WhirlwindAstrologer92
3 days ago
Q3 2024 Financial Results Conference Call
Management will host a conference call and live audio webcast to discuss these results and provide a corporate update on November 7, 2024 at 4:30 p.m. EST. To listen to the live or archived audio webcast, please register at https://edge.media-server.com/mmc/p/vxykqwaf. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com. The archived webcast will be available for one year.
Upcoming Conference Participation
Society for Immunotherapy of Cancer (SITC) 2024, November 6-10, 2024, Houston, TX
Friday, November 8, 2024, Rapid Oral, 12:30 p.m. CST
Abstract #409: Multimodal single-cell sequencing analysis reveals putative tumor reactive population in lifileucel TIL products
Saturday, November 9, 2024, Poster Session 9:00 a.m.–8:30 p.m. CST
Abstract #1488 (Late-Breaking): A multicenter phase 2 trial of lifileucel plus pembrolizumab in patients with checkpoint inhibitor-naive metastatic NSCLC: updated results
Abstract #416: Superior anti-tumor activity of IL12-engineered TIL IOV-5001 in simulated tumor microenvironment
The full abstracts will be available on November 5, 2024 at 8 a.m. CST as a supplement published in the Journal for ImmunoTherapy of Cancer (JITC).
badgerkid
1 week ago
FWIW, some good news with a little insight into OOS product and the attempt to still use whenever possible for cancer patients. Multiple potential benefits: cancer patient improves, OOS product may prove to be acceptable such that a lower threshold could be approved and billed, additional data collection leading to future mfg improvement, other. https://ctv.veeva.com/study/expanded-access-program-of-lifileucel-ln-144-in-patients-with-unresectable-or-metastatic-melanoma
So much depends on a good sample from the patient from which Amtagvi is manufactured. As the quality of samples and the health of the patients improve as a result of earlier line treatment, OOS numbers will likely drop, but the hope remains that a lower threshold for specs proves to still be more than acceptable not only for the benefit of the patients, but since we'll be doing this all over again as foreign markets open up to Amtagvi (Lifileucel).
surfkast
1 week ago
Thanks for the reply. Looks like you are into several high quality stocks. This one had a great run early this year. Dropped way down and is slowly climbing. Actually beating many projections. How this goes based on Amtagvi and a pipeline full of other programs looks good to me I see that the projections are for between $114 and $121 million in sales this year which is anticipated to grow to $475 or more in 2025. I have also seen projections for as high as $35 in 2025. I would to see this run sooner than later as I am not getting any younger. I already took a gamble and sold and brought back in.
The institutional holding really look great.
Iovance Biotherapeutics, Inc. (US:IOVA) has 524 institutional owners and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). These institutions hold a total of 249,134,762 shares. Largest shareholders include Vanguard Group Inc, Perceptive Advisors Llc, Mhr Fund Management Llc, BlackRock Inc., State Street Corp, Avoro Capital Advisors LLC, VTSMX - Vanguard Total Stock Market Index Fund Investor Shares, Soleus Capital Management, L.P., XBI - SPDR(R) S&P(R) Biotech ETF, and NAESX - Vanguard Small-Cap Index Fund Investor Shares .
UBS just jumped in with a goal of $17 short term.
Nice to see you here as it has been years! Good luck.
badgerkid
2 weeks ago
Short interest still high. Low volume down days, higher volume up days, and new analysts initiating IOVA as a buy. Yeah, shorts have their work cut out for themselves:
Shorts remain in trouble, not much movement:
10/15/2024 60,338,267
09/30/2024 59,945,282
09/13/2024 60,293,439
08/30/2024 57,686,674
08/15/2024 59,334,386
07/31/2024 61,318,556
07/15/2024 58,941,197
06/28/2024 56,421,027
06/14/2024 54,631,791
05/31/2024 49,964,621
GMH*
2 weeks ago
My estimate would put the MC at close to 30B which would be about the size of Seagen when they were taken over. The premium paid would be less (40% in that case) and would likely be a stock+cash deal if it were to happen. A BO is always possible but I think it would depend on how NSCLC and IOV-5001 were to be coming along (as well as any competition in the space).
