Baudax Bio, Inc.

Ladies and gentlemen, this is the operator. Today's conference is scheduled to begin shortly. Until the time your lines will again be placed on hold, thank you for your patience. Again, ladies and gentlemen, this is the operator. Today's conference is scheduled to begin shortly. Until the time your lines will again be placed on hold, thank you for your patience. Thank you. Thank you. Thank you. Thank you. Good morning and welcome to the Bodex Bio 3rd Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will be given at that time. As a reminder, this conference is being recorded at the company's request. I'd now like to turn the call over to Claudia Steislinger, Investor Relations. You may begin.

Good morning, and thank you for joining us on today's conference call to discuss BodexBio's third quarter 2021 financial results. This is Claudia Steislinger, and I'm joined today by Jerry Henwood, President and Chief Executive Officer, and Rick Kasten, Chief Financial Officer. On today's call, Jerry will provide some introductory remarks, provide a business update, and discuss the continued progress around the commercialization of Angesso. Following Jerry's prepared remarks, Rick will discuss the financial highlights from the quarter. Earlier this morning, we issued a press release detailing our financial results for the third quarter of 2021. The press release, along with the slide presentation that we will reference for today's call, is available on the events page of the news and investor section of our website at bodexbio.com. Please note the slides for today's presentation are viewer controlled. Before we begin our formal comments, I'll remind you that various remarks we make today constitute forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements related to our financial outlook. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from our expectations and forecasts, and can be identified by words such as anticipate, believe, could, estimate, target, expect, intend, may, plan, predict, project, will, and other words of similar meaning. The following are some of the factors that could cause our actual results to differ materially from those expressed in or underlying our forward-looking statements. The ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of Angesso or disruption in supply chain, our ability to maintain regulatory approval for Angesso, Our ability to successfully commercialize Angesso. The acceptance of Angesso by the medical community, including physicians, patients, healthcare providers, and hospital formularies. Our ability and that of our third party manufacturers to successfully scale up our commercial manufacturing process for Angesso. Our ability to produce commercial supply in quantity and quality sufficient to satisfy market demand for Angesso. and our ability to raise future financing for continued product development and AGESO commercialization, our ability to pay our debt and satisfy conditions necessary to access future tranches of debt, our ability to comply with the financial and other covenants under our credit facility, our ability to manage costs and execute on operational and budget plans, the accuracy of our estimates of the potential market for AGESO, our ability to achieve financial goals, and our ability to obtain, maintain, and successfully enforce adequate patent and other intellectual property protection. This list of important factors is not all inclusive. Any such forward-looking statements are not guarantees of future performance and involve certain risks and uncertainties. These risks are described in the risk factors in the management's discussion and analysis section of BODAC's bios and a report on Form 10-K for the fiscal year ended December 31, 2020, and any quarterly reports on Form 10-Q, which are on file with the Securities and Exchange Commission and available on the SEC's website. Any information we provide on this conference call is provided only as of the day of this call, November 4, 2021, and we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events, or otherwise. During the course of today's call, we will refer to certain non-GAAP financial measures. A reconciliation between the GAAP and non-GAAP financial measure is included in our earnings release, which is available on our investor relations website at badaxbio.com backslash news and investors. I encourage you to visit our investor relations site to access our earnings release, periodic SEC reports, a replay of today's call, or to learn more about BadaxBio. I would now like to turn the call over to Jerry Henwood. Jerry?

