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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE
SECURITIES EXCHANGE ACT OF 1934
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE
SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended Commission File No. 0-15443
December 31, 1995
THERAGENICS CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 58-1528626
(State of incorporation) (I.R.S. Employer Identification Number)
5325 Oakbrook Parkway
Norcross, Georgia 30093
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code:(770) 381-8338
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Name of each exchange on which registered
None None
Securities registered pursuant to Section 12(g) of the Act:
Title of Class
Common Stock, par value $.01 per share
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
As of March 20, 1996, the aggregate market value of the common
stock of the registrant held by non-affiliates of the registrant,
as determined by reference to the average of the closing price of
the common stock as reported by the National Association of
Securities Dealers Automated Quotation National Market system,
was $90,601,512.75.
As of March 20, 1996, the number of shares of common stock,
$.01 par value, outstanding was 11,504,954.
Part I
Item 1. Business
Theragenics Corporation ("Theragenics" or the "Company") was
incorporated in November 1981 to commercially engage in the
development, manufacture, and marketing of therapeutic
radiological pharmaceuticals and devices for use primarily in the
treatment of cancer. The Company's products are intended to
permit a physician to introduce short-range, short-lived
radioactive material directly into cancerous tissue, thereby
concentrating the impact of the radiation on the cancerous tissue
to be destroyed while minimizing the effect on surrounding
healthy tissue. To date the Company has internally developed two
products - TheraSeed, a radioactive implant designed for the
treatment of localized tumors, and TheraSphere, radioactive
microspheres for the treatment of liver cancer. TheraSeed is
being commercially distributed in the United States while
TheraSphere is being commercially distributed in Canada.
General
The conventional treatments for cancer to date have been
surgery, radiation and chemotherapy. The treatments which have
been most successful are those which remove or kill all of the
cancerous tissue while avoiding excessive damage to the
surrounding healthy, normal tissue. When the cancerous tissue
cannot be completely removed or killed, the cancer usually
returns to the primary site often with metastases to other areas.
The Company's products are intended to permit a physician to
place short-range, short-lived radioactive material near or into
a cancerous tumor, thereby concentrating the impact of the
radiation on the cancerous tissue to be destroyed. The Company's
products are most effective on encapsulated, confined tumors.
Each of the Company's products is based on established physical
principles and has the simple objective of delivering sufficient
radiation to the target cancer to kill it while minimizing the
radiation to surrounding tissue.
Products
TheraSeed, radioactive "seeds" approximately the size of a
grain of rice which are implanted directly into a tumor, is
presently marketed in the United States.
TheraSphere, microscopic radioactive glass spheres used to
treat liver cancer, is presently marketed in Canada by Nordion
International Inc. ("Nordion") under sublicense from Theragenics.
Additionally, Theragenics has granted to Nordion an exclusive
worldwide sublicense to manufacture, distribute and sell
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TheraSphere for any application.
Palladium-103 ("Palladium" or "Pd-103") is the radioactive
isotope providing the therapeutic benefit in the Company's
TheraSeed product. The Company will be exploring and
investigating opportunities to use this isotope in other
potential products as they are identified.
TheraSeed Implants
Prostate cancer is expected to strike 317,100 men in the
United States in 1996. The National Cancer Institute estimates
that one in three men over 50 years of age have microscopic
cancer of the prostate. This ratio is greater than the odds (one
in eight, as estimated by the American Cancer Society) for a
woman getting breast cancer. A projected 41,400 men in the United
States will die of this disease in 1996. Not including
experimental treatment options, treatments for prostate cancer
include prostatectomy (surgical removal of the prostate gland),
external beam radiation, radioactive implants, watchful waiting,
hormone manipulation and castration. Not all of these treatments
are for early stage disease. The Company's TheraSeed product is
usually classified as a treatment for early stage disease.
TheraSeed is best suited for solid localized tumors. To date
the most prevalent use of TheraSeed has been in the treatment of
prostate cancer, although it has been used to treat cancers of
the pancreas, lung, head and neck, oral cavity, base of the
skull, brain and eye.
Treatment of early stage prostate cancer with TheraSeed is a
one-time, minimally-invasive technique, usually performed under
local anesthesia in an outpatient setting. The seeds are loaded
into long hollow needles which are inserted through the perineum
and into the prostate gland. This procedure is facilitated by the
recent developments of imaging equipment such as CT scanning or
transrectal ultrasound. While visualizing the gland, the
physician can facilitate placement of the seeds allowing for a
homogeneous distribution of the radiation.
While providing equivalent success rates to external beam
radiation and surgery, TheraSeed offers the advantage of a much
lower incidence of impotence and incontinence. Because no major
surgery is involved, many TheraSeed patients are up and around
within 48 to 72 hours, compared to recovery periods as long as
four to six weeks for radical surgery. TheraSeed treatment also
offers a cost advantage to the patient (or insurance company)
over both surgery and external beam radiation. Cost of the
TheraSeed procedure is about one-half of the cost of surgical
removal and two-thirds that of external radiation.
TheraSeed does not represent the only currently available
radioactive isotope for cancer treatment, but does offer a much
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shorter half-life and a significantly greater dose rate when
compared to other isotopes.
It is an objective of the Company to explore and develop
other potential uses for TheraSeed in addition to the treatment
of prostate cancer whether oncological or non-oncological in
application. Theragenics hopes to identify and pursue
opportunities for TheraSeed use either through internal resources
or partnering where significant synergies can be exploited.
TheraSphere
Liver cancer, either primary or secondary to colorectal
cancer, incidence has changed very little from 1995 when it was
expected to afflict approximately 5,200 Canadians and
approximately ten times as many Americans. Associated deaths were
estimated at approximately 4,200 Canadians and 43,000 Americans
in 1995. Management estimates these North American statistics
represent about one-third of the world wide incidence of primary
liver cancer and liver cancer secondary to colorectal cancer in
areas which would present marketing opportunities to the Company.
From the point of diagnosis the average survival time for a liver
cancer patient using conventional therapies is one year.
TheraSphere is used to treat both primary liver cancer and
secondary liver cancer in cases where the primary cancer has been
or can be arrested.
Before the Canadian approval of TheraSphere, treatments for
liver cancer were primarily limited to surgery, external
radiation, and chemotherapy. Unfortunately surgery is indicated
for only 25% of the cases mentioned above and only 25% of that
number live for five years or more. External beam radiation has
the drawback that the amount of radiation deliverable to the
liver tumor is limited by the damage that can be done to healthy
liver tissue as radiation passes from outside of the body to the
tumor. Finally, chemotherapy, which is the indicated treatment
for the majority of liver cancer patients, offers life extension
(usually measured in months) but not without the nausea and other
side effects commonly associated with it. Also, chemotherapy must
be administered in a number of treatments over an extended period
of time.
A TheraSphere treatment dose (less than one-tenth of a
teaspoonful of material) contains approximately five million
yttrium-90 glass spheres which are each about half the diameter
of a human hair. Here again as in the TheraSeed treatment, the
key to effectiveness lies in the ability to get the radiation
dose in closest proximity to the tumor in order to sufficiently
irradiate the cancerous tissue while leaving healthy tissue
unaffected. This is done by inserting a catheter into the hepatic
artery which carries arterial blood to the liver and injecting
the TheraSphere microspheres into this bloodstream. Because of
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greater blood flow to tumors compared to healthy liver tissue,
the microspheres concentrate in the capillaries feeding the
tumor. The concentration of microspheres in healthy tissue is
much lower. Because of the ability to place the radiation source
in such close proximity to the tumor, TheraSphere can deliver a
radiation dose to the tumor cells five-times as strong as that
which can be delivered via external beam radiation.
Although it is impossible to predict the number of liver
cancer patients who might benefit from treatment with
TheraSphere, the Company estimates that approximately 50% of the
liver cancer patients identified above could be candidates for
treatment with TheraSphere. Based on clinical data, TheraSphere
offers life extension similar to the data for chemotherapy while
producing less severe side effects. TheraSphere has the
additional advantage of requiring only a single treatment. A
series of chemotherapy treatments equivalent to a single
TheraSphere treatment would cost $8,000 to $12,000 per patient.
