Q1 2022 Societal CDMO Inc Earnings Call
Good day, and thank you for standing by and welcome to the.
This is <unk> first quarter 2022 conference call.
At this time all participants are in a listen only mode. After the speaker presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero.
And the conference over to your Speaker today, Stephanie DFS was to say it is investor relations.
Go ahead.
Thank you Hello, and thank you for joining us on today's call, we have David and low President and CEO and Brian Lane, Chief Financial Officer.
We will be providing an overview of suicidal contract development and manufacturing business, including updates on corporate activities and financial results for the quarter ended March 31 2022.
After our prepared remarks, we will welcome your questions.
Before we begin I would like to caution that comments made during this conference call. Today May 11, 2022 will contain certain forward looking statements within the meaning of the private Securities Litigation Reform Act of 1095 concerning the current beliefs of the company, which involve a number of assumptions risks and uncertainties actual results could differ.
These statements and the company undertakes no obligation to revise or update any statements made today.
Encourage you to review all of the Companys filings with the Securities and Exchange Commission concerning these and other matters.
Our earnings press release, and this call will include discussion of certain non-GAAP information.
You can find our earnings press release, including relevant non-GAAP reconciliations on our corporate website at societal CMO Dot com.
With that I will turn the call over to David Enlo societal as president and CEO .
Thank you Stephanie and thank you to everyone, who has dialed in and to those who are participating today via webcast.
By any measure 2021 was a transformative year for the company management and team new facilities New capabilities. These factors contributed to other important changes, including a significantly expanded and diversified customer base and a stronger financial position.
I am pleased to report that the momentum created in 2021, just carry over into 2022.
Not only have we continued to advance each of the prior year goals, but we have established a new set of goals for 2022, which are executing specific segment specific sales and marketing strategies, while building a stronger corporate identity opt.
Optimizing and expanding our capabilities enhancing both our customers and our employees experienced working with and for the company.
And continuing to achieve growth and strengthen our financial position.
During the first quarter, our team made progress in each of these areas, giving us great optimism for the year ahead.
I will provide a review of our Q1 2022 achieve months following an overview of our financial results for the quarter, So with that I'll turn the call over to Ryan.
Thank you David.
Good afternoon, everyone.
Before I begin in addition to the brief financial overview I'll provide on the call today additional details on our financial results for the first quarter ended March 31, 2022 are included in our press release issued prior to this call and in our Form 10-Q, which is on file with the SEC.
Revenues for the quarter ended March 31, 2022, or $21 2 million. This represents a 26% increase compared to revenues of $16 $8 million per quarter during the prior year period the.
The increase of $4 4 million was primarily the result of increases in revenue due to the acquisition of viruses as well as higher revenues from our clinical trial materials business. In addition, there was an increase in revenue from our largest commercial customer teva correlated with pull through in demand resulting from market.
Share gains against the sole competitor for the mill ESR products.
Offsetting these increases was an unexpected decline in revenue per mile and that's commercial sales of the <unk> pm products, resulting from weaker than anticipated sales from our partners efforts in the market.
We are diligently identifying the root cause for these declines and exploring strategic options to restore sales levels.
Cost of sales for the quarter ended March 31, 2022 was $16 2 million compared to $14 4 million for the comparable period of 2021.
The increase of $1 8 million was primarily due to the acquisition of the San Diego facility and is partially offset by the reallocation of expenses, reflecting the post acquisition and organizational structure.
Selling general and administrative expenses for the first quarter were $5 7 million compared to $4 7 million recorded in the 2021 period.
The increase of $1 million was primarily related to increased personnel costs tied to the reallocation of expenses, reflecting the post acquisition organizational structure.
Set by lower stock based compensation expense.
As previously communicated as a result of our integration and reorganization effective October one 2021 certain expenses associated with employees. We now support our multi site organizational structure and operations are classified in selling general and administrative expenses.
Prior to October one 2021. These employees supported our plant operations and were classified in cost of sales.
