- Mannkind successfully transitioned manufacturing and commercial activities for Afrezza, the company's inhaled insulin product, from Sanofi, by July 4, the target date outlined in the co-marketing dissolution agreement.
- With a new marketing team and sales force in place, Mannkind will attempt to re-launch Afrezza in the third quarter of this year.
- The company also reported cash and cash equivalents of $63.7 million as of the end of the second quarter. The total amount owed to Sanofi is $70.3 million, which includes accrued interest of $4.3 million. Under the terms of this facility, it is not due for repayment until August 2024.
CA-based MannKind has been in triage mode ever since Sanofi severed the companies' co-marketing agreement for Afrezza in January. During a call with investors to review second quarter results, Chief Financial Officer Matthew Pfeffer focused on all of the efforts that the company took in the last six months to fully transition Afrezza back to MannKind.
"In January of 2016, I announced an audacious plan to pivot MannKind in a dramatic way, transforming the company from one whose primary purpose was manufacturing into a fully developed commercial enterprise," he said.
In the last six months, Mannkind has reduced its workforce, decreased operational expenses, set up a pharmacovigilance system and built up a sales and marketing team.
The goal is to re-launch Afrezza using a new marketing strategy, focused on targeting endocrinologists rather than primary care physicians. MannKind also plans to implement an educational program helping physicians meet all of the criteria needed to prescribe Afrezza. In addition, MannKind has launched a consumer awareness campaign focused on convenience and efficacy.
Despite having Michael Castagna, an experienced marketing professional who worked at both Amgen and Bristol-Myers Squibb, on board, Afrezza may not gain much traction due to complicated administration and the overabundance of diabetes treatments already available to patients.
The obvious positioning strategy for an inhalable insulin product would be to focus on the convenience over current injectable medications.
However, quite a few patients are excluded from treatment with Afrezza, including smokers and people with asthma, making that strategy less effective for a broad population. Add to that the need for spirometry-based lung-function testing at the beginning of treatment, and every six months afterwards, and it's clear that the deck was stacked against Afrezza when the FDA finalized its label in early 2015.
Nonetheless, Mannkind has enough cash to get through the year, and plans to re-launch in the third quarter. The company is looking for a new commercial partner to help it move forward.
"We executed a financing in May, which provides a sufficient runway to get us into the first quarter of next year. At the same time, we continue to weigh the value proposition of every expenditure the company makes to make our existing and anticipated cash last as far as far into 2017 as possible," said Pfeffer.