GW Pharmaceuticals plc
Q1 2017 Earnings Call Transcript

Published: 10 May 2017

[Operator:]

Good afternoon. Welcome to the GW Pharmaceuticals second quarter 2017 financial results conference call. All participants will be in listen-only mode. [Operator Instructions]. After today’s presentations, there will be an opportunity to ask questions. [Operator Instructions]. Please note this event is being recorded. I would now like to turn the conference over to Stephen Schultz. Please go ahead.

[Stephen Schultz:]

Welcome all of our and thank you for joining us today for our second quarter results call. Again, I’m Steve Schultz, Vice President of Investor Relations at GW. Today, I’m joined by Justin Gover, GW’s Chief Executive Officer; Dr. Stephen Wright, our Chief Medical Officer; Scott Giacobello, our new Chief Financial Officer; Chris Tovey, our Chief Operating Officer; and Julian Gangolli, President of North America. We hope you’ve had a chance to review our press release from earlier today. This document is supplemented by an additional 6-K filing. As a reminder, during today’s call, we will be making certain forward-looking statements. These statements reflect GW’s current expectations regarding future events, including, but not limited to, statements regarding financial performance, clinical and regulatory activities, patent applications, timing of product launches, and statements relating to market acceptance and commercial potential. Forward-looking statements involve risks and uncertainties and actual events could differ materially from those projected herein. A list and description of risks and uncertainties associated with an investment in GW can be found in the company’s filings with the US Securities and Exchange Commission. These forward-looking statements speak only as of today’s date, May 9, 2017. And, finally, an archive of today’s call will be posted to the GW website in the Investor Relations section. I’ll now turn the call over to Justin Gover, GW’s Chief Executive Officer.

[Justin Gover:]

Thank you, Steve, and welcome to all those who are able to join us on today’s call. Following my introduction, Dr. Stephen Wright will provide a research and development update, Julian Gangolli will provide an update on our US commercial operations, and Scott Giacobello will discuss our financial results. At the conclusion of our prepared remarks, we will open the line for questions. I’m pleased to report that the recent annual meeting of the American Academy of Neurology in Boston was another important medical congress for our company and for the Epidiolex clinical program. Dr. Wright will offer a brief review of the key presentations in his overview. But let me say how exciting it was for GW’s science to be highlighted in such a prominent way at this important and extensive neurology meeting. Many of you on today’s call joined us for our dinner, which featured presentations from Dr. Elizabeth Thiele of Massachusetts General Hospital and Dr. Anup Patel of Nationwide Children’s Hospital in Columbus. I thank you for taking the time to be there with us and hope it was a valuable event. Before moving to the clinical review, let me touch on some important recent management changes. I’m happy to be welcoming got Scott Giacobello to his first results call as our new CFO. Scott will be providing the financial overview today and on an ongoing basis. I’m sure that you will get to know Scott as we move forward and I have asked to join us at upcoming investor conferences. Scott brings 25 years of finance and operational experience to the company and is an accomplished executive, who most recently, and until its acquisition by Allergan in late 2016, served as chief financial officer for Chase Pharmaceuticals Corporation, a clinical biopharmaceutical company focused on treatments for neurodegenerative disorders. In anticipation of the Epidiolex approval and launch and with GW now solely listed on NASDAQ, we expect to transition to becoming a US domestic registrant reporting under US GAAP and in US dollars in future years. Scott’s significant financial and accounting expertise will be a major asset to the organization as we make this change. Adam George, GW’s CFO since 2012, has now taken on a newly created role of GW’s Managing Director, UK. This role will be instrumental in ensuring that GW’s UK operations achieve our strategic and operating goals, which include pipeline development, manufacturing scale up, and European commercialization. Adam is working with Scott, providing him with full support through the CFO transition. These important leadership appointments reflect GW’s continuing evolution into a trans-Atlantic commercial stage biopharmaceutical company. You will also recall that, last year, we announced that Dr. Stephen Wright will retire in May of this year. We have identified Stephen’s successor and we expect to announce the appointment of this new US-based CMO very soon. Although this will be Stephen’s final quarterly call in his capacity as chief medical officer, he will continue to play an important role as a senior medical advisor to GW, with dedicated focus on the Epidiolex NDA submission and European regulatory application. I shall now hand the call over to Stephen to provide a clinical update. Stephen?

