Q1 2021 Harmony Biosciences Holdings Inc Earnings Call

Ladies and gentlemen, thank you for standing by and welcome to the Harmony Biosciences first quarter 2021 financial update call at this time all participant lines are in a listen only mode.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Harmony Biosciences First Quarter 2021 Financial Update Call. At this time, all participant lines are in a listen-only mode.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would need to press Star than one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press Star rather than Zero. I would now like the Hemip Conference over to your host today, Lisa Caparelli, Investor Relations. Please go ahead. Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' first quarter 2021 financial performance and discuss business operations.

After the Speakers' presentation there'll be a question and answer session to ask a question. During the session you will need to press Star then one on your telephone. Please be advised that today's conference is being recorded if youre acquiring any further assistance. Please press Star then zero I would now like to hand, the conference over to your host today use the cash rally.

The relations. Please go ahead.

Thank you operator, good morning, everyone and thank you for joining US today as we review Harmony Biosciences first quarter 2021 financial performance and provide business updates before we begin I encourage everyone to.

Operator: Before we begin, I encourage everyone to go to the investor section of the Harmony Biosciences website to find the press release and slides that accompany our presentation today, including a reconciliation of the gap to non-gap financial measures. At this stage of our company life cycle, we believe non-gap financial results better represent the underlying economics of our business. Our presenters on today's call are John Jacobs, President and CEO, Dr. Jeffrey Dano, Chief Medical Officer, Jeffrey Dirk, Chief Commercial Officer, and Sandeep Capadia, Chief Financial Officer. Moving to slide two.

Go to the investors section of the Harmony Biosciences website to find the press release and slides that accompany our presentation today, including a reconciliation on the GAAP to non-GAAP financial measures at.

At this stage of our company lifecycle, we believe non-GAAP GAAP financial results better represent the underlying economics of our business.

Our presenters on today's call are John Jacobs, President and CEO, Dr. Jeffrey Day, now Chief Medical Officer, Jeffrey Berg, Chief Commercial officer, and Sandeep Kapadia Chief Financial Officer.

Moving 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 I encourage you to consult the risk factors referenced in our SEC filings for additional details.

Lisa Caparelli: 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 uncertainty, and our actual results may differ materially. I encourage you to consult the risk factors referenced in our SEC filings for additional details. At this time, I'd like to turn the call over to our CEO, John Jacobs. Okay, John?

At this time I'd like to turn the call over to our CEO John Jacob John.

Thank you for the introduction, Lisa and I would also like to thank all of the participants for joining our first quarter 2021 conference call. This morning.

John Jacobs: Thank you for the introduction, Lisa, and I would also like to thank all of the participants for joining our first quarter 2021 conference call. I am pleased to share with you that once again, we reported strong sales for WAKA. If you won 2021 revenues of approximately $60 million and achieved profitability for the first time, and our company did, We delivered these results despite the lingering challenges of a pandemic and the anticipated seasonal payer dynamics that impact all branded and specialty products in the first quarter, largely due to insurance resets at the beginning of each year.

I am pleased to share with you that once again, we reported strong sales for weighted with Q1, 2021 revenues of approximately $60 million and achieved profitability for the first time in our company history.

We delivered these results despite the lingering challenges of a pandemic and the anticipated seasonal payer dynamics that impact all branded and specialty products in the first quarter largely due to insurance resets at the beginning of each year.

We believe this performance driven by continued strong demand for wake exits underscores that wakes us addressing significant unmet medical needs in the narcolepsy market as our first in class meaningfully differentiated product for people living with this rare neurological condition.

John Jacobs: We believe this performance driven by continued strong demand for Wakeex underscores that Wakex is addressing significant unmet medical needs in the Narcolepsy market as our first in class, meaningfully differentiated product for people living with this rare neurological condition. Since our inception in 2017, we have focused on developing and marketing novel therapeutic options for people living with rare neurological conditions. Our commitment to these patients has never faltered, and we continue to help an expanding number of narcole Harmony's success is driven by our hardworking employees, patients, and healthcare professionals that have embraced Wakex and the investigators and patients involved in our clinical trials. The momentum we saw in 2020 has continued into 2021.

Since our inception in 2017, we are focused on developing and marketing novel therapeutic options for people living with rare neurological diseases.

Our commitment to these patients has never faltered and we continue to help an expanding number of narcolepsy patients with wake X, while making significant progress on our new clinical programs, which are designed to expand the utility of wakes to new patient populations beyond narcolepsy, including product Willi syndrome, and my Atonic dystrophy.

Harmony success is driven by our hard working employees.

Patients and health care professionals that have embraced awake.

On the investigators and patients involved in our clinical trials.

The momentum we saw in 2020 has continued into 2021 with our robust sales trajectory and strong cash position harmony is well positioned to continue to execute on our three pillars of growth. This year, which are seen on slide three and include.

John Jacobs: With our robust sales trajectory and strong cash position, Harmony is well positioned to continue to execute on our three pillars of growth this year, which are seen on slide three and include Pillar 1, optimize the commercial performance of Wake. We reported Q1 net revenues of $59.7 million driven by growth in the average number of patients and the number of healthcare professionals prescribing WACICs for a long. Pillar 2, expand the clinical utility of weight loss. By mid-year, we expect to have two phase two programs in the clinic investigating pitolocin for potential new indications. And Pillar 3

Pillar, one optimize the commercial performance of <unk>, We reported Q1 net revenues of $59 $7 million driven by growth in the average number of patients and the number of healthcare professionals prescribing wake since launch.

Pillar two expand the clinical utility of weighted by mid year, we expect to have two phase II programs in the clinic investigating pitocin for potential new indications.

And pillar three acquire new assets to expand our portfolio.

John Jacobs: Acquire new assets to expand our portfolio. We have a dedicated team that is focused on identifying new assets for potential acquisition within our area of expertise in order to expand our pipeline. We are starting this process early in our company lifecycle, so we have the time to be thoughtful in our approach and to execute well without unnecessary distraction to our core business with Ways. With more than $140 million in cash and cash equivalents on the balance, continued positive sales growth, and now having reached profitability, we are well positioned to act.

We have a dedicated team which is focused on identifying new assets for potential acquisition within our area of expertise in order to expand our pipeline.

We are starting this process early in our company lifecycle. So we have to trying to be thoughtful in our approach and to execute well without unnecessary distraction to our core business with <unk>.

With more than $140 million on cash and cash equivalents on the balance sheet continued positive sales growth and now having reached profitability, we are well positioned to act.

In summary, I am very pleased with our first quarter performance and look forward to keeping you updated on our progress as we continued to advance our three pillar strategy to grow the company.

John Jacobs: In summary, I am very pleased with our first quarter performance and look forward to keeping you updated on our progress as we continue to advance our three-pillar strategy to grow the company. I would now like to turn over the call to Jeff Dirk, our chief commercial officer.

I would now like to turn over the call to Jeff <unk>, Our Chief commercial Officer, Jeff.

Thanks, John I continue to be impressed with the momentum and progress we have achieved through our launch as indicated by another strong quarter of performance as noted on slide four.

Jeffrey Dierks: Thanks, John. I continue to be impressed with the momentum and progress we've achieved through our launch, as indicated by another strong quarter of performance, as noted on this slide. Net revenues for the first quarter were $59.7 million, demonstrating strong performance and representing our fifth consecutive quarter of net revenue. Moving on to slide five, for our Q1 commercial results, I'd like to highlight a few key performance metrics. We continue to increase the average number of wakes; In the first quarter, the average number of patients on WakeX increased to approximately 2,800, demonstrating continued strong demand for weight and the meaningfully differentiated product profile.

