Q1 2021 AcelRx Pharmaceuticals Inc Earnings Call
All of them against the three emails from them.
Unnamed: three emails from them. Thanks.
[music].
Welcome to the XL Iraq for.
Unnamed: Welcome to the Xcelorax First Quarter 2021 Earnings Call. This call is being webcast live on the events page of the investor select section of XLRX's website at acelrx.com. This call is the property of XLRS, and any recording, reproduction, or transmission of this call without the express written consent of XLRX is strictly prohibited. As a reminder, this call is being recorded. You may listen to a webcast replay of this call by going to the investor section of XLRX's website. I would now like to turn the call over to Rafi. Asidorian XLRX chief financial officer. Please go ahead.
First quarter 2021 earnings call.
This call is being webcast live on the events page of the investors section of <unk> website at H C E. L. R ex stock comp.
This call is the property of accelerant.
And any recording reproduction or transmission of this call without the express written consent of XL or ex is strictly prohibited as a reminder, today's call is being recorded.
May listen to a webcast replay of this call by going to the investors section of XL Orexis website.
I would now like the turn the call of her to Raffi, that's the Dorian accelerates Chief Financial Officer. Please go ahead.
Yeah.
Thank you for joining us this afternoon earlier today, we announced our first quarter financial results and some business updates in a press release. This press release and the slide presentation accompanying this call are available on the investors section of our website.
Raffi Mark Asadorian: Thank you for joining us this afternoon. Earlier today, we announced our first quarter 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 is Ben Tangadi, 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 security laws.
With me today is Vincent Gotti, 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 accelerates.
Raffi Mark Asadorian: These forward-looking statements involve risks and uncertainties regarding the operations and future results of Acceleries. 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 will now hand the call over to Vince. Thank you, Rafi. And good afternoon, everyone.
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 will now hand, the call over to vets.
Thank you Rafi and good afternoon, everyone. We appreciate you taking the time to join the call.
Vince: We appreciate you taking the time to join the call. I'll keep our prepared remarks brief since our last update was just a couple of months ago. On the year-end call, we discussed the expectation that the COVID backlog of collective surgeries would begin clearing up in the second half of this year. In particular, these last two months have provided more clarity on the post-COVID environment, as surgery centers and hospitals in the U.S. are beginning to open, accept visitors, and reinitiate elective surgery. In fact, April was our best commercial month since the launch of the students.
I will keep our prepared remarks brief since our last update was just a couple of months ago on.
On the year on call, we discussed the expectation that the COVID-19 backlog for elective surgeries would begin clearing up in the second half of this year.
In particular these last few months have provided more clarity on the post COVID-19 environment.
Surgery centers and hospitals in the U S for beginning to open except visitors and Reinitiate elective surgeries.
In fact April was our best commercial month since the launch of the studio.
We have a long way to go but we're seeing light at the end of the tunnel and trending back to the growth we expected prior to COVID-19.
Vince: We have a long way to go, but we're seeing light at the end of the tunnel and trending back to the growth we expected prior to COVID. Although the pandemic delayed formula reviews over the last year through April, we've achieved 432 approved. We're well on track to achieve our year-end target of 615 formulae. Also encouraging is the continued expansion of the clinical site study to Sudia, as well as growth in the diversity of physician specialties beginning to adopt.
Although the pandemic delayed formulary reviews over the last year through April we've.
We've achieved 432 approvals.
We're well on track to achieve our year end target of 615 formulary approvals.
Also encouraging is the continued expansion of the clinical sites studying dispute.
As well as growth from the diversity of physician specialties, beginning to adopt the studio.
One of our key messages that is resonating with health care providers is how the studios supports opioid stewardship, which.
Vince: One of our key messages that is resonating with health care providers is how Dissubias supports opioid stewardship, which is reinforced with real-world clinical data published in the second half of the last generation of highly relevant clinical and Beyond what was studied in our registration trials, remains a priority for us in 2021. We're supporting a diverse array of investigator-initiated studies with an emphasis on commonly performed orthopedic procedures. Now, I'll touch on each of these important points shortly as I update you on the progress within our four pillars of revenue growth.
Which is reinforced with real world clinical data published in the second half of last year.
The generation of highly relevant clinical endpoints beyond what was studied on a registration trials remains a priority for us in 2021.
We're supporting a diverse array of investigator initiated studies with an emphasis on commonly performed orthopedic procedures now I'll touch on each of these important points shortly.
Update you on the progress within our four pillars of revenue growth.
Our first pillar is focused on the department of defense.
Vince: Our first pillar is focused on the department. Progress on sales to the DOD and the first quarter remains slow as they continue to work through complex administrative and logistical matters, which we expect will be resolved soon. Although the Army has ordered each of the last three quarters, we're awaiting clarity on regular shipments for deploying troops and an estimate of purchases for the year.
Progress on sales to the D O D. In the first quarter remained slow as they continue to work through complex administrative and logistical matters, which we expect will be resolved soon.
