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spk03: Good day, ladies and gentlemen, and welcome to the AVID Bioservices Third Quarter Fiscal 2023 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 Bruns of AVID's Investor Relations Group. Please go ahead.
spk01: 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 Quitniak, 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 January 31st, 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, March 13th, 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 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.
spk04: Thank you, Tim, and thank you to everyone participating today via webcast. The third quarter was another positive period for AVID. On the financial front, revenues remained strong for both process development and manufacturing, and margins are beginning to trend upwards due to an increase in utilized capacity. Our business development team was highly productive, signing a significant number of new business agreements during the quarter, pushing our backlog to a new record high. Our facility expansions continue to progress well. The Myford South expansion has been handed over to operations and is now complete. Further, our new process development capabilities will be operational in a few weeks. We also expect our new cell and gene therapy facility to come online later this year. Matt and I will provide additional details on business development and operations for the period following an overview of our third quarter and first nine months of fiscal 2023 financial results. And for that, I'll turn the call over to Dan.
spk07: 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 nine months into January 31st, 2023. Revenues for the third quarter of fiscal 23 were $38 million, representing a 21% increase compared to $31.5 million recorded in the prior year period. For the first nine months of fiscal 23, revenues were $109.5 million, a 24% increase compared to $88.4 million in the prior year period. For both the quarter and the year-to-date periods, the increase in revenues can primarily be attributed to increases in manufacturing runs, process development services provided to new customers, and revenue recognized in the current period for changes in estimated variable consideration related to a contract where uncertainties have been resolved. Gross margin for the third quarter of fiscal 23 was 26%. compared to a gross margin of 29% for the third quarter of fiscal 22. Gross margin for the first nine months of fiscal 23 was 21%, compared to a gross margin of 34% for the same period during fiscal 22. For both the quarter and nine-month periods, the decreases in gross margins were primarily due to increases in cost associated with the growth of our business and our facility expansions. The primary driver of these costs were increases in labor, overhead, and depreciation, which accounted for incremental decreases in margins of approximately four percentage points and seven percentage points for the quarter and nine-month periods, respectively. It is also important to note that the current year third quarter and year-to-date margins benefited from a change in variable consideration under a contract where uncertainties have been resolved. And the same prior year period margins included a benefit from unutilized capacity fees. Excluding all of these factors, our third quarter and year-to-date adjusted gross margins were 30% and 28%, respectively. An increase as compared to the prior year third quarter and year-to-date adjusted gross margins of 26% and 27%, respectively. We expect the expansion-related costs incurred today will continue to affect the year-term margins. In the coming quarters, we foresee incrementally incurring additional expansion-related costs in line with anticipated growth and to support an anticipated ramp up in capacity utilization of substantial asset additions. Total SG&A expenses for the third quarter of fiscal 23 were $7.1 million. an increase of 22% compared to $5.8 million recorded in the third quarter of fiscal 22. SG&A expenses for the first nine months of fiscal 23 were $20.3 million, an increase of 33% as compared to $15.3 million recorded in the prior year period. The increases in SG&A for both the quarter and year-to-date periods are primarily due to increases in compensation and benefit-related costs, legal, accounting, and other professional expenses. For the third quarter of fiscal 23, the company recorded a net income of $500,000 or one cent per basic and diluted share as compared to a net income of $2.2 million or four cents per basic and diluted share for the third quarter of fiscal 22. For the first nine months of fiscal 23, the company recorded a net income of $900,000 or one cent per basic and diluted share as compared to net income of $12.1 million, or 20 cents per basic and 19 cents per diluted share, respectively, during the prior year period. For the third quarter and first nine months of fiscal 23, the company achieved an adjusted EBITDA of $7.4 million and $15.4 million, respectively. Our cash and cash equivalents on January 31, 23, were $60 million, compared to $126 million on April 30, 2022. We continue to make great progress on our facility expansions. As of the end of the third quarter, we estimate our remaining expansion-related capital expenditures to be between $27 million and $30 million. Upon completion of these expansion projects, we estimate that our combined facilities will have the potential to bring our total revenue generating capacity to up to approximately $400 million annually. depending on the mix of future customer projects. This concludes my financial overview. I'll now turn the call over to Matt for an update on commercial activities during the quarter.