Net revenues for the first quarter were $59 $7 million, demonstrating strong performance and representing our fifth consecutive quarter of net revenue growth.

Moving on to slide five.

For our Q1 commercial results.

I'd like to highlight a few key performance metrics.

We continue to increase the average number of week its patients.

In the first quarter. The average number of patients on <unk> increased to approximately 2800, demonstrating continued strong demand for weekends and meaningfully differentiated product profile.

The weakest prescriber base continued to increase with more than 3700 unique healthcare professionals have prescribed <unk> since launch through the end of the first quarter.

Jeffrey Dierks: The Wakeex prescriber base continued to increase, with more than 2,700 unique healthcare professionals prescribing Wakex since its launch through the end of the first quarter. This represents approximately 33% of the approximately 8,000 healthcare professionals who treat the diagnosed narcolepsy patient population. Market access for Wakes continues to be strong. We've maintained strong formulary access across commercial, Medicare, and Medicaid insurance, and will continue to see additional favorable access for wakeks subsequent to the approval of the cataplexe indication in October of 2020. And with respect to the cataplexy indication, the volume of prescription requests for narcolepsy patients with cataplexy or type 1 narcoleps continued to increase in the first quarter.

This represents approximately 33% of the approximate 8000 health care professionals, who treat the diagnosed narcolepsy patient population.

Market access for weeks continues to be strong we have maintained strong formulary access across commercial Medicare and Medicaid insurance plan and can.

To see additional favorable access per week X subsequent to the approval of the cataplexy indication in October of 2020.

And with respect to the cataplexy indication the volume of prescription requests for narcolepsy patients with cataplexy or type one narcolepsy continued to increase in the first quarter.

Jeffrey Dierks: This growth demonstrates the added value of the cataplexy indication to the overall benefit risk profile of Additional managed care plans made positive formulary changes for type 1 patients in Q1, building upon the decisions we saw in Q4 2020, further helping to accelerate patients' ability to get access to weight. Now, prior to the approval of Wakes, we heard through market research from the narcolepsy community that there were a number of unmet needs in the market.

This growth demonstrates the added value of the cataplexy indication to the overall benefit risk profile of wakes.

Additional managed care plans made positive formulary changes for type one patients in Q1 building upon the decisions we saw on Q4 2020.

Further helping to accelerate patients' ability to get access to <unk>.

Now priority approval of weekend, we heard from market research from the narcolepsy community.

There were a number of unmet needs in the market and there was excitement for how the differentiated product profile of weaker aligned to address those unmet needs.

Jeffrey Dierks: And it was exciting to see how the differentiated product profile of Week is aligned to address those unmet needs. The slides text shows what we heard in order of a need for non-scheduled treatment. Wakex is the first and only FDA-approved non-scheduled treatment, indicated for excessive daytime sleepiness, also known as EDS, or cataplexia, and narc, and a need for more tolerable treatment. Wakesh has an established safety profile with no box warning and no REMC. Wake use is not a stimulant with no evidence of drug tolerance or withdrawal symptoms in clinical studies.

Slide six shows what we heard in order of importance.

Our need for non scheduled treatment options wake acts as the first and only FDA approved nonscheduled treatments indicated for excessive daytime sleepiness also known as Etfs or cataplexy in narcolepsy.

Our need for more tolerable treatment options wake.

<unk> has an established safety profile with no box warning and no Rems program.

<unk> is not a stimulant with no evidence of drug tolerance or withdrawal symptoms and clinical studies.

Jeffrey Dierks: There was a need for more effective. In two phase three clinical trials, Wakex demonstrated a statistically significant reduction in EDF and Caterpins, a need for novel mechanisms of action. Wakex is a first in class molecule with a novel MOLA, only selective H3 receptor antagonist inverse agonist approved by the F2, and a need for less frequently dose. Wakes offers convenient, patient-friendly, once-daily, oral tablet administration in the morning upon, Now, with Wakes being on the market for over a year, we wanted to understand how the product was being received and meeting the expectations and the needs of patients and healthcare We recently commissioned research on behalf of Harmony with 50 Narcolepsy Trading Healthcare Profession, including those with and without experience prescribing weight 30 patients, all with wake, Slide 7 shows key insights obtained from the surveyed healthcare professionals.

There was a need for more effective treatment option.

In two phase III clinical trials week X demonstrated a statistically significant reduction in eds and cataplexy.

Our need for novel mechanisms of action.

<unk> is a first in class molecule with a novel MLA, the only selective <unk> receptor antagonist inverse agonist approved by the FDA.

And a need for less frequently dosing.

Waking offers convenient patient friendly once daily oral tablet administration in the morning upon awakening.

And with <unk> being on the market for over a year, we wanted to understand how the product was being received and meeting the expectations and the needs of patients and health care professionals.

We recently commissioned research on behalf of harmony with 15, narcolepsy treating health care professionals, including those with and without experience prescribing wages and 30 patients all with wake ex experience.

Slide seven shows key insights obtained from the survey health care professionals.

84% of the ACP surveyed share that there is a significant unmet need in the narcolepsy market and believe <unk> offers a unique treatment option for patients.

Jeffrey Dierks: 84% of the HCPs surveyed shared that there is a significant unmet need in the narcolepsy market and believe Wakex offers a unique treatment option for patients. More than 95% stated Wakex was effective for EDF, and more than 90% stated it was effective for Cata. Healthcare professionals with experience prescribing Wakex did even higher and the effectiveness of Wakex and EDS and Cataf and those who had not yet. And the majority of healthcare professionals surveyed stated their prescribing of Wakex had increased since the cataplex's end.

More than 95% stated wakes as effective for Etfs and more than 90 per cent stated it was effective for cataplexy.

<unk> care professionals with experience prescribing weighted stated even higher perception and the effectiveness of wakes in eds, and cataplexy and those who have not yet prescribed and.

And the majority of health care professionals surveyed stated their prescribing of weaker had increased since the cataplexy indication.

<unk> stated that weakness is suitable for the vast majority of narcolepsy patients.

Jeffrey Dierks: ACP stated that Wakex is suitable for the vast majority of narcolepsy, And that has increased since the approval of the cataplexia demonstrating that the overall benefit risk profile offers broad clinical utility for narcolepsy. Wakex is being well received by patients, and healthcare professionals view Wakex as having a lower discontinuation rate compared to other approved narcolepsy treatments, and nearly 90% share that they're expecting to Patient surveys communicated an overall good experience. Patients stated they had a better experience learning about and accessing the medication that other narcolepsy treatments treat.

And that has increased since the approval of the cataplexy indications demonstrating that the overall benefit risk profile offers broad clinical utility for narcolepsy patients.

Wait geeks is being well received by patients and healthcare professionals view waking as having a lower discontinuation rate compared to other approved narcolepsy treatment.

Nearly 90% share that they are expecting the prescribed the same or increase their use of waco and more of their narcolepsy patients in the future.

Now moving on to the patient perspective on slide eight.

Patient surveys communicated an overall good experience with <unk>.

Patient stated they had a better experience and learning about and accessing the medications and other narcolepsy treatments.

Jeffrey Dierks: 75% of patients surveyed share that they believe patients' interest in Wakeex is strong and has even increased since the approval of the cataplexi indication. 80% shared that they are likely to tell other people living with an archaeopsy about Wake. 90% of Wakey expects to continue to take weight. The feedback from this market research not only reinforces what we heard prior to the approval of Wake but also demonstrates how the meaningfully differentiated product profile of Waking is meeting the unmet needs of the market and highlights future growth potential. Summary, I'm extremely proud of our first quarter, which saw strong growth in revenue and average number of patients. And the market research reinforces the strong future growth potential with Wake in the large narcolepsy market opportunity for the 16 Jeff?

