Polarean Imaging plc
("Polarean" or the "Company" or the "Group")
Half-year Report
Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in advanced magnetic resonance imaging ("MRI") of the lungs, announces its unaudited interim results for the six months ended 30 June 2024.
Highlights
· Group revenues for H1 2024 of
· Operating expenses for H1 2024 of
· Successfully raised gross proceeds of
· Received de novo Xenon MRI System order from the University of
· Received and installed Cincinnati Children's trade-in agreement order, which exchanged their existing research hyperpolariser for a new clinical-grade Xenon MRI hyperpolariser system, thereby providing them additional flexibility for both research and clinical Xenon MRI scanning
· A significant
Post period end
· With the H1 2024 revenue and orders received to date, the Company is raising its revenue guidance for 2024 to a range of
· The Company now has 21 sites that have either installed or ordered hyperpolariser systems and five dedicated salespeople who will continue to drive sales for the remainder of 2024 and secure orders for 2025
· Received a trade-in agreement order to exchange the University of Virginia Health System's ("UVA Health") existing two research hyperpolarisers for two new clinical-grade Xenon MRI hyperpolariser systems
· Received a trade-in agreement order to exchange the University of Kansas Medical Center's ("KUMC") existing research hyperpolariser for a new clinical-grade Xenon MRI hyperpolariser system
· Appointed Alan Huang, Ph.D., as Vice President of Sales
· Appointed Chase Hall, M.D., as Chief Medical Advisor
· Submitted a New Drug Application ("NDA") supplement to the US Food and Drug Administration ("FDA"), to allow the administration of XENOVIEW™ to paediatric patients aged six years and older
Christopher von Jako, Ph.D., CEO of Polarean, commented: "We are very pleased with the results for the first half of 2024. The revenue is tangible proof that our five-pillar growth strategy to revolutionise pulmonary medicine is starting to produce results. The installation of the new hyperpolariser system at Cincinnati Children's and the receipt of the de novo order from UAB Hospital, expected to be installed later this year, are important milestones for the Company toward achieving the revenue targets laid out in our February 2024 strategy update. Additionally, the orders from UVA Health and KUMC in July 2024 further our progress toward converting legacy research sites to performing both research and clinical scans, and this continues to highlight the growing interest in this important technology from pulmonary clinicians.
"The first half of 2024 was marked by our efforts to successfully raise capital for the commercialisation of our pulmonary functional Xenon MRI platform. With gross proceeds of
"I would like to extend my gratitude to the Polarean team, our customers and investors who are helping us bring this important technology to patients suffering from chronic lung conditions."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018.
Enquiries:
Polarean Imaging plc |
www.polarean.com / www.polarean-ir.com |
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Christopher von Jako, PhD, Chief Executive Officer Charles Osborne, Chief Financial Officer |
Via Walbrook PR |
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Stifel (NOMAD and Sole Corporate Broker) |
+44 (0)20 7710 7600 |
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Nicholas Moore / Nick Harland / Ben Good |
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Walbrook PR |
Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com |
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Anna Dunphy / Phillip Marriage |
Mob: +44 (0)7876 741 001 / +44 (0)7867 984 082 |
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About Polarean
Polarean is a revenue-generating medical imaging technology company revolutionising pulmonary medicine through direct visualisation of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimise lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarisation science and has successfully developed the first and only hyperpolarised Xenon MRI inhaled contrast agent, XENOVIEW™, which is now FDA-approved in
XENOVIEW IMPORTANT SAFETY INFORMATION
Indication
XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
Limitations of Use
XENOVIEW has not been evaluated for use with lung perfusion imaging.
CONTRAINDICATIONS
None.
Warnings and Precautions
Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold.
Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated.
Adverse Reactions
Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness. Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age.
Please see full prescribing information at www.xenoview.net
CEO Statement
Introduction
Upon joining Polarean fifteen months ago, my top priorities were clear: craft a strategy for the successful commercialisation of our innovative pulmonary functional Xenon MRI platform technology, align our cost structure with the Company's market development stage, and secure the necessary financing to support our commercialisation efforts. I am pleased to report that we have achieved all three objectives, through the support of our shareholders and employees, as evidenced by our results in the first half of 2024.
Results overview
The results for the first half of 2024 show that we are successfully driving sales, while strictly controlling costs and focusing on the highest-value opportunities.
