Q1 2021 Insmed Inc Earnings Call

Ladies and gentlemen, thank you for standing by and welcome to the Internet first quarter 2021 financial results 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.

Operator: and thank you for standing by, and welcome to the first Finance Results Conference. At this time, all participants are in a listen-only mode.

Operator: There will be a question and answer session; ask a question, press star 1 on your Please be advised that today's conference is being recorded. If you require any further assistance, I would now like to hand the conference to Eleanor Barriser, Associate Director Investor. Please go ahead. Thank you, Natalia.

You will need to press star one on your telephone please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to your Speaker Eleanor barrister Associate director Investor Relations. Thank you. Please go ahead.

Eleanor Barriser: Good morning and welcome to today's conference call to discuss our first quarter 2021 financial results and provide a business update. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements. Please refer to our filings with the Securities and Exchange Commission, which are available through the SEC's website at www.sec.gov or from our website, for information concerning the risk factors that could affect the company. The information on today's call is not intended for promotional purposes and is not sufficient for prescribing decisions.

Thank you Natalia good morning, and welcome to today's conference call to discuss our first quarter 2021 financial results and provide a business update.

Eleanor Barriser: Joining me on today's call are members of the Insmet Executive Management Team, including Will Lewis, Chair and Chief Executive Officer, Dr. Martina Flammer, Chief Medical Officer, Roger Adset, Chief Operating Officer, and Sarah Bonstein, Chief Financial Officer. Now, I turn the call over to Will Lewis for prepared remarks. Upon completion of those remarks, we will open the call up for your question. Thank you, Eleanor, and good morning, everyone. As you were all aware, last year was the most transformative in In Sement's history. Several years ago, we set ourselves on a path to become a global, multi-product biotechnology company. At the time, this was a bold decision.

Haired remarks upon completion of those remarks, we will open the call up for your questions.

Thank you Eleanor on good morning, everyone did you are all aware last year was the most transformative and instruments history. Several years ago, we set ourselves on a path to become a global multi product biotechnology company at the time. This was a bold decision, but when we felt we could accomplish if we focused on three G. L.

William Lewis: But one we felt we could accomplish if we focused on three key elements, our company culture, great science, and a sincere ambition to help patients. Today, I am pleased to report that for the first time, we have secured approval for our lead product, ERACase, in the three major territories where we have built our own infrastructure, the U.S., Europe, and now Japan. We hope and believe this will be the first of many such approvals.

Elements, our company culture, Great science, and a sincere ambition to help patients.

Today I am pleased to report for the first time, we've secured approval of our lead product error case, and the three major territories, where we have built our own infrastructure. The U S. Europe and now Japan, We hope and believe this will be the first of many such approvals. This accomplishment building global capabilities for development and.

William Lewis: This accomplishment, building global capabilities for development and commercialization, is something we are very proud of, and we believe it represents just the beginning of the Insmed story. When I think about what we will be bringing forward in the coming years, our focus will center on three main areas: commercial performance, advanced clinical programs, and translational research. The first area of focus is the performance of our Eric Case commercial franchise, which Roger will address later on in this call.

Commercialization is something we are very proud of and we believe it represents just the beginning of the instrument story.

But I think about what we will be bringing forward in the coming years, our focus will center on three main areas commercial performance advanced clinical programs and translational research.

The first area of focus is the performance of our era case commercial franchise, which Roger will address later on this call. This.

This includes are approved indication in refractory MTM in the U S Europe and Japan.

William Lewis: This includes our approved indication in refractory NTM in the U.S., Europe, and Japan. The second area of focus is our three advanced clinical programs. These are Erichase, Brentso-Katib, and T-P-I-P. Erikaase and Brenso-Kadiv overlap in the pulmonary therapeutic space and are in global registrational trials to address very sizable populations with serious diseases where there are currently no approved therapies for these specific conditions.

The second area of focus is our three advanced clinical programs. These are are case brinser captive in TPI P. L.

Eric case in Brynza, Khatib overlap and the pulmonary therapeutic space and are in global Registrational trials to address very sizeable populations with serious diseases, where there are currently no approved therapies for these specific conditions.

Upon successful completion of these pivotal trials and potential regulatory approval, we plan to commercialize in the U S E U and Japan ourselves or.

William Lewis: Upon successful completion of these pivotal trials and potential regulatory approval, we plan to commercialize TPIP in the U.S., EU, and Japan ourselves. Our third program, TPIP, has the potential to be the cornerstone of therapy for the treatment of not just PAH but also PHILD and IPF, should relevant regulatory agencies view the data as supportive. It is our intention to bring that program through commercialization as well. Any one of these programs, if successful, will allow us to grow substantially from where we are today.

Our third program TPI P has the potential to be the cornerstone of therapy for the treatment of not just ph, but also P. H I L D and IPF should relevant regulatory agencies view. The data is supported it is our intention to bring that program through commercialization as well.

William Lewis: Martina will provide an update on these efforts later in the call. The third main area of focus is translational research. Our research efforts include a growing number of programs, which we believe could be ready for the clinic in the near term. We plan to develop programs in-house as well as augment our research through business development activities. While these efforts are difficult to set against specific timelines, we believe they are very promising.

William Lewis: We are hopeful that animal work will continue to demonstrate the viability of these potential medicines which address serious unmet medical needs in the pulmonary therapeutic area and well beyond. It is our intention to deploy our capital in a disciplined and strategic manner as we continue to add capabilities to these efforts. We look forward to sharing more details at the appropriate time in the future. From my perspective, 2021 is off to a great start, as Insmed continues to make important progress across our commercial performance, advanced programs, and translational research projects.

William Lewis: We believe we have enormous potential in every geographic region where we have built capability fueled by our growing pipeline. While the COVID-19 pandemic has lingered longer than many might have anticipated, we are in the beginning of the return to the new normal. Insmed is extremely well positioned for this future, bolstered by our strong financial position. With that, I'll now turn the call over to Sarah to walk through our financial results.

Sara M. Bonstein: Thank you, Will, and good morning, everyone. As Will mentioned, InSmed achieved several important achievements across our business in the first quarter. Earlier today, we issued our detailed first quarter financial results in a press release. At a high level, our financial results for the first quarter are in line with our internal expectations. Let me highlight just a few of those results for you now.

Financial results in our press release.

At a high level, our financial results for the first quarter are in line with our internal expectations.

Let me highlight just a few of those results for you now.

As reported this morning, we ended the first quarter with $410 million in cash on cash equivalent, which we believe will enable us to advance our three key programs are a case for the <unk> and C. P. I P along with our research and translational medicine efforts.

Sara M. Bonstein: As reported this morning, we ended the first quarter with $410 million in cash and cash equivalence, which we believe will enable us to advance our three key programs, Erichase, Fred Socative, and TPIP, along with our research and translational medicine efforts. Before I continue, let me take a moment to provide more color on our first quarter cash burns. In the first quarter, we incurred several large one-time payments, including a milestone payment to AstraZeneca related to the first patient doses in our Phase 3 Aspen trial, as well as initial start-up costs related to our registrational programs for both Ericase and Brentocassib.

