Talphera Inc (TLPH) 2022 Q1 法說會逐字稿

Welcome to the AcelRx First Quarter 2022 Earnings Call. This call is being webcast live on the Events page of the Investors section of AcelRx's website at www.acelrx.com. This call is the property of AcelRx, and any recording, reproduction or transmission of this call without the expressed written consent of AcelRx is strictly prohibited.

(Operator Instructions) As a reminder, this call is being recorded. You may listen to a webcast replay of this call by going to the Investors section of AcelRx's website.

I would now like to turn the call over to Raffi Asadorian, AcelRx's Chief Financial Officer.

Thank you for joining us this morning. Earlier this morning, we announced our first quarter 2022 financial results and some business updates in a press release. This press release and the slide presentation accompanying this call are available in the Investors section of our website. With me today are Vince Angotti, our Chief Executive Officer; and Dr. Pam Palmer, our Chief Medical Officer.

Before we begin, I'll remind listeners that during this call, we will make forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve risks and uncertainties regarding the operations and future results of AcelRx. Please refer to our press release in addition to the company's periodic, current and annual reports filed with the Securities and Exchange Commission for a discussion of the risks associated with such forward-looking statements.

I'll now hand the call over to Vince.

Thank you, Raffi, and good morning, everyone. A lot has changed in our first quarter of 2022, both in the macro market environment but also at AcelRx. We completed our acquisition of Lowell Therapeutics earlier in the quarter, which has provided us with a number of promising product candidates. We have also advanced preparation of the NDAs for our 2 prefilled syringe products ephedrine and phenylephrine and expect initial feedback from the FDA to our inquiries at the end of this month.

In addition, DSUVIA has continued to demonstrate impressive growth in the procedural suite market, even with the limited commercial team that we've maintained. In fact, we have further aligned our cost structure to concentrate on our recently expanded development pipeline. This reorganization is expected to generate annual savings of approximately $9 million.

The value of DSUVIA for patients and health care providers is evident based on the feedback we continue to receive from the health care community as well as the numerous studies that are being published, exploring the benefits of DSUVIA in various procedural environments. However, we realized that in this current market environment, DSUVIA's full potential as a unique analgesic can be maximized by an entity with broader resources. Accordingly, we're actively discussing strategic relationships with third parties with a more robust commercial presence that can help maximize DSUVIA's value for all stakeholders. Our goal is to enhance the value of DSUVIA with an organization that is better resourced and equipped to carry out the ongoing launch of this very valuable product and even further reduce our cost structure.

Now let's move on to provide further details on the progress made this quarter. As we had announced in January, we closed our strategic acquisition of Lowell, which is as a family of novel nafamostat products to our portfolio with diverse potential applications, including our lead asset, Niyad, which is intended for use in renal replacement therapy.

Given the importance of this asset, we recently held a key opinion leader webinar with 2 leading internationally renowned physician experts specialized in acute kidney injury. The replay of this webinar is currently posted on the Investors section of our website, and we'd encourage you to listen to hear many of the outstanding attributes in nafamostat. The webinar detailed the scientific and clinical basis behind the use of Niyad for anticoagulation of the extracorporeal dialysis circuit in both adults and children.

Niyad is a lyophilized form of nafamostat that is being regulated as a device by the FDA, given that its mechanism of action takes place outside of the body of the patient. That is within the extracorporeal circuit.

Nafamostat is approved and widely used for the syndication in Japan and South Korea, but it's never been developed for such use in the United States. The FDA has assigned Niyad with a breakthrough device designation, which provides us with several advantages in gaining regulatory approval.

Further, CMS has already assigned an ICD-10 procedural code for its use in extracorporeal circuit, which will facilitate reimbursement.

Once we've manufactured the first cGMP lot of Niyad, which is expected to occur early next year, we intend to apply to the FDA for an emergency use authorization, or EUA. We're currently in the final stages of securing supply and manufacturing partners for Niyad. After manufacturing of our initial lots, our development plan that has been informed by the FDA, includes a single registrational study in 160 patients, which is expected to begin in 2023. And if approved, Niyad would be the only regional anticoagulant for this indication in the U.S.

Our nafamostat portfolio is promising with the potential for Niyad, however, nafamostat has other beneficial therapeutic applications. Therefore, we'll be exploring other potential indications for nafamostat as an intravenous synthetic serine protease inhibitor to be developed in the future under the name LTX-608. In the near term, we intend to focus our resources on Niyad's approval for CRRT and potential emergency use authorization.

