Good day, and welcome to the Insmed Corporate Update Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I'd now like to turn the conference over to Sarah Bohnstein, Chief Financial Officer.
Please go ahead.
Thank you, Jason. Good afternoon, and welcome to today's conference call to discuss our 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 may involve risks and uncertainties that may cause actual results to differ from the results discussed in the forward looking statements. Please refer to our filings with the SEC, which are available through the SEC's website at www.sec.gov or on our website for information concerning the risk factors that could affect the company.
The information on today's call is not intended promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are Will Lewis, Chairman and Chief Executive Officer and Roger Asette, Chief Operating Officer. Let me now turn the call over to Will Lewis for prepared remarks. Upon completion of those remarks, we will open the call up for your questions. Will?
Thank you, Sarah. Good afternoon, everyone, thank you for joining us. Hopefully, you've had time to read today's press release. The last few days have seen an array of developments from the accomplishment of our filing in Japan ahead of schedule to the receipt of official notification from AstraZeneca that they intend to develop INS1007 in COPD or asthma. While these are noteworthy developments, the backdrop of the rapid spread of COVID-nineteen and its impact on the healthcare community and society more broadly places everything into a different context.
As we take prudent measures to respond to the virus, we also have reflected on our best course of action as a business and thought it would be helpful to provide a single update on all these developments by issuing a press release and hosting this call to provide additional context and give you time to ask any questions. I'll start today's comments with an acknowledgment of the dramatic consequences we have all witnessed due to the arrival of COVID-nineteen. In less than a month since our last call, the world has seen the effect of this pandemic and it now impacts nearly every aspect of our society. I'll speak more directly about how we are addressing it within our own organization and its potential impact on our U. S.
Commercial business in a moment. But I want to call attention to the important role the industry is playing in trying to combat this unexpected life threatening challenge we now all face. I think we all recognize the absolutely essential role our industry plays in providing solutions to this type of challenge the moment it arrives. Where we would be without the resources of an advanced global healthcare system is worthy of sober reflection. At every turn, innovation needs to continue.
Despite the very real challenges posed by COVID-nineteen, we will continue to advance the cause of medicine for patients suffering from rare and serious diseases, including bringing ARIKAYCE to patients in need. We anticipate that once this crisis has resolved itself, there is likely to be an even greater sensitivity to pulmonary symptoms and we want to be ready to provide products and support for physicians and their appropriate patients. To that end, today we are pleased to announce that we have submitted a Japanese new drug application to Japan's Ministry of Health, Labor and Welfare or MHLW for ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who do not sufficiently respond to prior treatment. This is a significant accomplishment for us as we work toward making ARIKAYCE available to patients globally. If ARIKAYCE is approved in Japan, we would be in the position to address the significant unmet need and bring the 1st inhaled treatment for NTM to patients in Japan.
As part of the approval process in Japan, we also plan to submit a separate Japanese medical device notification to the MHLW for approval of the Lomira nebulizer system in the Q2 of this year. This is the designated device for the administration of ARIKAYCE. In addition to progress with ARIKAYCE, we have recently seen some dramatic advances in our pipeline. Here I am specifically speaking about INS1007. Our recent top line Phase 2 data offers the promise to those with compromised lung function due to non CF bronchiectasis of a once a day pill that may help their condition and reduce pulmonary exacerbations.
We are anxious to explore it in a Phase III trial in bronchiectasis starting later this year. We are also gratified that our positive view on the promise of this drug is shared by its original scientific developer, AstraZeneca. Today, we were pleased to announce that AstraZeneca has exercised its first option under our license agreement, which allows AstraZeneca to advance the clinical development of INS1007 up to and including Phase IIb clinical trials for COPD and asthma. AstraZeneca's decision to exercise the option signals their interest in this product for COPD or asthma, to cornerstones of their therapeutic areas of expertise. We view this as further validation of the promising top line results we saw from our Phase 2 WILLOW study.
