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Post by celo on May 19, 2024 19:42:13 GMT -5
Good follow up to my tipsy musings. I would say, I think you are being a bit generous to Mannkind's future revenue streams.
Here are my opinions on Mannkind's revenue estimates:
Afrezza for your 2024 estimates would have a considerably different year when compared to its past and show exceptional growth. I understand this year may be different but I believe it will take more time to play out, as in 2025.
Afrezza will get a bump in Q2 and then probably be pretty flat on Q3 and raising a bit in Q4, similar to 2023. I hope it starts a new trend but history has said otherwise. Mannkind's card pay services were disrupted in Q1 for two weeks. Not sure how much that cost them, but it probably did a little.
The decrease in V-go we saw in Q1 was not an anomaly but the start of a trend away from V-go as Mike had stated on the Q1 conference call. We will probably see a steady slow decrease of revenue through the year.
Tyvaso DPI sales will sit somewhere between my 8% and your estimates. United has always shown great ability to beat estimates and continue push ahead of schedule. They will be ready to in 2024 again, but not to the degree you are showing.
The collabaration will bump up as you have shown in the second quarter but then flatten in Q3 and rise slightly in Q4. Q1 and Q2 were/will be annomolously high as stated on the Q1 earnings call, due to the PPQ of the finish line. Mike followed up in the RBC conf that the revenue bump will continue in Q2.
Here are my (very much personal opinion based on what I heard) estimates:
2024
Q1 Q2 Q3 Q4 Yr
Afrezza 14.4 16.6 17.5 18.9
V-Go 4.3 4.2 4.2 4.1
Tyvaso 22.7 25 27.8. 30
Coll 24.8 26.0 27 29.5
Total 66.2 71.8 76.5 82.5 297
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Post by ktim on May 20, 2024 3:25:43 GMT -5
Who do you hear things from? (Just a personal question, I promise I won't tell anyone)
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Post by prcgorman2 on May 20, 2024 7:30:39 GMT -5
Who do you hear things from? (Just a personal question, I promise I won't tell anyone) Mike, et al, at UTHR, RBC, and last earnings call I think, but celo will have to confirm. |
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Post by celo on May 20, 2024 8:47:24 GMT -5
Correct!
Mannkind just had a 5 cent/share profit. Not by some financial trick, but by keeping expenses down and raising revenue. That should see the same profit or better every quarter of this year.
That's a 2014 P/E of 20 to 25. If MNKD can keep expenses close to the same every quarter and continue to increase revenue the P/E will be a lot lower.
WTF share price! Catch up, you're behind!
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Post by ktim on May 20, 2024 12:05:06 GMT -5
For some reason the analysts don't seem to see profitability sustained at that level. I believe the highest of the estimates is $0.17 for the year... avg is $0.11 or $0.12. Not sure whether that is a GAAP or non GAAP.
Seems like we need to get some upward revisions so that the forward P/E is getting down to that range.
I suspect the estimates are stale with analysts that really aren't following MNKD closely. But there was a reaffirm since the last earnings.
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Post by jkendra on May 20, 2024 12:20:00 GMT -5
United Therapeutic's Citizen Peition: aboutblaw.com/bd6NPursuant to 21 C.F.R. §§ 10.30 and 10.31 and the Federal Food, Drug, and Cosmetic Act (“FDCA”) and on behalf of our client, United Therapeutics Corporation (“UTC”), We submit this Citizen Petition to request that FDA withdraw its unlawful tentative approval (“TA”) of Liquidia Technologies, Inc.’s (“Liquidia”) section 505(b)(2) New Drug Application (“NDA”) for YUTREPIA; issue Liquidia a Complete Response Letter; and refuse to grant final approval (“FA”) to Liquidia’s YUTREPIA NDA unless and until FDA makes a final determination that Liquidia’s sole supplier of active pharmaceutical ingredient (“API”) for YUTREPIA—LGM Pharma, LLC (“LGM”), whose involvement in YUTREPIA’s commercial supply chain may not be known to the Agency—has been brought into full compliance with all Current Good Manufacturing Practice (“CGMP”) requirements. The basis for this request is straightforward. LGM plays a critical role in Liquidia’s YUTREPIA manufacturing process: it is Liquidia’s sole API supplier. Yet LGM is the subject of an ongoing Consent Decree in which it admitted liability for committing serious and pervasive violations of FDA’s CGMP requirements in connection with its handling and processing of APIs for finished drug product manufacturers like Liquidia. The Consent Decree documents that those violations were ongoing before, during, and after the Agency’s award of TA to YUTREPIA, and indeed that LGM’s CGMP violations were so severe that they repeatedly caused the introduction of adulterated drugs into interstate commerce. Under the Consent Decree, LGM remains subject to a years-long course of corrective-action mandates that FDA designed to protect patients and ensure that LGM’s misconduct will not once again cause the introduction of tainted drugs into interstate commerce. Unless and until Liquidia successfully completes all steps required by the Consent Decree or finds a safe alternative to LGM, there can be no assurance that YUTREPIA is not tainted.1 |
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Post by jkendra on May 20, 2024 12:35:19 GMT -5
Actions Requested
UTC respectfully requests that FDA:
(1) Rescind its award of TA to Liquidia’s YUTREPIA NDA;
(2) Issue Liquidia a CRL for the YUTREPIA NDA; and
(3) Withhold any approval of the YUTREPIA NDA—whether a TA or
ultimately a FA—until LGM has fully and successfully discharged its
obligations under the Consent Decree and Liquidia supplies the Agency
with sufficient data and information to establish that the identity,
strength, quality and purity of its proposed YUTREPIA drug product in
fact meets all the statutory and regulatory requirements for approval.
