Jake Elguicze
Analyst · Morgan Stanley
Thank you, Dev and good morning, everyone. Before I discuss the financial results for the 3 and 12-month periods ending September 30, I would like to remind the investment community that Embecta was spun off from BD on April 1 of 2022 and that the financial results during the pre-spin periods were based on carved out accounting principles and do not reflect what Embecta's financial results would have been had Embecta operated as a stand-alone public company. Therefore, financial results for the 3 and 12-month periods ending September 30, 2022 and September 30, 2021 are not meaningfully comparable. Given the fact that Embecta's historical financial results for the pre-spin periods do not include all the actual expenses that would have been incurred had Embecta been a stand-alone public company during the periods presented, I plan on focusing the majority of my time today discussing Embecta's preliminary 2023 financial guidance and underlying assumptions. Turning to Slide 7 and beginning with revenue. During the fourth quarter, revenue totaled $274.6 million which represented a decline of 8.7% on an as-reported basis and 4.2% on a constant currency basis. The decline in Q4 constant currency revenue which was expected and something we foreshadowed on our third quarter earnings conference call, was primarily due to unfavorable comparisons stemming from a rebate reserve reversal which had occurred in the prior year period, coupled with decisions we made to exit certain legacy customer relationships at the very end of fiscal year 2021, as well as the timing of certain distributor orders in United States which positively impacted our revenue in Q3. These headwinds were partially offset by revenue generated related to the contract manufacturing of non-diabetes related product that was sold to BD which did not exist in the prior year period. In comparison to our prior expectations, Q4 2022 revenue came in better than we previously anticipated, largely due to better volumes within North America and EMEA as well as more than anticipated contract manufacturing revenue with BD. The better-than-expected revenue performance in the quarter was somewhat offset by greater-than-anticipated COVID-19 restrictions that impacted our business in China. From a regional standpoint, during Q4, U.S. revenues totaled $149.9 million which represented a decrease of 5.9% on both an as-reported and constant currency basis. The year-over-year decline in the U.S. was primarily due to the unfavorable comparison stemming from the rebate reserve reversal which had occurred in the prior year period, as well as the aforementioned timing of certain orders which occurred in Q3. These headwinds were partially offset by contract manufacturing revenue which did not exist in the prior year period. While International revenues totaled $124.7 million or a decrease of 11.9% on an as reported basis and 2.3% on a constant currency basis. The year-over-year decline in our International business was primarily due to decisions we made to exit certain legacy customer relationships at the very end of fiscal year 2021. For the full year, Embecta's revenues totaled approximately $1.130 billion which was down approximately 3.1% on an as-reported basis or down 0.5% on a constant currency basis. The drivers of the slight full year 2022 constant currency revenue decline were similar to the items that impacted our fourth quarter, including the prior year rebate reserve reversals which did not occur to the same extent in 2022, the decisions we took towards the very end of fiscal year 2021 to exit certain legacy customer relationships as well as COVID-19 restrictions in certain geographies. These headwinds were somewhat offset by contract manufacturing revenue which did not exist in the prior year. Moving to Slide 8 and a review of some of our remaining key financial indicators for the fourth quarter. GAAP and adjusted gross profit and margin for the fourth quarter of 2022 totaled $176.9 million and 64.4%, respectively. This compares to $209.7 million and 69.7% in the prior year period. Like revenue, the year-over-year decline in gross margin during the fourth quarter was expected and primarily due to contract manufacturing and supply agreement impacts, most notably the impact of increased cannula costs, product and geographic mix, incremental investments and standup costs and the continued negative incremental impacts of inflation and increased labor and material costs. Additionally, like my comments concerning revenue, our adjusted gross margin performance in the fourth quarter also exceeded our previously-provided guidance which called for adjusted gross margins to be in the low 60s during Q4. Turning to the bottom line. During the fourth quarter of 2022, we incurred a GAAP net loss of $17.2 million as compared to net income of $97.1 million in the prior year. The year-over-year decrease of approximately $114 million is primarily due to the reduction in gross profit dollars that I just referred to, the incurrence of separation and standup expenses related to Embecta becoming its own publicly traded company, interest expense that was incurred in the fourth quarter of fiscal 2022 as compared to $0 in the prior year period, as well as a non-cash impairment charge of $58.9 million associated with the decision to abandon certain manufacturing production lines in the United States and $5.5 million of costs incurred related to purchase commitments which was also related to the decision to abandon those same manufacturing production lines. As some additional background, the impaired assets were previously included as a component of construction and progress within property, plant and equipment on our balance sheet. These assets were transferred to Embecta in conjunction with the spin, were never placed into service and were related to certain diabetes syringe manufacturing production lines. These impaired assets were in no way associated with our insulin patch pump which continues to progress in its development. Lastly, from a P&L perspective, for the fourth quarter of 2022, our adjusted EBITDA and margin totaled approximately $87.2 million and 31.8%. This compares to $131.6 million and 43.8% in the prior year period. Due to the slight overachievement at the gross margin line as compared to our expectations, our adjusted EBITDA margin for the fourth quarter of 2022 also came in a bit better than we previously expected. Finally, with respect to our balance sheet and financial condition at year-end. As of September 30, 2022, we held approximately $331 million in cash