Madrigal Pharmaceuticals Inc

NASDAQ:MDGL

Good afternoon, and thank you for joining Lifecore's Financial 2025 Second Quarter Earnings Call. Now I would like to turn the call over to Stephanie Diaz, Manager of Investor Relations for Lifecore. Please go ahead.

Good afternoon, and thank you for joining us today to discuss Lifecore Biomedical's Second Quarter Fiscal 2025 Earnings results. Hosting the call today from Lifecore are Paul Josephs, President and Chief Executive Officer; and Ryan Lake, Chief Financial Officer.

Before we begin today, we'd like to remind everyone that certain statements made in the course of this conference call contain forward-looking statements. It is important to note that the forward-looking statements made during this call reflect management's judgment and analysis only as of today, January 2, 2025, and the company's actual results could differ materially from those projected in such forward-looking statements. For a more thorough discussion of the risks and uncertainties associated with any forward-looking statements, please see the disclaimer regarding forward-looking statements that is included in our fiscal 2025 second quarter earnings release which was furnished to the SEC today on Form 8-K as well as our other filings with the Securities and Exchange Commission, including, but not limited to, the company's Form 10-Q for Q2 fiscal 2025, which was filed this afternoon.

With that, I'd like to turn the call over to Paul Josephs, Chief Executive Officer.

Thank you, Stephanie. Good afternoon, everyone, and thank you for joining our fiscal 2025 second quarter update.

The second quarter was a very productive time at Lifecore. Our achievements during this period spanned finance, operations and business development, all of which supported our overall growth strategy. Revenues in the period were strong and in line with our fiscal guidance. Gross margins were improved during the period as compared to Q1 margins, reflecting greater leverage over our overhead costs across increased revenues and a favorable sales mix. Our business development team was successful in signing multiple new projects. And importantly, our balance sheet was materially strengthened during the period with the combination of the successful completion of our previously announced pipe financing and the restructuring of our revolving credit facility with BMO on significantly improved terms for Lifecore.

I will provide additional details on business development and operations for the period following an overview of our second quarter fiscal 2025 financial results. For that, I'll turn the call over to Ryan.

Thank you, Paul.

In conjunction with my comments, I'd like to recommend that participants refer to Lifecore's Form 10-Q filing with the Securities and Exchange Commission, which we filed today. I'll now go over the results for the second quarter and 6 months ended November 24, 2024, beginning with results for the quarter.

Revenues for the 3 months ended November 24, 2024, were $32.6 million, an increase of 8% compared to $30.2 million for the comparable prior year period. The increase in revenues was primarily due to a $1.9 million increase in CDMO revenues, which increase composed of $3.8 million of higher sales volume from our largest customer, partially offset by $1.9 million of lower sales volume from our other CDMO customers. In addition, HA manufacturing revenues increased $0.5 million, primarily from increased revenue from a customer due to timing, which increased shipments in the second quarter of 2025.

Gross profit for the 3 months ended November 24, 2024, was $11.1 million compared to $10 million for the same period last year. The $1.1 million increase in gross profit is primarily due to a $1.6 million increase in CDMO gross profit as a result of price increases to certain customers, partially offset by a $0.5 million decrease in HA manufacturing gross profit due to manufacturing variances.

Selling, general and administrative expenses for the 3 months ended November 24, 2024, was $11.1 million compared to $9.3 million for the same period last year. The increase was primarily due to increases in noncash stock-based compensation expense of $1.8 million, the majority of which was related to the new hire performance stock grants to our principal executive officers.

For the 3 months ended November 24, 2024, we recorded net loss of $6.6 million and $0.25 of loss per diluted share as compared to net income of $14.2 million and $0.39 of income per diluted share for the same period last year, which had included an infrequently large favorable $20.7 million noncash fair market value adjustment to our debt derivative liability associated with our term loan credit facility.

Adjusted EBITDA for the 3 months ended November 24, 2024, was $6.5 million, an increase of $1.1 million compared to $5.4 million in the prior year period. The increase in adjusted EBITDA was primarily due to the increase in gross profit.

