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The following contains a transcript for Pfizer Inc.’s analyst and
investor call to discuss the proposed acquisition of Biohaven
Pharmaceuticals Holding Company Ltd on May 10, 2022.
Presentation
Operator
Good day, everyone, and welcome to Pfizer's analyst and investor
call to discuss the proposed acquisition of Biohaven
Pharmaceuticals. Today's call is being recorded. At this time, I
would like to turn the call over to Mr. Chris Stevo, Senior Vice
President and Chief Investor Relations Officer. Sir. Please go
ahead.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
[Audio Gap]
Thank you, Jesse. Good morning, everyone, and thank you for joining
us on short notice. We'll be making forward looking statements,
commentary and statements during the call regarding, amongst other
topics, the proposed acquisition of Biohaven by Pfizer and
Biohaven's and Pfizer's pipelines, in-line products and product
candidates, which are subjects to risks and uncertainties,
additional information regarding forward-looking statements is
available under Risk Factors and forward-looking information and
factors that may affect future results in our SEC filings on Forms
10-K and 10-Q and in the press release we issued this morning.
Forward-looking statements on the call speak only as of the call's
original date, and we undertake no obligation to update or revise
any of the statements.
Joining us for the call today are Dave Denton, Pfizer's Chief
Financial Officer; Angela Hwang, Group President, Pfizer
Biopharmaceuticals Group; Aamir Malik, Chief Business and
Innovation Officer; and Vlad Coric, Chief Executive Officer of
Biohaven. Also joining us for the Q&A session will be Pfizer's
Internal Medicine leadership team, including Global President, Nick
Lagunowich; Chief Development Officer, Jim Rusnak; and Chief
Scientific Officer, Bill Sessa.
I will now turn the call over to Dave.
David M. Denton
Chief Financial Officer & Executive VP
Thank you, Chris, and good morning, everyone. Today, we're very
excited to announce the proposed acquisition of Biohaven's migraine
portfolio. The acquisition gives Pfizer access to the premium
products serving the large and growing unmet patient needs in the
global migraine market. Recall that Biohaven has developed the
first and the only breakthrough medication to both treat and
prevent migraines. Coupled with Pfizer's best-in-class primary care
footprint and our highly experienced field infrastructure, we see
the potential for annual global peak revenues in excess of $6
billion annually. Further, the acquisition is forecasted to not
only drive incremental revenues in the 2025 to 2030 time frame, but
is also forecasted to enhance the company's financial
returns.
Biohaven is a company we've known well and we admired, recently
taking the relationship to a new level and collaborating with them
on the ex U.S. rights to their migraine portfolio late last year.
This proposed transaction represents significant value for both
Biohaven and Pfizer shareholders with a price of $148.50 per share
for a total cash consideration for Biohaven's equity of
approximately $11.6 billion. Excluding shares already owned by
Pfizer, the purchase price represents a 33% premium over the 90-day
weighted average trading price.
Immediately prior to closing the transaction, Biohaven's
nonmigraine neuroscience assets and related personnel, along with
$275 million in cash, will be spun off into a new publicly traded
biopharmaceutical company owned by Biohaven's current shareholders.
Pfizer will retain all the commercial migraine assets as well as
all the late-stage pipeline and early-stage compounds related to
the migraine franchise.
I should note that this transaction is subject to the completion of
the spin-off and customary closing conditions, including the
receipt of regulatory approvals and the approval of Biohaven
shareholders. We expect the transaction to
close by early 2023.
Now with that, let me turn it over to Angela to delve more deeply
into the transaction rationale.
Angela
Hwang
Group President of Biopharmaceuticals Group
Thanks, Dave. This transaction is great for patients, Biohaven and
Pfizer. Pfizer's purpose is to deliver breakthroughs that change
patients' lives, and we see this as an opportunity to help address
this challenge for more than 1 billion patients around the world
suffering from debilitating migraines. NURTEC's differentiating
profile meets the needs of patients suffering from both acute and
episodic migraines, giving patients and health care professionals
an option that has not existed before.
This new business is also a strong strategic fit for Pfizer and our
Internal Medicine business unit. We have a strong legacy in pain
and women's health; a best-in-class commercial organization,
including a top-ranked sales, account management and marketing
team, who have been at the core of creating blockbuster brands such
as Eliquis, Lipitor, Lyrica, Viagra, just to name a few.
Our scale allows us to operate in over 125 markets around the
world. And with this acquisition, we can build global teams across
all markets to ensure the success of this new migraine franchise.
We are already actively planning for potential launches in 70
countries, and we're engaged with health authorities in these
countries to enable successful launches, subject to regulatory
approval.
This transaction is also good for Pfizer shareholders because we
expect to create value beyond the premium that we're already paying
for Biohaven. To accomplish this, we plan to build off the great
work done by Biohaven and bring the scale and expertise of the
Pfizer commercial engine to maximize the opportunities for patients
and our new migraine franchise. We're planning to combine the best
of Biohaven with Pfizer's go-to-market model, which focuses on
meeting customer needs, creating scientific partnerships, providing
best-in-class primary care and patient education to help HCPs
deliver great outcomes for their patients.
Now let me tell you a little bit more about the Pfizer Internal
Medicine business unit, where this new franchise will sit. Anchored
by the market-leading anticoagulant, Eliquis and with a significant
presence in women's health, Internal medicine is the home of
multiple customer-facing teams in commercial and medical who engage
with integrated delivery networks, hospitals, ambulatory centers,
primary care physicians and OB/GYNs. NURTEC ODT, and zavegepant
when approved, will fit well into this portfolio and bring another
market leader for Pfizer in Internal Medicine. In addition to the
marketed products, IM has a deep pipeline with potentially
best-in-class or first-in-class breakthrough assets in diabetes,
obesity, NASH and heart failure amongst others.
Now let me double-click on the market opportunity. Migraine
treatment and prevention represents attractive incremental growth
potential. First, migraine is extremely common with 1 billion
people or over 11% of the people -- of the population worldwide
suffering from migraine. In the U.S. alone, this amounts to 40
million people, which is 1 in 5 women.
Migraine is also debilitating. When at its most severe, it is
categorized by the World Health Organization as among the most
disabling illnesses in the world. Its impact is also magnified.
Migraines are very prevalent among younger working-age people who
care for their families. At the same time, the unmet medical need
is acute. Current standards of care aren't effective, convenient or
tolerable for many patients.
However, not only does migraine put a high burden on sufferers and
their families, it also impacts the economy. Migraines cost the
U.S. economy 157 million workdays and $36 billion per year.
