Core Insights - Idorsia Ltd reported significant financial improvements in Q1 2025, with net revenue reaching CHF 59 million, a substantial increase from CHF 10 million in Q1 2024, driven by strong sales of QUVIVIQ and a one-off exclusivity fee [4][6][11] - The company has streamlined its R&D organization and focused on its promising pipeline, which includes QUVIVIQ and TRYVIO, positioning itself for growth in 2025 [3][20] Financial Highlights - Q1 2025 net revenue was CHF 59 million, compared to CHF 10 million in Q1 2024, with QUVIVIQ product sales contributing CHF 25 million [4][6] - Operating income for Q1 2025 was CHF 67 million, up from CHF 31 million in Q1 2024, while net income increased to CHF 63 million from CHF 30 million [4][6][8] - Non-GAAP operating loss for Q1 2025 was CHF 17 million, a significant improvement from a loss of CHF 85 million in Q1 2024 [10][11] Product Performance - QUVIVIQ demonstrated strong performance with net sales of CHF 25 million in Q1 2025, and demand in Europe and Canada grew by 50% from Q4 2024 to Q1 2025 [5][31] - In France, QUVIVIQ's market share increased significantly, with a new-to-brand share growing from 1.1% in September 2024 to 9.3% in January 2025 [25] - TRYVIO received FDA approval and had its REMS requirement removed, allowing for broader distribution in retail pharmacies [3][38] Strategic Developments - Idorsia restructured its convertible bond debt and secured a CHF 150 million new money facility to alleviate short- to mid-term debt overhang [16][20] - The updated agreement with Viatris reduced Idorsia's development cost contributions and expanded territorial rights, enhancing financial flexibility [14][20] - The company aims for continued growth in 2025, projecting QUVIVIQ net sales of around CHF 110 million and a non-GAAP operating loss of approximately CHF 215 million [18][19] Research and Development - Idorsia is focusing its drug discovery efforts on fewer active projects, preparing some for out-licensing while developing others to the next inflection point [41][42] - Recent publications highlighted the efficacy of daridorexant in treating chronic insomnia and nocturia, supporting its market potential [44][45] Liquidity and Indebtedness - As of March 31, 2025, Idorsia's liquidity stood at CHF 51 million, down from CHF 106 million at the end of 2024 [21][22] - Total indebtedness remained stable at CHF 1.322 billion, with convertible loans and bonds unchanged [22][23]

Financial Data and Key Metrics Changes - The company has approximately $20 million in accounts receivable from COVID testing, with expectations to collect around $50 million through a collection agency [34][36] - The company sold the Cold-Eeze brand for $50 million and formalized manufacturing for $23 million, which helped clean up the balance sheet [21][22] - The company has undergone significant restructuring, reducing overhead and employee count, leading to a more efficient operation [54][56] Business Line Data and Key Metrics Changes - The company transitioned from COVID testing to focusing on its esophageal cancer test and other consumer products, indicating a shift in business strategy [12][58] - The esophageal cancer test is positioned as a breakthrough diagnostic tool, with plans for commercialization without incurring significant costs [60][64] - The company has shut down its Nebula Genomics laboratory due to high overhead and is now focusing on a direct-to-consumer model [51][89] Market Data and Key Metrics Changes - The company is exploring the sale of Nebula Genomics, which could provide significant liquidity and improve cash flow [45][126] - The market for esophageal cancer diagnostics is highlighted, with the company aiming to capture a share by offering a more accurate test compared to existing options [67][111] Company Strategy and Development Direction - The company aims to develop its assets methodically without incurring excessive costs or diluting shareholder value [64][86] - There is a focus on potential liquidity events, including the collection of accounts receivable and the sale of assets, to improve financial stability [23][48] - The company is exploring partnerships with larger diagnostic companies to enhance the commercialization of its esophageal cancer test [67][105] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about upcoming liquidity events that could significantly impact the stock price positively [37][134] - The company is committed to maintaining a lean operation while focusing on revenue growth and profitability [56][86] - Management emphasized the importance of not overspending on new initiatives, particularly in the current low stock price environment [64][86] Other Important Information - The company has a significant database from whole genome sequencing tests, which adds intrinsic value to its assets [127][128] - Management is considering acquiring a telehealth company to leverage marketing expertise and expand its service offerings [97] Q&A Session Summary Question: What is the projected timeline for securing CPT coding approval for the B Smart test? - The timeline can vary, but the company plans to explore multiple avenues for approval without significant expenditure [101][102] Question: Do you expect the cash pay diagnostic model for the B Smart test to generate significant revenue in the interim period before CPT approval? - It is viewed more as a trial period to get the product into GI offices and raise awareness [116] Question: You purchased Nebula and the rights to B Smart for just a few million dollars each. What is the potential you see in these assets that the sellers/marketplace does not? - The company invested significantly more than initially paid, enhancing the value of these assets through development and improved market strategies [120][122] Question: What is the possibility of a reverse split? - The company is optimistic about avoiding a reverse split by achieving significant liquidity events within the next nine months [134]