Production
TheraSeed Implants
The Company's TheraSeed devices have substantially the same
external envelopes as other seeds in use today and thus supplies
of the external envelope are readily available. The production of
TheraSeed is dependent upon the availability of Pd-103. In
January 1993, Theragenics completed construction of a
manufacturing facility to house its first cyclotron. This
cyclotron produces Pd-103 and ended the Company's dependence on
unreliable outside vendors. In February 1995, a second cyclotron
and a facility addition to house the cyclotron were completed. As
reported in Theragenics' Form 8-K dated June 29, 1995, the
Company entered into two agreements dated June 29 ,1995, each for
the purchase of one cyclotron. These third and fourth cyclotrons
are expected to be put into service in the late third quarter of
1996 and the mid to late first quarter of 1997, respectively.
Cyclotron operations constitute only one component of the
TheraSeed manufacturing processes performed at the Buford and
Norcross facilities. Significant attention and effort are being
focused on improving all aspects of the Company's manufacturing
processes with the goal to improve efficiency and provide
additional capacity for TheraSeed. Long lead-times (in excess of
18 months) associated with the purchase of a cyclotron and the
specially designed facilities to house the equipment creates
suboptimal conditions requiring order of this equipment long in
advance of its need. This lead-time factor naturally places
additional burden on the Company's ability to accurately forecast
sales growth. Also at issue is the fact that very rapid sales
growth may necessitate multiple purchases of equipment which
would then place strain on the Company's ability to finance this
type of growth. It is anticipated that if TheraSeed demand
continues to expand rapidly, additional cyclotrons will be
Page 5
ordered.
TheraSphere
Production of TheraSphere requires the services of a number
of outside vendors - all of which provide services which can be
provided through alternative sources. Theragenics, through its
exclusive worldwide sublicense of the TheraSphere product to
Nordion, has given Nordion worldwide manufacturing responsibility
for the product.
Marketing
TheraSeed Implants
Increased awareness of the TheraSeed product is the primary
focus of Theragenics' Marketing program. In June of 1994, results
of a five-year clinical study conducted by Dr. John Blasko,
Director of the Northwest Tumor Institute in Seattle, Washington,
showed seed therapy to be comparable if not superior to surgery
or external beam radiation for early stage prostate cancer. In
1995 Theragenics continued its work to see that this data was
available to the medical and lay communities. Theragenics
continues to support the expansion of this study.
The Company continues to distribute patient information
booklets to physician customers, patient support groups and any
person calling the Company's Cancer Information Center.
In 1995, marketing efforts increased dramatically. A higher
volume of advertising placements aimed at men over the age of 50
and retirement communities yielded significant benefits as
indicated by increased sales and increased calls to the Company's
Cancer Information Center.
Theragenics continues to support the writing of scholarly
articles by doctors using TheraSeed and the placement of these
articles in prestigious medical journals. Attendance at small and
large meetings of medical clinicians remains a top priority as
physician acceptance continues to grow.
The Company is pleased that it was able to play a part in
providing more equitable Medicare reimbursement for urologists
and radiation oncologists who perform the seed implant procedure.
TheraSphere
The Company does not directly market its TheraSphere
product. Under a manufacturing and marketing licensing agreement
with Nordion International, Inc. ("Nordion"), a Canadian company,
Nordion has the right to produce and market the TheraSphere
Page 6
product worldwide for all applications. Also under the agreement,
Nordion has substantially all responsibility for seeking
regulatory approval of the product in the United States and other
countries as it chooses. Nordion is a leading worldwide producer,
marketer and supplier of radioisotope products and related
equipment. Under a prior licensing agreement, Nordion has
distributed the TheraSphere product in Canada since 1991.
Patents and Licenses
TheraSeed Implants
Theragenics holds patents for certain TheraSeed
technologies in the United States, Canada, South Africa, Japan
and the ten countries of the European patent convention.
Theragenics also holds patents in the United States and South
Africa for additional TheraSeed technologies and has a PCT patent
application on file for Japan, Australia, New Zealand, Canada,
and Europe (representing 16 European countries) as well as a
direct filing in Mexico.
TheraSphere
The Company holds a worldwide exclusive license from the
University of Missouri for the use of technology required for
producing TheraSphere. Theragenics also holds the rights to all
improvements developed by the University of Missouri on this
technology. The Company, in turn, sublicenses exclusive worldwide
rights to this technology and all improvements to Nordion
International. The University of Missouri holds patents for the
TheraSphere technology in several countries including the United
States, Canada, Australia, South Africa, Japan and the ten
countries of the European patent convention. Pursuant to its
license agreement with the University of Missouri, the Company is
obligated to pay the University the greater of a fixed annual
amount or a percentage of the gross sales amount derived from the
sale of TheraSphere.
Theragenics holds patents for technology concerning methods
for delivery of the product in several countries including the
United States, Canada, Australia, Argentina, South Africa and the
ten countries of the European patent convention and has patent
applications on file in other countries including Japan. The
Company licenses this technology to Nordion for worldwide use.
Other
Theragenics holds patents related to another product used in
the treatment of brain cancer. Because of the significant
investment required and the uncertain return, this product is not
being commercially developed by Theragenics. Therefore, the
Company is unable to determine the value of these patents, if
any.
Page 7
The Company may file additional patent applications from
time-to-time and considers the ownership of patents important,
but not necessarily essential, to its operations. In general,
the Company will rely upon its personnel, trade secrets, and its
products' current position in a highly regulated industry, as
well as patent protection, to establish barriers-to-entry and to
maintain its industry position. It is possible that others may
independently develop similar technology or otherwise obtain
access to the Company's know-how. It is not certain that any
patents which may be granted to the Company will be valid and
enforceable or will withstand a challenge by litigation.
Competition
In general, competition to TheraSeed stems from conventional
methods of treating localized cancer such as surgery,
chemotherapy, and external beam radiation. Presently, surgery and
external beam radiation comprise the vast majority of the
prostate cancer treatment market, and those methods are viewed as
Theragenics' main competition. In addition, Iodine (I-125)
("Iodine") is commercially available as a permanent implant and
also competes with TheraSeed. However, TheraSeed utilizes
Palladium-103 (Pd-103) ("Palladium") as the isotope for its
permanent implant whose properties are very different from
Iodine. Iodine's dose rate is one-third that of Palladium and its
half-life is three times longer than Palladium's. Such properties
represent competitive advantages for Palladium in treating
certain kinds of cancer. The Company is aware of no other similar
radioactive products competing directly with TheraSeed.
Theragenics is the only company in the world, known to
management, that commercially produces Pd-103.
Liver Cancer, which TheraSphere treats, can also be treated
by surgery, external beam radiation, and chemotherapy.
TheraSphere does not represent a cure for liver cancer but has
been shown to prolong life expectancy of the patient and enhance
the quality of life during that period. Theragenics is not aware
of any other implant available for this type treatment.
There are many companies, both public and private, engaged
in research on new and innovative methods of treating cancer.
Also, there are many companies both public and private, including
many large, well-known pharmaceutical, medical and chemical
companies, engaged in radiological pharmaceutical and device
research. Significant developments by any of these companies
could lessen or eliminate the demand for any or all of the
Company's products.
Governmental Regulation
The Company's present and intended future activities in the
development, manufacture and sale of cancer therapy products are
Page 8
subject to various laws and regulations, regulatory approvals and
guidelines. Within the U.S., the Company's therapeutic
radiological devices must comply with the United States Federal
Food, Drug and Cosmetic Act which is enforced by the Food and
Drug Administration (FDA). The Company's handling of radioactive
materials is governed by the state of Georgia in agreement with
the Nuclear Regulatory Commission of the United States
Government. TheraSeed has regulatory approval for commercial
distribution in the United States and Canada, while TheraSphere
has regulatory approval for commercial distribution only in
Canada. The Company to the best of its knowledge is in compliance
with all its licenses for handling radioactive material.
The effect of various governments' regulations can delay the
marketing of products for a considerable period of time or impose
costly procedures upon the Company's activities.
