THIS ANNOUNCEMENT (INCLUDING THE APPENDIX) AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, THE REPUBLIC OF IRELAND, THE REPUBLIC OF SOUTH AFRICA, NEW ZEALAND OR JAPAN OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. PLEASE SEE THE IMPORTANT NOTICES AT THE END OF THIS ANNOUNCEMENT.
THIS ANNOUNCEMENT WAS DEEMED BY THE COMPANY TO CONTAIN INSIDE INFORMATION AS STIPULATED UNDER THE MARKET ABUSE REGULATIONS (EU) NO. 596/2014 AS THEY FORM PART OF UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018. WITH THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INFORMATION IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.
16 February 2023
Creo Medical Group plc
("Creo" or the "Company")
Proposed Placing and Subscription to raise a minimum of £25.0 million
Launch of Accelerated Bookbuild
Proposed Open Offer to raise up to approximately £5.2 million
Creo Medical Group plc (AIM: CREO), a medical device company focused on the emerging field of surgical endoscopy, is pleased to announce a proposed fundraising by way of an accelerated bookbuild to raise a minimum of £25.0 million (net of expenses) via a conditional placing and subscription of new Ordinary Shares at the Issue Price of 20 pence per share to certain institutional and other investors. The Placing which is being conducted by way of an accelerated bookbuild, will commence immediately following this Announcement and is expected to close later today.
Furthermore, the Company is proposing to raise up to approximately £5.2 million by way of an open offer, which will be available to all Qualifying Shareholders on the Record Date.
The Directors believe that, despite the backdrop of challenging macroeconomic conditions, 2022 was another year of significant operational progress for the Group, and the Company is pursuing the Fundraising in order to raise sufficient funds to maintain momentum in the business. The Fundraising is intended to enable the Company to progress into the next stage of the development and commercialisation of its minimally invasive electrosurgical devices, and the Directors expect that the Fundraising will provide the Company with a pathway to being cash flow breakeven and, ultimately, to profitability as well as give comfort to existing customers, suppliers and partners of increased balance sheet strength.
Transaction Highlights
· Placing and subscription to raise a minimum of £25.0 million, net of expenses, via a conditional issue of new Ordinary Shares at the Issue Price.
· Open Offer to raise gross proceeds of up to an approximate additional £5.2 million via a conditional issue of up to 26,048,909 new Ordinary Shares at the Issue Price.
· The Placing is to be conducted by way of an accelerated bookbuild process, which will commence immediately following this Announcement and will be subject to the terms and conditions set out in Appendix I to and as otherwise provided in this Announcement.
· The Issue Price of 20 pence represents a discount of approximately 27.9 per cent. to the closing mid-market price of 27.8p on 15 February 2023 and a discount of approximately 5.7 per cent. to the 30-day VWAP up to and including 15 February 2023 of 21.2p.
· The Directors and certain members of the Company's senior management have indicated an intention to participate approximately £2.1 million in the Fundraising.
· The net proceeds from the Fundraising are intended to be used by Creo and its Group to:
Ø provide the working capital required to accelerate the commercial roll out of its core technology products in the US, EMEA and APAC;
Ø continue to develop its pipeline of commercial licensing and partnering opportunities via its Kamaptive licensing programme;
Ø continue to develop the Company's IP portfolio;
Ø continue research and development to develop new devices for use in conjunction with CROMA;
Ø continue to expand and commercialise its range of Endotherapy consumable devices; and
Ø resolve the funding gap with the expectation of providing the Company with a pathway to being cash flow breakeven and, ultimately, to profitability.
· Completion of the Fundraising is conditional, inter alia, upon Shareholder approval at the General Meeting to be held on or around 8 March 2023 .
· Cenkos and Numis are acting as joint bookrunners and joint brokers in relation to the Fundraising.
A circular, containing further details of the Fundraising and Notice of General Meeting to be held at 10.00 a.m. on 8 March 2023 to, inter alia, approve the Resolutions required to implement the Fundraising, is expected to be published and despatched to Shareholders on or around 17 February 2023 (the "Circular"). Following its publication, the Circular will be available on the Company's website at https://www.creomedical.com/investors . Defined terms used in this announcement are set out at the end of the announcement.
Craig Gulliford, Chief Executive Officer of Creo, said: "We're delighted to announce the launch of this funding round which will not only provide us with the working capital to accelerate the roll out of our core technology, but will also resolve the funding gap to provide us with a pathway to being cash flow breakeven and, ultimately, to profitability.
"Over the last year we have demonstrated rapid growth in the core technology and product revenues coming out of the pandemic. We have seen excellent progress across our clinical adoption, Pioneer training programme, new product launches and partnering projects, and our Kamaptive partnerships with Intuitive and CMR Surgical, where our products are being adapted for use with robotic-assisted surgical platforms, continue to progress well. These funds will allow us to continue to support the commercial scaling up of our core technologies, expand our Kamaptive programme, which is focussed on large markets with significant growth potential, and develop our endoscopic suite of products for roll out on a global basis."
For further information, please visit www.creomedical.com or contact:
Creo Medical Group plc |
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Richard Rees (CFO) |
+44 (0)1291 606 005 |
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Cenkos Securities plc (Nominated Adviser, Joint Bookrunner and Joint Broker) |
+44 (0)20 7397 8900 |
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Camilla Hume / Stephen Keys (NOMAD) |
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Russell Kerr/ Michael Johnson (Sales) |
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Numis (Joint Bookrunner and Joint Broker) Freddie Barnfield / James Black / Duncan Monteith William Baunton (ECM) |
+44 (0)20 7260 1000 |
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Walbrook PR Ltd |
Tel: +44 (0)20 7933 8780 or creo@walbrookpr.com |
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Paul McManus / Sam Allen / Phillip Marriage |
Mob: +44 (0)7980 541 893 / +44 (0)7502 558 258 |
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Details of the Fundraising
Cenkos Securities plc ("Cenkos") and Numis Securities Limited ("Numis") are acting as joint bookrunners and joint brokers in relation to the Fundraising and Admission. The Placing is subject to the terms and conditions set out in the Appendix to this Announcement or as otherwise agreed with Placees.
The Banks will today commence the Bookbuilding Process in respect of the Placing. The final number of Placing Shares to be placed at the Issue Price will be determined at the close of the Bookbuilding Process.
The book will open with immediate effect following this Announcement. The timing of the closing of the Bookbuilding Process and allocations thereunder are at the absolute discretion of the Banks, having consulted with the Company. Details of the number of Placing Shares will be announced as soon as practicable after the close of the Bookbuilding Process. The Placing is not being underwritten.
The Banks reserve the right, by agreement with the Company, to increase the size of the Placing to accommodate additional demand.
In addition, in order to provide Shareholders who do not take part in the Placing with an opportunity to participate in the proposed issue of new Ordinary Shares, the Company is providing all Qualifying Shareholders with the opportunity to subscribe for Open Offer Shares at the Issue Price. Qualifying Shareholders subscribing for their full entitlement under the Open Offer may also request additional Open Offer Shares through the Excess Application Facility. The Open Offer is not being underwritten.
The Circular, containing further details of the Fundraising and convening the General Meeting in order to pass the Resolutions, is expected to be despatched to Shareholders on or around 17 February 2023 and the Circular, once published, will be available on the Company's website at www.creomedical .com/investors .
The Fundraising and the issue of the New Ordinary Shares are conditional upon, among other things, the Resolutions being duly passed by Shareholders at the General Meeting.
The New Ordinary Shares, when issued, will be fully paid and will rank pari passu in all respects with the Existing Ordinary Shares, including the right to receive all dividends and other distributions declared, made or paid after the date of issue.
Admission, Settlement and CREST
Application will be made for the New Ordinary Shares to be admitted to trading on AIM and a further announcement will be made in due course.
Subject to the passing of the Resolutions, settlement for the New Ordinary Shares and Admission are expected to take place at 8.00 a.m. on or around 9 March 2023 (or such later time and/or date as Cenkos and Numis may agree with the Company not being later than 8.00 a.m. on 31 March 2023). In addition to the passing of the Resolutions, the Fundraising is conditional upon, among other things, Admission becoming effective and the Placing Agreement not being terminated in accordance with its terms.
The Appendix sets out further information relating to the Bookbuilding Process and the terms and conditions of the Placing. Persons who have chosen to participate in the Placing, by making an oral, electronic or written offer to acquire Placing Shares, will be deemed to have read and understood this Announcement in its entirety (including the Appendix) and to be making such offer on the terms and subject to the conditions herein, and to be providing the representations, warranties, agreements, acknowledgements and undertakings contained in the Appendix.
This Announcement should be read in its entirety.
Expected Timetable for the Fundraising
Record Date for entitlement under the Open Offer |
2023 15 February |
Announcement of the Fundraising |
16 February |
Announcement of the results of the Placing |
16 February |
Ex-entitlement date of the Open Offer |
16 February |
Publication of the Circular, Form of Proxy and, to Qualifying Non-Crest Shareholders, the Application Form |
17 February |
Open Offer Entitlements and Excess Open Offer Entitlements credited to stock accounts in CREST of Qualifying CREST Shareholders |
20 February |
Latest recommended time and date for requested withdrawal of Basic Open Offer Entitlements from CREST |
4.30 p.m. on 1 March
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Latest time and date for depositing Open Offer Entitlements in CREST |
3.00 p.m. on 2 March
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Latest time and date for splitting of Application Forms under the Open Offer |
3.00 p.m. on 3 March
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Latest time and date for receipt of Forms of Proxy and CREST voting instructions |
10.00 a.m. on 6 March
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Latest time and date for receipt of Application Forms and payment in full under the Open Offer and settlement of relevant CREST instructions (as appropriate) |
11.00 a.m. on 7 March
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General Meeting |
10.00 a.m. on 8 March
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Results of the General Meeting and the Open Offer announced |
8 March |
Admission of the New Ordinary Shares to trading on AIM and commencement of dealings |
8.00 a.m. on 9 March
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Where applicable, expected date for CREST accounts to be credited in respect of New Ordinary Shares in uncertificated form |
9 March
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Where applicable, expected date for despatch of definitive share certificates for New Ordinary Shares in certificated form |
23 March |
Notes:
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Each of the above times and/or dates is subject to change at the absolute discretion of the Company, Cenkos and Numis. If any of the above times and/or dates should change, the revised times and/or dates will be announced through a Regulatory Information Service. |
2 |
All of the above times refer to London time unless otherwise stated. |
3 |
All events listed in the above timetable following the General Meeting are conditional on the passing of the Resolutions at the General Meeting. |
Each of the times and dates above refer to London time and are subject to change. Any such change will be notified to Shareholders by an announcement through a Regulatory Information Service. All events listed in the above timetable following the General Meeting are conditional on the passing of the Resolutions at the General Meeting.
FURTHER INFORMATION
BACKGROUND TO AND REASONS FOR THE FUNDRAISING
The Directors believe that, despite the backdrop of challenging macroeconomic conditions, 2022 was another year of significant operational progress for the Group, the highlights of which were:
· continued commercialisation of the Group's core advanced energy electrosurgical products in the USA, EMEA and APAC:
o further progress in the commercialisation of the Speedboat technology, including the release to the market of the upgraded slimmer Speedboat Inject device in November 2022, and the development of Speedboat Flush with 510k FDA clearance already submitted; and
o continued initial use of MicroBlate Fine for soft tissue ablation both within the pancreas as well as the liver;
· signing Kamaptive robotic licensing agreements with both Intuitive and CMR, with the first revenues having now been generated from Intuitive, and the first in-human robotic procedure expected during 2023;
· launching the Group's range of Endotherapy consumable products into the US market;
· launching the Pioneer clinical training programme to allow for physicians to be trained in larger group settings. This has resulted in the number of physicians in the Group's training process by the end of 2022 to have doubled to 450 as compared to the end of 2021; and
· the number of users of the Group's products have grown fourfold in 2022 from the previous year.