Before I continue let me take a moment to provide more color on our first quarter cash burn.

In the first quarter, we incurred several large one time payments, including a milestone payment to astrazeneca related to the first patient dosing in our phase III Aspen trial as well as initial startup costs related to a registrational programs in both aerospace and Bristow catchup.

Importantly, while our use of cash in the first quarter was in line with our internal budget.

Sara M. Bonstein: Importantly, while our use of cash in the first quarter was in line with our internal budget, we anticipate near-term quarterly cash burn to be below the first quarter levels. As Will mentioned, we are committed to being good stewards of cash and remain dedicated to ensuring our investment, or directed to areas, that support future growth and value creation. Total net revenue for Ericase was $40.2 million for the first quarter of 2021.

We anticipate near term quarterly cash burn to be below the first quarter levels as.

As will mentioned, we are committed to being good stewards of cash and remain dedicated to ensuring our investments are directed to areas.

And support future growth and value creation.

Sara M. Bonstein: As expected, our first quarter sales continued to be impacted by the pandemic. In addition, in the first quarter of the calendar year, like many companies in our industry, we are always impacted by the reset of the patient deductible, including the donut hole effect. Despite these challenges, we continued to demonstrate steady performance in the Erickase franchise. Importantly, our revenues were 9% higher in the first quarter of 2021 than they were in the first quarter of 2020.

Sara M. Bonstein: We anticipate error case revenue returning to sequential growth as the impact of the COVID-19 pandemic subsides. We are already seeing key indicators that may lead to positive trends, which Roger will address in more detail later on the call. Gross to nets for the first quarter of 2021, or approximately 17%. As previously disclosed, we anticipate our gross to net to be in the mid-teens for the full year 2021. As a reminder, Gross to Nets have historically been highest in Q1, mainly attributed to the coverage gap as a result of the benefit reset at the beginning of the year. Cost of product revenues for the first quarter was $9.8 million, or 24%, which was in line with our cost of product revenues for the first quarter of 2020.

Sara M. Bonstein: Turning to our gap operating expenses. For the first quarter of 2020, research and development expenses were $61.4 million, and SG&A expenses were $51.6 million. These spend levels were aligned with our internal expectations as we support our growing development pipeline and invest in our research and development capabilities. Of note, our first quarter STNA expenses remain flat compared to the first quarter of 2009.

Honey research for the first quarter of 2021 research and development expenses were 61 $4 million and SG&A expenses were 51 $6 million.

These sped levels were aligns with our internal expectations as we support our growing development pipeline and in depth and our research and development capabilities of note. Our first quarter SG&A expenses remains flat compared to the first quarter of 2020.

In 2021, we will continue to invest in our core operating business, including the commercialization in clinical support of Air case globally, the ongoing and planned development of Brexit Khatib that continued advancement of TPI P as well as our research and translational medicine capabilities. We've.

Martina Flammer: In 2021, we will continue to invest in our core operating business, including the commercialization and clinical support of ERACase globally, the ongoing and planned development of Brentocatib, the continued advancement of TPP, as well as our research and translational medicine capabilities. We remain laser focused on prioritizing appropriate development investment with responsible cost control. I will now turn the call over to Martina for an update on our pipeline.

Remain laser focused on prioritizing appropriate development investment with responsible cost control.

Let me now turn the call over to Martina for an update on our pipelines Martina.

Thank you Sarah and good morning, everyone.

Let me begin by speaking to our efforts and medical affairs, which is a more robust organization with an intimate than ever before we've capabilities across the globe.

These activities include educational efforts focused on the treatment of refractory Ntfs in order to ensure that our stakeholders have a complete understanding of the appropriate treatment of this disease.

Martina Flammer: Thank you, Sarah, and good morning, everyone. Let me begin by speaking about our efforts in medical affairs, which is a more robust organization within INMET than ever before, with capabilities across the globe. These activities include educational efforts focused on the treatment of refractory NTIM in order to ensure that our stakeholders have a complete understanding of the appropriate treatment of this disease. Further, we continue to assess the synergy across physicians who treat NTM and those who treat bronchiacst, in order to gain a deeper understanding of the ways in which these two indications overlap. Another key function of medical affairs is generating and presenting data at key conferences across the globe.

Further we continue to assess the synergy across physicians will treat NTN and those who treat bronchiectasis in order to gain a deeper understanding of the ways in which these two indications overlap.

Another key function of medical affairs is generating and presenting data at T conference this across the globe.

Importantly.

These presentations addressed the full spectrum of data from preclinical research to clinical development to helps economics on outcomes research that is relevant will physicians and drive healthcare decisions.

In fact, you will see data from all three of our programs presented in nine posters at the American Thoracic Society or Ats International Conference later this month.

Martina Flammer: Importantly, these presentations address the full spectrum of data, from preclinical research to clinical development, to health economics and outcomes research that is relevant for physicians and drives healthcare decisions. In fact, you will see data from all three of our programs presented in nine posters at the American Thoracic Society, or ATS, International Conference later this month. One abstract posted on the ATS website that we want to draw your attention to is a study highlighting the increased mortality of patients with COPD who also had NPM.

One abstract posted on the <unk> website did we want to draw your attention to is a study highlighting the increased mortality of patients with COPD, who also had MTN.

Martina Flammer: These patients had a 44% higher annual mortality rate with a steeper survival rate, meaning more patients who have COPD and NTM died, and they died sooner, than patients with COPD alone. These results underscore the need to urgently treat NTIM patients with these comorbid conditions. We're also excited to share that an abstract with data from the Phase 2 Willow study has been selected by the Board of the second annual European NTM and Brown Teactasis workshop to be included in the best oral presentation session, to be held on July 3, 2021.

Martina Flammer: We look forward to sharing the presentation titled Nutrivolcerin Protease levels in blood and sputum samples of patients on bronzocatib from the Willow Phase 2 trial in non-CF promcicthesis at that time. Now, let's now turn to our clinical development program. All of our ongoing trials are moving forward, and enrollment remains on schedule as anticipated. These include our Phase 3 S study, designed to assess the efficacy, safety, and tolerability of panopath in patients with bronchiak to, as well as our post-marketing studies in Encore, for Erichase is a frontline treatment for patients with neck lung infections.

Oh.

We believe T. P. I P represents an opportunity to harness the full potential of the profit right past week.

In February we presented top line data from our face one single and multiple of sending dose trial and healthy volunteers.

Martina Flammer: Beyond bronchiactasis, we remain on track to initiate in mid-2020 a phase two pharmacokinetic, pharmacodynamic, multiple dose study to explore the appropriate frenzocatop dose for cystic fibrosis patients. Through our discussions with CF stakeholders, including treating healthcare practitioners and key advocacy groups, it is clear that there is an opportunity for anti-inflammatory agents like Pranthotaphic and an opportunity to continue to advance Let's now turn to TPIPIP, a dry powder formulation of tropostinol-palmatil.

