Mirum(US:MIRM)2022-11-09 12:31Financial Performance - The net loss for the three months ended September 30, 2022, was $35.7 million, compared to $47.1 million for the same period in 2021, indicating a 24% improvement year-over-year[137] - The net loss for the three months ended September 30, 2022, was $35.7 million, a decrease of $11.4 million from a net loss of $47.1 million in the same period of 2021[174] - The net loss for the nine months ended September 30, 2022, was $99.2 million, a reduction of $42.3 million compared to a net loss of $141.5 million in the same period in 2021[185] Revenue and Sales - Total revenue for the three months ended September 30, 2022, was $18.8 million, an increase of $13.8 million from $5.0 million in the same period of 2021[174] - Livmarli product sales reached $18.8 million for the three months ended September 30, 2022, compared to zero in the same period of 2021[175] - Product sales, net were $47.2 million for the nine months ended September 30, 2022, compared to zero for the same period in 2021 due to the commercial launch of Livmarli[186] Expenses - Research and development expenses decreased to $26.2 million for the three months ended September 30, 2022, down $4.3 million from $30.5 million in the same period of 2021[178] - Selling, general and administrative expenses increased to $22.5 million for the three months ended September 30, 2022, up $5.2 million from $17.4 million in the same period of 2021[174] - Research and development expenses decreased to $75.7 million for the nine months ended September 30, 2022, down $27.9 million from $103.7 million in the same period of 2021[190] Cash and Investments - Cash, cash equivalents, restricted cash equivalents, and investments totaled $285.3 million as of September 30, 2022, compared to $261.5 million as of December 31, 2021[137] - As of September 30, 2022, the company reported cash, cash equivalents, and investments sufficient to fund operations for at least the next 12 months[201] - The company maintains significant cash reserves at a financial institution exceeding federally insured limits, exposing it to interest rate risk[222] Future Outlook - The company anticipates continued losses as it conducts ongoing clinical trials and commercial activities for Livmarli, with product sales expected to increase in the future[138] - The company expects to see increased product sales as it engages further with healthcare providers in the U.S. and globally[151] - The company anticipates continued net losses as it invests in research, product development, and market expansion for Livmarli[202] Clinical Trials and Product Development - The company reported positive topline data from the MARCH Phase 3 clinical trial for PFIC in October 2022, with further data expected from the EMBARK Phase 2b clinical trial in biliary atresia in the second half of 2023[130] - The company is developing volixibat for cholestatic liver diseases, with clinical trials showing significant activity on bile acid markers[131] Financing Activities - An underwritten public offering in August 2022 resulted in net proceeds of $86.1 million after deducting underwriting discounts and expenses[136] - The company issued and sold 1,160,915 shares of common stock during the nine months ended September 30, 2022, generating gross proceeds of $22.1 million[197] - Net cash provided by financing activities for the nine months ended September 30, 2022, was $109.4 million, primarily from a public offering and stock sales[217] Contractual Obligations and Risks - The company has contractual obligations related to license agreements that may result in future payments based on development and sales milestones[208] - The company has entered into the RIPA, with interest rate risk exposure linked to actual and forecasted net product sales, which may impact interest expense recognized each reporting period[223] - The company does not expect inflation to have a significant impact on its results of operations, despite ongoing geopolitical and macroeconomic events[225]