[Stephen Wright:]

Thank you, Justin. And good day, everyone. Let me begin by reflecting on the recent annual meeting of the American Academy of Neurology, which featured podium presentations of all three of our completed Phase III pivotal studies of Epidiolex. Notably, the Dravet syndrome trial was presented to several thousand attendees in the plenary session by Professor Helen Cross of Great Ormond Street Children’s Hospital. The communication of the Dravet syndrome data has progressed in ideal sequence, first introduced in a specialty congress – in this case, the American Epilepsy Society Annual Meeting in December; next, the broader and larger AAM Congress; and then in a peer-reviewed journal, publication of which you will see in the second quarter in a high status journal. The LGS results were presented in separate podium presentations. The single-dose study by Dr. Jackie French and the multidose LGS results by Dr. Anup Patel, where in the emerging science session additional safety and efficacy data were presented for the first time. GW is working with the investigators in these studies on manuscripts for peer-reviewed publication, which are expected in 2017. Finally, there were two encore presentation, one on the pharmacokinetics of Epidiolex in Dravet patients from Part A of the Phase III pivotal study, a second on the lack of effect of CBD on sodium channels, and a third presentation on an in vivo minipig animal model, showing that CBD does not convert to THC in the gut. Looking specifically at the multi-dose study where 20 mg per kilogram per day and 10 mg per kilogram per day Epidiolex dose arms were compared to placebo in 225 patients. Let me elaborate on the new data presented at AAN. Beyond achieving the primary endpoint of reducing drop seizures in both those arms with statistical significance, p equals 0.0047 for the 20 mg per kg dose group and p equaled 0.0016 for the 10 mg per kg dose group, Dr. Anup Patel presented new data on the maintenance period, which measures the patient response over the stable dose period. As was the case with the Dravet study and with the single-dose LGS study, response improved over this maintenance period in both drop seizure reduction and responder rates. In the latter, the responder analysis for both dose groups, a significantly greater proportion of Epidiolex patients achieved drop seizure reductions at 25%, 50% and 75% versus placebo. This reinforces the similar result we saw in the first LGS study. Finally, also consistent with the previous Dravet and LGS studies, Epidiolex patients and caregivers in both dose groups were significantly more likely to report improvement in overall condition. While Epidiolex did result in more adverse events than placebo and there were fewer adverse events in the low dose group, both doses were well-tolerated, with a consistent safety profile to that observed in the previous Phase III studies. Most adverse events were mild or moderate and the two most common, those occurring in more than 10%, were sleepiness and decreased appetite. The poster detailing this efficacy and safety data is available on the GW Pharmaceuticals’ corporate website in the Investor section. Looking forward, we are fully focused on completing and submitting the Epidiolex NDA with FDA and continue to expect the submission to be made mid-year. This timing is consistent with expectations set out at the time of the last Phase III data readout and reflects the fact that the IND for the product was first opened only in May 2014, representing a three-year development timeframe. We believe that the extent of data being presented in this NDA is comprehensive and robust, particularly in the context of an orphan drug application. There are no ongoing trials to be completed prior to the NDA submission now. And at this point, most of the elements of the filing are nearing completion. There are two principal final elements on which we are focusing. First is the integrated safety analysis, a significant body of safety data on more than 1,500 patients from both the expanded access program and open label programs, including over 400 patients with one year or more of continuous Epidiolex exposure. The second area is manufacturing data from our expanded scale production. Both of these final areas of focus are progressing well and will determine the exact timing of the submission. Let me also bring to your attention the fact that Epidiolex was recently awarded rare pediatric disease designation, conditionally granted by FDA. This conditional designation is a precursor to the potential award of a rare pediatric disease priority review voucher, which, if awarded, will be granted at the time of NDA approval. Outside the US, we continue to progress plans for a centralized European regulatory submission to follow soon after the NDA submission in the second half of 2017. As a reminder, all of our Phase III trials included European sites. GW has held initial country-level regulatory consultations and we expect to hold a formal pre-submission meeting with the EMA in the very near future. The expansion potential of the intended Epidiolex label beyond our first two indications of Dravet syndrome and Lennox-Gastaut Syndrome continues to advance as we are currently recruiting Phase III trials for our third target indication of tuberous sclerosis complex and our fourth target indication of infantile spasms. Beyond Epidiolex, our CBDV development program continues to progress well. Preclinical data suggests that CBDV may have beneficial effects on seizures and on cognition and behavior. GW is currently evaluating CBDV in a Phase II double-blind, randomized, placebo-controlled trial as add-on therapy in adult patients with inadequately controlled focal seizures. I’m pleased to report that recruitment into the efficacy phase of the trial is now closed, with approximately 150 patients expected to be randomized. Data from this part of the trial is expected in the fourth quarter of 2017. Following promising preclinical data on the effects of CBDV in cognition and behavior, we’re also excited about the upcoming development of this molecule in the field of autism spectrum related disorders. A small investigator led expanded access program in ten patients with autism is about to commence in the United States. In addition, we expect to start both an open label trial as well as a Phase II placebo-controlled trial for CBDV in the treatment of Rett syndrome, a condition for which GW has received orphan drug designation from the FDA. Rett syndrome affects about 10,000 females in the United States and is caused by a mutation in the MECP2 gene found on X chromosome. Most patients are non-verbal and have limited use of their hands. Treatment-resistant seizures are also a common [indiscernible] in patients with Rett syndrome. We have received scientific advice from the EMA on the Phase II study design and are very shortly to do so from the FDA as well. Of course, our recent positive results from the placebo-controlled clinical study of a combination of CBD and THC in patients with Recurrent Glioblastoma Multiforme, an aggressive form of brain cancer, represents a highly promising pipeline opportunity and one that we expect to move in to a pivotal clinical development program in due course. I’m pleased to note that the abstract from the Phase II study has been accepted at the ASCO Annual Meeting in June. Finally, Phase I trial of an intravenous formulation of CBD for use in neonatal hypoxic ischemic encephalopathy has been completed. NHIE is a devastating condition affecting newborn infants who have experienced a deprivation of oxygen to their brain during the birth process. GW has been granted orphan designation for NHIE in both the US and Europe and we also have fast track designation with the FDA. We are consulting with FDA on the most appropriate design for an efficacy and safety study in neonates. Thank you. And let me now ask Julian to provide some comments on the commercial preparations for Epidiolex.

