Myovant Sciences Ltd (NYSE:MYOV)
Baird’s 2017 Global Healthcare Conference Call
September 7, 2017 12:15 PM ET
Lynn Seely – President and Chief Executive Officer
Brian Skorney – Baird
Good afternoon, everybody. Welcome again from lunch. Thanks for coming immediately. I am Brian Skorney, considered one of Baird’s Senior Biotech Analysts. The subsequent firm we’ve presenting is Myovant Sciences. Myovant is a comparatively new IPOed firm. With me, I’ve the CEO, Lynn Seely. Lynn thanks for becoming a member of us at the moment. We actually respect the time.
Maybe in the event you might simply begin us off by giving us a quick overview of what the corporate does and the place you’re targeted proper now?
Sure, I see delighted too. First factor I’ve slightly Safe Harbor assertion only for enjoyable. So who’s Myovant Sciences? This is an organization that was created with a imaginative and prescient, a imaginative and prescient to develop into a worldwide chief in women’s health and endocrine illnesses. And it had a very distinctive starting and that it was shaped out of a strategic partnership with Takeda through which we in-licensed two product candidates and types Myovant round that. Our lead drug relugolix, which we’ll be spending I say in all probability most of our time speaking about immediately is the hormonal agent. It’s a focused remedy with a clinically validated mechanism of motion.
So we all know the way it works. And it has been in 1,300 topics already. So the security profile is comparatively de-risked. What we have been capable of do within the first half of 2017 is launch three Phase III medical packages together with 5 Phase III medical trials in three totally different indications: uterine fibroids, endometriosis and in superior prostate most cancers, every of those vital business alternatives and particularly women’s health underserved market. We have been in a position to try this as a result of as Brian alluded to we had a really profitable IPO in 2016 the place we raised slightly below $220 million.
And as well as, we try to grow to be the worldwide chief in women’s health. And so, we want to increase our pipeline. We have a second drug already, MVT-602, which we’re creating for women present process assisted copy as a part of their hormonal preparation after which we glance to broaden from there.
This slide exhibits the late-stage lineup. And we’re very pleased with our accomplishment. We made plenty of guarantees out in our IPO that we have been going to launch all of those Phase III packages within the first half and we have been profitable in doing that. You’ll see relugolix is our lead asset in women’s health. We’re creating relugolix with hormonal add-back remedy and there perhaps we’ll have slightly time to speak extra about that. We are setting two Phase III medical trials, LIBERTY 1 and LIBERTY 2, and women with heavy menstrual bleeding related to uterine fibroids. We truly noticed from the primary quarter. We have SPIRIT 1 and SPIRIT 2, which is for women with endometriosis-associated ache that launched at the top of second quarter.
And then we now have the HERO research, which is a research for males with superior prostate most cancers a local androgen deprivation remedy. And on this trial it is a big trial for international approvals and we launched that within the first quarter of 2017. And then lastly, we’re persevering with improvement of our medicine for infertility 602, which is a kisspeptin agonist, which perhaps if we’ve got time we’ll speak a bit bit about.
And then simply to ensure everyone is conscious of individuals ask me on a regular basis we’re actually bullish and such an excellent drug. Why does Takeda give it up? And in reality they did not give it up. They’re persevering with to develop it. And they’ve Phase III knowledge popping out this yr in women with uterine fibroids. And so, they’re conducting two trials: one in women with heavy menstrual bleeding, and the second Phase III trial women with ache related to uterine fibroids, and once more these are but to readout this yr.
So simply kind of huge image, we’ve launched medical trials in three Phase III medical trials in three areas: uterine fibroids, endometriosis and prostate most cancers. We’re ready Takeda’s Phase III trial knowledge later this yr. We’re persevering with our medical improvement of MVT-602. And then 2019 goes to be a really massive yr for Myovant and that we’ll be offering top-line knowledge from every of our Phase III packages and we intend to file for uterine fibroids and endometriosis additionally in 2019. So, that’s kind of a handful of slides, the large image.
Great. So as we acquired down deep into relugolix, actually assist us perceive to start out sort of the mechanism of motion and the a part of GnRH. What the variations between sort of antagonizing versus agonizing as a result of I feel there’s numerous streams that you could – you both and it appears to have an identical efficacy in these numerous indications. So simply give us all element on this mechanism, why we’re and the way early to those illnesses?
Sure. Well, I’m an endocrinologist by coaching. And I’ve been in all probability prescribing our research in hormonal illnesses for extra years and I care to confess this. And then I’ll inform you what’s very nice about hormonally focused medicine as you perceive and particularly this one how they work. So the hormonal management centre is definitely within the mind at the extent of the hypothalamus within the pituitary. And gonadotropin releasing hormone or GnRH is launched from the hypothalamus. It stimulates receptors at the extent of the pituitary after which the pituitary makes two hormones, luteinizing hormone and follicle-stimulating hormone.
