Paul Schwichtenberg
Analyst · Scott Henry with ROTH Capital. You may proceed
Thank you, Dan. This afternoon, I will review the financial highlights from our fourth quarter of 2022. As in previous quarters, there are slides available on our website that summarize these results. Net product sales were $49.9 million for the fourth quarter of 2022, compared to net product sales of $32.2 million in the prior year quarter and $34.3 million last quarter. The increase in net sales versus the prior year quarter is primarily driven by INDOCIN and the addition of OTREXUP and SYMPAZAN, which more than offset the expected declines in Zipsor and SoluMatrix. Full year 2022 net product sales were $155.1 million versus $109.4 million in 2021, representing a 42% year-over-year increase. INDOCIN family net sales in the fourth quarter increased by $15.9 million over the prior year quarter, primarily due to a volume mix shift to more profitable channels and a return to normal customer inventory levels after a reduction in the prior quarter. Approximately $5 million of this increase was related to the inventory change. OTREXUP and SYMPAZAN combined net sales for the fourth quarter were $4.2 million. There were no sales for OTREXUP and SYMPAZAN in the prior year quarter, as these products were acquired in mid-December 2021 and October 2022, respectively. CAMBIA net sales of $7.3 million were flat to the prior year quarter, primarily due to lower volume partially offset by lower rebates due to a volume mix shift to more profitable channels. SPRIX net sales in the fourth quarter were $2.7 million reflecting an increase of $900,000 versus the prior year quarter due to higher volume partially offset by higher commercial rebates and discounts. Overall portfolio net sales were up 55% and versus the prior year quarter. Consistent with the prior quarter products of goods sold in the fourth quarter reflect lower cost due to product mix and improved margins on INDOCIN resulting in a gross margin as a percentage of product net sales of 87.9%. The 2022 full year gross margin was also 87.9% versus 85.5% in 2021. Our continued focus on profitability across the portfolio throughout 2022 has led to improved net sales and gross profit margins and was achieved through lower co-pay and consignment costs and a reduction in the shipment of free goods, which resulted in lower gross to net expenses and cost of goods sold, respectively. Adjusted EBITDA for the fourth quarter was $33.4 million compared to $21.4 million last quarter and $17.8 million in the prior year quarter. The year-over-year increase was driven by $17.7 million of additional product net sales and the resulting increase in gross profit, partially offset by higher selling general and administrative expenses due to increased sales and marketing expenses for Otrexup and Sympazan. Adjusted EBITDA margin reflected as a percentage of total revenue in the fourth quarter was 66.3% versus 53.5% in the prior year quarter. 2022 full year adjusted EBITDA was $101.6 million versus $48.8 million in 2021 reflecting an increase of 108%. The year-over-year increase was driven by higher net product sales primarily Indocinn and the addition of Otrexup and sympazan, improved gross margins and lower SG&A expenses. The fourth quarter non-GAAP adjusted earnings per share was $0.32 versus $0.22 in the prior quarter and $0.21 in the prior year quarter. 2022 full year non-GAAP adjusted earnings per share was $1.19. Please note that earnings per share is now calculated using diluted shares including the if-converted impact of the convertible notes as is required under GAAP. The full additional diluted share impact is 17.1 million shares in the fourth quarter. Adjusted selling, general and administrative expenses in the fourth quarter were $11.1 million compared to $9.3 million last quarter and $10.1 million in the prior year quarter. The increase versus the prior year quarter is primarily due to additional costs for both Sympazan and Otrexup along with personnel costs due to new headcount additions. 