Avid Bioservices Inc

NASDAQ:CDMO

Earnings Call Analysis

Earnings Call Transcript 2025-Q1

[Operator]

Good day, and thank you for standing by. Welcome to the Avid Bioservices First Quarter Fiscal Year 2025 Financial Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today. Tim, please go ahead.

[Tim Brons]

Thank you. Good afternoon, and thank you for joining us. On today's call, we have Nick Green, President and CEO; and Dan Hart, Chief Financial Officer; and Matt Kwietniak, Avid's Chief Commercial Officer. Today, we will be providing an overview of Avid Bioservices contract development and manufacturing business, including updates on corporate activities and financial results for the quarter ended July 31, 2024. 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, September 9, 2024, will contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Concerning the current belief of the company, which involves 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 the company's filings with the Securities and Exchange Commission concerning these and other matters. Our earnings press release includes a discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations on our corporate website, avidbio.com.

With that, I will turn the call over to Nick Green, Avid's President and CEO.

[Nicholas Green, executive]

Thank you, Tim, and thank you to everybody participating today via webcast. Building on the momentum from quarter 4 fiscal '25 is off to a good start, and we are delighted to be reporting what I can only describe as a solid first quarter. We are encouraged by the strong revenues and new business signings which continue to build our backlog and improve our margins. Matt and I will provide additional details on business development and operations for the period following an overview of our first quarter fiscal '25 financial results.

And for that, I'll turn the call over to Dan.

[Daniel Hart, executive]

Thank you, Nick. Before I begin, in addition to the brief financial overview, I'll provide on the call today, additional details on our financial results are included in our press release issued prior to this call and in our Form 10-Q, which was filed today with the SEC.

I'll now provide an overview of our financial results from operations for the quarter ended July 31, 2024. Revenues for the first quarter of fiscal 2025 were $40.2 million, representing a 6% increase as compared to revenues of $37.7 million recorded in the same prior year period. The increase was primarily attributed to an increase in process development revenues during the period. Gross profit for the first quarter of fiscal 2025 was $5.7 million, 14% gross margin compared to $4.1 million or 11% gross margin in the first quarter of fiscal 2024. The increase in gross profit for the first quarter ended July 31, 2024, compared to the same prior year period was primarily driven by the increased revenues and lower material costs used for customer programs, partially offset by increases in compensation and benefit-related expenses, facility, manufacturing and other related expenses and depreciation expense.

SG&A expenses for the first quarter of fiscal 2025 were $8.2 million, an increase of 30% compared to $6.3 million recorded in the first quarter of fiscal 2024. The increase in SG&A for the first quarter ended July 31, 2024, compared to the same prior year period was primarily due to increases in compensation and benefit-related expenses in audit, legal and other consulting fees.

During the first quarter of fiscal 2025, the company's net loss was $5.5 million or $0.09 per basic and diluted share compared to a net loss of $2.1 million or $0.03 per basic and diluted share for the first quarter of fiscal 2024. For the first quarter of fiscal 2025, the company had an adjusted EBITDA of $3 million. Our cash and cash equivalents on July 31, 2024 were $33.4 million compared to $38.1 million on April 30, 2024.

This concludes my financial overview. I'll now turn the call over to Matt for an update on commercial activities during the quarter.

[Matthew Kwietniak, executive]

Thanks, Dan. Q1 2025 was a highly productive quarter for our team as we signed $66 million net in new project agreements and ended the quarter with a backlog of $219 million. The backlog sets another record high for the company and the net new wins are the highest since the third quarter of fiscal 2023. We are also pleased with the composition of these signings as a significant majority are projects with new customers, including the addition of another large pharma customer.

As we've discussed previously, the sales cycle with big pharma companies is generally long and involved. I'm very proud of our team and the professionalism they showed in showcasing Avid's exceptional service, skill and quality throughout this process. As we deliver for our new large pharma clients, we expect to capitalize on the reputation we build and increase our exposure to more large pharma over time. Our new signings also have a good mix of early and late-stage programs. Though we continue to be weighted more towards late-stage, during the first quarter, we were successful in bringing in programs at both ends of the development spectrum.

