Avid Bioservices Inc (CDMO) 2022 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Avid Bioservices Second Quarter Fiscal 2022 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; and Dan Hart, Chief Financial Officer; and Matt Kwietniak, Avid's Chief Commercial Officer. Today, we'll 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,

2021. 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, 2021, 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 who has dialed in and to those participating today via webcast. I am pleased to announce another strong quarter at Avid. Beginning with our financial results for the sixth quarter in a row, we have recorded an increase in revenues compared to the prior year period. On the new business front, our team signed numerous new clients and new orders further strengthening our pipeline. Finally, with respect to operations, the company successfully completed its annual maintenance shutdowns and broke ground on the Myford South construction.

Most significantly, the company recently announced its expansion into viral vector development and the manufacturing services for cell and gene therapy products. We believe this area offers significant opportunity for growth, and we are very excited to begin offering services to this sector.

Before I turn the call over to Dan for a review of the financial results, I would first like to welcome Matt, Avid's new Chief Commercial Officer to the call. Matt is an accomplished senior global sales executive with a proven track record of driving revenue growth.

In his new role, he will be responsible for the continuing growth of Avid' business through the ongoing expansion of the company's commercial and clinical client base. We are extremely pleased to have Matt join our team and we look forward to working with him. Matt and I will provide additional details on business development and operations for the period following an overview of our second quarter 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 second quarter 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 6 months ended October 31, 2021. Revenues for the second quarter of fiscal 2022 were $26.1 million, representing a 24% increase compared to $21.1 million recorded in the prior year period. The increase in revenues can primarily be attributable to fees received from a customer during the current year period for unutilized reserved capacity combined with an increase in our process development revenues, primarily associated with services provided to new customers.

For the first 6 months of fiscal 2022, revenues were $56.9 million, a 22% increase compared to $46.5 million in the prior year period. The increase in revenues for the first 6 months of fiscal 2022 can primarily be attributable to an increase in fees received from customers for unutilized reserved capacity combined with an increase in process development revenues primarily associated with services provided to new customers.

Gross margin for the second quarter of fiscal '22 was 35% compared to a gross margin of 30% for the second quarter of fiscal 2021. Gross margin for the first 6 months of fiscal '22 was 36% compared to 32% for the prior year period. The increases in gross margin for the quarter and the first 6 months were primarily from higher manufacturing and process development revenues during these periods. While we are pleased to report these improvements in gross margin compared to prior years, we do expect to increase hiring in the coming months to support our growing manufacturing capacity and our new viral vector business, and this may impact margins in future quarters.

Total SG&A expenses for the second quarter of fiscal '22 were $5 million, an increase to 21% compared to $4.2 million recorded for the second quarter of fiscal '21. For the first 6 months of fiscal '22, SG&A expenses were $9.5 million as compared to $8 million for the prior year period.

The increase in SG&A during the quarter and the first 6 months was primarily due to increases in stock-based compensation, facility and related expenses, advertising costs, partially offset by a decrease in payroll and benefit-related costs. For the second quarter of fiscal 2022, we recorded net income attributable to common stockholders of $3.5 million or $0.06 per basic and diluted share as compared to net income attributable to common stockholders of $800,000 or $0.01 per basic and diluted share for the second quarter of fiscal '21.

For the first 6 months of fiscal 2022, the company recorded a consolidated net income attributable to common stockholders of $9.8 million or $0.16 and $0.15 per basic and diluted share, respectively. Compared to a consolidated net income attributable to common stockholders of $4.5 million or $0.08 per basic and diluted share for the fiscal 2021 period.

The second quarter of fiscal '22 was the company's sixth consecutive quarter of operational profitability, and we are pleased to report that we achieved adjusted EBITDA of $7.6 million during the second quarter and $17.3 million for the first 6 months of fiscal '22.

Our cash and cash equivalents on October 31, 2021, were $163.7 million compared to our first quarter balance of $159.7 million on July 31, 2021, and prior fiscal year-end balance of $169.9 million on April 30, 2021. We are updating our previously announced planned capital spend for fiscal year '22, from $50 million to $60 million to approximately $55 million to $65 million, which now includes anticipated spend on the viral vector facility.

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

Hello, everyone. I am very pleased to be participating in my first earnings call as Avid's Chief Commercial Officer. Throughout my career, I have had the good fortune of working with many leading companies in the development and CDMO sectors. And in each role, I've been charged with driving revenue growth and building the business development teams that achieve that growth. I was eager to join Avid because I believe the opportunity to be a substantial. And after my first 2 months on the job, I can say that my enthusiasm has only grown for this company. While the ongoing expansion and the company's move into viral vector manufacturing present significant opportunities for growth in the future, our current team continues to deliver solid results for our existing mammalian cell business.

