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Post by mnholdem on Aug 3, 2018 7:11:03 GMT -5
MannKind will be presenting 4 posters (see search index) at the EASD Congress 2018 Oct 1-5, 2018.
upload.easd.org/download/AM2018/Flipbook/EASD2018_FinalProgramme.html#p=245
I believe that P-1046 (below) is clinical data that David Kendall MD mined from one of those 60+ studies referred to above. At a conference several months ago, Kendall mentioned that MannKind had clinical data involving CT Scans for lung function. This is just one example of how valuable MannKind's new CMO may be to the company and its shareholders.
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Post by mnholdem on Aug 3, 2018 6:01:44 GMT -5
Didn’t David Kendall say that they were planning on 20+ publications about Technosphere insulin in the next twelve months?
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Post by mnholdem on Aug 2, 2018 21:39:15 GMT -5
This topic is taken up on another thread, including the subject of high-mileage surcharges that are typical in fleet leases. The point made by the OP is that MannKind has a lease for a fleet of vehicles at $540/month per vehicle for the sales force.
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Post by mnholdem on Aug 2, 2018 21:27:42 GMT -5
That is correct. There would be a mileage surcharge.
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Post by mnholdem on Aug 2, 2018 14:00:51 GMT -5
Precisely my point in previous post in this thread and why Mike was excited when Libre came out and the price point advantage they have. Libre is covered, cost currently for me is $40/mo., it may not have the bells and whistles but they are not needed, the other benefits of Libre far outweigh relative to cost and ease of use for T2's. Libre/Afrezza combo is a no brainer Dexcom talked about this on the call as well. They said they are not concerned about Libre because it's a huge market and there is room for several players.[Clipped] That certainly sounds to me like Dexcom is conceding that they may lose a chunk of the future CGM market to Libre. Of course, the $1 billion question is "how much of the market"?
Joey makes a very good point about the Libre, especially since 3rd Party payers seem to place a higher criteria on cost. Cost will become even more critical if the current industry practice of rebates gets gutted by regulators/lawmakers.
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Post by mnholdem on Aug 2, 2018 13:49:23 GMT -5
Shouldn't this be in Other Topics? as its AMPH related? If not then whats this about ? Is the global moderator speculating that AMPH raised that $$ and working with MNKD with out explicitly saying it? That’s exactly what I’ve been saying for many weeks. I think Amphastar and MannKind have been hammering out a China sales agreement AND possibly manufacturing of Afrezza at Amphastar’s Chinese plant. |
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Post by mnholdem on Aug 2, 2018 10:59:16 GMT -5
SEC Filing: July 2, 2018
www.sec.gov/Archives/edgar/data/1297184/000129718418000036/amph-20180702x8k.htm
ITEM 1.01.Entry into a Material Definitive Agreement.
On July 2, 2018, Amphastar Nanjing Pharmaceuticals, Inc. (“ANP”), a Chinese subsidiary of Amphastar Pharmaceuticals, Inc. (the “Company”), completed a private placement of its equity to accredited investors for aggregate gross proceeds of approximately $57.2 million. In connection with the private placement, all of the executive officers of the Company, and Stephen Shohet, Howard Lee, and Richard Koo, independent directors of the Company, entered into subscription agreements (each, a “Subscription Agreement”) for the indirect investment in ANP. These Subscription Agreements were transacted either through an investment in Amphastar Cayman, a Cayman Islands limited liability company (“Amphastar Cayman”), or Qianqia, a Chinese partnership. The total aggregate gross proceeds from such executive officers and directors were approximately $23.5 million. The Company has retained approximately 58% of the equity interest of ANP immediately after the private placement. ANP intends to use the net proceeds from the private placement for its business expansion plans.
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I wasn't able to locate any information about this Chinese partner Qianqia. Is it misspelled?
Any diggers out there who can root out who this is?
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Post by mnholdem on Aug 2, 2018 10:55:22 GMT -5
SEC Fling July 2, 2018
www.sec.gov/Archives/edgar/data/1297184/000129718418000036/amph-20180702ex991dc7696.htm
Amphastar Announces Expansion of Amphastar Nanjing Pharmaceuticals Inc.
RANCHO CUCAMONGA, CA – July 9, 2018 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced business expansion plans for its subsidiary, Amphastar Nanjing Pharmaceuticals Inc. (“ANP”). To date, ANP has provided Active Pharmaceutical Ingredients (“APIs”) and starting materials specifically to Amphastar. After the expansion is completed, ANP intends to begin selling APIs both to Amphastar and externally around the world to expand its overall markets. More importantly, ANP is expanding to manufacture finished pharmaceutical products for distribution in China and in other markets globally.
To help fund this expansion, ANP completed a private placement of its equity, raising approximately $57 million. Multiple private equity investors from Mainland China, Taiwan, and the United States participated in the private placement. Amphastar has retained approximately 58% of the equity interest of ANP immediately after the private placement.
