Q4 2023 NRx Pharmaceuticals Inc Earnings Call
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Good morning, everyone and welcome to the <unk> Pharmaceuticals fourth quarter and full year 2023 results conference call.
Currently all participants are in a listen only mode.
As a reminder, this conference call is being recorded.
I will now turn the call over to Matthew Duffy, the Companys Chief Business Officer. Please go ahead.
Thank you Pamela and welcome everyone.
Before we proceed with the call I would like to remind everyone that certain statements made during this call are forward looking statements under U S Federal Securities laws.
These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.
Information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.
Forward looking statements made during this call speak only as of the date hereof and the company undertakes no obligation to update or revise the forward looking statements.
Information presented on this call is contained in the pre announced the press release issued Thursday company's Form 10-K filed Friday.
And the press release issued this morning.
All of which may be accessed from the investor page of the <unk>.
Our X pharmaceuticals website.
Joining me today are Jonathan Javits, our chairman and Chief scientist, Stephen Willard Chief Executive Officer, and Richard Arena, Chief Financial Officer and Treasurer.
Jonathan that Stephen will provide a summary of the company's progress Rich will review the company's financial results and then Jonathan will review upcoming milestones before making closing comments.
Following their prepared remarks, we will address investor questions.
I'll now turn the call over to Jonathan Johnson.
Yeah.
Thank you Matt Good morning, everyone and thank you for joining us on the 23 has been a pivotal year for an Rx and for the field of interventions dietary and its approach to suicidal depression and PTSD.
Last week, we were invited to give a keynote presentation at the 2024 International Ketamine Conference held at Oxford University.
Now 37 years since Daniel Jabber and his colleagues at the Albert Einstein School of Medicine, maybe unprecedented discovery at the NMDA receptor of the brain is key to understanding schizophrenia and depression.
It's 25 years since Rob Berman and his colleagues at Yale University may be equally surprised me discovery.
NMDA antagonist in this case ketamine can achieve rapid reversal of depression and later discovered the same for suicide Dallas.
Now on the tail of the Covid pandemic that practically put the science on hold for two years. It's clear the thought leaders in psychiatry has concluded the ketamine is a standard of care treatment for depression suicidal witty and is at least as effective if not more effective than electroconvulsive therapy.
Ketamine infusion has moved from the hospital and the emergency Ward the community clinics and some believe it should move to the hole we had in our X are on the cusp of that conversation.
With ketamine of course is that while it's dramatically effective in the short term well designed studies reported in the past two years have demonstrated that it's neurotoxic in other words it kills brain cells when given for months at a time, even at the low doses used to treat depression.
Data from Stanford and elsewhere document conclusively that ketamine not only blocks the NMDA receptor, but also binds to the opioid receptors that have been so central to the opioid crisis in the United States. That's why even if we launched hope therapeutics to seek to make short term ketamine avail.
The ball to all insured patients as a law.
<unk> therapy, not just to those who can pay out of pocket, we focus on and our X one on one and perhaps future non addictive non neurotoxic medicines, but also target the NMDA receptor without those side effects.
We already have scientific evidence that <unk> hundred one works to preserve the academy in effect as the follow on drug from Ketamine. It has the potential to help hundreds of thousands of patients in the next few weeks now that we're completing database lock on our clinical trial, we will have a first glimpse of weather and all.
101 is also sufficiently potent to treat severe depression and suicide LT without prior use of ketamine and to do so in the outpatient setting.
In our 10-K, we made a brief comment about a new opportunity that's still evolving to partner with the French funded some fundamental on the new drug with an entirely different mechanism of action that may represent the first drug in human history.
<unk> the brain injury that causes schizophrenia, not merely to treat schizophrenia is devastating symptoms.
Thus, we deeply appreciate the trust that you our shareholders have important as we emerge from the Covid pandemic and returned to our core mission in CNS disease.
At the end of 2022, the company's board and management at a single clinical trial initiated in bipolar depression.
Had no commercial stage partners and $11 million in debt.
2023, and the year to date, we've secured a global commercial partnership for the first indication of our lead drug interacts one on one.
We received a $5 million of advance on potentially 330 million in milestones for that indication. We've expanded our patent portfolio, which will include the use of <unk> 101 in chronic pain. We've opened an S. T E I N D and a weight efficacy data for chronic pain.
