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So we continue to feel very confident in the strong growth trajectory of that business |
And then finally, we started 2024 off very strong with record average daily and monthly volumes in January, February to-date is trending even more favorably |
Importantly, we ended the year with a strong cash position of approximately $346 million, which enables us to execute on the strategic priorities of both businesses |
I'm confident in our ability to continue to grow our clonoSEQ MRD business and to demonstrate our target and drug discovery capabilities in Immune Medicine |
2023 was a great year for clonoSEQ and we are well positioned to cement our leadership as the gold standard in MRD team for clinicians, patients, pharma partners and payers |
Volumes continue to grow quarter-over-quarter with 15,680 tests delivered in Q4, representing a 49% increase versus prior year and a 4% increase sequentially |
The MRD business grew 27% versus prior year excluding milestones as we experienced outstanding growth from clonoSEQ’s volumes |
And so, I think one thing to be aware of is that, for our specific business, we have a very strong position in that indication potentially maybe even stronger if and when the FDA accepts the MRD as a surrogate for accelerated approval |
On pharma side of the business, we are anticipating about 10% growth and I think roughly based on the fact that we anticipate continued industry-wide headwinds that we saw in the previous year, but then we do have a strong backlog, a healthy backlog of over $185 million, which we believe we will be able to continue to draw from we have in the past |
ASPs in the fourth quarter grew double-digits sequentially |
We are seeing really nice results |
We’re really excited about the work that we put in and how it's going to already starting to play out on a ASP increases |
Second, improving margins through ASP increases and operating leverage with the primary goal of reaching positive adjusted EBITDA in the second half of 2025 and cash flow breakeven in 2026 |
So, certainly excited about it and excited about what we're seeing early on from the Epic integrations that we've already done |
So obviously, pretty solid top-line growth and then you've maintained your expectations to hit MRD profitability in the second half of ‘25 |
First, further increase penetration by growing blood-based testing expanding into new indications like MCL and CTCL adding new use cases through data generation and enhancing the customer experience through EMR integrations |
And so, we're pretty encouraged by parallel processing those two work streams with the goal to ultimately have antibody candidates that we can designate as therapeutic candidates to advance over the next year - during the next two years into the clinic |
MRD revenue grew to $30.8 million, up 9% from a year ago |
In MRD, drive clonoSEQ’s penetration and revenue growth with the goal of reaching profitable profitability by the end of 2025 |
It is encouraging to see positive trends on clonoSEQ key indicators as shown on Slide 7 |
So the clinical business we expect to have a healthy growth trajectory |
Excellent |
It also includes MRD milestones in the low-single-digit millions, which could have upside depending on clinical trial outcomes |
But net-net I think from a national position that's coming down on the stage, you are seeing incremental evidence of kind of positive trends and insurance companies are starting to comply with this legislation |
We saw a really nice growth trajectory in DLBCL aligned with our internal expectations, and we continue to promote that very actively as well as focus on data generation |
Also ordering healthcare providers and ordering accounts grew 33% and 29% versus prior year respectively |
Excluding regulatory milestones, MRD revenue grew 18% from a year ago |
MRD Revenue was $102.7 million, up 18% from a year ago, driven by 27% increase from MRD service revenue, partially offset by a lack of regulatory milestones |
We completed at the end of last year a successful proof-of-concept in MS for antibody discovery approach |
clonoSEQ’s clinical Revenue the fourth quarter grew 56% versus prior year and 25% prior quarter with growth coming from both volume and ASP |
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Immune medicine revenue was $15 million, down 45% a year ago driven as expected by lower Genentech amortization, which decreased 53% year-over-year |
Immune medicine revenue was 67.5 million, down 31% from the prior year |
Full year 2023 revenue was $170.3 million, representing an 8% decrease year-over-year |
Versus the prior year, the decline was driven by lower amortization of the Genentech upfront and a lack of milestones which have a 100% margin contribution |
Full year revenue was essentially flat versus prior year due to broader macroeconomic factors impacting the biopharma industry, which resulted in lower sample volume across our portfolio prospective trials |
The number peaked in 2021 and since then it has been declining |
The number of trials hasn't started to decline |
Full year net loss was $225.3 million, compared to $200.4 million in 2022 while adjusted EBITDA was a loss of a $116.4 million, compared to a loss of $121.6 million in 2022 |
Obviously a devastating disease |
Net loss for the quarter was $69.5 million, compared to $40.2 million last year |
So just on the MRD business kind of the visibility, can you walk through the MRD revenue cadence expectations in the year? How should, shouldn't think about some of the milestones or other kind of payments from Pharma? And then, I just noticed a slight decrease in the sequential growth rate, and I noticed that same thing happened in Q4 of last year |
So, again, I don't think it's going to be an overnight success in obviously |
Obviously, you're fighting the insurance company lobbies that are trying to not pay |
Tycho Peterson And there's another couple of things we've highlighted we're doing a lens overhaul, in the first half of the year that will have implications for overhead |
Guidance includes conservative MRD Pharmacy Services growth as we continue to monitor broader impaction about Pharma industry |
clonoSEQ clinical performance was the main driver, partially offset by a reduction in revenue from pharma services and regulatory milestones |
We are reducing the number of extractions that we process |
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