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I hope they will break down royalties by product but they probably won't. The big question is how reliant we are now on SC Darzalex and wether it was enough to keep overall royalties growing significantly in Q1. Also, how soon we will have more products approved? So news about the phase 3 trials will be important too. If Genmab is right, the rest of the year should be very strong for Darzalex FasPro so I expect guidance to be confirmed if not raised.
Estimated study start date is June 1, two of the other 3 have estimated start dates in April so I'm not sure about the agreements but Halo may not have gotten any milestone payments except for the trial in myasthenia gravis. If not in Q1, of course it should be in Q2.
Perhaps there were other trial starts that we are not aware of and hopefully Helen will say that more phase 3 trial starts are imminent.
As biotechinvestor1 pointed out, those estimates were for royalties only. According to yahoo finance, average revenue estimates are $84.88M. But obviously it's crucial that royalties keep going up. I am a little nervous. Not sure what expectations are, but I would think $35M or below will be disappointing. Also, with the XBI dropping from about $175 in February to below $125, it's concerning that the whole sector is so out of favor.
I have kind of lost hope for new deals but perhaps we will soon have some positive news on progress in the clinic with existing partners.
If Genmab expects around 50% of global Darzalex sales will be SC in 2021, conversion to SC will increase probably to at least 70% in 2022 so royalties to Halo can probably grow 40% or more next year. My concern is about 2023 when Darzalex revenue growth will most likely slow down.
Well, if they are not declining you may be right with your $40M estimate. Even with Darzalex royalties at @21M, then total royalties should be at least $37M.
Also, it's quite possible that royalties excluding Darzalex are declining, except for Phesgo but that should be only $1.5M, not enough to offset the likely decline of SC Herceptin and SC Mabthera. We'll know soon. But that's assuming $21M in royalties as per GMAB's comment. Before their earnings call, I was expecting about $30M from Darzalex + $10M from the rest.
Well, before the GMAB's call I was expecting somewhere between $35M and $50M. It's that 64M dkk comment that is concerning to me. It may be a mistake.
I just doubled 450M DKK, which is what GMAB's management estimates to be the "headwind" or "impact" of JNJ making them pay 1/2 of the royalties due to Halozyme. Today google tells me that 450M dkk is approximately $$72.9M so Genmab estimates that Halo's royalties just from Darzalex will be around $145.8M for 2021. My guess is that they are being conservative so they probably expect them to be about $150M, perhaps a bit more.
I am a little concerned about their 64M dkk ($10.37M) "impact" for Q1, which would mean halozyme royalties would be around $20.7M. I am not sure if SC Herceptin and SC Mabthera sales are dropping as much as the IV formulations but I am afraid we cannot count on $16M of royalties excluding Darzalex. Maybe when/if Phesgo sales accelerate, we will get there but for now I'm expecting about $12M so if I am right, royalties will be under $35M for Q1, which would not be a blowout quarter. I hope I am wrong or Genmab is wrong about the 64M dkk. Perhaps there are still many countries where Darzalex FasPro has not been approved yet or it's not on the formulary, etc.
The good news is that Genmab expects the "impact" to accelerate to an average of 128M dkk (450-64=386) so average royalties to Halo for the next 3 quarters would be over $41M.
I was hoping the conversion rate in US would be even higher (50% at the beginning of the year and 60% now probably means Q1 average was 55%) but I am pleasantly surprised that it is 90% in some "nordic" countries in Europe. I am assuming Scandinavia is leading the way in being efficient and sensible. It is disappointing that, presumably, bureaucracy and financial incentives are slowing down adoption of Darzalex FasPro in several countries. Especially during a pandemic, it really makes no sense and it is unethical to use the IV formulation imo unless there are really strong reasons not to, perhaps when the patient is too underweight or is terrified of SC injections. But that shouldn't be much more than 10%.
From GMAB's Q1 earnings call transcript:
"Our first question comes from Wimal Kapadia from Bernstein. Please go ahead.
Wimal Kapadia
Great. Thank you very much for taking my question. I'm Wimal Kapadia from Bernstein. So just a first one a bit of clarity please, on the Halozyme royalty impact. I see a DKK 64 million impact on 1Q. But can you just confirm what percentage of your sales in the quarter came from the SubQ? And how do we think about -- how does Genmab think about that number by the end of the year? And what do you think will be a steady state?...
