Q3 2019 Earnings Call
Good day and welcome to accelerate this third quarter 2019 conference call. This call is being webcast live on the ovens page on the Investor section of accelerates as web site at accelerates Dot Com. This call is the property of accelerates and any recording reproduction or transmission of this call without the expressed written consent of accelerates its let's try.
Operator: and welcome to AcelRx's third quarter 2019 conference call. This call is being webcast live on the events page of the investor 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 investor section of AcelRx's website. I would now like to turn the call over to Raffi Asadorian, AcelRx's chief financial officer. Please go ahead, sir.
<unk> as a reminder, today's call is being recorded you may listen to webcast replay of this call like launch an investor section of accelerates its website I would now like to turn the call ever to Rafi also Dorian accelerates as Chief Financial Officer. Please go ahead Sir.
Thank you for joining us this afternoon earlier today, we reported our third quarter 2019 financial results and provided an update on our commercial launch of the Subia in a press release.
Raffi Mark Asadorian: Thank you for joining us this afternoon. Earlier today, we reported our third quarter 2019 financial results and provided an update on our commercial launch of Dissuvia 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 Vincent Angotti, our Chief Executive Officer, and Dr. Pam Palmer, our Chief Medical Officer. Also with us today is Dr. Charles Lee, a board-certified plastic surgeon locally here in San Francisco, using Dysuvia in his surgical suite for patients requiring various plastic and cosmetic procedures.
This press release and the slide presentation accompanying this call are available in the Investor section of our website.
With me today, our Vincent Gotti, our Chief Executive Officer, and Dr., Pam Palmer, our Chief Medical Officer.
Also with US today, its Dr. Charles Lane, the board certified plastic surgeon locally here in San Francisco, using just to be a in a surgical suite with patients requiring various plastic and cosmetic procedures.
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.
Raffi Mark Asadorian: 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 releases, 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 turn the call over to Vince. Thank you.
These forward looking statements involve risks and uncertainties regarding the operations and future results of acceleration.
Please refer to our press releases in addition to the company's periodically Kurt 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 turn the call over to that.
Thank you Rafi good afternoon, everyone. We appreciate you taking the time to join our call today.
Vincent J. Angotti: Thank you, Raffi, and good afternoon, everyone. We appreciate you taking the time to join our call today. We're pleased to share the progress of the launch, including some details around the continued acceleration of healthcare institutions' access to Dysuvia, as well as provide another opportunity for you to hear from a healthcare practitioner experiencing the benefits of Dysuvia in his practice. As we've said previously, the initial phase of the DeSuvia launch is focused on education and awareness to achieve positive formula reviews and REMS certifications, which sets the stage for DeSuvia The 2019 objectives established to measure the success of the Dissuvia launch, 125 formulae approvals and 125 REMS certified facilities, underscore this focus. I'm pleased to communicate that we're well on our way to having a successful Dissuvia launch as we've already achieved formulae approval for Dissuvia's use at 105 facilities and surpassed our REMS certifications objective two months early with 130 facilities now certified. We also expect to achieve our objective of 125 formal approvals by year-end.
We're pleased to show the progress of the launch, including some details around the continued acceleration of healthcare institutions access to the Serbia as well as providing another opportunity beauty here from a healthcare practitioners are experiencing the benefits of the shoes yet in his practice.
As we said previously the initial phase will distribute launch is focused on education and awareness to achieve positive formulary reviews, and rems certifications, which sets the stage for distributors future adoption and our targeted healthcare institutions.
2019 objectives established a measure the successor to distribute launch 125, formulary approvals and 125 rems sort of five facilities underscore this focus.
I'm pleased to communicate that we're well on our way having a successful the Soviet launch as we've already achieved formulary approval for distribute use at 105 facilities and surpassed our Rems certifications objective two months early with 130 facilities now certified.
We also expect to achieve our objective of 125 fromer your approvals by yearend.
Vincent J. Angotti: And as a reminder, this compares to 43 formulae approvals in 51 REMS-certified facilities announced last quarter. Additionally, Q3 was the first full quarter with our 40 hospital account managers on board. And we've seen strong acceleration in our access metrics since they joined. We expect the momentum of formulary approvals and certified facilities to continue as the level of engagement with healthcare institutions continues to expand and reach new highs each week. As an example, the majority of the REMS certifications completed since our last call occurred just in October.
And as a reminder, this compares to 43 formulary approvals and 51, rems sort of five facilities announced last quarter.
Sure three was the first full quarter with our 40 hospital account managers on board and we've seen strong acceleration and our access metrics since they've joint.
We expect momentum of formulary approvals and sort of five facilities to continue at the level of engagement with healthcare institutions continues to expand and reached new highs each week.
As an example, the majority of the Rems certifications completed since our last call occurred just in October .
Vincent J. Angotti: Our disciplined approach, utilizing a staged launch, initially with only 15 hospital count managers, allowed us to understand the process and speed of review at different types of institutions, the perspectives of each key decision maker on Dysuvia, and ultimately, how best to position Dysuvia within each. This experience allowed the additional 25 account managers to quickly leverage these learnings, which is driving the recent acceleration in access. With our access metrics continuing to track well, we expect an increasing focus in the upcoming months on the use of Vesuvia throughout these institutions. Adoption of the SUVIA is a process starting with P&T review followed by initial use in defined patient populations and eventually leading to routine and more widespread use as patients see the benefits of the SUVIA.
Our disciplined approach utilizing a stage launch initially with only 15 hospital account managers allowed us to understand the process and speed of review at different types of institutions. The perspectives of each key decision maker on the superior and ultimately how best to position.
Sure the within each.
This experience allow the additional 25 account managers to quickly leverage these learnings, which is driving the recent acceleration in access.
With our access metrics continuing to track well, we expect an increasing focus in the upcoming months on the use of the subia throughout these institutions.
Adoption of the Subia is a process starting with PNC review, followed by initial use and defined patient populations and eventually leading to routine and more widespread use as they see the benefits of the studio.
Hospitals remain a focus of our commercial strategy, despite the longer lead times to gain access compared to ambulatory surgical centers or <unk>.
Vincent J. Angotti: Hospitals remain a focus of our commercial strategy, despite the longer lead times to gain access compared to Ambulatory Surgical Centers, or ASCs. Our existing 40 hospital account managers are targeting a total of 800 hospitals, which represents an estimated 50% of the total value of the hospital opportunity for D'Souza. Beyond hospitals, we have seen broad interest and gained more rapid access across different specialties practicing within a variety of medically supervised settings. Our current account managers are now targeting approximately 1,100 ASCs in their existing territories, representing an estimated 60% of the disuviate-relevant procedures performed in these settings in the U.S. Many of the physicians that work at ASCs are also affiliated with and performing procedures at hospitals, and we expect this ASC experience to translate into support for additional formulary approvals within these hospitals.
Our existing 40 hospital account managers are starting a total 800 hospitals, which represents an estimated 50% of the total value of the hospital opportunity for the Sylvia.
Beyond hospitals, we've seen broad interest and gain more rapid access across different specialties practicing without a variety of medically supervised settings.
