Jef Akst: All right, week two of earnings. How are we all doing?
Heather: you
Annalee: I feel like I've been through it this morning. Pfizer was like unexpectedly, I was scrambling at the end there to get that finished. It was a little wild.
Heather: Pfizer was a little tame this year, weren't they? As opposed to wild?
Annalee: They were, yeah. Yeah, we're gonna talk about it, so I won't give it all away upfront, but yeah, they were a little tame. I think what's kind of throwing me ⁓ season is like, we had so much concentrated last week and then now there's just like a couple, like we had Pfizer today, we've got Novo on Wednesday, tomorrow, like, I don't know, it's been a weird season.
Jef Akst: And if there isn't that obvious headline, it can just feel like a little bit of a drag going through all those numbers. yeah, boring, a boring earrings call doesn't make for a quick turnaround.
Heather: See you.
Annalee: Yes.
Heather: let's get to it. let's get to intros. So I will start this I am Heather I'm ⁓ a senior editor at biospace and I curate clinic space, which, comes to hopefully all of your on Mondays.
Annalee: And I am Anneli Armstrong. am senior editor at Biospace and I put together the Biofarm executive newsletter every week, which goes out on Wednesday mornings.
Jef Akst: And I'm Jeff Axe, managing editor and always putting in some plugs for our other newsletters. Definitely sign up for our daily gene pool as well as manufacturing brief on Tuesdays and Career Insider on Thursdays.
Heather: JIN pool has been packed lately with earnings. So let's get to that. So Q1 earnings reports continue roll in. Pfizer, Vertex, Eli Lilly, and many more big pharmas have announced in the past week, but also the guys. These are the ones that I like to follow. The small to medium biotechs are beginning to report as well. But Emily, let's start with since they're the freshest in your mind.
Annalee: know love earnings. It is like my favorite time of year and it happens four times. It's like a holiday every quarter. yeah, Pfizer was this morning. I literally just filed that story and we got it published before we jumped on this podcast. It was a good quarter for Pfizer. They definitely beat expectations, but analysts were like really basically fussing about the fact that they didn't raise guidance for the year. They argued that they had a great quarter, they had 2 % growth, beat consensus ⁓ and everything, but they still did not raise guidance. This almost muted the shares, like Pfizer didn't really move very much. But basically what ⁓ executives said the call is their CFO Dave Denton was like, he's a pretty conservative guy, he doesn't like to raise... guidance in the first quarter. He also said that because their COVID products are so back heavy, they typically make most of their money in the second half. He just doesn't want to raise ⁓ guidance get people's hopes up. So basically they've really paved the way for a strong year with this They didn't really say whether they would raise their guidance for the of the year, but I think it seemed to analysts even if they were still just kind of hoping to see those numbers go up.
Jef Akst: say I have a lot of respect for that approach. We've had examples of overshooting either in guidances for earnings but also ⁓ loss expectations. Why Be conservative and then impress everyone when you beat it. That seems like the way to go. ⁓
Heather: you
Annalee: Yeah, no kidding. And Pfizer is kind of in this weird period, which was basically the highlight of this earnings call. They are, while they did do that 2 % growth for the quarter, they're really eyeing a more significant return to growth in the 2029 period and beyond. So that's what they laid out in this earnings period and on the call. So they recently received some clarity in the form of a litigation settlement for the patent on Vindamax, which is for ATTR Amiloid. ⁓ Amyloidosis, Heather, probably can pronounce this a lot better than I can. Amyloidosis, yep.
Heather: Amylidosis? yes. ⁓ of amylidosis. ⁓
Jef Akst: And specifically cardiomyopathy ⁓
Annalee: Yes, yes, Yes. So now they kind of have certainty that they were going to lose the patent exclusivity on this product. However, with this settlement, that's going to happen in 2031 instead of 2028. So that gives them an extra three years of exclusivity. And as Albert Borla said on the call, this is a $6 billion product for them. So that is like all extra bonus that's coming into Pfizer's pocket.
Jef Akst: So what are they gonna spend it on?
Annalee: I mean, ⁓ &A, of course. They have definitely added some of that pile to their war chest for deals. Analysts were really trying to get some more details from Borla and the team on what exactly they are looking for in deals. Borla kind dodged the question a little bit. However, he did say that they are looking at everything and kind of gave the never say never answer that a lot of CEOs give. Did not rule out a mega deal, but said that they're really focused on streamlining the business right now. ⁓ particularly with AI. So any kind of mega transformative deal like that would kind of that process more difficult.
Heather: Pfizer had one of last year's mega deals for Metcera. So ⁓ they're done for a little while or maybe not. ⁓
Annalee: Yeah, and like that deal was $10 billion, which is still pretty big by like, you know, today's ⁓ &A standards, but it was really a transformative one for Pfizer. And that is going to be key to the 2029 period and beyond. So that was something that they told analysts as well.