Although the army has ordered each of the last three quarters, we're awaiting clarity on regular shipments for deploying troops and an estimate of purchases for the year.
We still believe the $30 million for initial stocking of over three years is reasonable, but await further clarity on the timing of these purchases.
Vince: We still believe the $30 million for initial stocking over three years is reasonable, but we await further clarity on the timing of these purchases. Our second pillar is focused on specialty markets and partnering with larger, more established commercial partners. As you may recall, Zimmer Biomethental was our first partnership for the specialty market outside hospitals and general surgery. Approximately 70 commercial team members at Zimmer Biomet have now been trained, and were encouraged by the investments they're making in the distributia launch into the oral dental surgery space.
Yeah.
Our second pillar is focused on specialty markets and partnering with larger more established commercial partners.
As you May recall of Zimmer Biomet dental was our first partnership for especially the market outside of hospitals in general surgery centers.
<unk> 70 of commercial team members the Zimmer Biomet have now been trained in.
We're encouraged by the investments, we're making the <unk> launch into the oral and dental surgery space.
We expect the segment to gain more traction as Zimmer biomet dental progresses, the launch with the downstream personnel.
Vince: We expect this segment to gain more traction as Zimbribeomet Dental progresses the launch with the now-trained personnel. Importantly, we were informed by the American Dental Association in April about a code that can be used to guide reimbursement for the administration of Shuvia in this discipline. We believe this will also help with increased adoption within this space. Our third pillar is focused on hospitals and ambulatory surgery centers, as well as an increasing focus on surgeries and procedures moving into surgical sweep. Our internal commercial team is focused on this pillar, which is ultimately the largest market opportunity for the studio.
Importantly, we were informed by the American Dental Association in April about the code that can be used guiding reimbursement for the administration of the shoe of yet and this discipline we.
We believe this will also help with increased adoption within the space.
Our third pillar is focused on hospitals and ambulatory surgery centers as well as an increasing focus on surgeries and procedures moving into surgical suites.
Our internal commercial team is focused on this pillar, which is ultimately the largest market opportunity for the studio.
As mentioned at the beginning of the call the breadth of the type of physician specialists that are adopting the studio continues to grow from.
Vince: As mentioned at the beginning of the call, the breadth of the type of physician specialists that are adopting Sudia continues to grow, and the interest behind D'Suvia initiated with the Phase 3 clinical trial data demonstrating efficacy or a low rate of side effects and lack of cognitive impairment. But broader enthusiasm-mission building through recently published clinical data demonstrating significant reductions in the amount of opioids administered when using Dysuvia, faster discharge times, and better patient satisfaction, as noted in the poster presentation announced last week.
And the interest behind the shoe of you initiated with the phase three clinical trial data demonstrating efficacy of low rate of side effects, the lack of cognitive impairment.
But rather to do some enthusiasm as Youre building to the recently published clinical data demonstrating significant reductions of the amount of opioids administered when using the dispute.
Mr discharge times.
And better patient satisfaction as noted in the post of presentation announced last week.
Each physician specialists has a unique reason for adopting to see of yet but in the end the universal drivers are one patient satisfaction.
Vince: Each physician specialist has a unique reason for adopting Dysivia. But in the end, the universal drivers are one patient satisfaction, two, the differentiated pharmacokinetic profile, and three, the opioid sparing nature of juvia. Each of these can support an economic advantage of adopting the students.
To the differentiated pharmacokinetic profile and three the opioid sparing nature of the studio.
Each of the its can support an economic advantage of adopting the studio.
Our fastest growing specialty remains plastic surgery with sort of peak orthopedics being close shocking.
Vince: Our fastest-growing specialty remains plastic surgery, with orthopedics being a close second. In addition to these in oral and dental surgery, we're seeing increased interest in eye surgery, ENT procedures, and palliative care. I mentioned earlier that new data generation is a priority for us in 2021, data that was not available for a long time. We've always known that peer-to-peer shared experiences amongst clinicians regarding the use of D'Suvia is a powerful driver for adoption, disrupting the well-entrenched standard of care, IVO.
In addition to the east and oral and dental surgery, we're seeing increased interest in eye surgery.
E N T procedures and palliative care.
I mentioned earlier that new data generation is a priority for us in 2021.
Data that was not available at launch.
We've always known the peer to peer shared experiences amongst clinicians regarding the use of just showed you is the powerful driver for adoption as we are disrupting the well entrenched standard of care IV opioids.
So that and the clinical data from the investigator initiated studies will be extremely valuable to physicians and hospitals when the assessing the practical applications of the shoot you in their clinical protocols.
Vince: To that end, the clinical data from the investigator-initiated studies will be extremely valuable to physicians and hospitals when they're assessing the practical applications of the SUVIA in their clinical protocols. The two publications in the second half of last year that demonstrated reductions in overall local utilization when administering Subia perioperatively, as well as faster taxing discharge times that provided a strong value property. Opioid stewardship programs are becoming more common throughout institutions as clinicians realize the importance of including opioids in a multimodal treatment program, yet they want to minimize the side effects often seen with this drug class. From the clinical trial publications, as well as anecdotally discussions with physicians, Suvia is becoming recognized as the opioid that is opioid sparing in the perioperative center. In fact, the poster presentation last week at the ASRA annual meeting from a study performed at the University of Minnesota continued to illustrate this concept.