As a reminder, INS1007 is a novel oral reversible inhibitor of dipeptidyl peptidase 1 or DPP-one, an enzyme that catalyzes the activation of neutrophil serine proteases or NSPs. NSPs
are key agents
of needle mediated inflammation, tissue damage and excessive mucus production involved in bronchiectasis. We believe the ability to modulate neutrophil activity presents an opportunity to treat multiple indications beyond non CF bronchiectasis. Based on our top line Phase 2 data, we are advancing INS1007 into Phase 3 development as a treatment for bronchiectasis as a first, but by no means final area of unmet medical need. Under the terms of our agreement, AstraZeneca has the ability to advance the clinical development of INS1007 in COPD and or asthma in stages with their ability to commercialize it ultimately subject to our reaching mutual agreement. Per the agreement, the exercise of the first option provides AstraZeneca the right to conduct up to and including a Phase 2b clinical trial in COPD or asthma.
AstraZeneca is entirely responsible for all costs, including manufacturing of product related to these trials. In the event these trials are successful, the agreement also includes a second option for AstraZeneca to explore development of INS1007 beyond Phase 2b clinical trials in these indications, subject to our mutual agreement on commercially reasonable terms for such continued pursuit. Going forward, we will form a joint steering committee with AstraZeneca focused on the development of INS1007 in the indications of COPD and asthma. We look forward to working with AstraZeneca and recognize the validation that their interest represents for the potential of INS1007. Finally, let me remind you that Insmed retains full development and commercialization rights worldwide for INS1007 for all indications outside of COPD and asthma.
Several of these we have considered or already begun exploring including cystic fibrosis, alpha-one antitrypsin deficiency, GPA, inflammatory bowel disease, lupus and rheumatoid arthritis. Of note, due to its mechanism of action, we are also pursuing in vivo models to understand the potential of INS1007 against acute respiratory distress syndrome or ARDS, which may be brought on by a number of causes, including in those patients with respiratory failure due to COVID-nineteen. In light of COVID-nineteen, we have taken important steps to ensure the health and safety of our employees and the continuity of our operations. One response we have taken is to require our entire staff from headquarters employees contain the spread of this virus. While at this time, we are not aware of any Insmed employees having tested positive for COVID-nineteen, we are exercising an abundance of caution due to the exposure risk posed to the patient and provider communities we serve.
Having acknowledged the devastating effects we all know COVID-nineteen has had on our society, I must turn to the specific impact of COVID-nineteen on the U. S. Launch of ARIKAYCE. This pandemic is especially challenging for our efforts to help NTM MAC patients who have failed to respond to adequate therapy because both the target physicians and the patients they treat are at ground 0 in this crisis. To remind you, NTM patients tend to be older with underlying lung conditions and these are among the most vulnerable potential patients to get infected with COVID-nineteen.
Similarly, the infectious disease specialists and pulmonologists who treat these patients are rightfully focused on the containment of COVID-nineteen. Many of these healthcare providers are being pulled out of normal clinical practice in order to work directly on COVID-nineteen response planning and patients evidencing symptoms. As a result, many of these offices have prudently shut down access for non essential visitors, including our sales representatives in order to protect patients. As a consequence of the uncertainty introduced by this new reality, we are suspending our 2020 revenue guidance. I want to be clear that we continue to see new patient adds and prescription renewals.
We also have sufficient drug supply. Nonetheless, the introduction of this new and unexpected uncertainty regarding the effect of COVID-nineteen on our U. S. Commercial efforts related to ARIKAYCE directly affects our ability to confidently assess its impact on the commercial potential of ARIKAYCE at this time. Providing revenue guidance is fraught with uncertainty in the best of times.
The current circumstance demands a transparent communication about the new uncertainties that surround this kind of forecasting exercise. We believe the prudent action is to simply take this off the table and remain cautious, conservative and transparent. We are doing the best we can to adapt our efforts in the face of these new challenges, including increasing our remote outreach efforts via digital marketing and other forms of virtual outreach. It is important that refractory NTM MAC patients continue to receive care and attention and we are committed to help them and the physicians who attend to them. For example, Insmed's ARIKAYS trainers will now offer remote training for patients who initiate treatment with ARIKAYCE rather than conducting in person onboarding.
