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spk01: Good day, ladies and gentlemen, and welcome to the Societal CDMO Fourth Quarter and Full Year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference may be recorded. I would now like to hand the conference over to Stephanie Diaz of Societal's Investor Relations Group. Please go ahead.
spk00: Thank you. Hello, and thank you for joining us. On today's call, we have David Enloe, President and CEO, and Ryan Lake, Chief Financial Officer. Today, we will be providing an overview of Societal's contract development and manufacturing business, including updates on corporate activities and financial results for the quarter and full year ended December 31, 2022. After our prepared remarks, we will welcome your questions. Before we begin, I'd like to caution that comments made during this conference call today, March 1, 2023, will contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning the current beliefs of the company, which involve a number of assumptions, risks, and uncertainties. Actual results could differ from these statements, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations, on our corporate website at societalcdmo.com. With that, I will turn the call over to David Enloe, Societal's President and CEO. David?
spk05: Thank you, Stephanie, and thank you to everyone participating today via webcast. 2022 was an important and transformative year for societal, driven by the company's outstanding performance across each of its five strategic objectives for the year. As stated in early 2022, these five objectives were to employ new marketing segmentation strategies and strengthen the company's corporate identity, optimize our facilities and expand our capabilities, enhance our client experience through reliability, consistent quality and regulatory excellence, support talent retention by creating an inspiring and supportive environment for our employees, and finally, to significantly strengthen our financial position. We are pleased with the advancements that our team accomplished in each of these priority areas during the year, positioning us well to capitalize on the opportunities that lie ahead. We are also very happy to report that we were able to achieve our 2022 financial revenue and EBITDA guidance that was narrowly set and maintained from the outset, particularly given the generally unfavorable market dynamics, rebalancing of inventory from one of our sales and distribution partners, and the inflationary environment in which we currently operate. I will provide a more detailed review of our 2022 achievements following an overview of our financial results for the quarter and full year ended December 31, 2022. For that, I will turn the call over to Ryan.
spk06: Thank you, David. Good afternoon, everyone. Before I begin, in addition to the brief financial overview I'll provide on the call today, additional details on our financial results for the fourth quarter and year-end of December 31st, 2022 are included in our press release issued prior to this call and in our Form 10-K, which is on file with the SEC. I'll begin with an overview of our financial results for the fourth quarter. Revenues for the fourth quarter ended December 31, 2022, were $24.3 million and reflects our highest revenue quarter of the year, as well as higher than any quarter in the past two years. This represents a 9% increase compared to revenues of $22.3 million recorded during the prior year period. The increase of $2 million was primarily driven by an increase in European Ritalin LA demand from the company's new customer, Infectifarm, as well as an increase in revenue from the company's largest commercial customer, Teva, correlated with pull-through in demand resulting from market share gains against the sole competitor for the Verafimil SR products. These increases were partially offset by lower revenues from commercial product sales in San Diego compared to the prior year due to timing of customer shipments. Cost of sales for the quarter ended December 31, 2022, was $17.4 million compared to $15.7 million for the comparable period of 2021. The increase of $1.7 million was primarily due to increased costs associated with the clinical trial materials business as we expand capabilities, increased personnel costs primarily due to certain 2021 employment incentive tax credits that were not repeated in 2022 resulting in increased expense in 2022, and increased costs tied to the higher manufacturing revenue during the quarter. Selling general and administrative expenses for the fourth quarter of 2022 were $6 million compared to $5.3 million recorded in the 2021 period. The increase of $0.7 million was primarily related to costs associated with the refinancing in the fourth quarter of 2022 offset by lower public company costs and administrative