The two publications in the second half of last year, the demonstrated reductions in overall opioid utilization when administering dispute the of perioperative Lee as well as faster packaging discharge times of provided a strong value proposition.
Opioid stewardship programs are becoming more common throughout institutions as clinicians realize the importance of including opioids and the multimodal treatment program, yet they want to minimize the side effects often seen with the drug class.
From the clinical trial of publications as well as anecdotally discussions discussions with physicians.
It is becoming recognized as the opioid that is opioids sparing in the perioperative setting.
In fact, the poster presentation last week at the annual meeting from a study performed at the University of Minnesota continued to illustrate this concept.
So on statistically significant highlights from the poster supporting this opioid sparing of factors follows.
Vince: Some statistically significant highlights from the poster supporting this opioid sparing effect are as follows. In addition to patients receiving standard IV open, patients in the Distruvia group dose prior to extubation required 50% less opioids in the pack, with significantly more of them opioid-free, 36% versus 8%. Furthermore, the sugar-treated patients had improved overall benefit of analgesia scores referred to as Obas, O-B-A-F, compared to the control group. Obos is a validated seven-item tool that assesses pain intensity, adverse effects, and patient satisfaction with analgesics.
Compared to patients receiving standard by the opioids patients in the distribute group dose prior to the excavation.
Required 50% less opioids in the PACU.
With significantly more of them opioid free 36% versus 8%.
Furthermore, the sugar of treated patients had improved overall benefit of analgesia scores referred to as Oh boss Obi.
Compared to the control group.
The boss is a validated seven eight mm tool that assesses pain intensity.
Adverse effects and patient satisfaction with analgesia.
The limitations of the study include the dispute the was not compared to an active comparator. So please refer to on May 13th press release for the full poster on study results and for more information, including important safety information of Black box warnings. Please visit distribute dot com.
Vince: The limitations of the study include that Dissuvi was not compared to an active comparator, so please refer to our May 13th press release for the full poster and study results. And for more information, including important safety information in blackbox warnings, please visit Dissuvia.com.
Many physicians, particularly plastics and orthopedic surgeons are extremely sensitive the patient satisfaction given that the vast majority of their practice is elective surgeries for the surgical volume that is about to increase more than it has in years to address the COVID-19 backlog.
Vince: Many physicians, particularly plastic and orthopedic surgeons, are extremely sensitive to patient satisfaction given that the vast majority of their practice is elective surgeries with a surgical volume that is about to increase more than it has in years to address the COVID-backer. Pillar 4 is our focus on business development, and we continue to make progress on advancing multiple ongoing discussions from both an out licensing and in licensing stamps that we believe will add value to the company by enhancing our product portfolio.
We look forward to sharing more clinical data from the ongoing studies as it becomes available.
Pillar for us our focus on business development, and we continue to make progress on advancing multiple ongoing discussions for both on out licensing of life.
The thing and in licensing standpoint that we believe will add value to the company by enhancing our product portfolio.
Does not replace the priority with the studio, but potentially provides our commercial teams with additional sales opportunities on the same call.
Vince: This does not replace our priority with Pesuvia but potentially provides our commercial team with additional sales opportunities on the same call. And on the operations front, our contract manufacturer has taken possession of the automated packaging line, currently being installed at their facilities here in the U.S. We remain on track with our previously disclosed timeline to have initial commercial batches produced in the third quarter of 2022. We also expect that regulatory batches that would have been produced before this time will be able to be sold.
And on the operations from our contract manufacturers, taking possession of the automated packaging line.
Which is currently being installed at their facilities here in the U S.
We remain on track with our previously disclosed timeline to have initial commercial batches being produced in the third quarter of 'twenty 'twenty two.
We also expect the regulatory path is that would be produced before this time, we'll be able to be sold.
We're excited to finally get this phase of operations moving as we prepare for increased orders from the department of defense as well as for our commercial customers. We expect this will significantly reduce our cost of sales.
Vince: We're excited to finally get this phase of operations moving as we prepare for increased orders from the Department of Defense as well as our commercial customers. We expect this will significantly reduce our cost of sale. Finally, before handing the call over to Raphael, I'd like to provide an update on the FDA Warnings. We've submitted our response and have had excellent dialogue with the FDA to ensure a proper close out. We believe we've addressed all the points raised with the exception of finalizing the corrective action for the disjuvia banner ads that will run back in 2019. Two alternatives being evaluated as a corrective action for this are to include a Dear Doctor letter on the Deshuvia website or to run corrected banner ads without the tongue and done tagline and other minor ad.
Finally, before handing the call over to Raphael like the provide an update on the FDA warning letter.
We've submitted our response and the bad excellent dialogue with the FDA to ensure a proper closeout is received.
