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| Statement |
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| So the net result of strong revenue growth and expanding margins on stable operating expenses is a dramatic reduction in cash burn we achieved in 2023 |
| We can do this because our core fundamentals are so strong |
| Revenues were up 43% and gross margins expanded by almost 10 full percentage points |
| We've had a lot of great news since our presentation at the JPMorgan conference and we're excited to get into the highlights |
| So there's room for that to continue to improve above the expectations we've set this year |
| This combination of expanding revenues and improving margins on stable expenses fits precisely with the multiyear strategy we've laid out in the past |
| This cashes in a steady continuation of the strong underlying trends in volumes, ASPs and COGS we've seen over the past year but does not rely on upside drivers from potential guideline changes, any spike in volumes from further Signatera data or any meaningful benefit from the biomarker legislation in the calendar year |
| We processed 341,000 oncology tests in 2023, representing year-over-year growth of 73.5% and we also saw strong growth metrics in women's health and organ health |
| We believe this all provides a positive signal for the ALTAIR study |
| We estimate organic revenues in Q4 were roughly $306 million and gross margins were roughly 49%, which still represents a significant improvement versus previous quarters |
| And I think there are several sources of upside that could allow us to outperform once again this year |
| The guidance for 2024 reflects the continued momentum in the business that generated these very strong results in 2023 |
| What's most impressive is we will be achieving this cash flow breakeven quarter while still making very significant investments into our core business |
| We are making great progress on ASP's volume growth in COGS in our core business, as I just described |
| The study's initial results were presented at ASCO GI this year and showed exceptional asset performance consistent with prior readouts |
| We believe the advanced status of our work with the FDA gives us an advantage |
| We're in large expanding markets, our volume is growing rapidly and our margin is expanding with ASP increasing and COGS going down |
| First, we think our recent acquisition of Invitae's women's health assets is well timed given the clinical value of expanded carrier screening and the strong trends we are seeing there and we're feeling positive about our progress on the acquisition thus far |
| In organ health, we're building momentum as we complete enrollment and readout major innovative clinical trials |
| And finally, we are really excited about a number of significant product launches in women's health and oncology we have planned for this year |
| As the guidelines come in, we think that they will transition to broader panels, which will put Natera in a good position |
| In addition, we've also got a number of potential upside drivers to both revenue and gross margin that we'll discuss later in the call that aren't included in our guide |
| This is well above Street expectations |
| Finally, we've had a string of good results on the IP front that I think puts us in an excellent position in 2024 and beyond |
| Revenues exceeded our expectations at $311 million driven by continued strong volume growth and excellent ASP traction across the business, particularly in women's health and oncology |
| That's great news because we now think we can get a full year's benefit of higher ASPs in 2024 and we think there's still room to drive Signatera clinical ASPs another $50 to $75 higher just by continuing to execute on currently covered indications |
| From the upside opportunity, obviously, there's an enormous amount of upside in the guidance |
| We saw encouraging sequential quarterly progress throughout the course of 2023 and preliminary analysis of Q1 trends suggest that we are on track for continued improvement so far in 2024 |
| And we feel incredibly good about the evidence that's been produced particularly on 22q and on broad panel carrier screening |
| So we think we're a great opportunity |
| Statement |
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| That approach leads to a fairly cautious guide on further margin expansion |
| In a study of over 280 patients and over 1,000 time points, we have shown that early Signatera clearance was highly predictive of therapy response, and persistent ctDNA detection was associated with 4 surgical response as well as a very poor distant relapse-free survival |
| And as you go forward, that's really not going to be good enough |
| And I think that hurts us when you look at comparative claims that they're making based on different levels of plasma input |
| We anticipated that it could be difficult to collect that amount from Invitae given their financial issues |
| And although I think when you look at the performance of the NeoGenomics product, from an analytical standpoint, they've made some very significant claims |
| Those of you that have followed us for a few years know that we prefer to start the year with a guide that feels challenging but achievable to us |
| I think the first thing is that the volume that we started with at the end of January after the acquisition was, I think, a decent amount less than maybe where Invitae was in the last time they reported out their volume in Q3 |
| The net result of that is that we cut our Q4 loss per share by more than half compared to Q4 2022, and now have clear line of sight to a cash flow breakeven quarter as Steve described |
| So what percentage of patients do you prevent from recurring with a new therapy? And for that study, I think the event rate went down from 26.1% to something like 21.1% with addition of oxaliplatin |
| I think the median DSS improvement in absolute terms, that may be a little bit difficult, and I would not extrapolate those numbers from INTERCEPT to ALTAIR |
| And on the Ravgen trial, we were found to not willfully infringe and the damages awarded were obviously much lower than what Ravgen was requesting, but we still respectfully disagree with the outcomes of the trial and we plan to appeal certain of the rulings |
| Current tools, including imaging and biomarkers such as CA-125, are inadequate to guide adjuvant and surveillance decisions in Stage 2 to 4 disease |
| First, I'll say there is competition |
| In one report from a lab doing shotgun sequencing, the screen positive rate was approximately 1 in 6,500, which is 3 or 4 times lower than the expected population incidence, suggesting that they might be missing a significant number of affected pregnancies |
| The de-escalation cohort has multiple similarities to the VEGA study and if it meets its primary end point, could have significant implications for patient management, making it possible to reduce unnecessary and expensive treatment in the MRD-negative patient population |
| So once you've got a personalized assay designed for a particular patient, it's extremely unlikely that they would go design a new personalized assay with some other lab |
| Additionally, for the first time, it was shown that Signatera testing markedly reduced patient anxiety and over 73% of respondents |
| So it's not like there's going to be a delay about the trial |
| Ovarian cancer affects close to 20,000 women per year in the United States has a median age of diagnosis of 63 years and is the fifth leading cause of cancer death in women |
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