Q2 2023 ReShape Lifesciences Inc Earnings Call
Good afternoon, and thank you for joining the reshaped life Sciences' second quarter 2023 conference call I would like to turn the call over to Michael Miller from Rx Communications.
Good afternoon, and thank you for joining the reshaped life Sciences second quarter 2023 earnings call I'm pleased to be joined today by Paul Hickey, President and Chief Executive Officer, and Tom Stankevich, Chief Financial Officer.
Paul will provide an overview and update on the company's activities, which will include a discussion with Doctor Christine run fielding a member of reshape scientific Advisory Board.
Tom will review the financial results for the period. He will then turn the call back over to Paul for some closing remarks, after which we'll open the call to a question and answer session.
As a reminder, this conference call as well as reshape lifestyle, SEC filings and website, including the Investor information section of the website contains forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995 actual results could differ materially from those discussed due to known and unknown.
Risks uncertainties and other factors.
These and additional risk factors and uncertainties are described more fully in the company's filings with the Securities and Exchange Commission, including those factors identified as risk factors in the company's most recent annual report on Form 10-K.
One additional reminder, reshape stock is listed on NASDAQ trading under the symbol or S. L. At.
I'll now turn the call over to Paul Hickey, President and CEO retreat Lifesciences Paul.
Yeah.
Thank you Mike.
I'd like to thank all of you for joining US this afternoon for our second quarter 2023 earnings call.
After I provide an overview and update on reshaping activities will be joined by a member of our scientific Advisory Board Dr. Christine grandchildren.
Professor of surgery at NYU Grossman School of Medicine director of the NYU Mcgown weight management program and chief of the division of Bariatric surgery.
As an expert in key opinion leader in her field have asked doctor and fielding to provide her clinical insight on lap fans the adoption of G. L. P. One and the impact on the bariatric market.
You'll hear from her a little bit later during this call.
Before I recap, our second quarter highlights I'd like to discuss and comment on important events occurring within the obesity market today.
I will assume that all of you listening understand the size of the obesity market.
<unk> is a lifelong disease.
And it has an alarming gross rate globally as well as the significant medical repercussions and associated economic costs.
Further I am sure you are aware of the adoption of G. L. P ones worldwide and the prominence of the related big farmers marketing efforts, we are exposed to weekly if not daily on TV and other media channels.
The expanding popularity of shale P ones has brought significant benefits to those suffering from type two diabetes.
And they're used for weight loss has helped to normalize the stigma that often occurs around obesity and medical intervention.
There is no doubt that took a bite at big pharma marketing efforts. We're all seeing today have significantly increased the number of overweight and obese individuals who had previously avoided surgery.
Now actively seeking medically managed weight loss.
While in the past <unk> has been a sensitive topic and treatment has not been normalize we are pleased to see this shift in perception as.
As well as a greater awareness and acceptance of how critical obesity care is for both adults and children.
Shortly I'll have Dr. <unk> speak to her personal experience, but across the U S. Physicians are telling us that the G. L. P. One adoption, while potentially delaying surgical consults in the short term will ultimately increase the number of patients seeking out peritrich surgery.
Augments our replace the G L P one therapy and its known limitations.
We feel very confident with our last round and the expected future offering of our lap and to point out we.
We are uniquely positioned with having the least invasive safest and durable weight loss option for these patients that have historically had an aversion to medically manage weight loss and surgery.
Now I'll turn it back to a discussion of our second quarter highlights and growth initiatives.
A key takeaway from today's call.
As for all of you to understand that we remain dedicated to achieving profitability by executing our growth strategies and maintaining our emphasis on creating shareholder value.
Let me remind you of our three primary growth strategies, our pillars for growth.
The first pillar is to operate our business with a disciplined metrics driven approach to drive predictable revenue expansion through a scalable and sustainable business model.
Our second pillar is to continue to expand our product portfolio and pipeline across the care continuum.
And our last our third pillar is to continue to validate our evidence space weight loss solutions, leveraging our scientific advisory board for key insights on our strategic initiatives.
