Q4 2021 Harmony Biosciences Holdings Inc Earnings Call

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David Hoang: David Amsellem, David Hoang, David Hoang, David Hoang, Good day and thank you for standing by. Welcome to Harmony Bioscience fourth quarter 2021 Financial Update Conference call. At this time, all participants are in a listen only mode.

David Hoang: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star one on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then zero.

Good day and thank you for standing by welcome to Harmony Biosciences first quarter 2021 financial update conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need a press star one on your telephone please be advised that todays call.

May be recorded.

Are there any further assistance. Please press Star then zero I would now like to hand, the conference over to your host today Patti Bank Investor Relations. Please go ahead.

David Hoang: I would now like to hand the conference over to your host today, Patty Bank, Investor Relations. Please go ahead. Thank you, Operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' fourth quarter and full year 2021 financial performance and provide a business update. Before we start, I encourage everyone to go to the Investors section of the Harmony Biosciences website to find the press release and slides that accompany our discussion today, including a reconciliation of our GAAP to non-GAAP financial measures.

Thank you operator, good morning, everyone and thank you for joining US today as we review harmony Biosciences fourth quarter and full year 2021 financial performance and provide a business update before we start.

I encourage everyone to go to the investors section of the harmony Biosciences website to find our press release and slides that accompany our discussion today, including a reconciliation of our GAAP to non-GAAP financial measures at this stage of our lifecycle. We believe non-GAAP financial results are a useful measure and under.

David Hoang: At this stage of our life cycle, we believe non-GAAP financial results are a useful measure in understanding the underlying economics of our business. Our presenters on today's call are John Jacobs, President and CEO, Dr. Jeffrey Dayno, Chief Medical Officer, Jeffrey Dierks, Chief Commercial Officer, and Sandip Kapadia, CFO. Moving on to slide two. As a reminder, we will be making forward-looking statements today, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.

Standing the underlying economics of our business our presenters on today's call are John Jacobs, President and CEO , Dr. Jeffrey <unk>, Chief Medical Officer, Jeffrey <unk>, Chief Commercial officer, and Sandeep <unk> CFO .

Moving on to slide two as a reminder, we will be making forward looking statements today, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially.

Encourage you to consult the risk factors referenced in our SEC filings for additional details I would now like to turn the call over to Harmony Biosciences, CEO John Jacobs John .

John Jacobs: I encourage you to consult the risk factors referenced in our SEC filings for additional details. I would now like to turn the call over to Harmony Biosciences CEO, John Jacobs. John?

John Jacobs: Thank you, Patty, and thank you, everyone, for joining our conference call today. I'm proud to say that 2021 was a very successful year for Harmony as we continue to execute on our three-pillar growth strategy and help patients who are living with rare neurological disease. As we enter this year, we are confident that we can build upon our momentum from 2021 and make 2022 our best year yet.

Thank you Patti and thank you everyone for joining our conference call today.

I am proud to say that 2021 was a very successful year for harmony as we continued to execute on our three pillar growth strategy and help patients who are living with rare neurological diseases.

As we entered this year, we are confident that we can build upon our momentum from 2021 and make 2022, our best year yet.

John Jacobs: This year we expect to deliver continued growth with Wacox and to make significant progress on our vision to evolve Harmony into a leading rare orphan neurology company with a robust multi-product portfolio and significant long-term growth potential. Now I'd like to take a few minutes to highlight our progress on each of the three pillars of our growth strategy in the context of Q4 2021 performance. Let's start with Pillar 1, which is to optimize the commercial performance of weight kicks.

This year, we expect to deliver continued growth with <unk> and to make significant progress on our vision to evolve harmony into a leading rare orphan neurology company with a robust multi product portfolio and significant long term growth potential.

Now I'd like to take a few minutes to highlight our progress on each of the three pillars of our growth strategy in the context of Q4 2021 performance.

Let's start with pillar one.

Which is to optimize the commercial performance of <unk>.

John Jacobs: In Q4'21, we delivered another solid quarter of sequential growth for Wayfix, with revenues of $91.2 million, which represents a 13% quarter-on-quarter increase. The average number of patients on WAKIX is now approximately 3,800, and we expect continued growth and performance with WAKIX this year due to strong underlying demand, positive feedback from both the healthcare provider and patient communities, and the large and growing opportunity in narcolepsy, which is currently a $2 billion plus market segment.

In Q4, 'twenty, one we delivered another solid quarter of sequential growth for <unk> with revenues of $91 $2 million.

Which represents a 13% quarter on quarter increase.

The average number of patients on <unk> is now approximately 3800, and we expect continued growth and performance with <unk>. This year due to strong underlying demand positive feedback from both the health care provider and patient communities and the large and growing opportunity in narcolepsy, which is currently at $2 billion plus market says.

<unk>.

John Jacobs: Let's move on to pillar two, which is to expand the clinical utility of Wakeyx beyond narcolepsy. During Q4 21, we had our IND accepted for idiopathic hypersomnia, for which we intend to start a phase 3 registrational trial during the first half of this year. With IH now added as part of our strategy to expand the utility of WACACS into new patient populations, we are proud to say that this year we should now have three clinical programs underway with patellism, including Prader-Willi syndrome, myotonic dystrophy, and idiopathic hypersomnia.

Let's move on to pillar, two which is to expand the clinical utility of wake X beyond narcolepsy.

During Q4 'twenty, one we had our IMD accepted for idiopathic hypersomnia for which we intend to start a phase III Registrational trial during the first half of this year.

With IHS now added as part of our strategy to expand the utility of <unk> into new patient populations. We are proud to say that this year. We should now have three clinical programs underway with photographer, including product Willi syndrome, monotonic dystrophy and idiopathic hypersomnia.

John Jacobs: And that brings us to Pillar 3, acquiring new assets through business development to expand our portfolio beyond WACEC. Over time, our intention is to develop a broad portfolio of rare or from neurology assets and door assets and other neurological diseases where we can leverage our existing expertise and, And we are seeking assets across a range of development stages, including both early and later stage, with the potential to launch both during and after the WACCIC lifecycle.

And that brings us to pillar III acquiring new assets through business development to expand our portfolio beyond <unk>.

Over time, our intention is to develop a broad portfolio of rare orphan neurology assets <unk> assets and other neurological diseases, where we can leverage our existing expertise and infrastructure.

And we are seeking assets across a range of development stages, including both early and later stage with the potential to launch both during and after the <unk> lifecycle.

John Jacobs: HBS 102 was our first example of this last year, and while I can't speak to the exact timing of bringing in additional assets, it's important to note that we are beginning this journey early in our company history, so we can take the time to be thoughtful and prudent in what we acquire and flexible in the types of deals we're able to consider.

Hps 102 was our first example of this last year and while I can't speak to the exact timing of bringing in additional assets. It's important to note that we are beginning this journey early in our company history. So we can take the time to be thoughtful and prudent in what we acquire and flexible on the types of deals we're able to.

Consider.

John Jacobs: Even though we may be a newer organization, we have a deeply experienced and dedicated business development team, and our backgrounds in clinical development, regulatory affairs, and commercial launch execution give Harmony the internal capabilities to develop assets from very early stage all the way through to commercialization in the rare orphan neurology arena. [inaudible] The consistent growth of WACIC since launch has put Harmony in a strong financial position and provides us with a stable foundation to build upon for a bright future.

Even though we may be a newer organization, we have a deeply experienced and dedicated business development team.

And our backgrounds in clinical development regulatory affairs, and commercial launch launch execution give eharmony the internal capabilities to develop assets from very early stage all the way through to commercialization in the rare orphan neurology arena.

The consistent growth of wake since launch has put <unk> in a strong financial position and provides us with a stable foundation to build upon for a bright future.

John Jacobs: Wakex is obviously at the core of our business today and we are confident in its longevity as well as our ability to grow this unique portfolio in a product asset to become a potential one billion dollar plus franchise in the coming years via narcolepsy and additional indications. And we believe that our strong patent suite and layers of regulatory exclusivity, which we intend to strengthen and expand, will help us optimize WCAG's potential over the long term.

<unk> is obviously at the core of our business today, and we are confident in its longevity as well as our ability to grow this unique portfolio and a product asset to become a potential $1 billion plus franchise in the coming years via narcolepsy and additional indications.

And we believe that our strong patent suite and layers of regulatory exclusivity, which we intend to strengthen and expand will help us optimize wake ex potential over the long term.

John Jacobs: Our vision is to evolve into a leading rare neurology company with a broad portfolio of innovative assets, building upon our success and the strong performance of WACACS to help even more patients who are living with rare neurological diseases. I would now like to turn the call over to Jeff Dierks, Harmony's Chief Commercial Officer. Thanks, John.

Our vision is to evolve into a leading rare neurology company with a broad portfolio of innovative assets building upon our success and the strong performance of <unk> to help even more patients who are living with rare neurological diseases.

I would now like to turn the call over to ejector harmonies, Chief commercial officer, Jeff.

Jeff Dierks: Q4 represented another strong quarter of performance for WCAG, in line with our expectations, as measured by the key performance metrics noted on slide. Net revenue for the fourth quarter was $91.2 million, representing an approximate 13% increase from Q3 2021, and a 62% increase from the same quarter prior year. Full year 2021 net revenue was $305.4 million, which represented a 91% increase from full year 2020.

Thanks, John Q4 represented another strong quarter performance for waiting in line with our expectation as measured by the key performance metrics noted on slide four.

Net revenue for the fourth quarter was $91 2 million.

Representing an approximate 13% increase from Q3, 2021, and a 62% increase from the same quarter prior year.