spk08: Thanks, Dan. During the third quarter, the business development team continued to be very active in the industry, maintaining a strong presence at trade meetings and remaining highly engaged with existing and prospective customers. As we outlined last year, We felt that AVID's offering and capacity would not only be attractive to our current customer base, but it would also allow AVID to be viewed as a strategic supplier to big pharma accounts that require not only strong functional disciplines, but also a critical mass in terms of capabilities and capacity. To this end, our expanded business development team included a new position focused on large pharma accounts. We feel our BD strategy is starting to pay off. as one of the most noteworthy achievements during the period was AVID's new designation as a preferred provider for a top pharma company, an important strategic achievement as we continue to expand and diversify our customer base. In addition, other large pharma companies have already visited the facility and have conducted audits or have committed to doing so, which we view as very positive developments. We remain active in our interactions with the industry and our leading indicators remain strong. I am pleased to report that our team signed 67 million in net new business agreements during the quarter. This represents our second highest quarterly signing to date for the company, only behind the third quarter of fiscal 21 in which we signed a significant COVID-related agreement. In addition to the total dollar amount signed during the quarter, we also signed a significant number of new customer agreements during the period. In fact, the number of new customer signings during the third quarter of fiscal 2023 represents approximately half of the signings during all of fiscal 2022. As a result, our backlog achieved a new record high of 176 million at the end of the third quarter. While we expect the majority of this backlog to be recognized over the next 12 months, some of which may be recognized over a longer period, depending on the maturity of the project. Importantly, New proposal requests remain robust, a solid signal for the quarters ahead. We are very pleased with the performance of our commercial team and the significant success that they've continued to deliver, and we remain optimistic for a strong close to 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.
spk04: Thanks, Matt. During the third quarter, our team continued to make significant progress towards a number of important milestones for the year. As of the end of this month, we will have only one of our expansion projects still ongoing, with all the others, including MiFID South, the downstream processing expansion, along with the process development in both the melee and non-cell and gene therapy, all complete on schedule. Quarter three revenues also maintain our momentum towards achieving the guidance which we raised last quarter. Allied with strong top line performance, we were also pleased with the positive margin development as we increased utilization. As reported by Matt, our commercial team had another exceptional quarter with signings totaling $67 million. This represents the largest non-COVID related signing for a quarter that we have had in the company's history. Naturally, these new project wins have further expanded and diversified our customer base and significantly bolstered our backlog, which for a brief period at the end of the quarter exceeded our then current operating capacity. Given this demand and the fact that our backlog has hit a new high, we feel the timing could not be better for Avid to complete our mammalian cell facilities expansion. which will provide new state-of-the-art capacity to accommodate our growth in backlog. The Myford South expansion has been handed over to operations and is now complete. And we are pleased to report that our first customer is scheduled to begin manufacture next month. Further, our new process development capabilities will be operational in a few weeks. While this expansion was only initiated in June of 2022, Later this week, our PD staff will start the move into their new space, and we will then have even more capacity to onboard new clients destined to fill the new manufacturing capacity in MyFit. This is also well-timed, with the team posting another impressive quarter and PD revenues exceeding more than $18 million year to date. Our team has worked tirelessly over the last few years to complete the MyFit expansion. which we believe will not only allow us to service the backlog that we have today, but to continue to attract the new business that will fuel our next level of growth. This has been a long and complex process, which has required a great deal of coordination and collaboration, and one that has been executed with a great deal of professionalism every step of the way. I wish to extend a profound thank you to our exceptional team for making this expansion a reality. Parallel to this work, the company continues to make progress with the building out of its new cell and gene therapy facility, which we expect to come on open later this year. As we reported previously, we have already launched the analytical and process development capabilities for this business, and we currently have projects ongoing in these areas. As with operations and business development, the third quarter was a strong one from a financial perspective. we continue to log year-over-year revenue growth for both the quarter and the first nine months. During the quarter, we have seen positive margin development, and looking forward, we anticipate increased utilization will continue to drive this positive trend. In closing, I would like to emphasize that we are extremely pleased with the first three quarters of fiscal 2023. Our revenues remain strong, And we are on target to hit our revenue guidance for the full fiscal year 2023 of between $145 and $150 million. Combined, our revenues and increased capacity utilization are having a positive impact on our margin. Our commercial team continues to impress with significant new business wins from both existing and new customers. And finally, our facility expansions are nearing completion. providing an additional capabilities and capacity to drive Avid's next phase of growth. 2023 marks Avid's 30th year in the field of biologics and the 18th year of commercial manufacture. Over time, Avid has built a reputation as a true commercial grade CDMO capable of supporting its customers throughout the product lifecycle from cell line development to commercial manufacture. and one able to support customers' drug substance needs around the world. We believe the investments in capacity and capabilities over the past few years positions Avid as a top CDMO in the provision of mammalian cell-derived drug substance in North America. This concludes my prepared remarks for today. We can now open the call for questions.