Our current account managers are now targeting approximately 1100, Fcs and their existing territories, representing an estimated 60% over the distribute relevant procedures performed in these settings in the U.S.
Many of the physicians that workaday assays are also affiliated with and performing procedures at hospitals and we expect this assay experience to translate the support for additional formulary approvals within these hospitals.
The outpatient surgical procedure market is rapidly evolving and growing as patients are seeking more convenient less expensive and safer surgical options taking place outside the hospital.
Vincent J. Angotti: The outpatient surgical procedure market is rapidly evolving and growing. Patients are seeking more convenient, less expensive, and safer surgical options taking place outside the hospital. The number and diversity of surgical procedures now being performed in outpatient facilities expands the number of settings where Dysubia may be used. One example is plastic surgery, which is why we've asked Dr. Lee to provide his experience with Vesuvia on the call today. I will now ask Dr. Palmer to introduce Dr. Lee to discuss how he is using Dysuvia in his practice. Pam?
The number and diversity of surgical procedures now being performed an outpatient facilities expands the number of settings, where distribute may be used.
One example is plastic surgery, which is why we've asked start really provided experience with the subia on the call today.
I'll now ask Dr. Palmer to introduce Dr. Lee to discuss how he is using distributors in his practice Sam.
Pamela Pierce Palmer: Thank you, Vince. It is with great pleasure today that I introduce to you Dr. Charles Lee, who is a board-certified plastic surgeon locally here in San Francisco who is utilizing Dysuvia to manage acute pain in his surgical suite for patients undergoing various plastic and cosmetic procedures. Dr. Lee is the Chief of Plastic and Reconstructive Surgery and Director of Microsurgery at St. Mary's Medical Center in San Francisco, Associate Clinical Professor of Plastic and Reconstructive Surgery at the University of California, San Francisco, as well as the Assistant Director of Reconstructive and Microsurgery Fellowship at UCSF. The following information is intended for investors, not health care professionals or patients. Before we hand it over to Dr. Lee, I will cover some safety information for Dysuvian.
Thank you Ben it is with great pleasure today that I introduced Q Dr., Charles Lee with a board certified plastic surgeon locally here in San Francisco, who is utilizing to Sylvia to manage acute pain is surgical suite for patients undergoing varies plastic and cosmetic procedures.
Dr. Lee is a cheap plastic and reconstructive surgery and director of micro surgery at St. Mary's Medical Center in San Francisco.
So seat clinical professor of plastic and reconstructive surgery University of California, San Francisco as well see assistant director of Reconstructive and micro surgery Fellowship at you see us out.
The following information it's intended for investors not health care professionals are patients.
Sure we handed over to Dr. Lee I will cover some safety information for to Cvs.
Pamela Pierce Palmer: Dysuvia is a Schedule II controlled substance that may only be dispensed to adult patients in a certified medically supervised healthcare setting for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Risks include life-threatening respiratory depression, addiction, abuse, misuse, cytochrome P450-384 interaction, and risk from associated use with benzodiazepines or other central nervous system depress The most commonly reported adverse reactions are nausea, headache, vomiting, dizziness, and hypotension. AcelRx ensures proper use of dysthuvia via physician education and the Dysthuvia Risk Evaluation and Mitigation Strategies, or REMS, program. D'Souvi is only available to facilities that are part of the D'Souvia REMS program. Additionally, facilities that administer SUVIA must be able to manage acute opioid overdose, train relevant staff on Dissuvia, and implement policies and procedures to ensure the appropriate administration of Dissuvia. Full safety information and the black box warning for Dysuvia can be found at Dysuvia.com. Now, I would like to hand the call over to Dr. Lee to share his observations while using Dysuvia to manage his surgical patient's acute pain.
Just to be is scheduled to controlled substance that may only be dispensed with adult patients in a certified medically supervised health care setting.
For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Risks include life, threatening respiratory depression addiction abuse and misuse.
Cytochrome piece for 53, four interaction and risk from associates.
With Ben today's hippies, rather central nervous system depressant.
Most commonly reported adverse reactions are nausea, headache, vomiting, dizziness and hypertension.
Celebrex, ensuring proper use of dispute the DS physician education, and that just to be at risk evaluation and mitigation strategies or rents program.
As to the is only available to facilities that are part of the discovery of Rems program.
Facilities that administer the some of you must be able to manage acute opioid overdose.
Train relevant staff onto stevia, and implement policies and procedures to ensure the appropriate administration up to Sylvia.
Both safety information and the Black box warning for to see the can be found at the Subia dotcom.
Now I would like to hand, the call over to Dr. Lee just share his observations, while using it to subia to manage his surgical patients acute pain.
Dr. Charles Lee: Thank you, Dr. Palmer. Hello, I'm Dr. Charles Lee. As you heard, I'm a board-certified plastic and reconstructive surgeon in San Francisco. I am being reimbursed for my time to speak to you today; otherwise, I am not a paid consultant or speaker with AcelRx.
Thank you Dr. Palmer, Hello, I'm Dr., Charles Lean as you heard I'm, a board certified plastic and reconstructive surgeon in San Francisco.
I am being reimbursed for my time to speak to you today, otherwise I am not a paid consultant or speaker with a seller ex.
Dr. Charles Lee: There are approximately 7,000 board-certified plastic surgeons here in the U.S., and the number of cosmetic and plastic procedures performed is increasing annually. Surgical and procedural suites that are not within a hospital are becoming a much more common venue for many of our plastic and cosmetic surgeries. Patients often like having more minor surgeries, such as low-volume liposuction, in a convenient, friendly, and cost-effective environment, and many patients don't want to be fully sedated or go under general anesthesia for more minor surgeries. These procedures performed without an anesthesiologist and often without an IV have been coined as awake surgery in our specialty. We administer a low-dose oral sedative to relieve anxiety prior to the procedure.
There are approximately 7000 board certified plastic surgeons here in the U.S. and the number of cosmetic and plastic procedures performed is increasing annually.
Surgical and procedural suites that are not within a hospital are becoming a much more common venue for many of our plastic and cosmetic surgeries.
Patients often like having more minor surgeries, such as low volume liposuction.
In a convenient friendly and cost effective environment.
In many patients don't want to be fully sedated or go under general anesthesia for a more minor surgeries.
These procedures performed without anesthesiologist and often without an ivy have been coined as awake surgery in our specialty.
We administer a low dose oral sedative to relieve anxiety prior to the procedure.
Dr. Charles Lee: Since we, unfortunately, as surgeons, do create acute pain at levels of four out of ten and higher, an opiate analgesic is often required. Local anesthetics are also a critical part of performing these surgeries. However, the infiltration can be painful.
Since we unfortunately as surgeons do create acute pain at levels, a four out of 10 and higher and opioid analgesic is also often required.
Local anesthetics are also a critical part of performing these surgeries. However, the infiltration can be painful. Therefore, there is a need for systemic analgesia such as that provided by an opioid.