75% of patients surveyed share that they believe patient interest in <unk> is strong and has even increased since the approval of the cataplexy indication.

80% share that they are likely to tell other people living with narcolepsy about weekend.

And 90% of wake its users expect to continue to take Waco.

The feedback from this market research not only reinforces what we heard prior to the approval of <unk>, but also demonstrates how the meaningfully differentiated product profile waking is meeting the unmet needs of the market and highlights the future growth potential of wix.

In summary, I'm extremely proud of our first quarter performance, we saw strong growth in revenue and average number of patients.

And the market research reinforces the strong future growth potential with <unk> and the large narcolepsy market opportunity for the 165000 people living with narcolepsy.

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

Jeffrey M. Dayno: Thank you, Jeff, and good morning, everyone. At Harmony, the second pillar of our growth strategy is to expand the clinical utility of Patolocent by pursuing new indications in additional rare neurological disorders with unmet medical needs and by expanding the label in Narcolepsy to include pediatric patients. Our current development programs are shown on our pipeline chart, as seen on slide number nine. With regard to pursuing new indications in additional orphan rare neurological disorders, all sites have been activated and are currently enrolling patients in our phase two trial in patients with Prader Willie Syndrome, or PWS. This trial is evaluating petulocent for excessive daytime sleepiness or EDS, behavioral symptoms, and impaired cognitive functions.

Thank you, Jeff and good morning, everyone.

At harmony, the second pillar of our growth strategy is to expand the clinical utility of the tolson by pursuing new indications and additional orphan rare neurological disorders with unmet medical needs.

Expanding the label in narcolepsy to include pediatric patients.

Our current development programs are shown on our pipeline chart as seen on slide number nine.

With regard to pursuing new indications in additional orphan rare neurological disorders. All sites have been activated and are currently enrolling patients in our phase II trial in patients with <unk> Willi syndrome or PWM.

This trial is evaluating <unk> for excessive daytime sleepiness or eds, behavioral symptoms and impaired cognitive function.

Jeffrey M. Dayno: PWS affects approximately 15 to 20,000 patients in the United States and represents an unmet medical need for which Harmony is committed to pursuing a new treatment option for this patient community. A potential larger market opportunity is highlighted by another one of our development programs, that being in patients with myatonic dystrophy, or DM, which is the most common form of adult-onset muscular dystrophy and one that is a genetic disorder inherited in an autosomal dominant pattern. Recent estimates suggest a prevalence of about 5 per 10,000 people with the genetic defect from myotonic dystrophy type 1 or DM1, which is the most common form of this disorder.

Pwm's effects, approximately 15% to 20000 patients in the United States and represents an unmet medical need for which harmony is committed to pursuing a new treatment option for this patient community.

A potential larger market opportunity is highlighted by another one of our development programs that being in patients with my atonic dystrophy or D. M, which is the most common form of adult onset muscular dystrophy, and one that is a genetic disorder inherited and an autosomal dominant pattern.

Latest estimates suggest a prevalence of about five per 10000 people with the genetic defect from my attack gets her feet type one or <unk>, one which is the most common form of this disorder.

Jeffrey M. Dayno: This equates to about 160,000 people in the U.S. with the genetic defect for DM1. Based on the clinical presentation, with 50% of this population likely being symptomatic, and of those, about 50% being diagnosed, the current number of people diagnosed with DM1 in the U.S. is approximately 40,000. Of these, 80 to 90% experience excessive daytime sleepiness, and over 90% also report fatigue. Thus, EDS and fatigue are the two most common non-muscular symptoms in patients with DM1, and they also have a high impact on their daily functioning. There are currently no approved treatments for patients with myiotonic dysrophy.

This equates to about 160000 people in the U S with the genetic defect for D. M. One.

Based on the clinical presentation with 50% of this population likely being symptomatic and of those about 50% being diagnosed the current number of people diagnosed with DM one in the U S is approximately 40000.

Of these 80% to 90% experienced successive daytime sleepiness and over 90% also report fatigue.

So eds and fatigue are the two most common non muscular symptoms in patients with D. M. One and they also have a high impact on their daily functioning.

There are currently no approved treatments for patients with my tonic yesterday.

Jeffrey M. Dayno: As you heard from John and saw in today's press release, we are on track to initiate a phase two trial in patients with DM1 this quarter. Now, let me comment on our program in pediatric norgalepid. Our strategy with respect to pediatric narcolepsy has always been to achieve pediatric indications for both EDS and cataplexy and to obtain pediatric exclusivity. As you are aware, our strategic partner, Bioprege, has been conducting a phase three clinical trial evaluating ptollicin in pediatric patients with narcolepsy. Biopresge amended the protocol and increased the number of patients in the trial, which has pushed out the timeline for trial completion and read-up of the data.

As you heard from John and so on today's press release, we are on track to initiate a phase II trial in patients with DM one this quarter.

Now, let me comment on our program in pediatric narcolepsy.

Our strategy with respect to pediatric narcolepsy has always been to achieve pediatric indications for both eds, and cataplexy and to obtain pediatric exclusivity.

As you are aware our strategic partner <unk> has been conducting a phase III clinical trial evaluating <unk> in pediatric patients with narcolepsy.

I appreciate you amended the protocol and increase the number of patients in the trial, which has pushed out the timeline for trial completion and readout of the data.

Jeffrey M. Dayno: Together, Bioprige and Harmony have decided to wait for the readout of the data to inform how best to advance the pediatric narcolepsy program. We believe that our strategic decision to wait for this data before advancing the pediatric program is the most prudent and thoughtful path forward from a development and financial perspective. In the meantime, we are continuing to evaluate regulatory strategies with regard to obtaining pediatric exclusivity.

Together by appreciate on harmony have decided to wait for the readout of the data to inform how best to advance the pediatric narcolepsy program.

We believe that our strategic decision to wait for this data before advancing the pediatric program is the most prudent and thoughtful path forward from a development and financial perspective.

In the meantime, we are continuing to evaluate regulatory strategies with regard to obtaining pediatric exclusivity.

Jeffrey M. Dayno: We remain committed to pediatric patients with narcolepsy and will continue to pursue this indication, as well as seek pediatric exclusivity for Wakex. We look forward to providing an update on the status of this clinical program in the coming month. Lastly, I would like to highlight a few key points from data we recently presented at the American Academy of Neurology annual meeting last month and other data that were published in the journal Sleep Medicine earlier this year.

We remain committed to pediatric patients with narcolepsy and to continue to pursue this indication as well as seek pediatric exclusivity for <unk>.

We look forward to providing an update on the status of this clinical program in the coming months.

Lastly, I would like to highlight a few key points from data. We recently presented at the American Academy of Neurology annual meeting last month.

And other data that was published in the journal sleep Medicine earlier this year.

These data from post hoc analyses of the pivotal data for wake ex that address clinically relevant endpoints and helped to enhance the understanding of the product profile of <unk>, specifically related to its efficacy and onset of action.

Jeffrey M. Dayno: These data from post-talk analyses are the pivotal data for Wakex that address clinically relevant endpoints and help to enhance the understanding of the product profile of Wakex, specifically related to its efficacy and onset of action. We conducted post-talk analyses from the Harmony 1 and Harmony CTP pivotal trials that examined the efficacy of Wakex in patients with a high burden of narcolepsy symptoms, both EDS and cataplexy, and looked at the time to onset of response in patients on wakeics compared with placebo.

We conducted post hoc analysis from the harmony, one and harmony TTP pivotal trials and examine the efficacy of <unk> in patients with a high burden of narcolepsy symptoms, both eds and cataplexy.

