODY Foundry™ platform. Following
the IPO, Biotalys entered the Euronext BEL Small® index in
September 2021.
The company strengthened its Board of Directors
in 2021 with the appointment of Simon Moroney as Chairman of the
Board, as well as the appointment of Catherine Moukheibir and
Markus Heldt as Independent Directors.
In addition, the Board of Directors will propose
to the General Shareholders Meeting of 15 April 2022 to appoint
Michiel van Lookeren Campagne as Independent
Director as of 1 June 2022. Michiel van Lookeren Campagne is
currently Director Agriculture & Food at CSIRO, Australia's
national science agency, based in Canberra, Australia, and
previously had an international career as a scientific executive
and thought leader at multiple major companies in the agricultural
sector. Additional information will be shared once the appointment
is confirmed by the General Shareholders Meeting.
In October, Patrick McDonnell strengthened the
executive team as Chief Business Officer based in Biotalys’ offices
in Research Triangle Park (RTP), the heart of US AgTech activities,
in North Carolina. Biotalys also attracted key personnel for
various of its departments, including the Discovery, Development,
Finance and Business Development functions.
Outlook for 2022
Additional to the above achievements, Biotalys
anticipates achieving the following key milestones in 2022:
- receiving EPA
registration approval for Evoca in the US in H2 2022;
- initiating the
market calibration in the US with our partner Biobest focusing on
entering the high value markets of covered fruit and vegetables,
berries and grapes by leveraging the close relationship between
Biobest and its grower customers;
- appointing a
Chief Technology Officer to complement capabilities, leverage the
potential of the AGROBODY Foundry technology platform to secure new
collaborations and create additional value; and
- engaging further
academic and industrial collaborations to validate and accelerate
the development of the AGROBODY Foundry.
The financing obtained with the IPO in July 2021
provides the company with additional funding to further expand the
capabilities and potential of its proprietary AGROBODY Foundry
platform, and to continue progressing its product pipeline. The
company expects the cash burn in 2022 to range between €27 and 29
million, in line with the envisaged investments in the pipeline,
platform and manufacturing requirements.
Detailed financial review
In € thousand |
2021 |
|
2020 |
|
Other operating income |
1,995 |
|
1,402 |
|
Research and development expenses |
(13,880 |
) |
(11,488 |
) |
General and administration expenses |
(4,905 |
) |
(2,357 |
) |
Marketing expenses |
(1,289 |
) |
(834 |
) |
Operating loss |
(18,079 |
) |
(13,276 |
) |
Financial income |
1,510 |
|
2,710 |
|
Financial expenses |
(343 |
) |
(171 |
) |
Loss before taxes |
(16,913 |
) |
(10,737 |
) |
Income taxes |
(16 |
) |
(13 |
) |
Loss for the
period |
(16,929 |
) |
(10,750 |
) |
Remeasurements gains (losses) on defined benefit plans |
5 |
|
(6 |
) |
Exchange differences on translating foreign operations |
5 |
|
20 |
|
Total comprehensive loss of the period |
(16,919 |
) |
(10,736 |
) |
Basic and diluted loss per share (in EUR) |
(1.10 |
) |
(14.33 |
) |
Profit/(loss) for the period attributable to the owners of the
company |
(16,929 |
) |
(10,750 |
) |
Total comprehensive income for the period attributable to the
owners of the company |
(16,919 |
) |
(10,736 |
) |
Cash and cash equivalents |
56,107 |
|
23,103 |
|
Consolidated statements of profit and
loss
-
Other operating income amounted to €2 million and
relates to R&D tax incentives received and grants awarded to
support R&D activities. The primary increase relates to grants
from government and the Bill & Melinda Gates Foundation to
support Biotalys’ R&D activities, which accounted for €1.0
million for 2021 (2020: €0.45 million).
-
Research and development expenses amounted to
€13.9 million for 2021, an increase of €2.4 million compared to
2020. These increases primarily relate to increases in internal
staffing levels to develop the company’s pipeline product
candidates, depreciation of lab equipment and external spending for
production, field trials and regulatory expenses for Evoca.
-
General and administrative expenses amounted to
€4.9 million for 2021, compared to €2.4 million in 2020. The
increase was mainly driven by an increase in employee benefit
expenses, strengthening the company’s management team and an
increase in professional services related to the preparation for
the initial public offering in July 2021.
-
Marketing expenses rose from €0.8 million in 2020
to €1.3 million in 2021 as a result of strengthening of the sales
and marketing team in support of the expanded market calibration of
Evoca planned for 2022 and beyond.
