Q3 2022 Novan Inc Earnings Call
Hello, and welcome to the Nova and incorporate a quarterly update conference call and webcast. As a brief reminder, all participants are currently in a listen only mode. If you if anyone requires operator assistance during the event. Please press Star then zero on your telephone keypad. Following the presentation. There will be a question and answer session note that this webcast is being.
<unk> recorded at the company's request and a replay will be made available on the company's website. Following the end of the event.
At this time I'd like to remind our listeners that remarks made during this webcast may state managements intentions beliefs expectations or future projections. These are forward looking statements and involve risks and uncertainties forward looking statements on this call are made pursuant to the safe Harbor provisions of the federal Securities laws and based on <unk> current expectation.
Yeah.
And actual results could differ materially as a result, you should not place undue reliance on any forward looking statements. Some of the factors that could cause actual results to differ materially from these contemplated but such forward looking statements.
Are discussed in the periodic reports filed with the Securities and Exchange Commission.
These documents are made available in the investors section of the company's website and on the Securities and exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast relates to or based on studies publications surveys and other data obtained from third party sources and the company's own.
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Any information obtained from third party sources.
Joining us on today's call as he knows the leadership team.
Mrs. Paula Brown, Stafford, Chairman, President and Chief Executive Officer Mr.
Mr. John <unk>, Chief Financial Officer.
And Mr. John Don.
Oh Frito, Chief operating officer of know van and President of E. P. I health I would now like to turn the call over to MS. Paula Brown Stafford. Please go ahead.
Thank you Chuck.
Good morning, everyone and thank you for joining our corporate update including our vans financial results for the third quarter and year to date no.
Van team remains focused and passionate towards achieving our goals for 2022, I'm very proud of our many accomplishments. So far this year as a reminder, on March 11th we announced that know van had closed on our acquisition of Upi help providing no van with commercial infrastructure and <unk>.
Marshall revenue.
We expanded the depth and breadth of the Nova and opportunity to our stakeholders.
We have created a medical dermatology company that has the capabilities to discover develop and commercialize innovative therapies, bringing medications to patients with diseases of the skin.
We have made solid progress since July and have great momentum and focus going into the remaining weeks of 2022.
We're pleased to share that we are tracking toward our target submission date potentially the first FDA approved treatment formula Contagiosum.
We are very proud that in the third quarter. The results from our pivotal phase III study be simple for were published in the Jama Dermatology journal authored by Dr. John John Browning and others.
So last quarter, we paid off the $16 5 million promissory note with E. P. G ahead of plan saving the company nearly 11 million of future expense and no securitization of the company's marketed assets.
We've delivered strong volume growth year over year for our promoted prescription products with total revenue of over 5 million in the third quarter results for which we are very pleased and finally, we entered into a non binding memorandum of understanding with thought to pharmaceuticals on Friday.
So it potentially market road fade in Japan, and other Asia Pacific territories, representing an important milestone in the execution of our business development strategy.
We're driving the company forward with our development and commercial achievements.
Our lead product candidate is <unk> gel 10, 3% or S. B two O six a potential topical prescription treatment and likely the first FDA approved treatment for molluscum Contagiosum.
We are progressing our NDA submission for SB two O six as planned.
We have completed our drug product drug product stability testing necessary for the NDA submission.
We are now awaiting our drug substance stability testing and other ongoing analytical testing results were.
We're targeting the submission of our NDA around the end of 2022.
Plus or minus a week or so.
Just given ourselves a little room there.
Slide seven provides our anticipated timeline based on typical regulatory schedules.
So once we submit our NDA, we will await the F. D. A review of our submission which is usually approximately 75 days.
They're the F D a filing of our submission.
While providing a produce the date.
Yes. It is accepted so are likely produce a day is 12 months from our submission date.
During 2023, we anticipate a typical F D. A drug review process and we plan to execute on our prelaunch activities and prepare supply of drug product.
And if approved around the end of 2023.
We could then commercially launch <unk> gel 10, 3% in the first half of 'twenty 'twenty four.
As we prepare for our potential launch of <unk> gel 10, 3% for Mollusca, we have sponsored a series of market research activities.
First prepare for our potential market entry.
We have four primary audiences.
Matala just.
Pediatricians.
Here's.