spk03: as a reminder to ask a question you will need to press star 1 1 on your telephone please stand by while we compile the q a roster our first question comes from the line of sean dodge of rbc capital markets your question please sean yep thanks uh good afternoon uh and congratulations on the the strong bookings result um so the bookings looking back q3s have always
spk06: seasonally been the strongest, at least over the last several years. But Matt also mentioned the heightened interest now from large pharma. So I guess when we think about the $67 million level, how do you feel about that being a pace you can sustain going forward?
spk04: This is Nick Cashon. Thanks very much. I think, as we've always highlighted, that you do get swings in the amount of backlog or orders that we manage to post each quarter, but I think what you've seen is a pretty steady increase in backlog over the years. Not necessarily quarter to quarter, but certainly if you take a longer term view on it, we'd expect that to continue, but I think it'd be difficult for me to turn around and and suggest that we'd be signing 67 every quarter. So I think just like to see continuing on the trend that we've got for now.
spk06: Okay. Fair enough. And then, Dan, your comments around gross margin going forward, I just want to make sure I'm clear there. It sounds like for at least the next handful of quarters, we should expect cost and revenue kind of growing in line. So I guess the short answer there is maybe think about gross margin being kind of pretty flat sequentially somewhere in this 28% range after adjusting for the one-time items you mentioned.
spk07: Yes, Sean. So pulling out those one-time items, that's the run that we would be at. You know, I would just reiterate with, as we've been mentioning throughout this fiscal year, We've been investing aggressively in people and the build-out of our expansions. Further costs from, I'd say, this point forward would be in line with anticipated growth. We're at a point where the expenses are, I would say, flattening out as far as a ramp from prior quarters. So with that flattening out, that's where we believe that our margins will further be strengthened as we convert backlog and as our capacity utilization increases. Okay. That's great.
spk06: Thank you.
spk04: Yeah, just to add to that, Sean, I mean, I think, again, with the critical mass that we've got, it's obviously getting better over time, but there's always that sort of quarter-to-quarter fluctuation that we see. It's not a smooth line as much as we might always like it to be, but I think if you, again, take a slightly longer period, then you'll see that there's a general trend to the positive, which is kind of what we're looking for. But that doesn't mean to say that we don't go through a quarter where we have, for example, the shutdowns that we've seen in the past to lower revenue and the margins to suffer accordingly. So it's, I wouldn't say a bumpy road, but a fluctuating one.
spk06: Okay. Sure. Thanks, both.
spk03: Thank you. Our next question comes from the line of Matt Hewitt of Craig Hallam. Matt, your line is open.
spk02: All right, thanks. I'll echo. Congratulations on a strong quarter. Maybe first one, given the events over the weekend and what was already a very challenging environment from a funding perspective, what are you hearing from Customers that on the smaller end of the spectrum obviously you're moving to large pharma should Help, but what are you hearing from the smaller customers as far as funding? You know cash positions are you know are you seeing any movement with some of those contracts?
spk04: Yeah, I mean I think As you highlight the sort of funding environment for biotech has been I guess stressful for a while and You know, average portion of 50% of our revenues roughly somewhere close to that is commercial. And so obviously then as you add some big pharma to that, then that also then sort of reduces the amount of exposure to small biopharma, but they're still a very, very important part of our business. We've seen, I think, generally the market being sort of price conscious, sorry, cash conscious. When you're having discussions with customers, I always joke with Dan a little bit, you can always hear Dan speaking in the background saying, be cautious with the cash. I think what we're seeing is people maybe prioritizing later phase projects. Again, it's always difficult for us to see how much of that is real and how much of it is us because we actually probably do more later phase than earlier phase typically. maybe less effective by that. But I think it would be difficult for anybody to say that you can't see some sort of, I guess, responsible behavior going on in the marketplace with regards to making sure they have adequate cash.