Group revenues for H1 2024 (
Operating expenses for H1 2024 (
Finance income in H1 2024 (
The overall loss before tax decreased to
Commercial progress
During the first half of the year, we achieved significant sales growth compared to H1 2023, driven by the sale and completed installation of a new Xenon MRI hyperpolariser system to Cincinnati Children's and increased Xenon gas blend cylinder sales. We have been particularly pleased with our progress in advancing prospects through the sales pipeline, successfully securing sales in both the clinical and research markets, with a de novo order received from the UAB Hospital, and two trade-in agreement orders with current research sites upgrading them to hyperpolarisation systems approved for clinical scans. The trade-in agreements will result in lower gross margin in H2 2024, but are an important step towards activating more clinical sites. We now have 21 sites that have either installed or ordered hyperpolariser systems. Following the successful completion of our funding round in June 2024, we now have five dedicated salespeople and will continue to drive sales for the remainder of 2024 and secure orders for 2025.
We now feel confident to raise the previously disclosed lower range for our 2024 revenue target of
An important part of our growth strategy involves collaboration with industry partners in both the MedTech and the pharmaceutical sectors. Our ongoing partnership with Philips continues to evolve, offering valuable cross-selling opportunities. We also continue to have productive dialogues with both GE HealthCare and Siemens. Additionally, we are in active discussions with several pharmaceutical companies to integrate our Xenon MRI platform technology into their clinical trials. These partnerships not only enhance awareness of our technology but also allow us to engage with a broader audience of potential customers, all while maintaining a lean commercial team.
To efficiently execute our strategy, we are leveraging external consultants to bring in specialised expertise. We recently appointed Dr. Chase Hall as our Chief Medical Advisor on a consultancy basis, and Dr. Bastiaan Driehuys moved to a consultancy basis to serve his role as Chief Scientific Officer. Dr. Hall's extensive background in pulmonary medicine and clinical research with the Xenon MRI platform technology will be invaluable as we continue to identify and validate high-value clinical use cases for our technology. In addition, Dr. Driehuys, with his rich history in Xenon MRI and his clinical research work at Duke University Hospital, provides us with access to valuable intellectual property through our exclusive license with Duke Health.
Outlook
As we look to the future, I am very pleased with our progress in 2024 as we continue to execute our five-pillar growth strategy, which includes driving utilisation, expanding our user base, enhancing reimbursement coverage and payment, expanding our total addressable market, and continuing to develop key industry partnerships.
The sales traction we have achieved so far has been very encouraging, particularly given my experience with companies pioneering novel imaging technologies and our limited resources during the first half of the year. With the recent financing, we are confident in our ability to build an expanded team that will drive the commercialisation of our innovative pulmonary functional Xenon MRI platform technology and improve outcomes for even more patients with chronic lung disease.
We look forward to providing additional updates on our progress as we achieve future milestones.
Christopher von Jako, Ph.D.
Chief Executive Officer
4 September 2024
POLAREAN IMAGING PLC
Unaudited consolidated statement of comprehensive income
for the six months ended 30 June 2024
|
|
Unaudited |
|
Unaudited |
|
Audited |
|
|
6 months ended 30 June 2024 US$ |
|
6 months ended 30 June 2023 US$ |
|
12 months ended 31 December 2023 US$ |
|
Note |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
1,119,937 |
|
142,384 |
|
890,933 |
Cost of sales |
|
(536,889) |
|
(60,484) |
|
(555,450) |
Gross profit |
|
583,048 |
|
81,900 |
|
335,483 |
|
|
|
|
|
|
|
Administrative expenses |
|
(1,622,400) |
|
