blackjack1975
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titolo ai minimi storici 3.14 dollari ...acquisizione di una societa e il 24 novembre approvazione pfda
io ci provo
io ci provo
LIQUIDIA - LQDA.O chi conosce questa diavola????
- Creatore Discussione blackjack1975
- Data di inizio
ilovepablo
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Molto interessante!
Leggevo ora però che forse potrebbe non ricevere l'approvazione dell'FDA il 24, perché sono fermi con le ispezioni causa covid e se non ho capito male c'è anche in ballo una causa con un potenziale concorrente (UTHR) che sta anche creando una soluzione simile.
C'è un articolo davvero molto dettagliato ma anche piuttosto tecnico su SA che però non riesco a decifrare al 100% dato che non sono un esperto.
Se qualcuno è interessato posso postare il testo qui dato che non posso condividerlo perché è nell'area riservata agli iscritti.
Ho letto anche io qualche info in rete e la situazione sembra anche a me come quella da te descritta .
Vedremo come andrà
ilovepablo
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Lunedì ci studio sopra un po' e cerco di capire meglio il da farsi in vista del 24.
Grazie per la segnalazione!
Buon weekend
blackjack1975
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Lunedì ci studio sopra un po' e cerco di capire meglio il da farsi in vista del 24.
Grazie per la segnalazione!
Buon weekend
grazie....il titolo e' ai minimi storici.....cmq....
sax2021
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As of September 30, 2020, cash totaled $79.6 million. On July 2, 2020, the Company completed an underwritten public offering of 9.375 million shares at a price of $8.00 per share, resulting in gross proceeds of $75.0 million and net proceeds of approximately $70.3 million. The company has begun to implement a more cost-efficient operating plan and estimates that its cash will be sufficient to fund its operating plan into 2022. In addition, a successful close of the RareGen acquisition has the potential to improve the Company’s cash runway going forward.
sax2021
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Liquidia Technologies Inc.
Il candidato al prodotto di Liquidia Technologies LIQ861, proposto per il trattamento dell'ipertensione arteriosa polmonare, è all'altare della FDA, in attesa di una decisione il 24 novembre.
LIQ861 è un'inalazione di polvere secca di Treprostinil. Una formulazione sterile di Treprostinil come soluzione di inalazione, sviluppata da United Therapeutics Corp.
Liquidia e United Therapeutics sono bloccate in una disputa sui brevetti su Tyvaso. In una causa brevettuale depositata nel giugno di quest'anno, United Therapeutics aveva affermato che Liquidia In ha violato due brevetti per Tyvaso, che scadranno a dicembre 2028.
Il candidato al prodotto di Liquidia Technologies LIQ861, proposto per il trattamento dell'ipertensione arteriosa polmonare, è all'altare della FDA, in attesa di una decisione il 24 novembre.
LIQ861 è un'inalazione di polvere secca di Treprostinil. Una formulazione sterile di Treprostinil come soluzione di inalazione, sviluppata da United Therapeutics Corp.
Liquidia e United Therapeutics sono bloccate in una disputa sui brevetti su Tyvaso. In una causa brevettuale depositata nel giugno di quest'anno, United Therapeutics aveva affermato che Liquidia In ha violato due brevetti per Tyvaso, che scadranno a dicembre 2028.
blackjack1975
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SI!!!!
ilovepablo
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Summary
The recent unsolicited licensing offer is likely United Therapeutics, which has several compelling reasons to want to own Liquidia and could pay a large premium to block the RareGen merger.
If a near term deal with United Therapeutics does not come to fruition (it would have to occur by November 13th) then Liquidia would merge with RareGen.
This merged entity should see a successful PDUFA date later in November, and overcome the IP litigation in 2021 for a 2022 launch of their product.
This article was highlighted for PRO subscribers, Seeking Alpha’s service for professional investors. Find out how you can get the best content on Seeking Alpha here.
Synopsis: The market does not appreciate the significance of the news of a competing licensing offer and rejection therein (which suggested a price over $8). If this current suitor does not catalyze a purchase or deal, then LQDA becomes a compelling longer-term opportunity as they bring approved therapies to market in 2022 ($13-25). The stock is trading for $3.72 (11/5/2020 close) with ~$2.50 in cash on the balance sheet.
