Slide 1: Aroa Biosurgery (ARX) | Half Year Report
Aroa Biosurgery (ARX) | Half Year Report UNLOCKING REGENERATIVE HEALING FOR EVERYBODY
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer This presentation (Presentation) is dated 26 November 2024 and has been prepared by solely on their own judgement, review and analysis when making an investment decision Aroa Biosurgery Ltd, New Zealand company number 1980577, ARBN 638 867 473 (AROA about AROA. or the
Slide 3: Unlocking Regenerative healing for everybody
Unlocking Regenerative healing for everybody. World-leading outcomes Unmatched value Widespread impact
Slide 4: AROA at a Glance
AROA at a Glance Well established high-growth soft tissue regeneration company Four product AROA ECM platform families for new products, line >US$3B1 TAM predominantly sold to extensions & enables AROA’s for existing products US hospitals tissue apposition platform US Direct (AROA) & Commercial part
Slide 5: AROA ECM – Structure & Biology for Regenerative Healing
AROA ECM – Structure & Biology for Regenerative Healing Unique Extracellular Matrix (ECM) derived from ovine forestomach with proven tissue regeneration properties across multiple products1-6 Optimal Ideal Complex Source Structure Biology Tissue 1. Irvine, S. M., et al. (2011). "Quantification of in
Slide 6: Substantial Growth Opportunities > $3B TAM
Substantial Growth Opportunities > $3B1 TAM Total Addressable Market Total Addressable Market > $1.8B USD 2 > $1.3B USD 3 e.g. Diabetic Foot Ulcers, Venous e.g. Trauma, tumour removal, general e.g. Hernia repair, abdominal Ulcers, Pressure Ulcers, chronic wounds surgery, inflammatory skin disease de
Slide 7: Myriad
Myriad Clinical need VOLUMETRIC FILL VITAL PROTECTION PERSISTENCE Rapidly fill large Cover and protect vital Despite contamination defects structures1-3, 5 and inflammation.1-5, 7 Forms robust functional tissue. 1-4 1. Cormican, M. T., N. J. Creel, B. A. Bosque, S. G. Dowling, P. P. Rideout and W. M
Slide 8: Volumetric Fill
Volumetric Fill Rapidly fill large defects with functional tissue Exposed Time to tissue Reference Type of Defects Defect Size Sample Size structures coverage/fill (weeks) Cormican et al.(1) Traumatic Yes 217.3 ± 77.9 cm2 13 3.3 ±1.3 Taarea et al.(2) Open abdomen Yes 147 ± 62.7 cm2 3 3.5 ±1.3 Bosque
Slide 9: Vital Protection
Vital Protection Cover and protect vital structures Time to tissue Reference Type of Defects Exposed structures Sample Size coverage/fill (weeks) • Tendon Cormican et al.(1) Traumatic • Bone 13 3.3 ±1.3 • Viscera Taarea et al.(2) Open abdomen • Fascia 3 3.5 ±1.3 • Tendon Bosque et al.(3) Lower extre
Slide 10: Persistence
Persistence Despite contamination and inflammation Reference Type of Defects CDC Contamination Score Sample Size Infection Rate Cormican et al.(1) Traumatic Grade II & III 13 0% Taarea et al.(2) Open abdomen Grade II 3 0% Bosque et al.(3) Lower extremity Grade IV 50 0% Chaffin et al.(4) Pilonidal Gr
Slide 11: How does Myriad Compare?