The Company is pursuing the Fundraising in order to raise sufficient funds to maintain momentum in the business building on the success of 2022 and the milestones that it has achieved since IPO. The Fundraising is intended to enable the Company to progress into the next stage of the development and commercialisation of its minimally invasive electrosurgical devices, and the Directors expect that the Fundraising will provide the Company with a pathway to being cash flow breakeven and, ultimately, to profitability as well as give comfort to existing customers, suppliers and partners of increased balance sheet strength.
The Directors believe that the current usage patterns of Speedboat Inject suggest that there will be an accelerated growth in demand in future years. Together with the continued commercialisation of the Group's other core technologies, the expansion opportunities within its Kamaptive licensing programme, and the Fundraising completed, the Directors believe that the Company is well positioned to capitalise on the rise of endoscopic surgery.
The Company intends to use the net proceeds of the Fundraising to:
· provide the working capital required to accelerate the commercial roll out of its core technology products in the US, EMEA and APAC;
· continue to develop its pipeline of commercial licensing and partnering opportunities via its Kamaptive licensing programme, which would allow the Group's significant IP portfolio and products to be exploited and monetised, specifically in relation to RAS, laparoscopic surgical applications and plasma sterilisations;
· continue to develop the Company's IP portfolio in areas such as electroporation, plasma sterilisation, tissue sensing and other energy modalities for inclusion within CROMA;
· continue research and development to develop new devices for use in conjunction with CROMA;
· continue to expand and commercialise its range of Endotherapy consumable devices; and
· resolve the funding gap with the expectation of providing the Company with a pathway to being cash flow breakeven and, ultimately, to profitability.
Summary of Creo
Creo is a medical device company focused on the development and commercialisation of minimally invasive electrosurgical devices, bringing advanced energy to endoscopy.
The Company's vision is to improve patient outcomes through the development and commercialisation of a suite of electrosurgical medical devices, each enabled by CROMA, powered by Kamaptive. The Group has developed the CROMA powered by Kamaptive full-spectrum adaptive technology to optimise surgical capability and patient outcomes. Kamaptive is a seamless, intuitive integration of multi-modal energy sources, optimised to dynamically adapt to patient tissue during procedures such as resection, dissection, coagulation and ablation of tissue. Kamaptive technology provides clinicians with increased flexibility, precision and controlled surgical solutions. CROMA currently delivers bipolar RF energy for precise localised cutting and focused high frequency MW energy for controlled coagulation and ablation via a single accessory port. This technology, combined with the Group's range of patented electrosurgical devices, is designed to provide clinicians with flexible, accurate and controlled clinical solutions.
The Directors believe the Company's technology can impact the landscape of surgery and endoscopy by providing a safer, less invasive, and more cost-efficient option for procedures. To date the Company's core technology devices have been used in over 1,500 procedures.
Core Creo Technology Products
The Company has developed a suite of patented, single use, endoscopic electrosurgical devices, each of which is powered by CROMA, powered by Kamaptive. CROMA currently delivers bipolar RF and focused high frequency MW advanced energy through a single accessory port.
Unlike traditional open surgery and more advanced keyhole/laparoscopic surgeries that require incisions to be made in the patient to gain access to diseased tissue, endoscopic devices gain access to the patient via natural orifices. As no incisions are made through the skin, the risks associated with infection are significantly reduced, as are the procedure and recovery times. Furthermore, patients can undergo certain procedures without general anaesthetic and under mild or, in some cases, no sedation and can, therefore, usually be treated as day patients in endoscopy suites or outpatient clinics. In turn, this reduces the length of stay in hospital, the risk of infection, and the cost of procedure by transferring therapy from the operating theatre to the endoscopy suite.
Creo's core technology products are optimised around the core tissue effects of dissection, resection, haemostasis and ablation. These core tissue effects are optimised around the Group's four, advanced energy technology families - Speedboat, MicroBlate, SpydrBlade and SlypSeal :
1) Speedboat
The Directors believe that Speedboat is a rare device technology in that it is the only known bipolar RF surgical dissection blade in any form of surgery. Additionally, Speedboat integrates MW technology allowing for precise control of bleeding during procedures.
The features of Speedboat can also be uniquely integrated with irrigation and injection capability. As with all the Creo device families, the Speedboat device technology has applications in many different areas of clinical therapy and surgery, and with new users being added each week with multiple cases daily on a global basis, the rate of adoption and conversion is increasing.
Speedboat Inject (targeting GI lesions (including Bowel and Upper GI cancer) & swallowing disorders)
The first device commercially launched by the Group along with CROMA, Speedboat Inject has been used in over 1,500 clinical cases worldwide and is supported by excellent clinical publications and strong health economic data. Speedboat Inject was CE marked for lower GI use, gained FDA clearance for upper and lower GI use in 2017 and was commercially launched in October 2019.
Speedboat Inject is a flexible endoscopic device which enables endoscopists to: (1) lift tissue with viscous fluid injection via a retractable needle, (2) cut tissue precisely using bipolar RF energy which is delivered along the edge of the device for localised energy transfer (reducing the risks associated with monopolar tissue resection), and (3) deliver high frequency controlled and focused MW coagulation, all within a single instrument.
Data from the UK's leading clinical user of Speedboat Inject demonstrates that its use in a SSD procedure can save NHS hospitals nearly £10,400 per procedure versus a traditional surgical outcome for patients.
The number of both the users of Speedboat Inject and also the cases completed with the device increased fourfold and threefold respectively in the year ended 31 December 2022. This resulted in a threefold increase in the revenue generated from Creo's core technology in the period. The Directors expect two-to-three times growth in the number of users of Speedboat Inject in 2023 and forecast three-to-four times growth in cases in 2023 following the introduction of the slimmer Speedboat Inject device.
Slimmer Speedboat Inject (targeting GI lesions (including Bowel and Upper GI cancer) & swallowing disorders)
The second Speedboat Inject device in the Speedboat family of devices. With a "slimmer" profile, the device is compatible with endoscopes with a working channel of 3.2mm or greater and enables endoscopists to address more indications in patients where narrower and more flexible devices are required over the original Speedboat Inject. The device was CE marked in June 2020 and was commercially launched in November 2022.
Speedboat Flush (targeting GI lesions (including Bowel and Upper GI cancer) & swallowing disorders)
The third device in the Speedboat family, Speedboat Flush, is the slimmest of the three and is compatible for use in endoscopes with a 2.8mm working channel. Development of this device was completed in early January 2023 and a 510k submission for Speedboat Flush was be made to the FDA in early February 2023. The Directors expect that the Medical Device Regulation submission for CE marking will take place in April 2023. Subject to obtaining the necessary regulatory clearances, the Directors anticipate the initial clinical use of the device to be in the second half of 2023.
2) MicroBlate
MicroBlate is part of Creo's ablation family, bringing the Company's very high frequency 5.8GHz MW energy into clinical practice. Operating at such a high frequency offers unrivalled levels of control and feedback via CROMA allowing physicians to precisely ablate diseased tissue in multiple tissue types and many different clinical access methods.
MicroBlate Fine (targeting soft tissue ablation through the GI tract (initially Pancreas, Liver, Kidney & GI lesions)
MicroBlate Fine brings fine needle MW ablation into clinical practice for the first time. It is believed to be the smallest diameter MW ablation needle antenna in the world, with a diameter of less than 1mm. The MicroBlate Fine device can be used in a variety of ablation procedures such as open, laparoscopic and flexible endoscopic procedures. Designed to be the same form and dimensions as a standard biopsy needle, MicroBlate Fine is designed for the ablation of a wide range of tissue types (such as pancreas, liver, kidney and muscle) that are accessible through the GI tract. Due to the small diameter of the device, it can be used to ablate tumours in highly perfused organs without the risk of bleeding prior to energy delivery due to the sub-mm insertion tract.
The MicroBlate Fine device received 510(k) clearance from the US Food & Drug Administration in November 2020 and was CE marked (for use in the UK and EU) in June 2020.
The first in-man clinical use of the MicroBlate Fine device to successfully ablate pancreatic tumour tissue under endoscopic ultrasound guidance was completed in December 2020. Since December 2020, MicroBlate Fine has been used in over 25 cases across six centres globally for further pancreatic ablations and also the initial use for liver tumour ablation.
MicroBlate Flex (targeting bronchial access (lung) and Oesophageal access (stomach, oesophagus, and colon)
MicroBlate Flex is a new soft tissue ablation device, designed with the aim of being able to ablate nodules and tumours in several tissue types using the highest frequency MW energy used for tumour ablation. This device also has potential to be used to treat a number of other conditions, where a small diameter flexible device enables access into otherwise inaccessible regions of the body. The device could be particularly useful to treat a range of ENT indications, including nasopharyngeal cancer and nasal polyps.
The MicroBlate Flex device received 510(k) clearance from the US Food & Drug Administration in January 2021 and was CE marked in June 2020.
3) SpydrBlade
SpydrBlade optimises the power of CROMA, where advanced bipolar RF energy is used to cut tissue and precisely controlled MW energy is used for the coagulation and sealing of tissue during surgery. The SpydrBlade jaw structure utilises the unique blade technology of the Group's Speedboat technology, with no other laparoscopic surgical device known to have similar resection features. The Directors believe that the patented combination with MW energy for the sealing and coagulation of tissue adds up to a game-changing device technology platform.
SpydrBlade Flex (targeting GI lesions (including Bowel and Upper GI cancer) & swallowing disorders)
The first SpydrBlade device in the family and is described as "the holy grail of interventional endoscopy" by Rob Hawes MD, a world-renowned pioneer in the field of therapeutic endoscopy at the Florida Hospital in Orlando. Designed to operate in flexible endoscopes commonly used around the world, SpydrBlade Flex puts laparoscopic advanced energy capability into the hands of the endoscopist for the first time. Building on the Speedboat blade technology, SpydrBlade Flex enables the clinician to grasp, cut and coagulate highly perfused tissue (such as in the colon, stomach, liver or spleen). The ability to alternate between cutting and coagulating using RF and MW energy across the 'jaws' of SpydrBlade Flex gives the clinician significantly more control providing a gliding cut using a fixed bipolar RF field as well as a conventional bipolar RF cutting between two jaws at opposite polarities. It offers great utility to bloodlessly resect/dissect and coagulate in a wide range of organs within the human body by sequentially applying the MW field followed by the RF field to coagulate and then cut.
The SpydrBlade Flex device was CE marked in June 2020 and the business continues to develop this technology, including for laparoscopic and RAS applications.
4) SlypSeal
SlypSeal is believed to be the only "non-stick" electrosurgical haemostasis device technology in the market. This key feature overcomes the perennial challenge in surgery and transforms the surgeons' ability to precisely manage bleeding with the unique ability to reapply with the "non-stick" feature addressing the risk of "re-bleeds". This combined with the precision and control of MW coagulation, opens up many different device structures in the future.
SlypSeal Flex (targeting GI bleeding)
The first device in this family of devices targeting GI bleeds which is one of the most common clinical indications in the GI. SlypSeal Flex will target the treatment of upper and lower GI bleeds, such as stomach ulcers or bleeding polyps.
SlypSeal Flex received FDA clearance in March 2020 and was CE marked in June 2020.
Endotherapy and Consumable Devices
In addition to Creo's core technology products, the Group sells a comprehensive range of complimentary single-use products and equipment used in endoscopic diagnostic, therapeutic and hygiene procedures primarily in GI, Urology and Pulmonology areas.
Initially brought into the Group through the acquisitions of the now renamed Creo Medical SL and Creo Medical SRL during 2020, these products comprise of a mix of Creo's own manufactured products, Creo branded (third party manufactured) products and third-party branded (i.e. distributed) products, each sold predominantly in UK and major European markets via well-established sales teams.
During 2022, the Company introduced a number of its Endotherapy products to the US market with the aim of complementing the Group's core technology products and providing physicians and clinicians a complete product solution for everyday endoscopic procedures.
Strategy
The Directors believe that they have the opportunity to develop the business to enable a multi-tiered revenue structure. To date, the Directors have sought to achieve this through a three-tiered build, buy and partner strategy. Having made a number of successful acquisitions, giving the business a wider European footprint, revenue and additional products, the company is leveraging this growth and focussing on its core technologies and Kamaptive licensing programme.
