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To say it’s been a troublesome 12 months for retail buyers can be an understatement. That’s very true for expertise shares, with the Nasdaq down 35% for the 12 months in comparison with a couple of 20% drop for the S&P 500. Curiously, biotech shares haven’t accomplished as dangerous, based mostly on the broad NASDAQ Biotechnology Index (NBI), which at present tracks 273 biotech and pharmaceutical firms. It solely misplaced about 13% in 2022, because the clock winds down on one other 12 months. In fact, there are many biotechs that fared a lot worse, together with some in our personal Nanalyze Disruptive Tech Portfolio.
Take Guardant Well being inventory (GH), which has taken a beating this 12 months. In Might, we wrote concerning the coming storm proper earlier than the liquid biopsy firm launched its Q2-2022 outcomes. On the time, our unique thesis that Guardant Well being is nicely positioned to be a frontrunner within the rising most cancers blood-screening market was nonetheless stable. It appeared like a great time so as to add shares after the inventory value cratered. One other precipitous drop in Guardant Well being inventory earlier this month, based mostly on the considerably lackluster outcomes of a long-term examine (a minimum of in comparison with the present commonplace of a competitor), triggered one other evaluation.
Whereas we’re nonetheless enjoying the lengthy recreation with Guardant Well being inventory, we’ve devoted fairly a couple of articles not too long ago a few of its greatest opponents. One firm of explicit concern is Actual Sciences (EXAS), which is increasing into the liquid biopsy market after dominating the colorectal most cancers screening market with its well-known poop take a look at, Cologuard. In the meantime, GRAIL, a subsidiary (for the time being) of Illumina, is the one firm with a multi-cancer early detection take a look at. Freenome is a personal firm that’s nonetheless in scientific growth, so much less of a direct menace to Guardant Well being. After which there may be Natera inventory (NTRA).
About Natera Inventory
We briefly profiled Natera for an article about CareDx inventory, which is a pure play on organ transplant diagnostics. Each firms have developed assessments that may detect miniscule bits of DNA shed from the donor organ into the bloodstream. Greater ranges point out the potential for organ transplant rejection. Natera is a comparatively current entrant into the market, having first made a reputation for itself in non-invasive prenatal testing (NIPT). The truth is, we first lined the Silicon Valley firm approach again in 2014 as a part of a collection of articles about NIPT. Ultimately, we concluded that the market seemed to be slowing down and misplaced curiosity within the theme. Which may have been a wee untimely on our half, and we’ll revisit that assumption shortly.
Natera can be pushing into the liquid biopsy market, and in 2021 acquired breakthrough designations from the FDA for Signatera, a blood take a look at that may assist detect the potential recurrence of sure cancers after remedy. It additionally has a few different oncology assessments in its portfolio, together with Altera, which offers a genetic profile of a tumor from a tissue pattern.
Not like Actual Sciences, which has spent closely to increase past its flagship take a look at Cologuard via acquisitions, Natera has apparently developed its blood-testing platform internally for NIPT, organ transplants, and most cancers. That’s mirrored within the $264 million the corporate spent final 12 months in R&D on about $625 million in income – underscoring the truth that scientific trials ain’t low-cost. As you may see, income development has been robust, whereas losses are additionally piling up:
Regardless of being unprofitable since its 2015 IPO, Natera inventory had adopted the trajectory of different high-growth shares since 2019. In fact, this 12 months has been a distinct story: Natera inventory is down greater than 55% in 2022, although nonetheless up by about 340% during the last 5 years. Evaluate that to funds that observe broad tech indexes, such because the Invesco QQQ Belief (QQQ), which has gained simply 66% throughout the identical time interval. On the floor, Natera seems to be a robust play, because it expands its blood-testing expertise for detecting cell-free DNA into different purposes.
Market Analyses for Natera Inventory
As they are saying, previous outcomes don’t assure future returns, so let’s see what the longer term appears to be like like for Natera by diving into its present enterprise fashions for these three markets – NIPT or girls’s well being, organ transplants, and most cancers liquid biopsies.
NIPT Screening Market
For many of the firm’s historical past, its girls’s well being assessments have been its bread and butter. Its flagship NIPT product, Panorama, screens for genetic ailments similar to Down’s syndrome in pregnant girls. Final 12 months, it launched outcomes from its new Panorama AI, which had been educated on greater than two million assessments and validated in a scientific examine with greater than 20,000 members. Its different key product on this class, Horizon, is a genetic provider screening take a look at that identifies the danger of a dad or mum passing on a genetic situation to a toddler. Within the Q3-2022 earnings name, Natera administration stated it believes the NIPT market is “solely about 45% to 50% penetrated, so there’s nonetheless a big alternative to assist extra sufferers.” That’s actually one method to spin it.
Contemplating that Panorama and Horizon nonetheless account for a “vital majority” of complete revenues – let’s conservatively name it $500 million out of $567 million in product (i.e., testing) income, since Natera doesn’t break it down for us extra explicitly – that will recommend a complete addressable market someplace simply north of $1 billion. Final 12 months, the corporate carried out about 1.57 million assessments. Approach again in 2015, we estimated the total addressable market (TAM) for NIPT at 3.15 million assessments per 12 months, which nonetheless appears to jive (roughly) with the numbers we’re seeing from Natera.
