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

Filing Date
Filed May 13, 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 May 13, 2005. Cited figures are marked; the original filing is the authoritative source.

Insmed Incorporated's Amendment No. 3 to its Form 10-K for the fiscal year ended December 31, 2004 amends only Part III (Items 10 through 14: directors, executive compensation, security ownership, related transactions and accountant fees).

The filing reproduces the full annual report, which describes Insmed as a biopharmaceutical company developing drugs that modulate IGF-I activity for metabolic and endocrine diseases and oncology. Its lead candidate, rhIGF-I/rhIGFBP-3 (SomatoKine), was the subject of a New Drug Application submitted January 3, 2005 for growth hormone insensitivity syndrome (GHIS), accepted for FDA review on March 4, 2005, with a Phase III trial continuing and a European MAA planned. The company reported no commercial revenue to speak of: revenues were $137 thousanda in 2004, research and development expenses were $23.3 million, and the net loss was $27.2 million, bringing the accumulated deficit to $213.7 million.

Cash and cash equivalents were $9.2 millionb at December 31, 2004, and stockholders' equity was $7.2 million. On March 15, 2005, the company sold approximately $35 million of 5.5% convertible notes with warrants, which management says will fund operations for the next twelve months.

The filing discloses material risks, including patent infringement suits filed by Tercica, Inc. and Genentech, Inc. in the United Kingdom and the United States, which the company says could materially affect its business if decided adversely, and a competing Tercica NDA for rhIGF-I in severe primary IGF-I deficiency that could raise orphan exclusivity concerns. The company also relies on limited third-party and single-facility manufacturing capacity.

02—Key points

Key Highlights

  1. Net loss of $27.2 million in 2004 versus $10.3 million in 2003; research and development expenses rose to $23.3 million from $7.1 million.
  2. Revenues were $137 thousand in 2004, down from $150 thousand in 2003, reflecting a slight decline in royalties; the company has no commercial product sales.
  3. NDA for rhIGF-I/rhIGFBP-3 in GHIS submitted January 3, 2005 and accepted for FDA review March 4, 2005; a European MAA is planned.
  4. Accumulated deficit of $213.7 million and cash and cash equivalents of $9.2 million at December 31, 2004.
  5. March 15, 2005 financing of approximately $35 million in 5.5% convertible notes plus warrants for 14,864,883 shares at $1.36; management believes this funds operations for the next twelve months.
  6. Pending patent litigation with Tercica, Inc. and Genentech, Inc. in the UK and U.S.; the company says an adverse ruling could materially affect its business.
  7. Competitor Tercica, Inc. submitted an NDA for rhIGF-I in February 2005, creating potential orphan exclusivity risk for GHIS.

03—Questions

Frequently Asked Questions

  1. What is the purpose of this amended filing?

    Amendment No. 3 amends only the Part III information in Items 10 through 14 of the Form 10-K for fiscal 2004, covering directors and executive officers, executive compensation, security ownership, related transactions and principal accountant fees. The filing states that other information has not been updated for events after the original March 16, 2005 filing date.

  2. What is Insmed's lead product candidate and where is it in the regulatory process?

    The lead candidate is rhIGF-I/rhIGFBP-3 (SomatoKine) for growth hormone insensitivity syndrome. A New Drug Application was submitted to the FDA on January 3, 2005 and accepted for review on March 4, 2005. The company is continuing a Phase III trial for long-term data and plans to submit a Marketing Authorization Application to the EMEA.

  3. How is the company funding its operations?

    In 2004 the company raised about $8.0 million net from a private placement of common stock. On March 15, 2005 it issued approximately $35 million of 5.5% convertible notes and warrants for 14,864,883 shares at $1.36. The filing states management believes this provides sufficient capital for the next twelve months, while also noting it will need substantial additional funds for commercialization.

  4. What are the main legal risks disclosed?

    Tercica, Inc. and Genentech, Inc. have sued Avecia Limited and Insmed in the UK alleging infringement of EP patent 571,417, and Tercica and Genentech have sued Insmed in the U.S. District Court for the Northern District of California alleging infringement of several U.S. patents. Insmed filed a defense, counterclaim and a motion to dismiss. The company states it cannot predict the outcome and that an adverse ruling could have a material adverse effect on its business.

  5. What were the company's financial results for 2004?

    Revenues were $137 thousand, research and development expenses were $23.3 million, general and administrative expenses were $4.2 million, and the net loss was $27.2 million, or $0.69 per share. Total assets were $13.0 million and stockholders' equity was $7.2 million at December 31, 2004.

04—Continue

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