SAN FRANCISCO – On the third day of the 42nd annual JP Morgan Healthcare Conference, more omics and molecular diagnostics firms commented on their performance in the past year and unveiled their plans for 2024.
Pacific Biosciences CEO Christian Henry said the company expects sales of its Revio sequencer to grow year over year in 2024, noting that the company is entering the year with "a nice backlog" of orders for the instrument.
In preliminary results reported Monday, the company said it shipped 173 Revio systems in 2023, with 44 of those shipping in Q4. It also shipped 20 Sequel IIe instruments during the year. Overall, the company said it shipped a "record" number of sequencers in 2023.
Henry also said that PacBio began shipping its new short-read sequencer, Onso, in 2023, which marked the company's first foray into the short-read market. He highlighted the system's accuracy noting that "over 90 percent of the bases are Q40 or better." He said the system is particularly targeted toward applications in areas like oncology where it can identify rare variants present at levels as low as 0.1 percent.
Henry noted several product launches scheduled for the first half of 2024, including high-throughput DNA sample prep for the Revio as well as new native DNA kits that he said will reduce the sample input requirement, letting researchers work with more and different sample types to help drive sales of the system.
He also highlighted new platforms the company has in development, including a benchtop HiFi sequencing system that he said would help drive uptake of HiFi long-read sequencing and "serve as a feeder into the Revio platform."
PacBio is also working on a population-scale HiFi system capable of delivering "ultra-high-throughput long reads," Henry said, adding that it would offer "perhaps more than an order of magnitude more" throughput than the Revio system. He said that many of the core technologies for that system will be finished in 2024.
Henry also noted PacBio's plans to develop a high-throughput short-read sequencer based on technology acquired through its purchase of Apton Biosystems last year. He said the company is currently sequencing billions of reads at Q40-plus accuracy.
"We've made a lot of progress in the development of that [platform] in just a very short time," he said. "We're really encouraged that we are going to be able to bring this product to market really quickly, as well."
Commenting on the landscape for short-read versus long-read sequencing technologies, Henry said he believed the next five years would see an "incredible bifurcation" of the sequencing market, with perhaps up to half the market moving to long reads, which he said he expects will dominate germline genomic applications.
Short-read technologies will continue to be used for things like liquid biopsy testing and other oncology applications, "where you can't get those long fragments of DNA to begin with," Henry said. "I think that could be as much as a 50-50 split. We want to be able to play in the entirety of the market."
Grail CEO Bob Ragusa said the company generated full-year 2023 revenues of $93 million, up 68 percent year over year and in line with revenue guidance provided by Illumina, which plans to divest the firm by the end of the second quarter of this year. Grail notched $30 million in revenue in Q4 2023.
Ragusa said that to date, the company has performed 150,000 of its Galleri multi-cancer early detection (MCED) tests in the commercial setting and counts more than 9,000 ordering providers. He added that Grail has performed roughly 350,000 Galleri tests across both the commercial and research settings.
Ragusa highlighted several near-term growth drivers for the company, including plans by the UK's National Health Service this year to review early data from the NHS Galleri trial. If the results are favorable, the NHS "may initiate a pilot of up to 1 million tests over a two-year period starting in 2024," he said, noting that this would mark "the first national [health] system adoption," which could help drive adoption in other single-payor systems.
He said that the NHS Galleri study is on track to complete the final round of subject visits in Q3 2024 and anticipates having final results in 2026.
Ragusa said that Grail has enrolled 25,000 participants in its Pathfinder 2 study, which he noted will be the primary study supporting its US Food and Drug Administration premarket approval submission for Galleri.
He also highlighted the recently announced REACH/Galleri-Medicare study, in which the company plans to compare 50,000 Medicare beneficiaries receiving usual care plus an annual Galleri test to a similarly sized synthetic cohort.
Ragusa also pointed to Grail's activities beyond MCED, noting that it sees opportunities for its methylation-based technology in areas including minimal residual disease detection, patient stratification, and monitoring of treatment response.
He did not comment on Illumina's planned divestment of the company except to note that Illumina has publicly announced the divestment and to say that Grail has operated as a standalone company since Illumina announced its acquisition of the firm three years ago.
Seer Chair and CEO Omid Farokhzad said the company believes forthcoming academic publications using its Proteograph product suite will help drive interest in the platform and, ultimately, sales.
