Pfizer Inc. (PFE) Presents at Citi’s 17th Annual BioPharma Brokers Conference (Transcript)

Pfizer Inc. (NYSE:PFE) Citi’s 17th Annual BioPharma Conference September 7, 2022 10:30 AM ET

Company Representatives

Mikael Dolsten – President, Head of R&D and Medical

Chris Stevo – Senior Vice President, Chief Investor Relations Officer

Conference Call Participants

Andrew Baum – Citi

Chris Stevo

Alright, before Andrew and Mikael get started, I need to read a quick forward-looking statement. I’d like to point out that our discussion today may include forward-looking statements. Forward-looking information is subject to substantial risks and uncertainties that could cause actual results to differ materially from those projected in such statements. Additional information regarding forward-looking statements is available in our SEC, Form’s 10-K and 10-Q under Risk-Factors and Forward-Looking information and factors that may affect future results. Please note, forward-looking statements on today’s webcast speak only as of the webcasts original date and we undertake no obligation to update or revise any of these statements.

Andrew Baum

So welcome back. Thank you, Chris. So delighted to introduce our next speaker’s, Pfizer. So Chris, Head of IR, you’ve already heard and seen. The main event, the President, Head of R&D and Medical and CSO of Pfizer, Mikael Dolsten. Mikael, thank you so much for joining us today.

Question-and-Answer Session

Q – Andrew Baum

First thing, look I haven’t seen you in person since COVID, so you know we owe you a debt of gratitude for both the vaccine, execution and also discovery and development of PAXLOVID and we’ll come and talk a little bit about that later on the conversation.

But given the recency of the news flow on RSV, perhaps you could talk to the date that you have shared. The nature of the data points, because there’s a little bit of complexity there, and we can contrast it to what GSK seems to be suggesting they have delivered in terms of efficacy with their competing vaccines, so let’s start there.

Mikael Dolsten

Thank you. We’re obviously very excited about the data that we shared, the top-line of RSV, and it gives us an opportunity to expand our strong leadership on the currently most common respiratory viruses, SARS-CoV-2, COVID-19 and now with an RSV vaccine, and I would like to say we take a real science franchise approach in this area where we are the leaders of the world, when it comes now to treating the most burdensome and difficult respiratory virus.

As you said Andrew, we developed Comirnaty with Vyndaqel, Paxlovid and now we are developing the RSV vaccine for adults and maternal and seems enough to be a – we’ve acquired an empty viral drugs.

Now specifically to the adults trial, I feel very excited about this, I would say spectacular results. The study looks at lower respiratory tract symptoms and either two plus symptoms or three plus symptoms. The three plus symptoms all those patients with a more medically burdensome, impactful disease, and that’s where we reported our 86% reduction of death symptom score. It’s a very strong data set and we had 66% reduction in the more milder cases, still very nice results.

It’s underpinned by our immunogenicity data, which is really the data that’s more easier to compare across trials. In our hands it’s not that easy to compare how symptoms are scored in different index that describe them, in different studies with different sites. I can only say that 86% reduction off of the diseased events of the more severe it is just outstanding to me.

Immunogenicity wise, we have been the top notch, and I think the only one that have kept both activity against RSV A and B at the upper range fold increase over baseline. And we believe that relates to that we are the only vaccine that have both, the RSV A and prefusion protein expressed and included.

So all in, I think this result just stands out and it will be a transformative vaccine. I think there is room for obviously more than one vaccine, and I look forward to the GSK’s results for the benefit of patients, but I think it would be very hard to do a cross trial comparisons and feel that you can do much better than the 86% and we’ll just see how we can make sure of the regulatory review that the vaccine can really be advanced in the population.

And I should end Andrew by saying, we will have the unique opportunity of course, to have the leading pneumococcal bacterial vaccine for respiratory infections by bacteria, the leading COVID-19 vaccine for viruses. I think the leading RSV vaccine and we are on our way to start also pivotal studies with a flu vaccine, so a very comprehensive approach from us here.

