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Post by cretin11 on Aug 5, 2023 13:33:20 GMT -5
So basically what awesomo posted is correct.
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Post by hellodolly on Aug 5, 2023 14:12:09 GMT -5
A look back at the agreement announced in 2018:
WESTLAKE VILLAGE, Calif., May 09, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, today announced an exclusive marketing and distribution agreement for Afrezza® in India with Cipla Ltd., a global pharmaceutical company.
“Our partnership agreement with Cipla for Afrezza provides us with a long-term partner with a wealth of knowledge and experience in diabetes. Cipla is a leader across therapies in India with an established sales, marketing and distribution network. With this partnership, Cipla will leverage its strength in inhalation and extend it to diabetes therapy/portfolio,” stated Michael Castagna, Chief Executive Officer of MannKind. “The International Diabetes Federation estimates that 425 million people are currently living with diabetes worldwide, including 73 million in India. This agreement with Cipla, our second international partnership agreement for Afrezza, extends the potential opportunity for approximately 1 out of 4 people of the worldwide population with diabetes to manage their disease with our novel mealtime insulin, when combined with our earlier agreement in Brazil and our own efforts in the United States.”
“Cipla is committed to providing access to innovative medicines and newer drug delivery systems to the patients. Afrezza, an inhaled insulin, is a cutting-edge product which will increase patient convenience,” said Umang Vohra, MD & Global CEO, Cipla Ltd. “The innovative drug delivery system will revolutionize the diabetic care in India. This partnership with MannKind is another step from Cipla to cater to the unmet needs of the patients.”
Under the terms of the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza® in India, including approval from the Drug Controller General of India. Cipla will also be responsible for all marketing and sales activities of Afrezza in India. MannKind is responsible for supplying Afrezza to Cipla.
MannKind will receive a $2.2 million upfront payment from Cipla within 30 days of entering the agreement, with the potential to receive additional regulatory milestone payments, minimum purchase commitment revenue and royalties on Afrezza sales in India.
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Post by prcgorman2 on Aug 5, 2023 20:54:26 GMT -5
So basically what awesomo posted is correct. I don’t know if it is correct (and neither does awesomo) but I agree with one half of what he was saying. I’m skeptical of their being a strong tie between Blackstone’s investment in Cipla, and Cipla’s efforts to get approval to sell Afrezza. But he was incorrect in thinking I was getting excited about that possible tie between Blackstone, Cipla, and Afrezza (MNKD). I’ve noted it as a possibility but my opinion is it is a slim one. But the discussion did make me wonder if Blackstone would be at the Wedbush Healthcare investor’s conference. That would be interesting. |
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Post by cretin11 on Aug 5, 2023 20:57:33 GMT -5
With all due respect, I read awesomo’s post again, it’s still correct. But please carry on.
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Post by mymann on Aug 5, 2023 21:05:43 GMT -5
Another RLS deal. Nothing burger.
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Post by akemp3000 on Aug 6, 2023 4:19:46 GMT -5
RLS is TBD. Suppose it's possible, but it's still on the table and highly doubtful it's a nothing burger. It's true that pushing a new drug through the FDA gauntlet occurs at glacial speed but my money remains on Andrea and Al getting the last laugh on this one so to speak.
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Post by ktim on Aug 7, 2023 11:01:42 GMT -5
Another RLS deal. Nothing burger. Or is it an "Impossible burger". |
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Post by cretin11 on Aug 7, 2023 11:09:27 GMT -5
Another RLS deal. Nothing burger. Or is it an "Impossible burger". An "extreme longshot burger." |
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Post by prcgorman2 on Aug 7, 2023 21:39:46 GMT -5
Maybe it will materialize, but it’s possible its gone “Up in Smoke”.
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Post by prcgorman2 on Feb 28, 2024 11:01:10 GMT -5
You guys are acting like Afrezza is a significant portion of Cipla's business. Cipla had $2.6B in revenue last year. Even in the competely made up scenario where Afrezza get's India approval and sells the same amount as MannKind here ($43M in 2022), that would equate to 1.6% of Cipla's revenue. Blackstone doesn't care. Can't tell for sure but looks like Cipla (India's 3rd largest BP) never got acquired by Blackstone (or Torrent), and may now be looking at making acquisitions in the US according to a headline in EconomicTimes.
