Avid Bioservices, Inc. (NASDAQ:CDMO) Q2 2024 Earnings Call Transcript

Avid Bioservices, Inc. (NASDAQ:CDMO) Q2 2024 Earnings Call Transcript December 7, 2023

Operator: Good day, ladies and gentlemen. And welcome to the Avid Bioservices Second Quarter Fiscal 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference call may be recorded. I would now like to hand the conference over to Tim Brons of Avid Investors Relations Group. Please go ahead, sir.

Tim Brons: 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, 2023. 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, December 7, 2023, 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 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.

Nick Green: Thank you, Tim, and thank you to everybody participating today via webcast. Now, the second quarter revenues were impacted by a number of factors. These are now behind us and we are looking ahead to the second half of the year with some optimism. We closed the quarter with an improved cash balance. We have now completed the expansion program started almost three years ago. Our backlog has achieved a new record high, and as we amend guidance, we expect significant growth over the first half with revenues approximating those achieved in the second half of fiscal year 2023, the highest six months in the company’s history to-date. During the second quarter, our team continued to execute on both business development and operational front.

Despite the financial challenges faced by many of our current and prospective customers, important programs continue to advance. Avid’s commercial team had another strong quarter, securing new business wins of approximately $35 million, resulting in a record backlog of $199 million. This work comes from both new and existing customers, and stabs our capabilities, including our new cell and gene therapy services or CGT services, as I will refer to them. As reported last quarter, while we continue to win more projects in the later phases of clinical development, we were pleased to see several early-stage programs advancing during the quarter and we were delighted to see one of our customers receive FDA approval for a product which we are currently conducting a PPQ campaign to affect its transfer to Avid.

In support of our new CGT services, the company was recently accepted into an industry partnership with the California Institute of Regenerative Medicine or CIRM, which we feel both validates our newest business, as well as increases our visibility in the industry. CIRM is dedicated to the advancement of manufacturing of adeno-associated adenovirus, as well as other cell and gene therapy programs within the state of California, and Matt will provide a bit more information on this partnership shortly. In operations, during the quarter, Avid successfully executed its planned annual major shutdown. Most important, we also completed construction of the company’s CGMP manufacturing suites within our new world-class CGT development and manufacturing facility as scheduled.

The newly launched manufacturing suites are currently undergoing final environmental monitoring and performance qualifications, and as we rapidly approach the start of calendar 2024, we are looking forward to being able to engage with potential customers with our offering complete. Matt and I will provide additional details on business development and operations for the period, following an overview of our second quarter fiscal 2024 financial results. And for that, I’ll turn the call over to Dan.

Dan Hart: Thank you, Nick. Before I begin, in addition to the brief financial overview I’ll provide on the call today, additional details in 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 six months into October 31, 2023. Revenues for the second quarter of fiscal 2024 were $25.4 million, representing a 27% decrease, as compared to revenues of $34.8 million recorded in the prior year period. For the first six months of fiscal 2024, revenues were $63.1 million, a 12% decrease, compared to $71.4 million in the prior year period. The decrease in revenues for both periods as compared to the prior year periods was primarily attributed to fewer manufacturing runs, the reduction in process development services from early-stage customers and the reduction of revenue for changes in estimated variable considerations under a contract where some uncertainties have been resolved.

Gross margin for the three months into October 31, 2023 was negative 18%, compared to 12% for the same period in the prior year. Gross margin for the first six months of fiscal 2024 was negative 1%, compared to a gross margin of 19% for the same period during fiscal 2023. The decrease in gross margin percentage for both periods as compared to the same prior year periods was primarily driven by lower manufacturing volumes and costs related to expansions of both our capacity and our technical capabilities. This included adding staff and associated overhead, including depreciation expense, that will provide critical capacity for near- and medium-term growth. Margins during the three months and six months into October 31, 2023 were also impacted by the decision to defer a customer’s PPQ campaign until after our annual leaven [ph] had shut down, combined with a reduction of revenues for changes in estimated variable considerations under a contract where uncertainties have been resolved.

The decrease in gross margin for the first six months of fiscal 2024 was further impacted by a terminated project relating to the insolvency of one of our smaller customers and a delay in our ability to recognize revenues of a customer product pending the implementation of a process change. Excluding all of these factors, our second quarter and year-to-date adjusted gross margin percentages would have been 2 percentage points and 1 percentage point lower than the reported gross margin percentages in the same prior year periods, respectively. As disclosed previously, we expect the expansion-related costs will continue to affect near-term margins, especially the related increase in depreciation costs. Importantly, as we increase our capacity utilization, we will begin to absorb these increased costs, leading to improved gross profit.