Heather: Yeah, I noticed with the story you just put up, you called it a 2029 story for Pfizer. Yeah, so that's okay. Well, moving on to one of our favorite companies to discuss on this show, Eli Lilly.
Annalee: Yeah, yeah, for sure. Yeah, it was a huge quarter for Lilly. Whereas like Pfizer was kind of this muted Lilly was the exact opposite, which was to be expected. They growth of 56 % for a total of $19.8 billion in revenue, which is absolutely insane. Analysts all around were very pleased with this result. I kind of could not stop getting hung up on one key thing from their earnings though, which is that... Throughout their earnings release, Lilly was saying that their revenue could have been higher had they not lowered prices significantly on a lot of their medications. This is something they did throughout 2025. And now that's starting to hit earnings.
Jef Akst: would they really though? because the idea is you charge less, you sell more of it. so it's hard to tell whether they would actually have made less. they would not have sold as much as they did probably if prices hadn't started to come down.
Annalee: Yeah, absolutely, and they did sell more. That volume play is starting to show in earnings. But had they been charging $1,000 a month for the products, they certainly would have made more money.
Jef Akst: Yeah, but is that possible? Can you reach that volume at that sale price and you just can't because people can't afford that.
Annalee: Right, right, you can't. So we also got initial details from Lilly's launch of Foundao, their oral obesity asset, which just hit the market in There's been kind of some mixed messaging on how many people are taking this drug, how many have switched or started taking it anew. Lilly was able to give some numbers in terms of scripts. They say that scripts have been written so far, which is a lot. ⁓ We didn't get revenue numbers on that. We probably won't until the second quarter, but that seemed to, again, please the analysts who are desperate for any information there.
Jef Akst: We'll have to wait and see what those advertisements look like when they do come out.
Heather: Thank
Annalee: Yeah, no kidding. And what was kind of funny is that Lily said that they really have not done like a full court press advertise Foundeo yet. They're kind of starting with physicians, increasing familiarity to sure that everybody knows the product in the care And then they're gonna start doing those ads. So those are definitely coming to a TV near you at some point.
Heather: I saw a Zeph Bound on the Blue Jays mound the other day. So that was exciting. I even messaged him the group. was like, guess that bounds on the mound. And then Jeff asked me the guy's name is Zeph Bound. So then I had to explain. Yeah, they have these ads, they hover over the mound and then they change every inning.
Jef Akst: I didn't wonder. That's what limited knowledge of baseball I have.
Annalee: And you know. Yeah, and over on the NHL, which of course I've been watching the Stanley Cup Playoffs, it's all Wigoby all the time.
Heather: Yeah.
Jef Akst: I saw a ton of ad b advertisements at Wrigley Field this past weekend, so that caught my eye.
Heather: ⁓ yeah, I would.
Annalee: We should do like a listicle article of the sports and their primary drug that is being advertised.
Jef Akst: You
Heather: Oh, I would love to do that. I mean, they each have their own weight loss drug, I guess, but.
Annalee: Yeah. Getting back to Lily earnings, just to wrap things up, Lily has been of the most exciting companies every single earnings period. What's been really big this past quarter, which I'm sure we'll hear about ⁓ earnings period, ⁓ that Lily has been on an absolute ⁓ &A blitz. We had an analysis on this in BioFrame executive last week, but of course you can still check that out at Biospace. Lily has spent $21 billion this year already. tying their 2023 record in terms of the most transactions, which with six and it's only the second quarter. So I hope, you know, I can only imagine we're going to be continuing to have Lily at the top of our website for the rest of the year.
Heather: like that though, if you're going to make a lot of money, spend a lot of money putting it back into research for other diseases. I really like that with Lily. ⁓ Well, we covered Amgen last week and they about their upcoming, of course, obesity drug, Maritide. And Annaleigh, you what you love to call modernings. So you can check out all those stories at Biospace.
Annalee: Yep, that's the goal. That's what we're all here for.
Heather: We will of course be covering Lily's chief rival, Novo Nordisk, on Wednesday morning as the obesity beat continues. I'm looking forward to Sarepta earnings tomorrow, which has a big rest of the year ahead with a study testing their immunosuppressive regimen, sirelimus, during treatment with their gene therapy, alevitis, in patients with who unable to walk. And one analyst I spoke to for a biotech earnings preview piece that's out this morning, Tuesday as we record, he said that a return for alevitis in this patient population could potentially double its revenue.
Jef Akst: I too am curious to see where Sarepta goes. We covered them a lot last year with all the drama last summer and there was a lot of question about whether the company would even survive. So yes, let's see what they have to say tomorrow.
Annalee: Not to mention they're doing a hunt for a new CEO. So I wonder if we'll hear anything else on their earnings call.
