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Biotech / Medical : NNVC - NanoViricides, Inc. -- Ignore unavailable to you. Want to Upgrade?


To: KMBJN. who wrote (12406)11/6/2019 11:51:48 PM
From: HardToFind  Read Replies (2) | Respond to of 12873
 
You're right, my model is overly simplistic. I stopped refining it when it was clear to me that we were going to lose all of our money.

My model:
  • over-charges for R&D, and maybe manufacturing.
  • under-charges for a whole bunch of other factors: [licensing payments ($9 Mn for VZV, series A shares that dilute the common shares) ineffective management, corruption, conflicts of interest, higher financing costs due to recurring ethical lapses, a yes-men board, requirement to use TheraCour as a sole supplier of R&D and Mfg, an utter disregard for the common shareholders' interests, a CFO who is in cahoots with the CEO, etc.]
If you're going to make refinements to my simple model (which is fair), you should build a better model that takes these numerous, highly negative factors into consideration. Otherwise, all you have is a fairy tale...written to end hapily ever after.

Remember, you're in business with an utter crook, who thinks nothing of changing a contract so he can charge us again for something he already licensed to us (and for which he now "can't find" the original license). Only this time he's charging more than the current market capitalization of the company, for one crappy little indication that caused us to delay development a year or more to develop a new model rather than pursuing an HSV-1 or HSV-2 indications with ample animal models.

Think of it this way. You hop into a cab with a sleezy driver (Diwan) who starts the meter and takes you whatever way he wants...while the meter is running on your dime. How do you model Diwan's level of corruption? I model it this way: Diwan directs ALL of the money towards what he believes are in his best interests. He feels no obligation to make sure you (the shareholder) make any profit whatsoever. Yes, Diwan made a deal with himself, and your money. He will honor that deal until it's inconvenient, and then he will negotiate with himself again.

I don't think you've modelled that into your response. So share with me your modelling of those factors. Perhaps I can suggest my own refinements to your model.



To: KMBJN. who wrote (12406)11/7/2019 12:21:51 AM
From: HardToFind1 Recommendation

Recommended By
Savant

  Respond to of 12873
 
Good to see the 10 big pharma companies in your list average over 75% gross margins, with COGS including manufacturing, sales, and executive/corporate overhead one would assume.
Just to clarify...

Gross margins do include:
  • manufacturing labor & materials
  • variable production costs
Gross margins do not include:
  • SG&A (sales, general & administrative expenses...sales, and executive/corporate overhead)
  • R&D or capital expendatures.
investopedia.com
Gross margins are basically revenues minus COGS.

investopedia.com
Cost of goods sold (COGS) refers to the direct costs of producing the goods sold by a company. This amount includes the cost of the materials and labor directly used to create the good. It excludes indirect expenses, such as distribution costs and sales force costs.



To: KMBJN. who wrote (12406)11/7/2019 2:48:10 AM
From: HardToFind  Respond to of 12873
 
The main impediment has seemed to be their inability to produce the drugs reliably at scale. Why else did FluCide stall?
The FDA also didn't think NNVC had tested with enough flu strains. Thus the need to work w/ St. Jude Medical. (Is it St. Jude?)

I would sum up the FluCide stall as follows:

NNVC came out of their pre-IND meeting looking like rookies who thought they were contenders. They had made plans, budgets and set shareholders' & Wall Street's expectations (a new drug approval every six months, new drug candidates in 1-2 weeks, drugs for ebola and zika, financing the company with orphan drug vouchers) assuming nothing would go wrong...and then a whole lot went wrong...and very few things went right.

After their meeting w/ the FDA about an IND for FluCide, they basically said, "We've learned many valuable things." Only later did it come out that:
  • The FDA wasn't going to relax their need for drug material, even though NNVC claimed everything was non-toxic; and unfortunately, NNVC's ability to produce in a controlled way was quite inadequate.
  • The FDA wanted a lot more flu strains tested, and NNVC had no capacity to test them.
  • NNVC's regulatory & documentation procedures were wholly inadequate.
  • NNVC subsequently had serious problems scaling up batch size (for years).
It was also quite bothersome that they hid the problems so long from shareholders, so for years nobody could figure out why nothing ever got done. Newsletter writers dumped them from portfolios for that very reason.

And then the whole program was delayed for nearly a year "because of weather" (new lab in Shelton).

I guess until things change with the company, I sort of expect them to stay the same...



To: KMBJN. who wrote (12406)11/7/2019 2:50:59 AM
From: HardToFind  Respond to of 12873
 
I overreacted to your response to my Q&D profit/loss estimate. Your response was much more thoughtful than I originally thought.

Sorry about that. I wish I could say it won't happen again...but I know better.