This results demonstrated that TPI P will generally safe and well tolerated and support our plans to continue development of T. P. I P was once daily dosing as well as an uptight tuition approach and patience with P. A H.

We have begun the next stage of TPI clinical development patients with P. H.

This includes two phase two study.

The first will evaluate the impact of T. P. IP on basis inventory effect as measured by pulmonary vascular resistance are PDR or a 24 hour period.

We look forward to sharing preliminary data from a small number of patients with P. H in the second half of this year.

A second study will evaluate effective TPI Pee on P. B R and six minute walk distance over a 16 week period.

Martina Flammer: We believe TPP represents an opportunity to harness the full potential of the prosdenoid test. In February, we presented top-line data from our phase one single and multiple ascending dose trial in healthy volunteers. These results demonstrated that TPP was generally safe and well-tolerated and support our plans to continue development of TPIP with once daily dosing, as well as an up-situation approach in patients with PAHH. We have begun the next stage of TPI clinical development for patients with PAA.

In addition to the two studies in P. A H, we're planning to initiate a separate phase II study of T. P. IP in patients with pulmonary hypertension associated with interstitial lung disease or ILD. These.

These patients are classified as having group three pulmonary hypertension.

We also continue to explore potential development pathways for TPP, and idiopathic pulmonary fibrosis or Ips.

Another area of increased focus this year is the advancement of internet's capabilities in translation on medicine.

At the intersection of research and clinical development. Our goal is to identify validated preclinical targets that show significant efficacy safety and proof of concept data.

Martina Flammer: This includes two phase two studies. The first will evaluate the impact of TPI and its vasothilatory effect as measured by pulmonary vascular resistance or PVR over a 24-hour period. We look forward to sharing preliminary data from a small number of patients with PH in the second half of this year. The second study will evaluate the effect of TPI on PBR and six-minute walk distance over a 16-week period.

This will enable us to accelerate the process of bringing promising treatment from bench to bedside and.

And increase probability that the molecule chosen will be successful.

Equally important for US is the bedside community translation back to research to inform the search and design for treatments of the highest clinical relevance that address patient needs.

We are already well equipped with a strong collaboration between research clinical development and medicine, a prerequisite for successful translational efforts.

Martina Flammer: In addition to the two studies in PAH, we're planning to initiate a separate phase two study of GPIP in patients with pulmonary hypertension associated with interstitial lung disease, or ILD. These patients are classified as having group three pulmonary hypertension. We also continue to explore potential development pathways for TPP in idiopathic pulmonary fibrosis, or IPF.

This year, we plan to build additional technical capabilities across the research development and translational medicine continue.

In closing, we continue to make progress across our pipeline as we aim to deliver potentially life changing therapies to patients with brain and serious disease.

Our efforts on <unk>.

Focus on ensuring our clinical programs are executed with the utmost quality.

We look forward to sharing developments with Ya.

With that let me turn the call over to Roger to discuss some key operational update Roger.

Martina Flammer: Another area of increased focus this year is the advancement of internet capabilities in translational medicine, at the intersection of research and clinical development. Our goal is to identify validated pre-clinical targets that show significant efficacy, safety, and proof-of-concept data. This will enable us to accelerate the process of bringing promising treatments from bench to bedside and increase the probability that the molecule chosen will be successful. Equally important for us is the translation of community translation back to research to inform the search and design for treatments of the highest clinical relevance that address patient needs.

They can martina good morning, everyone on.

I am pleased to report a strong first quarter from an operational perspective.

R U S commercial business remains on solid footing with other kids continue it steady performance and the current COVID-19 environment.

Our team continues to perform well and customer engagement has remained solid.

Encouragingly in person sales call numbers are trending positively.

We believe these face to face interactions with physicians and health care professionals are most effective at are a key to unlucky future growth.

We will also encouraged by the ongoing vaccine rule out in recent C. D C data, indicating that in the U S. About 70 per cent of people age 65 years or older have been fully vaccinated for COVID-19.

Martina Flammer: We are already well equipped with a strong collaboration between research, clinical development, and medicine, a prerequisite for successful translational efforts. This year, we plan to build additional technical capabilities across the research, development, and translational medicine continuum. In closing, we continue to make progress across our pipeline as we aim to deliver potentially life-changing therapies to patients with rare and serious diseases. Our efforts are focused on ensuring our clinical programs are executed with the utmost quality. We look forward to sharing development with you. With that, let me turn the call over to Roger to discuss some key operational updates. Roger,

We expect more physicians offices will reopen and anticipate more N T M patients will become comfortable returning to in person visits.

Get together these elements give us confidence in the long term potential will be rk's franchise.

We anticipate that once the impact of the pandemic subsides.

U S commercial business will see a return to growth.

Bolstered by important learnings from a successful U S launch.

International expansion of error cases will underway and I'd like to report the highlights from the first quarter.

Roger Adset: Thank you, Martina, and good morning, everyone. To report a strong first quarter from an operational point of view, The U.S. Commercial Business remains on solid footing, with Arrakees continuing to perform steadily in the current COVID-19 environment. Our team continues to perform well, engagement has remained solid, person sales call numbers are trending positive, and these face-to-face interactions with physicians and health care professionals are most We are also In the US, about 70% of years or older have been fully vaccinated. We expect more physicians' offices will reopen and anticipate more NTM patients will become comfortable returning to in-person visits. Taken together, these elements give us confidence in the long-term potential of the Arrakees.

Let's start with Europe, where are case was graduate marketing authorization last October for the treatment of Mac lung infection and adults with limited treatment options, who do not have cystic fibrosis.

We launched in Germany first with a list price that is in line with the U S list price for ever case.

And we're also pleased to secure early reimbursement in the Netherlands at a price that is in line with the U S list price.

In addition.

<unk> programming, France has been extended providing patients access to Eric case until full reimbursement has agreed.

This allows us to derive modest revenue from sales in that country.

Roger Adset: We anticipate that once the impact of the pandemic has subsided, U, bolstered by important learnings from our successful U.S., international expansion of our case is well under way, and I'd like to report that, start with Europe, where Eric Case was granted marketing launch in Germany, line with the US list price for our case. And we were also pleased to secure early reimbursement in the Netherlands at a price that is in line with the U. In addition, the program in France has been extended, providing patients allows us to derive modest revenue Overall, we continue to apply the successful U model, that virtual sessions with physicians are being well received and well attended in Europe, and that patients returning to in-person office visits will have a positive impact on the trajectory of the European launch.

Overall, we continue to apply key learnings from a successful U S commercialization efforts to our ongoing launch in Europe.

Interest in our case from the physician community stroll.

We are encouraged that virtual sessions with physicians are being will received it will attendant in Europe.

Similar to our experienced in the U S patient visits to physician offices have been impacted by the pandemic.

We anticipate that patients returning to in person office visits will have a positive impact on the trajectory of the European launch.

