AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) Q1 2019 Earnings Conference Call May 8, 2019 4:30 PM ET
Raffi Asadorian - Chief Financial Officer
Vince Angotti - Chief Executive Officer
Pam Palmer - Chief Medical Officer
Conference Call Participants
Dan Busby - RBC Capital Markets
Brandon Folkes - Cantor Fitzgerald
Vamil Divan - Credit Suisse
Michael Higgins - Ladenburg Thalman
Andrew D'Silva - B Riley FBR
Aryeh Gold - Oppenheimer
Welcome to the AcelRx First Quarter 2019 Conference Call. This call is being webcast live on the Events page of the Investors section of AcelRx's website at acelrx.com. This call is the property of AcelRx and any recording, reproduction, or transmission of this call without the express written consent of AcelRx is strictly prohibited. As a reminder, today's 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 afternoon. Earlier today, we reported our first quarter 2019 financial results and provided an update on our commercial launch of DSUVIA in a press release. This press releases and a 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 our 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.
In addition to the company's periodic, current, and annual reports filed with the Securities and Exchange Commission, please refer to the text of our press release, for a discussion of the risks associated with such forward-looking statements.
I'll now turn the call over to Vince Angotti.
Thank you, Raffi and good afternoon everyone. We've had a strong start to our DSUVIA launch and though the first quarter represents only five weeks of selling with a staged sales team approach including only 15 account managers, we're confident we're on track to meet our objectives for the year.
Our number one priority for 2019 is building the foundation of success for the DSUVIA launch which primarily means achieving our targeted 125 formulary approvals by year end. These formulary approvals remain the first gate to realizing commercial success.
Furthermore, we announced earlier today that we'd become an approved vendor at one of the largest ambulatory surgical center, or ASC networks in the U.S., allowing physicians to use DSUVIA at the more than 300 locations much like a formulary approval at a hospital. We are excited to gain this approval as, in addition to hospitals, the ASC channel is an important healthcare segment for DSUVIA's use.
Now, these approvals alone will not define a successful launch, ultimately ensuring the adoption of DSUVIA by healthcare professionals, as part of their armament for safe and effective acute pain management is our goal.
Now, since the launch in late February, I've spent a significant amount of time in the field speaking with healthcare providers and I'll provide some color on what I've seen, as well as share the enthusiasm of our commercial organization in the early part of the launch.
Now, before sharing some of the commercial insights, I'd like to provide you with the key objectives for 2019 as we believe achieving these objectives will translate into a successful year for AcelRx and will set up the company for strong 2020.
Our first objective is already communicated is the achievement of at least 125 formulary approvals by the end of the year, which will set the foundation for further growth. The second objective is the hiring and training of 25 hospital account managers, raising the total number to 40. As a reminder, this planned hiring was accelerated at the beginning of the third quarter to capitalize on the greater than expected level of engagement seen to date with hospitals.
The third objective, resubmitting the Zalviso NDA before the end of 2019, would if approved provide us with another acute care product to market in the U.S. leveraging our commercial infrastructure. And as stated last quarter, we'd like to have two additional pieces of information for an expected Zalviso FDA Advisory Committee meeting. Those are one, the 12 months DSUVIA ramps report, and two, the data from a multinational prospective study on Zalviso use throughout Europe from our partner Grunenthal.
Specifically, this study is evaluating the efficacy, safety, usability, and health economics of Zalviso for the management of acute moderate to severe post-operative pain. Both datasets are expected late in the fourth quarter.
The fourth objective is to continue prudent cash management during the DSUVIA launch; this will be measured by not exceeding our planned quarterly combined R&D and SG&A expenses of $13 million to $16 million excluding stock-based compensation. The final objective is the refinancing of our existing senior loan to provide incremental capital and improve cash flow to reduce debt service and we're on pace to achieve all these objectives by the end of the year.
In addition, we continue to evaluate opportunities to maximize value from our product portfolio with the partnership to commercialize DSUVIA and or Zalviso outside the U.S. I mentioned earlier that, I've been spending time in the field with the hospital account team and healthcare providers. No, it's early in the launch. We've estimated that obtaining – we've estimated that obtaining formally approvals takes on average six months.
We are encouraged by the number of hospitals with whom we are having active discussions to bring DSUVIA on to their formularies. Again, with only 15 hospital account managers, we're currently engaged with over 400 hospitals, which is about a third of our hospital launch targets. We successfully completed or scheduled, 46 hospital formulary reviews by mid-year. This includes our first five formulary approvals, which we received just last month. And given that we're in the early weeks of the launch, we're providing a combined number of scheduled formulary reviews and approvals, which we believe provides a relevant measure of our progress.