How does Myriad Compare? Publications Number of Publications Reported Number of Published Reported Reference Product class Reporting Reported Reporting Graft Publications Patients Infection Range Infection Infections Graft Loss Loss Range Biologic – 1/159 Myriad 11 159 1 (9%) 0% to 11% 0 (0%) 0% ext
Slide 12: Myriad
Myriad Simplifies surgical soft tissue reconstruction 1 COMPLETE TISSUE FEWER SINGLE COVERAGE WITHIN COMPLICATIONS APPLICATION 4 WEEKS No graft loss and low infection A median of one 100% coverage and fill incidence even in highly application to achieve in 23-30 days.1-3 contaminated defects.1-11 cl
Slide 13: FY25 H1 Financial Results
FY25 H1 Financial Results1 NZ$39.2m 87% Total Revenue Product Gross Margin CC2 Total Revenue - $37.4m CC2 Product Gross Margin – 86% (NZ$1.5m) ~NZ$21.6m Normalised EBITDA3 CC2 Normalised EBITDA - $2.0m Cash Balance 1. Results are presented on a reported basis unless otherwise specified. 2. Constant
Slide 14: Myriad Sales
Myriad Sales 01 16 45% Top priority 14 PcP Growth 02 Momentum 12 03 Large volumetric defects 10 04 Compelling clinical data US$m 8 05 Disruptive Value 6 MYRIAD 4 US$ 14M FY'24 2 TOTAL ADDRESSABLE 0 MARKET FY21 FY22 FY23 FY24 FY25 H1 US$ 730M
Slide 15: TELA Bio Sales
TELA Bio Sales 01 70 19% Key partnership Hernia & breast reconstruction 60 PcP Growth 02 portfolio 50 03 Momentum 40 04 Compelling clinical data US$m 30 05 Disruptive value 20 OVITEX US$ 63M FY'24 10 TOTAL ADDRESSABLE 0 MARKET FY21 FY22 FY23 FY24 FY25 H1 US$ 1.9B
Slide 16: TELA Bio Sales & Inventory
TELA Bio Sales & Inventory % of revenue US$m $80 100% 90% $70 80% $60 70% $50 60% $40 50% 40% $30 30% $20 20% $10 10% $0 0% FY21 FY22 FY23 FY24 H1 FY25 (annualised) Financial Year1 TelaBio Inventory TelaBio Sales Aroa Sales to TelaBio TelaBio Inventory TelaBio Inventory % of Revenue 1. Reference to
Slide 17: FY25 Guidance
FY25 Guidance1 NZ$80-87m NZ$2-6m Total Revenue Normalised EBITDA (YoY CC growth 21 – 32%) 1. All guidance is presented on a constant currency basis using a NZ$/US$ exchange rate of 0.64. Constant currency removes the impact of exchange rate movements. Guidance is subject to TELA Bio delivering on it
Slide 18: H2 FY25 – Revenue growth & profitability
H2 FY251 – Revenue growth & profitability H1 FY25 H2 FY25 FY25 Actual (CC) Forecast (CC) Guidance Outlook for H2 FY25 • Myriad to continue momentum NZ$37m NZ$43-50m NZ$80-87m • Ovitex and Ovitex PRS continue Total Revenue Total Revenue Total Revenue to align with TELA Bio’s sales trajectory 86% 86%
Slide 19: FY25 Catalysts & Milestones
FY25 Catalysts & Milestones AROA sales Myriad trauma & TELA Bio sales momentum limb salvage evidence momentum Myriad is the major growth driver. Supports Myriad efficacy Sales team expansion, clinical and cost savings evidence, increasing adoption Symphony Enivo FDA clearance Completion of RCT and P
Slide 20: Questions & Answers
AROA BIOSURGERY Questions & Answers
Slide 21: WARNING
WARNING The following slides include sensitive medical images. Viewer discretion is advised.