Anthony Pagano
Great. Thanks, Jan and Wimal. First of all, I certainly appreciate that you want to fine-tune your models and I'll try to be how helpful as I can, but I think you can also appreciate. I really can't comment on the specific royalty that J&J is paying to Halozyme. That's really a relationship between the two of them. But maybe I'll try to walk you through some additional pieces of information and we can hopefully still be helpful.
So overall, the key message I want to leave you with here today is that the guidance that we gave on this back in February, remains intact. And here what I said was that the full year impact would be around DKK 450 million. For Q1, the headwind was DKK 64 million. For 2021, we expect more than 50% of global DARZALEX sales will be SubQ.
So far what we've seen is a rapid uptake of the SubQ in the US and in other parts of the world. To provide a little bit more context in the US market, where we have the best visibility to some data, currently SubQ accounts for around 60% of DARZALEX gross sales according to IMS and this compares to give you a sense to around 50% at the beginning of the year. And as a reminder, we do have limited access to timely info in terms of splits of sales between IV and SubQ in markets outside the US.
I think to get to the other part of your question, if we step back for a moment, we continue to believe the overall growth profile for dara, including the SubQ version, is exceptional. And we expect the trend towards strong SubQ conversion will continue. So, hopefully that gives you some context now in terms of where we're headed for the balance of the year and where we landed in Q1." ....
Anthony Pagano
Sure. Thanks, Jan. And yes Trung, I'd try to be helpful here. Again, I do appreciate similar to I said to the malls like you want to find your models but again just -- I'll talk you through the way I kind of think about this. It starts with that. We certainly expect the trend towards strong SubQ conversion will continue to update about the specific metrics in the US. And again here's where we actually have acts to really what we think is good data by IMS on a real-time basis. For Rest of the World, I mean we really don't have access to the same quality of information. I guess what I can say and this is I think reiterating what I said probably in the Q4 call in certain markets following the reimbursement, it almost becomes a little bit binary, not where it goes from 0 to 100, but zero to a very high number rather quickly. Again, this is on a market-by-market basis. So it comes down to the individual markets in terms of any particular market dynamics there for a particular market or country and also a function of reimbursement approval as well. So from -- probably where I got a little bit, but ultimately to conclude here we see the overall trend towards SubQ adoption to continue.
Jan van de Winkel
Thanks, Anthony. And I can probably share with you Trung that in some countries there's over 90% usage already of SubQ dara like some of the Nordic countries and some other European countries very large countries. And other countries it's closer to 30%, but building up rapidly. And I think Janssen can give you further color on that. We are not allowed to share anything further. But I think it's very, very rapidly progressing towards SubQ now in Europe."
If Gmab is paying for 1/2 of Halozyme's royalties and we double DKK 64 million for Q1 and DKK 450 million for 2021, this suggests royalties to Halo should be approximately $20M for Q1 and $144M for 2021. Their estimates are probably conservative. As more and more data come in, we should be able to figure out at some point if Halo's royalties are 4% or 5%.
Darzalex FasPro is 60% of Darzalex sales in US now (or in Q1, not sure), it was 50% in January (I think that's what they just said on the GMAB earnings call. They expect the conversion to SC to continue to grow everywhere. I was expecting it might be even a little bit higher but 60% is still excellent, higher than Herceptin's ever reached anywhere and it's less than a year from approval.
They also just said conversion in some nordic European countries is 90%!
Well, I meant analyst upgrades for GMAB not Halo and more specifically revised peak sales estimates for Darzalex, which should help Halo indirectly.
I think the combination of Opdivo with relatlimab could be a good Enhanze product. The question is, how long will it take to get it approved?
It's really all about Darzalex FasPro for now. On their May 5 earnings call, GMAB's management may say something about the conversion rate. That and maybe some analysts raising their peak sales estimates for Darzalex may take us to new highs. What we need is $10B peak sales estimates and 80% conversion to SC formulation at some point, and relatively soon. But I don't expect a huge rally until we get more visibility into the phase 3 trials.
I wonder if SC Opdivo was mentioned on the BMY earnings call. Unfortunately, sales were down 3%.