And the patients caregivers and families.
With respect to the ladder the majority of patients with molluscum, our children, primarily one to 14 years of age.
So in a refund digital ethnography research study more than a dozen research participants with molluscum Contagiosum, where each followed for up to three months.
We learned of the negative impact on the daily lives of sufferers.
Of molluscum.
Physical.
Auction all emotional social.
And on self identity.
Physical damage and mental damage can be an outcome of molluscum and or today's molluscum treatments.
Through our survey.
142 health care practitioners or H C piece, we validated that there is an unmet need.
For molluscum treatments.
We surveyed pediatricians dermatologists dermatologists pediatric dermatologists nurse practitioners and physicians assistants.
The majority of those surveyed confirmed that there is a need for new options now.
The highest level of need as with pediatricians, and dermatologists and nearly all dermatologists surveyed saw a need for a treatment option there.
They are clearly dissatisfied with current options available.
Then according to medical and pharmacy benefit claims data pediatricians, largely take a wait and see approach to trading in Alaska.
Greater than 90% of them.
Less than 10% tree at all.
Whereas dermatologists treat 65% of those who visit.
But the number of patients diagnosed by a dermatologist is approximately 25% of those diagnosed by pediatrician.
When a H C piece, we're asked to rate their willingness to prescribe a possible new topical treatments, specifically Britt asthma gel 10, 3% there was a high interest in such an option and that's confirmed our view that there is unmet need.
When it comes to Alaska children, and their caregivers their families and their health care providers are in need of options.
Well, let's look at one of those potential options. We previously reported robustly positive efficacy results from our pivotal phase III study known as be simple for.
And as mentioned earlier recently published in Jama dermatology.
So our knowledge be simple four included the largest cohort of patients with molluscum contagiosum randomized in a controlled clinical trial.
Patients were eligible to enroll as early as six months of age.
A topical prescription alternative to other therapies used is desired for this highly contagious and psycho socially challenging skin condition.
Visa before demonstrated clinical and statistical evidence of efficacy with our primary and secondary end points and a favorable safety profile.
If I look at the last audience that I discussed payors.
Our team is actively strategizing regarding payers pricing and reimbursement.
Our takeaways to date are that there is limited to no management of molluscum.
Hairs, maybe more favorably disposed because this is a pediatric population.
Most payers rated for gossamer gel.
Quite highly you'll see here 5.1 on a scale of one to seven.
And we saw that non coverage seems unlikely.
So our strategic efforts continue to make positive progress toward our responsible pricing strategy.
These previous lives.
Really are to share some of the results from our market research efforts as we plan and execute toward a potential commercial launch and launch success.
We've developed an in depth launch plan and importantly, we have acquired our commercial infrastructure to ready ourselves for a potential launch.
We've made solid initial progress and building awareness with H C piece through our medical education efforts and we've begun to develop our pricing and reimbursement strategy.
We will start to build up our commercial slot supply as we get closer to a potential approval.
No van we plan for success and a product launch is no different.
Yeah.
I'll now turn the call over to John Dunn offer you, our chief operating officer, and the President of Upi help for our commercial update John .
Thank you Paula good morning, everyone. I am pleased to report that our promoted products delivered strong year over year prescription growth both year to date and for the third quarter. This growth is due to our continued execution of our commercial plan strong prescriber base and solid product portfolio.
As noted in our Q2 earnings call seasonality of the third quarter, historically does not lead to quarter over quarter growth in some of our disease States. We saw this play out with <unk> with the reduction in prescriptions versus previous quarter. However, and importantly, both brands maintain their writer base levels from previous quarter and continue.
<unk> delivered strong growth compared to same quarter last year.
And increased commercial focus on our Acme brand mineral lira led to strong double digits year to date growth quarter versus last year and quarter over quarter growth.
While we don't yet provide revenue guidance I can say that we remain confident we will finish 2022 with strong double digit prescription growth in each brand versus 2021.
I will now provide additional highlights on each of our promoted products.
With rotate we continue to dominate the persistent facial erythema market owning approximately 90% of the market rotate as backpacks thing last all day improvement persist with regular daily use over 52 weeks prescription volume for rope eight in the third quarter came in at 37900 total.
