Earnings Labs

Summit Therapeutics Inc. (SMMT)

Q2 2019 Earnings Call· Fri, Oct 11, 2019

$21.45

-0.42%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-1.82%

1 Week

+3.64%

1 Month

-9.70%

vs S&P

-13.99%

Transcript

Richard Pye

Management

Thank you, and welcome to everyone joining us on the call today to discuss our financial results for the second quarter and half year ended July 31, 2019. Earlier today, we issued a press release summarizing these results. If you had not had a chance to review, it is available on our website at www.summitplc.com. I'd like to remind listeners that we will be making forward-looking statements during this call. I refer you to our filings with the Securities and Exchange Commission for a description of the risks and uncertainties associated with these forward-looking statements and an investment in Summit Therapeutics. While we may elect to update these forward-looking statements at some points in the future, we specifically disclaim any obligation to do so, even if our views change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to today. Joining me on the call today is our Chief Executive Officer, Mr. Glyn Edwards. And following our prepared remarks, there will be a question-and-answer session. I'd now like to turn the call over to Glyn for an overview of our activities during the first half of the year and expectations for the remainder. Glyn?

Glyn Edwards

Management

Great. Thank you, Richard, and thank you all for joining us today. To be a leader in the fight against antimicrobial resistance, you have to think differently. It's about having the technologies to precisely address the patient infection. It's about developing compounds to show that they're significantly better than that's already out there. And it's about demonstrating real value, value to the payer, but really importantly, value to their patients. And at Summit, we're doing all of these things. Each point to differentiate -- differentiation is exemplified by our lead precision antibiotic, ridinilazole. In early antibiotic discovery, the focus used to be on drugs that could address the greatest number of infections, so called broad spectrum agents. Several things have changed in the field that now allow us to instead focus on developing very targeted antibiotics, getting the right drug for the right bug for the right patient. Firstly, there's been a significant advance in diagnostics, which really continues at a pace allowing physicians to know not only what bacteria are causing the infection, but also there's a susceptibility to marketed antibiotics. And we believe that as the field of targeted antibiotics advances, this will only become faster and more specific. And then secondly, it's becoming clearer that the microbes that live on within us play a really major role in our health. Broad spectrum antibiotics and other non-antibiotic medicines cannot set the delicate and diverse mechanism of these microbiomes, and these could have long-lasting effects on human health. It's therefore, particularly, advantageous to specifically target the bad bacteria and spare the microbiomes. The impact of the microbiome on health and disease is extremely evident in C. difficile Infection or CDI. The onset of CDI is often linked to a conserved gut microbiome and further disruption by the broad spectrum…

Operator

Operator

[Operator Instructions] And the first question comes from the line of Ross Blair from Rx Securities.

Ross Blair

Analyst

Congrats on the progress you're making in your Phase III trial for ridinilazole. And I just have a couple of questions today. Firstly, given your recent appointment, and is it your intent to keep hold of U.S. rights for ridinilazole? And my -- and second question is, is there anything else you could tell us about the current commercialization plans for ridinilazole? And third question, third and final question is how are you planning on differentiating SMT-571 in gonorrhea? And would the future trials, for example, would they also aim to demonstrate superiority?

Glyn Edwards

Management

Ross, thanks very much, and congratulations on your new appointment. So let's take 571 first. It's very early days at this stage. Resistance is a big issue. Resistance is growing. So we would expect to show that it's better against resistant patients, but it's highly likely that a program like that is going to be picked up by significant third-party funders. And so we expect that the primary drive for that development and the -- almost all the cost pickup for that will be in NGOs, particularly, aiming it at the developing world where there is real problems, leaving us the opportunity to market in the -- or to retain rights for the developed world. So completely forgotten the first question. What was the first question? Oh, U.S. rights. Yes. Absolutely, we do intend to market within ridinilazole in the United States. It's a huge opportunity. There are 0.5 million new cases of C. difficile every year, and the current treatment, vancomycin, fails in approximately 1/3 of those patients. And we've shown in our Phase II and with all the signs that we have the opportunity to really make a big impact on that. And the trial is designed. So if successful, we'll have all the data that says why a doctor would want to prescribe it. We'll have all the data or including the quality of life data as well as the cure data that will mean the patient will want to be prescribed it. But also, we'll have the help of economic outcomes data that will tell the payers who are using ridinilazole frontline, and the majority of their patients will actually be a great economic move for them. So we think there is a massive opportunity for this product in United States. Currently, our thoughts are for the rest of the world that we will ultimately find partners who will want to do that. And interestingly, as we look at growth projections, probably the most attractive market after the U.S. is going to be China.

