Biotechs with escalating revenues?

My family is holding five biotechs at the moment: Novavax, Ionis, Immunomedics, bluebird bio, and Spark Therapeutics. Whether or not any of these would qualify as Saul stocks is debatable. Pharmaceuticals are heavily regulated by the FDA. If you get an approval, you often have a monopoly. And demand is usually built in. As a consequence, rapid revenue growth is often assured. And the stock jumps can be amazing.

Novavax (NVAX). They have a vaccine for a horrible disease that kills babies, called respiratory syncytial virus, or RSV. This is one of the benefits to investing in biotechs. We are funding research that is important and vital and helpful to the world. (And if our investments are smart, we make a lot of money). There are no RSV vaccines. Novavax was creamed a couple of years ago because their drug failed in a trial with old people. So the stock was very depressed when we bought it, a little over $1 a share. You won’t see Buffett buying biotech stocks any time soon. And yet, having a value mentality when you make your purchases is extraordinarily helpful. It’s one way to lower risk, anyway. Novavax’s trial was funded by Bill and Melinda Gates. In the next couple of weeks, NVAX investors will find out if our research was right or wrong. Up 66% in my port. We’re waiting on the results of a phase 3 trial. Bad news will kill our gains. Good news will dramatically escalate them. Fingers crossed. $815 million market cap. 2 billion dollar molecules in the pipeline (hopefully), including a vaccine for the flu that will actually work (hopefully).

Ionis (IONS). They had to change their name from Isis, I forget why. (Joke). In CAPS I bought this at $17 in 2007. 12 years later, it’s $59. Comfortably beating the S&P 500. In real life, I bought it, sold it, bought it again, sold it again, and bought it again. They have a deep pipeline stocked with drugs. Let me check the website. Holy crap, 30 drugs. Still no profits. On the other hand, if you like escalating revenues, Ionis has that. Sort of. Escalating and Oscillating.

2015 30%+ growth
2016 20%+ growth
2017 40%+ growth
2018 10%+ growth

$2 billion in cash.

Immunomedics (IMMU). They had a soap opera two years ago, when Seattle Genetics tried to buy one of their drugs for $2 billion dollars. The CEO loved the deal. Major shareholders did not love the deal. Big fight. CEO is out. New board, new CEO, new management. Now we’re waiting for this damn $2 billion dollar drug to get approved by the FDA. Slight hiccup with the manufacturing process. Stock down almost 50%. We bought right after the soap opera, and we’re still up 1%. Don’t blink or we’ll be in the red again. IMMU is actually down slightly in 2019, which is frickin’ impossible. I remain bullish and we’re buying more at these prices. The revenues are escalating, but in the wrong direction. This is an anti-Saul stock. Nonetheless, it’s an important cancer drug, people who know way more about cancer than I do wanted to buy it for $2 billion, and the company is now on sale because of a manufacturing hiccup. And I don’t want to hear about that guy who had the hiccups since World War 2.

bluebird bio (BLUE). Great company. I love the CEO. Here’s his Ted talk.

https://www.youtube.com/watch?v=Ez560GnkSrE

This is actually my best performer in 2019, up 38%. Slightly better than The Trade Desk. Unfortunately our 2017 performance was a train wreck. I think we bought this one at the all-time high. You can do that with Saul stocks. You almost have to. But never do that with a biotech. We are still underwater. Nonetheless, great company. Subtract the $1.7 billion in cash they hold, it’s a $6 billion market cap right now. Revenues are still negligible.

Spark Thereapeutics (ONCE).

What’s tricky with both BLUE and ONCE is that their drugs actually cure people. As in, one and done. That’s amazing. But it’s not as financially rewarding as a drug that people have to use for the rest of their lives. I think these guys (and Biomarin) are going to cure hemophiliacs. This is another stock that is up big in 2019. Up 35% so far this year, which is #4 in my port, after BLUE (up 38%), The Trade Desk (up 37%) and Ubiquiti Networks (up 36%). We bought Spark after the drug approval. The big problem here is getting insurance companies to pay for the drug.

We are also buying a new biotech this week, Amarin (AMRN). Stock has gone up dramatically. Up 368% over the last 52-weeks. They had a big drug trial that made it into the New York Times.

https://www.nytimes.com/2018/09/25/well/fish-oil-heart-attac…

It’s down about 20% off its highs. Revenue growth is nice.

2015 up 45%
2016 up 55%
2017 up 40%

We’re still waiting on the fourth quarter of 2018. Company is forecasting 50% revenue growth this year. That is aside from major growth they will have if the label is expanded. When the bad news is 50% revenue growth, that’s pretty interesting, yes?

9 Likes

I think NovoCure NVCR has potential to be healthcare recurring revenue powerhouse.