THESIS: LQDA is a long here because:
The recent unsolicited inbound licensing offer is most likely UTHR, which indicates that UTHR either has concerns about their own therapy or their ability to block LQDA through litigation. LQDA rejected the offer but that doesn't mean something couldn't still happen by November 13th (the end of their exclusivity with RareGen) or after their PDUFA on November 24th.
If the near term take out/licensing deal does not occur, LQDA should still be able to clear the patent litigation issues for a late 2022 launch and combined with RareGen have a large (and expanding) TAM in two categories.
BACKGROUND ON PAH: Pulmonary Arterial Hypertension (PAH) is a rare life-threatening disease that affects the blood vessels in the lungs and is characterized by increased pressure in the arteries. There are around 30k patients who have been diagnosed with the disease with the average age being around 35 and five different WHO group characterizations of the disease. Today there exist over a dozen approved therapies on the market (~$4.7 billion in sales) that are swallowed, inhaled and injected with UTHR having four of these therapies (~$1.3 billion in sales). The market itself is growing at a +5% CAGR as more patients are identified at earlier times and therapies became used for all stages of the disease and patients are put on more than one therapy. There is a need in the market today for an easy to use inhaled therapy given the current method is provided by nebulizers which have a limited ability to deliver dosage and are unwieldy.
BACKGROUND ON LQDA: Liquidia Technologies (LQDA) went public in July 2018 at $11 a share focused on the commercialization of its proprietary PRINT technology which is a particle engineering platform that they were using to develop two candidates – LIQ861 for the treatment of PAH (Pulmonary Arterial Hypertension) and LIQQ865 for the treatment of post-operative pain. Their lead candidate here is the PAH drug (LIQ861) which is designed to improve the therapeutic profile of treprostinil (Tyavaso) – a drug developed by United Therapeutics – by enhancing deep lung delivery and offering an easier use form as a dry powder inhaler (in current form this drug is delivered by bulky nebulizers). Its phase III INPSIRE trial showed that LIQ861 could deliver much higher doses of treprostinil than the current nebulized product and deliver overall better performance measures with no safety issues. The FDA accepted their NDA and set a PDUFA for this November 24th.
In early June, UTHR began a patent battle filing an infringement claim on two Tyvaso patents (‘066 and ‘901). This was a move that LQDA had anticipated having already filed for an IPR in March of 2020 (which is a mechanism put in place by the America Invents Act of 2012 that allows for a quicker pathway to dismiss patent litigation). By filing the lawsuit, UTHR triggered a 30 month stay on the FDA final approval (the PDUFA will still happen in November) and set up a claim construction hearing in May 2021 and a trial in March 2022. In late June, LQDA announced the pricing of a secondary at ~$8 a share for total gross proceeds of $75mm and concurrent plans to merge with RareGen, which had acquired the rights to produce the generic of a Treprostinil infusion. RareGen is collectively owned by investor Paul Manning and Roger Jeffs, the prior co-founder of United Therapeutics, both of whom would join the board of LQDA upon consummation of the merger and play active roles.
After reaching $12 a share, the stock fell following the equity offering and the litigation noise. On October 15th, they announced that the IPR review for one of the two patents (066) had been accepted but the other (‘901) had not – meaning that the patent issue would likely require a more expensive litigation to resolve – and the launch of the drug was pushed to 2022 as opposed to 2021, causing the stock to implode. This set this stage for what happened on October 19th, a headline came across that LQDA was postponing a shareholder meeting scheduled for October 21st to confirm the RareGen transaction and was now evaluating an unsolicited licensing offer.
LQDA has in turn rejected that offer. We saw proxy statement that seemed to fully point towards UTHR as the potential counter party and offered what appear to be very generous deal terms: $150mm upfront - $4.05 a share (pending a successful PDUFA) and a double digit royalty with an undisclosed minimum guarantee payment.
KEY INVESTING POINTS:
The licensing offer is very likely UTHR, which has many compelling reasons to act on the opportunity today.
