Avid Bioservices Inc (CDMO) 2023 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Avid Bioservices Second Quarter Fiscal 2023 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference call may be recorded.

I would now like to hand the conference over to Tim Brons of Avid's Investor Relations Group. Please go ahead.

Thank you. Good afternoon and thank you for joining us. On today's call, we have Nick Green, President and CEO; 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 October 31, 2022. After our prepared remarks, we will open to questions.

Before we begin, I'd like to caution that comments made during this conference call today, December 6, 2022, 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 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 avidbio.com.

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

Thank you, Tim, and thank you to everyone participating today via webcast. Based on the company's performance during the first 6 months, we anticipate that fiscal 2023 will be another strong year for Avid. During the second quarter, the company recorded record revenues for any Q2 period, reflecting increases in both process development and manufacturing work. On the new business front, we signed multiple new customer agreements with both existing and new customers, contributing to our strong backlog.

With respect to the company's facilities, we continue to make progress with our expansions and at the same time, successfully concluding both our Franklin and Myford annual shutdowns. We remain on track to have the Myford expansion complete by the end of quarter 1 calendar 2023. We also expect the new cell and gene therapy facility to come online mid calendar 2023. And finally, to manage our growing business and capabilities, during the period, we added significant talent across a broad range of functions, along with some notable additions to the senior management team in operations, process development and human resources.

Matt and I will provide additional details on business developments and operations for the period following an overview of our second quarter and first 6 months of fiscal 2023 financial results. And for that, I'll turn the call over to Dan.

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 and first 6 months ended October 31, 2022. Revenues for the second quarter of fiscal '23 were $34.8 million, representing a 33% increase compared to $26.1 million recorded in the prior year period.

For the first 6 months of fiscal '23, revenues were $71.4 million, a 26% increase compared to $56.9 million in the prior year period. For both the quarter and the year-to-date period, the increase in revenues can primarily be attributed to increases in process development and manufacturing revenues as compared to the prior year periods. Notably, our second quarter process development revenues were at an all-time high, representing a year-over-year increase of 74%. Gross margin for the second quarter of fiscal '23 was 12% compared to a gross margin of 35% for the second quarter of fiscal '22.

Gross margin for the first 6 months of fiscal '23 was 19% compared to a gross margin of 36% for the same period during fiscal '22. For both the quarter and 6-month period, the decreases in gross margins were primarily due to increases in costs associated with our growth of our business and our facility expansion. The primary drivers of these costs were increases in labor, overhead and depreciation, which accounted for incremental decreases in margins of approximately 11% and 9% for the quarter and 6-month periods, respectively, split roughly 50-50 between our mammalian and cell and gene therapy operations.

It is also important to note that the prior year's gross margin included benefits from unutilized capacity fees. Excluding all of these factors, our second quarter and year-to-date gross margins were in line with the same period of the prior year. We expect the expansion-related costs incurred to date will continue to affect near-term margins. In the coming quarters, we foresee incrementally incurring additional expansion-related costs in line with anticipated growth. Total SG&A expenses for the second quarter of fiscal '23 were $6.8 million, an increase of 36% compared to $5 million recorded in the second quarter of fiscal '22.

SG&A expenses for the first 6 months of fiscal '23 were $13.2 million, an increase of 39% compared to $9.5 million recorded in the prior year period. The increases in SG&A for both the quarter and year-to-date periods were primarily due to increases in compensation and benefits-related costs, legal, accounting and other professional fees. For the second quarter of fiscal '23, the company recorded a net loss of $1.2 million or $0.02 per basic and diluted share as compared to a net income of $3.5 million or $0.06 per basic and diluted share for the second quarter of fiscal '22.

For the first 6 months of fiscal '23, the company recorded net income of $400,000 or $0.01 per basic and diluted share as compared to net income of $9.8 million or $0.16 and $0.15 per basic and diluted share, respectively, during the prior year period. For the second quarter and the first 6 months of fiscal '23, the company achieved an adjusted EBITDA of $1.9 million and $8.1 million, respectively. Our cash and cash equivalents on October 31, 2022 were $77.3 million compared to $126.2 million on April 30, 2022.