2022 full year adjusted SG&A expenses were $38.5 million versus $48.1 million in 2021. The year-over-year decrease is primarily due to a year-over-year change and onetime legal reserves and settlements and the cost savings from our non-personal -- commercial platform. Net income for the fourth quarter was $88.6 million compared to $4.2 million last quarter and $4.6 million in the prior year quarter. The fourth quarter net income was positively impacted by an $80.4 million tax benefit from the reversal of a valuation allowance against our deferred tax assets. This adjustment reflects the positive change in the company's financial performance, which now has been consistently generating positive net income and operating cash flows. In addition to the higher sales, gross profit and change in SG&A expenses previously mentioned net income also included $9.8 million of higher fair value expense for contingent consideration as a result of an increase in the long-term Indocin sales forecast. Fourth quarter net income also reflected $1.1 million of lower interest expense, resulting from our convertible debt refinancing, which reduced our cash interest rate to 6.5% from 13%. Net cash provided by operating activities as reported in the company's statement of cash flows for the fourth quarter was $26.7 million. For the full year, we've generated $78.6 million in cash flow from operations, an increase of $73.1 million versus the prior year. In addition to the improvements in profitability, we've increased accounts receivable collections, collected an income tax refund, reduced debt service and effectively manage working capital throughout the year. Ending cash on December 31, 2022 was $64.9 million, reflecting a slight increase of $100,000 versus the prior quarter, despite making $25 million in final purchase price payments for Otrexup and Sympazan. The convertible debt refinancing in August resulted in the elimination of debt principal payments, resulting in $4.8 million of cash flow benefit in the fourth quarter versus the prior year quarter. On December 31, 2022, our long-term debt balance was $66 million, reflecting the $70 million convertible debt balance, less unamortized debt issuance costs of $4 million. On February 23, 2023, Assertio entered into exchange agreements, pursuant to which Assertio exchanged $30 million aggregate principal amount of exchange notes for a combination of an aggregate of $10.5 million in cash and an aggregate of approximately seven million shares of its common stock in the transactions. This reduces the amount of convertible debt outstanding that can become senior indebtedness in the event the company seeks to finance any of its future business development transactions with secured debt. Assertio did not receive any cash proceeds from the issuance of the shares of its common stock. The transactions reduced Assertio's overall debt by 43% will save the company $2 million in annual interest payments, reduce the potential dilution from the exchange convertible notes by 4.6% and will be accretive to 2023 diluted EPS by $0.02. Lastly, our annual guidance for 2023 is as follows. Full year product net sales are expected to be $150 million to $160 million, and adjusted EBITDA is expected to be $85 million to $93 million. Since we are more than 60 days into the first quarter, we have good insight into the start of the year. Based on sales to-date, we anticipate product net sales in the first quarter to be $36 million to $38 million, reflecting typical seasonality due to patient co-pay and deductible resets on January 1 and the loss of Cambia exclusivity. In addition, OXAYDO has been out of supply for most of the first quarter, but we do expect supply to resume by the second quarter. The guidance for our full year 2023 reflects the following factors. For net product sales, Cambia loss of exclusivity on January 1, 2023; the addition of SYMPAZAN, which partially offsets the Cambia loss of exclusivity; Indocin net sales growth driven by new commercial and channel strategies, including higher net pricing on Indocin driven by a volume shift to more profitable channels, less the one-time customer inventory benefit of approximately $5 million in Q4, 2022 that returned inventories to normal levels. EBITDA guidance reflects the step-up in operating expenses versus 2022 related to Indocin clinical expenses and additional costs for Sympazan, Otrexup samples and the annualization of employee costs. This guidance does not include the effect of the potential acquisition of new portfolio assets as well as the potential benefit from the recently updated ASGE guidelines that Dan mentioned. It's worth noting that as a result of our commercial execution and strategic actions in 2022, our 2023 guidance reflects the opportunity to increase net sales over 2022 despite the loss of exclusivity on Cambia, which was our second largest product. Additionally, we will be utilizing our operating cash flow to fund business development opportunities and continued investment in Indocin, Sympazan and Otrexup to maximize the revenue potential for these products. Overall, we are once again incredibly pleased with the quarter and full year results, most notably our commercial execution and operating cash flow generation. Looking ahead, our 2023 strategies and goals are aimed at continuing Assertio's path to long-term sustainable growth. And now, I'll turn the call back over to Matt.