Specialist
Former senior director at Exact Sciences Corp
Agenda
- Developments in liquid biopsy and early cancer detection relating to Exact Sciences (NASDAQ: EXAS)
- Pipeline overview – Oncotype IQ platform, advancements in biomarker-based technologies and biomarker identification
- Cologuard test update and assessment for colorectal cancer screening
- Q4 2021 outlook – product disruption and future innovation
Questions
1.
How do you think Exact Sciences’ positioning in the broader oncology diagnostics industry has shifted given the increased competition and continued M&A?
2.
PP: I think in terms of what’s been really interesting in that space over the last 5-6 years has been just how sensitive the publicly traded stocks are to even abstracts at conferences that affect forward-looking type statements of things. It could be years out, so that’s been really interesting to watch. The recent speculation around Exact and Invitae merger, whether that’s true or not, it certainly signalled the same phenomenon that these companies, with Exact having a market cap anywhere from USD 15bn to USD 20bn, the stock is still quite sensitive with a conference abstract around a new test like Liver Guard or a competitor’s abstract related to pan-cancer testing. That, to me, is an interesting signal in the life sciences space around just, again, how large the market potential is, around USD 150bn, and then how sensitive the stocks are to big news and even small news in certain ways, when we look at the grand scheme of the potential impact in the overall life sciences and biopharma market. I think it’s a great question, and I see the space is hypersensitive to news, and it doesn’t take a lot of news to move the stocks up and down from a Wall Street perspective.
3.
Exact Sciences boasts a unique position in the broader liquid biopsy and early oncology space, particularly given the company’s breadth and depth of portfolio and pipeline, which spans across the cancer care continuum. How important is this breadth and depth, particularly given what you noted about changing mindsets or broader processes to drive utilisation? Is there still room for Exact to improve?
4.
What is your overview of Exact Sciences’ Oncotype MAP test? It launched in the US in Q4 2020 and the assay is under an expectation in terms of the tissue-based companion diagnostic. What’s your assessment of the test speed, the tissue requirements and the increased rate of progression-free survival as a result of the test? What’s the market opportunity and what do you expect from the launch?
5.
When you say Oncotype MAP test adoption might be a little slower than expected, to what extent is that due to ongoing pandemic impacts vs other potential hurdles facing Exact Sciences? Can you quantify how much lower adoption might be?
6.
What do you make of Exact Sciences’ soft launch strategy for Oncoguard Liver? Management indicated that CMS [Centers for Medicare and Medicaid Services] reimbursement could be about 15 months away, and the company aims to address high-risk patients, including those with hep B. What is your performance outlook once CMS reimbursement is achieved?
7.
What would you highlight around Exact Sciences’ Cologuard performance? The company has alluded to the ongoing pandemic impact, particularly with Cologuard sales being sensitive to visits by its field force, whereas the backlog in colonoscopies throughout coronavirus could help expand Cologuard adoption. What’s your take on these dynamics? How might adoption or pent-up demand evolve?
8.
What are your expectations for Cologuard 2.0? Exact Sciences is seeking to increase specificity while maintaining the sensitivity level, which stands at 87% specificity and 92% sensitivity in colorectal cancer. What improvement would you expect due to ongoing work? What commercial impact could it have on adoption?
9.
Could you elaborate on the broader market opportunity of a blood-based colorectal cancer test and the discussion around adenomas? How might ongoing feedback from the medical community around the limitations of Cologuard inform the market opportunity of a blood-based test?
10.
To what extent does patient preference influence the test selection? Presumably it will differ across the type of tests, but how much of this is a patient vs physician decision? How might this affect the ultimate uptake of a stool-based and a blood-based test?
11.
It seems that having a broad portfolio with significant breadth and depth in tissue and liquid is key to driving physician adoption. Can you expand on the potential dynamic of having both tests commercialised under Exact Sciences, as well as some of the moves towards a pan-cancer test, particularly following the Thrive acquisition? What does that entail for Exact’s overall longer-term growth?
12.
What competitive dynamics would you highlight around Exact Sciences’ rivals coming out with a colorectal cancer test? What’s the threat posed by Freenome and Guardant?
13.
What’s your assessment of Exact Sciences’ Thrive acquisition and the pan-cancer studies? Exact is merging its methylation approach to the mutation and protein approach of Thrive’s CancerSEEK. A lot of liquid biopsy players are working on a multiomic approach, which seems to be a buzzword and might not correlate with stronger data. What do you make of Exact’s strategy and what could merging approaches mean for the market opportunity in pan-cancer testing?
14.
What’s your commercial expectation for Exact Sciences’ portfolio of tumour-specific and pan-cancer tests? Despite demonstrating lower sensitivity compared to other tests, the pan-cancer strategy should have a high enough sensitivity to prove significant in the real world, according to Exact. The commercial strategy for a pan-cancer test is still in progress – a target position and next steps when results come through remain unclear, which will limit uptake. Do you think Exact can devise a commercial strategy ahead of Grail, whether standalone or under Illumina, given the former’s broad portfolio?
15.
What’s the likelihood of an Exact Sciences-Invitae merger? How important would it be for Exact to grow in this way or to have a broader portfolio?
16.
What broader M&A considerations would you highlight? Whether an Invitae merger or similar transaction, how might gaps in Exact Sciences’ portfolio be filled via M&A?
17.
What proportion of patients don’t get tested for colorectal cancer and what percentage of patients would choose stool vs blood vs colonoscopy? It seems that not enough people are choosing colonoscopies, so would that be the main goal if a blood test has a much lower sensitivity bar of 90%? What repercussions would that have?
18.
What is your 12-18-month outlook for Exact Sciences? What would you highlight around growth prospects, positive data for pan-cancer and pipeline developments?
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