costs than the prior year. Interest expense was $3.7 million for the three months ended December 31st, 2022, an increase compared to $3.5 million for the comparable period of 2021. The increase of $0.2 million was primarily due to an increase in the variable LIBOR component of interest on the company's prior term loans. This increase was partially offset by decreases in capitalized interest in the extension of the maturity date of the company's prior term loans. which deferred a portion of the non-cash amortization of financing expenses to future periods, resulting in lower non-cash interest in Q4 2022 compared to Q4 of 2021. For the quarter ended December 31st, 2022, the company recorded a net loss of $9.2 million or $0.15 per diluted share as compared to a net loss of $2.4 million or $0.04 per diluted share for the comparable period of 2021. Net loss for the quarter ended December 31, 2022, included refinancing costs, loss on extinguishment of debt, and tax expense of $7.9 million, or $0.13 per diluted share. EBITDA, as adjusted for the period, was $5.3 million compared to $3.2 million in the prior year period. I'll now provide an overview of our financial results for the full year 2022. Revenue for the year ended December 31, 2022, was $90.2 million compared to $75.4 million for 2021. The increase of $14.8 million in revenue was primarily driven by an increase in European Ritalin LA demand from the company's new customer, Infectifarm, as well as an increase in revenue from the company's largest commercial customer, Teva, correlated with pull-through in demand resulting from market share gains against the sole competitor for the Verapamil SR products. In addition, there were higher revenues from the company's clinical trial materials business as well as a full year of revenue resulting from the acquisition of irises compared to approximately five months of revenue in 2021. The increase in revenue was partially offset by a decline in revenue from Lynette's commercial sales of the Verapamil PM products. Cost of sales for the year ended December 31st, 2022 was 67.1 million compared to 55.6 million in 2021. The cost of sales increase of 11.5 million was primarily due to the acquisition of the San Diego facility and certain 2021 employment incentive tax credits that were not repeated in 2022, resulting in increased expense in 2022. These increases were partially offset by the reallocation of expenses reflecting the post-acquisition organizational structure. Selling general and administrative expenses for the year ended December 31, 2022, were $21.9 million compared to $18.4 million in 2021. The increase of $3.5 million was primarily related to costs associated with the debt refinancing in the fourth quarter of 2022, and increased personnel costs tied to the reallocation of expenses. Specifically, effective October 1st, 2021, certain employees who previously supported the company's plant operations now support our multi-site organization structure and operations. Accordingly, expenses associated with these employees have been reclassified from cost of sales to selling general and administrative expenses. These increases were offset by lower IRASIS acquisition and integration costs. Interest expense was $14.1 million and $15.1 million for the 12 months of 2022 and 2021, respectively. The decrease of $1 million was primarily due to the extension of the maturity date of the company's prior term loans, which deferred a portion of the non-cash amortization of financing expenses to future periods and increased capitalized interest. These decreases were partially offset by a full period of interest on the debt portion of the IRS's acquisition purchase price and an increase in the variable LIBOR component of interest on our prior term loans with Ethereum. For the year ended December 31st, 2022, Societal reported a net loss of $19.9 million or $0.34 per diluted share compared to a net loss of $11.4 million or $0.26 per diluted share for 2021. Net loss for the year ended December 31, 2022 included refinancing costs, loss on extinguishment of debt, and tax expenses of $7.9 million, or $0.14 per diluted share. EBITDA, as adjusted for the year ended December 31, 2022, was $16.2 million compared to $16.6 million in the prior year period. During the 12-month period, lower sales of Arapamo PM by Lynette negatively impacted EBITDA as adjusted by approximately 2.3 million as compared to the 2021 period. At December 31st, 2022, Societal had cash and cash equivalents of 15 million compared to 25.2 million as of the end of the prior fiscal year. This concludes my financial overview. For those interested in reviewing our non-GAAP reconciliations, please refer to our 8K filing or the press release issued today. I'll now turn the call back over to David for an update on operations and achievements during the period.