Staring at a down quarter for Opdivo, Bristol Myers keeps its eyes on price competition potential in packed PD-1 market
Kyle Blankenship
Managing Editor
Despite its standing as one of the bestselling anti-PD-1s, Bristol Myers Squibb can ill afford a down quarter for its leading I/O amid a packed — and growing — class. With Covid-19 already nipping at sales, the drugmaker is also keeping close watch for a potential discounted disrupter in the PD-1 class, which could come sooner rather than later.
Bristol Myers’ anti-PD-1 Opdivo posted disappointing sales for Opdivo in the first quarter, down 3% from the same time period last year at $1.72 billion, according to earnings released Thursday.
The drugmaker tied that dip to Covid-19 disruptions at infusion centers and believes the drug will turn it around for the rest of the year, executives told analysts on a Thursday call. However, Opdivo’s poor performance stands in contrast to Merck’s market-leading Keytruda, which posted 19% growth on the quarter to a whopping $3.9 billion.
Opdivo’s stumble comes as the anti-PD-1 market welcomes its seventh entrant — GlaxoSmithKline’s Jemperli — and casts into stark relief a lack of price competition in that class. Earlier this month, Bernstein analyst Ronny Gal issued an open letter to Regeneron CEO Len Schleifer calling on the drugmaker to be the first drug in the class to jumpstart a discounting strategy for Libtayo. His argument goes like this:
While some of your peers may not be too happy with your strategy at first, you will be doing the industry a favor. The strongest argument in favor of government intervention in drug pricing is that market forces are failing. There are now six approved PD-1s [seven with Jemperli], none have done a head-to-head trial, and they are all raising prices every year. The best thing you can do for the industry is to demonstrate that market forces work. This is an opportunity for Regeneron to truly lead in pharma as the company has historically led biotech.
Chris Boerner
Analysts quizzed Bristol Myers CFO Chris Boerner on the possibility of any one of Opdivo’s anti-PD-(L)1 competitors — and even more are on the way — taking a discounting path, which if Gal is correct could steal some market share away from the bigger competitors. His response? We’re going to keep churning out data and approvals and see what happens.
“While we’re always a bit paranoid about new entrants, we have a good position to manage competition,” Boerner said. “In terms of risk, we absolutely think it’s something we need to stay on top of. The areas where we see the greatest risk don’t overlap with our biggest markets, at least today … (but) this is an area that’s very dynamic, and we’re paying very close attention to it.”
With hopes that Opdivo will make a turnaround, Bristol Myers spent much of the call fielding questions on relatlimab, the drugmaker’s LAG-3 molecule being tested alongside Opdivo in first-line melanoma. You’ll remember the drugmaker read out topline data from that combo in March showing significant benefit over Opdivo alone in the Phase III RELATIVITY-047 trial.
Bristol Myers is gearing up to reveal more data from that study at this year’s ASCO, and it clearly has high hopes for the drug, mostly as a combo therapy with Opdivo. The drugmaker will need it, too, as a series of patent cliffs in 2025 puts a big burden on the strength of the drugmaker’s pipeline.
Facing those cliffs, CEO Giovanni Caforio hinted that M&A will be a big part of Bristol Myers’ strategy moving forward, despite some unknowns around a suddenly steely FTC.
“It’s really difficult to speculate at this point what the evolving position of the FTC will be,” Caforio told analysts. “I feel there are plenty of opportunities to strengthen our portfolio across all of the areas in our portfolio where we have expertise.”
Bristol Myers posted $11.1 billion in sales on the quarter, a 3% increase from the same time period last year.
Biosimilars affect total sales whether it's IV or SC. Although sales have been dropping in the last couple of years, my point is that Herceptin and Mabthera have been huge blockbuster drugs in spite of biosimilars and Enhanze royalties have been modest. Doctors and patients have generally chosen to use the IV formulation. It's that simple. And insurance companies have been paying for the IV formulation even though administering the Enhanze formulation is more cost-effective. Blaming biosimilars makes no sense.
"The fact is that many IV drugs are not necessarily going to switch to subcu."
Agreed. Or, even if an Enhanze formulation is developed, the conversion rate is likely to be low.