We believe we've addressed all of the points raised with the exception of finalizing the corrective action for the dispute the of banner ads that will run back in 2019.
The two alternatives being evaluated as the corrective action for this are to include a dear Doctor letter on the dispute the website or to run corrected banner ads without the tongue on tagline and other minor adjustments. Once this is cleared resolved we expect the FDA to issue a closeout letter.
Rafi: Once this is cleared and resolved, we expect the FDA to issue a close-out letter. I'll now hand the call over to Rafi to take you through the first quarter financial results. Thank you, Vince.
I'll now hand, the call over the Rafi to take you through the first quarter financial results.
Thank you Vince despite the.
Continued COVID-19 headwinds in the first quarter, we strongly improved our financial position ending the quarter with $67 $3 million in cash while also reducing our senior debt to $19 $1 million at the end of the quarter.
Rafi: Despite the continued COVID headwinds in the first quarter, we strongly improved our financial position, ending the quarter with $67.3 million in cash, while also reducing our senior debt to $19.1 million at the end of the quarter. The remaining long-term liabilities principally relate to the accounting for the sale of the Zalviso royalty liability, which is non-recourse to the company. The obligation is only payable from royalties received on sales of Zalviso. If there are no royalties received, then there is no repayment required.
The remaining long term liabilities principally relate to the accounting for the sale.
Of the Zalviso royalty liability, which is non recourse to the company the.
The obligation is only payable from royalties received on sales of Zalviso.
There are no royalties received and there is no repayment required.
Revenues consisted mainly of product sales and were zero point $5 million in the quarter of 32% increase over the first quarter 2020 again, despite the negative impact from the pandemic restricting access and limiting elective surgeries, which was experienced across the sector.
Rafi: Revenues consisted mainly of product sales and were $0.5 million in the quarter, a 32% increase over the first quarter of 2020, again despite the negative impact from the pandemic restricting access and limiting elective surgeries, which was experienced across the sector. As Vince mentioned, we are beginning to see restrictions eased, with an expectation that the trend will continue, and a reduction in the high backlog of elective surgeries will have a favorable impact on DeSuvia sales. Gross profit remained negative as revenues did not exceed the fixed overhead costs.
As Vince mentioned, we are beginning to see restrictions eased with an expectation that the trend will continue and a reduction in the high backlog of elective surgeries will have a favorable impact on the Cvs sales.
Gross profit remained negative at the revenues of not exceeded the fixed overhead cost. However, this GAAP was reduced in the quarter as the higher sales led to an improvement in the gross margin compared to Q1 2020.
Rafi: However, this gap was reduced in the quarter as the higher sales led to an improvement in the gross margin compared to Q1 2020. We're excited that the automated packaging line is finally being installed and look forward to the efficiencies expected to be realized as volumes ramp up. Operating expenses, or combined SG&A and R&D expenses, were $8.6 million in the first quarter of 2021, compared to $14.7 million in 2020. Excluding stock-based compensation, first quarter 2021 cash operating expenses were $7.5 million.
We're excited that the automated packaging line is finally being installed and look forward to the efficiency is expected to be realized as volumes ramp.
Operating expenses or combined SG&A and R&D expenses were $8 $6 million in the first quarter of 2021 compared to $14 $7 million in 2020.
Excluding stock based compensation first quarter 2021 cash operating expenses were $7 $5 million.
The reduction in operating expenses were driven by focusing.
Rafi: The reduction in operating expenses was driven by focusing our resources on high priority territories. We expect to remain around this same level of cash operating expenses during the rest of the year. We continue to remain prudent with our cash and control our spending as the DeSuvia launch progresses into new specialty areas and further penetrates hospitals and ASCs. Finally, as mentioned last quarter, we expect to have an outlicensing transaction completed for DeZuvio in the near term.
Our resources on high priority territories.
We expect to remain around the same level of cash operating expenses during the rest of the year.
We continue to remain prudent with our cash and control our spending as the day Subia launch progresses into new specialty areas and further penetrate hospitals and the asc's.
Finally, as mentioned last quarter, we expect to have an out licensing transaction completed for <unk> in the near term.
I'll now turn the call back over to Vince.
Rafi: I'll now turn the call back over to Rafi. So, in summary, in Q1, we strongly improved our financial position, have continued to engage in the support of key studies that we believe will further demonstrate the Studious differentiation through opioid stewardship and patient satisfaction, and we remain committed to business development transactions from both an out-licensing and in-licensing standpoint. As a result, we feel that we are well positioned in the post-COVID setting. And I'd like to take, Now I'd like to open the line for any questions you might have. Debbie, operator, please.
Thanks, Rafi so in summary in Q1, we strongly improved our financial position have continued to engage on the support of key studies that we believe will further demonstrate distributes differentiation to opioid stewardship and patient satisfaction and we remain committed to business development transactions from both on out licensing.
And licensing standpoint.
As the result, we feel that we're well positioned for the post COVID-19 setting.
And I'd like to take.