And so far, patients are opting for virtual training in light of the current pandemic. It is also worth addressing that in this crisis, for many companies in addition to disrupting physician outreach, the potential for supply chain disruption is also possible. Let me assure you that to date we've experienced no discernible impact on our supply chain. For our manufacturing infrastructure, we have experienced no disruptions in our ability to manufacture ARIKAYCE. We believe we have an adequate supply of the active pharmaceutical ingredient used in ARIKAYCE to meet our anticipated global requirements, including commercial, clinical and compassionate use through the end of 2022.
Additionally, given historic demand trends, we currently estimate we have over 7 months of finished product on hand and production continues. In closing, the COVID-nineteen pandemic has changed the landscape for all of us. 2020 has already proven to be an unprecedented and challenging year. We have made great strides in an effort to ensure appropriate patients in need of receiving ARIKAYCE continue to have the opportunity to do In addition, we are doing everything we can to ensure the safety of our patients and their caregivers, our colleagues, our families, our communities and our shareholders. As the year progresses, we will remain focused as always on solid execution and this crisis will not alter that commitment.
With that, I'd like to open the call to questions. Operator, can we take the first question please?
We'll now begin the question and answer session. The first question is from Ritu Baral from Cowen. Please go ahead.
Hey guys, thanks for taking the question, and thanks for the update today. Will, it's been about, I would say, 3 weeks or so since the updates from Washington State and the Kirkland Center there, which put everybody on alert for the elderly. Can you talk about the trends that you've seen in the last 2 to 3 weeks on new starts, on refills, on potential discontinuations because people aren't training correctly on tolerability? And then can you talk a little bit more about this remote marketing and digital outreach? Are you going to be able to do sort of 1 on 1 detailing in any capacity?
Or is this really just going to be sort of like a mass push at events like ATS, if ATS is still even happening and how disruptive will that be if those aren't?
Yes. So I appreciate the questions. I think what I would just start up in response is to say the situation is changing on a daily basis. The best available information I have suggests that we're about 11 days behind where Italy is at the moment. And that suggests that somewhere in the 15 to 45 day timeframe from here before we reach peak.
Now that could change dramatically in that next couple of days. But I think the clear message is it's going to get worse before it gets better and the market I think is anticipating that. We have responded and I would just add, it was our decision to pull our reps out of the field before all the access that I'm referring to is entirely shut down. And our reps want to be out there. They want to be helping these patients.
They know that they're going to be in a tough spot and they want to be able to help the physicians to identify the appropriate patients and ensure that they can get access to medication. Their commitment remains 100%. So using appropriate and compliant tools, we will continue to support physicians so that they can support patients in the appropriate way, But respectfully, out of fear of not becoming unintentional carriers as we travel from these vulnerable offices, we've decided to pull our entire sales force and frankly have everyone have a work from home policy to support that social distancing. We're not going to comment on specific trends within the last several weeks. I think it's fair to say that we've seen things change dramatically in terms of the way access was going.
And so it was an easy decision for us to pull the reps out for the reasons I just mentioned. What I would like to say is, think it's very likely that ATS will be canceled. We of course have no involvement in that. I'd love to see it continue. But I just think we have to assume it's going to be canceled.
I will remind you, we were planning on an Analyst Day soon after ATS. And so I think we're going to redouble our efforts to do that in a remote way so that we can continue to feature all of the data and capture all of the good progress we're making on 1,009, 1,007, our ARIKAYCE program in terms of label expansion and global outreach, etcetera. So that information will still be made available to the market. In terms of specific things we're doing and perhaps trends we're seeing, I'd like to ask Roger to comment on the details.
Yes, perfect. Thanks, Will. Thanks, Ritu for the question. So let me just talk a little bit about what our plans are. As you know, we've talked previously about we have some pretty significant digital capabilities and we'll be deploying those in more earnest over the coming weeks.