1) Core technology
The Company is organically growing through the development and commercialisation of its core technology. This involves building the team across global markets to commercialise and develop the existing and continually developing core technology, bringing CROMA to market through the suite of electrosurgical devices as described above.
Market overview, activities and opportunity
Speedboat and the SSD procedure . Based on research undertaken by a UK NHS Trust, the Company believes that approximately 5.5 per cent. of lesions identified during routine colonoscopies are complex. Of those identified, approximately 49 per cent. require a therapeutic intervention which can be addressed by the Group's Speedboat technology. In the USA, there are c.16 million screening colonoscopy procedures performed annually. Using the above metrics, this would result in c.0.88 million complex lesions being found annually, of which approximately 431,000 would require therapeutic intervention that could be addressed using the Group's Speedboat technology. The Directors believe that this implies a total addressable market for Speedboat in the US of c.US$425 million and c.$1.1 billion worldwide. Furthermore, the Directors believe that the number of addressable procedures will increase as the routine screening age of patients trends lower.
In addition to enabling increased numbers of procedures, as explained above the Group's SSD procedure is estimated to lead to cost savings in NHS Hospitals of over £10,000 per procedure versus a traditional surgical outcome for patients and represents an approximate saving of 50 per cent. compared to a surgical intervention. Based on "The 2020 National Bowel Cancer Audit", the Directors also believe that potential NHS savings could amount to c. £180 million per annum.
In 2022, there was a significant increase in training on the use of Speedboat, with the number of users increasing fourfold. Management expects that this trend will continue in 2023. As new versions of Speedboat enter the market, the Directors believe the utilisation of the devices will increase by approximately 50 per cent. per user as a result of the ability to utilise endoscopes with smaller working channels. Currently 65 per cent. of users as at end FY22 were deemed 'early' users by management, with 20 per cent. and 15 per cent. 'normal' and 'high' users respectively. Management anticipates that by FY27 the split of 'early', 'normal' and 'high' users will become 33 per cent., 40 per cent. and 27 per cent. respectively on a much larger base of users, driving substantially higher usage rates.
Creo has established sales, training and mentoring teams in place. An area of focus for the conversion of trainees to users is the Group's increasing number of mentors who were introduced during 2022. As the number of trainees increase due to larger Pioneer training courses taking place, the greater number of mentors available will be utilised to assist in the conversion of trainees into users. Creo has run courses in all major regions of the US with smaller groups in 2022, and these are expected to get larger in 2023 in partnership with ASGE and leading academic centres (UCI, Mayo, Penn, Baylor), with the Group's increase in mentoring capacity directly resulting in increased users.
Speedboat Inject is cleared for use in both upper and lower GI tract procedures under the FDA. During 2022 a number of POEM procedures were undertaken using Speedboat Inject to treat swallowing disorders caused by muscle problems such as spasms in the oesophagus. The Directors believe that the introduction of the slimmer Speedboat Inject device will enable more clinicians to utilise the device for such procedures where it is cleared for use, creating additional market potential for the technology.
As more clinicians utilise the technology, it is likely that additional procedures will benefit from Creo's Speedboat technology. One notable example was seen in late July 2022, where a team of clinicians in Israel, led by Dr Sergei Vosko, utilised Creo's Speedboat Inject device to remove a GIST from a patient for the first time.
MicroBlate Fine . Pancreatic and liver cancers account for over 1.4 million cancers globally per annum. These types of cancers have a high mortality rate (liver at 80 per cent. and pancreas at 90 per cent. at five years) and most are inoperable due to the late diagnosis (less than 20 per cent. of pancreatic cancers are operable). The Group's MicroBlate Fine device, when used with endoscopic ultrasound, enables a less invasive, endoscopic alternative to treat hepatobiliary tumours and to treat patients where surgery is not an option and has an estimated cost per procedure of c.£3,000 to £4,000.
The first in-man clinical use of the MicroBlate Fine device to successfully ablate pancreatic tumour tissue under endoscopic ultrasound guidance was completed in December 2020. As announced in June 2021, subsequent scans of the patient's pancreas continued to confirm the treatment's durability. Since December 2020, MicroBlate Fine has been used in over 25 cases across six centres globally for further pancreatic ablations and also the initial use for liver tumour ablation. In May 2022, the first clinical cases using the longer version of the MicroBlate Fine (80 mm) were completed in Ecuador, with further cases subsequently undertaken in India, France, Thailand and Romania. In 2023, the Directors are expecting both more cases and centres globally to use MicroBlate Fine, including the first case to take place in the USA, and view it as a key product for the Group's future growth.
MicroBlate Flex. Lung cancer is the leading cause of cancer deaths globally with over 2.2 million new cases each year. Only 34 per cent. of lung cancers are diagnosed at early stages due to poor screening techniques resulting in high mortality. Surgery or percutaneous approaches have been the primary therapeutic treatments for early-stage cancer although these are invasive with a high risk of complications. MicroBlate Flex enables a less invasive, endoscopic alternative to treat pre-cancerous nodules as a first-line option, as well as treatment of patients not eligible for surgery.
The efficacy of the MicroBlate Flex has been validated for all areas of the lung in a cadaver lab.
The Board also believes that there is the scope to create future instruments for use with CROMA which can be evolved to deliver existing and new energy frequencies and modalities including electroporation and additional functionality, such as tissue sensing, for a range of laparoscopic, robotic, surgery and other open-source devices.
2) Acquisitions
The Company has sought to accelerate its growth through acquisitions of companies with existing and mature sales, distribution and/or manufacturing operations which complement and add infrastructure and capability in Creo's direct sales markets.
In 2020, the Group completed two acquisitions, Albyn Medical S.L. (now named Creo Medical S.L.) and Boucart Medical SRL (now named Creo Medical SRL). The Directors believe that these acquisitions have been transformational in providing the Group with direct access to key European markets, providing a European sales infrastructure. These acquisitions also brought a wide range of complementary GI products to the Group and broadened the Company's portfolio into urology and hygiene. The Company has recently introduced certain of these complementary Endotherapy products to the US market.
In November 2021, the Group consolidated a key part of its supply chain through the acquisition of Aber Electronics. Aber provides a key component to the Company's CROMA platform. The Directors believe this acquisition not only enhanced a key element of the Group's supply chain but also complemented the Company's research, design, and manufacturing processes, provided additional specialist MW and RF capability and expertise within the business.
Whilst the Company is not currently envisaging further acquisitions in the short term, the Board will evaluate opportunities presented to it which may accelerate its growth or ability to place products in the market or give the Company the opportunity to further leverage the potential in CROMA.
3) Kamaptive
Creo's Kamaptive licensing strategy includes the license of the Group's advanced energy technology, Kamaptive, to third parties to embed in their own solutions. Working with select partners to develop existing technology to be compatible with third party products enables Creo's core technology to be introduced to new and adjacent markets.
The Directors believe that there is great potential to work closely with third parties where certain mutual benefits can be identified. The Company has developed relationships with a number of significant industrial and commercial partners to commercialise the Group's technology.
The Board sees a sizeable opportunity for the Group in licensing its advanced energy, Kamaptive, to third parties for use in:
· laparoscopic and endoscopic RAS applications - platform for delivery of advanced energy and device technology into a number of surgical applications;
· general laparoscopic applications;
· non-thermal plasma - platform for wound care and endoscope decontamination; and
· electroporation - platform for non-thermal tissue effects including irreversible tissue "ablation" and cellular level sensitisation.
2022 was a year of significant progress for the Group on this aspect of its wider strategy. On 23 May 2022, the Company announced that it had signed a long-term, multi-year collaboration agreement with Intuitive, a NASDAQ-listed global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery with a market capitalisation of c.$85 billion and c.70 per cent. of the surgical robotic market with an install base of over 7,800 systems. In 2022 Intuitive completed c.1.8 million procedures. Intuitive estimates that there are approximately 20 million soft tissue surgery procedures annually, of which approximately 6 million are deemed 'line-of-sight' procedures to be undertaken robotically assisted.
The agreement will optimise certain Company products to be compatible with Intuitive's robotic technology. The agreement also provided a framework for joint clinical studies. The first revenues from this agreement were received in the first half of 2022 with future royalty structures agreed, which will apply when products are commercialised.
Further, the Company announced on 24 October 2022 that it had signed a non-exclusive IP license and a royalty agreement with CMR, the global surgical robotics business, to integrate certain aspects of the Company's technology with the Versius® Surgical Robotic System. Versius®, is a significant new entrant into the robotic surgery space, performing laparoscopic procedures worldwide across a range of specialties.
Within these agreements, the Company provides the advanced energy capability that surgical robotic companies need to allow RAS procedures to take place. Signing these agreements provides Creo with the opportunity both to further collaborate with Intuitive and CMR by widening the relationship as additional devices are developed by the respective partner, and also develop additional relationships with other robotic assisted surgery companies. The royalty income structure provides a solid source of repeatable and recurring revenues for the Group, including fixed and milestone development income plus revenues from the sale of CROMA systems and the service agreements attached. Furthermore, the cost of the development work is already built into the partnership cost models.
The Board is continuing to look at further partnering opportunities and has identified possible agreements for both laparoscopic and plasma sterilisation. The Board believes that pursuing such relationships with other industry players not only creates long term shareholder value but also aligns with the Company's objective to improve lives.
CURRENT TRADING AND PROSPECTS
The Company provided a trading update to the market on 11 January 2023 (RNS No: 3233M) for the year ended 31 December 2022. As announced in the trading update, further progress has been made in the commercialisation of the Group's core advanced energy electrosurgical products, with sales of core technologies (including Kamaptive licensing revenues) increasing more than eight times over the previous year. Sales of Speedboat Inject and the CROMA Advanced Energy platform grew threefold from 2021, with 45 per cent. growth in the second half of 2022 vs the first half.
The Company launched its Pioneer clinical training programme in 2022, which is recognised in the industry as class leading. The Pioneer programme sits at the heart of the sales process tracking doctors engaged with the business to join the programme. During FY22, the number of physicians in the pipeline doubled to more than 450 by Dec 2022. With 60 doctors trained in H1 and 90 during H2, this resulted in 80 confirmed users at December 2022, a fourfold increase from the start of the period.
New product innovation has also continued with the launch of the slimmer Speedboat Inject device to the market in November 2022, and the increased use of Microblate Fine for pancreatic ablations, and also the initial use for liver tumour ablation.
The Company's Kamaptive (IP) licensing deals announced during 2022 continue to progress well. First revenues were received during the period and are included within the Company's core technology sales. Development of the Company's core technology for use with both Intuitive's and CMR's robotic platforms is progressing well, and there are ongoing discussions to expand and broaden partnership opportunities substantially with additional and existing partners. Management expects that the first in-human robotic procedure using the Company's Kamaptive technology will occur during 2023.
The Group continues to progress towards profitability with revenues continuing to grow and the intensive investment product development and launch phase coming to an end. Material reductions in operating costs have contributed to a reduced underlying EBITDA loss for FY22 compared to FY21, which is expected to be in-line with market expectations. Management considers that this combination of strong core product revenue growth and active cost control means that the business is well-positioned to further reduce cash burn in FY23 and remains on track for EBITDA breakeven during FY25, also in-line with market expectations.
THE PLACING AGREEMENT
Pursuant to the terms of the Placing Agreement, the Banks, as agents for the Company, have conditionally agreed to use their reasonable endeavours to procure subscribers for the Placing Shares. The Banks have conditionally placed the Placing Shares with certain institutional and other investors at the Issue Price. None of the Placing, the Subscription or the Open Offer has been underwritten by the Banks. The Placing Agreement is conditional upon, inter alia, the Resolutions being duly passed at the General Meeting and Admission becoming effective on or before 8.00 a.m. on 9 March 2023 (or such later time and/or date as Cenkos and Numis may jointly agree, but in any event by no later than 8.00 a.m. on 31 March 2023).
