Ready to Launch. Industry Perspectives on Commercialization.

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Leigh Anne 0:00

All right, so why don't we go down the line and do quick introductions. Nick, would you like to start?

Nicholas Holsman 0:04

so my background, started in the diagnostic space probably about 20 years ago, then moved into the therapeutics, working at a. A small company called Stevie Therapeutics that was ultimately acquired by Gilead. Sciences was there for a couple of years working in the managed market space, really supporting all of their different franchises before getting into the start-ups. So right now I'm at. Start-up number five. The last three have all been ex-US, so I've, right now I'm working purely in oncology two Swedish companies and one Irish company. So glad to be here today.

Dina Lynch 0:42

Hi, I am Dina Lynch. I'm the vice president of market access for a company called Alzion. We're in development of a small molecule for Alzheimer's, so it's a very exciting space. I've been in mostly the last 10 years focusing on emerging startup companies. So this is my fourth one, fifth brand of the last 10 years, building all the market access functions from the ground up. So pricing, contracting, trade distribution, market access, strategy. And before that I was with the big pharma companies.

Paul Voss 1:11

Hi everybody. Paul Voss. I'm with Reneo Pharmaceuticals, vice President, market Access and Policy. Twenty-five years in the industry. Got my start in sales and and listening to all the conversations and presentations over the last couple days. It's interesting because one of the things that got me to where I am today was following the dollar. And as a sales rep, I remember sitting in an office sitting there with. Five Pfizer reps walking in and thinking, gosh, this is not sustainable. And somewhere along the way I've gotta reinvent my career. And if you and at the time follow the dollar and I'm like, payers are where I've gotta be. So 25 years later, I the last. 10 years have been head of market access mostly in the startup arena. And and really owning end-to-end from, pricing and reimbursement to pair engagement, to government price reporting, trading, distribution, et cetera.

Leigh Anne 2:02

I think between the three of you, you covered just about every commercial function there is and a ton of different product archetypes. So I'm just listening here. I hear buy and bill. SP light, small Molecule, IV Oncology, rare Disease. I know Paul, you've had experience in first-to-market, unmet need with competition, all different types of launch environments. So that cues us up to our first question, because this one's going to be very cool to hear from the perspective of the different product archetypes. So I call this one market access and emerging Pharma myth Busters edition. So fact or fiction the days of a year to access are now over. Now it's three years to access. How is this true or not true in your therapeutic area? If it is true, what are you doing in this landscape to where you won't have solid access in two, three years? What are you doing to mitigate for that? And what may you be doing innovatively to compensate? And then if false for you, what other access considerations are critical in your strategy and your execution? Paul, maybe you can kick us off. So for me, it's interesting I think from my leadership team, I'd like to point to the fact that it might be fact, but I think the reality is that. In rare in Orphan, there are strategies that, we've deployed to ensure that we can speed that time to access. And, we acknowledge that first six to eight months we're likely gonna live in a world of case-by-case Pro-authorization reviews, likely initiated by a lot of the PBMs and and payers who are instituting some sort of NDC block new-to-market block on a product. But I think the reality is and I gotta be honest with you, I don't think it matters whether we're in an era of that first six to eight months under a new-to-market block, or whether we are two and three years out, the obligation that we have. In access to be able to take our HCPs, our patients on a journey of what to expect remains the same. And so for us, I invest very heavily in what I call the nitty-gritty of market access and in supporting. Offices and the journey that they may expect in that first six to eight months and beyond. And a lot of it really comes down to understanding what a complete enrollment looks like, how we help support that. Capturing the right level of documentation to support that pro-authorization, the expected utilization management that we may. I expect from the payers. And then at the end of the day, being able to pull that together in a way in which we partner with our specialty pharmacies, pharmacy or pharmacies to pull that through. And so I would call it myth, but but I can imagine in some scenarios it may be fact. And I think for some of our HCP is depending on, how astute they're at navigating it or the support they get. It may be very different. That's a great answer. Great perspective, Paul. I wanted those little cardboard, double-sided factor if we couldn't pull those together in time. Dina, what's your perspective on this question?

