3/11/2024

speaker
Unknown
Investor Relations Representative

Thank you, and good afternoon, everyone. Thank you for joining us today to discuss Assertio's fourth quarter and full year 2023 financials. The news release covering our results for this period is now available on the investor page of our website at investor.assertiotx.com. I would encourage you to review the release and the tables in conjunction with today's discussion. With me today are Heather Mason, interim CEO, A.J. Patel, chief financial officer, and Paul Schwichtenberg, Chief Commercial Officer. In just a moment, Heather will open the remarks and provide an overview of the business. Then AJ will cover our financial results and guidance, followed by Paul with an update on our commercial strategies. After that, we will take a few questions from our covering analysts. During this call, management will make projections and other forward-looking statements regarding our future performance. Such forward-looking statements are not guaranteed in the future performance It involved risks and uncertainties, including those noted in this afternoon's press release, as well as Assertio's findings with the SEC. These and other risks are more fully described in the risk factors section and other sections of our annual report on Form 10-K. Our actual results may differ from the forward-looking statements, and Assertio specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. And with that, I will now turn the call over to Heather.

speaker
Heather Mason
Interim CEO

Please go ahead. Welcome, everyone, to our fourth quarter results, and thank you for joining. Today, I'm excited to be here with AJ, our CFO, and Paul, our Chief Commercial Officer, to give you a comprehensive update on Assertio, our business, and our direction. I'm here to share solid operating results for fourth quarter and a strong balance sheet at year end, Our strategy for Rolvidon, our most important growth driver, our outlook for Induson, including fourth quarter actual results in our 2024 assumptions, our lower operating expense base designed to maximize the commercial contribution and cash flow generation opportunities, our continuing plans on corporate business development, and importantly, updated guidance for the year ahead. Assertio's direction and financials have shifted as a result of the Rolvidon acquisition and generic competition for Indesign. We remain focused on cost-efficient operations and cash generation with Rolvidon as the primary growth driver. Our goal today is to frame future performance expectations given this evolution. I do want to thank all of our stakeholders, investors, and partners for their patience while we have navigated several challenging months in 2023. I'd also like to acknowledge the talented, hardworking team at Assertio who have demonstrated exceptional dedication to success in delivering the results reported today. Having worked with them over the past few months, I am confident in this team's ability to deliver on these and future plans. As you know, I've been an independent member of Assertio's board since 2019. In my prior professional roles, I focused on commercial execution and operational leadership by increasing product sales and share, aligning expenses with growth, and managing balance sheet efficiency, all highly relevant to Assertio today. In addition, We've made good progress in our search for a permanent CEO. The expectation is that this new leader will continue to deliver against our strategy of existing asset growth, lean operating expenses, and acquisitions that fit our go-to-market model. To that point, the results we released this afternoon demonstrate the durability of our Assertio business model. We are reporting sequentially increased Rolvidan revenue. We are thoughtfully managing indices in volume and price given generic competition. We remain operating cash flow positive. And today, we also shared our guidance for the year ahead with sales expected to be in the range of $110 to $125 million and EBITDA in the $20 to $30 million range. To reiterate, we are excited to have Rolvidon in our portfolio for its growth prospects, which have been brought to life by main meetings with key customers and in working with our sales and marketing organization. And as a reminder of the broader organization, AJ became our CFO in November, and Paul has now formally transitioned to Chief Commercial Officer. leveraging his in-depth knowledge of Assertio and strong commercial finance background. I'd also like to highlight the news included in today's release that Sig Kirk will be joining our board of directors in April. Sig joined Assertio as an external advisor in January, bringing extensive business development, finance, and strategic expertise. Sig most recently served as executive vice president overseeing corporate business development at Allergan, During his 11-year tenure, he led more than 75 deals from small tuck-in asset acquisitions and licensing to larger M&A transactions, driving both revenue and market cap growth. I look forward to working with SIG in his capacity as a board member. And with that, I'll pass the call over to AJ, who will cover the financials.

