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Post by dreamboatcruise on Sept 25, 2017 23:00:29 GMT -5
One thing missing from the presentation was an update or confirmation of the forward looking financials... revenue and burn.
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Post by slugworth008 on Sept 26, 2017 0:43:05 GMT -5
One thing missing from the presentation was an update or confirmation of the forward looking financials... revenue and burn. Probably because it hasn't changed since the last CC - JMO |
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Post by mytakeonit on Sept 26, 2017 0:56:46 GMT -5
One thing missing from the presentation was an update or confirmation of the forward looking financials... revenue and burn. Probably because it hasn't changed since the last CC - JMO Or maybe because it wasn't a CC |
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Post by straightly on Sept 26, 2017 2:07:40 GMT -5
Probably because it hasn't changed since the last CC - JMO Or maybe because it wasn't a CC And it is not very meaningful pening the re-cap. The re-cap will alter the financial structure significantly. |
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Post by dreamboatcruise on Sept 26, 2017 10:54:16 GMT -5
Or maybe because it wasn't a CC And it is not very meaningful pening the re-cap. The re-cap will alter the financial structure significantly. Being a conference for potential investors, I would think projections of an acceleration in revenue growth would be very meaningful. There are now several things that cause skepticism for me regarding the sales projections... 1) they didn't break out Q3 separately, so it gives management lots of time before they really would have to address shortfall, 2) comparing to the real data, we are still not on a trajectory that will match projections and now 3) lack of updating or confirming the projection. The success of MNKD is and always will be based on how Afrezza does in the world's biggest drug market (the US), and we're at a crucial juncture for the company. They should be doing anything and everything to convince investors they know how to win here. |
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Post by peppy on Sept 26, 2017 11:08:36 GMT -5
hopefully this slide will be significant. it was/is new. Added this Call. see Saudi? see United Arab Emeritus?
Australia is new. India is there. Over the counter would be nice.
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Post by sportsrancho on Sept 26, 2017 11:27:52 GMT -5
IMO what we need most, after money, ( capital..capital..capital ) is for the Afrezza commercials to be on Fox News, CNN or CNBC. ( Where ever they are airing the EXAS commercials.) That would cause us to need to hire more reps to cover more ground and help with insurance. 90%+ of the population has never heard of Afrezza! Huge up side....Tell the people and they will come:-)
And one day....we will all be out getting a coffee, or having a meal, and we'll hear that Dreamboat whistle. Afrezza....Freedom ...Yes!
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Post by dreamboatcruise on Sept 26, 2017 11:28:17 GMT -5
peppy... Australia is new by some standards, having achieved nation status only in 1901, but still it's not terribly new. Though Mike has finally shown the world where it is on a map  Will it be progress if Matt has identified some more countries on the next presentation given. Maybe one of his kids is in geography class. [sarcasm off] Come on, there is nothing new about a map of countries when nothing can be announced about progress. It's a map.
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Post by lakers on Sept 26, 2017 18:00:58 GMT -5
1. Why India, S Africa? Possible partnership with Cipla?
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.
Cipla Medpro, a 100% subsidiary of Cipla Limited, has a strong presence across therapies in the Republic of South Africa. Cipla also won government tenders in antiretrovirals (ARV), respiratory and newer areas such as mental health, cardiovascular and women’s health categories.
Cipla’s manufacturing facility at Durban provides a competitive edge and is the first Pharmaceutical Inspection Convention (PIC) compliant facility in the country. The brand inspires trust and has become a household name amongst consumers, pharmacies, prescribers and key opinion leaders.
Cipla has a clear commitment to provide access to Africa and other LDCs (Least Developed Countries). Cipla Quality Chemical Industries Limited ( CiplaQCIL ) is a state of the art manufacturing plant in Uganda that manufactures WHO prequalified anti-retrovirals antimalarials and antivirals for the treatment of hepatitis B. The plant is the largest in East Africa and supplies the Ugandan market and exports to East Africa, Cameroon and various markets in southern Africa. CiplaQCIL is currently expanding its portfolio to manufacture medicines for tropical diseases such as sleeping sickness, worm infestations and hepatitis C.