The Placing Agreement contains customary warranties from the Company in favour of the Banks in relation to, inter alia, the accuracy of the information in the Circular and other matters relating to the Group and its business. In addition, the Company has agreed to indemnify the Banks in relation to certain defined liabilities that it may incur in respect of the Fundraising.
The Banks have the right to terminate the Placing Agreement in certain circumstances prior to the Admission, in particular, in the event that any of the warranties in the Placing Agreement were untrue or inaccurate, or were misleading when given or in the event of a material adverse change affecting the business, financial trading position or prospects of the Company or the Group as a whole, whether or not arising in the ordinary course of business and whether or not foreseeable at the date of the Placing Agreement.
The Placing Agreement also provides for the Company to pay all costs, charges and expenses of, or incidental to, the Fundraising and the Admission including all legal and other professional fees and expenses.
The Placing Shares have not been made available to the public and have not been offered or sold in any jurisdiction where it would be unlawful to do so.
The Open Offer
The Company considers it important that Qualifying Shareholders have an opportunity (where it is practicable for them to do so) to participate in the Fundraising and accordingly the Company is making the Open Offer to Qualifying Shareholders. The Company is proposing to raise up to approximately £5.2 million (before expenses) (assuming full take up of the Open Offer) through the issue of up to 26,048,909 Open Offer Shares.
The Open Offer Shares are available to Qualifying Shareholders pursuant to the Open Offer at the Issue Price of 20 pence per Open Offer Share, payable in full on acceptance. Any Open Offer Shares not subscribed for by Qualifying Shareholders will be available to Qualifying Shareholders under the Excess Application Facility.
Qualifying Shareholders may apply for Open Offer Shares under the Open Offer at the Issue Price on the following basis:
1 Open Offer Share for every 7 Existing Ordinary Shares held by
the Shareholder on the Record Date
Entitlements of Qualifying Shareholders will be rounded down to the nearest whole number of Open Offer Shares. Fractional entitlements which would otherwise arise will not be issued to Qualifying Shareholders but will be made available under the Excess Application Facility. The Excess Application Facility enables Qualifying Shareholders to apply for Excess Shares in excess of their Open Offer Entitlement.
Further details of the Open Offer and the application process relating to the Open Offer will be set out in the Circular.
Recommendation
For the reasons set out above and in order to support the Group's progress towards profitability, the Directors consider the Fundraising to be in the best interests of the Company and its Shareholders as a whole and accordingly recommend unanimously, and encourage strongly, Shareholders to vote in favour of the Resolutions to be proposed at the General Meeting. The Directors draw Shareholders' attention to paragraph 10 in the Circular (Action to be Taken) and emphasise the importance of Shareholders following these instructions in order to ensure that the Fundraising completes successfully.
If Shareholders do not approve the Resolutions, the Company would not receive the proceeds from the Fundraising and, in such circumstances, the Company would be obliged to seek other forms of funding or explore other corporate options that may provide funding in the very near future. There can be no certainty that the Company would be able to find other forms of funding on commercially acceptable terms or at all; and the pursuit of other corporate actions may adversely affect the commercial prospects of the Company. The Directors consider that alternative options to the Fundraising are not as commercially attractive for Creo or the Shareholders as a whole.
The Directors therefore believe that it is important that Shareholders vote in favour of the Resolutions, and confirm that they intend to vote in favour of the Resolutions in respect of their beneficial holdings amounting, in aggregate, to 5,354,342 Existing Ordinary Shares, representing approximately 2.94 per cent. of the existing issued Ordinary Share capital of the Company.
This Announcement should be read in its entirety. In particular, you should read and understand the information provided in the Appendix below.
The Appendix to this Announcement (which forms part of this Announcement) sets out the terms and conditions of the Placing. Persons who have chosen to participate in the Placing, by making an oral or written offer to acquire Placing Shares, will be deemed to have read and understood this Announcement in its entirety (including the Appendix) and to be making such offer on the terms and subject to the conditions herein, and to be providing the representations, warranties, agreements, acknowledgements and undertakings contained in the Appendix.
APPENDIX 1 - TERMS AND CONDITIONS OF THE PLACING
IMPORTANT INFORMATION FOR INVITED PLACEES ONLY REGARDING THE PLACING.
THIS ANNOUNCEMENT, INCLUDING THIS APPENDIX AND THE INFORMATION CONTAINED HEREIN (TOGETHER THE "ANNOUNCEMENT") IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND, THE REPUBLIC OF IRELAND, THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. THIS ANNOUNCEMENT HAS NOT BEEN APPROVED BY THE LONDON STOCK EXCHANGE, NOR IS IT INTENDED THAT IT WILL BE SO APPROVED.
MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO TAKE PART IN THE PLACING. THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND IS DIRECTED ONLY AT: (A) PERSONS IN MEMBER STATES OF THE EUROPEAN ECONOMIC AREA ("EEA") WHO ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(e) OF REGULATION (EU) 2017/1129, AS AMENDED FROM TIME TO TIME (THE "PROSPECTUS REGULATION") ("QUALIFIED INVESTORS"); AND (B) IN THE UNITED KINGDOM, PERSONS WHO ARE "QUALIFIED INVESTORS" WITHIN THE MEANING OF REGULATION 2017/1129/EU AS IT FORMS PART OF DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 AND WHO ALSO: (I) HAVE PROFESSIONAL EXPERIENCE IN MATTERS RELATING TO INVESTMENTS FALLING WITHIN ARTICLE 19(5) (INVESTMENT PROFESSIONALS) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005, AS AMENDED (THE "ORDER"); (II) ARE PERSONS FALLING WITHIN ARTICLE 49(2)(A) TO (D) (HIGH NET WORTH COMPANIES, UNINCORPORATED ASSOCIATIONS, ETC.) OF THE ORDER; OR (III) ARE PERSONS TO WHOM IT MAY OTHERWISE BE LAWFULLY COMMUNICATED (ALL SUCH PERSONS TOGETHER BEING REFERRED TO AS "RELEVANT PERSONS").
THIS ANNOUNCEMENT AND THE INFORMATION IN IT MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. PERSONS DISTRIBUTING THIS ANNOUNCEMENT MUST SATISFY THEMSELVES THAT IT IS LAWFUL TO DO SO. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. THIS ANNOUNCEMENT DOES NOT ITSELF CONSTITUTE AN OFFER FOR SALE OR SUBSCRIPTION OF ANY SECURITIES IN CREO MEDICAL GROUP PLC.
THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE INTO THE UNITED STATES. THE PLACING SHARES (AS DEFINED BELOW) HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT 1933, AS AMENDED (THE "SECURITIES ACT") OR WITH ANY SECURITIES REGULATORY AUTHORITY OF ANY STATE OR JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. SUBJECT TO CERTAIN EXCEPTIONS AND AT THE SOLE DISCRETION OF THE COMPANY, THE PLACING SHARES ARE BEING OFFERED AND SOLD ONLY OUTSIDE THE UNITED STATES IN "OFFSHORE TRANSACTIONS" WITHIN THE MEANING OF, AND IN ACCORDANCE WITH, REGULATION S UNDER THE SECURITIES ACT AND OTHERWISE IN ACCORDANCE WITH APPLICABLE LAWS. NO PUBLIC OFFERING OF THE PLACING SHARES IS BEING MADE IN THE UNITED STATES, THE UNITED KINGDOM OR ELSEWHERE. NO MONEY, SECURITIES OR OTHER CONSIDERATION FROM ANY PERSON INSIDE THE UNITED STATES IS BEING SOLICITED AND, IF SENT IN RESPONSE TO THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT, WILL NOT BE ACCEPTED.
EACH PLACEE SHOULD CONSULT WITH ITS ADVISERS AS TO LEGAL, TAX, BUSINESS AND RELATED ASPECTS OF AN INVESTMENT IN PLACING SHARES. THE DISTRIBUTION OF THIS ANNOUNCEMENT, ANY PART OF IT OR ANY INFORMATION CONTAINED IN IT MAY BE RESTRICTED BY LAW IN CERTAIN JURISDICTIONS, AND ANY PERSON INTO WHOSE POSSESSION THIS ANNOUNCEMENT, ANY PART OF IT OR ANY INFORMATION CONTAINED IN IT COMES SHOULD INFORM THEMSELVES ABOUT, AND OBSERVE, SUCH RESTRICTIONS.
THE COMPANY'S JOINT BROKERS, CENKOS SECURITIES PLC AND NUMIS SECURITIES LIMITED, WHO ARE REGULATED BY THE FINANCIAL CONDUCT AUTHORITY, ARE ACTING FOR THE COMPANY AND NO ONE ELSE IN RELATION TO THE PROPOSALS SET OUT IN THIS ANNOUNCEMENT. NEITHER CENKOS NOR NUMIS HAS ANY AUTHORITY TO MAKE ANY REPRESENTATION OR WARRANTY ON BEHALF OF THE COMPANY OR ANY OTHER PERSON IN CONNECTION WITH THE COMPANY.
ANY PERSON WHO IS IN ANY DOUBT ABOUT THE INVESTMENT TO WHICH THIS ANNOUNCEMENT RELATES SHOULD CONSULT A PERSON DULY AUTHORISED FOR THE PURPOSES OF FSMA WHO SPECIALISES IN THE ACQUISITION OF SHARES AND OTHER SECURITIES.
The distribution of this Announcement and/or the Placing and/or issue of the Placing Shares in certain jurisdictions may be restricted by law. No action has been taken by the Company, either Bank or any of their respective affiliates, agents, directors, officers or employees that would permit an offer of the Placing Shares or possession or distribution of this Announcement or any other offering or publicity material relating to such Placing Shares in any jurisdiction where action for that purpose is required. Persons into whose possession this Announcement comes are required by the Company and each Bank to inform themselves about and to observe any such restrictions.
This Announcement or any part of it is for information purposes only and does not constitute or form part of any offer to issue or sell, or the solicitation of an offer to acquire, purchase or subscribe for, any securities in the United States (including its territories and possessions, any state of the United States and the District of Columbia), Australia, Canada, Japan, New Zealand, the Republic of Ireland, the Republic of South Africa or any other jurisdiction in which the same would be unlawful. No public offering of the Placing Shares is being made in any such jurisdiction.
All offers of the Placing Shares will be made pursuant to an exemption under the UK Prospectus Regulation, from the requirement to produce a prospectus. In the United Kingdom, this Announcement is being directed solely at persons in circumstances in which section 21(1) of FSMA does not apply.
The Placing Shares have not been approved or disapproved by the US Securities and Exchange Commission, any state securities commission or other regulatory authority in the United States, nor have any of the foregoing authorities passed upon or endorsed the merits of the Fundraising or the accuracy or adequacy of this Announcement. Any representation to the contrary is a criminal offence in the United States. The relevant clearances have not been, nor will they be, obtained from the securities commission of any province or territory of Canada, no prospectus has been lodged with, or registered by, the Australian Securities and Investments Commission, the Financial Markets Authority of New Zealand or the Japanese Ministry of Finance; the relevant clearances have not been, and will not be, obtained for the South Africa Reserve Bank or any other applicable body in the Republic of Ireland, or the Republic of South Africa in relation to the Placing Shares and the Placing Shares have not been, nor will they be, registered under or offering in compliance with the securities laws of any state, province or territory of Australia, Canada, Japan, New Zealand, the Republic of Ireland or the Republic of South Africa. Accordingly, the Placing Shares may not (unless an exemption under the relevant securities laws is applicable) be offered, sold, resold or delivered, directly or indirectly, in or into Australia, Canada, Japan, New Zealand, the Republic of Ireland or the Republic of South Africa or any other jurisdiction outside the United Kingdom.
Persons (including, without limitation, nominees and trustees) who have a contractual right or other legal obligations to forward a copy of this Announcement should seek appropriate advice before taking any action.
This Announcement should be read in its entirety. In particular, you should read and understand the information provided in this "Important Information" section of this Announcement.
The Company proposes to raise capital by way of a Placing and Open Offer.
