Post by jlaw277 on Jan 8, 2016 8:40:17 GMT -5
FWIW
Helpful to look back at Minimed and look for parallels that can be drawn:
articles.latimes.com/1995-08-08/business/fi-32818_1_infusion-pump
www.nytimes.com/1999/02/11/business/stalking-wild-glucose-level-minimed-chief-aims-bring-big-changes-diabetes.html?pagewanted=1
Also worth reviewing is Insulet's IPO prospectus where you can see that DeSisto joined as CFO in 2001, became CEO in 2003. Even at year end 2005, they still only had $50,000 in revenues but a lot of expenses as they progressed developing the Omnipod system. When DeSisto eventually left the company, they had a market cap of approximately $2 billion. Mission accomplished.
Between Al Mann and DeSisto, in many ways they have been here before, which gives some credence to the idea that they know how to handle this most recent setback and the many challenges it presents.
Insulet IPO Prospectus
www.sec.gov/Archives/edgar/data/1145197/000095013507002552/b63591rde424a.htm#108
From the Insulet Business Overview:
Since inception, we have devoted substantially all of our efforts to designing and developing the OmniPod System, raising capital and recruiting personnel. As a result, we were considered a development stage company pursuant to Statement of Financial Accounting Standards (“SFAS”) No. 7, Accounting and Reporting by Development Stage Enterprises, through December 31, 2005. The year 2006 is the first year during which we were an operating company and were no longer in the development stage. In October 2005, we shipped our first commercial OmniPod System. Since October 2005, in order to align the demand for the OmniPod System with our capacity to manufacture the OmniPod, we have engaged in limited marketing efforts focused in the Eastern United States and with some key diabetes practitioners, academic centers and clinics elsewhere in the United States. Our total revenues were $3.7 million for the year ended December 31, 2006. As of March 31, 2007, we have approximately 1,750 patients using the OmniPod System in the United States.
At present, the expansion of our business is constrained by our current capacity to manufacture the OmniPod insulin infusion device, and our primary near-term goal is to expand our manufacturing volume for OmniPods. Currently, the sale price of the OmniPod System is not sufficient to cover our direct manufacturing costs. We are in the process of completing the construction, testing and installation of automated manufacturing equipment to be used in the assembly of the OmniPod in order to increase our manufacturing volume. Increased volumes will allow for volume purchase discounts to reduce our raw material costs and improve absorption of manufacturing overhead costs.
During 2008, we expect to complete the planned automation of our existing manufacturing line, which is designed exclusively for the manufacture of the OmniPod, and begin construction of a second manufacturing line. Pending construction and installation of the remaining automated manufacturing equipment that we plan to use, we are manually performing these steps in the manufacturing process, which limits our ability to increase our manufacturing capacity and decrease our per unit cost of goods sold, thereby causing us to incur negative gross margins. We are exploring alternative site manufacturing capabilities both domestically and abroad. No assurances can be given that we will successfully complete the planned automation of our existing manufacturing line or subsequent lines in the future or otherwise reduce the per unit cost of manufacturing the OmniPod. Failure to do so would limit our production capacity and not allow us to achieve per unit cost improvements, which could severely constrain our ability to achieve profitability.
Additionally, as a medical device company, reimbursement from third-party payors is an important element of our success. If patients are not adequately reimbursed for the costs of using the OmniPod System, it will be much more difficult for us to penetrate the market. As of March 31, 2007, we had entered into contracts establishing reimbursement for the OmniPod System with national and regional third-party payors covering an estimated 92 million lives, and we believe that substantially all of the units sold have been reimbursed by third-party payors, subject to applicable deductible and co-payment amounts. As we expand our sales and marketing focus and increase our manufacturing capacity, we will need to maintain and expand available reimbursement for the OmniPod System.
Since our inception in 2000, we have incurred losses every quarter. In the year ended December 31, 2006, we incurred a net loss of $36.0 million compared to a net loss of $21.6 million for the same period in 2005. As of December 31, 2006, we had an accumulated deficit of $102.0 million. We have financed our operations through the private placement of equity securities and secured indebtedness. As of December 31, 2006, we had $30.0 million of secured debt outstanding, and, since inception, we have received net proceeds of $119.5 million from the issuance of redeemable convertible preferred stock.
Our long-term financial objective is to achieve and sustain profitable growth. Our efforts in 2007 will be focused primarily on expanding our manufacturing capacity, reducing our per unit production costs and expanding our sales and marketing efforts for the OmniPod System. The expansion of our manufacturing capacity will allow us to increase production volumes which will help us to achieve lower material costs due to volume purchase discounts and improve the absorption of manufacturing overhead costs. Achieving these objectives is expected to require additional investments in manufacturing and additional hiring of sales and administrative personnel with the goal of increasing our market penetration. We believe that we will continue to incur net losses in the near term in order to achieve these objectives, although we believe that the accomplishment of these combined efforts will have a positive impact on our financial condition in the future.