Heather: Yeah, but that'll definitely be a question. as usual, ⁓ regulatory space has not disappointed for news this past week. We were all gearing up to find out who would replace Banai Prasad at CBER. ⁓ then we got another interim director. That seems to be a kind of a common theme ⁓ within ⁓ lately. that new CBER director is Catherine Zerama. ⁓
Jef Akst: Yeah, that's right. So we've had so much turnover at these high level positions and they don't always have somebody lined up right away. So that seems to be the case here. They've put in Zorama as we await an announcement on who the permanent CBER director will be following Prasad. There ⁓ been a great reception to this. I think just the fact that she's only an acting director and we don't have a person the position just yet is a concern among industry watchers. People are also concerned about Zahrama herself. She was handpicked by Prasad to be his deputy last December. And as Capital Alpha Mark Partners analyst said, she and others that Prasad hired likely share his views. She does have some government experience. but she lacks the clinical experience and depth of background for a more typical FDA director as Capital Alpha. ⁓ We'll see the next month or two holds. We're hoping to get a permanent director at some point pretty soon. But at this point, it really does seem like regulatory uncertainty will remain an overhang for the industry. Capital Alpha did say that perhaps we'll see less drama with Prasad gone, maybe less, quote, personnel angst, which would be good for the remaining FDA staffers. But all in all, they definitely agree that, you know, a lot of questions remain about how CBER will be run. who will run it and if they'll be able to restore public trust and industry trust in the agency. And then again, I will just add too, as we started at the top of the section, there's such a high level of turnover at this position. Zorama is the fifth person to lead CBER since the beginning of the year. And that was back when we still had Peter Marks in the position and the industry was hopeful that he would be sticking around.
Annalee: Yeah, and it's not just CBER, there's been so much turnover across HHS.
Jef Akst: Yeah, mean, Cedar and the entire CDC have each had five or more leaders at the helm in the span of less than 18 months. It's just an insane amount of turnover and the industry is really clamoring for stability.
Heather: I know Jeff you said since the beginning of this year, obviously since the beginning of 2025, but it does all seem like it's been one year, doesn't it? One big long year. Well, another thing that happened at the FDA this week, they held their first advisory committee meeting in nine months. This was for a couple of AstraZeneca cancer drugs.
Jef Akst: Yes, thank you. Yes, yeah, you're right. So the beginning of 2025 when Trump took office.
Heather: And I spoke with chief medical officer at Precision for Medicine and also former oncology regulator, Harpreet Singh. And she said that this was missing the PES-DUR moment. So quote PES-DUR moment. And this is obviously Rick PES-DUR, the longtime oncology stalwart leader left the cancer leadership position to head up Cedar and he was one of those five Cedar last year and then he ultimately retired.
Jef Akst: ⁓ how that AstraZeneca adcom go?
Heather: ⁓ Yeah. So, so said it really would have worked as more of a conceptual discussion. So the way ⁓ this was due to AstraZeneca design, at least for the first drug that they discussed in the morning, ⁓ the oral third chemisestrant. And so the way that the was set up. patients with HER2-negative advanced breast cancer switch treatments at the point where a mutation was detected, as opposed to the current practice of changing regimens upon disease progression. this made it a bit challenging to determine the benefit of Astra's drug.
Jef Akst: Well, I guess now we wait and see if the FDA listens to the ICOM and what the outcome is for these two decisions.
Heather: Thank
Annalee: I do hope that this is issue that they take up. Like this is the kind of stuff that the FDA is so good at, is like coming up with these treatment paradigms that can really change how companies develop their drugs. So I hope that this is an issue that kind of gets debated and maybe we'll see some guidance on it at some point.
Heather: Mm-hmm. Yeah, she was, uh, Harpreet was even suggesting that there be more of these conceptual type, type outcomes where, where they do have these kinds of debates. Um, but ultimately it was a negative vote for chemist's assurance. So we'll, we'll see what happens.
Jef Akst: Yeah, having its first adcom in nine months is certainly a step in the right direction, but I do know, and Heather, you can speak to this more, we're still having transparency issues at HHS.
Heather: Thanks. Yeah, I think this might be about the third editorial that we at MedsBiospace have written checking up on health secretary R.K. Jr.' pledge that he made last year during his congressional hearings to prioritize, quote, radical transparency the health department. And because the most one ⁓ was driven a couple of recent incidents where the FDA and CDC don't appear to be taking this to heart.
Jef Akst: Yeah, what were the two that you focused on?
Heather: Yeah, well, the first, and this is one that I think is the most egregious, was the FDA's decision a couple of weeks ago to not disclose the names of its most recent commissioners national priority venture recipients. This for the psychedelics companies. And then the second was the CDC's, or more specifically, J. Bhattacharya's ⁓ decision not to publish a CDC-partnered study that was investigating the efficacy of the COVID-19 vaccine. ⁓ in hospitalization. ⁓
Jef Akst: Yeah, I guess he had some concerns over the methodology and said that this was normal protocol, but we don't know if we will ever. I mean, the study was published elsewhere online and so that it has the light of day.