By participating in the Placing, each Placee will be deemed to have read and understood this Announcement in its entirety, to be participating, making an offer and acquiring Placing Shares on the terms and conditions contained herein and to be providing the representations, warranties, indemnities, acknowledgements and undertakings contained in this Appendix.
In particular, each such Placee represents, warrants, undertakes, agrees and acknowledges (amongst other things) that:
1 it is a Relevant Person and undertakes that it will acquire, hold, manage or dispose of any Placing Shares that are allocated to it for the purposes of its business;
2 in the case of a Relevant Person in a Relevant State who acquires any Placing Shares pursuant to the Placing:
2.1 it is a Qualified Investor within the meaning of Article 2(e) of the Prospectus Regulation;
2.2 in the case of any Placing Shares acquired by it as a financial intermediary, as that term is used in Article 5(1) of the Prospectus Regulation:
2.2.1 the Placing Shares acquired by it in the Placing have not been acquired on behalf of, nor have they been acquired with a view to their offer or resale to, persons in a Relevant State other than Qualified Investors or in circumstances in which the prior consent of the Banks has been given to the offer or resale; or
2.2.2 where Placing Shares have been acquired by it on behalf of persons in a Relevant State other than Qualified Investors, the offer of those Placing Shares to it is not treated under the Prospectus Regulation as having been made to such persons;
3 in the case of a Relevant Person in the United Kingdom who acquires any Placing Shares pursuant to the Placing:
3.1 it is a Qualified Investor within the meaning of Article 2(e) of the UK Prospectus Regulation;
2.2 in the case of any Placing Shares acquired by it as a financial intermediary, as that term is used in Article 5(1) of the UK Prospectus Regulation:
2.2.1 the Placing Shares acquired by it in the Placing have not been acquired on behalf of, nor have they been acquired with a view to their offer or resale to, persons in the United Kingdom other than Qualified Investors or in circumstances in which the prior consent of the Banks has been given to the offer or resale; or
2.2.2 where Placing Shares have been acquired by it on behalf of persons in the United Kingdom other than Qualified Investors, the offer of those Placing Shares to it is not treated under the UK Prospectus Regulation as having been made to such persons;
4 it is acquiring the Placing Shares for its own account or is acquiring the Placing Shares for an account with respect to which it exercises sole investment discretion and has the authority to make and does make the representations, warranties, indemnities, acknowledgements, undertakings and agreements contained in this Announcement;
5 it understands (or if acting for the account of another person, such person has confirmed that such person understands) the resale and transfer restrictions set out in this Appendix; and
6 except as otherwise permitted by the Company and subject to any available exemptions from applicable securities laws, it (and any account referred to in paragraph 4 above) is outside the United States acquiring the Placing Shares in offshore transactions as defined in and in accordance with Regulation S under the Securities Act.
No prospectus
No prospectus or other offering document has been or will be submitted to be approved by the FCA in relation to the Fundraising or the Placing Shares and Placees' commitments will be made solely on the basis of the information contained in this Announcement and any Publicly Available Information and subject to any further terms set forth in the form of confirmation to be sent to individual Placees.
Each Placee, by participating in the Placing, agrees that the content of this Announcement is exclusively the responsibility of the Company and confirms that it has neither received nor relied on any information (other than the Publicly Available Information), representation, warranty or statement made by or on behalf of the Company, either Bank or any other person and none of the Company, the Banks or any other person acting on such person's behalf nor any of their respective affiliates has or shall have any liability for any Placee's decision to participate in the Placing based on any other information, representation, warranty or statement. Each Placee acknowledges and agrees that it has relied on its own investigation of the business, financial or other position of the Company in accepting a participation in the Placing. No Placees should consider any information in this Announcement to be legal, tax or business advice. Nothing in this paragraph shall exclude the liability of any person for fraudulent misrepresentation.
Details of the Placing Agreement and the Placing Shares
The Banks have today entered into a Placing Agreement with the Company under which, on the terms and subject to the conditions set out in the Placing Agreement, the Banks, each as agent for and on behalf of the Company, have each agreed to use their reasonable endeavours to procure placees for the Placing Shares at the Issue Price of 20 pence per Placing Share.
The Placing Shares will, when issued, be subject to the Articles and credited as fully paid and will rank pari passu in all respects with the Existing Ordinary Shares in the capital of the Company, including the right to receive all dividends and other distributions declared, made or paid in respect of such ordinary shares after the date of issue of the Placing Shares.
Application for admission to trading
Application will be made to the London Stock Exchange for Admission of the Placing Shares to trading on AIM.
It is expected that Admission will take place no later than 8.00 a.m. on 9 March 2023 and that dealings in the Placing Shares on AIM will commence at the same time.
Principal terms of the Placing
1 The Banks are acting as joint brokers to the Company in respect of the Placing, as agent for and on behalf of the Company. Each of the Banks is authorised and regulated in the United Kingdom by the FCA and is acting exclusively for the Company and no one else in connection with the matters referred to in this Announcement and will not be responsible to anyone other than the Company for providing the protections afforded to each of the Bank's customers or for providing advice in relation to the matters described in this Announcement.
2 Participation in the Placing will only be available to persons who may lawfully be and are invited by a Bank to participate. The Banks and any of their respective affiliates are entitled to participate in the Placing as principal.
3 The price per Placing Share is 20 pence and is payable to the Banks as agents of the Company by all Placees.
4 Subject to the Company's final approval, each Placee's allocation is determined by a Bank following consultation with the Company and has been or will be confirmed orally by the relevant Bank, as applicable, and a form of confirmation will be dispatched as soon as possible thereafter. That oral confirmation will give rise to an irrevocable, legally binding commitment by that person (who at that point becomes a Placee), in favour of the relevant Bank and the Company, under which it agrees to acquire the number of Placing Shares allocated to the Placee at the Issue Price and otherwise on the terms and subject to the conditions set out in this Appendix and in accordance with the Articles. Except with the prior written consent of the relevant Bank, such commitment will not be capable of variation or revocation at the time at which it is submitted.
5 Each Placee's allocation and commitment will be evidenced by a form of confirmation issued to such Placee by the relevant Bank. The terms of this Appendix will be deemed incorporated in that form of confirmation.
6 Each Placee will have an immediate, separate, irrevocable and binding obligation, owed to the Banks as agent for the Company, to pay to it (or as they may direct) in cleared funds an amount equal to the product of the Issue Price and the number of Placing Shares such Placee has agreed to acquire and the Company has agreed to allot and issue to that Placee.
7 Irrespective of the time at which a Placee's allocation(s) pursuant to the Placing is/are confirmed, settlement for all Placing Shares to be acquired pursuant to the Placing will be required to be made at the same time, on the basis explained below under "Registration and Settlement".
8 All obligations of each of the Banks under the Placing will be subject to fulfilment of the conditions referred to below under "Conditions of the Placing" and to the Placing not being terminated on the basis referred to below under "Termination of the Placing".
9 By participating in the Placing, each Placee will agree that its rights and obligations in respect of the Placing will terminate only in the circumstances described below and will not be capable of rescission or termination by the Placee.
10 To the fullest extent permissible by law and applicable FCA rules, none of (a) the Banks, (b) any of their respective affiliates, agents, directors, officers, consultants, (c) to the extent not contained within (a) or (b), any person connected with the Banks as defined in the FSMA ((b) and (c) being together "affiliates" and individually an "affiliate" of the Banks), (d) any person acting on behalf of the Banks, shall have any liability (including to the extent permissible by law, any fiduciary duties) to Placees or to any other person whether acting on behalf of a Placee or otherwise. In particular, neither of the Banks nor any of their respective affiliates shall have any liability (including, to the extent permissible by law, any fiduciary duties) in respect of their conduct in relation to the Fundraising or of such alternative method of effecting the Fundraising as the Banks and the Company may agree.
Registration and Settlement
If Placees are allocated any Placing Shares in the Placing they will be sent a form of confirmation or electronic confirmation by the Banks (or either one of them), as soon as it is able which will confirm the number of Placing Shares allocated to them, the Issue Price and the aggregate amount owed by them to the Banks.
Each Placee will be deemed to agree that it will do all things necessary to ensure that delivery and payment is completed as directed by the Banks in accordance with either the standing CREST or certificated settlement instructions which they have in place with the relevant Bank.
Settlement of transactions in the Placing Shares (ISIN: GB00BZ1BLL44) following Admission will take place within the CREST system, subject to certain exceptions. Settlement through CREST is expected to take place on 9 March 2023 unless otherwise notified by the Banks and Admission is expected to occur no later than 8.00 a.m. on 9 March 2023 unless otherwise notified by the Banks. Admission and settlement may occur at an earlier date, which if achievable, will be set out in the Circular. Settlement will be on a delivery versus payment basis. However, in the event of any difficulties or delays in the admission of the Placing Shares to CREST or the use of CREST in relation to the Placing, the Company and the Banks may agree that the Placing Shares should be issued in certificated form. The Banks reserve the right to require settlement of the Placing Shares, and to deliver the Placing Shares to Placees, by such other means as they deem necessary if delivery or settlement to Placees is not practicable within the CREST system or would not be consistent with regulatory requirements in a Placee's jurisdiction.
Interest is chargeable daily on payments not received from Placees on the due date in accordance with the arrangements set out above, in respect of either CREST or certificated deliveries, at the rate of 2 percentage points above prevailing LIBOR as determined by the Banks.
Each Placee agrees that if it does not comply with these obligations, the Banks may sell, charge by way of security (to any funder of the Banks) or otherwise deal with any or all of their Placing Shares on their behalf and retain from the proceeds, for either the Banks' own accounts and benefit, an amount equal to the aggregate amount owed by the Placee plus any interest due and any costs and expenses properly incurred by the Banks as a result of the Placee's failure to comply with its obligations. The relevant Placee will, however, remain liable for any shortfall below the amount owed by it and for any stamp duty or stamp duty reserve tax (together with any interest or penalties) which may arise upon the sale of their Placing Shares on their behalf. Legal and/or beneficial title in and to any Placing Shares shall not pass to the relevant Placee until such time as it has fully complied with its obligations hereunder.
If Placing Shares are to be delivered to a custodian or settlement agent, Placees must ensure that, upon receipt, the conditional form of confirmation is copied and delivered immediately to the relevant person within that organisation. Insofar as Placing Shares are registered in a Placee's name or that of its nominee or in the name of any person for whom a Placee is contracting as agent or that of a nominee for such person, such Placing Shares should, subject as provided below, be so registered free from any liability to United Kingdom stamp duty or stamp duty reserve tax. Placees will not be entitled to receive any fee or commission in connection with the Placing.
Conditions of the Placing
The Placing is conditional upon the Placing Agreement becoming unconditional and not having been terminated in accordance with its terms.
The obligations of the Banks under the Placing Agreement are, and the Placing is, conditional upon, inter alia:
(a) Admission taking place not later than 8.00 a.m. on 9 March 2023 or such later date as is agreed in writing between the Company and the Banks, but in any event not later than the Long Stop Date;
(b) the Company complying with its obligations under the Placing Agreement to the extent that the same fall to be performed prior to Admission;
(c) there not occurring, in the opinion of the Banks (acting in good faith), a Material Adverse Change, whether or not arising in the ordinary course of business and whether or not foreseeable at the date of the Placing Agreement;
(d) the general meeting to be held by the Company having taken place, no adjournment of the general meeting having occurred without the prior written consent of the Banks and the relevant resolutions having been passed at the general meeting without amendment;
(e) application having been made to Euroclear for admission of the Open Offer Entitlements to CREST as participating securities (as defined in the CREST Regulations) and the new ordinary shares in the capital of the Company to CREST as participating securities and no notification having been received from Euroclear on or before Admission becoming effective that such admission or the continued admission of the new ordinary shares as participating securities has been or is to be refused or revoked;
(f) satisfaction or, where appropriate, the waiver of certain other conditions set out in the Placing Agreement,
(all conditions to the obligations of the Banks included in the Placing Agreement being together, the "conditions").