And looked at the time to onset of response in patients on <unk> compared with placebo.

I will first comment on the high burden analysis, which was published in the journal sleep Medicine earlier this year.

Jeffrey M. Dayno: I will first comment on the high burden analysis, which was published in the journal Sleep Medicine earlier this year, the results of which are seen on slide number 10. High symptom burden for EDS was defined as patients with an F-worth, sleepiness scale, or ESS score greater than or equal to 16 at baseline.

The results from which are seen on slide number 10.

High symptom burden for eds was defined as patients with an F worth sleepiness scale or ESF score greater than or equal to 16 at baseline.

Jeffrey M. Dayno: This analysis included 118 patients. The results showed that patients on Wakex went from an ESS score of 19.0 at baseline to 13.1 at the end of the study, compared to patients on placebo who went from 19.4 at baseline to 16.9 at the end of the study. This finding was both statistically significant and represents a clinically meaningful improvement. A high symptom burden for cataplexy was defined as patients with greater or equal to 15 cataplexy attacks per week at baseline.

This analysis included 118 patients.

The results showed that patients on <unk> went from an ESG score of 19.0 baseline to $13. One at end of the study compared to patients on placebo, who went from $19 four at baseline to $16 nine at Endo study. This finding was both statistically significant.

And represents a clinically meaningful improvement.

High symptom burden for cataplexy was defined as patients with greater or equal to 15 cataplexy attacks per week at baseline.

Jeffrey M. Dayno: This analysis included 31 patients. The results show that patients on wakex went from a weekly rate of cataplexy of 23.9 at baseline to 9.4 at the end of the study, compared to patients on placebo who went from 23.1 at baseline to 23.0 at the end of the study, again resulting in a statistically significant and clinically meaningful improvement in patients with high symptom burden. This analysis demonstrates that in adult patients with narcolepsy, Pitolocin is efficacious for improving EDS and reducing cataplexy, even in patients with high symptom burden and severe disease.

This analysis included 31 patients.

The results showed that patients on wake ex went from a weekly rate of cataplexy of $23 nine at baseline to $9. Four at end of this study compared to patients on placebo, who went from $23. One at baseline to 23.0 at end of study.

Again, resulting in a statistically significant and a clinically meaningful improvement in patients with high symptom burden.

This analysis demonstrates that in adult patients with narcolepsy.

<unk> is efficacious for improving Etfs and reducing cataplexy.

Even in patients with high symptom burden and severe disease.

Moving to slide number 11, and the time to onset of response analysis for <unk>.

Jeffrey M. Dayno: Moving to slide number 11 and the time to onset of response analysis for WACIC. These data were recently presented at the American Academy of Neurology annual meeting last month. Onset of clinical response was defined as the first time point at which there was a statistically significant difference between ptollicent and placebo. This analysis showed that improvement in EDS and reduction in cataplexy begins at week two after the start of dosing, which is when Wakeex demonstrated a statistically significant separation from placebo on both the ESS score and the weekly rate of cataplexy, then continue to improve throughout the duration of the trials.

These data were recently presented at the American Academy of Neurology annual meeting last month.

On set of clinical response was defined as the first time point at which there was a statistically significant difference between <unk> and placebo.

This analysis showed that improvement in Etfs and reduction in cataplexy begins at week two after the start of dosing, which is when wake X demonstrated a statistically significant separation from placebo on both the ESF score and the weekly rate of cataplexy debt.

Continue to improve throughout the duration of the trials.

While the prescribing information for wake States that it may take up to eight weeks for some patients to experience a clinical response. This analysis shows that the effect of <unk> may be experienced prior to week eight and it's early it's week to after the start of treatment.

Jeffrey M. Dayno: While the prescribing information for Wake states that it may take up to eight weeks for some patients to experience a clinical response, this analysis shows that the effect of Patalcson may be experienced prior to week eight and as early as week two after the start of treatment.

I believe these analyses that we have shared with the medical community focused on clinically relevant outcomes add to the body of evidence in support of the efficacy profile of <unk>.

Jeffrey M. Dayno: I believe these analyses that we have shared with the medical community focused on clinically relevant outcomes add to the body of evidence in support of the efficacy profile of WACA. These data, along with the safety and tolerability profile, as well as its non-scheduled status, result in Wakex being a differentiated treatment option for both improving EDS and reducing attacks of cataplexy in adult patients living with narcolepsy. In closing, we remain committed to advancing our clinical development programs for Patolosan.

These data along with the safety and Tolerability profile as well as its nonscheduled status results and wake X being a differentiated treatment option for both improving etfs and reducing attacks of cataplexy in adult patients living with narcolepsy.

In closing, we remain committed to advancing our clinical development programs for Toalson.

Jeffrey M. Dayno: Based on its unique mechanism of action, we view Patalosin as a portfolio and a product opportunity, and our goal is to optimize the life cycle management plan for Patelicent in the pursuit of new indications in additional orphan rare neurological disease patient populations who are living with unmet medical needs. Thank you, and I will now turn the call over to our CFO, Sandeep Capadia, who will provide an update on our financial performance.

Based on its unique mechanism of action, we view <unk> as a portfolio and a product opportunity and our goal is to optimize the lifecycle management plan from <unk> in the pursuit of new indications in additional orphan rare neurological disease patient populations, who are living with unmet medical needs.

Thank you and I will now turn the call over to our CFO Sandeep Kapadia, who will provide an update on our financial performance so on deep.

Jeffrey M. Dayno: Sondi, Thank you, Jeff, and good morning, everyone. I'm excited to have joined Harmony Biosciences and look forward to meeting many of you. Earlier today, we posted our first quarter 2021 press release and filed our 10Q, where you can find details on our financial and operating results for the quarter. I'd like to take the opportunity to share with you some of the highlights from the quarter, which can be seen on slides 12 and 13.

Thank you, Jeff and good morning, everyone.

Im excited to have joined harmony Biosciences, and look forward to meeting many of you.

Earlier today, we posted our first quarter 2021 press release and filed our 10-Q, where you can find details on our financial and operating results for the quarter.

I'd like to take the opportunity to share with you some of the highlights from the quarter, which can be seen on slide 12 and 13.

I am pleased to see that the momentum from 2020 has continued into the first quarter of 2021.

Sandip S. Kapadia: I'm pleased to see that the momentum from 2020 has continued into the first quarter of 2021. We grew Waking Sales to our highest quarter to date, managed our operating expenses, and posted our first quarter positive net income and earnings for share. For the first quarter of 2021, Harmony posted 59.7 million in Wakey's nut product revenues, as compared to 19.8 million in the prior year quarter.

We grew weighted sales to our highest quarter to date.

Managed our operating expenses and posted our first quarter positive net income and earnings per share.

For the first quarter of 2021 harmony posted $59 7 million and <unk> net product revenues as compared to $19 8 million in the prior year quarter.

We're pleased with the continued sequential growth of revenues, especially in the first quarter is there a typical headwinds from insurance reauthorization and co pays resetting.

Sandip S. Kapadia: We're pleased with the continued sequential growth of revenues, especially in the first quarter, as there are typical headwinds from insurance reauthorizations and copays resetting. We continue to see an increase in the average number of patients on therapy during the first quarter, as well as the number of healthcare professionals prescribing Wake. For the first quarter of 2021, cost of product sold was 10.4 million versus 3.5 million in the prior year quarter. For the first quarter of 2021, GAAP operating expenses were 34.7 million, up significantly versus the prior year quarter of 26 million.

We continue to see on increase in average number of patients on therapy during the first quarter as well as the number of healthcare professionals prescribing <unk>.

