Akero(AKRO)2025-02-28 12:30Financial Performance - The company reported net losses of $252.1 million, $151.8 million, and $112.0 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $826.2 million as of December 31, 2024[528]. - The net loss for the year ended December 31, 2024, was $252.1 million, compared to a net loss of $151.8 million in 2023, reflecting a 66% increase in losses[545]. - The comprehensive loss for 2024 was $251,382,000, compared to $151,526,000 in 2023, representing a 65.9% increase[610]. - The company's accumulated deficit grew to $826,156,000 in 2024, compared to $574,096,000 in 2023, an increase of 44.0%[608]. - The company has not generated any revenue since inception and does not expect to do so in the near future[533]. Capital and Funding - The company has raised capital through various means, including a $25.0 million equity investment from Pfizer, Inc. in 2022 and a $35.0 million term loan from Hercules Capital, Inc.[528]. - The company raised gross proceeds of $127.4 million in 2023 and $80.3 million in 2024 through common stock offerings, with an additional $402.5 million raised in January 2025[557]. - The company raised $344.84 million from a follow-on public offering in 2024, compared to $216.20 million in 2023[617]. - The company anticipates requiring additional funding to complete the clinical development and commercialization of EFX, pending regulatory approval[625]. - The company has outstanding borrowings of $35.0 million under a loan agreement with Hercules, with the potential to borrow an additional $30.0 million until June 15, 2025[569]. Research and Development - The Phase 3 SYNCHRONY program consists of three trials evaluating EFX for patients with compensated cirrhosis (F4) and pre-cirrhotic MASH (F2-F3), with enrollment for the trials beginning in Q4 2023[525][526]. - The company anticipates significant increases in research and development expenses as it advances EFX through later-stage clinical development[535]. - Research and development expenses rose to $247.5 million in 2024, up from $141.8 million in 2023, marking a 75% increase, primarily due to increased costs associated with the EFX program[546]. - The company expects substantial increases in research and development expenses to support ongoing clinical development activities for the EFX program[547]. - The company has entered into various agreements for research and development, with costs recorded as expenses as incurred[641]. Clinical Trials and Product Development - In the SYMMETRY Phase 2b trial, 39% of patients treated with 50mg EFX experienced reversal of cirrhosis at week 96, compared to 15% for the placebo group[522]. - In the HARMONY Phase 2b trial, response rates for ≥1 stage improvement in fibrosis at week 96 were 75% for the 50mg EFX group and 46% for the 28mg EFX group, compared to 24% for placebo[523]. - EFX has shown statistically significant fibrosis regression and MASH resolution in previous Phase 2b trials with over 300 patients treated for up to 96 weeks[619]. - The first clinical milestone payment of $7.5 million was made to Amgen in December 2023, related to the Phase 3 SYNCHRONY program[576]. - The company is focused on developing treatments for metabolic diseases, particularly metabolic dysfunction-associated steatohepatitis (MASH)[619]. Operating Expenses - For the year ended December 31, 2024, total operating expenses increased to $285.4 million from $172.9 million in 2023, representing a 65% increase[545]. - Cash used in operating activities for 2024 was $230.1 million, significantly higher than $145.4 million in 2023, indicating increased operational expenditures[560]. - General and administrative expenses increased to $37.9 million in 2024 from $31.1 million in 2023, a rise of 22% due to higher stock-based compensation and staffing costs[548]. - Stock-based compensation expense was $29.7 million for the year ended December 31, 2024, compared to $21.5 million in 2023, showing an increase in compensation costs[583]. Liquidity and Assets - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $797.8 million, with an additional $402.5 million raised from a public offering in January 2025[532]. - Cash, cash equivalents, and marketable securities totaled $797.8 million as of December 31, 2024, providing a strong liquidity position for future operations[558]. - Total current assets increased to $770,380,000 as of December 31, 2024, up from $559,962,000 in 2023, representing a 37.5% increase[608]. - Cash and cash equivalents increased to $340,238,000 in 2024 from $234,207,000 in 2023, reflecting a 45.2% growth[608]. - The total fair value of short-term and long-term marketable securities was $771,683 as of December 31, 2024, up from $541,965 in 2023[667]. Stock and Equity - The weighted-average number of shares used in computing net loss per common share increased to 67,136,772 in 2024 from 52,568,159 in 2023, a rise of 27.7%[610]. - The company issued 12.65 million shares in a follow-on offering in 2024, contributing to an increase in total shares outstanding to 72.38 million[617]. - The company has reserved 577,089 options under the 2018 Stock Option and Grant Plan and 6,983,360 options under the 2019 Stock Option and Incentive Plan as of December 31, 2024[697]. - The total intrinsic value of stock options outstanding as of December 31, 2024, was $46,487,000, up from $35,133,000 at the end of 2023[710]. - Stock-based compensation classified within research and development expense for 2024 was $11,294,000, compared to $7,579,000 in 2023[717]. Debt and Liabilities - The Company has a Loan Payable under a Loan Agreement with Hercules Capital, with amendments made on June 7, 2023, and February 28, 2024[648]. - The total principal outstanding loan payable is $35,000,000, with an end of term charge of $2,048,000, leading to a total of $37,048,000 including the end of term charge[681]. - The Company reported accrued external research and development expenses of $28,925 as of December 31, 2024, compared to $10,041 in 2023[670]. - The Term Loan bears interest at a variable rate of at least 7.65% and matures on March 1, 2027[673]. - The company has a contingent liability to issue warrants for up to an additional 211,137 shares of common stock under the Loan Agreement as of December 31, 2024[681].