Slide 22: Myriad Morcells and Myriad Matrix Application in Chronic Venous Leg Ulcer
Myriad Morcells and Myriad Matrix Application in Chronic Venous Leg Ulcer Anthony J. LaLama, DPM Podiatric Surgeon – Premier Foot & Ankle Ascension Providence Hospital – Southfield, MI For educational purposes only
Slide 23: Initial Assessment
23 Initial Assessment Initial Assessment • 47-Year-old, male • Medical History: Venous insufficiency, hypertension • Description: Full thickness, painful venous leg ulcer of the right lateral leg • Wound Age: 2 years • Prior failed treatments included amnion grafts, skin substitutes/CTPs, compressio
Slide 24: Procedure
24 Procedure Week 0 Intra-Operative • Sharp, excisional debridement • Applied Myriad Morcells (500 mg) to wound bed, then applied Myriad Matrix (10 x 10 cm, 3-layer), rehydrated in sterile saline • Secondary dressing: Non-adherent contact layer, hydrofiber dressing, and Unna boot For educational pur
Slide 25: Follow-up
25 Follow-up Week 4 Week 4 • Pain significantly improved • Noted budding of granulation tissue • Residual Myriad noted in wound bed • No complications Continue with compression and absorbent secondary dressing changed daily or when saturated For educational purposes only
Slide 26: Follow-up
26 Follow-up Week 5 Week 5 • Pain continued to improve • Continued budding of viable granulation tissue • No complications Plan to epithelialize via secondary intention. Continue with compression and absorbent secondary dressing changed daily or when saturated For educational purposes only
Slide 27: Follow-up
27 Follow-up Week 7 Week 7 • Minimal discomfort reported • Approximately 80% epithelialized • Significant decrease in drainage • No complications For educational purposes only
Slide 28: Follow-up
28 Follow-up Week 8 Week 8 • Pain resolved • Approximately 85% epithelialized • Minimal drainage and no complications For educational purposes only
Slide 29: Follow-up
29 Follow-up Week 10 Week 10 • Approximately 90% epithelialized • Minimal drainage • No complications • Continue with compression and absorbent secondary dressing changed daily For educational purposes only
Slide 30: Follow-up
30 Follow-up Week 11 Week 11 • Approximately 95% epithelialized with one small area unhealed (arrow) • Minimal drainage and no complications For educational purposes only
Slide 31: Follow-up
31 Follow-up Week 16 Week 16 • Pliable tissue with good pigmentation • No complications • No recurrence Single application of Myriad For educational purposes only
Slide 32: Myriad Application in a Chronic Venous Leg Ulcer
32 Myriad Application in a Chronic Venous Leg Ulcer Anthony J. LaLama. Podiatric Surgery, Ascension Providence Hospital – Southfield, MI Week 0 Week 5 Week 11 4 Months Results may vary. Dr. LaLama has a consultancy agreement with Aroa Biosurgery. AROA, Aroa Biosurgery, Aroa ECM, Myriad, Myriad Matri
Slide 33: Myriad Morcells and Myriad Matrix Application in a Chronic Lower Extremity Wound
Myriad Morcells and Myriad Matrix Application in a Chronic Lower Extremity Wound Anthony J. LaLama, DPM Podiatric Surgeon – Premier Foot & Ankle Ascension Providence Hospital – Southfield, MI For educational purposes only
Slide 34: Initial Assessment
34 Initial Assessment Initial Defect • 40-Year-old, male • Medical History: Uncontrolled diabetes, peripheral vascular disease, history of prior amputation • Description: Full thickness ulcer of the right lateral foot, with exposed tendon and bone due to spontaneous varus deformity • Wound Age: 9 ye
Slide 35: Procedure
35 Procedure Week 0 Myriad Morcells Application Myriad Matrix Application • Applied Myriad Morcells (500 mg) to wound bed hydrated with saline, then applied Myriad Matrix (10x10 cm, 5-layer), hydrated in saline, secured with staples • Secondary dressing: contact layer, antibacterial foam, gauze wrap
Slide 36: Follow-up