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

Thanks, Dan. The second quarter was both busy and productive. We continue to see strong demand in the marketplace for Avid's current offerings as well as interest in the cell and gene therapy capabilities online -- and coming online in the near-term. Our expanded team continues to build visibility within the industry, regularly interfacing with potential as well as existing customers. We've seen an increase in client interaction through face-to-face meetings as well as through our increased presence at trade show conferences.

As a result, we continue to add to our client base. Our new business pipeline continues to be strong, and our proposal values and other leading indicators continue to develop in a very positive manner. During the second quarter, our team signed $26 million in net new project orders, bringing the total new business for the first 6 months of this fiscal year to $67 million. Our backlog at the end of the quarter was $147 million, representing a 23% increase compared to the backlog of $120 million at the end of the second quarter of fiscal '22. We expect to recognize the majority of our current backlog over the next 12 months.

We are already starting to see the impact of the investments made earlier this year in our commercial team as it relates to the leading indicators we measure internally. We anticipate these opportunities converting into backlog as we bring on our new capacity and capabilities. Looking ahead, we believe that the momentum generated during the first half of the year will continue and the team is ready to embrace the challenge and looking forward to a successful second half of the year. 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 period.

Thanks, Matt. I am pleased to report that our team continues to execute according to plan. Our business development team continues to fill our project pipeline on top of a significant year-over-year revenue growth. Our manufacturing team continues to produce and deliver on time while employing the highest quality standards. Our facilities and capabilities expansions remain on track, and we continue to invest in the talent required to ensure success across the business. This consistent execution has strengthened and expanded our customer base and significantly improved the company's financial position as compared to prior years. This is perhaps most evident through our revenue growth.

In the first 6 months of fiscal 2023, our revenues of $71.4 million represented a 26% increase compared to the same prior year period. It is very important to note that this growth is not simply a result of expanding the company's core manufacturing business. During the second quarter, we had a particularly strong revenues from process development services. Specifically, revenues from PD during the second quarter of 2023 exceeded TD revenues from the first quarter by 37% and exceeded our prior high PD revenue mark by 23%. This is particularly encouraging as PD is where the majority of new customers and new projects are on board, and it bodes well for the future growth of the business as a whole and validates our decision to invest in further expansions of both capacity and capabilities in this key element of our business.

As we look forward to the new calendar year and the new capacity we have coming online, we are excited to report that our recruitment in staff required to operate these facilities is progressing well. Our assets require high-quality, well-trained individuals, and in many cases, these must be brought in and trained ahead of time. As we forecast, these investments have impacted and will continue to impact our margins in the short-term. This investment in personnel is essential to meet anticipated process demand. What is particularly gratifying is as we have been making these investments, we have seen continued growth and the growing interest in Avid's offerings further validating the decision taken almost 2 years ago to move ahead with Phase 2 of our expansion.

With the expansions progressing to plan and coming online at the end of Q1 2023, we will be in a great position to start to consume this capacity. And at this stage, we look forward to seeing positive margin development towards our longer-term targets. During the second quarter, we continued to make progress with our cell and gene therapy expansion. As we announced during quarter 1, we have already launched the analytical and process development capabilities for this business, which has allowed us to escalate our dialogue with respect to new customers. We are pleased to report that our first customer is already onboarding in this facility.

With respect to the GMP suites for our cell and gene therapy business, construction continues on schedule, and we expect them to be completed by mid calendar 2023. Based on discussions with prospective customers, we believe this timing will align well with our customers' needs to advance early projects into GMP suites. Likewise, our mammalian cell business capacity expansion is progressing according to plan. During the first quarter, much of the downstream equipment was positioned in the facility and validation of this equipment was initiated. During quarter 2, we installed the upstream equipment. And as we stand today, the facility is mechanically largely complete and validation well underway as we remain on schedule for release to operations during quarter 1 of calendar 2023.

And finally, expansion of our process development capacity is also well underway. As we announced during quarter 1, this PD capacity will provide additional space to onboard future customers, ultimately seeking to utilize the new manufacturing capacity. I am pleased to report that we remain on track to have all the current mammalian expansions complete by the end of quarter 1 calendar 2023. During the quarter, we successfully completed both annual shutdowns in Myford and Franklin alike. It is also worthwhile noting that our shutdown this year was extended slightly to accommodate tie-ins of certain services and the new central utilities plant.