Thanks very much, Claudia, and good morning, everyone. I'm going to use the slide deck that we have filed with this earnings report and just go through some highlights of what's happened in the quarter. So, if I move first to the executive summary slide, just as an overview, I believe that we are tracking an exit rate for 2021 that will put us in a position to provide for more robust growth of Angesso in 2022. Everyone is leaning into that to make sure that we're in a position to be having a good start to next year with a good end to this year. Our growth we saw was accelerating in September after the summer Delta variant peak had definite impact during July and August, which we'll talk more about in a minute. Peer-to-peer programs, both in terms of things like speakers bureaus as well as former directors of pharmacy who are health economics experts interacting with their peers at hospitals, directors of pharmacy. I think both of those are helping us to gain some more momentum in addition to the very strong efforts of our field force and ancillary groups. And it's setting the stage for Q4 and for 2022. If we go to the next slide, you'll see that during the third quarter of 21, we saw not as robust a growth in existing hospital sales, which we account mostly to what was happening in July and August because of the Delta variant and the diminution of elective surgeries in the southern states in particular, which were most heavily affected and which you'll see accounts for a reasonable amount of our current business. However, growth in the ASC arena was more robust. That was about 66%, and I think reflects the fact that they were less affected generally than were the hospitals during this period of time. We go to the next slide. You'll see that we're over 150 formulary wins by the end of Q3. Our P&T success rate is continuing to be, we think, pretty robust at about 84%. The top five ASCs and service providers have been included from one of the accounts that we've gotten that has 125 nationwide accounts. We have their overall formula approval. We haven't counted more than the five that have individualized approval and then that plus another three are getting us into implementation right now. There are a number of others that are pending but haven't gotten it through, for instance, their electronic health records, et cetera. So we're encouraged that we're poised for more growth and more success because of that. If we go to the next slide, slide five, some of the highlights, you know, just wanted to talk about what's going on in the different sectors that we're dealing with. If we start at the top right corner of the circle, integrated delivery networks, We have had growth in IDNs, you know, a tough area to penetrate because they're big and quite deliberate about their decision making. But we have one top IDN nationally who has been using the product early uses in the orthopedic and anesthesia service lines. And then we've got a five hospital group that we've gotten formulary approval in and we're getting implementation in that that is beginning to help accelerate growth as well. If we go down to national ASC groups, as I referenced on the formulary page, there is a very large, one of the top five nationally, group that has approved us and we're in a rollout of those accounts. And in the first month since that was approved, we have about 10% of those accounts who have come online and are beginning to order. And I think that was a pretty quick turnaround for the amount of integration that had to happen in that But the goal is to continue nationwide in each of the regions to try and tick down more of these members. And the members who have been using the product prior to this national relationship with them have been very enthusiastic about the product and are spreading that to others within the group. If we keep going around the circle counterclockwise, no, I guess it's clockwise, to ASCs per se, Individual ASCs, we do have a number of large ASCs with whom we've got volume-based contracts, and we see good progress there in California and Texas with those ASCs. We go up to the top and just say, what's another segment of the market that's important to us? Regional hospitals and regional hospital groups. And so we have a surgical hospital in the south central area, that had had a change of anesthesia groups. They had switched out an anesthesia group that had been managing their patients, and a new group came in and had to be converted again in their decision. What were they going to be using? What products would be part of their normal routine usage? We were able to get renewed in that. There was a lag of a couple months in between those two situations. but we're back in the swing with surgeons who like the product and anesthesiologists who are happy with it. And we've got a top regional hospital that has just recently added Angesso based on their clinical experience. So we're feeling good that we're hitting all of the cylinders