Helpful to look back at Minimed and look for parallels that can be drawn:
articles.latimes.com/1995-08-08/business/fi-32818_1_infusion-pump
www.nytimes.com/1999/02/11/business/stalking-wild-glucose-level-minimed-chief-aims-bring-big-changes-diabetes.html?pagewanted=1
Also worth reviewing is Insulet's IPO prospectus where you can see that DeSisto joined as CFO in 2001, became CEO in 2003. Even at year end 2005, they still only had $50,000 in revenues but a lot of expenses as they progressed developing the Omnipod system. When DeSisto eventually left the company, they had a market cap of approximately $2 billion. Mission accomplished.
Between Al Mann and DeSisto, in many ways they have been here before, which gives some credence to the idea that they know how to handle this most recent setback and the many challenges it presents.
Insulet IPO Prospectus
www.sec.gov/Archives/edgar/data/1145197/000095013507002552/b63591rde424a.htm#108
From the Insulet Business Overview:
Since inception, we have devoted substantially all of our efforts to designing and developing the OmniPod System, raising capital and recruiting personnel. As a result, we were considered a development stage company pursuant to Statement of Financial Accounting Standards (“SFAS”) No. 7, Accounting and Reporting by Development Stage Enterprises, through December 31, 2005. The year 2006 is the first year during which we were an operating company and were no longer in the development stage. In October 2005, we shipped our first commercial OmniPod System. Since October 2005, in order to align the demand for the OmniPod System with our capacity to manufacture the OmniPod, we have engaged in limited marketing efforts focused in the Eastern United States and with some key diabetes practitioners, academic centers and clinics elsewhere in the United States. Our total revenues were $3.7 million for the year ended December 31, 2006. As of March 31, 2007, we have approximately 1,750 patients using the OmniPod System in the United States.
At present, the expansion of our business is constrained by our current capacity to manufacture the OmniPod insulin infusion device, and our primary near-term goal is to expand our manufacturing volume for OmniPods. Currently, the sale price of the OmniPod System is not sufficient to cover our direct manufacturing costs. We are in the process of completing the construction, testing and installation of automated manufacturing equipment to be used in the assembly of the OmniPod in order to increase our manufacturing volume. Increased volumes will allow for volume purchase discounts to reduce our raw material costs and improve absorption of manufacturing overhead costs.
During 2008, we expect to complete the planned automation of our existing manufacturing line, which is designed exclusively for the manufacture of the OmniPod, and begin construction of a second manufacturing line. Pending construction and installation of the remaining automated manufacturing equipment that we plan to use, we are manually performing these steps in the manufacturing process, which limits our ability to increase our manufacturing capacity and decrease our per unit cost of goods sold, thereby causing us to incur negative gross margins. We are exploring alternative site manufacturing capabilities both domestically and abroad. No assurances can be given that we will successfully complete the planned automation of our existing manufacturing line or subsequent lines in the future or otherwise reduce the per unit cost of manufacturing the OmniPod. Failure to do so would limit our production capacity and not allow us to achieve per unit cost improvements, which could severely constrain our ability to achieve profitability.
Additionally, as a medical device company, reimbursement from third-party payors is an important element of our success. If patients are not adequately reimbursed for the costs of using the OmniPod System, it will be much more difficult for us to penetrate the market. As of March 31, 2007, we had entered into contracts establishing reimbursement for the OmniPod System with national and regional third-party payors covering an estimated 92 million lives, and we believe that substantially all of the units sold have been reimbursed by third-party payors, subject to applicable deductible and co-payment amounts. As we expand our sales and marketing focus and increase our manufacturing capacity, we will need to maintain and expand available reimbursement for the OmniPod System.
Since our inception in 2000, we have incurred losses every quarter. In the year ended December 31, 2006, we incurred a net loss of $36.0 million compared to a net loss of $21.6 million for the same period in 2005. As of December 31, 2006, we had an accumulated deficit of $102.0 million. We have financed our operations through the private placement of equity securities and secured indebtedness. As of December 31, 2006, we had $30.0 million of secured debt outstanding, and, since inception, we have received net proceeds of $119.5 million from the issuance of redeemable convertible preferred stock.
Our long-term financial objective is to achieve and sustain profitable growth. Our efforts in 2007 will be focused primarily on expanding our manufacturing capacity, reducing our per unit production costs and expanding our sales and marketing efforts for the OmniPod System. The expansion of our manufacturing capacity will allow us to increase production volumes which will help us to achieve lower material costs due to volume purchase discounts and improve the absorption of manufacturing overhead costs. Achieving these objectives is expected to require additional investments in manufacturing and additional hiring of sales and administrative personnel with the goal of increasing our market penetration. We believe that we will continue to incur net losses in the near term in order to achieve these objectives, although we believe that the accomplishment of these combined efforts will have a positive impact on our financial condition in the future.