As we've discussed on prior earnings calls, a mix of early and late-stage programs provide the balance between near- and longer-term revenues as well as the opportunity to grow with new and existing customers. With respect to our newest late-stage programs, we are very pleased to report the 2 our PPQ programs. One of which is the Phase III program advancing towards commercialization and the other is a commercially approved product currently on the market. As we've discussed in the past, PPQ programs are particularly attractive as they are a pre-commercialization requirement. And while we caution that the execution of a PPQ campaign is only the beginning of a 1- to 2-year journey toward a potential commercial approval and subsequent manufacturer, we cannot underestimate the importance that we believe such programs may have on our growth now and in the future as we expect they will drive an increase in revenues, capacity utilization and ultimately, our margins.

In conclusion, I am extremely pleased with our performance during the first quarter of fiscal 2025, and we are looking forward to the balance of the year with great optimism. This concludes my overview of commercial activities. I will now turn the call back over to Nick for an update on operations and other achievements during the quarter.

[Nicholas Green, executive]

Thanks, Matt. During the quarter, we achieved several important time marks for the company including strong revenues, new business signings, both of which continue to drive a robust backlog and improving margins. The investments of the last few years in infrastructure, facilities, capacity and the expansion of our capabilities continue to attract new business and a wider range of opportunities. Our new infrastructure and organization are now better equipped to support the needs of large pharma with the same excellence and agility that we provide to smaller biotech companies. And we look forward to the continued diversification of our customer base and our project pipeline with key programs from early stage to commercialization. We're excited that our story has continued to unfold just as we have laid out in the past.

And I'd like to thank all my colleagues at Avid Bioservices for their part in executing this strategy.

Looking ahead, our primary focus is on filling our remaining capacity. As we continue to sign new business and execute on our backlog, we expect revenues and capacity utilization to increase, generating stronger margins and positioning Avid to achieve strong growth going forward.

This concludes my prepared remarks for today, and we can now open the call for questions. Operator?

[Operator]

[Operator Instructions] One moment for the first question. And our first question today will be coming from Sean Dodge of RBC Capital Markets.

[Sean Dodge, analyst]

Congratulations on the strong bookings quarter. On those bookings, so Matt mentioned lots of different contributors there, new customers, early-stage stuff, late-stage and then some stuff progressing towards commercial. I guess if we think about the mix there and compare it to your current backlog, including these $66 million of new wins, will this accelerate or decelerate your backlog burn rate over the next, call it, 4 or 5 quarters? Or is the makeup of this pretty similar to what's already in backlog so it really shouldn't affect backlog conversion, if that makes sense?

[Nicholas Green, executive]

Yes, Sean, it does make sense. I don't think it's going to have a dramatic effect, but it is going to be probably slightly more accelerating than decelerating, just due to the fact that we've got I think, a better proportion of the early phase clients in the quarter than we have in prior quarters. As you know, the prior quarters weren't the high watermark.

So -- but I think there's -- it was nice to see as I think Matt articulated to see a sort of a nice balance to the signing. So slightly accelerating, but I wouldn't say it was worth with being notable in that regard.

[Sean Dodge, analyst]

Okay. Great. And then you mentioned 2 PPQ campaigns you won in the quarter. I guess any more detail you can share on those? Or are these something you took away from another CDMO. Are you going to be serving as a secondary supplier in those cases? And then any detailed bookings you can share on what these things get fully ramped, what they could contribute kind of roughly in terms of annual revenue?

[Nicholas Green, executive]

Yes. We don't really go forward too much in terms of forecasting the future revenues. But in terms of where they came from, interestingly one of them actually is a commercial product that is being outsourced from internal manufacturer. So it's already approved, which is quite exciting. So that one probably a little more advanced than most in regard as I say, it's already on the market. The other one by virtue of the fact that it is coming in, it's coming in from another CDMO and in Phase III, obviously, Phase I and II have been manufactured somewhere else. And so that's kind of, I guess, a win to some degree. No second suppliers as far as I'm aware.

