Financial Data and Key Metrics Changes - GAAP revenues for Q2 2024 were 10.2 million in Q2 2023, primarily due to a 287,000, compared to a gross profit of 4.2 million, or 5.8 million, or 18.9 million, providing a runway expected to satisfy operational requirements until at least the end of 2025 [16] Business Line Data and Key Metrics Changes - The breast implant program has progressed to testing 200 cc volume implants in preclinical studies, with the potential to address a 6.5 billion by 2033 [6][7] - The dermal filler product, co-developed with AbbVie, is in the clinical phase, with a milestone payment of 10 million received last year [9][14] Market Data and Key Metrics Changes - The dermal filler market experienced a recent slowdown but has shown signs of recovery, evidenced by merger and acquisition activity [10] - The breast implant market is currently underserved in terms of safety and performance, with existing materials posing risks such as immunogenicity [7] Company Strategy and Development Direction - The company aims to lead in regenerative medicine through innovative collagen technology, focusing on the development of regenerative breast implants and dermal fillers [12][35] - The company has released its first environmental, social, and governance (ESG) report, emphasizing its commitment to sustainability and health [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regenerative breast implant's potential to revolutionize aesthetic and reconstructive procedures, addressing safety concerns associated with current implants [6][8] - The company plans to advance the dermal filler program with AbbVie and generate additional safety and efficacy data for the breast implants [35] Other Important Information - The company is avoiding the use of growth factors in its scaffold technology to prevent regulatory complications, instead relying on collagen and other biomaterials [27] - The degradation of the scaffold is controlled through enzymatic degradation, hydrolysis, and oxidation, with a degradation time of six to twelve months [28] Q&A Session Summary Question: Differences between breast implants and dermal fillers - The breast implants are 3D bioprinted scaffolds that degrade and are replaced by naturally grown tissue, while dermal fillers require repeat injections and serve different purposes [18][19] Question: Key findings in the preclinical study for breast implants - The studies aim to optimize formulations, design, performance, safety, and efficacy, with a focus on fat tissue regeneration and implant degradation kinetics [21][22] Question: Next steps in the AbbVie collaboration - The dermal filler product is in clinical studies, with expectations of reaching commercialization milestones totaling 26 million, plus royalties upon approval [24] Question: Growth factors in the scaffold - The company does not use growth factors to avoid regulatory issues, relying instead on collagen's cell-binding properties to attract surrounding tissue cells [27] Question: Predictiveness of animal models - The company has developed a reliable animal model and a computational biomechanics discipline to predict scaffold behavior in humans, which will support FDA submissions [30]
CollPlant(CLGN) - 2024 Q2 - Earnings Call Transcript