SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
| (Mark One) | ||
| [X] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. | |
| For the quarterly period ended September 30, 2002 | ||
| OR | ||
| [ ] | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. | |
| For the transition period from ________________________ to _________________________ |
Commission file number 0-26301
United Therapeutics Corporation
| Delaware | 52-1984749 | |
|
|
||
| (State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) | |
| 1110 Spring Street, Silver Spring, MD | 20910 | |
|
|
||
| (Address of Principal Executive Offices) | (Zip Code) |
(301) 608-9292
Indicate by check mark whether the registrant: (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes [X] No [ ]
The number of shares outstanding of the issuers common stock, par
value $.01 per share, as of November 12, 2002 was 20,918,686.
INDEX
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
UNITED THERAPEUTICS CORPORATION (In thousands, except share and per share data)
SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
1
UNITED THERAPEUTICS CORPORATION (In thousands, except share and per share data) SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
2
UNITED THERAPEUTICS CORPORATION SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
3
UNITED THERAPEUTICS CORPORATION 1. ORGANIZATION AND BUSINESS DESCRIPTION
United Therapeutics Corporation (United Therapeutics) is a
biotechnology company focused on the development and
commercialization of unique therapeutics to treat chronic and
life-threatening diseases. United Therapeutics is active in three
therapeutic areas cardiovascular medicine, infectious disease and
oncology with five therapeutic platforms prostacyclin analogs,
arginine formulations, telemedicine, monoclonal antibody
immunotherapy and glycobiology antiviral agents. United
Therapeutics was incorporated on June 26, 1996 under the laws of the
State of Delaware and has four wholly owned subsidiaries: Lung Rx,
Inc., Unither Pharmaceuticals, Inc. (UPI), Unither Telemedicine
Services Corp. (UTSC), and United Therapeutics Europe, Ltd.
On May 21, 2002, the U. S. Food and Drug Administration (FDA)
approved Remodulin® (treprostinil sodium) Injection for the
treatment of pulmonary arterial hypertension in patients with NYHA
class II-IV symptoms to diminish symptoms associated with exercise.
United Therapeutics agreed with the FDA that it would perform a
post-marketing phase IV clinical study to further assess the
clinical benefits of Remodulin. The phase IV study will commence in
late 2002 and must be completed within 24 months from the May 2002
approval. Continued FDA approval is conditioned on the completion
and outcome of the phase IV study. On October 7, 2002, the Canadian
Therapeutics Products Directorate approved Remodulin for long term
subcutaneous treatment of pulmonary arterial hypertension in NYHA
class III and IV patients who did not respond adequately to
conventional therapy. On October 31, 2002, the Israeli Ministry of
Health, Drug Registration Department, approved Remodulin for the
treatment of primary pulmonary arterial hypertension and pulmonary
arterial hypertension associated with connective tissue disorders.
Remodulin marketing applications are under review in France, Australia and
Switzerland, with additional European filings to follow approval in
France. Additionally, United Therapeutics is planning pre-pivotal
studies of Remodulin in critical limb ischemia to commence in late
2002.
As of October 31, 2002, approximately 500 patients receive
Remodulin therapy worldwide, of which approximately 70% are
reimbursable patients. Virtually all of the currently
non-reimbursable patients reside in countries where Remodulin is not
yet approved.
Non-reimburseable patients are those patients who do not yet pay for Remodulin.
Remodulin is sold and marketed to reimbursable
patients in the U.S. by Priority Healthcare Corporation and Accredo
Therapeutics, Inc. United Therapeutics is the manufacturer of
Remodulin and sells Remodulin in bulk shipments to these
distributors. The timing and extent of United Therapeutics sales
of Remodulin are based on the timing and extent of these bulk orders
from distributors. Sales of Remodulin and Remodulin delivery pumps
and supplies are recognized as revenue when delivered to the
distributors.
2. BASIS OF PRESENTATION
The consolidated financial statements included herein have been
prepared, without audit, pursuant to Regulation S-X promulgated by
the Securities and Exchange Commission. Certain information and
footnote disclosures normally included in consolidated financial
statements prepared in accordance with accounting principles
generally accepted in the United States have been condensed or
omitted pursuant to such rules and regulations. These consolidated
financial statements should be read in conjunction with the audited
consolidated financial statements and notes thereto contained in
United Therapeutics Annual Report on Form 10-K/A for the year ended
December 31, 2001 as filed with the Securities and Exchange
Commission.