Heather: Yeah. Yeah. You know, he was mentioning, you know, that rigor is important and that he had issues with the methodology. And that's totally understandable. But I can kind of see just from, you know, kind of the past 18 months why ⁓ would be a little concerned that this might be a type of censorship. ⁓
Jef Akst: Yeah, I feel like it's a perception issue as much as anything else. know, and in journalism, we talk all the time about conflicts of interest, and it's not just actual conflicts of interest. It's perceived conflicts of interest. You've got to disclose those because if people feel like you're pulling the wool over their eyes, there's going to be a trust problem there. And we know that FDA has a trust problem at this point. So even if there are justifiable reasons for some of these actions, which I'm with you, Heather, I can't really understand why they wouldn't have disclosed the name of the psychedelics makers. But even if there are reasons to not disclose what those reasons are and just to refuse to give us the information,
Heather: Yeah.
Jef Akst: It does not look, it's not a good look, especially when you're preaching radical transparency.
Annalee: I still go back to when McCary said that the whole reason or Prasad leaving was like always the plan. I just like feel like that was another breach of transparency. It's like, what do you mean? That was the plan all along. And then you just suddenly announced his departure. Like that kind of shook the industry.
Jef Akst: Absolutely.
Heather: in March, about a month and a half before his actual departure. So that would have been something good to know right at the beginning, but maybe they didn't because people wouldn't have listened to Prasad if they knew he was only temper. I mean, there are lots of reasons that you can choose to do things, but it just, it's not a good book. Yeah.
Jef Akst: Right. Yeah, you need to share what those reasons are if you want to rebuild trust. Well, maybe we turn to a more positive story to end this podcast. Heather, I know you've got kind of a hopeful story this week.
Heather: Yeah, well, I actually got to speak with a couple of executives from Curalis, which is an awesome name, by the way. ⁓ pronounced Curalis, but they're trying to cure ALS, which think is really cool. And I've liked their CEO, ⁓ Caspar Ruett, for a while. And I was like, yeah, I really wanted to do something good. So on Tuesday, they did. They presented ⁓ data at Target ALS. showing that their antisense drug, is dubbed QRL-201, led to up to a 50 % decrease in disease progression on a gold standard scale for ALS physical decline. The drug hit on key biomarkers, including neurofilament light and phosphorylated neurofilament heavy chain. Both of these are key markers of axonal damage.
Jef Akst: what did the CEO have to say?
Heather: Yeah, so Casper, I'll call him Casper because I don't quite know how to pronounce his last name, but he feels very strongly that targeting a genetic cause of ALS is or genetic contributor is the way forward. QRL 201 is intended to restore the expression of the staphin 2 protein. And that's a well-known, it's well known for neural repair and axonal stability. And it's also well known to be downregulated in nearly all people with ALS. So he also spoke a lot about biogens, calcoti, which was approved in 2023. That's also an A, and also an ASO. And it, it was one of the only bright spots in the ALS space recently. Although that is starting to change.
Jef Akst: Yeah, actually there was also Corsept that had some new results for us recently. A little bit of a mixed results, but still some positive news in there. So Corsept has, it's not a genetic drug, it's a cortisol modulator. I'm not even gonna try to pronounce it, but they had a followup extension to their phase two study where the phase two study itself missed its primary endpoint and did not show a significant effect on motor skills or other functional criteria. But the investigators noticed a survival signal there and there was a... less risk of death in the treatment arm versus the placebo arm. that survival has persisted through one year. They saw an even stronger survival signal. And now we're at two years out with an 87 % reduced risk of death on this drug. So the company is moving on to phase three. Very positive news for the ALL to have a few eggs in the basket this point. We all know this has been a terribly devastating disease with huge unmet need and very, very little luck from. the biotech side trying to treat this disease. So none of these are at market's door just yet, but good to have a little bit of positive momentum in this space.
Heather: and both are moving on to phase three and yeah, it's to see momentum in ALS. It's a really devastating disease. So, Annalee, biopharma exec, ⁓ out Wednesday, morning, as you're listening to this. What do we have on this week?
Annalee: have a really fun piece from my Salt Lake City trip where I to actually sit down with biotech founders and talk about the challenges of being a founder today. So you will to hear their stories, how they got their first checks and kind of how they're the advice that they're taking to ride out the bumps in the biotech markets right now. So just a really fun piece. ⁓ It's hopeful, I So you can check out in Biofarm. ⁓
Heather: Great, well happy to end on a hopeful note. will see you all next week and until then enjoy spring! Hi, welcome to Biospaces the Weekly. Q1 earnings continue to roll in from big pharmas like Eli, Lily, and Amgen, and smaller biotechs like Sarepta and Amelix, which both have key catalysts ahead this year. The FDA named an interim CBER director last week as Vinay Prasad's tumultuous tenure finally came to a close. Meanwhile, the agency held its first advisory committee meeting in nine months, and it was missing the, quote, PES-doer moment. And the ALS R &D space is experiencing somewhat of a renaissance as two companies, Curalis and Corecept, report positive results for their mid-stage candidates. Let's dive in.