This is essentially the crux of the matter. In general, the conversion rate to SC is going to be directly proportional to the reduction in administration time. So, unless Halo gets another Enhanze product where the reduction is as dramatic as that with Darzalex FasPro, it needs many new products to compensate for the lower conversion rate even if those drugs have huge sales with their IV formulations. Good examples are Herceptin and Mabthera, which I believe had combined yearly sales between $12B and $14B in 2018 and 2019, and yet Halo's quarterly royalties peaked at around $20M. I believe the Enhanze formulations were approved in 2013 and 2014 in Europe, Mabthera (Jun 2017) and Herceptin (Feb 2019) in US.
I am not a scientist and I am really not sure. But it appears that there are a number of factors at play:
1. Several companies, sometimes even Halo's partners (Roche, Alexion, probably others too), seem to be able to develop their own SC formulations.
2. My understanding is that Halo's partners get exclusive access to Enhanze for any product with a specific target. For instance, "The agreement provides argenx exclusive access to ENHANZE® for any product targeting the human neonatal Fc receptor FcRn, including argenx's lead asset efgartigimod (ARGX-113)". It's conceivable that some companies are mostly interested in preventing competitors from developing SC formulations with Enhanze in a specific target (perhaps Pfizer and Abbvie) and more inclined to push their IV formulations than sharing revenues with Halo (perhaps Roche with Herceptin and Mabthera).
3. I think doctors and hospitals have financial incentives to use IV formulations rather than SC formulations.
It seems the stars have perfectly aligned for Halo with Darzalex FasPro. Janssen probably used Enhanze to prevent competitors from using it to develop SC formulations targeting the CD 38 protein but the benefits are so dramatic that they also help fend off competing drugs so it would make no sense for Janssen to push their IV formulation of Darzalex. The huge shortening of the drug administration time also make it impossible for doctors and hospitals not to offer it to patients. The icing on the cake for Janssen (and Halo) is that for now Janssen is sharing with Genmab the cost of Halo's royalties.
This is as good as it gets and I fear it won't happen again. The best I am able to hope for is that we have 5 or 6 products in phase 3 trials by the end of the year, 2 or 3 new products approved by the end of 2023 and 2 more by the end of 2025. This could mean $600M in royalties plus perhaps $100M in milestone payments per year by then. If this becomes likely, will PPS get to $100 within a year or so? Maybe. The other wild card of course is the potential of an acquisition. It's really hard to predict whether that will help or hurt the stock.
$100 PPS would mean a market cap of over $14B, perhaps more. I am not sure about the share count.
I think it's reachable only if we get more visibility and less uncertainty as to how sustainable their business is. New partnerships are certainly possible and would of course help but it's hard to say how likely they are since they've only entered into two new partnerships since Dec 2017.
Also, new partnerships are no guarantee of new products. The Pfizer (2012) and Abbvie (2015) partnerships have generated no products and as far as I know have nothing in the clinic, Lilly's (2015) and Alexion's (2017), I believe, each have one potential target still in phase 1 trials.
So, I think it's much more important to have more potential targets in phase 3 trials. We have only three out of ten partnerships. This makes me nervous. Hopefully, there will be a couple more this year and we get lucky with the bridge trial on the ARGX drug and that gets approved for myasthenia gravis in 2022. But we need more for the stock to get to $100. I doubt very much there will be another "Darzalex" for Halo. Phesgo - a good product with strong and clear benefits - is a good example of how slowly things normally move and how royalties usually ramp up. The first patient in the phase 3 trial was dosed around July 30, 2018 and Phesgo was approved on June 29, 2020. We will get about $1.5M in royalties for Q1 2021.
If Halo did not have Darzalex FasPro, I fear the PPS would probably be below $25, perhaps much lower, and that is concerning.
I agree and yet I am tempted to sell some shares. I have a ridiculously large position. What are you planning to do?
At 4% royalties, 60% conversion rate and $5.5B in sales for Darzalex, Halo would get around $130M for 2021, which may be barely enough to meet the guidance of approximately $180M from all products. Stock action suggests market thinks we will do better. I do think conversion rate should be around 80% by the end of the year.
If I am right and Darzalex sales are $7B next year, royalties will be $224M at 4% and $280M at 5%. I think this is what the market is excited about.
I wonder if we'll ever know if it's 4% or 5%. I certainly hope it's not lower than 4%. In any case, I am probably a little too optimistic (conversion could be 70% in US and 30% abroad when you take everything into account) but I will be surprised if royalties are below $35M.
