Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Interesting ... thanks for sharing. The KDIGO PR and Executive summary emphasize two big reasons for updating the KDIGO clinical practice guidelines quicker than most expected: (1) the novel add-on therapies and in particular VOC/LUP approved by FDA (hard to ignore the results shown in the patient registry for LN patients treated with VOC/Lup both as initial therapy in that it acts fast in reducing UPRC and increasing eGRF and works well as maintenance therapy -- ergo: VOC/Lup gets KDIGO's high certainty of evidence rating); and (2) LN is an aggressive, devastating disease that requires immediate treatment to prevent permanent damage and potential loss of kidneys. I have seen the devastating nature of kidney disease first hand in my family. Thank God for Auph's investment in solving LN after more than 20 years of failed attempts by others including BP to solve LN. WT
Chatter I am seeing is that, based on the new KDIGO guidelines, the relevant US docs treating LN class III and IV are expected to make VOC/Lupkynis part of a new SOC for such LN patients. It might be too early for data, but it would be great if they had some data to show impact of KDIGO 2024 guidelines. WT
Love the "take away chart" for the 2024 KDIGO guidelines. Seem's strong for Auph's VOC/Lupkynis for LN class III, IV, and V, particularly when you consider that VOC/Lupkynis is the only recommended option to receive KGIGO's high certainty of evidence rating. WT
https://stocktwits.com/watsonturtle/message/560875481
the comparison to Benlysta is in plain view right in their corporate presentation ... assumed you would have found that by now. Good luck. WT
90% of the PSFs are being converted in a short time because the Insurance companies are already recognizing that VOC safes the insurance companies and health industry a lot of money by avoiding dialysis and kidney transplant. Count our blessings that Auph followed through and solved a very difficult disease --- think about it ... for 20 plus years and the only option was MFF and steroids which accomplished very little for those suffering with LN. My family has a history of kidney diseases and nothing pisses me off more than to see the construct BS hurdles and needless delays to avoid coverage that was promised.
WT
nope ... referring to the specific data and the comparison to Benlysta ... hardly a difficult bar ... and the suggestion that the two drugs that can't swim on their own can somehow be combined to produce a good result ... had to laugh. I would be shocked if the trial that was terminated (paused if you prefer) would be restarted. They are not that dumb.
WT
Auph is positioned well. But I would agree that it's time they flip the switch on and start to show significant increases in PSFs and Patient restarts. The one item that does concern me with Auph is that currently about 50% of SLE patients are not screened for LN. The new guidelines (Eular, ACR, and KDIGO) all now emphasis the importance of screening early and often for SLE patients. Also, all the guidelines also emphasize the need for early and aggressive treatment of LN with one of the newly recommended options. In the US, that boils down to either adding VOC/Lupkynis or Benlysta. Between those two, Voc is the only one to receive KDIGO's high certainty of evidence. Benlysta offers very little improvement over the prior SOC and thus only received KDIGO's medium and low certainty of evidence ratings. WT
Look. It's no secret that your talking about VERA. Vera paused as in stopped their LN trial. Don't hold your breath for Vera restarting the LN trial for Atacicept. The data they got for LN, IMO, was not that good as it offered very little improvement. My understanding is that they compared their results (showing that Atacicept barely works) to Benlysta (which barely works and offered very little improvement), and concluded that: if we combine two drugs, each that barely work or offer little improvement, we may have something. There is one reason that Benlysta was approved, and it's not because it offered any significant benefit. For more than 20 years, no one added anything to help LN patients. The LN indication was desperate for any hint of improvement. In most indications, the poor results that Benlysta offered would not support FDA approval. Vera is in a similar boat. Thus, IMHO, that trial is going nowhere. WT
That's funny!