Generally once you are using the Optune device you will use it for a few years, indefinitely until your disease progresses.

It is not ‘hypergrowth’ SaaS stock but if it gets Medicare payments approved (decision may be first half 2019) then revenue should go through a hypergrowth period as Medicare patients start to contribute to bottom line and as article below mentions, they are in trials to try to get approved for a major label expansion. Nevertheless the are profitable right now.

https://www.fool.com/investing/2018/12/24/is-novocure-a-buy…

1 Like

On Novavax

They have a vaccine for a horrible disease that kills babies, called respiratory syncytial virus, or RSV.

RSV can be scary to parents. I mean, hey, breathing is important. Seeing little ones grunt and struggle is certainly discomforting to see. And while it is responsible for 50,000 pediatric admits annually, it is rarely deadly.

“The KID data set estimated 121 deaths nationally in infants and children with RSV-associated admissions, 84 deaths during RSV season, and 42 deaths with a primary diagnosis of RSV in 2009. The PHIS data set had a mean of 56 deaths per year, with 39 during RSV season and 21 with a primary diagnosis of RSV… the majority of deaths in both the KID and PHIS data sets occurred in infants with complex chronic conditions and in those with other acute conditions such as sepsis that could have contributed to their deaths.”
http://pediatrics.aappublications.org/content/135/1/e24

The better question is why do we admit 50,000 of them a year? I suppose there might be a role for immunizing those with known congenital abnormalities, but that is a fraction of pregnancies.

There are wayyyyy more kids that die from unintentional injury than RSV. It’s not even close. Focus on gun control and womens health if you want to focusing on protecting pediatrics:
https://www.cdc.gov/injury/wisqars/pdf/leading_causes_of_dea…

From a different financial standpoint, 50,000 hospital admits a year. Lets say at a cost of $20k. That’s a billion dollars. But even a decrease in admits of 20% would be a 200m savings – but there are 4 million births annually, so they’d have to charge less than $50 to make it worth it. For comparison, CVS charges $35-65 for a flu shot depending the store location.

So, I suppose it might pass mustard, but it’s not really something that needs to be around, and probably not financially viable from a system-wide / population health standpoint. Plus I think going for maternal immunization is a flop. You’d require OBGYN docs to give them vaccinations, which is a bit of a culture shift. Honestly, your best hope here is that Sanofi buys them on positive data – which, by the way, NVAX doesnt even have yet!

Their flu vaccine?
severe systemic treatment emergent adverse event: 3% for NanoFlu vs 1.3% for FluZone. They have been trying for years to break into this market and failed repeatedly in the past. Novavax is a name that has been kicking around for over a decade, much like Sangamo, that has failed repeatedly. Some companies just dont have the right toolset to be successful, they just happen to stick around longer in biotech land for some reason. You might be able to make a quick buck, but the data and historical company skillset isnt there. The risk isnt worth the reward on this one. Any quick money made on this is due to dumb luck more than anything.


I’ve posted on Spark before, and I hold them (just under 1% of my port), moreso to follow the story. They are thusfar the most successful gene editing company out there, but I vaguely recall that they discontinued their SPK-7001: Choroideremia treatment due to lack of efficacy; this is concerning because I was hoping for a plug & play platform for inherited retinal diseases, and sadly, it doesnt look like it will be that easy.

4 Likes

RSV can be scary to parents. I mean, hey, breathing is important. Seeing little ones grunt and struggle is certainly discomforting to see. And while it is responsible for 50,000 pediatric admits annually, it is rarely deadly.

That’s an interesting link. According to WHO, RSV kills 60,000 children around the world every year. 2nd only to malaria.

http://vk.ovg.ox.ac.uk/rsv

NIH puts the number at 48,000 to 74,000 deaths every year.

About 99% of the deaths take place in developing countries.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5599304/

I suppose it might pass mustard, but it’s not really something that needs to be around, and probably not financially viable from a system-wide / population health standpoint.

A lot of companies are striving for a RSV vaccine, including Glaxo and Sanofi.

https://www.healio.com/pediatrics/vaccine-preventable-diseas…

About 99% of the deaths take place in developing countries.

This is true. How profitable do you think it is to market there? And how much of that is due to lack of resources (ie, knowledge gap about nasal suctioning? lack of supplemental oxygen/humidified high flow O2)?

What makes you think the perennial loser that is NVAX can beat Sanofi at their own game?

1 Like

This is true. How profitable do you think it is to market there?

I think you were mistaken when you said that RSV doesn’t kill anybody. And you are also underestimating the market for the RSV virus in the US and Europe. Why do you think Sanofi and Glaxo are trying to find a vaccine for RSV? If, as you say, there is no market for this drug?

