8-K
Perspective Therapeutics, Inc. (CATX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT TO
SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
| Date of report (Date of earliest event reported): September 9, 2021 | ||
|---|---|---|
| Isoray, Inc.<br><br> <br>(Exact Name of Registrant as Specified in Charter) | ||
| Delaware<br> (State or Other Jurisdiction<br> of Incorporation) | 001-33407<br> (Commission<br> File Number) | 41-1458152<br> (IRS Employer<br> Identification No.) |
350 Hills Street, Suite 106, Richland, Washington 99354
(Address of Principal Executive Offices) (Zip Code)
(509) 375-1202
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.001 par value | ISR | NYSE American |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On September 21, 2021, the Company issued a press release announcing its financial results for the fourth quarter and fiscal year ended June 30, 2021, the text of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Current Report on Form 8-K, including the exhibits, is furnished pursuant to Item 2.02 and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
In addition to historic information, this report, including the exhibits, contains forward-looking statements regarding events, performance, and financial trends. Various factors could affect future results and could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Some of those factors are identified in the Company’s periodic reports filed with the Securities and Exchange Commission, the most recent of which is the Company’s Annual Report on Form 10-K for the year ended June 30, 2020 and on Form 10-Q for the periods ended September 30, 2020, December 31, 2020 and March 31, 2021.
Item 8.01 Other Events.
On September 9, 2021, the Company issued a press release announcing that it will be holding a teleconference to discuss its financial results for the fourth quarter and fiscal year ended June 30, 2021, the text of which is attached hereto as Exhibit 99.2.
Additionally, the Company will hold its fiscal 2022 annual shareholder meeting on Tuesday, December 7, 2021, beginning at 11:00 a.m. Pacific Time. The board of directors has established October 14, 2021, as the record date for determining shareholders entitled to vote at the meeting.
The deadline for the receipt of any shareholder proposals for inclusion in the Company’s proxy materials was September 10, 2021. Proposals submitted pursuant to Rule 14a-8 of the Securities Exchange Act of 1934, as amended, must comply with the requirements set forth in Rule 14a-8. Shareholder proposals not submitted pursuant to Rule 14a-8 must comply with the requirements set forth in the Company’s bylaws. The Company intends to view any proposals received after September 10, 2021, as not having been received within the time periods set forth in Rule 14a-8 or the Company’s bylaws, as applicable. Any proposal submitted outside this timeframe will not be considered timely and will be excluded from consideration at the annual meeting.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| 99.1 | Press release issued by Isoray, Inc., dated September 21, 2021. |
|---|---|
| 99.2 | Press release issued by Isoray, Inc., dated September 9, 2021. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: September 21, 2021
Isoray, Inc., a Delaware corporation
By: /s/ Lori A. Woods
Lori A. Woods, CEO
ex_285498.htm
Exhibit 99.1
Isoray Announces Fourth Quarter and
Full-Year Fiscal Year End 2021 Financial Results
Record Full Year Revenue
Fiscal Fourth Quarter Revenue Increased 19% Year-Over-Year
RICHLAND, WASHINGTON – September 21, 2021 – Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy powering expanding treatment options throughout the body, today announced financial results for the fiscal fourth quarter and full-year ended June 30, 2021.
Revenue for the fourth quarter of fiscal 2021 grew 19% to $2.71 million versus $2.28 million in the prior year comparable period. The Company’s core prostate brachytherapy revenue grew 5% when compared to the fiscal fourth quarter of 2020. Prostate brachytherapy represented 74% of total revenue for the fourth quarter of fiscal 2021 compared to 84% in the prior year comparable period. Record non-prostate brachytherapy revenue increased 92% 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 increased to 49.7% for the three months ended June 30, 2021, versus 47.0% in the prior year comparable period. Fourth quarter gross profit increased 26% to $1.35 million versus $1.07 million in the fourth quarter of fiscal 2020, largely attributed to increased sales which were partially offset by higher non-isotope material costs and increased payroll and benefits expense due to greater headcount versus the prior year comparable period.
Isoray CEO Lori Woods said, “Isoray’s business is more diversified than it has ever been as represented by a quarter of the fourth quarter revenue being derived from our rapidly growing non-prostate cancer treatments. We continue to believe that the core prostate business is very well-positioned, and we expect to return to the higher pre-pandemic growth rates over time. We also look to continue to selectively diversify our portfolio of targeted radiation therapies and thus our market opportunities and revenue streams going forward.”
Woods concluded, “With the talent we have assembled and our focus on growth and new opportunities, we intend to expand Isoray’s role as a leader in the broader targeted radiation therapy market.”