And these two hormones are actually essential as a result of they’re the identical in males and in women. And in women, they stimulate the ovaries to make estrogen and progesterone, and in males, they stimulate the testes to make testosterone. And so this is one pathway stated management intercourse hormones. Our drug is a GnRH receptor antagonist, it instantly blocks this pathway the extent of the pituitary. And so with this drug, we will decrease estrogen in women, and we will decrease testosterone in males. And that’s so essential as a result of there are essential illnesses pushed by estrogen. So uterine fibroids, endometriosis as we all know are pushed by estrogen. And in males in fact prostate most cancers is a testosterone pushed illness.
And in order that’s why with one drug, we will have a possible to profit these three essential space. Now to your level proper now what’s getting used on this market is a GnRH agonist. And that sounds very counterintuitive why would you need an agonist if you need a block a pathway. An agonist to be stimulate of pathway. What’s occurs is once you chronically stimulate the trail of the pituitary, first you get to surge of hormones, so testosterone ranges rise, for instance in prostate most cancers. You can get a flare of signs, however then with that persistent stimulation the pituitary desensitizes and over weeks the hormone ranges will fall.
And so, up to now no one has been capable of make an oral GnRH receptor agonists. And the most effective, they might do was make an injectable GnRH agonist. And in order that’s why immediately the marketplace is dominated by injectable formulations, which stimulate the hormones after which over worsen medical signs after which over a interval of weeks the hormone ranges will fall.
We hope to deliver the market in oral as soon as a day drug which can instantly block this pathway quickly trigger the autumn of hormones and convey these illnesses symptomatic aid.
Great. So lets slide down a bit bit into the varied illnesses for many who aren’t conversant in endometriosis and uterine fibroids assuming health indications, perhaps you sort of give us a overview of what they’re with signs are and the way individuals are handled presently…
Well. I’ve to say I am a women and I am an endocrinologist and I had no concept concerning the debilitating signs of endometriosis, nor how widespread it was. And I’ve to say as I began studying increasingly more about it, I turned more and more enthusiastic about what we’re making an attempt to do. It phrases out that one in 10 women has endometriosis. That’s 10% of the inhabitants of these 75% to 80% are symptomatic. And what occurs with these women, it sometimes – the illness comes on of their teenage years. They get pelvic ache and it comes on very badly throughout their durations, dysmenorrhea, but in addition might be all month lengthy.
In this illness women get, we expect retrograde menstruation the place cells and tissue that sometimes strains the uterus will get out into the stomach within the pelvic. And it cycles there, identical to I goes throughout her interval however there’s nowhere for the tissue to shed. And so it units up this persistent inflammatory response within the pelvic, these women get very dangerous pelvic ache, they get scar tissue adhesions, intercourse can turn out to be painful. It’s extremely arduous to diagnose. So these women they’re complaining of ache, they don’t seem to be getting the analysis, they get to move, they get remoted and sadly for them it’s a number one reason for infertility.
So they’ve actually get fairly debilitated throughout their most efficient years. And our objective is to provide you with an oral remedy that may assist these women. Right now they get tried on contraception drugs, non-steroidals that helps a few of them, but when they’re refractory to that they obtained invasive procedures. They should laparoscopy to diagnose the illness and to ablate the lesions. And there are hundred thousand hysterectomy’s carried out annually for endometriosis, regardless that that basically doesn’t essentially remedy the illness.
So we’re hoping with the drug that may suppress estrogen one time as soon as a day, these women can get some symptomatic aid. So that endometriosis massively widespread, very debilitating illness for youthful women.
Then there’s uterine fibroids, which once more is amazingly widespread. And right here we take into consideration 25% of women have uterine fibroids, perhaps excessive as 80% in an African-American inhabitants. Of these a big proportion of symptomatic and what these are benign tumors rising within the uterus. And they trigger each signs, the place it looks like having a child, so you will get distension, low again ache you will get constipation and urinary frequency. But the large drawback is heavy menstrual bleeding. And these women are bleeding as much as ten or extra days each month and bleeding so closely that they’ve to vary sanitary merchandise a number of occasions a day. Live in fixed worry of social embarrassment and actually can’t do their actions of regular day by day dwelling.
And the truth is, spend days at houses than work as a result of they will’t tolerate this bleeding. They get anemic, they get weak and fatigue and lots of of them don’t even know that that is irregular, as a result of women don’t speak very a lot about such issues. And then they current with extreme anemia, they get an pressing hysterectomy. And in reality there are 250,000 hysterectomies carried out annually for this benign uterine fibroids.