speaker
A.J. Patel
Chief Financial Officer

Thanks, Heather. Today, I would like to cover our financial results for the fourth quarter of 2023 and provide some background and context on our financial guidance for full year 2024. Before I begin, as it relates to our comparison of the fourth quarter to the prior year fourth quarter, I want to establish that the 2022 fourth quarter was an all-time high for Indison, which contributed to those overall results. Since then, both Indison and Cambia have had generic entrants, and we have acquired Rovadon, which is a new growth driver. For the current year fourth quarter, our total sales were $32.5 million, including Rovadon sales of $11 million and Indison sales of $10.8 million. Rovadon sales improved sequentially since closing of the acquisition on July 31, 2023. We have now addressed the channel inventory issue highlighted in the prior quarter, as well as streamlined and focused our commercial team to continue to grow this asset. Indicent sales declined both sequentially and compared to prior year fourth quarter due to the entrance of a generic competitor in August 2023. Gross margin in the fourth quarter was 70%, decreased from 88% in the prior year fourth quarter, Of the change, inventory step-up amortization contributed nine percentage points of the decrease in margin, with the remaining reduction primarily due to change in sales mix from the addition of Robodon and decrease in higher margin in Dyssen and Cambia. Turning to operating expenses, SG&A expense was $24 million, increased from $13.7 million in the prior year fourth quarter. The fourth quarter included approximately $9.5 million in higher operating expense due to the addition of Spectrum. Adjusted operating expense in the fourth quarter was $21.8 million. Gap income from operation for the fourth quarter was a loss of $32.3 million, which included a few non-cash adjustments. We recognized a $41 million impairment charge for intangible assets, which primarily pertain to indecent, and a $17 million benefit for the change in fair value of the indecent contingent liability. Both adjustments were primarily driven by the impact of generic competition. Adjusted EBITDA is a good indicator of the operating performance of our core business. Q4 adjusted EBITDA came in at a positive $4.5 million, demonstrating the durability of our business model, even in a transitionary period. Please refer to our press release for a detailed reconciliation of our adjusted EBITDA results. Crossing over to the balance sheet, cash at year end was $73.4 million, and debt was $40 million. which consists of 6.5% convertible note due August 2027. We generated a positive $5.7 million in cash flow from operations during the fourth quarter. As Heather mentioned, today we announced guidance for 2024. We expect net product sales in a range of $110 million to $125 million. Historically, we have not provided product-level guidance, but we recognize that Q4 and the start of 2024 has been a dynamic period, including revenue composition and continuing outbox run rates. Therefore, for modeling purposes, we wanted to provide additional product-level context for Rovodan and Indicent on a one-time basis. As part of our 2024 plan, we expect Rovidon net sales to approach $60 million. Paul will provide additional context on our Rovidon outlook. For 2024, we expect Indus and net sales in a range of $18 to $25 million. We expect continued unfavorability as a result of generic competition throughout 2024, both from a pricing and volumes. Although we don't have visibility into the generic approval process, for purposes of our 2024 planning, we have assumed an additional generic entrant. From an operating results standpoint, we anticipate adjusted EBITDA in a range of $20 to $30 million. Gross profit will be impacted by a lower sales base and declining contribution from Indison, which previously contributed higher margins. we expect adjusted operating expenses for the total company to be between $65 and $70 million. When we announced the Spectrum acquisition, we expected a $55 million increase in operating expenses on top of the legacy Assertio organization of about $40 to $45 million. Subsequent to the fourth quarter, Assertio further refined its combined organization and now anticipates combined operating expenses to this much lower total range. These numbers are approximations and not formal guidance, but we hope that they will help you fully appreciate our focus on operating cost efficiency and aligning expenses to sales. I would also note that as we developed the plan for 2024, we were very mindful of the change in revenues and gross profits and responded with an intense focus on ensuring our planned costs and investments were supporting growth in Ropidon. As Heather mentioned, we expect to remain cash positive in 2024. And based on our adjusted EBITDA outlook, we are targeting to end the year with a cash balance of between $90 and $100 million. Closing out my remarks, I have a couple of notes that are important to keep in mind as well. First, I would remind everyone that the plan I've just highlighted makes no assumption about the potential impact from possible BD transactions, which we continue to seek and evaluate. Any action on that front would require an update to our outlook. Second, our shelf registration statement recently expired, so we have taken the customary action of filing a new registration statement today to renew our availability under that instrument. That renewal action is not an indication of any pending transaction or other activity. I'll now turn the call over to Paul to discuss our commercial organization and strategy.

Disclaimer

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