Friction, representing a 31% growth over year over year, and beating the total rose Asian market, which grew only 7% for the same time period. In addition, the number of unique prescribers exceeded over 8000 in Q3, demonstrating a strong base of health care providers, who believe in the value broker for their patients in fact.
Real estate increase its growth rate of new patients and new prescriptions in Q3 to 32% year over year compared to 26% growth year over year in Q2, demonstrating the increased use of <unk> to treat persistent facial erythema amongst rosacea patients.
<unk>, which was launched July of last year.
Can you still grow steadily year over year, we have a strong partnership in collaboration with <unk> therapeutics for the sale and marketing <unk> in the U S for plaque psoriasis.
This is the first and only water based combination product with the power of a high potency steroid and the added benefit of a vitamin D analogue and a cream formulation Windsor has quick onset of action with visible improvement at one week, including impact on itch and is ideal for localized blacks on knees.
Bose and scale.
As we covered on our Q2 call new competitors have launched in Q3, and then challenge the use of topical steroids for psoriasis.
Can see the impact in the reduction of total prescriptions from Q2, however, when Saar manage the finished Q3 with no loss in market share within the topical psoriasis market.
We maintain a writer base and when Saar consistently gets more new patients per writer than any other branded steroid based topical product.
We are confident in the continued use of topical steroids for the treatment of plaque psoriasis going forward and the benefits that <unk> brings to patients who need and desire quick relief.
Our growth strategy continues to focus on expanding our rider base. So more ports more patients can get the benefit of win Zara.
Minto lira and oral minocycline for the treatment of acne offering weight based flexible dosing and the first ever by basic delivery system, we have seen significant growth in prescriptions since increasing our promotional efforts on the brand. This year, we delivered our largest growth in mental air prescriptions. During this quarter as Middlebury hit another all time.
Hi, and total prescription over 12000 and grew 78% versus prior year and 23% over previous quarter.
We picked up almost half a share point in the very large oral antibiotic acme market, putting middle layer on a continued path for growth going forward.
Overall, we are very pleased with the continued prescription growth of our promoted brands in quarter, three, especially given the seasonality and significant noise of new competitors.
We look to close out 2022, with the same energy execution and performance that we've demonstrated over the last three quarters and we look further out with the excitement of our upcoming potential launch of SP. Two O. Six thank you and I'll now hand, it back over to Paula.
Thank you John .
So in summary, we're pleased with our commercial performance.
Quarter that met our internal expectations in terms of total prescriptions.
So now I I am.
Confident and our commercial team and their efforts to continue on a growth trajectory into the fourth quarter.
I'll now turn the call over to John Gay, our Chief Financial Officer to review, our third quarter and year to date financials John .
Thank you Paula good morning, everyone. This quarter represents the second quarter in which we have fully consolidated results from our commercial business.
I'll remind our listeners that when I refer to year to date figures. This represents 203 days of commercial activities based on a March 11th acquisition of E. P. I help.
Sure I'll touch on some of the key data points for this quarter I would like to remind our listeners that we are not yet in a position to provide guidance as it relates to full year 2022 revenues or EBITDA. However, as John noted, we see a path for continued year over year prescription growth and our promoted product portfolio.
As of September 30, our year to date commercial business reported total revenues of $11 2 million.
Net product sales will broke paid included in our commercial businesses total revenue was $8 6 million with other products in our portfolio contributing $2 6 million year to date.
Rotate prescriptions have continued to grow with a year over year increase of 37% for the nine months ended and a year over year increase of 31% for the three months ended September 30.
We continue to see opportunity for improvement in Windsor, which launched in Q3 of last year and.
In addition, mineral air prescriptions have continued to grow with a year over year increase of 59% for the nine months ended and a year over year increase of 78% for the three months ended September 30.
I will now provide a bit more detail of our Q3 financial results, which expands on the information filed this morning <unk>.
Commercial product cost of goods sold was $4 3 million for the nine months ended Q3 cost of goods includes the cost of procuring finished goods from our third party manufacturers. In addition to sales based royalty and milestone expenses and third party IP licensing costs.
Our R&D business incurred research and development expenses of $12 3 million for the nine months ended September 30, compared to $15 9 million in the prior year period.
The decrease of $3 7 million was primarily related to the S. B two six clinical program based on timing of the be simple for trial.
