GMH*
2 일 전
I have been thinking about the Piper downgrade this weekend, trying to see how much merit there is to the assessment. Most people are dismissing the report, but given that this analyst was the only one who called Q2 correctly, I am wary to do so. The original analysis stated that ramp-up was slow because "The slow uptake is attributed to extended waits for manufacturing slots, which delay infusion times and may restrict patient eligibility." (link: https://www.investing.com/news/company-news/piper-sandler-sees-manufacturing-delays-impacting-iovance-stock-potential-93CH-3540561). This was also confirmed by U of Kansas docs as well as Boston General. The Piper projected 24 infusions which was very close to the 25 actual. However, I think the issues were more than simply slot availability (which I think has been fixed with additional hiring ). I think the issues also included:
1) initial (bolus) patient health with high drop rate early on - note 100+ patients "enrolled" at Q2 ER but only 55 infused at Q3 ER. Now resolved via patient selection
2) Extended initial cycle-time of +/-90 days. to +/-75 days at Q3 and reduced to +/-63 days.
3) At JPM, GS reported Fred saying "management had previously suggested that out-of-spec product was occurring primarily due to poor tumor resection quality, arising in part due to the large number of surgeons resecting samples and where the level of training had been variable. Accordingly, efforts to retrain surgeons on appropriate harvesting techniques focusing on quality and size have been implemented. Management noting that on average, outcomes improve after 2-3 patients but additional efforts are underway, particularly with new ATCs ... to ensure correct tumor resections are occurring with the first patient". (confirmed by U of Kansas docs and also supported by the enrolled to infused number reported in Q2/Q3.
So, the current Piper theory is that, based on the 6 ATCs they surveyed, they have reached a "steady state" of patients. Here is my take on that thesis:
1) I assume that these are the same 6 ATCs that responded to the first survey. As such, they would have been part of the initial 30 ATCs, which are much more likely to be at "steady state" than any subsequently onboarded ATC. Therefore, extrapolation to other ATCs would be inappropriate.
2) IOVA hired most of the regional marketing staff in the last 3 months so community out-reach has really just started.
3) OOS rates should drop (based on above) so even at steady state of patient beds, infusion rates should increase.
4) IOVA has increased staff by 50+ in the 2 months from Nov 7th ER to Jan 13th JPM, so unless these are all marketing/RoW rollout hires, seems like there is still manufacturing growth.
5) Looking at the balance sheet, starting in Q2 2023 (after Proleukin purchase), IOVA started reporting inventory numbers. This was all under WIP and Finished Goods and this was steady at about $10M total until Q1 2024 and has increased $2M/quarter since then. From this, I assume the initial $10M was for planned stocking (very small sales until Q2 2024) and the $2M quarterly increase was being driven by Amtagvi and Proleukin usage. The bigger thing is that raw materials jumped from $0 to $5.6M in Q1 to $13M in Q2 to $23.9M in Q3. This obviously was all driven by Amtagvi manufacturing and the only reason for that build up would be for increased manufacturing.
Bottom line, while Piper got the Q2 call correct, I think they are missing the boat with this call.
badgerkid
3 일 전
Hicham, you're in good company. I've also increased my position, reduced my average cost, and I'm willing to add more shares in the coming months as my funds become available. I see more reasons now to be long IOVA than I did when the share price was $18. I'm also far more willing to wait for the multitudes of good news expected this year which most certainly should move the share price higher.
The sector has been a bear, but the low multiples that the biotechs are currently trading at should start returning to more realistic levels over the coming months and years. Lots of bargains out there right now including IOVA (or so I believe), but making good choices on what to buy and hold going forward is still the challenge. All of our due diligence on Iovance leading to our share purchases will likely result in very good returns.
Here's a little something I shared on another site: "These guys did okay. Catch Charlie's comment at 1:52:"
Good luck with your investing in 2025.
badgerkid
6 일 전
FUD or confusion? I'm seeing some comments being posted about Lung data with the usual what if comments on multiple message boards. Here's my view FWIW (and you're paying nothing for it, so that should establish its value).
TIL therapy works. That much you should know before spending your investment dollars on IOVA. 40 years of research has already proven that case. Where the challenge lies is in the commercialization of TIL therapy and creating a system that can succeed for both the patient and the profitability of the company - Iovance.
I'm investing in the ability of Iovance to succeed with its manufacturing capability and being organized in such a way as to meet the increasing demands of qualified patients while still turning a profit. For my purposes, TIL is already a given and will be approved for multiple cancers.
There were several bumps at the start last February and for several months due to logistics of managing multiple ATCs, docs, hospitals, surgical suites, and so on. Insurance was a minor concern, but that is also now almost fully resolved.