Heather: you
Annalee: I feel like I've been through it this morning. Pfizer was like unexpectedly, I was scrambling at the end there to get that finished. It was a little wild.
Heather: Pfizer was a little tame this year, weren't they? As opposed to wild?
Annalee: They were, yeah. Yeah, we're gonna talk about it, so I won't give it all away upfront, but yeah, they were a little tame. I think what's kind of throwing me ⁓ season is like, we had so much concentrated last week and then now there's just like a couple, like we had Pfizer today, we've got Novo on Wednesday, tomorrow, like, I don't know, it's been a weird season.
Jef Akst: And if there isn't that obvious headline, it can just feel like a little bit of a drag going through all those numbers. yeah, boring, a boring earrings call doesn't make for a quick turnaround.
Heather: See you.
Annalee: Yes.
Heather: let's get to it. let's get to intros. So I will start this I am Heather I'm ⁓ a senior editor at biospace and I curate clinic space, which, comes to hopefully all of your on Mondays.
Annalee: And I am Anneli Armstrong. am senior editor at Biospace and I put together the Biofarm executive newsletter every week, which goes out on Wednesday mornings.
Jef Akst: And I'm Jeff Axe, managing editor and always putting in some plugs for our other newsletters. Definitely sign up for our daily gene pool as well as manufacturing brief on Tuesdays and Career Insider on Thursdays.
Heather: JIN pool has been packed lately with earnings. So let's get to that. So Q1 earnings reports continue roll in. Pfizer, Vertex, Eli Lilly, and many more big pharmas have announced in the past week, but also the guys. These are the ones that I like to follow. The small to medium biotechs are beginning to report as well. But Emily, let's start with since they're the freshest in your mind.
Annalee: know love earnings. It is like my favorite time of year and it happens four times. It's like a holiday every quarter. yeah, Pfizer was this morning. I literally just filed that story and we got it published before we jumped on this podcast. It was a good quarter for Pfizer. They definitely beat expectations, but analysts were like really basically fussing about the fact that they didn't raise guidance for the year. They argued that they had a great quarter, they had 2 % growth, beat consensus ⁓ and everything, but they still did not raise guidance. This almost muted the shares, like Pfizer didn't really move very much. But basically what ⁓ executives said the call is their CFO Dave Denton was like, he's a pretty conservative guy, he doesn't like to raise... guidance in the first quarter. He also said that because their COVID products are so back heavy, they typically make most of their money in the second half. He just doesn't want to raise ⁓ guidance get people's hopes up. So basically they've really paved the way for a strong year with this They didn't really say whether they would raise their guidance for the of the year, but I think it seemed to analysts even if they were still just kind of hoping to see those numbers go up.
Jef Akst: say I have a lot of respect for that approach. We've had examples of overshooting either in guidances for earnings but also ⁓ loss expectations. Why Be conservative and then impress everyone when you beat it. That seems like the way to go. ⁓
Heather: you
Annalee: Yeah, no kidding. And Pfizer is kind of in this weird period, which was basically the highlight of this earnings call. They are, while they did do that 2 % growth for the quarter, they're really eyeing a more significant return to growth in the 2029 period and beyond. So that's what they laid out in this earnings period and on the call. So they recently received some clarity in the form of a litigation settlement for the patent on Vindamax, which is for ATTR Amiloid. ⁓ Amyloidosis, Heather, probably can pronounce this a lot better than I can. Amyloidosis, yep.
Heather: Amylidosis? yes. ⁓ of amylidosis. ⁓
Jef Akst: And specifically cardiomyopathy ⁓
Annalee: Yes, yes, Yes. So now they kind of have certainty that they were going to lose the patent exclusivity on this product. However, with this settlement, that's going to happen in 2031 instead of 2028. So that gives them an extra three years of exclusivity. And as Albert Borla said on the call, this is a $6 billion product for them. So that is like all extra bonus that's coming into Pfizer's pocket.
Jef Akst: So what are they gonna spend it on?
Annalee: I mean, ⁓ &A, of course. They have definitely added some of that pile to their war chest for deals. Analysts were really trying to get some more details from Borla and the team on what exactly they are looking for in deals. Borla kind dodged the question a little bit. However, he did say that they are looking at everything and kind of gave the never say never answer that a lot of CEOs give. Did not rule out a mega deal, but said that they're really focused on streamlining the business right now. ⁓ particularly with AI. So any kind of mega transformative deal like that would kind of that process more difficult.
Heather: Pfizer had one of last year's mega deals for Metcera. So ⁓ they're done for a little while or maybe not. ⁓
Annalee: Yeah, and like that deal was $10 billion, which is still pretty big by like, you know, today's ⁓ &A standards, but it was really a transformative one for Pfizer. And that is going to be key to the 2029 period and beyond. So that was something that they told analysts as well.