On a consolidated basis SG&A expenses were $27 2 million for the nine months ended Q3 compared to $8 1 million for the prior year period. They.
The increase of $19 1 million was primarily due to non point $3 million of selling general and administrative expenses related to EPS helps commercial operations.
$4 8 million of transaction related expenditures related to the EPS health acquisition, and a $2 3 million increase in investment costs related to the S. B G O six prelaunch strategy and commercial preparation.
For the nine months ended September 30, we had 3 million of other income primarily related to the net impact of the settlement of the promissory note related to the EPS health acquisition.
As previously noted in July of this year, we reached agreement with the seller and the Epi health acquisition regarding payment and termination of the previously outstanding $16 5 million note.
We achieved this termination with payment of $10 million when an approximate 39% discount on the original principal amount of the note.
In addition to saving $6 5 million of principal with this termination. We also avoid paying interest over the full term of the note of approximately $4 6 million.
Removing this previously existing liability allows us to use our cash for development of our product candidates rather than debt servicing and to support the commercialization of our products.
On a consolidated basis total revenue was $13 2 million year to date compared to $2 3 million for the prior year period.
Total net loss was $28 3 million for year to date third quarter as compared to $21 5 million in the prior year.
We continue to focus on optimizing our commercial business, while at the same time investing in and looking forward to the potential launch that's b two O six.
As you can see a 40% year over year growth in our marketed portfolio prescriptions.
Flirting with Saar, which was launched in Q3 of last year, and Clos Derm, which we're not actively marketing.
This gives us confidence that we'll be able to continue the prescription growth trend for the remainder of the year.
As it relates to our balance sheet as of the end of the quarter. We had a total cash balance of $14 9 million and accounts receivable also totaling $14 9 million, we will need additional funding to support our planned future operating activities and our S. P. Two of six product candidates and our promotional business, we believe that our cash balance as of September <unk>.
30, plus expected receipts from our commercial business will provide us liquidity to fund our operating needs into the beginning of 2023, however variability in our forecast driven primarily by commercial sales timing of certain operating expenditures and anticipated changes in net working capital may impact this runway.
We have been pursuing and we'll continue to pursue additional capital through a broad range of financing strategy and other strategic alternatives as an example of potential strategic non dilutive financing as we noted in our filings. This morning, we have entered into a nonbinding memorandum of understanding with Sato for a proposed exclusive license in order to <unk>.
<unk> rotate in Japan.
Other potential funding activities may include equity financings convertible debt or capital from non dilutive sources or traditional debt financing such as term debt revolving lines of credit or other asset based funding facilities.
We are working vigorously towards providing the additional capital needed to continue investment in our business of course, we will update our shareholders and other interested parties as appropriate and as required with that I'll turn it back to Paula.
Thank you John for providing an update on our financial results and status.
We're pleased with no advanced progress in the third quarter.
And let me just summarize with the following the good progress and are our top priority.
Priorities in the fourth quarter and going into 2023.
We continue to advance our efforts toward an NDA submission in 2022 or very early 2023, having our drug product stability results in house and yet a few moving parts towards the final dossier.
We are planning for success and preparing ourselves for a potential product launch of <unk> gel 10, 3% if approved.
We have commercial momentum here at the front end of the fourth quarter.
We continue to pursue evaluate and consider collaborations that could expand our existing commercial products beyond the U S and are pleased with our opportunity to finalize our license agreement with Sato pharmaceuticals to potentially market right fade in Japan as well as other Asia Pac territories.
In closing the full know van team remains energetic focused and confident in our future path.
We appreciate your continued support.
Operator, I'm going to now ask and turn the call back to you to facilitate our Q&A session.
Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys and to withdraw your question. Please press Star then two and at this time, we'll pause momentarily to assemble our roster.
Yes.
Yeah.
And the first question will come from Jeff Jones with Oppenheimer. Please go ahead.
Good morning, guys and thanks for taking the question.
I guess, a couple of things in terms of SP to a six and the.
The language you used around end of year just wanted to confirm there is no concerns around the drug substance registration batch stability, it's just a timing issue.
And then in terms of the product revenues in the flight pulled down due to seasonality.
Is that something you continue to expect to see in Q4 or when does that big.
Begin to reverse itself.
With that all hop back into the queue.