-
Financial income amounted to €1.5 million in 2021,
compared to €2.7 million in 2020, and related primarily to the full
release of the remaining derivative liability of the Anti-Dilution
warrants as they were cancelled upon the IPO.
-
Financial expenses amounted to €0.3 million and
related primarily to interest expenses for the leases and bank
loans (€0.2 million in 2020).
-
Income taxes expense remained negligible as in
2020.
-
Loss of the period was €16.9 million, compared to
€10.7 million in 2020.
-
Basic and diluted loss per share for 2021 amounted
to €1.10 compared to €14.33 in 2020 (following adjustment to
reflect the 2:1 reverse share split with the IPO).
-
Cash and cash equivalents increased to €56.1
million in 2021 (compared to €23.1 million in 2020), as a result of
the company’s IPO in July 2021, partially offset by changes in the
level of working capital, higher R&D expenditures and
strengthening of the company’s management team.
Auditor Statement
The statutory auditor has issued an unqualified
report dated 10 March 2022 on the Company’s consolidated financial
statements as of and for the year ended 31 December 2021 and has
confirmed that the cumulative full year accounting data reported in
the accompanying press release is consistent, in all material
respects, with the accounts from which it has been derived. The
condensed consolidated financial statements are derived from the
consolidated financial statements at 31 December 2021 that were
authorized for issue by the Board of Directors on 10 March 2022.
The condensed consolidated financial statements have been prepared
in accordance with the International Financial Reporting Standards
(IFRS) as adopted for use in the European Union.
Financial calendar and
upcoming IR-events
- 11 March 2022:
Online publication of annual report 2021
- 15 March 2022:
Biotalys’ CEO and CFO will meet with investors at the Berenberg’s
EU Opportunities Investor Conference (Benelux Day) in London
- 22-23 March
2022: Biotalys’ CEO, CBO and COO will meet with investors at the
World AgriTech Conference in San Francisco
- 30 March 2022:
Biotalys’ COO and Head of IR will give a presentation at the Bolero
webinar on food value chain
- 31 March 2022:
Biotalys’ CEO, CFO and Head of IR will participate in a virtual
investor roadshow organized by Kepler Cheuvreux
- 4-6 April 2022:
Biotalys’ CEO and CFO will give a presentation to investors at the
Global Ag Investing Conference in New York
- 15 April 2022:
Annual General Meeting
- 23 April 2022:
Biotalys’ CEO will give a company presentation at VFB’s Annual
Happening in Antwerp
- 5 May 2022:
First Biotalys Shareholders Club at Biotalys’ HQ in Ghent
- 1 June 2022:
Biotalys’ CEO, CFO and Head of IR will give a presentation at the
Kepler Cheuvreux ESG-conference
- 19 August 2022:
Publication of half year results 2022
Live webcast and conference
call
Company management will host a live webcast in English to
discuss its full year 2021 results and business highlights today,
11 March 2022, at 15:00 CET / 14:00 GMT / 09:00 EST.
Webcast link:
https://edge.media-server.com/mmc/p/vxozutog
Dial-in details:
Belgium: 027933847France: 0170700781Germany:
06922222625Netherlands: 0207956614Switzerland:
0445807145UK/International: +44 (0) 2071 928338 United States: +1
646 741 3167
Passcode: 5116258
-Ends-
About Biotalys
Biotalys is an Agricultural Technology (AgTech)
company protecting crops and food with proprietary protein-based
biocontrol solutions 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 is 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 & CommunicationT:
+32 (0)9 274 54 00E: Toon.Musschoot@biotalys.com
Important Notice
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. The 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.
CONSOLIDATED STATEMENT OF FINANCIAL
POSITION
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER
COMPREHENSIVE INCOME FOR THE YEARS ENDED 31
DECEMBER
(1) The denominator for the
purposes of calculating both basic and diluted earnings per share
has been adjusted retrospectively to reflect the 2:1 reverse share
split completed on 5 July 2021.
CONSOLIDATED STATEMENT OF CHANGES IN EQUITYFOR
THE YEARS ENDED 31 DECEMBER
CONSOLIDATED STATEMENT OF CASH FLOWSFOR THE
YEARS ENDED 31 DECEMBER
- Biotalys FY21 Results and Business Highlights_ENG
- Biotalys Jaarresultaten en Bedrijfshoogtepunten 2021_NL
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