Andrew Baum

Though it’s tough to benchmark this, of course GSK hasn’t shared the data, but they seem to be intimating for the equivalent of three plus symptoms, somewhere around the 80% mark, which would put them in a certainly competitive if not stronger position than you. But obviously we need to see the data and we can’t make judgments there.

One might imagine that the presence of the adjuvant may result in two impacts. Number one, a greater level of protection in the older, whether they are immunosenescence. And so I was curious as if you could share a little bit of information about how many patients in your trial were above the age of 65, 70? And whether you saw the same as you did in younger patients.

And then second, that may also translate into the duration of protection, and obviously we can’t comment yet, but data will – and that will emerge from this. Again, any thoughts there?

Mikael Dolsten

Well, you know we will share more data at conferences, and I can only say that the data looked at – looked really strong. I would have been having difficulties to imagine a better outcome that what we saw and I think it will be seen as a premiere vaccine for the older adult population, particularly that’s the most vulnerable.

And then we are the only one that have a maternal vaccine. I think the company referred to failed in that area. I tend to say that having an adjuvant is a liability if not needed, and we did study some adjuvants and found that our two RSV prefusion F antigens did so well by themselves and our tolerability is phenomenal. If you can avoid adjuvants, you are usually on a positive side, because with each adjuvant you elevate the risk for rare adverse events, particularly immunological rare events that may be seen as you cumulate more patients on your product.

Now, we also view that over time we will see a lot of combination vaccines evolved in this space. We don’t know exactly when would be a nice rhythm to re-vaccinate for RSV. But we certainly know there will be annual vaccinations, you know probably very likable for COVID, for flu and in some way RSV would likely be integrate. Having quite strong adjuvants, as starter company will hamper your ability to build a comprehensive combination franchise as we see has been so important in adult and infant vaccination schedules.

So this was part of our overall strategy, but of course you may think differently if you have success in pneumococcal, in COVID, in RSV than if you have more of a alone – standalone effort. But that’s really the strength of Pfizer. We go in, all in, and we want to offer patients friendly solutions to deal with the total burden of respiratory infections you know.

Andrew Baum

Yeah, it’s when you say the other company, I can’t help thinking about Voldemort, you know he who shall not be named. But just staying on the vaccines front, thinking about COVID, China recently approved the first inhale vaccine. And there is not sterilizing immunity with the existing systemic vaccines. There has been a lot of academic research with inhaled vaccines and IGM and the potential world of IGM, but seemingly industry has not been that interested despite strong scientific rationale. So where is Pfizer on inhaled vaccines? If not, why not? Over to you.

Mikael Dolsten

Andrew, I appreciated you use characters from British literature in our discussion. We tend yes, to be careful to speak about other companies, that’s why I…

Andrew Baum

I know, I was just teasing.

Mikael Dolsten

I like your familiarity with some of the great British writers. Now when you think about COVID, where it’s going, we are on one hand thrilled for the BA.4/BA.5 EUA approval in the United States, and I think as we speak, you can start to get slots for vaccination at many vaccination centers in the United States, and we are making great progress also in Europe and other places. To get this new updated variant vaccine from the science that’s available today, I think it will provide a much more desirable upgrade of the protection as the virus has invaded the first generational vaccines.

We are working on additional improvements to make vaccination more durable, with propriety engineering of the vaccine. We think that can improve the overall protection of the vaccine, including symptoms and then we are planning later this year for a study that includes a more of a PAN SARS-CoV-2 variant vaccines that should allow you to be less vulnerable as new strains evade.

Now you come to the approaches to deal with the upper respiratory symptoms of let’s say more mild to moderate character, which are still you know a nuisance, even though we feel very good about how we have changed the outcome of severe disease, mortality and keeping people away from the emergency rooms. I don’t think that inhale or intranasal is going to be an alternative for an intramuscular vaccine. I think the learning we have done in immunology vaccines tells us those are the most reliable, most potent ways to get the systemic protection.

