01—Abstract
Summary
Summary of the 10-K filed March 30, 2001. Cited figures are marked; the original filing is the authoritative source.
United Therapeutics Corporation's Form 10-K for the fiscal year ended December 31, 2000 reports a biotechnology company focused on cardiovascular, inflammatory and infectious diseases, with no pharmaceutical product revenues to date.
Total revenues were $2.05 milliona in 2000, while net loss was $75.6 million ($3.93 per share), up from $33.5 million in 1999. Research and development expenses rose to $70.2 million, including $19.8 million in beraprost licensing fees and $16.9 million of acquired in-process R&D tied to the Cooke Pharma and Medicomp acquisitions. The accumulated deficit reached $124.9 million at year-end.
The company's lead product, Remodulin, for pulmonary hypertension has an NDA filed October 16, 2000, with a six-month Priority Review granted by the FDA. The filing also notes a Marketing Authorization Application submitted in France on February 2, 2001, and a Phase III pivotal study completed in March 2000 involving 470 patients. Beraprost is in Phase III programs for early-stage peripheral vascular disease and pulmonary hypertension.
The company also expanded into arginine-based medical food (HeartBar) and telemedicine (Medicomp) in December 2000. At December 31, 2000, cash, cash equivalents and short-term investments totaled $215.4 millionb, against total stockholders' equity of $234.7 million.
Two private placements in 2000 raised net proceeds of approximately $74.8 millionc and $134.3 million. Management expects existing capital resources to fund operations through 2004, and expects approximately $14.0 million in cash to be used in 2001 under clinical and research contracts.
02—Key points
Key Highlights
- Revenues of $2,049,258 in 2000, versus $436,495 in 1999; the company has generated no pharmaceutical product revenues.
- Net loss of $75.6 million ($3.93 per share) in 2000, compared with $33.5 million ($2.51 per share) in 1999.
- Research and development expense of $70.2 million in 2000, versus $30.7 million in 1999, including $19.8 million in beraprost licensing fees.
- NDA for Remodulin filed October 16, 2000 for pulmonary hypertension; FDA granted a six-month Priority Review.
- Cash, cash equivalents and short-term investments of $215.4 million at December 31, 2000; stockholders' equity of $234.7 million.
- Accumulated deficit of $124.9 million at December 31, 2000; management expects existing resources to fund operations through 2004.
- December 2000 acquisitions of Cooke Pharma (arginine/HeartBar) and Medicomp (cardiac monitoring) added $16.9 million of in-process R&D charges.
03—Questions
Frequently Asked Questions
What is the company's lead product and where is it in the regulatory process?
The lead product is Remodulin, a subcutaneously delivered stable prostacyclin analog for advanced pulmonary hypertension. A New Drug Application was filed with the FDA in August and October 2000, and the FDA granted a six-month Priority Review. A Marketing Authorization Application was submitted in France on February 2, 2001.
Why did the net loss increase so significantly in 2000?
Research and development expenses rose to $70.2 million from $30.7 million. The increase was driven primarily by $19.8 million in beraprost licensing fees, higher patient enrollment costs, and $16.9 million in acquired in-process R&D from the Cooke Pharma and Medicomp acquisitions.
How is the company funded and how long will its capital last?
The company funded operations primarily through private placements of common stock, including approximately $74.8 million net in January 2000 and $134.3 million net in July 2000. Management expects existing capital resources to be adequate to fund operations through 2004.
What risks does the filing highlight for investors?
The filing cites the uncertainty of clinical and regulatory approvals, reliance on third parties for manufacturing, marketing and distribution (including MiniMed, Gentiva and Priority Healthcare), dependence on licenses from Toray, Glaxo Wellcome and Pharmacia & Upjohn, and the company's history of losses with no assurance of future profitability.
Does the company pay dividends or have significant insider ownership?
The company has never paid cash dividends and intends to retain earnings. Directors and named executive officers beneficially own approximately 26 percent of outstanding common stock, and the board adopted a shareholder rights plan in December 2000.
04—Continue