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Post by lakers on Sept 20, 2022 17:39:11 GMT -5
9/20/22 Long after first nod for inhaled Tyvaso, United Therapeutics scraps PhIII in PH with COPD After a recent court win for its inhaled pulmonary arterial hypertension drug, pushing off competition for a few more years, United Therapeutics has quietly scrapped a late-stage study of Tyvaso. The Phase III termination occurred because of a recommendation from the data safety monitoring committee “following a routine safety and efficacy analysis,” United said in an SEC filing Tuesday morning. The biopharma first lined up FDA approval of the inhaled drug in the summer of 2009, for PAH. The drug pulled in $480 million in sales in 2020 and $607 million in 2021. Cowen analyst Joseph Thome has modeled revenues peaking at $1.6 billion in 2025 for the inhaled franchise. The culled Phase III was observing the drug in patients with pulmonary hypertension due to chronic obstructive pulmonary disease, or PH-COPD. Just earlier this month, United had prolonged the trial’s primary completion date, moving it from July 31, 2022, to Dec. 31, 2024, according to an update to the federal trials database. United had expected to enroll 314 patients into the study, dubbed PERFECT, which started in June 2018. The company will take a look at the data and plans to present the results to scientists, according to the SEC document. It’s not the first time United has run into troubles trying to expand the label for Tyvaso, also known as treprostinil. In 2017, the company withdrew a Phase III study of the oral formulation in patients with PH associated with sickle cell disease. Another Phase III of the oral formulation was terminated in fall 2020, testing the drug in patients with PH associated with heart failure with preserved ejection fraction. endpts.com/long-after-first-nod-for-inhaled-tyvaso-united-therapeutics-scraps-phiii-in-ph-with-copd/ |
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Post by lakers on Mar 7, 2022 15:48:01 GMT -5
Trade Alert: The Independent Director Of MannKind Corporation (NASDAQ:MNKD), Jennifer Grancio, Has Just Spent US$300k Buying 83% More Shares
Simply Wall St
March 7, 2022, 2:59 am
Potential MannKind Corporation (NASDAQ:MNKD) shareholders may wish to note that the Independent Director, Jennifer Grancio, recently bought US$300k worth of stock, paying US$2.71 for each share. We reckon that's a good sign, especially since the purchase boosted their holding by 83%.
Notably, that recent purchase by Jennifer Grancio is the biggest insider purchase of MannKind shares that we've seen in the last year. That means that an insider was happy to buy shares at around the current price of US$3.00. That means they have been optimistic about the company in the past, though they may have changed their mind. If someone buys shares at well below current prices, it's a good sign on balance, but keep in mind they may no longer see value. In this case we're pleased to report that the insider purchases were made at close to current prices.
While MannKind insiders bought shares during the last year, they didn't sell.
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Post by lakers on Feb 24, 2022 15:49:16 GMT -5
'F--- the feds': Martin Shkreli barred from running all public companies as judge decries remorseless behavior The court losses continue piling up for ex-”Pharma Bro” Martin Shkreli. In a civil suit brought on by the SEC back in 2015, a US district judge in New York ruled Wednesday that Shkreli will be permanently barred from holding an officer or director role at any public company. The ban goes further than a federal judge’s ruling last month, which only barred Shkreli from running pharmaceutical companies. Judge Kiyo Matsumoto also imposed a relatively modest fine, saying Shkreli would have to pay $1.39 million for violating securities laws between 2009 and 2014. Matsumoto justified the lifetime ban by noting Shkreli has shown little remorse for his actions — actions that were so egregious that he’d likely break the law again if the ban were for a shorter amount of time. “Mr. Shkreli consistently and brazenly deceived his investors, acting as a chaotic, dishonest, and untrustworthy corporate leader in his role as a fiduciary and as the president and CEO of a public company,” Matsumoto wrote. The suit in question involved some of Shkreli’s earliest days at his former company Retrophin, a biotech he ran before launching the infamous Turing Pharmaceuticals that raised the price of a lifesaving antiparasitic more than 56-fold overnight. According to the ruling, Shkreli made fraudulent claims to investors at his old hedge fund, MSMB Capital Management, overexaggerating the returns he’d made. As the fund became insolvent, Shkreli continued promising high rates of return while misappropriating funds. By March 2011, when MSMB had “virtually no assets left,” Matsumoto wrote, Shkreli boasted to investors that the fund had returned more than 41% since its inception in November 2009. When Retrophin was founded that same month, the company — directed by Shkreli — began signing consulting agreements to repay disgruntled investors and try to head off potential lawsuits against himself. Matsumoto noted Shkreli almost certainly knew he was breaking the law, another factor in her decision to impose the lifetime