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01/11 04:07
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call summary indicates strong financial performance and optimistic guidance, particularly with the anticipated growth of INGREZZA and CRENESSITY. The Q&A section provides additional positive sentiment with high adoption rates and strategic sales force expansion. While there are concerns about unclear responses to regulatory issues, these are outweighed by the positive market strategy and product development outlook. The company's focus on R&D and potential new indications further support a positive sentiment. Overall, the positive aspects are likely to result in a stock price increase of 2% to 8% over the next two weeks.
Net Product Sales $790 million in net product sales, reflecting 28% year-over-year growth. Driven by continued progress both from CRENESSITY and INGREZZA.
CRENESSITY Sales CRENESSITY grew sequentially from $53 million in Q2 to $98 million in Q3, reflecting strong early adoption and persistency rates. 80% of dispensed prescriptions are now being reimbursed.
INGREZZA Sales Net sales of $687 million in Q3, with a third consecutive quarter of record new patient additions. Growth driven by improved access, sales force expansion, and double-digit TRx growth.
Combined Net Sales of INGREZZA and CRENESSITY Combined net sales of $785 million in Q3, reflecting strong performance and significant unmet need in their respective markets.
SG&A Expense Increase An SG&A expense increase of around $150 million in 2026 is anticipated due to expanded investment in both INGREZZA and CRENESSITY.
INGREZZA: Achieved record quarter for new patient starts and total prescriptions due to expanded sales force and improved patient access. Net sales reached $687 million in Q3, with a 28% year-over-year growth. Plans for further sales force expansion to accelerate TD market development and maximize patient share.
CRENESSITY: Strong launch with net sales growing from $53 million in Q2 to $98 million in Q3. Early adoption and persistency rates are strong, with 80% of prescriptions reimbursed. Over 1,600 patients initiated therapy since launch, with strong insurance coverage and affordability for patients.
TD Market: Significant unmet need remains, with only 10% of the estimated 800,000 TD patients currently treated. Sales force expansion aims to accelerate market development and strengthen position.
CAH Market: Estimated 20,000 patients in the U.S. with classic CAH. CRENESSITY is the first FDA-approved treatment for this condition, with strong adoption and insurance reimbursement.
Sales Force Expansion: Plans to expand sales teams for both INGREZZA and CRENESSITY to meet growing demand and support future product launches.
R&D Productivity: On track to meet goals of 4 new Phase I and 2 new Phase II study initiations in 2025. Advancing late-stage programs and early/mid-stage innovation.
Long-term Growth: Focused on sustained growth through investments in commercial assets, R&D, and sales force expansion. Preparing for anticipated launches of investigational psychiatric medicines in 2027.
Capital Allocation: Priorities include driving revenue growth, advancing R&D, enabling business development, and returning capital to shareholders. Over $2.1 billion in cash supports these initiatives.
Market Expansion Challenges: Despite the growth in the prescriber base for INGREZZA, only about half of the estimated 800,000 people with tardive dyskinesia have received a diagnosis, and only 10% are being treated with a VMAT2 inhibitor. This indicates a significant gap in market penetration and awareness.
Regulatory and Policy Risks: The company is navigating potential impacts of the Inflation Reduction Act, which could affect pricing and market dynamics for INGREZZA.
Sales Force Expansion Costs: The decision to expand sales teams for both INGREZZA and CRENESSITY will result in an SG&A expense increase of around $150 million in 2026, which could pressure financials if revenue growth does not meet expectations.
Clinical Development Risks: While the company is advancing multiple clinical programs, there is inherent risk in achieving successful outcomes in late-stage trials, particularly for osavampator in major depressive disorder and direclidine in schizophrenia.
New Market Development for CRENESSITY: As CRENESSITY is the first therapy for classic congenital adrenal hyperplasia (CAH), the company faces challenges in building a new market, including understanding prescriber behavior, patient dynamics, and potential seasonality trends.
Economic and Reimbursement Risks: Although CRENESSITY has strong reimbursement rates, any changes in payer policies or economic conditions could impact patient access and affordability.
Momentum for INGREZZA and CRENESSITY: Continued targeted investments in these commercial assets are expected to accelerate growth into 2026 and beyond.
Clinical Portfolio Progress: Phase III studies of osavampator in major depressive disorder and direclidine in schizophrenia are on track to meet enrollment objectives for the year. Four new Phase I study initiations and two new Phase II initiations are expected to be achieved this year.
Sales Force Expansion for INGREZZA: An additional sales force expansion is planned to accelerate the development of the tardive dyskinesia (TD) market through 2029, maximize patient share, and prepare for the anticipated launch of late-stage clinical programs in 2027.
Financial Guidance for 2026: SG&A expenses are expected to increase by approximately $150 million in 2026 due to expanded investments in INGREZZA and CRENESSITY.
CRENESSITY Market Growth: The company plans to expand the CRENESSITY sales team to support continued volume growth and capitalize on the favorable receptivity from the CAH community.
Upcoming Clinical Results: Top-line results for valbenazine in Dyskinetic Cerebral Palsy and the Phase II study of NBI-'770 in major depressive disorder are anticipated in Q4 2025.
R&D Day and Long-Term Vision: The company will provide greater detail on its long-term vision, including neuropsychiatry programs and next-generation clinical developments, during an upcoming R&D day.
Return capital to shareholders: Our capital allocation priority is to remain intact. Number one, drive revenue growth; number two, advance our R&D programs; number three, enable business development; and number four, return capital to shareholders.
The earnings call summary indicates strong financial performance and optimistic guidance, particularly with the anticipated growth of INGREZZA and CRENESSITY. The Q&A section provides additional positive sentiment with high adoption rates and strategic sales force expansion. While there are concerns about unclear responses to regulatory issues, these are outweighed by the positive market strategy and product development outlook. The company's focus on R&D and potential new indications further support a positive sentiment. Overall, the positive aspects are likely to result in a stock price increase of 2% to 8% over the next two weeks.
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