The Company is not currently conducting any clinical trial
of TheraSphere; but under the terms of the current licensing
agreement with Theragenics, Nordion will attempt to obtain
regulatory approvals in the United States, Europe, and other
areas of the world at its expense and discretion. Regulatory
approval of the TheraSphere product has been granted in Canada
and the product is presently being marketed in that jurisdiction
by Nordion.
Most countries require approval for the sale of
pharmaceuticals and medical devices. These approvals are
time-consuming and expensive and can delay or discourage the
marketing and development of a company's products in those areas.
Employees
As of March 20, 1996, the Company had 44 full-time employees
(including executive personnel). Of this total, twenty-eight are
engaged in development and/or production of the Company's
products. The balance of the Company's employees is engaged in
marketing and general corporate activities.
The Company's ability to market its products and services,
to develop marketable products and to establish and then maintain
its competitive position in light of technological developments
will depend, to a significant extent, upon its ability to attract
and retain qualified personnel. In recognition of this, the
Company has granted many of its employees stock options which are
contingent on their continued employment. Competition for such
personnel is, and should continue to be, intense.
Item 2. Properties
The Company owns a 10,500 square foot, single story,
Page 9
prefabricated building in Buford, Georgia, leases a 10,752 square
foot, single story, brick building in Norcross, Georgia and
leases a 2,692 square foot, suite of offices in a four-story
office building in Norcross, Georgia. The 10,752 square foot
Norcross facility houses the Company's assembly, shipping,
marketing and administrative operations. The 2,692 square foot
Norcross facility provides executive office space while the
Buford facility houses the Company's two cyclotrons and its raw
material processing operations. The Buford facility is currently
being expanded to house two additional cyclotrons. It is
anticipated that the Buford facility and neighboring land will
provide the core for expansion as manufacturing expands to meet
increasing sales demand and will eventually be expanded to
include all functions currently housed in the leased Norcross
facility.
Item 3. Legal Proceedings
There are currently no material legal proceedings pending
or, to the knowledge of the Company, threatened against the
Company.
Item 4. Submission of Matters to a Vote of Security Holders
The Company did not submit any matter to a vote of its
security holders during the fourth quarter of calendar 1995.
Page 10
PART II
Item 5. Market for Registrant's Common Equity and Related
Stockholder Matters
The Company's Common Stock is traded over the counter and
reported on the National Association of Securities Dealers
Automated Quotation ("NASDAQ") National Market System. The
trading symbol for the Company's Common Stock is "THRX." The high
and low prices as reported by NASDAQ for the Company's Common
Stock for each quarterly period in 1994 and 1995 are as follows:
1994 High Low
1st Quarter ................ 4 3/8 3 1/4
2nd Quarter ................ 4 3/4 3 1/2
3rd Quarter ................ 4 5/8 3 3/8
4th Quarter ................ 3 7/8 2 1/4
1995
1st Quarter ................ 3 3/4 2 1/4
2nd Quarter ................ 6 1/2 3 1/8
3rd Quarter ................ 6 3/8 4 7/8
4th Quarter ................ 12 1/2 4 7/8
As of March 20, 1996, the closing price of the Company's
Common Stock was $7-7/8 per share. Also, as of that date, there
were approximately 681 holders of record of the Company's Common
Stock. The number of record holders does not reflect the number
of beneficial owners of the Company's Common Stock for whom
shares are held by depositary trust companies, brokerage firms
and others.
Dividend Policy
The Company has not paid cash dividends in the past and does
not currently plan to do so. It is the present policy of the
Company's Board of Directors to retain future earnings to finance
the growth and development of the Company's business. Any change
in current policy will depend upon the financial condition,
capital requirements and earnings of the Company as well as other
factors which the Board of Directors may deem relevant.
Page 11
Item 6. Selected Financial Data
Set forth below are selected financial data derived from the
statements of operations of the Company for the years ended
December 31, 1991, 1992, 1993, 1994 and 1995 and the balance
sheets of the Company at December 31, 1991, 1992, 1993, 1994 and
1995.
For the Fiscal Years Ended
December 31,
1991 1992 1993 1994 1995
Net sales $2,469,413 $4,379,300 $4,090,803 $4,723,107 $7,781,962
Licensing Fee 300,000 - - - 85,431
Costs and expenses:
Cost of sales 818,184 1,227,154 1,677,631 1,790,450 2,645,730
Selling, general
and administrative 1,254,821 1,639,334 1,607,288 1,844,239 2,395,846
Research and
development 84,903 62,632 36,181 15,268 17,954
Other income
(expense) 113,865 67,831 (85,959) 110,215 64,462
Taxes 280,000 582,000 254,000 453,000 1,100,000
Net profit/(loss)
before extraordinary
credit and change in
accounting method 445,370 936,011 429,744 730,365 1,772,325
Extraordinary credit 270,000 556,000 - - -
Change in accounting
method - - 2,860,000 - -
Net profit/(loss) 715,370 1,492,011 3,289,744 730,365 1,772,325
Net profit/(loss)
per common share
before extraordinary
credit and change in
accounting method .04 .08 .04 .06 .15
Net profit/(loss)
per common share .07 .13 .28 .06 .15
Weighted average
number of common
shares outstanding 10,759,230 11,431,149 11,709,218 11,582,793 11,759,178
Total assets $3,299,375 $7,851,056 $12,618,869 $14,168,658 $16,878,182
Page 12
Item 7. Management's Discussion and Analysis of
Financial Condition and Results of Operations
The following discussion of the Company's financial
condition, results of operations and liquidity is intended to
clarify and highlight the Company's operating trends, liquidity
and capital resources. It should be read in conjunction with the
financial statements and related notes contained in the financial
section of this Report.
RESULTS OF OPERATIONS
1995 Compared to 1994
1995 Revenues - With increased production capacity,
consistent supply of product, enhanced marketing programs and
favorable clinical data, 1995 revenues increased substantially
(66.6%) to $7.9 million versus $4.7 million in 1994. Along with
the factors already noted, increased acceptance of its prostate
cancer treatment in the medical community and increased public
awareness of the medical advantages of the TheraSeed treatment
method versus other existing methods of treating prostate cancer
were major factors in driving the substantial sales increase.
Additionally, the Company believes sales were positively affected
in 1995 by further publication of supportive data from the
clinical study of patients treated with TheraSeed. This study had
shown no local recurrence of prostate cancer and low rates of
incontinence and impotence within the study group.
1995 Costs and Expenses - As a result of the increase in
sales, cost of sales rose. However, cost of sales as a percent of
sales fell to 34% versus 38% in 1994. This percentage improvement
was primarily attributable to increased utilization of production
capacity and economics of scale partially offset by increased
depreciation. Although management believes that cost of sales as
a percentage of revenue may continue to decline should sales in
future periods exceed those achieved in 1995, no assurances can
be given with respect to the operating margins in future periods.
In particular, continued improvements in manufacturing operations
and optimization of the production process may cause smaller
improvements in net margin.
Selling, General and Administrative ("SG&A") expenses
also increased in dollar amount but declined as a percent to
sales in 1995 to 30% versus 39% in 1994. In particular,
advertising and public relations expenses increased significantly
from 1994 to 1995 to support activities associated with increased
sales. Also, headcount expenses increased in response to the
additional workload created by the higher sales.
The addition of a cyclotron and facilities caused
depreciation and amortization to increase 45$ or $828,000 from
1994 to 1995.
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Operating margins increased to 36% in 1995 versus 23% in
1994 due to increased sales and a reduction in SG&A expenses as a
percent of sales reflecting efficiency gains from increased
volumes.
Other income and expense was slightly higher in 1995
versus 1994 due to a lower level of construction in progress in
1995 that, in turn, limited the amount of interest expense
capitalizable.
1995 Earnings - Earnings increased more than 142% to
$1,772,000 or $.15 per share in 1995 from 1994's earnings of
$730,000 or $.06 per share. Such increase again was primarily due
to increased sales and a reduction in SG&A expenses as a percent
of sales reflecting efficiency gains from increased volumes.