Interest expense was $3 4 million for the three months ended March 31, 2022, a decrease compared to $3 9 million for the comparable period of 2021.
A decrease of <unk> 5 million was primarily due to reduced term loan borrowings under the credit agreement with this area as well as a decrease in the LIBOR base rate of interest on our term loans under the credit agreement.
This decrease was partially offset by an increase in interest from the seller's note, which was a component of the irises acquisition purchase price.
For the quarter ended March 31, 2022, the company recorded a net loss of $4 3 million or <unk> <unk> per diluted share as compared to a net loss of $6 8 million or 23 per diluted share for the comparable period of 2021.
EBITDA as adjusted for the period was $1 4 million compared to $2 7 million in the prior year period.
During the period lower than expected sales of our rapid mill by our marketing partner led that negatively impacted EBITDA as adjusted by one 5 million as compared to the 2021 period.
Cash and cash equivalents as of March 31, 2022 were $15 3 million compared to $25 2 million as of the end of the prior fiscal year. This.
This concludes my financial overview for those interested in reviewing our non-GAAP reconciliations. Please refer to our 8-K filing or the press release issued today I will now turn the call back over to David for an update on operations and achievements during the period.
Yes.
Thank you Brian .
As I stated in my opening remarks, 2021 was transformational for the company but.
But the progress continues and we are thrilled to report early success with our 2022 priorities I'll begin with the most obvious indicator of change the company's name change to societal CD amount.
First I believe it's important to state that this name change is not merely a marketing tactic rather it is an important signal of the organizations evolving outlook and fundamentally to our approach to doing business.
As we strive to build a better better business our leadership continually contemplates what can we do better.
Strengthen our business part of that positioning discussion led us to conclude that our name and visual identity did not align with our mission and vision nor does it support the corporate values that define our behavior inside and outside of the company.
After undertaking a comprehensive branding exercise the company is very pleased to embrace the name societal CMO and our tagline, bringing science to society. We believe this name reflects the company's commitment to our people to our customers the communities in which we operate and most of all the patients that we ultimately serve.
In addition to expanding our capabilities enhancing our facilities, increasing our customer base and strengthening our financial position.
Last year, we also intensified our commitment in the areas of diversity and inclusion and environmental sustainability. We believe that excellence in these areas bring support better decision, making higher employee engagement and as a result improved financial performance. We believe our new name more appropriately reflects these priorities.
Since we announced the name change in March as well as our new tagline, bringing science to society. We've received exceptionally positive feedback and we believe this identity will support our continued efforts to achieve increased growth and financial strength in the years to come.
As disclosed during our fourth quarter and year end conference call Sidled has prioritized prioritized five goals for 2022 and this name change support several of these objectives. The first of these goals is to execute segment specific sales and marketing strategies and build a stronger corporate identity.
For all the reasons I have just outlined we believe our new name brings.
It brings with it a powerful message and identity.
With respect to the company's sales strategy, we have adopted a new approach designed to best serve each of the specific market segments that we engage specifically we currently support three discrete market segments first commercial oral solid dose products such as the otsuka drug the tech transfer of which is nearly.
Complete <unk>.
Second our legacy profit sharing products, such as <unk>, which I will discuss in greater detail later in my comments and then finally, the early stage development clients, whose programs we support both in San Diego and in Gainesville, Georgia.
As the needs of each of these segments are different so too should be our sales strategy for each the distinction between these segments include important factors such as different decision, making processes key drivers and metrics of success project management approach and the approach to creating productive relationships with our clients.
While we have been quite successful in attracting new and expanded business over the past year, we believe that a standardized approach to commercial development is not the best path forward to sustainably growing our business for these reasons. The company is working to employee segment specific marketing strategies tailored to the needs of each customer group.
Before speaking to the progress we've made with respect to sales I do want to comment on a couple of headwinds impacting our industry as well as one specific challenge societal currently faces.
I'll first speak to the macro factors.
The first is the increasing challenges, we see from a supply chain perspective.