Currently, 60% of the patients on continuous renal replacement therapy in the U.S. do not receive anticoagulants often due to the risk of currently available options. We believe Niyad can address this unmet market need. In addition, we believe the potential peak sales for Niyad alone exceed $200 million annually. And this amount is attributed to just the inpatient and outpatient dialysis markets. The markets for the other target indications for LTX-608 are also sizable.

Now consistent with our priority of advancing our late-stage pipeline assets, we've made progress on the regulatory pathway for our prefilled syringes. The prefilled ephedrine and phenylephrine syringes were licensed from Aguettant, who is also our European partner for DSUVIA or DZUVEO, as it's named in Europe. We anticipate feedback from the FDA by the end of this month on our plan for the first prefilled syringe product candidate, ephedrine or PFS-01.

Assuming agreement from the FDA, we expect to submit NDAs for these 2 products, these 2 product candidates this year. With 2 NDAs filed in 2022, we expect to have approved products to launch next year. The market opportunity for these assets exceeds $100 million, and we believe we'll be able to obtain a large share of this market with minimal commercial investment.

And while we're eager to concentrate resources on our pipeline, we've made very good progress focusing our commercial efforts for DSUVIA into procedural suites over the last 3 quarters. As a result of this continued growth and what we strongly believe are favorable prospects for DSUVIA, there is interest from other parties related to commercializing the product.

Accordingly, to ensure value is maximized for our shareholders, we're in active discussions with more resourced potential commercial partners to take on DSUVIA. This would potentially provide AcelRx the opportunity to benefit from a stronger commercial presence from a larger company, reduce investment required by AcelRx and provide an accelerated return on investment to our shareholders as DSUVIA continues to accelerate its growth trajectory.

The adoption for DSUVIA for use in procedural suites remains encouraging and is the largest driver of use. This is an important market as many painful procedures are now being performed in procedural suites which are more cost-effective than hospitals and ASCs.

In 1Q '22, DSUVIA achieved historical highs in new ordering customers, reordering customers, total number of unique orders, doses to end users and new REMS enrollments. This growth was driven by the procedural suite market as it now represents 71% of all commercial sales in 1Q '22. That's up from 59% in 4Q '21 and up from 28% in 1Q '21.

Now that we have identified where DSUVIA can be successful and increased presence is required in these locations to further grow sales, this is why we're confident that working with a commercial partner on DSUVIA is a necessary next step. In the meantime, we've restructured our commercial resources to consist of a small virtual sales team focused on procedural suites, which we believe is the most efficient approach.

Year-to-date, we've had a number of publications about DSUVIA, specifically for its use in plastic and cosmetic surgery, providing further real-world evidence of the many benefits both to patients and the overall health care system that can be experienced when administering DSUVIA in the procedural suite setting as well as other settings.

In terms of other markets for DSUVIA's application, you may have seen our year-end earnings release announcing a commentary published in the Journal of Military Medicine highlighting the favorable pharmacological properties of DSUVIA for use in the military setting. In addition, more recently, an editorial was published in the same journal describing DSUVIA's potential, psychological benefits to injured soldiers by initiating timely pain management on the battlefield. The editorial identified DSUVIA as "certainly a step forward in improving acute pain management in combat settings."

We're further encouraged that the DoD has finally initiated 2 studies that were originally planned to commence 18 to 24 months ago. We believe that the initiation of these 2 studies as well as the recent military publications further cement the DoD's commitment to DSUVIA for battlefield use. Despite the U.S. military deeming DSUVIA the preferred treatment choice for those in the battlefield, things have moved slower than anticipated to formally roll out DSUVIA in this setting. We continue to wait on final clearance related to the administrative and logistic prerequisites that once cleared, will facilitate the U.S. Army in purchasing DSUVIA for their sets, kits and outfits or SKOs.

The Army continues to make purchases for their prepositioned stockpiling program, but we expect an increase once the Army begins supplying the SKOs for deploying and deploy troops.

We remain excited about the upcoming launch of DSUVIA or DZUVEO in Europe. We expect Aguettant will launch DSUVIA in the third quarter this year and remain focused on all their prelaunch activities. We look forward to monitoring the uptake of this important drug in a new market and believe that Aguettant will definitely benefit from our experience in launching DSUVIA in the U.S. as they further their launch plans.

I'll now hand the call over to Raffi to take you through the first quarter financial results.

Thank you, Vince. Our first -- our financial position remains solid with $39.3 million in cash at March 31 and $11.4 million in senior debt. Our debt level continues to reduce each quarter as we reach maturity in Q2 2023.

