The bull case for Foundation Medicine

I have been receiving a lot of questions about Foundation Medicine (FMI), which is one of my favorite stocks right now. Below is a list of typical questions I receive and my answers to them.

What’s your investment thesis for FMI?

Foundation Medicine’s investment thesis relies on the realization that cancer treatment is undergoing a fundamental change. Instead of treating patients based on tumor type (breast, lung, skin etc.), treatment decisions are guided by the tumor’s genomic profile. Mutations identified in each tumor will serve as the basis for choosing the right drugs for a given patient (often referred to as personalized or precision medicine).

In order to fully realize the potential of precision medicine, two elements are required: (i) An arsenal of drugs against the various “driver” mutations, and (ii) A cost-effective tool for identifying these mutations.

Foundation Medicine utilizes next-gen sequencing (NGS) for identifying the different mutations in a single test, which is becoming a huge advantage given the expected increase in the amount of drugs that require patient selection. As tumor profiling is expected to become a $5B market within a decade, Foundation Medicine is ideally positioned as the market leader and the only company with meaningful commercial traction.

To date, driver mutations have been identified without FMI’s tests, why would the oncology community switch to FMI’s expensive tests (~$3500 per test)?

Theoretically, there are other ways to identify mutations and there are several marketed products sold as companion diagnostics for approved drugs (Abbott’s Vysis for ALK, Roche’s cobas for BRAF etc.). The problem is that each of these tests evaluates a single gene, whereas Foundation Medicine to identify many mutations (hundreds) in a single test. As the number of mutations for which there are relevant drugs is expected to surge (discussed in my ASCO recap), the single-test/single-gene approach becomes unfeasible. FMI’s multi-gene approach provides an elegant solution to this problem, and will be highly cost effective since it will replace many single-gene labor-intensive tests.

What about valuation? How can you justify FMI’s market cap ($700M) based on sales of only $60M in 2014?

I can’t. I view FMI as a biotech investment that should be valued by its long term potential and scarcity value as an acquisition target. Just like small biotechs are not valued based on their income statement but on future sales upon approval, Foundation Medicine should be valued by its ability to generate annual sales of $1B+ in 7-10 years.

In order to grow sales meaningfully, FMI must obtain reimbursement. Doesn’t this add a lot of risk to the equation?

Reimbursement is clearly a big issue for FMI (or any other company that would like to sell tumor profiling tests). In my opinion, concerns regarding this matter are overblown because eventually payors will realize (some already have) that multi-gene tests are a necessity. They will not only lead to better treatment outcomes but also to better economics and logistics (specimen availability, time to treatment decision and labor) relatively to single-gene tests.

The route to broad global reimbursement will be a long and gradual one, and reimbursers will probably start with populations for which the need to find rare driver mutations is greater. This is illustrated by the recent decision by Priority Health, which became the first US payor to cover Foundation Medicine’s tests. Initial coverage will be for specific populations (rare tumors, cancer of unknown primary, chemo-resistant tumors and NSCLC).

Lung cancer (NSCLC) appears to be the ideal bridgehead for multi-gene tests as the number of subsets for which there are approved drugs could reach 10 by 2020. (These include KRAS, EGFR, ALK, ROS, RET, HER2, TRK, AXL, BRAF and MET).

If meaningful sales are still 2-3 years away, why hold the stock now? Does FMI have any near-term growth engines?

In the near-term, a lot of the upside potential is tied to clinical stage drugs for which patients are selected with FMI’s tests. This should be viewed as a fast route to reimbursement, assuming an FMI test is approved by the FDA as a companion diagnostic. In that case, reimbursement should be automatic although pricing is an open question.

The most notable near term opportunity is Agios’ (AGIO) IDH1 (AG-120) and IDH2 (AG-221) inhibitors. Both drugs utilize FoundationOne to identify patients with IDH1 or IDH2 mutated tumors. AG-221 already generated encouraging results in AML and AG-120 will have data later this month, which are also expected to be positive (Based Agios’ decision to present them so early).

So should FMI be viewed as an Agios “derivative”?