NURTEC ODT will help address these needs. It offers an effective
oral treatment that can be conveniently used for both episodic
prevention and treatment for those who suffer with migraines. And
we expect to see robust growth ahead for the class as well.
I'm sure you saw that VYDURA was recently approved in Europe, and
we couldn't be more thrilled about the opportunity to now bring
this medicine to patients suffering across Europe. In addition, the
product is approved in other markets, including the UAE, Israel and
the U.S. We look forward to building on this momentum in other
markets this year, including the U.K. and China.
Zavegepant is Biohaven's next oral CGRP asset, which they expect
filing acceptance for the nasal intranasal formulation later this
quarter, following the previously announced positive Phase III
results. The intranasal form has ultrafast activity with
improvement seen versus placebo in as few as 15 minutes and allows
use in people with migraine who enjoy symptoms of nausea and
vomiting, and they represent 40% of sufferers. Biohaven also has an
oral form of zavegepant in Phase III clinical trials for prevention
with the results expected in 2023.
So now let me turn it over to Vlad to talk about NURTEC's recent
performance, including the first
quarter financial results that they announced this morning and
their expectations for the year. Over to you, Vlad.
Vladimir
Coric
Chairman of the Board, CEO & President
Thank you, Angela, for that kind introduction. Today, we took a
giant leap forward in delivering on Biohaven's mission to improve
the lives of people with neurological diseases. We are excited that
Pfizer recognized the value of our migraine franchise and will be
delivering this important breakthrough medication to
patients.
Under the leadership of Pfizer, NURTEC ODT will be well positioned
to continue to thrive, ensuring even greater access to a
life-changing migraine medication that finally brings a
debilitating disease under control. As a global drug development
powerhouse, Pfizer will unlock the full potential of our CGRP
franchise, building upon the work we have done in the last 5 years,
including advancing zavegepant, the only intranasal CGRP antagonist
for ultra-rapid pain relief in the acute treatment of migraine. On
this momentous occasion, we are hopeful that patients, caretakers,
physicians, shareholders and all key stakeholders of both Pfizer
and Biohaven can appreciate the long-term value proposition we are
presenting here today.
I want to take a few minutes to talk specifically about the
continued success of the NURTEC ODT launch and Biohaven's first
quarter performance. As Angela mentioned a few minutes ago, we were
very proud to announce in the first quarter, the European
Commission approved rimegepant for both acute and preventative
treatment of migraine. With this approval, rimegepant, under the EU
trade name VYDURA, is now the first approved oral CGRP receptor
antagonist in the EU and the only migraine medication approved for
both acute and preventative treatment. The Biohaven and Pfizer
teams work together with the regulatory agency in Europe to jointly
achieve this incredibly exceptional outcome with an
earlier-than-expected approval.
I also wanted to highlight the continued commercial success of
NURTEC ODT, with the achievement of approximately 2 million
prescriptions written to date in the U.S., an astounding milestone
reached only 2 years after our initial launch. NURTEC ODT is the #1
prescribed oral CGRP antagonist, and we expect this leadership
position will continue going forward.
I am also thrilled to report that NURTEC has now achieved
best-in-class commercial insurance coverage within the oral CGRP
category. Now we have greater than 96% commercial coverage and over
263 million lives covered, which compares to 89% or 238 million
lives covered in the fourth quarter.
In addition to the commercial success of NURTEC ODT, our team
continues to demonstrate its leadership in advancing the science of
pain treatment with 13 presentations at AAN last month.
Particularly noteworthy was a podium presentation we made related
to a reduction in opioid use in patients after starting NURTEC ODT
for their migraine management. Among over 14,000 patients with
migraine who used opioid prior to initiating treatment with NURTEC
ODT, approximately 41% had no opioids refills in the 9 months
following initiation. These findings support the benefit of NURTEC
ODT as an effective and safe migraine treatment that can reduce the
need for opioids and obviously have very broad and significant
long-term implications given the urgency of the opioid
crisis.
Now turning to NURTEC ODT revenue performance. Our commercial
organization performed strongly delivering growth volume of TRxs
for NURTEC ODT despite the expected first quarter seasonality that
we discussed at our last earnings call. NURTEC ODT delivered first
quarter net revenue of approximately $124 million, representing a
182% increase over first quarter of 2021 revenue.
Although first quarter 2022 represents a decrease in net revenue
compared to the fourth quarter of '21, we did see an increase of 8%
in prescription volume compared to last quarter. And the net
revenue decrease was anticipated due to the typical first quarter
insurance dynamics.
Growing NURTEC ODT volume and access for patients require a
significant investment. In these important initial years of product
launch, our strategy has been to drive brand trial and adoption of
NURTEC ODT by investing in patient support programs and working
with payers to ensure patient access, which also results in payer
rebates and volume discounts related to the investments we made for
incremental access.
Of course, this growth was driven in large part by strong TRx
volumes as well as the higher wholesale acquisition cost, or WAC,
we receive on our 2 packs or 16 tablet count prescriptions, which
post our expanded prevention approval in May 2021, has grown
relative to total prescriptions. Just to level set, for the balance
of my discussion, our product offering consists of 1 pack of 8
tablets and 2 packs consisting of 16 tablets, which helps patients
flexibly address migraine needs without ever needing to worry about
running out of supply.
As expected, resetting of insurance policies and deductibles in the
first quarter resulted in an increased copay assistance
program
costs that are seasonal but do impact first quarter revenues. Copay
assistance was also impacted by the dynamic of the increasing
2-pack mix since our approval of prevention last year. We
experienced increased volumes in our 2-pack sales, coupled with an
increased cost to support the prescriptions as our average WAC
increased.
This dynamic sends a high watermark for the year on copay assistant
support in January, and we have already seen a steady decline in
copay assistance coupled with an increase in the TRx volumes on the
latter side of the first quarter, which continues to improve. This
is a very positive sign for net revenue growth over the remaining
of this year.
With respect to the pack mix, we expect that 2 packs as a
percentage of total sales will continue to grow at a modest rate on
a sequential basis as the year progresses. We are estimating
approximately 60% of full year revenues will be achieved in the
second half of 2022, slightly lower than the 70% we experienced
last year as we benefited from a partial prevention approval, which
enhanced our second half '21 net revenue growth. We are expecting a
substantial rebound in second quarter, driven not only by the
alleviation of some of the seasonality factors we touched upon, but
also more favorable volume growth.