SG&A expenses for the second quarter of fiscal 2024 were $6.6 million, a decrease of 4%, compared to $6.8 million recorded in the second quarter of fiscal 2023. The decrease in SG&A for the second quarter was primarily due to a decrease in payroll and benefit expenses, and other professional fees. SG&A expenses for the first six months of fiscal 2024 were $12.8 million, a decrease of 3%, compared to $13.2 million recorded in the prior year period. The decrease in SG&A for the six months was primarily due to decreases in legal, accounting and other professional fees. During the second quarter of fiscal 2024, the company’s net loss was $9.5 million or $0.15 per basic and diluted share, compared to a net loss of $1.2 million or $0.02 per basic and diluted share for the second quarter of fiscal 2023.

For the first six months of fiscal 2024, the company recorded a net loss of $11.6 million or $0.18 per basic and diluted share, as compared to net income of approximately $400,000 or $0.01 per basic and diluted share during the same prior year period. For the second quarter of fiscal 2024, the company had an adjusted EBITDA of negative $6 million. For the first six months of fiscal 2024, the company had an adjusted EBITDA of negative $3.2 million. Our cash and cash equivalents on October 31, 2023 were $31.4 million, compared to $38.5 million on April 30, 2023. The second quarter cash and cash equivalents balance represents a 26% increase, compared to $24.9 million at the end of the first quarter of fiscal 2024. At the end of the second quarter, we estimate our remaining fiscal 2024 expansion-related capital expenditures to be approximately $2 million.

In other financial news, during the quarter, the company entered into an amendment to its revolving credit agreement with Bank of America. This credit facility was amended to extend the maturity date to October 2024 from the initial maturity of March 2024. This amendment also included an increase in the related interest rate applied to any borrowings under the revolver, an increasingly allowable amount of the debt admittance the company can incur at any one-time or face for capital assets. The other material terms of the credit agreement remained unchanged. While the company has no current plans to draw down on this facility, I would view this instrument as a valuable tool to ensure financial stability. This concludes my financial overview.

I will now turn the call over to Matt for an update on commercial activities during the quarter.

Matt Kwietniak: Thanks, Dan. I am pleased to report that our commercial team had another strong quarter. During the period, Avid recorded bookings of $35 million from new and existing customers, including a meaningful contract signed for the recently completed CGT facility. The company ended the quarter with a record backlog of $199 million, representing an increase of 35%, as compared to $147 million at the end of the second quarter of fiscal 2023. While certain early-stage projects in our pipeline remain on hold pending customer financing events, we continue to see growth in our later-stage and commercial project portfolio during the quarter. As a reminder, later-stage projects are generally larger and take longer to complete as compared to earlier-stage programs.

For that reason, we expect that recognition of our backlog for these projects will extend beyond one year. As these later-stage programs have significantly higher probability of regulatory approval in a shorter timeframe, we believe they are more likely to generate the recurring and ramping commercial revenues associated with such approval. While there is no guarantee that regulatory approval will be achieved for any program, we do believe that our pipeline, which remains weighted toward later-stage projects, offers enhanced opportunity for regulatory success, and ultimately, for stable growth in the medium- to long-term. We are pleased to see continued growth in this segment of our backlog and remain committed to pursuing and supporting projects at every stage of development and manufacturing.

We are, in fact, seeing some improvement in our early-stage pipeline. We remain fully engaged with new and prospective customers at every phase and continue to build visibility for the Avid brand through consistent outreach and industry events. As Nick mentioned previously, Avid joined the CIRM Industry Resource Partner Program to provide development and CGMP manufacturing services to CIRM-funded programs. Currently, CIRM has $5.5 billion in funding from the State of California and has more than 161 active stem cell programs in their portfolio. Avid will assist CIRM’s partners in accelerating gene therapy development and manufacturing through its suite of CDMO services, which span process and analytical development, cell banking, virus banking, drug substance manufacturing and cell finish activities.