And hysterectomy is a serious operation with main problems. So once more, if we will provide you with a medical remedy, an oral remedy to provide women an choice at least to time a hysterectomy or keep away from hysterectomy altogether and we expect that might be a big advance.
And it’s fascinating, as a result of each of those illnesses as women progress with the menopause and their estrogen degree fall naturally. These illnesses, the signs there are actually a lot, a lot better.
Great. So once we take into consideration the Phase III research that you simply talked about that Takeda is operating proper now. Talk to us just a little a few trial design, what we’re in search of, what variations if any there are between the research? Good two research variations from one another, in addition to variations in your research.
So Takeda is operating these two Phase III research. They are with relugolix 40 mg as soon as a day that’s the dose that we’re utilizing in our medical trial. They’re setting for little bit totally different cause then we’re a bit of – perhaps having been to speak about sooner or later. We’re in search of longer-term remedy for women. So they don’t want – they’ve an choice for operations perhaps. And so we’re utilizing add-back remedy, which is a bit little bit of a softening of that I might say, which has a number of the negative effects.
Takeda is creating this drug actually to look at remedy in advancing the surgical procedure and so they’re utilizing 40 mg as soon as a day with none add-back remedy and they’re wanting in a single research to stop heavy menstrual bleeding. They’ve already carried out a Phase II research with lovely knowledge displaying in a dose-dependent means that they will have a big drop in heavy menstrual bleeding and in overwhelming majority of women, 84% of women. And in that trial 74% of women had amenorrhea or no bleeding.
So they’ve carried out a Phase II trial. They at the moment are doing Phase III trial. Six months period with a 40 mg as soon as a day dose hopefully present that they will forestall heavy menstrual bleeding. And this trial is a non-inferiority research to lose a life, which is presently utilized in Japan as a regular of care.
In addition, they’re wanting at the ache related to uterine fibroids. So they’ve a second Phase III research enrolling women who’ve vital ache from their uterine fibroids after which displaying that they will lower the ache. And that’s a placebo-controlled trial.
And we take into consideration sort of the forefront to add-back, no add-back what there are literally now that’s behind add-back? How vital are a few of the security issues related to GnRH antagonism with out an add-back remedy.
So there isn’t any query, and I feel it has been confirmed in lots of ways in which when you decrease estrogen, you’ll be able to higher set uterine fibroids, you possibly can higher set endometriosis. But if have been to offer these long-term, we have now to mitigate a few of the negative effects of low estrogen. And it is very well-known that if a lady is in a low estrogen state, she will get scorching flashes, she will have bone mineral density loss. And I feel most individuals know that from postmenopausal women.
And so we’re decreasing estrogen in women, however we do not need them to get bone mineral density loss, as a result of that would not silent they usually would not realize it, however it might trigger actual issues down the street. And women definitely do not like scorching flashes, as a result of they are often very bothersome. And so it seems that standard tissues truly do not want very a lot estrogen to be regular. And so the bone simply wants very low quantities of estrogen to stop bone mineral density loss. The similar factor is true for decent flashes, for vaginal dryness. It takes a lot larger concentrations of estrogens to stimulate endometriosis and both in fibroids.
So this provides us this excellent alternative to the method the dire ranges to very low ranges in all women after which in a really managed trend add-back simply the extent of estrogen that we have to forestall bone mineral density loss within the scorching flashes. And we’re doing that in our trials, as a result of once more our objective is to permit women to take one capsule once-a-day over the long-term to have the ability to transition to menopause, to protect their fertility and to finally, hopefully as a option to forestall hysterectomy as time hysterectomy, it’s the time it’s tressed about.
How do you consider the suitable quantity of add-back therapies utilized in your mixture? We’ll speak a bit of concerning the type of aggressive panorama? But my perceive is have we spent a variety of time type of specializing in the right dosage of relugolix with add-back, which relugolix is a drug that’s lately submitted for approval for endometriosis with the identical pathway. So how are you assured that you’ve the correct mixture of relugolix dose with estradiol?
So we’re seeing very robust to what’s recognized. So we’re suppressing estradiol to very low degree. So everyone is beginning in a pleasant secure baseline. We know what to add-back, as a result of we’re not doing something very fancy, we’re utilizing a formulation that is authorised for years in postmenopausal women to stop scorching flashes and to stop bone mineral density loss.