For the first quarter of 2021 cost of product sold were $10 4 million versus $3 5 billion in the prior year quarter.

For the first quarter 2021, GAAP operating expenses were $34 7 million up significantly versus the prior year quarter of $26 million.

The increase was anticipated as we in 2020 advanced our pipeline programs and PWM and D. M increased sales and marketing activities associated with a weighted <unk> launched and expanded our operations as we became a public company.

Sandip S. Kapadia: The increase was anticipated as we advanced our pipeline programs in PWS and DM, increased sales and marketing activities associated with the Wayfix launch, and expanded our operations as we became a public company. For the first quarter of 2021, Harmony posted a Gap net income of $7.4 million, or 13 cents per share.

For the first quarter of 2021 harmony posted GAAP net income of $7 4 million or <unk> 13 per share. This.

Sandip S. Kapadia: This compares favorably to last year's first quarter net loss of $38.6 million, or $6.30 per share. I'm also pleased with the underlying operating profitability of the business. Harmony reported non-gap-adjusted net income of $22.4 million, or 38% per diluted share. Non-gap-adjusted net income excludes interest expense, amortization, depreciation, stock-based compensation, and other non-operating items.

This compares favorably to last year's first quarter net loss of $38 6 million or $6 30 per share.

I'm also pleased with the underlying operating profitability of the business.

Harmony reported non-GAAP adjusted net income of $22 4 million or <unk> 38 cents per diluted shares.

Non-GAAP adjusted net income excludes interest expense amortization depreciation stock based compensation and other non operating items.

Non-GAAP adjusted net income is a non-GAAP financial measure please see our press release for a reconciliation of this measure.

Sandip S. Kapadia: Non-Gap adjusted net income is a non-gap financial measure. Please see our press release for a reconciliation of this measure. We also closed the quarter in a strong cash position with 141.2 million. This is down sequentially from year-end 2020, primarily due to the 100 million milestone we remitted to Bioprege in early January, offset by positive cash flow from operations. So looking ahead to 2021, we continue to expect to see strong quarter-over-quarter sales growth as we continue to make incremental investments in our pipeline and the launch of WICT, all the while maintaining profitability for the year.

We also closed the quarter in a strong cash position with $141 2 million.

This is down sequentially from year end 2020, primarily due to the 100 million milestone, we remitted to bio per day in early January offset by positive cash flow from operations.

So looking ahead in 2021, we continue to expect to see strong quarter over quarter sales growth as we continue to make incremental investments in our pipeline and the launch of weight gain.

All the while maintaining profitability for the year.

Finally, a few words on our strategy and approach to business development.

Sandip S. Kapadia: Finally, a few words on our strategy and approach to business development. After spending the last 12 months focused on ensuring a successful commercial launch of weight, we are now determined to broaden our pipeline with additional assets that address orphan rare neurological disorders. We're taking a disciplined approach to review opportunities ranging from early clinical to commercial with a focus on leveraging our demonstrated clinical and commercial expertise while minimizing disruption to the Wakeex launch. In addition, we intend to be opportunistic with our existing financial resources while continuing to control our costs.

After spending the last 12 months focused on ensuring a successful commercial launch of <unk>. We are now determined to broaden our pipeline with additional assets that address the orphan rare neurological disorders.

We're taking a disciplined approach to review opportunities ranging from early clinical to commercial with a focus on leveraging our demonstrated clinical and commercial expertise, while minimizing disruption in the wake X launch.

In addition, we intend to be opportunistic with our existing financial resources, while continuing to control our cost.

We look forward to providing updates on our business development progress on future calls.

Sandip S. Kapadia: We look forward to providing updates on our business development progress on future calls. So, in conclusion, Harmony is in a strong financial position with growing revenues, prudent expense controls, and a healthy balance. As such, we are well positioned to continue to deliver on our three pillars of growth that John mentioned earlier in the call. With that, I'd like to turn the call back to John for his closing remarks.

So in conclusion harmony and a strong financial position with growing revenues prudent expense control and a healthy balance sheet.

As such we are well positioned to continue to deliver on our three pillars of growth that John mentioned earlier on the call.

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

Thank you Sandeep and the entire harmony team for your continued dedication.

John Jacobs: Thank you, Sandeep, and the entire Harmony team for your continued dedication. In summary, I am very pleased with our continued progress on our three pillars of growth. Q1 was an outstanding quarter representing our fifth consecutive quarter of sequential revenue growth. We continue to advance our development programs in Prada Willie Syndrome and Miatonic District. Financially, we are in a strong cash position, and for the first time in our company's history, we have reached profitability.

In summary, I am very pleased with our continued progress on our three pillars of growth.

Q1 was an outstanding quarter, representing our fifth consecutive quarter of sequential revenue growth.

We continued to advance our development programs in <unk> Willi syndrome, and my Atonic dystrophy.

Financially we are on a strong cash position and for the first time in our company history have reached profitability.

John Jacobs: This success positions us well to pursue our third pillar of growth, acquiring additional assets, and expanding our pipeline. Operator, we will now take questions from the audience. Thank you. As a reminder, to ask a question, you would need to press Star, then one on your telephone.

This success positions us well to pursue our third pillar of growth acquiring additional assets to expand our pipeline opt.

Operator, we will now take questions from the audience.

Thank you.

As a reminder to ask a question you will need to press Star then one on your telephone to withdraw your question. Please press the pound key please standby, while we compile the Q&A roster.

Operator: To withdraw your question, please press the pound key. Please stand by while we compile the Q&A Ross. Our first question comes from the line of David Anselaum with Piper Sandler. Your line is now open. Hey, thanks. So just a couple.

Our first question comes from the line of David <unk> with Piper Sandler Your line is now open.

Hey, Thanks, So just a couple so.

David A. Amsellem: So first, I wanted to get your high-level thoughts on more aggressive payer contracting down the road to the extent you think you need to do it. And the reason I ask is that Jazz has contracted fairly aggressively on ZyWave with some success. Obviously, not an apples-to-apples comparison here, but with contracting in the space, how do you think about your contracting position for WakeX? So that's number one. And then number two is, in terms of the cadence for sales this year, I mean, you talked about some headwinds for one queue, seasonality, things that are customary across the space. With that in mind, can you just talk about what that means for, say, 2Q in terms of moderation of gross penettes. Thanks.

So first wanted to get your high level thoughts on <unk>.

More aggressive payer contracting down the road to the extent you think you need to do it and the reason I ask is that.

Jazz is <unk>.

Contracted fairly aggressively on on XI waves.

And with with some success, obviously not on apples to apples comparison here, but.

With contracting in the space, how do you think about your.

Your contracting position for wake effects. So thats number one and then number two is.

In terms of the cadence of her.

For <unk>.

Sales this year I mean, you talked about some headwinds.

For one to seasonality things that are customary across the space.

With that in mind can.

Can you just talk about what that means for <unk> in terms of moderation of gross to net thanks.

David A. Amsellem: All right, Jeff, Dirk, want you to take David's first question? Good morning, David, and thank you for the question. So with respect to managed care, we're extremely pleased with the favorable market access coverage that we've seen with Wakex since launch. And, as we shared in previous calls, we've secured approximately 80% coverage of all U.S. insured lives across commercial Medicare, Part D, and Medicaid. And since the recent approval of the Cataplex indication, we've seen additional favorable access for Wakex, building on those that we've seen in Q4. And really, what that's doing is either eliminating or reducing the cost.

All right Jeff.

David's first question Okay.

Good morning, David and thank you for the question. So with respect to managed care. We're extremely pleased with the favorable market access coverage that we've seen with wake since launch and as we shared in previous calls we secured approximately 80% coverage of all U S insured lives across commercial Medicare part.