ban. Shkreli acted as though he was untouchable and was convinced he would only spend a few months in jail at worst, writing in one email “f*** the feds” where he claimed the government would not be able to take all his money. The only point in Shkreli’s favor was that he did not meet the standard of “repeat offender.” But all opposing evidence was so egregious that Matsumoto felt the lifetime ban was appropriate. The SEC’s victory follows last month’s ruling in favor of the FTC and seven states, which barred Shkreli from running pharmaceutical companies. The ban was upheld earlier this month, with the judge going a bit farther — the ruling stated Shkreli would not even be able to talk about pharmaceuticals as any statement could be construed as an attempt to manipulate the market. Turing, now known as Vyera Pharmaceuticals, continues to be mired in legal problems as well. In December, Vyera and parent company Phoenixus AG were ordered to pay more than $40 million for blocking generic access to the antiparasitic, part of another Shkreli scheme to create a virtual monopoly on the drug’s active ingredients. Correction: A previous version of this article incorrectly stated that Martin Shkreli’s Retrophin hiked the price of an antiparasitic drug by more than 56-fold. The company that hiked the price was Turing Pharmaceuticals, which has since rebranded as Vyera Pharmaceuticals. endpts.com/f-the-feds-martin-shkreli-barred-from-running-all-public-companies-as-judge-decries-remorseless-behavior/ |
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Post by lakers on Feb 24, 2022 15:38:44 GMT -5
When a citizen petition works: FDA's review of United Therapeutics' PAH drug extended to May Nearly every time a biopharma company or its law firm files a citizen petition to delay a new or generic drug’s approval, the petition is shot down with a quick explanation from the FDA. Research from 2016 shows more than 90% of these petitions are ultimately rejected by the FDA, particularly as many are only filed with the intention of delaying an approval. But in limited cases, as with United Therapeutics and MannKind’s reformulated pulmonary arterial hypertension drug Tyvaso DPI, a citizen petition can actually work to push back the agency’s review timeline. Potential blockbuster Tyvaso, an inhaled version of treprostinil, hauled in a little more than $600 million in 2021, and is already approved to treat PAH and patients with pulmonary hypertension associated with interstitial lung disease. But last October, a dry powder formulation of treprostinil, known as Tyvaso DPI, was rejected by the FDA due to an open inspection issue at a contractor that performs analytical testing of the drug substance. At the time of the CRL, according to an investor note from SVB Leerink, United said that the latest draft labeling indicated that the Tyvaso DPI label would include both PAH and PH-ILD indications with no boxed warning and no contraindications. But now, the FDA says it’s taking a closer look at a July 2021 citizen petition concerning the safety of an excipient in Tyvaso DPI that’s also used in United partner MannKind’s inhaled insulin drug Afrezza. That petition — filed by DC-based lawyer Scott Lassman on behalf of an unidentified client — explains how Tyvaso’s dry powder formulation uses fumaryl diketopiperazine (FDKP), which is a novel excipient that “poses a serious risk of acute bronchospasm in patients with chronic lung disease, such as asthma and chronic obstructive pulmonary disease.” FDA reviewers have suggested that FDKP, which the petition describes as an irritant, is responsible — at least in part — for the acute bronchospasm observed in the Afrezza clinical trials. “As a result, Afrezza’s approved labeling carries a prominent ‘boxed warning’ alerting healthcare providers that Afrezza is contraindicated in patients with chronic lung disease and requires pre-treatment testing to identify potential lung disease in all patients,” the petition notes. Earlier this month, the FDA requested additional information concerning the pulmonary safety of Tyvaso DPI related to this pending citizen petition, the company announced Thursday. “We responded to the FDA’s request, and the FDA indicated that our response constitutes a major amendment to the Tyvaso DPI NDA, which extends the FDA’s anticipated deadline to review the pending NDA to May 2022,” United said in a statement. The FDA has yet to issue a final response on the citizen petition, but in an interim response from January, the FDA said the petition “raises complex issues requiring extensive review and analysis by Agency officials.” Launch preparation is already underway for Tyvaso DPI, according to a fireside chat with MannKind CEO Michael Castagna at the SVB Leerink Global Healthcare Conference last week, with sufficient supply for both PAH and PH-ILD indications. “Management noted they have prepared manufacturing and supplies for commercialization of Tyvaso DPI in both PAH and PH-ILD indications. The company expects ~80% conversion from nebulizer formulation to Tyvaso DPI,” Leerink added in a note. SVB Leerink said in another note published Thursday, “We would have expected that if the FDA viewed the issues raised in the CP [citizen petition] as warranting a boxed warning or contraindication, this would have been made apparent earlier in the review and evident in these draft labeling discussions. However, with the review ongoing, we would not rule out the possibility of the FDA contemplating final labeling that could include a boxed warning/contraindication.” endpts.com/when-a-citizen-petition-works-fdas-review-of-united-therapeutics-pah-drug-extended-to-may/ |