UTHR and Actelion (a subsidiary of Johnson and Johnson) are the only two companies in the inhaled PAH space, but Actelion does $30mm in sales for its inhaled product while UTHR does +$430mm with Tyvaso. LQDA is a threat to UTHR not Actelion, which is more focused on the oral and IV portion of PAH. Thus, the economic logic alone would strongly suggest that the company offering to license the drug is UTHR.
The other relevant thing to note is that UTHR is run by Martine Rothblatt. This healthcare CEO is ferociously competitive. She presumably would not want her former co-founder and business partner, Roger Jeffs, to get ahold of another asset that could attack a key franchise.
Inhalers pose a replacement threat to nebulizers. Rothblatt knows this and has gone on record saying it:
I do believe there will be a very rapid replacement of nebulizers with that dry powder inhaler. It's so small. It's so convenient… I think there's going to be a 100% replacement of nebulizers with MannKind.
CEO of UTHR Martine Rothblatt (3/19/2019)
In recognition of this, Rothblatt struck a partnership with MannKind, which is creating its own inhaler Technosophere (TRET). This effort is currently in a phase 3 trial. That said, there are already some key competitive advantages that LIQ861 has over Technosophere (TRET).
LIQ861 can be stored at room temperature where as Technosophere (TRET) is refrigerated.
LIQ861 can be used from any position where as the Technosophere (TRET) must be held level or it results in loss of drug powder.
LIQ861 has the same warnings/precautions as Tyvaso (the branded drug) while Technosophere (TRET) has additional ones from acute broncospasms and a decline in lung function over time as measured by FEV1 and there is no data yet on the pulmonary function for treatment duration longer than 2 years.
LIQ861 has yet to show a maximum dose where as Technosophere (TRET) has a maximum dose of 150 mcgs.
MannKind should have phase three data out later this year (the data has been delayed by COVID). It is an open label trial which means that UTHR presumably already knows how it is going. If that data is looking less than clean, it would make sense to pivot and acquire/license from LQDA. To this point, the below language is from the licensing agreement between UTHR and MNKD:
“9.2 Termination Events (A)Without Cause. United Therapeutics shall have the right to terminate this Agreement without cause upon 30 days’ written notice to MannKind.”
So if the MNKD Phase 3 data is looking inferior to LIQ861, UTHR can either acquire/license from LQDA and pull the plug on MNKD and still have an inhaler on the market in a few months.
This strategy of using litigation and then acquiring is exactly what Martine used against SteadyMed. The stock traded from $7 to $3 before being bought for roughly $5 plus a CVR in 2018. In the case of STDY, they did not have a competing deal where as LQDA does.
So what were the terms offered to LQDA?
They got an offer for $150mm upfront (half now and half after the PDUFA) and a low double digit royalty with undisclosed minimum payments.
This was a very generous deal. This was $4.05 a share in cash up front, plus a royalty stream and minimum licensing payments. If you consider the $2.50 of cash on the balance sheet that would have meant at least $6.50 in cash and perhaps $2 or more at the least in minimum payments, which is more than $8.50 in cash considerations today (versus a share price of ~$3 at the time).
Why did they reject it?
It was because of "the lack of an obligation to commercialize LIQ861, and the degree of uncertainty to close the transactions (anti-trust risks) contemplated by the License Agreement."
This is telling because it means that whoever gave the deal had essentially a competing product - if they hadn't, commercial terms would not have been hard to agree to. Again, this leads us to believe that it was UTHR given they are the only folks with a competing product.
The fact that LQDA in turn rejected this deal is also telling. It means that the board, which is led by Dr. Bloch who owns 7% of the company, felt that either they could get a better deal once the PDUFA was passed or that they had a strong enough litigation case that the patent lawsuits would be easy to overcome.
As it was likley UTHR who offered the deal and the fact that LQDA rejected it - means that we've got a potentially very skewed risk-reward here. We could see this suitor come back in and offer another deal knowing how motivated they are. In the meantime, the stock languishes in the $3s.
Tyvaso (which LIQ861 is looking to unseat) should see its TAM grow a great deal with its INCREASE trials.
