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Post by lakers on Nov 24, 2016 18:04:20 GMT -5
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Post by lakers on Nov 16, 2016 19:16:01 GMT -5
investors.mannkindcorp.com/secfiling.cfm?filingID=1193125-16-767003&CIK=899460Exhibit 99.2 Excerpt of transcript of conference call held on November 9, 2016 Next, Sanofi will purchase $10.2 million worth of insulin from MannKind in early December. Note that this insulin is considered surplus to our current needs and is carried on our books at zero value. Finally, Sanofi will pay an additional $30.6 million in cash to MannKind in early January canceling and settling our insulin put agreement with them without our having to deliver any further insulin. In addition, it should be noted that the termination of the promissory note and security agreement allows MannKind to pursue the sale of its Valencia, California facility and the adjoining property which is now on the market for roughly $25 million without our being required to use the proceeds to reduce the balance of the loan. So this is another source of non-dilutive liquidity for MannKind. Collectively, as a result of this agreement, we have improved our financial position by over $130 million. This will go a long way towards meeting our near-term financial needs. We have also taken steps to reduce our cash requirements to amplify this effect. Finally, as described in our 10-Q filing we enacted a reorganization in September of this year, reducing our headcount by approximately 20%. This step was taken as part of our continuing efforts to reduce overhead and offset increased spend in the commercialization of Afrezza. As a result of these steps, we now have the financial resources to embark on important initiatives that will be discussed in more detail by Mike and by Ray. We also announced today the completion of a revision to our largest supply agreement, pushing out our next purchase commitments to the fourth quarter of 2017 and reducing our contractual cash burn under that arrangement by $65 million for the period of 2016 through 2018 compared to the prior contract. As a result of these items and steps taken previously, we have extended our financial resources comfortably into the third quarter of 2017.
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Post by lakers on Nov 16, 2016 18:42:53 GMT -5
TEAM Arthur Rubinfeld- Former President of Starbucks, globally recognized brand and product development expert and author. Gregory Wesner- Biopharmaceutical intellectual property and startups attorney and authority on drug delivery IP. Andrea Leone-Bay, Ph.D. - One of the world’s leading pharmaceutical development scientists and inventor of Receptor’s oral product; lead inventor on 93 biopharmaceutical patents. Traci Carman- Seasoned startups CFO and pioneer in cannabis business structures, development, and financing. Gregory F. Wesner Shareholder | Seattle | 206.223.7272 | wesnerg@lanepowell.com www.lanepowell.com/15687/gregory-f-wesner/Publications “Cannabis Trademark Strategy in Jeopardy,” Cannabis Law Journal, Second Edition (September 2016) “Cannabis Trademark Ruling ‘Against the Public Interest’; Threatens Big Brand Licensing on Legal Products,” World Trademark Review Blog Post, Quoted (July 22, 2016) “Cannabis Trademark Strategy in Jeopardy,” Lane Powell White Paper (July 15, 2016) www.lanepowell.com/27611/cannabis/
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Post by lakers on Nov 16, 2016 3:25:42 GMT -5
Next up is PAHale=Treprostinil+PDE5 inhibitor (Viagra®) Abstract Background: Inhaled treprostinil was recently developed for the treatment of pulmonary arterial hypertension. We investigated the safety and acute haemodynamic effects of the combination oral sildenafil and inhaled treprostinil in an open label study in patients with precapillary pulmonary hypertension. Methods and Patients: Inhaled nitric oxide (20 ppm; n=50), sildenafil (50mg; n=50) and inhaled treprostinil (15μg; n=25 or 30μg; n=25) were applied in subsequent order during right heart catheter investigation to consecutive patients with pulmonary arterial hypertension (PAH; n=28), non-operable chronic thromboembolic pulmonary hypertension (CTEPH; n=17) and pulmonary fibrosis associated pulmonary hypertension (n=5). Results: Inhaled nitric oxide reduced pulmonary vascular resistance (PVR) to 87.3 ± 5.1% of baseline values, reduced mean pulmonary arterial pressure (PAP) to 89.7 ± 3.5% and increased cardiac output (CO) to 102.4 ± 2.9%. Sildenafil reduced PVR to 80.1 ± 5.0%), mPAP to 86.5 ± 2.9 and increased CO to 103.8 ± 3.2%. Treprostinil, inhaled one hour after sildenafil, reduced PVR to 66.3 ± 3.8%, mPAP to 77.8 ± 3.3%, and increased CO to 107.1 ± 3.3% (mean ± 95% confidence interval). Subgroup analysis showed similar