(1,865,084) |
|
(3,337,836) |
Research, development and regulatory expenses |
|
(1,827,770) |
|
(2,460,547) |
|
(4,194,006) |
Depreciation |
|
(103,423) |
|
(165,509) |
|
(208,786) |
Amortisation |
|
(350,468) |
|
(306,126) |
|
(728,411) |
Selling and distribution expenses |
|
(832,221) |
|
(2,453,477) |
|
(3,562,412) |
Share based payment expense |
|
132,164 |
|
(433,892) |
|
(860,195) |
Total operating expenses |
|
(4,604,118) |
|
(7,684,635) |
|
(12,891,646) |
Loss from operations |
|
(4,021,070) |
|
(7,602,735) |
|
(12,556,163) |
|
|
|
|
|
|
|
Finance income |
|
51,937 |
|
192,826 |
|
298,899 |
Finance expense |
|
(5,172) |
|
(8,945) |
|
(15,990) |
Other (losses)/gains |
|
(38,324) |
|
67,685 |
|
388,451 |
Loss on ordinary activities before taxation |
3 |
(4,012,629) |
|
(7,351,169) |
|
(11,884,803) |
|
|
|
|
|
|
|
Taxation |
|
- |
|
- |
|
|
Loss and total other comprehensive expense |
|
(4,012,629) |
|
(7,351,169) |
|
(11,884,803) |
Basic and fully diluted loss per share (US$) |
3 |
(0.014) |
|
(0.035) |
|
(0.055) |
POLAREAN IMAGING PLC
Unaudited consolidated statement of financial position
at 30 June 2024
|
|
Unaudited |
|
Unaudited |
|
Audited |
|
|
As at 30 June 2024 US$ |
|
As at 30 June 2023 |
|
As at 31 December 2023 US$ |
Assets |
Note |
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
Property, plant and equipment |
|
190,182 |
|
351,109 |
|
288,627 |
Intangible assets |
|
671,580 |
|
1,275,465 |
|
969,339 |
Right-of-use asset |
|
105,420 |
|
212,373 |
|
158,129 |
Trade and other receivables |
|
363,961 |
|
413,539 |
|
387,961 |
|
|
1,331,143 |
|
2,252,486 |
|
1,804,056 |
Current assets |
|
|
|
|
|
|
Inventories |
|
1,977,581 |
|
2,061,931 |
|
2,221,823 |
Trade and other receivables |
|
529,536 |
|
1,505,254 |
|
685,117 |
Cash and cash equivalents |
|
15,215,775 |
|
9,879,595 |
|
6,171,636 |
|
|
17,722,892 |
|
13,446,780 |
|
9,078,576 |
Total assets |
|
19,054,035 |
|
15,699,266 |
|
10,882,632 |
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
Share capital |
4 |
570,336 |
|
103,861 |
|
104,780 |
Share premium |
|
70,503,443 |
|
59,291,496 |
|
59,305,160 |
Group reorganisation reserve |
|
7,813,337 |
|
7,813,337 |
|
7,813,337 |
Share-based payment reserve |
|
5,593,610 |
|
5,299,471 |
|
5,725,774 |
Accumulated losses
|
|
(68,663,236) |
|
(60,116,973) |
|
(64,650,607) |
Total equity |
|
15,817,490 |
|
12,391,192 |
|
8,298,444 |
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
Contract liabilities |
|
54,451 |
|
99,596 |
|
67,032 |
Lease liability |
5 |
- |
|
147,667 |
|
74,846 |
Trade and other payables |
|
180,000 |
|
300,000 |
|
240,000 |
Contingent consideration |
|
- |
|
316,000 |
|
- |
|
|
234,451 |
|
863,263 |
|
381,878 |
Current liabilities |
|
|
|
|
|
|
Trade and other payables |
|
2,627,568 |
|
2,169,530 |
|
1,831,587 |
Lease liability |
5 |
147,667 |
|
137,827 |
|
141,845 |
Contract liabilities |
|
226,859 |
|
137,454 |
|
228,878 |
|
|
3,002,094 |
|
2,444,811 |
|
2,202,310 |
Total equity and liabilities
|
|
19,054,035 |
|
15,699,266
|
|
10,882,632 |
POLAREAN IMAGING PLC
Unaudited consolidated statement of changes in equity
at 30 June 2024
|
Share capital |
Share premium |
Group re-organisation |
Share-based payment reserve |
Accumulated losses |
Total equity |
Balance as at 31 December 2022 (audited) |
103,463 |
59,288,383 |
7,813,337 |
4,865,579 |
(52,765,804) |
19,304,958 |
Loss and total comprehensive income for the period |
- |
- |
- |
- |
(7,351,169) |
(7,351,169) |
Transactions with owners |
|
|
|
|
|
|
Issue of shares |
398 |
3,113 |
- |
- |
- |
3,511 |
Share-based payments |
- |
- |
- |
433,892 |
- |
433,892 |
Balance as at 30 June 2023 (unaudited) |
103,861 |
59,291,496 |
7,813,337 |
5,299,471 |
(60,116,973) |
12,391,192 |
Comprehensive income |
|
|
|
|
|
|
Loss and total comprehensive income for the period |
- |
- |
- |
- |
(4,533,634) |
(4,533,634) |
Transactions with owners |
|
|
|
|
|
|
Issue of shares |
919 |
13,664 |
- |
- |
- |
14,583 |
Share-based payments |
- |
- |
- |
426,303 |
- |
426,303 |
Balance as at 31 December 2023 (audited) |
104,780 |
59,305,160 |
7,813,337 |
5,725,774 |
(64,650,607) |
8,298,444 |
Loss and total comprehensive income for the period |
- |
- |
- |
- |
(4,012,629) |
(4,012,629) |