Now let me provide you more specifics on our first pillar progress.
Youll see in our numbers.
Executing this growth pillar has impacted almost every department as we maintained discipline and adhere to key P&L metrics.
As a direct result of our focus on pillar one I am pleased to report that we are able to recognize a 53% reduction in operating expenses compared to last year's second quarter.
Further in July in response to the Companys revenue shortfall caused by <unk> adoption and other market factors, we made additional operational improvements with annualized savings estimated to total more than $4 million.
We expect to continue to further optimize organization to positively impact our operating expense level throughout the remainder of this year and into 'twenty four.
Chile, allowing us to extend our cash runway, while we continue to invest in our growth initiatives.
Our progress with our first growth pillar is also evidenced by our revamped digital lead generation and a patient re engagement initiatives.
We are steadily seeing our new marketing efforts yield higher quality and lower cost patient needs and specific markets that align with surgeon advocates.
Key to this improvement is our recently signed exclusive agreement with Hyatt medical.
Okay.
Excessive lead optimization software that will improve patient engagement and increased patient volume by utilizing an AI SMS patient self service technology.
Importantly data generated during our testing of the high platform in the first quarter at select Blackburn accounts, where we also have co op marketing revealed an impressive 100 per 707% plus increase in medical concentration consultation scheduling over the prior quarter.
In conjunction with our highly targeted direct to consumer marketing campaign. The high platform allows individuals to quickly and easily navigate new patient intake hurdles and book an appointment with a medical professional at any time.
Based on our learnings to date, we anticipate that adoption of our co op marketing and high platform.
Results in approximately 50% improvement and lead generation at sites executing these best practices.
As a part of our strategy to target key touch points and the patient's decision process for surgery.
Continue to develop an improved website experience, which we are on target to launch towards the end of the third quarter.
This new platform will provide for improved customer lead capturing and lead conversion with our shift in tone to joyful fun friendly exciting and most importantly patient centric.
Our platform will also include comprehensive lead routing automation, leveraging text email web chat and calendar integration to qualify and connect ever need that comsat.
We are building these core marketing competencies in house, including our call center to align with the high marketing automation and lead nurturing efforts.
This nimble marketing strategy will allow us to be more responsive to better address patient needs.
Taken together, we believe this strategy will better address patient needs with the intent of increasing conversions and.
And ultimately more lap and surgeries.
Now, let's discuss our progress executing our second growth pillar.
In June we submitted a PMA supplement application to the FDA for our next generation lap band to point out there.
Developed efficient physician feedback to improve the patient experience.
Similar to our current lab Pan the last answer you pointed out its adjustable postoperatively to increase or decrease the opening of the band in order to optimize an individual's eating habits and comfort.
Thereby improving therapy effectiveness.
At the same time, a new feature of the lap and to point out is a band reservoir or technology that serves as a relief valve piece.
Pieces of food that are too large to pass through the narrow passage created by the current lap band can pass through because the new feature allows the bank to relax momentarily and then returned to its rest in diameter.
This could allow for increased lapping constriction and resultant satiety, while helping to minimize discomfort from swallowing large pieces of food.
Which may otherwise required emergency in office patient van adjustments.
We expect FDA feedback by yearend or early 2024 at the latest.
As I've noted in the past surgeons I've spoken with about the improved product to lead the lap and to find out will allow us to engage new surgeons and reengage. Many of those who have used the lifespan historically.
As a part of our second pillar of growth, we continue to expand awareness of our best in class Health and wellness program reshape care reached.
Reshape carries an effective virtual health and wellness program that uses video base sessions with board certified health coaches.
All on our convenient easy to use app, providing a holistic approach to lifestyle modification.
Reshaped <unk> initial launch has been focused on patients that are either pursuing bariatric surgery. Her already had bariatric surgery and we have seen positive outcome responses to our program within this patient population.
We are also continuing our discussions with several self insured employers to provide reshape care to the employees in order to positively impact overall health and thus reduce employers' health care costs.