acute haemodynamic effects in PAH and CTEPH patients. Ventilation/perfusion distribution measurement in six patients with pre-existing gas exchange limitations was not changed by sildenafil and treprostinil. Relevant side effects were not observed. Conclusion: The combination of sildenafil and inhaled treprostinil was well tolerated and induced additive, pulmonary selective vasodilatation in pulmonary hypertension patients. This could be of relevance also for long term treatment of PAH and CTEPH patients. Acute effects of the combination of sildenafil and inhaled treprostinil on haemodynamics and gas exchange in pulmonary hypertension Drugs Treprostinil sodium was obtained from LungRX (Silver Spring, USA) as part of a clinical research collaboration. Sildenafil (Viagra®) is commercially available (Pfizer) and was obtained via the institutional pharmacy. Nitric oxide gas (2000ppm in nitrogen) was obtained from Linda AG (Pullach, Germany) and dosed to achieve an inspiratory concentration of 20-40 ppm. hal.archives-ouvertes.fr/hal-00499160/documentSildenafil, a PDE5 inhibitor, in the treatment of pulmonary hypertension www.tandfonline.com/doi/full/10.1586/14779072.4.3.293?scroll=top&needAccess=true
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Post by lakers on Nov 15, 2016 17:41:38 GMT -5
IMHO, next deals will model after RLS, more upfront cash, milestones, rev tiered royalty, no P/L sharing to avoid who has final say on how to mkt, sell.
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Post by lakers on Nov 15, 2016 17:01:10 GMT -5
Most likely EpiHale will have a partner after IND even though only Phase 1,2 are required. Trials are expensive. Mnkd can't go alone. Likewise, Treprostinil+PDE5 inhibitor aka PAHale will have a partner as four phases are required.
IMHO, RLS will be big with many states passed medical and/or recreational MJ. Revenue tiered 12-15% royalty on large volume can sustain Mnkd for years.
These deals will save Mnkd and Afrezza which may take a while to establish as std treatment.
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Post by lakers on Nov 15, 2016 0:26:47 GMT -5
"4. Epi Hale Progress towards a early 2018 Product Launch". This is a little bit shock to me. Any source that this trial could be done so quick? I believe Ray said, a couple of CCs ago, that they only had to show bio-equivalency. That's why they fast-tracked epi -- don't have to run the whole gauntlet. The last slide, the last one of our clinical development candidates is Epinephrine for Anaphylaxis. I think the one point I want to raise here is this can be an incredibly short timeline. No real clinical studies would be required. Obviously you cannot do a clinical study in the Anaphylactic setting. So that would be e-study and some human factor studies would probably suffice. So we're looking at this opportunity as again one of our priority ones. MannKind's (MNKD) CEO Matt Pfeffer Presents At 34th Annual JPMorgan Healthcare Conference (Transcript) $MNKD www.seekingalpha.com/article/3809206
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Post by lakers on Nov 11, 2016 18:10:07 GMT -5
Chinese Market Offers New Life to Many Drugs By finding local partners in China, global drugmakers have chance to make money on drugs that have fallen short elsewhere www.wsj.com/articles/chinese-market-offers-new-life-to-many-drugs-1459279444SHANGHAI—Drugs that failed to make it to the market in the U.S. and elsewhere are finding new life in China. In 2013, Bristol-Myers Squibb Co. stopped global trials of a first-line liver-cancer drug after it failed to outperform a rival. Instead, the company licensed the drug, brivanib, to a Chinese startup. The startup, Shanghai-based Zai Lab Ltd., sees high potential for brivanib in China because its rival—sorafenib, developed by Bayer AG and Onyx Pharmaceuticals Inc.—costs around $7,500 for one month of treatment and isn’t covered by national insurance. “We hope to give the Chinese patients a more reasonable price,” said Samantha Du, founder of Zai Lab, one of several Chinese firms joining forces with Western pharmaceuticals over partially developed drugs in China. They’re chasing a market where the best new global drugs face long delays while regulators clear a speedier path for Chinese medications. But the new trend also raises the question of whether China has become a dumping ground for inferior drugs. I. Glenn Cohen, a Harvard Law School professor who studies medical ethics, said that because of differences in regulatory standards it isn’t unusual or unlawful for a company to get a drug approved in one jurisdiction and not another. For one thing, in China a drug doesn’t have to prove superiority over existing drugs—a major hurdle in the U.S., where 90% of candidates get dropped in the clinical-trial process.