Further we expect reimbursement decisions across Europe to continue throughout 2021 and into 2022.

Let's now move to the opportunity for education, Japan.

In March we were excited to report that Japan's M. H L. W approved error case for the treatment of patients with N. T. M lung disease caused my back who did not sufficiently respond to prior treatment, where the multi drug regimen.

Roger Adset: Further, now moved to the opportunity. In March, we were excited to report that Japan's MHLW approved Arrogase for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multi-drug regimen.

Pricing discussions remain on track and we anticipate the reimburse launch by mid year.

In anticipation of this milestone preparations are progressing well, we believe we have the right infrastructure in place to support the launch.

Roger Adset: At this milestone, preparations are progressing well, and we believe we have the right infrastructure in place to support the launch. You may recall that prior to our approval, our therapeutic specialists engaged in promotion of a macrolide to educate physicians on NTM and NTM guidelines. Immediately after approval, our therapeutic specialists engaged in branded discussions with targeted physicians. Due to the strong interest in our case from physicians, we were able to increase our; To date, we have already reached almost 80% of the targeted 330 hospitals. Virtual and in-person meetings with healthcare practitioners also occurred throughout March and April. In April, approximately 40% of those interactions were in-person, and additional meetings are scheduled throughout the remainder of May and into June.

You may recall that prior to approval therapeutic specialists engaging promotion of a macrolide to educate physicians on N T M N T M guidelines.

Immediately after approval or therapeutic specialists engaged in Brady discussions with targeted physicians.

Due to the strong interest in our case from physicians, we were able to increase our targeted number of hospitals in Japan to date, we've already reached almost 80 per cent of the targeted 330 hospitals.

Virtual an in person meetings with health care practitioners also occurred throughout March and April.

Approximately 40 per cent of those interactions were in person and.

An additional meetings are scheduled throughout the remainder of may and into June.

Our case also continues to receive strong interest from Japanese kols.

We are gratified by the support that these physicians have offered to in Smith it bring it Eric case of Japanese patients will.

Roger Adset: Our case also continues to receive strong support by the Japanese Association for Infectious Diseases, the Japanese Respiratory Society, and the Japanese Society of Tuberculosis and NTM. In fact, we were pleased that the two key sessions were successfully held and enthusiastically received at the annual meeting of the Japanese Respiratory Society in April, where lead investigators of the Phase 3 study of Erichase presented to a full-on now briefly touched on the status of our technical operations. Insmec continues to provide adequate supplies, confident in our ability to meet future demand for AICES, including supporting the launch in Europe and anticipated launch in Japan. Our Arircase inventory position also remains strong.

<unk> had appropriate medical engagement with major medical associations in Japan, including the Japanese Association for infectious diseases. The Japanese respiratory society. The Jeopardy Society, you have tuberculosis and N T M.

In fact, we were pleased with the two key sessions were successfully held and enthusiastically received at the annual meeting of the Japanese respiratory Society at April where lead investigators at the phase three study of error case presented to a full audience of Japanese respiratory kols, who made the effort to attend in person.

Let me now briefly touch on the status of our technical operations.

And just make continues to manufacturer adequate supplies of barricades to meet current demand will.

We're also confident in our ability to meet future demand of error case, including supporting other launch in Europe and anticipated launch in Japan.

Are are case inventory position also remains strong.

[noise] finally for a clinical development needs. We are in a solid position with respect to manufacturing and clinical supplied product to support our ongoing trials per hour case, Brenzel catchup at G. P. I P.

Roger Adset: Finally, for our clinical development needs, we are in a solid position with respect to manufacturing and clinical supply products to support our ongoing trials for Arircase, Brenzo Katsib, and TPP. In summary, well from an opportunity of study, mobilized to support the geographic expansion of our case throughout Europe and Japan to ensure it reaches patients in need. I'd like to thank you. Thank you, Roger.

In summary, inspect continues to perform well from an operational perspective.

Against the backdrop of study U S performance team was mobilized to support the geographic expansion barricades throughout Europe, and Japan, too short beaches patients in need I'd.

I'd like to thank the intimate team for their dedication to the N T M community as we work to achieve these goals that on.

Will now turn the call back to will.

William Lewis: I'd like to close out our prepared remarks by underscoring the tremendous commitment and performance of our employees as we have collectively transformed our company. Finally, on behalf of the entire company, I would also like to offer my thanks to the patients who participate in our study. I'd like to extend my sincere gratitude to all of the caregivers who have gone the extra mile for patients of all kinds during this pandemic. We have all seen and appreciated the impact of your life-saving efforts. With that, I'd like to open the call to questions. Operator, can we take the first question?

Thank you Roger I'd like to close out our prepared remarks by underscoring the tremendous commitment and performance of our employees as we have collectively transformed our company.

On behalf of the entire company I would also like to offer my thanks to the patients who participate in our studies.

I'd like to extend my sincere gratitude to all of the caregivers who have gone on the extra mile per patients of all kinds during the pandemic. We've all seen it I appreciate the impact of your life saving efforts.

That I would like to open the call to questions. Operator can we fix the first question. Please.

To ask a question please price star one on your telephone keypad.

Operator: ask a question, please press star 1 on your telephone keypad, and for the first question, answer the line of Joseph Swartz with S. Hi, I'm Julie Daly and for Joe. Thanks for taking the time. In the opening remarks, you mentioned that pricing discussions are on track in Japan, but I was just wondering how satisfied you are with the pricing discussions there. And then would you be able to provide a tighter timeline on your launch in Japan? I know you previously said, like a launch timeframe of July, but wanted to know your latest thinking on that as we're getting closer and if there are any gating factors. Thanks for the question.

Your first question are you from the line of Joseph towards with the S. B B Leerink.

Hi, I'm, Jamie value for Joe Thanks for taking our questions Uhm any opening remarks, you mentioned that price name discussions are on track in Japan, but I was just wondering how satisfied you are with the ongoing pricing discussion there and then would you be able to provide a tighter time line on your lunch in Japan I know you. Please.

<unk>. So you mentioned you know like a launch timeframe on July but wanted to know your latest thinking on that as we're getting closer and if there are any gating factors to watching.

And thanks for the question I think you know the process in Japan is once you have secured approval from the drug there isn't typically a multi month process, where there is discussion between the Japanese government and the company about what is the appropriate price. It's a decision that the Japanese government will ultimately make and until.

Operator: I think, you know, the process in Japan is once you have secured approval for the drug, there is then typically a multi-month process where there is discussion between the Japanese government and the company about what is the appropriate price. It's a decision that the Japanese government will ultimately make.

That is complete uhm, we don't really have any comment on it. It's just a typical ongoing process I would say across the board our engagement with the Japanese the regulatory authorities. The Japanese government everything has been very constructive and positive and we continue to work Oh well in that region of the world are prior.

