Oncocyte(OCX) - 2024 Q4 - Annual Results

Financial Performance - Q4 2024 revenue reached $1.5 million in pharma services, with a full year revenue of $1.9 million[6] - Reported revenues of $1.5 million in Q4 2024 and $1.9 million for the full year, primarily from pharma services[5] - Net revenue for Q4 2024 was $1,486,000, compared to $314,000 in Q4 2023, representing a 373% increase[32] - Gross profit for Q4 2024 was $595,000, a significant improvement from a gross loss of $117,000 in Q4 2023[32] - Q4 2024 gross profit of $595,000, representing a 40% gross margin, with a full-year gross profit of $740,000 at a 39% gross margin[5] - The net loss for Q4 2024 was $33,511,000, compared to a net loss of $15,992,000 in Q4 2023, indicating a 109% increase in losses[32] - For the full year 2024, the consolidated GAAP loss from operations totaled $61.04 million, compared to $25.14 million in 2023[36] - The adjusted consolidated Non-GAAP loss from operations for the full year 2024 was $19.93 million, compared to $18.44 million in 2023[36] Operating Expenses - Operating expenses in Q4 2024 totaled $34.2 million, with a 12% sequential decrease and a 21% year-over-year increase when excluding non-cash items[5] - Full-year operating expenses grew from $25.5 million in 2023 to $61.8 million in 2024, primarily due to non-cash impairment losses[5] - Total operating expenses increased to $34,222,000 in Q4 2024 from $16,062,000 in Q4 2023, reflecting a 113% rise[32] - Research and development expenses decreased by 20% sequentially and 11% year-over-year to $2.3 million in Q4 2024[5] - Research and development expenses were $2,257,000 in Q4 2024, down from $2,547,000 in Q4 2023, a decrease of 11%[32] - Sales and marketing expenses increased to $1.2 million in Q4 2024 as the company commercializes research-use-only transplant test kits[5] - Sales and marketing expenses rose to $1,202,000 in Q4 2024, compared to $582,000 in Q4 2023, marking a 106% increase[32] Cash and Assets - Cash, cash equivalents, and restricted cash balance at the end of Q4 2024 was approximately $10.3 million[6] - The company reported a net cash increase of $5,273,000 in Q4 2024, contrasting with a decrease of $4,351,000 in Q4 2023[33] - Total assets decreased from $74.892 million in 2023 to $35.081 million in 2024, reflecting significant impairment charges[31] Strategic Developments - The GraftAssure research-use-only assay was launched in July 2024, capturing approximately 9% of German transplant volumes and 2% of U.S. transplant volumes within six months[15] - Medicare coverage for the VitaGraft Kidney assay expanded in January 2025, significantly reducing time to rejection diagnosis in patients with newly developed donor-specific antibodies[16] - The company expects to submit its kitted product technology to the FDA by the end of 2025, with authorization anticipated in 2026[8] - Oncocyte aims to have at least 20 transplant centers signed up for its kitted clinical assay by the end of 2025, with each center representing potential annual revenue of several hundred thousand dollars to $2 million[24] - The company signed a strategic partnership with Bio-Rad Laboratories, which now holds approximately 9.66% of Oncocyte's outstanding shares[17] - The clinical trial for the kitted test is expected to be conducted at several leading U.S. transplant centers and a prominent research institution in Europe[4] - The company plans to have transplant centers running GraftAssure tests through the end of 2025 as part of its growth strategy[29] Technology and Product Development - Oncocyte's kitted test leverages digital PCR technology to measure donor-derived cell-free DNA, aiming to democratize access to transplant rejection testing[11] - The company anticipates meaningful revenue growth in transplant rejection testing after reaching the clinical in-vitro diagnostic stage of its product development[13] Impairment and Losses - Impairment losses significantly increased to $41.90 million in Q4 2024, up from a minimal loss in Q4 2023[36] - Change in fair value of contingent consideration showed a loss of $13.70 million in Q4 2024, contrasting with a gain of $11.19 million in Q4 2023[36] - The total impairment loss on held for sale assets was recorded at $169,000 for the full year 2024[36]