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Insmed Annual Report, Year Ended Dec 31, 2002

Filing Date
Filed March 28, 2003
Period End
December 31, 2002
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 28, 2003. Cited figures are marked; the original filing is the authoritative source.

Insmed Incorporated, a Virginia biopharmaceutical company, filed this Form 10-K for the year ended December 31, 2002 on March 28, 2003.

The company develops drug candidates for metabolic and endocrine diseases. Its lead candidate, rhIGF-I/rhIGFBP-3, is being prepared for a pivotal trial in pre-pubertal Laron syndrome patients beginning in the first half of 2003, with a targeted approval for growth hormone insensitivity syndrome in the second half of 2004. Its second candidate, rhIGFBP-3, is in preclinical oncology development, with an IND planned for the second half of 2003.

The company has no product revenues and has not received regulatory approval for any product. Financially, the company reported a 2002 net loss of $36.4 milliona, down from $37.2 million in 2001, and research and development expense of $18.1 million, down from $35.5 million. The decline followed the September 2002 discontinuation of the INS-1 program and Taisho's termination of its joint development agreement.

The company also recorded a $2.5 millionb restructuring charge, a $15.4 million goodwill impairment charge, and 2002 revenues of $1.955 million. Cash and cash equivalents were $27.3 million at year-end, against an accumulated deficit of $176.2 million, and management states this cash will fund operations through 2004. Investors should note the stock listing risk: on January 22, 2003, Nasdaq issued a staff determination for failure to meet the $1.00 minimum bid price.

A hearing was held March 6, 2003, and the delisting action was stayed pending the Panel's decision. The last reported sale price on February 28, 2003 was $0.49c per share.

02—Key points

Key Highlights

  1. 2002 net loss of $36.4 million, compared with $37.2 million in 2001; accumulated deficit of $176.2 million at December 31, 2002.
  2. Research and development expense fell to $18.1 million in 2002 from $35.5 million in 2001, following the discontinuation of the INS-1 program.
  3. Cash and cash equivalents of $27.3 million at December 31, 2002; management believes this will fund operations through 2004.
  4. Lead candidate rhIGF-I/rhIGFBP-3 has Orphan Drug Status in the U.S. for growth hormone insensitivity syndrome; a pivotal pediatric Laron syndrome trial is expected to begin in the first half of 2003.
  5. The company has no approved products and no product sales; all candidates remain in research or development stages.
  6. Nasdaq issued a staff determination on January 22, 2003 for failure to meet the $1.00 minimum bid price; a hearing was held March 6, 2003, and delisting is stayed pending the Panel's decision.
  7. A $15.4 million goodwill impairment charge and a $2.5 million restructuring charge were recorded in 2002, with 32 employees (55% of the workforce) terminated.

03—Questions

Frequently Asked Questions

  1. Does Insmed have any approved products or revenue-generating products?

    No. The filing states that none of the company's products has received regulatory approval or been released for commercial sale, and that it has generated no revenues from product sales. Total 2002 revenues were $1.955 million, largely from recognition of deferred Taisho revenue.

  2. How long can the company fund its operations?

    Management believes existing cash reserves will sufficiently fund activities through 2004. Cash and cash equivalents were $27.3 million at December 31, 2002. The company states it will need substantial additional funds for continued development and commercialization and may seek funding through alliances, securities sales, or licensing.

  3. What is the status of the INS-1 program?

    On September 10, 2002, Insmed announced it would immediately discontinue internal development of INS-1 after Phase II results. Its Japanese partner, Taisho Pharmaceuticals, also terminated the joint development agreement. The company recorded a $2.5 million restructuring charge and recognized $1.7 million of previously deferred Taisho revenue.

  4. What are the near-term clinical and regulatory milestones?

    The company plans to begin a pivotal trial in pre-pubertal Laron syndrome patients in the first half of 2003, and a pivotal trial for growth hormone insensitivity syndrome in Europe in the first half of 2003. It intends to seek fast-track approval in the U.S. and Europe for GHIS in the second half of 2004. For rhIGFBP-3, toxicology studies are set to begin in the first half of 2003, with an IND filing planned for the second half of 2003.

  5. What is the risk of the stock being delisted from Nasdaq?

    Nasdaq issued a staff determination on January 22, 2003 for failure to meet the $1.00 minimum bid price. The company requested a hearing, held March 6, 2003, and the delisting is stayed pending the Panel's decision. If denied, the company intends to apply for listing on the Nasdaq SmallCap Market. The last reported sale price on February 28, 2003 was $0.49 per share.

04—Continue

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