At December 31, 1995, the Company's deferred tax asset
balance was $1,810,000. Since emerging from its development stage
in 1989, the Company has utilized approximately $3,900,000 of
operating loss carryforwards through December 31, 1995 and has
achieved twenty consecutive profitable quarters since 1991. To
realize income benefit from its remaining operating loss
carryforwards at December 31, 1995, it will be necessary for the
Company to generate future taxable income of approximately
$5,900,000, prior to the expiration of the operating loss
carryforward periods. Based on the Company's results of
operations subsequent to receiving FDA clearance in 1986 for its
product, and on expected future results of operations, management
currently strongly believes these net operating loss
carryforwards will be fully utilized prior to their statutory
expiration.
Historical Comparison
1994 Revenues - 1994 revenues increased more than 15% to
$4.7 million versus $4.1 million for 1993. In 1994, Theragenics
emerged from a two year manufacturing changeover that distanced
the Company from unreliable outside vendors. As the Company's
experience with cyclotron operations and subsequent radioactive
processes grew, the realities of these operations became clear.
No single cyclotron can be expected to run at full power for 52
weeks a year. In addition to the need for regular maintenance,
these operations require a "cool down" period before maintenance
can be performed. These "cool down" periods are imperative as
safety of the Company's employees (i.e., minimizing radiation
exposure) is among the Company's highest priorities.
During the first part of 1994, production dependability
of the #1 cyclotron dictated the pace of sales growth. Once
consistent supply was demonstrated, the Company began reclaiming
marketing momentum. Fueling this momentum were favorable
five-year clinical data (July 1994) and the dedication of
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additional financial resources to marketing.
1994 Costs and Expenses - As a result of the increase in
sales, cost of sales rose. However, cost of sales as a percent of
sales fell from 41% in 1993 to 38% in 1994. This decrease in
percent of cost of sales to sales reflected the economies of
scale associated with the large fixed cost component of the
Company's expense base.
Selling, General and Administrative ("SG&A") expenses
increased more than would have been expected if operations had
continued under the same structure as existed in 1993. Changes
were made in the advertising, public relations and investor
relations areas in 1994 which increased SG&A costs. These changes
proved to have significant success in increasing sales and
investor awareness.
Other income and expense improved by $196,000 due to
reduced interest expense. Both the higher level of construction
in progress in 1994 that increased the amount of interest expense
capitalizable and the replacement of an existing loan at 10.25%
interest with a new loan at 8.47% were the causes of this reduced
interest expense.
1994 Earnings - In 1994, the Company recorded a net
profit of $730,000 or $.06 per share. In 1993, the Company
recorded a net profit of $3,290,000, or $.28 per share. Included
in the 1993 profit number is a one-time positive earnings
adjustment of $2,860,000, or $.24 per share due to the mandated
implementation of FASB-109, "Accounting for Income Taxes." This
booking which appears on the balance sheet as an asset titled
"Deferred Income Tax Asset" primarily represents the tax benefit
which arises from the carryforward of prior years' operating
losses. Because of the differing accounting principles applied
between years, to accurately compare results of 1994 and 1993
requires that "Net Earnings Before Cumulative Effect of Change in
Accounting Principle" be the basis for comparison. Using this
method, 1994's earnings were $730,000, or $.06 per share and
1993's $430,000, or $.04 per share.
LIQUIDITY AND CAPITAL RESOURCES
Theragenics had cash, cash equivalents, short-term
investments and marketable securities of $3.3 million at December
31, 1995, compared to $2.4 million at year end 1994 and $3.4
million at year end 1993. Cash flows from operating activities
were $3.4 million in 1995 compared to $1.6 million in 1994 and
$1.1 million in 1993.
Capital spending was $2.4 million in 1995, $3.4 million
in 1994 and $2.7 million in 1993. Spending in each of these
years relates to construction of Theragenics' cyclotron facility.
Page 15
Spending in 1993 primarily represented a continuation of payments
began in 1992 for initial construction of the facility and the
installation of the first cyclotron. Spending in 1994 primarily
represented progress payments on a project to add a second
cyclotron to the facility. This project began in 1993 and was
completed in 1995. Spending in 1995 represents the beginning of a
project to add cyclotrons three and four to the facility. The
expansion project for addition of cyclotrons three and four which
began in 1995 is estimated to cost approximately $9,000,000 when
completed. As of February 15, 1996, approximately $3,000,000 has
already been expended on this project with the remainder
scheduled for expenditure before the second quarter of 1997.
Management believes that funding for the remainder of this
project should be available from current cash balances, cash from
future operations and Theragenics' credit facility.
In the last three years, the Company's working capital
has been obtained from internally generated funds and borrowings
from banks. Working capital totaled $3.7 million at December 31,
1995, including $500,000 representing the current portion of an
outstanding long-term obligation. This compares to $2.5 million
at year end 1994 which also included $500,000 representing the
current portion of outstanding long-term obligations. In the
first quarter of 1993, Theragenics received funding on a $1.9
million loan secured by the Company's cyclotron facility (the
"1993 Term Loan"). The 1993 Term Loan was to mature in 1995 and
bore interest at 10.25% per annum. In the third quarter of 1994,
Theragenics received funding on a $2.1 million loan secured by
the Company's cyclotron facility including a second cyclotron
(the "1994 Term Loan"). The 1994 Term Loan matures in 1998 and
bears interest at 8.47% per annum. Of the $2.1 million loan, $1.4
million was used to pay off the outstanding balance under the
existing long-term financing while the remainder was used to
provide partial financing for the purchase of the second
cyclotron and the facility expansion to house it. As of December
31, 1995, $1,500,000 remained outstanding on the 1994 Term Loan.
In December 1995, the Company amended and restated its other
existing bank credit facility (the "Bank Credit Facility"). The
Bank Credit Facility, as amended and restated, initially
consisted of a $1 million receivables credit facility and an
additional $2 million revolving credit facility. Based on the
Company meeting specified financial thresholds, the Bank Credit
Facility will be increased to $5,000,000 upon receipt by the bank
of the Company's Form 10-K for the year ended December 31, 1995.
Borrowings under the Bank Credit Facility are secured by
substantially all of the Company's assets. The Bank Credit
Facility contains certain covenants all of which the Company was
in compliance with at year end. Borrowings under the Bank Credit
Facility may be made, at the Company's option, at an interest
rate equal to the London Interbank Offered Rate ("LIBOR") plus 2%
or the lender's prime rate as defined. At year-end, $3,000,000 of
the Bank Credit Facility was available but unused. Although
internal forecasts had indicated that there would be a need to
access the credit facility in the fourth quarter of 1995, strong
Page 16
fourth quarter results did not require the Company to do so.
Management believes that cash flow from operations, the
availability of funds under its bank credit agreements and the
availability of other forms of financing should permit the
Company to meet its anticipated capital expenditures and working
capital needs as well as to service its debt and fund future
growth as new business opportunities arise.
INFLATION AND CHANGING PRICES
Management does not believe that inflation has had an
abnormal or unanticipated effect on the Company's operations.
Item 8. Financial Statements and Supplementary Data
See Index to Financial Statements (page F-1) and
following pages.
Item 9. Disagreements on Accounting and Financial Disclosure
Not Applicable
PAge 17
PART IV
Item 14. Exhibits, Financial Statement Schedules, and Reports on
Form 8-K.
a) The following documents are filed as part of this Report.
1. Financial Statements
See index to financial statements on page F-1
2. Financial Schedules
See the index to financial schedules on page G-1
3. Exhibits
3.1 - Certificate of Incorporation (1)
3.2 - Certificate of Amendment to Certificate
of Incorporation (1)
3.3 - Certificate of Amendment to Certificate
of Incorporation (1)
3.4 - By-Laws (1)
4.1 - See Exhibits 3.1 - 3.4 for provisions in
the Company's Certificate of Incorporation
and By-Laws defining the rights of holders
of the Company's Common Stock.
4.2 - Form of Warrant issued to the
Representatives of the Underwriters of the
Company's Public Offering (1)
4.3 - Warrant Agreements dated May 1, 1989 between
the Company and James Devas (4)
4.4 - Warrant Agreement dated May 8, 1993 between
the Company and James Devas
10.1 - License Agreement with University of
Missouri, as amended (1)
10.2 - Agreement with Atomic Energy of Canada, Ltd.
