Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and
innovator in seed brachytherapy, today announced its financial
results for the second quarter of fiscal 2022 ended December 31,
2021.
Revenue for the second quarter of fiscal 2022 grew 19% to $2.82
million versus $2.36 million in the prior year comparable period.
The Company’s core prostate brachytherapy revenue increased 13%
versus the second quarter of fiscal 2021. Prostate brachytherapy
represented 76% of total revenue for the second quarter of fiscal
2022 compared to 80% in the prior year comparable period.
Non-prostate brachytherapy revenue increased 46% versus the prior
year comparable period. The majority of non-prostate brachytherapy
revenue in the quarter was comprised of sales to treat brain
cancer, including sales of GammaTile® Therapy.
Gross profit as a percentage of revenues was 43.3% for the three
months ended December 31, 2021 versus 49.5% in the prior year
comparable period. The decline in gross margin was the result of
increased total cost of product sales due primarily to higher
isotope and non-isotope material costs as well as increased payroll
and benefits due to an increase in headcount. Second quarter gross
profit increased 4.5% to $1.22 million versus $1.17 million in the
second quarter of fiscal 2021.
Isoray CEO Lori Woods said, “This quarter represents the third
straight quarter of year over year growth for our core prostate
business and other treatment areas including brain, head and neck,
and lung cancers. In reviewing this quarter’s results and looking
toward the future, we believe the strategies we have been
implementing are working and will continue to have a positive
impact. We believe Isoray is well positioned to accelerate our
growth as our end markets rebound further from the ongoing effects
of the pandemic.”
Total operating expenses increased 40% in the second quarter to
$2.86 million from $2.04 million in the prior year
period. Total research and development expenses increased 88%
versus the prior year comparable period. The increase in research
and development expenses was primarily the result of increased
payroll and benefits expense due to greater headcount versus the
prior year comparable period.
Sales and marketing expenses increased 13% versus the prior year
comparable period. The increase in sales and marketing expenses was
driven primarily by increases in travel and tradeshow costs and
increased payroll and benefits expense due to greater headcount,
versus the prior year comparable period. General and administrative
expenses increased 43% versus the prior year comparable period. The
increases in general and administrative expenses were primarily the
result of increased payroll and benefits expense due to greater
headcount and increased employment hiring expenses versus the prior
year comparable period.
The net loss for the three months ended December 31, 2021 was
$1.60 million or ($0.01) per basic and diluted share versus a net
loss of $0.87 million or ($0.01) per basic and diluted share
in the comparable prior year period. Basic and diluted per share
results are based on weighted average shares outstanding of
approximately 142.0 million for the three months ended December 31,
2021 versus 83.0 million in the comparable prior year period.
For the first six months of fiscal 2022 ended December 31, 2021,
revenue increased 13% to $5.38 million versus $4.74 million in the
prior year comparable period. Prostate brachytherapy represented
76% of total revenue for the first half of fiscal 2022 compared to
80% for the first half of fiscal 2021. Total operating expenses for
the first six months of fiscal 2022 increased 54% to $6.16 million,
versus $4.00 million in the prior year comparable period. The net
loss for the first half of fiscal 2022 was $3.85 million, or
($0.03) per basic and diluted share, compared to a net loss of
$1.58 million, or ($0.02) per basic and diluted share, in the prior
year comparable period. Basic and diluted per share results are
based on weighted average shares outstanding of approximately 141.9
million for the six months ended December 31, 2021, versus 76.0
million in the comparable prior year period.
Cash, cash equivalents, and certificates of deposit at the end
of the second quarter of fiscal 2022 totaled $60.4 million and the
company had no long-term debt. Stockholders’ equity at the end of
the second quarter of fiscal 2022 totaled $64.4 million.
Conference Call Details
The Company will hold an earnings conference call today,
February 8, at 4:30 p.m. ET/1:30 p.m. PT to discuss operating
results. To listen to the conference call, please dial (888)
506-0062. For callers outside the U.S., please dial (973)
528-0011.
The conference call will be simultaneously webcast and can be
accessed at https://www.webcaster4.com/Webcast/Page/2199/44375. The
webcast will be available until May 8, 2022 following the
conference call.
ContactsInvestor Relations: Mark Levin (501)
255-1910Media and Public Relations: Sharon Schultz (302)
539-3747
About IsorayIsoray, Inc. is a medical
technology company pioneering advanced treatment applications and
devices to deliver targeted internal radiation treatments for
cancers throughout the body. Isoray, Inc., through its subsidiary,
Isoray Medical, Inc., is the sole producer of Cesium-131
brachytherapy seeds. Learn more about this innovative Richland,
Washington company and explore the many benefits and uses of
Cesium-131 by visiting www.isoray.com. Follow us on LinkedIn and
Twitter.