So the digital outreach, the emails, the digital detailing will be things that will expand. We will have the capability to reach out to physicians, individual offices, the health care professionals supporting those patients. And we'll have that ability to do that either over video or over the phone. And for those offices that are still treating the NTM refractory patients, we are absolutely there to support them and make sure that they get the service that they need to get access to the patient to the medicine for the patients. A couple of the specifics we're doing around the ARIKAYS support program.
So one of the key aspects as you know is to make sure we're doing the training and the onboarding for these patients. That's something that we've decided this week that we would move to virtual training as Will mentioned. So previously, we had given the option for, an in person training for these patients to walk them through the device. We now have 2 options that we can offer to these patients. 1 is a video, secure video link where we can have that 1 on 1 interaction remotely to make sure that there's no transmission risk for these patients from our health care professionals, our field trainers.
The second is we can provide a video on the device and telephone support if the capabilities for the patient are more limited. And in that way, we'd be able to make sure that they have the training they need. And of course, we can repeat that training if they feel like they need that reinforcement. So far those programs have been well received by patients. So we haven't had anybody to my knowledge defer training until we're back into an in person training session.
So that continues and I think and we continue to see new patient prescriptions for ARIKAYCE. Importantly and obviously one of the most important things is that for patients who have started on ARIKAYCE that we're able to see that them continue their therapy. We have our ARIKAYCE coordinators. While we've asked them not to come into work, we have remote capabilities set up, so they are all supporting their offices and most importantly the patients, from home with the technology solutions we have built in for that support. And they'll be able to continue to do that remotely.
We also have the specialty pharmacies will continue to reach out to these patients. And so as you know, we have a closed distribution network. So patients do not have to go to the pharmacy to receive their prescription. The SPs will the specialty pharmacies will reach out to the patient, check-in on do they need more ARIKAYCE. And if they confirm that, then they'll be able to ship directly to their door and the patient will be able to continue to take their therapy.
So obviously, this is not ideal situation, but I think we're well equipped and through the use of technology and the investments we've made, we're well equipped to continue to support the physician offices and the patients as they take their ARIKAYCE.
And one thing I'll just add to that, I think most companies do invest to varying degrees in their IT backbone and the capabilities of the human resources that surround IT. And it's not until a moment like this that everything really gets put to the test. And I could not be happier with the performance of the investment and the return we're getting from that in this kind of crisis situation. Everything is working. We're not missing a beat.
And that's really giving us the best possible ability to help physicians support patients who are appropriate for therapy.
The next question comes from Matthew Harrison from Morgan Stanley. Please go ahead.
Hi, everyone. This is Conor Meehan on for Matthew. Thanks for taking the question. Just two quickly for me. You mentioned that there's nothing there's no interruption yet to the supply chain, but could you just provide some detail on how any disruption might manifest if it were to happen?
And then maybe a timeline and when you would expect that sort of disruption to happen? And then just quickly on AstraZeneca, what do you think they need to do to progress the drug? And is there any sort of assurance on a timeline that they need to move the drug forward? Thank you.
So on the first question on supply chain, I don't think we anticipate any interruptions. What we were trying to provide today is where there may be questions, and I've heard some of these come our way about where does your API come from? Is it sourced in China? Is it sourced in Italy? Those sorts of things.
And how have you addressed potential need for API going forward in a world where freight were to be suddenly blocked crossing borders, for example. So in that sense, API, I think we have quite a bit of redundancy, as we mentioned on the call through 2022 to supply all our anticipated needs. Finished product is made obviously at the contract manufacturing operations and we have based on current forecast from historical standards, roughly 7 months of finished product in hand and manufacturing continues. So I don't anticipate any disruptions in a world where the pressure starts to mount in certain parts of the supply chain more generally in the industry, I think we are well insulated and that was the point I was trying to get across there. On the question with regard to AstraZeneca, I think exercising option 1 enables them to begin their efforts at their expense to develop the drug for COPD and asthma.