Full year 2021, net revenue was $305 4 million, which represented 91% increase from full year 2020.

Jeff Dierks: Our strong performance reflects not only the resilience and commitment of our team, but also speaks to how the overall benefit-risk profile of WACIX aligns to the significant unmet needs in the narcolepsy market. Moving on to slide five, and looking at Q4 2021 Key Performance Match. The average number of patients on WACIX increased to approximately 3,800, which represents an approximate 9% increase from what we reported last quarter. We continue to see consistent strong underlying demand for weight.

Our strong performance reflects not only the resilience and commitment of our team, but also speaks to how the overall benefit risk profile of weaker aligned to the significant unmet need in the narcolepsy market.

Moving on to slide five.

And looking at Q4 2021 key performance metrics.

The average number of patients on <unk> increased to approximately 3800, which represents an approximate 9% increase from what we reported last quarter.

We continue to see consistent strong underlying demand for wafer.

Jeff Dierks: Speaking to how the meaningfully differentiated product profile aligns well to the unmet needs of the narcolepsy market. Consistent with previous quarters, we saw approximately two-thirds of all field sales engagements with healthcare professionals conducted in person in their offices in Q4, with the other one-third of our engagements leveraging virtual technology. We anticipate this level of access to continue into 2022, given the ongoing Omicron variant and the evolution of telemedicine as an element of healthcare professional practice.

Speaking to how the meaningfully differentiated product profile aligns well to the unmet needs of the narcolepsy market.

Consistent with previous quarters, we saw approximately two thirds of all field sales engagements with healthcare professionals conducted in person in their offices in Q4.

But the other one third of our engagements leveraging virtual technology.

We anticipate this level of access to continue into 2022, given the ongoing omicron variant and the evolution of telemedicine as an element of healthcare professional practices.

Jeff Dierks: Through the pandemic, we have seen many HCPs adopt telemedicine in their practice and anticipate it will continue in the future to help offices with medication management visits and managing patients with chronic conditions such as narcolepsy. Harmony's business model and people have been resilient, nimble, and adaptable during the pandemic to meet the needs of the narcoleptic community and the evolution of patient care during this time. And we've seen the product profile of WACIC fit well into this environment. A non-scheduled product that can be written with refills through telemedicine. A product that's processed through a patient hub and specialty pharmacy network that's sent directly to a patient's home for delivery without a signature need.

Through the pandemic, we have seen many acp's adopt telemedicine in their practice and anticipate it will continue in the future to help offices with medication management visits and managing patients with chronic condition such as narcolepsy.

<unk> business model and people have been resilient nimble and adaptable during the pandemic to meet the needs of the narcolepsy community and the evolution of patient care. During this time.

And we've seen the product profile of wake ex fit well into this environment.

Unscheduled product that can be written with refills for telemedicine, a product thats process through our patient hub in specialty pharmacy network. This sent directly to a patient's home for deliver without a signature needle.

Jeff Dierks: Through the reduced access and increase in use of telemedicine, we've continued to be effective in educating the narcolepsy-treating healthcare professional community on the overall benefit-risk profile of WCAG and are extremely pleased with our progress to date. Market access for WACIS continues to be strong. Over 80% of all U.S. covered lives have favorable published policy access to WACIS. Within the majority of managed care plans, we've seen additional positive formulary decisions for type 1 patients, building on prior decisions since the cataplexy indication approval in October of 2020.

Through the reduced access and increase in use of telemedicine. We've continued to be effective in educating the narcolepsy treating health care professional community on the overall benefit risk profile of weak and are extremely pleased with our progress to date.

Market access for weakness continues to be strong.

Over 80% of all U S covered lives have favorable public policy access to Waco.

Within the majority of managed care plan, we have seen additional positive formulary decisions for type one patients building on prior decisions since the cataplexy indication approval in October of 2020.

Jeff Dierks: These decisions either reduce or eliminate generic step edits prior to WACUPS for adult patients with cataplexy, and these decisions also help take friction out of the managed care workflow, helping to accelerate a patient's ability to get access to weeks. Lastly, we continue to see broad and meaningfully clinical adoption of- We saw further growth in new prescribers for weeks in the fourth quarter of 2021. The majority of these new prescribers have become repeat.., mean they've started two or more of their narcolepsy patients on Wake Extension 1.

These decisions either reduce or eliminate generic step edits prior to wake for adult patients with cataplexy and these decisions also help take friction out of the managed care workflow, helping to accelerate a patient's ability to get access to the weekend.

Lastly, we continue to see broad and meaningfully clinical adoption of weekend.

We saw further growth in new prescribers per week in the fourth quarter of 2021.

The majority of these new prescribers have become repeat writers.

Started two or more of their narcolepsy patients on <unk> since launch.

Jeff Dierks: We continue to see broad utilization of wakix across the adult narcolepsy patient population with about half of new prescriptions written for wakix being for type one narcolepsy and half for type two narcolepsy patients. Wakeex is being prescribed as monotherapy as well as concomitantly with all other narcolepsy treatments, which speaks to the effectiveness of wakers for both EDF and cataplexy and the broad clinical utility of the product.

We continue to see broad utilization of <unk> across the adult narcolepsy patient population with about half of new prescriptions written for weaker being for type one narcolepsy and <unk> for type two narcolepsy patients.

<unk> is being prescribed as monotherapy as well as concomitantly with all other narcolepsy treatment.

Which speaks to the effectiveness of awakening for both eds, and cataplexy and the broad clinical utility of the product.

Jeff Dierks: Now a little over two years since our launch, we continue to see strong prescriber uptake and a broadening of the healthcare professional prescriber opportunity. The overall benefit-risk profile of WCAG and the broad clinical utility is demonstrating a broadening of the healthcare professional prescriber base beyond those who have prescribed the traditional narcolepsy treatment. We are not only seeing experienced narcolepsy-treating healthcare professionals prescribe Wacax, but also HCPs who have been reluctant to prescribe scheduled medicine, adopting the product for their narcolepsy.

Now a little over two years since our launch we continue to see strong prescriber uptake and a broadening of the health care professional prescriber opportunity.

The overall benefit risk profile of weakness in the broad clinical utility is demonstrating a broadening of the health care professional prescriber base beyond those who prescribed the traditional narcolepsy treatment.

We're not only seeing experienced narcolepsy treating health care professionals prescribed <unk>.

But also hcp's, who have been reluctant to prescribed schedule medicine, adopting the product for narcolepsy patients.

Jeff Dierks: Healthcare professionals point to the novel mechanism of action, WACI being the only non-scheduled treatment option, no REMS program, the ability to prescribe refills and prescribe via telemedicine, as reasons why some who have not prescribed other traditional medications, have begun to prescribe wakies for their adult narcolepsy.

Health care professionals point to the novel mechanism of action.

Being the only nonscheduled treatment option no rems program, the ability to prescribe refills and prescribed via telemedicine as reasons, why some who have not prescribed other traditional medications have begun to prescribe <unk> for their adult narcolepsy patients.

Jeff Dierks: As a result of this growing opportunity, we are in the process of expanding our field sales team by approximately 10% to scale our team for this broader opportunity and ensure we can provide this larger healthcare professional prescriber base with the education and resources necessary for an optimal patient experience. The work done in this expansion was thoughtful and was done to minimize disruptions and maintain as many field sales healthcare professional relationships as possible. We're currently filling these positions with strong qualified candidates in the first quarter, and anticipate having all of the new field team members trained and in their territories by the beginning of the second quarter.

As a result of this growing opportunity we are in the process of expanding our field sales team by approximately 10% the scale our team for this broader opportunity and ensure we can provide this larger health care professional prescriber base with the education and resources necessary for an optimal patient experience.

The work done in this expansion was thoughtful and was done to minimize disruptions and maintain as many field sales healthcare professional relationships as possible.

We're currently filling these positions with strong qualified candidates in the first quarter and anticipate having all of the new field team members train and in their territories by the beginning of the second quarter.

Jeff Dayno: We would anticipate the start to see the benefit of this expansion in the second half of 2022 with Euroly. This expansion gives us added confidence in our ability to continue to grow WACACS in the future and, more importantly, help additional adult patients living with narcolepsy. In summary, I'm extremely encouraged by the continued strong performance of Wacox in the narcolepsy market. I'm pleased with the strong adoption of WACIX from the narcolepsy-treating healthcare professional community, with our future growth opportunity coming from both a growing number of new prescribers as well as our existing prescribers.

We would anticipate to start to see the benefit of this expansion in the second half of 2022 at the earliest.

This expansion gives us added confidence in our ability to continue to grow <unk> in the future and more importantly helped additional adult patients living with narcolepsy.

In summary, I'm extremely encouraged by the continued strong performance of weakest in the narcolepsy market.

I am pleased with the strong adoption of weakness from the narcolepsy trading healthcare healthcare professional community.

Our future growth opportunity coming from both a growing number of new prescribers as well as our existing prescriber base.

Jeff Dayno: Most importantly, I'm excited about the difference that WAKEX is making in the lives of people living with ART. I'll now turn the presentation over to Dr. Jeff Dayno for an update on our clinical development program.

Most importantly, I am excited about the difference that <unk> is making in the lives of people living with narcolepsy.

I'll now turn the presentation over to Dr. <unk> for an update on our clinical development program.

Yes.

Thanks, Jeff and good morning, everyone I am pleased.