(1)
10.3 - Reassignment and Release Agreement among the
Company, John L. Russell, Jr., and Georgia
Tech Research Institute (1)
10.4 - 1986 Incentive and Non-Incentive Stock
Option Plan (1)
10.5 - Letter of Agreement between the Company and
Yale-New Haven Hospital (2)
10.6 - Lease between the Company and T. Rowe Price
Realty Income Fund II dated July 14, 1988(2)
10.7 - Form of Purchase Agreement between the
Company and ten institutional investors (3)
10.8 - Form of Custody Agreement between the
Company and IBJ Schroder Bank & Trust
Company (3)
10.9 - 1990 Incentive and Non-Incentive Stock
Option Plan (5)
10.10 - Employment Agreement of John V. Herndon
dated June 4, 1990 (5)
Page 18
10.11 - Employment Agreement of Bruce W. Smith (5)
10.12 - Purchase Agreement between Theragenics
Corporation and Production Equipment
Manufacturer (6)
10.13 - Term Loan and Security Agreement between
Theragenics Corporation and Heller
Financial, Inc. (7)
10.14 - Purchase Agreement between Theragenics
Corporation and Production Equipment
Manufacturer (8)
10.15 - Amendment to Purchase Agreement between
Theragenics Corporation and Production
Equipment Manufacturer (9)
10.16 - Employment Agreement of John V. Herndon
dated August 1, 1993 (9)
10.17 - Employment Agreement of M. Christine Jacobs
(9)
10.18 - Lease between the Company and T. Rowe Price
Realty Income Fund II dated January 1, 1994
(9)
10.19 - Term Loan and Security Agreement between
Theragenics Corporation and Bank South, N.A.
(10)
10.20 - Agreement with Nordion International Inc.
(11)
10.21 - Purchase Agreements between Theragenics
Corporation and Production Equipment
Manufacturer (12)
10.22 - Line of Credit Facility and Revolving Credit
Facility between Theragenics Corporation and
Bank South, N.A.
24.1 - Consent of Independent Public Accountants
for Incorporation by Reference of Audit
Statement into Registration Statement
(1) Incorporated by reference to the exhibits filed with the
Company's registration statement on Form S-1, File No.
33-7097, and post-effective amendments thereto.
(2) Incorporated by reference to the exhibits to the report on
Form 10-K for the period ended December 31, 1988.
(3) Incorporated by reference to the exhibits to the report on
Form 10-Q for the period ended June 30, 1989.
(4) Incorporated by reference to the exhibits to the report on
Form 10-K for the period ended December 31, 1989.
(5) Incorporated by reference to the exhibits to the report on
Form 10-K for the period ended December 31, 1990.
(6) Incorporated by reference to the exhibits to the report on
Form 10-K for the period ended December 31, 1991.
(7) Incorporated by reference to the exhibits to the report on
Form 10-K for the period ended December 31, 1992.
(8) Incorporated by reference to the exhibits to the report on
Form 10-Q for the period ended June 30, 1993.
Page 19
(9) Incorporated by reference to the exhibits to the report on
Form 10-K for the period ended December 31, 1993.
(10) Incorporated by reference to the exhibits to the report on
Form 10-K for the period ended December 31, 1994.
(11) Incorporated by reference to the exhibits to the report on
Form 8-K dated March 23, 1995.
(12) Incorporated by reference to the exhibits to the report on
Form 8-K dated June 29, 1995.
(b) Reports on Form 8-K
The Company filed a report on Form 8-K dated December
13, 1995, reporting the signing of an agreement for a
Line of Credit Facility and Revolving Credit Facility
between Theragenics Corporation and Bank South, N.A.
Page 20
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the
Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
THERAGENICS CORPORATION
(Registrant)
By:/s/ M. Christine Jacobs
M. Christine Jacobs
Chief Executive Officer
Dated: March 27, 1996
Norcross, Georgia
Pursuant to the requirements of the Securities Exchange Act
of 1934, this report has been signed below by the following
persons on behalf of the registrant and in the capacities and on
the dates indicated.
Name Title Date
/s/ M. Christine Jacobs Chief Executive Officer 3/27/96
M. Christine Jacobs (Principal Executive Officer);
Director
/s/ Bruce W. Smith Chief Financial Officer, 3/27/96
Bruce W. Smith Treasurer (Principal
Financial Officer) and
Secretary
/s/ Charles Klimkowski Director, Chairman 3/27/96
Charles Klimkowski
/s/ John V. Herndon Director 3/27/96
John V. Herndon
/s/ Orwin L. Carter Director 3/27/96
Orwin L. Carter
/s/ Peter A.A. Saunders Director 3/27/96
Peter A.A. Saunders
/s/ Otis W. Brawley Director 3/27/96
Otis W. Brawley
Page 21
THERAGENICS CORPORATION
TABLE OF CONTENTS
Page
REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS ................23
(For the periods ended December 31, 1993, 1994 and 1995)
FINANCIAL STATEMENTS
Balance Sheets - December 31, 1994 and 1995 .............24
Statements of Earnings for the Three Years Ended
December 31, 1995 .......................................26
Statement of Shareholders' Equity for
the Three Years Ended December 31, 1995 .................28
Statements of Cash Flows for the Three Years Ended
December 31, 1995 .......................................29
NOTES TO FINANCIAL STATEMENTS ...........................32
Page 22
REPORT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS
Board of Directors
Theragenics Corporation
We have audited the balance sheets of Theragenics Corporation
(a Delaware corporation) as of December 31, 1994 and 1995, and
the related statements of earnings, shareholders' equity, and
cash flows for each of the three years in the period ended
December 31, 1995. These financial statements are the
responsibility of the Company's management. Our responsibility
is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with generally accepted
auditing standards. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe our
audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of Theragenics Corporation as of December 31, 1994 and 1995, and
the results of its operations and its cash flows for each of the
three years in the period ended December 31, 1995, in conformity
with generally accepted accounting principles.
As described in Note E, the Company changed its method of
accounting for income taxes in 1993, as required by Statement of
Financial Accounting Standards No. 109.
GRANT THORNTON LLP
Atlanta, Georgia
January 17, 1996
Page 23
THERAGENICS CORPORATION
BALANCE SHEETS
DECEMBER 31
ASSETS
1994 1995
CURRENT ASSETS
Cash and short-term
investments (Note B-8) $ 2,317,463 $3,266,338
Marketable securities
(Note B-9) 50,000 -
Trade accounts receivable
(Note B-2) 732,424 1,335,645
Inventories (Notes B-3 and C) 192,161 166,955
Prepaid expenses and
other current assets 91,801 67,521
Total current assets 3,383,849 4,836,459
PROPERTY AND EQUIPMENT
(Notes B-4 and F)
Building and improvements 899,760 1,690,045
Leasehold improvement 138,978 138,978
Machinery and equipment 5,167,815 8,203,256
Office furniture and equipment 44,721 44,721
6,251,274 10,077,000
Less accumulated depreciation
and amortization (1,445,206) (2,194,164)
4,806,068 7,882,836
Land 49,485 49,485
Construction in progress (Note D) 3,602,825 2,140,894
8,458,378 10,073,215
OTHER ASSETS
Deferred tax asset (Note E) 2,179,000 1,810,000
Patent costs (Note B-5) 94,982 90,704
Other 52,449 67,804
2,326,431 1,968,508
$14,168,658 $16,878,182
Page 24
THERAGENICS CORPORATION
BALANCE SHEETS
(Continued)
DECEMBER 31
LIABILITIES AND SHAREHOLDERS' EQUITY
1994 1995
CURRENT LIABILITIES:
Current portion of
long-term debt (Note F) $ 469,765 $ 511,362
Trade accounts payable 226,209 348,191
Accrued salaries, wages,
and payroll taxes 110,132 225,138
Income taxes payable (Note E) 113 3,255
Other current liabilities 33,036 12,680
Total current liabilities 839,255 1,100,626
LONG-TERM DEBT: (Note F) 1,519,354 1,008,135
COMMITMENTS AND CONTINGENCIES:
(Note G)
SHAREHOLDERS' EQUITY: (Note I)
Common stock, authorized
50,000,000 shares of $.01
par value; issued and
outstanding 10,961,887 in
1994 and 11,394,785 in 1995. 109,618 113,948
Additional paid-in capital 15,207,453 16,390,170
Accumulated deficit (3,507,022) (1,734,697)
Total shareholders' equity 11,810,049 14,769,421
$14,168,658 $16,878,182
The accompanying notes are an integral part of these statements.