Now I'd like to open the line for any questions you might have.
Operator please.
We will now begin the question and answer session.
Operator: We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Brandon Folks with Cantor Fitzgerald. Please go ahead.
To ask a question you May press Star then one on your telephone keypad. If you are using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two at this time of a pause momentarily to assemble our roster.
Our first Chris question comes from Brandon Folkes with Cantor Fitzgerald. Please go ahead.
Hi, Thanks for taking my questions.
Brandon Richard Folkes: Hi, thanks for taking my questions. Maybe firstly, can you just elaborate on your comments on April being the best commercial month to date? Where are you seeing growth there? Any color would be very helpful.
Maybe firstly can you just elaborate in terms of your comment on April of being the best commercial month to date, where are you seeing growth day any color would be very helpful.
And then secondly, maybe just.
Vince: And then secondly, maybe just... at a high level strategically. Vince, in the past, you've talked about business development. What's your current thinking and sort of urgency? Obviously, it's been a different environment the last 12 months, but I'd love to get your update on that. Thank you. Sure, Brandon, thank you. So for question one, elaborate on April as the best day today. I can tell you.
Sort of at a high level strategically the Vince.
Vincent the past you've talked about business development.
What's your current thinking in sort of urgency other chips behavior.
On a different environment in the last 12 months, but.
I'd love to get your attack day. Thank you.
Sure Brandon. Thank you. So for question one elaborate on the April is the best to date I can tell you that in April we had the highest number of boxes to end users and unique orders for any given month since launch that even includes when we had 40 sales representatives for over a year ago.
Vince: Sure, Brandon, thank you. So for question one, elaborate on April as the best month to date. I can tell you that in April, we had the highest number of boxes to end users and unique orders for any given month since launch. That even includes when we had 40 cell phone representatives over a year ago.
It's interesting to watch the first quarter as the hospitals in particular, we're really focused on the vaccinations as they should be at the operations relative to the distribution of those vaccinations.
Vince: It was interesting to watch the first quarter as the hospitals, in particular, were really focused on the vaccinations as they should be in operations relative to the distribution of those vaccinations. So we started to see the momentum actually start to pick up a little bit in March, with March representing about 50% of our total orders for the first quarter in commercial. So you can see in the first couple months when the hospital was in particular focused on the vaccinations and their operations. It was relatively light in quantity, of orders or amount per order but really started to pick up in March, and we had our best months ever in April.
So we started to see the momentum actually you start to pick up a little bit March with March representing about 50% of our total orders for the first quarter in commercial so you could see the first couple of months when the hospitals from particular focus on the vaccinations in the operations. It was relatively light in quantity of orders or amount for <unk>.
Order, but really started to pick up in March and we had our best month ever in April so that was exciting to see from a leading indicator standpoint. We also remain on track for our goal of 615 formularies by the end of the year and they have ramped up in pace in the last couple of months as well and we believe that'll be further up ticking of that in the second half of this year.
Vince: So that was exciting to see from a leading indicator standpoint. We also remain on track for our goal of 615 formularies by the end of the year, and they have ramped up and pace in the last couple months as well. And we believe there will be further acceleration of that in the second half of this year as things become even more open.
I think become even more open.
That was question one brand of question two I believe with strategically from business development. Our current thinking at our urgency. We've always had the highest sense of urgency I think of it was evidenced by our M&A move last year early in the year.
Vince: Question two, I believe, was strategically from the business development, our current thinking, and our urge. We've always had a high sense of urgency. I think it was evident by our M&A move last year early in the year. We've continued to prospect for different business development opportunities, whether on the larger strategic opportunities like we tried last year or from a product basis, both from an in-licensing and out-licensing perspective. We're confident that we can monetize Pesuvia, particularly in other territories outside the U.S. and Europe, in particular, as targeted to be completed this year, and we feel comfortable that that can be achieved.
Continue to prospect for different business development opportunities, whether on the largest strategic opportunity like we tried last year or from a product basis, both from an in licensing and out licensing perspective, we're confident that we can monetize the studio a particular in other territories outside the U S and Europe.
In particular it is targeted to be completed this year and we feel comfortable that can be achieved.
We also of the opportunity we believe for opportunistic acquisitions of products that can help build our portfolio moving forward eventually to allow our sales team the multiple sales calls or multiple product deliveries on any particular institutional sales call.
Vince: We also have the opportunity, we believe, for opportunistic acquisitions of products that can help build our portfolio moving forward, eventually allowing our sales team to have multiple sales calls or multiple product deliveries on any particular institutional sales call. Rafi, is there anything you'd like to add to that? Nope, I think you got it. A high sense of urgency, I think, should be your takeaway, Brandon. But without being ignorant to proper business.
Ralph you is there anything you'd like to add to that.
Nope I think you've got it.
A high sense of urgency I think she'd be your takeaway Brendan but.
Without being ignorant to proper business.
Yeah.
The agreements.
Okay.
Great. Thank you very much.
Thank you Brian.
The next.
Question comes from Michael Higgins with Ladenburg Thalmann. Please go ahead.