We've not had any hospital with which we are engaged decline accepting DSUVIA onto its formulary. And in addition, as mentioned previously, we now have access to sell DSUVIA in over 300 ambulatory surgical centers. And one thing, we've learned about DSUVIA in the short period of time since the launch is DSUVIA's application for the management of acute pain in medically supervised settings is diverse. We've had physician champions interested in DSUVIA for use within the emergency department, whereas others believe, it'll be used initially in the postoperative setting, while we have others interested in its use for acute pain and intensive care units, burn centers, ambulatory surgery centers, vascular surgery and plastic surgery centers or for palliative care.
As expected, clinicians appreciate the non-invasive route of administration. But in addition, we repeatedly here that the unique pharmacokinetic profile, which allows for rapid onset, blunted peak plasma levels and duration of action without active metabolites, satisfies an important unmet need.
Again, it's early, in the next few quarters we will provide a good indication of where and how DSUVIA is being used within the healthcare settings. And add some color while in the field, I spent time touring ER with the head pharmacist of a large hospital emergency department.
Pointed to specific areas where she indicated DSUVIA would be an ideal treatment option to avoid initiating an IV while efficiently managing the patient's pain. And a separate institution, I met with an anesthesiologist, who is eager to have DSUVIA at his hospital in the postoperative setting to avoid having to re-insert an IV to address pain flare-ups after surgery. And these are just two of the many examples of healthcare professionals with whom I've met who are enthusiastic about getting DSUVIA on formulary at their hospitals.
In 2019, we total three advisory boards, with a total of about 40 healthcare providers and administrators. These advisory boards have proven invaluable in better understanding the user's perspectives and needs for acute pain management within their institutions. A consistent message from these advisory boards is that the route of administration and pharmacokinetic profile of DSUVIA fits nicely with the enhanced recovery after surgery or ERAS approach, which is the latest advancement in post-surgical care. The goal of ERAS is early mobilization and recovery of the patient, allowing for timely discharge from the hospitals.
In addition to timely postoperative discharge, we continue to hear avoiding bottlenecks in the emergency room is also critical and in their words, keeping vertical patients vertical in the emergency room meaning, not in the bed is an important factor improving patient wait times and ER throughput. DSUVIA's well suited support in this effort as there is no need for a bed or to incur the time and cost of initiating and maintaining IV access.
Finally and importantly, DSUVIA's discrete dose which eliminates leftover drug and the requirement for witnessed disposal has been an important feature of discussion. As one, it improves efficiency because nurses don't have to wait for another nurse to witness drug disposal during busy ER times, and two, it doesn't provide an opportunity for diversion due to leftover drug.
Outside the civilian setting, the military and military treatment facilities appreciate DSUVIA's product characteristics. The military has ordered DSUVIA; however, we do not intend to separately break out sales at this level going forward.
We will have many commercial product launches, several of them with many of the same team members we have at AcelRx. We're confident DSUVIA's non-invasive administration and PK profile to manage acute pain is an attractive alternative to IV opioids in medically supervised settings.
Knowing that it will take time to gain access to formularies and for physicians and institutions to adopt and change existing standards of care, we have been more confident our staged commercialization approach is the best way to launch DSUVIA.
We believe that once DSUVIA is initially used, its applications in acute pain will be broadly accepted within healthcare settings, given its efficacy, safety and ease of use characteristics that benefit the patient, as well as the healthcare systems.
Raffi will now take you through the financials.
Thank you, Vince. We ended the first quarter of 2019 with $90.2 million in cash and short-term investments. Our net cash outflow for the first quarter was $15.5 million, driven mainly by our $10.3 million of operating expenses or combined R&D and SG&A expenses, excluding stock-based compensation.
Debt service during the quarter was $2.3 million, which is attributed to our senior secured debt as currently amortizing. The amount of senior debt at the end of the first quarter of 2019 was $10 million. Revenues for the first quarter of 2019 were $0.3 million, in-line with 2018 and reflect only five weeks of DSUVIA being available for sale. Q1 2019 revenues include DSUVIA net sales of approximately $50,000 plus Zalviso collaboration related revenues.
Hospital formulary approvals in the first year of the launch remain the key to setting our foundation for commercial success. As previously mentioned, on average, we expect it to take six months to obtain formulary approval for DSUVIA. Therefore, we anticipate third and fourth quarter revenues to begin reflecting more meaningful DSUVIA sales contribution.