It is an incredibly busy time at Avid. The company is transforming, expanding and growing. And in order to manage this transformation, we recognize the need to bring on expertise and experience to manage and lead our growing workforce. As you have seen during the quarter, we have continued to strengthen our management team. In September, Avis promoted Michael Alston, Jr. to the position of Vice President of Operations. Mr. Alston was promoted from Avid's Director of Project Engineering, a role in which he led all of the company's ongoing facility expansions. Mr. Alston has more than 15 years of experience spanning operational and capital management responsibilities, supporting GMP manufacturing, facilities, engineering and environmental health and safety functions.

Oksana Lukash also joined Avid as Vice President of People. Ms. Lukash has more than 20 years of human resource experience with both established and entrepreneurial organizations across a range of industries. Prior to joining Avid, Ms. Lukash served as Vice President, People and Culture at Oncocyte Corporation, a precision diagnostics company. In closing, I wish to again highlight our accomplishments in the first half of fiscal 2023. Our top line revenues remained strong. Our backlog is substantial and has grown 23% year-over-year. And given the demand we continue to see in the market, we expect it to continue to grow.

As we approach full utilization of our current capacity and with additional capacity and services soon to come online, we expect this momentum to continue. For all of these reasons, I am pleased to report that Avid is increasing its revenue guidance for the full fiscal year 2023 from between $140 million to $145 million to between $145 million and $150 million. This concludes my prepared remarks for today, and we can now open the call for questions. Operator?

Thank you. (Operator Instructions) Our first question comes from Sean Dodge with RBC Capital Markets.

Yes. Maybe just starting with the macro backdrop. There continues to be a lot of concern around biotech funding, the extent to which that's affecting demand just kind of broadly. Nick, it sounds like client interest continues to be strong, but the $26 million you signed in new business in the quarter is lower than it had been running at. So I guess is there anything notable you can share there around -- are you seeing a change in behavior, body language around spending anything around delays and placing new work, reprioritizations, et cetera? Is this just new business can be lumpy quarter-to-quarter and this shouldn't necessarily represent a trend or a theme?

Hello, Sean, and I think the latter point is really the overall overarching comment that I would make is that it is about the lumpiness quarter-to-quarter. We've talked about this before in terms of sometimes people will sign just before the quarter end, which is always great, and some people are signed just afterwards, which is not so great when it comes to reporting quarterly numbers. But if you look at the -- if we look at the sort of backdrop behind that, we're very happy with the amount of interest and the demand, perhaps at least for Avid services that we see in the marketplace. You know, general trends in the marketplace, do we see some of the smaller players who were more cash strapped than others maybe doing a little bit more navel-gazing and taking a little longer.

I think that's probably the case. Sometimes it's always difficult to determine whether that's a macro impact as we only see a relatively small subset of everybody. But overall, in general, we wouldn't be raising guidance and if we were seeing continued strong demand, then -- and I would highlight that we saw the same thing in the last -- the same quarter last year as we did in this one, it was a little lower, but not -- again, there was no general influence of the strength of the market as we see. So we remain optimistic as far as the interest in Avid.

Okay. Great. And then, Dan, just on margins and trajectory over the next several quarters. I guess the question is, are we pretty much at the bottom here? You talked about Myford Phase 2 set to open very soon and the weight that the growth-related investments are adding to margins. And as those facilities open and become revenue producing, I guess, should the trajectory of margins, the direction of margins from here be upward?

Hello, Sean. Thanks for the question. Good question. As far as looking forward, I'm still confident that we will see incremental margins as we start to fill new capacity and start to absorb some of the costs that we brought on. We've invested aggressively through the second quarter and getting the folks in place and some other operational costs for the expansions and the standing up of the cell and gene therapy business.

Going forward on the cost side, we plan to make some further investments but we're going to make that investment in line with the anticipated growth. So essentially, as we start to roll out the new capacity and start to fill that new capacity, we should be able to move towards incremental margins and ultimately get to that margin goal that we've discussed in the past.

Okay. Great.

Our next question comes from Matt Hewitt with Craig-Hallum Capital Group.

Congratulations on the progress on building up the new capacity. Maybe the first one for me. As you talk to customers -- well, I guess, let's back up. You made a comment in response to one of the prior questions about some orders coming in late in the quarter, some coming in right after the quarter closed. Can you talk about -- has anything closed already this quarter?