spk02: That's really helpful. Thank you. And then maybe a second question. As far as the cell and gene therapy manufacturing pipeline, could you give us an update there? Obviously, once that comes online, how quickly do you think you'll be able to get that first contract kicked off and start utilizing some of that capacity. Obviously, you've had a lot of success with the capacity so far. I'm just curious on how that pipeline is looking. Thank you.
spk04: Yeah, I mean, we've talked to a lot of people. We've had a lot of site visits, which to me is always a strong indicator. It's been a bit interesting. I would go back to pre-COVID, and I would always say that if a client hasn't been on site, then they're never going to sign a piece of business with you. But clearly, during COVID, that wasn't the case. So it's trying to get you to a new norm, but we're certainly seeing a lot of interest, which gives us a lot of confidence that once we kick off the new GMP facility that people will be looking to go into there. I think the CNGT area has been impacted by funding a little more maybe than mammalian side over the past few years but we certainly are seeing continued interest in in what we do and you know again it goes back to the I think ensuring that you provide high quality assets and high and good strong quality culture there's always a place for that so we're we're hoping that that when we get to the facility up and running then we will see those interesting conversations and site visits converting to business
spk02: That's great. Thank you.
spk03: Thank you, Matt. Thank you. Our next question comes from the line of Jacob Johnson of Stevens. Your question, please, Jacob.
spk05: Hey, thanks. And I too will say congrats on a nice quarter, a nice backlog. Maybe first for Nick or for Matt, I'm just curious on the the new business development addition to go after large pharma. I'm curious about the strategy there. I mean, I think probably unfairly people might not think a, you know, quote, unquote, smaller CDMO like AVID would work with larger pharma. Again, probably unfair. But if you could just maybe touch on the strategy there. And I assume large pharma probably, you know, they don't just work on blockbuster drugs. And so there's probably plenty of things you could handle. But I figured I'd give you the forum to chat about that.
spk04: Yeah, thanks, Jacob. You broke up in the middle of that, unfortunately, so let me just clarify, you're asking about Big Pharma and why they're looking at Avid, am I correct?
spk05: Yeah, I apologize if I broke up, but yeah, I'm just kind of curious about the strategy going after large pharma and where Avid can help out large pharma customers in case, you know, and I think it's something investors uh, might not think of when they think of Avid. Yep.
spk04: No, absolutely. Um, good question. So no, I mean, I think, you know, what Avid has done over the last few years, obviously we spent a significant amount of capital on enhancing our capabilities, but also our capacity. Um, uh, you know, I, I, I actually love walking around the new facility now and, or even though they won't let me in anymore because it's all tied up and buttoned up ready for manufacturing, but, uh, we can look through the windows. It really is, you know, a fantastic facility and views very well. We've supported that with the process development capability and capacity again. So it's really a very strong value proposition to Big Pharma. And if you look at molecules, you know, today, I was only reading an article the other day looking at the number of molecules that will be sub-100 kilos of protein going forward that are currently in phase three. And there's a significant number of those, and some of those exist in big pharma. So, you know, it's not always about blockbusters. There's often drugs in smaller populations and the like. And I think, frankly, that's where the industry is heading as we've obviously cured a lot of the big blockbuster issues disease states then obviously we have to focus on the smaller disease states and as the drugs become better and more targeted and more therapeutic then obviously the the scale of the reactors comes down and then you've got the manufacturing yields that go up on top of that as well so you know reduced indications increase yields means that the 2000 leader platform becomes ever more relevant for both emerging and big pharma and can be a a commercially viable platform to launch from. And even if you've got a larger molecule and you're maybe a small or a medium-sized farmer, do you really want to go out and bet everything on going out and qualifying it at a very large scale as opposed to maybe getting your process qualified, succeeding with your VLA, and then moving on and maybe adding a second supplier who has larger larger capacity at a later stage. So the offering is across the board to small, medium, and large pharma today, I believe.