[Sean Dodge, analyst]

Okay. Got it. Congratulations again.

[Nicholas Green, executive]

Thanks very much, Sean, Appreciate it.

[Operator]

[Operator Instructions] And our next question will be coming from Jacob Johnson of Stephens.

[Unknown Analyst]

This is Mac on for Jacob. Just a few quick questions for me. Just a large pharma strategy, I know you called out another addition there. But given there's been some noise around large pharma pruning some earlier-stage pipelines in recent months, I guess there's 2 questions here. Is there any update on how your large pharma strategy is progressing as compared to your internal expectations? And two, any changes in demand from these customers as of late?

[Nicholas Green, executive]

I'll answer your second question first, Mark. No changes from them as late. So I think getting to your point of whether their strategies or issues have changed their demand from us personally than that wouldn't seem to be the case. I think in terms of the strategy as a whole, it's one of those strategies that's long.

And as Matt has alluded to, it's very involved. There's a lot of audit visits establishing your reputation, et cetera. I think we're on track for where we'd like to be in general. I think there are -- there are some areas we'd like to have moved a little bit quicker on some accounts, but there are other accounts that have developed that we didn't necessarily expect to develop as quick. So on the whole, roughly in line, being in it rather than patient individual, though I would say I'd always want it to be faster if we could be. I can assure you though, however, that speed is not down to anything that we're not trying to do ourselves.

[Unknown Analyst]

I appreciate the color there. And then just quickly on the cell and gene therapy side of things. I think you mentioned last quarter, this was a bit behind traditional biologics demand in terms of coming back and given your early phase comments, is this still the case? Or what are you seeing in those end markets?

[Nicholas Green, executive]

Yes. I think that still is the case. I certainly don't see it. I haven't seen any catch up in any way, shape or form at the moment. I do think the vast majority of the driver is in the mammalian conversations continue to be pretty nicely developing in the cell and gene therapy but I wouldn't say that the activity of the funding or what have you is flowing back into that sector yet. So mammalian ahead for sure. I don't think it's cell and gene caught up anything on from where we were last quarter. We do have some interesting conversations. And hopefully, in the next quarter or 2, we can start to convert the conversations into orders, but that's kind of where we are at the moment.

[Operator]

And our next question will be coming from Matt Hewitt of Craig-Hallum Capital Group.

[Matthew Hewitt, analyst]

Congratulations on the strong quarter. Maybe first up, and I apologize, the vote was happening right as we were coming on, but the Biosecure Act made it to the house floor. I did not hear. But I'm just curious what your thoughts are. And I know that your customers don't always call in and say, hey, because of this potential law, we're going to sign up. But I'm just curious if you're seeing any change or any increase in conversations that could possibly be tied to that act.

[Nicholas Green, executive]

Yes. I mean a very high level, Matt, I think, we obviously compete in that marketplace and we compete against Asian competitors and Chinese competitor, in particular, on a regular day-to-day basis. I would say that of the pipeline that we get from the numbers that we've managed to scratch through and be able to try to get some definition about half of the ones that we see from China are probably Biosecure associated to date, there's an element of that. Some of them were the others that we've already won or have been in progress with prior to any Biosecure conversation that they initiated.

So I think it's fairly safe to say the other half want nothing to do with that. How that builds up is going to be interesting. I think the -- 2 fundamental elements is that while ever there's no definition about it, there's obviously concern in fees. So that can drive decision-making. Although I do think there's also in the absence of the law, there's also people who feel that can we get in and out or can we progress as we might do in the past until it's more defined. So it's going to be interesting to see how that actually pans out. I mean it's difficult to say that it's a bad thing for a U.S.-based CDMO with capacity like we are. So we'll be certainly interested to see how that pans out over the near term.

[Matthew Hewitt, analyst]

Got it. And then second question. Regarding seasonality, obviously, this is the quarter we're currently in is normally the quarter you shutdown and kind of going through some cleaning and all that. But given the newness of the facilities and the equipment, is it safe to expect that, that shutdown period will be lighter this year than you witnessed the last few years? And if that's the case, you just maybe that normal seasonality isn't as big of a deal this year. Is that -- am I thinking about that right?