As we have indicated since our post prevention approval, our 1-pack
and 2-pack offerings represent flexible approaches for migraine
sufferers across the spectrum, and their utilization is not
necessarily correlated to the intensity or frequency of attacks.
This favorable evolving pack mix and the CGRP oral class growth in
the market provide further potential upside.
Recall, we received the expanded approval for NURTEC in the
prevention in May of '21. Since that time, 2 packs were
increasingly accounting for a greater percentage of volume growth,
which has a net favorable impact on our realized revenue per
prescription. Two-pack product sales are now trending at between
25% to 30% of total product sales, and we expect that trend to grow
in both acute and prevention as patients demand more freedom to
take their medication of choice without fear of supply
shortage.
We take a much more constructive outlook for the balance of 2022,
seeing favorable overall volume tailwinds as awareness for oral
CGRPs has driven patient demand, refining and growing our
physician-facing programs, which drove prescription volume and
resulted in a more fulsome payer coverage of 96% that will
contribute to less patient friction and access -- greater access to
NURTEC.
To provide additional information on the pacing of the seasonality
factors with copay assistance and patient affordability programs, I
want to focus on the next slide. Both patient affordability and
copay programs reached a high point in January and have already
started to decline in February and more appreciably in March, as
you can see in the graph on the left. We expect the GTNs related to
affordability and seasonality will continue to trend lower over the
course of the year. This will favorably impact our realized revenue
per prescription as the year unfolds.
In a similar vein, the chart on the right shows the sharp rise in
blended copay cost per claim paid by Biohaven at the start of the
year. That has recently steadily declined, and you can see in
April, the blended cost has even declined to lower levels than what
we observed in December of 2021.
In sum, investing in our affordability programs contributed to
strong year-end performance, and we're very encouraged that we're
observing early down trends in patient affordability utilization
and copay cost to Biohaven, which we expect will decrease
year-over-year. We think this bodes exceptionally well for the
remainder of the year, and we expect to see substantial increases
in net revenue from second quarter onward.
NURTEC ODT continues to be the #1 migraine treatment in its class,
leading in total Rx volume and share. Specifically, looking at
week-over-week performance, NURTEC ODT is currently maintaining
approximately 48% market share as of the latest script counts. We
believe our market leadership position is a byproduct of NURTEC's
unique product offering, one dose, no titration, one pill to treat
your migraine attacks and prevent future ones from occurring.
NURTEC ODT is the only all-in-one migraine therapy, and this will
continue to differentiate NURTEC ODT from other assets in the
class.
We continue to share this next slide every quarter, which shows a
visible step forward for the CGRP oral class this period as well.
We believe oral CGRP antagonists can ultimately be the first-line
therapy for migraine and could account for about 40% of the overall
migraine market.
The CGRP oral medications, though still somewhat newer entrants in
a deeply entrenched space, continue to make steady inroads in
disrupting the broader migraine market in the U.S. You can see the
oral CGRP lines are near the intersection with the CGRP mAbs this
period, and we believe it's only a matter of time before the oral
class fully overtakes the mAbs, thanks to the ease of use and
patient preference for orals over injectable.
Further, the oral CGRP class continues to make steady progress in
disrupting triptans and topiramate, which have slowly declined
since the emergence of the CGRP class as a whole. Let me provide a
little more insight into this specific segment.
The oral CGRPs are just at the beginning of our growth trajectory,
and NURTEC ODT is changing the standard of care for migraine
therapy. This slide shows the market penetration of the
oral
CGRPs versus the current standard of care: triptans for acute
treatment and topiramate for prevention. The oral CGRPs continue to
grow market share versus these older therapies, which are
associated with cardiovascular risk, cognitive effects and other
adverse events and limited efficacy profiles as well as the
numerous advantages that are now offered by the new oral CGRP
class.
Since the emergence into the class, the oral CGRPs have shown
quarterly increases in both TRx and NBRx volume compared to
triptans and topiramate. As you can see, the growth opportunity
remains sizable, and we continue to see increased penetration of
oral CGRPs as patients become more informed about the fast and
lasting benefits of all-in-one NURTEC ODT. Today, only 22% of
NURTEC ODT scripts are coming from primary care physicians, clearly
a segment where Pfizer excels and a massive opportunity ahead. But
I'll let Nick and team cover this in detail shortly. Pfizer takes
over NURTEC ODT at a very important time in its early development
in order to shape patient care and deliver this breakthrough
medication to patients.
Before I turn the call back over to Nick, I want to quickly thank
the patients who have enrolled in our clinical trials, their family
members and investigators who have participated and are advancing
our pipeline. And I want to reassure you the mission to improve the
migraine standard of care will continue. I also want to thank our
visionary investors, who have helped fund our studies, and our
dedicated employees who help to bring NURTEC ODT to patients. I'm
confident that our mission to restate the standard of care in the
migraine therapy and benefit patients will only accelerate under
Pfizer's leadership. Thank you to the team at Pfizer for
recognizing the importance of this medication, and we are happy to
hand it off into your capable hands.
Angela
Hwang
Group President of Biopharmaceuticals Group
Thank you, Vlad, for your excellent explanation of Biohaven's
success with NURTEC and some of the recent dynamics that you have
faced. Biohaven is a company we know well. We've tracked its
portfolio for several years now and were excited to enter into a
collaboration with them outside the U.S. in November of 2021,
buying a stake in the company at $173 per share. Now we're pleased
to own the rest of the company's migraine franchise on the current
terms.
We've reviewed the Q1 gross-to-net situation as part of our
extensive due diligence process, and we understand the dynamics,
which is why we've baked it into our forecast already. This is not
uncommon, especially during the first few years of a product's life
cycle. What we are compelled by is the long-term potential of
NURTEC, the significant unmet need for migraine patients who are
limited by the drawbacks of existing migraine therapies.
Now let me walk you through how Pfizer will add value to the
migraine portfolio. We have the scale and expertise to further
accelerate this best-in-class asset. Upon close, we will double the
number of our representatives detailing NURTEC and leverage their
strength in primary care, an area, as you've heard just Vlad say,
an area that is still underpenetrated for NURTEC. We expect this
will allow us to call on an additional 70,000 primary care
physicians and OB/GYNs.
Our U.S. primary care sales force is ranked #1 with primary care
practitioners and consists of highly experienced representatives
with an average tenure of 10 years. Our key account management
capabilities are also best-in-class. We also expect to
significantly expand the nonpromotional, field-based medical teams
by eightfold. They will be laser-focused on peer-to-peer engagement
and building health care professional confidence.
