In the following podcast, which was recorded on August thirtieth, part of our discussion relates to the legal theory on which the Federal Trade Commission based its lawsuit to block the merger of Amjen and Horizon. After the episode was recorded, the FTC settled with Amgen and cleared the deal to close with conditions. But in addition to discussing that matter, our podcast touches on many other topics relevant to the pharma and biotech industries. So we've gone forward with its
release and help you enjoy listening. Well.
Hello and welcome to the Votes and Verdicts podcast hosted by Bloomberg Intelligence, the investment research platform of Bloomberg LP. In this podcast series, we talk about the intersection of business policy and law. My name is Jennifer Ree. I'm a senior analyst with Bloomberg Intelligence covering US antitrust litigation and policy. Now, our litigation and policy teams really cover
a very wide variety of topics. I'm the only one covering anti trust and so because of that, this is the second Boats and Verdicts podcast focused on anti trust issues. And in the first episode I had Bill Alsaied as my guest and we discuss the more aggressive approach just in general of this administration's Federal Trade Commission and the Anti Trust Division of the Department of Justice, mostly with
respect to assessing transactions. And this episode, what we're going to do is kind of follow that subject, but take a deeper and narrow or dive to focus on transactions and just the biotech and pharmaceutical and how the FTC's approach to those deals impacts the industry. I guess I can kind of call it biopharma to put those two together. I'm really excited to be joined by two guests for
this episode. First, we have Arma Orik, who is perfectly suited for this discussion and one of the smartest people I know. He's currently a partner at the law from Goodwin, where he's co chair of the firm's Anti trust and competition practice, and he's advised numerous biotech and pharma companies engaged in deals thinking about deals involved in anti trust issues.
Prior to joining Goodwin, Arman was part of the founding team of Biosplice Therapeutics, once known as Samamed, where he served as the chief legal officer and a member of the board. Now second from right here with me. Within Bloomberg Intelligence, we have Mark engels Jerd. He is our senior industry analyst for biotech, and prior to joining Bloomberg, Mark was the oncology practice lead for in Thought Research.
He has a degree in cellular and molectical biology as well as a doctorate in medicine from the University of California, so he really knows what he's talking about in this subject area. So before we jump into our anti trust topic, I really would be interested for both to hear about your career paths because they're both unusual. So arman, why
don't we start with you? I mean, as we were just saying, a long time ago, seems like one hundred years ago, we practiced at the same law firm, and then you jump sort of the law firm ship, even though you were a partner, to go help start a biotech firm, which is a really unusual move and risky too. So talk to us about what prompted that, what it was like to be part of a biotech startup, and which of your roles you've liked the most.
Thanks for having me, Jennifer. This is a great topic and I love being part of it, especially with Mark. Yeah, so it is an unusual move, and I think it's it's going to become relevant in our discussion today about anti trust issues. I did leave a law firm as an anti trust practitioner, something I had been doing for a while at the time, to go explore an oncology startup. And when you say I was a member of the
board and chief legal officer, it sounds so serious. In reality, the task included everything from running running to Costco to get supplies, all the way down to cleaning cages in the in the vibe aium. But that that's the nature of a startup. And really the point I'm trying to make here is that there's so much uncertainty and then
so much unknown in life science. Is when you start a project and and then there's a lot going on, and things change very rapidly as data comes in, whether it's a pre clinical data from a Petri dish or a or some from rodent studies or whatever, and and it's a it's a it's full of surprises, good and bad. Uh,
And and there's a lot to do. And in that you asked me what my favorite roles were, whether it ranged from doing actual legal work occasionally all the way down to on occasion running the chemistry team or or or regulatory and quality and UH and of course dealing with intellectual property issues. And it was a fascinating ride. And what prompted it was an interest in doing something interest thing, especially on the oncology side, at a time when it was possibly doable for anybody to jump into
the industry. The capital Marcus were very, very welcoming to a lot of different projects. So it was a once in a lifetime opportunity and I will never regret having taken it. It's been an amazing ride.
I mean, you had so much exposure to so many parts of the business. It just makes you so well suited to be dealing with this topic back in the anti trust world now. I mean it's really kind of an you kind of have an amazing resume and experience. So if I were a biotech firm, I'd want to hire you as my lawyer.
I would like to talk to more before I jump.
So, Mark, what about you? I mean, like your inequity analysis after getting a doctorate in medicine, and that's also kind of an unusual jump, So tell us about your career.
Yeah, so I did not always dream of being a biotech equity analyst. In fact, if you had asked me, you know, in high school or college what I was going to do, I was going to become a surgeon.