Total operating expenses increased 8% in the fourth quarter to $2.44 million compared to $2.26 million in the prior year comparable period. Total research and development expenses increased 45% 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 and higher market research expenses versus the prior year comparable period. Sales and marketing expenses decreased 4% versus the prior year comparable period. The decreases in sales and marketing expenses were driven primarily by decreased incentive compensation which were partially offset by increased travel expenses compared to the prior year comparable period. General and administrative expenses increased 5% 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 employment hiring expenses which were partially offset by decreased public company related expenses versus prior year comparable period. Historically, the majority of annual employee and director stock grants have been granted in the fiscal fourth quarter, however this year’s awards were granted in July 2021, subsequent to the close of the fiscal fourth quarter 2021, thus reducing share-based stock compensation expense in the fourth quarter and full-year fiscal year-end 2021 compared to the prior year quarter and fiscal year.
The net loss for the three months ended June 30, 2021, was $1.06 million or ($0.01) per basic and diluted share versus a net loss of $1.19 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 141.7 million for the three months ending June 30, 2021, versus 68.1 million in the comparable prior year period.
Revenue for the full year ended June 30, 2021 increased 4% to a record $10.05 million versus $9.68 million in the prior fiscal year. Prostate brachytherapy represented 78% of total revenue for fiscal 2021 compared to 86% for the fiscal year 2020. The Company’s core prostate brachytherapy product sales declined 6% for the fiscal year 2021 but were more than offset by 68% growth in non-prostate revenue. Full year non-prostate revenue growth was driven by growth in sales to treat brain cancers, including sales of GammaTile Therapy, lung, and head and neck cancers. Gross profit as a percentage of revenue declined to 50.9% for the year ended June 30, 2021 versus 52.9% in the prior fiscal year. 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. The company anticipates gross margins in the first and second quarters of fiscal year 2022 to be negatively impacted by approximately 5-10 percentage points as a result of temporary increased costs of goods sold associated with greater isotope purchases related to the initial setup of a second nuclear reactor to support future growth. Gross profit for the full year ended June 30, 2021 was flat at $5.12 million.
Total operating expenses for the 2021 fiscal year decreased to $8.57 million compared to $8.60 million in the prior fiscal year. Total research and development expenses increased 27% versus the prior fiscal year. The year over year increase in total research and development expenses was primarily the result of increases in protocol, payroll, and market research consulting expenses versus the prior fiscal year. Sales and marketing expenses decreased 18% versus the prior year comparable period. The decrease in sales and marketing expenses were primarily driven by decreased incentive compensation and declines in travel and convention costs due to COVID-19 when compared to fiscal year 2020. General and administrative expenses increased 3% versus the prior year comparable period. The increase in general and administrative expenses was driven primarily by increased payroll and benefits expenses due to higher headcount and employment hiring expenses, and insurance premiums which were partially offset by decreases in public company related, legal, and travel expenses when compared to fiscal year 2020.
The net loss for the fiscal year ended June 30, 2021 improved to $3.39 million or ($0.03) per basic and diluted share versus a net loss of $3.47 million or ($0.05) 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 103.8 million for the fiscal year ended June 30, 2021, versus 67.6 million in the prior year comparable year.
Cash, cash equivalents, and certificates of deposit at the end of the fiscal year ended June 30, 2021 totaled $63.8 million and the company had no long-term debt. Stockholders’ equity at the end of the fiscal year ended June 30, 2021 totaled $67.4 million.
Conference Call Details
The company will hold an earnings conference call today, September 21, at 4:30 p.m. ET/1:30 p.m. PT to discuss operating results. To listen to the conference call, please dial 844-369-8770. For callers outside the U.S., please dial 862-298-0840.
The conference call will be simultaneously webcast and can be accessed at https://www.webcaster4.com/Webcast/Page/2199/42729. The webcast will be available until December 21, 2021.
