Theragenics Corporation Reports Results for Third Quarter, 2004.BUFORD, Ga. -- Theragenics Corporation(R) (NYSE NYSE See: New York Stock Exchange : TGX TGX Theragenics Corporation (stock symbol) TGX Trajectory Generator External ), the Georgia-based manufacturer and marketer of TheraSeed(R), the premier palladium-103 cancer treatment device, today announced revenue and earnings for the third quarter ended October 3, 2004. Revenues for the quarter were $8.3 million compared to $8.5 million in the corresponding period of last year, a $0.2 million reduction. For the nine-month period, revenues were $24.9 million, a decrease of 12.9 percent compared to the prior year's $28.6 million. Net loss in the quarter was $1.1 million, or $0.04 per share, compared to a net loss of $388,000, or $0.01 per share in the third quarter of 2003. For the nine-month period, net loss was $3.0 million or $0.10 per share compared to net income of $875,000, or $0.03 per share in the prior year after cumulative effect of accounting change. Commenting on the results, Ms. M. Christine Jacobs, Chairman, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and President, stated, "Third quarter results unfortunately reflect a continued slide in sales by one of the distributors of our premier TheraSeed(R) palladium-103 device. Disruptions in the marketplace, continued pricing pressure, and predatory predatory pertaining to predator. predatory behavior the hunting of birds, mice and small reptiles by cats and the hunting and herding behavior of dogs, often facilitated in a pack. sales tactics by our competitors continued. On a more positive note, Theragenics'(TM) direct TheraSeed(R) sales and sales by our other distributor increased over the same quarter last year. Overall, results indicate our in-house sales efforts are critically important. And, in the quarter, diversification efforts increased as long-term strategy continues to be our primary focus." Ms. Jacobs continued, "This quarter, The American Society for Therapeutic Radiation and Oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. (ASTRO) convention was held in Atlanta. Results were released following the conclusion of the largest clinical study of prostate prostate /pros·tate/ (pros´tat) a gland surrounding the bladder neck and urethra in the male; it contributes a secretion to the semen.prostat´ic pros·tate n. The prostate gland. adj. brachytherapy brachytherapy /brachy·ther·a·py/ (-ther´ah-pe) treatment with ionizing radiation whose source is applied to the surface of the body or within the body a short distance from the area being treated. performed to date. This study showed brachytherapy resulted in a 93 percent disease specific survival rate at 12 years. This was good news for our industry as a whole, and for Theragenics(TM) in particular, since the vast majority of the patients in the study were treated using the TheraSeed(R) palladium-103 device (1,129 of the 1,449 patients). The study clearly shows brachytherapy treatment to have equal or better survival rates than surgery or any other treatment option. "In another positive development, the U.S. Senate just last week adopted a resolution encouraging doctors to inform prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. patients about all proven treatment options available for prostate cancer, including brachytherapy. This was consistent with the earlier resolution passed by the U.S. House of Representatives. These resolutions, along with the new clinical data, could lead to a better informed end-user. The Company plans media exposure and patient awareness campaigns around these two positive developments. "Regarding our R & D initiatives, this past quarter Theragenics(TM) received IDE (1) (Integrated Development Environment) A set of programs run from a single user interface. For example, programming languages often include a text editor, compiler and debugger, which are all activated and function from a common menu. (Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and ) approval from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. that will enable Theragenics(TM) to begin a human clinical trial of its TheraSight(TM) device. This device is designed to treat the wet form of age-related macular degeneration Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. (AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ), a devastating dev·as·tate tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates 1. To lay waste; destroy. 