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 2021 ended September 30, 2020.
Revenue for the first quarter of fiscal 2021
grew 3% to $2.38 million versus $2.32 million in the prior year
comparable period. The company’s core prostate brachytherapy
revenue declined 9% versus the first quarter of fiscal 2020 as
procedure volumes continue to be impacted by general patient and
physician concerns related to COVID-19. Prostate brachytherapy
represented 79% of total revenue for the first quarter of fiscal
2021 compared to 90% in the prior year comparable period.
Non-prostate brachytherapy revenue increased 104% 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. Net new physician
customer count for the twelve-month period ended September 30, 2020
increased 11% versus the prior year comparable period.
Gross profit as a percentage of revenues
decreased modestly to 52.3% for the three months ended September
30, 2020 versus 53.4% in the prior year comparable
period. First quarter gross profit increased 1% to $1.25
million versus $1.24 million in the first quarter of fiscal 2020,
as increased sales were offset by higher isotope unit costs
resulting from increased transit costs due to the COVID-19
pandemic’s decrease in international commercial flight capacity and
increased labor expenses.
Isoray CEO Lori Woods said, “Our fiscal first
quarter 2021 is representative of the current dynamics within the
markets we serve. As we continue to navigate these uncertain times,
I am encouraged by Isoray’s performance and I am increasingly
enthusiastic about the substantial opportunities for growth
ahead.”
“The fundamentals have not changed. Cancer does
not stop for the coronavirus and will ultimately need to be
treated. Cesium-131, or Cesium Blu as it is known commercially,
represents an important treatment option for patients and the
doctors who care for them,” Woods concluded.
Woods noted that the Company continues to
explore how Cesium-131 may be effective in the treatment of
additional cancers. Isoray recently entered into a research grant
agreement with a leading cancer center to study the treatment of
metastatic melanoma. In this immuno-oncology study, Cesium-131 will
be used in combination with an immune checkpoint inhibitor. Woods
also pointed to Isoray’s latest product innovation, which is the
focus of a recently filed provisional patent application for a
device designed to achieve directional dosing using Cesium-131
seeds.
Total operating expenses decreased 5% in the
first quarter to $1.96 million from $2.07 million in the prior year
period. Total research and development expenses increased 34%
versus the prior year comparable period. The increase in total
research and development expenses was primarily the result of
increased protocol expenses related to new research agreements as
well as a mutually agreed termination of a grant agreement in the
fiscal first quarter of 2020 which resulted in a reversal of the
accrual that was not repeated during the fiscal first quarter of
2021. This increase was partially offset by a reduction of
development expenses for the Blu Build™ delivery system versus
the comparable prior year period. Sales and marketing expenses
decreased 29% versus the prior year comparable period. The decrease
in sales and marketing expenses was driven primarily by significant
declines in travel and tradeshow costs due to COVID-19 restrictions
as well as decreased incentive compensation resulting from lower
revenue growth compared to the prior year comparable period.
General and administrative expenses decreased 3% versus the prior
year comparable period, primarily the result of decreased travel
costs due to COVID-19 restrictions as well as decreased employee
hiring expenses, which were partially offset by increased
insurance expenses.
The net loss for the three months ended
September 30, 2020 decreased 13% to $0.71 million or ($0.01) per
basic and diluted share versus a net loss of $0.82 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 68.9 million for the
three months ended September 30, 2020 versus 67.4 million in the
comparable prior year period.
Cash, cash equivalents, and certificates of
deposit at the end of the first quarter of fiscal 2021 totaled
$1.94 million and the company had no debt. Stockholders’ equity at
the end of the first quarter of fiscal 2021 totaled $5.1 million.
During the fiscal second quarter of 2021 the Company closed a
public offering of 18.27 million shares of its common stock at a
price of $0.52 per share. Gross proceeds, before underwriting
discounts, commissions and estimated offering costs, were
approximately $9.50 million.
Conference Call DetailsThe
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) 407-8035. For
callers outside the U.S., please dial (201) 689-8035.
The conference call will be simultaneously
webcast and can be accessed at
https://www.webcaster4.com/Webcast/Page/2199/38502 by clicking on
the link. The webcast will be available until November 10, 2021
following the conference call.
ContactsInvestor Relations:
Mark Levin (501) 255-1910Media and Public Relations: Sharon Schultz
(302) 539-3747
About IsorayIsoray, Inc.,
through its subsidiary, Isoray Medical, Inc., is the sole producer
of Cesium Blu brachytherapy seeds, which are expanding
brachytherapy treatment options throughout the body. Learn more
about this innovative Richland, Washington company and explore the
many benefits and uses of Cesium Blu by
visiting www.isoray.com. Join us on Facebook and follow us on
Twitter.