Contacts
Investor Relations: Mark Levin (501) 255-1910
Media and Public Relations: **** Sharon Schultz (302) 539-3747
About Isoray
Isoray, 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 Statement
Statements in this news release about Isoray’s future expectations, including: the anticipated results in fiscal year 2022, the impact of COVID-19 on our financial results and the 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 our gross margins will decease solely in the two quarters ending December 2021 and the ultimate amount of the decline in gross margins, 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 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 ultimate amount of barium we need to order and resulting costs related thereto and timing of the usage as well as volume ordered to set up the second nuclear reactor we need, 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 | |||||
| (In thousands, except shares) | |||||
| June 30, | |||||
| --- | --- | --- | --- | --- | --- |
| 2020 | |||||
| ASSETS | **** | **** | **** | **** | **** |
| Current assets: | |||||
| Cash and cash equivalents | 63,828 | $ | 2,392 | ||
| Accounts receivable, net | 2,013 | 2,044 | |||
| Inventory | 980 | 645 | |||
| Prepaid expenses and other current assets | 481 | 426 | |||
| Total current assets | 67,302 | 5,507 | |||
| Property and equipment, net | 1,958 | 1,735 | |||
| Right of use asset, net | 768 | 1,001 | |||
| Restricted cash | 182 | 181 | |||
| Inventory, non-current | 76 | 137 | |||
| Other assets, net | 130 | 138 | |||
| Total assets | 70,416 | $ | 8,699 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | **** | **** | **** | **** | **** |
| Current liabilities: | |||||
| Accounts payable and accrued expenses | 730 | $ | 654 | ||
| Lease liability | 252 | 236 | |||
| Accrued protocol expense | 98 | 35 | |||
| Accrued radioactive waste disposal | 100 | 94 | |||
| Accrued payroll and related taxes | 362 | 352 | |||
| Accrued vacation | 259 | 204 | |||
| Total current liabilities | 1,801 | 1,575 | |||
| Non-current liabilities: | |||||
| Lease liability, non-current | 524 | 769 | |||
| Accrued payroll and related taxes, non-current | 77 | 55 | |||
| Asset retirement obligation | 608 | 577 | |||
| Total liabilities | 3,010 | 2,976 | |||
| Commitments and contingencies | |||||
| Stockholders' equity: | |||||
| Preferred stock, .001 par value; 7,000,000 shares authorized: Series B: 5,000,000 shares allocated; no and 59,065 shares issued and outstanding | - | - | |||
| Common stock, .001 par value; 200,000,000 shares authorized; 141,915,266 and 68,897,779 shares issued and outstanding | 142 | 69 | |||
| Additional paid-in capital | 158,589 | 93,592 | |||
| Accumulated deficit | (91,325 | ) | (87,938 | ) | |
| Total stockholders' equity | 67,406 | 5,723 | |||
| Total liabilities and stockholders' equity | 70,416 | $ | 8,699 |
All values are in US Dollars.
| Isoray, Inc. and Subsidiaries | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Consolidated Statements of Operations | ||||||||||||
| (Dollars and shares in thousands, except for per-share amounts) | ||||||||||||
| Three months ended June 30, | Twelve months ended June 30, | |||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Sales, net | $ | 2,710 | $ | 2,279 | $ | 10,053 | $ | 9,680 | ||||
| Cost of sales | 1,364 | 1,208 | 4,932 | 4,556 | ||||||||
| Gross profit | 1,346 | 1,071 | 5,121 | 5,124 | ||||||||
| Operating expenses: | ||||||||||||
| Research and development | ||||||||||||
| Proprietary research and development | 468 | 322 | 1,427 | 1,126 | ||||||||
| Collaboration arrangement, net of reimbursement | - | - | - | - | ||||||||
| Total research and development | 468 | 322 | 1,427 | 1,126 | ||||||||
| Sales and marketing | 659 | 690 | 2,440 | 2,976 | ||||||||
| General and administrative | 1,312 | 1,248 | 4,691 | 4,571 | ||||||||
| Gain on equipment disposals | 9 | - | ||||||||||
| Change in estimate of asset retirement obligation | - | - | - | (73 | ) | |||||||
| Total operating expenses | 2,439 | 2,260 | 8,567 | 8,600 | ||||||||
| Operating loss | (1,093 | ) | (1,189 | ) | (3,446 | ) | (3,476 | ) | ||||
| Non-operating income: | ||||||||||||
| Interest income | 32 | 1 | 59 | 30 | ||||||||
| Other income | - | - | - | - | ||||||||
| Non-operating income, net | 32 | 1 | 59 | 30 | ||||||||
| Net loss | (1,061 | ) | (1,188 | ) | (3,387 | ) | (3,446 | ) | ||||
| Preferred stock dividends | - | (3 | ) | (3 | ) | (11 | ) | |||||
| Net loss applicable to common shareholders | $ | (1,061 | ) | $ | (1,191 | ) | $ | (3,390 | ) | $ | (3,457 | ) |
| Basic and diluted loss per share | $ | (0.01 | ) | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.05 | ) |
| Weighted average shares used in computing net loss per share: | ||||||||||||
| Basic and diluted | 141,673 | 68,075 | 103,841 | 67,601 |
ex_285337.htm
Exhibit 99.2
Isoray To Announce Fourth Quarter and Fiscal Year End 2021
Financial Results on September 21, 2021
Conference Call is Tuesday, September 21 at 4:30 p.m. ET/1:30 p.m. PT
RICHLAND, WASHINGTON – September 9, 2021 – Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in brachytherapy powering expanding treatment options throughout the body, today announced that it will host a conference call to discuss its financial results for the fourth quarter and fiscal year ended June 30, 2021 on Tuesday, September 21, 2021, at 4:30 p.m. Eastern Time. The Company will issue a press release announcing its financial results for the fourth quarter and fiscal year ended June 30, 2021 after the close of the U.S. stock markets on September 21, 2021.
To listen to the conference call, please dial 844-369-8770. For callers outside the U.S., please dial 862-298-0840.
The conference call will be simultaneously webcast and can be accessed at https://www.webcaster4.com/Webcast/Page/2199/42729. The webcast will be available until December 21, 2021 following the conference call.
Contact
Investor Relations: Mark Levin (501) 255-1910
Media and Public Relations: **** Sharon Schultz (302) 539-3747
About Isoray
Isoray, 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.