And obviously the Joint Steering Committee will facilitate exchange of information on the clinical data, etcetera, once we have completed all of our work there. And once they have that, it will be, of course, their discretion how they choose to proceed and go forward.
Great. Thank you.
The next question comes from Adam Walsh from Stifel. Please go ahead.
Hi, guys. Thanks for taking my questions. The first one is, it seems like there's maybe a couple of things going on, Will, with the retraction of the guidance. One of which is that you mentioned that doctors are being pulled away in pulmonologists and infectious disease specialists. And then the other part of it has to do with the inability to actually market and detail the product.
Can you parse out for us at this point in time kind of where the balance falls in terms of those two issues when it comes to attracting the guidance? That's the first one. Thank you.
Yes. I think my the way I would capture our decision on guidance is that, as I said in the remarks, I think revenue guidance is uncertain in the best of settings and we now have this massive externality that is arriving. The full scope and brunt of it is yet to be revealed. And I think for that reason alone, that uncertainty necessitates the prudent move of simply saying we can't rely on the assumption sets that we had to provide the original guidance. Where we go from here, I don't think we have very much data to judge.
What I would say is there are some docs that are being pulled away, we know explicitly for preparation of the hospitals in which they work for the arrival of significant numbers of patients infected with COVID-nineteen. And there are other physicians who are trying to manage their practices in such a way to limit the amount of social interaction. So these are unusual constraints without precedent and they make it very difficult to really, I think, intelligently estimate what the future will bring. And so for that reason, we pulled it. I don't think I would want you to walk away with we have lots of detailed information on the consequences of all these changes, yet we don't.
But I think we expect that there will be disruption. And for that reason, that breeds uncertainty that we can't wrap our arms around at this time. And so it just seems to be in order to be transparent, we need to say that the assumptions we had that originally informed our guidance are no longer the sole forces that are at play here. So we have to step away. I don't know, Roger, do you want to add anything about specifics about breakdown between different changes we've seen on the front lines?
Hi, Will. Yes, thanks.
I don't think I want to
specifically break down other than to comment that it varies from region to region. And I think that as we see this the COVID spread, we're going to see more impact in different offices. And certainly, I believe in the and we have seen the impact of sales force and taking them out of a day to day interaction with office staff and physicians is certainly not ideal from our perspective. But as I said, we're going to continue to reach out to these physicians and the health care professionals in the office virtually and support them as best we can. I think the other thing we need to be cognizant of is some of these patients are quite nervous, the NTM patients.
So there may be some as we talk to NTM IR and some of the feedback we're hearing is that they may want to defer their appointment until this clears. That we'll have to see if how that manifests itself. But it could be that at least in the short term, you'll see less opportunity for the patients to visit the physicians and the physicians may in fact advise them depending on their individual situation to not come into the office. But I think that in the medium to long term, I think we're going to see that, that resolve itself. Fundamentally, nothing's changed about the attractiveness of ARIKAYCE the desire to treat these NTM patients.
I think right now, we're just trying to understand with COVID-nineteen what exactly that means in the short term.
That's really helpful. Thanks for the clarification.
The next question comes from Joseph Schwartz from SVB Leerink. Please go ahead.
Hi, guys. Thanks so much for all the proactive transparency. I was wondering if AstraZeneca had evaluated or whether they had the option to enter into an agreement to develop INS1007 for the indication that you're pursuing?
So they only have the rights to pursue COPD and asthma under option 1 of the agreement and that is limited through Phase 2b. At the conclusion of that trial work, they then can exercise option 2 and that would permit them to enter Phase 3 and commercialize. In order to do that, we would have to reach a mutually agreeable agreement. So the agreement needs to be reached and we would have to be all the elements that surround that would have to be reconciled to our satisfaction. Indication or
2 that's different than, the bronchiectasis that you an indication or 2 that's different than, the bronchiectasis that you go for, how do you envision that that kind of a commercialization agreement would work in practice and would there be any reconciliation of prescriptions or sales or anything? You typically don't see those kinds of agreements where a pill is divided across indications and partner?