The problem I have with the BO scenario is that you cannot model that. It is purely guess work on something someone said. Fred said "Iovance would be a good bolt-on" but that was 8 months ago, Everyone say "WR sells companies", but he has sold more stakes in companies than he has sold companies.
With modeling out fair value, I can make a judgement on the stock regardless. If the SP runs past where I think fair value is (given the facts at the time), I will liquidate, but if I had a BO thesis, I am kind of forced to hold until a BO happens.
badgerkid
2 weeks ago
GMH, regarding your unsolicited long term thesis: first and foremost, thanks for the work and food for thought.
I know we've kicked some of this around before, but assuming your projections are in the ball park and given WR's history of letting a big one get away, does the company try to go it alone with those kind of projections, or do you see a number that Big Pharma can pay that would satisfy both sides in what could be viewed as a "fair" buyout number?
My thesis remains the same, Iovance is building a turn key operation which will then be sold to the highest bidder and the mfg process is being designed to be replicatable (and almost modular). But to your point, revenue numbers keep edging up and Iovance is creating a working model. Will they have access to the necessary capital to take it to that next level? Do they have the team that can do that? Does Iovance go out and acquire the right people to build a team for a high growth company, or is the writing on the walls (my view) that a sale is far more likely.
I contend that the evidence currently suggests that a sale of the company is more likely and possible over the next 6-15 months. I think a few more pieces still need to be put in place before that ultimate deal, but all signs point to success regardless the final decision by Iovance.
I look forward to any additional thoughts you care to throw at my ramblings.
Good luck to the longs.
badgerkid
2 weeks ago
GMH, thanks. We'll have to look at the Q3 rev numbers to see if we can deduce how it's applied to the bottom line. I would figure that certainly worst case it's fully deductible as an expense if it's supplied at no cost to the patient (but that is likely a much smaller number based on production cost). If it's not technically a trial, then hopefully Iovance can recapture some of the cost or some partial payment. Regardless, I would assume as the patient population improves, so does the quality of the tissue samples thereby producing higher quality TILs that are more likely in spec. I've mentioned this before, but I'll be curious to see if the specs loosen up at all as more data comes in on using the OOS product and the results of those patients. Hopefully it proves to be a win-win.
GMH*
2 weeks ago
Posted my short term Q3 thesis, so here is my long term (2029-30) thesis (not that anybody asked):
Peak L2+ MM patients/slots (US): 1,900/yr (largely due to screening vs label)
Peak L2+ MM patients/slots (RoW): 2.800/yr - approval very likely in 2025
Peak L1 MM patients/slots (US): 3,000/yr - likely approval given interim top line - expected in 2027
Improved manufacturing/infusion success rate from est 55% to 80% - feasible given addressable items in label.
Gross Margins to 70% - management guidance and should follow success rate improvement
SGA/R&D spend increases 5%/yr: $404M to $515M
Dilution of 20%
Using IBB PE of 18.8 and PEG of 1.50 given growth/pipeline
Without showing the math, SP would be in the $100-$110 range.
Additional patients from NSCLC would simply add (5,000 patient/slots per year) but need more data before incorporating
IOV-5001 would open up eligible patients significantly due to elimination of IL2 - but still pre-clinical so will wait and see
Regarding a Buyout, was reminded that WR invested in Pharmacyclics. He got in sub $2 and sold his stake for $7 for a nice return, but Pharmacyclics eventually was sold for $261/share. I am guessing his current cost basis is around $10 and I do not think he wants to make the same mistake as he did with Pharmacyclics.
Just my opinion. As always, do your own DD.
GMH*
3 weeks ago
In the Q2 earnings call, JMB (CFO) said that, when the product was OOS, the doctor had the decision to use or not. If the doctor used, those expenses were moved over to the R&D line and out of COGS. I suspect the doctor/patient would make that decision depending on how far out of spec the product was and whether the chemo/IL2 treatment would be worth the risk. On Stocktwits, someone confirmed this was how CAR-T was handled. Only question I have is if they would also give away IL2, but I suspect that this would still be covered by insurance so probably would add to revenue.