The INCREASE Study by UTHR could allow for a potential expansion of Tyvaso’s label to include patients with Group 3 PAH, which is not at all factored into the analysis above and would lead to an exponentially larger TAM for Tyvaso and subsequently for LIQ861. UTHR’s Phase 3 data in the INCREASE study cleared all primary and secondary end points and Martine sounded confident on the earnings call on October 28th, 2020 that this product should launch next Spring. It was this commentary surrounding this label expansion that drove UTHR to new all time highs on October 28th, 2020.
We remain on schedule to launch our Tyvaso product for IPF associated pulmonary hypertension in April '21, subject to FDA approval on its PDUFA date. We expect to further penetrate that 30,000 patient market for patients with pulmonary fibrosis associated on their hypertension with the launch of our Dreamboat TreT product by the end of 2021 or possibly early 2022. I'd like to remind everyone that systemic drugs for treating this type of pulmonary hypertension, the pulmonary fibrosis associated pulmonary hypertension are contra indicated leaving Tyvaso as probably the only medicine approved by the FDA to treat this 30,000 patient population. We then expect to greatly expand our pulmonary fibrosis footprint with our TETON study in pure pulmonary fibrosis patients starting in the first quarter of '21.
Martine Rothblatt (October 28, 2020)
This is what a potential incremental TAM could look like (depending on penetration) versus roughly $~450mm today.
(author's own estimates)
All this provides further motivation for UTHR to look to protect their franchise.
If the deal does not go through, then LQDA will be able to overcome the patent litigation and bring this drug to market.
We would strongly prefer a near term deal with UTHR because it removes the patent litigation and allows for this product to be brought to market quickly and gives us a tremendous near-term IRR. Were such a deal not to occur by November 13th, the stock might trade down but there still would be the incremental catalyst of a successful PDUFA on November 24th and possibly another deal attempt afterwards.
Why do we think the PDUFA is a slam-dunk? Aside from the fact that 85% of PDUFAs get approved, the reality is that this formulation showed great efficacy, had no side effects, did not reach a maximum tolerated dosage and the FDA is comfortable with the compound having approved multiple other versions of it.
The big hurdle following the PDUFA would be the patent litigation. There are three key facts here that will argue for an eventual dismissal of this litigation.
The patents in question ‘901 and ’066 on which UTHR is filing its infringement claims are a continuation patent of the ‘393 patent that has already been invalidated (SteadyMed succeeded in invalidating it before being bought out).
The ‘901 and ‘066 patents are process patents which are based on purification processes, which generally fail the obviousness standard in light of prior art.
These purification processes involve removing certain trace impurities from the salt. The LQDA process does not remove these impurities – it leaves the trace impurities in the salt. So the process that they claim is being infringed upon is not a process that LQDA actually engages in.
From a non-technical standpoint LQDA seems to be the “good guy”, having developed a drug that is superior to the current treatment options that is being aggressively blocked by an over litigious UTHR. The Obama appointee to this litigation, Judge Richard G. Andrews may have a degree of sympathy here.
At the moment, the FDA approval will likely require the expiration of the 30 month stay (in Oct. 2022) or a resolution of the infringement lawsuit which goes to trial in March 2022 – but for the reasons there in we are confident that they would eventually prevail.
RareGen Merger Valuation:
If we make very conservative assumptions on penetration, we get a cash flow model as below.
(author's estimates)
Depending on the multiple of the terminal value, you get a range of price targets for Liquidia.
(author's estimates)
This does not account for a potential increase in TAM from the label expansion and assumes a split market with MannKind and that all the current cash is burned to get to market. The take-away here is that with a successful PDUFA in hand and some confidence in the patent litigation, you can get to a much higher share price relative to where we are today.
The recent unsolicited licensing offer is likely United Therapeutics, which has several compelling reasons to want to own Liquidia and could pay a large premium to block the RareGen merger.
If a near term deal with United Therapeutics does not come to fruition (it would have to occur by November 13th) then Liquidia would merge with RareGen.
This merged entity should see a successful PDUFA date later in November, and overcome the IP litigation in 2021 for a 2022 launch of their product.
This article was highlighted for PRO subscribers, Seeking Alpha’s service for professional investors. Find out how you can get the best content on Seeking Alpha here.