In the opinion of United Therapeutics management, the
accompanying unaudited consolidated financial statements contain all
adjustments which are of a normal recurring nature necessary to
present fairly its financial
4
position as of September 30, 2002 and its results of operations
and its cash flows for the three and nine-month periods ended
September 30, 2002 and 2001. Interim results are not necessarily
indicative of results for an entire year.
3. MARKETABLE INVESTMENTS
United Therapeutics marketable investments, mainly corporate
and federally sponsored debt securities and certificates of deposit,
were historically considered held-to-maturity securities due to
United Therapeutics ability and intent to hold those investments
until maturity. Held-to-maturity investments are recorded at
amortized cost in the balance sheet. The portfolio consisted of
over 100 issues and had a weighted average maturity of approximately
1.6 years. In March 2002, United Therapeutics reported a $538,000
write-down due to an other-than-temporary decline in value of one of
its marketable investments. In June 2002, as a result of adverse
changes in the bond markets, United Therapeutics began reassessing
its investment program. As a result of this reassessment, United
Therapeutics decided to liquidate all marketable debt securities in
the portfolio and invest the proceeds in money market funds,
commercial paper and federal instruments. The entire investment
portfolio was sold in July 2002. A write-down of investments
totaling approximately $3.6 million was necessary to adjust the
value of United Therapeutics marketable investments to their fair
market value based on quoted market prices at June 30, 2002. In
July 2002, United Therapeutics recorded an additional realized loss
of approximately $3.3 million as a result of the liquidation of the
investment portfolio.
4. INVENTORIES
Inventories are accounted for under the first-in, first-out
method. At September 30, 2002 and December 31, 2001, inventories
consisted of the following (in thousands):
(Former Name, Former Address and Former Fiscal Year,
If Changed Since Last Report)
Page
Item 1.
1
2
3
4
Item 2.
Managements Discussion and Analysis of Financial
Condition and Results of Operations
10
Item 3.
19
Item 4.
19
Item 6.
19
20
21
22
CONSOLIDATED BALANCE SHEETS
September 30,
December 31,
2002
2001
(Unaudited)
$
133,807
$
24,373
31,677
11,675
1,452
114
2,772
1,692
917
7,334
6,025
533
1,787
155,155
69,003
116,249
632
605
7,465
7,465
7,209
7,900
8,585
6,403
6,396
4,342
433
1,598
154
$
187,473
$
212,121
$
3,922
$
6,349
318
3,787
3,454
1,942
500
111
102
34
75
9,796
10,798
1,781
1,836
1,765
3,079
22
9
13,364
15,722
214
208
363,996
365,235
(11
)
(183,216
)
(162,170
)
(6,874
)
(6,874
)
174,109
196,399
$
187,473
$
212,121
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three months ended September 30,
Nine months ended September 30,
2002
2001
2002
2001
$
4,358
$
505
$
15,599
$
1,729
770
572
2,499
1,746
186
541
53
96
5,128
1,316
18,098
4,112
6,640
8,014
18,423
26,080
2,580
3,378
8,108
10,374
1,170
963
2,499
2,696
833
535
2,724
1,094
442
324
1,234
1,295
11,665
13,214
32,988
41,539
(6,537
)
(11,898
)
(14,890
)
(37,427
)
537
2,186
4,396
7,924
(25
)
(31
)
(90
)
(125
)
(7
)
(107
)
(151
)
(261
)
65
39
10
28
(2,893
)
(2,893
)
(3,328
)
(7,428
)
(5,651
)
2,087
(6,156
)
7,566
(12,188
)
(9,811
)
(21,046
)
(29,861
)
$
(12,188
)
$
(9,811
)
$
(21,046
)
$
(29,861
)
$
(0.58
)
$
(0.48
)
$
(1.02
)
$
(1.47
)
20,899,094
20,250,167
20,550,978
20,306,124
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(UNAUDITED)
Nine months ended September 30,
2002
2001
$
(21,046
)
$
(29,861
)
1,532
2,115
(46
)
331
16
228
742
1,113
42
495
151
262
7,428
2,893
(10,177
)
(409
)
2,658
(1,617
)
(2,195
)
(1,443
)
(776
)
(70
)
(1,855
)
(707
)
(2,427
)
(981
)
(809
)
198
333
25
(28
)
(165
)
(22,528
)
(31,522
)
(2,644
)
(436
)
1
25
(4,913
)
(1,218
)
(102,444
)
140,576
22,779
131,802
(80,076
)
206
6
(2,802
)
(15
)
(13
)
(31
)
(49
)
160
(2,858
)
109,434
(114,456
)
24,373
200,935
$
133,807
$
86,479
$
101
$
129
$
$
115
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2002
(UNAUDITED)