Adaptive Biotechnologies(ADPT) - 2022 Q4 - Annual Report

Revenue Growth - Revenue increased by 20% to $185.3 million in 2022, with double-digit percentage increases in both MRD and IM business areas[16] - IM Pharma Services revenue increased by 67% from 2021, with over 85 partners and more than 140 active studies utilizing immune receptor data[19] - The company aims for revenue growth at a compound annual growth rate of 20% to 30% through 2027[16] clonoSEQ Performance - clonoSEQ test volume grew by 51% to 36,871 tests delivered, with unique patients tested increasing by 53% to over 33,000[17] - clonoSEQ has received Medicare coverage for over 245 million covered lives for ALL and MM, over 190 million for CLL, and over 70 million for DLBCL[24] - clonoSEQ testing has been ordered for over 33,000 unique patients and is utilized by more than 60 biopharmaceutical companies in 187 active clinical trials, representing approximately 21% penetration in lymphoid cancers[24] Market Opportunities - The estimated global market opportunity for the immune medicine portfolio is approximately $49 billion, including $5 billion for MRD and $44 billion for IM[15] - The company aims to deepen penetration of clonoSEQ by increasing blood-based testing and expanding into new patient populations within NHL, starting with DLBCL[25] Financial Outlook - The company expects positive adjusted EBITDA by the end of 2025 and cash flow breakeven by the end of 2026[16] - The company has $498.2 million in cash, cash equivalents, and marketable securities as of December 31, 2022, with a goal of achieving positive adjusted EBITDA by the end of 2025[42] Partnerships and Collaborations - The partnership with Genentech has advanced TCR cellular therapies in oncology, with three TCR fully characterized data packages delivered[19] - The partnership with Genentech aims to develop TCR therapeutics for oncology, with progress made on both shared and personalized product pathways[41] - The company has transferred clonoSEQ technology to seven labs across multiple countries, including France, Germany, and Japan, to provide local testing options[66] Technology and Innovation - The clonoSEQ assay is the first and only MRD test to receive Medicare coverage for DLBCL patients[17] - The MIRA technology allows for the identification of TCRs specific to thousands of antigens simultaneously, significantly enhancing sensitivity compared to standard techniques[58] - The company has identified and characterized over 5,000 unique antigen-specific TCRs against 600 different clinically relevant targets, forming a pipeline of potential clinical candidates[60] Regulatory and Compliance - The company holds necessary federal and state licenses, including CLIA certification, to operate clinical laboratories[136] - The company must comply with various federal, state, and local regulations regarding the handling and disposal of medical waste, which adds complexity to operations[148] - The company’s compliance program is designed to prevent and detect violations of law, incorporating principles from the AdvaMed Code of Ethics and HHS OIG guidelines[154] Employee and Corporate Culture - The entrepreneurial and data-driven corporate culture includes a team of 147 professionals with medical or doctoral degrees, enhancing the company's capabilities in drug discovery and commercialization[45] - As of December 31, 2022, the company had 790 full-time employees, with 147 holding medical or doctoral degrees[99] Intellectual Property - The company has filed 799 patent applications, with 470 issued, covering improvements in sequencing methods and adaptive immune receptor applications[44] - The intellectual property portfolio includes 799 patent applications filed worldwide since 2009 and 429 issued patents across the immune medicine platform[113] Clinical Trials and Studies - A retrospective cohort analysis showed that MRD status influenced treatment decisions for 67 out of 400 newly diagnosed myeloma patients, indicating the potential for MRD to modify treatment[27] - The Watch Registry, a clinical registry launched in 2020, aims to enroll approximately 500 patients with lymphoid malignancies, with over 400 patients enrolled to date[66] Financial Agreements - The company received a $300 million upfront payment from Genentech and may receive up to $1.8 billion in total, including milestone payments[104] - Under the Revenue Interest Purchase Agreement, the company received $124.4 million in September 2022 and may receive up to an additional $125 million by September 2025[108]