We've obtained efficacy data for the use of ketamine and suicidal depression from both national clinical trials and positioned ourselves to seek FDA approval for ketamine.
In 2024, and finally, we've obtained unexpected data that demonstrates the efficacy of <unk> 101 in treating complicated UTI and pyelonephritis with a company recognition from the S. T E. In the form of qualified infectious disease product and fast track.
Nation wide.
We've done that with a dedicated team of fewer than a dozen scientists and business leaders together with your financial support.
While achieving these scientific advances we've created a new subsidiary Hope Therapeutics, which is completed manufacturing of the first batch of released symbol ketamine.
That will be distributed under national pharmacy licenses, even as we seek FDA new drug approval.
Our 2023 developed in partnership with Allergan, and Lotus Pharmaceuticals to develop our lead candidate <unk> hundred one and suicidal bipolar depression is key to a global launch of <unk> 101 to treat bipolar depression worldwide.
In March we recorded last patient last visit in that clinical trial of an Rx one one versus low ratchet up.
In 2023, we published a peer reviewed randomized trial led by Professor Andrew Nierenberg from Harvard Mass General demonstrating that <unk> hundred one significantly reduces both depression and suicide reality after ketamine compared to that standard of care drugs.
The purpose of this trial is to see if we can demonstrate effectiveness of <unk> 101 without prior use of ketamine, we expect to lock the database from the trial this week.
And we expect to be reporting topline results from the trial. This month positive results from this trial and comments from the FDA will trigger an additional $4 million milestone from albertson and begin transfer of all expenses related to <unk> hundred one for bipolar depression through our partner.
Yes.
In addition, we are eligible for an additional $320 million in milestones plus a royalty that reaches 15% on net sales.
<unk> hundred one demonstrates success either as a standalone drug.
As the drug to preserve the known efficacy of ketamine or both.
101 has the potential to be used in the therapy of millions of Americans and many more around the world who suffer from bipolar depression.
And he was the only approved therapy today is electroshock therapy.
The partnership agreement leaves an Rx the potential to continue to own and to develop <unk> hundred one.
For the much larger indications of PTSD and chronic pain.
With the database lock, we expect to report topline data later this month, our patents on <unk> 101 cover both composition of matter and its method of use to treat many forms of depression PTSD and chronic pain in 2023, we partnered with professor <unk> carrion and his research.
Team at northwestern University around the use of entering its one on one in treating chronic pain.
Their 2016 clinical trial demonstrated efficacy on a post hoc analysis and this week they were achieving data lock on a 200 person department of defense funded trial.
That seeks to replicate the efficacy findings in today's world. There is essentially nothing to treat chronic pain that bridges, the relatively mild effects of tylenol and motrin like drugs on the one hand, and the potent but addictive and dangerous class of opioids on the other.
The magnitude of the effect in chronic low back pain seen in the 2016 trial with such that a replication of that finding could provide a pain drug that has an effectiveness that's close to opioids, but its safety profile, thus far closer to the non opioid pain drugs.
We aspire to unlock a path to breakthrough nontoxic addictive pain drugs.
Could improve the lives of some 50 million American adults, who suffer from chronic pain and nearly half a billion around the world.
This partnership in 2023 on chronic pain for <unk> hundred one.
It has not diminished our interest in pursuing an indication for <unk> hundred one and post traumatic stress disorder.
And the Oxford Conference last week made clear that NMDA antagonist have enormous potential to treat PTSD.
We hope to initiate our work in PTSD later in 2024.
As we announced we incorporated hooked therapeutics as a specialty pharmaceutical company to advance and commercialize intravenous ketamine for suicidal depression.
Initially we expected the ketamine would be developed by others for the treatment of bipolar depression.
Wherever the scientific record thus far suggests that intravenous racemic ketamine I E. The form that we're manufacturing and expect to deliver.
It's effective and rapidly reducing suicide and depression, while nasal and other forms of administration may be less effective in 2023, we've partnered with leading researchers to be able to submit definitive efficacy findings of government supported placebo controlled trials.
The F D a.
To support a new drug approval for ketamine when.
When we embarked on this mission, we always expected ketamine to outperformed placebo.