SLE trial already underway: The P3 trial for a new treatment protocol for SLE is already underway and I would expect that trial to be completed in 2026 (but don't know). I believe it started shortly after the FDA approved Auph's treatment protocol (using VOC or Lupkynis). The trial costs Auph nothing because the NIH is paying for it ... but Auph's patents (i.e., the ones that provide protection to 2037) also cover the use of Voc for SLE (the treatment protocol) and so Auph would be the only entity that could market the use of VOC for the SLE indication. WT
It's a hot market, so you can always expect some entity will be chasing a solution that will likely be added to the graveyard of failures over the past 20 years. FWIW, the IgaN indication is not the same as LN. As far as the LN indication, my research says the only trial that seemed promising was the NVS trial, and of course that one failed. LN is a very tricky disease. Auph is protected with patents through 2037 and now the standards, including KDIGO now (in its recent 2024 clinical practice guidelines for treating LN) recommend VOC/Lupkynis for treating LN class III and IV.
What's important to understand about KDIGO guidelines is that they not only recommend VOC/Lupkynis, but my understanding is that the guidelines emphasize that VOC/Lupkynis is the only option that received KDIGO's a high certainty of evidence rating ... that is KDIGO finds high certainty of evidence that the the therapy that adds VOC to the baseline therapy is superior over the baseline therapy alone. The other options, not so good ... read for yourself at page S32 of KDIGO's practice guidelines. It seems pretty clear that this is a big step toward VOC becoming the new SOC. WT
[/img]
https://sih-st-charts.stocktwits-cdn.com/production/original_559447358.png
[/img]
Kiwi,
Fair points. That's why they call it a rare disease. About 400K with Lupus in US develop SLE. So your metrics line up with Auph's metrics, 80k to 100K develop LN. LN class 3 to 5 accounts for about 80% of that ... .
I agree that Auph has been presented with multiple hurdles ... . But evidence-based treatment seems to getting more traction and the trend to 3 years treatment period presents a nice star factor on the opportunity. Unless they regress in PSFs + restarts, then it seems to be a safe bet that Auph is good value here.
Good luck.
WT
Kiwi,
As your spouse probably knows through experience, Insurance companies seem to use PAs (and make them confusing as hell) to delay and sometimes avoid paying for patient care. That's why congress is taking action.
https://www.ama-assn.org/practice-management/prior-authorization/big-step-forward-congress-fix-prior-authorization
In Dec of 2023, Lorddragon (who I understand is a nephrologist) published a "Notice of Approval for Medicare Prescription Drug Coverage" for use of Lupkynis for 15 months and the approval was open ended in that, effectively, if the doc continued to prescribe the Voc, the coverage would be extended beyond 15 months. Again, this is simple recognition that failure to treat in most cases results in a far greater cost to the insurance entities -- IMO, cost of Lupkynis is trivial compared to cost of dialysis, hospital stays, and transplant.
WT
Otsuka is not alone ... many other BP entities pass on EU or discontinued sales of life saving drugs for rare diseases. It's all part of price negotiation. drug saves insurance/health industries the burden of more patients on dialysis and transplants (500K to 1M per patient) and now they don't want to pay. Some think that that the move is all part of the on-going negotiations ... i.e., the EU rights under the K would revert back to Auph ... which gives Auph another asset to include in a sale. NVS would negotiate a much better deal.
You have odd logic on your Icer point. I am also on Vascepa (not for high triG but for other issue -- got a PA exception). I was also an investor. Bought at 3 sold 1/2 at 12. Sold other 1/2 at 18. Amrn would have sales and would have been IMO bought out at 25 to 30ish. But mgnt had a big FU. The story is simple. don't file your pharma suit to defend your patent in Nevada. For that, AMRN deserved to lose. It's the area I work in and it seemed odd as hell. After that loss the sales went to generics. It's well known that Delaware is where you should defend a pharma patent. Icer has nothing to do with it. WT
That's the knee jerk reaction by many. But it's short-sited in my view. This is the nature of a rare disease indication (meaning there are few patients in the TAM) ... such drugs would never be developed for the rare diseases if the price was not reflective of some ability to recoup development cost. Look at what's going in in Germany -- Otsuka pays a small fortune to acquire the rights ... but Germany sets a price so low that it makes no sense to even offer Voc in Germany. Thus, Otsuka shut down its sales operation in Germany and rumor has it they may do so for all of EU.