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Post by lakers on Feb 24, 2022 15:24:50 GMT -5
2/24/22 MannKind said it has learned that the FDA considers a response by United Therapeutics to the agency's request for additional information to be a major amendment to the new drug application, which will extend the review deadline to May. The company, which is focused on inhaled therapeutic products for patients with endocrine and orphan lung diseases, said it was informed earlier this month that the FDA had requested additional information from United Therapeutics regarding the pulmonary safety of Tyvaso DPI related to a pending citizen petition, to which United Therapeutics promptly responded. Last October, MannKind said the FDA had declined to approve the application at that time for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The regulator at that time identified a deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil, the active ingredient of Tyvaso DPI, though the FDA's response didn't pertain to MannKind, the company said. MannKind Corp.'s shares slid 20.4% to $2.92 Thursday after the company warned the deadline for the Food and Drug Administration to complete its review of the new drug application for a pulmonary arterial hypertension treatment being developed with United Therapeutics Corp. The stock has now fallen 33% so far this year, and more than 50% over the last 12 months. www.marketwatch.com/story/mannkind-shares-slump-20-after-delay-in-fda-review-of-tyvaso-dpi-271645719880United Therapeutics Earnings: Q4 FY21 sales increased 8% Y/Y to $415.2 million, missing the consensus of $427.62 million. Treprostinil-based product sales (Tyvaso, Remodulin, and Orenitram) grew by $23.5 million. The growth in Tyvaso revenues resulted primarily from an increase in quantities sold, reflecting the expansion of the Tyvaso label to include pulmonary hypertension associated with interstitial lung disease. Operating income increased from $65.3 million to $169.8 million, and net income improved from $98.8 million to $112.2 million. The company posted Q4 adjusted EPS of $3.51 missing the consensus of $3.72. Operating expenses declined to $245.4 million, down from $319.6 million on lower R&D and SG&A costs. Price Action: UTHR shares closed at $193.11, MNKD shares closed at $3.66 on Wednesday. |
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Post by lakers on Dec 25, 2019 17:05:55 GMT -5
Talk about making a mountain out of a mole hill...this entire thread passionately arguing over something very minor where no one knows the background story about an event that will have little affect on this company moving forward. Mole hill??? Been waiting for an entire YEAR for the warrants to expire. Then, 4.5 of 23 million (about 20% of the total) are allowed to be exercised at only 82% of full value. Even worse CVI's other 7.25 million (??) warrants are EXTENDED another six months. I don't call that minor or a mole hill. And then to NOT say a g*damn thing about it until finally doing so in a text? It stinks. 23M - 4.5M - 7.25 M = 11.25M shares. 11.25/206.41 OS = 5.45%, reserved for 5% ?? SH will likely reject request for more new share authorization. Besides that will be looked frown upon by the new directors including HFM nominated ones such as mnholdem. The remaining 5% could be earmarked for something....market cap should be higher than 276.6M after Breeze is completed. |
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Post by lakers on Dec 25, 2019 15:14:27 GMT -5
A year ago, 12/28/18, CVI Investments discloses 6.3% passive stake in MannKind. CVI Investments reports a 6.3% stake in MannKind, which represents 11.75M shares. The filing does not allow for activism. Read more at: thefly.com/landingPageNews.php?id=2841870 |
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Post by lakers on Dec 25, 2019 3:58:19 GMT -5
Spencerosborne
12/23/19, 10:19 AM
@whiskyqueen don't forget, there is another 11-12 million warrants at $1.60 which are currently not renegotiated. At the moment these expire on 12/26. We could see another announcement dealing with those in a similar fashion....or they simply expire
spencerosborne
12/23/19, 06:49 AM
@whiskyqueen the company does not have many good options. This move eroded market cap by a level higher than the cash raised. That in and of itself should give a clue as to how few options
spencerosborne
12/23/19, 06:42 AM
@whiskyqueen this is essentially tapping the ATM without really tapping it. It takes some of the warrants out, creating a smaller overhang for June. The new overhang is 7.25m shares st $1.60. This provides enough capital to pay $5m due to Deerfield their milestone on $50m aggregate Afrezza net revenue sales. The midcap covenants require sales targets AND a minimum cash on hand. That $5m could be important in q2 of next year. IMO the company will need to seek authorization of additional shares at next ASM to provide flexibility. Warrant holder now has wiggle room to play its game, while company preserves relationship for possible future offering.
