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Submission: On December 30 via manual from US — Scanned from DE
Submission: On December 30 via manual from US — Scanned from DE
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BioTech
MRNA $250.13 -1.47 0.58%
HERE’S WHAT HAPPENED TO BIOTECH THIS YEAR
Contributor
Brad Loncar
Published
Dec 28, 2021 10:40AM EST
Credit: Photo by National Cancer Institute on Unsplash
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After seeing the successes of the likes of Pfizer (PFE) and Moderna (MRNA) in
the news practically every day during this second year of the pandemic, the
casual observer could be forgiven for assuming that the biotech sector is having
a banner year in 2021. Such an assumption would also seemingly fit, one would
think, with the fact that the broader stock market has been regularly making new
highs this year. However, if you are the casual observer, you might be surprised
to learn that the reality is far from it. Not only is biotech not having a
rip-roaring 2021, but the sector is in fact arguably having its worst year in a
decade. We biotech investors are really feeling it.
Below is the harsh reality laid out in a chart. While the total return of the
S&P 500 Index is up 29.4% year-to-date through December 27 (as represented by
the SPY ETF that tracks it), the S&P Biotechnology Select Industry Index is down
-18.2% over the same period (as represented by the XBI ETF that tracks it). In
fact, biotech is the worst performing of any of the 11 S&P 500 sectors this year
(note: XBI is equal weighted. Within the biotech community, it is generally
believed to represent the performance of typical mid-to-small cap biotech
stocks). As a biotech investor, it is honestly bad enough to be having such a
challenging year, but to be having it at a time when the broader stock market
makes all-time highs is about as frustrating as it gets. So, what in the world
is going on here?
If you are surprised to see the chart and want to better understand the context
and the drivers causing it, I’ll try to bring you up to speed by explaining what
I think are the elements that have contributed to this year’s challenging
environment for biotech. Also, I’ll try to inject some optimism throughout my
analysis. While this has been a year we biotech investors would like to forget,
I am personally optimistic heading into 2022 (note: I generally wasn’t heading
into 2021) and will explain why I think things might be much better next year
regarding these elements.
1. The Honest Truth: Many biotech stocks started 2021 in a bubble valuation
territory
If one looks back on the year with an open mind, I think you realistically must
accept the fact that a large portion of biotech, which peaked on February 8,
entered the year in a bubble valuation territory. I was worried about the
possibility of this happening heading into the year because the pandemic and
other factors put biotech in the spotlight, and too much money was flowing into
the sector as a result. It is of course generally a good thing when investment
in biotech increases. However, given the scale of the sector, it is best when it
flows in with moderation and over a reasonable period. Biotech can only handle
only so much at a time, or otherwise dislocations occur. That is what I believe
caused a mini bubble this time last year.
For example, there is a genomics ETF that grew from $2.5 billion in assets to
$12.5 billion over a three-month period from mid-Nov 2020 to the mid-Feb 2021
biotech peak. Approximately $7 billion of this was due to pure cash flowing into
the fund. This kind of explosion in AUM (assets under management) for one fund
is unprecedented in our sector. While it is a nice accolade for the manager, it
caused a big problem for stocks. Biotech is a shadow of the tech sector and
individual biotech companies do not have the scale to take in the kind of money
that comes with those inflows over such a short period of time without stock
prices being significantly moved. That is how a genomics company like Editas
Medicine (EDIT) tripled from $30 to $90 during the same three-month period with
no change in fundamentals, to illustrate one dislocation out of many.
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I believe what has been happening ever since February 8 is simply a
rationalization of prices as they come back down from the inflow-fueled mania.
XBI is now down -34% since then, which I think is essentially a hangover effect
from all the attention. While it has been painful to experience, the good news
is that I personally do not believe this is the type of dislocation that takes
years to recover from such as some of the bigger bubbles we have seen in history
like the internet bubble of the 1990’s. The fundamentals of biology today are
too strong for that to be the case, I believe. I think this is more likely the
kind that results in roughly a bad year like we have been experiencing lately. A
lot of good companies have been dragged down with it, and I believe there is
compelling value in certain areas of the sector today if you follow the right
science.