[Julian Gangolli:]

Thank you, Stephen. As we approach our regulatory submissions and the prospect of approval and launch, GW’s commercial preparations are well underway. GW is planning to commercialize Epidiolex in both US and EU geographies using its own sales and marketing and support organizations. The European commercial team is being led by Chris Tovey, GW’s Chief Operating Officer, who has a wealth of experience commercializing products approved for the treatment of epilepsy. Looking more closely at the US, we will commercialize Epidiolex under our US company name Greenwich Biosciences. The Greenwich team continues to expand organizationally and I’m pleased that we are drawing some of the best epilepsy professionals in the industry to our growing team. Working with clinicians, the company expects to continue dissemination of important new scientific data from the Epidiolex clinical program and anticipates data presentations at important upcoming medical congresses, which will reinforce awareness of Greenwich Biosciences within the physician and epilepsy community. We continue to build out the medical affairs and medical science liaison teams. The US medical affairs team has enabled Greenwich to open appropriate scientific and consultative communications with key stakeholders in the US such as the patient and physician communities. Throughout 2017, this team will continue to develop Dravet and LGS disease state information, rollout programs in cannabinoid education and intensify interaction with key epilepsy opinion leaders to collect their insights related to the science from the Epidiolex program. We currently have seven medical science liaisons in place now and expect this team to increase to 15 by the end of 2017. As the company moves closer to a potential approval of Epidiolex, a major focus is on payer education and readiness. These initiatives are assisted by new FDA guidance on appropriate interactions with payers prior to NDA submission approval, which allows for discussions around the data and potential pricing and contracting strategies ahead of product launch. Beyond the medical teams, Greenwich is now an experienced team of professionals focused on the development of various pharmacoeconomic data to assist payer and formulary discussion, including burden of illness and cost offset data. This team is also working to use the expanded access program, our compassionate use program, and the clinical data from that as compendia support to demonstrate the real-life usage of Epidiolex. Greenwich will also continue to focus on support for, and outreach to, the major epilepsy patient advocacy groups. These initiatives include relationship building and education. Finally, as we approach the expected Epidiolex approval, the company anticipates hiring a US sales team of approximately 50 to 60 sales professionals to target approximately 4,000 to 5,000 US physicians. We have a lot of work ahead of us. However, I am confident we have the talent and experience to achieve our goals. I thank you for your time and attention today and now hand the call over to Scott Giacobello to provide the financial review. Scott?