Heather: Yeah, I noticed with the story you just put up, you called it a 2029 story for Pfizer. Yeah, so that's okay. Well, moving on to one of our favorite companies to discuss on this show, Eli Lilly.
Annalee: Yeah, yeah, for sure. Yeah, it was a huge quarter for Lilly. Whereas like Pfizer was kind of this muted Lilly was the exact opposite, which was to be expected. They growth of 56 % for a total of $19.8 billion in revenue, which is absolutely insane. Analysts all around were very pleased with this result. I kind of could not stop getting hung up on one key thing from their earnings though, which is that... Throughout their earnings release, Lilly was saying that their revenue could have been higher had they not lowered prices significantly on a lot of their medications. This is something they did throughout 2025. And now that's starting to hit earnings.
Jef Akst: would they really though? because the idea is you charge less, you sell more of it. so it's hard to tell whether they would actually have made less. they would not have sold as much as they did probably if prices hadn't started to come down.
Annalee: Yeah, absolutely, and they did sell more. That volume play is starting to show in earnings. But had they been charging $1,000 a month for the products, they certainly would have made more money.
Jef Akst: Yeah, but is that possible? Can you reach that volume at that sale price and you just can't because people can't afford that.
Annalee: Right, right, you can't. So we also got initial details from Lilly's launch of Foundao, their oral obesity asset, which just hit the market in There's been kind of some mixed messaging on how many people are taking this drug, how many have switched or started taking it anew. Lilly was able to give some numbers in terms of scripts. They say that scripts have been written so far, which is a lot. ⁓ We didn't get revenue numbers on that. We probably won't until the second quarter, but that seemed to, again, please the analysts who are desperate for any information there.
Jef Akst: We'll have to wait and see what those advertisements look like when they do come out.
Heather: Thank
Annalee: Yeah, no kidding. And what was kind of funny is that Lily said that they really have not done like a full court press advertise Foundeo yet. They're kind of starting with physicians, increasing familiarity to sure that everybody knows the product in the care And then they're gonna start doing those ads. So those are definitely coming to a TV near you at some point.
Heather: I saw a Zeph Bound on the Blue Jays mound the other day. So that was exciting. I even messaged him the group. was like, guess that bounds on the mound. And then Jeff asked me the guy's name is Zeph Bound. So then I had to explain. Yeah, they have these ads, they hover over the mound and then they change every inning.
Jef Akst: I didn't wonder. That's what limited knowledge of baseball I have.
Annalee: And you know. Yeah, and over on the NHL, which of course I've been watching the Stanley Cup Playoffs, it's all Wigoby all the time.
Heather: Yeah.
Jef Akst: I saw a ton of ad b advertisements at Wrigley Field this past weekend, so that caught my eye.
Heather: ⁓ yeah, I would.
Annalee: We should do like a listicle article of the sports and their primary drug that is being advertised.
Jef Akst: You
Heather: Oh, I would love to do that. I mean, they each have their own weight loss drug, I guess, but.
Annalee: Yeah. Getting back to Lily earnings, just to wrap things up, Lily has been of the most exciting companies every single earnings period. What's been really big this past quarter, which I'm sure we'll hear about ⁓ earnings period, ⁓ that Lily has been on an absolute ⁓ &A blitz. We had an analysis on this in BioFrame executive last week, but of course you can still check that out at Biospace. Lily has spent $21 billion this year already. tying their 2023 record in terms of the most transactions, which with six and it's only the second quarter. So I hope, you know, I can only imagine we're going to be continuing to have Lily at the top of our website for the rest of the year.
Heather: like that though, if you're going to make a lot of money, spend a lot of money putting it back into research for other diseases. I really like that with Lily. ⁓ Well, we covered Amgen last week and they about their upcoming, of course, obesity drug, Maritide. And Annaleigh, you what you love to call modernings. So you can check out all those stories at Biospace.
Annalee: Yep, that's the goal. That's what we're all here for.
Heather: We will of course be covering Lily's chief rival, Novo Nordisk, on Wednesday morning as the obesity beat continues. I'm looking forward to Sarepta earnings tomorrow, which has a big rest of the year ahead with a study testing their immunosuppressive regimen, sirelimus, during treatment with their gene therapy, alevitis, in patients with who unable to walk. And one analyst I spoke to for a biotech earnings preview piece that's out this morning, Tuesday as we record, he said that a return for alevitis in this patient population could potentially double its revenue.
Jef Akst: I too am curious to see where Sarepta goes. We covered them a lot last year with all the drama last summer and there was a lot of question about whether the company would even survive. So yes, let's see what they have to say tomorrow.
Annalee: Not to mention they're doing a hunt for a new CEO. So I wonder if we'll hear anything else on their earnings call.