To some extent yes, because Agios represents a significant near-term opportunity for getting FDA approval and recognition as the first NGS-based companion diagnostic test. Market penetration is expected to be fast given the unmet need and lack of treatment options in AML. Agios could file for accelerated approval for both drugs as soon as 2H:15, which should result in an uptick in commercial revenues for Foundation Medicine in 2H:16.           

And how big is the Agios opportunity?     

It depends on the indications in which AG-120 and AG-221 will be approved. So far, activity was seen only in AML but IDH mutations occur in additional tumor types. AML has a US incidence of 19,000 and 15-20% of cases are expected to be IDH1+ or IDH2+. 10% of AML cases are APML that have very good treatment options and are not likely to be candidates for Agios’ drugs which results in a relevant population of 17,000. Assuming a price of $3000 per test (both mutations should be assessed in the same test) and an incidence of 17,000, Foundation Medicine’s opportunity is $51M per year in the US. To put this in perspective, Agios’ (and partner Celgene) opportunity in AML should be $350M assuming 3500 eligible patients and an average cost of $100k per patient.

Any use beyond AML is pure upside for both companies.

Are there additional industry collaborations with a significant near-term impact?

Another partner of note is Clovis (CLVS), which uses a panel developed with Foundation Medicine to identify patients who are sensitive to Clovis’ PARP inhibitor, rucaparib (BRCAness). Results from a phase II ovarian cancer study (ARIEL2) should validate the genes included by Clovis in the “BRCAness” panel and inform patient selection in an ongoing phase III. Phase III readout is expected in the 1H:16, with commercial revenues for Foundation Medicine expected in 2017.

Foundation Medicine is working with additional pharma and biotech partners. Some of these collaborations are likely to result in inclusion of Foundation Medicine’s tests as companion Dx.

What about competition? Other companies must have realized that NGS-based tumor profiling represents a huge opportunity.

Multiple diagnostics companies are expected to enter the tumor profiling field, some already announced products or plans to develop NGS-based panels. Activity ranges from broad panels from traditional diagnostic players such as LabCorp and Quest, to more focused panels usually pursued by pharma companies. It is important to note that FMI has the broadest and most clinically validated test on the market. It also has a significant first-mover advantage and appears to be the undisputed market leader.

So aren’t you concerned about intensifying competition? Are you sure a small company could compete with giants such as LabCorp and Quest?

I am not naive enough to think FMI will have 80% of the market down the road but I strongly believe its first-mover advantage and market experience will enable it to be a meaningful player and capture a ~20% market share. This should translate to annual revenues of >$1B, similar to a successful biotech product. Importantly, FMI’s products could be more successful in the hands of a large diagnostics company, which make the acquisition scenario very likely in my opinion.

But why would one of the diagnostics giants prefer to acquire FMI over supporting its internal products?

The NGS tumor profiling market is still nascent with multiple companies working on several fronts. As with any evolving field, some companies will be more successful than others in penetrating the market due to a myriad of factors (logistics, number of genes covered, time to market, web interface etc.). In such a competitive environment, if one or two players feel they are left behind they might try to leapfrog competition by buying the market leading product. Such a deal will be complimentary: FMI will tap into a global marketing infrastructure whereas the acquirer will have the most popular and clinically validated NGS test. In this scenario, market share for FMI’s products could be higher than on a standalone basis (40-50%).

An acquirer may also be interested in the genomic database Foundation Medicine is generating. With thousands of samples analyzed being added every quarter, this database is a valuable tool for guiding target selection and drug development.

Who is the company most likely to acquire Foundation Medicine?

My guess is as good as anybody else’s but my bet is on Roche Diagnostics or Abbott (ABT). Both companies have a strong presence in cancer diagnostics but neither have commercially available NGS-based tumor profiling panels. Importantly, both companies have companion diagnostics based on FISH (Abbott) and PCR (Roche), which may become obsolete in a market dominated by NGS tests.

Is there a way to hedge the investment in FMI via a position in a competing company?

Not really. FMI represents a unique opportunity: It is the only company which is 100% focused on NGS-based tumor profiling and also the undisputed leader in the field. It reminds me of the ADC field 5 years ago, when the market was dominated by Seattle Genetics (SGEN) and Immunogen (IMGN). The two companies worked on ADCs almost exclusively (they had naked antibodies as well) and were the only ones with attractive clinical stage ADCs in development. If an investor believed in ADCs, all he/she had to do is buy both stocks to get maximal exposure to the ADC segment.