that we need to hit. Obviously, we want to do more and more of that, but a lot, as you know, hospital launches, a lot of it, and this year really we see as our first year of a launch because last year with COVID, was not really representative at all. We're looking at getting the kinds of layout of approvals that we need to have to be able to expand on and grow on and use as references for further growth as we're in 22. If we move up to slide six, there's a way that we approach these larger accounts that we think make sense and that has seemed to be very successful for us So we're continuing to implement that, and that is, you know, we start with the smallest circle where we're creating awareness, clinical advocacy, making sure that we have individuals who have had an experience with the product because we find that trial usage is very converting. People use the product and see that it does work, that it does contribute meaningfully to pain relief over a 24-hour period for their patients. they are often converted to becoming champions and widening their adoption and initial orders. Subsequent to that, we will work with their teams and with the organization that they're a part of to make sure that we've got communication that's top-down coming as kind of the next step. So we're working with their pharmacy director, we're working with others in their administration, to talk about the product, talk about its advantages, do in-services, so that as there is demand bubbling up from people who are using it in trial usage, we're then in a situation where we can go to that third circle, which is a direct model setup. They have the opportunity to order directly from us, and there is some discount that can be passed on to them through that based on the volume of their usage, and then ultimately doing a defined contract that supports that once they have a little bit more comfort about what they anticipate their near intermediate term volume to be, and that's something that we can adjust if their volume picks up. So that's just a way of looking at how are we approaching both from the bottom up and the top down, working these larger accounts such as IDNs or national accounts on the ASC side. I'll talk for a minute about the impact of the pandemic. I know we're all sick to death of hearing about COVID, me too, but it is still a factor that periodically in sort of whack-a-mole fashion pokes its head up. And that certainly did happen this past summer. So on slide seven, you'll see that Florida, Texas, and North Carolina are our top three states and account for about 40% of our sales right now. And these states were among the highest percentage of hospitals suffering from extreme stress based on COVID hospitalizations. Now this extreme stress doesn't mean that people were feeling tired. This means they were in a situation where they had to curtail or eliminate elective surgery because they had such bed demand for treatment of COVID patients that they could not add major surgeries that could result in people needing a bed even if it was anticipated to have been a same-day surgery, but complications do occur. So this did impact us, as you can see, pretty dramatically in these three states, and it had an impact. Now, in spite of this, we did grow, and I'll just reinforce this a little bit. If we go to the next slide, which is based on IQVIA data, you see that orthopedic and other procedures declined significantly during this summer COVID flare-2. That's just to reinforce what was happening in these states in particular, although there were some other states affected. Separately, just because we've had some folks asking, where are we seeing the highest usage of Angesso surgically? Just under half of our usage is in orthopedic procedures. About 20-some percent is associated with other types of pain and with the use of a radiofrequency ablation procedure, which itself produces pain. and about 16% in urologic and gynecology cases. If we go to slide nine, you see that we are getting quarter-over-quarter growth. So in spite of what I just talked about with respect to the impact of COVID in July and August, for the quarter, we still showed growth. We showed growth. You can see the rebound in the line slide to the left. And this was through the end of September and the units sold by quarter are continuing to grow very nicely even through the COVID. And that's really part of what we're trying to help our team be able to do, find ways to win even when the unexpected happens. So whereas last year we were very stymied by COVID, this year it did slow the impact a bit in that quarter, but we still grew through that quarter. and we're still getting new contracts, and we're still moving ahead, and that's what we continue to see going forward as part of the plan for the brand. I'm going to switch now to have Rick talk a little bit about the financial results, and then I'll come back and talk a little bit about closing the year and what we expect for 22. Rick?

