Yahoo Finance Achieve Life Sciences Inc Reports Year-End Loss, Progresses Towards FDA Approval
Net Loss: Reported a net loss of $29.8 million for the year ended December 31, 2023.
EPS: Basic and diluted net loss per share of $1.50, aligning with analyst estimates of -$1.47.
Research and Development: R&D expenses totaled $15.8 million for the year, reflecting ongoing investment in cytisinicline trials.
Equity Financing: Completed equity financing of up to $124.2 million, bolstering the company's financial position.
Cash Position: Pro forma cash, cash equivalents, and restricted cash of $71.8 million post-financing.
Shares Outstanding: As of March 28, 2024, Achieve had 34,251,911 shares outstanding.
Corporate Update: Achieve Life Sciences progresses towards NDA submission for cytisinicline with FDA agreement on study requirements.
Achieve Life Sciences Inc (NASDAQ:ACHV) released its 8-K filing on March 28, 2024, detailing its financial results for the fourth quarter and year-end 2023. The company, which is focused on the development and commercialization of cytisinicline for nicotine addiction, reported a net loss of $29.8 million for the year, with a basic and diluted net loss per share of $1.50. This performance aligns with the analyst estimates of an earnings per share (EPS) loss of -$1.47.
Achieve Life Sciences is a specialty pharmaceutical company committed to advancing cytisinicline as a treatment option to help people battling nicotine addiction. The company has one operating segment dedicated to the development and commercialization of cytisinicline for nicotine addiction, which is an established smoking cessation treatment approved and marketed in Central and Eastern Europe.
Financial Performance and Corporate Highlights
In the recent earnings release, Achieve Life Sciences highlighted several corporate achievements and challenges. The company reached an agreement with the U.S. Food and Drug Administration (FDA) on long-term cytisinicline exposure requirements to support a New Drug Application (NDA) submission. The planned submission is anticipated in the first half of 2025. Achieve also successfully completed an equity financing that could provide up to $124.2 million, which is expected to fund the company's development activities into 2026 and through potential FDA approval.
The importance of these achievements cannot be overstated for a biotechnology company like Achieve Life Sciences. The agreement with the FDA represents a significant step towards commercialization, and the successful financing provides the necessary capital to continue the development of cytisinicline. These milestones are crucial for a company that is yet to generate revenue and relies on the success of its lead product candidate.
Year-End Financial Results and Future Outlook
Achieve Life Sciences reported total operating expenses for the fourth quarter and year ended December 31, 2023, of $4.4 million and $27.3 million, respectively. Research and development expenses accounted for a significant portion of the operating expenses, indicative of the company's investment in the advancement of cytisinicline. The company's cash, cash equivalents, and restricted cash as of December 31, 2023, were $15.6 million. However, considering the February 2024 equity financing, the pro forma cash balance would have been $71.8 million.
John Bencich, Achieves CEO, provided insights into the company's progress, stating:
"2023 marked a significant turning point for Achieve as we accomplished several key milestones... We are appreciative of the strong support and confidence from our stakeholders, including new investors who participated in the recent financing and smoking cessation opinion leaders who share in our enthusiasm for cytisiniclines potential."
This commentary underscores the company's commitment to bringing cytisinicline to market and the confidence of its stakeholders in its potential success.
Looking ahead, Achieve is preparing to initiate the ORCA-OL open label exposure trial in the second quarter of 2024, which will include investigators and sites who have participated in the ORCA clinical trial program. This trial is a critical component of the company's path to NDA submission.
For more detailed financial data and insights into Achieve Life Sciences Inc's performance, visit GuruFocus.com, where we provide in-depth analysis and up-to-date information for value investors and potential members.
Explore the complete 8-K earnings release (here) from Achieve Life Sciences Inc for further details.
This article first appeared on GuruFocus.