2. To overwhelm; confound; stun: was devastated by the rude remark. condition that is the leading cause of blindness in the U.S. Theragenics'(TM) device is designed to deliver a one-time treatment, unlike photodynamic therapy photodynamic therapy n. A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells. or drug therapies, which require multiple re-treatments or injections. We anticipate treating our first patient before Thanksgiving Thanksgiving annual U.S. holiday celebrating harvest and yearly blessings; originated with Pilgrims (1621). [Am. Culture: EB, IX: 922] See : America Thanksgiving national holiday with luxurious dinner as chief ritual. [Am. Pop. . Also, during the quarter, our radiochemical facility began to supply and sell Indium-111 chloride chloride (klōr`īd, klôr`–), chemical compound containing chlorine. Most chlorides are salts that are formed either by direct union of chlorine with a metal or by reaction of hydrochloric acid (a water solution of hydrogen chloride) in addition to Gallium-67 chloride. Such radiochemicals, after further processing, can be used for medical imaging applications. Existing cyclotrons and production equipment are used to manufacture these chemicals." Ms. Jacobs concluded her remarks by saying, "Efforts to maintain TheraSeed(R) momentum, coupled with diversification efforts, continued to be our primary focuses during the quarter. This includes both our internal R & D pipeline and external opportunities." Theragenics(TM) will host a conference call today at 11:00 a.m. Eastern Time. To access the call, dial 800-538-9844 or 706-634-7274 and give Theragenics'(TM) name. This call is also being broadcast live over the Internet, and a recording will be available for one month on the Company's website. To access the webcast, log on to www.theragenics.com and select the Investor Relations Investor relations The process by which the corporation communicates with its investors. button followed by the Overview button. You can also access a replay of the call until Midnight on Tuesday, October 26 by dialing 800-642-1687 or 706-645-9291 and providing the conference ID code: 1205933. Theragenics Corporation(R) is committed to being a leading provider of brachytherapy treatment devices for prostate cancer and other degenerative disease A degenerative disease is a disease in which the function or structure of the affected tissues or organs will progressively deteriorate over time, whether due to normal bodily wear or lifestyle choices such as exercise or eating habits. states. The Company is the manufacturer and marketer of the palladium-103 device TheraSeed(R) and I-Seed, an iodine-125 based device. Both devices are used in the treatment of localized prostate cancer in one-time, minimally invasive procedures Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an . Theragenics(TM) is the world's largest producer of palladium-103 and is involved in research and development utilizing palladium-103 and other isotopes An isotope a type of neutral atom but the number of neutrons is different from the number of protons in the nucleus. May be radioactive. Elements 1-15 Hydrogen
World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City. under the symbol TGX. Additional information can be found on the Company website: www.theragenics.com. This release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, the accuracy of which is necessarily subject to risks and uncertainties, including, without limitation, optimism for the effectiveness of the direct distribution system and of new sales and marketing initiatives, institution of activities and plans that could benefit Theragenics'(TM) goals in its diversification efforts and anticipated positive results in general. Actual results may be affected by among other things, risks and uncertainties related to new product and process development cycles, potential costs and delays associated with preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. and clinical studies, potential costs and delays in production optimization (especially as it relates to the Oak Ridge Oak Ridge, city (1990 pop. 27,310), Anderson and Roane counties, E Tenn., on Black Oak Ridge and the Clinch River; founded by the U.S. government 1942, inc. as an independent city 1959. facility), effectiveness and execution of marketing and sales programs by Theragenics(TM) and its distributors, changes in product pricing or selling tactics by Theragenics(TM) or other brachytherapy seed producers, changes in costs of materials used in production processes (especially as it relates to isotope isotope (ī`sətōp), in chemistry and physics, one of two or more atoms having the same atomic number but differing in atomic weight and mass number. The concept of isotope was introduced by F. production), continued acceptance of the products by the market, continued demand for Pd-103, demand for isotopes or isotopically engineered materials for new or expanded applications, introduction and/or availability of competitive products by others, third-party (including CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. ) reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. , Congressional action affecting Medicare reimbursement, physician training, third-party distribution agreements, and other factors set forth from time to time in the Company's Securities and Exchange Commission filings. All forward looking statements and cautionary statements included in this document are made as of the date hereby based on information available to the Company as of the date hereof, and the Company assumes no obligation to update any forward looking statement or cautionary statement.
