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ASX Announcement
ASX:4DX
Quarterly Activity Report and Appendix 4C for Q2 FY2022
31 January 2022
Highlights
- Successfully initiated commercial rollout of its XV LVAS™ software with I-MED, Australia's largest diagnostic imaging provider, with the completion of first respiratory scans at the Berwick clinic, Melbourne
- Expanded XV LVAS™ software rollout to I-MED sites in Brisbane and Wagga Wagga, with further locations anticipated in 2022
- Imaging complete at Johns Hopkins COPD clinical trial
- Continued progress on commercial pilots in the U.S., particularly with Veterans Health Administration
- XVD project developing federally funded (Medical Research Future Fund) project to design world first dedicated lung scanner proceeding on track and on time
- Novartis U.S. pharmaceutical-led clinical program to validate therapies to treat COPD achieves 1st milestone with enrolment of clinical trial subjects
- Ms Evonne Collier appointed as independent non-executive director of 4DMedical
- Strong cash position with $60.2 million held as at 31 December 2021, well-funded to scale-up and execute commercialisation opportunities
4DMedical Limited (ASX:4DX, "4DMedical", or the "Company"), a medical technology company focused on commercialising its FDA-cleared and TGA-approved respiratory imaging platform, is pleased to release its Quarterly Activity Report and Appendix 4C Cash Flow Report for the quarter ended 31 December 2021.
Commercial rollout with I-MED
4DMedical sealed its commercial arrangement with Australia's largest diagnostic imaging provider with its first commercial respiratory scan at I-MED Radiology Network (I-MED)'s clinic in Berwick, Melbourne in December. This arrangement was secured following the successful completion of 4DMedical's XV Lung Ventilation Analysis Software (XV LVAS™) clinical pilot program with I-MED during the quarter ended 31 December 2021.
I-MED is Australia's largest outsourced provider of radiology, with more than 200 clinics nationwide, offering a range of diagnostic imaging services to private and public hospitals. The commencement of this commercial arrangement follows the successful completion of comprehensive pilot programs conducted at multiple clinical locations by 4DMedical in collaboration with I-MED.
As announced in December 2021, 4DMedical's state-of-the-art respiratory technology is available to general practitioners, specialists and their patients based in and around the Casey region of Victoria, Australia, on a pay-per-scan basis. Patients referred to I-MED's imaging clinic in Berwick can access 4DMedical's unique XV Technology which provides rich, quantitative information to medical practitioners enabling more appropriate treatment plans.
The future of lung health
Melbourne | Los Angeles | 4DMedical Limited | |
7/700 Swanston St, | 21600 Oxnard St #300, | ABN: 31 161 684 831 | |
Carlton, Victoria, 3053 | Woodland Hills, 91367, CA | Email: info@4DMedical.com | 1 |
Tel: +61 (3) 9545 5940 | Tel: +1 (818) 794-6467 | www.4DMedical.com |
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As foreshadowed, 4DMedical's XV LVAS software was also successfully installed at I-MED's Brisbane and Wagga Wagga sites in early January 2022, allowing general practitioners, specialists, and their patients in these areas to begin to benefit from 4DMedical's groundbreaking technology.
The Company continues to look to rapidly expand to selected locations across I-MED's nationwide network of clinics.
Clinical trial updates
Clinical trials remain a fundamental pillar of the Company's commercialisation plan. The Company continues to make strong progress with these clinical trials, and we are pleased that imaging is complete in the Johns Hopkins COPD trial. Results from these trials will undergo analysis with results being disseminated via scientific conferences and peer reviewed journal publications.
Commercial pilot progress & updates
In addition to the commercial rollout with I-MED, 4DMedical continued to make progress with commercial pilots in the United States during the quarter. The Company has a strong near-term commercialisation pipeline in the U.S. market, particularly within the large and important Veterans Health Administration (VHA) healthcare system.
The VHA healthcare system represents the largest integrated healthcare system in the U.S., providing life-long care and services to eligible military veterans and their families. The US$250B p.a. VHA operates 1,255 healthcare facilities, including 170 medical centres and 1,074 outpatient clinics, offering a variety of care to over 9 million veterans enrolled in the VHA healthcare program. As announced last year, 4DMedical has won the right to paid contracts in the VHA without the need for further reimbursement.
XVD Generation One scanner
4DMedical's vision to transform medical imaging has evolved through significant progress with development of the prototype XVD scanner at the Company's Advanced Manufacturing Facility in Port Melbourne. This is the world's only dedicated lung scanner integrating software and hardware in one platform.
Powering up this first scanner in January 2022 validated its systems and functions, representing significant progress towards obligations to the Medical Research Future Fund (MRFF) against $28.9 million of funding from the Australian Government's Department of Health.
4DMedical holds exclusive rights to commercialise XVD scanners worldwide and will receive
100 percent of revenue from hardware sales, in addition to software revenue from SaaS-enabled scanning operations using these scanners.
Contract with Novartis
The Company has previously announced that it had signed its first pharmaceutical-focused contract with international pharmaceutical giant Novartis for the commercial use of XV LVAS. The clinical program with Novartis has delivered its first milestone with the successful enrolment of the trial subjects. While the contract is not material in terms of revenue, the Company has invoiced Novartis for the milestone achievement, continues to build on this relationship, and looks to commercialise other opportunities in the lucrative pharmaceutical space.
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Other corporate updates
On 17 December 2021, 4DMedical appointed Ms Evonne Collier as an independent non-executive director of the Company. Ms Collier brings to 4DMedical considerable multinational experience across SaaS, sales and marketing in industries spanning MedTech, FinTech, Pharmaceutical/Health, eCommerce/Digital and FMCG.