Dr. Charles Lee: Therefore, there is a need for systemic analgesia, such as that provided by an opioid. I was first intrigued by Dysuvia due to its rapid onset of action within 15 minutes without requiring an IV. I don't start IVs in my awake surgery patients, and a sublingual opiate approach seemed tailor-made to my practice. Over the years, I have found that many of my patients are interested in having surgeries performed under conscious sedation instead of general anesthesia, and I have performed a wide variety of surgical procedures safely in this manner. However, inadequate analgesia can slow down the operation as I need to stop and provide more local infiltration of the anesthetic. I have found that Dysubia creates a rapid and sustained level of acute pain control in my patients.
I was first intrigued by the Sylvia.
To its rapid onset of action within 15 minutes without requiring an Ivy I.
I don't start Ivys in my awake surgery patients and sublingual opioid approach seem tailor made to my practice.
Over the years I have found that many of my patients are interested in having surgeries performed under a conscious sedation instead of general anesthesia and I have performed a wide variety of surgical procedures safely in this manner.
However in adequate analgesia can slow down the operation as I need to stop and provide more local infiltration of the anesthetic.
I have found it does seem to be it creates a rapid and sustained level of acute pain control in my patients I agree I have recently used to Sylvia and 15 patients and im finding it quite simple to dose and convenient to use in our setting.
Dr. Charles Lee: I have recently used Dysuvia in 15 patients and am finding it quite simple to dose and convenient to use in our setting. The types of surgeries I have performed with Dysuvia include low-volume liposuction, typically less than 2,000 cc Fat Grafting Procedures, vein laser ablations as well as rhinoplasty, facelifts, blepharoplasty, and various hand reconstructive surgeries.
The types of surgeries I have performed with the Sylvia include low volume liposuction typically less than 2000 Ccs.
Fat grafting procedures.
Vein laser ablations as well as rhinoplasty facelift.
Well deferral, plastiki and various hand reconstructive surgeries.
Tumescent anesthesia is a large component of my surgical technique.
Dr. Charles Lee: Tumescent anesthesia is a large component of my surgical technique. Tumescent is giving a low dose of lidocaine with a high volume of saline infiltrated into a large area in preparation for liposuction or surgery. It is quite painful.
To mess. It is a low is giving a low dose of lighter came with a high dose of say volume of sailing infiltrated into a large area in preparation for liposuction oral surgery.
It is quite painful.
Dr. Charles Lee: With Dysuvia, my patients are reporting pain levels of 0 to 1, with previous pain levels at 5 to 8. I actually had one patient dosed with DeSuvia describe abdominal liposuction as feeling like a deep tissue massage, which I can guarantee you I have never heard before. Another patient for whom I did a liposuction procedure for male gynecomastia, which is a condition where men have excessive breast-like tissue on their chests, did not even flinch when I performed power-assisted liposuction on his chest and removed over 300 cc of fat on each side. In my past experience, liposuction of the chest was very painful, even with significant tumescent anesthesia over the chest area.
With the Soviets my patients my patients are reporting pain levels of zero to one.
With previous pain levels at five to eight.
I actually had one patient, though dosed with the Sylvia describe abdominal liposuction as feeling like a deep tissue massage, which I can guarantee you I have never heard before.
Another patients for whom I did a liposuction procedure for male gynecomastia, which is a condition where men have excess of breast like tissue under chest.
Did not even flinch when I performed power assisted liposuction.
It is chest and removed over 300 Ccs of fat on each side.
In my past experience liposuction other chest was very painful even with significant tumescent anesthesia over the chest area.
I have a nurse present throughout the case as well as post operatively to monitor is vital signs and oxygen saturation levels as well as observing for side effects.
Dr. Charles Lee: I have a nurse present throughout the case, as well as post-operatively, who monitors vital signs and oxygen saturation levels, as well as observes for side effects. We have not experienced any significant adverse events associated with the use of dasuvia in our patients, other than the expected occurrence of nausea or vomiting, which we are now starting to treat prophylactically with an oral anti-emetic prior to the start of the case. Given the three-hour duration of action with Dysubia, I have never used more than a single dose per patient. Therefore, in my experience, its additive cost of the procedure is negligible. I have not had to dose any supplemental opioids, either during or following the procedure. In our clinic, we keep Dysuvia.
We have not experienced any significant adverse events associated with the use of the subia in our patients other than the expected occurrence on occasion of nausea, vomiting, which we're now starting to treat prophylactically with an oral anti emetic prior to the started the case.
Given the three hour duration of action with this Sylvia I have never use more than a single dose per patient.
Therefore my experience.
It's additive cost of the procedure is negligible.
I have had not had to dose any supplemental opioids either doring are following the procedures.
And that clinics, we keep the Sylvia under luck double lock storage, which is standard for scheduled drugs by nurses able to dose of drug quite easily with the pre filled applicator and the single dose single strength aspect of the Sylvia makes takes the guessing out of dosing.
Dr. Charles Lee: under lock and double lock storage, which is standard for scheduled drugs. My nurse is able to dose the drug quite easily with the pre-filled applicator, and the single dose, single strength aspect of the DeSuvia takes the guessing out of dosing. We have all the safety equipment and drugs, such as Naloxone and supplemental oxygen, that allows us to qualify for the Dysuvia REMS program, and my nurses went through an in-service on its proper and safe use. We are looking forward to performing more surgeries with Dysuvia. There's no question that Dysuvia has made a positive impact on my practice. Thanks.
We have all the safety equipment and drugs, such as no axon and supplemental oxygen that allows us to qualify for the Dcbs Rems program and my nurses went through an in service honest proper and safe use.
We're looking forward to performing more surgeries with for Sylvia. There's no question that decision. He has made a positive impact in my practice.
Pamela Pierce Palmer: Thanks, Dr. Lee, for sharing your experience with Dysuvia, and I hope those remarks provide a perspective on yet another real-world application of Dysuvia. As a note, Dr. Lee will be available during the Q&A portion of today's call as well.
Thanks, Dr. Lee for sure on your experience with the Serbia and I Hope those remarks provided perspective on yet another real ward application of the Subia.
As a no dr. Lee will be available during the Q and a portion of today's call as well.
Vincent J. Angotti: Before handing the call over to Raffi, since we've had various questions on the military's use of Dissuvio, I wanted to provide an update on that, as well as Zalviso. As a reminder, the Department of Defense was a key partner helping in the development and funding of the Suvi. Broad adoption across the Department of Defense takes time as it's a very large organization, but it's certainly progressing, and we expect we can provide further information on this in the near future. I can confirm that military treatment facilities, or military hospitals, are included in our formulary approvals, and the military has purchased and is using D'Souza. With regard to Salviso, on September 17th, the FDA held a public meeting on a proposed risk-benefit framework for new opioid approval.
Before handing the call over to Rafi since we've had various questions on the militaries use of the Sylvia I wanted to provide an update on this as well as zalviso.
As a reminder, department of defense was a key partner, helping in the development and funding of the Subia.
Broad adoption across the department of Defense takes time as its very large organization.
