Neola Medical Ab · OMXSTO:NEOLA
Neola Medical Ab — Q3 2024 Earnings Presentation
27 slides from Neola Medical Ab's earnings presentation, Nov 6, 2024
Slide 1: Q3 2024
Q3 2024 Published November 6, 2024 ”As we advance to clinical validation, we are intensifying our preparations for the pivotal clinical study on preterm born babies in the U.S., a cornerstone in our forthcoming FDA application and journey toward securing approval for the U.S. market.” CEO Hanna Sjös
Slide 2: Neola Medical Presentation: CEO and CFO
Neola Medical Presentation, Hanna Sjöström David Folkesson CEO CFO Neola Medical since 2019 Neola Medical since 2024 2 Neola Medical Q3, 2024
Slide 3: Forward looking statements
Forward looking statements This presentation and our discussion include forward-looking statements regarding our business strategies, market opportunities, anticipated financial performance, product development, and other related topics. These statements involve inherent risks and uncertainties, inc
Slide 4: Founded in 2016 based on advanced research at Lund University
2016 10 2 2026 Founded in 2016 based HQ Ideon Gateway in Late-stage development Aiming for FDA on advanced research at Lund with 10 employees of class II medical device application for U.S. Lund University market launch in 2026 4 Neola Medical Q3, 2024
Slide 5: Instant detection of pulmonary complications for proactive care
Instant detection of pulmonary complications for proactive care, reduced morbidity and improved quality of life Neola Medical Q3, 2024
Slide 6: 1 in 10 babies are born preterm every year
1 in 10 babies are born preterm every year Early detection of pulmonary complications is key to avoid costly complications 1.1 million <5 years 1st cause 50 % Preterm born babies die Most common cause of Respiratory failure Of very and extremely every year death of children <5 leading cause of death
Slide 7: Current standard of care in need of new technology
Current standard of care in need of new technology Current monitoring methods are insufficient: Neola Medical’s monitoring method: - Only give snapshots of lung status - Continuous monitoring of lungs - Slow to show results - Fast to show results (below seconds) - Handling disturbs the infant - Safe
Slide 8: Great clinical support for Neola
Great clinical support for Neola® “I actually really love this as a neonatologist because a lot of what I see are either pneumothorax where a lung can collapse, and we don't notice it until the vital signs change. X-rays aren’t always that helpfully. So really understanding oxygenation as well as ho
Slide 9: Growing and non-cyclical market
Growing and non-cyclical market Neola Medical is well positioned to benefit from favourable market trends Global neonatal respiratory device market USD million 3,001 2,816 Growing number of patients 2,662 Increase in preterm births worldwide, leading to more children 2,534 developing RDS or other lu
Slide 10: Huge addressable market with one Neola per baby
Huge addressable market with one Neola® per baby France United Kingdom 57,000 2,547 53,887 Preterm NICU care 1,782 babies places Preterm NICU care babies places Germany United States 66,752 Preterm 2,140 NICU care babies places ▪ Focus market due to large number of newborns and the particularly high
Slide 11: Revenue streams
Revenue streams Include sales of device, disposables and service agreement One Neola® unit per baby/bed Daily change of disposable Service agreement revenue probes Neola Medical Source: BasedQ3, on2024 Pricing project findings by MCRA 2022 incl. field market research of 40 providers, 20 neonatologis
Slide 12: Unlocking Exponential Revenue Potential: Devices + high margin Disposables
Unlocking Exponential Revenue Potential: Neola® Devices + high margin Disposables Targeting a Total Addressable Market of 35,600 Beds (and Growing) in the U.S. Sales split year +3 Total addressable 35% market 65% 1 424 854 hospitals with 35 600 Main unit Disposables hospitals with NICU beds* NICUs*
Slide 13: 10 leading children's hospitals with Level III or IV NICUs
