| • | | Ended the fourth quarter with cash, cash equivalents, restricted cash and investments of $75.5 million. |
“We are very pleased with the progress made in 2021, particularly with respect to addressing items raised in the Complete Response Letter that we received from the FDA in late 2020,” stated John Tucker, chief executive officer of scPharmaceuticals. “With the completion of the additional device testing, which met all of our expectations, and the recent change to an alternate packaging vendor, we are on track to resubmit the FUROSCIX NDA in the first half of April and continue with our focused preparation for a potential commercial launch of FUROSCIX later this year.
“We believe that FUROSCIX, if approved, represents an important new option in the treatment of congestion related to heart failure. Further, the results of our FREEDOM-HF study offer compelling pharmacoeconomic and quality of life data. We believe we are well-funded and are optimistic that we will introduce this promising new therapy to the benefit of patients, payers and providers with the potential to generate significant health system cost savings.”
Fourth Quarter and Full Year 2021 Financial Results and Financial Guidance
scPharmaceuticals ended the fourth quarter 2021 with $75.5 million in cash, cash equivalents, restricted cash and investments, compared to $105.3 million as of December 31, 2020.
scPharmaceuticals reported a net loss of $7.3 million for the fourth quarter of 2021, compared to $7.8 million for the comparable period in 2020.
Research and development expenses were $4.5 million for the fourth quarter of 2021, compared to $3.7 million for the comparable period in 2020. The increase in research and development expenses for the quarter ended December 31, 2021 was primarily due to an increase in clinical study activity, employee-related costs and quality and regulatory consulting, offset by a decrease in device and pharmaceutical development costs.
General and administrative expenses were $2.2 million for the fourth quarter of 2021, compared to $3.4 million for the comparable period in 2020. The decrease in general and administrative expenses for the quarter ended December 31, 2021 was primarily due to a decrease in legal costs and costs related to commercial preparations.
scPharmaceuticals reported a net loss of $28.0 million for the year ended December 31, 2021, compared to $32.2 million for the comparable period in 2020.
Research and development expenses were $16.0 million for the year ended December 31, 2021, compared to $18.1 million for the comparable period in 2020. The decrease in research and development expenses for the year ended December 31, 2021 was primarily due to a decrease in device and pharmaceutical development activities, offset by clinical study activity and employee-related costs.
General and administrative expenses were $9.8 million for the year ended December 31, 2021, compared to $11.8 million for the comparable period in 2020. The decrease was primarily due to employee-related and professional service costs, including legal costs and costs related to commercial preparations. This decrease was offset by increases in public company costs, including costs related to directors and officers insurance.
Based on its current operating plan, the Company forecasts its 2022 net loss to be $43 to $48 million. As of December 31, 2021, scPharmaceuticals total shares outstanding was 27,366,707.