spk05: David. Thanks, Brian. One year ago, the company outlined an aggressive roadmap for 2022, including objectives spanning sales and marketing, corporate identity, facilities and capabilities, stakeholder engagement, and finally, our financial positions. During the year, we successfully executed on these objectives, creating a stronger and more capable CDMO. I will first address the company's strategic achievements impacting sales, marketing, and corporate identity. During 2022, the company adopted three discrete sales strategies designed to best serve each of the market segments within which we engaged. Commercial oral solid dose products, including commercial tech transfers, our legacy profit-sharing products, such as verapamil, And finally, the early stage development clients who represent a growing segment of our business. Our customer businesses range from early stage development to commercially mature, and as such, the economic and industry-related factors impacting their decisions are distinct. Considerations regarding inventory, supply chain, outsourcing, et cetera, are considerably different between market segment and from customer to customer. And in order to best support our clients, so too should be our sales strategies and support infrastructure. To this end, during 2022, Societal employed a segment-specific sales approach that accounts for important factors such as different decision-making processes, key drivers and metrics of success, project and product lifecycle management, and the approach to creating productive relationships with our clients. As a complement to our evolved sales and marketing approach, During 2022, the company changed its name from Recro Pharma to Societal CDMO and adopted the tagline, Bringing Science to Society. We believe this new identity, hand-in-hand with our bespoke approach to our sales and marketing efforts, signals the corporate transformation that is underway and the company's commitment to our people, our customers, the communities in which we operate, and most of all, the patients we ultimately serve. These strategic steps contributed to strong sales in 2022, with our clinical trial services business growing 58% compared to the prior year. Importantly, we ended the year with a significantly expanded and diversified customer base compared to 2021, with more than three times the number of customers that we had just two years ago. Our deployment of best practices and robust sales processes through the year contributed to our new business win rate increasing threefold throughout the year. During 2022, we signed 15 new customers and added 22 new programs amongst our customer base. Combined, we signed over 170 new or expanded or scope changes for projects with 33 different customers. Despite our success during the year, we cannot ignore the potential challenges presented by our current market environment. In today's market, many capital market dependent biopharma companies are facing funding challenges and therefore taking measures to preserve their cash as long as possible. It has been estimated that more than 60% of publicly traded biotech companies have low or negative enterprise values with limited opportunity to raise money in the near term. It is no surprise that many of these companies are employing strategies to preserve cash and it has been reported by a number of CDMOs that customers' current cash restraints are impacting customer decisions regarding inventory, production, and development timing and prioritization. We believe there is potential for such circumstances to impact our business during the 2023 year should customers decide to delay clinical trial development and manufacturing services. Given this change in our operating environment, the societal team is proactively reorienting our business development efforts to best meet these market conditions. As part of this new focus, we have recently repositioned certain of our business development team so they are singularly dedicated to optimizing the approximately 65 client relationships that we currently have and working to expand business with those established clients. We've also hired new personnel with expertise in the injectables market to take full advantage of the opportunities in this relatively new and important offering we have on the West Coast. We've enhanced our market intelligence effort to better assist us in targeting new business. And finally, we are investing in marketing software tools to create a curated and increasingly relevant experience for visitors to our website. Combined, these moves create business development expertise and a common client experience for both our current and future new customers with programs across the spectrum of our offerings. Oral solid dose capsules and tablets, both as immediate and extended release formulations from preclinical all the way through commercial production. High potency products, oral solid dose commercial tech transfers for which we have seen good growth as clients want their programs produced in the U.S. or second source sites established. fill finish and lyophilization, other small molecule dosage forms such as gels and films, and packaging, labeling, and distribution. Before moving on, I'd like to reiterate that the company had strong sales in 2022, and we're very pleased with the results from our sales, marketing, and branding work during the year. But we cannot stand still and continue to operate as if the general market conditions haven't changed. I'm excited to see these adjustments to our sales approach in 2023, all of which we feel best position us to succeed in a much different financial backdrop than the past several years. I'll now shift gears to discuss another important contributor to attracting new business, our state-of-the-art facilities and the breadth of our capabilities. During 2022, we launched our new aseptic fill finish and lyophilization services. In order to continue to expand our capabilities and better support our clients, we are pleased to announce that we are now prepared to provide filling and lyophilization of biologics. This expertise will allow us to access an entirely different subset of our market. The company continues to evaluate the market and customer demand and will continue to explore opportunities for growth through facilities enhancement and expansion of our capabilities. Beyond our brick and mortar, Societal made substantial investments in two pillars of our business, our customers and our employees. Strengthening relations with these key stakeholder groups represented two of the company's core goals for 2022. And we are pleased to report that we are successfully meeting these important milestones. While Societal implemented a number of key internal process enhancements to improve the customer experience, we also introduced the