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Insmed Annual Report (Amendment), Year Ended Dec 31, 2004

Filing Date
Filed June 10, 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/A filed June 10, 2005. Cited figures are marked; the original filing is the authoritative source.

Insmed Incorporated (filed as Insmed Incorporated, a Virginia corporation) is a biopharmaceutical company focused on metabolic and endocrine diseases and oncology, with three lead drug candidates: rhIGF-I/rhIGFBP-3 (SomatoKine), rhIGFBP-3, and INSM-18.

Its most advanced program is rhIGF-I/rhIGFBP-3 for growth hormone insensitivity syndrome (GHIS). The company submitted a New Drug Application for GHIS on January 3, 2005, which the FDA accepted for review on March 4, 2005, with a User Fee Goal Date of July 3, 2005. The company has no commercial sales, reported a 2004 net loss of $27.2 milliona, and had an accumulated deficit of $213.7 million at December 31, 2004.

Financially, cash and cash equivalents fell to $9.2 millionb at December 31, 2004 from $29.5 million a year earlier, and stockholders' equity was $7.2 million. Research and development expenses rose to $23.3 million in 2004 from $7.1 million in 2003, reflecting a broader clinical trial program and increased manufacturing activity. In November 2004 the company completed a private placement of 6,455,551 shares at $1.35 per share, raising about $8.0 million net.

On March 15, 2005, it sold approximately $35 millionc of 5.5% convertible notes and warrants, and management states this funding is sufficient to fund operations through the next twelve months. The company faces significant litigation from Tercica, Inc. and Genentech, Inc. over several patents, including suits in the United Kingdom and the Northern District of California.

The filing states that an adverse ruling could materially affect the company's business. This Amendment No. 4 revises certain MD&A and Note 1 disclosures from the original 10-K filed March 16, 2005.

02—Key points

Key Highlights

  1. Lead candidate rhIGF-I/rhIGFBP-3 (SomatoKine) for GHIS: NDA submitted January 3, 2005, accepted for FDA review March 4, 2005, with a User Fee Goal Date of July 3, 2005
  2. No commercial product sales; all revenue is minimal (2004 revenues of $137 thousand, mainly royalties)
  3. 2004 net loss of $27.2 million; accumulated deficit of $213.7 million at December 31, 2004
  4. Research and development expenses increased to $23.3 million in 2004 from $7.1 million in 2003
  5. Cash and cash equivalents of $9.2 million at year-end 2004, down from $29.5 million at year-end 2003
  6. March 15, 2005 issuance of approximately $35 million of 5.5% convertible notes with warrants for 14,864,883 shares at $1.36; management believes this funds operations for the next twelve months
  7. Ongoing patent litigation with Tercica, Inc. and Genentech, Inc. in the UK and U.S. courts, which the company states could materially affect its business if adversely decided

03—Questions

Frequently Asked Questions

  1. What is Insmed's most important near-term catalyst?

    The FDA's review of the NDA for rhIGF-I/rhIGFBP-3 in GHIS, which the company has accepted for review with a User Fee Goal Date of July 3, 2005. The filing notes there can be no assurance the FDA will act by that date.

  2. How much cash did Insmed have and how is it funded?

    Cash and cash equivalents were $9.2 million at December 31, 2004. The company raised about $8.0 million net in a November 2004 private placement and approximately $35 million in convertible notes and warrants in March 2005. Management states this is sufficient to fund operations through the next twelve months.

  3. What are the main risks identified in the filing?

    Key risks include regulatory approval uncertainty in the U.S. and Europe, dependence on limited manufacturing capacity at its Boulder facility and contract manufacturers, competition from Tercica's rhIGF-I product and other companies, possible orphan drug exclusivity conflicts, and patent litigation with Tercica and Genentech.

  4. What is the status of the Tercica litigation?

    Tercica and Genentech have sued Insmed and Avecia in the United Kingdom and Tercica has sued Insmed in the U.S. District Court for the Northern District of California over several patents. Insmed has filed a defense, counterclaim, and motion to dismiss. The company says it cannot predict the outcome, and an adverse ruling could materially affect its business.

04—Continue

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