Jeff Dayno: I am pleased to provide an update on our clinical development programs and Pillar 2 of our three-pillar growth strategy to expand the clinical utility of pitolisin. There has been a lot of hard work toward advancing our current clinical trials and there continues to be much interest from both healthcare professionals and patients in these trials. We appreciate the efforts of our clinical investigators and the participation from the patients and families of the rare disease communities that we are actively working with.

To provide an update on our clinical development programs and pillar two of our three pillar growth strategy to expand the clinical utility of the telephone.

There has been a lot of hard work toward advancing our current clinical trials and there continues to be much interest from both health care professionals and patients in these trials.

We appreciate the efforts of our clinical investigators and the participation from the patients and families of the rare disease communities that we are actively working with.

Jeff Dayno: Before I provide a clinic update, I first want to highlight two post-hoc analyses for WACIX that were published in the journal CNS Drugs during Q4, as shown on slide number six. One publication sheds light on the time course of response to WACIX for both excessive daytime sleepiness and cataplexy, which occurs in the first two to three weeks after initiating treatment. The other publication presents the results of an analysis of the pivotal data expressed as effect size and number needed to treat or NNG, both of which are clinically relevant indicators of efficacy. The results demonstrate large effect sizes and low NNTs for both excessive daytime sleepiness and cataplexy, which further support the robust efficacy profile of WACIX.

Before I provide a clinical update I first want to highlight two post hoc analyses for wake effects that were published in the journal CNS drugs. During Q4 as shown on slide number six.

One publication shed light on the time course of response to wake effects for both excessive daytime sleepiness and cataplexy, which occurred in the first two to three weeks after initiating treatment.

The other publication presents the results of an analysis of the pivotal data.

Spreads as effect size and number needed to treat or both.

Both of which are clinically relevant indicators of efficacy.

The results demonstrate large effect sizes, and low end and cheese for both excessive daytime sleepiness and cataplexy, which further support the robust efficacy profile of <unk>.

Jeff Dayno: Turning to slide seven and our clinical development programs. I am happy to share that we are on track to initiate our Phase 3 clinical trial in adult patients with idiopathic hypersomnia, or IH, in the first half of this year. This trial is a double-blind, placebo-controlled, randomized withdrawal design with a target enrollment of about 200 patients. We are preparing for off to 80 clinical trial sites in the US and have identified even more sites with interest in participating. The primary objective of this phase 3 trial is to assess the safety and efficacy of the tollsons compared with placebo and treating excessive daytime sleepiness in adult patients with IH.

Turning to slide seven and our clinical development programs.

I am happy to share that we are on track to initiate our phase III clinical trial in adult patients with idiopathic hypersomnia for IH in the first half of this year.

This trial is a double blind placebo controlled randomized withdrawal design with a target enrollment of about 200 patients.

We are preparing for up to 80 clinical trials sites in the U S and have identified even more sites with interest in participating.

The primary objective of this phase III trial is to assess the safety and efficacy of <unk> compared with placebo in treating excessive daytime sleepiness in adult patients with IH.

Jeff Dayno: Key secondary endpoints include assessment of the symptom complex of IH, utilizing the idiopathic hypersomnia severity scale, and patient global impression of change. We are excited about this trial, which accelerates our lifecycle management programs for pitolicin into late phase development toward a potential new indication for another patient population living with a rare neurological disease with significant unmet medical need. With regard to our ongoing clinical development programs, it is well known that the clinical development enterprise across our industry has been impacted by the COVID pandemic, especially recently with the emergence of the Omicron variant.

Key secondary endpoints include assessment of the symptom complex of IH utilizing the idiopathic hypersomnia severity scale and.

And patient global impression of change.

We are excited about this trial, which accelerates our lifecycle management programs for Tulsa and into late phase development toward a potential new indication for another patient population living with a rare neurological disease with significant unmet medical needs.

Yes.

Jeff Dayno: [inaudible] This has had a specific impact on our Phase 2 clinical trials in Prader-Willi Syndrome, or PWS, and Type 1 Myotonic Dystrophy, or DM1, because of the need to have access to sleep labs to do objective sleep testing. In addition, many of the trial sites are at academic medical centers, which have either been closed down to clinical trials due to COVID or have diverted a lot of resources towards caring for COVID patients, resulting in staffing shortages for clinical trials.

With regard to our ongoing clinical development programs. It is well known that the clinical development enterprise across our industry has been impacted by the Covid pandemic, especially recently with the emergence of the omicron variant.

This has had a specific impact on our phase two clinical trials in <unk>, Willi syndrome, or PWM and type one my tongue dystrophy or DM, one because of the need to have access to sleep labs to do objective sleep testing.

In addition, many of the trials sites are at academic medical centers, which have either been closed down to clinical trials due to COVID-19 .

Diverted a lot of resources towards caring for COVID-19 patients, resulting in staffing shortages for clinical trials.

Jeff Dayno: To address these challenges, our clinical development teams have been working extremely hard to find solutions that would keep these trials moving forward while not compromising patient safety or the quality of the data being generated. A few examples of the approaches we have taken are outlined on slide 8 and include, Mechanisms have been put in place that allow for electronic signatures for e-concent on informed consent forms. This then allows for remote screening.

To address these challenges our clinical development teams have been working extremely hard to find solutions that would keep these trials moving forward, while not compromising patient safety or the quality of the data being generated.

A few examples of the approaches we have taken are outlined on slide eight and include <unk>.

<unk> mechanisms have been put in place that allow for electronic signatures for E consent on informed consent forms. This then allows for remote screening.

Jeff Dayno: Protocol amendments have been executed that allow for some of the study visits to take place remotely, utilizing telemedicine to conduct efficacy assessments, and visiting nurses going to where the patients are to draw labs and do ECGs for safety assessments. This reduces the amount of travel that patients and families would normally need to do and reduces the overall burden of the trial. Clinical trial sites have been connected with additional or alternate sleep lab to perform objective sleep testing when their institution sleep lab is not available due to resources and personnel being prioritized for COVID patients, and additional clinical trial sites have been added to support the enrollment efforts for these programs.

Protocol amendments have been executed that allow for some of the study visits to take place remotely utilizing telemedicine to conduct efficacy assessments and visiting nurses going to where the patients are to draw lives into ecg's for safety assessments.

This reduces the amount of travel that patients and families would normally need to do and reduce the overall burden of the trials.

Clinical trial sites have been connected with additional or alternate sleep lab to perform objectively testing when their institution sleep lab is not available due to resources and personnel being prioritized for COVID-19 patients.

And additional clinical trial sites have been added to support the enrollment efforts for these programs.

Jeff Dayno: We have learned a lot through this experience and our contingency efforts have had a positive impact overall, helping to keep the clinical trials up and running. With that as background, I would like to provide an update on the timelines of our two phase two clinical trials, as shown on our pipeline slide, or slide nine. For our PWS phase two proof of concept trial, we now anticipate top line data in the second half of this year. For our DM1 Phase 2 trial, top-line data is now anticipated in 2023 and we will provide an update later in the year to better inform this timeline.

We have learned a lot through this experience in our contingency efforts have had a positive impact overall, helping to keep the clinical trials up and running.

With that as background I would like to provide an update on the timelines of our two phase III clinical trials as shown on our pipeline slide slide nine.

For our PWM phase II proof of concept trial, we now anticipate top line data in the second half of this year.

For our <unk>, one phase III trial topline data is now anticipated in 2023, and we will provide an update later in the year to better inform this timeline.

Jeff Dayno: We remain committed to the PWS and DM1 development programs and to both of these rare disease patient communities for which there is significant unmet medical need. We look forward to updating you on our progress on future calls. Lastly, a few words on our other development programs. With regard to pediatric narcolepsy, our partner BioPerget has completed its Phase 3 trial. We will look to the data as a key input to help inform our strategy related to pediatric exclusivity and a potential pediatric narcolepsy indication.

We remain committed to the PWM and <unk> development programs and to both of these rare disease patient communities for which there is significant unmet medical need.

We look forward to updating you on our progress on future calls.

Lastly, a few words on our other development programs with.

With regard to pediatric narcolepsy, our partner <unk> has completed its phase III trial.

We will look to the data as a key input to help inform our strategy related to pediatric exclusivity and a potential pediatric narcolepsy indication.

Jeff Dayno: For HBS 102, our early stage asset, we are exploring potential clinical targets within the realm of rare neurological diseases and plan to begin preclinical proof-of-concept studies on one or two of those targets in the second half of this year.

For <unk> 102, our early stage asset we are exploring potential clinical targets within the realm of rare neurological diseases and plan to begin preclinical proof of concept studies on one or two of those targets in the second half of this year, we will provide more color on this program later in the year.

Sandip Kapadia: We will provide more color on this program later in the year. Finally, I am proud of the efforts and perseverance of the Harmony team which has enabled us to keep our trials moving forward in these rare disease patient populations. We appreciate the collaboration with our clinical investigators and the commitment of the patients and families who are participating in our PWS and DM1 clinical trials. And I am excited about our Phase 3 trial in idiopathic hypersomnia, which is on track to initiate first half of this year.

Finally, I am proud of the efforts and perseverance of the harmony team, which has enabled us to keep our trials moving forward in these rare disease patient populations.

We appreciate the collaboration with our clinical investigators and the commitment of the patients and families who are participating in our PWM and DM one clinical trials.

And I am excited about our phase III trial in idiopathic hypersomnia, which is on track to initiate first half of this year.

Sandip Kapadia: Thank you, and I will now turn the call over to our CFO, Sandip Kapadia, for an update on our financial performance. Thank you, Jeff, and good morning, everyone. This morning, we issued our fourth quarter 2021 earnings press release and filed our 10-K, where you'll find the details of our financial and operating results.

