- Enrollment in Mannkind’s clinical trials should be completed soon. The Company has
screened about 85% of the patients needed for enrollment in its type 1 diabetes trial that is
required for FDA approval and a separate type 2 diabetes study that is being conducted to
expand the drug’s label. The challenge has been to enroll sufficient poorly controlled patients
to ensure the average starting HbA1c levels are close to the 8.5% defined in the trails’
protocols. Mannkind expects to complete enrollment in the two trials in September.
- The cash burn rate will likely peak in the current quarter, after operations used $24.2
million in the June quarter. The burn rate should increase with the trials fully enrolled in
September and then decline through the second quarter of 2013 when the studies will end.
- Mannkind is preparing for Afrezza’s launch. True, the Company will need to raise
additional capital before this year closes. But the trials’ completion is now better defined, and
management has created teams to analyze the data from each, thereby expediting preparation
of the final submission. The Company has also settled legal disputes that might otherwise
have been a distraction, and it is prepared to take delivery of two more fill/finish lines in
2013. Meanwhile, potential marketing partners are being kept abreast of developments to
facilitate completion of negotiations soon after the clinical trials’ data are analyzed.
Share Price (8/8/2012) $2.08
52-Week Price Low / High $1.57 - $3.95
Mkt. Capitalization (issued) $415 million
Shares Outstanding (issued) 199.3 million
12-month Target Price $14.00
Average Daily Volume (3 mos.) 2,197,860
Est’d 2012 Profit (Loss)/shr ($0.92)
Est’d 2013 Profit (Loss)/shr ($0.59)