DSUVIA gross to net sales percentage in the first quarter was 37%, compared to 35% expected for the year. We continue to track to achieving 125 formulary approvals by the end of 2019 with a significant increase in approvals expected in the second half of the year.
Combined R&D and SG&A expenses for the first quarter of 2019 totaled $11.4 million compared to $7.5 million for the first quarter of 2018. Excluding stock-based compensation expense, these amounts were $10.3 million for the first quarter of 2019, compared to $6.5 million for the first quarter of 2018.
The increase in R&D and SG&A expenses is primarily due to higher personnel-related expenses attributable to the commercial launch of DSUVIA. We expect the combined R&D and SG&A expenses, excluding stock-based compensation in the remaining quarters of 2019 to be within the $13 million to $16 million range previously communicated.
With that, let me turn the call back over to Vince.
Thanks, Raffi. So to summarize, we remain confident in the success we'll have with DSUVIA to believe this product has the ability to create meaningful positive change in acute pain management in healthcare settings. We'll continue to methodically execute against our 2019 plan, while maintaining financial discipline.
I'd now like to open the line up for any questions you may have. Operator?
Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question today comes from Randall Stanicky with RBC Capital Markets. Please go ahead.
Hey, everyone. This is Dan Busby on for Randall. I've got a few questions. First off, could you help us put the ambulatory surgical center opportunity into perspective, 300 is obviously a big number and without going into specific numbers. Could you compare the frequency of DSUVIA use that you would expect to see at a typical ASC as a percentage of what you might expect to see at a typical hospital, this if you were to compare them on a relative basis.
Yeah, Dan, this is Vincent. Thanks for the question. I'll give you a little bit of color behind it and then about comparative use. Apart from the hospital calls, the sales team also frequents ASCs in their respective territories. So based on these visits, obviously, there was enough interest created to allow AcelRx to approach this particular ASC's corporate office to have them evaluate loss and distributed gain approval.
Without this approval, DSUVIA is unable to utilize. So of these interestingly, about 70% of these ASCs actually fall within our occupied territories. So that's important. And the other it thing provides is cross pollinization with the hospital. So it potentially allows a physician or nurse to experience DSUVIA prior to a hospital formulary process. So they can take these learnings to the hospital.
So while we've been mainly focused on the formularies in hospitals, because of the multiple settings of use for those particular institutions, the ASCs obviously for same-day surgeries is an appropriate place for use and each ASC is different from the next and different from the hospital patient flow, because some ASCs might have two or three surgeons, they might just have one surgeon in them, who owns it on their own versus the hospitals, which have obviously multiple physicians there. So it's difficult to put them on a comparative basis of one versus the other, because they're all unique to themselves.
Okay, that's fair. And then just to confirm from the opening remarks, you mentioned 46 hospital formulary reviews were cited and five of those have been approvals, so that would imply 41 are still ongoing discussions. Is that correct?
Correct. Yeah. So our first five wins actually came in April.
Yeah. They're actually -- just to clarify, the ongoing discussions, I mean those are scheduled P&T committee reviews that will -- that are happening here.
Okay, understood. Thank you. And then just one last one for me, on REMS, I think you mentioned on the last earnings call that your first REMS report was due six months post approval. I think that fell last week, so are you able to speak to well -- I guess first correct me if I'm wrong, but are you able to speak to any takeaways or highlights from that report at this point?
Yes. We did turn in that REMS report and that first six months report has just some very basic information in it, which we supply the FDA, but the -- it's not as detailed as the year they reported.
Okay, got it. And then just maybe a follow-up on REMS. Is it -- it all burdensome for hospitals to get their REMS protocols established and put into place? I'm just wondering, because you mentioned, it takes six months on average to get on formulary. Should we be adding any time on top of that to allow for these REMS programs to be put in place or is that pretty much taking care of when it is approved?
Yeah, I wouldn't say, it's taking -- taking care of the day of approval, they are long completed typically shortly thereafter. But, they're preparing for it and evaluating that all along inclusive of the formulary review. So it's component what they review moving forward. It hasn't been an obstacle or a concern. I can tell you that of the five wins that we have all the REMS are already completed for those particular institutions. I can't promise you it will be that efficient moving forward, but that's a fair indicator. We even have a few institutions that while it's on the schedule for the P&T during the course of the next couple of months have already become REMS certified, so a few of them actually got ahead of the game. So there's not one formula fits all, but it clearly doesn't seem to be a significant lagging issue beyond an approval.
That's helpful color. Thank you.
You're welcome. Thank you.
Your next question comes from Brandon Folkes from Cantor Fitzgerald. Please go ahead.