2. Partnership with Takeda in Japan?
3. Why UAE, Oman (new), Saudi Arabia (new)?
Gulf states with similar approval process. National Health Care.
4. Why Mexico?
No need for refrigeration for 30 days.
Pharmaceutical Import Regulation in Mexico. Issues / Trade barrier
• Mexico imposes higher average tariff on finished products than on raw materials.
– Inpharmaceuticals,althoughtheaveragetariffrateofthesemi‐processed products is a litter lower than that of the raw materials, the average tariff rate of the finished products is still much higher than that of the raw materials.
• North American Free Trade Agreement (NFTA) agreement strengthened IP Rights and provide favorable environment for innovator companies.
• NFTA eliminated import duty for US & Canada.
– While US & Canada enjoy no import duty(Post NFTA), other country face average tariffs of 18%, providing both US & Canada with a competitive advantage over their overseas exporters.
• In view of no generic drug registration fee in US which is the largest generic market globally; the registration fee for generic drugs in Mexico could be considered high.
Prospects in Mexican market
• Under New regulation (Aug 2008) overseas Pharmaceutical producer no longer need to have local manufacturing facilities in order to operate in Mexico. Such requirement will be phased out over two years [COFERPRIS 2008]
– Initially this requirement was introduced to promote investment in the country but have resulted in lack of competition and subsequently higher prices of medicine.
Important Points to Keep in Mind
The process for making a drug available in the public health system is as follows:
1. Secure regulatory approval from COFEPRIS
2. Petition for inclusion in the Health Systems Supply Catalogue
3. Once listed, the drug may be prescribed by any doctor within the public health system
In the case where a drug is not approved for general use, a demonstration of immediate need can be submitted to a Ministry of Health committee for special approval on a case-by-case basis.
Once drugs have been added to the Social Health Services Register, pricing is determined by institutional agreement between the manufacturers and payers. A drug’s value and price in the private system is determined by the market and in the public sector via public tender and subsequent negotiations (see compras consolidadas below). Though COFEPRIS sets the maximum price limits on drugs and procedures, the shelf price of a drug under this limit is ultimately left up to the manufacturer.
For delivery of medical services, including prescription drugs, those covered under the public health system are limited to attending (and receiving prescriptions from) federal- and state-run hospitals. Federal hospitals accept all forms of insurance, public and private, but private clinics only extend benefits, including medications, to those who have private insurance (or if that person can pay out-of-pocket).
Financial schemes and performance-based agreements have become commonplace in the Mexican pharmaceutical market:
1.Financial: Since 2013, “compras consolidadas” (consolidated purchases) have emerged as a key mechanism by which the government purchases medicines for publicly funded insurance schemes. In doing so, the government’s numerous entities and health insurance programs combine their negotiating power to obtain discounts and secure price/volume guarantees from manufacturers. In doing so, the government aims to achieve efficient, transparent and effective use of public resources.
2.Performance-based: Risk-sharing arrangements (RSAs) have also emerged as a key practice in Mexico. In these arrangements, authorities transfer some of the risks (both financial and in effectiveness) to manufacturers in exchange for government purchases of branded medicines.
In the private system, major retailers such as Wal-Mart (Walmex) and Fármacos Nacionales have traditionally held tremendous influence over the availability and pricing of medicines. However, this influence has been drawn into question due to the case of Casa Saba’s pharmacy, which prior to 2014 was the largest retail chain in Mexico. The pharmacy chain liquidated its assets and dismantled its Mexico operations at the same time that it owed $7 billion pesos to more than 500 pharmaceutical and device suppliers. This action resulted in millions in fines for the company’s previous owners, and a wake-up call for industry.
Overall, access into the Mexican healthcare market is largely dependent on demonstrated value. Private payers make decisions based on the value of a medication to patients’ health, and public health systems choose to include medication in their catalogue based on the value to the population.
5. Why China?
Most populous, AMPH has 1st right of refusal for partnership.