I am intrigued that for example, intranasal, which is a much more, I would say local delivery then going deep into the lung. Intranasal maybe in a joint approach. What do I mean by a joint? It may be an opportunity to augment, particularly if there is a rapid surprising strain shift, augment protection from the milder symptoms.

So this is something we are intrigued and monitor to see if it could be an adjunct, but not a replacement substation for the intramuscular. I think it would be yes just top off in order to maybe remove or attenuated some of the upper airway symptoms which could benefit from delivery of possibility mRNA based technologies into the nose.

So something we’re looking at, but right now I think you should see them more as an add on and I have no reason to believe that they would ever replace an intramuscular.

Andrew Baum

I asked from a, much as a public health perspective, because I’m concerned about high replication rates, and reducing transmission, and anything what seems to have a role in that, and clearly systemic vaccines do, but I think potential for inhaled vaccines to do so to a greater extent seems to have an important role. But I understand what you’re saying, and I guess we will see that later.

I want to segway a bit to a completely different topic, so Nitrosamines, and [inaudible] that some of the other companies are struggling, and their share prices has been solely impacted by the fear of liability risk. You’ve had a couple of withdrawals, in fact three I think, but you know unless I’ve missed one or two, namely Chantix or Accuretic. Could you talk to what you see as the potential levels exposure, ongoing lawsuits, anything you can add would just be helpful.

Mikael Dolsten

I know you Chris, you have some internal remark given this area.

Andrew Baum

Hang on a sec and we’ll just get…

Mikael Dolsten

May be you use the mic there Chris.

Chris Stevo

Is that given agreements we have with other companies, and given the science and the facts and circumstances of legal cases, we’re very comfortable both with our scientific and legal case, as well as limitations to our liabilities. So it’s unlikely to represent a material financial impact advisor.

More broadly regarding nitrosamines in general, as you know we just like many companies have worked very expeditiously to test our products and where necessary to make changes in our supply chain or to remove products from the market where that’s not possible. So again, we worked with a lot of diligence and with a lot of speed where possible, and we feel like we substantially mitigated the issue.

Andrew Baum

And in the activity in low cases, you’re staying on either Chantix or Accuretic?

Chris Stevo

I’m sorry?

Andrew Baum

In terms of the lower loops [ph] that have been filed for both, your smoking-cessation drug Chantix but also Accuretic.

Chris Stevo

No, I was – regarding the – I was speaking regarding the legal liability for Zantac. I wasn’t saying anything…

Andrew Baum

No, no, my question was specifically away from Zantac on those two other products.

Chris Stevo

No, we haven’t spoken to that at this point.

Andrew Baum

Got it, okay. Thank you very much. So, perhaps moving to, some of the internally discovered pipeline products and Pfizer’s backgrounds is one of deep medicinal chemistry, right. I mean you are a medicinal chemistry and where you have delivered drugs such as ALK inhibitors or Xeljanz or Ibrance. It is a medicinal chemistry, it’s your core competency and I’m a great believer in institutional knowledge and that panning out over sort of generations.

So perhaps you could talk about your GLP1 or GLP1 analogs, and as I know you have a lead compound which is twice a day, and you have a once a day compound, and I think initially the plan was to take both quickly into Phase 3. Could you talk to given the rapidly evolving landscape with the Parenterals, how the profile of these drugs looks and how you see the commercial opportunity and the clinical trial design and the timelines as you look to take these drugs forward?

Mikael Dolsten

Could you specify these drugs what your…

Andrew Baum

So I’m talking to number one, semaglutide. So [inaudible] and you’ve also got the GLP1 agonist as well. That’s when I think I’m talking about GGG and some of the ultimate modules. Just the current next-gen agents.

Mikael Dolsten

You know, I think one very important part of our success has been the focus of having excellence in how we design medicines and vaccines. And clearly small molecules where we have probably the largest in the world, knowledge base about structure activity, we have a leading structure based drug design virtual screening, AI powered technology, all of that were example behind PAXLOVID. They are examples that helped us to design. I think the only in-house pharma or albeit one, that’s a true small molecule based on that unique small molecule capability.

