Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) Q3 2023 Earnings Call Transcript

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Turning to Fanapt. Fanapt net product sales of $68.3 million for the first 9 months of 2023 reflect a 3% decrease compared to $70.3 million for the same period in 2022. For the first 9 months of 2023, Vanda recorded net income of $4.9 million compared to a net loss of $0.6 million for the same period in 2022. Net income for the first 9 months of 2023 included an income tax provision of $3.1 million as compared to an income tax provision of $2.3 million for the same period in 2022. Operating expenses for the first 9 months of 2023 were $154.2 million compared to $190.2 million for the same period in 2022. The $36 million decrease was primarily driven by lower R&D expenses, lower SG&A expenses and lower cost of goods sold. The decrease in R&D expenses was primarily driven by decreases related to our late-stage clinical program for Fanapt and our VQW-765 development program, partially offset by increases related to our tradipitant activities and our early-stage ASO program.

The decrease in SG&A expenses was primarily driven by lower expenses associated with marketing, sales and commercial support activities for our commercial products. The lower cost of goods sold is due to lower HETLIOZ net product sales and the decrease in the royalty rate owed to BMS on HETLIOZ net product sales from 10% to 5% effective in December 2022. Vanda’s cash, cash equivalents and marketable securities referred to as cash as of September 30, 2023, was $489.9 million representing an increase of $35.1 million to cash compared to September 30, 2022, and an increase of $23 million compared to December 31, 2022. Turning now to our quarterly results. Total revenues for the third quarter of 2023 were $38.8 million, a 41% decrease compared to $65.3 million for the third quarter of 2022.

HETLIOZ net product sales were $17.5 million for the third quarter of 2023, a 58% decrease compared to $41.3 million in the third quarter of 2022. The at-risk launch of a generic version of HETLIOZ continued to have a significant impact on HETLIOZ performance during the third quarter of 2023. The decrease in net product sales was attributable to a decrease in volume. Our HETLIOZ net product sales as reported for the first quarter of 2023 reflected higher unit sales as compared to recent periods. The higher unit sales during the first quarter of 2023 resulted in a significant increase of inventory stocking at specialty pharmacy customers throughout 2023. HETLIOZ net product sales during the third quarter of 2023 reflect lower unit sales, which was partially attributable to the continued reduction of the elevated inventory levels at specialty pharmacy customers at the end of the first quarter of 2023.

Turning now to Fanapt. Fanapt net product sales were $21.3 million for the third quarter of 2023, an 11% decrease compared to $24 million in the third quarter of 2022. Fanapt net product sales in the third quarter of 2023 decreased by 11% as compared to $24.1 million in the second quarter of 2023. This decrease between the second and third quarters of 2023 was primarily attributable to destocking of Fanapt inventory at the wholesaler level and unfavorable gross to net adjustments during the period. Fanapt prescriptions in the third quarter of 2023, as reported by IQVIA Xponent decreased by approximately 4% compared to the second quarter of 2023. For the third quarter of 2023, Vanda recorded net income of $0.1 million compared to net income of $3.3 million for the third quarter of 2022.

Net income for the third quarter of 2023 included an income tax benefit of $0.3 million as compared to an income tax provision of $2.2 million for the same period in 2022. Operating expenses in the third quarter of 2023 were $44.8 million compared to $61.4 million in the third quarter of 2022. The $16.6 million decrease was primarily driven by lower R&D expenses related to our late-stage Fanapt development program and our early-stage ASO program, lower SG&A expenses related to spending on marketing and sales activities for our commercial products, and lower cost of goods sold due to lower HETLIOZ net product sales and the decrease in the royalty rate owed to BMS on HETLIOZ net product sales from 10% to 5% effective in December 2022. Operating expenses in the third quarter of 2023 decreased by $4.1 million as compared to $48.9 million in the second quarter of 2023.

This decrease was primarily driven by lower SG&A expenses related to spending on sales activities for our commercial products. Given uncertainties surrounding the U.S. market for HETLIOZ for the treatment of Non-24 as a result of the ongoing HETLIOZ patent litigation and the at-risk launch of a generic version of HETLIOZ, Vanda is unable to provide 2023 financial guidance at this time. Vanda will continue to evaluate its ability to provide financial guidance in future periods. HETLIOZ net product sales will likely decline in future periods, potentially significantly related to the at-risk launch of a generic version of HETLIOZ in the U.S. Additionally, the company constrained HETLIOZ net product sales for the first 9 months of 2023 to an amount not probable of significant revenue reversal.

As a result, HETLIOZ net product sales could experience variability in future periods as the remaining uncertainties associated with variable consideration are resolved. With that, I’ll now turn the call back to Mihales.

Dr. Mihael Polymeropoulos: Thank you very much, Kevin. At this point, we will be happy to answer your questions.

Operator:

Dr. Mihael Polymeropoulos: Thank you all for joining us in this third quarter 2023 call, and we’ll see you in future periods. Thank you.

Operator: This concludes today’s conference call. You may now disconnect.

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