Skip to content
AnalystLens

Insmed Annual Report, Year Ended Dec 31, 2004

Filing Date
Filed March 16, 2005
Period End
December 31, 2004
Security
INSM
In the record · 2016–202610-K1110-Q338-K134

INSM filed 11 annual reports (10-K), 33 quarterly reports (10-Q) and 134 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · Oct ’16Oct ’16
  2. FY2018 annual report10-K · Feb ’19Feb ’19
  3. Leadership change8-K · Jun ’21Jun ’21
  4. Leadership change8-K · May ’25May ’25

01—Abstract

Summary

Summary of the 10-K filed March 16, 2005. Cited figures are marked; the original filing is the authoritative source.

Insmed Incorporated, a Virginia biopharmaceutical company focused on metabolic and endocrine diseases and oncology, reports in its annual report for 2004 that it has no commercial product sales yet.

Its lead candidate, rhIGF-I/rhIGFBP-3 (SomatoKine), was submitted to the FDA as a New Drug Application on January 3, 2005 for growth hormone insensitivity syndrome (GHIS), and the FDA accepted it for review on March 4, 2005. The company also has rhIGFBP-3 in Phase I and pre-clinical cancer development and INSM-18 planned for clinical trials in 2005. Revenues were $137 thousanda in 2004, research and development expenses rose to $23.3 million from $7.1 million, and the net loss was $27.2 million, leaving an accumulated deficit of $213.7 million.

Financial condition is weak. Cash and cash equivalents fell to $9.2 millionb at December 31, 2004 from $29.5 million a year earlier, and total stockholders' equity was $7.2 million. The filing states that on March 15, 2005 the company sold approximately $35 million of 5.5% convertible notes along with warrants for 14,864,883 shares at $1.36 per share, and that this funding should sustain operations for the next twelve months.

The filing also states that the company will need substantial additional capital and has no committed sources of funding. The filing highlights significant legal and competitive risk. Tercica, Inc. and Genentech sued Insmed and Avecia over patents, and the filing says an adverse ruling could have a material adverse effect on the business.

Tercica has also submitted an NDA for a rhIGF-I product for a related indication, which could affect orphan exclusivity for GHIS. Insmed's 2004 Form 10-K also reports that it has 55 full-time employees and that its Boulder, Colorado manufacturing facility is central to its supply plans.

02—Key points

Key Highlights

  1. NDA for rhIGF-I/rhIGFBP-3 in GHIS submitted January 3, 2005 and accepted for FDA review March 4, 2005; Phase III trial continuing
  2. No commercial product sales; 2004 revenues were $137 thousand, down from $150 thousand in 2003
  3. 2004 net loss of $27.2 million, versus $10.3 million in 2003; R&D expense rose to $23.3 million from $7.1 million
  4. Accumulated deficit of $213.7 million at December 31, 2004
  5. Cash and cash equivalents of $9.2 million at year-end 2004, down from $29.5 million; stockholders' equity of $7.2 million
  6. March 15, 2005 sale of approximately $35 million of 5.5% convertible notes with warrants for 14,864,883 shares at $1.36 per share
  7. Tercica, Inc. and Genentech patent infringement suits in the U.S. and UK, which the filing says could have a material adverse effect if ruled against the company

03—Questions

Frequently Asked Questions

  1. Does Insmed have a product on the market?

    No. The filing states that the company currently has no commercial sales. Its lead product candidate, rhIGF-I/rhIGFBP-3, is under FDA review for growth hormone insensitivity syndrome, and the company's other candidates are in Phase I, pre-clinical, or pre-clinical-to-clinical stages.

  2. How much cash does the company have, and will it be enough?

    Cash and cash equivalents were $9.2 million at December 31, 2004. The company reports a March 15, 2005 convertible note financing of approximately $35 million and states that, with this funding, it believes it has sufficient capital to fund operations for the next twelve months. The filing also says the company will need substantial additional funds for commercialization.

  3. What are the main legal risks?

    Tercica, Inc. and Genentech filed suits alleging infringement of several patents, including a UK suit against Avecia Limited and Insmed and a U.S. suit in the Northern District of California. Insmed has filed defenses, counterclaims and a motion to dismiss, but the filing says it cannot predict the outcome and that an adverse ruling could have a material adverse effect on the business.

  4. What drives the increase in operating losses?

    The filing attributes the rise in research and development expense, from $7.1 million in 2003 to $23.3 million in 2004, to a broader clinical trials program and increased manufacturing activity at the company's ITP facility in Boulder, Colorado and at contract manufacturer Avecia, which produced rhIGF-I/rhIGFBP-3 for clinical trials.

04—Continue

← View all 10-K filings