But it's certainly progressing we expect we can provide further information on this in the near future I can confirm that military treatment facilities or the military hospitals are included in our formulary approvals and the military has purchased and is using to suit.
With regards to sell VSOE on September 17th the FDA <unk> public meeting on a proposed risk benefit framework for new opioid approvals.
Vincent J. Angotti: There were no new resolutions from this meeting, but the participants provided input to the panel. While we believe Zalviso fits well with the proposed risk-benefit framework, since the agency appears to be in the process of updating its policy regarding opioid approvals, and has previously canceled or postponed the advisory boards for two other upcoming opioid reviews, we'll continue to hold the Zalviso NDA resubmission until more clarity on the proposed policy So that's it, Raffi; we'll now take you through the financials.
There were no new resolutions from this meeting, but the participants provided input to the panel.
Well, we believe zalviso fits well within the proposed risk benefit framework since the agency appears to be in process of updating its policy regarding opioid approvals and as previously cancel or postpone the advisory boards for two other upcoming opioid reviews will continue to hold the zalviso NDA resubmission to more clear.
Already on propose policy is made available.
With that said Rafi will now take you through the financials.
Thank you Vince.
Raffi Mark Asadorian: Our attention to cash management during this initial launch period remains strong. We ended the third quarter of 2019 with $80.4 million in cash and short-term investments. Our net cash outflow for the third quarter was $11.1 million, which was driven mainly by our $10.7 million of cash operating expenses, or combined R&D and SG&A expenses excluding stock-based compensation. This compared to $11.2 million of cash operating expenses for the second quarter of 2019. Combined R&D and SG&A expenses, inclusive of stock-based compensation, for the third quarter of 2019, totaled $12 million, compared to $8.8 million for the third quarter of 2018. We continue to focus on investing in the most impactful areas of driving the launch and remain prudent in overall cash spending. Revenues for the third quarter of 2019 were $0.6 million, reflecting $0.5 million in sales of Zalviso to our European partner and $0.1 million in revenues from the sale of Dissuvia.
Attention to cash management. During this initial launch period remained strong.
We ended the third quarter of 2019 with $80.4 million in cash and short term investments.
Our net cash outflow for the third quarter was $11.1 million, which was driven mainly by our $10.7 million of cash operating expenses or combined R&D and SGN expenses, excluding stock based compensation.
This compared to $11.2 million of cash operating expenses for the second quarter of 2019.
Combined R&D and SGN, a expenses inclusive of stock based compensation for the third quarter of 2019 totaled $12 million compared to $8.8 million for the third quarter of 2018.
We continue to focus on investing and the most impactful areas of driving the launch and remain prudent and overall cash spending.
Revenues for the third quarter of 2019 were zero point $6 million, reflecting zero point $5 billion in sales of Zalviso through our European partner and zero point $1 million of revenues from the sale of the Sylvia.
Raffi Mark Asadorian: We continued our focus on facilitating healthcare institutions' access to Dissuvia, the success of which is evident by our increased number of formulary approvals and REM certified facilities. We expect to increase our focus on driving Dissuvia demand within approved facilities next year as we leverage the access gained in 2019. The gross to net sales percentage of Vesuvia in the third quarter was 28%, compared to 35% expected for the year. Our year-to-date September gross to net sales percentage was 31%, with the variation driven mainly by customer mix. We expect to provide updated guidance on 2020 operational launch metrics and financials on our year-end call. With that, let me turn the call back to Vince.
We continued our focus on facilitating healthcare institutions access to this Sylvia.
The success of which is evidenced by our increased number of formulary approvals and Rems certified facilities.
We expect to increase our focus on driving to Sylvia demand within approved facility next year as we leverage the access gained in 2019.
The Sylvia gross to net sales percentage in the third quarter was 28% compared to 35% expected for the year.
Our year to date September gross to net sales percentage was 31%, but the variation driven mainly by customer mix.
We expect to provide updated guidance on 2020 operational launch metrics and financials on our year end call.
With that let me turn the call back to this thanks Rafi.
Vincent J. Angotti: Thanks, Raffi. So to summarize, we continue to strongly believe in CVS' benefits and long-term success in the market, as well as its ability to change the standard of care for acute pain management in medically supervised settings. We're pleased with the progress you've made to date and with the increased access to Vesuvium made possible by our new hospital account managers added just this past July. And as you heard from Dr. Lee, D'Souza is a differentiated, non-invasive solution for the management of acute pain, and we expect continued success in expanding its use by healthcare professionals.
So to summarize we continue to strongly believe with distributors benefits and long term success in the market as well as its ability to change the standard of care for acute pain management and medically supervised settings.
We're pleased with the progress you've made to date with the increased access to decision made possible by our New hospital account managers added just this past July .
And as you heard from Dr. Lee distribute is a differentiated noninvasive solution for the management of acute pain, and we expect continued success and expanding its use my health care professionals.
Operator: In addition, we'll continue to responsibly manage our cash, and I'd like to open the line for any questions you may have. Operator?
In addition, we'll continue to responsibly manage our cash.
And I'd like to open the line for any questions you may have operator.
Operator: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2.
Thank you we will now begin the question and answer session to actually question. You May Press Star then one on your Touchtone phone. If you are using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then to at this time, we'll pause momentarily to assemble roster.
Vincent J. Angotti: At this time, we'll pause momentarily to assemble our roster, and our first question will come from Brandon Folkes of Cantor. Please go ahead. Hey, this is Brian on behalf of Brandon. Congratulations on the quarter. I was wondering if you could provide some color on the uses that the two of you have in hospitals versus ambulatory surgical centers. Thanks.
And our first question will come from Brandon Folkes of Cantor. Please go ahead.
Hi, This is Brian on for brand and congrats on the quarter I was wondering if you could provide some color on that you should that that you've you in hospital versus ambulatory surgical centers. Thanks.
Sure so of the mix of approvals today about 25% to 30% of them or hospitals and it is a mix we have some that have isolated it for the pack you.
Vincent J. Angotti: Sure, so of the mix of approvals today, about 25 to 30% of them are hospitals, and it is a mix. We have some that are isolated for the PACU, for perioperative analgesia, associated with those same-day surgery patients. We have some use in the ER.
Prepare you operative analgesics associated with those same day surgery patients.
We have some use in the E R.
Vincent J. Angotti: oftentimes for patients that are difficult to stick with. So those have been the two majorities of use, but it is diverse beyond that.
Often times for the patients that are difficult to stick.
So those have been the two majorities abuse, but it is diverse beyond that.
Vincent J. Angotti: from
Vincent J. Angotti: We also have a burn center, which has recently put on a formulary, and a wound center, and we also have two EMS systems that recently became REM certified. So while it's being used in the expected areas in the hospital, what we're finding is that the diversity of interest in it goes beyond that in those different settings I just mentioned. Does that help, Brian?
We also have burn center actually has recently, putting on formulary and a wound center and we also have to mess systems that recently became Rems certified so while it's being used in the expected areas in the hospital. What we're finding is that the diversity of interest in it goes beyond that for those different settings. So just.
You mentioned.