Finally, our real-world evidence team will focus on understanding
the impact of migraine on health systems around the world and
evaluating real-world utilization of NURTEC and VYDURA. The global
footprint we will have will allow us to generate real-world data
globally, enabling us to further strengthen the scientific platform
behind these products and improve the way health systems deliver
care for migraine patients and improve patient outcomes.
The market for oral CGRPs is very underpenetrated, and we will work
to accelerate that. In 2021, they represented only 5% of oral
migraine scripts written. But given their advantages over older
drugs on the market, we believe, as we continue to educate doctors
and patients about NURTEC that this class has the ability to grow
significantly to more than 40% of scripts increasing the
penetration by 8x.
Now let me turn it over to Aamir to talk about the fit with
Pfizer's business development strategy and to close out our
presentation.
Aamir
Malik
Executive VP & Chief Business Innovation Officer
Thanks so much, Angela. This transaction aligned with the
priorities that Pfizer has previously detailed for our business
development efforts. First and foremost, we want to create value
for our shareholders by focusing on breakthrough medicines where we
can make a difference. And we believe this transaction does exactly
that by bringing a breakthrough migraine franchise into our
portfolio, which we can then enhance and bring to even more
patients with our commercial capabilities, as Angela just
articulated.
Second, we're looking for bolt-on deals that fit nicely with our
existing therapeutic areas and which have the ability to provide
meaningful revenue growth in the second half of this decade. The
growth trajectory that we expect for NURTEC/VYDURA and zavegepant
delivers squarely during this time frame.
Third, we want to bring in exciting science to strengthen our
therapeutic areas, not deals where the primary value driver is cost
synergies. This proposed acquisition brings to Pfizer the leading
asset in a high unmet need area and one where we plan to
thoughtfully invest to drive top line growth. Collectively, we
believe that the efforts here could enable us to potentially grow
these oral CGRPs to a more than $6 billion global migraine
franchise at peak.
Importantly, we've communicated our ambition to add at least $25
billion in risk-adjusted revenues to 2030 through business
development transactions. And this transaction is expected to
contribute significantly to that goal, building on our recent
acquisition announcement of ReViral and our recently completed
acquisition of Arena. The capital we had planned to deploy at just
over 2x peak sales -- peak revenues reinforces our belief that we
have both the capital necessary and the substrate available to
achieve our goal.
So in conclusion, migraine is one of the most prevalent diseases
worldwide, impacting close to 1 billion patients. There is
significant unmet need, severely impacting patients' daily function
and ability and overall quality of life.
NURTEC is currently the #1 prescribed oral CGRP. Experience, scale,
capabilities will enable Pfizer to maximize this migraine
franchise. And with today's announcement, we are maximizing the
opportunity for patients, and we expect to create a compelling
value for Pfizer shareholders.
And with that, let me turn it back to Chris for the
Q&A.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thanks, Aamir. We will now be pleased to address your questions. As
mentioned earlier, in addition to our speakers, Nick Lagunowich,
President of Internal Medicine; Jim Rusnak, IM Chief Development
Officer; and Bill Sessa, IM CSO, will also be joining us for the
Q&A session. Jesse, please poll for the first
question.
Question and Answer
Operator
[Operator Instructions] Speakers, the first question is from the
line of Evan Seigerman of BMO Capital Markets.
Evan David Seigerman
BMO Capital Markets Equity Research
Really, congrats on the deal, and Vlad it's really good to hear
from you. Can you speak to why Pfizer opted not to fully acquire
Biohaven's assets? I know that there are some earlier assets, and
these arguably could add some interesting signs for what may not
have been a significant additional premium to what you paid. Love
for you to walk me through kind of the thinking there.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thanks, Evan. Aamir will take that question.
Aamir
Malik
Executive VP & Chief Business Innovation Officer
Thanks for the question, Evan. Our business development criteria
has been very clear. We want to focus on breakthroughs that can
make a difference for patients, and we want to focus on where we
can add value through our capabilities. And in doing that, being
very thoughtful and disciplined about how we create value for our
shareholders.
So for us, when we looked at this opportunity, the place where we
feel like we can add the most value is on the CGRP franchise
through the deployment of our commercial capabilities globally, as
Angela articulated, and also in supporting the advancement of
zavegepant. We think that the Biohaven team is very well positioned
to advance their other therapies, and this allowed for us to create
a creative deal structure that creates value for both sets of
shareholders and allows us to continue to be thoughtful and
disciplined.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thanks, Evan.
Operator
Your second question from the line of Louise Chen from
Cantor.
Louise Alesandra Chen
Cantor Fitzgerald & Co., Research Division
Congratulations on the deal. So first question for you is, would
you have any interest to add any additional migraine products to
your portfolio, such as an injectable toxin or anything like that?
And then secondly, how do you see the entry of Pfizer into the
migraine market potentially disrupting the competitive
landscape?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thanks, Louise. Angela will take that question.
Angela
Hwang
Group President of Biopharmaceuticals Group
Sure. We look at all of our opportunities. I think the principles
and the parameters behind our BD deals, you heard Aamir talk about.
And so we will continue to look at all opportunities in that vein.
And when the right one emerges, we'll be able to take that on. But
I think the principles behind how we think about BD,
how they add value to our long-term growth, those are the most
important parameters to consider, not just the therapeutic
area.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Very good. Thank you.
Operator
Your third question is from the line of Robyn Karnauskas of Truist
Securities.
Robyn Kay Shelton Karnauskas
Truist Securities, Inc., Research Division
Congrats on the deal. So could you talk a little bit about maybe
the rate limiting steps toward taking more share from injectables?
And why they've held on to the share that they've had? And how you
overcome that? And second, what are your thoughts for the
opportunity for the inhaled version of your drug?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Yes. That's for Vlad.
Vladimir
Coric
Chairman of the Board, CEO & President
I'm happy to take that. So look, the injectable was launched a
couple of years ago. And what you've seen is that the oral CGRPs
really have taken over the growth in this segment. And what you've
seen is a plateauing of the injectable monoclonal antibodies. We
expect that plateauing is likely to actually start
declining.
And I have to say as a physician, it's a simple choice for
patients, and patients often will prefer orals over injectables. So
I think we're going to continue to do well in the differentiation
there. And it is good for patients to have multiple different
options. But ultimately, we think this is going to be a space
primarily driven by oral CGRP antagonist.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thank you.
Operator
Your next question is from the line of Terence Flynn of Morgan
Stanley.