Thank you and I will now turn the call over to our CFO <unk> <unk> for an update on our financial performance Sandeep.

Sandip Kapadia: Our fourth quarter and full year 2021 performance is also shown on slides 11, 12, and 13. We once again achieved our highest quarterly net revenues to date, posting year-over-year growth in both sales and operating income, while continuing to generate strong cash flow from operations. I'm pleased with how we closed out 2021 and the momentum we're seeing going into 2022. For the fourth quarter of 2021, we reported $91.2 million in net revenues for weight kicks, compared to $56.3 million in the prior year quarter.

Thank you, Jeff and good morning, everyone.

This morning, we issued our fourth quarter of 2021 earnings press release and filed our 10-K, where you'll find the details of our financial and operating results.

Our fourth quarter at full year 2021 performance. It's also shown on slide 11, 12 and 13.

We once again achieved our highest quarterly net revenues to date posting year over year growth in both sales and operating income while continuing to generate strong cash flow from operations.

I am pleased with how we closed out 2021, and the momentum we're seeing going into 2022.

For the fourth quarter of 2021, we've reported $91 2 million in net revenues for <unk> compared to $56 3 million in the prior year quarter.

Sandip Kapadia: This represents a growth of 62% compared to the prior year quarter. And on a full year basis, we closed 2021 with $305.4 million in net sales, a 91% increase over 2020. We're pleased to see the continued growth in average number of patients throughout 2021. Further demonstrating the unique treatment option that wake ex-offers for adult narcolepsy patients.

This represents a growth of 62% compared to the prior year quarter.

And on a full year basis.

<unk> 2021, with $305 4 million in net sales and 91% increase over 2020.

We're pleased to see the continued growth in average number of patients throughout 2021.

Further demonstrating the unique treatment option that <unk> offers for adult narcolepsy patients.

Sandip Kapadia: For the fourth quarter of 2021, operating expenses for 44.8 million, compared to 38.6 million in the prior quarter. With full year 2021 operating expenses of $162.4 million, a growth of 41% over 2020. The growth in operating expenses continues to be driven by a commercialization of wages, and the advancement of our pipeline program. Operating profitability improves on both the quarterly and yearly basis. We posted fourth quarter 2021 operating income of 28.46 million compared to 7.8 million in the prior year quarter.

For the fourth quarter of 2021 operating expenses were $44 8 million compared to $38 6 million in the prior year quarter.

With full year 2021, operating expenses of $162 4 million a growth of 41% over 2020.

The growth in operating expenses continues to be driven by our commercialization of <unk> and the <unk>.

<unk> of our pipeline programs.

Operating profitability improved on both a quarterly and yearly basis.

We posted fourth quarter 2021 operating income of $28.

$6 million compared to $7 8 million in the prior year quarter.

Sandip Kapadia: On a full year basis, operating income was $87.5 million, an increase of over $70 million compared to 2020. Non-GAAP-adjusted net income for the fourth quarter for $37.8 million or $0.63 per diluted share compared to $15.1 million or $0.25 per diluted share in the prior year quarter. So the full year diluted EPS of $2.07 reflects the positive sales growth and the prudent expense management we have shown over the past year. And as a reminder, non-GAAP-adjusted net income excludes interest expense, amortization, depreciation, stock-based compensation, and other non-operating items.

On a full year basis operating income was 87 5 million an increase of over $70 million compared to 2020.

non-GAAP adjusted net income for the fourth quarter were $37 8 million or <unk> 63 per diluted share compared to $15 1 million or 25 cents per diluted share in the prior year quarter.

For the full year diluted EPS of $2 seven reflects the positive sales growth and prudent expense management, we have shown over the past year.

And as a reminder, non-GAAP adjusted net income excludes interest expense amortization depreciation.

Compensation and other non operating items.

Sandip Kapadia: Please see our press release for a reconciliation of this matter. During the fourth quarter, we generated $44.6 million in cash, closing with $234.3 million in cash and cash equivalents. December 31st. As we move into 2022, we will likely see the same seasonal pair dynamics that affect specialty products early in the year. However, we expect continued full-year revenue growth with increased investment in R&D and SG&A as we continue to successfully execute on our three-pillar growth strategy.

Please see our press release for a reconciliation of this measure.

During the fourth quarter, we generated $44 $6 million in cash closing with $234 $3 million in cash and cash equivalents at December 31.

As we move into 2022, we will likely see the same seasonal paradigm NAMIC that affect specialty products early in the year.

However, we expect continued full year revenue growth with increased investment in R&D and SG&A as we continued to successfully execute on our three pillar growth strategy.

Sandip Kapadia: As a reminder, we have crossed the cumulative 500 million sales, since launch threshold after your end 2021. And we'll be making the final milestone payment to our partner, Fire Project, a $40 million in Q1 of 2020. So in conclusion, we continue to operate from a position of strength. Growing Revenues, Crude and Expense Control, a Solid Balance Sheet, and Access to Additional Calculus.

As a reminder, we have crossed the cumulative $500 million sale.

<unk> launched threshold after our year end 2021, and we will be making the final milestone payment for our partner buyer per day, a $40 million.

In Q1 of 2022.

So in conclusion, we continue to operate from a position of strength with growing revenues.

<unk> expense control, a solid balance sheet and access to additional capital.

John Jacobs: As John mentioned, we believe that the Wayfix has the potential to be a $1 billion plus franchise on Narcolepsy and Additional Indications in the coming years. We look forward to reinvesting our capital to fund our ongoing development program and acquiring additional assets. And with that, I'd like to turn the call back over to Jon for his closing remarks. Jon?

As John mentioned, we believe that the <unk> has the potential to be a $1 billion franchise.

<unk> in additional indications in the coming year.

We look forward to reinvesting our capital to fund our ongoing development.

And acquiring additional assets.

And with that I'd like to turn the call back over to John for his closing remarks.

John .

Thank you Sandeep so.

John Jacobs: Thank you, Sandip. So in summary, as we look ahead at 2022, we expect to build on the momentum we generated last year, and we are excited about our potential to make 2022 our best year yet through continued execution on our three-pillar growth strategy. Our intent is to continue growing Wackex sales in narcolepsy via good commercial execution and strong organic demand for this unique and meaningfully differentiated product. To continue to move our clinical programs forward with the eventual goal of expanding the utility of WACIX beyond narcolepsy, to help bring this innovative therapy to new patient populations, and to acquire new assets beyond WACIX to expand our portfolio with the goal of evolving Harmony into a leading rare neurology company with sustainable long-term growth potential.

So in summary, as we look ahead at 2022, we expect to build on the momentum we generated last year and we are excited about our potential to make 2022, our best year, yet through continued execution on our three pillar growth strategy.

Our intent is to continue growing <unk> sales in narcolepsy via good commercial execution and strong organic demand for this unique and meaningfully differentiated product.

To continue to move our clinical programs forward with the eventual goal of expanding the utility of <unk> beyond narcolepsy to help bring this innovative therapy to new patient populations.

And to acquire new assets beyond <unk> to expand our portfolio with the goal of evolving harmony into a leading rare neurology company with sustainable long term growth potential.

Operator: We look forward to updating you on our progress throughout the year. This concludes our planned remarks for today. Thank you so much for joining our call, and I will now turn things back over to the operator to facilitate questions and answers. Operator, can we please open the call to questions? Thank you. If you have a question at this time, please press star then 1 on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.

We look forward to updating you on our progress throughout the year. This concludes our planned remarks for today.

So much for joining our call and I will now turn things back over to the operator to facilitate questions and answer operator can we please open the call to questions.

Thank you if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

Go ahead ask that you please limit yourself to one question and one follow up question.

Operator: We also ask that you please limit yourself to one question and one follow-up question. Our first question comes from the line of Danielle Brill with Raymond James. Your line is open.

First question comes from the line of Danielle Brill with Raymond James Your line is open. Please go ahead.

Danielle Brill: Please go ahead. Hi, guys. Good morning. Thanks so much for the questions. I guess first I wanted to ask about how we should think about 1Q given the deductible reset and the general seasonality. Should we be expecting growth sequentially or could it be flat to down versus 4Q? And then as a follow-up...

Hey, guys. Good morning. Thanks, so much for the question I guess I guess first.

I wanted to ask about how we should think about one Q given the deductible reset and the general seasonality, so we'd be expecting growth sequentially or could be flat to down versus Q and then as a follow up just.

Danielle Brill: I'm curious when you may be comfortable providing financial guidance for investors and are you comfortable with where 2022 consensus estimates are for the year? Good questions. Good to hear from you, Danielle.

I'm curious when you may be comfortable providing financial guidance for our investors and are you comfortable with where our 2022 consensus estimates are for the year. Thank you.

Good questions good to hear from you Danielle Thanks for joining the call Jeff Berkes will handle the opening question first about the Q1 seasonality and dynamics followed by Sunbeam and then we'll address the guidance question after that Jeff Hey, Good morning, Danielle. So obviously, we're extremely pleased with the continued commercial performance with <unk> and we continue to see strong demand for the brand and.

John Jacobs: Thanks for joining the call. Jeff Dierks will handle the opening question first about the Q1 seasonality and dynamics, followed by Sandip, and then we'll address the guidance question after that. Jeff?

Jeff Dierks: Hey, good morning, Danielle. So, obviously, we're extremely pleased with the continued commercial performance with Wacox, and we continue to see strong demand for the brand, and we're consistently adding average number of patients, new prescribers, and growth in net sales each quarter, which we believe is speaking to the meaningfully differentiated product profile and how well it aligns to the unmet needs. And although we're not providing guidance moving forward, what I can do is point you back to our performance in the previous six quarters.