Part D and Medicaid and since the recent approval of the cataplexy indication we've seen even additional favorable access for wake ex building on those that we've seen in Q4 and really what that's doing is either eliminating or reducing some of the step edits for type one lives.

Jeffrey Dierks: Some of the step edits for type 1 lives. And so we believe we're very well positioned within the market access landscape to support our patients. We have selectively contracted with a handful of plans that we do not believe that there will be a need for aggressive contracting, given the overall benefit risk profile of Wakex and what we've been seeing in the market. So with that, if that answers your question, I can turn it over to Sandeep and answer the second part of your question with respect to cadence on sales. Yeah, go ahead, San Dieh. Hi.

And so we believe we're very well positioned within the market access landscape to support our patients we.

We have selectively contracted with a handful of plans that we do not believe that there will be a need for aggressive contracting given the overall benefit risk profile of wakes and what we've been seeing in the market.

So with that if that answers your question I can turn it over to Sandeep and answer the second part of your question with respect to cadence on sales. Yes go ahead, Sandy yes, hi.

Sandip S. Kapadia: We had a really strong quarter. I was very pleased with, you know, $15,000 and $7 million in top line revenue, really solid growth versus the fourth quarter and certainly versus the prior year. As you mentioned, typically, you have first quarter headwinds, which results in slightly higher growth than that in the first quarter. But we obviously see that reversing as we go through.

Hi.

We had a really strong quarter on great placement.

$7 million on topline revenue really we saw a solid growth versus fourth quarter certainly versus prior year.

As you mentioned typically you have first quarter headwinds, which results in slightly higher gross to net.

This quarter, we obviously see that reversing as we go through the rest of the year and we expect strong quarter over quarter growth for the balance per year. So very very pleased with how we came out of Q1 and I think.

Sandip S. Kapadia: the rest of the year, and we expect, you know, strong quarter over quarter growth for the balance of the year. So very, very pleased with how we came out in Q1 and I think, you know, well positioned for the balance of the year as well. Hopefully, that gives you some color.

Well positioned for the balance of the share as well hopefully that gives you some color there.

David A. Amsellem: Yeah, no, that's really helpful. If I may just ask one more question, speaking, on business development and M&A. Obviously, you've been talking about that for a while. Can you give us a sense of how aggressive you're willing to be in terms of, you know, potential deal size?

Yeah, No that's really helpful and if I may just ask one more sneak in one more just on business development and M&A, obviously, you've been talking about that for a while.

Can you give us a sense of how aggressive youre willing to be in terms of.

John Jacobs: I know that's a tough one to answer. They're probably looking at a lot of different assets, but, you know, how big can you go for an asset, whether it's a commercial stage or pipeline? You know, David, what I would say is we're determined to broaden our pipeline with additional assets, as you've stated. We're starting early in our company history so we can take our time to do this thoughtfully, and we want to make sure that whatever we acquire is complementary to what we do now at Harmony, what we know how to do well, and that it allows us internal synergy to leverage our current infrastructure and expertise.

Potential deal size.

I know thats, a tough one to answer probably looking at a lot of different assets.

How big can you go.

For an asset whether it's commercial stage or pipeline.

David What I will say is what I will say is we are determined to broaden our pipeline with additional assets as you've stated.

We're starting early in our company history. So we can take our time to do this thoughtfully and we want to make sure that whatever we acquire that it's complementary to what we do now with harmony, what we know how to do well and that it allows us internal synergy to leverage our current infrastructure and expertise.

John Jacobs: And it should be in the rare orphan neurological and CNS arena where we have that infrastructure deployed right now. And certainly, we want to make sure that we have the right capability to acquire that, and that's one of the reasons we chose to go public last year. We're in a very strong cash position right now, so we have options on how to finance a potential deal when we do find the correct deal for Harmony. Thanks, that's great.

And it should be in the rare orphan neurological and CNS arena, where we have that infrastructure deployed right now.

And certainly we want to make sure that we have the right capability to acquire that and that's one of the reasons. We chose to go public last year, where on a very strong cash position right now we have optionality on how to finance a potential deal when we do find the correct deal for harmony.

Okay, that's great. Thanks.

Operator: Thanks. Thank you. Our next question comes from the line of Chris Howardton with Jeffries. Your line is now open.

Thank you.

Our next question comes from the line of Chris Howerton with Jefferies. Your line is now open.

Chris Howerton: Hi, good morning everybody. Thanks so much for taking the questions and congratulations on the new website. So I think maybe just a couple of questions from me, likely mostly related to Jeff Dano. I guess, first of all, with respect to myotonic dystrophy, I guess, you know, if you could just give us a sense in terms of what it takes to obtain that diagnosis, and maybe, you know, if you have some thoughts as to what the shape or trajectory of that diagnosis rate might be when and if, you know, therapy.

Hi, good morning, everybody. Thanks, so much for taking the questions and congratulations on the progress this quarter.

So I think maybe just a couple of questions from me.

Likely mostly related to just day now.

I guess first of all with respect to my atomic dystrophy I guess.

If you could just give us a sense in terms of what does it take to obtain that diagnosis and maybe if you have some thoughts as to what the shape or trajectory of that diagnosis rate might be when and if.

Therapies become available for those patients such as <unk>.

Chris Howerton: These become available for those patients, such as wake eggs. That would be question one. And then question two is just with respect to the pediatric narcolepsy study that was described by BioProge. I'm curious if we could get a little more color.

Would be question one and then question two is just with respect to debt.

Pediatric narcolepsy studies debt was described.

Bye Bye approach a just I'm curious if we could get a little more color I might've missed it in terms of what exactly the headwinds were true that study and maybe just.

Jeffrey M. Dayno: I might have missed it in terms of what exactly the headwinds were to that study and maybe just a reiteration of what we can know about. Yeah, sure, Chris. Good morning. Thanks for the question. So with regard to myatonic dystrophy, the diagnosis is a genetic disorder, and it's inherited in an autosomal dominant pattern. So it's basically a genetic diagnosis You know, that's how the diagnosis is confirmed. Symptoms include what's called myotonia, so the problems of difficulty with muscle relaxing, which results in muscle weakness.

Reiteration of what we know about the timelines at this point. Thank you.

Yeah sure Chris Good morning, Thanks for the question so with regards to my Atonic dystrophy.

So the diagnosis, it's a genetic disorder and it's inherited in an autosomal dominant pattern. So it's basically a genetic diagnosis that that's how the the diagnosis is confirmed.

Symptoms include.

What's called Myotonia, so the problems of difficulty muscle relaxing with which results in muscle weakness, but also what we've learned and as the disorder is more recognized over the years that eds excessive daytime sleepiness and fatigue are the two most common non muscular symptoms in 80%.

Jeffrey M. Dayno: But also, you know, what we've learned, and, you know, as the disorder is more recognized over the years, that, you know, EDS, excessive daytime sleepiness, and fatigue are the two most common non-muscular symptoms in, you know, 80 to 90 percent of those patients. So they come to medical attention and eventually get to a neurologist, and then the diagnosis is confirmed, as I said, through genetic testing, a defect basically on chromosome 19 of a certain protein.

Andy percentage of those patients so they come to medical attention and eventually getting to a neurologist and then the diagnosis is confirmed as I said through genetic testing.

Defect basically.

On chromosome 19 of a certain protein on.

Jeffrey M. Dayno: Then with regard to overtime, you know, with regard to any disease state, as it becomes more recognized, onset is, you know, usually symptoms late adolescence into early 20s, but then, you know, it is a bit of a long journey to diagnosis because there's, there are no approved treatment options for myiotic dystrophy.