Thank you, Geri. Good morning, everyone. Now I'll refer you to slide 11. the Q3 versus Q3 21 versus Q3 20 financial results. Since we issued a press release and filed our form 10Q with the SEC early this morning, outlining our full financial results for both the quarter ended and year to date periods ending September 30th, 2021 and 2020, I will just touch on some of the key highlights from the quarter. As of September 30th, 2021, we had cash, cash equivalent and short term investments of $24.9 million. The change from Q2 reflects our normal operating cash burn for the quarter supporting our commercial research and development and commercial and corporate operations. Net product revenue recognized according to US GAAP for the three months ended September 30th, 2021 was 0.3 million and was related to the sales and ingesto in the US. There's approximately 0.1 million dollars of product revenue recognized for the three months ended September 30th, 2020. The increase was primarily attributable to the additional formulary approvals and generating trial and adoption in GESO, resulting in increased end-user demand when compared to the prior year quarter. Cost of sales for the three months ended September 30th, 2021 and 2020 was $0.5 million and consisted of product costs, royalty expense, and certain fixed costs associated with the manufacturing in GESO, including supply chain and quality costs. We expect that over time, Product costs and cost of sales will increase as sales increase and inventory values change to include all direct and indirect costs. Research and development expenses were $0.7 million for the three months ended September 30, 2021, compared to $1.5 million in the prior year quarter. The decrease was primarily attributed to lower personnel costs as well as lower clinical costs in the current year period. Selling, general, and administrative expenses for the three months ended September 30, 2021 were $11.1 million, compared to $13.8 million for the same period a year ago. The decrease of $2.7 million was primarily a result of a decrease in personnel costs of $3.1 million as compared to the prior year period. We reported a net loss of $17 million, or a loss of 20 cents per diluted chair outstanding for the three months ended September 30, 2021. which includes a non-cash charge of approximately $5.7 million, primarily associated with the change in fair value of contingent consideration, stock-based compensation, and amortization expense. Our adjusted net loss for the three months ended September 30th, 2021 was $11.3 million, compared to an adjusted net loss of $13.5 million in the prior year period, a decrease of $2.2 million. With that, now I will hand the call back to Jerry for comments on closing Q4 and preparing for 2022. Jerry? Thanks, Rick.