2. It has been hard for the sector to digest the numerous IPOs that have been
happening
The last two years have seen an incredibly strong IPO market for biotech. Just
as with inflows into already public stocks, a strong IPO market is generally a
good thing, but this is another element that is best when played out in
moderation and over a reasonable period, or dislocations occur. In 2020, there
were over 75 biotech IPOs, and in 2021, there have been over 100. These numbers
do not even include the numerous SPAC mergers that have taken place. This IPO
volume is twice the typical rate for our industry. That’s too many new companies
over too short a period, in my opinion, for the biotech market to be able to
efficiently handle. It is going to take time for specialist investors to digest
all of that. There are approximately 700 publicly traded biotech companies on
U.S. markets today vs. approximately 125 in 2012. It is a great thing overall,
but this type of explosive growth at times can cause natural growing pains.
Another issue with the IPO market lately is not just the sheer number of
companies going public, but how early stage they generally are in their
development. In fact, many biotech IPOs today are preclinical companies, meaning
they have not yet started the human stage of testing of their drugs. A handful
of years ago it was unusual, if not taboo, for a preclinical company to go
public, but today it is quite common. This is a sign that many companies going
public lately are immature and have not yet reached a proof-of-concept moment
that helps investors gain a higher conviction through data that their drug or
platform might work. It also means that the failure rate of such companies is
likely to be high. Earlier stage companies also typically have much thinner
liquidity than later stage ones and can get dragged down hard in a bad market
like we have today.
I expect the IPO market to rationalize in 2022 and believe this will be a good
thing for the sector overall. For years, crossover investing, which is when
funds invest in private companies shortly before they go public and often also
participate in the actual IPOs as well, has been like printing money in biotech.
Earlier this year, I heard crazy stories about funds that are new to biotech
fighting to get in on crossovers since the market has historically been so
lucrative. However, the music finally stopped and many of those crossover
investors are now underwater in the companies they have helped bring public, and
in many cases they are stuck in less than ideal liquidity situations.
Approximately, 80% of the 100+ class of 2021 biotech IPOs are currently
underwater today. After being stung for the first time in many years, I think
many of these crossover investors will be more discerning about the companies
they take public in the future, and this will reduce the overall numbers of
them. That’s not necessarily a bad thing for the overall sector.
3. Uncertainty raised by the Federal Trade Commission (FTC) put a chill on
mergers and acquisitions earlier this year
Mergers and acquisitions (M&A) is always an important contributor to the overall
health of biotech markets. Because biotech is so risky and volatile, a part of
owning any smaller biotech company is your hope as an investor that there is at
least a chance it could be acquired by a larger pharmaceutical company for a
premium. In investing we call this a call option, and it has value. Take the
call option away, and the risk vs. reward ratio of investing in these smaller
companies changes dramatically. Therefore, it is always important for there to
be a healthy level of M&A activity in the sector. When one company gets
acquired, investors think they know what other companies might be acquired, and
this dynamic tends to lift all boats and creates a healthy valuation floor when
M&A news is regularly happening.
Unfortunately, 2021 has been one of the slowest years for biotech M&A in a
decade, and I believe this has been a big factor in biotech’s mediocre year. One
reason for this is because large companies have been focused on COVID, but also
another key reason is because of something else that unexpectedly arose in
Washington in March that threw extra uncertainty into the mix. On March 16, the
Federal Trade Commission (FTC) issued a press release saying it was going to
create a working group with its European, Canadian and other global regulatory
counterparts to study whether pharmaceutical sector M&A was contributing to high
drug prices, and therefore, whether deals should get a higher level scrutiny in
the future. The problem is that it was announced in a very vague way that
created a lot of uncertainty in the market.
Biotech industry people and investors realistically understand that FTC may want
to scrutinize mega mergers more closely, such as when Bristol Myers Squibb
acquired Celgene, for example. What is less clear is whether this announcement
was also referring to smaller, bread and butter type deals where a large pharma
buys a mid-cap or smaller biotech company. One such deal when Roche bought a
gene therapy company called Spark Therapeutics in 2019 took many months longer
than expected to be reviewed and made some of us wonder if there was change
afoot at FTC. In March, the acting FTC Commissioner was asked about the
Roche/Spark category of deals on a press call and she inferred that the FTC’s
new interest was not about size and that those kind of deals could in fact be
fair game for increased scrutiny in the future. If true, I believe this could be
problematic because, as I described above, the biotech sector needs call options
on companies like Spark to be funded robustly.