Dina Lynch 5:07

I have definitely seen a change in the last five years on the different molecules I've worked on from being really plug-and-play, right? Distribution looks like this. Payer strategy looks like that reimbursement strategy looks like this to market them now where every single payer and SP has told me, I'm so glad you're talking to us two years out because we're not ready for you. And we need to create the market. So I think it really depends on the molecule. That you have, how complicated is it in this, in the ecosystem, right? Is it an orphan drug and an oncology drug that's gonna follow the same path as everyone else? Or are you gonna bring something to the market that's incredibly different or new, or an unmet need where the market is really not ready for you? So I think you have to put a filter on that. So I would say that yes, you definitely need to get. Engaged earlier, the more complicated your molecule is. I'm definitely the lucky one that my product is almost all Medicare Part D and we're gonna get slapped with IRA from the moment out. So at the end of the day, I'm having conversations with finance and with the bankers on is that really the revenue stream? And really is it gonna take these kinds of gross to net hits in order to get this product to market? And really thinking through the profitability. So there's a lot more that I'm doing now than I ever have been for molecules, which tend to be more like plung and play.

Leigh Anne 6:22

Thanks Dina. I'm gonna tap into a little bit of IRA expertise in the next question. Nick, how about you on your. Perspective to access, time

Nicholas Holsman 6:31

Access. Yeah. I think certainly if the therapeutic area makes it, that's certainly the crux of this question. Certainly things were going towards, I never thought it was gonna go towards three years, maybe 18 months. We are lucky enough to be in the oncology space. Where 505B2, the reference product is pretty well known. The data is out there and we should have a clinical differentiation. We have done, the market research spoke to both HCPs and payers who both said that, within CML all products are covered with a PA to label. So that's what we're expecting. Obviously, there are gonna be certain payers who are going to, come in at different timings, so you are gonna get some who earlier, more early adopters and that's, part of pulling some data, pulling some of the integrotator Integral change data as well as, Symphony and IQ via data. Sort of mapping out what that roadmap looks like and figuring out, if someone does put you in a preference position or if someone does, put a certain step edit or pa, what does that mean to the launch? So certainly that's what we are mapping our net right now. But we are expecting pretty broad coverage from the start, unless. we play around with pricing and get all cute with pricing. As soon as you get cute with pricing, then all bets are off It's helpful in oncology 'cause they are willing to write those PAs, write those medical exception letters and things like that. So certainly there is a support mechanism in the, CML field.

Dina Lynch 7:54

The age-old market access question, is it covered? Sure. Yeah.

Leigh Anne 8:01

Looking at and planning for the future financial outlook of your product and how that changes from phase to phase in clinical versus. As post, right as you launch, post-launch and then into steady state, what are the types of continuous net revenue questions that are impactful that leadership must ask and be able to answer quickly? Maybe let's focus on like post-launch. Definitely within the first three years, and I'll give some examples. Maybe deal analysis. What does that even look like for things like specialty medicine versus what it may have used to look like how transactional is this for you or have you seen versus strategic based on things like internal capabilities, partners, systems, et cetera. So I think for this one, I'm going to start with Nick from like a pricing and deal analysis perspective, since you have an excellent commercial ops and analytics background and they will pass it to Dina to touch on IRA and what that looks like from a, those implications on commercial strategy and execution.

Nicholas Holsman 8:59

Certainly from a data perspective that's what we are digging into right now. Unfortunately, or fortunately you're working for an ex-US company the window to launch is always fairly short, right? If you work for a bigger company, you tend to have 18 months plus for a launch. You work for an ex-US startup company you've got nine to 12 months launch, so you're like scrambling already. So trying to figure out what data you need and educating, the senior management about why you need that data and how that's going to drive decisions is key. Right now we are working through the channel strategy, just understanding the whole implication of gross to net. Where are those pieces, where are those lever points? And, and starting to think about, not even think about starting to write contracts right now, but then ultimately we're gonna get into, once we have those contracts in place, measuring those contracts and then how are we gonna support the patient, like looking at, patient assistant models and things like that. So there certainly is a lot of data to work through and, building a gross-to-net model. We're still, that's still in the hopper right now, but that's certainly trying to get your arms around the data to make those decisions is pretty, pretty crucial.

