Many have expressed a concern over Mannkind's ability to survive. Others have stated that Mannkind needs to prove its success via a rapid increase in Afrezza in the next one or two months. I believe these views are either too pessimistic or drastic.
IMHO, September will not be live/death time, neither November or December will be.
As long as Matt, Mike and their team keep their noses down, putting up new plans/programs (like what they are doing right now), executing these plans/programs, and adjusting/fine tuning them based on feedbacks as necessary, I believe we will see a sustained growth of TRx.
As long as the growth is sustained, even though it may be slow, I think Mannkind will be very successful, ultimately.
Based on the latest conference call, I would think Matt, Mike and their team have one year's time from now on to turn the trend around and show sustained growth. Personally, I think by this time next year we will know whether Matt, Mike and their team are successful or not in turning around the ship.
Yes, they may need another round of financing, whether through ATM or otherwise, but that is OK.
There are a lot of things that the team is implementing to right the ship. Any of the following should, to some degree, help the company in achieving its goal:
Things that are happening or will most likely happen in the near future:
1. Rebranding (instead of focusing on the fact that Afrezza is inhaled-i.e., the "Surprise, its insulin" campaign under Sanofi, the new marketing campaign will focus on the unique PK/PD profile of Afrezza): appears to be the right strategy as the "Surprise, its insulin" campaign does not distinguish Afrezza at all.
2. Adjusting target patient group (from Tpye 2s (under Sanofi) to Type 1s): appears to be the right strategy as Type 1s will have better incentive to get Afrezza and better knowledge get the best results. They will also be more successful in getting insurance coverage (than Type 2s) as it will be easier for them to prove the medical necessity (to get Afrezza). Additionally, CGMs are more commonly used by Type 1s and we know CGMs are a big help in demonstrating the effectiveness of Afrezza.
3. Mannkind care (now up): will help streamline reimbursement for patients and therefore help retention of patients.
4. Direct to patients marketing via journal ads (will be up Sept./Oct.): will improve awareness of Afrezza
5. Direct to patients marketing via digital marketing (will be up Sept./Oct.): will improve awareness of Afrezza
6. Direct to patients marketing via direct mail (will be up Sept./Oct.): will improve awareness of Afrezza
7. Presence of Mannkind in community events and patient conferences (occurring right now and from now on): will improve awareness of Afrezza
8. Voucher for one-month supply of titration pack (occurring right now): supplement the current sample program and will help retention of patients.
9. New titration packs (being shipped right now): will help retention of patients.
10. New sample packs (will be up Sept./Oct.): will help retention of patients.
11. Afrezza CoPay card program (up since end of July): simple and consistent $15 co-pay reimbursement program help reduce confusion of different (past programs).
12. A doc-finder (will be up sometime this year): increase access of Afrezza for patients.
13. Potential milestone payment from RLS (first milestone expected sometime this year): help extend the cash runway.
14. Further payments from Sanofi via insulin put (additional payments later this year and next year): reduce Mannkind's expenditure on insulin purchase from Amphastar by 65% and therefore help extend the cash runway.
15. 100% revenue of Afrezza (starting from now): anything earned will help extend the cash runway.
16. $50 million ATM and $30 million line from Mann Group (available right now): can be used if necessary and appropriate and therefore will help extend the cash runway.
Things that will take some time to happen:
17. Potential label change (may be submitted to FDA in Sept./Oct.): improve competitive advantage of Afrezza.
18. Potential dosage titration study: will improve competitive advantage of Afrezza if lead to improved label
19. Potential pediatric trial (details being finalized): will increase access of Afrezza and potentially improve competitive advantage of Afrezza.
20. Other TS applications: will help the market cap of Mannkind and therefore capital-raising capability assuming good progress.
Things that may or may not happen:
21. Potential international partnership (if happens): help extend the cash runway.
22. Termination settlement with (and payment from) Sanofi (if happens): help extend the cash runway.
Disclosure: I am/we are long MNKD.