Page 25
THERAGENICS CORPORATION
STATEMENTS OF EARNINGS
FOR THE THREE YEARS ENDED DECEMBER 31, 1995
Year Ended December 31,
1993 1994 1995
REVENUES (Notes G and J)
Product sales $ 4,090,803 $ 4,723,107 $ 7,781,962
Licensing fees - - 85,431
4,090,803 4,723,107 7,867,393
COSTS & EXPENSES:
Cost of sales 1,677,631 1,790,450 2,645,730
Selling, general,
and administrative 1,607,288 1,844,239 2,395,846
Research and
development 36,181 15,268 17,954
3,321,100 3,649,957 5,059,530
OTHER INCOME (EXPENSE):
Interest income 114,905 135,888 143,424
Interest expense
(Note F) (195,035) - (51,967)
Other (5,829) (25,673) (26,995)
(85,959) 110,215 64,462
NET EARNINGS BEFORE
INCOME TAXES,
AND CUMULATIVE EFFECT
OF CHANGE IN
ACCOUNTING PRINCIPLE $ 683,744 $ 1,183,365 $ 2,872,325
Income tax expense
(Note E) 254,000 453,000 1,100,000
NET EARNINGS BEFORE
CUMULATIVE EFFECT
OF CHANGE IN
ACCOUNTING PRINCIPLE $ 429,744 $ 730,365 $1,772,325
Cumulative effect on
prior years of change
in accounting for
income taxes (Note E) 2,860,000 - -
NET EARNINGS $ 3,289,744 $ 730,365 $ 1,772,325
Page 26
THERAGENICS CORPORATION
STATEMENTS OF EARNINGS
FOR THE THREE YEARS ENDED DECEMBER 31, 1995
Year Ended December 31,
1993 1994 1995
NET EARNINGS PER COMMON
SHARE (Note B-7)
NET EARNINGS BEFORE
CUMULATIVE EFFECT
OF CHANGE IN
ACCOUNTING PRINCIPLE $ .04 $ .06 $ .15
Cumulative effect on
prior years of change
in method of accounting
for income taxes .24 - -
NET EARNINGS PER
COMMON SHARE $ .28 $ .06 $ .15
WEIGHTED AVERAGE SHARES 11,709,218 11,582,793 11,759,178
The accompanying notes are an integral part of these statements.
Page 27
THERAGENICS CORPORATION
STATEMENT OF SHAREHOLDERS' EQUITY
FOR THE THREE YEARS ENDED DECEMBER 31, 1995
Common Stock Additional
Number of Par value paid-in Accumulated
shares $.01 capital deficit
Total
BALANCE,
December 31, 1992 10,583,635 $105,836 $14,866,040 $(7,527,131) $ 7,444,745
Exercise of
warrants 200,000 2,000 173,000 - 175,000
Exercise of stock
options, net 129,302 1,293 122,902 - 124,195
Net earnings
for the year - - - 3,289,744 3,289,744
BALANCE,
December 31, 1993 10,912,937 $109,129 $15,161,942 $(4,237,387) $11,033,684
Exercise of stock
options, net 48,950 489 45,511 - 46,000
Net earnings
for the year - - - 730,365 730,365
BALANCE,
December 31, 1994 10,961,887 $109,618 $15,207,453 $(3,507,022) $11,810,049
Exercise of stock
options, net 432,898 4,330 469,717 - 474,047
Income tax benefit
from stock options
exercised - - 713,000 - 713,000
Net earnings
for the year - - - 1,772,325 1,772,325
BALANCE,
December 31, 1995 11,394,785 $113,948 $16,390,170 $(1,734,697) $14,769,421
The accompanying notes are an integral part of these statements.
Page 28
THERAGENICS CORPORATION
STATEMENTS OF CASH FLOWS
FOR THE THREE YEARS ENDING DECEMBER 31,
1993 1994 1995
CASH FLOWS FROM
OPERATING ACTIVITIES:
Net earnings $3,289,744 $ 730,365 $ 1,772,325
Adjustments to
reconcile net earnings
to net cash provided
by operating activities:
Cumulative effect of
change in accounting
for income taxes (2,860,000) - -
Deferred income tax
expense 248,000 433,000 1,082,000
Depreciation and
amortization 515,831 571,615 828,072
Loss on disposal of
property and equipment 3,458 1,571 1,677
Change in assets and
liabilities:
Accounts receivable (18,347) (197,133) (603,221)
Inventories 84,737 (32,834) 25,206
Prepaid expenses and
other current assets (17,228) 22,448 24,280
Other assets 17,526 (200) -
Trade accounts payable (102,239) 78,402 121,982
Accrued salaries,
wages and payroll
taxes (7,938) 21,400 115,006
Income tax payable (20,387) (1,500) 3,142
Other current
liabilities (21,001) 16,442 (20,356)
Total adjustments (2,177,588) 913,211 1,577,788
Net cash provided
by operating
activities 1,112,156 1,643,576 3,350,113
Page 29
THERAGENICS CORPORATION
STATEMENTS OF CASH FLOWS - CONTINUED
FOR THE THREE YEARS ENDING DECEMBER 31,
1993 1994 1995
CASH FLOWS FROM
INVESTING ACTIVITIES:
Purchase and
construction
of property
and equipment (2,740,263) (3,376,967) (2,426,961)
Maturities of
marketable securities 205,127 309,765 50,000
Patent costs (51,346) (587) (3,632)
Net cash used
by investing
activities (2,586,482) (3,067,789) (2,380,593)
CASH FLOWS FROM
FINANCING ACTIVITIES:
Proceeds from
long-term debt 1,900,000 2,100,000 -
Repayment of
long-term debt (569,561) (1,441,320) (469,622)
Proceeds from exercise
of stock options and
warrants, net 299,195 46,000 474,047
Other assets - (46,025) (25,070)
Net cash (used)
provided by
financing
activities 1,629,634 658,655 (20,645)
NET INCREASE (DECREASE)IN
CASH AND SHORT-TERM
INVESTMENTS 155,308 (765,558) 948,875
CASH AND SHORT-TERM
INVESTMENTS AT
BEGINNING OF YEAR 2,927,713 3,083,021 2,317,463
CASH AND SHORT-TERM
INVESTMENTS AT
END OF YEAR $ 3,083,021 $ 2,317,463 $ 3,266,338
Page 30
THERAGENICS CORPORATION
STATEMENTS OF CASH FLOWS - CONTINUED
FOR THE THREE YEARS ENDING DECEMBER 31,
Supplemental Schedule of Non Cash Financing Activities
During 1995, the Company realized an income tax benefit from the
exercise and early disposition of certain stock options,
resulting in an increase in the deferred tax asset and additional
paid in capital of $713,000.
Supplementary Cash Flow Disclosure:
1992 1993 1994
Interest paid, net of
amounts capitalized $ 195,035 $ - $ 53,843
Interest received $ 120,032 $ 144,452 $ 139,693
Income taxes paid $ 26,387 $ 21,500 $ 14,858
The accompanying notes are an integral part of these statements.
Page 31
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS
December 31, 1994 and 1995
NOTE A - ORGANIZATION AND DESCRIPTION OF BUSINESS
Theragenics Corporation (the "Company") was organized in November
1981 to develop, manufacture, and market radiological
pharmaceuticals and devices used in the treatment of cancer.
The Company manufactures and markets primarily one product, which
is used in the treatment of cancer. Use of the Company's product
is regulated by the U.S. Food and Drug Administration (FDA). The
Company sells its product primarily to hospitals, physicians and
other health service providers in the United States. The Company
therefore is directly affected by FDA regulations and the well
being of the health care industry.