Total sales of $0.4 million in the first quarter was an increase of 17% over the fourth quarter of 2021. DSUVIA's sales volume growth continues to accelerate with volume growth, excluding DoD of 64% in the first quarter compared to the fourth quarter of 2021. This is the fourth consecutive quarter of commercial or ex Department of Defense sales growth -- sales volume growth, which was led by procedural suites. All of this, despite a limited commercial infrastructure.

Operating expenses or combined SG&A and R&D expenses were $8.7 million in the first quarter of 2022 compared to $8.6 million in 2021. Excluding noncash depreciation and stock-based compensation, first quarter 2022 cash operating expenses were $7.7 million. The increase in operating expenses in Q1 2022 was mainly driven by increased DSUVIA manufacturing-related costs, partially offset by reductions in personnel-related expenses.

The restructuring, Vince discussed earlier on this call, is expected to generate approximately $9 million in annual savings and an estimated $500,000 restructuring charge that will be recorded in our second quarter financial statements.

I'll now turn the call back over to Vince.

Thank you, Raffi. We're excited about the many upcoming potential catalysts and value drivers, our future and the transformation we made over the past year with our late-stage development assets.

I'd now like to open the line up for any questions you might have. Operator?

(Operator Instructions) The first question comes from Brandon Folkes with Cantor Fitzgerald.

Congratulations on all the progress. Just 2 for me this morning. Firstly, maybe just on the OpEx saving. How should we think about those savings being reinvested back into the new programs that you do bring on board versus -- or that you have brought on board, I beg your pardon, versus dropping to the bottom line? And then secondly, can you talk about the interest you've had in DSUVIA? And what are you looking for in terms of an agreement to get it over the line here? How important is a large upfront?

Brandon, it's Raffi. I missed that last part of it, but you got -- Vince got it. So I'll answer the first question. I mean the savings we have this year, most all of that, that will be dropping to, if you want to call it the bottom line, but will be additional cash savings because the development costs are not significant early-on for our pipeline products. So I think for this year, most of that comes back as a cash savings.

As it relates to the second question, Brandon, interest in DSUVIA and kind of how that looks, it actually runs the gamut, anything from licensing in particular aspects of the market, whether it'd be a segment in procedural suites, hospital, other to full divestiture of the program. And we're entertaining all as we move through these discussions.

The next question comes from Ed Arce with H.C. Wainwright.

This is Thomas Yip asking a couple of questions for Ed. So first, announced today the headcount reduction. Can you provide an estimated number of acquisitions and what are their primary work functions in general area?

Yes. It's in the neighborhood, I'll give you a percentage, of between 40% to 45% of our headcount, predominantly in the commercial arena, with other tangential positions that might affect that, that have multiple duties.

Got it. Okay. And also somewhat related to that, you also announced discussions with potential partners to support commercial plan for sales expansion of DSUVIA. And you just talked about a little bit about the general framework. Should we expect any impact on your work with the DoD and how would that work out?

No, you shouldn't expect any impact on that. We've had a long-standing relationship now with the DoD. We are in frequent communication with them, and it wouldn't have an impact relative to that. I mean, again, the functions we're looking at is anything from a full divestiture actually us keeping certain segments of it like the DoD or some others that may have small resourcing. But again, it's the full gamut of possibilities for the product and the DoD will not be affected.

Okay. Thanks for the added color. And perhaps as you just pointed out, we'll exclude DoD and range of possibilities. Can you give us some ideas of how you envision this new plan, either through your own efforts and also through partners as well? Any road map to kind of elevate DSUVIA's sales in the U.S. from current levels?

Yes. The plan here, look, so we like the response we're getting from our communications. We made a lot of adapt. We adapted a lot of new mechanisms to move into the procedural suite market, in particular, during COVID, but not only because of COVID, because we see the market moving away from hospitals for many of these procedures and the selling cycle being shorter.

With that said, we still think hospitals are an opportunity moving forward. We still believe the ASCs are an opportunity, obviously, moving forward. But all this requires a much larger infrastructure than we have even in the procedural suites. So we're maintaining primarily a virtual sales team today, which is a more efficient cost structure and has been very responsive to communications and educations for DSUVIA, but it's not enough. And that not enough factor is the point where we believe for our shareholders, for DSUVIA, for the education of health care practitioners, it has to come with a larger effort, an effort that we can't do well while we're also concentrating on the recently acquired late-stage development pipeline.

So as opposed to trying to do both, we are going to really focus on that late-stage development pipeline. We'll continue the momentum on DSUVIA, but hope to expand it in a much greater degree moving forward with a partner.

