01—Abstract
Summary
Summary of the 10-K filed March 22, 2001. Cited figures are marked; the original filing is the authoritative source.
Insmed Incorporated (filed as Insmed Incorporated, a Virginia corporation, Nasdaq: INSM) is a pharmaceutical company developing products for metabolic and endocrine diseases associated with insulin resistance.
Its lead candidate, INS-1, an orally active insulin sensitizer, is in Phase II trials for type 2 diabetes and polycystic ovary syndrome (PCOS). Its second candidate, SomatoKine, a recombinant IGF-1/BP3 complex, is in Phase II development for type 1 and type 2 diabetes. The company has no approved products and no product sales; its only 2000 revenue was $60 thousanda.
Financially, the company reported a 2000 net loss of $79.9 millionb ($79,862 thousand), driven mainly by a one-time $50.4 million non-cash charge for purchased research and development from the May 2000 acquisition of Celtrix Pharmaceuticals, plus $21.6 million in research and development expense and $6.0 million in general and administrative expense. The accumulated deficit reached $102.6 million. Cash, cash equivalents and marketable securities were $83.1 million at year-end, and the company states this is sufficient to fund operations until at least the end of 2002.
Equity financings in 2000 produced net proceeds of $97.3 millionc. The filing also highlights significant risks: the company has no internal manufacturing or marketing capability, relies on contract manufacturers, faces a patent dispute risk with Genentech and others regarding SomatoKine, and depends on its collaboration with Taisho Pharmaceutical for INS-1 in Asia. The company had 40 full-time employees at year-end 2000.
02—Key points
Key Highlights
- No approved products or product sales; 2000 revenue was $60 thousand, with all candidates still in development
- 2000 net loss of $79.9 million, including a one-time $50.4 million non-cash purchased research and development charge from the Celtrix acquisition
- Research and development expense rose to $21.6 million in 2000 from $5.7 million in 1999
- Cash, cash equivalents and marketable securities of $83.1 million at December 31, 2000; company expects this to fund operations until at least the end of 2002
- Accumulated deficit of $102.6 million at December 31, 2000
- $97.3 million in net proceeds from three equity financings during 2000
- Taisho Pharmaceutical licensed INS-1 rights in Japan and certain Asian countries, with a potential pre-commercialization value of $32 million
03—Questions
Frequently Asked Questions
What are the company's lead product candidates?
INS-1, an orally active insulin sensitizer in Phase II trials for type 2 diabetes and polycystic ovary syndrome, and SomatoKine, an injectable recombinant IGF-1 and BP3 complex in Phase II trials for type 1 and type 2 diabetes.
Why was the 2000 net loss so large?
The largest component was a one-time, non-cash charge of $50.4 million to write off in-process research and development from the May 2000 acquisition of Celtrix. The loss also included $21.6 million of research and development expense, $6.0 million of general and administrative expense and a $3.6 million non-cash stock compensation charge.
How long will current cash last?
The company believes its cash position of $83.1 million will be sufficient to fund its operations until at least the end of 2002, but it states it will need to raise substantial additional funds to continue development and commercialization.
Does the company have manufacturing or sales capabilities?
No. The company has no internal manufacturing or marketing capability and relies on contract manufacturers. It has no sales, marketing or distribution capability and plans to build a direct sales force for INS-1 for PCOS in the United States or partner for other indications.
04—Continue