and cash equivalents and approximately $1.65 billion in debt which taken together with our last 12 months adjusted EBITDA, resulted in a net leverage ratio of approximately 2.9x. That completes my prepared remarks as it relates to Embecta's financial results for the second half of fiscal 2022. Next, I would like to discuss Embecta's preliminary 2023 financial guidance and certain underlying assumptions. Beginning with revenue on Slide 9. On a constant currency basis, we currently anticipate that our revenues will be flat to down 2% as compared to 2022. At the low end of the guidance range, we are assuming about 1/2 of the decline will result from reduced contract manufacturing revenue of non-diabetes care products to BD, with the remainder coming from slight volume pressure within developed markets as well as periods of uncertainty in emerging markets due to the potential for lingering COVID-19 restrictions like those we saw impact our business in China during the latter part of 2022, while the high end of our constant currency range assumes a slightly smaller year-over-year headwind associated with contract manufacturing revenue, flattish product volumes and the ability for us to modestly raise prices on our product offerings. Given how new the partnership agreements are that we were able to execute, we assumed an immaterial amount of revenue associated with them as part of our 2023 revenue guidance range. Turning to our thoughts on FX. Embecta has a larger presence outside of the United States than many other companies of our size and as such, our initial guidance calls for a foreign currency headwind of approximately 5% during 2023. This assumption is based on foreign exchange rates that were in existence around the mid-November time frame, including a euro to U.S. dollar exchange rate of approximately 0.98. On a combined basis, our as-reported revenue guidance calls for a decline of between 5% and 7%, resulting in an initial revenue guide of between $1.05 billion and $1.073 billion. Turning to adjusted gross margin, I'll be comparing 2023 again for Q4 2022 jump-off point as our fourth quarter 2022 adjusted gross margin is the most representative to date of our business as an independent entity. During 2023, we currently anticipate that our adjusted gross margin will be approximately 62% or a decline of about 240 basis points as compared to Q4 2022, with the largest drivers being additional standup costs inclusive of various regulatory, quality, supply chain and manufacturing expenses as we continue to invest in these capabilities in advance of exiting the TSAs, increased raw material costs, including those associated with the cannulas that we purchased from BD and continued headwinds because of inflation. We estimate that additional stand-up costs and increased material costs will drive the majority of the adjusted gross margin change. While despite several cost improvement programs that are underway at the company, we expect inflationary pressures to make up the remainder of the adjusted gross margin fluctuation. Continuing down the P&L, we expect that we will maintain adjusted SG&A near a 30% level despite periods of time during 2023 in which we may incur a combination of both TSA expense and standup costs, while we also intend to invest more heavily in R&D, most notably behind our Type 2 insulin pump development program. And because of this, R&D as a percentage of revenue may exceed 7% during 2023. All totaled, we anticipate that our adjusted operating margin during 2023 will be approximately 25% which is near best-in-class as compared to other med tech companies of our revenue size. Moving to earnings. During 2023, our initial guidance calls for an adjusted diluted earnings per share range of between $1.75 and $2. This includes an assumption that our annual net interest expense will be between $115 million and $120 million, that our annual adjusted tax rate will be approximately 25% and that we'll have approximately 57.7 million weighted average diluted shares outstanding. With respect to our interest expense expectations, our full year guidance assumes that SOFR will continue to increase as we move throughout the year, peaking near 5.25%. As a reminder, our capital structure is comprised of approximately $950 million of Term Loan B debt which is a floating rate instrument, bearing interest at SOFR plus 300 basis points and approximately $700 million of senior secured notes which are fixed rate instruments. While from a tax rate standpoint, our 25% adjusted tax rate assumption is based on a few key variables, including the geographic mix of global earnings by legal lending as well as limitations associated with U.S. interest expense deductibility. Finally, from a guidance standpoint, that takes me to adjusted EBITDA margin which we expect to be approximately 30% during 2023. The adjusted EBITDA margin in 2023 is expected to be down from the levels achieved during the fourth quarter of 2022 largely due to the gross margin items I mentioned earlier, coupled with very deliberate investments we intend to make within R&D which we are willing to do to accelerate our constant currency revenue growth rates sustainably in the future. And before I turn the call over to Dev for some final remarks, I'd like to highlight some considerations regarding the cadence of quarterly revenue expectations during 2023 and briefly touch on our previously provided 2024 financial objectives. Moving forward, we may not provide any further commentary concerning the quarterly cadence of revenue on an ongoing basis. During fiscal year 2022, we generated approximately 50% of our as-reported revenue dollars during the first half of the year, including approximately 26% during the first quarter. During 2023, we currently anticipate generating a slightly lower percentage of our annual revenue during both the first quarter and first half of 2023 as compared to the prior year periods. Lastly, as it relates to the 2024 financial goals and objectives that we provided to the investment community in March of this year prior to spin, we remain committed to the achievement of those objectives, including maintaining an adjusted EBITDA margin of approximately 30% in 2024. And this comes despite a significantly more challenging operating environment as compared to the one that existed when we originally provided those targets, including inflation at near 40-year highs, rising interest rates as well as additional foreign exchange headwinds. That completes my prepared remarks. And at this time, I would like to now turn the call back over to Dev for some final remarks. Dev?