Heather: Yeah, but that'll definitely be a question. as usual, ⁓ regulatory space has not disappointed for news this past week. We were all gearing up to find out who would replace Banai Prasad at CBER. ⁓ then we got another interim director. That seems to be a kind of a common theme ⁓ within ⁓ lately. that new CBER director is Catherine Zerama. ⁓
Jef Akst: Yeah, that's right. So we've had so much turnover at these high level positions and they don't always have somebody lined up right away. So that seems to be the case here. They've put in Zorama as we await an announcement on who the permanent CBER director will be following Prasad. There ⁓ been a great reception to this. I think just the fact that she's only an acting director and we don't have a person the position just yet is a concern among industry watchers. People are also concerned about Zahrama herself. She was handpicked by Prasad to be his deputy last December. And as Capital Alpha Mark Partners analyst said, she and others that Prasad hired likely share his views. She does have some government experience. but she lacks the clinical experience and depth of background for a more typical FDA director as Capital Alpha. ⁓ We'll see the next month or two holds. We're hoping to get a permanent director at some point pretty soon. But at this point, it really does seem like regulatory uncertainty will remain an overhang for the industry. Capital Alpha did say that perhaps we'll see less drama with Prasad gone, maybe less, quote, personnel angst, which would be good for the remaining FDA staffers. But all in all, they definitely agree that, you know, a lot of questions remain about how CBER will be run. who will run it and if they'll be able to restore public trust and industry trust in the agency. And then again, I will just add too, as we started at the top of the section, there's such a high level of turnover at this position. Zorama is the fifth person to lead CBER since the beginning of the year. And that was back when we still had Peter Marks in the position and the industry was hopeful that he would be sticking around.
Annalee: Yeah, and it's not just CBER, there's been so much turnover across HHS.
Jef Akst: Yeah, mean, Cedar and the entire CDC have each had five or more leaders at the helm in the span of less than 18 months. It's just an insane amount of turnover and the industry is really clamoring for stability.
Heather: I know Jeff you said since the beginning of this year, obviously since the beginning of 2025, but it does all seem like it's been one year, doesn't it? One big long year. Well, another thing that happened at the FDA this week, they held their first advisory committee meeting in nine months. This was for a couple of AstraZeneca cancer drugs.
Jef Akst: Yes, thank you. Yes, yeah, you're right. So the beginning of 2025 when Trump took office.
Heather: And I spoke with chief medical officer at Precision for Medicine and also former oncology regulator, Harpreet Singh. And she said that this was missing the PES-DUR moment. So quote PES-DUR moment. And this is obviously Rick PES-DUR, the longtime oncology stalwart leader left the cancer leadership position to head up Cedar and he was one of those five Cedar last year and then he ultimately retired.
Jef Akst: ⁓ how that AstraZeneca adcom go?
Heather: ⁓ Yeah. So, so said it really would have worked as more of a conceptual discussion. So the way ⁓ this was due to AstraZeneca design, at least for the first drug that they discussed in the morning, ⁓ the oral third chemisestrant. And so the way that the was set up. patients with HER2-negative advanced breast cancer switch treatments at the point where a mutation was detected, as opposed to the current practice of changing regimens upon disease progression. this made it a bit challenging to determine the benefit of Astra's drug.
Jef Akst: Well, I guess now we wait and see if the FDA listens to the ICOM and what the outcome is for these two decisions.
Heather: Thank
Annalee: I do hope that this is issue that they take up. Like this is the kind of stuff that the FDA is so good at, is like coming up with these treatment paradigms that can really change how companies develop their drugs. So I hope that this is an issue that kind of gets debated and maybe we'll see some guidance on it at some point.
Heather: Mm-hmm. Yeah, she was, uh, Harpreet was even suggesting that there be more of these conceptual type, type outcomes where, where they do have these kinds of debates. Um, but ultimately it was a negative vote for chemist's assurance. So we'll, we'll see what happens.
Jef Akst: Yeah, having its first adcom in nine months is certainly a step in the right direction, but I do know, and Heather, you can speak to this more, we're still having transparency issues at HHS.
Heather: Thanks. Yeah, I think this might be about the third editorial that we at MedsBiospace have written checking up on health secretary R.K. Jr.' pledge that he made last year during his congressional hearings to prioritize, quote, radical transparency the health department. And because the most one ⁓ was driven a couple of recent incidents where the FDA and CDC don't appear to be taking this to heart.
Jef Akst: Yeah, what were the two that you focused on?
Heather: Yeah, well, the first, and this is one that I think is the most egregious, was the FDA's decision a couple of weeks ago to not disclose the names of its most recent commissioners national priority venture recipients. This for the psychedelics companies. And then the second was the CDC's, or more specifically, J. Bhattacharya's ⁓ decision not to publish a CDC-partnered study that was investigating the efficacy of the COVID-19 vaccine. ⁓ in hospitalization. ⁓
Jef Akst: Yeah, I guess he had some concerns over the methodology and said that this was normal protocol, but we don't know if we will ever. I mean, the study was published elsewhere online and so that it has the light of day.