So, if you don't mind, we'll go to slide 13 in that same deck we were in before. Just a look at how are we, we've talked about the ingredients that we're using to try to efficiently and cost effectively penetrate the market, lay the plank, so that there's an opportunity to accelerate in 22 and beyond. So I'm going to start from the top right again, looking at the telesales support. So we've mentioned to you before that we were using telesales. We are using a traditional telesales support that is quite cost-effective to support the field sales, which expands reach and gives us a little more opportunity for reinforcing some messages It is not effective enough that it could replace representatives, but it is certainly very helpful and augments the impact of the messaging. We added an experienced specialist telesales group, which has much more experienced reps. They are more expensive than the traditional telesales, but still less expensive than a full rep. But they're helping us to cover areas where we've had indications of interest. and we don't have a rep in that field, and it's not large enough at this point in time to warrant putting a rep there, but this is a group that has done an effective job even recently. They've only been really in position since late summer, and they have already had one conversion where they followed up, had a series of Zoom calls, had some of our specialists also on those calls, but then were able to convert and get a formulary approval, and the product is now on formulary in that hospital. So we're trying to use novel means that leverage the terrific assets that we have in our reps and have allowed us to make some progress there. Our ACSs are acute care specialists. They're leading in targeted accounts. And they have obviously short-term, mid-term, and long-term goals for their territory for the accounts that they have. They're working them, making progress on both formulary approvals and then penetration and addition of service lines and within service lines expanding to other providers and through that getting more business throughput in the hospitals and in the ASCs. Our regional business directors are player coaches. So, you know, in our organization, everybody sells, everybody supports, And the RBDs, you know, are a key part of that. They're not only managing and coaching the reps, but they are covering a number of accounts themselves and some of the bigger accounts that require, you know, more than one person to be working them. They're working that they act as the quarterback regionally and they manage performance, but they're also bringing home the bacon themselves. HEORs, Health Economics Specialists, these are former directors of pharmacy and hospitals, and we think that experience and perspective is key in relating to important gatekeepers at institutions, particularly hospitals, but in some of the larger ASC networks as well, where they need to have enough information to validate the P&T approach, because often they're the ones who are the organizers and administrators of the P&T, with other membership, and so getting them on board is key. And then it has been helpful because not only can we cover the clinical data essential to formularies with them, but also situational usage, service line appropriateness, so that they're not concerned that we're trying to be everywhere in the hospital. The way to get onto the formulary is to have some individual lines of usage have that work out, have everybody see that it can happen in a responsible and effective way, and then expand from there. Our key account managers, directors of national accounts, they work top down. They're going into the C-suite, to larger IDNs, to larger ambulatory surgery center chains, working through with them both the benefits of the product bringing and other specialists as they need, for those discussions around formularies and ultimately typically doing some volume-based contract that would allow for the acquisition price to remain competitive for those IDNs and those systems. They are also very important in orchestrating with our ACSs, our reps, where are the sort of fallout of those contracts so that the pull through can happen. And, you know, just having a contract in place doesn't mean that there is business there. You have to work through and make sure it's gotten into the electronic health records and so on. And that is all being coordinated with the RBDs and the DNAs and the individual reps. And then we have the internal team, you know, which is our field leadership, our brand leadership, sales operations, all of that team is providing analysis and support for decision making to the regional directors, to the DNAs, to the HEORs, etc. So this team is working together very well and we just recently had a field leadership meeting to go back through what has been working well and what do we need to tune up and tighten up as we go through the fourth quarter and readiness to start the new year. So if we flip from there to the next slide, slide 14. Another key part of the market research that we've done on the brand as we got into the September timeframe is, you know, tailoring the message more to the specialty. So, you know, the lane that works for orthopedic surgeons and the anesthesiologist working with them is a little bit different than the one that would be most appropriate for general surgeons. And we're seeing increasingly more use in plastic surgery, so trying to deal with that without spending too much money. As you may know, it has become significantly easier than it used to be to target certain journals, certain regular weekly news type formats that we can have the information in so that it's appropriate to that particular specialty. If we go to slide 15, you know, again, I mentioned earlier, trial usage seems to be the key. I think people like the story, like the profile, but they need to see for themselves that what we have been talking about is what they're going to generally experience with the patients in whom they use the product. So early trial usage is important. So once we have an opportunity to get into an account, it's really key that we are getting the surgeons to select an appropriate patient and try the product and follow that patient and then try a couple more. And that really seems to be the key to be able to expanding usage of the product and for them to see Ingesto as a solution to some of their problems and some of the patient types where they may not want to use another type of agent. So keeping everybody focused on the business plans that lead to this is key. for our continued success. So if we go to slide 16, you know, what are we doing now that we think is going to help us through the entrance to and the kickoff for 22? We've got to end the year at or above our forecast. We think that is in place and that we're moving towards that. We're positioning 22 for accelerated performance, and we believe that we are still on a track that can let us have as a realistic goal getting the brand to be approximately cash flow break even by the end of 2023. Long-term prospects for the brand remain positive from all the feedback we have from clinicians. Those that are using the product really like it and more people are saying they want to use the product and we're trying to help them get it through the formulary process. The tactical plan remains in place. People are hyper-targeting accounts based on priorities to make sure that We are getting into places where we have an opportunity to expand and deepen the usage. Expanding the contracting strategy helps with large system wins. And these market research insights, such as I went through on the page before about targeting messaging, is a part of that. In terms of staffing, because of the COVID impact in certain markets during July and August, We have deferred some plans that would have added additional territories in this quarter. By the beginning of October, we had talked about roughly being at 40 reps. Instead, we have just grown to 34, and we're going to stay at about 34 reps until we get into 22 and have an opportunity to get a couple more contracts signed, which would seem to make sense for the additional reps to be able to pull through and service those. We are continuing to work to enhance the effectiveness of our representatives with ongoing training, including competitive product training, microlearning, targeting, et cetera. So we, in summary, are feeling very good about Ingesta. We are not satisfied with the sales. We know you are not satisfied with the sales. But it's hard to launch a hospital product. We're making good progress this year, and we think we'll be able to expand on that significantly in 2022. So I would like to sort of summarize everything in saying that we think the product is continuing to show meaningful growth and revenue is up 40% in the quarter-over-quarter period. And because of COVID last year, we see the kind of crazy number of 300% up year-over-year, but I really think if we focus on continuing quarterly growth, that's important for us. And despite the regional impact of Delta variants, On the number of surgeries in the southern U.S., we did see a significant uptick in sales to new accounts in Q3, growing an estimated 66% quarter over quarter. With respect to our NMVs, which I have not spent much time on on this call, we do look forward to providing an update on BX1000, our intermediate duration neuromuscular blocking agent drug candidates. In the not too distant future, once we've completed the data analysis portion of the dose escalation trial that recently completed the clinical portion of that trial, we've remained very enthused about our NMB portfolio and reversal agent as well. In closing, we continue to receive positive feedback from those using NGESO and looking forward to more progress and keeping you updated on that progress as we continue to educate healthcare professionals, and physicians on the overall benefits of Angesso. I'll now turn the call over to the operator for any questions.

