Earnings Release • Mar 11, 2022
Earnings Release
Open in ViewerOpens in native device viewer
Press release – regulated information – inside information
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."
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' pipeline of product candidates includes programs in biofungicides, biobactericides and bioinsecticides.
• 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:
o 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.
Biotalys earned recognition for its products and innovation in several awards in 2021:
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.
In July 2021 Biotalys successfully listed on Euronext Brussels with the support of local and international investors, raising a total of €52.8 million. he 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 riangle 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.
Additional to the above achievements, Biotalys anticipates achieving the following key milestones in 2022:
• 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.
| € | 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 |
to develop the company's pipeline product candidates, depreciation of lab equipment and external spending for production, field trials and regulatory expenses for Evoca.
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.
15 April 2022: Annual General Meeting
23 April 2022: Biotalys' CEO will give a company presentation at VFB's Annual Happening in Antwerp
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
Belgium: 027933847 France: 0170700781 Germany: 06922222625 Netherlands: 0207956614 Switzerland: 0445807145 UK/International: +44 (0) 2071 928338 United States: +1 646 741 3167
Passcode: 5116258
-Ends-
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.
Toon Musschoot, Head of IR & Communication T: +32 (0)9 274 54 00 E: [email protected]
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.
| ASSETS | 31 December | 31 December 2020 |
|
|---|---|---|---|
| (in thousands of euros) | 2021 | ||
| Non-current assets | 11,336 | 10,757 | |
| Intangible assets | 665 | 792 | |
| Property, plant and equipment | 5,407 | 4,617 | |
| Right-of-use assets | 3,885 | 4,344 | |
| Other non-current assets | 1,380 | 1,004 | |
| Current assets | 58,938 | 25,505 | |
| Receivables | 451 | 226 | |
| Other financial assets | 2,100 | 2,100 | |
| Other current assets | 279 | 76 | |
| Cash and cash equivalents | 56,107 | 23,103 | |
| TOTAL ASSETS | 70,274 | 36,262 | |
| EQUITY AND LIABILITIES | 31 December | 31 December | |
| (in thousands of euros) | 2021 | 2020 | |
| Equity attributable to owners of the parent | 58,915 | 25,648 | |
| Share capital | 81,969 | 62,822 | |
| Share premium | 31,303 | 675 | |
| Accumulated losses | (55,855) | (34,117) | |
| Other reserves | 1,498 | (3,732) | |
| Total equity | 58,915 | 25,648 | |
| Non-current liabilities | 6,150 | 4,468 | |
| Borrow ings | 6,037 | 4,332 | |
| Employee benefits obligations | 26 | 50 | |
| Provisions | 87 | 86 | |
| Current liabilities | 5,209 | 6,146 | |
| Borrow ings | 1,186 | 888 | |
| Other financial liabilities | - | 1,302 | |
| Trade and other liabilities | 3,119 | 3,301 | |
| Other current liabilities | 904 | 655 | |
| Total liabilities | 11,359 | 10,613 | |
| TOTAL EQUITY AND LIABILITIES | 70,274 | 36,262 |
in € thousands 2021 2020 Other operating income 1,995 1,402 Research and development expenses (13,880) (11,488) General and administrative expenses (4,905) (2,357) Sales and 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) Other comprehensive income (OCI) Items of OCI that will not be reclassified subsequently to profit or loss Remeasurement gains (losses) on defined benefit plans 5 (6) Items of OCI that will be reclassified subsequently to profit or loss 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 €) (1) (1.10) (14.33) Profit/(loss) for the period attributable to the ow ners of the Company (16,929) (10,750) Total comprehensive income for the period attributable to the ow ners of the Company (16,919) (10,736)
(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.
| Attributable to equity holders of the Company | |||||||
|---|---|---|---|---|---|---|---|
| Other reserves | |||||||
| Share capital | Share premium |
Share-based payment reserve |
Anti-dilution reserve |
Currency translation reserve |
Accumulated losses |
Total Equity |
|
| (in thousands of euros) | |||||||
| Balance at 1 January 2020 | 47,822 | 540 | 512 | (4,439) | - | (23,362) | 21,073 |
| Loss for the period | - | - | - | - | - | (10,750) | (10,750) |
| Other comprehensive income | - | - | - | - | 20 | (6) | 14 |
| Total comprehensive loss | - | - | - | - | 20 | (10,756) | (10,736) |
| Issuance of shares | 15,000 | 136 | - | - | - | - | 15,136 |
| Issue of ant-dilution w arrants | - | - | - | (375) | - | - | (375) |
| Share-based payments | - | - | 550 | - | - | - | 550 |
| Balance at 31 December 2020 | 62,822 | 675 | 1,062 | (4,813) | 20 | (34,117) | 25,648 |
| Loss for the period | - | - | - | - | - | (16,929) | (16,929) |
| Other comprehensive income | - | - | - | - | 5 | 5 | 10 |
| Total comprehensive loss | - | - | - | - | 5 | (16,924) | (16,919) |
| Issuance of shares | 19,147 | 30,528 | - | - | - | - | 49,675 |
| Cancellation of anti-dilution w arrants | - | - | - | 4,813 | - | (4,813) | - |
| Share-based payments | - | 99 | 412 | - | - | - | 511 |
| Balance at 31 December 2021 | 81,969 | 31,303 | 1,473 | - | 25 | (55,855) | 58,915 |
| in € thousands | 2021 | 2020 |
|---|---|---|
| CASH FLOW FROM OPERATING ACTIVITIES | ||
| Operating result | (18,079) | (13,276) |
| Adjustments for: | ||
| Depreciation, amortisation and impairments | 1,470 | 1,037 |
| Equity-settled share-based payment expense | 511 | 550 |
| Provisions | (20) | 13 |
| R&D tax credit | (405) | (444) |
| Other | 7 | 20 |
| Operating cash flows before movements in working capital | (16,516) | (12,099) |
| Changes in w orking capital: | ||
| Receivables | (225) | 262 |
| Other current assets | (175) | (42) |
| Trade and other payables | (70) | 1,692 |
| Other current liabilities | 256 | 655 |
| Cash used in operations | (16,731) | (9,533) |
| Taxes paid | (23) | - |
| Net cash used in operating activities | (16,754) | (9,533) |
| CASH FLOW FROM INVESTING ACTIVITIES | ||
| Interests received | 1 | 15 |
| Purchases of property, plant and equipment | (1,324) | (3,817) |
| Purchases of Intangible assets | (8) | (114) |
| Proceeds from disposal of PPE | 7 | - |
| Investments in other financial assets | (0) | (2,100) |
| Net cash used in investing activities | (1,324) | (6,016) |
| CASH FLOW FROM FINANCING ACTIVITIES | ||
| Repayment of borrow ings and other financial liabilities | (1,127) | (1,022) |
| Proceeds from borrow ings | 2,780 | 1,220 |
| Interests paid | (244) | (39) |
| Proceeds from issue of equity instruments of the Company (net of issue costs) | 49,675 | 15,136 |
| Net cash provided by financing activities | 51,083 | 15,295 |
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 33,005 | (255) |
| CASH AND CASH EQUIVALENTS at beginning of year | 23,103 | 23,358 |
| CASH AND CASH EQUIVALENTS at end of year | 56,107 | 23,103 |
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.