Q-linea Ab · OMXSTO:QLINEA
Q-linea Ab — Q1 2024 Earnings Presentation
17 slides from Q-linea Ab's earnings presentation, May 31, 2024
Slide 1: Presentation Q1(24)
Sustainable healthcare for a new generation Presentation Q1(24) May 31, 2024
Slide 2: Key messages for today
Key messages for today FDA clearance in April has enabled full commercial activities in US 1 market and expanding opportunity pipeline Strong clinical results from Q-linea’s scientific partners were 2 presented at leading scientific conferences 3 Cost saving program successfully completed and will g
Slide 3: Q1 highlights: Progress against top priorities with breakthrough on FDA approval
Q1 highlights| Progress against top priorities with breakthrough on FDA approval Overall, solid progress on top priorities for first 90 days in-role as CEO • First commercial shipment of ASTar instrument (Italy) Commercial • Strong reception for initial clinical results presented at AMCLI and ECCMID
Slide 4: Live in the USA! FDA clearance for ASTar awarded on April 26, 2024
Live in the USA! | FDA clearance for ASTar awarded on April 26, 2024 Most comprehensive panel with 18 antibiotics and 12 microbial species; 7 – 11 two-fold dilutions per antibiotic ASTar v1 US menu The ASTar AST disc: 336 reaction wells in a 120 mm CD format. 10 different sectors Enables unparallele
Slide 5: ASTar: Revolutionizing AST
ASTar: Revolutionizing AST ~6 ~2 1st Hours Minutes Fully-automated, turn-around time Hands-on time random access platform ➢ Save lives ➢ Simple interface ➢ Comprehensive menu ➢ Save money ➢ Load-and-Go ➢ High reproducibility ➢ Reduced effort ➢ Minimal training need ➢ High throughput with 12 samples
Slide 6: Excellent and accurate data as evidenced from the US FDA Clinical Study
Excellent and accurate data as evidenced from the US FDA Clinical Study FDA and ISO requirements1,2) Essential agreement = Same MIC value as reference The ASTar® Instrument and ASTar® BC G- Kit offer the broadest combination of antimicrobials and dilution ranges in a single FDA ISO analysis for Gram
Slide 7: ~20m patients in US | ASTar optimized for labs covering >90% of PBCs
~20m patients in US | ASTar optimized for labs covering >90% of PBCs ASTar target market of 1,200 – 1,600 US hospitals & labs BC sets taken per hospital category (by discharges) in USA 4 500 50 000 46 679 4 170 Q-linea primary customers 4 000 Analyzing >90 % of blood cultures 45 000 Very large ASTar
Slide 8: ESCMID 2024: Q-linea stepped out with FDA announcement in Barcelona
ESCMID 2024 | Q-linea stepped out with FDA announcement in Barcelona • Largest microbiology conference globally • Rapid AST emerged as a theme with numerous clinical seminar sessions and scientific posters focused on the need and impact of rAST • Q-linea hosted poster sessions to highlight findings
Slide 9: Clinical evidence growing | Early results very strong, more studies coming
Clinical evidence growing | Early results very strong, more studies coming Q-linea sponsored studies generating strong initial results Preliminary LIFETIMES study results Presented at the AMCLI Congress (Mar 2024) and ESCMID (Apr 2024) 20-34 Faster time to optimized therapy hours of patients with 45
Slide 10: Commercial efforts | Accelerating in priority markets
Commercial efforts | Accelerating in priority markets Focus is on building and converting near-term pipeline; discussions with partners in ‘next wave’ markets ongoing Active in key geographies in Europe with high AST US commercial operations now fully active following need, either direct or using pa
Slide 11: Focused innovation | Prioritising expansion of ASTar capabilities in near-term
Focused innovation | Prioritising expansion of ASTar capabilities in near-term On-market Product 1 to 3 years 3 to 5 years ASTar® • Expanded panel Expansion • Expansion: Isolates BC G- other indications • Expansion: Urine CE-IVDR FDA Cleared Podler® EU/US clinical trials Commercial launch Extended c
Slide 12: Podler | Portable blood culture solution valued at SEK million
Podler | Portable blood culture solution valued at SEK 70 million Will seek 3rd-party financing to take Podler to next level of development Initiate incubation at point of collection • Bring the microbiology to the patients • Save >10 hours for blood culture results • Enable more streamlined workflo
Slide 13: Restructuring program | New organisation is live with full run-rate effect from July 2024
Restructuring program | New organisation is live with full run-rate effect from July 2024 Q-linea implemented a cost saving program during H1 2024 with ambition to reduce SEK 50 million of annual spend Program has been completed successfully with savings already being realised; full effect anticipat
Slide 14: Financial highlights | During (and after) first quarter
Financial highlights | During (and after) first quarter • Cost savings program inititiated in January, estimated savings amount to SEK 50 million annually, restructuring costs of SEK 5 million • Cost savings to have full effect as from Q3 2024 • Shift in spending from development to commercial, acce
Slide 15: Consolidated statement of profit and loss | First quarter
Consolidated statement of profit and loss | First quarter • Instrument sales and other operating income recorded, SEK 2.9 million (0) • Operating result SEK -55,9 million (-62,2) or -18.6M on average per month • Improvement thanks to cost saving program 2023 • The company reported a loss after tax o
Slide 16: Consolidated statement of financial position | End of first quarter
Consolidated statement of financial position | End of first quarter • Cash and cash equivalents amounted to SEK 29.3 million (81.9) • SEK 17.5 milion average monthly burn-rate • Remaining loan facility from main owner of SEK 41.5 million (41.5) • Total: SEK 70.8 million availale funds as of 31 March
Slide 17: Future financing
Future financing • As of 31 of March we have a total of SEK 70.8 million in available funds, whereof cash at bank 29.3M and 41.5M in an unutlized loan facility from main owner (SEK 15 million paid out May 13) • Additional loan facility of SEK 60 million offered from main owner Nexttobe (PR May 29),