Based on 20 years of academic research findings. The surprise of 2023 was the release of the 400 person Harvard led patient centered outcomes research initiative or core initiatives that demonstrated a larger anti depressant effect for ketamine.
For electric shock therapy, with none of the undesirable side effects of D. C T such as short term memory loss.
The <unk> group is now embarking on a larger trial in patients with suicidal depression, and we look forward to partnering with them in that process.
Hope is a specialty pharma company not a drug development company, we've already been offered term sheets property more than $60 billion of funding for hope because of the recognition that the paradigm for treating suicidal depression is changing as we speak and understanding the old model of hospitalist.
Asian, and electric shock is rapidly becoming a second line therapy yet.
Yet the evidence is clear that the ketamine effect as measured in days to weeks and that long term repeated use of ketamine may lead to addiction and neurotoxicity.
Therefore, we believe that <unk> hundred one may well have a long term role in transforming the lives of those who suffer from suicidal depression.
Hope will incorporate other therapies, including potentially digital therapeutics as it seeks to build a network of lifesaving care around patients, who today have a higher mortality risk than those who suffer from breast cancer prostate cancer and other common malignancies.
Rate limiting step and filing our new drug application for ketamine is having a new drug in your hands with which to apply it.
It's easy to say well, let's just apply to the FDA for a label, but you actually have to have a drug with which to do it.
The formulation and presentation of ketamine as an anesthetic dates to the Korean war, it's an old drugs that is increasingly plagued by critical drug shortages as reflected on the F. D. A database.
We partnered with Nephron Pharmaceuticals of South Carolina to develop a new formulation and diversion and resistant presentation FCA regulations require at least nine months of stability in the presentation you intend to market before you can file for new drug approval and we will reset time point this.
This quarter at.
At the same time, given the critical drug shortage of ketamine, that's been announced by F. D. A.
With nephron to delivered ketamine immediately the high quality clinics, who will one day form the backbone of hopes delivery system.
Last week, the first batch of ketamine was approved for shipment in a pharmacy presentation and on the loading dock.
To augment and extend the efficacy of IV Caribbean, we're beginning to work on a companion digital therapeutics I previously participated in developing such a digital therapeutics for the U S. Navy.
The results to reduce stress and warfighters.
It's an effective product that is still in use we will build on that and learning and technological advances to help suicidal patients get back on track. Additionally, as the proprietary product this will enhance our market exclusivity.
We're sure that some of you are curious about why we invested a small amount of capital really less than $100000 in establishing an indication for complicated UTI and pyelonephritis for inner X 101.
First of all just conditional said, 20% of Americans, who develop urinary tract infections and that percentage is climbing as antibiotics that have served us well for 50 years increasingly sale of.
Of the 15 million Americans, who develop U T. I every year 3 million to progress the complicated UTI and at least 15000 diet urinary sepsis DC.
Cyclists heres an interesting drug it works by a completely different mechanism than other antibiotics and it's the only antibiotic that's highly concentrated in the Europe. There's no evidence that it can cause the debilitating diarrhea and other side effects of the new fourth line antibiotics.
Importantly, it can be given by mouth, whereas many of those require intravenous administration.
Dcs fell out of favor as an antibiotic in the 19 sixties in part because of its propensity to cause mild CNS side effects. However, we seem to neutralize those side effects with the addition of Blue rasp alone to interact one on one.
The mechanism of action is simple in a.
Brain cell D. C. S mimics the immunoassay glycine and inhibits the NMDA receptor and a bacterium. However, dcs mimics the amino acid alanine gets incorporated into the cell wall and causes the bacteria to explode animal cells don't have cell walls. So this effect is seen.
Only in bacteria.
The peer review data for <unk> hundred one in the treatment of bugs that caused complicated UTI.
As published in the peer reviewed literature last week and we invite you to read the results.
At any rate now that we know that <unk> hundred one is a potent <unk> agent against resistant bacteria that harm millions of Americans, we expect to identify a product already engaged and anti biotic marketing for this opportunity.
It is important to understand what that F. D. AQR D. P designation means it means that even without a patent for use of D. C S isn't antibiotics, where.
We're entitled to five years of market exclusivity fast track designation and priority review.