[Scott Giacobello:]

Thank you, Julian, and good afternoon. I will now provide some high-level comments on GW’s financial results for the three months and six months ending March 31, 2017. A more detailed discussion of our results is provided in the 6-K filing issued earlier today. We present GW’s results in accordance with International Financial Reporting Standards in British pound Sterling. For convenience purposes on this call, I will refer to US dollar equivalents, using an indicative rate. Starting with revenue, total revenue for the quarter was $2 million compared to $3.3 million in the second quarter of 2016. This decrease, as previously guided, is primarily due to reduced R&D fee recharges following the end of the partner-funded Sativex cancer pain studies during the prior financial year. Moving to R&D spend, total research and development expense for the quarter increased to $34 million compared to $32.3 million in the second quarter of 2016. This increase reflects the ongoing Epidiolex clinical development program, our other pipeline studies and additional costs related to the scale-up of Epidiolex growing and manufacturing processes. Turning to SG&A, our sales, general and administrative expenses increased to $11.6 million in the quarter from $4.1 million in the second quarter of 2016. This is the result of a substantial increase in our commercial presence and launch planning activities in the United States and Europe. Foreign exchange volatility continues to have a significant impact on our results. During the second quarter, weakening of the US dollar against the pound sterling has resulted in the recognition of a net foreign exchange loss of $5 million. This loss is primarily due to the revaluation of the company’s dollar-denominated cash balances at the closing sterling exchange rate. This has all resulted in a loss before tax for the second quarter of $49.3 million. For the six-month period ended March 31, 2017, our loss before tax amounted to $72.2 million. Moving to cash flow, capital expenditure for the six months ended March 31, 2017 was $11.8 million compared to $6 million for the comparative period in 2016. This increase reflects planned upgrades to our cannabinoid growing and production facilities, including buildout of a new 45-acre glasshouse growing facility, which is now operational. Net cash outflow from operating activities for the six months to March 31, 2017 was $82.7 million compared to $58.1 million for the comparative period in 2016. This increase is a result of our continued scale-up of commercial and launch planning activities as well as the ongoing Epidiolex development program. Total net cash outflow for the six months ended March 31, 2017 amounted to $85.4 million. At March 31, we held closing cash equivalent to $383.9 million. Moving to guidance, we expect total cash outflow for 2017 to be at the upper end of our previous guidance range of $130 million to $150 million. This guidance includes $30 million of capital expenditure and operating spend of $100 million to $120 million. Thank you. I will now turn the call back to Justin.

[Justin Gover:]

Thank you, Scott. In closing, our regulatory, manufacturing and commercial preparations for Epidiolex remain on track with expectations of delivering first-class launches in both the US and Europe. We are proud of the depth and consistency of the clinical data that underpins our NDA, the extent of this data being unusual for an orphan drug application. We believe that this extensive body of knowledge will be an important driver of the expected success of Epidiolex in the marketplace, providing physicians, patient and payers with a robust body of science to support the product’s use in the treatment of Dravet syndrome and LGS. We also continue to [indiscernible] diligently on seeking to enhance exclusivity for Epidiolex beyond the orphan drug period. GW’s patent portfolio relating to the use of CBD in the treatment of epilepsy includes 13 distinct patent families. Most of the patent families in this portfolio claim the use of CBD in the treatment of particular childhood epilepsy syndromes or seizure subtypes. These medical use and method of treatment type patent families are supported by additional patent families claiming CBD formulations. To date, this has resulted in three patents granted by the USPTO and our current expectation is that a number of additional pending patent applications may be granted by the USPTO towards the end of 2017 and the first half of 2018. We are also excited by the progress in our pipeline, the direct result of approximately 18 years of dedicated cannabinoid research activities across a range of therapeutic areas. As cannabinoid science becomes increasingly prominent as a new area for drug discovery, we believe GW is well-positioned to remain at the forefront of these efforts worldwide. Our platform offers significant potential for development of pipeline assets that can deliver value for GW’s investors well into the future. Thank you for your time today and for your interest in GW. And I would now like to open the call for a few questions.

[Operator:]

[Operator Instructions]. Our first question comes from Salveen Richter at Goldman Sachs.

[Kerry Tang:]

Congrats on all the progress and thanks for taking my questions. This is Kerry on the line for Salveen. First, on your CBDV program, when can we expect to see data from the open label study in Rett syndrome and what are some of the endpoints you are assessing? And then, just on the program in partial onset epilepsy in adults, do you see any mechanistic read-through to Epidiolex in this condition and use in adults? I just have a follow-up question. Thanks.