Ever since the announcement in March, I think the uncertainty of the messaging
by FTC made pharma companies a little apprehensive about doing deals. Second
quarter M&A volume plunged by the most in a decade and the third quarter was not
much better. However, the good news is that pharma companies did in fact begin
to test the waters starting with relatively safe deals over the summer, and we
have seen them all go through smoothly. These include Sanofi acquiring Translate
Bio, Sanofi acquiring Kadmon, Pfizer acquiring Trillium Therapeutics and Merck
acquiring Acceleron. The recent Pfizer for Arena Pharma deal could be a little
more of a close call. If deals like these continue to go though, I think biotech
should be fine over the long term. It is good news for our sector that they are
happening, and I think this could open the flood gates to more deals in 2022.
In fact, the number one element I think could catalyze a positive year for
biotech in 2022 is that I believe it might be a mega year of M&A ahead. Large
companies like Pfizer, Novartis and Sanofi have a lot of cash on the balance
sheet that they need to spend to earn a return on capital. Consider the many
billions that Pfizer will likely be bringing in from both covid vaccines and
treatments in years to come. They need to spend a lot of it in the relative near
term to be financially efficient. I believe a perfect storm is coming together
to spark an M&A boom: large companies will have billions to spend, targets are
generally trading at materially lower prices than they were a year ago, and the
FTC issues appear to be improving (though not going away entirely) for the kind
of deals that are so important for the health of the sector. In my view, this
alone can spark a generally strong year for biotech in 2022 if M&A roars back to
fruition.
4. The changing of administrations in Washington has naturally caused and other
regulatory uncertainties
FTC is not the only source of uncertainty in Washington that has impacted
biotech lately. Given how highly regulated biotech is as a sector, it is only
natural that investors and the industry at large would take a cautious stance
during a transition period in administrations like has happened this year.
Unfortunately, in addition to the more common issues you might expect to arise
during such a time, this year has also been marked by a few unexpected surprises
in policy that I think have negatively affected investor sentiment as well.
First, it was unexpected in May of this year when the United States Trade
Representative publicly spoke in favor of waiving intellectual property (IP) on
Covid-19 vaccines. IP is the lifeblood of biotech. If you have no IP, then you
have no biotech sector. Therefore, it was disappointing to see the United
States, the world leader in biotech, not firmly stand behind IP. Given the
sophistication required to manufacture Covid-19 vaccines, it is unlikely that
such a waiver would accomplish anything tangible, and I believe it was therefore
unnecessarily damaging to even suggest it publicly. Other nations such as
Germany came out against the policy and stood up for IP.
Second, also relating to IP protection, President Biden signed an executive
order in July that lifted a ban on using “March-In-Rights” to lower drug prices.
March-In-Rights are a tool where if the federal government believes it has
contributed to the creation of intellectual property of a company’s drug through
federal grants or research, it may be able to waive the IP and allow another
company to manufacture the drug for a lower cost. Utilizing March-In-Rights has
been floated in the past as an idea to cancel the IP on innovative HIV and
prostate cancer medicines, for example, but was ultimately not followed through
on. It is such a touchy subject for the industry that the Trump administration
formally banned March-In-Rights as a lever to give owners of IP peace of mind on
this. To potentially put it back on the table erodes confidence in a fundamental
core principle of the business.
Third, the administration and congress have increased efforts to enact policies
they believe will lower drug prices. We all strive for more affordable prices
for patients, but we also strive to ensure it is done wisely. I believe the most
potentially damaging idea floated recently has been to allow Medicare and other
government purchasers to negotiate drug prices unilaterally. The idea of drug
price negotiations is not unworkable, the problem is that congress’s initial
idea on how to structure it would have been to impose large fines on companies
if the government believes they are not negotiating in good faith. The problem
here is that it creates an atmosphere that is not a true negotiation. While this
specific element has been discarded for now, the future direction of drug
pricing reform seems clear. All of it has likely contributed to the weakness of
the sector in 2021.