Understood that, that makes a lot of sense. And perhaps one final question. Speaking of nafamostat, can you discuss what are the next steps to move nafamostat into Phase III and has study protocols been agreed with the FDA?

Yes. I'll have that question relative to nafamostat move to Dr. Palmer about the next steps on nafamostat and our plan over the course of the next year.

Yes. So Thomas, we're planning on initially making the first batch of product. And as Vince mentioned, applying for an EUA, which has already received very favorable feedback from the FDA, and we talked about that on the KOL data we had recently.

But the protocol itself, the endpoints have been agreed upon. They're very straightforward. Again, it's a simple study of 80 nafamostat patients versus 80 placebo patients, so that's a patient getting no anticoagulation while they're undergoing renal replacement therapy. And the primary endpoint is looking at the activated clotting time. So it's straightforward. It's been informed by the FDA, and we're excited to start that Phase III program after batches of the drug are made.

Thank you so much, Dr. Palmer. And thank you very much, Vince. Looking forward to your progress in coming months.

Thank you, Thomas.

The next question comes from Robert LeBoyer with NOBLE Capital.

There was a mention of the use in the procedural suites. And it sounds as...

Robert, just a comment, you went blank on us there at the start. Could you repeat the question of the beginning? I apologize.

Okay. There was a mention that DSUVIA is being used and growing in the procedural suites, which sounds like you're identifying procedures and settings where the drug is growing and could continue to grow. Could you just elaborate a little bit on the types of surgeries and the procedures where it's being used?

Absolutely. I'll refer this to Dr. Palmer in one moment, but there's 3 main categories where physician disciplines are using it. And I think the thing you have to commonly think of are awake surgeries. Those 3 disciplines are primarily plastics, oral maxillofacial, and ENT. And within those 3 disciplines, Pam, maybe you can talk about the results we've seen in the concentration of efforts on certain procedures.

Sure. Plastics has been the most straightforward one from -- for years and years, plastics have been working away from hospitals and ASCs into the procedural suites. It's more patient-friendly. Frankly, it's less expensive. And as we know, a lot of plastic surgeries are self-pay from the patient. So they have adopted DSUVIA fairly quickly.

Something like ENT, for example, that's a specialty that only recently has been focusing their painful procedures in an outpatient setting. They typically were done in hospitals and ASCs before. But because of the reimbursement to the physicians, that's changed recently. They get actually more reimbursement for performing these in an outpatient procedural suite. Then we've seen a large volume of those sinuplasties, et cetera, move into that setting. And so they've been more recently very interested in learning more about DSUVIA and the ENTs that have adopted it are really excited about what they're able to do comfortably with the patient in an office-based setting.

And then oral surgeons, of course, we've been interested in that group for a while. There has been a slow and steady adoption with the oral surgeons, but we really feel that it could be reaching a tipping point soon as more of them are hearing about DSUVIA.

And that's just the 3. I mean we've always believed that colonoscopies, as the scopes become smaller, with time and a little less painful on the actual procedure, they don't need that heavy sedation they've typically had in the past with your IV propofol, IV fentanyl, et cetera. So we are really excited about DSUVIA to be going into those areas as well.

So from a procedural suite standpoint, that's the movement. All procedural -- painful procedures are really sort of moving in that direction. And we believe DSUVIA is just the perfect opportunity to create a noninvasive analgesic that can really address the unmet need in that market.

Robert. So while we've had personal exposure to the plastics for anything from liposuction or radio frequency microneedling, which we just saw a published paper on more recently, neck lifts, awake neck lifts and blepharoplasties. And for the ENTs, as Pam mentioned, the sinuplasties for oral maxillofacial full-mouth tooth extractions and full arch implants are really painful procedures for these patients. That's only where we've concentrated our efforts. And I think that's an important point that Pam mentioned.

And as we move to a strategy where others can be involved, markets like GI, as you mentioned, OB/GYN, others that we can't adjust just based on limited resources, I think, will now become more transformational for our product within their particular practices moving forward.

This concludes our question-and-answer session. I would like to turn the conference back over to Vince Angotti for any closing remarks.

Yes. Well, thank you for joining us today and for your continued support of AcelRx. We're especially grateful to our employees for all their hard work and dedication.

Again, we believe we're well positioned for the future. We're excited about the prospects of our development pipeline, maximizing the potential for DSUVIA and we'll remain focused on driving shareholder value while controlling expenses. We look forward to sharing more developments in the near future. Thank you. Be safe and take care.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.