Alright, Thank you Jeff.
I'll take that first one to six and then I'll have John don't offer you discussed the product revenue for fourth quarter.
So they are it is that a concern or is it timing. It is the latter so it's not a concern it is the timing.
Of getting those stability testing and other analytical testing that we're doing getting those results, but most of it is with third parties and so we are partnering and we don't have a concern with the timing I just want to give ourselves some room, if we don't get it.
At the expected time to be able to put it in the full dossier.
So not a concern with the results that are concern potentially you know with the timing, but we don't think that it would and that's why I say a week or so is our expectation at this time.
If if we need an expert.
Yeah.
Okay. Thank you Jack good morning, and yes in regards to Q4, we do not expect seasonality in Q4 and again.
Again, we feel like it's a for rosacea and psoriasis. Its a Q2 Q3 dynamic with some within the summer months and as we've seen kind of the October end of October and what we expect for November and December we feel confident on the Q4 uptick in seasonality.
I appreciate that.
Just one more follow up question on Sato.
Is and beyond the DIAM up new program or any other update around the other programs that they have rights and then the timing and or financial implications around potential milestones.
Yeah.
Hmm not not any update at this time they are continuing to pursue SB two O six and molluscum and are advancing their development program.
As expected.
Okay. Thank you.
Sure. Thank you Jeff.
Our next question, Yes, ma'am. The next question will come from Jennifer Kim with Cantor Fitzgerald. Please go ahead.
Hey, everyone. Thanks for taking my questions I have a few here one is that it's sort of a follow up on the last question. The memorandum of understanding with <unk> could you give any color on what the terms of agreement could ultimately look like and look when we get an update.
On that agreement moving forward and then.
Later to that I'm, just wondering how your discussions around other territories, how that's going.
Okay.
Thanks, Jennifer.
In terms of the memorandum of understanding you know we are moving toward the definitive agreement and its our plan to have that before the end of the year. So we will share those terms as soon as we can but those terms generally include an upfront milestone payment.
And royalties thereafter, and that would be for Japan, and then right two or Sato to have agreements on other Asia Pac territories as well.
So as soon as we have those details we will certainly share them and we're trying to move to a definitive agreement.
Quickly.
And in terms of other territories, we do have interest and continue to have conversations.
As you've seen and as John described with rotate in the U S. A there is a it's a it's a good product and there is interest in other countries.
Countries to bring rotated market, we have global rights to rotate and it is currently only marketed in the U S. So it's a product that we see gaining momentum.
The momentum and in the other territories.
Okay. That's really helpful. My second question is on wind Zora I think during the call. You commented that you lost no market share within the topical psoriasis market does that mean the impact from this quarter.
It was primarily due to seasonality because I think if you were topical or expanding the overall tactical market you maintaining market share means that you're sort of benefiting from that expansion.
Yes, great question and yes, that's what we're seeing in <unk>.
If you look at it obviously, the non steroidal have had an impact a positive impact on the market.
When you look at the steroids themselves the mono steroids.
It's tough because it written for multiple things outside of psoriasis, but when you look at the segment. They maintained and we saw the loss are really in the branded and.
And the combination products. So that's where you saw the hit quarter over quarter, but when you look at the overall market, we were able to maintain.
Our market share and a writer base so.
Yes, yes overall to your question and we've seen that stabilize.
Towards the end of Q3 and in the beginning of Q4 and as we noted.
We're excited about new innovation and new entrants into into overall medical dermatology and especially in the psoriasis market on the topical side and we feel like we're very complementary to the new product entrants and it was a lot of investment a lot of resource and a lot of noise.
That was again very positive for our industry and I think that as it continues to sort itself out we will continue to benefit from the growth of the market.
Okay, Great and then maybe one more quick question on molluscum regarding that analytical testing is the way that you're thinking about timing based on your latest communications with those third parties.
It is.
And that's you know I am not ruling out 2022 and that's why I, just said plus or minus I'm, just oh as we await final results coming coming and that's that is our latest information.
Okay, and do you anticipate issuing an update once that testing is complete or would the next sort of update would be the filing.
Unless we have any issues. The next update will be the filing so I am.
Feeling good about the next update in our filing.
[laughter], Okay, great. Thanks, guys.