Terence C. Flynn
Morgan Stanley, Research Division
Maybe 2 for me. Aamir, it sounds like based on your comments, you
expect to continue along this string-of-pearls strategy, so things
like Array, Arena, Biohaven. But just wondering if larger deals are
also on the table still at this point.
And then with respect to the commercial opportunity, the peak sales
guidance of $6 billion is somewhat ahead of consensus expectation.
So just wondering how you guys thought about pricing dynamics,
compliance, maybe the ex U.S. market opportunity, anything you
think the Street is underappreciating?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Okay. Why don't we have Nick take that question. And then if Aamir
has anything to add.
Nick
Lagunowich
Global President of Internal Medicine
Yes. Maybe I'll start with the second question first, Chris, and
then I'll have Aamir jump back to the question about string of
pearls, if that's okay. Okay. So the $6 billion -- so thank you for
the question, Terence. I appreciate it.
This market in migraine is incredibly large. It impacts over 1
billion patients globally. And in the U.S. alone, we got $40
million sufferers of migraine with only about 20% taking a
prescription. And so this is still underdiagnosed and undertreated.
The oral CGRP class has reached blockbuster status already in the
U.S. in 2021 of -- with sales of approximately $1 billion combined.
Well, it really only accounted at that time in 2021 for 5% to 6% of
the overall migraine market.
The oral CGRP class, it has the potential to redefine the standard
for the reasons that you heard from Vlad and that we're seeing in
the marketplace. And we anticipate it's going to grow to 40% of the
total migraine market or potentially beyond. That's 7 to 8x higher
than in 2021.
And NURTEC ODT, it has that unique market position to both treat,
prevent. Its flexibility, I think, is what's really appealing to
health care professionals and to patients. And when you then layer
on zavegepant, the intranasal spray, it relieves pain in less than
15 minutes. And if approved, it will be a breakthrough for patients
who suffer from severe migraines. And these are for patients who
have attacks that hit them at their most unpredictable
times.
And I guess additionally, it's also being developed in an oral
form, which adds another option and expands the franchise into
chronic migraine as well potentially. So with the addition of
zavegepant to the NURTEC combo, we have potentially the ability to
help more patients, addressing their needs and bringing these
innovative treatments forward.
And really, in terms of our ability to execute, I think you heard a
stat there that 22% of the NURTEC volume is coming in primary care.
If you look at sumatriptan for example, about 50% or so comes from
the gap and the opportunity and the ability to execute in primary
care.
And you heard some stats from Angela in her presentation that
talked about the expansion that we're planning. We plan to double
our sales footprint, which will allow us to cover even more PCPs,
ambulatory care centers, urgent cares, EV departments, places where
these patients seek care. And we're going to add in the U.S.
coverage of about 70,000 more PCPs, OB/GYNs and other
specialists.
We're going to engage our key account management teams to take an
organized system approach. So if you look at the work with primary
care as kind of the bottoms-up connection with health care
professionals, the work that the key account management team is
more of a top-down, working with systems of care to identify
challenges understanding the migraine category and working with
those systems to help reduce costs and improve patient
care.
Of course, as Angela said, we're going to build on the body of
evidence with our real-world evidence team, which becomes easier
underneath one umbrella, as one company. And we're going to deploy
our medical teams to support decision-making and to make sure that
health care professionals have the information that they need to
help solve patients' medical challenges.
So we believe that this is a growth market. We're incredibly
excited about this, and I appreciate the chance to take your
question.
Aamir
Malik
Executive VP & Chief Business Innovation Officer
Terence, on your question on deal size, I think you've seen from
our recent deals that we have thoughtfully and deliberately pursued
a strategy of diversification. Between transactions like ReViral,
Arena, Trillium and others, we've been active in multiple
therapeutic areas, in multiple stages of development, including
early commercial with our Biohaven deals. And you've also seen us
do a combination acquisitions, but also other forms of
collaboration and partnership. And we think that, that will
continue to serve us well.
Now specifically, we've also said we are agnostic to size. So if
the right larger opportunity presents itself, we certainly have the
capital and the capabilities to pursue it. But we've also been
clear that we're going to focus on driving our top line growth in
the back half of the decade, rather than large deals that are
anchored on cost synergies. So under that lens, we will continue to
look at all opportunities, and we're genuinely very excited about
the substrate that is ahead.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thanks, Aamir. Thanks, Nick.
Operator
Next question is from the line of Charles Duncan with Cantor
Fitzgerald.
Charles Cliff Duncan
Cantor Fitzgerald & Co., Research Division
Yes. Congratulations to both teams on the transformational
transaction for patients and other stakeholders. Had a question
regarding the NURTEC-driven migraine franchise. And specifically,
when you think about zavegepant, the drug that may be approved, how
could that really add to the current, very successful NURTEC
franchise? And then I had a follow-up regarding the royalties, the
sub-royalties to Biohaven. Can you provide any color on how you
anticipate those being paid?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
So Vlad will talk about the first part on zavegepant, and then Dave
will talk about the royalties, Charles.
Vladimir
Coric
Chairman of the Board, CEO & President
Charles, thanks for the question. And we really think that
zavegepant is going to be a nice, complementary medication for
patients suffering from migraine. As I said earlier, we know
patients typically prefer orals over other routes of
administration. So typically, it's orals are preferred over
intranasal over injectables. And intranasal becomes very important
for the speed of onset because you don't know when a migraine is
going to hit. And as Nick commented, we have a very quick speed of
onset for intranasal zavegepant, within 15 minutes. And so if a
migraine is striking as you're trying to get out of the house or an
important business meeting or the like, you'll have a nice option
there.
In many ways, with Biohaven, we've thought of it as the EpiPen of
migraine, right. Everyone with migraine should have a zavegepant
intranasal around to take control of their migraine and make sure
it doesn't get under way if it comes up in the most inopportune
time.
And lastly, I would add about half the patients experience some
nausea or vomiting during a migraine attack. But what's interesting
is the degree of nausea or vomiting does vary between attacks, and
sometimes you can't take an oral pill. And again, the intranasal
zavegepant offers that flexibility to patients. So we think it's
going to be a nice, complementary addition to the
franchise.
David M. Denton
Chief Financial Officer & Executive VP
And Charles, this is Dave. I think specifically as it relates to
your question. One, I'll just point you to a review of the 8-K that
Biohaven will be filing later today after the market closes with
the SEC on specific deal terms. But specifically to your point
around royalties, suffice it to say that think about this as a low
double-digit percentage for U.S. sales at each tier of sales above
$5.25 billion on an annual basis.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Great. Thank you very much.