William Lewis: And until that is complete, we don't really have any comment on it. It's just a typical ongoing process. I would say across the board, our engagement with the Japanese regulatory authorities, and the Japanese government, everything has been very constructive and positive, and we continue to work well in that region of the world. Our prior guidance was that we would launch on or around July. We don't have any reason to believe it would be any different than that at this time. As soon as we have any updated information, though, we'll certainly pass it along. Okay, great, thank you for that. And then my second question is about Brantso Katip.

<unk> was that we would launch on or around July. We don't have any reason to believe will be any different than that at this time as soon as we have any updated information that we will certainly pass on the wall.

Okay, great. Thank you for that and then my second question is on Grand some cabinets.

How should we back to see the stop COVID-19 data to be released you know will likely be released from a press release or are you thinking like a medical meeting for example, like I know a T. S is coming up maybe can be presented there.

Yeah. Thanks for the question so just to levels that everybody. The stock COVID-19 study is the study that's being run by its investigator initiated so they being run by James Chalmers at the University of Dundee in Scotland involving about 10 hospitals across Scotland about a year ago. He approached US we agreed to provide.

Both drug product and a modest amount of money to support his investigation of the drug in the COVID-19 patient population will.

William Lewis: How should we expect to see the stop COVID data released? You know, will it likely be released through a press release, or are you thinking like a medical meeting, for example, like I know ATS is coming up; maybe it could be presented there? Yeah, thanks for the question.

What we get from this is both what we've already got on the first part of it which is the safety information and that is that the day. The safety monitoring board has been been concluded that there were no issues in the study on the second thing, we're gonna get which room looking forward to his information around the mechanism of action in the particular biomarkers and how they operate in this page.

William Lewis: So just to level say everybody, the Stop COVID-19 study is a study that's being run by, its an investigator-initiated study being run by James Chalmers at the University of Dundee in Scotland, involving about 10 hospitals across Scotland. About a year ago, he approached us, and we agreed to provide both the drug product and a modest amount of money to support his investigation of the drug in the COVID patient population. What we get from this is both, well, we've already gotten the first part of it, which is the safety information, and that is that the data safety monitoring board has met and concluded that there were no issues in the study.

Population. During this 28 day study as soon as the data is complete and he has analyzed.

Analyzed all but I'm sure he'll release it but this being his study will be completely on his hands. Once that's available happy to to talk about what the results are.

Alright, thank you so much.

Sure.

Your next question is from the line of her to Mara with Kelly.

Hi, Good morning. This will go ahead long period too congrats on a pattern and thank you for taking the question on me.

Maybe as a follow on to the positive change of scene in key indicators.

'kay could you maybe talk about on that.

What kind of prescription from Christine Cherokee one in April.

William Lewis: The second thing we're going to get, which we're really looking forward to, is information around the mechanism of action and the particular biomarkers and how they operate in this patient population during this 28-day study. As soon as that data is complete, and he has analyzed all of it, I'm sure he'll release it, but, this being his study, will be completely in his hands. Once that's available, I'll be happy to talk about what the results are. All right, thank you so much. Sure, the line from Routou Barral with Cal, Hi, good morning, God. Blah La La Lawn period, too.

The bigger crowds and the second half a day here. Thank you.

So I will just start off it will turn it over to Roger provide more thoughts, but I think we are incredibly pleased with the way your case franchises perform throughout the COVID-19 error, if you will will.

Distantly described in the study I think the sales the infrastructure it and submit it has done a stellar work and trying to find a way to get this medicine to patients by supporting physicians through every medium needed an available that's appropriate.

And the consequence of that is that we've seen that that's fairly performance notwithstanding the over pressure just remind everybody. We are on the front lines of this pandemic, calling on Pulmonologists, an infectious disease specialist and I think when we look back over this error on one thing that will be very clear is that almost universally the physicians have praised the support and information that.

William Lewis: Congratulations on the progress, and thank you for taking the time. Maybe as a follow-on to whether you're seeing any key indicators. Maybe talk a little bit about how you're, what kind of prescription trends you're seeing through Q1 and growth in a second. So I will just start off, then I'll turn over to Roger to provide more thoughts, but I think we are incredibly pleased with the way the Air Case franchise has performed throughout the COVID era.

Therapeutic specialists have been able to provide during this time, which has been very challenging Roger do you want to talk more about the the trends in where we are where we may be going.

Yeah, absolutely. Thanks will so I think as we as we stated in spite of of COVID-19, and the pandemic. We continue to see patient starts it's at the lower level than the pre COVID-19 level levels that we had seen.

William Lewis: We've consistently described it as steady. I think the sales infrastructure at Insomet has done stellar work in trying to find a way to get this medicine to patients by supporting physicians through every medium needed and available. That's appropriate.

But but we continue to see steady demand for forever case, I think as we think about what's happening now and looking into the future. We do see reasons for optimism as we see more offices open and as the Pulmonologist, an infectious disease specialist, they're able to turned her attention back to the N T M patients away from the COVID-19 page.

William Lewis: And the consequence of that is that we've seen that steady performance, notwithstanding the overpressure. Just remind everybody, we are on the front lines of this pandemic, calling on pulmonologists and infectious disease specialists. And I think when we look back over this era, the one thing that will be very clear is that almost universally, physicians have praised the support and information that our therapeutic specialists have been able to provide during this time, which has been very challenging. Roger, do you want to talk more about the trends and where we are, and where we may be going? Yeah, absolutely. Thanks, Will.

<unk>.

Really encouraging sign and importantly, we think as patients become vaccinated, we talked about almost 70 per cent of over 865 are are now vaccinated in the U S against COVID-19, that's a significant because of the demographics and the phenotype of our patients which are typically elderly on older patients.

<unk>. So we think that that's going to encourage those COVID-19 those MTM patients to get back into the physician's offices, and we do think that in person visits where the patient the physicians are able to take a sputum.

Roger Adset: So I think what, as we stated, in spite of, but we think about what's happening now. We do see reasons for optimism as we see more offices open and as the pulmonologist, Specialist, or any other And importantly, we think as patients become vaccinated, about almost 70% of over 865 are now vaccinated, type of our So we think that that's going to encourage those Kovet, those NTM patients to get back And we do think that in-person visits where the physicians are able to take a sputum and actually determine that these patients have not converted in our refractory are going to be an important trend for us.

And actually determined that these patients have not converted a refractory is gonna be an important important trend for us.

We also see that where physicians offices reopening and they're able to not only to a physician take patient visits but also take visits from my therapeutic specialists and we do see a positive trend.

Towards in person visits and we know that Ah the in person visit or the most effective sales calls that we can make and so we look forward to continuing to to trend positively they're austron regional differences, we know the Texas looks completely different the Michigan.

Roger Adset: We also see that physicians' offices are reopening, and they're able to not only take patients, but also take visits from our therapeutic specialists. And we do see a positive trend toward in-person visits. And we know that there are some regional differences. We know that Texas looks completely different than Michigan.

We think that as we get on the other side of the pandemic in those things start to return to normal that we will see or whatever a return to growth forever case.