We're consistently adding average number of patients new prescribers and growth in net sales each quarter, which we believe is speaking to the meaningfully differentiated product profile and how well it aligns to the unmet needs and although we're not providing guidance moving forward. What I can do is point you back to our performance in the previous six quarters, we have been able to demonstrate.

Jeff Dierks: We have been able to demonstrate strong sequential growth quarter over quarter in a lot of the key metrics, and we do anticipate that growth moving forward. Now, to talk a little bit about some of the payer dynamics and growth, then I'll turn it over to Sandip. Thanks, Jeff, and hi, Danielle. In terms of Q1, as Jeff mentioned, I mean, we continue to see good dynamics in terms of we'll see patient growth going into Q1.

Strong sequential growth quarter over quarter, and a lot of the key metrics and we do anticipate that growth moving forward now to talk a little bit about some of the payer dynamics in gross to net I'll turn it over to Sandeep.

Thanks, Jeff and Hi, Danielle.

In terms of Q.

As Jeff mentioned, we continue to see good dynamics in terms of we will see patient growth.

Into Q1, I think in terms of in terms of the payer dynamics.

Jeff Dierks: I think in terms of the payer dynamics, we'll experience higher growth in net deductions in the first quarter, just as it is across most specialty products in general, and we'll see, obviously, a normalization of growth in nets starting in Q2 overall, and probably relatively stable for the balance of the year.

<unk> experienced higher gross to net deductions in the first quarter just as it is across most specialty products in general and we will see obviously a.

The normalization of gross to nets, starting in Q2.

Overall, and then probably relatively stable for the balance of the year.

Sandip Kapadia: Thank you, Sandip and Jeff. And Danielle, I believe, did we hear you correctly? Your second question is related to our contemplating the potential of providing guidance. Did we hear you correctly? That is correct. Yeah, Sandip. Did you want to handle that on your end?

Thank you Sandeep and Jeff and Danielle I believe it did we hear you correctly. Your second question is related to our contemplating the potential of providing guidance could we hear you correctly.

Thats correct.

Yes, Sandeep did you want to handle that one yes I think.

Sandip Kapadia: Yeah, I think, you know, I think I'll just build upon what Jeff mentioned. I mean, in terms of we've got good consistent growth overall, you know, a good history of last two years, consistent growth that, you know, we feel is a good basis for investors to at least, you know, make forecasts for the future. You know, we expect quarter over quarter growth for this year. You know, in terms of, you know, consensus, I mean, that's generally, you know, obviously moves around generally overall.

I think I'll just build upon what Jeff mentioned I mean in terms of we've got good consistent growth overall.

A good history of last two years consistent growth that we feel is a good basis for investors to at least.

Make forecasts for the future.

We expect quarter over quarter growth for this year.

In terms of.

Consensus I mean, that's generally obviously moves around generally overall, but I think.

Sandip Kapadia: But I think, you know, many of you have built in a similar dynamic for the balance of the year. And I think we'll have to see what, you know, the variance in the pandemic, although obviously we're seeing a bit more of a normalization. But, you know, we'll have to see how that plays out in the balance of the year.

Many of you have had to have built in.

A similar dynamic for the balance of the year and I think we'll have to see what the.

The variance in the pandemic, although obviously, we're seeing a bit more of a normalization but.

Well have to see how that plays out in the balance of the year.

Sandip Kapadia: Thank you, Sandip. Thank you. Thank you. Thank you. Thank you. And our next question comes from the line of Chris Howerton with Jeffreys. Your line is open.

Thank you Sandy.

Thank you.

Thank you and our next question comes from the line of Chris Howerton with Jefferies. Your line is open. Please go ahead.

Chris Howerton: Please go ahead. Hi, good morning. Really, congratulations on the quarter, and it's great to hear from you all. I'm here, Chris, and thank you so much.

Hi, good morning, really congratulations in the quarter and great to hear from you all here Chris.

<unk>.

Chris Howerton: Absolutely. So I guess, you know, obviously, Danielle asked a big question in terms of what it's going to look like for this next year. But I guess one of the questions that I have was just with respect to the clinical development of the ongoing phase two trials, Can you tell us at all where you're at in terms of enrollment at this point and maybe some of the pushes and pulls that you're considering in terms of changing the timing of the readouts of those trials?

Absolutely so I guess.

Obviously, Danielle asked the big question in terms of what it's going to look like for this next year, but I guess.

One of the questions that I have was just with respect to the clinical development.

Of the ongoing phase two trials can you tell us at all where you're at in terms of enrollment at this point and maybe some of the pushes and pulls that you are considering in.

In terms of changing the timing of the readout to those trials and then the second question that I had is more of a clarification because I think Jeff said and I just didn't hear it you were describing a new set of physicians that maybe and again I think I heard this right was that physicians that have not prescribed other.

Chris Howerton: And then the second question that I had is more of a clarification question because I think Jeff said it, and I just didn't hear it. You were describing a new set of physicians that maybe, and again, I think I heard this right, were those physicians that have not prescribed other narcolepsy medications for whatever reason and that you're trying to tap into. So I guess if you could,

Narcolepsy medications for whatever reason and that you are trying to tap into those physicians I guess, if you could just.

Sorry, I muted myself tell us a little bit more about how you identified those and how youre thinking of.

Chris Howerton: Tell us a little bit more about how you identified those and how you're... Attracting them to prescribe. Thank you, Chris. Two excellent questions. Why don't we start with the clinical question to Dr. Dayno. Yeah, good morning, Chris.

<unk> them prescribed.

Prescribing <unk>. Thank you.

Thank you Chris two excellent questions why don't we start with the clinical question to Dr. Dana.

Jeff Dayno: Thanks. Thanks for the question. Yeah, with regards to our, you know, development programs, I think, as you know, as you're all aware, most companies in our industry have been facing challenges in conducting clinical trials, you know, due to the COVID headwinds, especially more recently with the emergence of the Omicron variant. So as these challenges surfaced, you know, I think, you know, our teams, and I think all sponsors quickly pivoted, and, you know, put mitigation efforts in place, and the contingency plans to keep the trials going.

Yes, good morning, Chris. Thanks, Thanks for the question with regard to our development programs I think is as you're all aware most companies in our industry have been facing challenges in conducting clinical trials due to the COVID-19 headwinds, especially more recently with the emergence of the omicron Varian.

So as these challenges surfaced I think our teams and I think all sponsors quickly pivoted and put mitigation efforts in place.

Jeff Dayno: I think I spoke to that on the call, some of the specifics, you know, that we did, you know, a lot of it was to design in flexibility into the trials, a lot of, you know, sort of the remote visits, contingency plans, and trying to reduce overall burden. So we're not providing specifics in terms of enrollment numbers. But what I will say is, you know, based on what I've seen from the changes that we've made, amendments that have been written into the protocols, you know, I'm confident that the plans we put in place have resulted in improved momentum in the Phase 2 trials. And, you know, I'm proud of the perseverance of the team.

And the contingency plans to keep the trial is going I think I spoke to that on the call. Some of the specifics that we did a lot of it was to design in flexibility into the trials a lot of sort of the remote visits contingency plans and trying to reduce overall burden. So we're not providing.

Adding specifics in terms of enrollment numbers, but what I will say is base.

Based on what I've seen from the changes that we've made amendments that have been written into the protocols.

I'm confident that the plans we put in place.

Have resulted in improved momentum.

In the phase III trials and I am proud of the perseverance of the team. So we have seen improvement in the pace of enrollment and especially on the DM one trial.

Jeff Dayno: So we've seen, you know, improvement in the pace of enrollment, and especially on the DM1 trial, academic medical centers where a lot of the sites are, you know, are starting to open up more, sleep labs are starting to open up more. So we've seen improvement in activation of sites, you know, in that program. So overall, the trends, there's been response to the contingency efforts, and confident that, you know, we'll be able to move forward, and we'll provide updates on those programs as the year goes forward.

Academic medical centers, where a lot of the sites are starting to open up more sleep labs are starting to open up more so we've seen improvement in activation of sites and that program. So overall the trends theres been response.

Two the contingency efforts and confident that we'll be able to move forward and we will provide updates on those programs as the year to go full goes forward. Thank you Dr. Dana and Chris I believe your second question related to the breadth and depth of the prescriber universe that we're seeing for wake exit are we adding patients from physicians, who havent priest.

Jeff Dayno: Thank you, Dr. Daino, and Chris, I believe your second question related to the breadth and depth of the prescriber universe that we're seeing for WACIX, and are we adding patients from physicians who haven't prescribed some of the traditional therapies before? Did we hear you correctly on that? Yeah, basically, yes. Jeff Dierks, comment?

<unk> some of the traditional therapies before it did we hear you correctly on that.

Yes, basically yes.

Jeff Berkes comment, yes, good morning, Chris. So we originally targeted about 8000 health care professionals that have responsibility for 90% of the diagnosed patient population and the other 10% of patients that were managed by the other physicians were thought to have been simply physicians that we're refilling medicines as they only have really had written <unk>.

Jeff Dierks: Good morning, Chris. So we originally targeted about 8,000 healthcare professionals that had responsibility for 90% of the diagnosed patient population. And the other 10% of patients that were managed by the other physicians were thought to have been simply physicians that were refilling medicines, as they only really had written weight-promoting agents.