What's interesting is that ICER played a roll in arriving at this price ... in that they gave a favorable rating to Auph's price, concluding that it would save the health/ins industry significant $ as it was the first contribution in over 20 years to the LN indication and the only contribution that actually works.
WT
Those are current numbers ... keep in mind that when Lupkynis was launched, the expectation is that the period of treatment would be 6 months to 1 year. And revenue estimates were based on those numbers. Now, nearly 50% of those patients continue to be on therapy past 18 months. That's huge.
- In fact, since launch, the persistency and length of treatment has gone up each Q. And now they are seeing patient restarts (recognizing that it was a mistake to discontinue therapy). This is all having a material impact on revenue estimates. Currently they have about 2100 patients on therapy, but because period of treatment is trending toward 3 years, they have a annual rev run rate of about $200M.
WT
Kiwi
- the guidelines (EULAR and ACR) each recommend using Voc for at least 3 years. ISN/KDIGO says up to 3 years.
- Since 3 year study (and the EULAR guidelines) the length of treatment is trending toward 3 years
- current persistency metrics are as follows.
- at 1 year 54% remain on therapy
- at 15 months 48%
- at 18 months 43%
- and, due to the new 2023 guidelines, Auph is starting to see significant number patient restarts, i.e., patients that stop treatment and due to flare up or other issues are coming back to treatment and staying on a maintenance plan for 3 years ... I expect that trend to continue. Why? Docs that don't follow the clinical practice guidelines open themselves up to liability. And given that LN destroys the kidneys in a very short period of time, the liability ramps up fast ...
- bottom line: after therapy starts: I would expect most patients to say on Lupkynis (Voc treatment protocol) for at least 3 years.
WT
Kiwi,
I read the ISN guidelines. Keep in mind, those are international standards. If read thru the US market lens, there is no question in my view that Lupkynis will become SOC for LN class III-V. Look at the "graded recommendations" in conjunction with the "certainty of evidence."
In the US the recommended added immunosuppressive agent will either be Lupkynis (VOC) or Benlysta.
For Lupkynis (VOC), there is high certainly of evidence that adding VOC gets results that are superior to the current SOC (with the added benefit that VOC allows the rapid tapering of steroids). Here's the quote.
Kiwi,
Thanks for the information. Be curious to know your spouse's view on the US metrics for LN: (1) estimate of US population that gets LN each year (I have seen estimates from 80K to 200K, noting that many never get diagnosed or treated); (2) estimate number of patients that get diagnosed with LN each year (this number is apparently increasing significantly each year); and (3) I would think that most LN patients when they initially get diagnose (assuming it was caught early enough) would have an eGFR that is greater than 45. Particularly now that we have guidelines preaching screening all SLE patients early and often. My understanding is that about 80% of LN patients fall under the Class 3, 4, 5 LN category and ... very few would have an eGFR under 45 and thus be excluded under the ISN guidelines. Does you spouse agree with that?
WT
Kiwi,
you can ignore my question ... I see the reference to ISN.
WT
Kiwi,
Which guidelines are you quoting from: EULAR? ISN? Or ASR (which I recall was in the draft stage ... but was told it will be very close to EULAR which would be good). ISN is good as well as I recall it was fussy on the other CNIs like TAC ... i.e., it did not provide the clear differentiator that EULAR provided for VOC.
WT
Kiwi,
Appreciate the response. Still own my ARDX. 3/4 of position bought in mid-3s but continued to take nibbles in the 4s, 5s, and 6s ... and closed some calls along the way, giving up my premiums. Oiy! It always seems to be an ugly path. But happy where I sit today. Currently expect to sit on my holdings for LT gains at some point.
Auph: it will be fine. Auph a premium generating machine with cash secured puts and covered calls.
UNCY: I will take a look at this one and get back to you on that board.