Synopsis: The market does not appreciate the significance of the news of a competing licensing offer and rejection therein (which suggested a price over $8). If this current suitor does not catalyze a purchase or deal, then LQDA becomes a compelling longer-term opportunity as they bring approved therapies to market in 2022 ($13-25). The stock is trading for $3.72 (11/5/2020 close) with ~$2.50 in cash on the balance sheet.
THESIS: LQDA is a long here because:
The recent unsolicited inbound licensing offer is most likely UTHR, which indicates that UTHR either has concerns about their own therapy or their ability to block LQDA through litigation. LQDA rejected the offer but that doesn't mean something couldn't still happen by November 13th (the end of their exclusivity with RareGen) or after their PDUFA on November 24th.
If the near term take out/licensing deal does not occur, LQDA should still be able to clear the patent litigation issues for a late 2022 launch and combined with RareGen have a large (and expanding) TAM in two categories.
BACKGROUND ON PAH: Pulmonary Arterial Hypertension (PAH) is a rare life-threatening disease that affects the blood vessels in the lungs and is characterized by increased pressure in the arteries. There are around 30k patients who have been diagnosed with the disease with the average age being around 35 and five different WHO group characterizations of the disease. Today there exist over a dozen approved therapies on the market (~$4.7 billion in sales) that are swallowed, inhaled and injected with UTHR having four of these therapies (~$1.3 billion in sales). The market itself is growing at a +5% CAGR as more patients are identified at earlier times and therapies became used for all stages of the disease and patients are put on more than one therapy. There is a need in the market today for an easy to use inhaled therapy given the current method is provided by nebulizers which have a limited ability to deliver dosage and are unwieldy.
BACKGROUND ON LQDA: Liquidia Technologies (LQDA) went public in July 2018 at $11 a share focused on the commercialization of its proprietary PRINT technology which is a particle engineering platform that they were using to develop two candidates – LIQ861 for the treatment of PAH (Pulmonary Arterial Hypertension) and LIQQ865 for the treatment of post-operative pain. Their lead candidate here is the PAH drug (LIQ861) which is designed to improve the therapeutic profile of treprostinil (Tyavaso) – a drug developed by United Therapeutics – by enhancing deep lung delivery and offering an easier use form as a dry powder inhaler (in current form this drug is delivered by bulky nebulizers). Its phase III INPSIRE trial showed that LIQ861 could deliver much higher doses of treprostinil than the current nebulized product and deliver overall better performance measures with no safety issues. The FDA accepted their NDA and set a PDUFA for this November 24th.
In early June, UTHR began a patent battle filing an infringement claim on two Tyvaso patents (‘066 and ‘901). This was a move that LQDA had anticipated having already filed for an IPR in March of 2020 (which is a mechanism put in place by the America Invents Act of 2012 that allows for a quicker pathway to dismiss patent litigation). By filing the lawsuit, UTHR triggered a 30 month stay on the FDA final approval (the PDUFA will still happen in November) and set up a claim construction hearing in May 2021 and a trial in March 2022. In late June, LQDA announced the pricing of a secondary at ~$8 a share for total gross proceeds of $75mm and concurrent plans to merge with RareGen, which had acquired the rights to produce the generic of a Treprostinil infusion. RareGen is collectively owned by investor Paul Manning and Roger Jeffs, the prior co-founder of United Therapeutics, both of whom would join the board of LQDA upon consummation of the merger and play active roles.
After reaching $12 a share, the stock fell following the equity offering and the litigation noise. On October 15th, they announced that the IPR review for one of the two patents (066) had been accepted but the other (‘901) had not – meaning that the patent issue would likely require a more expensive litigation to resolve – and the launch of the drug was pushed to 2022 as opposed to 2021, causing the stock to implode. This set this stage for what happened on October 19th, a headline came across that LQDA was postponing a shareholder meeting scheduled for October 21st to confirm the RareGen transaction and was now evaluating an unsolicited licensing offer.
LQDA has in turn rejected that offer. We saw proxy statement that seemed to fully point towards UTHR as the potential counter party and offered what appear to be very generous deal terms: $150mm upfront - $4.05 a share (pending a successful PDUFA) and a double digit royalty with an undisclosed minimum guarantee payment.