That's why we think this drug has a real application as we identify a partner in the anti infective space.
He's not going to address some of our corporate achievements during 2023 and the quarter that follows.
Thanks, very much Jonathan.
As you know I joined <unk> as CEO in July 2022.
My job was to reduce the daunting cash burn and help align the management team into a dedicated group that has the potential to take our drugs to market.
Although we have not yet generated our first dollar of revenue we have demonstrated progress that motivated a discerning corporate partner to advance its milestone payments for our first clinical indication.
Not only that we survive 2023, we expect to see the revenue flow from commercial operations again by the end of 'twenty 'twenty four that's clearly a forward looking statement, but one that we believe it's within our capacity to achieve.
Everyone on this call knows that 'twenty two 'twenty three was possibly the worst year in the history of the biotechnology industry and many pre market biotechnology companies did not survive.
We emerged from 2023 on a more solid front than we entered and are poised for ongoing success, particularly if the clinical data that we read out later this month is positive.
Even if two highly promising trials don't give us the short term answers we seek we project that the Ketamine Foundation, we have built will yield positive cash flow by the end of 'twenty 'twenty four I believe that is reinforced by the response, we have received from large institutional investors.
On the corporate front, we raised approximately $17 million in new capital. In addition to working capital since the beginning of 2023.
Recently, we have reduced corporate debt by more than 50% from 11 million down to approximately $5 4 million through the first quarter of 2024.
Finally, we have taken steps to maintain our NASDAQ listing by first achieving compliance with the market value of listed securities requirement.
And then affecting a reverse split to comply with the $1 minimum bid price by their design and combating illegal shorting <unk> securities all to support shareholder value.
It's important that we keep our share price in the zone that it's in basketball by high quality institutions.
I'm incredibly proud of our team grateful to our partners and investors as well as all of the patients who participated in our clinical trials, we look forward to advancing the company and further continue this growth.
In December we were delighted to add nationally recognized attorney Janet Rehnquist to our company's board of directors Janet brings vast experience and insight to our company in critical areas and we welcome her.
I expect you will see us add other members to our board who have direct experience in the commercialization of pharmaceuticals, as we move from pure research and development to commercial operations.
Jonathan has explained some of the value drivers that underlying our purpose unhooked therapeutics.
To build value for <unk> shareholders, we intend to distribute shares of hope therapeutics to existing shareholders in the near term.
And then to gain a public listing for the company on a national exchange.
We have received considerable interest from investors both for bridge around to get a listing and a more substantial raise to support the launch of the product.
We are actively building out our team partners and network with the goal of launching the product at the beginning of 2025.
Delaware corporate law requires us to deliver on a dividend within 60 days of declaring it.
Thus, we are waiting until we have the audits and SEC filings in place to launch hope prior to officially declaring the dividend.
Some may ask given that ketamine is a generic drug why the F. D. A brute why seek FDA approval for use in depression.
Simply put without FDA approval, the only people who have access to this life saving treatment are those who can pay cash.
FDA approval is key to insurance reimbursement.
Our discussions with clinics to date have indicated the lack of reimbursement is the key impediment to patients getting the treatment they need.
We aim to solve this problem.
In advance of this there is still considerable need for high quality reliable sources of ketamine to that end, we have formed collaborations with a 503, a 503 b pharmacy to provide ketamine clinics it neat.
First lots have recently become available and sales can commence shortly.
Additionally, these near term activities will serve as an excellent entre into those clinics once our NDA is approved and we have full licensed and reimbursable product to offer.
As you can see we have been careful stewards of your funds, we have trimmed our operating expenses reduced our corporate indebtedness rather than non dilutive partnership support realigned our executive team and expanded our pipeline to a robust clinical development program with a multibillion dollar potential.
We'll work hard every day to bring news to reality and to bring hope to life.
I'll now ask Richard to redo, our CFO to review the fourth quarter financials rich.
Thank you, Steve and good morning, everyone I will now review the highlights of our fourth quarter and full year 2023 financial results.
Before reviewing the numbers, it's important to recognize that we have consistently reduced our cash expenditures and expect to further reduce those expenditures.
We have completed the <unk> 101 clinical trial.
By getting data like imminently and I expecting data readout early in second quarter of 2024.