Michael Higgins: The question comes from Michael Higgins with Leidenberg Thalman. Please go ahead.
Hey, guys good to talk with you again here.
Michael Higgins: Hey guys, good to talk with you again here. You've got your press release, a really nice list of the studies, the pilot studies, pharmaco-economic reviews, et cetera. Just curious what ending you may be in in that effort. This is certainly a big boost in adoption compared to what you had at launch, but I'd be curious to see how many more we should look for over the coming years. Pam, I'll refer to you to comment on the pilot studies and kind of how you see timing moving forward in the importance of these data outputs.
You've got in your press release of real Nice list of the study as the pilot studies Pharmacodynamic reviews et cetera, just curious what inning you may be in and that efforts. This is certainly a big boost in the adoption compared to what you had at launch, but just curious to see how many more of we should look for over the coming years. Thanks.
Sam I'll refer to you to comment on the pilot studies and kind of how you see timing moving forward and the importance of being.
Al touched on one of them.
Sure Yes.
Pamela Pierce Palmer: Yeah, so we've got a number of investigator-initiated trials ongoing, and, you know, they're definitely enrolling well, but by the time they analyze the data and write it up, it's definitely going to be the latter half of the year to get most of that data out and published. There are also studies going on, though, that aren't via IITs that we know of.
Yes, so we've got a number of investigator initiated trials ongoing and on.
They are definitely enrolling well.
By the time, they analyze the data and write it up it's definitely going to probably be the latter.
Half of the year to get most of that data out and published on.
There are also studies going on now that arent in the eye team that we know of so it'll be exciting to have some of that more near term data come out as well and.
Pamela Pierce Palmer: So it'll be exciting to have some of that more near-term data come out as well. And, you know, in general, whether it's anecdotally or through published papers, we're really seeing this consistent lowering of oral opioid use perioperatively and faster discharge times. You know, really, like we say, that DeSuvia is becoming the opioid that is opioid sparing. And I think that's a really important point that is consistent across all these studies. And we look to see that also, hopefully, from these IITs, as that really feeds into the opioid stewardship protocols that a lot of these institutions are adopting.
In general, whether it's anecdotally or through the published papers for really seeing this consistent lowering of overall opioid use perioperative Lee faster discharge times.
You know really like we say that the suite.
The becoming the opioid that has the opioid sparing and I think that's a really important.
<unk> that is consistent across all of the study can we look to see that also hopefully from these AI team and that really feeds into the opioid stewardship protocols that a lot of these institutions are adopting.
Hey, Pat can you comment on the diversity of the orthopedic trials that we also have underway or are supporting.
Vince: Hey, Pan, can you comment on the diversity of the orthopedic trials that we also have underway or are supporting?
Right.
Pamela Pierce Palmer: Exactly, and as Dean mentioned during the call, the key thing about orthopedic cases is that a lot of them are elective. And so, you know, patients can really shop for their doctor, and they want to go to doctors who are using the latest techniques and the latest approaches to treat pain, et cetera. So we're really excited. We've got a couple of spine surgeries that are either ongoing or are in the queue. We've got a couple of total joint replacements.
Exactly and I think of it.
As mentioned during the call. The key thing about Orthopedics cases has got a lot of them are elective and so on.
Patients can really shop, their doctor and they want to go to doctors for everything.
The latest techniques and the latest.
Approaches to treat pain et cetera. So we're really excited we've got a couple of spine surgeries that are either ongoing or are in the queue. We've got a couple of total joint surgeries as well from that standpoint, and so yes. The orthopedics on the huge focus some plastics is.
Pamela Pierce Palmer: surgeries as well from that standpoint. And so, yeah, so orthopedias is a huge focus, some plastics as well. And then we've got IITs are always sort of leading the commercialization in that they look into new areas that we're not necessarily going after right now. So sickle cell, you know, ophthalologic surgery are really exciting areas that we're also seeing these IITs being requested from. So it'll be fun to go into those new areas as well.
Well and then we've got <unk> are always sort of leading.
The commercialization that it looks into new areas that we're not necessarily going after right now for sickle cell.
You know.
Ophthalmologist surgery is really exciting areas that we're also seeing <unk> being requested from the so it'll be fun to go into those new areas as well.
Okay.
Michael Higgins: That's great, guys. I appreciate all that color. If you can comment on whether this is a, and it seems to be an ongoing effort on the next
That's great guys I appreciate all that color.
You can comment on if this is a C.
Seems to be an ongoing effort.
The next couple of years.
Michael Higgins: Yeah, from a Chinese standpoint.
Yeah.
Yeah.
Pamela Pierce Palmer: Yes. So, absolutely.
Yeah. So the after all of the timing of again.
Yeah. So the the Bottomline is the these are the.
Pamela Pierce Palmer: Yeah, so the bottom line is these are rolling admissions, so as they're submitted in, and we assess them, and we approve some, we don't approve others, and then they go through the hiring process. So it's a bit of an approach to each of them, and so they will be, you know, rolling enrollment for all of these different things, and we definitely expect this to go on for the next few years because there are so many different indications. The CD's label is so broad that even these on-label utilization are quite varied.