CIRM-funded programs will be offered access to Avid services in order to reduce the timelines required to advance through clinical development. All partnership activities will be performed at Avid’s recently launched world-class CGT manufacturing facility. We are very pleased to have entered this validating partnership with CIRM, which we believe will further strengthen our presence broadly among CDMOs, and more specifically, as a manufacturer of CGT products. In closing, I’d like to reiterate how pleased we are with the commercial team’s performance during the second quarter and we are looking ahead with optimism to the 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.

Nick Green: Thanks, Matt. I will provide an overview of the company’s operational activities. First, Avid successfully executed its planned annual maintenance shutdown during the quarter, while this temporary shutdown contributes to the low revenues for the period and it has been a priority, it is an essential activity to ensure the efficiency of our systems and we are very pleased to have this process complete for another year. As we announced in October, we have completed the construction of our cell and gene therapy manufacturing facility on schedule. These newly launched suites, which are housed within the company’s new world-class CGT development and manufacturing facility, are currently undergoing final environmental monitoring and performance qualification.

With the completion of this latest expansion project, Avid has now completed all phases of a broad multiyear expansion and will have deployed upwards of approximately $180 million of capital from 2020 to 2023 into expansions of both revenue generating capacity and technical capabilities. Looking ahead, we are now well positioned to meet the manufacturing needs of current and future customers, advancing both mammalian and CGT products. Today, we estimate that our combined facilities have the potential to bring our total revenue generating capacity to up to $400 million annually, more than triple the revenue generating capacity of our pre-expansion business. And while the operating costs associated with these facilities and service expansions have impacted our margins, we believe this new infrastructure has been a major contributor in attracting the later phase projects currently in our backlog, as well as positioning Avid to serve a large pharma segment of the market previously underserved by the business.

This strategy is already paying off, demonstrated by the increasing customers with whom we work, aligned with a strong weight towards later phase. Further, we are now beginning to onboard projects for utilizing the capabilities offered by our CGT services. When we combine Avid’s new capacity and services with decades of experience in biologics and commercial manufacturing, a track record that demonstrates our focus on quality and the talent spanning early-stage development through commercialization, we believe we have established an organization and brand that will continue to thrive in this growing and attractive market. Not only did the quarter see the completion of our current expansion program, it also saw the cessation of manufacturing in the company’s legacy small scale stainless steel facility.

And while the effect of this impacted the second quarter, as we look forward, Avid now benefits from all its mammalian GMP manufacturing under a single roof, with one of the most modern and high quality facilities available in the industry. This will further enhance the company’s ability to improve margins as we continue the process of growing Avid and filling this capacity. As we are all more than aware, the downturn in the biotech funding has certainly impacted the business in a short. This, combined with other factors we have reported, has led to a disappointing first half of fiscal 2024. And as a result, we are compelled to amend guidance to $137 million to $147 million. That being said, as we look forward, we have an improved cash position, we have seen an increase in our early phase signings during the second quarter, we have completed all our current expansion activities, enter the second half with our backlog at an all-time high and one of the products in our late stage pipeline has already received FDA approval.

As we look more closely at the second half of the year, we anticipate revenues approximating half year of fiscal year 2023, which represents the best half year performance in the company’s history. As we approach the end of our 30th year, we are delighted to mark the completion of what has been a three-year program of increasing capacity, modernizing the asset base, as well as transforming the capabilities of the mammalian business, and at the same time, broadening the Avid offering to include the new CGMP capabilities in both process development and now GMP manufacture. Also during our 30th year, we look back at where we came from, as we retire the old stainless reactors, which marked the start of our CDMO business and close to 20 years of commercial manufacturing.

While the challenge of 2023 has had its challenges, the team has worked diligently in pursuit of our goal. As we enter calendar 2024, Avid is a company with 30 years in biologics manufacturing, a 21-year regulatory track record and more than 200 commercial batches under our belt, operating out of a modern asset base with capacity to accommodate commercial needs of our late phase clinical programs, some of which we hope will soon become commercial products and a business with an increasingly diverse customer base and pipeline. While there will be much of 2023 we will be happy to put behind us, it would not surprise me that we look back at this year as the start of a new phase, not only in how our company looks, but also in the market which we serve.

I feel genuinely blessed to work with a team that has shown the fortitude to undertake such a monumental task and one that has not wavered one bit in the pursuit of the targets we set ourselves and I look forward with a high level of excitement at the prospect of filling this capacity and continuing to guide the future development of Avid. This concludes my prepared remarks for today. We can now open up the call for questions. Operator?