Jeff Dierks: And what we're finding from that approximate additional 1,000 physicians is that they do have a strong interest in starting new patients. And obviously the novelness of the product, the fact that it's not scheduled, working through histamine as a new MOA, really has sort of expanded the opportunity for us to think about a larger physician universe. And that is really one of the driving factors behind expanding our sales team. We do look at patient claims data as a way to be able to identify some of those physicians, Chris. But the big thing we've seen is these are physicians that do not prescribe stimulants, do not prescribe Oxibate, that have only been prescribing weight-promoting agents, and originally it's thought to be only refills.

Jeff Dierks: And this really represents a pretty unique, untapped opportunity for us, and a growing opportunity within the physician universe. And we're really excited about our ability to reach this additional group of physicians, most importantly to help additional adult patients living with narcolepsy. And Dr. Dano, would you like to comment from a medical perspective on that? Yeah, thanks, John.

Jeff Dayno: Yeah, and Chris, from a medical perspective, I think that pattern would be expected in terms of as you get more experience with a product in the marketplace and sort of more physicians, and especially talking to peers and colleagues and understanding the product profile. So I think the pattern that Jeff spoke to would be sort of is not uncommon from a medical perspective and new treatments that are out in the marketplace over time. Yeah, that totally makes sense to me. And I know I'm only allowed one clarification. You can say no if you don't want to.

Promoting agents and what we're finding from that approximate additional thousand physicians is that they do have a strong interest in starting new patients and obviously the novel Ness of the product. The fact that it is not scheduled working through histamine is a new MLA really is sort of expanded the opportunity for us to think about a larger.

Physician universe and that is really one of the driving factors behind expanding our sales team.

We do look at patient claims data as a way to be able to identify some of those physicians, Chris but the big thing. We've seen is these are physicians that do not prescribed stimulants do not provide prescribe <unk> that have only been prescribing wake promoting agents than originally thought to be only refills and this really represents a pretty unique untapped opportunity for us.

And a growing opportunity within the physician universe, and we're really excited about our ability to reach this additional group of physicians. Most importantly to help additional adult patients living with narcolepsy and Dr. Daniel did you want to comment from a medical perspective on that yes, Thanks, John Yes, and Chris from a medical perspective, I think that pattern.

It would be expected in terms of as you get more experience with the product in the marketplace and sort of more more physicians.

Especially talking to peers and colleagues and understanding here the product profile. So I think the pattern that Jeff spoke to would be sort of is not uncommon from a medical perspective.

And new treatments that are out in the marketplace over time.

Yes.

It makes sense to me and I know I'm only allowed one clarification you could say now if you don't want to but.

Chris Howerton: But Jeff Dierks, would it be fair to assume that those physicians maybe are averse to setting up a REMS? Might that be a fair statement? So I think there's obviously a lot of different reasons why a physician may or may not enrol in a REMS program, but I do believe, you know, as Dr. Dayno and Jeff always talked about the threshold to treat. I think there's a lot of that group.

Jeff.

<unk>.

Would it be fair to assume that those physicians may be are averse to setting up a rems might that be a fair statement.

So I think there's obviously a lot of different reasons, why a physician may or may not enrolling a rems program, but I do believe as Dr. Dana and Jeff always talks about the threshold the tree weakest overall benefit risk profile may just fit better into their practice as being a product thats nonscheduled with no rems you can write a refill.

Via telemedicine, and I think theres lots of attributes about the overall benefit risk profile for weeks. It wakes that makes it attractive for that position and maybe other traditional therapies may not work for that group.

Okay, all right well very good well again, congrats everybody and thanks for taken the multitude of questions. Thank.

Chris Howerton: All right, well, very good. Well, again, congrats, everybody, and thanks for taking... Thank you, Chris.

Thank you Chris.

Chris Howerton: Thank you. And our next question comes from the line of Ami Fadia with Needham. Your line is open.

Thank you and our next question comes from the line of Amit Patio.

<unk> with Needham Your line is open. Please go ahead.

Ami Fadia: Please go ahead. Hi, good morning, everyone. Hi, good morning. I have two questions.

Hi, good morning, everyone.

Correct.

Sure.

Ami Fadia: Firstly, just with regards to the existing indication for weight gains, you commented earlier in the year that, A three to 400 station for a quarter was very much doable and You know, with what we've seen with Omicron, it seems like things are, Beginning to settle back into a normal market. With that, could you give us any color on what your expectation would be if that trend continues? And then, um, you know, just with regards to the phase two studies in PWS and DNA. Some of the changes you're making, especially using, you know, other sleep labs or adding more sites.

Hi, Good morning, I have two questions Firstly, just with regard to.

Indications.

You've commented on in the year that.

Two to 400 patient adds per quarter was maintenance doable.

With what we're seeing with.

Connie.

Our.

Beginning to come back to.

Normal market with that could you give us any color on what your expectation would be.

That trend continues.

And then.

Just with regards to the phase two study MPW at Indiana.

Some of the changes youre, making especially.

Using other sleep labs or adding more sites.

Ami Fadia: Can you talk about how you're controlling for any variability that might get introduced in these trials? because of just expanding the number of sites and, Centers that are evaluating patients. Thanks. And then, though we aren't providing forward-looking guidance, I will ask Jeff Dierks just to comment on the strong underlying demand that we're experiencing from both healthcare providers and the patient community and our feelings about, you know, a forward look without providing guidance. Jeff?

Can you talk about how you're controlling for in variability that Mike.

<unk>.

The car Park.

Finding the number of sites.

Some groups that are evaluating patients. Thanks.

Outstanding on my agenda, we arent, providing forward looking guidance I will ask Jeff Berkes, just to comment on the strong underlying demand that we're experiencing from both healthcare providers and the patient community.

Our feelings about.

Forward look without providing guidance Jeff.

Good morning, and thanks for the question and so to reiterate what I shared earlier for Daniel's question. I think we're continue we continue to be really pleased with our strong performance Q4 represented our eighth consecutive quarter of growth and all of the key performance metrics looking at net sales and average number of patients and unique prescribers of the <unk>.

Jeff Dierks: Sure. Good morning, Ami, and thanks for the question. And so, you know, to reiterate what I shared earlier for Danielle's question, I think we're continue – we continue to be really pleased with our strong performance. You know, Q4 represented our eighth consecutive quarter of growth, and all the key performance metrics looking at net sales and average number of patients and unique prescribers of the product. And, you know, quite honestly, we haven't really known a time during our launch without COVID, so it's really difficult to sort of speculate moving forward, thinking about growth.

And quite honestly, we haven't really known at time during our launch without Covid. So it's really difficult to sort of speculate moving forward thinking about growth, but as we've shared before we're not providing guidance, but I think we can kind of look back at the six previous quarters as a public company to be able to provide you a little bit of insight thinking forward.

Jeff Dierks: But as we shared before, we're not providing guidance, but I think we can kind of look back at the six previous quarters as a public company to be able to provide you a little bit of insight thinking forward. We continue to see, you know, a very consistent level of access for our field sales team in terms of in-person engagements with healthcare professionals over the last couple of quarters into early 2022. Foot traffic for patients seems to be relatively consistent.

We continue to see a very consistent level of access for our field sales team in terms of in person engagements with health care professionals over the last couple of quarters into early 2022 foot traffic for patients seems to be relatively consistent offices are leveraging telemedicine very effectively and we know how well <unk> fits.

Jeff Dierks: Offices are leveraging telemedicine very effectively, and we know how well WACIX fits within that profile as well. We have a lot of confidence we're going to continue to be able to grow as we have grown historically in terms of the key performance metrics without being able to really kind of give you any forward-looking guidance, if that helps. And Ami, one additional comment. It's John.

Within that profile as well and we have a lot of confidence we're going to continue to be able to grow as we have grown historically in terms of the key performance metrics without being able to really kind of give you any forward looking guidance if that helps.

And one additional comment its John just to think about how vast the opportunity is in narcolepsy alone.

John Jacobs: Just to think about how vast the opportunity is in narcolepsy alone, for any of these therapies. I mean, you've got a $2 billion plus marketplace as a whole in narcolepsy that's growing. Yet, even as new products get added, those products continue to grow and expand that marketplace with 72,000 diagnosed patients and a total, including those 72, of about 165,000 Americans thought to be living with this disease.

For any of these therapies I mean, if you've got a $2 billion plus marketplace as a whole in narcolepsy, that's growing even as new products get added those products continue to grow and expand that marketplace was 72000 diagnosed patients.

Total, including those 72 of about 165000 Americans thought to be living with this disease. So plenty of opportunity for growth in the future as Jeff said, we hardly know what time without COVID-19 and our launch. So it's hard to predict is that does start to lift and I share your optimism and hope that it does as we move into the future what might be possible for wafer.

John Jacobs: So plenty of opportunity for growth in the future. As Jeff Dierks said, we hardly know a time without COVID since our launch, so it's hard to predict as that does start to lift.

John Jacobs: And I share your optimism and hope that it does as we move into the future, what might be possible for WACIX there. But thank you for that question. And your second question, I believe, related to our clinical trials, controlling for variability based on the adjustments Dr. Dayno and his team have been making. Jeff?

There, but thank you for that question and your second question I believe related to our clinical trials controlling for variability based on the adjustments Dr. Dana and his team have been making sure Jon Good morning, Amie and.

Jeff Dayno: Yeah, sure, John. Good morning, Ami. And a really excellent question, you know, regarding the potential for variability in the trials, you know, based on these sort of mitigation efforts. And I think it, you know, it comes down to a balance.

Really excellent question regarding sort of the potential for variability in the trials based on the sort of mitigation efforts and I think it comes down to a balance I think it's a balance of some of the efforts and the strategies, we need to take to keep the clinical trials moving forward amidst some of the Coca.