For the three months ended December 31st 2023, we had four months of nickels reduced our net loss from $10 2 million in the final quarter of 2022.
The $4 3 million in 2023.
Representing nearly a 60% improvement year over year.
Over that same period, we reduced research and development expenses for $4 5 million in 2022 to $2 5 million in 2023, while substantially improving and finalizing our clinical trial enrollment.
The $2 million decreases related primarily to a decrease of $1 1 million clinical trial expenses.
0.6 million stock based compensation, and <unk> 2 million in consulting and personnel wage costs.
Also in that three month period, we recorded a 67% reduction in general and administrative expenses.
From $5 4 million in 2022 to $1 8 million in 2023.
Decrease of $3 6 million was related primarily to a decrease of $1 3 million in insurance expense.
$1 3 million in stock based compensation.
Europe was $5 million employee expenses 0.2 million in legal and professional and consulting fees and.
0.2 million and franchise tax expenses.
For the year ended December 31st 2023, and Rx Pharmaceuticals, we reduced that loss to $30 2 million compared to $39 8 million.
Prior year.
These efficiencies represent an improvement in net loss of nearly $10 million year over year and.
And a 20 cent.
Or 34% improvement in our net loss per share year over year.
Over the annual period, we recorded $32 4 million of research and development expenses compared to 17 million for the same period in 2022.
Representing a 21% decrease year over year.
The decrease of $3 6 million was related primarily to a decrease of $2 1 billion a quake.
Trial and development expenses.
<unk> 9 million related to fees paid for regulatory and processes involved when appropriate.
While offset by 0.2 million increase in tonnes cost as our patent portfolio has expanded.
Please note that the improvement in G&A expenses is even larger than the improvement in the other areas.
We decreased G&A by $13 1 million from $27 3 million 2022.
The $14 2 million in 2023.
Nearly 50% decrease year over year.
As of December 31st Lien 23, we had $4 6 million in cash and cash equivalents.
Over the first three months of 'twenty 'twenty four we improved our access to working capital like 8 million in total.
Representing $2 9 million from equity sales and $5 1 million from the Allergan muscle advanced while reducing our corporate indebtedness by 50%.
We continue to implement operational efficiencies to extend runway and focus on our path to generating revenue.
We believe that the near term delivery of clinical trial data.
And the planned launch of hope therapeutics will be defining events in the second quarter of 2024.
With that I will turn it back to Jonathan for closing remarks, Jonathan.
I think it's time to take questions.
Thank you we will now be conducting a question and answer session.
If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate that your line is in the question Kim and.
And you May press star two if he would like to remove your question from the queue.
For participants using speaker equipment may be necessary to pick up your handset before pressing the star keys.
One moment, please pull for questions.
Thank you. Our first question comes from the line of Tim Moore with E. F. Hutton. Please proceed with your question.
Thanks, and good morning, everyone.
You know if you made a lot of great progress over the past few quarters like you said it wasn't easy and biotech land last year and you came out even stronger.
And I was just wondering maybe Jonathan and Matt If you can elaborate more on the.
The hope and digital Therapeutics, you know maybe give investors a little more color on the anatomical coherence you know the software possibility there.
Just pathways and just what you're thinking you know it was a development route over the next year or two.
Thank you, Tim and it's really exciting to see you in and people of your caliber joining our calls.
So.
This area of digital Therapeutics really began in the military it began with a recognition that if.
You can teach someone to synchronize breathing and heart rate, which you know three years, it's been achieved through meditation, but that's extraordinarily difficult for most people to master.
Are you actually reduce physiologic evidence of stress you can show reduction in serum cortisol levels and other.
Hard laboratory findings.
So what was done back in the early two thousands with funding from DARPA. The defense Advanced research projects agency.
Was to build something that looks like a video game, but you're actually when the video game by synchronizing breathing and heart rate and the the target audience at the time with special forces operators I was involved in a demonstration project, where a group of Navy special forces operators.
One through the combat simulator and Quantico, both with and without using this technology.
And demonstrated not only improve comeback performance, but substantially reduced measures of stress and depression on the backend.
So much so that.
That the the private remains for sale within the military.
Well the challenge we have is you know as the paradigm shifts and people recognize that ketamine achieves a rapid reduction in both suicide and depression and the question is how do you maintain that effect.