NOTE B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A summary of the significant accounting policies consistently
applied in the preparation of the accompanying financial
statements follows:
1. Use of Estimates in Preparation of Financial Statements
In preparing financial statements in conformity with Generally
Accepted Accounting Principles ("GAAP"), management is required
to make certain estimates and assumptions that affect the
reported amounts of assets and liabilities and the disclosure of
contingent assets and liabilities at the date of the financial
statements and revenues and expenses during the reporting period.
Actual results could differ from those estimates.
2. Accounts Receivable
The Company considers accounts receivable to be fully
collectible; accordingly, no allowance for doubtful accounts is
required. If amounts become uncollectible, they will be charged
to operations when that determination is made.
3. Inventories
Inventories are stated at the lower of cost or market. Cost is
determined using the specific identification method. Inventory
costs consist primarily of costs incurred in the extraction,
purification and irradiation processes of an isotope which is the
basic component of the Company's primary product.
Page 32
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1994 and 1995
NOTE B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Continued
4. Depreciation
Depreciation is provided for in amounts sufficient to relate the
cost of depreciable assets to operations over their estimated
service lives on a straight-line basis. Estimated service lives
are as follows:
Building 30 years
Machinery, leasehold improvements,
furniture and equipment 5-10 years
A significant portion of the Company's depreciable assets are
utilized in the production of its product. Management
periodically evaluates the realizability of its depreciable
assets in light of its current industry environment. Management
believes that no impairment of depreciable assets exists at
December 31, 1995. It is possible, however, that management's
estimates concerning the realizability of the Company's
depreciable assets could change in the near term due to changes
in the Company's technological and regulatory environment.
5. Patent Costs
The Company capitalizes the costs of patent applications for its
products. Amortization is computed on a straight line basis over
the estimated economic lives of the patents, commencing at the
date of grant of the related patent. Patent costs are net of
accumulated amortization of $29,366 and $37,276 at December 31,
1994 and 1995, respectively.
6. Research and Development Costs
The costs of research and development and consumable supplies and
materials to be used for the development of the Company's
intended products are expensed when incurred.
7. Net Earnings Per Common Share
The net earnings per common share is based on the weighted
average number of common shares and common equivalent shares
outstanding during each period (11,709,218 in 1993, 11,582,793 in
1994 and 11,759,178 in 1995).
Page 33
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1994 and 1995
NOTE B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Continued
Fully diluted information is not presented, as fully diluted
earnings per share is not materially different from the primary
earnings per share presented.
8. Statements of Cash Flows
For purposes of reporting cash flows, cash and short-term
investments include cash on hand, cash in banks and commercial
paper with original maturities of less than 90 days.
9. Marketable Securities
The Company adopted Statement of Financial Accounting Standards
No. 115, Accounting for Certain Investments in Debt and Equity
Securities (SFAS 115), effective January 1, 1994. The adoption of
SFAS 115 had no effect upon prior periods.
At December 31, 1994, marketable securities are categorized as
available for sale and as a result are stated at fair value,
which approximated cost. The Company held no marketable
securities at December 31, 1995.
10. Stock Based Compensation
The Company stock option plans are accounted for under APB
Opinion 25, Accounting for Stock Issued to Employees, and related
interpretations.
NOTE C - INVENTORIES
Inventory consists of the following:
December 31,
1994 1995
Raw material $ 17,361 $ 17,361
Work in process 79,820 92,887
Finished goods 33,361 56,707
Raw material to be recovered 61,619 -
$192,161 $166,955
Page 34
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1994 and 1995
NOTE C - INVENTORIES - CONTINUED
"Raw material to be recovered" includes finished products which
cannot be sold due to loss of radiation. The irradiated isotope
contained in these products can be recovered and reused through a
purification process.
NOTE D - CONSTRUCTION IN PROGRESS
At December 31, 1995, construction in progress represented
payments made for the construction of manufacturing equipment and
facility expansion. Total cost of this project is expected to be
approximately $9,000,000, and is expected to be completed in
February 1997.
At December 31, 1994, construction in progress represented
payments made for the construction of manufacturing equipment
which was completed and placed in service during 1995.
NOTE E - INCOME TAXES
The Financial Accounting Standards Board ("FASB") issued
Statement of Financial Accounting Standards ("SFAS" and "FASB")
No. 109, Accounting for Income Taxes, which requires a change
from the deferred method to the asset and liability method of
accounting for income taxes. Under the asset and liability
method, deferred income taxes are recognized for the tax
consequences of "temporary differences" by applying enacted
statutory tax rates applicable to future years to differences
between the financial statement carrying amounts and the tax
bases of existing assets and liabilities.
The Company implemented SFAS 109 as of January 1, 1993. The
deferred tax asset recorded is primarily a result of the
recognition of the Company's net operating loss carryforward. The
cumulative effect on prior years of the change in accounting
principle increased net earnings by $2,860,000 ($.24 per share)
and is included in earnings for 1993. The effect of the change on
1993 was to decrease net earnings before cumulative effect of a
change in accounting principle by $248,000 ($.02 per share) and
increase net earnings by $2,612,000 ($.22 per share).
Page 35
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1994 and 1995
NOTE E - INCOME TAXES - Continued
The provision for income tax is summarized as follows:
1993 1994 1995
Current tax expense $ 6,000 $ 20,000 $ 18,000
Deferred tax expense 248,000 433,000 1,082,000
$ 254,000 $ 453,000 $1,100,000
Significant components of the deferred tax asset are as follows:
December 31,
1994 1995
Loss carryforwards $2,455,000 $2,240,000
Depreciation (370,000) (565,000)
Other 94,000 135,000
$2,179,000 $1,810,000
The significant portions of the operating loss carryforwards were
incurred while the Company was in the development stage. Upon
receiving clearance to market its "TheraSeed " product from the
U.S. Food and Drug Administration (FDA) in 1986, the Company
commenced manufacturing and distribution of its product in 1987.
Since emerging from the development stage in 1989, the Company
has utilized approximately $3,900,000 of these operating loss
carryforwards through December 31, 1995 by generating taxable
income. In order to realize income benefit from the remaining
operating loss carryforwards at December 31, 1995, it will be
necessary for the Company to generate future taxable income of
approximately $5,900,000, prior to the expiration of the
operating loss carryforward periods. Based on the Company's
results of operations subsequent to receiving FDA clearance to
market for its product, and on expected future results of
operations, management believes that currently it is more likely
than not that the income tax benefits of the operating loss
carryforwards will be realized within the carryforward period.
The amount of deferred tax asset considered realizable, however,
could be reduced in the near term if estimates of future taxable
income during the carryforward period are reduced.
Page 36
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1993 and 1994
NOTE E - INCOME TAXES - Continued
The provision for income taxes differs from the amount of income
tax determined by applying the applicable federal rates due to
the following:
1993 1994 1995
Tax at applicable
federal rate of 34% $ 232,000 $ 402,000 $ 977,000
State tax, net 22,000 47,000 115,000
Other - 4,000 8,000
$ 254,000 $ 453,000 $1,100,000
For income tax purposes only, the Tax Reform Act of 1986 enacted
an alternative minimum tax system for corporations (the "AMT").
AMT is imposed at a 20% rate on the Company's AMT income which is
determined by making statutory adjustments to regular taxable
income. A company pays the greater of the taxes computed under
the "regular" tax system or the AMT system. Because AMT net
operating loss carryforwards may only be utilized to offset 90%
of the AMT income, the Company was subject to the AMT in 1993,
1994 and 1995, resulting in an alternative minimum tax of $6,000,
$20,000 and $18,000, respectively. These amounts will be allowed
as a credit carryover to reduce the regular tax liability in
future years, but not below the AMT of such years.
At December 31, 1995, the Company had approximate net federal
operating loss carryforwards for regular tax and AMT purposes as
follows:
Net operating Net operating
loss (regular) loss (AMT)
Year of expiration
2002 $1,013,000 $ -
2003 2,485,000 2,254,000
2004 1,806,000 1,765,000
2005 590,000 555,000
$5,894,000 $4,574,000
Page 37
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1994 and 1995
NOTE F - NOTES PAYABLE
In December 1995, the Company entered into an amended and
restated loan and security agreement (the "loan agreement") with
a financial institution. This loan agreement incorporated and
restated the Company's existing term loan and line of credit
facility. A summary of the applicable terms follows.