[Nicholas Green, executive]

I mean, in general terms, I think what I would say for this year is I wouldn't be looking at it that way right off the bat. We've got -- we've just got the new facilities online. So we do still need to maintain those facilities. We still do need to do certain activities to make sure everything is up to date and any calibrations and things like that are all done. So we are trying a few things that we think we'll be able to, in the longer term, reduce the scope of that shutdown.

But I -- on the basis that it's our first year with the new facilities, I wouldn't be building in too much to that effect, if you know what I mean.

[Operator]

Thank you. One moment for the next question. Our next question is coming from Paul Knight of KeyBanc Capital Markets.

[Paul Knight, analyst]

Hi Nick, were you -- did you spell out how much of the new orders maybe Matt were in the cell and gene therapy area?

[Nicholas Green, executive]

Small proportion, Paul, we don't break that one out, but it's certainly not material in the overall scheme of things. So we don't segment those two just yet, but nothing [indiscernible].

[Paul Knight, analyst]

A company in the kind of in the medium market as said they expect a 4-quarter lag on cell therapy funding. Do you think that's kind of in the ballpark?

[Nicholas Green, executive]

I'm not sure I'd go quite as far as 4 quarters. It depends on -- it's a difficult way to look at. We've seen some pickup. I think if I look -- looking back at the mammalian side, I think November was the low for end of October, beginning of November was below. So we're not gone for 4 quarters. I think I've seen some pickup in certainly, our activity in terms of the cell and gene therapy. But I wouldn't say it's accelerating at the level that we saw from November in the mammalian side. And even in the mammalian side, we are getting some sort of conflicting data.

I think Charles River has indicated that they were seeing a reduction in the early phases. So I think it's coming through. I think I'd be probably a little more optimistic from what we've seen, but we certainly know bellwether for the overall industry. So I'm not going to argue somebody else as easy as 4 quarters, and we might see it at 2 or 3, but that's where we are at the moment, I think.

[Paul Knight, analyst]

And Nick, you had previously indicated that sometimes the backlog now would extend beyond a year. I'm assuming that, that's still the case. But is it stretched even more in terms of duration of the project? Or is it kind of similar to what you've been seeing?

[Nicholas Green, executive]

No, I think that was kind of the crook of Sean's question at the beginning was that I think the mix of the signings that we've got this quarter are a little richer in the early phase than traditionally. Still the majority of them are late phase, but there's a higher proportion than we are on a higher number of early phase than we had seen in the last 2 or 3 quarters of last year. So if anything, it's slightly accelerating it and maybe reducing it from 15 to a little bit less but it's not material. So but I would say it's a definite not extending as it were.

[Paul Knight, analyst]

And then lastly, I know there's Biosecure here in the United States, but is there anything new on the regulatory front in Europe that puts you in a bit better of a position?

[Nicholas Green, executive]

No. I mean I heard some rumblings that the people might believing that they may take similar actions in Europe. I haven't seen anything definitive that suggests that, that's going to be the case. So really, all we have today, as far as I can see in the immediate horizon is the Biosecure act here in the U.S.

[Operator]

Thank you and one moment for the next question. And our next question will be coming from Max Smock of William Blair.

[Max Smock, analyst]

Start just echo Sean's comments early and congrats on the nice bookings quarter here in the first quarter. I wanted to ask a follow-up on Matt's question on Biosecure, it sounds like you have some customers that are still waiting to see how it plays out before moving away from China. But is it fair to say that most of the companies you're talking about are already committed to changing their behavior and moving away from China kind of regardless of what happens of the bill here near term? And in your conversations, are you picking up on any material differences in terms of how small biotech and large pharma are currently reacting or playing to react to the Biosecure?

[Nicholas Green, executive]

Good questions, Max. I think when people are talking to us, we obviously get, I guess, a more biased view of the impact of Biosecure because if you are in China and you're coming to Avid and you talking to me about it, then that suggests that you've already caused the problem. So the person who isn't looking to move on even call me, so I won't even hear their voice. So that one is always a little bit difficult to judge on the total pipeline of customers, are they -- what we're seeing, obviously, is thinking of moving or are moving. So I'm not sure how much I would actually rely on that as a data point.