Thank you that's very helpful.

Roger Adset: Thank you. That's very helpful. Your next question is from the line of Matt. Hi, this is Connor on behalf of Matthew.

Your next question is from the line of Matthew Harrison Morgan Stanley.

I will this is corner on from Matthew Thanks for taking the question and congrats on the quarter Uhm. So just a couple from US can you provide any analogs or I guess reason launches in Japan that that you think might be beneficial on drawing parallels that how you'd see the arcades uptake curve how.

William Lewis: Thanks for taking the question and congrats on the, So just a couple. Can you provide any analytics? is in Japan that you think might be beneficial and drawing parallels, there is a case update curve happening in Japan. And then I guess what are some unique aspects that we should take into account? Model out the Japan launch and then on Europe, Germany, and the Netherlands, to the one Q revenues. And then I guess how we should think about the European contribution going through.

Turning in Japan, and then I guess, what are some unique aspects, but that we should take into account when we model out of your pay a large and then on Europe did did you have any you know loans contribute materially to the to the once you revenues and then it gets how should we think about the contribution your contribution going forward and two.

William Lewis: Thanks very much for the question. So in Japan, I think it's really hard to provide a proxy, even if there was one we thought would be reasonable. We're still going to be, I think, probably more in the shadows than in the center of the COVID pandemic. If we're launching in the middle of the year, a good portion of the vaccination program in Japan should be at least well underway, if not completed, and very likely, they will be following the same pattern that we did here in the States, which is to start.

The second half of the year. Thank you.

Thanks very much for the question. So on Japan, I think it's really hard to provide a proxy even if there was one we thought would be reasonable. We're we're still gonna be I think probably more of the shadow than in the center of the COVID-19 pandemic.

Launching in the middle of the year a good portion of the vaccination program in Japan should be the least well underway if not completed and they're very likely they will be following the same pattern that we did here in the states, which is to start with the most vulnerable who are actually many of the patients that we are targeting I think points of encouragement, but you hurt.

William Lewis: with the most vulnerable, who are actually many of the patients that we are targeting. I think points of encouragement, as you heard from Roger's comments, really come from the fact that the KOLs and the treating community here are not only very interested and engaged, but our therapeutic sales force over there is making real progress, having reached 80% of the 330 target hospitals at this stage already with branded discussion. That's really encouraging.

From Rogers comments.

Really come from the fact that the Kols and the treating community here are not only very interested and engaged but our therapeutic sales force over there is making real progress having reached 80% of the 330 target hospitals at this stage already with branded discussion that's that's.

Really encouraging when we think about Japan and it's unique challenges is we've commented on the past. This is from for every new drug in Japan day prescription is given two weeks at a time because they are very focused on safety and I think you know that that is just something that everyone always has to deal with over there, but overall I would say that will.

William Lewis: When we think about Japan and its unique challenges, as we've commented in the past, this is true for every new drug in Japan. The prescription is given two weeks at a time because they're very focused on safety. And I think, you know, that that is just something that everyone always has to deal with over there.

You are very hopeful for where Japan may go has an opportunity for error case, because there is a higher prevalence rate over there in Japan of this disease. This drug is perceived as a meaningful.

William Lewis: But overall, I would say that we are very hopeful for where Japan may go as an opportunity for error case because there is a higher prevalence rate in Japan for this disease. This drug is perceived as a meaningful contributor to the treatment of the disease, as proven in the phase three study that included a very significant cohort of Japanese patients. So there's very good data, there's a great need, and there's a drug that we think is going to have an impact.

Contributor to the treatment of of the disease as proven in the face free study that included a very significant cohort of Japanese patience. So there's very good data, there's very good need and there is a drug that we think is going to have impact on Europe Europe is always a slow and staggered launch and that's.

Nothing to do with the drug it has everything to do with the way Europe works. They approved the drug first centrally and then each country sequentially goes through a process of reimbursement some of their early signs that are very positive. There are the fact that both Germany, which is a free pricing environment and the Netherlands, which is not have decided to reimburse at the level.

William Lewis: In Europe, it is always a slow and staggered launch, and that's nothing to do with the drug but everything to do with the way Europe works. They approve the drug first centrally, and then each country sequentially goes through a process of reimbursement.

Will to the U S. So that sets us up for additional good discussions and the rest of Europe, but those will take time, it's very important for everyone understand that just because you were approved in Europe does not mean you can sell on your own you have to come to a negotiated agreement with each country. One at a time and those typically take in some cases more than a year to finalize.

William Lewis: Some of the early signs that are very positive there are the fact that both Germany, which is a free pricing environment, and the Netherlands, which is not, have decided to reimburse at a level equal to the U.S. So that sets us up for additional good discussions in the rest of Europe, but those will take time. It's very important for everyone to understand that just because you're approved in Europe does not mean you can sell it.

In our case, we've already had some early wins and some very positive friends. So we think that's gonna lay strong groundwork for success in Europe.

The team over there has done fantastic work in especially in places like Germany, where frankly, when we launched the country was basically on a lockdown.

William Lewis: in Europe. You have to come to a negotiated agreement with each country one at a time, and those typically take, in some cases, more than a year to finalize. In our case, we've already had some early wins and some very positive trends, so we think that's going to lay strong groundwork for success in Europe. The team over there has done fantastic work in, especially a place like Germany, where, frankly, when we launched, the country was basically in a lockdown.

And so using some of the techniques that have worked in the U S. A telemedicine digital outreach remote conferences, all of which Roger had mentioned have been well attended I think we're doing what we can and making good progress I think we feel good about where we are in Europe and that will continue to contribute as we add additional countries.

With reimbursement so the international picture for intimate and are a case in the refractory MTM market is particularly strong.

Your next question is from the line of Anita Dustsheet with bearing per capital.

Hi, Good morning, that's on the practice and thanks for taking my questions. Just have a couple yeah. I know you spoke to the outside you at that option I'm, sorry, your lunch and other options and he can't just wanted now Oh.

William Lewis: And so using some of the techniques that have worked in the U.S., telemedicine, digital outreach, remote conferences, all of which Roger mentioned had been well attended, I think we're doing what we can and making good progress. I think we feel good about where we are in Europe, and that will continue to contribute as we add additional countries with reimbursement. So the international picture for insomede and error cases in the refractory NTM market is particularly strong.

And how many countries in Europe, you think might come on boy before the end of this year.

Alright.

<unk>.

So I can take that question and then and then you could have a follow up it sounds like you've got more than one.

Yeah.

Okay. Roger do you want to address that what our sequences for the year.

Yeah sure. So we think that over over this year, we believe that the U K will secure reimbursement this year in the various countries that comprised the U K.

William Lewis: Thank you.

Operator: The next question is from the line of Anita Dushaint with Beringberg Capital. Hi, good morning. Just have a couple here. I know you. I'm sorry, Lange. Eric Case.

Each other on review process, so that will will that will come out on overtime.

Anticipate approval in Ireland and Italy.