During the second quarter, the business development team signed new project orders totaling approximately $36 million from the new and existing customers. This work will span process development, new projects with existing customers, and additional orders for commercial products.

As a result, we ended the second quarter with a backlog of approximately $120 million and expect to recognize most of that backlog over the next 12 months. We are also pleased to report that during the first 6 months of fiscal '22, we have signed as many new projects from new and existing clients as we did in the whole of fiscal '21.

We believe this is an early indicator of the trajectory ahead and the entire business development team is looking forward with great optimism. This concludes my overview of business development activities for the quarter.

I will now turn the call back over to Nick for an update on operations and other achievements during the quarter.

Thanks, Matt. The company made great progress in operations during the quarter. Most notably, Avid recently announced that the company was expanding its CDMO service offering into the rapidly growing cell and gene therapy market. This decision was driven by continued strong growth in this sector, combined with the CDMO industry's overall lack of proven high-quality CGMP manufacturing expertise and capacity for viral vectors.

To lead the company's strategic expansion into this market, we are actively building an industry-leading team of experts with established track records of success in this field. To this end, I had recently appointed Drew Brennan, an experienced executive from the viral vector sector of the CDMO market to lead the company's expansion into cell and gene therapy market.

Drew, most recently spent more than a decade in senior commercial and operational positions at Novasep, where he was credited with driving significant growth of Novasep's U.S. CDMO services business, including the securing of several major biovector CDMO contracts.

In addition, the company recently appointed Elie Hanania, as Vice President, Process Development. Elie is a seasoned life science industry executive with more than 30 years of experience in the field of cell and gene therapy. So [how is] this new business, the company is constructing a world-class purpose-built 53,000 square feet viral vector development and CGMP manufacturing facility in Costa Mesa, California, approximately 5 miles from Avid's existing operations in Tustin, California.

Based on current projections, Avid expects the entire new facility build-out to take up to 18 months at an estimated cost of approximately $75 million. The new facilities analytical and process development laboratories are expected to come online more rapidly with the potential to be operational during the first quarter of fiscal '23. Given Avid's strong record of quality and manufacturing, our exceptional regulatory inspection history and our customer-centric approach to business, we believe this company is uniquely qualified to bring these values and skills to the cell and gene therapy sector and look forward to bringing this business online during fiscal year '23.

I'll now provide an update on other operational achievements. As of today, the company has successfully concluded its annual maintenance shutdowns. [Pro ground] on Phase 2 of the Myford South expansion untied in the Phase 1 expansion, which we expect to be available to operations by January 2022, as we previously communicated.

And we are also scheduling clients into this space during quarter 1 of calendar 2022. As we've disclosed previously, we estimate that the addition of the viral vectors to the ongoing expansions will bring the company's total annual revenue-generating capacity to approximately $350 million. As I hope is evident, the second quarter was highly productive and a transformative time for Avid. The company's financial status is increasingly strong supported by year-over-year revenue growth, continued new business wins and substantial backlog.

For these reasons, we believe we remain on track to achieve our stated full year '22 revenue guidance of between $115 million and $117 million. Our business development team continues to perform, signing $36 million in new business during the quarter and ending the period with a backlog of $120 million.

And under the new leadership of Matt, we believe our new business opportunities will only grow. Leveraging the company's operational strengths, we are pleased to expand our service offerings into the cell and gene therapy market, and we are confident in our ability to establish an industry-leading viral vector CDMO business, and we are actively building the team and facilities that we believe will drive our success and expand our revenue-generating capacity.

Also during the quarter, we are pleased to have our progress as measured in the value created for shareholders recognized as the company's stock was named for the first time to the S&P SmallCap 600 Index. We are honored to join this index, and we believe it speaks to the collective effort of everyone at Avid while building greater visibility for the company with investors and the industry alike.

We are pleased with our progress and we believe that each of our accomplishments during the quarter will facilitate the growth and move us towards our overarching goal of establishing Avid as a best-in-class CDMO focused on biologics. This concludes my prepared remarks for today, and we can now open the call for questions. Operator?

(Operator Instructions) Our first question comes from the line of Sean Dodge from RBC Capital Markets.