And in order that, the quantity of estrogen that is wanted to try this is understood, it has been properly studied and that is what we’re utilizing. We’ve achieved a Phase I research with our drug and the hormonal preparation to point out that the estradiol ranges that we’re attaining are precisely what has been proven within the literature it’s essential to forestall bone mineral density loss, that aren’t so excessive that they might stimulate endometriosis or both in fibroids.
And so we really feel very assured that we now have that dose that’s proper to maximise the profit to women with endometriosis, uterine fibroids, whereas offering them security, in order that they do not should have the tolerability or the silent negative effects of bone mineral density loss. And that’s what we hope to point out within the Phase III trial. And one factor we’re doing is as a result of we’ve got a really potent drug that has an extended half-life we may give it once-a-day. And so we’re launching and we intend to launch with a hard and fast dose mixture, which suggests the hormonal add-back remedy and the relugolix will probably be in the identical capsule.
So once more very straightforward to take and the security insurance coverage coverage is given proper in the identical capsule with the lively drug, which we expect shall be straightforward to prescribe for adequate but in addition good for women.
Great. And then once we take into consideration the ultimate end result of your Phase III research, I imply what are – perceive type of the first endpoints and it looks like a lay out which are – the FDA have to see on the security aspect of issues when it comes to bone mineral density loss can be snug with the profile?
Well, there is no such factor as we lay out that totally different enterprise as everyone knows. And I feel this can be a Phase III execution play. We’ve received an lively drug, I feel we all know the way it works and the aim is to run very top quality Phase III medical trials. So that we will present that distinction in that profit to women and males, we’re going to have to point out as you do in all Phase III trials not solely robust efficacy however we’re going to have to point out security after which it is once more it is the rationale why we’re creating with this add-back remedy, as a result of we would like a dose in a regimens that’s protected and properly tolerated within the overwhelming majority of women. And we expect with this add-back remedy, we will current the widespread unwanted side effects of our drug, which when given as monotherapy does trigger scorching flashes it causes bone mineral density loss.
And the FDA is especially involved about bone mineral density loss, as a result of over the long-term, it isn’t good for women they usually end result a few years later in fractures and since it is silent we need to make it possible for we’ve got this add-back remedy. So that women aren’t affected by bone mineral density loss. Fortunately, it is easy to watch, however we expect with this add-back remedy with relugolix that we should always be capable of have what I name a bone mineral density impartial remedy that’s the bone mineral density loss is prevented by the add-back remedy.
And so our preliminary main endpoint, it’s a six months and that shall be good, however as we all know that is not enough. And so we’re persevering with the trial on for a 4 yr to point out the security as a long run of remedy.
Great. So shifting on from uterine fibroids and endometriosis and take into consideration the chance in prostate most cancers, lots of different choices for medical castration in prostate most cancers. Why do you assume that the chance for GnRH antagonist right here is attractable?
So I spend a variety of time creating medicine in prostate most cancers. I received to supervise the event of increasing from the primary preclinical experiment all the best way to international approval. So I spent lots of time speaking to urologist. Right now the standard-of-care for androgen deprivation remedy is generates once more. So we talked earlier about depot injections, then first stimulate testosterone after which with prostate most cancers, which you’ll be able to think about is just not good when you’ve got bone metastatic illness or urinary signs that first stimulate and one other weeks at decrease hormonal degree.
So you’d by no means out of the gates design that generate agonists of this illness, you’d need to quickly and instantly suppress has quicker than PSA ranges with an antagonist, which is – they could not make one. Ultimately Ferring has come out with an injectable GnRH antagonist relugolix, which has been used, have been bought at present as a month-to-month injection. It does work quickly decrease in testosterone degree the issue is it has some vital variety of injection sort reactions, however it’s nonetheless an injection.
And so we’ve got a really potent lengthy half life drug, and so this enables us additionally to develop this drug for males with prostate most cancers. Interestingly, we have now to make use of 3 times the dose in males that we use in women. And we have carried out two Phase II research after which with prostate most cancers at this larger dose. So that once more properly derisk the security profile for the women’s health indication.
And what we have been capable of present is with one capsule once-a-day and males with prostate most cancers, testosterone could be decrease to castration ranges identical to with leuprolide. And then to staying and to ranges similar to leuprolide or relugolix. And these are in small proof-of-concept Phase II trials, however what they confirmed is at two weeks and at 4 weeks – at 4 weeks there was 50% whenever you look at the 80% of sufferers on a 50% discount in PSA as in comparison with 20% of males on leuprolide. So rather more speedy onset of motion, as you’d anticipate from an antagonist. But then what’s very fascinating is once you cease for remedy, testosterone ranges get well they usually recuperate above castrate ranges shortly inside a month. That’s not true with the depot different injectable medicine, whether or not its relugolix or leuprolide takes months for these testosterone ranges to get well and typically they do not get well.