At the start, Amtagvi manufacturing capability at the iCTC wasn't fully ironed out. With lots of new hires, some initial staffing shortages, the usual when starting up what has never been done before, it was logical to assume some glitches. It's easy to criticize the launch, but you don't know what you don't know. Iovance did learn quickly and made all necessary corrections and adjustments.
There are now several reports and comments by the docs themselves that the process to treat patients with Amtagvi has been successfully organized and the operation from beginning to end is much smoother.
Do your due diligence, understand the facts of TIL therapy, the trial process, and what Iovance is doing to become the first and only successful TIL therapy company for years and possibly decades to come.
Iovance may be under a different name (acquired by BP) in the not too distant future, but TIL therapy is here to stay.
Good luck to the longs.
And wishes for good health to all that have to get treatment for cancer.
badgerkid
2 주 전
Iovance is significantly undervalued at this time for any number of reasons that have been discussed to death on this board and on numerous other boards. Do your due diligence. Your multiples are not correct, they should be much higher by simple comparisons to similar companies.
Here's just one of any number of discussions regarding valuations. https://finerva.com/report/biotech-genomics-2024-valuation-multiples/ Here's an excerpt:
"Revenue multiples for BioTech & Genomics companies grew throughout all of 2020, peaking at 17.5x in Q4 2021. After a continued fall throughout all of 2021, revenue multiples stabilised between the 5.5x and 7x mark for the past two years. In Q4 2023 the median EV/Revenue Multiple for BioTech & Genomics companies was 5.7x, after hitting a 5x low in Q3."
The point is that Iovance's TAM is significant, the company continues to build out manufacturing to meet the increasing demand, but Iovance is also notorious for limiting their PRs and updates, which makes it hard for an investor to get a handle on how the company is doing. The next few months should prove very telling with all the expected news that's right in front of us including the Q4 report, annual report, and a 2025 forward guidance update is also expected.
If you dig deep, you'll find plenty to support a much higher share price, but right now biotechs have been beaten down, and some like Iovance have been beaten down even more than the average. When the reversal happens, those are the companies that will likely have the bigger bounce.
Lots of investors want to be spoon fed reasons to buy - Iovance just doesn't do that. That's also why so many investors just follow the crowd and wonder why they never quite get those great returns.
It's your money, it's your rules, do your due diligence, make your choices.
GMH*
3 주 전
Analysts still seem to have a lot of question marks on the guidance. Gross Margins should continue to expand, rapidly at first but decreasing over time. They added 100 employees last quarter, assuming most were for manufacturing, salary of $80k+30% fully loaded costs, and 1 slot / employee / qtr would represent less than 5% of COGS, the rest is a spread of fixed which should diminish quickly with growth. Assumed growth rate for 2025 is 25% QoQ which is really high, but given demand ramp, improving drop rates and 56 to 70 ATC growth, should be an achievable stretch (IMO). That level of growth / margin improvement should get to cash breakeven by Q3/Q4 based on my modeling. Will see, but I view that as the inflection point... and we get 2 data read outs and EMA decision as catalysts on top of quarterly earnings. We will see how the data emerges.
badgerkid
3 주 전
Goldman Sachs reiterates Buy with a $22 price target.
https://www.investing.com/news/analyst-ratings/goldman-sachs-reiterates-buy-on-iovance-stock-following-meeting-with-management-93CH-3811217
Goldman Sachs reiterates Buy on Iovance stock following meeting with management
Investing.com
Editor Rachael Rajan
Analyst Ratings
Published 01/14/2025, 06:11 AM
Goldman Sachs reiterates Buy on Iovance stock following meeting with management
IOVA
On Tuesday, Goldman Sachs reaffirmed their Buy rating on Iovance Biotherapeutics (NASDAQ:IOVA) with a steadfast $22.00 price target. The endorsement follows a recent meeting with Iovance's management at an investor conference. The focal point of the discussion was the 2025 outlook for Amtagvi, as it enters its inaugural full calendar year of sales for melanoma treatment.
Iovance has upheld its revenue guidance for fiscal year 2024, projecting $160-165 million, aligning with Goldman Sachs' estimate of $162 million. This guidance reflects a successful Amtagvi launch, indicated by consistent patient demand, enhanced ATC operations, and improved out-of-spec rates.
Despite this positive outlook, Goldman Sachs anticipates ongoing investor discussions, particularly regarding the breakdown of Amtagvi versus Proleukin revenues leading up to the fourth-quarter earnings report. Investors are keen to dissect the fundamentals of the launch and judge the feasibility of the fiscal year 2025 revenue guidance, which stands at $450-475 million as previously announced.