Safe Harbor StatementStatements
in this news release about Isoray’s future expectations, including:
the anticipated continued growth in revenues in fiscal year 2021,
the impact of COVID-19 on our financial results and the timing of
recovery in our brachytherapy procedures, if any, 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 further manufacturing and production process
improvements will be completed or will result in lower costs,
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 length and severity 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) |
|
September 30, |
|
June 30, |
|
2020 |
|
2020 |
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
1,940 |
|
|
$ |
2,392 |
|
Accounts receivable, net |
|
1,758 |
|
|
|
2,044 |
|
Inventory |
|
641 |
|
|
|
645 |
|
Prepaid expenses and other current assets |
|
407 |
|
|
|
426 |
|
|
|
|
|
Total current assets |
|
4,746 |
|
|
|
5,507 |
|
|
|
|
|
Property and
equipment, net |
|
1,814 |
|
|
|
1,735 |
|
Right of use
asset |
|
951 |
|
|
|
1,001 |
|
Restricted
cash |
|
182 |
|
|
|
181 |
|
Inventory,
non-current |
|
204 |
|
|
|
137 |
|
Other assets,
net |
|
128 |
|
|
|
138 |
|
|
|
|
|
Total assets |
$ |
8,025 |
|
|
$ |
8,699 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
758 |
|
|
$ |
654 |
|
Lease liability |
|
241 |
|
|
|
236 |
|
Accrued protocol expense |
|
91 |
|
|
|
35 |
|
Accrued radioactive waste disposal |
|
100 |
|
|
|
94 |
|
Accrued payroll and related taxes |
|
110 |
|
|
|
352 |
|
Accrued vacation |
|
222 |
|
|
|
204 |
|
|
|
|
|
Total current liabilities |
|
1,522 |
|
|
|
1,575 |
|
Long-term
liabilities: |
|
|
|
Lease liability, non-current |
|
715 |
|
|
|
769 |
|
Accrued payroll and related taxes, non-current |
|
108 |
|
|
|
55 |
|
Asset retirement obligation |
|
585 |
|
|
|
577 |
|
|
|
|
|
Total liabilities |
|
2,930 |
|
|
|
2,976 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
Preferred stock, $.001 par value; 7,000,000 shares authorized:
Series B: 5,000,000 |
|
|
|
shares allocated; 59,065 shares issued and outstanding |
|
- |
|
|
|
- |
|
Common stock, $.001 par value; 200,000,000 shares authorized; |
|
|
|
68,897,779 and 68,897,779 shares issued and outstanding |
|
69 |
|
|
|
69 |
|
Treasury stock |
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
93,677 |
|
|
|
93,592 |
|
Accumulated deficit |
|
(88,651 |
) |
|
|
(87,938 |
) |
|
|
|
|
Total stockholders' equity |
|
5,095 |
|
|
|
5,723 |
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
8,025 |
|
|
$ |
8,699 |
|
Isoray, Inc. and
Subsidiaries |
|
|
|
|
Consolidated
Statements of Operations (Unaudited) |
|
|
|
|
(Dollars and shares in
thousands, except for per-share amounts) |
|
|
|
|
|
|
|
|
|
|
Quarter ended September 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
Sales, net |
$ |
2,384 |
|
|
$ |
2,315 |
|
|
Cost of sales |
|
1,138 |
|
|
|
1,079 |
|
|
Gross profit |
|
1,246 |
|
|
|
1,236 |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
|
|
Propriety research and development |
|
312 |
|
|
|
233 |
|
|
Collaboration arrangement, net of reimbursement |
|
- |
|
|
|
- |
|
|
Total research and development |
|
312 |
|
|
|
233 |
|
|
Sales and marketing |
|
581 |
|
|
|
815 |
|
|
General and administrative |
|
1,067 |
|
|
|
1,097 |
|
|
Change in estimate of asset retirement obligation (Note 9) |
|
- |
|
|
|
(73 |
) |
|
Total operating expenses |
|
1,960 |
|
|
|
2,072 |
|
|
|
|
|
|
|
Operating loss |
|
(714 |
) |
|
|
(836 |
) |
|
|
|
|
|
|
Non-operating income: |
|
|
|
|
Interest income, net |
|
1 |
|
|
|
20 |
|
|
Change in fair value of warrant derivative liability |
|
- |
|
|
|
- |
|
|
Other income |
|
- |
|
|
|
- |
|
|
Non-operating income, net |
|
1 |
|
|
|
20 |
|
|
|
|
|
|
|
Net loss |
|
(713 |
) |
|
|
(816 |
) |
|
Preferred stock dividends |
|
(3 |
) |
|
|
(3 |
) |
|
|
|
|
|
|
Net loss applicable to common stockholders |
|
(716 |
) |
|
|
(819 |
) |
|
|
|
|
|
|
Basic and diluted loss per
share |
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
Weighted average shares used
in computing net loss per share: |
|
|
|
|
Basic and diluted |
|
68,898 |
|
|
|
67,388 |
|
|
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