[Justin Gover:]

Maybe I’ll start with guidance and then hand to Stephen. These studies haven’t started yet, so I think it will be premature to give guidance. I might first to start to see [ph] data. So, there’s two open label programs we’re referring to. One is, there’s an expanded access program and then there’s the Rett syndrome open label. Neither of them have yet commenced. So, I think it’d be premature for me to give data. I don’t think you’ll be seeing any data in this calendar year, however.

[Stephen Wright:]

Yes. Perhaps I can add to that, Justin. It’s Stephen Wright here. We are – and I think we’ve actually announced that we’re taking specific guidance from both the FDA and the European Medicines Agency with regard to finalizing the protocol for a placebo-controlled trial on Rett syndrome. So, once that guidance is incorporated into our protocols and the protocols are ready to start, we’ll be in a much better position to give guidance about when we’re going to have results on our Phase II Rett syndrome placebo-controlled trials. So, I hope it adds to Justin’s answer. And, I’m sorry, can you remind me the second part of the question?

[Kerry Tang:]

Just in partial onset epilepsy in adults, do you see any mechanistic read-through to Epidiolex in the condition and in adults?

[Stephen Wright:]

No, I think that’s a very good question. There is no doubt there are some differences in the proposed mechanism of action to CBDV than for CBD. I think we’re going to be in a much better position to answer that question more definitively once we’ve seen the results, the efficacy results, in partial onset seizures in adults, which we’ve announced we’re highly likely to see towards the end of this calendar year. So, I think before we’ve got a full proof of concept to CBDV in partial onset seizures, it may be a bit premature to speculate on the similarities and differences between mechanisms of action.

[Kerry Tang:]

Okay, thank you. I just have one follow-up question. You had previously guided for a supply capacity of Epidiolex of about 60,000 patients in your first year of launch. Is there any update? Are you still on track for that? Or are you looking to a larger manufacturing capacity at launch? Thank you.

[Justin Gover:]

Kerry, maybe I’ll make an introductory comment. Chris may want to add. I think we’re going to move away from getting too granular on each of our supply capacities on a calendar year basis. Suffice to say that we have a high expectation for the product. So, you should assume that we are continuing to not only ensure that we have good capacity at launch, but that post-launch, over the medium and long-term, you will continue to see investment in our capacity as we look to the lifecycle of the product. But I don’t think we wish today to give updates on exact patient numbers.

[Chris Tovey:]

I think, Justin – yeah, I will add to what Justin said. I think as Scott mentioned it a couple of minutes ago, that sort of commitment to scale, evidenced obviously quite recently by our expansion and obviously onboarding of a 45-acre glasshouse, so I think that we’re very clear that we need to make the investment in potential scale manufacturing at all – in all sort of phases of the manufacturing process and we’re planning to do that.

[Operator:]

The next question is from Phil Nadeau at Cowen and Company.

[Phil Nadeau:]

Good afternoon. Thanks for taking my questions and congratulation doctor right on your upcoming retirement. First one for Julian. You mentioned that you have begun working with payers. I’m curious, in your early conversations, whether you’ve picked up any changes in their desire to or their ability to pay for seizure medications off-label and in their appreciation of the pricing environment.

[Justin Gover:]

As I mentioned in the more formal part of this discussion, we have a lot of work that’s ongoing. As you can imagine, this is not just a singular discussion with payers. This is a discussion on multiple levels. I think payers have come back to us and indicated that they are reasonably well-educated on what has happened with drugs that they term reference drugs, and this, in the epilepsy community, the likes of Onfi and Banzel. They do appreciate that there is an unmet medical need in the marketplace [indiscernible] they are currently reimbursing and they have access for patients who may not have a specific diagnosis according to the label. I think at the end of the day, though, these questions and answers are going to get refined as we move more into discussing what the label language is going to look like. I think that’s when it really becomes really meaningful discussions. And, obviously, as we start to talk about the pricing corridors, it’s very early days for us to be talking about that in a wider context, but those discussions are starting to take place. One observation to the sort of second part of your question, Phil, around – is there a heightened awareness for drug pricing altogether? Obviously, there is, particularly in the rare and orphan space area. But I’d have to say is that the pricing ranges that we have been talking about with – in early days with the payers has not attracted a visceral response from them. But we’ve still got a lot of work to do. So, hopefully, that addresses your question.

[Phil Nadeau:]

Yeah, that’s very helpful. And, Justin, a second one for you, on the patent families and patents that we may see some decisions on towards the end of the year, can you briefly talk about your ability to harmonize the expected FDA label with those patents? Is this something that you are able to do or is that more of a challenge for some reason?