launch of our new 2080 second source tech transfer service for our commercial oral solid dose customers. Our team created this new service model in response to the growing risks and vulnerabilities associated with the global supply chain that has significantly elevated the importance of second source suppliers within the pharmaceutical industry. This new program reflects the way that our team is exploring and implementing new strategies to strengthen our relationships, our pipeline, and ultimately our overall business. And while our customers are critical to our growth, we're equally passionate about supporting the employees that drive every aspect of our business. From on-time delivery to regulatory to quality and everywhere in between, Societal's team is exceptional, consistently delivering high-quality product while employing the highest industry standards. During a time when staffing talent is exceedingly difficult, we believe it is essential to prioritize retention. To that end, Societal has committed to a culture of support, growth, and professionalism that allows our employees not only to work, but to thrive. During 2022, the company built an expanded people and culture organization, sponsored events to address the personal and cultural interests of our team, facilitated educational forums, and most importantly, created the opportunity for professional growth across the business. This effort was recognized in November 2022 and Societal CDMO was certified by Great Place to Work in the United States. The prestigious award is based entirely on what current employees say about their experience working at Societal, and we're very pleased to have our efforts validated in this way. While we are proud of all the company's accomplishments during the year, perhaps the most impactful achievement during 2022 was our successful execution of a multi-step strategy designed to recast our capital structure, improve our balance sheet, and strengthen our overall financial profile. The concurrent multiple transactions we successfully executed were as follows. First, in August 2022, we signed a sales and purchase agreement to sell approximately 121 acres of lakefront land to a leading national home builder for approximately $9.1 million. The unused land is located adjacent to Societal's manufacturing facility in Gainesville, Georgia. Subject to completion of diligence, we expect the sale to close in the second half of 2023, and we intend to use the proceeds from the sale to further strengthen our balance sheet by paying down more of our outstanding debt with the expectation that our net debt leverage ratio will be below 2.0. Second, in December 2022, we executed a sale and leaseback transaction for our Gainesville, Georgia manufacturing site and campus with tenant equity, which yielded $39 million in non-dilutive gross proceeds. Through this agreement, Societal CDMO entered into a 20-year lease agreement with tenant equity with multiple renewal options. This transaction does not impact Societal CDMO's other facilities, including its development, high potency, and clinical packaging site also located in Gainesville, Georgia, and its development and sterile biofuel finish and liophilization facility in San Diego, California. The third step also occurred in December 2022, with the company closing concurrent public offerings of common stock and preferred stock, generating gross proceeds of approximately $35.6 million prior to deducting the underwriting discounts and estimated offering expenses. And finally, in December 2022, we secured a new debt facility for $36.9 million from Royal Bank of Canada. The facility is in the form of a three-year Term A loan bearing interest at the floating secured overnight financing rate, or SOFR, plus an initial base rate of 4.5% per annum. The terms of the new debt facility significantly improved the terms of the company's previous credit facility with Ethereum, which carried an interest rate of approximately 13% and held a near-term maturity date of December 31, 2023. Combined, these transactions were transformational for the company. Prior to year end, the company was able to repay and retire its $100 million debt facility with Ethereum and replace it with a $36.9 million Term A loan with Royal Bank of Canada. that carries terms that are significantly more advantageous to societal CDMO in the areas of debt leverage, maturity date, and interest obligation. In addition to significantly reducing the company's total debt, these transactions helped improve the company's net debt leverage ratio from greater than six times EBITDA to just over two times EBITDA, immediately reducing our annual interest burden by an estimated $6 million. with the potential to increase that number to approximately $7 million annually. We expect that our financial position will be further strengthened with the closing of the land sale, which is expected to generate proceeds of $9.1 million later this year. By any standard, 2022 was a highly productive and successful year for societal. We set out with an aggressive set of goals, all of which were achieved. And as a result, we began 2023 with multiple key advantages. From a market perspective, our expertise with oral solids and small molecules requiring complex formulation puts us in a position of strength as we are seeing a growing number of compounds in development in both of these areas. And we have added expertise to better support injectables opportunities, including biologics. We currently have capacity in the U.S., which is strategically advantageous as our customer base navigates the supply chain and geopolitical headwinds. We have a highly experienced and motivated team, a track record of operational execution success, and the agility to work with the changing needs of CDMO customers. Some of the larger CDMOs have reported that their delivery times have been impacted by recent supply chain challenges. On the contrary, Societal continues to take innovative steps to anticipate the future needs of our customers, provide supply security and stability, and do so in a cost-efficient manner. And our reliability and growing reputation has allowed us to expand and diversify our customer base. As of the end of 2022, societal had more than three times the number of customers we had only two years ago, creating an exciting opportunity to win expansion orders and new business from our growing client base. Finally, we began 2023 with a renewed position of financial strength on the heels of our successful cleanup of our balance sheet. For all of these reasons, we look ahead with great optimism. For the full year 2023, we are projecting revenue of between 94 and 100 million and an EBITDA of between 15 and 18 million. This concludes my prepared remarks for today. We can now open up the call for questions. Operator?