And I started kind of executing on that pathway. Went to medical school, matched at my top choice for a general surgery residency, and then it was at that point I had this sort of epiphany in my call room one night where I realized, I love you know, I like being in the operating room, but I don't actually love it enough to do ten more years of residency
and fellowship training and then go down this pathway. So I pivoted after my surgery internship and did a residency in anatomic pathology, which is a little more of a kind of behind the scenes consultative specialty. And I finished that, but I, you know, I didn't really see myself doing that over a multi decade career. So really, at that point, you know, after four years of medical school and ultimately four years of residency training, I decided to branch out.
And you know, perhaps at that point, which was an undisclosed number of years ago, that was a little bit of a atypical decision. I think it's becoming more common now for people, certainly people that pursue their PhD or even their medical degree to kind of leverage that background in a non traditional way. But you know, I always so at that point, I became very opportunistic in terms of how my career unfolded. I always kept one foot, so to speak, in the science kind of biomedical world.
But I spent some time at an early stage investing group that was helping to support drug and device startups. I then came to New York, spent some time on Wall Street as part of some more traditional cell side research shops, had a long run at in Thought, as you mentioned, which is a kind of boutique healthcare consultancy,
and then came to Bloomberg. And you know, from my perspective, it's I've never looked back, and because I'm sort of charged with keeping up to date with cutting edge drug development and biology and science and kind of helping to translate that for the investment community and other individuals. So you know, it's a lot of fun and and you know, I am enjoying it.
Yeah, it's interesting because it's like me, it's a much more of a research job, right than a hands on job, and even though way beyond anything that I've ever accomplished in my life, it's kind of my jump too, because I was, you know, a lawyer representing clients and I moved from that to doing the research side of Its really really interesting because you have to stay on top
of all the topics. You get to read about them all the time and sort of as an observer, and if you're interested in that kind of thing, it can be a really great job. But I'm clearly you listening to the two of you, I'm clearly talking to two people who are a lot smarter than.
I am, So I'm not sure about that.
As we go forward in this podcast, I'm going to let you guys do most of the talking. But you know, the interesting thing is that, well, I hope it's a good discussion because we all really think about this in a different way. I mean, right now, Armand's really grappling
with an aggressive and unpredictable FTC with his clients. I mean, he has to advise clients and he has to steer clients, and you're really thinking about it in terms of how does it impact the industry and how do you advise the people that read your material, and I'm trying to
predict things. I'm trying to look at deals like Biser, Siegan, Amgen in Horizon or anything else coming and trying to predict what's going to happen, mostly more for the merger art community, So we all come from a different approach.
I think it's best to start this by sort of laying the groundwork on the way the Federal Trade Comission, and I'm sticking with the FTC because it really it's the FTC that reviews pharma and biotech deals with the way for many years traditionally these kinds of deals were reviewed and the reason and how they got cleared. So Arman, you know you've done so many deals. Walk us through kind of what we think of as the traditional assessment for these sorts of deals.
Well, the traditional assessment, like in any other industry, is to look at the overlaps right between the whever the buyer company is and the target company and do a product by product, technology by technology analysis of how they may or may not be competing with each other. Typically, you start with commercial products and you go down the line and really the exercises to understand whether the transaction is going to result in what we anti trust lawyers
call one of two effects. One of them is coordinated effects, meaning with less competitors out there will there be pulling
off punches, less competitive rigor in the industry. And the other effect that the agencies typically look at is what is called the unilateral effects, which is whether the target and the buyer imposed on each other before the transaction a unique competitive constraint, whether they see each other as each other's closest competitors in any in any respect, and the elimination of that typically is problematic for the agencies.
And so you do you do a nose count, as it were, for the coordinated effects, how many players are there, et cetera, et cetera. If we go from five five to four players is not going to be a problem probably and uh, and it needs to be sorted out by the same token. Especially in life sciences, you want to look at whether the two companies are each other's very close competitors or a small set of competitors, and
elimination of that is going to be a problem. And in twenty nineteen is really the landmark year to look at these theories in play. That was IFDC that was led by Joe Simons, who was a legendary practitioner in the industry, and they looked at at the Allergan did a very similar approach there as they did in the BMS Celgen BMS celging transaction, both of which in both of which they found overlaps that needed to be resolved.
And these were actual competing assets. In the case of BMS and cell Gene, you had, ironically, you had an oncology our house acquiring a hematology powerhouse. Yet the overlap that they have DC identified happened to be in rheumatology, specifically the soriusis drug Tesla. It was pretty ironic. I think at the time most practitioners and and and the two of us might have had a conversation back then. I know I talked to a lot of people about that.