The statute also makes clear that any such facility’s non-compliance with CGMP is not
only a basis for withholding approval in the first instance, but also for withdrawing a
previously granted approval whenever new information “evaluated together with the
evidence before [FDA] when the application was approved, [shows that] the methods
used in, or the facilities and controls used for, the manufacture, processing, and packing
of such drug are inadequate to assure and preserve its identity, strength, quality, and
purity.” 21 U.S.C. § 355(e). Taken together, these provisions leave no doubt that
CGMP compliance is a prerequisite to any form of approval and that CGMP
noncompliance requires withdrawing any previously granted approval.
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Post by Clement on May 20, 2024 12:55:50 GMT -5
^ Thanks, jkendra, this looks like a very big deal to me. It appears that UTHR has a strong case.
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Post by celo on May 20, 2024 17:01:35 GMT -5
Where is the old hippy? He usually has some good reasons why this is just litigation gymnastics by united
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Post by prcgorman2 on May 20, 2024 17:07:29 GMT -5
I'm also curious what agedhippie thinks. Given LQDA was up 5% today you would have thought investors were celebrating UTHR's petition. |
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Post by cretin11 on May 20, 2024 21:46:01 GMT -5
Where is the old hippy? He usually has some good reasons why this is just litigation gymnastics by united He may assume we surely have figured it out on our own by now. But he probably does need to remind us before folks go astray speculating that this litigation stands a chance… |
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Post by prcgorman2 on May 20, 2024 22:33:36 GMT -5
Where is the old hippy? He usually has some good reasons why this is just litigation gymnastics by united He may assume we surely have figured it out on our own by now. But he probably does need to remind us before folks go astray speculating that this litigation stands a chance… I’m confident it stands a chance of doing what it was intended which is to delay LQDA further. LQDA already has a delay from trying to get two indications approved at the same time. Remember how much time it took the FDA lawyers to respond to the “citizen’s” petition questioning the approval of Tyvaso DPI? |
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Post by ktim on May 21, 2024 0:02:30 GMT -5
He may assume we surely have figured it out on our own by now. But he probably does need to remind us before folks go astray speculating that this litigation stands a chance… I’m confident it stands a chance of doing what it was intended which is to delay LQDA further. LQDA already has a delay from trying to get two indications approved at the same time. Remember how much time it took the FDA lawyers to respond to the “citizen’s” petition questioning the approval of Tyvaso DPI? How long was the delay of Tyvaso DPI? I don't recall. |
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Post by prcgorman2 on May 21, 2024 6:30:20 GMT -5
I’m confident it stands a chance of doing what it was intended which is to delay LQDA further. LQDA already has a delay from trying to get two indications approved at the same time. Remember how much time it took the FDA lawyers to respond to the “citizen’s” petition questioning the approval of Tyvaso DPI? How long was the delay of Tyvaso DPI? I don't recall. I want to say it was like a few months but maybe it just felt that way. My memory is first the FDA declined to give UTHR the benefit of the acceleration voucher (that I think UTHR bought, sold, then bought again for $150M), and then after approving Tyvaso DPI, there was a delay while the FDA lawyers worked on investigating and responding to the “citizen’s petition” and poured over the 500+ pages of lung health safety material provided by MNKD to UTHR and the FDA. I think that’s perhaps part of the reason UTHR has been willing to sue their federal regulator. Payback. |
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Post by agedhippie on May 21, 2024 7:25:22 GMT -5
I'm also curious what agedhippie thinks. Given LQDA was up 5% today you would have thought investors were celebrating UTHR's petition. This goes nowhere. The manufacturer is YS Lifesciences, not LGM as UTHR claim so the cGMP issue UTHR raises is irrelevant to LQDA. This is purely an attempt at a delaying tactic. LGM is just the importer so if this was going to impose a delay LQDA would simply switch importers. Doing a quick spot of research (I have been slacking on the LQDA front) this was bought up at the BoA Healthcare conference and the response was that in the FDA have not been in touch with them in the year since the consent order was issued, and that the petition inaccurately identifies LGM as the manufacturer of the drug. The FDA action would be to review the data associated with the petition relating to the complaint. If it's lung safety they will want to see the lung data, if it's a supplier they will want to see the supplier's role. The delay is directly related to the complexity of the review which in this case is trivial (show that the drug is not manufactured by LGM - evidenced by the contracts with LGM for the import and YS Lifesciences for the manufacture.) UTHR also rather misses the point of a consent order - it's not to prevent a company from doing business (nobody can use a drug you handle) but to provide a legal framework allowing the company to continue doing business in exchange for remediating an issue. In other words a consent order is not disqualifying for a supplier. |
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