
Revenue and Profit - Revenue for the year ended December 31, 2024 was $43.5 million, compared to $0 for the same period in 2023, reflecting the launch of DefenCath[210]. - Gross profit for the year ended December 31, 2024 was $40.3 million, with a cost of revenue of $3.2 million[209][211]. - For the year ended December 31, 2024, the company achieved revenue of $31.2 million in the fourth quarter, a significant increase compared to $11.5 million in the third quarter and $0.8 million in the second quarter[219]. - The company reported a net income of $12.9 million in the fourth quarter, contrasting with a net loss of $3.3 million in the third quarter and a loss of $15.3 million in the second quarter[219]. Expenses - Research and development expenses decreased by 70% to $3.9 million for the year ended December 31, 2024, down from $13.2 million in 2023[212]. - Selling and marketing expenses increased by 59% to $28.7 million for the year ended December 31, 2024, compared to $18.1 million in 2023[213]. - General and administrative expenses rose by 69% to $30.0 million for the year ended December 31, 2024, up from $17.7 million in 2023[214]. Losses - The loss from operations for the year ended December 31, 2024 was $22.4 million, a 54% decrease from the loss of $49.0 million in 2023[209]. - The net loss for the year ended December 31, 2024 was $17.9 million, a 61% decrease from the net loss of $46.3 million in 2023[209]. Product Information - DefenCath is the first and only FDA-approved antimicrobial catheter lock solution in the U.S., shown to reduce the risk of CRBSI by up to 71% in clinical studies[194]. - DefenCath received NTAP reimbursement of 75% of the wholesaler acquisition cost per hospital stay, with a potential maximum NTAP of $3,656.10[193]. - The company estimates that up to 100,000 HD-CVC placements occur each year, with pass-through status providing separate reimbursement under Medicare for DefenCath[197]. Cash Flow and Investments - The company generated net cash used in operating activities of $50.6 million for the year ended December 31, 2024, an increase of $12.2 million from $38.4 million in 2023[222]. - Net cash provided by investing activities was $21.2 million for the year ended December 31, 2024, compared to a net cash used of $17.1 million in 2023[223]. - The company had total cash, cash equivalents, and short-term investments of $51.7 million as of December 31, 2024, down from $76.0 million in 2023[225]. Future Expectations and Agreements - The company expects to continue funding operations through cash collections and capital raising sources, which may be dilutive to existing stockholders[226]. - A three-year agreement with Syneos Health Commercial Services was entered into in December 2024, committing the company to a minimum of $9.6 million for promoting DefenCath[230]. - The company anticipates payment of $2 million in net sales milestones in 2025 under the ND License Agreement with ND Partners, LLP[231]. - The company received $1.4 million from the sale of unused New Jersey net operating losses in March 2024, contributing to its tax benefit[221]. - The company has $30.2 million of common stock available for potential sale under the ATM program as of December 31, 2024[225].