I was not at a law firm at the time, so I was a lot more free and what I could say and couldn't say. But it was a surprise that they found that overlap problematic. And NBMS had a pipeline asset that was very promising in soriasis in phase two, and Celgene owned a premo lasso tesla, which was which continues to be a relatively successful drug at least commercially clinically I don't know, but certainly certainly commercially and UH, and the agency was concerned that BMSS incentives UH to
continue developing Ducra was the name of the drug. I don't know, I can't remember the full name of it, but UH that there would be a problem there because Ducre was the promising next generation asset that was slated to compete against a primo last and they forced a divestiture. Very similar dynamics in the at V al organ transaction where they forced a the vesture of two assets where there were overlaps between av Aalergan I believe both for
both companies those were commercial products. In the contrast is helpful as well. Same year, same timeframe, UH, the agency
was reviewing Roach's acquisition of Spark UH. There were overlaps in the pipeline I believe for hemophilia gene therapy for hemophilia, and both companies had assets in clinical trials, and the agency reviewed that for a long time I believe, up to like a year, and finally let it go after deciding that determining that there were enough competitors in the pipeline to impose the kind of discipline, competitive discipline that
the agency likes to see. That's the traditional approach. So twenty nineteen it's the useful timeframe to go back to and look at what typically has been done. Of course, all of those investigations came with harsh criticism from other certain members of the Commission at the time who wanted the staff to do more and for the Commission to be more aggressive, and I think we're seeing those voices prevail in the current environment. Yeah.
I mean there were two Democrats on the Commission at that time, and they think for both of those matters that had the divestitures, they both dissented for various different reasons, but they were in the minority, so the deals got through with those settlements. I have a nice little chart and the article that you wrote that was really helpful also Arman about a year ago that walked through the Bristol Myers Squib deal and Happy Allergan, which I highly
recommend to anyone who hasn't read it. Right, So the interesting thing there is that, right, and that was great because really back when I was practicing, you know, if you had a farm a deal that came in front of you. It was kind of a no brainer because you just expected, well, let's just look, let's see where we have the overlaps and then figure out what we have to divest, and we'll go from there and we'll
get it cleared. And so there really weren't concerns. You knew it might take a little while, you might have to have a consent order, but it was pretty par for the course. You could predict what was going to happen. You could give some certainty to the clients. So we had this foreshadowing of what might come with those descents
in Bristol, Meyers celgene In at biel Agen too. And what has happened now that the Democrats have taken the majority at the FTC, so we're going to move into kind of the new approach that's happening now is that
they started really looking closely at pharma deals. And this started with the formation of a Multilateral Pharmaceutical Merger Task Force that was in twenty twenty one, and then there was the workshop in twenty twenty two, which was summarized about a year later in June of twenty twenty three, and there were a lot of concerns that were raised in out that came out of that workshop, concerned that pharmaceutical and biotech deals were killer acquisitions, deals that might
take potential competitors out of the market before they can compete, essentially, allegations that they're might be illegal bundling and tying practices that and also dampened innovation. And there were a lot of suggestions where made how to deal with this, and all of them were aimed at basically increasing anti drus
scrutiny of pharma and biotech deals. And these include things like looking at more at innovation effects just rather than the drug by drug overlap that Arma just described prior bad acts, applying a heightened level of scrutiny, applying a presumption of competitive harm to very big deals, and then putting the burden on the companies to show that there are efficiencies that weigh potential harm, a broader, stricter set
of remedies. That's kind of an example. And on top of all this, the agencies are right now proposing a new set of merger guidelines. The kind of the guidelines talk through how they're going to look at deals and how they're going to iness deals generally, not just pharma, all deals, and those guidelines really look like they're intended to increase scrutiny, increase deal challenges, and are designed to make it easier for the FTC and DJAT to succeed
in blocking deals. And they'll apply to pharma deals as well. So, you know, it remains to be seen what's going to happen, what's going to come out of all these initiatives, and whether it's really going to impose hurdles or not. But Mark, why don't you talk for a few minutes, since we see things are changing, we see it's going to get more difficult. We're going to talk about amten rise and
challenge in just a minute. What is the importance of M and A in the biotech sector and what might it mean for these companies if it gets a lot tougher to get even small deals over the line.
Yeah, for sure. I mean I can't stress this enough. I mean it, and you know I focus on biotech and pharma. I don't really have that level of detail of other sectors or other industries. But for biopharma, m and A is absolutely an accepted and expected component of the way that ecosystem, if you want to think of it that way, functions, and you know, it serves multiple purposes. You know, for larger diversified pharma in the case of Amgen,
you know, large cap biotech companies, it's a critical way. Yes, they have their own internal R and D capabilities and successes, but it's a critical way of sort of layering on additional sources of innovation and top line growth because a lot of these companies, especially when they get to a certain scale, you know, it's hard to kind of extract
additional revenue growth. And then of course, you know, the reality for the entire industry, which I think is probably somewhat different than others, has to do with you know, the ticking patent clock and the ticking sort of market exclusivity clock. So there's a constant you know, not only the science continuing to evolve, but there's a constant need to sort of refresh if your Amgen or Pfizer or
merk your commercial offerings. So buying companies which may have marketed products, may have late stage promising, you know, products that are perhaps nearing the market. Companies that have technology or platform capabilities that the larger company thinks, will you know, sort of help them to continue to expand and grow.