THERAGENICS CORPORATION(R) CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
(In thousands except per share data)
Three Months Ended Nine Months Ended
10/03/04 10/05/03 10/03/04 10/05/03
--------- --------- --------- ---------
Total revenues $ 8,283 $ 8,519 $ 24,882 $ 28,570
Cost of sales 3,282 3,614 10,147 12,110
--------- --------- --------- ---------
Gross profit 5,001 4,905 14,735 16,460
Operating expenses:
Selling, general &
administrative 4,463 3,404 13,004 10,025
Research & development 2,749 2,348 7,335 5,461
--------- --------- --------- ---------
7,212 5,752 20,339 15,486
--------- --------- --------- ---------
Operating income/(loss) (2,211) (847) (5,604) 974
Other income, net 355 225 785 678
--------- --------- --------- ---------
Income/(loss) before income
tax and cumulative effect
of accounting change (1,856) (622) (4,819) 1,652
Income tax expense/(benefit) (734) (234) (1,797) 555
--------- --------- --------- ---------
Income/(loss) before
cumulative effect of
accounting change (1,122) (388) (3,022) 1,097
Cumulative effect of
accounting change,
net of tax - - - (222)
--------- --------- --------- ---------
Net income/(loss) $ (1,122)$ (388)$ (3,022)$ 875
========= ========= ========= =========
Net income/(loss) per common
share
Basic:
Income/(loss) before
cumulative effect of
accounting change $ (0.04)$ (0.01)$ (0.10)$ 0.04
Cumulative effect of
accounting change - - - (0.01)
--------- --------- --------- ---------
Net income/(loss) per common
share $ (0.04)$ (0.01)$ (0.10)$ 0.03
========= ========= ========= =========
Diluted:
Income/(loss) before
cumulative effect of
accounting change $ (0.04)$ (0.01)$ (0.10)$ 0.04
Cumulative effect of
accounting change - - - (0.01)
--------- --------- --------- ---------
Net income/(loss) per common
share $ (0.04)$ (0.01)$ (0.10)$ 0.03
========= ========= ========= =========
Weighted average
Shares outstanding -
Basic 29,974 29,932 29,967 29,890
Shares outstanding -
Diluted 29,974 29,932 29,967 30,055
Three Months Ended Nine Months Ended
KEY RATIOS 10/03/04 10/05/03 10/03/04 10/05/03
------------------------------------
Gross Margin 60.4% 57.6% 59.2% 57.6%
Operating Margin (26.7)% (9.9)% (22.5)% 3.4%
Income/(Loss) Before Tax and
Before
Accounting Change Margin (22.4)% (7.3)% (19.4)% 5.8%
Income/(Loss) After Tax and Before
Accounting Change Margin (13.5)% (4.6)% (12.1)% 3.8%
Income/(Loss) After Tax and After
Accounting Change Margin (13.5)% (4.6)% (12.1)% 3.1%
ROE (3.2)% (0.1)% (2.9)% 1.0%
THERAGENICS CORPORATION(R) CONDENSED BALANCE SHEETS
(UNAUDITED)
(In thousands)
Assets October 3, December 31,
2004 2003
-----------------------
Cash, short-term investments
& marketable securities $ 62,328 $ 66,431
Trade accounts receivable 5,772 3,831
Inventories and other current assets 9,106 6,800
---------- ----------
Total current assets 77,206 77,062
Property, plant & equipment, net 70,968 73,372
Other assets 2,801 2,355
---------- ----------
Total assets $ 150,975 $ 152,789
========== ==========
Liabilities & Shareholders' Equity
Accounts payable & accrued expenses $ 4,051 $ 3,053
Deferred income taxes 7,000 6,830
Other liabilities 606 580
---------- ----------
Total liabilities 11,657 10,463
Shareholders' equity 139,318 142,326
---------- ----------
Total liabilities &
shareholders' equity $ 150,975 $ 152,789
========== ==========
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