These discussions have a long sales cycle and are often linked to an employer's benefit enrollment period and.
Importantly, reshaped care is on par with what companies are looking for.
With a holistic approach that can be customized to meet the needs of the employer and their employees.
In fact, some employers have indicated that reshape care has the ability to replace our consolidate three or four vendors from current employer sponsored wellness programs.
We'll provide further details in future upticks.
Excitingly with our reshape care program, we have recognized that women are seeking health care information much more than bad and having unique health care needs. This presents an incredible opportunity for us to have a positive impact on women's health issues by tailoring reshape care to help glamour women advanced gracefully through life stages.
Yeah.
Lastly, one of our most innovative products under development and as our proprietary diabetes block stem neuromodulation, our DBS and device, which I've spoken about in past calls.
The DBS ends dual vagus nerve neuromodulation selectively modulate stagger block and stimulation to the liver and pancreas, respectively to manage insulin and blood glucose levels.
We presented compelling preclinical evidence on the Bbs N at multiple conferences, including the Keystone symposia in type two diabetes in May and the American society for metabolic and bariatric surgery or S. MBS 2023 annual meeting in June .
And we'll do so again at the upcoming International Federation of the surgery of obesity and metabolic disorders or if so meeting later this month.
Notably this promising technology may be able to reduce diabetics dependence on medications and the very end of other individualized manner.
We have funded the DBS and with non dilutive finance grants and will seek additional non dilutive grants to support further development potentially including in human clinical trials.
Progress at our last our third growth pillar was achieved with our first meeting with our scientific Advisory Board in June .
<unk> is comprised of internationally recognized experts and surgeons in the obesity and metabolic disease fields there.
Their insights already proving valuable for our growth initiatives to drive revenue and expand our product pipeline.
Specific to enhancing our clinical data supporting our products.
B is fully engaged in helping us develop our strategies to collect and publish data on both our lap and to point out and data on lap and patients who are also using <unk> as combination therapy.
[noise] combination therapies, comprising G. L P wines and other gastric surgeries, including Latam are being prescribed today to help those who have plateaued with their weight loss.
As a result, we are exploring a retrospective study of lap band in combination with <unk>.
With our goal to have this exciting data peer reviewed and published as soon as possible.
Well at this time I'd like to introduce Dr. Chris <unk> from NYU.
As previously mentioned Dr. Fielding as a member of our scientific Advisory Board and it's been a key opinion leader and expert in our field of bariatric surgery for decades.
Chris I'd like to ask you to give everyone. Your background and then maybe give you or did you on the recent changes in the field of obesity treatment, including the <unk> and the adoption and the overall impact they'll have on the surgical procedures available today.
Thanks, Paul.
Good afternoon, ladies and gentlemen, I've mentioned earlier I'm, a professor of surgery at anyway.
With school of Medicine, and the director of the NYU.
Weight management program.
And I'm the chief of the Division of Bariatric surgery at NYU Langone Medical Center in New York City.
We created the bariatric surgery division in 2000 with myself being the first bariatric surgery at NYU.
I was first out of training.
I was recruited to build a division it was the following year end 2001, when the lap bandwidth.
That I became one of the first or do you think you have to be trained on how to implant and Madison device.
So within two months after approval I became one of the busiest and most prominent surgeons performing Wap ad surgery.
The first 10 years after FDA approval I am plans at approximately 5000 lap that.
You cannot consultants from bio <unk> toric and sat on their clinical Advisory Board.
And other searches on lap band surgery by running workshops and being a proctor.
Electric a lot better surgery at other academic institutions and other <unk>.
Training workshops and at National and International conferences.
I've published over 45 scientific research article.
Typically involving surgery outcomes in an effort to improve quality and decreased competition.
Continued like consulting roles with the subsequent companies that all of the bad that was.
Allergan and now reshape lifestyle.
Over the past three years <unk> grown the bariatric surgery division at NYU and it now consists of six bariatric surgeons five nurse practitioners three registered dietitian curious psychologists and social worker.