But I think we've certainly seen an increasing number of conversations around that area. Big Pharma to emerging pharma I think is not necessarily the easiest one. Again, I don't deal with all big pharma, but I would say that we've seen interest in Avid is that interest in Avid more because they're looking at getting rid of somebody else or looking at other alternatives that may be backups it could well be. I think also, it depends on what phase that you're in the biotech phase. I think if you're in early phase, then maybe there's a view that you could get in and out before that occurs, in which case, then you could still source from that region or those people.

In the case of the later phase, then that obviously becomes a little bit more concerning because you may have a regulatory filing that could get caught up in the outcome of whatever the outcome ends are being. So I think I would see the larger concern from what we can see would be probably the later phase clinical candidates that are probably getting more attention than anybody else. But I do hasten to point out that we are not the bellwether of the whole industry. So it's the microcosm that we see.

[Max Smock, analyst]

Yes. Fair enough and a lot of good stuff in there. Maybe following up on an unrelated one. I wanted to ask about Halozyme which obviously, a key customer was over half your revenue in fiscal '23. But that was down to about 1/3 in fiscal 2024. Can you just give us an update around what exactly happened in fiscal 2023? How Halozyme revenues trended so far or trended so far here in the first quarter. You got what you're baking in for Halozyme revenue here in fiscal 2025 and just your overall level of visibility into revenue this year from this key customer.

[Nicholas Green, executive]

Yes. Again, I obviously do know what went on between ourselves and Halozyme. I don't think any of it is negative in any way, shape or form. But I try to avoid commenting on somebody else's business, particularly in a public environment in a public company rather. So I think that I'll leave that one as is. But what I can say is that I think the relationship remains strong. I think that what's been going on over the last few years is nothing but positive as far as I can see. We continue to be the best supplier we possibly can be and service that as well as our other clients to the highest possible standard that we can.

I've said it publicly in the past, I'd love to see the Halozyme revenues continue to grow, and I'd love to see them become a smaller proportion of our business as we continue to grow ourselves and diversify our customer base. And we remain pretty much the same. So I think what I would take out of the last year is that we're still growing compared to where we were over the last few years, and it is becoming a smaller number over the long term, and that's I think, in the direction that we've been articulating. And again, I just hope that we can continue to grow along with Halozyme.

[Max Smock, analyst]

Yes. Understood. And again, not necessarily a bad thing, right? I think it speaks to the strength of the rest of your customer base there. Maybe just sneaking a final one in here for me. I wanted to ask about margins and just whether or not there's any color you can give us in terms of expectations for adjusted EBITDA or adjusted EBITDA margin here in fiscal 2025? And from a modeling perspective, is it reasonable to think about this quarter as kind of being a good jumping off point for the rest of the year and assuming something like that 40% to 60% drop-through rate on incremental revenue that you pointed to in the past?

[Daniel Hart, executive]

Max, good question. It was nice to see that we've built off the momentum of where we were coming off of Q2 of last year, looking into Q3 and Q4 increases and seeing where we ended up for Q4. As far as fall through of overall gross margins right down to EBITDA margin as we continue to grow and approach the guide for this year, I'd like to see EBITDA continue to grow. But as we always say, the quarters can be lumpy. So we will have some pluses and minuses as we grow. But I'd like to see something similar and continue to grow as we go forward.

[Operator]

Thank you. And that does conclude today's Q&A session. I would like to turn the call back over to next closing remarks. Please go ahead.

[Nicholas Green, executive]

Thank you, operator, and thank you to everyone participating on today's call. We are highly encouraged by the progress during the first quarter, and we look ahead to the remainder of fiscal 2025 with some optimism. We thank our customers for their trust and partnership, our investors for their continued support, and we wish to recognize the exceptional employees who continue to drive this success.

Thank you again for participating today and for your continued support of Avid Bioservices.

[Operator]

This does conclude today's conference call. You may all disconnect.