The impact of COVID-19 to our professional and personal lives has lessened in recent months. We are now beginning to encounter a residual supply chain issues that we believe may potentially impact the timing of certain project completions biles blister packs and other key components as well as the clients.
<unk> API materials being shipped to our site for continued processing are all being stressed right now.
Secondly, it is important that we remain mindful of the impact that clinical failures <unk> poor financing conditions may have on the businesses of our customers as we've seen in prior economic cycles, such as this these trends may create a general slowdown in clinical development activity.
As for the specific challenge that societal that space I would like to address the sales of our drug product verapamil.
As a reminder, societal <unk> owns the NDA and the drug Master file for <unk> mill and approved calcium channel blocker for the treatment of hypertension for.
For the past several years Teva has and continues to be a strong marketing partner for the dosage forms representing the largest portion of the overall for rapid mill franchise sales. While <unk> has served as our marketing partner for certain formulations of this drug since 2014.
As the market for <unk> is mature revenues for the entire franchise were expected to remain flat for the duration of the year.
The significant decline in sales volumes during the quarter was related to those formulations sold through <unk>.
Concurrent with our efforts to better understand the reason for the declines we've initiated steps to more fully address this matter and to evaluate opportunities to restore sales levels resolving this matter as a paramount priority for societal CMO and we will keep the financial community apprised as to our <unk> sales strategy.
Going forward.
While there is no way to know with certainty how matters will continue to all to date, we have a plan and are successfully navigating these headwinds both of those impacting the overall market and the specific one net sales of verapamil. Accordingly, we see no current need to adjust our guidance for 2022.
Speaking specifically to the first quarter sales activity the company secured new business in both the oral solid dose commercial tech transfer and development stage TD in most segments.
Several of these new contracts have been communicated publicly during the quarter and our corporate investor deck has been updated to reflect important additions to our portfolio.
Subsequent to quarter end societal has continued its momentum securing two additional new contracts. One of these agreements, which was previously disclosed as a new manufacturing and packaging task order agreement by the National Cancer Institute Division of cancer treatment and diagnosis.
The new contract as an individual task order of more than $400000 for the manufacturer and packaging of a chemical compound known as <unk> capsules to support clinical development of that compound.
We look forward to being able to share more about our new business wins to the extent we are permitted by these contracts until then I do want to share that these programs will utilize multiple services provided by societal strengthening the nature of these relationships. Given these early successes, we are optimistic that our sector specific.
Marketing strategies will continue to attract and support new business in the future.
I will now pivot to our four remaining priority efforts for 2022, which are <unk>.
Optimizing and expanding our capabilities enhancing our customers' experience working with the company enhancing our employees experienced working for the company and finally, continuing to strengthen our financial position.
I'll first address the company's ongoing progress towards optimizing and expanding our capabilities as reported following the acquisition of viruses. The company formed an integration team, which is focusing on 15 discrete work streams to ensure all synergies and opportunities are being captured and optimize these efforts focus.
Key areas, including sales and marketing quality and regulatory systems human resource and people engagement practices, environmental health and safety policies business systems and operational excellence processes. We're pleased to report that the integration process continues according to plan the majority of the word.
Creams are complete with the few remaining integration efforts moving towards completion on schedule.
The changes implemented to date have already enhanced our operations, creating a more efficient and effective organization.
With respect to expanding our technical capabilities during the first quarter societal continued validation and commissioning activities for its a aseptic fill finish and lie optimization capabilities.
We are beginning to provide these services to clients. This quarter Q2, 2022 and already have customers under contract I would like to thank our technical to use for all of their efforts in getting these important services up and running.
Another priority for the company. This year is improving the engagement experience for key stakeholders at the forefront of this effort being our customers while societal enjoys strong customer relationships. We believe it is important to anticipate the needs of our growing customer base in order to provide the highest standard.
As a service to this end we are actively implementing procedural enhancements designed to strengthen our client interactions continue to create unparalleled trust and establish valuable partnerships from process development through commercialization.