Matt, can't really talk about the next quarter as we just conclude the prior quarter. But again, I just go back, we've raised guidance. We've obviously brought in the labor ahead of the capacity coming online for a reason. We remain very optimistic regarding the interest in the business that we see. And again, we see lumpy quarters that we've had them in the past. We have some lumpy good ones, and we have some lumpy not so good ones. It's not a trajectory of the overall business, which I think is pretty clear.

Got it. And then maybe one of your peers had talked a little bit about not just kind of delays or dragging of the feet and signing new contracts, but even on the payment side. Now looking at your DSOs for the quarter, I think I'm coming up with 54 for the DSO here in Q2. But are you seeing any of that from customers? Or are payments coming in as you would anticipate?

From our side, Matt, payments continue to come in as we would anticipate. I do see some more conversation than we've had in the past. But, yes, as you can see with the DSO dropping, I think it's approximately 20 days or so from the prior quarter. People are still paying.

Fantastic. And then maybe one last one, and then I'll hop back in the queue. But as far as your conversations with customers, both existing and new customers, as they look at this new capacity and the timelines for those to come on, are you hearing from those prospects, some excitement that, hey, this is going to work out perfectly with our internal timelines. Is anybody pushing you to maybe try and get something done a little bit faster, I guess, just what are you hearing from your customers?

Yes. I mean, I think Matt alluded to that, and I'll let him add to any comments I make if you've got anything further, Matt. But I mean, I think we've had some really good response to the facilities. It's been really quite nice over the last few months, probably the last 5 to 6 months, if not more, to our people around without having to go up and go and see every little bit of it and [indiscernible] around the flows and the like. And I think we've had nothing but good comments -- positive comments and people are very happy that this sort of high-quality capacity alongside Avid's offering is going to be available shortly. So we're delighted to have -- be standing that up in the very near future.

I think timing is pretty much close to ideal. I mean obviously, I think on the first phase of expansion that we did last year with [DS 1 -- DSP 2], we -- our backlog actually hit our capacity in the same quarter we brought it online. So we look to do that again this next quarter coming up. And if we did that, then I don't think we could have timed it any better. So again, my summary would be lots of really good interest and just excited to have it online and then starting to fill it and then absorb some of those costs that we've invested in ahead of time and see that progression in margin. Matt, anything further on your side?

No, I think well said. I think it's accurate, a lot of client interest in the build-out and the additional space and a lot of excitement and positive really great feedback. We've had a number of clients come out and actually tour the site as was early on in construction and eager to get back and see how the progress is going and get engaged. So it shows very, very well, and there has been a lot of interest. So we remain optimistic for sure.

That's great.

Our next question comes from Jacob Johnson with Stephens.

As we think about kind of forward-looking KPIs, I think backlog was a bit shy of what many of us expected, but that you also had a record quarter in process development. Can you just talk about how -- what that record quarter in process development could mean as we think about looking forward? And then just a related question. Can you remind us kind of how much process development capacity you have today and maybe where you are in the PD capacity expansion on the biologics side?

Yes. So the PD is, in my view, a really encouraging sign. I mean when somebody takes transfers the project into the business, typically, it will go in, we'll do some small-scale runs in PD. Depending on the client, obviously, we may do some work on that process or if the process are well-developed, we're just basically sort of demonstrating what they've already told us ready to moving it across into the manufacturing facility. So it's really the front end of the business where things are coming in.

So I just see those sort of revenues in there for me is a good indication that people are getting in. And then obviously, we hope to see those people move from small to leader scales up to the larger 2,000 ultimately. So that to me is a really good indicator for -- to where the business is heading. And then in terms of the capacity, the $7 million this quarter is actually over-capacity. I think we've often talked about capacity as a little bit of a fungible number because it's not a perfect science. It can vary between certain different activities and whether you're doing campaigns and all that sort of thing.

So we actually beat our capacity. We would have had our capacity down somewhere around $5 million for the quarter, and we hit $7 million. So that was really sort of a super quarter. In terms of where the capacity is going, so $5 million would give us $20 million a year annual. We are doing the expansion that comes on in quarter 1 as well. And that would give us then effectively $40 million or $10 million a quarter. Obviously, give or take, based on the super performance in the last quarter.

Got it. And then just as a follow-up to maybe put a finer point on the gross margin discussion. I think cost of goods sold up sequentially. You called out a variety of things, but it sounds like a lot of hiring. And I don't know if there's a way to quantify kind of the number of people you have and the revenue that would support. But could you just talk about maybe as we think about the journey of staffing up the various capacity expansions, how much you accomplished during this quarter and maybe how much is left to go going forward?