Yes. Congratulations on the success of the new business wins. Nick or Matt, you touched on it a bit in your prepared remarks, but can you talk a little bit more about the broader demand environment? Are you seeing any noise from supply challenges?

And then maybe with the backlog and then the visibility you may have through your sales pipeline. Can you just give us some kind of idea of how quickly you think you can fill the incremental capacity that will be coming online in the next couple of months here?

Yes. I think with a strong backlog already and positive growth with our issuance in the last few months, I think that's -- we're going to remain on track for continued growth.

Okay. And then maybe, I guess, on the forward margin trajectory, there's a couple of different dynamics that will be affecting you over the coming quarters. Dan, you mentioned increasing hiring soon, but you also have this new space opening up and generating revenue.

Is there any general direction you can give us on how we should be thinking about the trajectory of margins over the next year, 1.5 year?

Yes. I think I'll firm up, Sean, with what I've said in the past that with the current installed capacity, we should see a gross margin that's roughly 30%, plus or minus, depending on mix. Moving into the first phase and second phase for that matter of the mammalian expansion, we should see a good positive 50% to 70% or so margin expansion. But that's fully dependent on the mix that comes through the timing of the revenues and filling that first phase and second phase and onboarding the cost.

So in general, we should see continued growth as the top line increases, but just to point out in the near term, we'll have based on mix and the costs associated with bringing on the new facilities and absorbing the depreciation and other costs, including personnel costs, could impact how quick it expands.

Okay. And then just to follow on to that, the cell and gene therapy expansion. How quickly will you be hiring to begin to staff that? Or are those kind of more G&A additions at this point? And then we'll start to get to a kind of more of the facility-specific people? Or will those happen, I guess soon.

Yes. So Sean, it's Nick speaking. I mean I think it's a mixture to be frank with you. We -- some of the first people we're bringing in, we've already got people in engineering, obviously. And we've obviously got Elie on the R&D side. But we also -- we're looking at bringing in operational people, quality people. We've got to build the quality systems and everything else ahead of opening up manufacturing.

But I think you're probably going to see more in the development side of the business as we bring new clients initially into development and then move them into GMP. And that's the way we're bringing the facilities online. So we're bringing the development hopefully in quarter 1 of fiscal '23. And then obviously, we said the GMP completion is about an 18-month program. So that will be somewhat later on after that.

Our next question comes from the line of Jacob Johnson from Stephens.

First, just because I'm getting a number of questions on it, just to get out of the way. On COVID-19, can you just talk about how much of your backlog today is comprised of COVID-19 related work?

Yes. I think we're around 15% roughly, give or take, Jacob, of the backlog.

Okay. And then, I guess, shifting gears to the viral vector build-out. Maybe first, Nick, what kinds of viral vectors will you be manufacturing? Is it AAV, lenti, both? And then also, any interest in getting into plasmids?

So first question on the vectors, both AAV and lenti, Elie has a tremendous range actually. I am sure there were vectors that I haven't even heard of to be frank with you that he's been involved within in his 30-year history. So not that I would surprise anybody. But it's -- He's been involved in a large number and a good variation. But clearly, AAV and lenti, adenovirus as a sort of the main throws of the viral vector market for cell and gene therapy. But there will be others, I'm sure.

We obviously need then as we go along to bring additional expertise around those to support Elie, which we're obviously out there looking for as we speak. So -- but AAV and lenti will certainly, I think, be a key cornerstone of the business.

Got it. And then just one last follow-up along the same lines. Nick, can you just remind us the synergies that exist between the mammalian capacity in the viral vector business?

Yes. I mean, obviously, we still grow the cells in the mammalian cell in [HEC] and more often than not, which is not a lot different to what we do with (inaudible) in the mammalian cell business. So a lot of the key fundamentals, the size of reactors, the disposable technologies, the unit steps, the purification are all very common.

Obviously, the quality systems under a biologics operation as well is very similar. But there are other challenges, obviously, that are dissimilar. So airflows and construction of the facility are slightly different in terms of viral vectors. And obviously, we've got to do the viral component, which is why we brought people like Elie, and because that's the new technology that we need to add to what we already know how to do. So a lot of commonality there. With respect to your comment regarding plasmids, I mean, I think that obviously is an interesting field. Every viral vector that requires a plasmid or 2 or 3.

And so that clearly is an area that there could be potential interest going forward, as I think we probably highlighted some time in the past. But right at this moment in time, we've got a few things that we're occupied with getting up and running. So not right at this minute.