Then with regards to overtime.

With regards to any any disease state as it becomes more recognized on set is usually symptoms laid out of lessons into early twenties, but then.

It is a bit of a long journey to diagnosis because there are no approved treatment options from my time dystrophy.

Jeffrey M. Dayno: There are, you know, other sponsors working on new treatments, and as we step into this arena and bring more attention and awareness, I think over time, diagnosis rates will increase. So does that answer your question, Chris, about my autotomystrophy? Yeah, it does.

There are other sponsors working on new treatments and as we step into this arena.

Bring more attention and awareness and we think over time diagnosis rates will increase.

Does that answer your question, Chris from my time dystrophy.

Yes, it does if I might just maybe ask.

Chris Howerton: If I might just maybe ask a quick follow-up to that is that, at least for many genetic abnormalities, there's newborn screening. So is there any discussion about the potential for that genetic defect to be detected in such a manner? Chris, it's a great question.

A quick follow up to that is that I know that at least four.

Many genetic abnormalities theres newborn screening so is there any discussion about the potential for that genetic defect could be detected in such a manner.

Chris It's a great question there it actually it is included on some of the newborn screening panel is the latest epidemiologic data that we have actually comes from a large study from the New York State Department of health and their newborn screening which is.

Jeffrey M. Dayno: It is actually included on some of the newborn screening panels. The latest epidemiologic data that we have actually comes from a large study from the New York State Department of Health and their newborn screening, which we cited in terms of about 150,000 patients in the U.S., potentially with the genetic defect from myotonic dystrophy type 1 or DM1, which is the most common form of myotomy dystrophy.

What we cited in terms of about 150000 patients in the U S potentially with the genetic defect from my Atonic dystrophy type, one or <unk>, which is the most common form of my Aton dystrophy. So there is similar with other rare on.

Jeffrey M. Dayno: So there is, you know, similar to other rare orphan disorders in terms of genetic screening, there is the opportunity to pick up these genetic defects much earlier in life and then, you know, with greater awareness in the medical community, hopefully leading to earlier diagnosis. Okay, all right, very good. So turning to your question about pediatric narcolepsy and the Biopurge study with regard to a little more color. First, let me say, you know, we remain committed to patients with pediatric narcolepsy, and it was always our plan to wait for Biopurge's pediatric narcolepsy trial to read out before beginning our own trial.

Orphan disorders in terms of genetic screening there is the opportunity to pick up these genetic defects much earlier in life, and then with greater awareness in the medical community hopefully leading to earlier diagnosis.

Okay, Alright very good.

Okay.

So turning to.

Your question about pediatric narcolepsy.

Narcolepsy.

Bye I appreciate study with regards to a little more color.

So first let me say, we remain committed to patients with pediatric narcolepsy.

And it was always our plan to wait for bio <unk> pediatric narcolepsy trial to readout before beginning our own trial.

Jeffrey M. Dayno: So Biopurge's trial is delayed. Basically, they amended the protocol, as I mentioned in my earlier comments, they amended the protocol and increased the sample size to make the study more robust, and that led to a delay in the readout of the trial.

So <unk> trial is delayed basically they amended the protocol as I mentioned in my earlier comments the amended the protocol.

And increase the sample size.

And sort of the two.

This study more robust and that led to a delay in the readout of the trial.

Jeffrey M. Dayno: So, along with our partner, Bioprge, we made a strategic decision to wait for the Phase 3 trial to read out before initiating our own, which was our original plan. You know, at this point, I think it makes the most sense to wait for the data before starting another trial and let the data inform us going forward. It can give us some optionality.

Along with our partner bio <unk>, we made a strategic decision to wait for the phase III trial to readout before initiating our own which was our original plan.

At this point I think it makes the most sense to wait for the data before starting another trial and let the data inform us going forward and could provide us some optionality.

Jeffrey M. Dayno: We feel that's a prudent approach and thoughtful, and we're working with our partner, Biobrege, to that end. So, you know, we remain committed to the pediatric population obtaining this indication, and we'll provide an update in the coming months on that program. Okay. And so at this point, it's difficult to say when those data may become available, and you'll just, that'll be the expected update, maybe. That'll be the expected update in the coming months, yes. Got it.

We feel thats, a prudent approach and thoughtful.

And we're working with our partner <unk> to that and so we remain committed to the pediatric population obtaining on that indication and we will provide an update in the coming months on that program.

Okay.

And so at this point, it's difficult to say when those data may become available and Youll just that'll be the expected update maybe.

That'll be the expected update on the coming months, yes got it okay. All right well. Thank you very much Jeff I appreciate it thanks, Chris.

Chris Howerton: Okay. All right. Well, thank you very much, Jeff. I appreciate it. Thanks, Chris.

Operator: Thank you. Our last question comes from the line of Greg Submanavia with Goldman Sachs. Your line is now open.

Yes.

Thank you.

Our last question comes from the line of Greg <unk> with Goldman Sachs. Your line is now open.

Graig C. Suvannavejh: Hey, good morning, everyone, and thanks for taking my questions about progress with the commercial launch. I had a couple of questions and thanks for the granularity on some of the details in your slide deck, but I could just ask about the metrics you provide. The average number of Wakex patients at 2,800, I think that compares to about 2,500 from the last quarter, and then you're 2,700 compares to about 2,400. So just trying to see if I understand your perspective on what you think should be a good rate going forward on each of those metrics.

Hey, good morning, everyone and thanks for taking my questions on.

Nice progress.

The commercial launch of.

Couple of questions.

Thanks for the granularity on some of the details on your slide deck, but like adjusted.

Jeff.

On.

The metrics you provide on.

The average number of weighted patients.

Patients at 2800, I think that compares to about 2500 from the last quarter and then your unique prescribers of <unk> 2700 compares with about 2400 so.

Just trying to.

See if I can get your perspective on on what you think.

It should be a good rate going forward on on each of those metrics.

Graig C. Suvannavejh: And then, if I could ask a follow-up question with regard to the patient assistance program, it's been a focus for some over the past several quarters, and given where we are with the recovery or reopening or unemployment, I was just hoping if you could provide color on the latest update on how you think that dynamic is evolving as it relates to wake exales and perhaps getting some sales back that you had perhaps previously lost. Thank you for Jeff Dirks, want you to handle those two for Greg?

And then if I could ask a follow up question with regards to the patient assistance program that's been our focus.

You know for some over the past several quarters and given where we are.

With.

Net recovery of reopening or.

Unemployment was just hoping if you could provide some.

Color on the latest update on on how you think that dynamic is evolving as it relates to weighted sales and perhaps.

Getting some sales back that you had perhaps previously lost thank you.

Thank you for those questions Greg Chapter one of your handle on those two for Greg sure. Good morning, Greg Great to hear from you. So with respect to your first question on average number of patients and unique number of health care prescriber professionals prescribing since launch. So clearly we're extremely pleased with our continued strong performance in Q1.

Jeffrey Dierks: As we've stated, it was our fifth consecutive quarter of growth in average number of patients, net revenue, and number of unique prescribers. And in Q1, we saw really strong underlying demand, resulting in about 9% increase in the average number of patients quarter over quarter. You've noted about an 11% increase in the average number of prescribers quarter over quarter, and that growth is seen even with the Q1 seasonal payer dynamics and the lingering pandemic.

As we've stated it was our fifth consecutive quarter of growth in average number of patients on net revenue and number of unique prescribers and in Q1, we saw really strong underlying demand, resulting in about 9% increase in the average number of patients quarter over quarter. You've noted about on an 11% increase in the average number of prescribers quarter over quarter and that grew.