We are blessed to have two different drugs, many of you may be familiar with danuglipron that have been shown in repeat Phase 2 studies do have a very nice effect on both lowering of HbA1c in body weight. As we refined our drug design, we have been able to move a second one with a Pfizer 1532, which has beyond what danuglipron has, a once a day very optimal half-life with a sustaining, very nice active dose over the entire 24 hours in patients. And that 1532 is now entering Phase 2B studies.

We will share later at conferences how we were able to normalize studies of only four to six weeks titration studies. We will normalize fasting plasma glucose; have a remarkable effect on HbA1c and robust short-term effect on body weight reduction. So that looks to me as a potential, really premier, best-in-class oral, small molecule.

Why is that so important? Well the GLIP and to come, the GLIP class is the most powerful anti-diabetics and today by far maybe the only really persuasive anti-obesity medicines. But still they are used among patients that need just a low number of percentage. Whether you have diabetes or obesity, there you could say in diabetes they have still moderate market share, because they are injectable and not oral.

In obesity they have a higher market share, but very few patients are treated because they are injectable and not oral. So we see a tremendous opportunity based on 1532 and danuglipron as an alternative over the next year, maybe year and a half to cherry pick the dose and move swiftly with one of them into pivotal studies.

And our vision here is really to within the oral segment be by far the most efficacious drugs and within the segment of any diabetic obesity drug be as good, but the most convenient opportunity for patient, to really capitalize on the great story, so for how these drugs have near term improved glucose and weight control and long term really good vascular outcomes.

I think they will also be you know in cardiovascular outcomes, powerful drugs for other diseases such as NASH. So it’s one of our big next efforts. We kind of now label it light-speed project and we bring in all of our knowledge we had from many other light-speed programs. It started of course with the way we developed Comirnaty and PAXLOVID, and you will see a tremendous focus from us in building what we think would be one of the big next oral drugs segments.

Q – Andrew Baum

So listening to what I’m saying, it’s less about trying to match the efficacy of the next-gen rentals. It’s more about dominating the oral class.

Mikael Dolsten

No, it’s an end.

Andrew Baum

Do you think you can deliver… [Cross Talk]

Mikael Dolsten

Our data suggests we can be as good as any of the injectables, but have a much more convenient profile, much more patient friendly way of titrating – that’s division, it’s an end to be the preferred drug, whether you’re going for the most efficacious but much more convenient, and an even larger segment, oral segment that’s probably you know 80% today of the medicine used in diabetes or oral.

Why do we still treat with many old fold effectives? It’s because people prefer oral in the core metabolic sector, but hasn’t been as powerful agent yet, and we think 1532 and oral danuglipron could have that property. But for those that want to have the best, we think this would offer efficacy as good as injectable, but with much better convenience.

Andrew Baum

And you’re starting to Phase 2b this year?

A – Mikael Dolsten

We are moving very swiftly to start it this year.

Q – Andrew Baum

And the duration of that program will be what, 16 weeks, in terms of…

A – Mikael Dolsten

We will share the design soon, but it would be a study that will allow us to feel absolutely confident in the dose, and you know this drug class have usually dose titration to reach the highest tolerable dose that allow you to be able to drop HbA1c and body weight that continues to drop over time more and more in this balance between tolerability, convenience and efficacy. So we’ll probably do trials that allow us also to follow a little bit longer time points.

I’m estimated that we will have data within 18 months to then share a big dose and right, I’m of course leaning towards that 1532. It just looks so spectacular, but I was very excited about danuglipron too, so we are maybe in the fortunate situation to have two such great drugs to choose them on.

Q – Andrew Baum

And then I do want to spend some time talking about oncology, but before we go there, there is one question I forgot to ask when we were talking about vaccines, was the pneumococcal vaccines and GSK, the other company, made a acquisition of Affinivax, which offers you know a higher number of serotypes targeting and they would claim you know raising the bar again. Obviously you were prohibited from looking at that transaction I assume given anti-trust reasons.