Transactions with owners |
|
|
|
|
|
|
Issue of shares |
465,556 |
12,112,876 |
- |
- |
- |
12,578,432 |
Share issue costs |
|
(914,593) |
|
|
|
(914,593) |
Share-based payments |
- |
- |
- |
(132,164) |
- |
(132,164) |
Balance as at 30 June 2024 (unaudited) |
570,336 |
70,503,443 |
7,813,337 |
5,593,610 |
(68,663,236) |
15,817,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POLAREAN IMAGING PLC
Unaudited consolidated cash flow statement
for the six months ended 30 June 2024
|
|
Unaudited |
Unaudited |
Audited |
|
|
6 months ended 30 June 2024 US$ |
6 months ended 30 June 2023 US$ |
12 months ended 31 December 2023 US$ |
Cash flows from operating activities |
|
|
|
|
Loss for the period before taxation |
|
(4,012,629) |
(7,351,169) |
(11,884,803) |
Adjustments for non-cash/non-operating items: |
|
|
|
|
Depreciation of property, plant and equipment |
|
103,423 |
103,594 |
208,786 |
Amortisation of intangible and right-of-use assets |
|
350,468 |
368,041 |
728,411 |
Loss on disposal of property, plant and equipment |
|
- |
- |
- |
Share based payment expense |
|
(132,164) |
433,892 |
860,195 |
Net foreign exchange (gains)/losses |
|
38,324 |
(67,685) |
(72,451) |
Writeback of contingent consideration |
|
- |
- |
(316,000) |
Finance expense |
|
5,172 |
8,945 |
15,990 |
Finance income |
|
(51,937) |
(192,826) |
(298,899) |
|
|
(3,699,343) |
(6,697,208) |
(10,758,771) |
Changes in working capital: |
|
|
|
|
Decrease/(increase) in inventories |
|
244,242 |
(350,512) |
(510,404) |
Decrease in trade and other receivables |
|
179,581 |
57,587 |
1,024,108 |
Increase/(decrease) in trade and other payables |
|
393,191 |
227,538 |
(267,413) |
Increase in contract liabilities |
|
328,191 |
42,421 |
77,482 |
Net cash flows from operating activities |
|
(2,554,138) |
(6,720,174) |
(10,434,998) |
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
Purchase of property, plant and equipment |
|
(4,979) |
(36,205) |
(78,915) |
Interest received |
|
51,937 |
192,826 |
298,899 |
Net cash generated from (used in) investing activities |
|
46,958 |
156,621 |
219,984 |
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
Proceeds from issue of shares |
|
12,578,432 |
3,511 |
18,094 |
Cost of issue |
|
(914,593) |
- |
- |
Interest paid on lease liabilities |
|
(5,172) |
(8,945) |
(15,990) |
Principal elements of lease payments |
|
(69,024) |
(73,344) |
(142,146) |
Net cash generated from (used in) financing activities |
|
11,589,643 |
(78,778) |
(140,042) |
|
|
|
|
|
Net increase/(decrease) in cash and equivalents |
|
9,082,463 |
(6,642,331) |
(10,355,056) |
|
|
|
|
|
Cash and equivalents at beginning of period |
|
6,171,636 |
16,454,241 |
16,454,241 |
Effect of foreign exchange rate changes on cash |
|
|
|
|
and cash equivalents |
|
(38,324) |
67,685 |
72,451
|
Cash and equivalents at end of period |
|
15,215,775 |
9,879,595 |
6,171,636 |
|
|
|
|
|
NOTES TO THE INTERIM ACCOUNTS
1. Basis of presentation
This interim consolidated financial information for the six months ended 30 June 2024 has been prepared in accordance with AIM rule 18, 'Half yearly reports and accounts'. This interim consolidated financial information is not the Group's statutory financial statements within the meaning of section 434 of the Companies Act 2006 (and information as required by section 435 of the Companies Act 2006) and should be read in conjunction with the annual financial statements for the year ended 31 December 2023, which have been prepared in accordance with
The interim consolidated financial information has been prepared in accordance with the accounting policies adopted in the Group's most recent annual financial statements for the year ended 31 December 2023. A number of amendments to IFRS accounting standards have become applicable for the current reporting period. The Group did not have to change its accounting policies or make retrospective adjustments as a result of adopting these amended standards.
The judgements, estimates and assumptions applied in the interim condensed consolidated financial information, including the key sources of estimation uncertainty, were the same as those applied in the Group's last annual financial statements for the year ended 31 December 2023.