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Post by dreamboatcruise on Sept 26, 2017 18:08:55 GMT -5
lakers... Mike gave some crayons to one of his kids? Without some progress it doesn't much matter what might be making Mike identify something as a "target". That term means nothing. It would almost be more meaningful to ask about the countries that seem to be removed from the target list. Why is EU off the target list? Do you have any speculation on that? Since we have no positive news about the ones still targeted (other than Brazil), what is the criteria for removing a region/country as a target?
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Post by lakers on Sept 26, 2017 18:26:50 GMT -5
EU process takes too long, not as populous as BRIC w/o R. Canada, Mexico make sense due to NAFTA's no tariff (Sorry, Novo, Sanofi) and shorter approval process. Oman, UAE, Saudi Arabia are single payer systems, simple approval process, no need to refrigerate for 30 days which also lends itself well to Mexico, India, S Africa, Brazil. Mike wants the fastest path to approval, market access. We want partnership with upfront money now. The superior label would catalyze the recap, partnership, pipeline, payor coverage, adoption, No PA, No Step therapy.
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Post by sayhey24 on Sept 26, 2017 18:48:54 GMT -5
lakers ... Mike gave some crayons to one of his kids? Without some progress it doesn't much matter what might be making Mike identify something as a "target". That term means nothing. It would almost be more meaningful to ask about the countries that seem to be removed from the target list. Why is EU off the target list? Do you have any speculation on that? Since we have no positive news about the ones still targeted (other than Brazil), what is the criteria for removing a region/country as a target? Why do you say no progress? There is a big difference between announcing a deal which may be in final negotiation and no progress. Lets see what the label says. MNKD knows what they asked for and probably have a pretty good idea of what it should be. I don't think we will be waiting much longer. |
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Post by dreamboatcruise on Sept 26, 2017 19:14:20 GMT -5
EU process takes too long, not as populous as BRIC w/o R. Canada, Mexico make sense due to NAFTA's no tariff (Sorry, Novo, Sanofi) and shorter approval process. Oman, UAE, Saudi Arabia are single payer systems, simple approval process, no need to refrigerate for 30 days which also lends itself well to Mexico, India, S Africa, Brazil. Mike wants the fastest path to approval, market access. We want partnership with upfront money now. The superior label would catalyze the recap, partnership, pipeline. I want something concrete... a partnership with meaningful upfront would be amazing (likely out of reach at this point in time) but I'd settle for almost anything real, but not just an aspirational map. Put some dates up for regulatory submission in each of those countries on the map and I'll pay attention and give management the benefit of the doubt. As it is, it simply seems like smoke and mirrors. 50% of the world's population is a great number, but all we've been told is that he'd like to achieve it. Great, but might as well make it 100% if there is no criteria we can be told for why we should take the shaded countries on this map seriously. I didn't like these little tease things like the map and mention of RLS... it could mean something or it very well could mean absolutely nothing. |
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Post by nadathing on Sept 26, 2017 19:22:07 GMT -5
lakers ... Mike gave some crayons to one of his kids? Without some progress it doesn't much matter what might be making Mike identify something as a "target". That term means nothing. It would almost be more meaningful to ask about the countries that seem to be removed from the target list. Why is EU off the target list? Do you have any speculation on that? Since we have no positive news about the ones still targeted (other than Brazil), what is the criteria for removing a region/country as a target? Spot on. The word "target" means nothing. Have they filed for approval to sell? Is distribution in the work? Is there a partner? |
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Post by nadathing on Sept 26, 2017 19:25:03 GMT -5
EU process takes too long, not as populous as BRIC w/o R. Canada, Mexico make sense due to NAFTA's no tariff (Sorry, Novo, Sanofi) and shorter approval process. Oman, UAE, Saudi Arabia are single payer systems, simple approval process, no need to refrigerate for 30 days which also lends itself well to Mexico, India, S Africa, Brazil. Mike wants the fastest path to approval, market access. We want partnership with upfront money now. The superior label would catalyze the recap, partnership, pipeline, payor coverage, adoption, No PA, No Step therapy. If EU had been filed for 3 years ago, like Al told us it would be, we might be approved. How long will it take if they file a year from now? Answer: The same amount of time plus another wasted year. |
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