What are the major catalysts for FMI in 2015?

On top of quarterly commercial performance, the most significant catalysts in 2015 are:

‒      Reimbursement by additional payors

‒      Data for Agios’ IDH1/2 inhibitors – should increase visibility regarding likelihood of success and commercial opportunity (based on indications pursued).

‒      Data for Clovis’ rucaparib in BRCAness+ patients (preliminary results next week) – should increase confidence and likelihood of approval.

‒      Additional partnerships with biotech companies and emergence of more companion Dx collaborations.

‒      Progress for drugs targeting rare mutations in lung cancer – expected to illustrate the need for multi-gene tumor profiling for this indication (annual US incidence of ~200k).

Biotech portfolio – Nov 9th, 2014

biotech portfolio - Nov 9 2014biotech etfs - Nov 9 2014

55 thoughts on “The bull case for Foundation Medicine

  1. great posting Ohad!

    ——

    have you ever looked at liver disease (ALF/NASH/…) drug companies? this is a HUGE and fast growing market, and to pick a small basket of promising companies now might not be a bad idea.

    I like eg CNAT; have you looked at them?

  2. Thanks Ohad for great summary of FMI. Regarding ESPR, has been extremely volatile of late, perhaps due to recent financing or pending IMPROVE-IT trial results. It is a good value at these levels or would you wait until after IMPROVE-IT.

    thanks.
    Steve

  3. Ohad
    thank you for explaining the FMI case.
    There is another completion you did not mentioned – Nant system. It is used in Providence Health & Services – 27 hospitals.They plan to offer the service to their 25,000 cancer patients each year. They claim to cover much more than 343 genes which FMI covers at $3000 cost per test.
    Also ILMN can bypass FMI and collaborate directly with the hospitals or other providers.
    I like FMI and have a small position, but it looks that the barrier to enter is not that high.

  4. Thanks Ohad for a comprehensive analysis. Andre does makes a good point..it certainly seems like healthcare if headed towards ‘personalized medicine’, and it is hard to discount Dr. Patrick Soon-Shiong’s Nant-Health platform as it seems to overlap with FMI’s business. There are several recent Forbes articles on his projects.

  5. Christian – Thanks. I am looking at the NASH/NAFLD field for quite some time but can’t say I managed to get my arms around it. CNAT is very interesting, I like the fact they don’t focus on NASH but on other liver diseases (ACLF, liver transplant) and the longer term safety database they have. Valuation is also attractive (106M).

    Steve – I plan on holding ESPR following the excellent p2b data. IMPROVE-IT may have industry-wide implications (so does FDA’s decision re: PCSK9 antibodies), but it’s hard for me to assess the readthroughs for ESPR. Even if LDL-C is no longer an approvable endpoint, ES-1201 has a broad metabolic effect that may allow it to demonstrate a benefit in CV outcome study like IMPROVE-IT. The timeline risk is clearly there but valuation is still modest enough to trigger an acquisition (remember, CV outcome studies must be ongoing before approval anyway.)

    andre – A lot of players will try to get into the field, which is big and lucrative enough for multiple organizations. ILMN is already working with companies on developing narrower panels and could potentially develop products which compete with FoundationOne. There’s a big difference between providing tumor profiling services on a small scale or for a limited number genes and providing a good comprehensive panel on a global basis. I still believe FMI is the only one with proven and reliable performance and that its expertise coupled with first-mover advantage will allow it to stay a dominant player even as a standalone company.

    JQ – Thanks, very interesting. Good proof of concept for the approach in myeloma where there are no companion Dx (luckily most regimens are highly effective). Activity was not stellar in the overall population, perhaps some mutations are more sensitive than others.

    Dan – There is always the risk with every technology to be antiquated by something better/cheaper/faster. Based on my understanding, NGS appears to be an excellent tool for tumor profiling for the foreseeable future. Don’t think other approaches a re ready for prime time. Re: Nant, I won’t pretend I understand exactly what they do but it doesn’t look like something that competes directly with FMI, if anything it is complimentary.