Jeff Dayno: I think, you know, it's a balance of, you know, some of the efforts and the strategies we need to take, you know, to keep the clinical trials moving forward, you know, amidst some of the COVID headwinds. In general, the increase in trial sites, it's not a big increase. We're just trying to sort of complement some of the existing sites. And it is also opening sites in areas of the country that was a bit more open, where sites, existing sites, you know, were, had some of the restrictions due to COVID.

Headwinds in general.

The increase in trial site, it's not a big increase we're just trying to sort of complement some of the existing sites and it is also opening sites in areas of the country that was a bit more open where sites existing sites were had some of the restrictions due to COVID-19 .

With regards to the sleep labs, and the need to have additional or alternate sleep lab.

Jeff Dayno: With regards to the sleep labs, and the need to have additional or alternate sleep labs, you know, they are operating under standard protocols. So, you know, you're right, there is always that risk, you know, in a lot of these mitigation efforts, even telemedicine, some of the remote visits. But with regards to the sleep labs, there are standard protocols, you know, that we would expect to minimize the variability in that data being generated.

They are operating under standard protocols. So youre right there is always that risk.

A lot of these mitigation efforts, even telemedicine in some of the remote visits.

But with regards to the sleep labs, there are standard protocols.

That we would expect to minimize the variability in that data being generated.

I think that the FDA has acknowledged the challenges of Covid they provided.

Jeff Dayno: I think that, you know, the FDA has acknowledged the challenges of COVID, you know, they've provided sort of insight on types of flexibility, you know, all of which could contribute to variability, but you know, we're taking a careful, thoughtful approach in terms of the mitigation strategies and, you know, and we'll be mindful of that, you know, in the trials. But, you know, really good question, you know, something that we've been sort of following closely. Thank you. Thank you. Thank you, Armin.

Sort of insight on types of flexibility all of which.

Could contribute to variability, but we're taking a careful thoughtful approach in terms of the mitigation strategies.

We will be mindful of that in.

In the trials, but really good question something that we've been following closely.

Thank you. Thank you ma'am, thank you amie.

Ami Fadia: Thank you. And our next question comes from the line of David Amsellem with Piper Sandler. Your line of open, please go ahead. Hey, thanks. So just a few.

Thank you and our next question comes from the line of David Lim with Piper Sandler. Your line is open. Please go ahead.

David Amsellem: So first on the Salesforce expansion, I can't say I'm surprised, but what I wanted to get a sense of is what's the extent to which further headcount expansion could be in the cards as you work to reach a wider audience, particularly an audience that doesn't have experience with Oxibate. So I wanted to get your thoughts there. Secondly, how do you think about DTC and expansion of DTC, whether it's unbranded or brand-specific?

Hey, Thanks, So just a few so first on the sales force.

Expansion carefully.

But what I wanted to get a sense of is what's the extent to which further head count expansion could be in the cards.

As you work to.

Reach a wider audience, particularly on an audience that doesn't have experience with with OXXO bait.

So I wanted to get your thoughts there secondly, how do you think about DTC and expansion of the DTC, whether it's unbranded or brand specific I.

David Amsellem: I know that going back to Oxibate, there's been some – there's heavy investment in DTC. So how do you think about that and the need for it? And then lastly, as you think about the Salesforce and as it gets bigger, does that enter into your BizDev calculus regarding your willingness to acquire a commercial-stage asset? In other words, the Salesforce is a leverageable asset.

I know that going back to Oxidate theres been some.

There is heavy investment in DTC.

So how do you think about that and the need for it.

And then lastly, as you think about the sales force.

And as it gets bigger.

Does that enter into your Biz Dev calculus regarding your willingness to acquire commercial stage asset in other words, the sales forces of leverage will asset.

David Amsellem: So does that make it more likely that to the extent you do something, it would be something that is market-ready or already on the market? Thanks. Why don't we take your first question with Jeff Dierks about, and I believe, David, when you said headcount expansion, you are referring to the sales organization, correct? That's correct, yes. Okay, go ahead, Jeff Dierks.

So does that make it more likely that to the extent you do something it would be.

Something that is market ready or already on the market. Thanks.

Why don't we take your first question with chapter I believe David When you said head count expansion you are referring to the sales organization correct. That's.

Thats correct, yes, Okay go ahead, Jeff.

Jeff Dierks: Thanks for the question, David. So we believe that we're scaled for the opportunity within narcolepsy with this expansion of 10%. We're going to be reaching approximately 9,000 healthcare professionals that are managing almost the large, broad base of the diagnosed eligible adult narcolepsy patients. And so I'm not anticipating a further expansion in the future.

Yes. Thanks for the question David So we believe that were scaled for the opportunity within narcolepsy with this expansion of 10%, we're going to be reaching approximately 9000 9000 health care professionals that are managing almost.

Large broad base of the diagnosed eligible adult narcolepsy patients so on.

Im anticipating.

Further expansion in the future, obviously, we'll see what transpires with our growth uptake, but I think that we are scaled for the opportunity in adult narcolepsy with this expansion.

Jeff Dierks: Obviously, we'll see what transpires with our growth uptake, but I think that we're scaled for the opportunity in adult narcolepsy with this expansion. Yeah, and David, your second question along commercial lines that you had, I will refer that to Jeff as well. Yes, so David, the question on DTC is a potential vehicle for promotion. It's not something that we're anticipating doing.

Yes, David Your second question, our long commercial lines, but you had that will refer that to Jeff as well David the question on DTC as a potential vehicle for promotion.

It's not something that we are anticipating doing as John shared we've got an audience of 72000 diagnosed eligible patients for weeks.

Jeff Dierks: As John shared, we've got an audience of 72,000 diagnosed eligible patients for WACIX. You know, we have about 3800 average number of patients on product, we really barely scratched the surface for the opportunity here. We think that with additional products in the marketplace, additional investments in education, we're going to see growth in diagnosis rates, we're going to see patients come back into physician offices. You know, we've been very selective in our investments, I think we've really made some, some, some prudent choices in terms of our ability to reach patients and reaching healthcare professionals. So I don't foresee us looking at a broad based DTC in terms of an investment as part of our promotional mix.

About 3800 average number of patients on product, we've really barely scratched the surface for the opportunity here.

Think that with additional products in the marketplace additional investments in education, we're going to see growth in diagnosis rates, we're going to see patients come back into physician offices.

We've been very selective in our investments I think we've really made some some.

Some prudent choices in terms of our ability to reach patients and reaching health care professionals. So I don't foresee us looking at a broad based DTC in terms of an investment as part of our promotional mix I think we're extremely pleased with how we've been able to continue to grow the brand in and leveraging our existing infrastructure and tactics.

Jeff Dierks: I think we're extremely pleased with how we've been able to continue to grow the brand and, and leveraging our existing infrastructure and, And thank you, Jeff. And if you refer to DTC, David, as a broad-based television commercial campaign, that's probably not an area we would pursue, right, because it's such a narrow orphan disease. As you know, David, television goes to millions of Americans. It's quite expensive.

Thank you, Jeff and if you refer to DTC, David is it broad based television commercial campaign.

It's probably not an area, we would pursue right because it's such a narrow orphan disease as you know David TV goes to millions of Americans, it's quite expensive, but we do have Jeff direct some direct to consumer efforts through the internet through the web website. So we know when narcolepsy patients are online in the evening for instance, and we have add some pull through there. So the team has.

Jeff Dierks: But we do have, Jeff Dirks, some direct-to-consumer efforts through the Internet, through the web, websites. We know when narcolepsy patients are online in the evening, for instance, and we have ads and pull through there. So the team has been engaging consumers, David, all along through the Internet and more effective lower-cost options that have had a good return for us in this space, but we do not anticipate, Jeff Dirks, any kind of broad-based, expensive television-type campaign.

Been engaging consumers, David all along through the Internet and more effective lower cost options that have had a good return for us in this space that we do not anticipate Jeff berkes, any kind of broad based expensive TV type campaign correct, yes, we have.

Jeff Dierks: Correct, yes. We've kind of looked at nomenclature, direct-to-patient versus direct-to-consumer, because we've been able to sort of identify who are eligible patients and investing those dollars in those individuals. But, yes, so direct-to-patient, we've been doing even earlier prior to launch. But direct-to-consumer, broad-based television advertising is something that just who we are and the audience that we're looking to reach, we will not look to invest in.

Kind of looked at nomenclature direct to patient versus direct to consumer because we've been able to sort of identify who are eligible patients and investing those dollars in those individuals', but yes, so direct to patient we've been doing even earlier.

Yes.

Direct to consumer broad based television advertising is something that just who we are in the audience that we're looking to reach we will not look to invest thanks for that question David Okay. David Your third question related to business development. The expansion of about 10% of our sales team does not change our perspective on business development.

Jeff Dierks: Thanks for that question, David. Okay, David, your third question related to business development. You know, the expansion of about 10% of our sales team does not change our perspective on business development, because we've had all along the intent to build out a broad portfolio of assets that are both early and later stage, that have the potential to launch both during and after the WCAG's life cycle. So though our first acquisition in HBS 102 last year was an early-stage asset, a very early-stage asset, that does not signal our only intent, right?

Jeff Dierks: So that intent, I'll say again, is to have that broad-based portfolio in neurology, rare orphan neurology, or in neurology where we can leverage our expertise and infrastructure. Yes, we do have a little bit more infrastructure now, which makes it helpful, but certainly, our intent is to acquire across that stage of development so we can shore up a robust portfolio over time, both during and after WCAG's life cycle.