Operator
Your next question is from the line of Mohit Bansal of Wells
Fargo.
Mohit
Bansal
Wells Fargo Securities, LLC, Research Division
Congrats on the deal. Maybe if you can talk a little bit about the
process of deciding the capitalization of the new company. Given
that they have multiple Phase III or Phase III-ready assets, how do
you determine the capitalization? And could this be an FTC issue in
terms of whether or not the new company is getting enough
money?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Okay. So a question for Vlad, please.
Vladimir
Coric
Chairman of the Board, CEO & President
Yes. Happy to take that. We spent some time ensuring that the new
company would be adequately capitalized and the amount going into
that company will be sufficient to get us through our inflection
points in well over a year. And I know typically, we like to only
guide just over a year, but it's actually a longer period than
that. I would also point out that we do have some important trial
readouts coming up very shortly on some of those programs, and that
also will affect the company moving forward. So we're excited about
the New Biohaven, and it's very well capitalized for our budgetary
needs well past the year.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Awesome. Thank you, Vlad.
Operator
Your next question is from the line of Umer Raffat of
Evercore.
Umer
Raffat
Evercore ISI Institutional Equities, Research Division
I want to start by saying a huge congratulations to Vlad and his
team for all the hard work over the years. So maybe, Vlad, let me
ask you a question on the call first. Can you remind us how many
total patients have taken the drug so far on a cumulative basis
commercially? And what are you learning about the average duration
in prevention setting?
And I had a couple for the Pfizer team as well. Could you walk us
through -- I understand you're implying $5 billion sales potential.
But what's the breakeven net of Bristol payments, Royalty Pharma
payments and the debt, et cetera? What's that breakeven to make
this deal at least be breakeven? And secondly, what are your
expectations on the 724 patent? And are you expecting to go out the
724 path?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
First question is for Vlad.
Vladimir
Coric
Chairman of the Board, CEO & President
So on the first question. So the number of patients, sorry, Umer,
thanks for the question, by the way. So to date, we have over 2
million prescriptions of NURTEC. We haven't kind of characterized
it as the exact number of patients. But we're at the very early
stages in the hundreds of thousands, several hundreds of thousands
of patients. And we do know that, that is increasing
quarter-over-quarter, so we're really excited about the growth. And
as trial continues, we see further adoption by both physicians and
patients.
The duration of use, Umer, is interesting. Since the prevention
indication, we are seeing an increase of pill utilization and the
number of second 8 packs that has brought our total number of pills
up. And patients, we hear, really appreciate the ability to flex
back and forth between acute and prevention. And so not only does
that help with the pill count and the durability of refills, but it
gives patients real maximum control over their migraine in order to
dial up or down prevention as they need in their lives. So
thanks.
David M. Denton
Chief Financial Officer & Executive VP
Umer, this is Dave. I think just a couple of things to keep in
mind. One, as Angela said, this is a market where we have 1 billion
patients worldwide that really has an unmet need from a therapeutic
perspective, number one.
Secondly, our forecast is for peak volumes of around $6 billion.
And I would say that as we look at the deal structure and we look
at the economics around the deal, not only is this deal going to
drive significant value for the patients that we're going to serve
globally, but importantly, it's going to have a high-level return
for Pfizer shareholders specifically.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thanks very much.
Operator
Your next question is from the line of Chris Shibutani of Goldman
Sachs.
Unknown Analyst
This is [ Dan ] on for Chris. Congrats on the deal. Two from us.
First, could you please talk about your focus on partnerships
within your business development strategy? Are there certain areas
or situations where you see this as most advantageous? And do you
see it as a potential precursor to full acquisition as it was in
the situation?
And second, on the ex U.S. opportunity within the $6 billion peak
sales, if you could talk generally just kind of about the
contribution ex U.S. to your expectations of the product sales at
peak?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Okay. Thanks very much, [ Dan ]. So on partnerships versus full
acquisition, Aamir will address that. And then on the ex U.S. sales
contribution, Nick will address that, please.
Aamir
Malik
Executive VP & Chief Business Innovation Officer
Thanks for the question, Dan. On partnerships, as I alluded to
earlier, as we embark upon our business development strategy,
partnerships are very much part of what we were thinking about. And
in fact, some of our most successful BD deals have come through
collaborations and partnerships. So we very much see that as part
of what we are going to do going forward. And with regards to
whether that's a precursor to something else or not, we look at
every deal and every transaction in collaboration as what we do in
the moment being the right opportunity for us to create value for
our shareholders. As situations change over time, we continue to
reassess, and we will do that with all of our deals.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Nick, on the ex U.S. sales. Sorry, go ahead.
Nick
Lagunowich
Global President of Internal Medicine
Yes. Yes. Thanks, [ Dan ], for the question. So first, I want to
mention how thrilled we are by the approval in the EU for VYDURA.
We see significant growth potential outside the U.S. We're actively
planning in 70 markets around the world, and we expect to begin in
the second half of the year to bring medicines to
patients.
We're tremendously excited by the opportunity because migraine has
such a high impact there and high unmet need globally. And this is
pretty universal across the board. In terms of your question
regarding the mix, we expect to see sales more heavily skewed
towards the U.S. So thanks for the question.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thank you.
Operator
Next question is from the line of Carter Gould of
Barclays.
Carter Lewis Gould
Barclays Bank PLC, Research Division
Congrats to both teams. Maybe just following up a little bit on the
prior question. Since you guys just negotiated the OUS
collaboration a few months ago, I guess can you just comment on
kind of what was the spark to change the evolution in the
relationship? Was it just getting comfortable with the U.S.
competitive dynamics? Or does the broader market kind of create an
opportunity that wasn't there before?
And then as you think about the deal, did Pfizer make any
assumption or have interest, I guess, in the additional
indications, whether the pain adjacency or nonmigraine indications?
And how we should think about those?
Aamir
Malik
Executive VP & Chief Business Innovation Officer
Thanks for the question, Carter. This is Aamir. When we initially
did the ex U.S. deal, we were incredibly excited about the
breakthrough potential of NURTEC and zavegepant. And at the time,
we felt the best way for us to add value and create value for our
shareholders was to leverage our ex U.S. commercial capabilities to
help accelerate the launch and bring it to patients outside the
U.S.