Does that help Brian Yes doesn't maybe you could just expand on a little bit if you could just share any of the feedback you proceed from hospitals in PNG committees and position. Thanks.
Vincent J. Angotti: Yeah, it does, and if you could just expand on it a little bit, if you could just share any of the feedback you've received from hospitals and P&T committees and physicians. Thanks.
Vincent J. Angotti: Yeah, let me give you a little bit about the process and what we're seeing with the use of the drug. And, of course, I usually get, you know, usually the good stuff on the use of the drug, so let's be honest, it'll be a little bit biased.
Yes, let me, let me give you a little bit about the process and what we're seeing in the use of the drug.
And of course, I get usually the goods on the use of the drug so let's be honest it will be a little bit biased, but the process for the hospitals. It's interesting. So often go through the PMT Committee as you might imagine and then a subsequent month or two though confirm that decision based off the clinical review and the voting members of the PMT within EMEA.
Vincent J. Angotti: But the process for the hospitals is interesting. So they'll often go through the P&T committee, as you might imagine, and then a subsequent month or two, they'll confirm that decision based on the clinical review and the voting members of the P&T with an MEC, a medical executive committee. So it's often a two-step process, at least that's what we find in hospitals based on meetings and reviews. Once that occurs, and we've mentioned it in the script here, then we focus on the use moving forward, and that's coming up into 2020. And by use, we mean now they're establishing certain protocols for areas of use, so in the PACU, which patients they should be used on, which types of surgeries, when it's dosed and how many doses, or in the ER, something similar. And our MSLs are often involved with that protocol. Then we'll have ourselves representatives go in for the training and do in-services.
See a medical Executive committee. So it's often a two step process at least we're finding with us and the hospitals based on meeting and review.
Once that occurs and we've mentioned it in the script here is then we focus on the use moving forward that's coming up into 2020 and by use we mean now they are establishing certain protocols for areas of use on the pack, you, which patients to be used on which types of surgeries when its dose and how many doses or in the or something similar and.
RMS cells are often involved with that protocol then we'll have ourselves represents going for the training Doin' services. So just a couple of weeks ago. I think it's about three weeks now we train 200 people in E R and one of the institutions in the U.S. So it required three shifts worth of training for the different shift workers coming in in that emergency room.
Vincent J. Angotti: So just a couple of weeks ago, I think it's been about three weeks now, we trained 200 people in an ER in one of the institutions in the U.S. So it required three shifts worth of training for the different shift workers coming in that emergency room. So that's been the process. It takes a little bit of time in the hospitals. It moves faster in the ASCs.
So that's been the process it takes a little bit of time of the hospitals it moves faster in the diocese, but I can tell you and I think you hear from Dr. Hutchens on our last call and you heard from Dr. Lee today on the drugs delivering on its promise and analgesics, yes.
Vincent J. Angotti: But I can tell you, and I think you heard it from Dr. Hutchins on our last call, and you heard it from Dr. Lee today, the drugs are delivering on their promise in analgesia. We're finding they're timing the dose to the PK profile and acute pain. And the most common feedback we're getting is one dose. Very rarely do we find that the users of the product thus far happen to go beyond one dose, even in different circumstances with the demographics of patients, etc. Dr. Lee, have you seen one dose for all your different types of patients as well?
We're finding their timing the dose to the PK profile and the acute pain.
And the most common feedback we're getting is one dose.
Very rarely are we finding that the users of the product thus far have to go beyond one dose.
Even in different circumstances with demographics of patients et cetera, Dr. Lee you've seen one dose for all your different types of patients as well that's correct. Yes. So it just continues to be confirmed.
Dr. Charles Lee: That's correct, yeah.
Vincent J. Angotti: Yeah, so it just continues to be confirmed, and importantly, what we have continued to hear is that the clarity of the patients remains as we expected it to occur, meaning the cognition remains clear. And so those are the key things that we've heard that you hoped would happen based off of clinical trials, but in real practice, you wanted to come to fruition. So we're seeing limited dosing because it's all that's needed and the clarity of the patients following that dosing. Did that further answer your question, Brian?
And importantly, what we have continued to here is that the clarity of the patients remains as we expected to occur.
Meaning cognitive the cognition remains clear.
And so those are the keys that we heard that you hope would happen based off of clinical trial. It's been a real practice you wanted to come to fruition. So we're seeing the limited dosing.
Because it's all that's needed and clarity of the patients following that dosing.
Did that further answer your question, Brian Yes. It did thanks for your time.
Vincent J. Angotti: Yes, it did. Thanks for your time.
Vincent J. Angotti: You're welcome. Thank you.
You're welcome thank you.
Our next question will come from Ed Arce of H.C. Wainwright. Please go ahead.
Operator: Our next question will come from Ed Arce of HC Wainwright. Please go ahead. Hi everyone, thanks for taking my questions and congratulations on the progress in the quarter.
Hi, everyone. Thanks for taking my questions and congrats on the progress in the quarter.
Dr. Charles Lee: The first question is for Dr. Lee. I think you mentioned in your remarks that you've treated about 15 patients so far, and I'm just wondering, a couple of questions. Given your brief experience so far seems pretty positive, would you expect to continue to expand the types of procedures that you would use the SUBYA for? And then the other question is, I was intrigued by the differential in pain that you had mentioned of pain scales of 5 to 8 prior to and 0 to 1 after administration. Even if, how do you view that as compared to other sorts of products you've used, even invasive analgesics?
First question is for Dr. Lee.
Thank you had mentioned in your remarks, Dr. Lee that treated about 15 patients so far.
And I'm just wondering a couple of questions given youre brief experienced so far seems to be.
Pretty positive.
Would you expect to continue to two.
To expand the types of procedures that that you would use the subia for.
And then the other question is.
I was intrigued by the differential in paying that you'd mentioned.
A pain scales of five to eight prior to and zero one after administration.
Wondering if.
How you view that as compared to.
Other sorts products used even even invasive.
Dr. Charles Lee: Thanks.
Analgesics. Thanks.
Yes.
Dr. Charles Lee: Yeah, so let me address the types of procedures that you asked about. So my current range is pretty broad, liposuction, facelifts, vein ablations, and blepharoplasty is a pretty broad range. I do foresee myself actually expanding my procedure list to add some breast procedures, such as breast lifts, and even potentially breast augmentation. So, I think the range of procedures is still quite broad and can be further broadened.
So let me address the types of procedures that you had asked about so my current ranges.
It's pretty pretty broad liposuction face lives.
Doing vein ablations to two Bluff Replas. He is a pretty broad range I do foreseen myself Ashley expanding.
My procedure.
List to add some breast procedures, such as breast lifts and even potentially breast augmentation.
So I think the the range of procedures is still.
Still quite broad and can be further broadened the the paint scale.
Dr. Charles Lee: The pain scale, I have to say, yes, it is significant. I've never had patients describe an abdominal liposuction procedure as just getting a little belly massage. And as I said, the case that really made me realize that.
I have to say, yes, it is significant.
I've never had patients ever described.