I'll now review results for the first 6 months of fiscal 2025. Revenues for the 6 months ended November 24, 2024, were $57.3 million, an increase of 5% compared to $54.7 million for the comparable prior year period. The increase in revenues was due to a $2 million increase in HA manufacturing revenues, primarily due to higher sales volume from our largest customer and a $0.6 million increase in CDMO revenues, which increase composed of $3.3 million of higher sales volume from our largest customer, partially offset by a customer working down inventory levels built in the prior year period of $2.6 million.

Gross profit for the 6 months ended November 24, 2024, was $16.5 million compared to $12.7 million for the same period last year. The $3.8 million improvement in gross profit is due to a $5.1 million increase in CDMO gross profit, which reflected a $3.2 million increase due to price increases to certain customers and a $1.9 million increase due to a favorable sales mix, partially offset by a $1 million write-down on existing inventories to their net realizable value and a $0.3 million decrease in HA manufacturing gross profit due to manufacturing variances.

Selling, general and administrative expenses for the 6 months ended November 24, 2024, was $25.9 million compared to $18.5 million for the same period last year. The increase was primarily due to a $4.4 million increase in professional fees, including legal fees related to the civil litigation related to Yucatan Foods and the stockholder activist settlement. Additionally, noncash stock-based compensation expense increased by $2.7 million, the majority of which was related to performance stock unit grants to our principal executive officers.

For the 6 months ended November 24, 2024, we recorded a net loss of $22.8 million and $0.76 of loss per diluted share as compared to net income of $3.5 million and $0.10 of income per diluted share for the same period last year, which had included a frequently large favorable $20.9 million noncash fair market value adjustment to our debt derivative liability associated with our term loan credit facility.

Adjusted EBITDA for the 6 months ended November 24, 2024, was $4.7 million, a $1.3 million increase from $3.4 million in the prior year period. The increase in adjusted EBITDA was primarily due to the increase in gross profit, partially offset by increased legal and audit costs.

During the second quarter, we reported 2 additional important financial achievements. First, in October, we successfully closed the previously announced $24.3 million PIPE offering with various new and existing shareholders. These funds significantly improved our liquidity position and have allowed management to focus on opportunities to further grow the business. In addition, in late November, we successfully amended and extended our revolving credit facility with BMO. The terms of the amendment provide, amongst other items, a 3-year extension as well as a reduction in interest rates that we believe have further strengthened our balance sheet and overall financial position.

We are very pleased with our financial performance during the quarter, which was bolstered by a successful pipe financing and debt restructuring, which we believe helps to position us well for future growth.

This concludes my financial overview. For those interested in reviewing our reconciliations of our non-GAAP financial measures, including adjusted EBITDA, please refer to our 8-K filing or earnings release issued today.

I will now turn the call back over to Paul for an update on operations and achievements during the period.

Thank you, Ryan.

During the second quarter, our company held its first Investor Day webcast where we outlined our plan for growth in the coming years. I am very pleased to report that we believe the achievements during this period position us well to achieve the ambitious goals that we have articulated.

As we discussed during our Investor Day, Lifecore has put into action a 3-pronged growth strategy that seeks to drive a 12% revenue CAGR and increase EBITDA margins to over 25% over the next few years. This strategy seeks to maximize our existing customer business, advance programs within our development pipeline towards commercialization, and finally, drive new business to our company through expanded business development efforts. And though this growth program is in its early days, progress was made in each arm of the strategy during the second quarter.

With respect to the first strategic goal, the company made great progress to maximize our business with our existing customers in both our fermentation and fill/finish operations. During the second quarter, our team worked closely with our customers on their changing supply chain needs to ensure that they have adequate supply to meet their demand. Recently, after working with one of our customers to meet their near-term challenge, a senior executive at a large multinational pharma company said, "Lifecore support is a strength of our business." This comment represents the trust that we are working to establish with every one of our customer base.

This brings us to our second area of focus in achieving our growth, which is the advancement of development -- our development pipeline towards commercialization. We continue to maintain 10 late-stage programs and all have the potential to achieve commercial approval status by 2028. While there is no guarantee that they will each reach the finish line, even a modest subset of this group could generate substantial and impactful growth for the company in the midterm.