Since then, we've got a chance to know the company better, know the
asset better. And we felt that there was an additional opportunity
for us to leverage our capabilities in the U.S. And for that
reason, we expanded what we're doing in terms of what we're
announcing today. So it was very much an evolution of how we saw
the opportunity and how we saw the ability to create value and add
value. And we did both things in a way that we felt was very
thoughtful and responsible.
With regards to other indications, we're excited to see what the
upcoming data will show. And to be clear, all of the projections
that we've talked about today are focused on the CGRP franchise in
migraine. And as data becomes available and other opportunities
present themselves, we'll certainly look at it and assess
it.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thank you.
Operator
Your next question is from the line of Steve Scala of
Cowen.
Stephen Michael Scala
Cowen and Company, LLC, Research Division
I apologize for a skeptical question, but Pfizer noted that there
are 1 billion migraine sufferers worldwide. I would imagine that
there were hundreds of millions, if not, billion migraine sufferers
in 2002 when it looks like Imitrex peaked at $1 billion, which I
think was the most successful migraine drug ever. I know it's often
said that triptans were avoided because of tox, but I watched their
development, launch and decline and don't recall safety being as
big an issue at that time as it is being made out to be today. And
I don't think Imitrex has a black box. So I think that there is a
reasonable chance that the Biohaven franchise won't fulfill the
potential that Pfizer believes. So how did Pfizer become
comfortable that it will be different this time than, say, back in
2002?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
I think Vlad can best address the history there.
Vladimir
Coric
Chairman of the Board, CEO & President
I'm happy to talk about also the differentiation versus triptans.
I'll say as a physician, I prescribed these, and there is a
distinct difference, I believe, in the profile of the novel agents
that have come on the market versus the older triptans and other
medications. Take a look at the triptan label, you'll see that
one's supposed to administer the first dose in the presence of a
physician due to the vasoconstrictive effects on the cardiovascular
system as well as the potential impacts in the cerebrovascular
system. Those -- when you have new options that don't have those
side effects, it's clear that I believe those -- it will become the
standard of care due to the lack of vasoconstrictive effects and
the lack of effects on cerebrovascular.
I would also add that the older class of medications are well-known
to cause medication over use headache or rebound headaches. So
think about this. You have a migraine, and the treatment that you
use actually causes more migraines, right. That's what a rebound
headache is. That is a phenomenon you do not see with CGRP class of
medications.
So I think when clinicians and patients who experience the
treatments view the new profile of the novel agent, there is a
distinct advantage over the older agents regarding the risk
characteristics. And I believe we are now moving into a new
standard of care that is going to finally treat migraine the way it
should be.
And I've heard patients tell me when they get a treatment for
migraine, they want their migraine going away and they don't want a
lot of new problems. And I think the novel agents bring you closer
to that patient desire.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Vlad, thank you very much for that perspective.
Operator
Your next question is from the line of Chris Schott of
JPMorgan.
Christopher Thomas Schott
JPMorgan Chase & Co, Research Division
Just 2 questions for me. I'm trying to get a sense in terms of the
Pfizer infrastructure. How much does this deal leverage your
existing Internal Medicine infrastructure, maybe specifically
existing sales reps? Or is this more about the company has this
experience building markets like this? So we should think about
this functioning more as a kind of a stand-alone migraine franchise
with incremental OpEx supporting the step-up in the brand as a
whole. So I'm trying to get a sense of just the incremental cost
associated with the increased support you're going to put behind
the brand.
And then the second question was on BD priorities. Are there
business units that make particular sense at this point for future
deals and where there's capacity to add pipeline and commercial
assets over others? I guess it seems like we've seen a deal in
Internal Medicine and previously, we saw one in I&I. Should we
think about those as areas that there -- maybe there's going to be
a pause in BD as you digest those acquisitions? Or is there enough
capacity across the organization that -- which is kind of, I think,
is still the whole scope of the Pfizer range of business units all
looking at transactions going forward?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Okay. Thanks for the great question. Angela is going to start, and
then Aamir will add on the BD priorities.
Angela
Hwang
Group President of Biopharmaceuticals Group
Yes. So Chris, earlier in my opening comments, we talked about the
fact that Pfizer's scale and the expertise is what we bring to this
deal and what we could do to increase the value. So from that
perspective, certainly, there are going to be incremental things
that we can do, right. So now these incremental things already
exist. So these are not more people we have to hire or more teams
we have to set up. We are already in the primary care space. And
we'll be able to add a call list of 70,000 more physicians to what
NURTEC is currently doing, just using our existing field
force.
So I think that -- and let's take another one, the medical
expertise that we also talked about. We'll be able to
multiple-fold, I think 8x, the amount of medical, peer-to-peer
interactions that over and above what is currently done, again,
just using the existing footprint of Pfizer.
So I think that from a fixed cost perspective, there is not
incremental spending. But of course, the ability to make additional
calls, the ability to expand the opportunity to more targets, more
accounts, that's sort of what we bring to the table. And again, it
comes back to the scale of the machinery that we have and the depth
of expertise that we have in primary care.
Aamir
Malik
Executive VP & Chief Business Innovation Officer
Chris, on your question about BD priorities, I mentioned earlier,
our focus is going to be guided by places where we can bring
breakthroughs to patients and where we have the ability to add
significant value to shape those breakthroughs. And the good thing
is, across all of our therapeutic areas, across all of our various
functions, we feel that we have ample capabilities and capacity to
do many transactions. And we also have the capital firepower to
pursue those. So you should expect to see us following the science
and not limiting our BD focus to any one particular therapeutic
area.
We're going to continue to be very disciplined about where we can
leverage those capabilities to create real value for our
shareholders. But we see opportunities across the board for us to
do that internally. And externally, we think the substrate is quite
compelling across a broad range of therapeutic areas.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thank you very much.
Operator
Last question is from the line of Kerry Holford of
Berenberg.
Kerry Ann Holford
Joh. Berenberg, Gossler & Co. KG, Research
Division
Just 2 quick ones for me, please. You talked about doubling the
number of sales reps in the field. I wonder if you would be willing
to detail the actual numbers of reps that Biohaven has in place
today?
And then secondly, you see intranasal CGRP designed to be used as
monotherapy in the acute setting. Or are you also looking perhaps
at combination in the chronic setting, perhaps with NURTEC, for
patients who have breakthrough symptoms?
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thanks very much. Angela is going to answer the question on the
reps.
Angela
Hwang
Group President of Biopharmaceuticals Group
Just a quick response on that. Just for competitive reasons, it's
just a level of detail that we are not able to share, both on
Biohaven's side.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
For the combo or mono use for zavegepant, Vlad is going to address
that.