Financial Data and Key Metrics Changes - The company ended 2024 with just under $103 million in cash and cash equivalents, which is expected to support operations into the first half of 2026 [24] - Net revenues from XOLREMDI were reported at $1.4 million for the fourth quarter and $2.6 million for the full year 2024 [25] - R&D expenditures totaled $21.7 million for the fourth quarter and $81.6 million for the full year, while SG&A expenses were $15.1 million and $61.5 million respectively [25] - The net loss for the fourth quarter was $39.8 million, and for the full year, it was $37.5 million, reflecting a one-time sale of a priority review voucher for $105 million in May of the previous year [25][26] Business Line Data and Key Metrics Changes - XOLREMDI sales topped $2.5 million for the 7.5 months since its launch in mid-May 2024 [10] - The company has successfully engaged with top-tier immunologists and hematologists, which is expected to continue to increase patient finding and shorten the time to prescription [11] Market Data and Key Metrics Changes - The company has made significant progress in expanding the global reach of mavorixafor, with the EMA accepting the submitted MAA for review, potentially leading to approval as early as Q1 2026 [12] - The company entered into a partnership with Norgine for commercialization in Europe, Australia, and New Zealand, receiving EUR 28.5 million upfront and potential milestone payments of up to EUR 226 million [13] Company Strategy and Development Direction - The company aims to maximize the opportunity for mavorixafor in chronic neutropenia, which is viewed as a larger market opportunity [22] - A strategic restructuring is expected to decrease annual spending by about $30 million to $35 million, implemented to sharpen focus on chronic neutropenia [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the engagement with regulatory agencies, indicating a supportive environment for the trial design [32][34] - The company is focused on building awareness and education around WHIM syndrome and chronic neutropenia, with plans to pivot efforts towards the patient community [86] Other Important Information - The company has initiated a peer-to-peer speaker program to enhance physician education regarding WHIM syndrome [7] - The 4WARD trial for chronic neutropenia has been activated at about 90% of targeted sites worldwide, with expectations for full enrollment by Q3 or Q4 of this year [22] Q&A Session Summary Question: Regulatory conversation regarding ANC threshold - Management indicated that the FDA is supportive of the trial design focusing on moderate to severe patients, and the change in ANC threshold is not expected to impact trial pace [32][33] Question: Inventory and discounting trends - The company noted that inventory reflects stocking up in Q4, and there are no current trends in discounting as they have a tight distribution channel [43][49] Question: Patient numbers and price increase for XOLREMDI - Management did not disclose patient numbers but confirmed a 7% price increase for the new year [54][56] Question: Commercialization experiences since launch - The company has successfully engaged physicians and identified additional patients, with ongoing efforts to build demand through conferences and education [70][71] Question: Expected patient numbers for WHIM and CN - Management reiterated the guidance of approximately 1,000 diagnosed WHIM patients in the U.S. and about 50,000 total chronic neutropenia patients, targeting the refractory severe end of that population [78]

As filed with the U.S. Securities and Exchange Commission on June 16, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 180 Life Sciences Corp. (Exact name of registrant as specified in its charter) Delaware 2834 90-1890354 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) Palo Alto, CA ...