[Justin Gover:]

No. It’s clearly – the nature of the patents that are being prosecuted relate to the use of CBD within the field of epilepsy and, clearly, there’s a strong overlap between the research we’ve done in epilepsy and the data which we produced and upon which the label will be written. So, no, I think it’s very clear that those patents, if granted, will link into the nature of the label that is being written. As we’ve stated in our release, these are various features of seizure types in certain some diagnoses with an epilepsy and other characteristics that have emerged through preclinical and clinical development. And they’re relevant in different ways to the label.

[Phil Nadeau:]

Great. And one last question. Just on the second Dravet Phase II trial, it wasn’t mentioned in your prepared remarks and I don’t believe it’s mentioned in the press release, what’s the status of that trial? When could it completed and release data?

[Stephen Wright:]

Hi, Phil. Stephen Wright here. I guess it’s probably good for me to answer that. We’re still coming towards the end of the recruitment period in that study. So, we do not anticipate any results being available from the second Dravet syndrome study until the – probably mid calendar year 2018. Certainly unlikely to be available for the NDA filing.

[Phil Nadeau:]

Great. Thanks for taking my questions.

[Operator:]

The next question is from Tazeen Ahmad at Bank of America.

[Tazeen Ahmad:]

Hi. Good evening, guys. Thanks for taking my questions. Just a follow-up on IP, can you give us maybe some examples of any naturally occurring substances for which method-of-use patents have been granted? And I am asking this question because I’m curious to know. Marijuana has always been used for various types of ailment and epilepsy has been one of it. So, how would you be able to defend against any kind of challenge, taking into account, obviously, you’ve got a very unique formulation of CBD, but could there be any challenges based on the fact that it’s based on a plant that’s been used to treat epilepsies?

[Justin Gover:]

Yeah. The example are ours. We have three for CBD in the field of epilepsy that are actually already granted and we have patents for other products. We had a patent for Sativex for the use of in-cancer pain, for example, from one of our earlier developments. So, absolutely, this is not uncommon. I think what we’ve been navigating around, obviously, as you rightly point out, is a historic understanding, or at least literature, that talks to cannabis and epilepsy, but that’s very different to the use of CBD in – and sort of surprising findings that have emerged, both in preclinical and clinical. So, there are some limitations, of course, that result from that literature, but there’s still a number of important observations and unexpected findings, which have emerged throughout. We wouldn’t be guiding you to review the progress of our IP unless we thought there was a good chance of a number of these patents being successful.

[Tazeen Ahmad:]

Yeah. I guess I was trying to reference anything outside of your own patents that have been given to other companies. But in terms of the 13 patent families, can you give us an idea of how specific they got?

[Justin Gover:]

I think the only way I can really answer this is talking to specifically seizure types and specific diagnoses with an epilepsy. I think that is the two kind of key features under which most of these patents are for. The additional element, which is relevant, relates to formulation of patents. Those are another form of IP which are being prosecuted. We talked before about lifecycle management for Epidiolex in terms of additional formulations being introduced during the lifecycle of the product and IP is attached to some of those lifecycle formulations as well.

[Tazeen Ahmad:]

Okay. And then the second question for me, Justin, is about your view of whether or not you expect an advisory committee meeting. And if, in fact, you do get a meeting, are you planning to release any drug-drug interaction data ahead of what would appear in the briefing document?

[Justin Gover:]

So, obviously, we don’t know whether there will be ad com, but we’re working on the assumption that there will be and preparing very much on that basis. And, obviously, we don’t know if there will be an ad com and what they would cover. But we would – as you would expect, we’re preparing for such an eventuality. I recognize the heart of your question, which is wanting to make sure that there are – the ad com itself is not a cause of cool surprise for people. We’re mindful of that. And I think once we understand, in full, the timetable, it would be, I think, the company’s intention that some additional data on that particular subject is disclosed in a medical meeting as opposed to it being first disclosed at an ad com.

[Tazeen Ahmad:]

Okay. Thanks, Justin.

[Operator:]

This concludes our question-and-answer session. I would like to turn the conference back over to management for closing remarks.

[Justin Gover:]

Thank you. This is Justin. Just a quick signoff. Thank you for your time today. We’ll look forward to updating you throughout mid-year and on our Q3 call in early August, but thank you for your time today.

[Operator:]

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.