This process will take time, however. President and CFO David Horn noted that until the body of evidence supporting the platform "really grows … we're going to continue to be relatively modest in terms of growth."
With regard to 2024, he said the company remains "relatively conservative in terms of the outlook."
"There are still some macro uncertainties out there," Horn said. "Also … I think we're just in that phase of really demonstrating the biological insights" enabled by the platform.
Seer's technology, which uses nanoparticles to enrich plasma samples for proteomic analysis, was an integral part of dramatic advances made in plasma proteomics in 2023. At the American Society for Mass Spectrometry annual meeting last year, Thermo Fisher Scientific presented data using Seer's new Proteograph XT kits on its Orbitrap Astral instrument to measure roughly 6,000 proteins in plasma. At the JP Morgan conference this week, Farokhzad presented data showing that across a 2,500-sample study, the combination of the Proteograph XT and Orbitrap Astral identified more than 10,000 proteins in total. To date, around 50 percent of Seer's customers have transitioned from the original Proteograph to the XT, he added.
Despite these advances, the company saw slower-than-expected sales of the Proteograph system in 2023.
In June, the company launched a service business, the Seer Technology Access Center (STAC), through which researchers can use the Proteograph XT on the Orbitrap Astral. To date, the STAC program has served 48 organizations including six large pharma firms, Farokhzad said. He noted that in its STAC projects, the company's analyses provided on average a nearly sevenfold increase in protein IDs compared to the equivalent analysis in plasma not run on the Proteograph system.
Farokhzad said the company does not have plans to expand the STAC initiative, however, as it does not ultimately want to be in the service business.
"We want the STAC to be a mechanism, a pathway, for the customer to be able to access and see the power of the Proteograph product suite and the kinds of data they can generate with it," he said.
Ultimately, Seer believes Proteograph sales growth depends on publication of data demonstrating the technology's utility. Farokhzad highlighted several preprints using Seer's technology that the company expects will be published in peer-reviewed publications this year, including work by diagnostics firm PrognomiQ in which company researchers used the Proteograph system along with other omics techniques to build a multiomic classifier for the early detection of lung cancer. Seer owns a roughly 15 percent stake in PrognomiQ.
Farokhzad said that in total, the company's technology has been used in eight preprints and four peer-reviewed publications so far.
Akoya Biosciences is aiming to maintain what it believes is a dominant position in spatial protein analysis while adding new analytes like nucleic acids to its platforms, said Chief Business Officer Niro Ramachandran.
The company highlighted a pair of recent moves it made toward this goal, a license and distribution agreement it announced this week with Thermo Fisher Scientific involving that company's ViewRNA in situ hybridization assays and a collaboration with Enable Medicine to offer the MaxFuse algorithm developed by Garry Nolan, Akoya's cofounder and scientific advisory board member.
Under the Thermo Fisher deal, Akoya will market products, including its PhenoImager systems and PhenoCode reagents, with Thermo Fisher's ViewRNA assays, allowing customers to look at both proteins and RNA in tissue samples.
The MaxFuse algorithm is a tool for integrating multiomic single-cell datasets with spatial datasets, allowing Akoya users, for instance, to combine their spatial information with single-cell data generated on platforms like 10x Genomics' Chromium.
Akoya continues to build out its clinical business, which CEO Brian McKelligon highlighted as a key priority for the company. He said the firm aims to increase its clinical trial participation in order to grow its pipeline of companion diagnostic opportunities.
He cited as an example Akoya's collaboration with Acrivon Therapeutics on a companion diagnostic, OncoSignature, for Acrivon's targeted DNA damage response inhibitor, ACR-368. Developed on Akoya's PhenoImager HT, the test is currently being used in a Phase II study, interim readouts from which are expected in the first half of 2024, McKelligon said.
McKelligon also highlighted the recent launch of Akoya's PhenoCycler-Fusion 2.0, which he said "effectively doubles the throughput" of the PhenoCycler-Fusion system. He said the company is producing new, ready-made panels to maximize the instrument's multiplexing abilities.
Akoya is also in the middle of rolling out the 2.0 version of its PhenoImager system as a field upgrade. It is likewise producing new panels — particularly in the area of immuno-oncology — to take advantage of that instrument's increased capacity, McKelligon said.