Hi, thanks for taking my questions. I wonder if you could share some of the consistent feedback you've received in terms of where DSUVIA is getting used in hospitals, perhaps the key benefits that facilities are seeing with the product? And what they are replacing use of in place of DSUVIA?
And then secondly, maybe could you provide any color on the impact of the IV opioid shortage, has this provided a tailwind for you guys to get in front of hospitals? Thank you.
Hi, Brandon, thanks. This is Vince. I'm going to turn the first part of that question over to Pam and as much time as I was spending in the field, Pam has been marrying it with her work at different institutions around the country as well. So Pam?
Yes. So I have had a tremendous opportunity to speak to folks in all different levels of healthcare. And obviously, as we said in the call that the non-invasive nature is the immediate thing that people think about as being an advantage. But as soon as they hear about the PK profile and that is being a noninvasive route of administration that allows an onset in 15 minutes. A very blunted peak plasma level.
And what that means is, if I gave you the same dose IV, 30 micrograms of sufentanil, you would have a very high peak plasma level and when they're used to using these drugs, whether it's IV fentanyl or IV sufentanil in the hospital. They're used to that sharp high peak plasma level causing side effects and then falling off quickly and then the patient is in pain again, and then they have to re-dose quickly. But they love these drugs, because they don't have any active metabolites, they are very cardiac stable.
So to give them this drug without that peak and trough, PK profile is really profound, I mean that really from an anesthesiologist point of view from -- from whether it's cardiac surgeon standpoint or even emergency room doctors that understand opioids, when they see the PK profile, it really speaks to them above and beyond the non-invasive route of administration.
I hope that add some color to it, Brandon. To your second question on the impact of the IV opioid shortage, I can tell you, we just had an add couple of weeks ago on the first two questions, wanted to confirm that we'd be able to have supply, which continues to tell us that these IV shortages -- IV opioid shortages throughout the country are continuing. We continue to hear in all aspects of areas of the country where we certainly have sales representatives and doesn't seem like it's going away anytime soon. So just the fact that we have supply seems to be a bit of a tailwind for us.
Great. Thank you very much.
You're welcome. Thank you, Brandon.
The next question comes from Vamil Divan with Credit Suisse. Please go ahead.
Hi, great. Thanks for taking the question. So maybe just one following up on the ASC commentary, I think you said about 70% of the ASCs would be within your covered territories. So I'm just wondering if you are -- how you're thinking about the other 30%, is that something you may look to as things you won't expand into or so if your plan is always serve and focus more on the -- on sort of the core 70%? And then second, maybe just from a modeling perspective, maybe give us a little more color on the contract and other revenue line. Just so we can think about how to model that, because we -- the revenues did this quarter, I'm -- just want to make sure we got it right as we go forward. Thanks.
Yes. Good questions, Vamil. So for the ASC, that's correct. About 70% of those ASCs for this particular system fall within our currently occupied territories, which is obviously the bulk of them. About 80% of them total fall within our sales alignment. So as we expand, we'll get to about 80% of them. We're likely not going to expand, just to cover these ASCs. So beyond that 80% are those that likely we wouldn't cover with a personal touch for potentially as some telemarketing or reach out in a different fashion moving forward. So, I hit part of the question, Raf?
Yeah, superb. On the -- so we have the collaboration and then we have the contract in other, I mean historically that contract in other was mainly the DoD contract that we had for development of DSUVIA. So I don't see which you've modeled. But I wouldn't have much in the contract line, it's really going to be coming through that collaboration line which will mainly be our deferred revenue with the collaboration agreement with GRT as well as the royalties and milestones that we would get from any sales that GRT -- Grunenthal makes for us.
Okay. All right. Thank you so much.
[Operator Instructions] Our next question comes from Michael Higgins with Ladenburg Thalman. Please go ahead.
Thanks, operator, guys, thanks for taking the questions. Couple here stemming from comments I am hearing on the call, we spoke last time about ERAS, the Enhanced Recovery After Surgery. Hearing it again, I'm just curious, is that down the road setting, in which you may be able to generate some data, which will help you in future sales of the product to show maybe from a pharmacoeconomic way or at least from safety efficacy, how that affects patient outcomes?
We’ll have Pam answer that one, Michael. Thanks.
Sure. Yeah, the whole point of ERAS is early mobilization and getting out any invasive tubes and lines, catheters et cetera. So the patient can ambulate, get healthy and get out of the hospital before they catch an infection or pneumonia or have a deep vein thrombosis or all the complications of staying around hospitals.