John Jacobs: David, hopefully that answers your question clearly. Yeah, yeah, super helpful. Thanks, guys. Thanks, David. Good to hear from you.

Corinne Jenkins: Thank you. And our next question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is open.

We've had all along the intent to build out a broad portfolio of assets that are both early and later stage that have the potential to launch both during and after the <unk> lifecycle. So, though our first acquisition in <unk>, one or two last year was an early stage asset a very early stage asset that does not signal our only intent.

Right. So that intent I'll say again is to have that broad based portfolio in neurology railroad from neuro orphan neurology, where we can leverage our expertise and infrastructure, yes, we do have a little bit more infrastructure now, which makes it helpful. But certainly our intent is to acquire across that stage of development. So we can shore up a robust portfolio over time, both during and <unk>.

<unk> lifecycle.

David hopefully that answered your question clearly.

Yes Super helpful. Thanks, guys. Thanks.

Thanks, David good to hear from you.

Corinne Jenkins: Hi, Corinne. Please go ahead. Hey, good morning. Maybe just what portion of narcolepsy patients are currently being treated by that additional thousand or so healthcare providers that you're not going to be able to target? And I'm curious, are we talking about prescribers that have, you know, a handful of narcolepsy patients or prescribers where it is a significant, Jeff Dierks, you want to take that question from Corinne?

Thank you and our next question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is open.

Go ahead.

Yeah, Hey, good morning, maybe just what portion of narcolepsy patients are currently being treated by that additional Alexander So health care providers that youre not going to be able to target and I'm curious are we talking about prescribers that have a handful of narcolepsy patients are prescribers, where it is a significant portion of their practice.

Jeff do you want to take that question from correct sure. Good morning, Karin So about 10% of the patient opportunity is going to reside within that additional thousand health care professionals that we're looking at so it is meaningful when youre thinking about growth potential for the brand and these are going to be physicians that probably have between three and five narcolepsy patients within.

Jeff Dierks: Sure. Good morning, Corinne. So about 10% of the patient opportunity is going to reside within that additional 1,000 healthcare professionals that we're looking at. So it is meaningful when you're thinking about growth potential for the brand. And these are going to be physicians that probably have between three and five narcolepsy patients within their care.

Their care, but again I think that there is opportunity in terms of growth upside understanding that these physicians are no longer simply refilling medicines, but they do have the ability to better diagnose and treat these individuals'. So hopefully those two pieces of information help with your question.

Jeff Dierks: But again, you know, I think that there's opportunity in terms of growth upside, understanding that these physicians are no longer simply refilling medicines, but they do have the ability to better diagnose and treat these individuals. So hopefully those two pieces of information help with your question. Yeah, very helpful. And then maybe on the BD Bryant, I'm just curious how the current market backdrop is impacting conversations you're having with potential targets and if there's anything qualitative to highlight.

Yeah very helpful and then maybe on.

Brian I'm just curious how the current market backdrop is impacting conversations youre, having with potential targets and if there's anything qualitative to highlight there.

Jeff Dierks: You know, what I will say, Corinne, is there's been, in our opinion, a bit of a renaissance in neuroscience and in neurology in general. And I believe even Goldman put out some perspective on that more recently, right?

What I will say current as there has been in our opinion a bit of a renaissance in neuroscience and in neurology and general and I believe even Goldman put out some perspective on that more recently.

But we've seen a renewed interest at least in our experience in neurology in this arena.

Do think the backdrop of the market is facilitating.

Energy toward toward deals so very interesting opportunity, but we have a dedicated team here with our nose to the grindstone. We're starting early in our company history. As we said before so we can take the appropriate amount of time to be thoughtful and choice full in what we do and to build that portfolio across a broad spectrum of opportunities that have the potential.

John Jacobs: But we've seen a renewed interest, at least in our experience in neurology in this arena. And I do think that the backdrop of the markets is facilitating, you know, energy toward deals. So very interesting opportunity. But we, you know, we have a dedicated team here with our nose to the grindstone.

To launch both during and after the <unk> lifecycle as we've said before.

John Jacobs: We're starting early in our company history, as we've said before. So we can take the appropriate amount of time to be thoughtful and choiceful in what we do, and to build that portfolio across a broad spectrum of opportunities that have the potential to launch both during and after the WCAG lifecycle, as we've said before. Thank you, Corinne, for your questions. We appreciate it. Thank you. And again, if you have a question at this time, please press star then one. Our next question comes from the line of Francisco Brisebois with Oppenheimer.

Your current for your questions. We appreciate it.

Okay. Thank you.

Thank you and again if you have a question at this time. Please press Star then one our next question comes from the line of Francisco principally splits Oppenheimer. Your line is open. Please go ahead.

Francisco Brisebois: Your line is open. Please go ahead. Hi. Thanks for taking the questions. Congrats on the progress. I was wondering in terms of the pediatric narcolepsy on the BioProject front, when you say we will look to the data, I was just wondering, any clarification on is the data out? Have you seen it?

Francisco Brisebois: And then just the second half of that question, maybe discuss how that can help your, you know, with the exclusivity, how that can help the IT situation and just maybe remind us of the current IT situation. Thanks. Jeff Dayno, can you address the pediatric question?

Hi, Thanks for taking the questions congrats on the progress.

I was wondering yes of course I was wondering in terms of the.

Pediatric narcolepsy and the bulk appreciate strong.

When you say, we will look to the data I was just wondering any clarification on is the data out have you seen it and then just second half of that question, maybe discuss how that can help you with the exclusivity how that can help the situation and just maybe remind us of the current IP situation. Thanks, Jeff.

Jeff David can address the pediatric question, yes, sure good morning, Frank.

Jeff Dayno: Yeah, sure. Good morning, Frank. Yeah, with regards to BioPerge's, you know, Phase 3 trial.

Yes, with regards to <unk> phase III trial. So <unk> is the sponsor of that trial. So they will be disclosing the trial results. According to their timeline and the plans they have for presenting the data as the sponsor of that trial and sort of working with that timeline.

Jeff Dayno: So, you know, BioPerge is the sponsor of that trial. So, you know, they will be disclosing the trial results according to their timeline and the plans they have for presenting the data, you know, as the sponsor of the trial and sort of working with that timeline. Also, as our partner, you know, as we get a look at the data and sort of work with them, then we will, you know, that will, understanding the data in terms of from a FDA and a regulatory perspective, you know, inform the strategy with regards to the potential opportunity around pediatric exclusivity, you know, and a potential pediatric indication.

So as our partner.

As we get to look at the data and sort of work with them then we will.

We'll understanding the data in terms of from a FDA and a regulatory perspective informed this strategy with regards to the potential opportunity around pediatric exclusivity.

Potential pediatric indication.

Jeff Dayno: So, as they have just completed the Phase 3 trial, we are in the process of, you know, reviewing the data, and working with them in terms of their timeline for disclosing the data as the sponsor of the trial.

So.

As they just completed the phase III trial or in the process.

That and looking at the data.

Working with them in terms of their timeline for disclosing the data as the sponsor of the trial. So we will we will provide further updates this year as we get more insight on that.

Jeff Dayno: So, we will, you know, we'll provide further updates this year, you know, as we get more insight on that. Thank you, Jeff. And Frank, your second question, just reminding you about our patents, we have our core patents carry into 2029. And we're expecting approximately one year of patent term extension, that we would get to apply to one of those core patents, which would carry us out into 2030. WCIC also has layers of protection from a regulatory standpoint, including orphan exclusivity for orphan indications from the time of launch of that indication.

Thank you, Jeff and Frank Your second question, just reminding you that our patents.

Our core patents carry into 2029, and we're expecting approximately one year of patent term extension that we would get to apply to one of those core patents, which would carry us out into 2030. <unk> also has layers of protection from a regulatory standpoint, including orphan exclusivity for orphan indications from the time of launch of that <unk>.

<unk> and we intend to continue to strengthen that position over time.

John Jacobs: And we intend to continue to strengthen that position over time. Thank you, Frank. Great to hear from you. Thanks. Thank you. And I'm showing no further questions and this is going to conclude today's question and answer session. Also, ladies and gentlemen, this does conclude today's conference call. Thank you for participating and you may now disconnect. Everyone have a great day.

Thank you Frank Great to hear from you.

Thanks.

Thank you.

And I am showing no further questions and this is going to conclude today's question and answer session.

Ladies and gentlemen, this does conclude today's conference call. Thank you for participating and you may now disconnect everyone have a great day. Thank.

Thank you everyone.

Okay.

Okay.

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Operator: Price, Sarah C. T. W. E. N. N. M. R. S. S. E. N. N. R. S. S. E. N. M. R. S. E. N. M. R. S. E. N. M. R. S. E. N. M. R. S. E. N. M. R. S. S. E. N. M. N. R. S. E. U. M.. ... C. R. S. E. N. M. R. S. E. N. M. S. S. E. N. David Amsellem, David Hoang, David Hoang, David Hoang, David Hoang, David Amsellem, David Hoang, David Hoang, [music] Thank you for watching! Sushi Sushi, David Amsellem, David Hoang, David Hoang, ,.

Unknown Executive: ... David Amsellem, David Hoang, David Hoang, Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Harmony [music] CLOSING CREDITS CLOSING CREDITS CLOSING CREDITS CLOSING CREDITS Unknown Executive, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Luis Sanay, Ami Fadia, Corinne Jenkins, Jeffrey Dierks, Harmony, Music Music Music Music Music Music Music Music , , , , E. E. E. E. Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music

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