Operator: Just want to know how many countries in Europe do you think might come on board before the end of this year? So I can take that question and then you can have a follow-up. It sounds like you've got more than one.

Roger Adset: Yes. Okay, Roger, do you want to address that, what our sequence is for the year? Yeah, sure. So we think that this year, we believe that the UK will secure reimbursement this year, and the various other countries, They each have their own review process, so that will come out over time. We anticipate approval in Ireland, Italy, and Austria this year. I think the laggard, the longer timeline, is always associated with France, and so we think France is probably, as we mentioned.

William Lewis: That's how. And also, I know you, guidance. Just wanted to know that you're likely to be giving guidance, especially how to think about expenses for the second half. That second half is kind of 20. Yeah, so on the guidance question, let me just talk philosophically about how I think about guidance. I think we like to provide as much transparency and clarity as we can, but first of all, we have to have confidence that what we're looking at is a clear picture and one we can quantify.

William Lewis: And while we have very strong conviction that we're going to return to growth this year, COVID is a little difficult to predict, as Roger mentioned. Michigan is a good example of what can happen that is unexpected and can be a constraint. And yet, at the same time, we've seen very positive friends that we think suggest that we are going toward growth in the not too distant future here.

William Lewis: And historically, when we provided guidance, it has not always been to the benefit of our shareholders. There was sometimes more confusion than clarity provided by specific guidance. So for those reasons, I think we're a little reticent to engage in that exploration now. There may come a time when we revisit that, but I don't see that happening in the next couple of quarters.

William Lewis: But we'll revisit it as things become more clear. In terms of guidance on expenses and other aspects of the business, I'll just ask Sarah to make any comments. Sure. I'm happy to.

Sara M. Bonstein: Thanks, Will. And thanks, Nita, for the question. So similarly, we have not provided expense guidance.

What I can share is we do anticipate for research and development on expense that to grow from 20 from the 2020 levels that in 2021, those would grow from the 2020 levels SG&A I commented in my prepared remarks, Interestingly we were.

Sara M. Bonstein: What I can share is we do anticipate for research and development expense, and expenses that we do anticipate, to grow from the 2020 levels in 2021, those would grow from the 2020 levels. SG&A, I commented in my prepared remarks. Interestingly, we were flat from 2020 in Q1 to 2021 in Q1.

Flat from 2020, Inc.

Q1 to 2021 in Q1, so you can see by those financial results that we are laser focused on keeping our financials in check being prudent with our spend investing in research and development, which ultimately drives value creation and shareholder opportunity.

Okay. Thank you and then as far as enrollment on all day trials go have you seen as you've had them have you seen any any sort of no more disease or is that still going on.

Sara M. Bonstein: So you can see from those financial results that we are laser focused on keeping our finances in check, being prudent with our spends, investing in research and development, which ultimately drives value creation and shareholder opportunities. Okay, thank you. And then as far as enrollment in all the trials goes, have you seen any sort of no more delays, or is that still going on with some delays?

With some delay.

So to be clear the trials right now are enrolling.

Anticipated.

All right.

Against our own models I think we feel comfortable with what's going on.

Sara M. Bonstein: So to be clear, the trials right now are enrolling as anticipated inside, you know, against our own models. I think we feel comfortable with what's going on. But it's still relatively early days in the midst of everything that's been going on more broadly.

Still relatively early days in the midst of everything that's been going on more broadly.

But I don't anticipate that there will be disruptions to the enrollment patterns that we've been seeing and I think a lot of work has been done in anticipation of the presence of COVID-19 and all of the pressures that it brings to bear on so many fronts and those things have really enabled us to I think meet our internal objectives as we move forward here.

Martina Flammer: But I don't anticipate that there will be disruptions to the enrollment patterns that we've been seeing, and I think a lot of work has been done in anticipation of the presence of COVID and all of the pressures that it brings to bear on so many fronts. And those things have really enabled us to, I think, meet our internal objectives as we move forward here. Remote monitoring and other state-of-the-art clinical trial execution approaches have really been brought to bear here. And I think that's paid dividends. Great, thank you. That love you see.

Remote monitoring and other state of the art kind of clinical trial execution approaches have really been brought to bear here and I think that's paid dividends.

Great. Thanks, Lewis that love Disney.

Your next question is from the line of Greg <unk> with Goldman Sachs.

Great. Good morning, Thanks for taking my questions I've got.

Two just on <unk>.

My first just on your plans to explore the potential for <unk>.

Operator: Your next question, line by Greg Savan of A with Goldman Sachs. Great, good morning, thanks for taking my questions. I've got two just on TPIP.

On IPF I'm just.

Wondering if you've done the preclinical work yet.

In IPF.

Whether it's from y.

Operator: My first, just on your plans to explore the potential for TPIP in IPF. I'm just wondering if you've done the pre-clinical work yet in ITF, you know, whether it's, Lyomycin mouse models and what you've seen there, whether in combination with profenadone or an intensive And then just on your pH program, I'm just wondering if at some point you're thinking that you're going to have to run some head to head with an active comparator and, you know, which compound makes the most logical sense, whether, POS perspective, given the analogs that already exist or whether there's another active comparator that you'd think commercial or competitive landscapes.

Why on Bison mouse models, and what you've seen there whether in combination with percentage of donor intends on it and then just on your P. H program I'm just wondering if at some point youre thinking that youre going to have to run from head to head.

With an active comparator, and which which compound makes the most logical sense, whether it's from a Pos.

Pos perspective.

Kevin.

The analogs that already exist or whether it is another.

Active comparator that you'd think about from a commercial or competitive landscape perspective. Thanks.

Yeah sure. So thanks for those questions on the IP upfront.

Yes, we have four compressional palm until run models in the Bleomycin mouse model and that data has been published but that was with the emulation solution. The nebulizer form several years ago. What was interesting about the preclinical work just to go to sidebar is that not only did we see what is commonly observed.

Operator: Yeah, sure, so thanks for those questions. On the IPF front, yes, we have for troposinopal run models in the bleomycin mouse model, and that data has been published, but that was with the inhalation solution and the nebulized form several years ago.

And that model, which is not always.

William Lewis: What was interesting about that preclinical work, just to go on the sidebar, is that not only did we see what is commonly observed in that model, which is not always..., strongly predictive, you know, the prevention of the inflammatory response, but we actually saw a reduction in the fibrodic components that form as a byproduct of that provocation in that model. So it's those two elements that we observed that we found more encouraging than would normally be the case.

Strongly predictive.

The prevention of the influence inflammatory response, but we actually saw a reduction in.

The fibrotic.

Components that form as a byproduct of that provocation in that model. So it's those two elements that we will observe that we found.

I'd say.

More encouraging than would normally be the case, we are replicating that work and other work to augment our understanding of TPI P. In the mouth and the potential treatment of IPF and I would say while that is a very difficult disease to treat and has a lot of.

