Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and
innovator in seed brachytherapy powering expanding treatment
options throughout the body, today announced its financial results
for the first quarter fiscal 2023 ended September 30, 2022 and
provided updates regarding the pending merger with Viewpoint
Molecular Targeting.
Isoray CEO Lori Woods said the pending merger signifies a
watershed moment in the evolution of the company. “The pending
merger represents an exciting transformational opportunity for
Isoray and all our stakeholders. It provides us with the
opportunity to build on Isoray’s existing business with a pipeline
of very exciting products that have the potential to change the
paradigm of patient care,” Woods said.
Revenue for the first quarter of fiscal 2023 decreased 33% to
$1.72 million versus $2.56 million in the prior year comparable
period. The year over year decline in revenue was primarily the
result of the isotope supply chain disruption in August that
limited the company’s ability to supply customers with product
during the quarter. The company’s core prostate brachytherapy
revenue decreased 41% versus the first quarter of fiscal 2022.
Prostate brachytherapy represented 68% of total revenue for the
first quarter of fiscal 2023 compared to 77% in the prior year
comparable period. Non-prostate brachytherapy revenue decreased 7%
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 24.1% for the three
months ended September 30, 2022 versus 40.1% in the prior year
comparable period. First quarter gross profit decreased to
$0.41 million versus $1.03 million in the first quarter of fiscal
2022. The year over year decrease was primarily the result of the
decrease in sales resulting from the lack of isotope within the
quarter which exceeded the decrease in total cost of product sales
versus the year ago quarter.
Total operating expenses in the first quarter were $4.62 million
compared to $3.30 million in the prior year period. Total
research and development expenses increased 1% versus the prior
year comparable period. The increase in research and development
expenses was primarily the result of increased payroll expense due
to annual merit increase and bonuses related to certain
merger-related milestones which was offset by lower market research
and consulting expenses versus the prior year comparable
period.
Sales and marketing expenses increased 5% versus the prior year
comparable period. The increase in sales and marketing expenses was
driven primarily by increased payroll and benefits expense due to
annual merit increases, new hires to replace sales professionals
that left in fiscal 2022 and an increase in compensation payments
to support sales professionals during the unplanned service
disruption to ensure they did not leave due to the competitive
labor environment. General and administrative expenses increased
69% versus the prior year comparable period. The increases in
general and administrative expenses were primarily the result of
legal expenses, third-party due diligence consulting, and
investment banking expenses related to the merger with Viewpoint
Molecular Targeting, Inc. Also contributing to the increase were
payroll and benefits expense due to annual merit increases, bonuses
related to merger-related milestones, D&O insurance expense,
increased audit and legal fees, and increased travel.
The net loss for the three months ended September 30, 2022 was
$4.07 million or ($0.03) per basic and diluted share versus a net
loss of $2.24 million or ($0.02) 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 142.1 million for the three months ended September
30, 2022 versus 141.9 million in the comparable prior year
period.
Cash, cash equivalents, and short-term investments at the end of
the first quarter of fiscal 2023 totaled $54.1 million and the
company had no long-term debt. Stockholders’ equity at the end of
the first quarter of fiscal 2023 totaled $57.7 million.
Conference Call Details
The company will hold an earnings conference call today,
November 10, at 4:30 p.m. ET/1:30 p.m. PT to discuss operating
results. To listen to the conference call, please dial (877)
545-0320. For callers outside the U.S., please dial (973)
528-0002.
The conference call will be simultaneously webcast and can be
accessed at https://www.webcaster4.com/Webcast/Page/2199/46923. The
webcast will be available until February 10, 2023 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 synergies and benefits of the proposed merger with
Viewpoint Molecular Targeting, Inc., the recovery from the supply
chain disruption, 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, 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 whether the proposed merger with Viewpoint
Molecular Targeting, Inc. is completed and, if so, whether the
anticipated benefits of the merger are realized, including whether
its pipeline of products reach the market, 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
a resurgence of the COVID-19 pandemic, whether all of our suppliers
shut their facilities down again, 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, whether revenues
recover from the supply chain distribution, 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) |
|
|
September 30, |
|
|
June 30, |
|
|
|
2022 |
|
|
2022 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
18,989 |
|
|
$ |
55,890 |
|
Short-term investments |
|
|
35,123 |
|
|
|
- |
|
Accounts receivable, net |
|
|
1,213 |
|
|
|
1,608 |
|
Inventory |
|
|
1,553 |
|
|
|
1,396 |
|
Prepaid expenses and other current assets |
|
|
662 |
|
|
|
435 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
57,540 |
|
|
|
59,329 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
1,999 |
|
|
|
1,976 |
|
Right of use asset, net (Note
9) |
|
|
445 |
|
|
|
512 |
|
Restricted cash |
|
|
182 |
|
|
|
182 |
|
Inventory, non-current |
|
|
2,271 |
|
|
|
2,333 |
|
Other assets, net |
|
|
101 |
|
|
|
107 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
62,538 |
|
|
$ |
64,439 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
2,495 |
|
|
$ |
966 |
|
Lease liability |
|
|
272 |
|
|
|
268 |
|
Accrued protocol expense |
|
|
201 |
|
|
|
150 |
|
Accrued radioactive waste disposal |
|
|
125 |
|
|
|
120 |
|
Accrued payroll and related taxes |
|
|
637 |
|
|
|
509 |
|
Accrued vacation |
|
|
271 |
|
|
|
253 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
4,001 |
|
|
|
2,266 |
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Lease liability, non-current |
|
|
186 |
|
|
|
256 |
|
Asset retirement obligation |
|
|
649 |
|
|
|
640 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
4,836 |
|
|
|
3,162 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock, $.001 par value; 7,000,000 shares authorized:
Series B: 5,000,000 shares allocated; no shares issued and
outstanding |
|
|
- |
|
|
|
- |
|
Common stock, $.001 par value; 200,000,000 shares
authorized; 142,112,766 and 142,040,266 shares issued and
outstanding |
|
|
142 |
|
|
|
142 |
|
Additional paid-in capital |
|
|
160,225 |
|
|
|
159,732 |
|
Accumulated deficit |
|
|
(102,665 |
) |
|
|
(98,597 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders' equity |
|
|
57,702 |
|
|
|
61,277 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
62,538 |
|
|
$ |
64,439 |
|
Isoray,
Inc. and Subsidiaries |
Consolidated Statements of Operations
(Unaudited) |
(Dollars
and shares in thousands, except for per-share
amounts) |
|
|
Three months ended |
|
|
|
September, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
Sales, net |
|
$ |
1,717 |
|
|
$ |
2,564 |
|
Cost of sales |
|
|
1,303 |
|
|
|
1,535 |
|
Gross profit |
|
|
414 |
|
|
|
1,029 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
708 |
|
|
|
702 |
|
Sales and marketing |
|
|
800 |
|
|
|
761 |
|
General and administrative |
|
|
3,114 |
|
|
|
1,840 |
|
Total operating expenses |
|
|
4,622 |
|
|
|
3,303 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(4,208 |
) |
|
|
(2,274 |
) |
|
|
|
|
|
|
|
|
|
Non-operating income: |
|
|
|
|
|
|
|
|
Interest income, net |
|
|
140 |
|
|
|
31 |
|
Non-operating income |
|
|
140 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(4,068 |
) |
|
|
(2,243 |
) |
Preferred stock dividends |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shareholders |
|
$ |
(4,068 |
) |
|
$ |
(2,243 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share |
|
$ |
(0.03 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares used
in computing net loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
142,072 |
|
|
|
141,915 |
|
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