Operator

Operator

And the next question comes from the line of Tim Chiang from BTIG.

Timothy Chiang

Analyst

I know you've provided the enrollment figure for the 2 new qualified studies. Could you talk a little bit about which of the 2 studies is enrolling faster? Also, you said more than half of your sites are now online. Could you talk a little bit about the U.S. study sites? How many of those are now open?

Glyn Edwards

Management

Yes. So the U.S. opened first. And -- so most of the sites are opened in the U.S. I don't have the exact figures in front of me but it's the majority of the northern half. And both studies are roughly neck and neck; and the recruitment, we opened them both at the same time. And while technically, we have to run 2 studies in terms of our enrollment goals, we're trying to get both of these studies finished at the same time. We started them both at the same time. We have projections, and we've obviously given you that we think we'll have this data in the second half of 2021. It is really early days. You can see from that number that it's a small proportion. We will be giving regular quarterly updates as this progresses. And the time to really see how the recruitment rate is going is -- as in all of these infectious disease studies, which start off slow. They start like [ RP ] stated it. He's always said he's going to be around the second quarter of the next year. That's when we would expect to be on full enrollment rate at that time. The hospitals that come on stream tend to be the small studies to start with. And in the U.S., we're just starting to see the really large census coming on and they take longer to get through their procedures. And we've also got some big enrolling countries that have not actually joined in yet. So Canada has a -- is very -- traditionally very good at enrolling in C. diff studies, and some of the Eastern European countries are also very good at enrolling in C. diff studies. So we're fortunate in that we have a fairly good insight into the studies that have been carried out, and we're using that information to try and inform our recruitment. But it is heavy lifting. These infectious disease studies are difficult where we're working very hard. We're looking for help wherever we can, and we will report on how this goes. We are encouraged. We're working very hard. We need to work harder.

Timothy Chiang

Analyst

Glyn, just a follow-up. And obviously, it's a financial question. You guys sort of highlighted cash needs about $115 million, $50 million of which you probably need to get near term. Could you talk a little bit about your views in terms of getting that type of funding near term? How much progress have you made so far?

Glyn Edwards

Management

Yes. We're obviously working very hard to get this closed. We've got cash only to -- the right way of going, which is, obviously, we want to get this trial done as quickly as possible, so we have the pedal to the metal. We are now opening centers. We're opening sites. We're pushing people really hard to get this trial opened as fast as we can. So we really need to get something done in the next couple of months. We've -- nothing's done until it's done. We have supportive shareholders, but they don't commit until they commit. And we're optimistic, but it's a difficult area. Antibiotics have been hard. But we feel here, there is an opportunity to transform a particular area of infectious diseases. And most of the recent antibiotic launches have been done on the back of noninferiority trials with products that are relatively similar in indications that are pretty crowded. So we have the opportunity here, the unique opportunity in the near term to find an indication where the current standard of care just is not working that well. So that means with a superior product, we can show superiority in our trial, and that gives you a great position for achieving a switch in the market. There's every reason, if this trial delivers, why we should be able to get wholesale switching of patients in the United States in the front-line setting from vancomycin to ridinilazole. And this whole science program up to date, the new data on IDWeek, the data that we've built into the trial is aimed at hitting the 3 core constituencies, the publics that we need to speak. I'll prove the most important is the patient. But if we can get patients so that they're not only cured at a high rate but they maintain that cure, that their microbiome is preserved so they feel a whole lot better, then they'll be wanting the drug. The medical profession will want it if we hit superiority, if we show we have better clinical outcomes. And the payers should want to use this because we can have a fair price for this and still mean that there is an economic drive to switch front-line setting to ridinilazole. So we think if we can make this argument to investors and stakeholders that we expect to -- with a lot of hard work and to bring this -- the money in that we need to bring in. But it's not done until it's done, but we're working hard and we're optimistic

Operator

Operator

[Operator Instructions] And the next question comes from Yun Zhong from Janney.

Yun Zhong

Analyst

And I have a quick question on SMT-571. I think last quarter's update, you decided to postpone the development where potentially expedited pathway. So I wonder, are there any updates on the plan for 571? And also, I think in the past other company has been able to secure government funding to support gonorrhea program. And I wonder is that a possibility that you're considering?