And we as a group to fall approximately 1000 bariatric operationally here that includes sleeve gastrectomy gastric bypass and lap band surgery. However.
However, about 30% of our operations, our revisions or corrective operation.
Wait regain our comprehension.
Over 10 years ago I also created the medical weight management program by hiring an obesity medicine Doctor.
Yes.
And she has grown our nonsurgical weight management practice, specifically utilizing diet plan meal replacements and medication.
This program complements our surgical practice on many levels and it includes helping patients who had undergone bariatric surgery, but did not reach their weight loss goals.
And by referring patients for surgery, who exhaust their option.
Our medical weight loss program is so successful that we havent.
I've been involved with clinical trials, new weight loss medications with both Novo Nordisk, a maker of Liraglutide and <unk>, otherwise known as extender Victoza was downtick.
We've also been involved with Eli Lilly maker of Tis appetite or <unk>.
In fact, we have just received two new grad for these companies to trial, new medications, which are not on the market yet.
There is no doubt that.
<unk> our game changer in the obesity treatment arena and are here to stay.
Firstly, they really work the efficacy of these medications are appetite control at the tidy with no serious side effects with fantastic.
There are about seven other medications that are thin and can be used for weight loss, but our distant second and how well they work or their side effects.
They validate obesity treatment other than diet, and exercise, which when used alone have proven and effective.
I just realized that medical intervention allows them to be successful with weight loss and destigmatize it their condition.
However, many factors on making an impact on utility of DLP wise, primarily cost the majority of insurance companies do not cover these medications, which run about $1000 a month.
In addition, there have been and continue to be major supply chain issues, which lead to shortages of medication.
Our practice rights over 1500 prescriptions, a monthly medications, but at least 30% of patients do not start or continue that would be cause pharmacy capital stock.
The only way to maintain weight loss is to stay on them in a coastal and oftentimes they're interruption in treatment.
In addition, many patients will be kind of a tolerance to the effects of the DLP market where they.
No longer feel the drug is working.
Switching.
And thank all the goals the tumor gyro.
But the problem here is that the indication Berman Giro presently is to treat diabetes and obesity, which continues to be at.
Provide patient access problems.
Finally, there are many patients who will not take L. P model.
Cause of the side effects of contraindications.
And let's call it that affected Asia. However, the most serious side effects of gallbladder attacks, which require surgery for removal and pancreatitis attack.
Women, who are pregnant or trying to get pregnant cannot use DLP one angle.
There are many patients who do not want to take these medications long tariff sphere of unknown complications such as cancer.
So we are now seeing a growing number of patients who are frustrated with these issues and want a more permanent solutions in the form of theatrics surgery.
The unreliability of G. L P. One supply.
Along with the long term alliance and oftentimes development of Torres will be the driving force for obese patients to conquer surgery.
<unk> will be the gateway drug for patients to Congress surgery, because they have had a case of successful weight loss utilizing modern medical intervention.
<unk> has also been a modern medical intervention with the lighting fixed pool, but it has been vastly underutilized.
However people are naturally afraid of surgery and in fact less than 2% of patients with obesity, who qualify for bariatric surgery actually have surgery.
Hello, It's common operations being performed presently our sleeve gastrectomy gastric bypass.
But these operations requires surgically, removing the stomach or cutting and rearranging the stomach test centers.
Sleeve gastrectomy gastric bypass a very safe there are surgical and nutritional complications that can occur and people are afraid.
The safest operation by far is the lap band as proven by multiple large population studies and vast personal experience.
This was the primary reason for the rapid initial intake and uptake of Wap and surgery in the 2000.
Patients loved it because it was an outpatient procedure with quick recovery time that allow them to lose more weight every time they came in.
Back to the office for their bank to be titled It also gave them accountability and long term connection with a practice, which motivated them.
Childbearing women have been very successful with weight management during pregnancy and weight loss after delivery because of the adjustability of the band.