And that concludes our prepared remarks. We'll now open the call up for questions. And to ask a question, you will need to press star 1 on your telephone. And to withdraw your question, press the pound key. Your first question comes from the line of David Amsalem from Piper Sandler. Your line is now open.

Hey, everyone. This is Zach for David. Thanks for taking my question, and congrats on the payer access front. Just qualitatively, do you expect the pace of P&T committee meetings to continue to be robust going forward? And I was just trying to get a sense of your target generally in terms of formulary wins over the next few months and maybe the next couple of years.

Yeah, so, I mean, theoretically, we expect that the national formulary approval of that very large top five ASC national chain will, in the reasonably near future, add significantly to that number. In addition to that, you know, we are focused on particularly IDNs because the impact that they can have in terms of leveraging usage in a number of institutions and then the pull through in those institutions. In the reasonably near term, you know, we could see anywhere between 60 and 120 approvals, and it could grow to be more than that. So, you know, it's a key area for us. But we're not just picking flowers just to increase the count. It takes a while to get the bigger institutions through, but they're worth a lot more volume. So that's really where our focus is. Is that helpful, Zach?

Yep, that makes sense. And then just one follow-up. Sorry if I missed this, but what is the current mix between the ASC and hospital settings right now for NGESO? And we just had – yep, sorry.

Yeah, go ahead. We're about 50-50. It's just like, you know, varies on the given month. One's up a couple percent, the other's up a couple percent. But it has been roughly the same, and that's why I think it hit us a little more when Delta hit, you know, Texas, Florida – Alabama, and a number of other southern states because the hospitals there were affected, as you could see, in the growth rate in the hospital sector compared to ASCs.

Yep, that makes sense. Thank you.

Thanks, Zach.

And again, if you'd like to ask a question, just press star 1 on your telephone keypad. Your next question comes from the line of Leland Gershaw from Oppenheimer. Your line is now open.

Hey, good morning. Thanks for taking my question. Good to see the pickup, particularly in the ASCs in the third quarter. It looks like hospitals, as you say, were suppressed by the COVID stress. Based on what you're seeing so far in 4Q, can you kind of comment on where you're seeing hospitals versus the prior trend? Is that kind of getting back on track versus what we had seen from 1Q to 2Q? Is it even better? And I also wanted to ask, with respect to pull-through between both the ASEs and the hospitals, once the product is available on formulary, are there protocols in place for which NGESO becomes kind of required or part of a protocol, or is it ultimately always part of a physician or anesthesiologist's choice with respect to use the product? Thank you.

Leland, great questions as always. So first I'll talk about hospitals. There's a little bit of funkiness going on in certain geographies right now. It seems more related to staffing issues in hospitals than to COVID. So in September, which was our strongest month ever, we saw things looking, quote, more normal. But in October, there seems to be a little bit of – drop-off in surgery rates for elective surgeries or postponement. And the reason that we're hearing from physician surgeons who are frustrated because they want to be doing more surgeries is staffing issues either for managing those patients postoperatively or associated with the team with whom they operate. So I don't know if that will have an impact, but, you know, we're going to hit the goal no matter what because the team is concentrating on those areas which are less affected by that issue, and also with the ASC growth, that gives us some opportunity for balance and continued growth there. In terms of pull-through, it's a good question. How does this set up? So let's talk inpatient first. On the inpatient side, once we get on formulary, getting into the electronic health record, which generally reflects that service line's agreement on a protocol, and you're in the drop-down menu that they can check off for the post-op surgical routine. Now, if you've got a big hospital that has multiple groups, let's say multiple orthopedic groups that are practicing, you might have to insinuate yourself into two or three of those EHR drop-down protocols because they all vary a little bit in terms of the tweaks, but virtually all of them want to have an NSAID in there and where we have been able to get onto formulary and where we are able to do some volume-based contracting, we want to be that NSAID of choice and are typically in there as the only choice for the NSAID that would be in that particular protocol. We don't have as broad A set with general surgeons yet in the hospital environment, their volume of surgery has seemed to lag the return to normal volumes that we're seeing more with the orthopedic group than with the general surgery group. In the outpatient environment, it's a little bit easier to get into their record sets, and typically the surgeon doing surgery in the ASC environment also has a bigger voice And so that is a little bit more efficient in terms of an adoption. We do still see that there are, you know, a significant number of patients who are being managed in the hospital. So it's trying to keep both of those tracks running at the same time. It's important to us.

Great. That's very helpful. Thank you.

Thanks, Lola.

And we are showing no further questions. I'll now turn the call back to Jerry for closing remarks.

Thank you, Operator, and thanks, everybody, for joining us this morning. I hope you have a great rest of the day. Be well and stay safe. Bye-bye.

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