A key initiative, we are undertaking is to upgrade the project management approach across both of our sites. We have added a seasoned director of project management and she is leading the charge here, making sure. We are deploying best industry practices in this important area.
It is our belief that optimize communication and professional trust will play critical roles in our ability to continue to attract new customers and to expand our existing relationships both of which are expected to be core drivers of our future growth.
Another key stakeholder group of course is our societal teeth and for 2022, we have prioritized the creation of an industry, leading employee experience and corporate culture. In addition to changing our name and brand to be more reflective of our organizational values, we have elevated our internal talent acquisition and <unk>.
Resource teams to ensure we are attracting the best of the best join us as we grow.
And to support that talent once the board, we've curated a series of meaningful events in our developing educational activities addressing both the personal interest and professional growth of our team.
We believe that these efforts result in a more engaged workforce and lower turnover, leading to higher productivity better ideas to address challenges space all of which ultimately leads to increased profitability.
It is our belief that the successful achievement of these four goals will facilitate our fifth and final goal for the year.
<unk>, the Companys financial position.
As reported by Ryan first quarter revenues of $21 million represents a strong year over year improvement and demonstrates the momentum in our corporate development efforts complementary. This topline growth societal is carefully managing every aspect of the business in an effort to preserve cash and reduce debt.
And beyond typical cost saving measures, we are pursuing opportunities to monetize non core assets such as real estate in order to generate non dilutive funds that can be used to pay down our debt. Since initially disclosing. These efforts. We're pleased to announce that we expect to enter into a letter of intent for the sale of our <unk>.
<unk> 121 undeveloped acres surrounding our facility in Gainesville, Georgia in the coming months, we are actively taking steps to facilitate the sale and we will provide an update as appropriate. We are also exploring the potential opportunity to execute the sale leaseback of our Gainesville facility and will provide additional.
Additional detail as this process advances.
As I hope is evident societal is deliberate and it's planning and is executing according to that plan.
As we've outlined today during the first quarter the company made progress with each of our stated goals for 2022.
During the period the company's name recognition and sales were bolstered by our segment specific marketing strategy as well as our new and stronger brand identity. We continued work to bring additional capabilities online when we're launching our new aseptic fill finish and my optimization capabilities later this quarter.
During the period, we also made meaningful progress towards strengthening the engagement experience for both our customers and our employees and this effort will be ongoing as we continue to identify and implement best practices for a changing workplace.
We believe that early successes with each of these efforts have already improved the financial strength of the organization. Despite weaker than expected <unk> sales societal had a strong first quarter reporting revenue of $21 million for the period.
In closing I wish to highlight that societal executed precisely according to plan. During 2021 2022 has brought on difficult economic conditions overall, but we remain on a path to deliver in line with our guidance again this year as well we look forward to reporting continued progress with each of our 2022 goals and the.
The months ahead.
This concludes my prepared remarks for today, we can now open up the call for questions operator.
As a reminder to ask a question you'll need to press star one on your telephone.
Until I draw your question press the pound key.
Standby, while we compile the Q&A roster.
Our first question will come from the line of Matt Hewitt from Craig Hallum. Your line is open.
Good afternoon, and thank you for all the detail and for taking the questions maybe the first one.
Going through your slide deck slide nine you provided that kind of.
To install and suffer and the relationships with some of your existing partners, but there is a new one on the list and I was curious what you can tell us about the via Tris unnamed oral solid dose tech transfer that's listed on that page.
Sure.
Yeah. Thanks, Matt This is David.
There are as you know a lot of restrictions on what and how much we can communicate about a lot of our client programs.
That being said we are excited to now be carrying out tech transfer activities in order to be the manufacturer of one of their commercial products.
Matt I'm afraid that's all that we can share at this time.
But we're very pleased for the win.
Well congratulations on that front.
Maybe shifting gears a little bit obviously, there are some headwinds I'm just curious as you look at.
Gross margins, let's start there over the remainder of the year, how should we be thinking about those kind of trending as you bring in some of these new capabilities and bring on some of these new contracts.