How do you think about the technology that’s there in the hands now? I believe they have got breakthrough status, their timelines are fairly aggressive in pursuing Phase 3 trials. How should we think about this? Is this apparently changing hands or despite are confident that they can expand the serotypes. So in fact the serotype expansion is going to be clinically irrelevant, because it’s going to get resting serotypes, which in other associates is a severe disease.

A – Mikael Dolsten

Well, I recall that the – that company made an attempt earlier to break in with our bivalent and I think it’s a hardly used vaccine. I think it’s a very late entrant with the highest it being by far the leader with our bivalent. Merck being a long term player as the second company there. We have monitored this technology that you referred to and we didn’t think it had the technological sophistication that was interesting to us, and I think you need a very deep knowledge base on how many different serotypes you can put into one single vaccination campaign. We design and get the date that allow you to establish a new vaccine as the preferred standard.

We’re working on numerous follow-on vaccines. This is a game where you never can relax in a comfortable chair like this. You always need to lean forward and push the frontier and believe me, I think there’s little room for the company referred to, and I wish them the same luck as they had in the COVID and hopeful they will do better here.

Andrew Baum

I will put that, the other companies ahead of vaccines when I see them later tomorrow.

Mikael Dolsten

Well, I know – well obviously he trained with us, so…

Andrew Baum

But that’s the new – yeah, so the new Head of R&D, absolutely! So going to oncology, so Ibrance is approaching its LOE. You have licensed the Arvinas degrader. There’s obviously been with one exception a stream of negative data with sets.

Now, in your view is this a patient selection trial design issue? Does it undermine the potential or you are degrading within this category. Obviously you have ADCs coming in that I’m assuming people are going to hit the ER access until it gives up before they turn to an ADC. So how is your pro being adjusted for the commercial potential of the Arvinas degrader, given the data set….

[Audio Gap]

Mikael Dolsten

But improve even further outcomes in also early breast cancers with so many now new treatment regimens available in our hands, in our portfolio.

Andrew Baum

And whereas, remind me where your CDK4 inhibitor is?

A – Mikael Dolsten

It’s now in I would say Phase 1b2 studies, both on CDK 4/6 progressed patients showing interesting data and also on CDK 4/6 naive patients. And having being really inspired by the light speed spirit coming from Albert’s way of challenging or indeed to think differently, you could just imagine what’s going on in my head about those data that’s so starting week-by-week, looked very intriguing, working out light speed scenario, how we’d possibly configuring both, CDK4 ARV 471 on a relatively short time frame and to pivot and start this. These are some of the scenario I see coming up based on again, our unique ability to design molecules, pick partners and to be able to execute with enormous growth resources behind the drugs that matters.

Q – Andrew Baum

And then as we think within oncology, this time on hematology, so you have you know an entree drug into even with Elranatamab in BCMA and you’ve got your CD47 from Trillium, which we believe may not share the hemolytic anemia associated with beating FC enabled approaches. Maybe starting with Elranatamab, so from memory its subcute, correct?

Mikael Dolsten

It has unique subcute properties, absolutely. It’s again, designed inside Pfizer with proprietary technology, and I say that mainly because of our focus on having the best platforms. We love to collaborate with other companies to augment them further, but truly we combine platforms with a deep understanding of the diseases we’re going into.

Andrew Baum

And I’m assuming that you’ve got a – you’re going to file or you are looking to file on the Phase 2 data in refractory MM correct?

A – Mikael Dolsten

That’s our view. We have very strong data sets. You have seen responses in the you know 60% to 70% long lasting response, patients that have been through CART’s, ADC’s or types of patient subclasses respond dramatically.

What we think may be unique with this compared to teclistamab is that the profile of this drug also shows a very nice balance between strong efficacy and manageable cytokine release syndrome, and that’s what’s really part of the design when you designed Affinity for the two arms. It’s a two-arm antibodies. The arm for the T-cell versus the myeloma was particularly refined, but what we think is the recipe to get this very high efficacy and moderate the cytokine release syndrome, which puts this class I think way ahead of Car-T.