Amphastar's CEO, Dr. Jack Zhang, stated: "We believe that the expansion of ANP is the most effective way for us to leverage our existing assets on a global scale. We expect ANP to begin selling products externally to expand its markets in 2019. The raise of this money by ANP will also allow Amphastar to deploy more of its existing cash towards expanding its research and development for its pipeline."
Company Information
Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable and inhalation products. Additionally, the Company sells insulin API products. Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers.
Amphastar Nanjing Pharmaceuticals currently has four APIs and starting materials approved by the US Food and Drug Administration (“FDA”), nine Drug Master Files (“DMFs”) on file with the US FDA and is developing nine additional DMFs.
More information is available at the Company’s website at www.amphastar.com
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Post by mnholdem on Aug 2, 2018 7:19:38 GMT -5
Image enhancement is more likely the reason than philanthropy, IMO.  |
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Post by mnholdem on Aug 2, 2018 6:47:44 GMT -5
I'd sure like to see MannKind do something similar to this:
Lilly Diabetes Solution Center Now Open to Help People with Insulin Affordability
Excerpt:
INDIANAPOLIS, Aug. 1, 2018 /PRNewswire/ -- The Lilly Diabetes Solution Center, a new patient-focused helpline with representatives who will identify personalized solutions to address insulin affordability, is now available to residents in the U.S. and all U.S. territories. Beginning today, this suite of solutions will provide many options – some being offered for the first time – that can significantly lower and cap high monthly out-of-pocket costs for some people who use Lilly insulins such as Humalog® (insulin lispro) and Humulin® (insulin human injection). Dedicated representatives will review the personal circumstances and identify options for people who pay near the full list price, such as the uninsured and people in the deductible phase of their high-deductible insurance plans, as well as potential solutions for people with lower incomes.
"We don't want anyone to have to pay full list price for their insulin, and many people who do will be able to pay significantly less by calling our helpline," said Mike Mason, senior vice president, Connected Care and Insulins. "Our goal is to ensure that people paying high out-of-pocket costs for Lilly insulins are matched with the best solution available to reduce their financial burden and help ensure they receive the treatment they need."
Savings will vary based upon the individual circumstances of each person who calls the helpline. For people who already have co-pay or co-insurance plans, or are enrolled in Medicare Part D, the cost at the pharmacy may not change. Based on estimates from market research data, more than 400,000 people living with diabetes in the U.S. and Puerto Rico could benefit from the new solution center. Lilly is promoting the helpline in a variety of ways including through paid advertising, social media and outreach to the diabetes community.
Source: www.prnewswire.com/news-releases/lilly-diabetes-solution-center-now-open-to-help-people-with-insulin-affordability-300689746.html
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Post by mnholdem on Aug 1, 2018 8:40:01 GMT -5
Long term, this could have an effect on insurance premiums as well. Hard to say whether good or bad, since insurers will be losing rebate revenues, they may elect to make up for the loss by raising premium prices. Drugs are only one part of what healthcare companies cover, but rebates have been a cash cow for many years.
However the new business model looks after the feds make changes, you can be certain that the insurers will find a loophole or two to make money. I think many would luv to see the PBMs cut out of the system, but BPs would lose preferential treatment for their drugs over the competitors.
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Post by mnholdem on Jul 31, 2018 19:55:06 GMT -5
pdfs.semanticscholar.org/fa41/680938d9878c73cbbb55440763ac042c5df6.pdfExcerpt: Results: Baseline demographics and pulmonary function were similar between diabetes treatment groups. Lung function declined from baseline in all groups. TI was non-inferior to usual care for mean change in FEV1 from baseline to month 24 [mean (s.e.m.) 0.037 (0.0119) l; 95% CI 0.014 to 0.060] using mixed-model repeated-measure with a pre-specified non-inferiority margin of 50 ml/year. After a greater initial decline at month 3 with TI, rate of change (slope) in FEV1, FVC and DLCO (months 3–24) was not statistically different between treatment groups. TI was well tolerated; no serious safety concerns emerged. The most common respiratory event associated with TI was mild, transient cough, occurring within minutes of inhalation. [Reprint from 2011]
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Post by mnholdem on Jul 31, 2018 19:23:14 GMT -5
Does the bank need it to finance your neighbor’s yacht?
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Post by mnholdem on Jul 31, 2018 11:42:27 GMT -5
It will be a few days before I update state and national healthcare coverage tables for Afrezza but, for those who think that United Health does not cover Afrezza, it should be noted that most (86%) of United Health's healthcare plans currently cover Afrezza with Pre-Authorization. As you can see, CVS Caremark Rx and Express Scripts PBM have nearly full unrestricted coverage.
So those who are pushing the agenda that patients not getting insurance coverage is the BIGGEST obstacle facing growth in Afrezza prescriptions, that seems not to be the case but for one notable exception.
National Medicare coverage for Afrezza is still at 0% as of this date. What's up with that, MannKind? |
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Post by mnholdem on Jul 31, 2018 9:24:43 GMT -5
Excellent point about market sentiment.
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