Operator: Certainly. [Operator Instructions] And our first question comes from the line of Jacob Johnson from Stephens. Your question please.

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Q&A Session

Jacob Johnson: Hey. Thanks. Good afternoon. Maybe, Nick, kind of leading off or starting off where you just left off. I guess, can you — on the backlog and the 2Q revenue and the 2024 outlook. So pretty good bookings in the quarter, record backlog, but revenues down year-over-year. Can you just kind of help us square those two items? And I guess along those same lines, you keep pointing to the backlog extending beyond a year. Has these — has that backlog lengthened, like extended even further? Is it taking even longer to close that or are we just waiting for things like this PPQ campaign to hit? I know that’s a lot, but I’ll stop there with the first question.

Nick Green: No. Thanks very much, Jacob, and good question. First to sort of answer your last question, has the backlog extended? The answer to that is no. Pretty much the stable in terms of where it is. So certainly no further spread. I think, at the end of the day, what we’ve seen here apart from some of the things that Dan highlighted in the earnings in the first half, obviously, is the impact of the biotech defunding. But we’ll continue to sign the business and then it really is a matter of bringing through those late phase programs, which are just a lot bigger in size and take longer to execute and you’ve got to line them up. So we’ve got — I mean, I recently published on the website, our investor presentation, which kind of shows you a good indication of the maturity of the pipeline that we have.

And simply to put large volumes of material into that new asset, one has to, first of all, obviously, attract the customer. The second thing then is to execute on the PPQ campaign, which ultimately will lead to a BLA filing and then the commercial volumes that come after that. And I think that, for those of us that are in the market on a day-to-day basis, is that that take that there’s just unfortunately a natural time phase that that takes to execute and once you’ve completed the PPQ campaign, you have to file that data along with the clinical data to the FDA and get approval and then the commercial volumes come. And of course, one of the other issues is, of course, nobody’s going to put a PPQ campaign together with a supplier that doesn’t have that capacity to meet the commercial demand.

So it’s really just a transition of the business as we’ve been trying to highlight from what was originally a clinical company that was with a significant large commercial demand into one that’s got a very much more diverse customer base with a significant number of late phase programs, which we’re just trying to get executed, get that data off and then, obviously, I look forward to at least an industry average of commercial approvals that we can then execute against. And actually, we couldn’t have asked for a better situation than we’ve got right now, which is that as we’re concerning one of those in, they’ve already got approval. So that’s about as fast as it ever goes. So looking forward to that one.

Jacob Johnson: Got it. Thanks for that, Nick. And then maybe I guess for my follow up on what you just alluded to, I think in that deck, you suggest that these later stage opportunities could be $100 million to $200 million revenue opportunities. I think the inevitable question is, what is the timeline for — assuming all goes well and I know that’s impossible for any of us to handicap, but assuming all goes well, what is that — is that a peak revenue that could be five years out or how should we think about the path to that kind of revenue potential?

Nick Green: Well, again, without trying to get into each of the individual ones, because they all have such different profiles, to be frank with you, in terms of the size of the market they serve and also the probability of success. So, I mean, you could have four out of eight, for example, getting approval and if all four of those are small ones and the impact is not that great, if all four of those are the large ones, the impact is enormous and then there’s all the different timelines. So that’s a really difficult question to ask, but to answer rather. But I think in general terms, you look at the sort of growth that we’ve seen in this business in the past, I don’t see — we know the growth in the marketplace going forward and we know the capacity we’ve got.

And you draw those lines and — anywhere between sort of, I think, on the fast side would be three years to fill that capacity. On the longer side, you’re probably looking at somewhere like six years. But anywhere in that window, I think is not unreasonable. Obviously, we’re aiming for as quickly as we possibly could. But it’s — the fact that we’ve got so many is really, really a good strong indicator to us that we will be filling that capacity.

Jacob Johnson: Got it. I’ll leave it there. Thanks for taking the question.

Nick Green: Thanks, Jacob.

Operator: Thank you. One moment for our next question. And our next question comes from the line of Matt Hewitt from Craig-Hallum. Your question please.

Matt Hewitt: Good afternoon. Thank you for taking the question. Maybe the first one, I think, Matt, I think you mentioned in your prepared remarks that you did win a nice cell-gene therapy contractor in the quarter. I’m assuming that’s on the manufacturing side or is that development and did that come through the new CIRM relationship?