They're rolling admissions so as they are submitted in an assessment.
And the upstream some.
Some we don't improve others and then they go through a contracting so it's a bit of the.
And the approach to each of them and so they will be rolling enrolled.
Enrollment for all of these different things and we definitely expect this to go on for the next few years, because there's so many different indications.
On the label is so broad.
But even the on label Utilizations are quite on.
Bearing and very interesting.
Michael Higgins: That is great to hear. Thanks.
That is great.
Vince: It almost feels like we're just launching the product in the second half of last year with this new data and that it continues to build. And we feel like we're well positioned, in particular for orthopedics, moving forward because it's estimated when we look at the data that there is a backlog of more than a million, you can imagine that total joint spine surgery cases by mid-22, and that the country may need up to 16 months to work through the backlog of that orthopedic care. Three of the top four inpatient elective surgeries annually are orthopedic.
Appreciate you are.
Almost feels like we're just launching the product in the second half of last year with this new data and that it continues to build and we feel like we're well positioned in particular for orthopedics moving towards.
It's estimated when we looked at the day that there's a backlog of more than a million you could imagine that total joint and spine surgery cases by mid 'twenty two.
And that the country may need up to 16 months to work through the backlog of that orthopedic care.
Three of the top for inpatient, let the surgeries annually or orthopedics. So we've got a significant amount of different the diverse orthopedic studies, we're supporting hopefully to help them work through the backlog with proper patient care, but through efficiency with the studio as well. So we're excited about the positioning of the product moving forward.
Vince: So we've got a significant amount of different diverse orthopedic studies we're supporting, hopefully to help them work through this backlog with proper patient care but through efficiency with the studio as well. So we're excited about the positioning of the product moving forward. That's really great color, I appreciate that.
That's really great color appreciate that one one other question would be if you can give us an update on the size of the marketing force right now.
Michael Higgins: One other question would be, could you give us an update on the size of the marketing force right now, where that sits? If you can give us some support in terms of its overall cost and how you see that playing out, you've got a lot of great information. Just, you know, the next step, of course, is getting it out there, and that can happen a variety of ways, but one of which is the Salesforce. Thank you.
Where that sits.
Can you give us some some support in terms of its overall cost and.
And how you see that playing out.
Got a lot of credit information just the net.
Step of course is getting it out there and that can happen variety of ways, but one of which is the the sales force. Thanks.
Yeah. So our sales team remains fairly tight we're very cost conscious and we did that last year moving at the COVID-19 to be sure. We conserve cash and really focused on hyper targeting of certain markets. We've got 15 sales representatives with the accelerates that are employed we've got on additional 10, we've got a co promote with with La Jolla.
Michael Higgins: Yeah, so our sales team remains fairly tight. We're very cost conscious, and we did that last year, moving into COVID to be sure we conserved cash and really focused on hyper-targeting certain markets. We've got 15 sales representatives with AccelerX that are employed, and we've got an additional 10.
Vince: We've got to co-promote with La Jolla, who really focuses more on hospitals as opposed to the ASCs or plastics or anything of that matter. In our 15 rep territories, we focus on all of it, those hospitals, the adjacent ASCs, and to a lesser extent, plastics. But plastics has been coming on strong lately. In the fourth quarter of last year, we started an experiment with two virtual sales representatives, virtual sales calls, and virtual educational programming.
Really focused more on hospitals as opposed to the ASC use of plastics or anything of that matter.
On our 15 Rep territories, we focus on all of it those hospitals, the adjacent <unk> and to a lesser extent of plastics, but part of plastics is becoming on strong lately in the fourth quarter of last year. We started to experiment with two virtual sales representatives and virtual sales calls and virtual.
<unk> programming and it appears that the plastic surgery discipline is very adaptable to that type of setting. It makes quit makes decisions fairly quickly. So the very efficient very efficient small team of two virtual sales representatives that have follow up from our team and virtual programming.
Vince: And it appears that the plastic surgery discipline is very adaptable to that type of setting and makes decisions fairly quickly. So the very efficient, very efficient small team of two virtual sales representatives that have follow-up from our team and virtual programming. We're seeing plastics really start to take the lead, believe it or not, in some of the most recent approvals.
Seeing plastics, you really start to take the lead believe it or not in some of the most recent.
Approvals. In addition to that we've got three federal team members that really focus on training the military.
Vince: In addition to that, we've got three federal team members that really focus on training the military for preparation for use of the product when it's deployed in the field, and a couple of national accounts people. So we're fairly tight from that perspective. We also have a small team of fewer than five medical science liaisons that are out there working with the key opinion leaders, receiving the calls about the IITs, taking them to headquarters to have them evaluated, and then going back and working with them on what might be or might not be appropriate for our studies in the product. So that's our team. It's fairly tight,
For preparation for use of the product when it's deployed in the field and a couple of national accounts people. So we're fairly tight from that perspective, we also have a small team of fewer than five medical science liaisons.