The stroke drug cinepazide was withdrawn from Spain, Italy and France in the late 1980s and 1990s, after reports of blood disorders associated with its use. By 2010, it had become China’s top-selling drug, according to Credit Suisse Equity Research. The company that markets it, Sihuan Pharmaceutical Holdings Group Ltd., says the generic cinepazide it produces is more purified than the branded version that was sold in Europe, and its safety and efficacy is recognized by Chinese authorities and patients. By finding local partners in China, global drugmakers have a second chance to make money on drugs that have fallen short elsewhere. Beijing, which wants to build a competitive domestic pharmaceutical market, welcomes such partnerships.
For Chinese consumers, the trend could mean shorter wait times and lower costs for new drugs—even if they aren’t the best in their class. For now, Chinese regulators ask for additional testing of drugs approved by the U.S. FDA. Approval to start trials can take more than a year. By comparison, the U.S. regulator says clinical trials can start 30 days after an application has been submitted.
Only 21% of drugs launched globally between 2008 and 2012 were available in China as of 2013, compared with 68% in the U.S., according to market researcher IMS Health.
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Post by lakers on Nov 11, 2016 17:25:48 GMT -5
stocktwits.com/NatesNotesNatesNotes @longtermliability at this stage of the game, it would certainly appear that there must have been some reason for China to have come up in Nov. 10 at 6:12 PM NatesNotes @longtermliability the course of discussing $MNKD insulin needs vs. cash needs with Amphastar; now that relationship w/ Sanofi is fully Nov. 10 at 6:13 PM NatesNotes @longtermliability severed, it should, in theory anyway, allow other cos to feel more comfortable entering into talks (of any sort) w/ $MNKD
Nov. 10 at 6:14 PM NatesNotes @longtermliability (and the fact that $MNKD was willing to take less from Sanofi than some felt they could have held on for certainly does Nov. 10 at 6:16 PM NatesNotes Nate Pile @longtermliability lend itself to the idea that there could be some sort of deal coming "sooner rather than later"... but who knows :-) ) With respect to our insulin API business, we continue to have discussions with MannKind regarding delaying their minimum commitments under the supply agreement due to their cash flow issues. We believe that we're close to an agreement on this issue. Additionally, we have previously disclosed a commitment to invest an additional $12 million in our business in Nanjing, China. We plan to complete this estimate by the end of the year. Amphastar Pharmaceuticals' (AMPH) on Q3 2016 Results - Earnings Call Transcript $AMPH www.seekingalpha.com/article/4021356On November 9, 2016, the Company entered into an amendment (the “Amendment”) to the Supply Agreement (the “Amphastar Agreement”), dated July 31, 2014, by and between the Company and Amphastar Pharmaceuticals, Inc. (“Amphastar”). Pursuant to the Amendment, the term of the Amphastar Agreement was extended from December 1, 2019 to December 31, 2023. In addition, the delivery schedule was modified to provide that Amphastar will ship €2.7 million of insulin to the Company in the fourth quarter of 2017, €8.9 million in 2018, €11.6 million in 2019, €15.5 million in 2020 and in 2021, and €19.4 million in 2022 and in 2023. The Company also granted Amphastar a right of first refusal to participate in the development and commercialization of Afrezza in China through a potential business collaboration.On November 9, 2016, the Company entered into an amendment to the Insulin Purchase Option Agreement, dated January 1, 2015, by and between the Company and