10 leading children’s hospitals with Level III or IV NICUs Target customers for market launch Top 10 target pilot hospitals Pittsburgh Cincinnati Logo Boston SF Philadelphia LA Washington, DC Columbus Houston Neola Medical Source: Q3, 2024 American Hospital Directory *based on available American Hos
Slide 14: Neola will bring financial value to customers
Neola® will bring financial value to customers in the form of avoided costs and reduced length-of-stay Reduced length of stay in the NICU Reduced number of blood gas samples and chest x-rays Reduced manual observation time for nurses Potential reimbursement via MS-DRG payments Neola Medical Source:
Slide 15: Commercialization strategy and plan
Commercialization strategy and plan Reaching Milestones that Drive Value Creation Pre -launch Launch Scale 2021-2024 2026-2027 2028 -> Neola Medical Q3, 2024
Slide 16: Focus 2024
Focus 2024 Preparations for 1 Clinical validation 2 FDA process 3 market launch in the U.S 16 Neola Medical Q3, 2024
Slide 17: Highlights Q1-Q2 2024
Highlights Q1-Q2 2024 Silver medal winner in Stanford Pediatric Device Consortium (PDC) Accelerator Pitch Competition 2024 Obtianed CB certificate, achieving milestone that meets partial regulatory requirements for FDA approval Concluded Human Factors Validation Study, instrumental for FDA market ap
Slide 18: Significant events Q3 2024: Entering clinical validation phase
Significant events Q3 2024 1. Entering clinical validation phase Announced first pivotal clinical study on preterm born babies in the U.S. Instrumental for securing market approval by the FDA in the U.S. Milestone in our mission to improve neonatal care and save lives 18 Neola Medical Q3, 2024
Slide 19: Significant events Q3 2024: Strengthened competitive position
Significant events Q3 2024 2. Strengthened competitive position Patent Grants in the U.S. and Europe Reinforcing the Protection of the Company’s Innovation Pipeline Safeguarding Market Leadership 19 Neola Medical Q3, 2024
Slide 20: Significant events Q3 2024: GASMAS technology lecture
Significant events Q3 2024 3. GASMAS technology lecture by U.S. key opinion leader U.S. professor recognizes importance of Neola® Prominent role at largest and most prestigious scientific gatherings outside the U.S. Network of global neonatal experts 20 Neola Medical Q3, 2024
Slide 21: Financial summary
Financial summary 21 Neola Medical Q3, 2024
Slide 22: Financials
Financials Third quarter, July-September 2024 Interim report, January-September 2024 Summary Summary Operating income: SEK 0k (0) Operating income: SEK 0k (0) Operating result: SEK -2 476k (-2 540) Operating result: SEK -8 055k (-7 482) The period’s cash flow: SEK -4 950k (-3 565) The period’s cash
Slide 23: About the share
About the share Share capital, shareholders and the share 2024-09-30 As of September 30th 2024 Neola Medical’s share capital was 5 010 751,19 SEK Number of Percentage of Percentage of Shareholders 2024-09-30 (Top 10) with a total of 70 150 234 shares. All shares are of the same type, have an equal s
Slide 24: Reaching Milestones that Drive Value Creation
Reaching Milestones that Drive Value Creation Scientific evidence Product Studies for FDA FDA application Neola® meets partial Positive clinical results Subsidiary in regulatory requirements from Irish independent the USA for FDA approval study of 100 newborns Clinical study on Technical verificatio
Slide 25: Financial calendar and contact
Financial calendar and contact 12 9 21 22 Feb 2025 April 2025 May 2025 Aug 2025 Year End Financial Annual report 2024 Q1 report 2025 and Annual Q2 report 2025 Statement 2024 General Assembly in Lund Financial reports Questions about the report is answered by: Financial reports are available at www.n
Slide 26: Investment highlights
Investment highlights 1 Large and growing addressable market 2 Great clinical need and demand 3 Attractive business model 4 Proven technology 5 Highly experienced team 26 Neola Medical Q3, 2024
Slide 27: LinkedIn I Facebook I Website
LinkedIn I Facebook I Website Neola Medical Q3, 2024