If any of the conditions set out in the Placing Agreement are not fulfilled or, where permitted, waived in accordance with the Placing Agreement within the stated time periods (or such later time and/or date as the Company and the Banks may agree), or the Placing Agreement is terminated in accordance with its terms, the Placing will lapse and the Placee's rights and obligations shall cease and terminate at such time and each Placee agrees that no claim can be made by or on behalf of the Placee (or any person on whose behalf the Placee is acting) in respect thereof.
By participating in the Placing, each Placee agrees that its rights and obligations cease and terminate only in the circumstances described above and under "Termination of the Placing" below and will not be capable of rescission or termination by it.
Certain conditions may be waived in whole or in part by the Banks, in their absolute discretion, by notice in writing to the Company and the Banks may also agree in writing with the Company to extend the time for satisfaction of any condition. Any such extension or waiver will not affect Placees' commitments as set out in this Announcement.
Either Bank may terminate the Placing Agreement in certain circumstances, details of which are set out below.
Neither of the Banks, the Company nor any of their respective affiliates, agents, directors, officers or employees shall have any liability to any Placee (or to any other person whether acting on behalf of a Placee or otherwise) in respect of any decision any of them may make as to whether or not to waive or to extend the time and/or date for the satisfaction of any condition to the Placing nor for any decision any of them may make as to the satisfaction of any condition or in respect of the Placing generally and by participating in the Placing each Placee agrees that any such decision is within the absolute discretion of the Banks.
Termination of the Placing
Either Bank may terminate the Placing Agreement, in accordance with its terms, at any time prior to Admission if, inter alia:
1 any of the warranties in the Placing Agreement were untrue or inaccurate, or were misleading when given; or
2 the Company fails to comply with its obligations under the Placing Agreement where such failure is material in the context of the Fundraising or Admission; or
3 any statement of material fact contained in the Placing Documents has become or been discovered to be untrue, inaccurate or misleading in any respect or there has been a material omission from the Placing Documents; or
4 a matter, fact, circumstance or event has arisen such that in the opinion of the Banks (acting in good faith) a supplementary circular and/or supplementary press announcement is required to be published; or
5 a Material Adverse Change (as defined in the Placing Agreement) has occurred which, in the opinion of either of the Banks (acting in good faith), would or would be likely to prejudice materially the Company or the transaction or render the creation of a market in the ordinary share capital of the Company temporarily or permanently impracticable.
If the Placing Agreement is terminated in accordance with its terms, the rights and obligations of each Placee in respect of the Placing as described in this Announcement shall cease and terminate at such time and no claim can be made by any Placee in respect thereof.
By participating in the Placing, each Placee agrees with the Company and each Bank that the exercise by the Company or either Bank of any right of termination or any other right or other discretion under the Placing Agreement shall be within the absolute discretion of the Company and / or the relevant Bank and that none of the Company nor the Banks need make any reference to such Placee and that none of the Company, the Banks nor any of their respective affiliates, agents, directors, officers or employees shall have any liability to such Placee (or to any other person whether acting on behalf of a Placee or otherwise) whatsoever in connection with any such exercise.
By participating in the Placing, each Placee agrees that its rights and obligations terminate only in the circumstances described above and under the "Conditions of the Placing" section above and will not be capable of rescission or termination by it after the issue by either Bank of a form of confirmation confirming each Placee's allocation and commitment in the Placing.
Lock-up Arrangements
The Company has undertaken to each of the Banks that, during the period ending 90 days after the date of Admission, it will not without the prior written consent of the Banks allot or issue, or enter into any agreement or arrangement which would give rise to an obligation or an increased obligation (in each case whether contingent or otherwise) to allot or issue, any share in the capital of the Company (save for the allotment and issue of new ordinary shares in the capital of the Company pursuant to the Fundraising, the grant and exercise of options pursuant to the option schemes, agreements and arrangements disclosed in the audited accounts of the Company for the 12-month period to 31 December 2021 and/or the Circular (together with, for avoidance of doubt, any new grant of options to employees or consultants pursuant to existing share option schemes)).
By participating in the Placing, each Placee agrees that the exercise by the Banks of any power to grant consent to the undertaking by the Company of a transaction which would otherwise be subject to the lock-up provisions under the Placing Agreement shall be within the absolute discretion of the Banks and that it need not make any reference to, or consult with, any Placee and that it shall have no liability to any Placee whatsoever in connection with any such exercise of the power to grant consent.
Representations, warranties and further terms
By participating in the Placing, each Placee (and any person acting on such Placee's behalf) irrevocably represents, warrants, acknowledges, undertakes and agrees (for itself and for any such prospective Placee) that in each case as a fundamental term of such Placee's application for Placing Shares (save where the Banks expressly agree in writing to the contrary):
1 it has read and understood this Announcement in its entirety and that its acquisition of the Placing Shares is subject to and based upon all the terms, conditions, representations, warranties, indemnities, acknowledgements, agreements and undertakings and other information contained herein and that it has not relied on, and will not rely on, any information given or any representations, warranties or statements made at any time by any person in connection with Admission, the Fundraising, the Company, the Placing Shares or otherwise, other than the information contained in this Announcement and the Publicly Available Information;
2 it has not received a prospectus or other offering document in connection with the Fundraising and acknowledges that no prospectus or other offering document: (a) is required under the Prospectus Regulation; and (b) has been or will be prepared in connection with the Fundraising;
3 the ordinary shares in the capital of the Company are admitted to trading on AIM, and that, in addition to complying with its obligations pursuant to MAR, the Company is therefore required to publish certain business and financial information in accordance with the AIM Rules, which includes a description of the nature of the Company's business and the Company's most recent balance sheet and profit and loss account and that it is able to obtain or access such information without undue difficulty, and is able to obtain access to such information or comparable information concerning any other publicly traded company, without undue difficulty;
4 it has made its own assessment of the Placing Shares and has relied on its own investigation of the business, financial or other position of the Company in accepting a participation in the Placing and none of the Banks, the Company nor any of their respective affiliates, agents, directors, officers or employees or any person acting on behalf of any of them has provided, and will not provide, it with any material regarding the Placing Shares or the Company or any other person other than the information in this Announcement, or the Publicly Available Information; nor has it requested any of the Banks, the Company, any of their respective affiliates, agents, directors, officers or employees or any person acting on behalf of any of them to provide it with any such information;
5 neither the Banks nor any person acting on behalf of them or any of their respective affiliates, agents, directors, officers or employees has or shall have any liability for any Publicly Available Information, or any representation relating to the Company, provided that nothing in this paragraph excludes the liability of any person for fraudulent misrepresentation made by that person;
6 (a) the only information on which it is entitled to rely on and on which it has relied in committing to subscribe for the Placing Shares is contained in the Publicly Available Information, such information being all that it deems necessary to make an investment decision in respect of the Placing Shares and it has made its own assessment of the Company, the Placing Shares and the terms of the Placing based on Publicly Available Information;
(b) none of the Company, the Banks nor any of their respective affiliates, agents, directors, officers or employees has made any representation or warranty to it, express or implied, with respect to the Company, the Placing or the Placing Shares or the accuracy, completeness or adequacy of the Publicly Available Information;
(c) it has conducted its own investigation of the Company, the Placing and the Placing Shares, satisfied itself that the information is still current and relied on that investigation for the purposes of its decision to participate in the Placing; and
(d) has not relied on any investigation that either Bank or any person acting on their behalf may have conducted with respect to the Company, the Placing or the Placing Shares;
7 the content of this Announcement and the Publicly Available Information has been prepared by and is exclusively the responsibility of the Company and that neither of the Banks nor any persons acting on behalf of them are responsible for or has or shall have any liability for any information, representation, warranty or statement relating to the Company contained in this Announcement or the Publicly Available Information nor will they be liable for any Placee's decision to participate in the Placing based on any information, representation, warranty or statement contained in this Announcement, the Publicly Available Information or otherwise. Nothing in this Appendix shall exclude any liability of any person for fraudulent misrepresentation;
8 the Placing Shares have not been registered or otherwise qualified, and will not be registered or otherwise qualified, for offer and sale nor will a prospectus be cleared or approved in respect of any of the Placing Shares under the securities laws of the United States, or any state or other jurisdiction of the United States, Australia, Canada, Japan, New Zealand, the Republic of Ireland or the Republic of South Africa and, subject to certain exceptions, may not be offered, sold, taken up, renounced or delivered or transferred, directly or indirectly, within the United States, Australia, Canada, Japan, New Zealand, the Republic of Ireland the Republic of South Africa or in any country or jurisdiction where any such action for that purpose is required;
9 it and/or each person on whose behalf it is participating:
9.1 is entitled to acquire Placing Shares pursuant to the Placing under the laws and regulations of all relevant jurisdictions;
9.2 has fully observed such laws and regulations;
9.3 has capacity and authority and is entitled to enter into and perform its obligations as an acquirer of Placing Shares and will honour such obligations; and
9.4 has obtained all necessary consents and authorities (including, without limitation, in the case of a person acting on behalf of a Placee, all necessary consents and authorities to agree to the terms set out or referred to in this Appendix) under those laws or otherwise and complied with all necessary formalities to enable it to enter into the transactions contemplated hereby and to perform its obligations in relation thereto and, in particular, if it is a pension fund or investment company it is aware of and acknowledges that it is required to comply with all applicable laws and regulations with respect to its subscription for Placing Shares;
10 it is not, and any person who it is acting on behalf of is not, and at the time the Placing Shares are subscribed will not be, a resident of, or with an address in, or subject to the laws of, the United States, Australia, Canada, Japan, New Zealand, the Republic of Ireland or the Republic of South Africa and it acknowledges and agrees that the Placing Shares have not been and will not be registered or otherwise qualified under the securities legislation of the United States, Australia, Canada, Japan, New Zealand, the Republic of Ireland or the Republic of South Africa and may not be offered, sold, or acquired, directly or indirectly, within those jurisdictions;
11 the Placing Shares have not been, and will not be, registered under the Securities Act and may not be offered, sold or resold in or into or from the United States except pursuant to an effective registration under the Securities Act, or pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with applicable state securities laws; and no representation is being made as to the availability of any exemption under the Securities Act for the reoffer, resale, pledge or transfer of the Placing Shares;
12 it and the beneficial owner of the Placing Shares is, and at the time the Placing Shares are acquired will be, outside the United States and acquiring the Placing Shares in an "offshore transaction" as defined in, and in accordance with, Regulation S under the Securities Act;
13 it (and any account for which it is purchasing) is not acquiring the Placing Shares with a view to any offer, sale or distribution thereof within the meaning of the Securities Act;
14 it will not distribute, forward, transfer or otherwise transmit this Announcement or any part of it, or any other presentational or other materials concerning the Fundraising in or into or from the United States (including electronic copies thereof) to any person, and it has not distributed, forwarded, transferred or otherwise transmitted any such materials to any person;
15 none of the Banks, nor its respective affiliates, agents, directors, officers or employees nor any person acting on behalf of any of them is making any recommendations to it, advising it regarding the suitability of any transactions it may enter into in connection with the Fundraising and that participation in the Fundraising is on the basis that it is not and will not be a client of either of the Banks and that neither Bank has any duties or responsibilities to it for providing the protections afforded to its clients or for providing advice in relation to the Fundraising nor in respect of any representations, warranties, undertakings or indemnities contained in the Placing Agreement nor for the exercise or performance of any of its rights and obligations thereunder including any rights to waive or vary any conditions or exercise any termination right;
16 it has the funds available to pay for the Placing Shares for which it has agreed to subscribe and acknowledges and agrees that it will make payment to the Banks for the Placing Shares allocated to it in accordance with the terms and conditions of this Announcement on the due times and dates set out in this Announcement, failing which the relevant Placing Shares may be placed with others on such terms as the Banks may, in their absolute discretion determine without liability to the Placee and it will remain liable for any shortfall below the net proceeds of such sale and the placing proceeds of such Placing Shares and may be required to bear any stamp duty or stamp duty reserve tax (together with any interest or penalties due pursuant to the terms set out or referred to in this Announcement) which may arise upon the sale of such Placee's Placing Shares on its behalf;