Leigh Anne 10:08

Thank you, Nick. Yeah, you wanna, Dina, you wanna talk about from a, again, what you're looking at as far as IRA potential IRA implications when you're going into net

Dina Lynch 10:15

revenue planning. My life is spent between what the bankers think the revenue stream is, what the commercial organization thinks it is, what the clinical people think it is, what the, all these external factors. And then one of the awesome, most awesome questions I get is IRA is really not gonna impact us, is it? We're not gonna be a top-ten drug for a while. It's not gonna hit us until 20 thirty-two, et cetera, et cetera. I'm like there's this thing called catastrophic that you're gonna put these people into immediately, pretty much after first, the first couple of doses. And yes, it does have an impact on revenue, right? And so you need to look at. I think what I think is like your worst possible revenue and what's the potential if you go into other areas of the disease state with more commercial balance, when you have a really high Medicare Part D population, it's incredibly challenging to be profitable just with emerging pharma. One of the things that we are constantly looking for is revenue streams, right? So you're having conversations with the outside investors and they're just like, and I literally had an investor say this to me in San Diego. We're just gonna walk away from small molecule Medicare products. We're not gonna invest. And I was like, so you're walking away from the entire senior population forever and no innovation in that space. I said, that's really kind of short-sighted. So we need to think better about that. And I think one of the things that we're doing, at least in the Alzheimer's space, is we're engaging the patient groups, because they're incredibly powerful, as in oncology and Endoprology and other areas. And so people need to be educated in the fact that this is not good for humanity. And so we're balanced. I'm balancing all of these things right now in terms of, how do you launch a product in this. Perfect storm and balance all the things and be profitable and look like a good partner and look like a good opportunity for investment. And so it's just more challenging. I think that it's ever really been with IRA, to be honest.

Paul Voss 11:50

I think, IRA can, even though we've heard some really good messages, I think the last couple of days about where we're headed and things to be thinking about, I think there's still a lot of unknowns about how it's all gonna play out. Do some of the large manufacturers have some success on their efforts as it relates to price negotiation? I think, I just saw some legislation proposed that, the second orphan drug indication actually may have some life again, whereas a couple weeks ago it didn't. So I think, we're, we've gotta keep our finger on the pulse of how things continue to evolve, but I think the core investments remain the same. One of the kind of consistent themes that I've heard though from, my two panel members is, I think, managing expectations of your senior leadership team is probably one of the more important things that we can do from an access perspective. And I think also just taking them on a journey and I appreciate, Nick's perspective because having worked previously for a UK based company who doesn't have a great understanding of the US market it takes a little bit more of an investment of taking them on that journey of the US market and how things are gonna unfold. And I've seen it's very easy to dismiss that and just put your head down and plow forward to get things done to launch. But the reality is I think those investments are critically important.

Leigh Anne 13:02

Absolutely. A lot of our customers that we speak with early on who are ex-US, and we're seeing more and more of them, right? Those first, so many months are just education, right? Yeah. What is government pricing? What does the US market look like? Going right back to follow the dollar and then implications on things like net revenue, gross to net accruals cash forecasts, et cetera,. It's a it's a long battle.

Dina Lynch 13:24

Actually had a conversation during one of these panels. Somebody said why don't we just launch XUS first because of IRA? And I was like, okay, we've done a 180 now. I'm like, no. There, there's just all kinds of conversations going on, and I think to your point, we have to see how it plays out. I'm glad to see that there's legislation from the Congress 'cause there wasn't a few weeks ago, so that's good. I think the orphan thing will get overturned. That's a problem. But let's see how it plays out. 'cause I remember back in the day when I was a rep and there was a very famous CEO who said, this managed care thing is gonna go away. And I remember thinking. That's not gonna happen. I was a California rep, so that's all I knew was managed care. But yeah, so we'll see how it plays out. We all survived Two-thousand-three when Medicare Modernization Act happened, and we survived, right? It was job security for us as market access people. So we'll see what happens.

Leigh Anne 14:11

It is fun to listen to some of the back of the envelope solutioning. It's always fun to listen to. All right, let's move on to our last question here, so lots of buzz around alternative channel design. Direct versus indirect, et cetera, So lots of buzz around this in the industry. What are you seeing or possibly what you're not seeing and what's your wish list for an alternative innovative strategy in and around channel and or provider. What questions are you asking yourself and what's the process you're going through to establish channel design in the moment? Again, what are you left wanting again, make it a wish list. So I'll kick that over to Dina first.