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Post by lakers on Dec 19, 2019 14:51:30 GMT -5
spencerosborne 13m neil36 not that simple. To qualify they must be at $36m on July 31. If they miss that date, they are out of compliance. Assume that q3 and q4 of this year bring $13.4m. That means the first 30 weeks of 2020 must bring in $22.6m. That's an average of $753,333 in net per week. They must average $1.8 million retail over 30 weeks....not 52. 13 of those 30 weeks are in a typically weak q1. spencerosborne 46m jcb322000 not really that simple. They must be at $36m traiking net revenue on July 31, 2020. Q2 of 2019 had net revenue of $6.4m. Let's assume q4 of 2019 is 7 million. That gives us $13.4m. This means they need to generate $22.6m in net revenue in the first 30 weeks of 2020. That means an average net revenue of $753,333 must happen. That would require each week to be about $1.8m in retail sales. It makes no sense to model to the $40m trailing required december 31st of 2020, when the next measure date is July 21st and requires $36m. spencerosborne 07:22 AM @shabi93 @vibes121 @detroitish tranche 2 requires only $25.4m by March 31. spencerosborne 06:53 AM @jdhouse30 the next fee is now 7%. Tranche 3 of $25m will be tough to attain. |
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Post by lakers on Dec 19, 2019 2:40:15 GMT -5
clinicaltrials.gov/ct2/history/NCT03950739?A=4&B=5&C=Side-by-Side#StudyPageTopChanges (Side-by-Side) for Study: NCT03950739 Compare v3 to v4September 26, 2019 (v4) -- October 23, 2019 (v5) Assigned Interventions: Drug: Treprostinil Inhalation Powder Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID) Other Names: TreT Added: United States, Georgia Emory University Hospital [Recruiting] Atlanta, Georgia, United States, 30322 Contact: Jane Gillespie, RN 404-712-8204 jane.gillespie@emory.edu Principal Investigator: Micah Fisher, MD United States, Texas Houston Methodist [Not yet recruiting] Houston, Texas, United States, 77030 Contact: Jennifer Lee 713-363-7537 Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso (BREEZE) clinicaltrials.gov/ct2/show/NCT03950739The “Applicable Funding Conditions” section in the Credit Facility #3 Schedule in the Original Credit Agreement is hereby deleted and replaced in its entirety with the following: “Applicable Funding Conditions: means the following: (a) (x) Agent has received evidence satisfactory to it, in its discretion, that United Therapeutics has received positive clinical data on the Phase 1b BREEZE trial and (y) Agent has received evidence satisfactory to it (in its discretion) that United Therapeutics definitively intends promptly to file or has filed Treprostinil Technosphere for approval by Food and Drug Administration of the United States of America for the treatment of Pulmonary Arterial Hypertension; (c) (x) Agent has received evidence satisfactory to it (in its discretion) that Borrower has received the full amount of all Milestone Payments (as defined in the United Therapeutics License as of the Closing Date) under the United Therapeutics License and (y) immediately prior to and after giving effect to the funding of the Credit Extension under this Credit Facility #3, Borrower is not in breach or violation (nor has United Therapeutics asserted any such breach or violation by Borrower) of the United Therapeutics License Agreement and United Therapeutics shall not have delivered any termination notice pursuant to Section 12.3 of the United Therapeutics License; and
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Post by lakers on Dec 19, 2019 1:51:23 GMT -5
spencerosborne
03:57 PM
@vibes121 @detroitish interest rate was not mentioned specifically. Exit fee is now 7%. Net rev targets lowered. Tranch 3 has raised net rev targets, which seem unlikely to be attained. Bottom line...they can borrow $10m more on this deal with relative ease, but the final $25m is not easy. All things considered, they have funds to mid 2020, and another $35m in anticipated funds to get toward end of 2020.
