SAN FRANCISCO – It was another busy day on Wednesday at the 42nd annual JP Morgan Healthcare Conference with one day left.
Below are brief reports on individual presentations from the conference. A report from Day 1 of the conference can be found here, and news from Day 2 can be found here.
Grail
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 patient response to treatment.
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.
Myriad Genetics
Myriad Genetics has completed its turnaround after years of struggle, but "the work is never done," CEO Paul Diaz said at the JP Morgan Healthcare Conference. After describing the growth of each of its product lines in 2023 and laying out its product roadmap for the following year, Diaz said that 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 quarterly 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 some 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." The firm expects strong growth this quarter in the prenatal business, he added. 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 feto-maternal blood compatibility.
Bio-Techne
At the 42nd annual JP Morgan Healthcare Conference, 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 downturn in the macroeconomy, 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."
In China, Hippel previously predicted that 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 market, 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 the markets Bio-Techne plays in 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, he said that although Bio-Techne would've liked to acquire Olink, which is in the process of being bought for $3.1 billion by Thermo Fisher Scientific, that deal 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.
Quanterix
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.