Side Q: what's going on with BB scripts? Someone suggested that script data will no longer be provided by BB ... perhaps a dispute about publication on msg boards? Any insights?
WT
WT
A lot of good news appears to be building up for Auph:
(a) NVS terminates LN trial, (b) Eular recommendations and guidelines, (c) treatment period per Eular guidelines trending to 3 years, (c) some apparently seeing Medicare issuing very liberal approvals for use of VOC treatment protocol (per Lorddragon on X), (d) Otsuka EU sales appear to be strong ... appears to have added 3K to 5K patients in only its second Q of sales in EU (per derived by Lorddragon on X from Otsuka's royalty payments to Auph). WT
Yes. I plan to be this LT. WT
I recall Novartis recently terminated a trial for SLE. Is that correct? And, does it involve the same drug being used in the LN trial? WT
Thanks Kiwi. Biotech/pharma across board getting hammered. ARDX and AUPH are good pick ups at this point as they don't need to raise case. E.g., Auph has about 2.5 share points in cash and I expect it to go up in Q3 with milestone payments.
Re ARDX, I am surprised there hasn't been more discussion of ARDX being a target for BO. I am also surprised at the daily volume and volatility.
Re Auph and insurance, keep in mind that they did get a very favorable icer report, so it's hard for insurance companies to push back too hard. I think it's more the types of policies (high deductibles and thresholds) that are being sold ... such policies put a heavier burden on the patients. But, in view of the icer report, the cost of developing and bringing the treatment protocol to market, and the long runway for IP protection, I would not expect auph to be dropping price at this early stage. That's really a call for they buyer of auph. I expect they will be close to a $200M/year run rate for Q3. The RETA BO intrigues me because, as I recall, they were not expected to hit peak sales 2029, with IP protection running out in 2033. Auph would seem to much better positioned.
WT
Kiwi -
Are you still in AUPH ?
NVS has just completed a major trial with Cosentyx for LN. Not sure when they will publish results but it's something you may want to watch for if you're still in that co.
Thanks for the NVS info on Auph. Yes. I still hold my AUPH. Been in Auph since 2017 and other than FB its been my most profitable investment. Sold about 1/2 position after P3 (2019, early 2020) and have been selling calls on the rest ever since for monthly income. Didn't play the run up to 34 well (took some profits, sold some calls, but not enough). Really don't mind the volatility, i.e., I took advantage of the patent dispute to reload under 5.
WT
will do some DD. but I would assume it will take years to get to market. WT
interesting ... that would seem to be a ways out there in time ... and still somewhat speculative. Nonetheless most stocks having revenue tied to dialysis dropped to today. An overreaction I suspect. But don't know. WT
Good Info. Agree with you ... ARDX looks strong. How long does a patient stay Ibsrela? I am assuming its less than 1 year as I recall seeing numbers that the annual cost per patient is about 12K? is that correct? WT
Agree. IMO any offer under 30 will not even open the door to further DD. I expect they already have multiple offers, including one at 40+. With 400M in cash, sales rising, and a much stronger patent position, any offer less than the highest offer received in late 21/early 22, IMO would be a non-starter. WT
- something appears to be driving KIWI to be transparently biased on every metric. but his posts are useful in that it shows the BS spin we could expect from BP. I wish him luck. Admittedly, my posts should be viewed as biased as well. I have a long position since 2017ish, taking profits along the way and buying some back along the way.
- high level, here's my biased opinion: all the metrics have gotten stronger since the last round of negotiations. while we can all quibble the degree in which certain metrics are stronger such as sales (2021: 45M/ 2022: 103M) or (Q4 2021: 21M to Q4 2022: 28M), in the end all BP cares about is the IP at this point
- regarding the IP, in my biased view, one read of the response to SUN's IPR and that is all BP needed to know. The 2037 patent was tested and it is strong. The pending app on track one has also been strengthened and should be allowed soon.