And so this provides us an actual alternative for males with prostate most cancers, we will quickly decrease testosterone ranges and PSA with none flare signs. So meaning we do not have to fret about giving a capsule to dam the flare, which is what urologist should do proper now. And then secondarily males are increasingly more being handled with intermittent remedy if in case you have prostate most cancers, you are capable of have – in lots of males are capable of have intermittent remedy, the place they will take break and permit their testosterone to get well. And that is been proven to be not inferior to steady remedy.
And so this provides us one other alternative, the place if you are going to get a drug vacation permits your testosterone to get well. So urologist and radiation oncologist have been fairly enthusiastic concerning the research, as a result of it provides us a chance to point out that for the primary time with an oral drug, we will obtain testosterone suppression.
Great. I do need to spent a few minutes speaking about 602, it’s an earlier stage asset, clearly, it’s not the identical focus as relugolix, however very fascinating market, large unmet want when it comes to feminine infertility, inform us a bit bit about that asset its mechanism and…
Sure. So infertility is a large drawback in a quickly rising market, I feel everyone is aware of. And we’re creating our kisspeptin agonist to assist with a hormonal preparation earlier than in vitro fertilization. Kisspeptin works on precisely the identical pathway nevertheless it stimulates at the extent of the hypersomnolence. And it seems that kisspeptin is likely one of the pure regulators of that month-to-month LH surge that happens in women every month for ovulation. And so we will benefit from that and we will use this drug to assist set off egg maturation throughout in vitro, the preparation for in vitro fertilization.
And the rationale we have now a necessity there’s as a result of the present medicine which might be utilized in specific human chorionic gonadotropin, which is kind of the final hormone given to set off egg maturation has a aspect impact referred to as as ovarian hyperstimulation syndrome, and these women can get loads of irritation of their ovaries, they will get fluid of their stomach, fluid of their lung and even go into renal failure. And so you are taking a wholesome lady making an attempt to have a child, it might make her fairly sick.
It’s not tremendous widespread, perhaps 1% to 2% of the inhabitants; some critical, say extra like 5%. But in women at excessive danger and these are women with polycystic ovary illness, that women who had it earlier than it is considerably greater. And so if we will discover a safer method to get the identical fertility charges that might be actually essential and kisspeptin as a result of it is a physiologic regulator at this LH surge shouldn’t have the identical degree of ovarian hyperstimulation syndrome.
And there’s been some research with native kisspeptin in women at excessive danger for OHSS, however it’s displaying precisely that, this was labored on out of the Imperial College of London and delightful work suggesting that if we will successfully harness this kisspeptin pathway, it may work to the benefit of women and stop ovarian hyperstimulation syndrome. So this can be a medical stage assay, it’s been in 150 males, as a result of it was being developed by Takeda for prostate most cancers. We’re switching it up and shifting it into improvement for women. And so we hope to be in a security proof-of-concept research by the top of the yr.
Great, I need to depart a pair minutes if there’s any questions within the viewers. Okay. So I assume – then, I’ll ask the final query. [Indiscernible] so the variety of GnRH antagonist in improvement, how can we sort of take into consideration that aggressive panorama with probably a number of belongings coming to market over the subsequent couple of years and what do you assume relugolix’s benefits in comparison with different choices early?
Well, I feel we’re delighted to see women’s health getting this type of consideration and it is solely good for women that they’re going to be decisions within the market. I might say that we really feel very proud of our drug and assume that it should have some vital benefits of potent with the lengthy half life and we now have provide you with a quite simple improvement plan, the place we’re going to be launching as soon as a day capsule and the six tablets mixture, which we – one dose for uterine fibroids and endometriosis, 40 milligrams as soon as a day with the add-back remedy, which we expect goes to be – sorry, straightforward for physicians to prescribe, you do not have to have a better diploma in hormonal remedy to know this drug. And then you possibly can – it’s going be straightforward for women to take.
And we expect it has the profile to have a very nice efficacy [indiscernible] being nicely tolerated. And so the Phase III knowledge are going to show that, however I feel that basically is the place we expect our benefit is. And it actually comes from the truth that this drug has an extended half life and it’s extremely potent. So it has a really good pharmacokinetic properties.
Great. And then simply on the money place of the corporate because it presently sits, what’s the burn price ongoing, how far are you able to get when it comes to improvement on the present evaluation?
So, as of our final Q we had $154 million in money. So that permits us to aggressively transfer ahead with our Phase III plans and that is clearly what our money goes by means of proper now.
Lynn, thanks a lot. Really recognize you taking the time.
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