    Ohad

  6. I think in regards to what u mentioned earlier…(players who may acquire FMI)…I do not think it would be Abbott but rather Abbvie…Abbott no longer is involved with pharmaceuticals, Abbvie handles that now and they r trying to build an oncology division for the first time.

  7. Ohad, What is your take on the 3rd quarter results for ARQL? Enrollment for the HCC seems to be almost six months ahead of schedule. ARQ-092, ARQ-087 and ARQ-761. all proprietary, seem to be moving ahead nicely. And then there are the positive results from NIH in prostate cancer for tivantinib.

    Cash should carry them into 2017.

    All this and the Market responds with a collective yawn, although volume is up substantially. The stock seems very undervalued to me. Do you agree?

  8. Ohad, what are your thoughts on XNPT? I recall you had written up about them a while back, but have yet to add to your portfolio. Thanks.

  9. Hey Richard – on ARQL – I have the same reaction as you!

    Ohad, thanks for this excellent post on FMI.
    Dan

  10. Hey Dan,

    I can understand the non-reaction to the prostate trial; EXEL’s Cabo had similar PFS, but failed in Phase III OS.

    But I thought moving up the timelines in HCC would move the stock more.

    Maybe just a bunch of retail investors taking their penny profits. Might be a delayed Market reaction. I may buy more, even though I’m overloaded already.

    There will be another CC after the results are presented on the proprietary drugs at EORTC.

    Richard

  11. Richard – I thought they pretty good, a lot of new directions with potential upside. It was great to hear about the planned study for 092 in proteus syndrome and plans to pursue similar diseases, commercial opportunity is not huge but this is something that needs to be done even from a pure ethical standpoint. The HCC update is also encouraging although I think the market needs something beyond tivantinib to become excited. Bottom line, agree with youe assessment, the stock is undervalued.

    Dan – I am still tracking XNPT, they seem to make good progress. The Forward Pharma IPO should have had more impact on the imo.

    Dan/ Richard – EORTC should be a good opportunity to understand the basis for their p1b plans but I dn’t expect anything dramatic. The major catalyst for ARQ092 is paradoxically data from competitors like Roche and AZ, who may identify a route to market with Akt inhibitors.

    Ohad

  12. Hello Ohad, isn’t Morphosys now overvalued with a marketcap of Eur 2,1 bn? Mor-208 is nothing exiting and there is competition for the other compounds. Genmab seems to be ahead regarding CD38. Regards

  13. Ohad, wanted to say thanks again for the postings. Your insight into this market is truly exceptional and you have helped make me lots of money. I wanted to try to offer some insight into a stock that I have been invested in (IMSC), small defense company that landed huge TSA contract today. IMO stock should double in the next couple days.

  14. Toby – Morphosys is definitely not cheap at these levels, especially if you believe (like I do) MOR208 has limited commercial value. Regarding the CD38 program, the fact Celgene is not presenting anything at ASH (again) is disturbing. The positive side is the partnered pipeline where MOR has a 3-4% royalty stake but the p3 programs from Novartis, Roche and JNJ have blockbuster potential, which should translate in $30M-$100M in annual royalties going straight to the bottom line. The question is how to risk-adjust these programs for their current value.

    jh – Thanks, glad I could help.

    Ohad

  15. hi Ohad,

    I agree that MorphoSys is not cheap/undiscovered at these levels anymore.

    RE MOR208: the received fast-track designation for DLCBL; do you know whether fast-track designation is data-bound in general?

    RE MOR202: latest information is they’ll present first clinical data at ASCO 2015. they have added further cohorts in the current trial, and combination studies with POM and LEN and ? are planned for early 2015.

    RE: ROYALTIES: note that for Gantenerumab, they disclosed royalty rate is 5,5 – 7,0 % (depending on net sales volume).
    I saw another royalty rate of 5% from Contrafect (one small partner of MOR) in an S-1.
    That’s the 2 official rates I am aware of.

    The 3-4 % you mentioned seem to be to low, I assume for the average deals are with 4-6% royalty (depending on net sales volume)

    brgds
    Christian

  16. Hey Ohad

    what do you think of OPHT – they released news that Fovista comnined with Lucentis (anti-VEGF) reduced retinal fibrosis. Right after came the announcement by AVEO of a license deal with OPHT for Tivo.
    You have to admire how OPHT is going after an opportunity.