Ramachandran said customer feedback for both upgraded instruments has been positive. The company expects most customers to upgrade to the 2.0 versions of the systems in the next 12 to 18 months.
Akoya this week reported between $25.5 million and $26.5 million in preliminary Q4 earnings compared to $21.2 million for the prior-year quarter. It also anticipates $95.6 million to $96.6 million in full-year 2023 revenue compared to $74.9 million in 2022. The company projected 20 percent growth in 2024 compared to 2023.
Myriad Genetics has completed its turnaround after years of struggle, but "the work is never done," said CEO Paul Diaz. After describing the growth of each of its product lines in 2023 and laying out its product roadmap for the following year, Diaz said he is "quite confident that the market's going to see … the opportunity here that we have to grow and expand multiple and create shareholder and patient value."
Diaz also provided preliminary financial results during his presentation. Preliminary Q4 revenue is expected to be between $196 million and $197 million, slightly above analysts' consensus estimate of $194.4 million and putting Myriad at the high end of its fiscal year 2023 guidance of between $747 million and $753 million. Adjusted earnings per share is expected to be between $.02 and $.03 for Q4, beating analysts' consensus estimate of $.01.
Diaz said he sees a large market opportunity across all of its products and expects to gain more market share as smaller players struggle with the infrastructure investments needed in the space, such as integrating with electronic medical records and dealing with reimbursement and regulatory challenges.
In pharmacogenomics, although payor coverage for its GeneSight test has been "slow going in some regards," it has been an "underappreciated growth engine for the company, and we see a lot of opportunity to improve payor coverage and improve [average selling price]," Diaz said.
Its oncology franchise is poised for additional growth as it prepares for the Precise Liquid launch in Q3 2024, a liquid-based version of its Precise tumor profiling test.
A commercial launch of the firm's minimal residual disease monitoring test, Precise MRD, is expected in the second half of 2025. The test is currently undergoing studies with researchers at MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center in renal cancer and breast cancer, respectively. The whole-genome sequencing-based assay is built on Myriad's proprietary technology, and Diaz said the firm is "quite confident in our freedom to operate" regarding intellectual property. The MRD space has seen a spate of litigation in recent years, including a recent preliminary injunction against NeoGenomics' MRD test and permanent injunctions against Invitae and ArcherDx in litigation brought by Natera.
"The IP related to this and the chemistry and the proprietary workflows on this whole-genome assay are differentiated from some of the other assays that are in controversy in the marketplace," he said.
The company is also working on expanding its MyChoice CDx test for ovarian cancer to other indications, such as breast and prostate cancer, Diaz said.
In its women's health business, Diaz said the Prequel prenatal screening test and the Foresight carrier screening test "see a lot of runway," and the firm expects strong growth this quarter in the prenatal business. The company plans to launch in Q1 2024 the Foresight Universal Plus assay, an expanded carrier screening panel of 274 genes.
The FirstGene multiple prenatal screening test, meantime, is expected to have a soft launch in Q3 2024, with a full commercial launch the following quarter. The test is an integrated assay for noninvasive prenatal screening, carrier screening, fetal recessive status, and fetal-maternal blood compatibility.
Quanterix CEO Masoud Toloue said that with the company's corporate reorganization and assay redevelopment program complete, it is now in a position to accelerate its assay development and expects to produce on the order of tens of new assays in 2024 and beyond.
Citing the impact of the reorganization plan, he noted that Quanterix has reduced its cash burn by threefold since 2022 and delivered double-digit revenue growth for full-year 2023. The firm also expects to report fourth quarter revenue of $30 million, up 16 percent year over year and above analysts' consensus estimate of $28.6 million.
Neurology remains central to the company's plans, with Toloue saying Quanterix believes the space is poised to grow over the next decade in much the way areas like oncology and immunology have in recent years.
He pointed to the large number of central nervous system (CNS) drug programs ongoing, noting that there are currently more than 120 CNS programs and that Quanterix is involved in a substantial percentage of these programs.
Alzheimer's disease is at the center of Quanterix's work within neurology. In October, the company launched its LucentAD p-Tau 217 lab-developed test for assessing brain amyloid pathology in patients suspected of having Alzheimer's disease.