I'll now move to our third area of focus for growth, which is driving new business to our company through expanded business development efforts. We continue to collaborate with our clients and grew our development pipeline by 2 programs. As we discussed during our Investor Day, we have deployed a new sales strategy to expand our target market, capitalizing on investments we have made in technology and creating a more agile organization to support our expanding pipeline.

As many of you know in the past, Lifecore was focused only on complex, highly viscous formulations. In an effort to achieve significant growth, our new team is committed to expanding its focus to include other products and formulations across multiple modalities. As a result, our BD project pipeline has grown significantly in the recent months with our team working aggressively to qualify and advance more than 50 new opportunities.

In addition, with our expanded business development deployment plan, we have seen an increase in the number of large multinational pharmaceutical companies where we are qualifying leads being evaluated and progressing opportunities towards closure. We are confident that our expanded team and increased level of activity will result in an expanded and more diverse customer base that we expect will continue to fuel our pipeline with new and impactful programs for years to come.

To further support this effort, our company has adopted a team approach to driving new business, including engagement at the highest level of our organization. I have begun working closely with our business development team to strengthen and expand our BD platform and brand awareness across the market.

Everyone at Lifecore sells. This is a philosophy at the heart of all we do at Lifecore, and we are committed to meeting the needs of our customers and working hard to position ourselves for new opportunities as our customers' needs arise.

As I mentioned earlier, we signed 2 new project agreements during the period with new customers. These new programs added to our early-stage pipeline. Earlier this month, we announced one of these deals with Nirsum Laboratories. Nirsum selected Lifecore to provide CDMO services focused on supporting Nirsum's clinical development of its lead development candidate, NRS-033.

NRS-033 is a novel treatment for opioid use disorder and alcohol use disorder. NRS-033, which is wholly owned and internally discovered by Nirsum, is currently entering Phase II of clinical development. Pursuant to the newly signed agreement, Lifecore will provide Nirsum with filled syringes for use in the clinical development of NRS-033. We are excited to add Nirsum to our growing list of customers and appreciative that their team has entrusted us to collaborate with them on these activities.

Supplementing these efforts during the second quarter, the company installed a high-speed multipurpose 5-head isolator filler. This filler, which has the capability to fill vials, syringes and cartridges, has doubled the company's available capacity and increased our revenue-generating capacity to approximately $300 million annually and expanded the range of project opportunities we can support. The isolator technology is state-of-the-art and provides the capabilities and compliance that the world's leading pharmaceutical companies would expect and demand from a leading CDMO business.

Finally, during the second quarter, as part of our leadership team transformation, we added significant talent with the appointment of Thomas Guldager as our Senior Vice President of Operations, an experienced pharmaceutical industry professional with extensive CDMO experience. Thomas brings a strong operations and finance background, which we believe will help him drive operational productivity within our company's performance-driven culture. In conjunction with his appointment, Jackie Klecker has been named Executive Vice President of Quality and Development Services, a newly created position, which will take advantage of her leadership and strong regulatory compliance experience to maintain the company's reputation for excellence in this area.

This organizational change strategically bifurcates the operations and quality functions, representing a natural but critically important evolution for Lifecore as we embark on our next phase of growth. This will allow us to leverage the strengths of both Thomas and Jackie and advancing our key sustaining objectives of reducing operational expenses and maintaining exceptional quality.

In closing, I would like to reemphasize that we are executing against our transformational plan and that significant changes have been made at Lifecore over the past year, ranging from capabilities to leadership to an enhanced commercial strategy. These changes are designed to maximize the great opportunities in front of us to serve a larger segment of the drug development and commercial manufacturing market. In doing so, we believe that we will be best able to serve our existing customers as well as new customers and achieve the aggressive growth objectives that we are targeting, including significantly increased revenues as well as improved margins and adjusted EBITDA.

We are pleased with our progress in the first half of fiscal 2025 and are increasingly confident that our growth strategy and leadership priorities are tracking the company for success in the near, mid and long term. This concludes our prepared remarks for today. Operator, you may now open the call for questions.