That is absolutely, you know, normal course of business. And when you look at it from the other side of the table and you start to think about investors in private companies that maybe hope to go public or early stagg pre revenue sort of smaller in mid cap biotechs, it's a very accepted kind of exit strategy, you know, for those companies and investors in those companies. So, you know,
not every company is. If you ask founders of biotech companies, they may not always admit that, you know, one of the things they're hoping is that, let's say Pfizer will buy them one day. But that's certainly you know, that's whether it's been committed to paper somewhere. That's a very has been I guess I should say historically a very real possibility.
You know, how have you seen that pattern, so let's say that pattern has been playing out, and have you viewed it as being something that's beneficial for the end let's say from consumers that ends up being beneficial when it comes to drug development, drug distribution, innovation. How do you view that?
Yeah, I think it's a little nuanced to be fair, you know, you can make the case that a keep picking on Pfizer or an Engine or a Bristol. Yeah,
they're they're large. You know, they have resources just strictly on a capital basis, they have their own internal R and D. And then you know, very importantly, they have capabilities when it comes to commercialization payer negotiations, which maybe we'll get into a little bit and just kind of the the capabilities that are needed to take what might actually be biologically or medically effective drug and actually get
it out into the world to patients. They have those capabilities that a smaller company.
May not have.
And so yes, it serves other needs from the perspective
of the large company and the company that's acquired. But if I think you can make a case that in many instances those assets that were resident at a small biotech company maybe are able to be sort of their potential could be maximized on a larger platform, I mean, I think you can in a more cynical way, you can maybe take the other side of that argument and say a small company might be more uniquely focused on their one product or their one platform, but of course
you have some of those other expertise and resource constraints that they would be dealing with.
Sure our money, know, you have to have some thoughts on this. What do you think.
Look as a small company, the especially in life sciences, your your development strategy typically it's about getting data so you can raise money. Right that that that's a that's a fact of life in the industry. And uh and and that ecosystem of get data to raise money so you can go to the next phase or next stages whatever it may be, whether it's moving from in vitro to in vivo, or from from pre clinical to clinical, or face one to face two, whatever, whatever those transition
points are. Each one comes with larger and larger budget requirements and and as you kind of go down the path, the capital constraints become a real issue. And it certainly once you start talking about mark to your point about commercialization, once you start talking about that, that's uh, that's a completely different startup idea. Right. The second you get to that point, you're no longer being run by the chief
medical officer of the company. Uh. So that transition from the chief scientific officer to the chief medical officer and at some point you need to hand it over to the key decisions now are being made by the by the folks who might might not have pH D after their names or or m B after their names. That that's a completely different business model. And uh, making that transition is really hard. Very few companies successfully do it. And and and at the same time there's big pharma
with with the infrastructure already in place. So there is a very strong argument why it's far more efficient for for these promising assets to to effectively transition to an entity that already has the commercialization machine in place. There there are a lot of efficiencies there, without a doubt, And and the same is probably true on the regulatory side.
We all would like to think that we can figure out the ft A, but but the mileage that you have with them really matters, right And and of course larger pharmaceutical companies have a lot more experience dealing with reading the tea leaves and having those softer interactions with the with the f d A, so from for later
stage development, there are a lot of efficiencies. The point that that really troubled me during the last couple of years about all of this was probably the meta within transaction, which was which was not in Life of Sciences. But this whole notion that Meta is a potential competitor without ever having declared so in a different market because it can its mere presence is a disciplining force, and that potential threat of entry is competition enough for antitrust purposes,
and therefore its acquisition of within could be problematic. I mean, obviously the case got decided against the FDC in that case, but if you apply that logic, a lot of these big pharma acquiring pipeline transactions start to look really well risky, right if the FDC is going to take that approach, I sure hope they don't take that approach in this industry because the inherent efficiencies are just too many in a lot of these transactions.