Term Loan
The term loan is payable in monthly installments of $51,862,
including interest at 8.47%. $1,989,119 and $1,519,497 were
outstanding under the term loan at December 31, 1994 and 1995,
respectively. Interest expense of approximately $140,000 and
$106,000 was capitalized with expansion of the manufacturing
facility and construction of certain manufacturing equipment
during 1994 and 1995, respectively.
Line of Credit
The loan agreement provides for a line of credit of up to
$1,000,000. Interest on outstanding borrowings is payable monthly
at the prime rate or, at the Company's option, may be payable at
the LIBOR rate plus 2%. There was no outstanding borrowings under
the line of credit at December 31, 1994 or 1995.
Revolving Credit Facility
The loan agreement also provides for a revolving credit facility
of up to $2,000,000. The maximum borrowings under the revolving
credit facility can be increased to $4,000,000 under certain
conditions. These conditions include, among other things, that
the Company achieve certain minimum earnings levels, as defined,
for four consecutive quarters. The Company has met the minimum
earnings requirements as of December 31, 1995, and management
expects that the revolving credit facility will be increased to
$4,000,000 during 1996. Interest on outstanding borrowings is
payable monthly at the prime rate or, at the Company's option,
may be payable at the LIBOR plus 2%. No amounts were outstanding
under the revolving credit facility at December 31, 1995.
All outstanding borrowings under the revolving credit facility
are due in April 1997. However, the outstanding borrowings can be
repaid in sixty equal and consecutive monthly installments
commencing in May 1997 if the Company meets certain minimum
earnings levels, as defined, and certain other financial ratios
Page 38
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1994 and 1995
NOTE F - NOTES PAYABLE - Continued
for the year ending December 31, 1996. Additionally, certain
mandatory repayments based on "excess cash flow", as defined,
would be required commencing in May 1998 and annually thereafter.
All outstanding borrowings under the loan agreement are
collateralized by substantially all of the Company's assets.
Provisions of the loan agreement limit the amount of annual
capital expenditures, the incurrence of additional debt and,
among other things, require the maintenance of certain minimum
financial ratios. As of December 31, 1995, the Company was in
compliance with the provisions of the loan agreement.
NOTE G - COMMITMENTS AND CONTINGENCIES
Licensing Agreement
The Company holds a worldwide exclusive license from the
University of Missouri for the use of technology, patented by the
University, used in the Company's "TheraSphere" product. The
licensing agreement provides for the payment of royalties based
on the level of sales and on lump sum payments received pursuant
to a licensing agreement with Nordion International, Inc. (see
below).
The Company has granted certain of its geographical rights under
the licensing agreement with the University of Missouri to
Nordion International, Inc., a Canadian company which is a
producer, marketer and supplier of radioisotope products and
related equipment. Under the Nordion agreement, the Company will
receive a licensing fee for each geographic area in which Nordion
receives new drug approval. The Company will also be entitled to
a percentage of future revenues earned by Nordion as royalties
under he agreement. Royalties from this agreement for each of the
three years in the period ended December 31, 1995 were not
significant.
In March 1995, the Company received approximately $85,000 from
Nordion for the right to use certain patents and to manufacture,
distribute, and sell TheraSphere for all applications worldwide.
Letter of Credit
The Company has a letter of credit outstanding for approximately
$315,000 relating to regulatory requirements.
Page 39
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1994 and 1995
NOTE G - COMMITMENTS AND CONTINGENCIES - Continued
Lease Commitment
The Company leases office space under a noncancelable lease which
expires in December 1998. Approximate minimum lease payments
under the lease are as follows: 1996, $64,000; 1997, $67,000;
1998, $69,000.
Rent expense was approximately $70,000, $61,000 and $61,500 for
the years ended December 31, 1993, 1994 and 1995, respectively
NOTE H - TRANSACTIONS WITH RELATED PARTIES
Certain shareholders and directors provide consulting
services to the Company. Total consulting fees paid to
shareholders and directors were approximately $77,500, $5,500 and
$1,000 during the years ended December 31, 1993, 1994 and 1995,
respectively.
NOTE I - STOCK OPTIONS AND WARRANTS
The Company's board of directors has approved three stock option
plans which in aggregate cover up to 2,200,000 shares of common
stock. The plans provide for the expiration of options ten years
from the date of grant and requires the exercise price of the
options granted to be at least equal to 100% of market value on
the date granted. Stock option transactions for the three years
ended December 31, 1995 are summarized below:
Option Shares
1993 1994 1995
Outstanding,
beginning of year 1,188,316 1,258,116 1,226,716
Granted 200,000 40,000 221,000
Exercised (130,200) (49,900) (450,000)
Canceled - (21,500) -
Outstanding,
end of year 1,258,116 1,226,716 997,716
Option Price $1.00-$6.38 $1.00-$6.38 $1.00-$6.38
As of December 31, 1995, options covering approximately 773,000
Page 40
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1994 and 1995
NOTE I - STOCK OPTIONS AND WARRANTS - Continued
shares were exercisable. Expiration dates for these options range
from 1996-2005.
Two hundred thousand warrants (200,000) were exercised during
1993, resulting in proceeds to the Company of $175,000. The
Company also has warrants outstanding at December 31, 1995,
covering 100,000 shares of common stock. The warrants are
exercisable at a price of $7.50 per share and expire in May 1999.
The Company follows the practice of recording amounts received
upon the exercise of options by crediting common stock and
additional capital. No changes are reflected in the statements of
operations as a result of the grant or exercise of options. The
Company realizes an income tax benefit from the exercise or early
disposition of certain stock options. This benefit results in an
increase to the deferred tax asset and an increase in additional
paid-in capital.
NOTE J - MAJOR CUSTOMERS
During 1994, there were sales to one major customer that equaled
approximately ten percent of sales. During 1993 and 1995, there
were no customers which individually comprised ten percent of
sales.
NOTE K - EMPLOYEE BENEFIT PLAN
The Company sponsors a defined contribution 401(k) Plan covering
all employees with at least six months of service and at least 21
years of age. The Plan permits participants to defer a portion of
their compensation through payroll deductions. The Company may,
at its discretion, contribute to the Plan on behalf of
participating employees. No such Company discretionary
contributions have been made during any of the three years ended
December 31, 1995.
Note L - RECENTLY ISSUED ACCOUNTING STANDARD
The Company currently accounts for the issuance of stock options
to employees in accordance with Accounting Principles Board
Opinion ("APB") Number 25, "Accounting for Stock Issued to
Employees." In October 1995, the FASB issued SFAS Number 123
("SFAS 123"), "Accounting for Stock Based Compensation." SFAS 123
allows for the continued use of the method prescribed by APB 25,
referred to as intrinsic value method. SFAS 123 also provides an
Page 41
THERAGENICS CORPORATION
NOTES TO FINANCIAL STATEMENTS - CONTINUED
December 31, 1994 and 1995
NOTE L - RECENTLY ISSUED ACCOUNTING STANDARD - Continued
alternative method, referred to as the fair value method. If the
intrinsic value method of accounting for the issuance of stock
options is used, then SFAS 123 requires disclosure of pro forma
net income and earnings per share, as if the fair value method
had been used.
Management anticipates that the Company will continue to account
for the issuance of stock options to employees in accordance with
APB 25. Therefore, the only effect of adopting SFAS 123 will be
the new disclosure requirements. These disclosure requirements
are effective for the year ending December 31, 1996.
Page 42
File No. 0-15443
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
EXHIBITS FILED WITH
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED
DECEMBER 31, 1995
under
The Securities Exchange Act of 1934
THERAGENICS CORPORATION
(Exact Name of Registrant as specified in its charter)
Page 43
THERAGENICS CORPORATION
INDEX TO EXHIBITS
Page No.
10.22 Line of Credit Facility and Revolving Credit 45
Facility between Theragenics Corporation and
Bank South, N.A.
24.1 Consent of Independent Certified Public 89
Accountant for Incorporation by Reference
of Audit Statement into Registration
Statement
Page 44