Dan could be loosened during pregnancy, and then we tightened Atkins delivery.
To this day I still have hundreds of patients who have had their lap and attack for over 15 years and have maintained hydropower laidlaw.
However over time the issues of management band afterwards in regards to adjusting it, particularly when it required urgent listening to relief food obstruction.
Surgeons and patients became frustrated and eventually became this franchise with the device.
I believe that lap and to your point I will address this issue because of the ability for self correction utilizing internal reservoir system.
In addition weight regain had been an issue at the lap band surgery, primarily because it has been utilized for over 20 years and the natural condition of these patients is eventual weight regain for reasons not clearly understood. This.
This holds true for all of our operations as well, which is why <unk>. One agonists have been utilized widely by bariatric surgeons, such as myself to help their patients with COPD.
<unk> have been shown to complement and augment weight loss after sleeve gastrectomy gastric bypass.
We personally are seeing with no practice after lap and surgery multimodal therapy is now becoming mainstay in the bariatric surgery failed, which may make lap and searching more attractive to patients who would otherwise never have a more invasive operation.
I believe that the combination of improvements to lap end device and a tremendous guilty. One use will result in a greater interest in demand for lab and surgery.
Our over 130 million obese Americans, who qualify for Chelsea Wang and will also qualify for wideband surgery.
Difficult percentage will develop tolerance the GOP line.
Or will not be able to continue them or will not want to be dependent on medications long term.
He is in the other people who will be looking for a different long term sustainable option, which is surgery.
Safer surgery available today as lap and surgery.
I hope my insights into the Bariatric World has been helpful. I will now pass the call back to Paul.
Thank you Chris.
You have provided excellent insight to our listeners.
So our listeners know Ive asked Chris to stay on for our Q&A session at the end of this call.
Well it should be evident with today's call that with the known limitations of behavior modification side effects and durability issues surrounding.
Pharmaceutical therapies, such as DLP ones.
Along with the anatomy altering.
Irreversible nature of other bariatric surgical approaches.
That there is a substantial need for less invasive adjusted from our grocery bill that fan.
As Chris noted our product has proven to be safe effective and durable solution, providing long term weight loss.
Additionally, due to the growing evidence that weight loss with pharmacological therapies alone.
Results in plateaus and can often lead to another bolt noncompliance due to their currently known side effects, we believe reshape care with resources, including the personalized health coaching can be a meaningful adjunct for these patients helping them to make necessary lifestyle changes to obtain long term weight loss.
I'd like to now turn the call over to Tom Stankevich to provide a recap of our financial performance Tom.
Thanks, Paul and once again, thank you all for joining our webcast. This afternoon.
As a reminder, a full discussion of our financials is available in our press release and 10-Q.
Before I discuss some of our financial details I want to point out the overall reduction in our operating expenses of $6 million or 53% improvement reported in the second quarter compared to the second quarter of 2022.
And an $8 4 million reduction or 41% improvement reported in the first half compared to the first half of 2022.
Which were consistent across all expense categories and exemplifies our focus on achieving greater operating efficiencies.
Additionally in July we further reduced operating expenses with expected annual savings of approximately $4 million.
These reductions combined with our expectation for increased revenue, resulting from our targeted digital media campaign focused on geographies near bariatric surgery centers that sell the lap and system combined with the rollout of the highest platform.
Are expected to positively impact revenue for the remainder of 2023 and beyond and move reshape closer to cash flow breakeven.
Yes.
Moving on to other key financial metrics for the second quarter ended June 32023.
Our revenue totaled $2 3 million for the three months ended June 32023.
It represents a reduction of 600000 compared to the same period in 2022.
The primary reason the decrease in sales volume was throughout most throughout the U S and in Europe during.
During the three months ended June 32023, the company focused on its new strategies for marketing through a targeted digital media campaign, Youre bariatrics surgical centers, while reducing costs and increasing efficiencies.
We expect that during the second half of 2023. These efforts in executing our growth pillars will help drive growth through the remainder of 2023.
