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United Therapeutics Annual Report, Year Ended Dec 31, 2003

Filing Date
Filed March 12, 2004
Period End
December 31, 2003
Security
UTHR
In the record · 2016–202610-K1110-Q338-K152

UTHR filed 11 annual reports (10-K), 33 quarterly reports (10-Q) and 152 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · May ’17May ’17
  2. Leadership change8-K · Jun ’19Jun ’19
  3. Material agreement8-K · Apr ’22Apr ’22
  4. Leadership change8-K · Jan ’26Jan ’26

01—Abstract

Summary

Summary of the 10-K filed March 12, 2004. Cited figures are marked; the original filing is the authoritative source.

United Therapeutics Corporation, a Delaware biotechnology company based in Silver Spring, Maryland, filed its 10-K for fiscal 2003 focused on developing therapeutics in cardiovascular medicine, infectious disease and oncology.

Its lead product, Remodulin, was approved by the FDA on May 21, 2002 for pulmonary arterial hypertension, and Remodulin sales accounted for approximately 85% of 2003 revenues. Total revenues rose to $53.3 milliona in 2003 from $30.1 million in 2002, while the net loss narrowed to $10.0 million from $23.7 million. The company reported an accumulated deficit of $195.8 million at December 31, 2003, and management expects to keep incurring losses and cannot assure future profitability.

The company's liquidity remained substantial but declined, with cash, cash equivalents and marketable investments of $117.3 millionb at year-end 2003, down from $132.7 million. Management believes total revenues and existing capital resources will fund operations through 2006. Key open items include the Phase IV post-marketing study of Remodulin, which must be completed by December 2005 and on which continued FDA approval is conditioned, and a pending supplemental NDA for intravenous Remodulin filed in January 2004.

Phase III trials of OvaRex for ovarian cancer are ongoing. Investors should weigh the concentration of revenue in a single product, dependence on third-party distributors and suppliers, and the risks inherent in clinical and regulatory outcomes. The filing also discloses that the company's directors and named executive officers beneficially own approximately 13%c of outstanding common stock.

02—Key points

Key Highlights

  1. Total revenues of $53.3 million in 2003, up from $30.1 million in 2002; Remodulin sales were $45.1 million.
  2. Net loss narrowed to $9.97 million ($0.47 per share) in 2003 from $23.7 million ($1.15 per share) in 2002.
  3. Remodulin accounted for approximately 85% of 2003 revenues, and approximately 15% of U.S. prostacyclin-treated patients were using Remodulin.
  4. Cash, cash equivalents and marketable investments totaled $117.3 million at December 31, 2003; management expects revenues and capital to fund operations through 2006.
  5. Remodulin's FDA approval is conditioned on a Phase IV post-marketing study, with a final report due by December 2005; approximately 11 patients were enrolled as of February 2004.
  6. A supplemental NDA for intravenous Remodulin was filed with the FDA on January 30, 2004 and is under review.
  7. Accumulated deficit was $195.8 million at December 31, 2003, and the company expects to continue incurring net losses.

03—Questions

Frequently Asked Questions

  1. What drove the increase in revenue in 2003?

    Revenues rose to approximately $53.3 million from $30.1 million, mainly due to Remodulin sales of approximately $45.1 million to distributors and about $1.7 million of pumps and supplies, compared with $21.2 million and $3.7 million in 2002. Other products and services rose about $1.3 million to approximately $6.5 million.

  2. Is the company profitable, and when does it expect to be?

    No. United Therapeutics reported net losses in each year since inception and an accumulated deficit of approximately $195.8 million. The filing states that the company expects to continue incurring losses and cannot provide assurances that it will become profitable.

  3. What risks could affect Remodulin's continued approval?

    FDA approval is subject to completion of a post-marketing Phase IV study, with the final report due by December 2005 and the number of patients reduced to 39. The filing notes that outcomes of this study, side effects such as infusion site pain and reaction, and reimbursement by third-party payers could affect sales.

  4. How much cash does the company have, and is it sufficient?

    Cash, cash equivalents and marketable investments were approximately $117.3 million at December 31, 2003, down from $132.7 million. Management believes total revenues and existing capital resources will be adequate to fund operations through 2006, while noting it is investigating financing alternatives for a planned $30.0 million laboratory facility.

04—Continue

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