Growth is seen even with the Q1 seasonal payer dynamics and the lingering pandemic and we do expect to continue to grow the average number of patients on <unk> and the number of unique health care professionals each quarter during 2021 and the research that we recently filled it really shows strong outlook for future growth for <unk>. So.

Jeffrey Dierks: And we do expect to continue to grow the average number of patients on Wakex and the number of unique healthcare professionals each quarter during 2021. And the research that we recently fielded really shows a strong outlook for future growth for Wakex. The research demonstrated that physicians believe that Wakex is an appropriate treatment option for the vast majority of patients. Physicians shared that Wakex was extremely strong for EDS. 95% of physicians stated it was effective for EDS.

The research demonstrated that physicians believe that wake acts as an appropriate treatment option for the vast majority of patients physicians.

Physicians share that wakes was extremely strong for eds, 95% of physician stated it was effective for Etfs, 90% stated wakes was effective for cataplexy and 90% of the health care professional is expect to prescribe the same or increase their use of wakes and more of their narcolepsy patients in the future. So I know.

Jeffrey Dierks: 90% stated WACX was effective for cataplexy, and 90% stated that wakex was effective for cataplexy. And 90% of the patients. The health care professionals expect to prescribe the same or increase their use of wakeics in more of their narcolepsy patients in the future.

Jeffrey Dierks: So I know we're not providing guidance, but we believe that we are going to expect to grow the average number of patients and unique health care professionals each quarter and year. So hopefully, that helps answer your first question just with respect to, you know, growth moving forward. And then the second question you asked about the patient assistance program and sort of what we have seen related to, you know, the reopening and a little bit broader COVID vaccination. So, you know, as we shared previously throughout the pandemic, we have seen an increased demand for our patient assistance program. And it's been relatively consistent.

We're not providing guidance, but we believe that we are going to expect to grow average number of patient in unique health care professionals each quarter in 'twenty. One so hopefully that helps to answer your first question just with respect to <unk>.

Growth moving forward.

And then second question you asked about patient assistance program and sort of what have we seen related to the reopening and a little bit broader COVID-19 vaccination. So you know as we shared previously throughout the pandemic. We have seen an increased demand for our patient assistance program and it's been relatively consistent and that's even until.

Jeffrey Dierks: And that's even until the first quarter of 2021. It's difficult to speculate when there will be less reliance on patient assistance as the country continues to open up. We certainly do have a strong conviction to support eligible patients through this program, knowing the difference that Wakex can make in these patients' lives. And importantly, as you've seen, we've been able to demonstrate strong growth in net revenues for five consecutive quarters, even with this elevated demand. And we expect to continue to grow our net revenue and average number of patients throughout 21. Okay, thanks.

Into the first quarter of 2021.

It's difficult to speculate when there will be less reliance on patient assistance as the country continues to open up we certainly do have a strong conviction to support eligible patients through this program knowing the difference that wakes can make in these patients' lives.

And importantly, as you've seen we've been able to demonstrate strong growth in net revenues for five consecutive quarters, even with this elevated demand and we expect to continue to grow our net revenue and average number of patients throughout 'twenty one.

Okay, Thanks, and if I could just follow up on on an answer you gave previously on when we think about that.

Graig C. Suvannavejh: And if I could just follow up on an answer you gave previously, when we think about the number of subscribers that you've been able to reach. As it relates to 2021, and in terms of your ability to have face-to-face interactions with those prescribers, you know, from the 2,700 that you have now, is there a number we should be thinking about for, as a goal for calendar 2020? One, I don't want to give guidance, but I'm just trying to figure out what that penetration might look like among the 8,000.

Prescribers.

On that you've been able to.

To targets.

As it relates to 2021.

And in terms of.

Your ability to do.

Face to face interactions with those prescribers.

From the 2700 <unk>.

Now is there a number we should be thinking about.

Four.

Our goal for calendar 2020.

One I know you.

Don't want to give guidance, but I'm just trying to figure out in terms of what that penetration might look like.

Thousands of patients who treat narcolepsy.

Graig C. Suvannavejh: No, I appreciate the question, Greg, and our expectation is that we will continue to grow the number of unique healthcare professionals. You know, our 2,700 unique healthcare professionals represent about 33% of the overall target universe. And so we believe that there's a significant opportunity to continue to penetrate that group.

No I appreciate the question Greg on our expectation our expectation is that we will continue to grow the number of unique health care professionals are 2700 unique healthcare professionals represents about 33% of the overall target universe and so we believe that there are significant.

Opportunity to continue to penetrate that group, we've seen the receptivity to the broad clinical utility and the overall benefit risk profile of <unk>, we have seen.

Jeffrey Dierks: We've seen receptivity to the, you know, broad clinical utility and the overall benefit risk profile of Wakeex. We have seen, you know, with COVID, there are more healthcare professionals offices that are opening up and seeing patients. We are starting to see more of our field sales team make more in-person sales calls. And you certainly know the benefit of in-person education, especially during a launch. So while we're not providing guidance, we do expect to grow the average number and the number of unique healthcare professionals, quarter over quarter, quarter throughout 2021. Yeah, and Greg, it's Sean.

With COVID-19 there are more health care professionals offices that are opening up and seeing patients. We are starting to see more of our field sales team make more in person sales calls and you certainly know the benefit of in person education, especially in a launch so while we're not providing guidance, we do expect to grow the average number and the number of Uni.

Health care professionals quarter over quarter throughout 2021.

It's Sean we're optimistic about the opportunity as COVID-19 lifts as vaccinations continue throughout the United States and we have yet to really get a feel for the true run rate.

John Jacobs: You know, we're optimistic about the opportunity as COVID lifts as vaccinations continue throughout the United States. But we have yet to really, I think, get a feel for the true run rate. As COVID starts to lift throughout the rest of this year, we'll get a much better feeling for the true run rate. But I think what you've seen here, hopefully today, and heard from us today is very strong underlying demand. We're getting excellent feedback from physicians and patients on their experience with our product.

As COVID-19 starts to lift throughout the rest of this year, we'll get a much better feeling for the true run rate, but I think what you've seen here hopefully today on heard from US today is very strong underlying demand, we're getting excellent feedback from physicians and patients on their experience with our product and there remains tremendous on unmet need in this space that is a chronic disease. These patients are living with this disease.

John Jacobs: And there remains tremendous, unmet need in this space. There's a chronic disease. These patients are living with this disease before, during, and they will be after COVID, and we're here to help them, and that demand isn't going anywhere.

For ordering and they will be after COVID-19 and we're here to help them and that demand isn't going anywhere. So as we get into the next couple of quarters I think we'll be excited to share with you.

John Jacobs: So as we get into the next couple of quarters, I think we'll be excited to share with you the way we're able to penetrate the marketplace as COVID starts to live. Okay, thank you very much. Thank you. There are no further questions. I would now turn the call back to John Jacobs for his closing remarks. Thanks again for joining us today. I hope that you can appreciate that Harmony has continued our strong launch momentum for Wakex and that we are poised well to execute on our three pillars of growth strategy, which should enable us to grow our business and shareholder value as we continue on our mission to help patients who are living with orphan, rare neurological disorders. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

The way, we're able to penetrate the marketplace as COVID-19 starts to lift.

Okay. Thank you very much.

Thank you there on no further questions I will now turn the call back to John Jacobs for closing remarks.

Thanks again for joining us today I hope that you can appreciate that harmony has continued our strong launch momentum for wake X and that we are poised well to execute on our three pillars of growth strategy, which should enable us to grow our business and shareholder value as we continue on our mission to help patients who are living with orphan.

Rare neurological disorders. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

Operator: Thank you.

Okay.

[music].

And on that.

Sure.

On.

[music].