spk05: Thanks for that, Nick. And then maybe just one for Dan. I appreciate kind of the outline of the CapEx left on the expansion projects. Maybe just if you touch on kind of two dynamics as it relates to cash flow, just now that this capacity is a lot of this capacity is online and you start running revenue through it and getting the margin on that along with, you know, the additional capacity investments you're making the next couple quarters. You can just talk about the outlook for cash flow in the near term and maybe beyond as well.
spk07: Sure. Thanks for the question, Jacob. As I outlined in the prepared remarks and within the filings today is The estimated capital spend for this fiscal year is going to be roughly $90 million. Through the third quarter, we've had cash expenditures of 53, and we had incurred 24, which that will flow through our fourth quarter here. Looking ahead, there's an additional roughly $25, $27 million left of capital to be spent to close out all of the facilities. And those facilities, you know, some of that cash lingers past, you know, once those get commissioned as things get closed out. But looking forward, we firmly believe that the existing cash and cash flow events on hand and the cash from operations going forward are sufficient to fund the operations.
spk05: Got it. Thanks for that. Appreciate it.
spk03: Thank you. Our next question comes from the line of Paul Knight of KeyBank. Your question, please, Paul.
spk09: Yeah, Matt, could you talk to that earlier statement you made about new customer signings are one half of what backlog built over the last 12 months? Was that the comment?
spk08: No, it was new client signings in the period was equal to half of the prior year, number of new clients. Got it. Yep.
spk09: The other question, Nick, is you mentioned earlier in your call about 400 million capacity. That seems a touch higher than in the past. Are you seeing better yields, anything behind that 400 million potential?
spk04: Yeah, I mean, I draw your attention first and foremost, I guess, to process development. We've always kind of said that PD was 20 million capacity, but they've already done 18 year to date. So clearly, they're doing better than that. So we've seen something similar in the other areas of the mammalian capacity that would suggest that it's certainly 400 plus today. So it's really the throughput that we're actually getting. Again, I wish that it was a perfect science. Sometimes it's product mix. Sometimes it's process efficiency. So it can vary. And there's always a little bit of an element of judgment. But I think it's, I feel, well, certainly we wouldn't be saying it if we didn't feel very confident that it was 400 plus.
spk09: And then the last question, Nick, would be, you know, we see the capacity announcements from Lonza, from Catalan, from WUSHI, et cetera. And with this capacity going on, yet your success at building backlog, what do you think people are liking about AVID relative to what others are as well doing in terms of capacity?
spk04: I'm certainly not going to comment on anybody else. That's for them. But I mean, again, Paul, it's really Worrying about everything and focusing on everything. So it's a solid quality basis. I think that's the quality culture that was here, I think, coming back even to Peregrine days and before, well, certainly back to the Peregrine days and before, it's a solid quality culture. Maybe comes out of being that one step closer than a CDMOT to the patient. um on top of that building solidly assets the assets on the end of the day is what you build a facility on then you build the quality on top of that then you build a quality system then you build the quality culture and i think that's the way that we've built the business we have a strong um a strong ethos here that we're as only as good as the last batch we made so a really strong focus on everything that you're doing day in day out um It goes back to a little bit from England, so my football or soccer analogy that you don't win the Premier League over 38 games, you focus on every one. And after 38 games, you've either done it or you didn't. So we just take that mentality every day. And then we've also done a lot to standardization across the company. So we have a standardized platform on the upstream, a standardized platform on the downstream. We have high-quality assets. A very large portion of our assets today are either brand new or only seven years old. And then minimizing the amount of variability means that you thaw on time, you deliver on spec, and with the desired yield. So I wish I could focus on one thing because that would make my job real easy, but it's a little bit more complicated than that, I'm afraid.
spk09: Thanks.
spk03: Thank you. I would now like to turn the conference back to Nick Green for closing remarks. Sir?
spk04: Thank you, operator, and thank you for everyone participating on the call today. In closing, I would once again like to acknowledge the exceptional employees and their impressive achievements. It truly is the dedication and professionalism of our team that has driven Abbott to success to date. We look forward to the new opportunities ahead. Thank you again for participating today and for your continued support of Avid Bio Services.
spk03: This concludes today's conference call. Thank you for participating. You may now disconnect.
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