INGREZZA® (valbenazine) First Quarter Net Product Sales of $303 Million
INGREZZA® (valbenazine) 2022 Net Product Sales Guidance Reiterated at $1.25 - $1.35 Billion
SAN DIEGO, May 4, 2022 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the first quarter ended March 31, 2022 and reiterated financial guidance for 2022.
"INGREZZA's first quarter performance reflects the opportunity we have to help patients living with tardive dyskinesia (TD). We completed our salesforce expansion in April and we now have three dedicated teams across psychiatry, neurology, and long-term care who are focused on improving diagnosis and treatment rates for TD," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With a growing product in INGREZZA, several mid-to-late-stage clinical data read-outs this year and next, and a strong financial profile, Neurocrine Biosciences continues to establish our position as a leading neuroscience-focused company."
Financial Highlights
Three Months Ended March 31, | |||
(unaudited, in millions, except per share data) | 2022 | 2021 | |
Revenues: | |||
Product sales, net | $ 305.0 | $ 231.0 | |
Collaboration revenue | 5.6 | 5.6 | |
Total revenues | $ 310.6 | $ 236.6 | |
GAAP Research and Development (R&D) | $ 102.2 | $ 73.2 | |
Non-GAAP R&D | $ 89.7 | $ 58.2 | |
GAAP Selling, General and Administrative (SG&A) | $ 200.7 | $ 129.0 | |
Non-GAAP SG&A | $ 176.2 | $ 111.1 | |
GAAP net income | $ 13.9 | $ 32.1 | |
GAAP earnings per share – diluted | $ 0.14 | $ 0.33 | |
Non-GAAP net income | $ 29.7 | $ 48.8 | |
Non-GAAP earnings per share – diluted | $ 0.30 | $ 0.50 | |
(unaudited, in millions) | March 31, 2022 | December 31, 2021 | |
Total cash, cash equivalents and marketable securities | $ 1,205.9 | $ 1,272.0 | |
First Quarter INGREZZA Net Product Sales and Commercial Highlights:
- Net product sales were $303 million with total prescriptions (TRx) of approximately 57,600
- Net product sales and TRx grew 32% and 33%, respectively, vs. first quarter of 2021
- Improved levels of persistence and compliance for existing patients when compared to prior first quarters driven by strong commercial execution
- Record number of new patients
- In April 2022, salesforce expansion was completed establishing separate psychiatry, neurology, and long-term care teams
Financial Highlights:
- First quarter 2022 GAAP net income and diluted earnings per share of $14 million and $0.14, respectively, compared with $32 million and $0.33, respectively, for first quarter 2021
- First quarter 2022 non-GAAP net income and diluted earnings per share of $30 million and $0.30, respectively, compared with $49 million and $0.50, respectively, for first quarter 2021
- Differences in first quarter 2022 GAAP and non-GAAP financial results compared with first quarter 2021 driven by:
- Increased R&D expense in support of an expanded and advancing clinical portfolio
- Increased SG&A expense primarily due to ongoing commercial initiatives, including the TD Spotlight-branded direct-to-consumer INGREZZA advertising campaign which launched in May 2021 and deployment of the expanded salesforce in March 2022
- At March 31, 2022, the Company had cash, cash equivalents and marketable securities of $1.2 billion
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.
Recent Events:
- In March 2022, Mitsubishi Tanabe Pharma Corporation (MTPC) received Japanese Ministry of Health, Labour and Welfare approval for DYSVAL® (valbenazine) for the treatment of tardive dyskinesia in Japan. Under the terms of the license agreement, the Company is entitled to receive a milestone payment of $20 million upon MTPC's first commercial sale of DYSVAL in Japan, which is expected to occur in the second quarter of 2022.
- In April 2022, Neurocrine Biosciences presented Phase 3 data for the KINECT-HD study evaluating valbenazine for chorea associated with Huntington disease. In the study, valbenazine met the primary endpoint of significant (p