Mannkind

and
The Inhaled Insulin
 About Mannkind Corporation

 Biopharmaceutical company focused on designing, development and

commercialization of therapeutic products for diabetic like disease.

 Founded in 1991 and headquartered in California,USA.

 Alfred E. Mann is the owner and Executive Chairman of Mannkind

Corporation.

 Among the products developed by Mannkind corporation, the rapid-

acting inhaled insulin named as “Afrezza” is worth to mention.
 About Afrezza

 An inhaled insulin that breathed-in through the lungs and used to

control high blood sugar in diabetic patients.

 Not suitable for diabetic patient who smokes.

 FDA approved Afrezza on June 2014.

 Mannkind entered into exclusive licensing with Sanofi to sell Afrezza

in the market.

 The licensing agreement was terminated on 2016 due to lack of

coordination, inaccurate market forecast and poor sales.
 Opportunities for Afrezza

 Number of insulin intake patients in USA are projected to increase to

a significant level in next couple of years.

 Unmet global diabetic market for Mannkind Corporation which can

be entered through FDI(foreign direct investment) and licensing
agreements as a means of innovation and new testing device.

 Probability of increased acceptance of Afrezza in the global market

due to its easy-to-handle, convenience, efficiency and requirement
for no injection.
 Threats for Afrezza

 Changes of health care environments and regulatory laws by the

government and authority.

 Failure in the international market due to lack of integration,

cooperation and wrong projection.

 Oligopolistic insulin market in several regions.

 New improved treatment options.

 Why Afrezza Failed Initially?

 Over estimation of the market appeal for inhaled insulin over the
traditional injected insulin by business co-partner Sanofi. Mannkind
also seemed to ignore the actual market data as well as facts and
relied on the over estimation.

 Mandatory lung testing with a spirometer before getting access to the

Afrezza insulin made the product less appealing to the patients and
doctors.
 Why Afrezza Failed Initially?(Cont.)

 There was insurance barriers as most of the insurance providers

kept Afrezza product as coverage tier 3 or 4 (non preferred brands).
It has made adopting Afrezza a major obstacle for the users. Tier 3
or 4 medications have higher co-payments compared to other
preferred medicine brands.

 Concern regarding possible side effects, especially those with the

problem of cough or respiratory system further diminished its
viability initially.
 Response from Mannkind

 Successful transition of Afrezza from Sanofi-Mannkind venture to

solely Mannkind istelf.

 Transforming the company from solely manufacturing into a fully

developed commercial enterprise.

 Hiring new commercial management team, hiring nurses and

medical science liaisons.

 Reducing workforce, decreasing operational expenditures and

setting up pharmacovigilance system.
 Marketing & Strategy of Afrezza
 Formation of new sales and marketing team.

 As a positioning strategy, Mannkind focused on the convenience of the

inhalable insulin over traditional injectable insulin.

 Focused on targeting endocrinologists instead of primary care physicians.

 As for patients, primary target is diabetic patients with need for insulin.
But patients who smoke or have respiratory problem are excluded from
the primary target.

 Launching consumer awareness campaign and educational program to

help physicians meet all the requirements and prescribe Afrezza.
 The Future of Diabetic Market & Afrezza

 There will be highly increased number of diabetic patients in the

next 15-20 years globally.

 Need for a safe, easy and affordable solution to keep blood sugar
level optimum will also rise.

 Advancement of technology will result in emerging therapies and

newly medical equipment to provide more convenient option for
patients.

 As for Afrezza, there is room for sales growth and gaining market
share due to projected high number of patients in future. But in
order to cope with the market, it needs to embrace new technology,
do research as well as innovation and perceive market demand.
 The Lung Test Process
 As per FDA, spirometer (device used for lungs functioning) testing is
mandatory before getting access to any inhaler insulin.

 The main reason is inhaler insulin like Afrezza is detrimental for the
diabetic patient with chronic lung diseases like asthma or COPD.
Therefore safety and efficacy should be the first priority for Mannkind.

 The duty of Mannkind regarding streamlining with spirometer testing

include right spirometer selection, staff training, reimbursement and
regular monitoring of patients. Also purchasing a spirometer that is
easy, accurate, maintenance free and reimbursable.

 Before using Afrezza, each patient should be gone through medical

history check, physical examination and regular assessment after
medical approval to use Afrezza. Mannkind has a lot to do for
integration with spirometer assessment in this regard.
 The Next Forecast
To increase efficiency of sales projection of Afrezza, sales forecasting
of Mannkind should be:

Collaborative and should not be over/under estimated

Data driven and realistic
Produced in real time
Single sourced with multiple views
Improved over time
Anticipate market trends accurately
Appropriate benchmarking
Accurate projection of risks through scenario analysis (What-if)
Efficiency in setting price, target customers and distribution channels
 Recommendation

 Create more awareness and benefits of the product to the diabetic

consumers, educating patients and doctors as well as make the access
to the usage of inhaled insulin easier.

 Accurate sales projection with appropriate business modeling and

forecasting technique considering historical facts and numbers.

 Achieving favorable insurance payer coverage remains one of the

topmost concerns for Afrezza. To get favorable coverage, price of
Afrezza insulin needs to be set at competitive range with the competitive
branded products.

 Constant modification of the device testing method to adjust with newer

version of technology.
Recommendation for entering UK Market
 Pros:
 Access to one of the globally enriched markets.
 Expanding customer base and revenue diversification.
 Regulatory issues might be less than FDA in USA.

 Cons:
 Increase in marketing expenses to introduce a new product in UK.
 Patient’s reluctance to newly method of diabetic testing.
 Difficulty in sales projection as well as initial high operating cost.

 Recommendation:
 Extensive R&D of the UK diabetic market before entering.
 Enter initially through licensing agreements or online distribution channels
rather than FDI (foreign direct investment).
THANK YOU