    Dan

  17. Hey Ohad
    also, what is your take of KBIO – I’ve asked you before and you were intrigued. I see now they have a poster for ASH – the title is as follows: KB004 is active and well tollerated in ph1/2 study (anti-ephA3 program). The share price went on a small run the last few days, but market cap is stil below $70M, and the ph2 program on Pa infections will read out next year.
    Thanks, as always
    Dan

  18. Dan
    Ohad said in August that he thinks that “they (OPHT) got the target right but with a problematic agent”. Curious if the latest development changed his opinion.

    I think AVEO deal makes sense, since OPHT with have their own anti-VEGF to combine with Fovista. Unfortunately Asia market is excluded, which is actually pretty big.

  19. Christian – Re fast track designation, I don’t think it attests to the strength of the data but more to the unmet need. In any case, MOR208 does not look better than other CD19 targeting agents.
    Thanks for providing the royalty info, I was under the impression they had to pay Cambridge Antibody Technologies (Now part of AZ) a portion of the royalties they receive but not sure.

    Dan – No doubt OPHT pioneered the use of PDGF inhibitors, my primary concern there is the ability to compete with single shot solutions in the form of bispecific antibodies or co-formulation of 2 antibodies which REGN is pursuing (Thanks, andre)

    Re KBIO – I like their anti-infective program and their p2 data, albeit small and preliminary, generated interesting signals imo. Might be a good idea to get in before results are announced given the low expectations but I would risk very little.

    Ohad

  20. Ohad
    Re: XNPT. Do they have any patent protection? It looks that FWP has some composition and delivery patents.

  21. Any opinion on the oxgn
    or the latest cldx data?
    Also biotest very high on bt062, imgn has opt in rights of 50%, 15 mil buy in…though that may elicit a need for a share offering.

    I am looking to add some more cldx

  22. andre – From what I understand, XNPT’s drug is a prodrug of monomethyl fumarate and should not be part of the Biogen/Forward Pharm patent dispute.

    Alex – Don’t think it is.

    Robert – Re OXGN, there is a lot of skepticism around their data.
    CLDX’s results were very nice in my opinion, small study but first randomized data that bode well for rindo’s chances of succeeding in p3.
    Re BT062 – The more intersting angle is teh triple negative breast cancer trial, should have data next year.

    Allen – I like FGEN’s anti-CTGF antibody for fibrosis. Still studying the data but at first glance there are encouraging signs.

    Ohad

  23. hi Ohad,

    regarding Morphosys royalties: CAT patents are already expired or will expire soon, and payments to AZ are not expected.

    All in all, I see the MorphoSys royalties (approx. 5%, sometimes more like we can see from gantenerumab’s 5,5 % to 7%) as pretty remarkable given they do not have to shoulder any development costs (their costs for generation/optimizing the mabs are marginal and anyway covered with the research payments).

    Others could get (much) less, e.g. I think Medarex had about 3,5% or so, Xencor has 2,5% for xmabs, etc.

    What would be very interesting to know is which conditions Adimab gets. It’s a pity that this company is not public in my opinion.

  24. Hey Ohad

    what is your take on the GERN deal with Janssen?

    And how does the CLDX release change your opinion, are you going reopen a position in CLDX?

    Did you ever look NSPH up – the company has a short life line from secondary (6 month cash), shares plunged back to $0.40 – management better deliver… but from all the reports I have seen, it seems they have decent technology compared to competitors…

    Thanks
    Dan

  25. Christian – Thanks for this information. Agree that a 5%+ royalty rate is favorable compared to what other discovery companies get for projects at similar stages ( Dyax gets 2.5% from BIIB for the LINGO mAb). I guess it shows that for a high quality product you can charge a premium. Don’t know about Adimab’s royalty rate.

    Dan – GERN’s deal with JNJ is an important validation imo. JNJ has accumulated a lot of expertise in hematology (Velcade, ibrutinib, daratumumab…), this means they believe the resolution of fibrosis GERN presented.