It's early days to sort of speculate on what might happen from here. I guess what I would say at this point is AstraZeneca has shown strong interest in this compound and its potential in those indications. And so this is the beginning of the journey to understand where that may go.
Okay. And then I was just intrigued by the mention that there could be potential utility in addressing some of sequelae of something like a SARS or COVID infection. Can you just expand on that and what preclinical work, if any, has been performed there?
Sure. So I mean, I think what I the way I would say this is we're looking at INS1007 for a number of different potential diseases, and that may include the list of diseases I mentioned earlier, but also more recently looking closely at acute at acute respiratory distress syndrome. So looking at INS1007 and ARDS, which is one of the outcomes of getting COVID-nineteen for some patients, we think there may be a potential role in treating that ARDS. And so we're looking at an animal model of that disease with this compound. There's much more work to be done.
It's early days. And I think we've got a lot of questions we want to answer before we sort of go any further with the representations about this. But we are reflecting on how we might do that in the most effective way and time efficient way if these early models were to be in some way promising. That could include considerations of things like formulation as well as, how we would bring it forward for this particular indication.
Okay, great. Thanks again for the update.
The next question comes from Gregg Svanavai from Goldman Sachs. Please go ahead.
Hey, good afternoon. Thanks for taking my questions. I've got 3, if you don't mind. My first is, I know it's very early days with trying to assess the impact of COVID-nineteen, but do you have an idea when you might be in a position to revisit 2020 sales guidance? Is it something that we should expect that maybe we'd get a periodic update or just when you feel you're in a better position realizing that we just don't know looking in the future what the impact can be.
So just trying to get a sense on when you might anticipate providing an update to The Street. So that's my first question. My second question has to do with your current prescriber base and perhaps your patient base that's on ARIKAYCE right now. And certainly, there are some hotspots in terms of where COVID-nineteen is having a real impact. So I'm wondering if there's if you could provide any color on kind of that distribution of physicians and patients and whether they are also kind of in these hotspots or any color around kind of the distribution throughout the country?
And then my third question just goes back to the AstraZeneca relationship and if you could remind me or us if there are sources of non dilutive funding that come along with the exercise of the option, whether this option or the next option or any other arrangement? Thank you very much.
Sure. So on the issue of guidance, guidance is provided here's how I think about it theoretically. Guidance is provided when you have enough certainty around the direction you think you're going to be traveling to be able to give that visibility to The Street in a way that's useful. I think the uncertainty is the watchword for the day. Once again, I would emphasize that it's not that there's been a catastrophic modification of what's going on with our day to day business.
What we're seeing is a lot of uncertainty about what could happen and not knowing a circumstance that has no precedent and its implications for us And the fact that we pulled our sales force, those are going to have consequences. What they look like, we don't know. And I think that uncertainty will continue to guide our hesitation to provide guidance for as long as it's present. So it's a little early for me, I think, to give any kind of hint of how we might think about guidance in the future. On the second question, I guess I'd turn it over to Roger to talk about any regional specifics or prescriber base behaviors related to ARIKAYCE.
Yes.
Thanks, Will. So I would a couple of things I would say. I think as you would expect, we saw the earliest hints of this, in the areas of the country where, the first cases were reported. Washington State was very early, and we saw the impact of that, very quickly, as far as, physicians responding and requesting that our sales rep respect their time and their offices. More broadly, our patients are distributed roughly with population centers, but also around the Gulf States, Florida, California, around water, and around population centers where you have a skew to an older population.
And so I would say that as COVID spreads, you'll see that these patients will be impacted and the physicians will be impacted much as the general population. And as we track these hotspots and these outbreaks and as this if it continues, then we'll be able to understand the difference in the regional the impact regionally. But right now, it's probably too early other than to say, hopefully, that the self isolation and trying to restrict as much as we can contact will cause this to abate. But I think right now, the assumption is that we're not yet at peak. And therefore, we'll see in physician excuse me, in population centers, we'll see the impact on physicians and patients for ARIKAYCE and the NTM population.