And DSUVIA by being non-invasive fits very easily and when we talk to the leaders of ERAS over the years that was very clear. One of the other things in addition, again to the non-invasive is the PK profile. When ERAS uses opioids, the protocol calls them a breakthrough opioid. So they're using non-opioid analgesics as the baseline treatment and they're using opioids only as breakthrough. And in that treatment paradigm, you need to have a very specific PK profile, meaning fast onset and then a reasonable duration of time and then a nice offset.
They don't want round the clock dosing of these opioids. So we are excited. Some of the top leaders of the ERAS movement here in the U.S. have actually contacted us around investigator initiated trials and we're working right now, do some protocols with them.
Okay, that's interesting to hear. Thanks. It just strikes me as a great opportunity for the drug. And then just to get back to the approved vendor that you are penetrating locations. Can you name the system, yet? Are we too early for that and just to help us in understanding, how big this might be, the number of patients they treat, the number of potential DSUVIA patients that may be treated at the 300 locations over a year and should we look for any more of these agreements to be struck in 2019? Thanks.
Good question, Michael. We can't provide you forecasting or modeling data as it relates to the size of this particular team. What we can tell you is that we've identified 12 including this one that really of specific interest to us, because they have a certain size or magnitude to them. This is the largest of those identified.
Just to give you little more color, the top five of these 12, the top five alone account for about 90% of the sites around the country of these 12. So it's highly concentrated with potential in these higher volume accounts.
And yeah, we'll look to some of the others. Again, we really want to continue to focus on the hospitals. But this is an opportunity we see moving forward for these physicians again to gain experience outside of the hospital and bring those learnings to that institution.
It is important to realize that for each of these particular installations, they would have to be REMS certified just to qualify it. So each site that would actually receive product would have to become certainly certified through in order to carry our product to our REMS program, but they all already carry -- most of them ideal candidates so they will be eligible.
And then just a follow-up, as you look out to the back half of the year, what percent of the sales may come from these ASCs like this, you certainly seen it within ER products. You consider the pack year as the great opportunity to locks terms as well in the hospital. But the ASCs, that's a meaningful piece of the revenue outlook in 2019 or is it a nice to have?
Yeah. No. It's difficult to estimate these versus the balance of it. We have some hospitals looking at it for the ER use only, some hospitals looking at it for the same day surgery, some hospitals looking at it for across the board. Yeah, we've got other institutions looking at it for their burn center. So it's difficult to give a proportion of the sales that will come specifically from these ASCs.
Yeah, I would say, Michael, that we still have to pull it through, right? This is like -- it's like a formulary win. We still have to pull it through and the sales force still needs to go out there and work that each of those units. So I wouldn't expect any material changes to what we are expecting.
Appreciate the feedback. Thanks, guys.
The next question comes from Andrew D'Silva with B Riley FBR. Please go ahead.
Hey, thanks for taking my questions. Actually, I only got one. Most of mine were already answered. But I was just curious as it relates to formulary lists and your target within the year. Are you counting that on a per hospital basis -- is some health systems, if you get in a formulary list, it carries over to multiple hospitals, so, is it per hospital or per formulary list?
It's a per hospital list, but we have some systems currently that are looking at -- what do we call them, high-control level force and those would be the ones that where if they have five, six or seven units meaning installations, brick and mortar buildings, they would all automatically put it on formulary. Others, unless they're high control. You'd have to go work each formulary within that particular system. So right now, we're actually looking as brick and mortar buildings that have access to the product based on approval.
Okay. But it should be a fairly similar number just kind of based on that context, you just gave since -- seems like most of them are for individual hospitals?
Correct. We have some systems in there, but most of them individual right now.
Got it. Perfect. Thank you very much. Good luck going forward this year.
Thank you, Andrew.
The next question comes from Leland Gershell with Oppenheimer. Please go ahead.
Hi, this is Aryeh Gold on for Leland Gershell. I had -- I just have one quick question at this point. Were these initial sales mostly a few large bulk orders or were they multiple repeated orders?
So these were -- the first sales for the first quarter came without formulary approvals. Remember, all of our formulary approvals started in the second quarter of April. So this was just the early stocking by the wholesalers, which as expected along would be limited. You're not going to see large stockings of opioid products in the wholesaler channel.
All right. Thanks for taking my question.
This concludes our question-and-answer session. I would like to turn the conference back over to Vince Angotti for any closing remarks.
Thank you, operator and thank you for joining us today and for your continued support of AcelRx. We know it's early, but based on the initial feedback, we remain confident DSUVIA's impact for acute pain in these medically supervised settings. So, again, thank you for your support and have a great day.
This conference is now concluded. Thank you for attending today's presentation. You may now disconnect.