The MannKind slides from yesterday's excellent earnings report indicated India's CDSCO (equivalent to US FDA) will rule on Cipla's application to commercialize Afrezza in India. The speculation here has been the sale of Afrezza in India will largely serve to improve the unit cost of Afrezza by underwriting manufacturing (scale?).
If we assume 25K Afrezza users (and really don't know how many there are), if 1% of India's ~5M insulin-using persons with diabetes chose to use Afrezza, that would triple the existing Afrezza user base. If that happens, and Afrezza sales improve domestically, at some point, MNKD is going to need a bigger boat. i.e., larger manufacturing capacity. Hopefully, we'll get some insight to MNKD's thoughts on production capacity for Tyvaso DPI, Afrezza, Clofazamine, closer to 2025.
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Post by mnkdfann on Feb 28, 2024 21:22:57 GMT -5
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Post by mnkdfann on Feb 28, 2024 21:24:50 GMT -5
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Post by sayhey24 on Feb 29, 2024 7:28:31 GMT -5
You guys are acting like Afrezza is a significant portion of Cipla's business. Cipla had $2.6B in revenue last year. Even in the competely made up scenario where Afrezza get's India approval and sells the same amount as MannKind here ($43M in 2022), that would equate to 1.6% of Cipla's revenue. Blackstone doesn't care. Can't tell for sure but looks like Cipla (India's 3rd largest BP) never got acquired by Blackstone (or Torrent), and may now be looking at making acquisitions in the US according to a headline in EconomicTimes.
The MannKind slides from yesterday's excellent earnings report indicated India's CDSCO (equivalent to US FDA) will rule on Cipla's application to commercialize Afrezza in India. The speculation here has been the sale of Afrezza in India will largely serve to improve the unit cost of Afrezza by underwriting manufacturing (scale?).
If we assume 25K Afrezza users (and really don't know how many there are), if 1% of India's ~5M insulin-using persons with diabetes chose to use Afrezza, that would triple the existing Afrezza user base. If that happens, and Afrezza sales improve domestically, at some point, MNKD is going to need a bigger boat. i.e., larger manufacturing capacity. Hopefully, we'll get some insight to MNKD's thoughts on production capacity for Tyvaso DPI, Afrezza, Clofazamine, closer to 2025.
Maybe after years and years we will finally get the shareholders meeting in Danbury and can get a look at what the factory expansion looks like. Its been so long the last time I was there Receptor Life Sciences was the big thing and notices were posted about being a schedule 1 site. I would hope the new high speed fill/finish line for Tyvaso DPI would handle most demand and the area it was housed in would then free up space to backfill with for afrezza space if needed. Then again back in 2014 we thought afrezza's biggest issue would be keeping up with production demand and we had 3 lines. We should have listened to those in the know, who knew BP through the PBMs would limit afrezza to a niche product. I doubt we have any where near 25k users but this would be a more interesting number than 27% growth on Mike's slide. Bill from VDex was hoping to get to a 25k to 50k user base to get some respect with the ADA. Most users are T1s since they can get insurance coverage but only if they are MDI. We know we have about 1k scripts a week and 80% don't get the refill so 200 do so maybe we have 4k of them? Ginger V. might have a good guess at this number. The vast majority of T1s using afrezza are probably part time users who use it as a rescue tool. Maybe 5k of them who are paying for 1 box every 3 to 6 months. So maybe 10k full and part time users. The factory was built assuming millions. |
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Post by prcgorman2 on Feb 29, 2024 7:33:36 GMT -5
I recall a target of 1 million users. Somewhere I have an elaborate spreadsheet from 2014 that tracked production capacity and weekly scripts. The plant was built to be able to support more than 1 million, but as you mentioned, only 3 lines with space for 9 more. No idea what it’s like now.
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Post by sayhey24 on Feb 29, 2024 21:13:21 GMT -5
Space for 9 more? I thought any additional expansion and they would be building out in the parking lot. Lets hope that ends up being the case and the parking lot is gone. Then we have a real happiness problem. If they do that I will need to leave my truck home for the ASM and take the wife's car.
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