KEY INVESTING POINTS:
The licensing offer is very likely UTHR, which has many compelling reasons to act on the opportunity today.
UTHR and Actelion (a subsidiary of Johnson and Johnson) are the only two companies in the inhaled PAH space, but Actelion does $30mm in sales for its inhaled product while UTHR does +$430mm with Tyvaso. LQDA is a threat to UTHR not Actelion, which is more focused on the oral and IV portion of PAH. Thus, the economic logic alone would strongly suggest that the company offering to license the drug is UTHR.
The other relevant thing to note is that UTHR is run by Martine Rothblatt. This healthcare CEO is ferociously competitive. She presumably would not want her former co-founder and business partner, Roger Jeffs, to get ahold of another asset that could attack a key franchise.
Inhalers pose a replacement threat to nebulizers. Rothblatt knows this and has gone on record saying it:
I do believe there will be a very rapid replacement of nebulizers with that dry powder inhaler. It's so small. It's so convenient… I think there's going to be a 100% replacement of nebulizers with MannKind.
CEO of UTHR Martine Rothblatt (3/19/2019)
In recognition of this, Rothblatt struck a partnership with MannKind, which is creating its own inhaler Technosophere (TRET). This effort is currently in a phase 3 trial. That said, there are already some key competitive advantages that LIQ861 has over Technosophere (TRET).
LIQ861 can be stored at room temperature where as Technosophere (TRET) is refrigerated.
LIQ861 can be used from any position where as the Technosophere (TRET) must be held level or it results in loss of drug powder.
LIQ861 has the same warnings/precautions as Tyvaso (the branded drug) while Technosophere (TRET) has additional ones from acute broncospasms and a decline in lung function over time as measured by FEV1 and there is no data yet on the pulmonary function for treatment duration longer than 2 years.
LIQ861 has yet to show a maximum dose where as Technosophere (TRET) has a maximum dose of 150 mcgs.
MannKind should have phase three data out later this year (the data has been delayed by COVID). It is an open label trial which means that UTHR presumably already knows how it is going. If that data is looking less than clean, it would make sense to pivot and acquire/license from LQDA. To this point, the below language is from the licensing agreement between UTHR and MNKD:
“9.2 Termination Events (A)Without Cause. United Therapeutics shall have the right to terminate this Agreement without cause upon 30 days’ written notice to MannKind.”
So if the MNKD Phase 3 data is looking inferior to LIQ861, UTHR can either acquire/license from LQDA and pull the plug on MNKD and still have an inhaler on the market in a few months.
This strategy of using litigation and then acquiring is exactly what Martine used against SteadyMed. The stock traded from $7 to $3 before being bought for roughly $5 plus a CVR in 2018. In the case of STDY, they did not have a competing deal where as LQDA does.
So what were the terms offered to LQDA?
They got an offer for $150mm upfront (half now and half after the PDUFA) and a low double digit royalty with undisclosed minimum payments.
This was a very generous deal. This was $4.05 a share in cash up front, plus a royalty stream and minimum licensing payments. If you consider the $2.50 of cash on the balance sheet that would have meant at least $6.50 in cash and perhaps $2 or more at the least in minimum payments, which is more than $8.50 in cash considerations today (versus a share price of ~$3 at the time).
Why did they reject it?
It was because of "the lack of an obligation to commercialize LIQ861, and the degree of uncertainty to close the transactions (anti-trust risks) contemplated by the License Agreement."
This is telling because it means that whoever gave the deal had essentially a competing product - if they hadn't, commercial terms would not have been hard to agree to. Again, this leads us to believe that it was UTHR given they are the only folks with a competing product.
The fact that LQDA in turn rejected this deal is also telling. It means that the board, which is led by Dr. Bloch who owns 7% of the company, felt that either they could get a better deal once the PDUFA was passed or that they had a strong enough litigation case that the patent lawsuits would be easy to overcome.
As it was likley UTHR who offered the deal and the fact that LQDA rejected it - means that we've got a potentially very skewed risk-reward here. We could see this suitor come back in and offer another deal knowing how motivated they are. In the meantime, the stock languishes in the $3s.
