Slide 1: Future Proof Healthcare - Presentation Q3(23)
FUTURE PROOF HEALTHCARE A sustainable healthcare for a new generation Presentation Q3(23) Jonas Jarvius, CEO Christer Samuelsson, CFO/IR
Slide 2: Disclaimer
Disclaimer DISCLAIMER THIS PRESENTATION AND ITS CONTENTS ARE CONFIDENTIAL AND ARE NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH DISTRIBUTION IS
Slide 3: Q-linea 3rd quarter
Headquarters, Marketing and demo lab, Consumable production in Uppsala Q-linea 3rd quarter Q-linea is developing disruptive solutions for faster infectious disease diagnostics, first product targeting sepsis Introduction to the company Lead product ASTar® Implementation of new commercialisation stra
Slide 4: Time to actionable results is important
Time to actionable results is important Sepsis is the most common cause of death in our hospitals More common than lung + prostate + breast-cancer combined Accounts for approximate 30% of all deaths in the hospital Most expensive condition to treat in the US. >27B USD1) Time to correct treatment is
Slide 5: ASTar can provide up to 48 hours faster actionable results
Rapid AST & a broad antimicrobial panel matters: ASTar can provide up to 48 hours faster actionable results Transportation of blood culture from patient to laboratory: 1 – 24+ hours DAY 1 DAY 2 DAY 3 DAY 4 Plates are streaked CURRENT WORKFLOW Gram Susceptibility Patient to perform a Colony blood dra
Slide 6: Tentative market for rAST from blood cultures in 2025
Tentative market for rAST from blood cultures in 2025 If one assumes that rAST is important for patients with Sepsis Sepsis Positive blood cultures 1) Assume 20% eligible for If equally divided by selected2) 20 M testing with rAST 1) current rAST providers 4 M test 1 M test Key: Primary markets Othe
Slide 7: Updated commercialisation strategy – summary so far
Updated commercialisation strategy – summary so far During 2023, we have significantly increased commercial footprint in Europe and have started in the USA Goal is to demonstrate ASTar commercially & Enable a strong ramp-up in 2024 7 7 Source: Company information
Slide 8: 2023 goal is to set a foundation for successful 2024
2023 goal is to set a foundation for successful 2024 Focus on coverage in Europe, approval in USA and performing customer evaluations We see that the sales cycle is currently 9-15 months • Initial discussion of interest to evaluate ASTar • Evaluation 1 to 2 months • Analysis of workflow integration
Slide 9: ASTar performance is strong and it is easy to use
ASTar performance is strong and it is easy to use “Patients may currently be on empiric treatment for 48 hours “ASTar fits right into before we can change Evaluation of commercial systems for rapid antimicrobial our processes and that treatment. ASTar susceptibility testing (rAST) of positive blood
Slide 10: Evaluation of the performance of ASTar in a 24/7 laboratory
Evaluation of the performance of ASTar in a 24/7 laboratory Poster E0169 ECCMID 2023. Laboratoires de Bactériologie CHU Angers and Laboratoire HIFIH, Université d'Angers, France Relevance “The performance of this system is high, and could ASTar´s panel covered 96%1 of all organisms add value for ear
Slide 11: Evaluation of the performance of ASTar in a laboratory open 8 a.m.-18 p.m.
Evaluation of the performance of ASTar in a laboratory open 8 a.m. -18 p.m. Esse et al. Journal of Clinical Microbiology 10.1128/jcm.00549-23 Relevance “The use of ASTar significantly shortened the time ASTar´s panel covered 94%1 of all organisms from BC sampling to the delivery of the included in t
Slide 12: Evaluation of the performance of ASTar on patients from ITU and ED
Evaluation of the performance of ASTar on patients from ITU and ED Poster IBMS_2023 HHFT Goring et al1 Relevance “The ASTar system represents an exciting innovative platform “To complement categorial AST results the ASTar with potential for significantly decreasing the interval to assay also include
Slide 13: Evaluation of the performance of ASTar on patients from a Teaching hospital
Evaluation of the performance of ASTar on patients from a Teaching hospital Poster IBMS_2023 Monkhouse et al Relevance “Reduces MIC turnaround time by at least half”1 Expert rules and exceptional phenotypes are automatically applied 1 Performance 98 % Categorical Agreement with Standard of Care Work
Slide 14: Evaluation of ASTar in an endemic area for multi-drug resistant bacteria
Evaluation of ASTar in an endemic area for multi-drug resistant bacteria P0319_ECCMID 2023 Angelis et al Relevance “Based on these findings, ASTar may be a valid In the limited dataset, 4 out of 101 isolates had laboratory tool for rapid AST of BSI-causing Gram- beta-lactamase resistance mechanisms
Slide 15: Evaluation of rapid phenotypic AST methods for gram negative rods
Evaluation of rapid phenotypic AST methods for gram negative rods Oral presentation ECCMID 2023, Callebaut et al Relevance “Overall, ASTar® provides the microbiology Provide SIR interpretation and EUCAST expert rules automatically – as compared to RAST laboratories and physicians with a fast tool fo
Slide 16: 2023 goal is to set a foundation for successful 2024
2023 goal is to set a foundation for successful 2024 Focus on coverage in Europe, approval in USA and performing customer evaluations In summary • All ASTar evaluations has been positive • The value of rAST is clear • We have also seen value extending beyond correct and timely antibiotic treatment R
Slide 17: The US market is coming closer
The US market is coming closer We are in active discussions with FDA We submitted additional data for our US FDA 510k application in June • We have during end of the 3rd quarter and into 4th quarter been in regular and frequent discussions with FDA • We expect to submit our final 510k application du
Slide 18: Way forward for Podler
Way forward for Podler Several business opportunities are being evaluated During the 3rd quarter the discussions on way forward for Podler have intensified • We have received positive feedback from the US market • Trade shows • Direct customer discussions • Discussions with several strategic collabo
Slide 19: Financial highlights - third quarter
Financial highlights - third quarter • Successful rights issue --- SEK 263 million before transaction costs • Increase in number of shares from 29 537 947 to 117 166 372 • Lower costs thanks to cost saving program • Decision to scrap LTIP program 2023/26 19 19 Source: Company information.
Slide 20: Consolidated statement of profit and loss - third quarter
Consolidated statement of profit and loss - third quarter • Net sales amounted to SEK 3.0 million (2.9) – on par. • Operating result totalled SEK -48.2 million (-58.5) - improved. • The company reported a loss after tax of SEK -48.6 million (-59.0). • Earnings per share, before and after dilution am
Slide 21: Consolidated statement of financial position - end of third quarter
Consolidated statement of financial position - end of third quarter • Cash and cash equivalents amounted to SEK 54.9 million (72.9). • Short term investments SEK 80.0 million (0) • Inventories amounted to SEK 43.4 million (42.3). • Equity amounted to SEK 244.1 million (163.2) Figures in parentheses
Slide 22: Cash flow statement third quarter
Cash flow statement third quarter • Cash flow from operating activities SEK -54.5 million (-53.7). On par with last year, 10M better operating result off-set by payments related to cost saving program • Cash flow from investing activities SEK -79.5 million (64.6). Short term investments (bank risk)