And just picking up on your third question, Greg, on AZ and whether there's non dilutive funding associated with either option 1 or option 2. In the case of option 1, there is not any funding trigger. This just permits them to begin Phase 2 development in COPD or asthma at their expense. In the case of the exercise of option 2, we would have to reach a mutual agreement on terms that are satisfactory. And so if that were to be reached, then they would be able to proceed through to Phase 3 and commercialization.
And obviously, that would include a commercial agreement if we were to get to that point of agreement.
Okay. Thanks and good luck.
The next question comes from Marty Auster from Credit Suisse. Please go ahead.
Hey, guys. Thanks for hosting this call today and
kind of being proactive on these issues. It's very helpful for us. I think just a couple of questions to follow-up on, maybe some earlier topics have been hit on, but maybe for Roger. So when the virus, the coronavirus begins to kind of ebb out, I know that you had some impact in Q1 from the donut hole earlier in the quarter and maybe you can confirm that that effect seems to have kind of fully receded now that we're into March. And obviously now you're getting hit with the impact from coronavirus rising up.
Do you expect there to be
a warehousing and a snapback? So I mean, for example, the virus was kind of ebbing out over the June, July timeframe. Would you expect then that you'd have a Q3 start that would kind of reflect not only just resumption of normal trends, but kind of some excess as well? And then the other question I had was, I know you're in the planning phases, both for your frontline and TMAC study as well as your Phase 3 bronchitis study. How long would the coronavirus how long would the current environment have to persist for those trials start to be at risk and delayed?
And then how should we think about kind of as we're thinking about the longer term model there?
Raj, do you want to take the first question and I'll take the second?
Yes, happy to. Thanks, Will. So thanks, Marty. So yes, you're right. We talked about the donut hole on that on our Q1 call.
And we had seen that, that as we had anticipated that was a transitory effect and we're starting to come on to the other side of that And before, obviously, we now are facing additional uncertainties based on COVID. And so your second part of that question which is around warehousing and do we think we'll see a snap back in after all of this dies down. I think that's a real potential. I think as I mentioned before, the a lot of the patients, who maybe are older patients, they all, of course, have an underlying lung condition to go with their NTM infection, and are maybe choosing not to visit their office and put themselves at risk and are trying to follow this policy of self isolation. If that's the case, then I think you would obviously, the disease is still there, still needs addressing, they're still symptomatic and they're feeling bad, and not responding to the standard of care, I would expect that they would follow-up afterwards and make an appointment to visit their physician after all of this has died down.
So I think that there's we still certainly believe that there's a significant amount of patients who have not yet been treated, a significant amount of refractory patients who would benefit from ARIKAYCE. And we all know that the intention to prescribe from physicians is very strong. So matching those together, getting the patients in the office, reactivating our sales team and that's certainly something that we're taking advantage of with our work from home policy for our sales team. We're taking the time to sharpen the saw, redouble our training, bring them up to speed on the paper around practical management of AEs, etcetera. So we're back to normal and I'm sure we will be.
We're ready to go and we're back in engaging with the offices with new materials that we'll be able to get them to take care of these patients when they show up and ask for some help in managing their NTM.
So real briefly, can you just confirm, so I think what you're saying or what I'm hearing is, you see this is potentially kind of delaying the overall ARIKAYCE opportunity, not kind of permanently shifting it out. Is that a fair interpretation?
Yes. In my mind The opportunity here, you're shifting
to the right a little bit. You're delaying a little bit.
I certainly believe that the opportunity is intact. I think what this does is disrupting the ability of physicians to pay attention to these patients and the patients are reluctant, in some cases to go and seek the care right now. But I do believe that that the patient the physicians will be able to turn their attention back to these patients and the patients will be back into the office once all of this goes into return to normalcy. So I believe the fundamental opportunity remains intact.