What makes you think the perennial loser that is NVAX can beat Sanofi at their own game?

NVAX has the first RSV vaccine to show efficacy in any population. They are the leaders in this space. Sanofi and Glaxo are playing “me too,” which is what big pharma often does with biotech.

Shingrix may not make it on the top five best-selling vaccines list in 2024, but a diversified portfolio will still secure GlaxoSmithKline the lead position in the vaccine industry at that time, followed by Merck &Co., Sanofi, Pfizer and a dark horse biotech, life science commercial intelligence firm Evaluate predicts.

In its new World Preview report, Evaluate projects GSK’s vaccines business will grow 7% CAGR to reach $10.74 billion in 2024, and expects Merck to place second with $9.40 billion. While GSK and Merck land the same positions as in Evaluate’s report released last year through 2022, Sanofi and Pfizer have swapped places. Now, the analysts expect the drugmakers to pull in $8.13 billion and $7.26 billion, respectively, in 2024 vaccine sales.

Sanofi’s strong growth will come from two major products, according to the group. Compared to 2017, Pentacel and flu shot Fluzone will together grow nearly $1.45 billion by 2024, Evaluate predicts, more than double the pair’s $680 million contribution in the firm’s last report, which covered the 2016-2022 period.

Analysts previously said Merck’s Gardasil franchise has stabilized at around $2.5 billion, but this time around, they predict a $900 million sales jump over the report period “based on continuing positive data showing its efficacy as a preventative treatment for cancers caused by HPV, higher rates of use and course completion amongst females and males.”

With 90% share in 2017, the four Big Pharmas dominate the vaccine market today, but analysts predict the number will drop below 80% by 2024. One big reason? Novavax and its blockbuster-potential RSV-influenza combination vaccine.

Maryland-based Novavax doesn’t have any meaningful revenue today, but Evaluate analysts say it will be able to collect $2.65 billion in 2024. A big chunk, or $1.82 billion, will be coming from the respiratory combo shot currently still in preclinical stages. The vaccine will be so successful that analysts predict it will bump GSK’s shingles star Shingrix and meningococcal B vaccine Bexsero off the 2024 top 5 vaccines-by-revenue list.

That doesn’t mean Shingrix isn’t important for GSK. Approved by the FDA last October, the vaccine is deemed preferential by the CDC over Merck’s Zostavax. For the first quarter of 2018, it generated about $150 million and quickly occupied over 90% of the U.S. market share based on pharmacy data that represent over half of all prescriptions.

Novavax is currently testing its RSV F vaccine—one component of the biotech’s combo shot—as a maternal immunization to protect infants in a 4,600-participant phase 3 study, with an interim analysis expected early 2019. The shot was rolled back to phase 2 in the 60-and-older population after a phase 3 flop in 2016. The company itself has recently set the vaccine’s peak sales at $1.5 billion, while Evaluate analysts figure it will contribute about $668 million to Novavax’s top line in 2024, likely offset by its own combo shot.

https://www.fiercepharma.com/vaccines/sanofi-beats-pfizer-an…

Ah. Good find.

The shot was rolled back to phase 2 in the 60-and-older population after a phase 3 flop in 2016.

They’ve already failed in adults. Let’s trust them with pregnant women. :joy:

Other failed trials from NVAX this decade:
MERS
bird flu
Swine flu
Seasonal flu
Shingles

How anyone keeps trusting them as a company is beyond me. This is a gamble on a penny stock, not an investment.

5 Likes

This is a gamble on a penny stock, not an investment.

It’s a calculated risk. You can read more here:

https://www.fiercepharma.com/vaccines/novavax-details-pre-co…

In slides accompanying the conference call, the company said an informational analysis of 1,307 infants observed a vaccine efficacy between 45% and 100%. Based on that analysis, the company continued enrollment into this year, according to a December press release.

I’m not saying anybody should invest in an unprofitable biotech without any revenues.

But if you are investing in an unprofitable biotech without any revenues?

It’s way, way, way better to shop in the under $10 department, after the hype has disappeared and depression has set in.

This is why I am not buying Moderna (MRNA) today, or tomorrow, or next week, or next month. Even though their technology is amazing and very exciting.

https://www.modernatx.com/moderna-blog/an-emotionally-specia…

The market cap is way too high. Also I want to wait for the lock-up to expire.

I might be buying them in 2020 or 2021, after they have had some bad news. Because there is always bad news, sooner or later.

https://www.statnews.com/2016/09/13/moderna-therapeutics-bio…

Anyway, Novavax is certainly cheap, at $2 a share. And it was even cheaper when I bought in, at $1 a share.

I will never understand why it’s “risky” to buy a biotech at $1 a share, but acceptable to buy the same biotech at $13 a share.