If you keep giving ketamine for months at a time at least a clearer evidence from primates is that youre going to kill brain cells.
So one of the things we're pursuing is civilian I seen that population that was developed with millions of dollars of department of defense R&D.
Into something that can be useful for patients who are coming to ketamine clinics of course, we hope that they'll take an Rx one on one on a long term basis once we have demonstrated.
<unk> got an FDA approval for it.
But we also think that these kinds of digital technologies have real potential.
Not only that if they become part of the label the drug they extend the intellectual property horizon backdrop.
So I hope that begins to give you a sense and we're going to hope to do a teach in on that sometime over the next quarter.
Well, that's very helpful and we all look forward to that teach them, where they can make better sense of the.
Optionality there and it just seems like it's such a good untapped market nobody else is playing in.
Pretty good for first mover advantage.
My other questions around you know your database lock occurring it sounds like this week topline data probably by the end of this month can you just walk us through the next two steps you plan to take and maybe just provide more details on that if you were to just give us a sense of kind of the roadmap over the next 12 months now Thats got topline data will become.
Yeah.
Well, David the database lock means that.
We we have once and for all confirmed every endpoint.
From the <unk>.
Patient forums in the study site through the database and at that point, we had the the data file the statisticians.
And they perform this technical analysis. According to the V. S E T. The statistical analysis plan and we've put that up on clinical trials like dogs, so anybody who wants to read it.
Should be able to.
If the data are positive.
The plan is to conduct the meeting together with Alpha Chin with the F D. A.
And to gain FDA for alignment on a registration study.
That would bring in are excellent and one to market for patients with <unk>.
Severe depression and suicidal ideation.
Yeah.
Remember, we previously showed that the drug works after ketamine, that's why FDA gave us breakthrough therapy. So the purpose of this trial is to see whether the drugs can work without prior use of ketamine.
Either way dip.
Depending on the results of this trial were going to be going to S. P. A and saying we want to bring the drug to market either with or without requiring prior use of ketamine.
And aligning on the final design of that study.
Now one of the things, we're likely to be able to do is to do the trial against placebo.
If we're not working with acutely suicidal patients, which is a much easier trial.
In a trial that has a much higher probability of success remember in this trial, we're comparing interacts one on one to a known effective drug, namely Lurasidone. If we're comparing <unk> one on one to placebo.
That that tough comparisons already succeeded in numerous academic studies.
Great. Thanks for those added details and color and I really appreciate your methodical strategic plan that you share and that's it for my questions. This morning.
Yeah.
Our next question comes from the line of Edward with Ascendant Capital markets. Please proceed with your question.
Yeah. Congratulations on the progress you've done have you talked about your pricing of reimbursement strategy for ketamine.
Well.
And as you know there is an approved form of ketamine that's for sale in the marketplace today and suffered by J&J.
And you know J&J reported sales in AR.
I think you know above $600 million associated with with that drug.
There's an established market. The problem is that drug is not only not indicated for bipolar depression.
And you know that about 40% of people, who commit suicide have bipolar depression.
A rems around that drug that precludes its use in people with bipolar depression.
So we think there's a real pricing opportunity.
<unk>.
You're in a better position than we are to advise the public as to the current pricing.
Of that currently marketed drug.
But as we have third party indications of pricing will certainly report them.
Suffice it to say.
Then if you can get insurance coverage for people.
Payers have indicated a real willingness.
To pay for this therapy, because the alternative of psychiatric hospitalization and electroshock therapy.
It is something that you know first of all it's horrible for patients and second of all costs payers, the better part of $40000 in the first year.
So we believe there's a market opportunity, but we're certainly going to be guided by the security analysts as well.
Great for the detail and thank you for answering my questions I wish you guys. Good luck. Thank you. Thank.
Thank you Ed.
Yeah.
Thank you there are no further questions at this time I would like to turn the floor back to Matt Duffy for any closing remarks.
Thank you everyone. That's all the time, we have for today. We appreciate you joining us this morning, and this concludes the <unk> pharmaceuticals fourth quarter 'twenty, three and full year conference call. Thank you all for participating.
This concludes today's teleconference. You may disconnect your lines at this time, thank you for your partner.
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