Gross profit for the three months ended June 32023 was $1 2 million compared to $1 9 million for the same period in 2022, a decrease of 700000.
Gross profit as a percentage of total revenue for the three months ended June 32023 was 53% compared to 65% for the same period in 2022 the.
The decrease in gross profit percentage is primarily due to the decrease in volume of sales.
Sales and marketing expenses for the three months ended June 32023 decreased by $2 5 million or 53% down to $2 2 million compared to $4 6 million for the same period in 2022.
The decrease is primarily due to a decrease of $1 $6 million in advertising and marketing expenses due to the move to a targeted digital marketing campaign.
There were also reductions in payroll expenditures, including commissions stock based compensation travel and consulting related services all totaling $900000.
General and administrative expenses for the three months ended June 32023 decreased by $2 9 million or 53% to approximately $2 five $2 5 million compared to $5 4 million for the same period in 2022.
The decrease is primarily due to a $1 $9 million reduction in legal related expenses and other decreases in payroll stock based compensation reduced amortization costs and rent all totaling approximately $1 million.
Research and development expenses for the three months ended June 32023 declined by 200000 or 22% to 600000 compared to approximately 800000 for the same period in 2020 to the.
The decrease is primarily due to lower payroll expenses, along with consulting and clinical related expenses.
We ended the quarter with $4 7 million in cash and cash equivalents and remain debt free on our balance sheet. As we continue in 2023 and beyond we anticipate our revenues increasing and a continued reduction in our operating expenses.
With that I will now turn the call back over to Paul.
Thanks, Tom excuse me Thanks, Tom before we open the call for Q&A.
As important to reiterate that.
We are committed to improving our marketing systems and bringing critical components in house to ensure optimum lead generation lead nurturing and lead conversion.
I'll further reducing lead generation costs.
We will continue to develop and offer portfolio a portfolio that is differentiated from the competition with transformative technologies that consists of a selection of patient friendly <unk> nanometer changing lifestyle enhancing products programs and services that provide alternatives to more invasive bariatric surgeries and help patients.
Achieve healthy turbo weight loss.
As Tom detailed we have significantly reduced operating expenses across all categories. So we can invest in the <unk>.
I mentioned growth strategies.
And finally, we'll work closely with our World Class Scientific Advisory Board to continue our plan for success in a global market that is changing and historic fashion to normalized safe and effective treatments for obesity.
This concludes our prepared remarks, so now we'd like to open the call to your questions.
Stacey.
Thank you we will now conduct the question and answer session. As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again please.
Please standby, while we compile the Q&A roster.
Our first question comes from Anthony Vendetti with Maxim Anthony Go ahead with your question.
Thank you.
I was wondering.
First question, maybe for sure the Doctor on the call Dr. Chris.
I didn't get your last name but.
I was wondering if you could talk just a little bit about.
What youre seeing in terms of the you said the <unk> one drugs.
They are here to stay fantastic with low side effects.
All of them being pancreatitis.
His brain swelling one of them and if so is it is it.
So remote that it's really not something you're concerned about.
And then just a follow up go ahead.
No no sorry.
Especially we're finished with your question I apologize.
Yes, no no no that's fine.
And then the.
The follow up is just is.
Is it possible that.
You could use the weight loss drugs in conjunction with lap band surgery or.
Is that.
Probably not recommended.
Okay. So thank you for your for your questions.
Brain swelling I am not familiar with that.
A side effect of guilty ones.
Typically the way that <unk> work.
I apologize if you already know all this but but it's it decreases emptying of the stomach so that the stomach states Fuller and food leave stomach leaves the stomach and a much slower fashion. So thats why people aren't they get full faster they are hungry.
They'll eat less.
And Thats why nausea, as the most common lines.
<unk> of the way it affects the movements are food through the stomach. It also.
Next movement of the gall bladder in the pancreas.
Not really sure about the brain swelling is not something that.
I have heard of.
It is a side effect, it's extremely rare because I certainly have not seen it personally in the patient.
Okay.
That's helpful.
