Company: BIVIW
Filing Date: 2025-02-11
Form Type: 10-Q
Source: 0001520138-25-000056
Chunk: 4

Company: BIOVIE INC.
Filing Date: 2025-02-11
Form: 10-Q
Item: Part I, Item 2
Chunk 4
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 the active agent, terlipressin, is approved
in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these
authorizations. Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in
annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The FDA has not approved any drug to treat refractory
ascites.

 23 

Table of Contents 

Comparison of the three months ended December 31, 2024 to the three
months ended December 31, 2023

Net loss

The net loss for the three months ended December 31,
2024 was approximately $7.1 million as compared to the net loss of $8.4 million for the three months ended December 31, 2023. The net
decrease of $1.3 million for the three months ended December 31, 2024 was comprised of a decrease in research and development expenses
of $1.8 million, offset by increased selling, general and administrative expenses of approximately $277,000 and a decrease in other income,
net of approximately $200,000.

Total operating expenses for the three months ended
December 31, 2024 were approximately $7.3 million as compared to $8.8 million for the three months ended December 31, 2023. The net
decrease of approximately $1.5 million for the three months ended December 31, 2024 was comprised of decreased research and development
expenses of approximately $1.8 million primarily due to the completion of clinical trials in the prior fiscal year, offset by a net increase
in selling general and administrative expenses of approximately $277,000.

Research and Development Expenses

Research and development (“R&D”) expenses
were approximately $4.7 million and $6.5 million for the three months ended December 31, 2024 and 2023, respectively. The $1.8 million
net decline was primarily attributed to the increase in direct cost related to the development and preparation of the new clinical studies
to be launched in the first calendar quarter of 2025 of $3.4 million; offset by the decline in cost of approximately $3.1 million from
completed studies; and other decreases in related expenses such as the clinical teams’ payroll of approximately $461,000, reflecting