- also in my biased view, I believe BP is moving now to acquire Auph because it's the only chance to get it done in the prior negotiating range ... rumored to be in 35 to 45 range. I see no reason why Auph would even consider anything lower at this point. IMO, Auph is in a very strong position and, also IMO, BP has to know that if Auph does not stick to that range or higher, they are simply magnifying the downside to SH lawsuit.. All of the above is just my view ... and I have been known to be wrong on many of occasions. WT
Not clear to me what this "free source" is but IMO no entity is better at putting a spin on the data than GSK. And when you see "Disclosure: This research was supported by GlaxoSmithKline. Please see the original reference for a full list of disclosures" you should run fast.
When GSK extension safety study got bad results (i.e., by comparison to Voc's 2 and 3 year data), GSK appeared to call out all the dogs to go into full spin mode. The constant and repeated efforts by GSK and it's docs to refer to Voc as a typical CNI is getting really old. ACR22 did a nice job of moving the ball forward and bringing clarity to why Voc and its treatment protocol is gaining ground with the rheumatologist group.
Kiwi, I appreciate your posts. Your posts help to define the world of BP spin IMO. I wish you all the luck in the world and I hope you do well.
WT
Kiwi makes fair point about insurance company hurdles due to cost ... but data is outdated. I
- with lit done, costs will come down -- and should fall in the range of 40M to 50M.
- from BB script data, it would appear Auph is having a very good quarter ... and there will be an inflection point in 2023 IMO.
- Per Kiwi, Nephs already on board.
- Per cowen, Rheums getting more comfortable (which I find funny, ... like they have a choice because you either start following evidence-based treatment or you will lose all your patients and credibility). Benny is not a real option for LN patients in class 3-5. Having watched a family member go on dialysis and die of kidney disease, treating LN is not only about getting results, but getting there fast. The insurance companies have for the most part stepped up and approved. Evidence based treatment (coupled with a very favorable icer report) will carry the day.
- Just speculation, but IMO BO will be completed in 2023. Why? BP could probably pick this one off for 30 to 35 pps now ... but if sales hit an inflection point ... it will take 3x that number.
WT
From Motley Fool ... "Aurinia Pharmaceuticals is likely to be bought out soon."
WT
https://www.fool.com/investing/2021/10/24/2-biotech-stocks-that-could-go-parabolic-this-week/
Is CoolG73 still on this board? I recall that ahead of P3, that CoolG73 made the big predictions ahead of P3 release that, in view of the test results (about one month in front of PR) showing that Voc did not vitiate the effectiveness of MMF (steroids, or the SOC), that Voc P3 would show superior results.
CoolG73 ... what say ye at this point? Any thoughts on current valuation? is PFZ the buyer? BO price?
Personally, I would prefer that Auph not sell unless the PPS on BO is North of 70.
WT
Immuno-Oncology patents around NR2F6 are the key assets IMO. That they discovered (a) small molecules that activate and (b) small molecules that inhibit the NR2F6 checkpoint is a very, very big deal. I believe Regen (via Harry Landers) is the first to solve that puzzle for the NR2F6 checkpoint.
For background on other system checkpoints and Immuno-Oncology ...
https://www.cancerresearch.org/immunotherapy/treatment-types/immunomodulators-checkpoint-inhibitors
WT
A few comments.
IMO, great technology is the driver here. The volume and revenue pushing the pps higher makes this clear in my view. Soon there will be more talk about the NR2F6 technology ... look back at Harry's discussion on that technology.
But at this stage (pre-dividend), people will start to figure out that commons have the same value as preferred and thus I expect a rapid rise in pps for commons until they match preferred.
WT
It would appear that, based on Website changes, we are about to see leadership change. Very positive. WT
Apparently, the link below is causing some chatter about AMGN and AUPH ... got this from a ST poster. CEO Bob Bradway responding to Q on M&A yesterday ...
Here's $AMGN CEO Bob Bradway in response to a Q on M&A yesterday: pic.twitter.com/cdGn89xwlm
— Ned Pagliarulo (@NedPagliarulo) January 31, 2020