And then to your second question.
It is absolutely possible to use <unk> in conjunction with lap band surgery, and we do it all the time.
We've been using guilty ones.
Conjunction.
With lapped with patients with pad lap and serve you for years and they get a little bit of a stall and so we'll add DLP one.
<unk>, we started at the time immediately right after surgery.
Those studies are actively being addressed right now. So there is no reason not to start the right away. There are patients who are already on <unk> and we will perform surgery will do lap and surgery and they'll just continue to stay on their medications and they actually do great.
Okay great.
Sorry go ahead.
Anthony This is Paul I was just going to add.
Chris for the answer.
Obviously totally agree.
Two points I think.
I think in.
Dr. <unk> can comment on this as well the the risk of carrying obesity for years in terms of that disease and increase rates or cancers.
You have just with being obese I think.
Going to balance out any of the potential negative side effects with a risk of cancer with <unk> and <unk>.
And not just cancers theres other obviously.
Comorbidities related too.
Obesity.
Our well studied and this is I hear about the paralyzed stomach orbit Gobi face. We go via your fingers wherever there is so many other benefits to losing weight overall.
Yes.
Im kind of doubtful.
Based on what I've heard.
And obviously, you're talking to advisory board that these GOP you wanted to have.
Short life on the market I think they are here to stay based on all the benefits they provide.
Yes that was that was the one comment and that combination therapy I think that's that was the point we're trying to.
Collect data retrospectively patients at NYU and other places that already house.
<unk> ones.
In addition to that pad. So we can we can study retrospectively, how how well they've done in terms of getting off of that plateau, which is where they don't get the weight loss.
Summer months in a row and then they look for in an adjustment but.
Geo pier ones are kind of a way of giving other boost to to their system. So that obesity is shut down for a bit and it can get back on the weight loss.
Okay, Great and then just a quick follow up on lap as you pointed out.
I know you gave an update can you give a little bit more of a timeline of.
When do you think that could potentially be approved.
Sort of like a window of comments back.
And then ultimately approval sure yes, sure we're all chomping at the bit so to speak with waiting for the FDA. So what we know with a PMA supplement that we submitted.
The day, we announced it in June we actually waited we gave it to the FDA, we waited until they checked all the boxes and look for sort of our <unk> two what they at a minimum they required once they they assign a review on a sort of check all the boxes. They tell us it's not going to be rejected so we got past that hurdle.
We do have a reviewer.
That's looking at it we've had one softball question I think that we have.
<unk> II, but we expect over the next several months to start getting more interactive with the FDA in terms of their questions on our submission.
And we believe this submission is very comprehensive.
But again Thats cft's job to look at those with a high level of scrutiny.
Our expectation is that by the end of the year.
Latest first quarter, we'll have a.
A lot of interaction ongoing with the FDA.
And as we as we know more of their concerns or questions.
Sure those appropriate, but so far it's kind of we're just we're waiting for that interaction to to ramp up with the FDA. So we can fill.
<unk>.
Hopefully getting it approved.
And starting the next phase of it should be how to commercialize.
Okay, great. Thanks for answering all those questions and I'll hop back in the queue. Thanks, so much.
This concludes our question and answer session I would like to turn the conference back over to Paul Hickey for any closing remarks. Please go ahead.
Sure.
I Hope you appreciate the candor and transparency shared during this call and hear our enthusiasm and excitement for the road ahead.
We continue to streamline the organization to be more disciplined sustainable and scalable.
And we will continue to work diligently to build our commitment to provide evidence based personalized devices in therapeutics.
A special thanks to Dr. Christiane fielding for participating in today's call and the Q&A as well.
As always I want to thank our employees board members customers consultant adviser suppliers existing and new shareholders for your continued support of reshape as we progress on our mission to become the Premier physician led Us company.
I do look forward to continuing to engage with our stakeholders healthcare partners and shareholders.
The conference has now concluded. Thank you for attending today's call you may now disconnect.
Okay.
Okay.
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Okay.
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