17 no action has been or will be taken by any of the Company, either Bank or any person acting on their behalf that would, or is intended to, permit a public offer of the Placing Shares in the United States or in any country or jurisdiction where any such action for that purpose is required;
18 the person who it specifies for registration as holder of the Placing Shares will be: (a) the Placee; or (b) a nominee of the Placee, as the case may be. None of the Company or the Banks will be responsible for any liability to stamp duty or stamp duty reserve tax resulting from a failure to observe this requirement. Each Placee and any person acting on behalf of such Placee agrees to acquire Placing Shares pursuant to the Fundraising and agrees to pay the Company and the Banks in respect of the same (including any interest or penalties) on the basis that the Placing Shares will be allotted to a CREST stock account of a Bank or transferred to a CREST stock account of a Bank, whereupon the relevant Bank will hold them as a nominee on behalf of the Placee until settlement in accordance with its standing settlement instructions with it;
19 it is acting as principal only in respect of the Placing or, if it is acting for any other person, (a) it is duly authorised to do so and has full power to make the acknowledgments, representations and agreements herein on behalf of each such person and (b) it is and will remain liable to the Company and each of the Banks for the performance of all its obligations as a Placee in respect of the Placing (regardless of the fact that it is acting for another person);
20 the allocation, allotment, issue and delivery to it, or the person specified by it for registration as holder, of Placing Shares will not give rise to a stamp duty or stamp duty reserve tax liability under (or at a rate determined under) any of sections 67, 70, 93 or 96 of the Finance Act 1986 (depository receipts and clearance services) and that it is not participating in the Placing as nominee or agent for any person or persons to whom the allocation, allotment, issue or delivery of Placing Shares would give rise to such a liability;
21 it will not make an offer to the public of the Placing Shares and it has not offered or sold and will not offer or sell any Placing Shares to persons in the United Kingdom or in the EEA prior to the expiry of a period of six months from Admission except to persons whose ordinary activities involve them in acquiring, holding, managing or disposing of investments (as principal or agent) for the purposes of their business or otherwise in circumstances which have not resulted and which will not result in an offer to the public in the United Kingdom within the meaning of section 85(1) of the FSMA or within the meaning of the UK Prospectus Regulation, or an offer to the public in any member state of the EEA within the meaning of the Prospectus Regulation;
22 if it is within the United Kingdom, it and any person acting on its behalf (if within the United Kingdom) is a person of a kind described in: (a) Article 19(5) (Investment Professionals) and/or 49(2) (High net worth companies etc.) of the FSMA (Financial Promotion) Order 2005, as amended, and/or an authorised person as defined in section 31 of FSMA; and (b) section 86(7) of FSMA ("Qualified Investor"), being a person falling within Article 2(e) of the UK Prospectus Regulation. If it is within a member state of the EEA, it is a Qualified Investor as defined in Article 2(e) of the Prospectus Regulation. For such purposes, it undertakes that it will acquire, hold, manage and (if applicable) dispose of any Placing Shares that are allocated to it for the purposes of its business only;
23 it has only communicated or caused to be communicated and it will only communicate or cause to be communicated any invitation or inducement to engage in investment activity (within the meaning of section 21 of the FSMA) relating to Placing Shares in circumstances in which section 21(1) of the FSMA does not require approval of the communication by an authorised person and it acknowledges that this Announcement is not being issued by the Banks as authorised persons under Section 21 of FSMA and therefore is not subject to the same controls applicable to a financial promotion made by an authorised person;
24 it has complied and it will comply with all applicable laws with respect to anything done by it or on its behalf in relation to the Placing Shares (including all relevant provisions of the FSMA in respect of anything done in, from or otherwise involving the United Kingdom);
25 if it is a financial intermediary, as that term is used in Article 5(1) of the UK Prospectus Regulation or the Prospectus Regulation, the Placing Shares acquired by it in the Placing will not be acquired on a non-discretionary basis on behalf of, nor will they be acquired with a view to their offer or resale to, persons in the UK or in a Relevant State other than Qualified Investors, or in circumstances in which the express prior written consent of the Banks has been given to the offer or resale;
26 it has neither received nor relied on any confidential price sensitive information about the Company in accepting this invitation to participate in the Placing;
27 neither of the Banks nor any of their respective affiliates, agents, directors, officers or employees or any person acting on behalf of any of them has or shall have any liability for any information, representation or statement contained in this Announcement or for any information previously published by or on behalf of the Company or any other written or oral information made available to or publicly available or filed information or any representation, warranty or undertaking relating to the Company, and will not be liable for its decision to participate in the Placing based on any information, representation, warranty or statement contained in this Announcement or elsewhere, provided that nothing in this paragraph shall exclude any liability of any person for fraud;
28 none of the Company or the Banks, nor any of their respective affiliates, agents, directors, officers or employees or any person acting on behalf of the Company, either Bank or their respective affiliates, agents, directors, officers or employees is making any recommendations to it, advising it regarding the suitability of any transactions it may enter into in connection with the Fundraising nor providing advice in relation to the Fundraising nor in respect of any representations, warranties, acknowledgements, agreements, undertakings, or indemnities contained in the Placing Agreement nor the exercise or performance of The Banks' rights and obligations thereunder including any rights to waive or vary any conditions or exercise any termination right;
29 acknowledges and accepts that the Banks may, in accordance with applicable legal and regulatory provisions, engage in transactions in relation to the Placing Shares and/or related instruments for their own account for the purpose of hedging their underwriting exposure or otherwise and, except as required by applicable law or regulation, the Banks will not make any public disclosure in relation to such transactions;
30 the Banks and each of their respective affiliates, each acting as an investor for its or their own account(s), may bid or subscribe for and/or purchase Placing Shares and, in that capacity, may retain, purchase, offer to sell or otherwise deal for its or their own account(s) in the Placing Shares, any other securities of the Company or other related investments in connection with the Placing or otherwise. Accordingly, references in this Announcement to the Placing Shares being offered, subscribed, acquired or otherwise dealt with should be read as including any offer to, or subscription, acquisition or dealing by the Banks and/or any of their respective affiliates, acting as an investor for its or their own account(s). None of the Company or the Banks intend to disclose the extent of any such investment or transaction otherwise than in accordance with any legal or regulatory obligation to do so;
31 it has not offered or sold and will not offer or sell any Placing Shares to persons in the EEA prior to the expiry of a period of six months from Admission except to persons whose ordinary activities involve them in acquiring, holding, managing or disposing of investments (as principal or agent) for the purpose of their business or otherwise in circumstances which have not resulted and which will not result in an offer to the public in any member state of the EEA within the meaning of the Prospectus Regulation;
32 it is aware of the obligations regarding (i) insider dealing in the Criminal Justice Act 1993, FSMA, MAR and the Proceeds of Crime Act 2002 and confirms that it has and will continue to comply with those obligations; and (ii) otherwise arising under the Regulations;
33 in order to ensure compliance with the Regulations, either Bank (each for itself and as agent on behalf of the Company) or the Company's registrars may, in their absolute discretion, require verification of its identity. Pending the provision to the relevant Bank or the Company's registrars, as applicable, of evidence of identity, definitive certificates in respect of the Placing Shares may be retained at the relevant Bank's absolute discretion or, where appropriate, delivery of the Placing Shares to it in uncertificated form may be delayed at either Bank's or the Company's registrars', as the case may be, absolute discretion. If within a reasonable time after a request for verification of identity the Banks' (each for itself and as agent on behalf of the Company) or the Company's registrars have not received evidence satisfactory to them, the relevant Bank and/or the Company may, at their absolute discretion, terminate their commitment in respect of the Placing, in which event the monies payable on acceptance of allotment will, if already paid, be returned without interest to the account of the drawee's bank from which they were originally debited;
34 acknowledges that its commitment to acquire Placing Shares on the terms set out in this Announcement and in the form of confirmation will continue notwithstanding any amendment that may in future be made to the terms and conditions of the Placing and that Placees will have no right to be consulted or require that their consent be obtained with respect to the Company's or each Bank's conduct of the Placing;
35 it has knowledge and experience in financial, business and international investment matters as is required to evaluate the merits and risks of subscribing for the Placing Shares. It further acknowledges that it is experienced in investing in securities of this nature and is aware that it may be required to bear, and is able to bear, the economic risk of, and is able to sustain, a complete loss in connection with the Fundraising. It has relied upon its own examination and due diligence of the Company and its affiliates taken as a whole, and the terms of the Fundraising, including the merits and risks involved;
36 it irrevocably appoints any duly authorised officer of either Bank as its agent for the purpose of executing and delivering to the Company and/or its registrars any documents on its behalf necessary to enable it to be registered as the holder of any of the Placing Shares for which it agrees to subscribe or purchase upon the terms of this Announcement;
37 the Company, the Banks and others (including each of their respective affiliates, agents, directors, officers or employees) will rely upon the truth and accuracy of the foregoing representations, warranties, acknowledgements and agreements, which are given to the Banks, on their behalf and on behalf of the Company and are irrevocable;
38 if it is acquiring the Placing Shares as a fiduciary or agent for one or more investor accounts, it has full power and authority to make, and does make, the foregoing representations, warranties, acknowledgements, agreements and undertakings on behalf of each such accounts;
39 time is of the essence as regards its obligations under this Appendix;
40 any document that is to be sent to it in connection with the Fundraising will be sent at its risk and may be sent to it at any address provided by it to either Bank;
41 the Placing Shares will be issued subject to the terms and conditions of this Appendix; and
42 these terms and conditions in this Appendix and all documents into which this Appendix is incorporated by reference or otherwise validly forms a part and/or any agreements entered into pursuant to these terms and conditions and all agreements to acquire shares pursuant to the Placing will be governed by and construed in accordance with English law and it submits to the exclusive jurisdiction of the English courts in relation to any claim, dispute or matter arising out of any such contract, except that enforcement proceedings in respect of the obligation to make payment for the Placing Shares (together with any interest chargeable thereon) may be taken by the Company or either Bank in any jurisdiction in which the relevant Placee is incorporated or in which any of its securities have a quotation on a recognised stock exchange.
By participating in the Placing, each Placee (and any person acting on such Placee's behalf) agrees to indemnify and hold the Company, the Banks and each of their respective affiliates, agents, directors, officers and employees harmless from any and all costs, claims, liabilities and expenses (including legal fees and expenses) arising out of or in connection with any breach of the representations, warranties, acknowledgements, agreements and undertakings given by the Placee (and any person acting on such Placee's behalf) in this Appendix or incurred by the Company, the Banks or each of their respective affiliates, agents, directors, officers or employees arising from the performance of the Placee's obligations as set out in this Announcement, and further agrees that the provisions of this Appendix shall survive after the completion of the Placing.
The agreement to allot and issue Placing Shares to Placees (or the persons for whom Placees are contracting as agent) free of stamp duty and stamp duty reserve tax in the United Kingdom relates only to their allotment and issue to Placees, or such persons as they nominate as their agents, direct by the Company. Such agreement assumes that the Placing Shares are not being acquired in connection with arrangements to issue depositary receipts or to transfer the Placing Shares into a clearance service. If there are any such arrangements, or the settlement related to any other dealings in the Placing Shares, stamp duty or stamp duty reserve tax may be payable. In that event, the Placee agrees that it shall be responsible for such stamp duty or stamp duty reserve tax and none of the Company or the Banks shall be responsible for such stamp duty or stamp duty reserve tax. If this is the case, each Placee should seek its own advice and they should notify the Banks accordingly. In addition, Placees should note that they will be liable for any capital duty, stamp duty and all other stamp, issue, securities, transfer, registration, documentary or other duties or taxes (including any interest, fines or penalties relating thereto) payable outside the United Kingdom by them or any other person on the acquisition by them of any Placing Shares or the agreement by them to acquire any Placing Shares and each Placee, or the Placee's nominee, in respect of whom (or in respect of the person for whom it is participating in the Placing as an agent or nominee) the allocation, allotment, issue or delivery of Placing Shares has given rise to such non-United Kingdom stamp, registration, documentary, transfer or similar taxes or duties undertakes to pay such taxes and duties, including any interest and penalties (if applicable), forthwith and to indemnify on an after-tax basis and to hold harmless the Company and each Bank in the event that any of the Company and/or either Bank has incurred any such liability to such taxes or duties.