And abdominal liposuction procedure is just getting a little belly massage.
And and as I said.
The the case that really.
Let me realize.
Dr. Charles Lee: How powerful it was in terms of controlling pain was the liposuction procedure on the male gynecomastia patient, which is suctioning fat from the male chest, which historically, I can tell you I've used additional tumescent anesthesia, local anesthesia with trying to give additional time and all those things still be quite a discomforting and painful procedure, and to have someone who actually said he had a pain level of So that was quite remarkable, and I would say that that has been the consistent result that I have tried other pain POs, pain opiates such as Vicodin or Percocet, and they really didn't work very well. It was inconsistent pain control, and the side effects were significant, such as nausea and vomiting, which I actually had during the procedure, and that was actually quite difficult to manage. So I really steered away from oral opiates such as Vicodin and Percocet.
How powerful it was in terms of controlling pain was the liposuction procedure on the male clinic mass ship.
Patient, which is suctioning fat from the male chest.
Which historically I can tell you I have used.
Additional tumescent anesthesia local anesthesia with trying to give.
Additional time and all those things still be quite quite a discovery and team procedure and to have someone who who actually said he had.
A pain level of one.
For that procedure so.
That was quite remarkable and I would say that.
That has been the consistent result that I have had with all of my to Subia patients.
I have tried other.
[noise] pain PEO pain.
Opiates such as.
Bike it in our Perkins said and.
They really didn't work very well.
It was inconsistent pain control and.
The side effects were significant such as nausea, and vomiting, which I actually had during the procedure.
And that was actually quite difficult to manage so I released steered away from the oral opiates.
Vincent J. Angotti: Great, thank you. Thank you for that, Dr. Lee.
Vincent J. Angotti: And perhaps a follow-up question for Vince, perhaps just thinking through the 130 or so formulary approvals that you've achieved so far. How does that fit and how does that mesh with the different types of... facilities that you're approved for. In other words, the different kinds of plans, be it, you know, local, regional, state, or what have you that are being approved on Formula. Thank you.
Such as Viking and in Percocet.
Great. Thank you thank you for that.
Dr. Lee.
And perhaps a follow up.
For for for Vince perhaps.
Just thinking through.
The 130 or so.
Formulary approvals that you've you've achieved so far.
How does that fit and how does that match with the.
Different types of.
[noise] facilities.
Youre approved or in other words, a different kinds of.
Vincent J. Angotti: Yeah, so it's actually 130 REMS with 105 approvals, just for clarification. And it's diverse. So, well, 25 to 30 percent are hospitals, and they are in different areas of the hospitals, depending on the champion for that particular hospital. As I mentioned previously, it might be ER for one hospital, it might be the PACU for another hospital, or it might be both for another hospital. We have found, just in general, that hospitals are moving slower than the balance of the approvals being the ASCs. In the ASCs, it's become very diverse. And when I say ASCs, let me just be careful. We're categorizing kind of all other ASCs, so whether that would be Dr. Lee, whether that would be your classic ASC, like a specialty surgery hospital where they're doing just mostly orthopedics. Whether it's one that takes all different comers and disciplines.
Plans.
Be a local regional state or what have you that are being approved on formulary.
Thank you.
Yeah. So it's actually a 130 Rems Ed 105 approvals just for clarification.
And it's the birth, so well, 25% to 30% or the hospitals and they are in different areas of the hospitals, depending on the champion for that particular hospital as I mentioned previously might be IAR for one hospital it might be the pack you for another hospital and might be both.
For another hospital.
We have found just in general that the hospitals are moving slower than the balance of the approvals being the season in the yes see it's become very diverse and when I say a sees let me just be careful were categorizing kind of all other and hfcs, so whether that would be dr. Lee.
Whether that would be your classic AMC or like a specialty surgery hospital, where they're doing just mostly orthopedics.
Whether it's one that takes all different commerce and disciplines.
Vincent J. Angotti: They tend to move faster with the Dissuvia, and there's not one particular area of use to date that we've seen more often than another. It often depends on the champion for that ASC, which brings me to, I think, a final point to help with this, Ed. When we target the ASCs, the 1,100, and it's evolved from 600 just a few months ago, we have a diligent process that looks really at two or three things. The first is the types of procedures they're doing, and are they relevant for modus vira acute pain or the management of acute pain for dysuria? The second is, beyond those types, we rank them based on volume. And then once we've got those relevant types in volume, we map them out in proximity to our current 40 sales representatives.
They tend to move faster.
With the distributor and there's not one particular area of use to date that we see more often than another it often depends on the champion for that assay, which brings me to I think a final point to help with the said when we target. The FCC 1100, it's evolved from 600, just a few months ago.
We have a diligent process it looks real yet two or three things.
First is the types of procedures, they are doing and all the relevant for on March for acute pain or the management of acute pain for distribute.
The second is beyond those types, we rank on based off of the volume.
And then once we've got those relevant types in volume we map of mountain proximity to our current 40 sales representative so the limits a fair amount that might be in the white space and that takes us down from thousands of diocese to about 1100, we're looking at and we don't have a bias someone procedure to another it just has to we have to know that it create.
Vincent J. Angotti: So that limits a fair amount that might be in the white space, and that takes us down from thousands of ASCs to about 1,100 we're looking at. And we don't have a bias on one procedure to another; it just has to, we have to know that it creates relevant pain conditions for the suit of your treatment. And we try to anchor those around those hospitals that are our core targets outside of the ASC. So that's the process we're using. The data on ASCs is not great. Relative to historical procedures or disciplines, et cetera. So we use just the best data we can find. And it's turning out that as we go into one, we often get referrals to another. So I hope that helped answer your question. There's not a perfect model for which ASC versus another, meaning these procedures only. It's very diverse in collection, and many ASCs do different procedures, either within or separately from one another.
It's relevant pain condition for distribute treatment.
And we try to anchor those around those hospitals that are our core targets outside of the assay. So thats the process we're using.
The data on AOCF is not great relative to historical procedures disciplines et cetera. So we used just the best data we can find.
And it's turning out that as we go into one we often get referrals to another.
So I hope that helps answer your question Theres not a perfect model for with JSC versus another meaning these procedures only it's very diverse in collection and many SCS do different procedures, either within or separately from one another.
That's great thanks rents for the extra detail.
Vincent J. Angotti: That's great. Thanks, Vince, for the extra detail. Thanks, guys.
Thanks.
Okay.
And the next question will come from Chris Howerton of Jefferies. Please go ahead.
Operator: And the next question will come from Chris Howerton of Jeffries. Please go ahead. Hi guys, this is Saeed here in place of Chris. I had a couple questions. The first one was, and I'm sorry that I don't know this, but of the 130 REMS-certified facilities and the 105 formulator approvals, are those 105 approvals in those 130 REMS facilities, or is that an overlap, or are there kind of like facilities that are certified but are not yet approved?
Hi, guys. This is sayed here in for Chris had a couple of question first one wasn't I'm, sorry that I don't know this but of the 130 ran certified facilities and the 105 formulary approval.