spk01: Ladies and gentlemen, if you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered, you wish to move yourself from the queue, please press star 1-1 again.
spk07: One moment for our first question.
spk01: Our first question comes from Matt Hewitt with Craig Hallam. Your line is open.
spk02: Good afternoon, gentlemen. Thanks for the update and congratulations on the strong finish to the year. I've got a handful of questions. Maybe first up, you announced on the call that you are prepared to potentially launch a biologics manufacturing capability. How should we be thinking about that opportunity? What does the sales cycle look like? How quickly do you think that you could sign a contract in that market? Hello?
spk05: Can you hear me okay?
spk02: Now I can, yep.
spk05: Okay. Okay. I'll start over. Yeah, so this is not related to large molecule production, you know, drug substance-wise, but as I stated, to fill, finish, and lio capabilities. And so, you know, we view this as an opportunity to increase our target markets. And I would look at it really no differently than anything that we've talked about or discussed before, other than the fact that we knew going in to the acquisition of IRISIS a year and a half ago that that expertise existed historically. We just wanted to make sure everything was up and running, functioning well, and we had seen some success in the new line and the new LIOS. So we're ready to roll that forward, and the business development team members we've added also have that expertise, and so it's time to step that out in a more formal way.
spk02: Got it. And then on the 2080 market opportunity, maybe if you could update us on how that pipeline is coming together, opportunities there.
spk05: Yeah. I mean, a lot of discussions are in that area, and this is going to be a place of focus for going forward. And right now, it is still nascent, I would say. It is novel. And I'll just say that we've gotten the attention of a couple large non-U.S.-based entities to examine this as an opportunity for them.
spk02: Got it. And then, obviously, a strong performance here in Ritalin and Verapamil. How should we be thinking about those products for fiscal 23? How was that captured in your guidance?
spk06: Hi, Matt. It's Ryan. First, I'd say that generally speaking, and maybe I'll back into your question, is that from a development revenue perspective, we're expecting to see an increase of about 35% to 50% in our development revenue over 2022. And that's really our growth segment of our business. And our commercial business, we're expecting it to be relatively flat to down slightly. So the overall average of the revenue growth would be in the high single digit range and keep in mind that the development revenue is growing you know at three to five times the market rate and because the commercial revenue weighting um being about 70 percent of our total revenue the overall revenue growth is weighted down a little bit and kind of mutes the the growth that we're seeing in the development revenue but we've got really good line of sight to our development revenue and expecting to earn approximately 60% of the backlog that we had at the end of 2022. So that was approximately 24 million. And, you know, just looking at – and there's a deck in our – slide in our deck that we put out as well that shows what our funnel looks like and what some of those pipeline opportunities are, but, you know, based on, you know, what we have is fine backlog as well as signing and executing on additional new business and scope changes based on, you know, as David mentioned, a much larger customer base. You know, we feel like we're in a good shape from a sales funnel perspective to execute on the strategy.
spk02: Excellent. Maybe one more and then I'll hop back into queue. But On the gross margin side, a nice pop here in Q4. As you look at fiscal 23 and maybe even beyond, if you're willing to comment on that, but for fiscal 23, as you continue to increase your utilization, I mean, is it reasonable to expect your gross margins to continue to expand over the course of the year? I realize that there's some puts and takes with inflationary pressures and all of that and some new hires, but as you look at fiscal 23 versus fiscal 22 gross margin should be up. Is that fair?