Vladimir
Coric
Chairman of the Board, CEO & President
Yes. No. So look, patients who need preventative therapy do need
something for breakthrough. So obviously, if somebody is on NURTEC,
they're going to be able to flex back and forth. And then
zavegepant is a different molecule. And so we do believe it will be
complementary and add to the market share rather than take away
from anything on NURTEC.
And I do want to comment that I think regardless of whether one's
on NURTEC, a mAb, a competitor agent that's an oral, the need for
an intranasal, there is no other CGRP antagonist intranasal that
can deliver this speed of onset with the profile I referred to
earlier, regarding the lack of rebound headaches and the lack of
addiction potential and lack of cardiovascular effects. So we think
that intranasal is going to be another important tool in patients'
tool kit to combat migraine.
Christopher J. Stevo
Senior VP & Chief Investor Relations Officer
Thank you, Vlad. Thank you, Angela. Thanks for that question,
Kerry. All right. That was our last question. I'd like to thank all
of our speakers for their time and our listeners for their interest
and for joining us on such short notice. Should you have any
further questions, please reach out to the IR team, and we'll get
you answers. Thank you very much. Good day.
Operator
This concludes today's conference call. Thank you all for
participating. You may now disconnect.
Disclosure Notice
This release contains forward-looking information about Pfizer’s
proposed acquisition of the Company, the Company’s related spin-off
of its development stage pipeline compounds, the Company’s
commercial and pipeline portfolio, including rimegepant and
zavegepant, expected best-in-class and growth potential, and
Pfizer’s Internal Medicine portfolio and growth potential,
including their potential benefits, that involve substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, risks related
to the satisfaction or waiver of the conditions to closing the
proposed acquisition (including the failure to obtain necessary
regulatory approvals and failure to obtain the requisite vote by
the Company’s shareholders) in the anticipated timeframe or at all,
including the possibility that the proposed acquisition does not
close; the possibility that competing offers may be made; risks
related to the ability to realize the anticipated benefits of the
proposed acquisition, including the possibility that the expected
benefits from the acquisition will not be realized or will not be
realized within the expected time period; the risk that the
businesses will not be integrated successfully; disruption from the
transaction making it more difficult to maintain business and
operational relationships; risks related to diverting management’s
attention from the Company’s ongoing business operation; negative
effects of this announcement or the consummation of the proposed
acquisition on the market price of Pfizer’s common stock, the
Company’s common shares and/or their respective operating results;
significant transaction costs; unknown liabilities; the risk of
litigation and/or regulatory actions related to the proposed
acquisition, spin-off or the Company’s business; risks and costs
related to the implementation of the separation of Biohaven
Research Ltd., including timing anticipated to complete the
separation and any changes to the configuration of the businesses
included in the separation if implemented; the risk that the
integration of the Company and Pfizer will be more difficult, time
consuming or costly than expected; other business effects and
uncertainties, including the effects of industry, market, business,
economic, political or regulatory conditions; future exchange and
interest rates; changes in tax and other laws, regulations, rates
and policies; future business combinations or disposals; the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as the
possibility of unfavorable new clinical data and further analyses
of existing clinical data; risks associated with interim data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from the clinical studies; whether and when drug
applications may be filed in particular jurisdictions for
rimegepant or zavegepant or any other investigational products;
whether and when any such applications may be approved by
regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the product's
benefits outweigh its known risks and determination of the
product's efficacy and, if approved, whether rimegepant, zavegepant
or any such other products will be commercially successful;
decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of rimegepant,
zavegepant or any such other products; uncertainties regarding the
impact of COVID-19; and competitive developments.
You should carefully consider the foregoing factors and the other
risks and uncertainties that affect the businesses of Pfizer and
the Company described in the “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results” sections of
their respective Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q and other documents filed by either of them from time to
time with the U.S. Securities and Exchange Commission (the “SEC”),
all of which are available at www.sec.gov. These filings identify
and address other important risks and uncertainties that could
cause actual events and results to differ materially from those
contained in the forward-looking statements. Forward-looking
statements speak only as of the date they are made. Readers are
cautioned not to put undue reliance on forward-looking statements,
and Pfizer and the Company assume no obligation to, and do not
intend to, update or revise these forward-looking statements,
whether as a result of new information, future events, or
otherwise, unless required by law. Neither Pfizer nor the Company
gives any assurance that it will achieve its
expectations.
Additional Information and Where to Find It
In connection with the proposed transaction, the Company will be
filing documents with the SEC, including preliminary and definitive
proxy statements relating to the proposed transaction. The
definitive proxy statement will be mailed to the Company’s
shareholders in connection with the proposed transaction. This
communication is not a substitute for the proxy statement or any
other document that may be filed by the Company with the SEC.
BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS
ARE URGED TO READ THE PRELIMINARY AND DEFINITIVE PROXY STATEMENTS
AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH
THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE IN THE PROXY
STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Any vote in
respect of resolutions to be proposed at the Company’s shareholder
meeting to approve the proposed transaction or other responses in
relation to the proposed transaction should be made only on the
basis of the information contained in the Company’s proxy
statement. Investors and security holders may obtain free copies of
these documents (when they are available) and other related
documents filed with the SEC at the SEC’s web site at www.sec.gov
or on the Company’s website at
https://www.biohavenpharma.com/investors.
No Offer or Solicitation
This communication is for information purposes only and is not
intended to and does not constitute, or form part of, an offer,
invitation or the solicitation of an offer or invitation to
purchase, otherwise acquire, subscribe for, sell or otherwise
dispose of any securities, or the solicitation of any vote or
approval in any jurisdiction, pursuant to the proposed transaction
or otherwise, nor shall there be any sale, issuance or transfer of
securities in any jurisdiction in contravention of applicable
law.
Participants in the Solicitation
The Company and certain of its directors, executive officers and
employees may be deemed to be participants in the solicitation of
proxies in connection with the proposed transaction. Information
about the Company’s directors and executive officers is set forth
in its proxy
statement for its 2022 annual meeting of shareholders, which was
filed with the SEC on March 11, 2022. Other information regarding
participants in the proxy solicitations in connection with the
proposed transaction, and a description of any interests that they
have in the proposed transaction, by security holdings or
otherwise, will be included in the proxy statement described above.
These documents are available free of charge at the SEC’s web site
at www.sec.gov and by going to the Company’s website at
https://www.biohavenpharma.com/investors.
Biohaven Pharmaceutical (NYSE:BHVN)
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