The interim consolidated financial information for the six months ended 30 June 2024 is unaudited. In the opinion of the Directors, the interim consolidated financial information presents fairly the financial position, and results from operations and cash flows for the period. Comparative numbers for the six months ended 30 June 2024 are also unaudited.
This interim consolidated financial information is presented in US Dollars (US$).
2. Going concern
The interim consolidated financial information for the six months ended 30 June 2024 have been prepared on the going concern basis.
The Directors consider the going concern basis of preparation to be appropriate in preparing the financial statements. In considering the appropriateness of this basis of preparation, the Directors have received the Group's working capital forecasts for a minimum of 12 months from the date of the approval of this financial information and considered the gross proceeds of
3. Loss per share
The basic and diluted loss per share for the period ended 30 June 2024 was
4. Called up share capital
|
|
Unaudited |
|
Unaudited |
|
Audited |
|
|
30 June 2024 US$ |
|
30 June 2023 US$ |
|
31 December 2023 US$ |
Allotted, issued and fully paid |
|
|
|
|
|
|
Ordinary Shares |
|
570,336 |
|
103,861 |
|
104,780 |
|
|
|
|
|
|
|
The number of shares in issue was as follows: |
Number of shares |
Balance at 1 January 2023 |
213,047,509 |
Issued during the period |
|
Exercised warrants |
852,822 |
Balance at 30 June 2023 |
213,900,331 |
Issued during the period |
|
Exercised warrants |
1,948,262 |
Balance at 31 Dec 2023 |
215,848,593 |
Issued during the period |
990,768,532 |
Exercised options |
267,200 |
Exercised warrants |
148,456 |
Balance at 30 June 2024 |
1,207,032,781 |
On 17 June 2024 and 18 June 2024, the Company issued a total of 990,768,532 new ordinary shares in the capital of the Company at the issue price
5. Borrowings
|
|
Unaudited |
|
Unaudited |
|
Audited |
|
|
30 June 2024 US$ |
|
30 June 2023 US$ |
|
31 December 2023 US$ |
Non-current |
|
|
|
|
|
|
Lease liability |
|
- |
|
147,667 |
|
74,846 |
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
Lease Liability |
|
147,667 |
|
137,827 |
|
141,845 |
Total |
|
147,667 |
|
285,494 |
|
216,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6. Share based payments
Share Options
The Company grants share options at its discretion to Directors, management and employees. These are accounted for as equity settled transactions. Should the options remain unexercised after a period of ten years from the date of grant the options will expire unless an extension is agreed to by the Board. Options are exercisable at a price equal to the Company's quoted market price on the date of grant or an exercise price to be determined by the Board.
Details of share options granted, exercised, forfeited and outstanding in the period ended 30 June 2024 are as follows:
|
|
Number of share options |
|
Weighted average exercise price
|
Outstanding at 1 January 2024 |
|
24,475,279 |
|
0.4567 |
Granted during period |
|
- |
|
- |
Exercised during period |
|
(267,200) |
|
0.0041 |
Forfeited during period |
|
(2,957,314) |
|
0.4693 |
Outstanding at 30 June 2024 |
|
21,250,765 |
|
0.4606 |
Exercisable at 30 June 2024 |
|
14,701,714 |
|
0.4191 |
There were no options granted in the period to 30 June 2024. There were 267,200 options exercised and 2,957,314 options forfeited in the period to 30 June 2024. The forfeiture of the 2,957,314 resulted in the reversal of previous share based payment expense.
The weighted average contractual life of the share options outstanding at the reporting date is 6 years and 45 days.
Share Warrants
The Company grants share warrants at its discretion to Directors, management, employees, advisors and lenders. These are accounted for as equity settled transactions. Terms of warrants vary from agreement to agreement.
Details of warrants granted, exercised, forfeited and outstanding in the period ended 30 June 2024 are as follows:
|
|
Number of |
|
Weighted average exercise price (US$) |
Outstanding at 1 January 2024 |
|
249,645 |
|
0.12000 |
Exercised during the period |
|
(148,456) |
|
0.00037 |
Forfeited during the period |
|
- |
|
- |
Outstanding at 30 June 2024 |
|
101,189 |
|
7.92200 |
Exercisable at 30 June 2024 |
|
101,189 |
|
7.92200 |
There were 148,456 warrants exercised and no warrants forfeited in the six months ended 30 June 2024. There were no warrants granted during this period.
The weighted average contractual life of the share warrants outstanding at the reporting date is 2 years and 280 days.
7. Related party transactions
In the first half of 2024, the Company purchased
8. Events after the reporting period
On 26 July 2024, the Company repriced existing options over ordinary shares of
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