Tyvaso (which LIQ861 is looking to unseat) should see its TAM grow a great deal with its INCREASE trials.
The INCREASE Study by UTHR could allow for a potential expansion of Tyvaso’s label to include patients with Group 3 PAH, which is not at all factored into the analysis above and would lead to an exponentially larger TAM for Tyvaso and subsequently for LIQ861. UTHR’s Phase 3 data in the INCREASE study cleared all primary and secondary end points and Martine sounded confident on the earnings call on October 28th, 2020 that this product should launch next Spring. It was this commentary surrounding this label expansion that drove UTHR to new all time highs on October 28th, 2020.
We remain on schedule to launch our Tyvaso product for IPF associated pulmonary hypertension in April '21, subject to FDA approval on its PDUFA date. We expect to further penetrate that 30,000 patient market for patients with pulmonary fibrosis associated on their hypertension with the launch of our Dreamboat TreT product by the end of 2021 or possibly early 2022. I'd like to remind everyone that systemic drugs for treating this type of pulmonary hypertension, the pulmonary fibrosis associated pulmonary hypertension are contra indicated leaving Tyvaso as probably the only medicine approved by the FDA to treat this 30,000 patient population. We then expect to greatly expand our pulmonary fibrosis footprint with our TETON study in pure pulmonary fibrosis patients starting in the first quarter of '21.
Martine Rothblatt (October 28, 2020)
This is what a potential incremental TAM could look like (depending on penetration) versus roughly $~450mm today.
(author's own estimates)
All this provides further motivation for UTHR to look to protect their franchise.
If the deal does not go through, then LQDA will be able to overcome the patent litigation and bring this drug to market.
We would strongly prefer a near term deal with UTHR because it removes the patent litigation and allows for this product to be brought to market quickly and gives us a tremendous near-term IRR. Were such a deal not to occur by November 13th, the stock might trade down but there still would be the incremental catalyst of a successful PDUFA on November 24th and possibly another deal attempt afterwards.
Why do we think the PDUFA is a slam-dunk? Aside from the fact that 85% of PDUFAs get approved, the reality is that this formulation showed great efficacy, had no side effects, did not reach a maximum tolerated dosage and the FDA is comfortable with the compound having approved multiple other versions of it.
The big hurdle following the PDUFA would be the patent litigation. There are three key facts here that will argue for an eventual dismissal of this litigation.
The patents in question ‘901 and ’066 on which UTHR is filing its infringement claims are a continuation patent of the ‘393 patent that has already been invalidated (SteadyMed succeeded in invalidating it before being bought out).
The ‘901 and ‘066 patents are process patents which are based on purification processes, which generally fail the obviousness standard in light of prior art.
These purification processes involve removing certain trace impurities from the salt. The LQDA process does not remove these impurities – it leaves the trace impurities in the salt. So the process that they claim is being infringed upon is not a process that LQDA actually engages in.
From a non-technical standpoint LQDA seems to be the “good guy”, having developed a drug that is superior to the current treatment options that is being aggressively blocked by an over litigious UTHR. The Obama appointee to this litigation, Judge Richard G. Andrews may have a degree of sympathy here.
At the moment, the FDA approval will likely require the expiration of the 30 month stay (in Oct. 2022) or a resolution of the infringement lawsuit which goes to trial in March 2022 – but for the reasons there in we are confident that they would eventually prevail.
RareGen Merger Valuation:
If we make very conservative assumptions on penetration, we get a cash flow model as below.
(author's estimates)
Depending on the multiple of the terminal value, you get a range of price targets for Liquidia.
(author's estimates)
This does not account for a potential increase in TAM from the label expansion and assumes a split market with MannKind and that all the current cash is burned to get to market. The take-away here is that with a successful PDUFA in hand and some confidence in the patent litigation, you can get to a much higher share price relative to where we are today.
Ultima modifica:
ilovepablo
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Alla fine ho deciso di postarlo comunque, perchè mi sembra un articolo davvero molto ben fatto.