Heather: Yeah. Yeah. You know, he was mentioning, you know, that rigor is important and that he had issues with the methodology. And that's totally understandable. But I can kind of see just from, you know, kind of the past 18 months why ⁓ would be a little concerned that this might be a type of censorship. ⁓
Jef Akst: Yeah, I feel like it's a perception issue as much as anything else. know, and in journalism, we talk all the time about conflicts of interest, and it's not just actual conflicts of interest. It's perceived conflicts of interest. You've got to disclose those because if people feel like you're pulling the wool over their eyes, there's going to be a trust problem there. And we know that FDA has a trust problem at this point. So even if there are justifiable reasons for some of these actions, which I'm with you, Heather, I can't really understand why they wouldn't have disclosed the name of the psychedelics makers. But even if there are reasons to not disclose what those reasons are and just to refuse to give us the information,
Heather: Yeah.
Jef Akst: It does not look, it's not a good look, especially when you're preaching radical transparency.
Annalee: I still go back to when McCary said that the whole reason or Prasad leaving was like always the plan. I just like feel like that was another breach of transparency. It's like, what do you mean? That was the plan all along. And then you just suddenly announced his departure. Like that kind of shook the industry.
Jef Akst: Absolutely.
Heather: in March, about a month and a half before his actual departure. So that would have been something good to know right at the beginning, but maybe they didn't because people wouldn't have listened to Prasad if they knew he was only temper. I mean, there are lots of reasons that you can choose to do things, but it just, it's not a good book. Yeah.
Jef Akst: Right. Yeah, you need to share what those reasons are if you want to rebuild trust. Well, maybe we turn to a more positive story to end this podcast. Heather, I know you've got kind of a hopeful story this week.
Heather: Yeah, well, I actually got to speak with a couple of executives from Curalis, which is an awesome name, by the way. ⁓ pronounced Curalis, but they're trying to cure ALS, which think is really cool. And I've liked their CEO, ⁓ Caspar Ruett, for a while. And I was like, yeah, I really wanted to do something good. So on Tuesday, they did. They presented ⁓ data at Target ALS. showing that their antisense drug, is dubbed QRL-201, led to up to a 50 % decrease in disease progression on a gold standard scale for ALS physical decline. The drug hit on key biomarkers, including neurofilament light and phosphorylated neurofilament heavy chain. Both of these are key markers of axonal damage.
Jef Akst: what did the CEO have to say?
Heather: Yeah, so Casper, I'll call him Casper because I don't quite know how to pronounce his last name, but he feels very strongly that targeting a genetic cause of ALS is or genetic contributor is the way forward. QRL 201 is intended to restore the expression of the staphin 2 protein. And that's a well-known, it's well known for neural repair and axonal stability. And it's also well known to be downregulated in nearly all people with ALS. So he also spoke a lot about biogens, calcoti, which was approved in 2023. That's also an A, and also an ASO. And it, it was one of the only bright spots in the ALS space recently. Although that is starting to change.
Jef Akst: Yeah, actually there was also Corsept that had some new results for us recently. A little bit of a mixed results, but still some positive news in there. So Corsept has, it's not a genetic drug, it's a cortisol modulator. I'm not even gonna try to pronounce it, but they had a followup extension to their phase two study where the phase two study itself missed its primary endpoint and did not show a significant effect on motor skills or other functional criteria. But the investigators noticed a survival signal there and there was a... less risk of death in the treatment arm versus the placebo arm. that survival has persisted through one year. They saw an even stronger survival signal. And now we're at two years out with an 87 % reduced risk of death on this drug. So the company is moving on to phase three. Very positive news for the ALL to have a few eggs in the basket this point. We all know this has been a terribly devastating disease with huge unmet need and very, very little luck from. the biotech side trying to treat this disease. So none of these are at market's door just yet, but good to have a little bit of positive momentum in this space.
Heather: and both are moving on to phase three and yeah, it's to see momentum in ALS. It's a really devastating disease. So, Annalee, biopharma exec, ⁓ out Wednesday, morning, as you're listening to this. What do we have on this week?
Annalee: have a really fun piece from my Salt Lake City trip where I to actually sit down with biotech founders and talk about the challenges of being a founder today. So you will to hear their stories, how they got their first checks and kind of how they're the advice that they're taking to ride out the bumps in the biotech markets right now. So just a really fun piece. ⁓ It's hopeful, I So you can check out in Biofarm. ⁓
Heather: Great, well happy to end on a hopeful note. will see you all next week and until then enjoy spring! Hi, welcome to Biospaces the Weekly. Q1 earnings continue to roll in from big pharmas like Eli, Lily, and Amgen, and smaller biotechs like Sarepta and Amelix, which both have key catalysts ahead this year. The FDA named an interim CBER director last week as Vinay Prasad's tumultuous tenure finally came to a close. Meanwhile, the agency held its first advisory committee meeting in nine months, and it was missing the, quote, PES-doer moment. And the ALS R &D space is experiencing somewhat of a renaissance as two companies, Curalis and Corecept, report positive results for their mid-stage candidates. Let's dive in.