Dina Lynch 14:52

No. I think about this a lot. So in, when I'm talking to my executive team and they're like, whoa, can't you just do this and do that? And I said, the channel is not flexible. You have widgets and you need to get 'em to the end. I think it would be great with some of our channel partners to be a little bit more integrated in their companies because they do have the ability to be more flexible, but they just can't get outta their own way. If you're talking about the top three, there'd be some things that would be really interesting if you're going more direct to patient, like the Amazon model. If they could get more sophisticated in that. And some of them are, some of 'em are thinking through it because I think right now there's just too many steps along the way in the channel. I'd like to see it a little bit easier, more direct to patient. That would be my wish. And I think we're getting there. A lot of them are really open-minded to those discussions, but we'll see if somebody can actually pull it off. How about you,

Leigh Anne 15:35

Paul?

Paul Voss 15:37

Yeah, this is the near and dear one to me. I. I've grown up to see a lot of different distribution models. And more recently, because my career has been in ultra rare rare and orphan I've seen a bit of an evolution from the limited distribution networks light on physician and HCP support, patient support to, more recently, my last two launches have been in exclusive specialty pharmacy relationships. And and interestingly, I have found that, what it takes to manage an exclusive versus what it takes to manage a limited is almost the same. In a limited, they hold each other accountable and in an exclusive, now I have to hold them accountable and work just as hard to do and I think there are a lot of different models that have different opportunities for creating solutions for patients. But one of the things that has been critically important, I think is an output of covid. No different than it is for us on the payer side as well, which is. Unfortunately a lot of our engagements are virtual and I think patients are similarly expecting more innovation from us as well. And so one of the things I spend a lot of time thinking about is how can I engage patients and caregivers virtually to take 'em on the same journey That I take a lot of other stakeholders within my, in my organization and on. And so I think virtual engagement, digital engagement managing expectations on onboarding of your therapy creating touch points, outreach. And I think the other thing too, in rare and Orphan, we often dismiss the need or the opportunity for adherence. And 'cause we just assume we're the only drug in the market, so of course, they'll take our drug, but that doesn't mean that the experience doesn't create disruption in their lives. And so I think staying on that is critically important as well. My challenge to a lot of the distribution providers as well is that look how many different products you have under management. Come to me with what you think is the right fit match for my drug. Because you've got all these others, you've seen what good looks like. Tell me and innovate on my behalf, rather than me coming to you and tell you, telling me what, or me telling you what I think the right solution is. I think patient journey's critically important as well. I can't dismiss that. Like understanding the journey as a whole.

Leigh Anne 17:41

Yeah. Having your partners innovate on your behalf. And Paul, I remember that question from years ago. You gave us that question. Love it. Show me what good looks like. Nick, anything to add on that

Nicholas Holsman 17:50

one? Yeah, certainly. In terms of the channel strategy for us being in oncology, it's just try to make that product as widely as available. The decision-maker is the provider, right? They're the ones who are gonna put product on put patients on product. However, we have been wrestling with the adherence issues and certainly we are hearing from some of the independent SPs about their value prop, that they, that their ability to keep patients on therapy longer. It's certainly resonating with our leadership as well. Although we are gonna have a fairly broad channel strategy there, there are certain players that we've identified that we do not want we are trying to not engage with. So we are working through some of the recent oncology launchers who have had have gone down that route. And I've spoken to a couple of people here that, to see how successful and how and what the ability to do that is, with a single product. But critically important.

Leigh Anne 18:47

Absolutely. So let me throw one more thing in. How about three PL selection? What innovation may you be seeing in the three PL space, and what new considerations may you be looking at that you weren't a few years ago when selecting a partner, a vendor, a capability, so on and so forth.

Nicholas Holsman 19:03

Yeah. We just went through the three PL selection. I know we had some conversations last night about, some of the new startup groups out there for me. I'm at the time I was the only US employee, I'm trying to go for, to minimise risk as well as we were potentially gonna be in a title model. So I was looking for flexibility on the title model. One of the groups that we were talking to would do it State-by-State Month-by-Month. So that was one of the, that's the key driver of our cost, given that it is a fairly expensive product. I wasn't, I didn't entertain a lot of the smaller, more nuanced groups I was looking for low title fees, low risk.

Dina Lynch 19:44

I would just add from an emerging perspective, there are a couple of three pl I. Companies out there, and you may have seen this in some of the investor relations, is they're going in and they're saying, we can do everything for you plus X, US plus commercialization plus, right? There's a couple of them. The larger ones that have those abilities, some don't. And so I think it depends on kinda what your global strategy is too. We chose one that had some flex with the global markets just because we needed some expertise there, but I think the top three really, it's, they all do a very good job. Really just. They all do a very good job. They get the product where it needs to go. I think you have to think about longer term strategies and like capabilities that are missing in your company if you're in small emerging. Like we just don't have people who understand XUS. And so bringing in those types of that knowledge base is, was important for us.