And it comes from the line of Matt Hewitt with Craig-Hallum Capital Group.

Congratulations on all the progress in the second quarter. Maybe first up, if we could dig in a little bit on the Nirsum opportunity, a couple of different questions here. First and foremost, how did this come into the pipeline? Secondly, as you look at this opportunity, is there any way to size up? I assume that there's some services in addition to the CMO fill/finish services. Is there also some development opportunities with them? And maybe even beyond the current opportunity, do you see other things in their pipeline that you could ultimately win?

Thanks, Matt. First of all, and happy New Year. Yes, we're excited about the Nirsum opportunity. As I think about it and any opportunity that comes in, it really is our BD team working aggressively to identify potential opportunities to drive new business into our organization. So that's how the lead manifested itself.

And then from there, although we've signed a limited scope of work to start the program, the thought and the idea is contemplating ongoing development over the long term through Phase II to Phase III and then ultimately to commercialization. And we'll finalize those agreements as development continues down the way, if you will.

As it relates to commercial volumes and numbers, we haven't yet quantified those with the customer at this point, but we think it will be meaningful.

Got it. That's helpful. And then maybe a more broad question. But over the past couple of months, I assume that you've been having lots of conversations with your pharma customers, those existing and potential new customers. What are you hearing from them as they look at fiscal '25 or calendar year '25, either from a budgeting perspective or whether or not they're looking at prioritization of pipelines? What is the feedback you're getting from the customers? And how can you be a solution to any bottlenecks that they're coming up against?

Great question. So I see ongoing and continued momentum as it relates to development programs and also the opportunity for late-stage site transfers, which maybe, heretofore, Lifecore hasn't participated in. The other leading indicator that I take some solace in is the growth in our pipeline with related to large multinational pharmaceutical companies. It now represents close to 30-plus percent of our overall pipeline. And when I joined the organization, it was less than 10%.

So it tells me that not only the combination of the momentum in the market, but I would say our hunting business development strategy is leading to what I would say, indicators of potential future success, which we're very optimistic about.

One moment for our next question. It comes from the line of Jacob Johnson with Stephens.

Maybe, Paul, sticking on the business development front side of things. You alluded to, I think, maybe trying to win some late-stage customers. I guess thinking about the fill/finish capacity you have and some of the dynamics in that end market, is it possible for you to go after a commercial tech transfer project? Obviously, it's good to see the early-stage wins. So I'm just curious kind of the opportunities on maybe later stage or commercial opportunities for fill/finish.

Jacob, thanks for the question. Happy New Year. 100%. I think that, that's certainly part of our strategy. What I think I may have articulated to you or to others is we want to be strategically positioned to take advantage of late-stage or commercial site transfers, of which we've had now significant opportunities enter our pipeline.

So we're working aggressively to close those. We want to be positioned and be top of mind within our customers' minds when those needs arise. And that's what we're working hard to do with our expanded business development team. But certainly, we have meaningful ones in our pipeline that we're working on today.

Got it. And then -- maybe for Ryan, just on the margin side of things, obviously, nice top line beat that flowed through to solid gross margin outperformance, at least versus our expectations. I'm just curious, how should we think about gross margins trending throughout the rest of the year? Was there any kind of benefit from the HA timing in the quarter that we need to be cognizant of? And I guess the other kind of piece of this is the new 5-head filler, is there any impact on gross margin that we need to take into account there?

Thanks, Jacob. So as we've mentioned previously, we have some great opportunities to continue to improve gross margins and as adjusted EBITDA as well over time. Sequentially, the primary improvements in the Q2 margins were driven by higher revenues, a favorable sales mix and favorable absorption of overhead costs, coupled with lower operating supplies and headcount expenses.

We still expect overall margins for the year to be in the low 30% range. And with the improvement in Q2, I think that makes kind of the gross profit split roughly in the 40% range in the first half and improving to approximately 60% in the second half. I don't think that you'll see anything dramatic this year as it relates to the 5 heads in terms of improvement in margins. But as we look out to the future, it's certainly one of the areas where we do expect as revenues continue to grow in future years that we're going to continue to experience increased leverage of our overhead costs over greater revenues.