Yeah, And you know that's a part of the problem because what they need you as an expert witness, I guess the drug company is when they up there, because those inherent efficiencies are being downplayed now right by the FTC,
not just in these deals but across the board. And you know, there it seems like they're already sort of exercising their new approach here and not really thinking about everything that the both of you just talked about with respect to why m and a kind of has to happen for some of these really small companies, and we've seen them challenge Amgen and Horizon, and we're going to talk about that now because it's a really to me, this is a really was a surprise, and it's an
interesting case because if we go back to what Armand started with, where he talked about overlaps vertical relationships, these companies have neither. They don't have if you look at even pipeline and marketed products, they don't have a horizontal overlap. They it doesn't vertically integrate Amgen in any way. But yet the FTC has went ahead ensued to try to block the deal. Now we've heard in the news lately that they've paused a few things to maybe talk about
settlement doesn't necessarily mean it's going to settle. Hasn't settled yet. It's supposed to go to trial on the FTC's motion for preliminary injunction on September thirteenth. Armand talk to us a little bit about that case. What are the FTC's concerns, what is the theory of harm there, and what are your thoughts about that theory of harm.
Okay, so the theory is really hard. It is very rare, probably unique, but not so novel. Right, Well, we've seen investigations based on a similar theory in the past, and we can talk about some past transactions where similar issues were explored by the agencies. But in essence, what's happening
here is Horizon a fantastic company. They have amazing technology and they have, in the FDC's viewed, they have two assets commercialized in two separate rare diseases, one in gout, the other one was I forget which one it was exactly yeah, iright, disease, and according to the f d C, both have effectively a monopoly position. So this is a monopoly position changing hands from Horizon to the buyer and this transaction, so why why does that matter? There's already
a monopoly. According to the f d C, Amgen is in a better position to maintain that monopoly and maybe leverage that monopoly potentially to other products, maintain the monopoly by presumably keeping new competitors for these monopoly assets. I call them monopoly. I don't know if that's the case,
but that's that's effectively. What's what is being alleged, So I'll go with that as the worst case scenario for the parties and UH and the theory is that Amgen is in a better position to keep stiff arm whatever competitors for these two products, and that Verizon will not be able to do it as effectively as Amgen. So it's a monopoly maintenance kind of theory. We we typically would call that a conglomerate effect because there is no overlap.
It's not a referring back to my earlier comments, there is no coordinated effects story here. There is no Uni ladder effects. The two companies are not competitors. No, there's no allegation that there's going to be less competitors in the market. So in that sense, it's a conglomerate effect. Amgen is just bigger and better at keeping competition at Bay. That's the theory. Now we've seen a lot of investigations
with with such theories. We just haven't seen them actually go to go to a courtroom, and for good reason, because they typically fail on the facts. You really need to have facts line up uniquely to be able to allege that and then actually prove it in front of an arbiter. A judge or alj what have you, and I suspect, look, I haven't seen the record in the case, but it's going to be really hard for the FDC to prove a case like this.
Yeah, I agree with that, And I read recently Amgen's response to the FTC's motion for preliminary junction, and I thought it was actually really strong and well written. Convinced me even more that the FTC would have a real uphill climb if this ends up going to court. It'll
be interesting to see whether they settle or not. I can't I'm not sure how that will look because Amgen has offered a behavioral settlement, in other words, a settlement promising to not bundle those two the to horizon drugs you just talked about, and the FTC has been pretty clear about not wanting to accept that kind of a settlement. So I'm not sure what they're talking about right now.
We know they're having settlement talks, they have said, so I don't know if Amgen's going to offer up something more than that, But I can't think of anything structural
that it could offer up. But I would think, at least from the FTC's perspective, it might be the sensible thing to do, not only because I think they'd have a tough time winning, but also because Amgen has also made put in as an affirmative defense and put in for summary judgment that the FTC structure is unconstitutional, and I really doubt the FTC wants to get into that. So Mark, but let's just assume we're talking about settling. We're talking about they probably we don't think they can
win in court. But let's just assume, for argument's sake, if this went to court on the theory that armand just described right, and the FTC did manage to win this. Now I say win, I mean, get the preliminary injunction go forward before the alj What kind of impact do you think that I'll have? Like how how will that reverberate amongst.
That would be a chilling and sort of broad reaching scenario to play out. I mean, I think you know, for if we think about Amgen specifically for a second, I mean, where does that leave them?
Right?
I mean, this is a large company, as we've discussed that sort of, I think it's fair to say has a revenue growth challenge. And that's not a secret. I've been writing about that in my research for a couple of years. But this is, you know, one of the standard ways that a company like Amgen layers on some additional revenue growth. So what are they to do then, in this sort of scenario where they're not allowed to
buy a company like Horizon. I mean, Arman just talked about the fact that they're buying a couple of of monopolies commercial monopolies well from Amgender any other potential acquirers perspective. You know, if you take the anti competitive or anti trust aspects out of the picture, that's almost exactly what
they would want to acquire, right. You know, you don't want to go out and buy a company that has a stable of kind of me too or just incremental or you know, bit players in a crowded market necessarily, So you know that I'm not sure what amgine would do at that point. They would probably have to maybe start to think about some a larger number of smaller deals that by definition would probably take longer to kind of play out in terms of actually translating into revenue.