Da quello che ho capito:
- il 24 novembre verrà quasi certamente approvato il PDUFA
- se viene fatto il merge con RareGen la valutazione potrebbe oscillare tra 13 e 25$
- c'è il rischio che FDA venga rimandato causa covid e impossibilità di eseguire l'ispezione
- c'è in ballo una disputa legale con UTHR che potrebbe risolversi velocemente oppure richiedere più tempo e soldi del previsto
- il prodotto concorrente MannKind è in fase 3 di sperimentazione e potrebbe creare problemi, anche se il prodotto LQDA sembra più promettente e dovrebbe essere approvato prima
se mi sono perso qualcosa per favore correggetemi
Da quello che ho capito:
- il 24 novembre verrà quasi certamente approvato il PDUFA
- se viene fatto il merge con RareGen la valutazione potrebbe oscillare tra 13 e 25$
- c'è il rischio che FDA venga rimandato causa covid e impossibilità di eseguire l'ispezione
- c'è in ballo una disputa legale con UTHR che potrebbe risolversi velocemente oppure richiedere più tempo e soldi del previsto
- il prodotto concorrente MannKind è in fase 3 di sperimentazione e potrebbe creare problemi, anche se il prodotto LQDA sembra più promettente e dovrebbe essere approvato prima
se mi sono perso qualcosa per favore correggetemi
sax2021
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Alla fine ho deciso di postarlo comunque, perchè mi sembra un articolo davvero molto ben fatto.
Da quello che ho capito:
- il 24 novembre verrà quasi certamente approvato il PDUFA
- se viene fatto il merge con RareGen la valutazione potrebbe oscillare tra 13 e 25$
- c'è il rischio che FDA venga rimandato causa covid e impossibilità di eseguire l'ispezione
- c'è in ballo una disputa legale con UTHR che potrebbe risolversi velocemente oppure richiedere più tempo e soldi del previsto
- il prodotto concorrente MannKind è in fase 3 di sperimentazione e potrebbe creare problemi, anche se il prodotto LQDA sembra più promettente e dovrebbe essere approvato prima
se mi sono perso qualcosa per favore correggetemi
Tutto giusto. Segue la storia di SPPI e BRISTOL-M. Ma un cippo lo merita in ogni caso, a mio avviso.
ilovepablo
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Alla fine ho deciso di postarlo comunque, perchè mi sembra un articolo davvero molto ben fatto.
Da quello che ho capito:
- il 24 novembre verrà quasi certamente approvato il PDUFA
- se viene fatto il merge con RareGen la valutazione potrebbe oscillare tra 13 e 25$
- c'è il rischio che FDA venga rimandato causa covid e impossibilità di eseguire l'ispezione
- c'è in ballo una disputa legale con UTHR che potrebbe risolversi velocemente oppure richiedere più tempo e soldi del previsto
- il prodotto concorrente MannKind è in fase 3 di sperimentazione e potrebbe creare problemi, anche se il prodotto LQDA sembra più promettente e dovrebbe essere approvato prima
se mi sono perso qualcosa per favore correggetemi
L’acquisizione è stata fatta Fda non approverà perché c’è una disputa legale in corso. Non ricordo i termini tecnici,ma il succo è che per 30 mesi o la risoluzione della disputa (l’evento che si verificherà prima) non può essere approvato.
L’Adc a 8 era stato fatto per finanziare l’acquisizione,se non ricordo male e non molto più in là avrà bisogno di cash. Quando troveranno l’accordo esploderà.
Ero entrato attendendo news sulla disputa (rumors) prima di pdufa,ma ho preso i 3 soldatini nei denti. Fortunatamente ne sono uscito quasi indenne,ma resta il mio peggior trade dell’anno.
Ad ogni modo quella era una battaglia,non la guerra.
Immagino che chi la vede a 13/25 si sia riempito le tasche nei mesi scorsi
ilovepablo
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Oggi batte +6.69% in premarket.
Qualcuno entra o è meglio aspettare?
Qualcuno entra o è meglio aspettare?
sax2021
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Io ho rinunciato perchè non ero sicuro al 100%.
Forse anzi probabilmente ho sbagliato.
blackjack1975
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entrato in chiusura.....vera scommessa vediamo domani....
ilovepablo
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