Go ahead, Paul.

I'm sorry. I would just add, some of the things that are maybe not revenue dependent, we're working very hard at, spending a lot of time on scheduling, labor utilization. We want to ensure that we have an efficient indirect and SG&A structure. Those things will positively affect margins over time. Not all of that will manifest itself this year, but those are areas where we're spending significant time and focus on building this organization.

Got it. And if I could just sneak in one kind of clerical question. You guys reiterated EBITDA guidance for the year in the press release. I don't think I heard any update on the revenue outlook. Any change in thinking to, I think, the $126.5 million to $130 million range for the year?

No changes in the top line revenue guidance.

One moment for our next question that comes from the line of Michael Petusky with Barrington Research.

Lots going on. So let me start real quick with housekeeping. I haven't seen the Q hit yet. And Ryan, I'm just curious because I know your debt calculation is a little bit funky, and I think you have to have the debt discount figure to sort of figure out total debt. Can you either give that figure or the total debt figure as of the end of the quarter by any chance?

It should be filed, Michael, but I believe roughly $160 million, I believe.

Total debt figure is $160 million.

For Alcon, yes.

Okay. All right. Okay. So in terms of the quarter really looks strong, including the adjusted EBITDA. Ryan, did you say that there was some -- in addition to favorable mix that there was some favorable timing that impacted that? I'm just curious because I would have -- honestly, with the historical seasonality of this business, particularly second half and particularly the fourth quarter, I would have expected you to take EBITDA guidance up unless you felt like there was some, I guess, pull forward in Q2.

Yes. I mean we did see some early fulfillment of some orders in the quarter, which is just timing between the quarters. And you're correct. I did mention an improvement in the overall mix of that revenue for the quarter.

Okay. So I mean, can you, by any chance, quantify the pull forward?

I think it was a few million more than what we had originally anticipated.

And how does that flow to EBITDA?

I don't have the specifics of that.

Okay. All right. Fair enough. So Paul, in terms of -- now you've been in the chair for a bit, I'm just curious, early learnings, conversations with multinationals. Is there anything -- like is this sort of -- you've talked about the sales cycle for some of these types of conversations maybe being 6 to 18 months.

I mean, has anything changed in your thinking on that? Have you learned anything about how they -- how Lifecore is viewed in terms of the space? Is there more education required in terms of your new capabilities? Can you just talk about early learnings, I guess?

Great question, Michael, thank you, and Happy New Year. I would say this that there is a level of ignorance as it related to knowledge about Lifecore, I'll say, our expanded capabilities. Certainly, Lifecore is very well known for our HA capabilities and fermentation. But really, the great opportunity is expanding that and opening the aperture to our sterile fill/finish capabilities. And I think that's been welcomed greatly by our potential customers directly related to the growth in, I will say, large multinational programs within our BD pipeline and the level of customer visits to Chaska that are planned in the future and that have taken place in the past. So again, I'm optimistic about the opportunity we have based on the early learnings and experience that I've had in the early days.

Okay. Great. And just one quick clarification. I just want to absolutely make sure I heard this right. Did you say, Paul, that you have roughly 50-ish opportunities -- new opportunities in the pipeline and 30% of which involve large multinationals? Is that correct?

Yes, sir.

And this concludes our Q&A session, and I will pass the call back to Paul Josephs for closing comments.

Thank you, operator. In closing, again, happy New Year to everyone. I wish to thank our investors who continue to support our growth strategy for the future. I wish to acknowledge our customers and collaborators and our Board who continue and trust Lifecore as a partner of choice. And importantly, I wish to extend my gratitude to our incredibly hard-working and talented team for driving each of the successes at Lifecore.

With the support of each of these stakeholders and with our strategic priorities clear and achievable, we believe we are well positioned to achieve growth and sustainable profitability in the coming years.

Thank you very much. That concludes our call today.

And thank you, everybody, for participating in today's conference. You may now disconnect.