Is that are those 100 and a five approvals in those 130 rems facilities or is that an overlap or are there kind of like facilities that are certified but are not approved yet.
Yes, it's not a perfect overlapped.
Vincent J. Angotti: Yeah, it's not a perfect overlap. We have close to 60% of the approved facilities are also REM certified. It's interesting though, often times the REMs are a lead indicator for the approvals that are coming moving forward, but it's fluid. I'll give you an example. Just recently, we had a large ASC system approve it, and while we've got one or two REM certifications in it, we've got another 20 plus to go. So you're not going to find a perfect match as you go. What we have found, just in general, is that the REMS are typically a lead indicator of the approvals to come. So not a perfect match.
Close to 60% of the approved facilities are also rems certified.
It's interesting, though it's often times the Rams are lead indicator for the approvals that are coming moving forward.
But it's fluid I'll give an example, just recently we had a large assay system approve it and what we've got one or two Ram certifications in it we've got another 20 plus to go.
So you're not going to find a perfect match as you go what we have found just in general is that the Rams are typically a lead indicator of the approvals to come so not a perfect match.
Got it Okay and then in terms of like these approvals that you're getting what what gives you confidence that this is going to trend or translate into.
Vincent J. Angotti: Got it. Okay. And then in terms of these approvals that you're getting, what, uh, what gives you confidence that this is going to trend or translate into revenues for DeSuvia? Like, are they being certified because there's a certain promise of DeSuvia usage or like, you know, I just want to know, like, what gives you confidence in revenue translation there?
Revenues for the CMBS like are they being certified because there's a certain my promise.
I see the usage or I, just wanted to look to not like what gives you confidence and revenue transition there.
Vincent J. Angotti: Yeah, there's no promise. They're coming to us wanting to be. Certified because of their interest and use of the product. So, it's really, we'll go on, we'll educate them, and then they'll ask us to be certified more times than not. And, you know, that comes with some commitment from them just based on being a REM certified facility. That means, obviously, you have to qualify to access the drug, but it also means you're going to submit yourself to audits moving forward. And we're very clear with them, and the fact that they're signing up for it, I think, is telling us, obviously, that it's worth it for them moving forward.
Yes, there is no promise, they're coming to us wanting to be.
Certified because of their interest in use of the product. So it's really will go on will educate them and then I'll ask us to be certified more times than not and that comes with some commitment from them just based off being a rems certified facility that means obviously you have to qualify to access the job. It also means you're going to submit yourself to auditz moving forward.
And we're very clear with them in the factor the signing up for it I think is telling us obviously that it's worth it for them moving forward.
Vincent J. Angotti: Most often, what we're getting is going to be used as first-line pain management for any particular procedure, but there are no promises. We think it's going to translate into use because they see an unmet need. In the ASCs, what they see is efficiency in use and trying to keep their schedules daily on par because the drug's delivering on its promise of efficacy, and you heard that from Dr. Lee today, just as you heard that from Dr. Hutchins before.
Most often what we're getting it it's going to be used as first line pain management for any particular procedure, but yes theres no promises we think it's going to translate into use because they see an unmet need in the hfcs, what they see is efficiency in use and trying to keep their schedules daily on par because.
The drugs delivering on its promise of efficacy and you heard that from Dr. Lee today, you heard that from Dr. Hutchens before.
Vincent J. Angotti: You know, very different than you might hear formulary approvals or commitments with other products. I don't know whether it's antibiotics or something else that might go into a hospital where you see a lot of formulary approvals just to have them on the shelf but maybe not a lot of use because they're not put in first line. For us, we expect them to be in first line.
You know very different than you might hear formulary approvals or or commitments with other products on whether it's any biotics or something else that might want to hospital, we see a lot of formulary approvals.
Just to have it on the shelf of maybe not a lot of use because they're not put in first line.
For us we expected to be in first line and I think the number one reason is the drugs delivering.
Vincent J. Angotti: And I think the number one reason is the drugs delivered. And It's filling an unmet need that they haven't been able to fill before. And we always thought, I'll reiterate it one more time, that the non-invasive nature of the drug, which you heard from Dr. Lee and even Dr. Hutchins last time, is important because the pharmacokinetic profile of this drug that they can't achieve with other acute pain opioids. Those opiates indicated for cupane are really making it a differentiating factor. The one dose is economical, it's efficient, and that's the real difference. It's a very fair question because it is a process in these institutions, but I think having these REMS-certified institutions and committing to audits moving forward would tell you that there is a genuine interest.
And it's during an unmet need that they haven't been able to fill before and we always thought I reiterate it one more time that it was the noninvasive nature of the drug which you heard from Dr. Lee and even Dr. Hudson last time is important.
But the pharmacokinetic profile discharge that they can achieve.
With other acute pain.
Opioids.
Those openreach is indicated for Q paint, a really making is differentiating factor.
The one dose its economic it's sufficient and that's been the real difference maker. It's a very fair question because it is a process in these institutions, but I think having these ram certified institutions and committing to audit is moving forward.
I would tell you that theres a genuine interest.
Vincent J. Angotti: Got it, great, and I think I tend to agree there as well. Okay, so the last question that I had was a gross to net question. I think in the third quarter you said the gross to net was 28%. Just curious to know, like, where do you see that trending over the next several quarters for Dissuvia?
Got it great and I think I tend to agree there as well.
Okay. So last question that I had was a gross to net question I think in the third quarter and you said the gross to net was 28% just curious to know like where do you see that trending over the next several quarters for the Sylvia.
Vincent J. Angotti: Yeah, we'll stick with our expectations of a 35% growth to net, but as you've seen, we've tracked favorably to that every quarter, and it really has to do with the customer mix, you know, who's using the product, but we'll stick with 35% for now. Great, thanks for taking the question. Thanks.
Yes, well, we'll stick with our expectations of a 35% gross to that but as you've seen that we've tracked.
Favourably to that every every quarter.
And it really has to do at the customer mix.
Who is who is using the product but.
We'll stick with 35% for now.
Great. Thanks for taking the questions.
Thanks.
Our next question will come from Michael Higgins of Ladenburg Thalman. Please go ahead.
Operator: Our next question will come from Michael Higgins of Lattinburg, Thalman. Please go ahead. Hi guys, thanks for taking the questions.
Hi, guys. Thanks for taking the questions.
Dr. Charles Lee: I apologize, I'm juggling calls on a busy night here, so let me know if this has been discussed already and I can move on, but a question for Dr. Lee, your comments on the male patient in particular are really striking. You mentioned previously that the pain levels were 5 to 8. I assume it was with an opioid, and if so, if you could describe what you're replacing Dysluvia with, it would be helpful
Oh size I'm juggling calls on busy unite here. So let me now this is Ben and discussed and that can move on but.
A question for Dr. Lee.
Your comments.
On the male patient in particular are really striking.
You mentioned previously the pain levels were five eight.
I assume that was with an opioid and if so if you could describe what youre, replacing this will be aware.
We would be helpful. Thanks.
Right.