These issues aside, I do think the Washington factor might quiet down next year.
It is not uncommon for new administrations to aim high with new policies in
their first year and then come back to a more rational position during back and
forth of negotiations. We have already seen this play out to a certain degree on
elements of drug pricing, and I think we will likely see it occur on some of
these other issues as well now that the negative impact has been clearly felt
and communicated.
5. Financial sector issues may have affected biotech prices
There are also a handful of other issues relating to the financial markets that
some people believe have contributed to biotech’s difficult year in 2021. I
think probably the most legitimate one is inflation. Most biotech companies have
no revenue today and therefore are valued based on the present-day value of
revenue (risk adjusted) that is far off into the future. This means that if the
present value of a future dollar becomes worth less today due to inflation, it
will be these companies with far out revenue that are most affected in valuation
today. Unfortunately, there isn’t anything an investor can really do about
inflation, but it is something to be aware of. My philosophy is to mostly ignore
it and to focus virtually entirely on a company’s scientific merits, because
science is make or break and something like inflation will at best affect the
periphery.
Related to inflation is deciphering what kind of moves the Federal Reserve will
be making and how it might affect the sector. For years the Fed has flooded the
market with dollars via an easing policy, which has benefited risk assets like
biotech. Alternatively, as the Fed pulls back on the money supply through
tapering, it might make some elements of investing in our sector a little more
of an uphill battle. Again however, my policy is to focus on finding good
companies conducting the best science and to not obsess about something that is
out of my control like the Federal Reserve. A company that succeeds for patients
is likely to do well regardless of the interest rate environment.
Another issue that some people think has impacted biotech stocks lately is the
idea that cryptocurrency mania has lured away speculators from biotech who look
for high risk areas. I personally think this theory is bunk and is not material
enough to have a tangible impact on the sector’s long-term success. I am not
sure it is the type of capital we want in the sector anyway. In my opinion,
biotech can thrive no matter how big crypto becomes (or not) and I believe the
two are entirely unrelated.
6. Biotech is naturally volatile and years like this do happen
Lastly, I will conclude with a closing thought relating to this challenging
year. Biotech is a rollercoaster. It is not uncommon for years like this to
happen. In fact, two of the prior five years were down not unlike this one. It
always feels difficult when you are going through it. Past performance is no
guarantee of future results, and nobody can predict what will happen in the
future. Challenging year aside, I have never been more excited about advances in
science that are happening today. I cannot wait to see where science takes us
next year.
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S&P 500, Dow close down but still poised for big annual gain
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BRAD LONCAR
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Brad Loncar is a biotech investor and CEO of Loncar Investments, a firm that
specializes in the creation of precision biotech indexes. He is the creator of
two Nasdaq-listed biotech focused ETFs.
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Why Moderna Stock Plunged TodayWhat happened Shares of Moderna (NASDAQ: MRNA)
fell 12% on Wednesday after a court ruling placed a portion of the biotech's
blockbuster COVID-19 vaccine proceeds at risk.Nasdaq
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Fauci says coronavirus infections might be plateauingDr. Anthony Fauci, the top
U.S. infectious disease expert, said on Thursday that based on recent seven-day
averages, coronavirus infections may be about to hit a plateau in the United
States.Nasdaq
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Pfizer Rewards Shareholders With 2.6% Dividend
HikePharmaceutical and biotechnology company Pfizer, Inc. (PFE) recently
announced a quarterly dividend of $0.40 per share, an increase of about 2.6%
from the previous dividend of $0.39. Following the news, shares of the company
rose 1.3% on Friday to close at $52.78 Dividend Payment Date The dNasdaq
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Stimulus Update: The Push for a Fourth Stimulus Check and Who Should Get ItImage
source: Getty ImagesNasdaq
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Moderna, Pfizer, Johnson & Johnson: How Are Covid Vaccine Stocks Doing?Our
indicative theme of Coronavirus Vaccine stocks – which includes a diverse set of
U.S. based pharma and biotech stocks that are working on Covid-19 vaccines – is
up by about 730% year-to-date, on an equally weighted basis, compared to the S&P
500 wNasdaq
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