Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and
innovator in seed brachytherapy, today announced its financial
results for the third quarter of fiscal 2022 ended March 31, 2022.
Revenue for the third quarter of fiscal 2022 grew 12% to $2.91
million versus $2.60 million in the prior year comparable period.
The Company’s core prostate brachytherapy revenue increased 8%
versus the third quarter of fiscal 2021. Prostate brachytherapy
represented 75% of total revenue for the third quarter of fiscal
2022 compared to 78% in the prior year comparable period.
Non-prostate brachytherapy revenue increased 28% 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 49.5% for the three
months ended March 31, 2022 versus 52.4% in the prior year
comparable period. The decline in gross margin was the result of
increased total cost of product sales due primarily to increased
isotope costs due to ordering additional supply and payroll and
benefits due to an increase in headcount. Third quarter gross
profit increased 5.8% to $1.44 million versus $1.36 million in the
third quarter of fiscal 2021.
Isoray CEO Lori Woods said, “We are very pleased by the record
sales we achieved this quarter which reflects the continued rebound
in our core prostate market as well as unprecedented revenue in our
brachytherapy treatments for other cancers. We look forward to
capitalizing on this growth to advance our market goals as the
impact from the effects of the pandemic continue to diminish.”
Total operating expenses increased 32% in the third quarter to
$2.82 million from $2.13 million in the prior year
period. Total research and development expenses increased 52%
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 and an increase in consulting expenses
relating to market research.
Sales and marketing expenses increased 18% 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 merit increases, new
hires, and increased incentive compensation, versus the prior year
comparable period. General and administrative expenses increased
34% 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 annual merit
increases and greater headcount, employment hiring expenses, IT
consulting expenses, D&O insurance premiums, public company
expenses, audit and legal expenses, severance, and travel expenses
versus the prior year comparable period.
The net loss for the three months ended March 31, 2022 was $1.35
million or ($0.01) per basic and diluted share versus a net loss of
$0.75 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 March 31, 2022 versus
122.6 million in the comparable prior year period.
For the first nine months of fiscal 2022 ended March 31, 2022,
revenue increased 13% to $8.29 million versus $7.34 million in the
prior year comparable period. Prostate brachytherapy represented
76% of total revenue for the first nine months of fiscal 2022
compared to 79% for the first nine months of fiscal 2021. Total
operating expenses for the first nine months of fiscal 2022
increased 46% to $8.98 million, versus $6.13 million in the prior
year comparable period. The net loss for the first nine months of
fiscal 2022 was $5.19 million, or ($0.04) per basic and diluted
share, compared to a net loss of $2.33 million, or ($0.03) 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 142.0 million for the nine months
ended March 31, 2022, versus 91.3 million in the comparable prior
year period.
Cash, cash equivalents, and certificates of deposit at the end
of the third quarter of fiscal 2022 totaled $58.9 million and the
company had no long-term debt. Stockholders’ equity at the end of
the third quarter of fiscal 2022 totaled $63.2 million.
Conference Call Details
The Company will hold an earnings conference call today, May 10,
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/2199/45391. The
webcast will be available until August 10, 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, whether the COVID-19
pandemic continues to abate, 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, the
impact of the military situation in Ukraine on our ability to
obtain supplies of Cesium-131 from Russia and the ability to make
wire transfers to obtain supplies with the Russian banking system,
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 SubsidiariesConsolidated Balance Sheets
(Unaudited)(In thousands, except
shares) |
|
|
|
March 31, |
|
|
June 30, |
|
|
|
2022 |
|
|
2021 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
58,904 |
|
|
$ |
63,828 |
|
Accounts receivable, net |
|
|
2,140 |
|
|
|
2,013 |
|
Inventory |
|
|
1,163 |
|
|
|
980 |
|
Prepaid expenses and other current assets |
|
|
551 |
|
|
|
481 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
62,758 |
|
|
|
67,302 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
1,935 |
|
|
|
1,958 |
|
Right of use asset, net |
|
|
577 |
|
|
|
768 |
|
Restricted cash |
|
|
182 |
|
|
|
182 |
|
Inventory, non-current |
|
|
562 |
|
|
|
76 |
|
Other assets, net |
|
|
99 |
|
|
|
130 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
66,113 |
|
|
$ |
70,416 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
769 |
|
|
$ |
730 |
|
Lease liability |
|
|
264 |
|
|
|
252 |
|
Accrued protocol expense |
|
|
125 |
|
|
|
98 |
|
Accrued radioactive waste disposal |
|
|
94 |
|
|
|
100 |
|
Accrued payroll and related taxes |
|
|
448 |
|
|
|
362 |
|
Accrued vacation |
|
|
256 |
|
|
|
259 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
1,956 |
|
|
|
1,801 |
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Lease liability, non-current |
|
|
324 |
|
|
|
524 |
|
Accrued payroll and related taxes, non-current |
|
|
- |
|
|
|
77 |
|
Asset retirement obligation |
|
|
632 |
|
|
|
608 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,912 |
|
|
|
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 |
|
|
159,578 |
|
|
|
158,589 |
|
Accumulated deficit |
|
|
(96,519 |
) |
|
|
(91,325 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders' equity |
|
|
63,201 |
|
|
|
67,406 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
66,113 |
|
|
$ |
70,416 |
|
Isoray,
Inc. and SubsidiariesConsolidated Statements of
Operations (Unaudited)(Dollars and shares in
thousands, except for per-share amounts) |
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, net |
|
$ |
2,910 |
|
|
$ |
2,600 |
|
|
$ |
8,290 |
|
|
$ |
7,343 |
|
Cost of sales |
|
|
1,469 |
|
|
|
1,238 |
|
|
|
4,600 |
|
|
|
3,568 |
|
Gross profit |
|
|
1,441 |
|
|
|
1,362 |
|
|
|
3,690 |
|
|
|
3,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
549 |
|
|
|
362 |
|
|
|
1,786 |
|
|
|
959 |
|
Sales and marketing |
|
|
687 |
|
|
|
581 |
|
|
|
2,150 |
|
|
|
1,781 |
|
General and administrative |
|
|
1,581 |
|
|
|
1,183 |
|
|
|
5,039 |
|
|
|
3,379 |
|
Loss on equipment disposal |
|
|
- |
|
|
|
2 |
|
|
|
- |
|
|
|
9 |
|
Total operating expenses |
|
|
2,817 |
|
|
|
2,128 |
|
|
|
8,975 |
|
|
|
6,128 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(1,376 |
) |
|
|
(766 |
) |
|
|
(5,285 |
) |
|
|
(2,353 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
29 |
|
|
|
21 |
|
|
|
91 |
|
|
|
27 |
|
Non-operating income |
|
|
29 |
|
|
|
21 |
|
|
|
91 |
|
|
|
27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(1,347 |
) |
|
|
(745 |
) |
|
|
(5,194 |
) |
|
|
(2,326 |
) |
Preferred stock dividends |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shareholders |
|
$ |
(1,347 |
) |
|
$ |
(745 |
) |
|
$ |
(5,194 |
) |
|
$ |
(2,329 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used
in computing net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
142,040 |
|
|
|
122,566 |
|
|
|
141,970 |
|
|
|
91,277 |
|
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