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United Therapeutics Annual Report (Amendment), Year Ended Dec 31, 2001

Filing Date
Filed October 17, 2002
Period End
December 31, 2001
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/A filed October 17, 2002. Cited figures are marked; the original filing is the authoritative source.

This Amendment No. 1 to United Therapeutics Corporation's Form 10-K for fiscal year 2001 was filed to supplement Items 7, 8 and 14 in response to SEC review of a Form S-3 registration statement.

The amendment adds disclosures on R&D project status, product and service sales and their costs, the Synergy license amendments and write-down, purchase price allocations for Unither Pharma, Medicomp and Telemedical Procedures, accounting for Northern Therapeutics, and segment information. The company reported 2001 total revenues of $5.73 milliona, against a net loss of $37.29 million ($1.84 per share), compared with a net loss of $75.61 million in 2000. Remodulin was deemed approvable by the FDA in February 2002 and was approved in May 2002 for pulmonary arterial hypertension in NYHA Class II-IV patients, subject to a required Phase IV study.

The balance sheet at December 31, 2001 showed cash, cash equivalents and marketable investments of $172.3 millionb, down from $215.4 million a year earlier, and total stockholders' equity of $196.4 million. The company stated that existing capital resources are expected to be adequate to fund operations through 2004. Its accumulated deficit reached $162.2 million, and it expects to keep incurring net losses.

Net cash used in operating activities was $38.9 millionc in 2001. The filing also flags uncertainty around the timing of Remodulin revenue, noting that prior revenue projections will be adversely affected by the delay in commercial launch. It also states that the cost of completing the major R&D projects is not estimable, and that the research programs in Remodulin for critical limb ischemia and glycobiology antivirals depend on clinical and regulatory outcomes that remain uncertain.

02—Key points

Key Highlights

  1. 2001 total revenues were $5.73 million, up from $2.05 million in 2000, driven mainly by Remodulin and telemedicine sales.
  2. Net loss narrowed to $37.29 million ($1.84 per share) in 2001 from $75.61 million ($3.93 per share) in 2000, which included large licensing and acquired IPR&D charges.
  3. Research and development expenses fell to $32.6 million in 2001 from $70.2 million in 2000.
  4. Cash, cash equivalents and marketable investments totaled $172.3 million at year-end 2001, versus $215.4 million a year earlier.
  5. Remodulin received FDA approvable status in February 2002 and was approved in May 2002 for PAH in NYHA Class II-IV patients, conditioned on a Phase IV study.
  6. The company stated that existing capital resources are expected to fund operations through 2004.
  7. Net operating loss carryforwards were about $95.9 million and business tax credit carryforwards about $24.7 million at December 31, 2001.

03—Questions

Frequently Asked Questions

  1. Why was this 10-K amended?

    The company filed Amendment No. 1 to clarify Items 7, 8 and 14 at the SEC's request during its review of a Form S-3 registration statement. The amendments add disclosure on R&D project status, sales and costs of sales, the Synergy license amendments and write-down, purchase price allocations for recent acquisitions, the Northern Therapeutics accounting, and segment information.

  2. How did United Therapeutics perform financially in 2001?

    Revenues were $5.73 million and the net loss was $37.29 million, or $1.84 per share. This compares with a $75.61 million net loss in 2000, which included large licensing fees and acquired in-process R&D charges. Net cash used in operations was $38.9 million.

  3. What is the regulatory status of Remodulin?

    The FDA deemed Remodulin approvable in February 2002 for pulmonary arterial hypertension in NYHA Class II-IV patients. The filing states that Remodulin was approved in May 2002 for this indication, with a condition that a Phase IV clinical study be completed within two years of approval. Canadian approval came in October 2002, and European reviews are expected to finish in 2003 and 2004.

  4. Does the company have enough cash to operate?

    The company expects existing cash and marketable investments, which totaled $172.3 million at December 31, 2001, to be adequate to fund operations through 2004. Its future capital needs depend on factors including Remodulin approval, the scope of Phase IV studies, and milestone and royalty payments.

  5. What are the main risks to the development pipeline?

    The filing lists risks including clinical trial failures, low patient enrollment, severe side effects, FDA requests for additional studies, and supply shortages. It also states that the cost of completing the major R&D projects cannot be estimated, and that any delays would postpone regulatory approvals and revenue.

04—Continue

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