So, Halo should get approximately $1.5M from Phesgo in Q1. With Herceptin and Mabthera sales plummeting, my guess is between $5M and 8M from them, then I think Darzalex FasPro may have captured 60% of $1,365M (I am assuming not every country outside of US has approved it, not yet on formulary, etc) so possibly between$32M and $40M (4% to 5% royalties on approximately $800M). This should exceed consensus estimates at least from last week. If we got $49.5M in royalties, it would be a blowout report. Perhaps I am being too optimistic on the 60%. We'll find out soon enough.
Well, the way I see it is that the good news is Darzalex is doing great, the bad news is that perhaps only Darzalex is doing great and we have a long way to go before other products get approved. But maybe Phesgo will do well too. Time will tell.
In the meantime, we have a shot at exceeding expectations and guidance with Darzalex alone. It looks like Darzalex will generate over $5B in revenues in 2021. If conversion is 80% (if the articles I read and posted are not fake news it seems possible and even likely), we should have between $160M and $200M in royalties from Darzalex FasPro alone depending on whether Halo's royalties are 4 or 5 percent.
"Darzalex sales beat ($1.365B vs. $1.273B Cons): Johnson & Johnson, Genmab's partner on Darzalex, reported earnings this morning. Worldwide Darzalex sales for 1Q21 were $1.365B ($691M U.S., $674M ROW), up from $1.253B in 4Q20. Genmab receives tiered global royalties of 12-20% from Johnson & Johnson on global sales of Darzalex. As a reminder, Darzalex is Genmab/J&J’s leading treatment for Multiple Myeloma. Full 1Q21 results will be available 5/5/21. We see net sales of $1.365B and a 7% beat as encouraging, especially during 1Q21 which typically seasonally weak."
Darzalex sales $1,365M and they probably said something about Darzalex FasPro on their call. i haven't listened to it yet.
https://www.loncarblog.com/darzalex-quarterly-sales
Positive news on Tepezza and Opdivo today.
We've outperformed IBB and XBI lately. This run up is probably due to Darzalex FasPro doing exceptionally well. We'll probably learn something about that from JNJ on 4/20. I hope it's also something else. It would be great to learn of progress in the phase 3 trials especially and/or sign a new deal since we've only had two new collaborations since the one with ALXN in Dec 2017.
I am not positive but I think Regeneron developed the SC formulation and Roche is helping with the manufacturing.
But Halozyme is not an investment manager. It's a very competitive field and they will probably make an acquisition that may or may not work. Anyway, it's a mixed bag.
In terms of what will move the stock in the near term, it's more important to monitor how well Darzalex Faspro and Phesgo are doing (JNJ and Roche may soon provide some useful information on their earnings calls) and progress in the phase 3 trials. Halo needs to prove that it is a sustainable and high growth business beyond Darzalex. This is the biggest issue imo.
I'm guessing it'll be another 9 million shares. There is definitely going to be quite a bit of dilution, which for a company that is already profitable and, as far as I know, management without a proven track record in M & A is a questionable move that makes me nervous.
On the other hand, I have to assume that the investors who bought the convertible expect the stock to appreciate more than 10% per year from the $77 conversion price, so at least $150 by 2027. Given the current market conditions for the sector, it doesn't seem to be a terrible deal for Halo and I am not too concerned about it at this point except for a potential acquisition that may raise doubts about management's confidence in Enhanze and that the market may not appreciate.
You should take a look at the convertible NVTA just issued. Perhaps I am missing some important details but it appears that Halo was able to get better terms. It's not an identical situation but similar. NVTA raised $1.2B. Their market cap now is about $8B, strong revenue growth and good prospects, though not profitable yet. It doesn't sound like they'll use the funds for stock buybacks and they announced an acquisition the same day of the issue, all of which I would've preferred to see with Halo but perhaps we've been too negative on this.
I am more concerned about the lack of new deals, especially large deals since the BMY agreement (9/2017), the uncertainty about when we will get new Enhanze products, etc.