And I think you would see much the same sort of shift and strategy throughout the industry, and it would have significant I think negative or you know, it would be a significant sort of headwind for a number of sort of emerging smaller biotech companies, which, as we discussed, you know, kind of have as a tantalizing part of their potential valuation or their potential corporate arc, you know,
growing into something that is ultimately attractive to suitors. I mean, I guess we in this as you're I think suggesting unlikely scenario, you know you'd I guess we would have to try to figure out how far down the food chain sort of this effect would go. I mean, would it just be companies like Horizon that already have moultiple marketed products or with the FTC sort of make the same argument, even if it's a biotech company that just
has some Phase three, you know, late stage programs. I mean, so the farther, you know, the the the more broad they were at net would be cast or that shadow would sort of fall to earlier and earlier stage biotech companies. I mean that would be fairly disastrous I think for the for the sector.
So we have another pending deal visor, Siegen, right which they were issued a second request, meaning they got into an in depth investigation with the FTC in July, so they're kind of at a month into this in depth investigation. This was after they gave the FTC a little extra time by pulling and refiling their notification of the deal, and so I think some people might have gotten a little excited when they pulled in refiled, thinking they could get it cleared in thirty days, But now they're kind
of in for the long haul. And I, you know, I'm not really sure what I think is going to happen in that deal, because before the Amjen Horizon lawsuit, when I thought about the FTC bringing some kind of a new type of case, a novel case or a test case in pharma to try to slow down generally just in general pharma consolidation, I kind of thought it might be Pheiser Siegen, And now I'm not really so sure.
Armand if you can talk about it, I know you represent clients, but if you can't talk about it, what are your thoughts about what you think is going to happen there?
Yeah, that one is a really good question. Jetnif First, So, obviously there's been a lot of talking and policy statements from agencies across the globe certainly the FDC, but others as well, and in quotation marks the troubling state of affairs in the pharmaceutical industry, the prevalence of killer acquisitions, minimally innovation by leading drug companies, things like that, that it's been kind of circulating in the anti trust bar
for the last couple of years now. As a factual matter, I don't necessarily understand where this anst is coming from. Obviously there are pharmaceutical companies that have run into problems with anti trust law. But but to suggest that there is minimal innovation, I think is it's a stretch past.
I mean, it's been a tremendous source of innovation. It's been incredible, the pace with which development has happened, despite the regulatory environment, and the and the and and the expense and the and thelatory scrutiny that goes with what the clinical trial process. Despite that, I see an amazing over arching trend, a secular trend in incredible innovation, life saving innovation, better quality of life, et cetera, et cetera.
I could go on and on and how wonderful this industry is generally as as a as a general matter of course, at the individual level, there are issues, but not as it's not necessarily problematic from an overall anti trust policy perspective. Now with that background, of course, it was a given that this is going to be a long protracted investigation. It is the largest transaction since I believe that at the Allergan transaction we talked about earlier,
at forty three billion dollars. This is right in the sweet spot of things that the FDC probably should invest gate depends based on their track record in the last three years. But the lack of any material overlap, especially with Pfizer, which has A and Mark would know far better than I would relatively targeted on college of portfolio.
To my recollection, I've done deals on the Indian College is spaced across from Pfizer, where I had the pleasure of getting somewhat familiar with their portfolio and UH and I don't see how this is creating any tangible anti trust issue. Putting together an a d C portfolio a large one UH into into into the Pfizer platform, I don't necessarily see an anti trust issue here unless you go into things like those conglomerate effects et cetera, et cetera.
You know some some more less used theories, but I again, on the facts, it's going to be really really hard for the agency to uh to to find things to complain about here. Uh Aviser doesn't have a bad track record in antitrust conduct, which I know the Task Force has effectively made a part of our anti trust analysis. Now bad actors is now all of a sudden the part of the merger analysis. But the visor doesn't really
suffer from that, neither does Segen. So I would expect this to clear and unless there are some facts that are not known to the public, right, let let's hope that's what happens.
Yeah, you're your analysis aligns with mine because that's that's where I've come out on it too. And you know, I was rereading the article that you wrote about a year ago and something that jumped down out at me.
I was actually really surprised. You were talking about the Bristol Meyers Script Cell Gene deal and you said the FDC investigated whether the transaction would have an impact on innovation competition in a broader oncology space, and the staff concluded that it was unlikely because the FTC found that there were no fewer than seven hundred and eleven companies conducting late stage research and development in oncology. Now, I know oncology is really.
Broad, but it's probably eight hundred now, yeah.