spk06: Yeah. So we're, we're expecting gross margins to be in the mid 20% range. So, you know, 25 to 27% or so. You're not seeing some of the leverage improvement due to some of the infrastructure growth and cost inflation that we're experiencing. And I'd say that, you know, this business is significantly different than it was just a couple of years ago, as David mentioned in his opening remarks. I mean, we're supporting, you know, a lot more of different and not more of the same. And we've been running, you know, very lean as well from a headcount perspective. So there's a kind of a tremendous workload and complexity our teams are managing due to our growth and, you know, juggling all the supply chain challenges, the timing of production runs, and completing those services.
spk02: So maybe a little bit of an uptick here this year, but maybe a more pronounced pickup and gross margin in 24 and beyond.
spk06: Yeah, I think that's fair, Matt.
spk02: Okay. Thank you very much.
spk01: Yeah. One moment for our next question. Our next question comes from Jacob Johnson with Stevens. Your line is open.
spk04: Hey, good afternoon. David, maybe going back to your comments around the funding backdrop, I guess two questions. One, does your guidance assume kind of a somewhat more challenged, if we want to use that word, environment? And then two, I'd just be curious how this environment, you talked about how the environment is impacting kind of your business development effort and where you're hunting. How does it impact kind of the, does it impact the customers you want to work with, that piece of it?
spk05: Well, yeah, I mean, good question. We talked about this several quarters ago before it really started happening, but I at least could see and we could see it coming. For me, it only further emphasizes the importance of the tech transfer gains that we've been able to see, these new projects that we've been able to add that are either commercial and coming in or near commercial income in because those typically, those programs are by and large less capital market dependent, right? However, you know, the early part of the product development curve where so many of our programs are arriving, I mean, there's no question that we're seeing, and other companies are too, obviously, you know, companies who might have three programs that they intend to go into the clinic, and they were going to do that concurrently, and then, quote, you know, go raise more money at the end of that when they figured out what they're doing on the next phase, and that there is more care now and more conservatism now as those smaller emerging companies are being more cash conscious and preserving their cash as long as they can. So I think, well, first of all, directly to your question, I mean, we did factor that into our guidance and into what we're seeing in terms of our funnel, but it is something that we've got to be aware of and be careful with with respect to making sure that companies we're spending time trying to work with are funded or have site uh, line of sight to that funding before we expend a bunch of energy on something that's not going to go anywhere.
spk04: Okay. That's helpful. Thanks for that. Um, and then just, just on the verapamil side of things, I think you called out some share gains that benefited growth in 2022. Is that something that, is there a risk for those gains reversing next year? Or do you see that kind of remaining kind of where it is today?
spk06: Hey, Jacob. It's Ryan. So I would say that we continue to see Teva performing at a very high level and maintaining their market share position and even increasing it a little bit. And we actually think they've won or increased their business with a new customer that should help contribute to increase profit sharing for us. But You know, we did, I would say, experience, you know, in the fourth quarter, and something we've, you know, baked into our guide is that there was some softness in kind of the net pricing by our partners. So their gross to nets were a little bit higher. So that's something we're keeping our eye on. But the market share position for Verapamil is still very strong.
spk04: Okay. Thanks for that, Ryan. And then just last question. For David, just congrats on getting the balance sheet in a much better place. I guess that begs the question in terms of capital allocation. Does that change your view or appetite around anywhere you'd want to invest organically or I suppose inorganically?
spk05: I mean, there's a lot of activity right now with companies paying very close attention to the assets they have and the assets that they want to have. I'll say it like that. And so, you know, there's a lot of activity in that area. We're not actively trying to do something else right now. I mean, this is still a tough market, right? And we've got capacity that we need to fill. And that's where Our business development efforts are focused, and that's why we've re-engineered the way we're approaching the market where we're really delving more deeply and intensely into the relationships that already exist for us and examining and exploring ways that we can deepen those relationships with incremental work and extra projects in addition to the finished line capacity that we have available and also other tech transfer opportunities. So I would characterize 2023 more that way, though there's no question that opportunities are going to arise, and we've got to assess those.
spk04: Got it. Makes sense. Thanks for taking the questions.
spk01: One moment for our next question.
spk07: Our next question comes from Max Mark with William Blair.
spk01: Your line is open.
