01—Abstract
Summary
Summary of the 10-K filed March 22, 2000. Cited figures are marked; the original filing is the authoritative source.
United Therapeutics Corporation (filed as United Therapeutics Corporation, Nasdaq: UTHR) reported in its Form 10-K for the fiscal year ended December 31, 1999 that it develops pharmaceuticals to treat vascular diseases, including pulmonary hypertension and peripheral vascular disease, and has not yet generated product revenues.
Its lead product, Uniprost, is in two pivotal Phase III trials for advanced pulmonary hypertension, with enrollment of 224 and 235 patients completed. The company reported a net loss of $33.5 milliona for 1999 (or $2.51 per share) on total revenues of $436,495, and an accumulated deficit of $49.3 million at year-end. The filing states that all of the company's products remain in clinical trials.
The balance sheet strengthened during the year. Cash, cash equivalents and short-term investments totaled $51.6 millionb at December 31, 1999, and total assets were $59.9 million. Stockholders' equity was $53.6 million.
The company completed its initial public offering in June 1999 at $12.00c per share, with net proceeds of approximately $48.9 million, and sold over-allotment shares for about $7.5 million. In January 2000, it closed a private placement of 2.5 million shares at $32 per share, with net proceeds of about $75.0 million. The filing states that existing capital resources are expected to fund operations through 2002.
The company's pipeline also includes beraprost (Phase III for early-stage peripheral vascular disease and early-stage pulmonary hypertension), UT-77 (Phase II for chronic obstructive pulmonary disease), and Ketotop (preparing Phase III for osteoarthritis). The company acquired SynQuest, Inc., its Uniprost manufacturer, in October 1999.
Subsequent events in March 2000 include an agreement with Synergy Pharmaceuticals for anti-viral patent rights, with milestone payments of up to $22.2 milliond per approved product. The filing also notes 63 employees as of March 15, 2000 and that the company is not a party to any legal proceedings.
02—Key points
Key Highlights
- Net loss of $33,506,698 in 1999 ($2.51 per share), compared with $12,835,399 in 1998, with total revenues of $436,495 and no product sales beyond SynQuest manufacturing revenue of $225,245.
- Uniprost, the lead product for advanced pulmonary hypertension, has two pivotal Phase III trials with 224 and 235 patients enrolled, and the company says it could be the first non-intravenous prostacyclin therapy.
- Cash, cash equivalents and short-term investments were $51.6 million at December 31, 1999, and the January 2000 private placement raised approximately $75.0 million in net proceeds.
- Accumulated deficit reached $49.3 million at December 31, 1999, and the company expects substantial additional losses over the next several years.
- Completed IPO on June 17, 1999 at $12.00 per share, with net proceeds of about $48.9 million, followed by over-allotment proceeds of about $7.5 million.
- Acquired SynQuest, Inc. in October 1999 for approximately $3.2 million, gaining manufacturing capacity for Uniprost.
- The filing says all products are in clinical trials and the company has not yet sold any products, with the MiniMed pump partnership expected to handle Uniprost delivery.
03—Questions
Frequently Asked Questions
Does United Therapeutics currently sell any products?
No. The filing states that the company has generated no product revenues and that all of its products are still in clinical trials. Its 1999 revenues of $436,495 consisted of grant revenue of $211,250 and sales of $225,245 from SynQuest's contract manufacturing.
What is the status of the company's lead product, Uniprost?
Uniprost is in two pivotal Phase III trials for advanced pulmonary hypertension, with 224 and 235 patients enrolled at about 40 medical centers. The primary endpoints match those used to approve Flolan. Uniprost is also in a Phase II study for late-stage peripheral vascular disease. The company plans a pre-pivotal study before Phase III for that indication.
How much cash does the company have, and how long will it last?
Cash, cash equivalents and short-term investments totaled $51.6 million at December 31, 1999. The company received about $75.0 million in net proceeds from a January 2000 private placement. The filing states that existing capital resources are expected to fund operations through 2002, and about $19.0 million in clinical and research spending is anticipated during 2000.
What risks does the filing highlight for investors?
The filing highlights several risks: clinical trial failure or delay, the need for FDA approval, dependence on third-party manufacturers and partners such as MiniMed, Toray and Global Medical, and a history of losses with an accumulated deficit of $49.3 million. It also notes that the company has limited manufacturing experience, that insiders own about 30 percent of the stock, and that the company does not pay dividends.
04—Continue