Safe Harbor StatementStatements in this news
release about Isoray’s future expectations, including: the
anticipated continued growth in revenues in fiscal year 2022,
timing of recovery in our brachytherapy procedures, suppliers,
scheduling of procedures, and employees, advantages of our products
including Blu Build and the GammaTile Therapy delivery system,
whether interest in and use of our Cesium-131, commercially known
as Cesium Blu, products will increase or continue, whether use of
Cesium-131 in non-prostate applications will continue to increase
revenue, whether research and development we conduct will result in
viable revenue opportunities, whether our market presence and
growth will continue, and all other statements in this release,
other than historical facts, are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995 (“PSLRA”). This statement is included for the express
purpose of availing Isoray, Inc. of the protections of the safe
harbor provisions of the PSLRA. It is important to note that actual
results and ultimate corporate actions could differ materially from
those in such forward-looking statements based on such factors as
physician acceptance, training and use of our products, market
acceptance and recognition of our products, our ability to
successfully manufacture, market, and sell our Blu Build products
and the success of the GammaTile Therapy, the inability to staff
personnel of hospitals to perform our procedure and cancellations
of patient surgeries as a result of the COVID-19 pandemic, our
ability to manufacture our products in sufficient quantities to
meet demand within required delivery time periods while meeting our
quality control standards, our ability to enforce our intellectual
property rights, whether additional studies are released that
support the conclusions of past studies, whether ongoing patient
results with our products are favorable and in line with the
conclusions of clinical studies and initial patient results,
patient results achieved when our products are used for the
treatment of cancers and malignant diseases, successful completion
of future research and development activities, whether we, our
distributors and our customers will successfully obtain and
maintain all required regulatory approvals and licenses to market,
sell and use our products in its various forms, continued
compliance with ISO standards, the success of our sales and
marketing efforts, changes in reimbursement rates, the procedures
and regulatory requirements mandated by the FDA for 510(k) approval
and reimbursement codes, changes in laws and regulations applicable
to our products, the scheduling of physicians who either delay or
do not schedule patients in periods anticipated, the use of
competitors’ products in lieu of our products, less favorable
reimbursement rates than anticipated for each of our products, and
other risks detailed from time to time in Isoray’s reports filed
with the SEC. Unless required to do so by law, we undertake no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
|
Isoray,
Inc. and Subsidiaries |
Consolidated Balance Sheets (Unaudited) |
(In
thousands, except shares) |
|
|
|
December 31, |
|
|
June 30, |
|
|
|
2021 |
|
|
2021 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
60,354 |
|
|
$ |
63,828 |
|
Accounts receivable, net |
|
|
1,647 |
|
|
|
2,013 |
|
Inventory |
|
|
1,068 |
|
|
|
980 |
|
Prepaid expenses and other current assets |
|
|
535 |
|
|
|
481 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
63,604 |
|
|
|
67,302 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
1,973 |
|
|
|
1,958 |
|
Right of use asset, net (Note
8) |
|
|
642 |
|
|
|
768 |
|
Restricted cash |
|
|
182 |
|
|
|
182 |
|
Inventory, non-current |
|
|
741 |
|
|
|
76 |
|
Other assets, net |
|
|
110 |
|
|
|
130 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
67,252 |
|
|
$ |
70,416 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
847 |
|
|
$ |
730 |
|
Lease liability (Note 8) |
|
|
260 |
|
|
|
252 |
|
Accrued protocol expense |
|
|
153 |
|
|
|
98 |
|
Accrued radioactive waste disposal |
|
|
103 |
|
|
|
100 |
|
Accrued payroll and related taxes |
|
|
223 |
|
|
|
362 |
|
Accrued vacation |
|
|
259 |
|
|
|
259 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
1,845 |
|
|
|
1,801 |
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Lease liability, non-current |
|
|
392 |
|
|
|
524 |
|
Accrued payroll and related taxes, non-current |
|
|
- |
|
|
|
77 |
|
Asset retirement obligation |
|
|
624 |
|
|
|
608 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,861 |
|
|
|
3,010 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Common stock, $.001 par value; 200,000,000 shares authorized;
142,040,266 and 141,915,266 shares issued and outstanding |
|
|
142 |
|
|
|
142 |
|
Additional paid-in capital |
|
|
159,421 |
|
|
|
158,589 |
|
Accumulated deficit |
|
|
(95,172 |
) |
|
|
(91,325 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders' equity |
|
|
64,391 |
|
|
|
67,406 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
67,252 |
|
|
$ |
70,416 |
|
Isoray,
Inc. and Subsidiaries |
Consolidated Statements of Operations
(Unaudited) |
(Dollars
and shares in thousands, except for per-share
amounts) |
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, net |
|
$ |
2,816 |
|
|
$ |
2,359 |
|
|
$ |
5,380 |
|
|
$ |
4,743 |
|
Cost of sales |
|
|
1,596 |
|
|
|
1,192 |
|
|
|
3,131 |
|
|
|
2,330 |
|
Gross profit |
|
|
1,220 |
|
|
|
1,167 |
|
|
|
2,249 |
|
|
|
2,413 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
535 |
|
|
|
285 |
|
|
|
1,237 |
|
|
|
597 |
|
Sales and marketing |
|
|
702 |
|
|
|
619 |
|
|
|
1,463 |
|
|
|
1,200 |
|
General and administrative |
|
|
1,618 |
|
|
|
1,129 |
|
|
|
3,458 |
|
|
|
2,196 |
|
Loss on equipment disposal |
|
|
- |
|
|
|
7 |
|
|
|
- |
|
|
|
7 |
|
Total operating expenses |
|
|
2,855 |
|
|
|
2,040 |
|
|
|
6,158 |
|
|
|
4,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(1,635 |
) |
|
|
(873 |
) |
|
|
(3,909 |
) |
|
|
(1,587 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
31 |
|
|
|
5 |
|
|
|
62 |
|
|
|
6 |
|
Non-operating income |
|
|
31 |
|
|
|
5 |
|
|
|
62 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(1,604 |
) |
|
|
(868 |
) |
|
|
(3,847 |
) |
|
|
(1,581 |
) |
Preferred stock dividends |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shareholders |
|
$ |
(1,604 |
) |
|
$ |
(868 |
) |
|
$ |
(3,847 |
) |
|
$ |
(1,584 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used
in computing net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
141,955 |
|
|
|
83,047 |
|
|
|
141,935 |
|
|
|
75,972 |
|
IsoRay (AMEX:ISR)
Historical Stock Chart
From Aug 2024 to Sep 2024
IsoRay (AMEX:ISR)
Historical Stock Chart
From Sep 2023 to Sep 2024