Additionally, gross margins are under scrutiny as investors seek to understand the long-term profitability of the launch. While Amtagvi remains at the forefront of Iovance's 2025 strategy, Goldman Sachs is also closely watching for pipeline updates that could bolster the credibility of Iovance's TIL platform. Notable developments include expected registrational data from the IOV-LUN-202 study in second-line non-small cell lung cancer (NSCLC) and from the Phase 2 IOV-END-201 study in second-line endometrial cancer, both anticipated in 2025.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
GMH*
3 주 전
Here is my take on the Corporate Deck Update:
Negatives:
1) Re-iterating guidance was insufficient for The Street. At Q2, they guided (mid-points) of $54M and $162.5. Given the YTD revenue, the Q4 discrete revenue would be $76.7M, but given that $58.6M was a $4.6M beat, re-iterating guidance means new discrete Q4 is $72.1M which is viewed as a significant deceleration.
2) 70 ATCs "including ATCs in final stages of readiness" is a miss. They should have never guided to the higher number as there was no upside. I am still surprised they got this close given 56 ATCs at Q3 earnings call.
Positives:
1) I think the revenue guide as a simple carry-forward rather than a true update, so I think they meet discrete Q4 revenue and come in somewhere in the $165-170M range (with a relief rally from wherever the SP is).
2) Employee count (going back across various updates);
- 2023 JPM (500+)
- Pre-approval Q4 2023 (500+)
- June 3-Q1 2024 (600+)
- Aug 9-Q2 2024 (700+)
- Nov 7-Q3 2024 (750+)
- Jan 13-JPM Update (800+)
Given Fred's Q3 comments that growth was primarily driven by capacity and capacity is limited by staffing (footnote Corp Deck), the trend seems favorable.
3) GM-201 (PD1 knockout) trial P1 is fully enrolled- reported in Nov but just noticed now. These generally take time as patients are usually done sequentially. P2 should enroll quicker as they can be treated in parallel.
Uncertain:
1) Manufacturing Milestone - Fulfill patient demand for commercial launch and clinical trials. Does this mean demand is slowing or are they are now ahead of the curve on hiring? Thinking the latter, but could be some of the former as well.
These are the facts I gleaned from the update and my take on them. Do with them what you will. I always appreciate people sharing facts and their opinion (bull or bear). I personally try to base my investing thesis on facts rather than opinion and think I can discern between the two so appreciate everyone's input.
badgerkid
3 주 전
Sunman, if you're the brilliant investor that you continually suggest you are, then why did you invest in the first place and why did you apparently wait so long to sell? I continue to see what the future holds for this company, I accept the risk. You obviously didn't and you want to blame me and others for your supposed failures and losses. If that gets you through the day, so be it.
IOVA is solidly and unfortunately trading with the sector funds right now which has not been good for share price as of late. I know that, most investors here know that, and our hopes of a better share price sooner than later did not materialize. The company still exists, they're still growing revenues, and they're still expanding business operations into numerous new markets. They even issued an updated corporate deck today: https://ir.iovance.com/static-files/f81194ff-6f65-4ed4-af92-67362eb17901
If you're done with IOVA, then be done and move along.
I'll still be here one year from now - assuming Iovance hasn't been acquired by then.
Iovance will still be improving cancer patients' lives and many will even be fully cured. The revenues will continue to rise, macros will likely improve for the sector, and Iovance will also gain more attention from additional investors.
You have no knowledge of who I am and you continually display your foolishness by what you've implied as of late.
Take a vote. If the board wants me gone, I'll be gone. But I'm not going to be silent just because you see the world differently than I do. You can always ignore my comments. I don't recall asking for your approval.
BK
badgerkid
3 주 전
Sunman, let me continue on this vein. What is Iovance worth today should BP wish to acquire it? What is its terminal value? What will IOVA be trading at 1 year from now assuming they continue to meet or even slightly beat their guidance numbers. What is Iovance worth to BP if and when nsclc TIL is approved? What will IOVA be trading at after European approval is announced? How about one year after European approval is announced, along with Australia, Canada, and other foreign markets?
I'm not telling anyone when to buy a stock, I'm pointing out what I believe will be a significant winner in the coming years regardless the current share price. At $10, it's cheap. At $6, it's crazy cheap. At $3, the entire market is broken and it becomes a wild west for traders.