I think there is an interesting battle between bulls and bears with reasonably good arguments on both sides imho. The real question regarding the convertible issue is whether it reveals lack of confidence in their current business model. In other words, if you are confident in your technology and that you are going to have $1B in royalties in 2027 and beyond plus hundreds of millions of dollars in milestone payments per year, why in the world would you consider an acquisition, feel the need of $800M in debt and want overhang at $77 for you stock? Do you fear that your prospects will dim considerably after Darzalex? Also, there is uncertainty with Darzalex as well. Competition is heating up. Sanofi's Sarclisa was just approved for a second indication in multiple myeloma yesterday. Other drugs that will compete with Darzalex have recently been approved. Morgan Stanley estimates peak sales of $9.1 in 2025. Will they be right? How quickly will sales drop after that? Will the next Enhanze products be even remotely as successful as Darzalex Faspro? Their benefits won't be as dramatic so there are good reasons to expect that they won't be.
On the other hand, there are good reasons to believe Darzalex Faspro may beat expectations and be approved for more indications (a long shot but perhaps even Alzheimer) and we finally have 3 products in phase 3 trials. I checked a presentation from Aug 2020 where 3 phase trial starts were expected in 2020.
"What is your experience with the subcutaneous formulation of daratumumab (Darzalex Faspro)?
I would just say from our experience that we’ve done tons of daratumumab subcutaneously. It’s the rare time where you are better in safety—less than 10% infusion-related reaction; comparable efficacy; markedly more convenient, 3 to 5 minutes. Patients love it, nurses love it, pharmacists love it. It’s going to be a slam dunk, and in the era of COVID-19 particularly, people can act faster. I think it will save everybody a lot of time and hassle."
https://www.targetedonc.com/view/combination-regimens-show-different-levels-of-efficacy-for-patients-with-myeloma-ineligible-for-transplant
"When you use daratumumab up front, are you giving patients subcutaneous daratumumab (Darzalex Faspro) or the intravenous (IV) regimen?
Subcutaneous daratumumab is not approved in the frontline setting for the patients who are transplant eligible. The regimens approved in the frontline setting for subcutaneous daratumumab are the transplant-ineligible regimens DRd [daratumumab, lenalidomide, dexamethasone] and daratumumab VMp [bortezomib, melphalan, prednisone] and in the relapse setting with DVd [daratumumab, bortezomib, dexamethasone] and daratumumab/pomalidomide [Pomalyst]/dexamethasone; so, not specifically for this transplant-eligible patient. Nevertheless, when you use daratumumab monotherapy, from a practical perspective, it is almost impossible for our pharmacy to change from giving subcutaneous for some and IV for the others.
We made a change, going completely from IV to subcuta- neous in August, and we never had any insurance pushbacks. The treatment is tolerable. I’ll give you the examples—this is off-label use of data; this is not approved by the FDA, and the FDA-approved indications are the ones that I just discussed. But anybody that goes in for the subcutaneous formulation, the initial wait time, [after the drug is administered over 3 to 5 minutes, is] 3.5 hours after the first dose because that was the median time to infusion reaction in the COLUMBA study [NCT03277105]. If the patient does not have any infusion reactions, [then they are] discharged. From the next time onward, starting the next week, we [discharge] the patient 3 to 5 minutes after they receive the dose.
This is a practical consideration that led us to change, not based on the data. Subcutaneous daratumumab is well tolerated, with a minimal number of infusion reactions compared to the IV administration. The patient satisfaction questionnaires that we have done—these are unpublished data at this point, but what we see are significantly superior. We did not have a single patient of the 100 patients we converted wanting to go back to IV administration."
https://www.targetedonc.com/view/addition-of-daratumumab-to-3-agent-regimens-deepens-response-to-therapy-according-to-nooka
I am not clear what you mean. Do you think they are more focused on raising money for an acquisition and stock buybacks than on signing new deals?
It appears that Argenx has 6 phase 3 trials going or about to start for Efgartigimod PH20 with primary completion dates ranging between Sep 2021 to Oct 2026.
I like it. It shows they are serious about it and we have a decent shot at having this product approved in 2023 since 4 of the trials have primary completion dates in 2021 and 2022. Efgartigimod has not been approved yet but it will very likely be approved by Dec 2021.
I am very bullish on Darzalex Faspro and pretty bullish on Phesgo but I am also concerned about the following:
1. I agree that the convertible issue creates overhang and will be a positive only if they make a brilliant acquisition, which of course is no sure thing. The potential acquisition also makes me nervous because it makes you wonder, if Halo thinks Enhanze is so great and is not concerned about its patents' expiry, why do they want/need another platform/technology?