Certainly price adds to risk. But it’s high prices that add to risk, not low prices.

I’m not saying that a low price equals a good investment. But it doesn’t equal a bad one, either. The success of the investment depends upon the success of the company. And it also depends upon the price you pay. And in the latter scenario, the lower the better. Especially in biotech.

There is currently a vaccine for RSV. Synagis, by MedImmune, an AstrZeneca subsidiary. It is indicated for kids in first year or two of life. Generally with severe health problems like being very premature (born before 29 weeks gestational age, normal “full term” is 36 weeks 6 days), chronic lung disease, congenital heart defects, babies needing heart transplants, cystic fibrosis. These are very sick kids to start with so the virus poses a much more serious threat. Normal, healthy kids can get RSV, but it generally is not as serious since they don’t have the underlying health conditions. So, while a serious health problems for those at risk, it is a fairly limited market with an established player already. Personally, I wouldn’t invest if the sole thesis was for treating the RSV population. Or, would more likely invest in AZN if I wanted exposure to this market. But they are more of a dividend stock, not really of interest here.

Hope that helps a little.

Kevin

1 Like

How anyone keeps trusting them as a company is beyond me.

Couple of things suggests that this maternal Ph III RSV trial maybe better than the failure in 2016 on older adults.

  1. Phase II maternal trial showed 51% efficacy on a smaller population.
  2. One third of the Phase III data that was unblinded back in late 2017 showed efficacy between 45 and 100%. They see success as 40% efficacy for the whole population of 4646 moms.
  3. It appears that the maternal vaccine has an adjuvant which improves efficacy.

https://ir.novavax.com/news-releases/news-release-details/no…

Also, note that last month Nanoflu Phase II successful.

https://ir.novavax.com/news-releases/news-release-details/no…

1 Like

The problem with this study is that they are not showing efficacy for the child - the target population.

They are using a surrogate marker, in this case mom’s antibody status (not looking at longitudinal data from the children and whether or not there was a decrease in the amount of admits / RSV infections)…
While it in theory makes sense, you have to also realize that the medical literature is full of failed surrogate markers that should have worked, but just didnt pan out for one reason or another.

Surrogate markers are a big red flag when designing trials for me; they often pass the FDA less frequently, generally dont pan out in the real world, and often times are not well received by clinicians (they should at a minimum be taken with a grain of salt).

I do note that nanoflu P2 was successful, but so were a bunch of their prior flu vaccines that inevitably flopped later on. Forgive me for being a skeptic on this one. Too much of a risk for my $$, and I think there are better places for my money. to each their own, good luck with NVAX.

4 Likes

Actually for the Phase III even though it is a maternal vaccine they are monitoring infants for the first 180 days for RSV incidence/efficacy.

In our ResVax program we started the year with results of information and analysis of our Prepare trial that indicated that our vaccine was performing well in the first one third of the trial. That analysis told us that the level of efficacy in the first 1307 children who’s mother’s were given ResVax or placebo was somewhere between 45% and 100% and although we remain blinded to the specific point estimate we continue to believe that any level of vaccine efficacy in this range would represent an historic breakthrough and would be licensable by the FDA and EMA.

https://seekingalpha.com/article/4219592-novavax-inc-nvax-ce…

It is a high risk/reward situation and the result can make/break the company. But I agree that past history of this company has not been promising. So, the enthusiasm has been a lot more muted this time around unlike 2016.

2 Likes

I will never understand why it’s “risky” to buy a biotech at $1 a share, but acceptable to buy the same biotech at $13 a share.

That’s actually quite simple. The Firm has become less risky at $13 than at $2.

Obvs, if it’s a 50-50 shot their breakthrough disease cure gets approved, you’d always buy at $2 if your downside is zero and upside is $11. That’s not how it usually works, but I agree sometimes it does due to temporary market mispricings.

Also, most of these money-losing small-mid biotechs have fierce burn rates and you can be left with a busted firm, no approved drugs and no real revenues in 2 years. If you’re lucky you get a few scraps when a bigger pharma buys them for a penny on the $1. Or you can be massively diluted in a secondary raise.

Long ALNY, PTCT, RCKT

2 Likes

https://www.marketwatch.com/story/novavax-shares-crater-69-p…

Novavax Inc. shares NVAX, -67.13% slid 69% in premarket trade Thursday, after the company said a trial of a treatment for the main cause of viral pneumonia in infants and young children failed to meet its main goal. Gaithersburg, Md.-based Novavax said the phase 3 trial of ResVax, an aluminum adjuvanted respiratory syncytial virus (RSV) fusion (F) protein recombinant nanoparticle vaccine, did not meet its primary endpoint of preventing medically significant RSV lower respiratory tract infection.

1 Like