You and I both know full well that IOVA is getting killed by algos and the biotech sector being out of favor. It's not the result of some secret conspiracy being waged against Iovance alone. And it's certainly not because Iovance isn't succeeding. They are. Without relevant news, IOVA will continue to languish until order is restored to biotechs or some newsworthy information is released about Iovance specifically. Even assuming a mediocre return to average valuations in biotech, and with the conservative expectations offered in Iovance guidance for 2025, what will IOVA be trading at going into next year? Higher or lower? Answer honestly. Everyone here knows my answer.
You're not happy with your investing at this time? Who is? Will you be happy with your decisions one year from now? I fully believe I will be.
I get it, you're trading a stock, you want to maximize your investment dollars. But what if you're just a casual investor looking for a place to invest a few dollars and you're looking for a good growth company with a promising future? Is IOVA a good purchase right now? Does it fit that category? If I buy IOVA and put it in my IRA, will it look good 2 years from now? 10 years from now? 20 years? Neither one of us knows for sure, but I see what Iovance is doing and I believe they are a company to be reckoned with and they're going to be instrumental in improving cancer care significantly. Does that mean their stock value will go up? Yeah, probably. Tell me one place that you can invest your money where you can't lose? Spoiler alert, there is no such place.
This is not just a board for day traders, nor is it a board that necessarily needs to be reminded that things are tough in biotechs without a corresponding discussion about future value and potential. I have confidence that many investors and day traders can and hopefully do think for themselves. I also wish to share information that benefits the decisions that other investors may make regarding Iovance.
***And even more importantly, I want everyone to think of Iovance when their friends, their loved ones, or even they get that cancer diagnosis and they want to know all of their options. The word is just barely getting around now and we have a long way to go for everyone to have access to this treatment in the event that it's the best option for their specific type of cancer.
I believe Iovance will be a significant company in cancer treatment options. I have no qualms about buying IOVA at any of the prices we've seen over the past year as I expect that IOVA will be significantly higher in the coming years.
I want Iovance to succeed for all kinds of reasons, including my own selfish reason for profit on my investment.
BK
badgerkid
3 주 전
FWIW, to all of you who don't like the optimism of others, so be it. I'm on the other side of the track, I'm growing tired of all the pessimism around the biotech sector and all the complaints by day traders who don't accept the risk of what they're doing with their money.
The biotech sector is a minefield right now, and many have finally surrendered and limped away as evidenced in the price action. I'll continue to selectively buy shares in companies that I see as ultimate winners.
I guarantee I will not time the market very well and my purchases would sicken all those day traders that expect daily gains and nothing but wins. I will not look like the sharpest tool in the trading shed, but one year, two years, even three years and beyond, I expect to still be excited about my stock purchases and my eventual gains.
At any time, the market could fall in love with a stock like IOVA, I prefer to own it when it does.
Good luck to my fellow investors.
badgerkid
3 주 전
Hicham, I'm still on this ride with you.
To all, looking at outside evidence of where IOVA is relative to XBI and LABU, I challenge you all to go look at the 5 year comparison, the 1 year comparison, and even the 3 month and 1 month. What you'll find is that the game keeps taking IOVA back to the median with a tendency more toward a tie with LABU. This is why trading a stock like IOVA is so challenging (as is all trading for that matter and why most day traders lose money), you're trying to compete against computer trading and all those algos. I'm an investor who tries to focus on fundaments, but I accept that there's a lot of outside pressures that have nothing to do with the company per se.
Yes, current share price stinks, but Iovance is still building a fantastic business and delivering a winning new cancer treatment based on the testimony of thousands of people in the oncology sector. The share price doesn't reflect it yet, but it will. I can be excited about what Iovance has to offer and accept at the same time that the market value doesn't necessarily jibe with what we see as future value. In time, it will, but knowing the when is far more challenging than knowing if.
I'm ultimately responsible for my own trading decisions as are each of you. I see what's coming for Iovance. I don't know for certain when the market value will be more reflective of IOVA's fair value based on what we expect for future revenues, but I'm confident it will.
The biotech sector has been a bear and despite all that we expect for this company, IOVA still trades with the sector as well and as such has fallen out of favor. I expect the company to be wildly successful, but the market hasn't gotten to that point yet. In time, it will. If the ride is too rough, you all have control over your own investments. Your money, your rules. Buy, hold, or sell, it's your decision on what to do with your money. You can base your decision on what others may say, but that is still your decision. My money, my rules, and my decision was to buy more and hold.
Some see me as a cheerleader - I am and I'm excited for TIL therapy to continue in it's market penetration. It is one big step forward for improving cancer treatment. Iovance has many more big steps coming. The company's success will prove to be a reward to shareholders and even more importantly a potential improvement or cure for 10's of thousands of cancer patients that were running out of options.
Good luck to the longs.