2. I am concerned our royalties are heavily reliant on Darzalex Faspro. Could it be 70%, perhaps even higher? Does anybody have an educated guess? In any case, any slowdown in Darzalex revenue growth could really hurt us unless Phesgo surpasses expectations and/or we sign several new deals, we have more phase 3 trial starts, etc.
3. When will we get a new product approved? Will it be close to Jan 2023 or closer to Dec 2025?
4. I believe Halo has signed only two new deals, with Horizon (Nov 2020) and with Argenx (Feb 2019) since the deals with ALXN and BMY in 2017. Why haven't there been more new collaborations?
They did not do well when there was no generic competition either.
I meant that the SC trial seems to be for just one indication.
In any case, I hope you are right. I thought SC Herceptin and Mabthera would do a lot better but Halo's royalties peaked around $20M per quarter when Herceptin and Mabthera were having sales between $12B and 14B in 2017 and 2018. Their Enhanze formulations had more meaningful benefits in terms of reducing time in the infusion room. Why do you think SC Opdivo will do better?
The phase 3 trial start is great but I think this is for just one indication and the opdivo infusion is 30 or 60 minutes so the benefits of a SC formulation won't be nearly as impressive as with SC Darzalex or Phesgo. Hopefully, BMY will do their best to use it to compete with Keytruda but, assuming it will be approved, I don't feel this will be a game changer for Halo.
Unfortunately, REGN chose not to partner with Halo. We do have competition, sometimes from companies that do their own SC formulations, including some of our own partners like Roche.
https://investor.regeneron.com/news-releases/news-release-details/phase-3-trial-shows-regen-covtm-casirivimab-imdevimab-antibody
A companion dose-ranging Phase 2 trial of 803 outpatient COVID-19 patients was conducted to evaluate the antiviral effect of several different REGEN-COV doses (IV: 2,400 mg, 1,200 mg, 600 mg and 300 mg; SC: 1,200 mg and 600 mg). All tested doses met the primary endpoint, rapidly and significantly reducing patients' viral load (log10 copies/mL) compared to placebo (p<0.001). Each dose demonstrated similar efficacy, including the lowest doses tested (IV: 300 mg; SC: 600 mg).
How do you invest in RA Capital? Are their funds open to private investors? Thanks.
Any good reasons PAND is trading above $60, the buyout price per share Merck has agreed to pay? Is this one more example of irrational exuberance?
Good find. Thanks and I hope you are right that approvals will come faster.
Immunogenicity of Protein-based Therapeutics
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Principal Investigator: Zuben E. Sauna, PhD
Office / Division / Lab: OTAT / DPPT / HB
General Overview
A major problem with protein-based therapeutics is their immunogenicity, that is, their tendency to trigger an unwanted immune response against themselves. One form of immune response is activation of B cells, which produce antibodies that bind to the proteins and reduce or eliminate their therapeutic effects. Such antibodies can also cause complications that can be life-threatening. Therefore, a critical part of determining the clinical safety and efficacy of protein-based therapeutic products is measuring their tendency to trigger antibody formation.
https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/immunogenicity-protein-based-therapeutics
They are repurchasing the old notes so they will have less than $400M left for stock purchases and everything else. At least, that's how I understand it. I am also not so happy they had to issue 9.08 million shares but I guess that was part of the old deal.
In any case, all this borrowing in order to buy back stock and 'maybe' buy another company seems crazy to me. I suppose interest rates are going up so the timing may be good.
"In connection with the Note Repurchases, the Company expects to pay approximately $370.2 million in cash, which includes accrued interest, and issue approximately 9.08 million shares of its common stock, to settle such exchanges."
I am not an expert and may be paranoid but my impression is the stock was manipulated yesterday so that the old note holders could convert at $23.85 and sell their shares at $55.
"The Convertible Notes have an initial conversion rate of 41.9208 shares of the Company's common stock per $1,000 principal amount of Convertible Notes (which is equivalent to an initial conversion price of approximately $23.85 per share of the Company's common stock, representing an initial conversion premium of approximately 35.0% above the closing price of $17.67 per share of the Company's common stock on November 13, 2019)."