Dr. Charles Lee: Right, so previously I was, so I'm always using Tumescent, some sort of local anesthetic. In that particular case, I typically give a patient a low-dose anxiolytic, like a PO or oral Valium, and then, as I said, as I mentioned, I tried to use Vicodin or Percocet in a tablet form, and it just wasn't giving me adequate pain control. So, but since Zesuvia, having used Zesuvia, it has made a significant change in the pain profile during the procedure, where, again, patients are extremely comfortable, very minimal pain, I mean, a reduction of pain score by over half, a half a reduction in pain score, certainly way down, much lower. So that's really been the impressive part of using Zesuvia. Does that answer your question a little bit?
So previously I was so I'm always using tumescent, some sort of local anesthetic.
In that particular case, I typically give a patient.
A low dose analytic like.
Appeal or oral volume and then.
As I said as I mentioned I tried to use a viking in or Percocet as that as a tablet form and it just wasn't giving me.
Adequate pain control so but since this is the having used as Sylvia It has made a significant.
Change in that pain profile during the procedure where again.
Patients are extremely comfortable.
Very minimal pain reduction of pain score.
In over half half a reduction in pain score a certain way down much lower so that's really been the impressive part of using that to Sylvia.
Does that answer your question.
Dr. Charles Lee: Yeah, absolutely. It's really impressive compared to what you've normally been using. So, it's great to hear. Thank you.
Yeah, absolutely, it's really impressive versus what you normally been using so.
Thats great here. Thank you.
Vincent J. Angotti: Question for you, Vince. You mentioned the military has purchased a drug. Is that NQ4? Has that happened in the last...
For events, you mentioned militaries purchased a drug that in Q4 is that happened last.
Vincent J. Angotti: Yeah, that was a purchase in Q3.
35 days or so or that happened in Q3.
Vincent J. Angotti: And we're working with them, as I said, on the broader application of it moving forward. You know, it's a process, and most people aren't familiar with how these things work, but at the Department of Defense, and just for simplicity's sake, you could actually Google this and look it up without giving too much detail, because it's really their business.
Yes that would so those are purchased in Q3.
And we're working with them as I said on the broader application of it.
Moving forward, it's a process and most people aren't familiar with how these things work, but in the department of defense and just for simplicity sake, you could actually Gould with us on look it up without giving too much detail because it's really their business.
Vincent J. Angotti: But they follow a standard process, meaning they need to complete their required Milestone C meeting. And the Milestone C meetings are public in definition on the web as well. But that milestone meeting review happens at the end of what they call an EMD, or Engineering and Manufacturing Development phase of the defense acquisition process. You know, fancy terminology for that collaboration and execution of the project. And its purpose is to make a really recommendation or seek approval to enter the production and deployment phase of what the product of that production was.
But they follow standard process, meaning they need to complete the required milestone C meeting in the milestone C meetings or public and definition on the web as well, but that milestone meeting review happens at the end of what they call an empty or engineering and manufacturing development phase of the defense acquisition process.
Fancy terminology for that collaboration and execution of the project.
And its purpose is to make really a recommendation or seek approval to enter in the production of deployment phase of what of that the product of that production was and so thats, where we are now.
Vincent J. Angotti: And so that's where we are now. I can't tell you the exact timelines. That's their timeline that we expected early in the year. We did. But we're staying close to them as they finish out this project and this Milestone C meeting moving forward. And that's about the best of the detail I can give you.
I can't tell you the exact timelines that's their timelines on do we expected early in the year, we did but it's we're staying close to them or was there finishing out. This project in this milestone C mute meeting moving forward and.
That's about the best of the detail I can give you.
Vincent J. Angotti: With that said, certain units of the military, including military treatment facilities, are allowed to use it without that milestone C meeting. So if it's an MTF or a hospital, they can order it, and a few of them have, as well as other branches of the military. So we'll stay in close contact with the military moving forward; it's at their pace, it's at their discretion, and we'll keep you posted as we move forward. Thanks.
With that said assert units of the military including military treatment facilities. They are allowed to use it without that milestone C meeting. So if it's an MTF or hospital. They can order it and a few of them half as well as other branches of the military.
So we will stay in close contact with the military moving forward it's out there pace.
It's at their discretion.
Vincent J. Angotti: I'll give you a background. I'm sure you understand the process very well. This is a pretty up-and-wait analogy. One final one, could you give us an update on the IV opioid shortage and how that's impacting formulary discussions?
And.
We'll keep you posted as we move forward.
Thanks.
For your background I'm sure you understand the process very well on there.
Good afternoon weights.
He is.
Just coming home here again.
One final one.
Can give us an update on the Ivy opioid shortage and how that's impacting formulary discussions. Thanks.
Vincent J. Angotti: Yeah, it depends on the day or week that they're experiencing those shortages.
Yes.
It depends on the day or week that they're experiencing those shortages.
Vincent J. Angotti: You know, a year or two ago, they were having significant issues with that, where they were clearly looking at Dissuvia just to get it in and have it in stock as a just-in-case. I can tell you one thing that has been made public is that the DEA is limiting quotas on certain opioids moving forward. You know, some of those clearly are competitors in these markets. The good news for us is we have our DEA quota set already for this year as well as moving forward. So we're in good shape with our supply, and I expect that you'll see institutions in the field start to experience this. Intermittent supply challenges in the future based on those constrained supplies by the DEA.
A year or two ago, they were having significant issues with that where they were clearly looking at this you've you just to get into haven't stock is it just in case I can tell you. One thing that has been made public is that the D.A. is constraining quotas on certain opioids moving forward.
Some of those clearly our competitors in these markets. The good news for US as we have our D.A. quota set already for 20.
For this year as well as moving forward. So we're in good shape with our supply.
And I expect that you will see institutions, the fueled start to experience.
Intermittent supply challenges in the future based off of those constraints supplies by the DJ.
That's helpful. Thanks, guys.
Vincent J. Angotti: That's helpful. Thanks, guys. Okay, thank you.
Okay. Thank you.
Vincent J. Angotti: This concludes our question and answer session. I would like to turn the conference back over to Vince Angotti for any closing remarks. Please go ahead.
This concludes our question and answer session I would like to turn the conference back over to Vince and gaudy for any closing remarks. Please go ahead.
Vincent J. Angotti: Thank you, operator. Just to summarize, we continue to strongly believe in shared benefits and long-term success in the market, as well as its ability to change the standard of care. We want to thank you all for joining us today and for your continued support of AcelRx. We're pleased with the progress thus far, and we'll continue with our disciplined execution of the launch plan while managing our cash resources prudently. We look forward to showing the continued success of our launch moving forward and appreciate your interest in our company. That concludes our call, Operator. Thank you.
Thank you operator.
Just to summarize we continue to strongly believe and distribute benefits and long term success in the market as well as its ability to change the standard of care.
We want to thank you all for joining us today and your continued support of accelerates. We're pleased with the progress thus far and we'll continue with our disciplined execution of the launch plan, while managing our cash resources prudently and we look forward to show the continued access for a launch moving forward.
And appreciate your interest in our company that concludes our call operator. Thank you.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.