Paul Voss 20:32

Yeah, the three-PL piece is interesting to me. I actually launched a drug under a title model as well, and it played well. Part of it was because of a need for state licenses, and so we were able to leverage the three-PL's state licenses. So that played well from moving to market quickly. Interestingly enough, we fully expected in that launch to move out of the title model. Within six months and three years later we were still in it. And a lot of it was because there was just some efficiency there. We, and also just from an infrastructure standpoint, it made things a lot easier for our company. I think, the reality is that's maybe not the most ideal model unless you're constrained by time. And I feel like it's got a little bit of resurgence right now, and Novorex and some others are and even some specialty pharmacies that are starting to think about offering three PL services. I admittedly, as I'm doing a channel strategy assessment right now I'd be hard pressed not to think about some of those because look, my objective and the purpose of this conference is about preserving gross to net. And if I can reduce some of the discounts in channel by, maybe stepping around the traditional, three PL, SPSD model and going all in one I'd be foolish not to take a look at that.

Dina Lynch 21:39

I wouldn't worry about the, I think it depends on, again, I'm gonna say this again, it depends on your brand, but going with the non-Title model is just the state licenses, right? And there's about twenty-seven states that require, but it also depends on your channel, right? So if you're only gonna ship to three SPs and they're in two states, go get those state licenses because it's less expensive for you. So I think you really have to think that economics through, and you usually takes about a year out to get your state licenses in place. So it's not super scary.

Leigh Anne 22:03

All right. I am gonna throw one more question, at you guys, other than a larger budget, is there anything and more time, I guess other than a larger budget and more time is there anything you would change in hindsight as you led up to your first launch? What was the ah-ha, 6, 12, 18, twenty-four months out for the folks in the room who are sitting here ready to launch their very first product.

Paul Voss 22:26

This is probably not the, what most folks would expect, but I think again, having worked for a lot of startups, often I'm compressed in time and and while we may be able to create the right network design, we might be able to create certain tools to help speed time to therapy I think the reality is that the greatest value of time is being able to educate your field on being able to engage HCPs and be able to take them on that journey. Help them understand and empower them to own the process that you've set up. Create best practices create handoffs between, field sales and FRM field reimbursement or patient access. Creating that sort of seamless ecosystem for the patient. I think a lot of times where we don't, we're not afforded the time to do it and even if we're working for a large pharma company where maybe we were afforded a time, the time we've got so many different stakeholders involved that sometimes it's hard to knit it all together. So I think that's probably the thing that if afforded time, I would take advantage of.

Dina Lynch 23:31

I don't know if this has happened to any of you before. But I've created amazing market access strategies, but the commercial strategy wasn't right on, and all I would say is that you really need to get involved as the market access lead in the patient journey, the marketing strategies and so forth, because if they're not mirrored and the marketing team doesn't necessarily know what your struggles are. There'll be a disconnect, and then there'll be, commercial failure.

Leigh Anne 23:56

That's a great point. The cohesion be between the commercial strategy and the market access strategy, for sure.

Nicholas Holsman 24:01

Yeah. I think the third component here from money and time is people, right? So for any startup. That's what you struggle with is that, we still think about things that are like revenue management, so we are outsourcing that to all of these different people. We don't really have the budget to bring in a team of 10 to 20 people in house. Like we've probably got right now, there's two of us now, and we'll probably be bringing in probably another three or four. But basically there's gonna be about five of us in house. So we are we're a very small team, so getting access to the payers and getting access to decision-makers on at SPs, so certainly that's a struggle that we deal with is just having a big enough team to execute.

Paul Voss 24:46

Wanna jump in on Nick's comment about, and even Dina knitting everybody together. It's so easy as a department head to put your head down and just plow forward to get, what you have done in front of you get done. And and sometimes that comes at a cost because then you're not mirroring the marketing messages, or you're not ma or they're not matching up with your access strategies and think, again, afforded the time being able to create that connectivity between different part departments is probably one of the more important things you can do to ensure a successful launch.

Leigh Anne 25:19

Awesome. Thank you everyone. So we are at time. Thank you Nick Dina and Paul for participating and sharing your insight.