Exactly, And so it would be hard, it would be really difficult for me to see how the FTC could bring a case based on a theory that actually had a good chance in court on this one, right, And I know that was a different FTC that came to that conclusion for Bristol Myers squip. But still, the facts are the facts. So it's an interesting point there, Mark, What are you seeing with respect to companies investors with respect to this kind of new FTC? Are you seeing concern?
Are you getting a lot of questions and are you at adapting your own analysis in any way?
Yeah, I think definitely a lot of questions, But I I don't know if investors are Maybe they've been reading your research on Amgen Horizon, you know, where You've been pretty clear that you think it's an uphill battle for FTC for example, But I mean it's taken on a new level of importance I think for clients of Bloomberg and investors, But I don't get the sense that they
have a sky's falling kind of view. I mean, certainly, that negative kind of doomsday scenario that I was just walking through, I'm sure is in the back of biopharma investors' minds and at the companies. So, you know, I think how things unfold with Amgen Horizon will probably and Pfizer Cgen, I think will kind of dictate if there really needs to be a fundamental shift in how investors think about
M and A or getting involved in in biotech. I mean, you know, I can tell you on the day that the Amgen Horizon deal was announced, which I was down in New Orleans attending the ASH conference, which is the big hematology conference, and I was getting ready to go on Bloomberg TV to talk about it, and I was getting a lot of inbound investor client questions, but they were you know, and maybe it's because even though we've been hearing about this new FTC, people are still kind
of operating in the old mode, which you know, the questions were about overlap and possible remedies, you know, the things that Armon and you were talking about, kind of the pre the twenty nineteen and before mindset. So I think investors are still to some extent kind of operating in that framework. Maybe that's a bit of optimism or a bit of inability to kind of contemplate a new harsher reality.
I think some of that could also be that things This new FTC that we're talking about is kind of advancing slowly, because I actually made myself a list of a lot of deals that were filed, and I probably missed some, but I think I got most of them. And I looked at from about May of twenty twenty two forward because that's when there was a solid democratic majority at the FTC with kind of this new approach
or new mindset. And I have here twelve deals where the HSR expired, one that HSR expired fter or a pull and refile, one that was investigated but then closed without any concessions or remedy, and then just the one single lawsuit Amgen Horizon. So it's been kind of up until l Amgen Horizon, it would kind of seem like business as usual, right. We keep seeing the foreshadowing of something different, and that's why I thought it might be
Advisor Siegen. But because we're waiting for this something different, I guess we got it with Amgen horizon, but it might be part of why some of the investors are just thinking in terms of the old, the traditional analysis and kind of status quo armon your advising clients. I mean, that's got to be hard right now. I would think it would be hard to advise on legal matters. And have you changed your approach in the way you're talking to clients about these things?
We certainly have. I mean getting involved early is now the key issue. And I say that because it might have come across as a constant thing in all of my prior comments. Facts really matter, right, I mean, the agency is moving in a different kind of theoretical approach, but theory can get anybody so far, and the facts
really matter. And in the in this industry where there is so much innovation in different corners of the world happening as we speak, getting to know the facts better than the next person is really key, and understanding those uncertainties on the innovation side, because look, competition and UH and oligopoly theory is all about uncertainties and risk and
how to avoid it, et cetera, et cetera. Right, It's that it's that competitive kind of wild animal in the in the forest and who's going to eat you kind of mentality that that drives anti trust analysis, or should drive anti trust analysis. We want that, right, want that predator prey kind of mental framework, and this industry is full of that. So it's just a matter of lining up your facts, uh, to put to put yourself in
the best position to avoid a second request. That's really like the key issue, especially advising companies that are pre revenue that that is one of the key issues because a second request is not just a second request in the sense that you're dealing with an expensive process, but it comes with all the other And this is where I need to put on my life science's guy hat. What do you do during that timeframe? What's going to
happen to the clinical development? What are what are the showers operating covenants going to work?
Uh?
What about the material adverse events clauses and the agreements?
Right?
What happens if if if you have a serious adverse event in one of your clinical trials is not going to mean the deal is off? Do you need financing during a twelve month FTC investigation? Right? Things like that, Getting involved early on and understanding those is really where we focus right now. And then we hope for the best with the FDC that we avoid the prolonged investigation. But really the focus is on helping the clients get
through the process, not just the second request investigation. I think on the facts you develop as much as you can, but advising them on how do you deal with the rest of the operation and the risks that the buyer might walk away for this reason or that reason during that process. Those are key issues that we grapple with and advise the clients.
Yeah, so you're looking at it in a much more holistic way than I think a standard anti trist lawyer would, which you're perfectly suited for that. Having come from sam and Meed, I call it Salm and Met because I can't remember the new name by the company.
What was it Biasplice, I think now.