And I also would just add, those patients are in their own mind going to be wondering about pulmonary symptoms or conditions to a degree that may be very different than what they have been in the past. There is a heightened awareness that we certainly anticipate. How that will read out? We don't know and I certainly wouldn't overly speculate on that, but I just would draw attention to the fact that the number one topic in everyone's house today is respiratory health. And I think as people begin to examine and look for answers and solutions to problems, that's probably going to draw more awareness to physicians of potential patients who fit the appropriate suitability criteria for the use of our drug.
There's going to be disruption here. What it means, we don't yet know. And I think if there's one thing I would leave you with, it would be that we don't yet know what the impact of this is, but it certainly is significant enough uncertainty to cause us to pull guidance. And I don't think that that should be a controversial decision from anyone's perspective. You also asked about studies and the impact of this on potential clinical studies.
All of the work continues. We are remote, but we are continuing our execution and we're very fortunate that we're not in the middle of a clinical study where something like this could disrupt the execution of it or the data or what have you. In our circumstance, we don't anticipate initiating a study for 1,007. We'll certainly do it as quickly as we can, but the current timeline has it after our meeting with FDA once we have all of our data together late this year. And the frontline study in ARIKAYCE for those patients, we expect in sort of the second half of the year.
So I think the timing of this will be such that those studies will not be impacted, but that will remain to be seen and of course we'll keep you apprised as we learn more and we see how the situation evolves.
All right. Thanks, Will and Roger. Appreciate the answers.
The next question comes from Liisa Bayko from JMP Securities. Please go ahead.
Hi guys, Neil on for Liisa. Just two questions. One, you might have touched on it before, but what activities specifically can the sales force do right now? And then number 2, is there any chance that you could actually diagnose more patients with NPM due to being evaluated for COVID? Thanks.
So I appreciate those questions and I'll turn them both over to Roger.
Thanks, Will. Yes. So Neil, I think specifically what can a sales force do? So we're committed to supporting the offices, the physicians and the healthcare professionals, the office staff, as they care for NTM patients. What we can do is specifically outreach to them.
So we'll be having digital detailing capabilities. We'll be able to share materials, education materials. We'll be able to provide them with patient enrollment forms. We'll be able to provide them with patient support materials and via video or if they would prefer we can of course always take advantage of the telephone and connect with them in this manner. So we also have a pretty sophisticated digital marketing capability and we will be turning that up as well.
So that's going to be focused on emails. It's going to be focused on the websites and the materials that we have available for physicians to engage with us from a digital perspective. Those have always been in place, but we're enhancing and rolling those out in more with more vigor, I would say, over the coming weeks. The second question was around diagnosing more. And I think that that's certainly a possibility.
One of the symptoms that is common between NTM and COVID, as I understand it, is a significant cough. And so if a patient presents with and is concerned about what's going on from a respiratory perspective, hopefully it's not COVID and hopefully it's not NTM. But if it is, then that could facilitate a diagnosis. You may be taking, a CT scan. They may be taking a culture, to understand what's happening there.
So I think as Will had mentioned, the increased focus on respiratory health and understanding and getting an accurate diagnosis, I think could ultimately benefit if the patients present. The one more thing I want to focus on beyond just the physicians, but I want to reiterate, the patient support that we have in place and the support virtually for the ARIKAYCE patients that are that have started therapy and are continuing therapy, will continue unabated. We have our ARIKAYCE team who is working virtually working from home and is in regular contact with their patients and supporting them as they go through their journey with ARIKAYCE. We continue to support patients and we are getting new patients starting on ARIKAYCE. We continue to support them with the training to make sure they have the adequate information they need, including around the device and what to expect from therapy and we're doing that virtually.
And patients have been very receptive so far to the offer of being able to train these patients via video secure video link and or through a telephone and video on the website. So there's a lot of efforts being put in place and we will do the best we can. Nothing replaces in person, but as best we can and respect in the situation here, we're going to continue to support our physicians and our patients.
There are no more questions in the queue. This concludes our question and answer session. I'd like to turn the conference back over to Will Lewis for any closing remarks.
Thank you for joining the call today, everyone. Stay healthy.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.