That are out there working with the key opinion leaders received on the calls about the Ts taking them to the headquarters to have the bet and then going back and working with them on on what might be or might not be appropriate for are the studies and the products. So that's our team it's fairly tight.
That's great I appreciate it thanks guys.
Michael Higgins: Great, I appreciate it. Thanks, guys. The next question is from Ed Ars with H.C. Wainwright. Please go ahead.
The next question is from Ed Arce with H C. Wainwright. Please go ahead.
Hi, everyone. Thanks for taking my questions Congrats as well on.
Ed Ars: Hi everyone, thanks for taking my questions. Congratulations as well on the
On the the.
Latest progress.
Ed Ars: Congratulations as well on the latest progress through this quarter. The first question is, you know, going back to the comments at the top of your release about April being the strongest month to date. As you and everyone else look at, you know, sort of the light at the end of the tunnel in terms of COVID restrictions and all of that, could you discuss how Uh, uh, I think I lost you there, Ed. Yeah, I think he got cut off, Vince.
Through this quarter.
First question is going.
Going back to the the.
The comments at the top of your release about months.
The the April month being the strongest to date.
As you.
As you and everyone else looks.
Sort of the the light at the end of the tunnel.
In terms of COVID-19 restrictions on all of that.
Could you discuss.
How.
Uh huh.
Okay.
I think I lost you there Ed.
Think he got cut off of Vince.
Okay.
Yes somehow he did get cut off I'm so sorry.
Vince: Okay.
Operator: Okay. Yes, somehow, he did get cut off. I'm so sorry. Yeah, he's disconnected.
Okay.
Yeah. He he has disconnected.
I don't know.
Yes.
I can just give some brief commentary to where I think he was heading in this direction of that was April being the strongest months and outlook on COVID-19 moving forward as I mentioned earlier from Brandon's question April.
Vince: I can just give some brief commentary on where I think he was heading in his direction, and that was April being the strongest month and the outlook on COVID moving forward. As I mentioned earlier in response to Brandon's question, April was a strong month for us in that it was our highest number of commercial boxes to end users and our highest number of unique orders since we launched the product just a couple years ago, and this is with an even more tight sales team.
April was the strong month for us on that it was our highest number of commercial boxes. The end users and our highest number of unique orders since we've launched the product just a couple of years ago on this is where the even more tightened sales team.
The second half of March was very strong for us as well so those of the leading indicators that we see where things are starting to open up I can't tell you that a good chunk of the orders in the first quarter came from <unk> and plastics and while the hospitals were ordering in frequency the size of the orders were a little bit less simply because they were seeing fewer.
Vince: The second half of March was very strong for us as well. So those are the leading indicators that we see where things are starting to open up. I can't tell you that a good chunk of the orders in the first quarter came from ASDs and plastics.
Vince: And while the hospitals were ordering in frequency, the size of the orders was a little bit less simply because they were seeing fewer patients during their focused time on the vaccinations and rolling out COVID operations. And we expect that now that the vaccinations are continuously appropriate. in the U.S. to continue to loosen up and in the second half of the year, fingers crossed without a resurgence, getting back to normal operations for COVID moving forward with everyone, including hospitals and ASCs, looking for better efficiencies to make up for the lost revenue during this COVID period of time. And we think we can help with that based on the data that continues to be produced. So I'm hoping that that helped answer Ed's question, and I apologize that he got dropped.
Patients during their focus time on.
On the vaccinations and rolling out COVID-19 operations, and we expect that now that the vaccinations are continuously improving in the U S to continue to loosen up and in the second half of the year.
Fingers crossed without a resurgence of getting back to normal operations for COVID-19 moving forward with everyone, including hospitals and ASC looking for better efficiencies to make up for the lost revenue. During this COVID-19 period of time, and we think we can help with that based on.
On the day to that continues to be produced.
So I'm, hoping that that helped the answer ed's.
Question and I apologize for that you've got dropped.
Yeah.
This concludes our question and answer session I would like to turn the conference back over to Vincent <unk> for any closing remarks.
Vince: This concludes our question and answer session. I would like to turn the conference back over to Vince Angotti for any closing remarks.
Vince: Thank you, Debbie. Again, we appreciate everyone joining us today and for your interest in continued support of AccelerX. Again, we believe we're very well positioned for future growth, while continuing to control expenses, expand our data set and body of evidence, and looking forward to sharing more with business development here in the near and distant future.
Thank you Debbie again, we appreciate everyone joining us today and for your interest and continued support of accelerates again, we believe we're very well positioned for future growth. While continued control of expenses expand our data set and body of evidence and looking forward to share more with business development here in the near and distant future. So thank you for <unk>.
Joining us much appreciated thank you Debbie.
Vince: So thank you for joining us. It is much appreciated. Thank you, Debbie. Thank you, Debbie.
This conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Operator: This conference has now concluded. Thank you for attending today's presentation. You may now disconnect.