William Lewis: We are replicating that work and other work to augment our understanding of TPP and the potential treatment of IPF. And I would say, while that is a very difficult disease to treat and has a lot of... issues in terms of interpretation and early models, we are encouraged to date to continue the work, and I think we'll continue to report out on what we see there. With regard to the possibility of a head-to-head study against another compound, the first thing I would draw your attention to is all the preclinical animal work we did, in which we did, in fact, compare TPP and various animal models against other approved medicines that treat PAHs today.

Issues in terms of interpretation and early models. We are encouraged to date to continue the work and I think we will continue to report out on on what we see there.

With regard to the possibility of a head to head study against another compound first thing I would draw your attention to is all of the preclinical animal work, we did and which we did in fact compare TPI in various animal models against other approved medicines that treat ph today and there we saw superiority across a number of different per.

<unk>, both hemodynamic and histologic in terms of improvement in those animal models and I think that is one of the strongest points of encouragement for this drug and its ultimate clinical profile, whether we actually ended replicating that in a human.

William Lewis: and there we saw superiority across a number of different parameters, both hemodynamic and histologic, in terms of improvement in those animal models. And I think that is one of the strongest points of encouragement for this drug and its ultimate clinical profile. Whether we actually end up replicating that in a human has not been finalized or discussed, but I certainly don't think, as a point of departure, that it is essential that we do so.

William Lewis: However, there is some active discussion about whether we would like to do so to demonstrate what we believe will be a superior profile of the drug. Of course, the most important thing to do here is to get the drug to patients who can benefit as expeditiously as possible.

William Lewis: Something like the head-to-head study could be the kind of thing that takes longer to discern a relative benefit, and so we wouldn't want that to be something that limited our ability to secure approval of the drug. So that's how we're thinking about it right now, but more to come as we've learned more about the. Okay. Thanks so much and congrats on the progress. Thank you. Again, if you would like to ask a question, please press Star. Yeah, good morning.

Program before the end of this year.

Just wondering if that's still on the table and if so what is that update look like should we just expect some kind of qualitative commentary around where enrollment is tracking to or is there something else that we should be keeping an eye on.

Operator: Thanks for, a quick one for me. So I think you had mentioned that you would be providing, I guess, some kind of update on the progress and on court before the end of the year. Just wondering if that's still on the table and, if so, what does that update look like? Kind of quality carry around where enrollment is tracking to, something else that we should. No, I think it's a fair question.

I think it's a fair question for all of our clinical development programs. We obviously want to provide transparency on where things are going as you know.

Call me once once bitten twice shy from my history of trying to provide an early and transparent predictions on where clinical trials are going to go up.

I'm just going to be cautious about the time that we do bring forward updates that are sort of for lack of other way of describing them quantitative and that's only because I want to make sure that things will continue in the future as they have in the past when I started to see that predictive behavior than we can rely on it a bit more and I think at that time, it's easier.

William Lewis: For all of our clinical development programs, we obviously want to provide transparency on where things are going. It's, you know, call me once, once bitten twice shy from my history of trying to provide early and transparent predictions on where clinical trials are going to go. I'm just going to be cautious about the time that we do bring forward updates that are sort of, for lack of a better way, describing them quantitatively. And that's only because I want to make sure.

To provide forward looking guidance on when we think something might complete for example, I want to emphasize right. Now we are very comfortable with where our clinical trials are the progress they are making against our internal.

Objectives, and I think the team is doing exceptional work and encouraging our opening of sites around the world are securing patients screening and randomized them all of those things are going as we would want them to.

I hope to be able to provide more detail as the year goes on for sure.

William Lewis: that things will continue in the future as they have in the past. When I start to see that predictive behavior, then we can rely on it a bit more. And I think at that time, it's easier to provide forward-looking guidance on when we think something might complete, for example. I want to emphasize right now that we are very comfortable with where our clinical trials are, and the progress they're making against our internal objectives.

Understood.

Taking the questions.

And we do have a question from the line of Matthew Harrison with Morgan Stanley.

Hi, all this is Connor on again, just hops back in the queue. So.

So just a quick one for the six minute walk data in the second half.

Can you just give us an idea of what you expect to see from that is it sort of do you plan for it to be directional or where is it going to be I guess, what do you expect to see for that day.

William Lewis: And I think the team is doing exceptional work in encouraging the opening of sites around the world, securing patients, screening, and randomizing them. All of those things are going as we would want them to, and I hope to be able to provide more detail as the year goes on for sure. Understood. Thanks. Question from the line of Matthew Harrison with Morgan. Hi, this is Carter.

So just to be clear there are two phase two studies one that Martina was referring to is the phase what we call. The <unk> study that will be reporting out a handful of patients from the second half of this year that will not be six minute walk data that will be pulmonary vascular resistance data on that sort of the primary point of analysis and just to clarify the details of that.

<unk>. This is a patient who will be right heart catheter is in an intensive care unit for a 24 hour period and administered a single dose of our TPI Pea.

William Lewis: So just a quick one, minute walk data, and can you just give us an idea of what you expect to see from that? Is it sort of, do you plan for it to be directional or not? What do you expect to see for that data? So just to be clear, there are two phase two studies; one that Martino is referring to is the phase, what we call a 2A study, that will be reporting out a handful of patients in the second half of this year.

We will then monitor what happens to the hemodynamic behavior of the patient.

Through that right heart catheterization, so it'd be very accurate measurement there'll be a longitudinal measurement, but it will be limited to that 24 hour exposure that they are kept in the ICU as we go into phase two b, which we anticipate kicking off by the end of the year that is the 16 week study that will track over time the impact on six minute walk test as well.

William Lewis: That will not be six-minute walk data. That will be pulmonary vascular resistance data, and that's sort of the primary point of analysis. And just to clarify the details of that study, this is a patient who will be right-heart catheterized in an intensive care unit for a 24-hour period and administered a single dose of our TPP. We will then monitor what happens to the hemodynamic behavior of the patient during that right-heart catheterization. So it'll be a very accurate measurement.

<unk> and other measures. So those are two different studies, we will not be releasing any six minute walk data. This year just to be clear two different studies.

Understood. Thank you.

Sure.

There are no further questions.

Are there any closing remarks.

So thanks, everyone for joining us today.

William Lewis: It'll be a longitudinal measurement, but it'll be limited to that 24-hour exposure that they're kept in the ICU. As we go into Phase 2B, which we anticipate kicking off by the end of the year, that is the 16-week study that will track over time the impact on the 6-minute walk test as well as PBR and other measures. So those are two different studies.

Yeah.

This concludes the first quarter 2021 financial results conference call. Thank you for your participation you may now disconnect.

[music].

William Lewis: We will not be releasing any six-minute walk data this year, just to be clear, two different studies. Understood, thank you. No further questions. Are there any closing remarks? Thanks for joining us today. This concludes the first quarter financial results conference call. Thank you for your participation. You may now disconnect.

Okay.

Good day.

[music].

Operator: and so on. Thank you. Thank you. Thank you.