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The following segment was excerpted from this fund letter.
Kodiak Sciences (NASDAQ:KOD)
A great example of companies that can perform in any environment is busted biotech world. One of the sectors undergoing the most pain in the recent year has been biotech, where we have invested in since 2004. Subsequent to the quarter end, we added a second company to our portfolio, and are actively engaged in researching more busted biotechs. Both our newest, Kodiak Sciences (KOD) and MEI Pharma (MEIP) have important regulatory catalysts in the very near future, and they have ample cash to get them through to the value inflection catalyst points.
These are the types of names that can perform in any economic environment. The downside is protected by the cash position, and yes, while those cash positions are being spent on funding drug development, the long runways give us ample time to realize these value inflection milestones. We have been buyers of both companies as the market remains relatively indifferent to the looming regulatory updates.
Kodiak Sciences busted earlier this year as its first of six pivotal Phase 3 trials on its lead compound, tarcocimab (formerly KSI-301), failed its very poorly designed clinical trial. The company’s drug will fill a significant unmet medical need, particular for diabetic and elderly patients with macular edema who have given up going to their doctor every 1-2 months to get their eye injected with Regeneron’s EYLEA. Industry research suggests that well over half of patients have chosen deteriorating vision over the inconvenience of getting their eyes injected every 1-2 months. That’s where tarcocimab comes in.
In recent trials, even the “failed” trial, it has shown that 60-70% of patients can go five months or longer while maintaining the same significantly improved vision. While there are multiple therapies available for these patients, there are none that have the durability of tarcocimab.
Subsequent to us taking a stake, Kodiak announced positive data on its most recent registration trial BEACON. Tarcocimab seeks to disrupt a $13 billion industry, but more importantly, fill an important gap in the macular edema market. In our conversations with doctors actively engaged in research & clinical trials, they are very eager to have a drug that they can dose less frequently.
Shares have perked up since announcing the BEACON top line data, but given they still trade below cash levels, they give us a lot of upside as subsequent trials prove out that the drug works. Given the rest of the pivotal trials will read out in the next nine months, we won’t have to wait long until tarcocimab is able to serve the significant unmet medical need, and file for approval with the FDA next year.
We also expect a very important update to MEIP’s regulatory strategy which will alleviate market concerns on its own drug’s timeliness to market. While many catalysts depend on a healthy market environment to play out, these do not. They can perform in any economic scenario. Trying to predict with accuracy when the stock will reflect the underlying developments is impossible.
But we do know that if you miss the most material upside days of certain stocks, the realized returns are significantly more mediocre. To the extent we are well-aligned with the insiders at the company and the improving fundamentals, we can’t really just “sit this out,” until market conditions improve.
The bulk of the returns we will experience in both busted biotechs will likely happen on a single day. This reminds us of the JP Morgan research from earlier this year that showed missing the ten best days in the market over the past two decades would have cut in half investors’ realized returns in the S&P 500, from 9.5% annualized to 5.3%. While that data applied to the entire market, it is even more relevant for biotechs. We think both companies have extremely high upside velocity, with the downside protected by both their current valuations and the cash positions, which remain comfortably higher than current stock prices.
Editor’s Note: The summary bullets for this article were chosen by Seeking Alpha editors.
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