Matt This is Ryan so.
I'd say that the gross margins in the <unk>.
Cadence for that second quarter will certainly depend on the various <unk>.
Production and timing of shipments we would currently expect those to be in the 20% range and the full year, we're still expecting gross margins in the mid 20% range.
Okay, Great and then maybe one last one then I'll hop back into the queue.
And you've touched on this a little bit I'm. Just curious if you can elaborate but obviously theres been a lot of questions about biotech funding as you look at your customer list, obviously government contracts I would think are much more stable and reliable.
But as you look at the rest of your portfolio and your relationships with customers is there a way to quantify.
What percentage of your customers would be considered maybe medium to large sized pharma versus.
Smaller pharma and biotech.
I think that's the end of the spectrum that investors seem to be a little bit more nervous about it.
If there's any color that you can provide on that scale that that'd be helpful. Thank you.
Yes, David again here, Matt so.
This.
Your question really speaks to why we chose this three pronged strategy.
Terms of the our sales market. So the early stage CDMA space is still active and still growing is still robust.
In terms of quantifying I would say to you that we're engaging with customers and having discussions.
Up and down the spectrum of size.
However, you are reading the same things that we are and we are keeping a close eye on the fact that.
So much capital was raised in 17, 18, 1920 capital got put to work.
And you see a lot of clinical trials now.
Not progressing to the next stage and and so now people are sort of circling the wagons and figuring out which of their portfolio Dave wants to advance.
I think the big observation I would make that is that.
The primary observation I would make is that rather than.
This is a small biotech talking rather than Oh, let's go raise more capital for our other programs it feels like.
We're going to have a cycle, where the number of programs in development for our company is going to shrink and be more focused as they preserve cash and kind of hang on to dry powder. So to speak. So we haven't seen anything materially different yet, but I did want to make sure that we mentioned that this is.
A different year than the past couple in terms of activity.
That's helpful. Thank you very much.
Thank you Matt.
Last question will come from the line of Christy.
From William Blair. Your line is open.
Hi, Thanks for taking the question David.
My first question is on the.
Yes.
Or at least that you had about the new commercial contract with any facto pharma.
And is it incrementally additive to their business or is it just maintaining the listing business given novartis.
Estimate of its European right, So ritalin la.
Also.
The contract with Novartis for rest of the world.
Back to Ed to expire in 2023 are you anticipating a regulator here.
Yes.
Thanks, Christine So first with respect to pharma agreement the exclusivity periods is consistent with the Novartis agreement, but this agreement actually extended out to 2025.
And then effectively is taking.
The no.
Vargas Riddle and franchise.
Splitting it.
In particular, the ritalin long acting <unk>.
Capsules being sold by in fact that farm I think that this is a very important product strategically for in fact a farm.
Expands their geographic reach and the EU and particularly in the Nordic countries.
Sweden, Norway, Denmark and in fact, the firms kind of aim is really to increase their pediatric reach and presence.
It's one of their most important target groups and their focus I think about 80% of their business focused on autism ADHD and other spectrum diseases. So we're really excited to be <unk>.
<unk> with Novartis.
We do not.
At this time any reason why that.
Current agreement with Novartis would not be extended.
Yes.
Okay. Thanks, that's really helpful and then.
And the National Cancer Institute contract I know that Viper has several government contracts, including.
With the NIH can you quantify the number and scale contribution of current government.
Contracts and what your growth trajectory for this part of your businesses.
I would say Christine in general if you look back this is part as.
David mentioned, our segmented sales strategy as it relates to.
New business development sales to smaller mid size, our emerging biotech companies I think that the ultimate.
Market for these products is ending up with smaller and mid sized pharma pharma companies out of Neste and NIH.
So it is a component of what we're anticipating this year, which is roughly 25% 30% of our overall revenue.
Ponant of that but we don't specifically breakout what what component, though those government grants are of that amount.
Okay. That's helpful and then my last one.
Is.