spencerosborne
06:53 PM
@vibes121 @notmykind @woody81 I laid out just after the deal was announced that the covenants would ge difficult and laid out that the miss would happen in October or November. It was simply a realistic assessment. I stated that it would lead to an amendment and that midxap would get their pound of flesh. Making tranche 3 almost unreachable removes $25m in potential funds from the coffers. There will be ramifications from that, as the street must now contemplate what will happen in mid to late 2020. They key to playing this equity is to look at it from an accounting perspective until such time that the company demonstrates that close bean counting is not necessary.
neil36
06:46 PM
$MNKD
To qualify for the third tranche, the Dec 2020 Afrezza revenue look-back is $40 million. My conservative math, using 42% of retail sales, would require $95 million of retail sales in 2020 or $1.8 million per week.
We are currently averaging $1.3 million per week retail sales. To AVERAGE $1.8 million for 2020, it means retail sales would need to be well over $2 million per week the second half of 2020.
If the average script stays around $1700 per, MNKD would need to be moving 1,200 to 1,400 scripts per week the second half of 2020 to qualify for the third tranche
My back-o-napkin and Sharpie model.
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Post by lakers on Dec 7, 2019 17:04:32 GMT -5
If UT becomes the majority SH of a future profitable Mnkd who pays no tax for a foreseeable future due to $3B NOL, Ops margin becomes pure profit margin. Furthermore, UT could potentially give generous mfgr and R&D contracts to Mnkd to make MNKD more profitable while not paying tax, maybe dividend.
Even SO saw it too. He said UT could buy in phases to take advantage of $3B NOL.
Once UT becomes majority SH, UT and Mnkd’s interest align. UT would want to make Mnkd tax free profitable.
Mnkd would become an outsourced R&D and mfgr arm of UT plus tax free royalty - a legal non-Bermuda tax shelter for both companies.
You can ask if the future Mnkd Director, mnholdem, likes the idea such as how much % for the initial stake, valuation, 2nd stake, 2nd valuation, the trigger. Let’s start the mock interview before he becomes the official Director, then can’t say much. It’s a golden opps to pick his brain as he can freely talk now.
Mnholdem’s chance of being elected is high as I believe Thompson will certify 5%, then he will get more than enough vote. I’d treat Mnholdem as Director elected now. Pick his brain everyone for all biz matter. I still believe UT may likely take the initial stake before next May ASH meeting, before the new slate of Directors getting elected when it will be harder to get a unanimous approval and valuation will be higher.
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Post by lakers on Dec 7, 2019 11:34:23 GMT -5
kevinmik 12/6/19, 06:56 AM $MNKD Mike said during Piper Conference to expect within 3 to 5 years, Mannkind will be focused on Organ & Lungs that will include Diabetes and a Pulmonary Division including a commercial organization. He also suggested the remaining pipeline will shake out going forward ideally packaging out non-pulmonary disease drug candidates to one source (partner). It looks like United Therapeutic is going to play a major role in what Mannkind looks like within 3 to 5 years and we need to see how Mannkind will be structured. The fact Mike said within 3 to 5 years Mannkind will be focused on Organ & Lungs that will include Diabetes & a Pulmonary Division suggest a restructuring of the company is coming. David Kendal : former Lilly CMO, Cialis -inhaled Tadalafil James Shanon: former GSK CMO, Mnkd Board, Imitrex - inhaled Sumatriptans, Aloxi- inhaled Palonosetron CINV. These can be bundle-licensed to GSK. Focusing on Organ dovetails with UT’s Organ transplant roadmap. Ditto Pulmonary. This points to UT will likely take an equity stake in Mnkd after 12/27/19 to benefit from $3B NOL and avoid 1.6 Warrants dilution. Read more: mnkd.proboards.com/user/1882/recent#ixzz67RGoWqYF |
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Post by lakers on Nov 28, 2019 3:11:22 GMT -5
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Post by lakers on Nov 16, 2019 20:22:09 GMT -5
spencerosborne
11/14/19, 07:15 PM
@quentc @sophia_Petrillo @truckie the covenant issue could be as simple as the following:
Midcap - what do you think you need
Mnkd - $49m at a good rate
MidCap. - how about libor + 8.75
Mnkd - we will get killed if we announce that level of interest. Can you go lower
MidCap- those are the terms we can offer...tell you what...we will sign at 6.75% + libor, but you gotta hit these harder numbers. This allows you to announce more friendly terms, but hold you to a hard standard to keep that low rate.
Mnkd - ok.
In simple terms, I think MidCap knew from the start mnkd would likely miss.
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