Amphastar, pursuant to which the aggregate cancellation fees that the Company will incur in the event that such additional insulin is not purchased were lowered from $5.3 million for the period October 1, 2016 through 2018 to $3.4 million over the same period. investors.mannkindcorp.com/secfiling.cfm?filingID=1193125-16-764506&CIK=899460One of the most frequently asked questions they are coming through on online we has to do with delisting. I am not sure what exactly to say about that. I am not terribly concerned about delisting, I think the news today we're long way to solving that problem, it's not going to be an issue till sometime in like the second quarter of next year by which point we have, we expect to have a lot of things accomplish that will make this whole issue go away.seekingalpha.com/article/4021887-mannkinds-mnkd-ceo-matthew-pfeffer-q3-2016-results-earnings-call-transcript?part=single
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Post by lakers on Nov 11, 2016 13:23:05 GMT -5
PAHale partner Rev tiered 12-15% royalty (can be significant) in addition to milestones from RLS products now that many states passed medical and/or recreational MJ. Canada, China... Stay tuned...
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Post by lakers on Nov 11, 2016 13:05:47 GMT -5
Pfizer settled $125M with Nektar in 2007 close to SNY's settlement 71.56+0.5+10.2+30.6+25(Valencia)= $137.86M Sny could have taken the building. The LOC with 8% compound interest could grow quite large by 2024. Pfizer established a precedence. Many folks here got arrows on their backs for insisting that there would be a settlement. They were ridiculed by naysayers every time the possible settlement was brought up. Execs could not say anything while negotiating. They took quite a beating for that. Not a single naysayer came out to apologize. Hmm... The Inhaled GLP first right of refusal was released. The promissory note and security agreement between MannKind and Aventisub LLC, a Sanofi affiliate, are terminated, with Aventisub agreeing to forgive the full outstanding loan balance of $71.56 million. MannKind is also relieved from its obligation to pay $0.5 million in previously uncharged costs related to the collaboration. Sanofi will purchase $10.2 million worth of insulin from MannKind in early December as part of its preexisting commitment to purchase insulin following termination of the collaboration and MannKind's exercise of a "put" option. The balance of the insulin "put" option ($30.6 million) is accelerated with Sanofi completing the cash payment of $30.6 million to MannKind by January 9, 2017. This payment will be made without MannKind being required to deliver any insulin to Sanofi. All issues arising out of the license and collaboration agreement, the supply agreement, the promissory note, the security agreement and the transition agreement are resolved. investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=998691
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Post by lakers on Nov 11, 2016 2:48:02 GMT -5
And then, finally, now that we have our infrastructure built and our distribution channels at the door and salesforce continue to built the coverage footprint, we are seeking complementary opportunities that will continue leverages infrastructure, as we know one product sell bags are not always the easiest thing to maintain from overhead.
However, we do think we can be profitable in the long run with given the model we have, but as of now we can accelerate MannKind growth trajectory by finding opportunities co-promote and collaborate with other products.
[Co-promote with Tresiba, RLS products, DEXcom CGM, Amphastar products. If Docs like the result from the D(EXcom)A(frezza)T(resiba), Novo may sign up w/ Mnkd.]