Ms Collier is an experienced leader in business scale-up, transformation and digital disruption, and has served as non-executive director on various boards since 2011. Evonne currently serves as non- executive director of Sage Automation (global SaaS analytics), Curae Health (digi-healthtech), Sniip (SaaS FinTech), and Motorama Group Holdings.
During the quarter, CEO Andreas Fouras presented at the Bell Potter Healthcare Conference on
9 November 2021 (https://youtu.be/a5lHi7G9zkU) and at the NWR Virtual Healthcare Day on 24 November 2021 (https://youtu.be/IO4XmdbuGyU).
Financials
4DMedical's cash balance was $60.2 million as at 31 December 2021. Net operating cash outflows for the quarter were $9.9 million, mostly relating to payments for research and development, staff costs, administration, and general operating costs. Allowing for the additional $23.9 million in MRFF funds yet to be received, and the existing strong cash balance of $60.2 million, the Company has a cash runway of over eight quarters.
4DMedical commenced commercial rollout with I-MED in December and expects cash receipts in the quarter ending 31 March 2022.
The Company's strong cash balance includes unspent MRFF funds of $0.4 million. MRFF funding received to date total $5.0 million ($4.6 million spent).
Use of Funds (Listing Rule 4.7C.2) | ||||
Prospectus | Period ended | |||
dated 6 July | 31 December | |||
2020 | 2021 | |||
Amount | Amount | % of | ||
Uses of Funds | ($'000) | % | ($'000) | total |
Marketing through clinical trials and trade | $15,230 | 30.5% | $5,949 | 39.1% |
shows | ||||
Operating expenditure (inc. governance & | $13,035 | 26.1% | $16,857 | 129.3% |
working capital) | ||||
Product R&D and platform development | $12,810 | 25.6% | $10,196 | 79.6% |
U.S. sales and distribution (inc. clinical | $3,075 | 6.1% | $5,869 | 190.9% |
liaison & reimbursement) | ||||
Intellectual property and trademarks | $1,450 | 2.9% | $248 | 17.1% |
Cost of the offer | $4,400 | 8.8% | $4,456 | 101.3% |
Total from proceeds of issue of New Shares | $50,000 | $43,576 |
©4DMedical Limited | 3 |
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The expenditure for the 18-month period ended 31 December 2021 as set out in the table above is broadly in accordance with the Use of Funds outlined in the Company's prospectus dated 6 July 2020. The largest deviation relates to the significant underspend in marketing through tradeshows, with every relevant tradeshow in Australia and the U.S. since the IPO cancelled due to COVID-19.
Related Party Transactions (Listing Rule 4.7C.3)
Payments to related parties of $0.3 million included in Item 6 of the attached Appendix 4C Cash Flow Report was for salaries and fees paid to executive and non-executive directors during the quarter ended 31 December 2021.
-ENDS-
Authorised by the 4DMedical Board of Directors.
Contacts
Corporate | Investor | Media |
Charlene Stahr | Simon Hinsley | Matthew Wright |
Company Secretary | + 61 401 809 653 | + 61 451 896 420 |
companysecretary@4dmedical.com | shinsley@4dmedical.com | matt@nwrcommunications.com.au |
About 4DMedical |
Based in Melbourne, Australia and Los Angeles, U.S., 4DMedical Limited was founded in 2012 and is listed on the Australian Securities Exchange (ASX:4DX).
4DMedical is a medical technology company aiming to deliver the global gold standard in respiratory diagnostics for all lung disorders including: coronavirus, asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis and cancer. The unique 4DMedical technology accurately and quickly scans lung function as the patient breathes, to assist in providing sensitive, early diagnosis, and to monitor changes over time. Our Software-as-a-Service (SaaS) scans deliver much more complete results, showing even subtle variations in lung function down to the finest details, using lower levels of radiation than traditional methods.
Respiratory diagnostics is a US$31 billion per annum global industry. Through its technology, 4DMedical provides clinicians with greater insights into diseases of the lung. 4DMedical is focused on providing better information to doctors and patients about lung function. Better information means better decisions, and better outcomes.
©4DMedical Limited | 4 |
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Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Name of entity
4DMedical Limited | |
ABN | Quarter ended ("current quarter") |
31 161 684 831 | 31 December 2021 |
Consolidated statement of cash flows | Current quarter | Year to date | ||
$A'000 | (6 months) | |||
$A'000 | ||||
1. | Cash flows from operating activities | |||
1.1 | Receipts from customers | 149 | 149 | |
1.2 | Payments for | |||
(a) | research and development | (4,776) | (8,055) | |
(b) product manufacturing and operating | ||||
costs | (217) | (218) | ||
(c) | advertising and marketing | (610) | (943) | |
(d) | leased assets | (226) | (377) | |
(e) | staff costs | (2,708) | (5,073) | |
(f) administration and corporate costs | (1,509) | (3,604) | ||
1.3 | Dividends received (see note 3) | - | - | |
1.4 | Interest received | 25 | 55 | |
1.5 | Interest and other costs of finance paid | (18) | (38) | |
1.6 | Income taxes paid | - | - | |
1.7 | Government grants and tax incentives | - | - | |
1.8 | Other (provide details if material) | 28 | 11 | |
1.9 | Net cash used in operating activities | (9,862) | (18,093) | |
2. | Cash flows from investing activities | |||
2.1 | Payments to acquire or for: | |||
(a) | entities | - | - | |
(b) | businesses | - | - | |
(c) property, plant and equipment | (1,874) | (2,142) | ||
(d) | investments | - | - | |
(e) | intellectual property | - | - | |
(f) | other non-current assets | (28) | (65) |
ASX Listing Rules Appendix 4C (17/07/20) | Page 1 |
+ See chapter 19 of the ASX Listing Rules for defined terms. |
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4DMedical Ltd. published this content on 30 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 January 2022 22:00:02 UTC.