In different phrases, we nonetheless imagine the ceiling for NIPT and associated genetic testing is comparatively low. As well as, the NIPT market is dealing with a number of headwinds. As an illustration, whereas insurance coverage protection for the core Panorama take a look at that detects extra frequent genetic ailments like Down’s syndrome is fairly complete, reimbursement charges stay low. As well as, many third-party carriers don’t reimburse for microdeletion screenings, that are small lacking items of chromosomes that may trigger uncommon genetic problems. A New York Instances article in January 2022 claimed that constructive outcomes on these assessments are incorrect about 85 p.c of the time. The identical article famous that in 2020 Natera carried out greater than 400,000 screenings for one microdeletion (the one within the Panorama AI examine) – the equal of testing roughly 10% of pregnant girls in the USA. In April 2022, the FDA warned the general public towards blindly following the outcomes of NIPT screenings.
These findings don’t look like hurting revenues a lot. In Q3-2022, product revenues (principally NIPT screenings) jumped almost 30% in comparison with the third quarter in 2021. Nevertheless, we imagine that the corporate’s long-term development might want to come from its different cell-free DNA assessments.
Organ Transplant Screening Market
In 2019, Natera rolled out its Prospera platform for early detection of organ transplant rejections. It has assessments for kidney, coronary heart, and lung transplants. The corporate estimates the TAM for these three assessments is greater than $2.75 billion, which is in the identical neighborhood as our $4 billion estimate from the CareDx breakdown of the organ transplant rejection market. A current examine confirmed that the Prospera Kidney outperformed the usual diagnostic donor-specific antibody (DSA) take a look at by almost 20 factors in predicting rejection:
At this level, it doesn’t sound just like the Prospera assessments outdoors of the kidney one are but contributing to income. In the meantime, CareDx has a wholesome head begin.
Most cancers Testing Market
The most cancers screening and diagnostic market is clearly the place Natera is betting on its long-term future. The corporate has printed 35 peer-reviewed research on Signatera for recurrence and remedy monitoring throughout a number of sorts of most cancers, together with in big-time publications like Nature Medication. It estimates a TAM of greater than $15 billion. That doesn’t embrace the $6 billion market alternative for Altera, a tissue-based biopsy take a look at that’s designed to assist most cancers remedy choice based mostly on tumor genomic profiles. For 2022, Natera expects to carry out 175,000 Signatera and Altera assessments, representing development of about 130%.
As well as, the corporate says that roughly 1 / 4 of the 12,000 neighborhood oncologists in the USA have ordered a Signatera take a look at up to now quarter.
Ought to You Purchase Natera Inventory?
The truth is, the oncology enterprise is the principle driver behind the corporate’s current announcement that it was elevating its full 2022 income outlook to fall between $810 million and $830 million, whereas burning via the same amount of money as final 12 months:
The money burn is actually a priority, even with about $520 million in money and different belongings to cowl the continued losses. The $320 million in complete debt isn’t crushing, however it all provides as much as the truth that Natera might want to determine a method to turn into breakeven someday in 2024 or search for different methods to fund its operation – together with shareholder dilution.
However there are different causes to keep away from Natera inventory. Between the New York Instances article in January and the FDA announcement in April, the activist short-selling analysis agency Hindenburg Analysis launched a brief report on the corporate titled “Natera: Pioneers In Misleading Medical Billing” in March. The gist of the allegations is that the corporate’s revenues have been “fueled by misleading gross sales and billing practices geared toward docs, insurance coverage firms and expectant moms.” Natera naturally denied the allegations on the time. Within the Q3-2022 presentation, firm administration stated an impartial third-party investigation by worldwide regulation agency WilmerHale “concluded that the allegations of wrongdoing towards the corporate within the report have been unfounded.”
That hasn’t stopped authorities regulators from snooping round, although there doesn’t look like an official investigation underway. Nevertheless, Natera is at present engaged in quite a lot of unrelated lawsuits, principally revolving round patent disputes. It has been battling CareDx since a minimum of 2019 over patents associated to organ transplant rejection assessments. It has additionally filed lawsuits towards precision oncology firm ArcherDX and its dad or mum firm, Invitae (NVTA), a biotech chief in medical genetics that can be having a fairly powerful 12 months. Natera has additionally been concerned with lawsuits and counter-suits with Guardant Well being. And that is on no account an exhaustive record. An excessive amount of drama for our tastes.
Conclusion
Natera affords buyers various publicity to a number of markets via its blood-testing expertise that detects miniscule bits of genetic materials from placenta DNA, donor DNA, and tumor DNA. The corporate is the market chief within the first, difficult a long-standing incumbent within the second, and faces a big area of opponents within the third. Natera is pouring lots of of tens of millions of {dollars} into R&D that might make it a frontrunner in genetic testing – if it doesn’t go bankrupt first. Since our portfolio is already closely invested in life sciences, we see no cause so as to add Natera inventory, which comes with loads of monetary and regulatory threat at the moment.
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