So Jacob, so on the gross margin front, as far as heads, we ended the quarter with approximately 360 folks, which is up significantly over where we were last year. Looking forward, as far as how many heads do we need to bring in, that's kind of a function of what the anticipated growth looks like and as we start to fill and backfill or add the specific needs that we see in the different groups. Yes, I think that's essentially kind of where we're at, why we see that we'll -- as we start to fill these expansions and start to load some of that additional revenue within that capacity, we'll be able to absorb some of those costs as we move forward.

Yes. And I think the other part I'd add as well, Jacob, is that you've seen the sort of costs come into the organization in different areas. So for example, we started beefing up the commercial organization with additional BD representation. We also increased marketing and increased proposal rises and all those sort of things that are all on the front end with 0 revenue associated with those. The initial BD [calls], the marketing stuff, all of that doesn't get any revenue. So that certainly hits the margins in the short-term. Again, I don't think we need very large numbers of increases in those areas to fill out those facilities. So we don't need to repeat those as we go forward.

And that sort of goes then also through the organization as you start to bring in project managements and things like that, that have got to onboard these in PD. And then ultimately, as we see going forward and I think this is where you'll see more of the growth as we go forward is in the more hands-on operational people where they're actually making the batches. So what you've seen is the early investment and that effect a little hit on margin is by standing up all the things that you need to get the business in. And then as we go forward now, then we'll start to just supply the people which is kind of the -- you had a variable cost associated with the [indiscernible].

Got it. That's helpful context.

(Operator Instructions) Our next question comes from Paul Knight with KeyBanc.

Nick, I didn't quite catch the number of process development revenues and how much that number was up in the quarter.

So process revenues, I think, is about $7 million, Dan?

$7.1 million for the quarter, and it was up 74% year-over-year.

Okay. And then is this in cell and gene therapy development or monoclonal or both?

It's in both, but primarily in monoclonal.

Okay. And the -- I guess a question for Matt and that is what are customers responding to -- well, what's giving Avid the edge on some of the larger competitors today?

Yes. I think the available capacity, I think the track record of success, the quality background, I think, resonates very, very well. I think our approach to dealing with clients is unique in that we're accommodating and flexible and a good partner to work with. So the clients respond well to that. So a lot of active engagement for sure.

And Matt, what's your customer? Is it large biopharma, medium, small? Is there a profile that they like or they fit in your view?

It's -- at this point, it's all of the above, everything that you mentioned. We had brought on someone to manage key accounts for us 6, 9 months ago. And we're already seeing an impact there and always -- had already previously been engaged with the small and emerging biotechs and that continues. So we're encouraged by the add each quarter of new client base as well as additional work from existing client base.

Okay. And Nick, a question for you, and that is can you talk to -- in your opinion, is there still tight supply in monoclonal manufacturing? And secondly, how is the supply chain for you in getting things brought online and produced?

Yes. So I mean I think when you -- you've always got to look at the mammalian capacity in some of the segments that you operate in. And when it comes to sort of commercial grade, high-quality mammalian capacity, we still see plenty of a shortage of capacity, I would say. We see lots of demand for what we're doing. And I think that's the only explanation you can have really [for the steps] to see in the demand that we are doing. So in terms of the supply chain itself, again, it's one of those things that just seems to continue to slowly get better. I wouldn't say it's perfect by any stretch of the imagination.

So we still do scramble for things here and there. We are able to anticipate some customer demands. So we do find that customers will come here where there maybe is a shortage in the market. And fortunately, we have actually have the various components available so we can move quickly on that one. So it continues to get better, not where it needs to be and still a little bit variable because it's not always in the same place where you see the shortage, which makes it difficult to manage. But again, quarter-on-quarter, better than previous.

Thank you. And I'm not showing any further questions. I would now like to turn the call back over to Nick Green for any closing remarks.

Thank you, operator, and thank you to everyone participating on today's call. In closing, I would like to emphasize our excitement as we draw closer to launching our new capacity and capabilities. This could not be possible without the hard work of our many talented employees who drive and take pride in Avid's continued success. Thank you again for participating on today's call and for your continued support of Avid Bioservices.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.