Toloue said Quanterix is currently running a prospective clinical trial for the assay with the goal of submitting it to the US Food and Drug Administration for regulatory approval. He said readout from that trial is expected in 2024.
Quanterix is also working to develop the LucentAD p-Tau 217 assay for use with dried blood spot samples, which Toloue said could help improve accessibility to the test globally.
Toloue said that in addition to assay development, the company is also investing in the development of a next-generation platform with a focus on combining single-molecule sensitivity with higher levels of multiplexing and throughput. Key to that process will be reducing the size of the instrument in order to meet what Toloue said is the company's goal of having Simoa, the firm's digital biomarker platform, not just in specialty labs but in all laboratories.
He said the company expects to provide more details on this instrument development work in 2024.
Ginkgo Bioworks CEO and Cofounder Jason Kelly told investors that 2023 was a "breakout year in [the pharmaceutical] market" for the Boston-based firm.
Revenues from pharma and biotech customers grew more than 50 percent year over year and accounted for 36 percent of active cell engineering programs as of Q3 2023, twice the percentage in the first quarter of 2021.
Kelly also provided preliminary financial results for 2023. The firm expects revenues in the range of $250 million to $260 million, in line with previous guidance, with cell engineering revenues of $145 million to $150 million and biosecurity revenues of up to $110 million. New cell programs were also in line with recent guidance of 80 to 85 programs. The firm ended the year with approximately $950 million in cash and cash equivalents.
Kelly highlighted several key deals with pharma customers from the past year, including one with Pfizer on RNA drug discovery worth up to $331 million, another with Boehringer Ingelheim worth up to $406 million, and a Merck deal worth up to $490 million.
So far in 2024, Ginkgo has announced the completion of a collaboration with Biogen on adeno-associated viral vector manufacturing as well as the formation of a new biopharma advisory board.
Kim Kelderman, Bio-Techne's chief operating officer and incoming CEO, discussed what to expect when he takes control of the company on Feb. 1. Although he said there is no need to change Bio-Techne's strategy in the short term, because of the macroeconomic downturn, the firm would be looking internally at its footprint and efficiencies.
Bio-Techne is "making sure that we get ready to come out stronger than anybody else when the headwinds subside," he said.
According to CFO Jim Hippel, the firm's fiscal second quarter was negatively impacted by issues including softness in biotechnology funding, which Bio-Techne had forecast in its fiscal Q1 earnings call. The firm has seen "more conservatism of our pharma customers, particularly in North America," he said, while the second quarter played out as the company expected.
Hippel noted that Bio-Techne has heard from customers that demand for its products, particularly for larger purchases of reagents and instrumentation, is "as high as it's ever been." While new instrument placements have declined due to budgetary constraints, use of existing instruments has reached record highs, he said, which "speaks to the insatiable demand of our products and what we hope will be a pent-up demand once budget starts to get released."
Hippel previously predicted that the Chinese market would get worse before it improved. The first part of his prediction has happened, but he is hopeful the market will stabilize in January and funding may begin flowing again after the Chinese New Year.
Kelderman also laid out some of the firm's pipeline plans in his presentation. The Minneapolis-based company plans to launch a spatial biology assay that will include 12 RNA probes and 20 antibodies in one workflow. "That combination … is a big step towards our mission in spatial, which is to have a multiomic view [on the] same slide [with a] full assessment of your tissue," he said.
Bio-Techne has multiple plans for the liquid biopsy and molecular diagnostics markets, as well. Kelderman cited the development of a colorectal cancer test, for which the firm is currently generating data, and exosome-based solid tumor mutation assays. The company would "like to partner" on the colorectal cancer assay with another firm, he noted.
Kelderman discussed the competitive landscape in Bio-Techne's markets in light of two major acquisitions last year, saying that Danaher's $5.7 billion acquisition of Abcam wouldn't change Bio-Techne's position in protein sciences. "I think we're ready to compete, and I'm very confident that we will continue to be successful," he said.
Also, although Bio-Techne would have liked to acquire Olink, he said, that firm's current acquisition by Thermo Fisher Scientific for $3.1 billion could still work out for Bio-Techne, which provides "a lot of content" for Olink's platform.
"If it goes to a good company that can place many instruments, it will be for our benefit because we'll see more pull-through," he said.
M&A will continue to be a priority for Bio-Techne, Kelderman added.