I don't know if youre at Liberty to say, what you said you had two additional contract.
Corner and that quarter, sorry, one was with the cancer Institute.
Which one or the other at least can you share what therapeutic area.
Net clinical side cracks.
Christine that is.
We can't announce the name of that yet what it is.
Across opportunity, though for our sites.
Meaning that there is work being done and it represents one of our first projects that we've won where we're seeing the synergistic value.
And being able to utilize both our skills and talent and San Diego as well as Gainesville, Georgia.
Yes, Christine let me. This is David let me just say that we've now officially seen opportunities that are under contract, where we've had an existing customer.
Expanding from Gainesville, expanding scope.
For services that we can now perform in San Diego.
We have seen now an opportunity that had originated in San Diego that we have redeployed and positioned.
In Gainesville, which was asked about earlier.
<unk>.
And now we have a contract where part of the work will be done in San Diego, and then product shipped to Gainesville for completion and so.
Very happy with the way our teams have been able to work together on making that experience seamless to our clients.
Great. Thank you both for the color.
Thank you.
Thank you. Our next question will come from the line of Jacob Johnson from Stephens. Your line is open.
Hey, good afternoon.
This is Mac on Jacob I, just had a few quick questions first start.
On the headwind from declining commercial sales of <unk> mill.
Is this something that you all have any control over.
And.
If this isn't resolved soon would this represent.
Potential risk to your guidance.
Thanks for the question Matt.
So we are first and foremost we're maintaining our full year guidance of 90% to $95 million and EBITDA as adjusted of $16 million to $18 million. We currently expect about 45% of our revenue to come in the first half of this year and then about 55% in the second half of the year and.
This outlook does include updates.
Two our anticipated revenues based on an updated forecast from all of that and their revised expectations, which created headwinds of approximately $3 million for us in revenue for 2022. This decrease is expected to be less than that offset by.
Anticipated increases from improvements that we have from other commercial customers I think it's also important just.
The back up in regards to <unk> XR capsules that are sold by Teva.
We continue to see.
Increased market share, they're continuing to remain steady in the market with over 60% market share.
Saar capsule market and we view that as very positive.
As it relates to the rapid mill PM sales with that.
During Q1, the third party data.
We subscribe to shows about a 16% decline in units.
Third to Q1 2021.
Net sales in the channel were down by an even greater amount than that which is why there was such a negative impact to our EBITDA as compared to the prior year period of about one 5 million.
We have had a series of meetings with Lynnette to better understand the underlying conditions that resulted in these disappointing sales so their distribution network and so far we don't have a root cause for the decrease keeping in mind. We only received these results a few days ago.
But we are actively.
And.
Our mode of better understanding.
Not only the situation, but our alternatives.
To restore the sales.
At a minimum.
Prior levels, but we don't see this as a rapid mill problem in general we are not seeing this impact and the larger BRAF mill market and it appears to be confined to distribution channels. So.
I just want to assure you we are diligently looking at this and devoting the appropriate attention to this matter.
Great that's some pretty helpful color.
Also can you all talk about the backlog trends in the quarter and how much visibility do you have into the FY 'twenty revenue guidance here.
No.
I'd say its consistent with what we reported just a couple of months ago with the year end guidance. So we have a deck.
Slide in our investor deck that lays out the backlog that we had at year end, which is with very strong backlog number.
A portion of that that we expect to earn this year and our funnel continues to be the biggest that that it's ever been.
So so.
Even with.
The cautionary.
Headwinds in the general economic environment, I think we're happy at the general trend in direction of the funnel.
Great. Thanks for taking the questions.
Thanks.
Thank you.
I'm not showing any further question.
Q I would like to turn the call back over to David for any closing remarks.
Many thanks to all of our clients, our supply chain and other service providers and partners and particularly to our excellent societal team. We look forward to many great achievements in the months ahead. Thank you again for participating today and for your continued support of societal CDM up.
And this concludes today's conference call. Thank you for participating.
Now disconnect everyone have a great day.
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