Glyn Edwards

Management

Yes. There's no new update on -- when 571 will be in the clinic. We actually do have significant funding. As of today, 70% of the funds are covered. And I think there's every chance that we'll be able to get the future developments of this program fully covered or as close to fully covered as makes no difference. You're right, it is a major public health problem, gonorrhea. We need not just one new treatment, we need several new treatments over the next 5 to 10 years. And so far, the efficacy data on 571 in the way it is able to hit no resistant strains is really encouraging. I think part of the background should be while we're excited by these longer-term programs. The biggest value that we can generate for patients and shareholders right now is to really make sure that we are really focused on delivering ridinilazole that -- this is the potential. We have very significant product, which will give very significant patient benefit and give very significant revenues. So we are not stopping our research activity. Don't get me wrong on that. But our focus and our expenditure management time right now is completely dedicated to delivering the huge promise that we have for ridinilazole.

Operator

Operator

And the next question comes from the line of Justin Kim from Oppenheimer & Co.

Justin Kim

Analyst

Could you speak a little more to the pharmacoeconomic benefit associated with the 15% improvement in recurrence rate? Do you have a sense of sort of the components of those costs totaling over a $1 billion and sort of how they are broken up?

Glyn Edwards

Management

Yes. Can we take that offline? If you look at some of our previous corporate presentations, we have a slide on that. But actually and it -- there is potentially a lot more benefit than that because all we focused on is the saving -- if you've treated a 100 patients and as a result, 15 fewer of them had a recurrence than would have had it before, then the cost of those recurrences is very high, and then you share that benefit over all the patients treated. That's where you come up with those numbers. Tantalizingly, in the Phase II, we also saw some evidence of reduced hospital stay. And if we can see those benefits as well, then the economic value goes up very, very considerably. But we can take you offline on the mass and show you the publications where the cost per recurrence comes up and how we derive that. But it's truly robust. It's pretty robust.

Justin Kim

Analyst

Great. And maybe just one question on the microbiome. Do you observe any regional differences and sort of like that microbiome based on patient geography? And would you expect to sort of any variability based on sort of the sites or countries enrolling patient?

Glyn Edwards

Management

So first of all, this is an emerging field right now and not in our study, but there are conferences and presentations on the microbiome. And your microbiome and mine will change very significantly from one day to another depending on what we need -- some of our -- but the one characteristic that seems to be really important for C. diff is diversity. And although today, microbiome is diverse and looks like one thing, and after I've had fish solidly for 3 days, it will be diverse and looks like something else. It's the diversity that's important. So it's not a sort of individual quantities. In fact, there's lots of them. And what we see with broad antibiotic treatment is that diversity gets absolutely hammered and is very significantly reduced. And it's -- there is highly reduced microbiomes that are really important for susceptibility to C. diff infections. And that's been reported all around the world. So whether you're in Japan on a seafood diet with high salts or whether you're in India on a vegetarian diet or in the U.S. on a more western diet, being treated with vancomycin will very significantly reduce your gut diversity. And that, that then leads to broad susceptibility. Diving into the detail of that, we're starting to get some evidence of the various components that are important both in terms of the bacteria in the gut and also the products they produce, the so-called metabolome. The metabolome is all the small molecule -- molecules that are produced by the -- all the components of the gut, not just bacteria but phages, viruses and particularly yeast. So we're starting to understand that. And it all holds together well. The metabolome of patients treated with the broad-spectrum agents is very conducive to C. diff growing, where metabolome in patients treated with ridinilazole is not conducive to germination and not conducive to growth. So the science behind here is very strong. But to get back to your original question. We as yet have no evidence from our work and no evidence from other people's works that the effect will differ by geographic region because of diversity of microbiome by geographic regions. The biggest determiner is going to be as the microbiome being hit by an antibiotic or to a certain extent people at long-term nursing care can have depleted variation and that may contribute too.

Operator

Operator

Thank you. There are no further questions at the moment. Please continue.

Glyn Edwards

Management

Okay. Well, everybody, thank you very much indeed for listening to our call and asking these great questions. Thank you very much for joining us today. We look forward to providing you with updates on our novel antibiotic both from the financial progress, the progress in the trial and the scientific progress. And we look forward to speaking to you again soon. Thank you.