spk03: Hi, thanks for taking our questions. Maybe just following up on one of Jacob's questions about what's embedded in a guide here. In terms of your shift to biologics, are you expecting any contribution in 2023? And then from a competitive standpoint, is this Is there anything to read into in terms of this being an indictment of growth in small molecules, or is it just the function of demand and biologics being so robust? And what do you think you can do in that market that really differentiates you from some of the larger, more established players in the space?
spk05: Hey, Max. I mean, on the filling of biologics, I think We've had this experience. The people and the team in San Diego have filled biologics before. I mean, certainly the crux and focus and vast majority of the work that we're doing is small molecule focused and centered. However, once we got the line up and running and, in fact, have already engaged in a fill biologics, and LIO opportunity that involves a biologic and a complex one at that, it's time for us to step that forward and increase the number of opportunities that we can possibly take on. I think from a differentiation perspective, the focus that we have on the client experience is the same. available and having a scientific sort of best foot forward, if you will, and really working to solve problems that our clients have with respect to their programs and be ready and able and to apply the quality system and regulatory expertise and supply chain expertise we have. didn't take stepping into the biologic space from a Phil and Lio perspective lightly. I mean, we've walked all the way around this in terms of incremental skills we need or knowledge that we need to have to be competent and competitive, and we feel like we're in a good place now to step that forward. Not sure there was a first part of the question, Max, and I dove into the second part if I...
spk03: I lumped too many in there. That was my fault. The first part of the question was just around what exactly you're expecting or what's embedded in the guide from biologics here in 2023.
spk05: Yeah, I mean, I would just say that the expansion of opportunities is baked in to the forecast and the guidance that we're providing. Got it.
spk03: All right, thank you. Maybe a longer-term one here on margins. I guess, you know, I'm assuming the wages, obviously, is the big headwind here in 2023. But is there anything else that you'd call out in terms of what's behind the step-down in margin in 2023? And then beyond 2023, any commentary you can provide around how we should think about the potential for and cadence of margin improvements longer term? Yeah.
spk06: Yeah, Max. So first, I wouldn't say there's a step down in margin. It's relatively in the same range as 2022. And it's really a factor of more of different, not more of same. So as we continue to grow in the development business and absorb our overheads, it's really important for us, as David mentioned, that we're filling out our capacity. And that's where we're really going to see the margin improvement and the leverage of our fixed costs and absorption of our overhead. So it's a little tough right now to look out much past 23, but certainly we expect a pretty significant improvement as we absorb our fixed development costs and then as some of these tech transfer programs start to come online, including two of them this year from a commercial standpoint.
spk03: Got it. Okay. And then maybe one last one for me. Just in terms of results in the quarter, I think when we spoke last quarter, you had mentioned that you had a potential headwind from delays in API shipments from Italy for Veracomo. It doesn't seem like that impacted results in the quarter, but is there any risk of that carrying over here in 2023? And then relatedly, maybe on the other side, was there any positive impact from the ADHD shortage that we've seen really over the last year or so now?
spk06: Yeah, I don't recall, you know, I know we talked about API availability, but not necessarily a shortage on the verapamil side. Certainly our supply chain folks are monitoring that and doing a good job at making sure that we have the appropriate levels. I don't think that we saw, again, anything discernible from an ADHD perspective from the Adderall shortage. I mean, we still continue to see, let's call it back to normal levels from pre-COVID in terms of our ADHD products. And our new partner, Infectifarm, is doing really well with Ritalin in Europe. And what's included in our guide for next year is, But for all of our commercial products is based on customer forecasts that we receive, which are 12 to 24-month forecasts, and those are risk-adjusted slightly by us as well. So we feel good about the commercial projections that we've provided. Perfect.
spk05: Yeah, Max, let me just – this is David. Let me just reiterate. I tip my hat to the supply chain team. We did get out ahead of the API challenge that was – you know, had real potential. We've heard less about power crises in Western Europe than were anticipated when this all came up, you know, last quarter. And it was really one of the main topics of the CPHI conference in Europe last end of October, early November. And we are in better shape and more confident about the api situation with verapamil than we were at that point got it thank you david very helpful and thanks ryan absolutely nice one moment for our next question our next question comes from m marin with that your line is open thank you so i have two questions um one is the follow-up to prior
spk08: questions and discussions we've just had. In terms of what's fully baked into guidance, you had said that you have been running kind of lean in terms of headcount. So should we think in terms of supporting the growth that you've outlined, the opportunities you've identified, that you believe you have sufficient bandwidth now in terms of headcount to fully support these opportunities? Or at some point, do you think we might see some ramp up in staffing at some point in 2023?