36 Follow-up Week 3 Week 3 • Noted budding of granulation tissue • Myriad integrating well into wound bed • No complications For educational purposes only
Slide 37: Follow-up
37 Follow-up Week 10 Week 10 • Vascular, granular neodermis formed and Myriad fully integrated into the wound bed • Evidence of epithelialization • No complications Continue to close via secondary intention For educational purposes only
Slide 38: Follow-up
38 Follow-up Week 14 Week 14 • Near full epithelialization • No complications For educational purposes only
Slide 39: Myriad Application in Chronic Lower Extremity Wound
39 Myriad Application in Chronic Lower Extremity Wound Anthony J. LaLama. Podiatric Surgery, Ascension Providence Hospital – Southfield, MI Week 0 Week 3 Week 10 Week 14 Results may vary. Dr. LaLama has a consultancy agreement with Aroa Biosurgery. AROA, Aroa Biosurgery, Aroa ECM, Myriad, Myriad Mat
Slide 40: Wagner DFU of the Heel
Wagner 2 DFU of the Heel Anthony J. LaLama, DPM Medical Director, Amputation Prevention Center Ascension Providence Hospital Residency Director, Ascension Providence Hospital, Southfield, MI, USA For educational purposes only
Slide 41: Initial Examination
41 Initial Examination Week 0 • 56-Year-old, female • Medical History: Uncontrolled diabetes mellitus, history of Charcot arthropathy, and hypertension • Wound: Wagner 2 DFU of the plantar heel persisting for 6 months of conservative care prior to presentation • Measurement: ~3 cm x 3 cm For educati
Slide 42: Symphony Application
42 Symphony Application Day 0 Symphony Application • Plan: Sharp debridement with bedside application of Symphony (5 x 5 cm), hydrated with saline, trimmed to size, and secured with Steri-Strips® • Dressed with gentian violet/methylene blue foam dressing and hypochlorous acid solution • Heel offload
Slide 43: Follow-up
43 Follow-up Day 4 Day 4 • Symphony well-adhered and integrating • Continue to offload For educational purposes only
Slide 44: Follow-up
44 Follow-up Week 2 Week 2 • Symphony integrated completely • Notable reduction in area (1.0 x 1.0 cm) • Continue to offload For educational purposes only
Slide 45: Follow-up
45 Follow-up Week 3 Week 3 • Further reduction in area noted (0.8 x 0.5 cm) • Sharp debridement performed • Continue to offload For educational purposes only
Slide 46: Follow-up
46 Follow-up Week 5 Week 5 • Wound area reduced significantly (0.2 x 0.2 cm) • Sharp debridement performed • Continue to offload For educational purposes only
Slide 47: Follow-up
47 Follow-up Week 6 Week 6 • Near full epithelialization (0.1 x 0.1 cm) • Sharp debridement performed • Continue to offload For educational purposes only
Slide 48: Long-term Follow-up
48 Long-term Follow-up Long-term Follow-up (5 Months) • Epithelialized by week 7 (not pictured) • Site remains epithelialized after 5 months • Patient able to ambulate with offloaded shoe • No complications One application of Symphony in HOPD setting For educational purposes only
Slide 49: Symphony in DFU of the Heel
49 Symphony in DFU of the Heel Anthony J. LaLama, DPM. Podiatric Surgery, Ascension Providence Hospital – Southfield, MI, USA Initial Defect Symphony Applied Week 2 Week 3 Week 6 Long-Term (5 Months) Results may vary. Dr. LaLama has a consultancy agreement with Aroa Biosurgery Limited. AROA, Aroa Bi
Slide 50: Myriad
Myriad Clinical need VOLUMETRIC FILL VITAL PROTECTION PERSISTENCE Rapidly fill large Cover and protect vital Despite contamination defects structures1-3, 5 and inflammation.1-5, 7 Forms robust functional tissue. 1-4 1. Cormican, M. T., N. J. Creel, B. A. Bosque, S. G. Dowling, P. P. Rideout and W. M
Slide 51: Questions & Answers
51 AROA BIOSURGERY Questions & Answers For educational purposes only
Slide 52: Thank you for attending
Thank you for attending JAMES AGNEW investor@aroa.com VISIT www.aroa.com www.linkedin.com/company /aroa-biosurgery-limited/ 64 Richard Pearse Drive, Auckland 2022, New Zealand PO Box 107111, Auckland Airport, Auckland 2150, New Zealand