Our next question comes from the line of Matt Hewitt from Craig-Hallum Capital.

Congratulations on all the progress. Maybe the first one regarding the first phase at Myford, now that that's complete, I think early on, there was the potential that if that was completed on time, that could be as much as $12 million of upside to your guidance for the year. If I'm reading the press release, correctly, it sounds like that will be dependent upon validation. And I'm just curious what could delay that validation and push that into February, March time frame versus getting that done here before the end of the year?

Yes. So, as we speak, we are in pretty good shape. So we fully expected to be on in January. I don't anticipate there been much in terms of validation that would cause us not to be able to do that, to be frank. So I think the major issue for us was getting to where we are now coming out of shutdown and having tied it into the existing operations, which we've done all of that. So fundamentally, it's mechanically complete. So I guess the main thing is their upside into is where you're getting at regarding the forecast. And it remains the same as it was before. Yes, there is.

Now we've got it on site. Obviously, we can leverage that. But we've got to have it -- we -- it has to be operational before you can book people in. We are already starting booking people in, in quarter 1. But we can't switch those as I've mentioned from the one DSP suite to the new one. So it doesn't always mean just because I put the client in there, that's above our initial guidance. But as I think probably the set of more positive one towards that one is the backlog that Matt highlighted which is a $120 million.

So, clearly if Matt continues to add to that and some of them we can squeeze into this year, then if our capacity is $120 million and it hits $125 million, then we've got some additional revenue opportunities there. So a kind of let's get Christmas out of the way. I'll get everything up and running. And then obviously, we'll obviously be driving to do as much as we can. But at the moment, our guidance remains the sort of $115 million to $117 million mark, and we'll work really hard in the new year to try to see if we can find any opportunity to improve it if it's possible.

That's great. Dan, thank you for the color there. Shifting gears a little bit regarding the new viral vector opportunity. I would assume at this point, you've had an opportunity to check with existing customers that are developing cell and gene therapies in addition to maybe their traditional large molecule products.

And I'm curious if there is any overlap there and if those are the low-hanging fruit to the existing customer base that could come in earlier or quickly once that new facility is up and ready to go?

Yes. I mean I think I would say that it's probably not just about going around on our existing customers and the like. Obviously, those would be people that we would go out and talk to. But to be very frank, the main thrust of the focus at the moment is making sure we bring the right level of expertise in getting the construction of the design absolutely nailed on moving that forward as fast as we can. And then putting a quality system in again, we're here to do this right.

That's a kind of one of the fundamentals of our business is quality first, and making sure that we have a real world-class facility well equipped with the right level of competence. I think the customer side of it is always a challenge and bringing new business in, but we feel that -- with those things in place, that we'll be able to attract the attention that we need to the facility.

Our next question comes from the line of Paul Knight from KeyBanc.

Dan, what was the contract fees in the quarter just posted?

I'm sorry, could you repeat that question, Paul?

Effectively.

I'm sorry, Paul, can you repeat that question for me?

Sorry. A certain part of the revenue is from manufacturing not performed, but still a charge, a revenue recognition. What was that level in the quarter?

That number was roughly $5 million during the quarter.

Okay. And then the COVID is about 15% of backlog. Is that where you're getting the most non -- recognition of nonmanufacturing revenue.

No. Most of the nonmanufacturing revenue is coming just from the PD side of the house, which is the entry point into the mammalian side. new programs come in and have the PD side, tech transfer, what have you, analytical before it gets to CGMP.

Okay. And then that $5 million, what was that a year ago?

A year ago, it was the $3.1 million.

Okay. And then on the cell and gene therapy expansion, how many square feet did you mention, Nick?

54,000 square feet, Paul.

And $75 million of CapEx that you're a kind of implying about what about [$100 million] -- about [$80 million] of potential revenue. That -- would you view that as kind of a conservative level of revenue out of the facility of that size.

It will depend on mix, obviously, in capacity utilization. But I think it's one that -- a little early for me to be absolutely frank, on whether we could squeeze more out of it until we start getting it operational and see the opportunities. But I would be surprised if it was any less for sure.

Thank you. At this time, I'd like to hand the call back to Nick Green for any closing remarks.

Thank you, operator, and thank you to everyone participating on today's call. In closing, I'd just like to thank Avid's customers, partners and investors for their ongoing collaboration. And as always, I'd like to acknowledge of its extraordinary employees who together are driving the continued company's success. Thank you again for participating on the call today and for your continued support of Avid Bioservices.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.