    Re:CLDX -The data are great news, first time they show an OS benefit in a randomized setting not to mention the tough therapeutic setting of recurrent GBM. The big question is whether they could file with this data set, my working hypothesis says that no but who knows, FDA is becoming very flexible.

    Ohad

  26. Hi Ohad,

    First time poster, but been following the site for a bit. Thanks for all your hard work and willingness to share it with us.

    Looks like one of the overhangs for ESPR is being lifted today based on the data coming from Merck (Vytorin) indicating that lower LDL is beneficial for preventing heart attacks/strokes:

    http://www.forbes.com/sites/matthewherper/2014/11/17/after-years-under-attack-mercks-vytorin-proves-effective/

    Full data is not out until later today, but this seems like extremely good news for ESPR and makes it an even more likely target for a takeover.
    What are your thoughts?

  27. James – I prefer not to comment on the CAR space as the fund I work for (Pontifax) is one of KITE’s founders.

    Elyas – Completely agree, excellent news for ESPR and of course also for PCSK9 antibodies. Given the limitations and confounding factors associated with such a huge trial plus the limited added effect Vytorin has on LDL compared to statins, one could argue that ETC-1002 could have a much more profound impact on CV outcomes.

    Ohad

  28. Mike – I am tracking both companies closely but don’t have a concrete opinion. MEIP’S abstract in AML continues to show strong efficacy (57% CR rate) and good durability but skepticism is justified given the fact that this is a broad spectrum HDAC inhibitor (a class that has had limited success to date) and the fact the drug was given in combination with Vidaza that has single agent activity in AML.
    PRTA’s has 2 interesting antibodies with novel modes action (one partnered with Roche) but valuation is still high and NEOD001 had mixed data at the last update.

    aoganes – What part is inaccurate there?

    Ohad

  29. Ohad:

    Re Juno IPO inaccurate part

    “Patients with DLBCL who are unable to undergo autologous HSCT and are treated solely with chemotherapy have a poor prognosis with a median survival of approximately six months, compared to a median survival of approximately 12 months for patients who are able to undergo autologous HSCT”

    More accurate in my opinion :

    The standard first line treatment of advanced DLBCL is combination chemotherapy plus immunotherapy ( not autologous HSCT)
    DLBCL is curable with combination chemotherapy (First line R-CHOP) and should be treated promptly and aggressively.
    The vast majority of patients with localized disease are curable with chemotherapy plus immunotherapy alone. For patients with advanced-stage disease, 50% of presenting patients are cured with doxorubicin-based combination chemotherapy and rituximab( R-CHOP).
    Second line treatment for relapsed or refractory disease is autologous HSCT and it may cure a portion of patients.

  30. Hi Ohad,

    Thanks for your excellent anaylsis as usual. Do you have any thoughts on Curis and their PIK/HDAC drug in R/R DLBCL in which they released data stating 3/8 pr or cr and 7/8 disease control? I know you called this area (DLBCL) out in the past as an area that could use improved therapies in a analysis of DLBCL therapies of Seattle Genetics and Genentech. The numbers are small but this response rate as monotherapy seems impressive.

  31. hi Ohad

    do you see any read-through re: ARRY by the CLVS announcement to study their drug CO-1686 in combo with Mekinist?

    they partner with GSK now, a few months before GSK-NOV transition. wonder whether they considered also binimetinib…and what they got to hear from NOV..

  32. Clvs sample is small but pfs just above 10m. Not impressive. Do you follow tesaro? Any thoughts? Thanks

  33. Mike – re CRIS, agree it’s a positive surprise although the drug utilizes 2 “old” mechanisms that even in combination may not be enough vs. other small molecules. Tolerability is very important given the checkered history with broad spectrum pi3k and HDAC inhibitors.

    Christian – not sure there is any readthrough, perhaps Mekinist was chosen since it is approved.

    Mike – Expectations were higher (12 months), looks as efficacious as azd9291 and the side effects profile implies they can reasonably get 50% market share in t790m. I was positively surprised by the PFS in t790m-negative pts, small sample size though.

    Ohad

  34. Ohad, when you said the valuation was high, did you take into account that PRTA has about $300 million in cash?

  35. Dan – Yes, if the stock stays in these levels by Sunday.

    Richard – That still implies an enterprise value of $330M for a program with a lot of potential but ambiguous data set in patients so far.

