Specialist
Former VP at Guardant Health Inc
Agenda
- Key liquid biopsy developments relating to Guardant (NASDAQ: GH)
- Early detection landscape – Grail vs Guardant
- Impact of M&A activity from Illumina (NASDAQ: ILMN) and Exact Sciences (NASDAQ: EXAS)
- Specificity vs sensitivity expectations and improvements compared to industry peers 5. 2020 outlook – growth and broader assay development expectations
Questions
1.
What is your take on trends and developments in the liquid biopsy market, particularly the significant uptick in M&A over the last year or so?
2.
Guardant seemed to have the most robust portfolio prior to Exact’s October 2020 acquisition of Thrive and Illumina’s November 2020 acquisition of Grail, given its footprint across companion diagnostics, early detection and MRD [minimal residual disease]. Do you think that’s still the case? How do you think the landscape has changed for Guardant given these recent shifts?
3.
Could you compare the size and total addressable opportunity of the MRD and early detection markets?
4.
Which players do you think are best-positioned to capture the growth we’ve discussed, given how the landscape has shifted? Do you think that’s Guardant or another player?
5.
You mentioned that the early-stage category is highly competitive, and that success in it will largely depend on physician relationships. How would you compare Guardant’s positioning to Illumina’s in this area? Guardant has a wide portfolio of approved products, a strong relationship with the FDA and experience in launching these tests, but Illumina’s portfolio is broader still. Could another player have a similar edge?
6.
Could you compare the GuardantOmni to alternative offerings? How do you assess its growth potential, given Guardant’s good relationships with the FDA and payers?
7.
How do you assess Guardant360 and its growth outlook, particularly given it received a CE mark in March 2021?
8.
Could you elaborate on Guardant’s ex-US strategy? You said the CE mark will drive moderate revenue uplift for the 360 and mentioned some of the considerations in Asia. What growth can we expect beyond the US, and how could Guardant’s international performance compare to that of other players?
9.
Could you comment further on the importance of a liquid biopsy player having a tissue offering? We’ve heard before that this is a significant factor in physician adoption. What advantage could having both offerings give Guardant?
10.
What are your expectations for Guardant’s upcoming tissue biopsy launch?
11.
How else can Guardant raise barriers to entry for the 360 in cancer profiling beyond the turnaround time considerations, given increased competition from laboratories such as NeoGenomics that have similar testing?
12.
What are your expectations for Guardant’s ability to continue driving demand from biopharma as competition increases? Do you expect new entrants in this segment? We know NeoGenomics is strengthening its offering here, so could there be further competition from other laboratories?
13.
What are your thoughts on the Guardant Reveal colorectal cancer test, launched in February 2021? What are your uptake expectations, given the launch?
14.
Do you have any further comments on how Reveal compares to peers’ offerings, particularly Natera’s Signatera?
15.
Do you think Reveal or Signatera will have greater success and adoption, notwithstanding that trial outcome data is not yet available for Reveal?
16.
Would you say Guardant’s colorectal screening offering has a technological advantage over Freenome’s? How do the players’ technologies differ?
17.
Could you comment on reimbursement across Guardant’s portfolio, particularly highlighting your concerns or opinions on the FDA’s minimum threshold? How do you expect competition to develop?
18.
How could liquid biopsy utilisation trend? We’ve touched on resistance to this diagnostic method, with varying percentages of patients taking up early screenings, even if available. What hurdles will Guardant and its peers have to work through to increase utilisation?
19.
What are your expectations for Guardant given the Q4 2020 earnings call? The firm noted increased investment across the launches that have already occurred and those that are set to occur in the next year or so. It also commented on significantly increased R&D spend and a commitment to invest in the new products.
20.
Do you think the recent pace of consolidation will continue? What could be some likely targets for a player seeking to enter liquid biopsy? Agilent and NeoGenomics have recently made deals, so options are decreasing.
21.
Could Guardant acquire any smaller players, as Exact has done? You said Guardant’s market cap means it wouldn’t be an acquisition target.
22.
Is there anything we’re yet to touch on that could be key to our assessment of Guardant and the liquid biopsy market? What’s your outlook for the industry, and what do you suggest we continue to monitor?
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