The representations, warranties, acknowledgements and undertakings contained in this Appendix are given to the Banks for themselves and on behalf of the Company and are irrevocable.
Each Placee and any person acting on behalf of the Placee acknowledges that neither Bank owes any fiduciary or other duties to any Placee in respect of any representations, warranties, undertakings, acknowledgements, agreements or indemnities in the Placing Agreement.
Each Placee and any person acting on behalf of the Placee acknowledges and agrees that the Banks may (at their absolute discretion) satisfy their obligations to procure Placees by itself agreeing to become a Placee in respect of some or all of the Placing Shares or by nominating any connected or associated person to do so.
When a Placee or any person acting on behalf of the Placee is dealing with either Bank, any money held in an account with a Bank on behalf of the Placee and/or any person acting on behalf of the Placee will not be treated as client money within the meaning of the relevant rules and regulations of the FCA made under FSMA. Each Placee acknowledges that the money will not be subject to the protections conferred by the client money rules; as a consequence this money will not be segregated from either Bank's money (as applicable) in accordance with the client money rules and will be held by it under a banking relationship and not as trustee.
References to time in this Announcement are to London time, unless otherwise stated.
All times and dates in this Announcement may be subject to amendment.
No statement in this Announcement is intended to be a profit forecast, and no statement in this Announcement should be interpreted to mean that earnings per share of the Company for the current or future financial years would necessarily match or exceed the historical published earnings per share of the Company.
The price of shares and any income expected from them may go down as well as up and investors may not get back the full amount invested upon disposal of the shares. Past performance is no guide to future performance, and persons needing advice should consult an independent financial adviser.
The Placing Shares to be issued or sold pursuant to the Placing will not be admitted to trading on any stock exchange other than AIM.
Neither the content of the Company's website nor any website accessible by hyperlinks on the Company's website is incorporated in, or forms part of, this Announcement.
DEFINITIONS
The following definitions apply throughout this Announcement unless the context otherwise requires:
"Admission" |
admission of the New Ordinary Shares to trading on AIM becoming effective in accordance with Rule 6 of the AIM Rules |
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"AIM" |
the AIM Market operated by the London Stock Exchange |
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"AIM Rules" |
the AIM Rules for Companies published by the London Stock Exchange from time to time |
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"Application Form" |
the application form accompanying the Circular to be used by Qualifying Non-CREST Shareholders in connection with the Open Offer |
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"APAC" |
the Asia-Pacific region |
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"Articles" |
the articles of association of the Company |
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"Banks" |
Cenkos and Numis, as the Company's joint brokers |
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"Business Day" |
a day (other than a Saturday, a Sunday or a public holiday) on which clearing banks are open for all normal banking business in the city of London. |
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"Cenkos" |
Cenkos Securities plc, as the Company's nominated adviser and/or joint broker |
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"certificated form" or "in certificated form" |
an Ordinary Share recorded on a company's share register as being held in certificated form (namely, not in CREST) |
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"Circular" |
the circular, containing further details of the Fundraising and notice of the General Meeting to, inter alia, approve the Resolutions, which is expected to be published and despatched to Shareholders on or around 17 February 2023 |
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"CMR" |
CMR Surgical Limited |
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"Company" or "Creo" |
Creo Medical Group plc, a company incorporated under the laws of England and Wales with company number 10371794 |
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"CREST" |
the relevant system (as defined in the CREST Regulations) in respect of which Euroclear is the operator (as defined in those regulations) |
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"CREST Regulations" |
the Uncertificated Securities Regulations 2001 (S.I. 2001 No. 3755) (as amended) |
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"Creo Medical S.L." |
Creo Medical S.L. (previously known as Albyn Medical S.L.), a company incorporated and existing in accordance with the laws of Spain, with its registered office in Cordovilla (Navarra), at Poligono Industrial Cordovilla, Celle D, 1, 31191 Cordovilla, Navarra, Spain, and holder of Spanish tax identification number (NIF) B.62.943.063. |
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"Creo Medical SRL" |
Creo Medical SRL (previously known as Boucart Medical SRL), a company incorporated under Belgian law, having its registered offices at 1070 Anderlecht, rue des Veterinaires 42 and registered with the Banque Carrefour des Enterprises ("Kruispuntbank van Ondernemingen) under number 0443.933.069 (RLE Brussels) |
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"CROMA" |
Creo's CROMA Advanced Energy Platform |
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"Directors" |
the directors of the Company whose names are: Charles Spicer, Craig Gulliford, Richard Rees, Professor Christopher Hancock, David Woods, John Bradshaw and Ivonne Cantu, or any duly authorised committee thereof |
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"EMEA" |
Europe, Middle East, and Africa |
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"EU" |
the European Union |
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"Euroclear" |
Euroclear UK & International Limited, the operator of CREST |
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"Excess Application Facility" |
the arrangement pursuant to which Qualifying Shareholders may apply for additional Open Offer Shares in excess of their Open Offer Entitlement in accordance with the terms and conditions of the Open Offer |
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"Excess Open Offer Entitlements" |
an entitlement for each Qualifying Shareholder to apply to subscribe for Open Offer Shares in addition to his Open Offer Entitlement pursuant to the Excess Application Facility which is conditional on him taking up his Open Offer Entitlement in full and which may be subject to scaling back in accordance with the provisions of the Circular |
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"Excess Shares" |
Open Offer Shares applied for by Qualifying Shareholders under the Excess Application facility |
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"Ex-entitlement Date" |
the date on which the Existing Ordinary Shares are marked "ex" for entitlement under the Open Offer, being 16 February 2023 |
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"Existing Ordinary Shares" |
the 182,342,363 Ordinary Shares in issue at the date of this announcement, all of which are admitted to trading on AIM |
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"FCA" |
the UK Financial Conduct Authority |
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"Form of Proxy" |
the form of proxy for use in connection with the General Meeting which accompanies the Circular |
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"FSMA" |
the Financial Services and Markets Act 2000 (as amended) |
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"Fundraising" |
the Subscription, the Placing and the Open Offer |
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"General Meeting" |
the general meeting of the Company to be held at the offices of Osborne Clarke LLP, 2 Temple Back East, Temple Quay, Bristol BS1 6EG at 10,00 a.m. on 8 March 2023, notice of which will be set out at the end of the Circular |
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"GHz" |
gigahertz |
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"GI" |
gastrointestinal |
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"GIST" |
gastrointestinal stromal tumour |
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"Group" |
the Company, its subsidiaries and its subsidiary undertakings |
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"Intuitive" |
Intuitive Surgical, Inc. |
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"IP" |
intellectual property |
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"IPO" |
the admission of the Company's Ordinary Shares to trading on AIM, effective on 9 December 2016 |
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"Issue Price" |
20 pence per New Ordinary Share |
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"Kamaptive" |
Creo's Kamaptive technology |
|
"London Stock Exchange" |
London Stock Exchange plc |
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"MAR" |
the Market Abuse Regulation (EU) No 596/2014 as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 |
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"Material Adverse Change" |
a material adverse change in, or any development involving a prospective material adverse change in or affecting the condition (financial, operational, legal or otherwise), or in the earnings, management business, affairs, solvency or prospects, or results of operations of the Company or the Group (taken as a whole), whether or not arising in the ordinary course of business and whether or not foreseeable as at the date of the Placing Agreement |
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"Money Laundering Regulations" |
the Money Laundering, Terrorist Financing and Transfer of Funds (Information on the Payer) Regulations 2017 (as amended) |
|
"MW" |
microwave |
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"New Ordinary Shares" |
the Subscription Shares, the Placing Shares and the Open Offer Shares |
|
"Notice of General Meeting" |
the notice convening the General Meeting which will beset out at the end of the Circular |
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"Numis" |
Numis Securities Limited, as the Company's joint broker |
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"Open Offer" |
the conditional invitation by the Company to Qualifying Shareholders to apply to subscribe for the Open Offer Shares at the Issue Price on the terms and subject to the conditions which will be set out in the Circular and, in the case of Qualifying Non-CREST Shareholders, in the Application Form |
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"Open Offer Entitlement" |
the individual entitlements of Qualifying Shareholders to subscribe for Open Offer Shares allocated to Qualifying Shareholders pursuant to the Open Offer |
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"Open Offer Shares" |
up to 26,048,909 new Ordinary Shares to be issued by the Company pursuant to the Open Offer |
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"Ordinary Shares" |
ordinary shares of £0.001 each in the capital of the Company |
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"Overseas Shareholder(s)" |
Shareholder(s) with a registered address outside the UK |
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"Placees" |
subscribers for the Placing Shares |
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"Placing" |
the conditional placing of the Placing Shares by the Joint Brokers, as agents on behalf of the Company, pursuant to the Placing Agreement, further details of which will be set out in the Circular |
|
"Placing Agreement" |
the conditional placing and open offer agreement dated the same date as this Announcement and made between the Joint Brokers and the Company in relation to the Placing and Open Offer, further details of which will be set out in the Circular |
|
"Placing Shares" |
the new Ordinary Shares to be issued pursuant to the Placing |
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"POEM" |
Peroral endoscopic myotomy |
|
"Prospectus Rules" |
the prospectus rules made by the FCA pursuant to section 73A of the FSMA |
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"Publicly Available Information" |
information publicly announced through a Regulatory Information Service (as defined in the AIM Rules) by or on behalf of the Company on or prior to the date of this Announcement |
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"Qualifying CREST Shareholders" |
Qualifying Shareholders holding Existing Ordinary Shares in uncertificated form |
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"Qualifying Non-CREST Shareholders |
Qualifying Shareholders holding Existing Ordinary Shares in certificated form |
|
"Qualifying Shareholders" |
holders of Existing Ordinary Shares on the register of members of the Company at the Record Date but excluding any Overseas Shareholder who has a registered address in any Restricted Jurisdiction |
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"RAS" |
Robotic assisted surgery |
|
"Record Date" |
15 February 2023 |
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"Registrars and Receiving Agent" or "Equiniti Limited" |
Equiniti Limited, Aspect House, Spencer Road, Lancing, West Sussex BN99 6DA |
|
"Regulations" |
the Proceeds of Crime Act 2002 (as amended), the Terrorism Act 2000 (as amended), the Terrorism Act 2006 (as amended) and the Money Laundering, Terrorist Financing and Transfer of Funds (Information on the Payer) Regulations 2017 (as amended) |
|
"Regulatory Information Service" |
a service approved by the FCA for the distribution to the public of regulatory announcements and included within the list maintained on the FCA's website |
|
"Relevant State" |
a member state of the EEA |
|
"Resolutions" |
the resolutions set out in the Notice of General Meeting |
|
"RF" |
radiofrequency |
|
"Restricted Jurisdiction" |
has the meaning set out on in the Circular |
|
"Shareholders" |
holders of Ordinary Shares |
|
"SSD" |
Speedboat Submucosal Dissection |
|
"Subscription" |
the subscription for new Ordinary Shares at the Issue Price |
|
"Subscription Shares" |
the new Ordinary Shares to be issued pursuant to the Subscription |
|
"UK" |
the United Kingdom of Great Britain and Northern Ireland |
|
"UKCA" |
UK Conformity Assessed |
|
"UK Prospectus Regulation" |
the UK version of the Prospectus Regulation, which is part of UK law by virtue of the European Union (Withdrawal) Act 2018, as amended from time to time, and includes any relevant implementing measure in any member state |
|
"US" or "United States" |
the United States of America, each State thereof, its territories and possessions (including the District of Columbia) and all other areas subject to its jurisdiction |
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"uncertificated" or "in uncertificated form" |
an Ordinary Share recorded on a company's share register as being held in uncertificated form in CREST and title to which, by virtue of the CREST Regulations, may be transferred by means of CREST |
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"£", "pounds sterling", "pence" or "p" |
are references to the lawful currency of UK |
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