The next question will come from Kempt, Oliver with Brookline capital markets. Please go ahead.
Thank you good morning.
First.
As we go into 2023.
You had any consequential changes in your coverage with the health plans.
Yes. Thank you very much for the question and.
No we've been able to maintain coverage.
Our existing coverage that we've contracted for both road fade and mental lira, and we will continue to see access to covered life of about 55 million 55 million covered lives on wings or so we've been able to maintain the coverage for each of those products are heading into <unk>.
23.
Okay.
Thank you Kevin do you have another.
Okay, Yes. The other question is with her on the topic.
License agreements.
Yeah.
With SB two O six and I'm thinking really specifically EU are you actively engaged in any discussions there with that product.
Yeah.
Uh huh.
Not at this time count.
You know we are really focused on.
ROE fade and it's immediate.
<unk> ability to add you know positive cash flow for us.
Or are you now add cash to our runway I should say the S. V. Two six were really waiting more for our submission and then will more heavily pursue that as well.
<unk>.
Yeah.
Great. Thank you.
The next question will come from Jon Vander motion with Zacks. Please go ahead.
Good morning, Paula John and John I thought I'd start out with a question on.
The filing.
The the NDA it looks like you'll be pretty close parallel track with your closest peer and I'm wondering if you think that having the F. D. A looking at two similar or the two products that are addressing the same indication provides any any benefit or hurdle, perhaps two or three of them.
You know with the FDA, we don't see it as a hurdle the F. D. A has has been reviewing.
Our.
I want to say a competitor because really.
Because it's not a competitor I think that there's space for both because they are a medical benefit we are a pharmacy benefit if either or both are approved.
I think that with the F D a.
The FDA is reviewing primarily there.
Contract manufacturing organization.
To my knowledge and I think to everyone's publicly so ours.
Is a very different product they are a device.
We are a topical and you know they're very different products. So we don't see that as being an issue. The FDA is always reviewing multiple products at a time.
In the dermatology area, so that it's not a concern for us.
Okay, Great and then <unk> had a lot of interactions with yesterday over the last couple of years.
The millennium products and I'm, just wondering if you've been able to learn or glean anything from those interactions that will help you and in the AR and the submission youre going to make coming up here in a few weeks or months or so.
Yeah, we've been focused on our interactions with the FDA is quite frankly, so we've had a number through the last several years and even this year as we.
Prepare to file we've had ongoing.
You know letters to and from the F D. A.
Really making sure that we are you know filing everything that they are interested in seeing a need and so we've been very focused on our submission so I'm not I.
Really not glean anything from from Theres other than.
You know learning about their crlf's with contract manufacturing and we are manufacturing here at our facility in our drug substance and it is zimmer only so it is not competing with any other products in the plant and then we are using a drug.
CMO for our drug product and we've been working with them since 2018, and they have a very good regulatory inspection history. So we have not had those concerns.
Okay, great, Yeah, I think pretty clean on that side of.
The size of the submission last one for me is on <unk> six and some of the competitors who may be looking for in terms of pricing in your analysis. When it finally goes to market, but what are you looking at there to come up with the appropriate.
Price that will.
Gotta go successfully go into formularies and get your insurance and things like that.
Right no. Thank you. Thank you John for the question there really arent a comparator. So we're just having to look at what.
What we believe that the market.
You know and and is necessary for.
I think John Gay has shared in the filing how much we have previously put into the company I mean, you're seeing a lot of Oh. The averages. It takes a billion dollars they get a product to market and I think were around 300 million. So I think we're doing well.
In terms of our investment and potential return, but in terms of where we see a unit on a unit supply is around 28 days on a unit supply would probably based on our research be somewhere between $601000 a unit.
And that is based on our research and Payor Payor and pricing strategy.
Okay, Great. That's very helpful. Thank you Paula appreciate it okay. Thank you Dan.
This concludes our question and answer session I would like to turn the conference back over to MS. Paula Brown Stafford for any closing remarks. Please go ahead.
Thank you operator.
We made good progress in the third quarter with our development efforts and with our promoted product sales, we achieved many milestones and have momentum in the fourth quarter with six or so weeks ago. We.
We look forward to sharing our progress as we move through the quarter and into 2023. Thank.
Thank you all for attending today's call.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Okay.
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