spk06: Yes, so included in our guide is that anticipated hiring of those individuals to support the revenue and just, you know, generally speaking, they're not even new positions, they're just backfills of positions that we had previously included in there. And that's, you know, the lean part is we've been running, you know, kind of down without them. But that is included in our guide, those additional headcounts to support the revenue that we have, just more in a sustained manner and also one that is supporting, as I mentioned earlier, more of different and not more of the same given the number of development customers that we have now.
spk08: So given the state of the labor market, do you think there's any potential risk that you might have to provide additional incentives or inducements in that regard?
spk06: I don't think so, not at this time. Our people and culture team does a tremendous job at making sure that we're benchmarking and staying competitive. And as we've talked about previously, we made some changes during the year as well in terms of talent acquisition, bringing it in-house, as well as a number of initiatives from a culture perspective to make societal a really great place to work at and attract and retain talent.
spk05: Yeah, Marla, I want to reinforce something there. I meet every month, our chief people officer and I meet every month with all the new employees and had a chance to do that yesterday. And I just want to say, I mean, excellent new team members that we've been able to add who are very, you know, bring a lot of experience from other places, either from the client side or other CDMOs. And I really appreciate really been pleased with the talent that we've been able to attract and secure at the company.
spk06: I think one other common, Marla, that maybe will help you with maybe how to think about cadence of revenue and supporting expenses. For the total year, I would say that revenue is going to be weighted about 45 percent toward the first half of the year and then about 55 percent toward the second half of the year and the breakdown of the first half of the year you know will depend on a number of factors including timing and completion of our second step of the serialization compliance is the aggregation step under the drug supply chain security act and that'll cause some shifting of production and shipments between quarters but we expect revenue would be you know, weighted more heavily toward Q2 in the 55% range and about 45%, you know, weighted toward Q1. And then, you know, we also experienced an extremely high throughput of clinical development services in Q4 of 22, which included some really large project milestones being met, including the OTSUKA process qualification batches. or anticipating lower development backlog to be earned in Q1. So that's what's driving some of that quarter over quarter. And then, you know, I would say, you know, from an EBITDA perspective, that cadence, you know, again, it's based on revenue timing and mix, but it would be weighted about 40% toward the first half and 60% toward the second half. And the breakdown of the first half of the year, again, depending on timing and the aggregation compliance, is expected to be weighted about 75% toward Q2 and about 25% to Q1, given the production revenue timing and absorption of overhead. So, overall, I think the EBITDA margins, which includes, you know, the new headcount, you know, for the year, will be in the mid to high teens. And if you're looking at some of the EBITDA comparisons, one thing to note, and we included it in the back of the press release, is a historic EBITDA as adjusted number, which excludes adjustments for the adoption of the Revenue Recognition Standard. And now that we've kind of have all periods, prior periods that are presented, you know, exclude that new standard for comparability purposes, we're going to eliminate that adjustment to reduce and simplify the number of variables for EBITDA estimates from period to period. So, we provided those calculations, again, in the non-GAAP table, so you can see the impact to the historical periods and how we're guiding for 2023 compared to 2022.
spk08: Got it. Thank you.
spk01: And I'm not showing any further questions at this time. I'd like to turn the call back over to David for any closing remarks.
spk05: Yeah, just a quick point of clarification before I completely wrap up, and that is I want to make sure that the listeners here that are on the biologic side, the extent of production capabilities that we're offering is limited to formulation, fill, and finish, and not drug substance production. So I just wanted to clarify that. So on that note, many thanks to all of our clients, our supply chain, our other service providers and partners, and particularly to our excellent societal team. We look forward to many great achievements in the months ahead. And thank you again, everybody, for participating today and for your continued support of societal CDMO.
spk01: Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
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