    Ohad

  36. For CLVS, “ORR is 70% in BRCA-mutant patients” but actually this is RECIST plus CA-125 response. The real ORR is only 61%, which reduced from 71% shown in previous result. Do you have any concern about this?

  37. Bought some arql at 1.09… Thank u

    Now the company has gone insider buying berserk! I guess they have been reading your blog also! Lol

    Tiv is dead so it can’t be the hcc trial.
    I liked your comments about going after these rare orphan diseases…..Do u see anything else in your crystal ball for them?

  38. Just going by what the market tells me….metmab failed its trial, Cabo failed crpc in which they called the indication “low hanging fruit” and Tiv being studied in hcc with men who highly expressed met, when in reality it’s not even a true met inhibitor…..FAIL…JMHO

  39. Hey Ohad
    what do you think the value and market potential of Rucaparib might be for CLVS – seems theyr ar edoing some good progress, with the help of FMI.
    Thanks for you prespective,
    Dan

  40. Hello Ohad, Loxo presented pre-clinical data on the Company’s pan-TRK inhibitor candidate, LOXO-101, in a poster session at EORTC-NCI-AACR (Abstract #391). The pps was weak within the last two days. Do you see an interrelation?

    And the other ARRY connection ONTY will present the first preliminary data of 2 ONT-380 combination trials in December (San Antonio). Do you have expectations? Thanks.

  41. Cloud (CLVS)- imo this is very good efficacy, in line with other PARP inhibitors. The real good news is from the BRCAness cohort.

    Robert (ARQL)- always good to see insiders buying but the amounts are rather modest. The ultra orphan angle is very positive but don’t forget oncology is still relevant. On that front ARQL will be a follower behind Roche and AZN.

    Dan – will touch on this in tomorrow’s post. Overall I agree, they are making good progress which is good for both CLVS and FMI.

    Toby- Don’t think LOXO is reacting to the results which were overall positive. ONT380 has very low expectations and represents pure upside. Personally I am optimistic about the Ont380 +Kadcyla trial but data should be still preliminary.

    Ohad

  42. Thanks for the insights into FMI, it was an interesting read.

    Do you feel that in the sub-$1000 genome sequencing environment that’s fast approaching a $3,500+ NGS test will continue to feasible?
    My understanding is that FMI does not really have significant IP. Their mutation-therapy database builds on publicly available research papers, and it’s unclear how valuable the data they are gathering from sequencing is at this time. In a sense they’re true service is the easy-to-read report, which might not be very difficult to duplicate.
    They’re also treading some dangerous regulatory grounds, and if the FDA decides they’re report guides treatment it could require a PMA, which I’m not sure FMI will be fully prepared for.

    Happy Holidays!

  43. Elijah – Thanks.
    The way I see it, the continued drop in NGS prices is important for the widespread adoption of products like FoundationOne. FMI is like a company developing Apps for mobile phones, what matters is not the hardware that is getting cheaper and better all the time or the fact that on paper anybody can create another FoundationOne. What matters is the “software” (in their case, adequately capturing genomic data and analyzing it in light of known actionable drivers). I am no NGS expert but it appears to me that providing a broad, robust and reliable tumor profiling test is not trivial even for companies that do NGS for a living.

    IMO the bull case for FMI does not rely on IP but on being the market leader with a clear 2 year head start + expertise gained in commercial operations. This should be enough for Roche/Abbott/ILMN to acquire FMI.

    Ohad

  44. Ohad

    Do you attribute the continued weakness in Foundation Medicine to year end tax selling or perhaps the reluctancy of other healthcare insurers to cover the tests.Or do you have another reason?

  45. david – It’s always hard to explain a stock’s behavior in the absence of important news. Reimbursement and competition are two major overhangs but I don’t think anything changed recently.

    Ohad

  46. Ohad – thanks for the insights on FMI. How does this compare with Nanostring? NSTG’s screening technology seems to be well suited for cancer R&D (uses FFPE samples), they have an FDA approved Rx for breast cancer, and their recent deal with Celgene seems to put them squarely in the CDx business. I appreciate your thoughts!
    Bob

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