Biosp former Samamed. When armand started with a Samamed, it
changed over to Biosplies different places. But yes, okay, So just one last question that I'll pose to both of you and then we'll kind of wrap up, and that is just simply, are you seeing given the threat of this aggressive scrutiny, are you seeing slow down like companies that might have entered a deal, but have chosen not to because they're they're concerned about exactly what you just laid out, armand the second request, the aggressive FDC, the
cost of it, all of those issues. I'll start with Mark, Are you seeing talk of less activity?
Yeah, I mean armand might have more sort of behind the scenes insight into this. From my perspective, I don't. I can't really point to any either specific instance, I mean, whether a company would comment on such a thing or not as clear. You know, I think there remains a need for large biotech, in large pharma to kind of deal with some of their patent cliffs, to put some
of these large stockpiles of money to use. And then of course, you know, we haven't really talked about the biotech downturn, but in you know, there's potential value or you know, more attractive valuations, at least for some smaller companies.
But so I think there's still a lot of potential for there to be M and A. And actually, if you look at the data, I mean we've sort of using the terminal as a resource, have been looking at biopharma deals maybe that are a billion dollars or greater in value, and we're sort of looking at the data announcement of the deal and counting as completed deals that have been announced but haven't been you know, consummated yet.
But you know, we're a little over halfway through twenty twenty three, and by those metrics, were already at the same number of deals as all of last year. And we're actually like eighty five billion dollars in deal value so far this year versus seventy last year. Now that's kind of a low bar because twenty twenty one and twenty twenty two were kind of less standout year, certainly compared to twenty nineteen. We talked about a vi Allergan
and Bristol cell Gene. But so you know, I don't really see I haven't heard commentary, and I don't really see evidence of a of a slowdown. But again, depending on how things go with these two more landmark deals that we've been discussing, I think that may chart a new course from here.
Sure, what about you, armand do you see any kind of chilling effect?
I think the conventional wisdom based on PERF just anecdotal evidence and uh and kind of the rumor mill from from some of our investment bank or friends and other council boards are a lot more hesitant in looking at deals. I think that's the reality, of course on the cell side. On on the target side, the options are pretty limited, right. The capital markets are still not great. So if you need the if you need that, you know, two hundred million to go to a phase three development, and then
you're not going to be able to raise it. You're not going to be you're not going to be able to do an I p O or you're not going to be able to raise the money at the at the valuation that you want without giving away the company. Your options are limited, right, you need to do M and A transactions, So so the numbers are not necessarily
going down that asked. But I think there's a more peer to peer merger of equals then you would otherwise see just putting together cash and rationalizing the pipeline of two struggling companies. That kind of stuff is happening a lot because you can't find a buyer who's gonna take the risk on the or you don't want to take the risk on the FTC front. And these are not necessarily good things. I mean, some of these assets would be far better off in the hands of somebody with
deeper pockets and the expertise. So there's some anecdotal evidence, but I agree with Mark that there's still plenty of transactions out there and that overall numbers haven't necessarily dipped in any meaningful way.
Well, this has been really really interesting. I think before I close up, I just want to give either of you an opportunity if you had any other thoughts that you weren't able to express any last words, Mark.
Well, I don't know how profound this is, but I'll just point out it doesn't that you know, armand talked about Bristol Celgene and the old school remedy of divesting o Tesla, which I guess it's irony, but you know Amgen bought that right and they and that really, again putting my equity analyst hat on, that was an incredibly strategically positive move for Amgen because you know, that was a marketed product, continues to do reasonably well and really
kind of served as a patch for Amgen's revenue over the past few years. So, you know, I don't know what I conclude from that other than the old way of having even potentially very large deals go through with certain remedies seem to work.
A mine. Yeah, look, they I'm sure we can do a retrospective on a lot of deals and reach very similar conclusions. Overall, nobody at the FDC during the Joe Simon's years I have any reason to be embarrassed by anything they've done. They did a fantastic job and they probably cleared the right deals and investigated the right ones,
so that that was all good. And yeah, there's some wisdom and doing things the way they've been done for for a long time, there's a there were a lot of benefits and and I'm not suggesting that the current FDC is necessarily doing something completely different. They're not right. I mean, we went through a lot of bass transactions where a lot for for many transactions is business as usual and and for the benefit of patients and and all of us, let's hope it continues that way.
Yeah, I guess the moral of that story is that if it's not broken, don't fix it.
Right.
Well, you guys were really great and it was so interesting, so thank you so much for joining me on this. This has been a lot of fun because it carried out further out of antitrust and out of sort of just the legal arena into the business area and that was great. So that's it for us. Thank you everyone for listening to the Votes and Verdicts podcast of Bloomberg Intelligence. Please feel free to reach out to Mark or to me on the Bloomberg terminal if you'd like with any
questions or any comments. And everybody have a great day.