There was earlier the first targeted therapy that went in into BCMA. I think it was an ADC coming from the company we spoke so much about before and that data set of course looks very dismal if you compare it to the bifunctional antibodies. So it really shows the power of immunotherapies for liquid tumor based on bifunctional antibodies, and we’re super excited about establishing this drug class.

While you spoke about the triple-class refectory, while we’re on our way, you know plans to file, we have a very comprehensive program that we think we can be absolutely in the first wave for us for double-class exposed naive patients that are coming back after cell transplant, etc., and we’re running a big basket of combination among which I think the CD47 has a unique interest.

We think it’s really unique within all the CD47’s that are around. I’m happy later to say why, and it acts with another autoimmune system, the Miley [ph] macrophage, which we think will do very well as a supplement to the T-Cell. So really an area where we now in blood cancers, myeloma particularly, but other blood cancers are trickling down with this type of new immunotherapy.

Andrew Baum

And when you think about the – because – and Albert always approach me for this, it reminds me that he ran the oncology for many years. But [inaudible] my view is that Pfizer is not among the leading oncology players. And while you have notable successes, for example with getting out in Ibrance, the breadth of technologies and competences and the translation into drugs from discovery hasn’t been as what it could have been, and the question is how do you get there? And one, there’s ways to add molecules as you have done, and the other way is to add the right individuals, so you could identify technologies earlier and then either develop them, discover them internally or bring them in.

Anywhere where I am going with this is, another company has gone out of its way to build very deep relationships. They brought in an academic oncologist, so I’m going to be about the late [inaudible] at Astra, they have become an oncology powerhouse. Now yes, they did have a legacy in oncology, something to build on and they were coming from a stronger base. When you look at where Pfizer is, do you see that something that Pfizer needs to do, do they need to grow the academic relationships, build that base or do you think that with the systemic process of adding high profile assets in certain large areas it’s going to get you there?

Mikael Dolsten

Well you know, I’m glad for our success. Early in my carrier I worked with the company and it was thought that you know as you know as a legacy. I think it just illustrates that its technology driven, and those that were the old, large oncology companies will figure it out, have vanished. But those that were in the techsol era, those that where in the CMLA area have you know lost presence. All that had all this wonderful connections and been overrun with other companies that have picked up new technology.

We have built a tremendous leadership in the new era of targeted treatment for home and independent cancer, whether we spoke about breast cancer and I alluded to the many drugs or prostate cancer, we were a leader with extending with multiple drugs coming into combinations. We have spoke about new technology disrupting the blood cancer myelomas and how maybe the previous innovations around protease inhibitor are now likely going to be displaced by the immunotherapies coming in and I feel pleased that we with another company, J&J, that neither used to the oncology companies of the past are taking the lead in breaking up that.

We have been one of the premier in precession medicine through our work with the other company. Lorbrena I think is a very powerful agent and now though our acquisition of Array and BRAF and the whole family of RAF, RAS opportunities, in line in colorectal, in melanoma, so that’s how we are three legged: The home independent cancer, the blood cancer, the precession medicine and we have built a very strong relationship in those areas, and it’s based on new powerful technologies.

Oncologists are not people that look to old family relationships, they look to the best for their patients and the best for the patient is to have the new medicines from the company that have used the newest technologies and are able to run those studies. We have felt that we are having a premier place whenever oncologists are looking for companies, whether it’s invite to conferences or reaching out for knowledge and getting together. So I think we have everything we need, particularly in those areas where we go deep as I alluded to: Breast, prostate/urology, blood, precision medicine and that’s how we win. You select where to win and how to play and you go for it based on understanding the patient’s, designing the best medicines.

Oncology is a huge area. It’s hard for anyone to be everywhere and different companies are carving out their niche. I feel very comfortable that we’re going to grow our place in oncology, through both organic and acquisitions. There are lots of things and you would see us cluster among those areas where we really already are the big player.

Andrew Baum

Excellent! Well, I’m afraid we have run out of time and there’s a lot we could have spoken about, but we didn’t. But Mikael, thank you so much for joining us today. Thank you again.

Mikael Dolsten

Thank you.