Precigen, Inc. ((PGEN)) has held its Q3 earnings call. Read on for the main highlights of the call.
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In a recent earnings call, Precigen, Inc. expressed an optimistic outlook, driven by the transformative approval and rapid deployment of their new treatment, Papcemias. The company highlighted its strong financial positioning and manufacturing capabilities, despite increased expenses, and anticipates reaching cash flow breakeven by 2026.
FDA Approval of Papcemias
Papcemias has received full FDA approval, making it the first and only treatment available for recurrent respiratory papillomatosis (RRP) in adult patients. This broad label approval marks a significant milestone for Precigen, positioning them as a leader in this niche medical field.
Papcemias Clinical Efficacy
The clinical efficacy of Papcemias is notable, with 51% of patients achieving a complete response, eliminating the need for surgery for twelve months post-treatment. Additionally, 86% of patients experienced a reduction in their surgical burden, underscoring the treatment’s effectiveness.
Rapid Commercial Deployment
Precigen’s sales team has been swiftly deployed, engaging 90% of target institutions. The company has made significant strides in payer coverage, with over 80 million lives now covered, facilitating widespread access to Papcemias.
Strong Financial Position
The company expects its cash reserves, investments, and projected revenues from Papcemias to sustain operations until they reach cash flow breakeven by 2026. This financial strategy reflects confidence in their long-term growth prospects.
Manufacturing Capacity
Precigen boasts a dedicated in-house cGMP facility, which is fully operational and has passed FDA inspection for Papcemias drug substance manufacturing. This capability ensures a steady supply of the treatment to meet demand.
Increased Operating Expenses
The company reported a $14 million increase in SG&A costs, primarily due to commercialization efforts related to the Papcemias launch. This investment is seen as necessary for establishing a strong market presence.
Net Loss Attributable to Common Shareholders
Precigen ended the quarter with a net loss of $1.06 per share, influenced by significant non-cash items such as changes in warrant liability and a deemed dividend. This reflects the financial adjustments accompanying their strategic initiatives.
Forward-Looking Guidance
Precigen’s guidance highlights the promising future of Papcemias, with over 100 patients registered in their service hub and plans for pediatric trials and geographic expansion. The company remains focused on achieving cash flow breakeven by 2026, despite recent increases in SG&A costs.
In summary, Precigen’s earnings call conveyed a positive sentiment, emphasizing the transformative impact of Papcemias’ approval and deployment. The company’s strategic initiatives and strong financial positioning suggest a promising future, with expectations of achieving cash flow breakeven by 2026.