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Insmed Annual Report, Year Ended Dec 31, 2010

Filing Date
Filed March 16, 2011
Period End
December 31, 2010
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, 2011. Cited figures are marked; the original filing is the authoritative source.

Insmed Incorporated's 10-K for fiscal 2010 centers on its December 1, 2010 business combination with Transave, Inc., a privately held New Jersey pharmaceutical company focused on inhaled treatments for serious lung infections.

Insmed paid off Transave's $7.8 milliona debt, issued about 25.9 million common shares and about 91.7 million Series B Conditional Convertible Preferred shares, and paid cash consideration of $561,280. Former Transave stockholders hold approximately 47% of the combined company on a fully diluted basis. On March 2, 2011, Insmed completed a one-for-ten reverse stock split, and the preferred shares converted to common stock on March 1, 2011.

The company's lead product candidate is ARIKACE (liposomal amikacin for inhalation). Insmed plans to begin Phase 3 patient accrual in the second half of 2011 for cystic fibrosis patients with Pseudomonas lung infections and for patients with non-tuberculous mycobacteria (NTM) lung infections, and it filed an IND for NTM in the first quarter of 2011. Revenue is small and comes mainly from the IPLEX Expanded Access Program in Italy.

The filing states that IPLEX supply is expected to be exhausted in about the third quarter of 2011, after which the company expects no material operating revenue unless it executes an income-generating transaction. For 2010, revenues were $6.9 millionb, the net loss was $6.4 million ($0.49 per share), and cash and investments totaled $110.2 million.

The accumulated deficit was $235 millionc. The filing also flags several risks: the company must regain compliance with the NASDAQ $1.00 minimum bid price by June 13, 2011, or face delisting; it has no committed sources of capital; and it faces pending litigation, including the Cacchillo suit and the Mackinson quasi-appraisal class action, with no estimate of possible loss stated for either.

02—Key points

Key Highlights

  1. Completed the Transave, Inc. business combination on December 1, 2010; former Transave stockholders hold approximately 47% of the combined company on a fully diluted basis.
  2. Lead candidate ARIKACE is planned for Phase 3 trials in CF patients with Pseudomonas lung infections and in NTM lung infections, with patient accrual expected to start in the second half of 2011.
  3. 2010 total revenues were $6.9 million, down from $10.4 million in 2009, and the net loss was $6.4 million, or $0.49 per share.
  4. Cash, cash equivalents, short-term investments and certificate of deposit totaled $110.2 million at December 31, 2010.
  5. IPLEX supply is expected to be exhausted around the third quarter of 2011, which the filing says will end Expanded Access Program cost-recovery revenue from Italy.
  6. A one-for-ten reverse stock split became effective March 2, 2011, and the company must regain NASDAQ minimum bid price compliance by June 13, 2011.
  7. The accumulated deficit was $235 million at December 31, 2010, and the company states it has no committed sources of capital.

03—One dollar

04—Financials

Financial Highlights

Figures from 10-KFY2010filed March 16, 2011
Revenue$6.92MNet Income-$6.43M-93.0% Net MarginEPS (Diluted)$-0.49Total Assets$196.26MCash & Equivalents$10.74MFree Cash Flow-$7.72M

Financial Statements

FY2010 against FY2009

Line itemFY2010FY2009Change
Revenue$6.92M$10.37M−33.3%
R&D Expenses$4.70M$9.21M−48.9%
Operating Expenses$15.01M$19.05M−21.2%
Operating Income-$8.09M-$8.67M+6.7%
Interest Expense$109K$781K−86.0%
Net Income-$6.43M$118.35M−105.4%
EPS (Basic)$-0.49$9.31−105.3%
EPS (Diluted)$-0.49$9.30−105.3%
Shares Outstanding (Basic)13.25M13K+104132.2%
Shares Outstanding (Diluted)13.25M13K+104009.4%

05—Questions

Frequently Asked Questions

  1. What is the Transave merger and how did it change the company's share structure?

    On December 1, 2010, Insmed acquired Transave, Inc. Insmed paid off Transave's $7.8 million debt, issued about 25.9 million common shares and about 91.7 million Series B Conditional Convertible Preferred shares, and paid $561,280 in cash. The preferred shares converted to common stock on March 1, 2011, and former Transave stockholders hold about 47% of the combined company on a fully diluted basis.

  2. What is ARIKACE and what are its next development steps?

    ARIKACE is a liposomal amikacin for inhalation, given once daily via the investigational eFlow Nebulizer System. The company plans Phase 3 trials for CF patients with Pseudomonas lung infections, with patient accrual starting in the second half of 2011, and filed an IND for Phase 3 in NTM lung infections in the first quarter of 2011.

  3. How much revenue and loss did Insmed report for 2010, and what funds does it have?

    Revenues were $6.9 million for 2010, compared with $10.4 million for 2009. The net loss was $6.4 million, or $0.49 per share. Cash, cash equivalents, short-term investments and a certificate of deposit totaled $110.2 million at December 31, 2010. The filing states the company has no committed sources of capital.

  4. What are the main risks to the company's listing and near-term revenue?

    The company must regain compliance with the NASDAQ Capital Market $1.00 minimum bid price by June 13, 2011, or its stock may be delisted. IPLEX supply is expected to be exhausted around the third quarter of 2011, which would end Expanded Access Program revenue from Italy unless an income-generating transaction is executed.

06—Continue

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