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Post by lakers on Nov 11, 2016 2:32:21 GMT -5
#2 was delivered as promised. Afrezza in NFL game-day pamphlets for SD Chargers, LA Rams, Phily Eagles, Chicago Bears. These are large markets. An Ads could show up in USA Today.Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=1#ixzz4PgPQxXJhThe second part of the accelerated patient outreach is continue to expansion of journal advertizing, you will see us in the for Diabetes Awareness Month in USA Today online and print editions coming out shortly. And we continue to enhance our public relations activities as you may have seen Fox News segment few weeks ago, we have several more opportunities, we are trying to work with third-parties to get these out the door. MannKind's (MNKD) CEO Matthew Pfeffer on Q3 2016 Results - Earnings Call Transcript $MNKD www.seekingalpha.com/article/4021887
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Post by lakers on Nov 10, 2016 16:06:05 GMT -5
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Post by lakers on Nov 10, 2016 15:09:02 GMT -5
If FDA's Dec review of EpiHale pre-IND clinical works goes well, Mnkd will file NDA in Jan '17. Then, clinical trials will start. Ray said the whole process to FDA approval is 10 months. Once IND is filed, Mnkd will have better leverage to negotiate with potential partners. IMHO, a partner will take it to the finish line and commercialize it. Raymond Urbanski Our currently candidate is our inhaled epinephrine for the treatment of type 1 hypersensitivity reactions. We believe that by utilizing MannKind’s innovative inhalation technology, we can not only deliver effective plasma concentrations, but the addition of the direct effect on the pulmonary system will lead to improve clinical outcomes, an inhaled epinephrine in setting offer several other advantages over the currently available epinephrine oral injectors. This will also provide patients and healthcare providers with another option that offers benefits related to convenience, ease of use and costs. We have a pre-IND meeting scheduled with the FDA in early December and our briefing book for this meeting has already been submitted, I will provide further updates on out type 1 and type 2 study concepts that I just articulated, as well as our epi program on our fourth quarter earnings call. Yes. Certainly, so we have a range of compounds in development, slightly more than 10 on the list, some include NCEs related to sort of pain management, others are B2 type of drugs which will be looking at, some are related to diabetes such as Symlin, for example, others are related to other disorders like parathyroid hormone, for example. So we have -- we do have a fairly extensive portfolio that we are still looking at to leverage innovative oral inhalation technology in the pharmacokinetic profile that will provide. We believe we’ll have several compounds in development in 2017. seekingalpha.com/article/4021887-mannkinds-mnkd-ceo-matthew-pfeffer-q3-2016-results-earnings-call-transcript?part=singleIMHO, the next compound will be Treprostinil+PDE5 inhibitor. Ray said "The first is Treprostinil for pulmonary arterial hypertension, PAH. PAH is a sizeable market expected to reach $10 billion by 2020. Treprostinil, a prostacyclin vasodilator is currently available in several formulations. However, these often carry a significant burden. This often leads to poor compliance and poor clinical outcomes. Our Tresprostinil program is in the early technical assessment phase. Preclinical is expected to begin in the second quarter of 2016 followed by clinical trials beginning in first quarter of 2017. We are actively looking for a development partner for this program. Ideally, the partner would be companies that already are active in this space." Competitor is United Therapeutics. The first product to look at is Remodulin, where 7 out of 10 patients on continuous PAH therapy are prescribed this drug. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion. A drug they market under the name Tyvaso. And guess how Tyvaso is dosed? If you guessed that it is dosed with a United Therapeutics inhaler---BINGO! If you guessed it's treprostinil for PAH, then you get to move to the head of the class. Tyvaso has $450 M/yr run rate. Injected Remodulin has $650M/yr run rate. If the bong-like Tyvaso can sell well, why can't TS PAHale succeed if a reliable partner is found? Tyvaso had to go through the same 5-yr lung and 2-yr pediatric trials as Afrezza will. Somehow, UT marketed it well and made it a success.Mnkd needs to learn from the United Therapeutic Master. ir.unither.com/releasedetail.cfm?ReleaseID=981603 Picture of the huge Tyvaso bong. www.tyvaso.com/hcp/dosage-administration/tyvaso-inhalation-systemRead more: mnkd.proboards.com/thread/6389/inhaled-trespostinil-pah-tyvaso-450m#ixzz4PdersLIF
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