Form 8-K Isoray, Inc. For: Apr 29

 

 

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): April 29, 2021

Isoray, Inc.

(Exact name of registrant as specified in its charter)

  

Delaware (State or other jurisdiction of incorporation)

001-33407 (Commission File Number)

41-1458152 (IRS Employer 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 May 13, 2021, the Company issued a press release announcing its financial results for the third quarter of fiscal 2021 ended March 31, 2021, the text of which is attached hereto as Exhibit 99.1.

 

The information in this item of 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.

 

Item 8.01     Other Events.

 

On April 29, 2021, the Company issued a press release announcing that it will be holding a teleconference to discuss its financial results for the third quarter of fiscal 2021 ended March 31, 2021, the text of which is attached hereto as Exhibit 99.2.

 

Item 9.01      Financial Statements and Exhibits.

 

(d)     Exhibits

 

99.1

Press release issued by Isoray, Inc., dated May 13, 2021.

99.2

Press release issued by Isoray, Inc., dated April 29, 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: May 13, 2021

 

Isoray, Inc., a Delaware corporation

 

 

 

 By: /s/ Lori A. Woods          

       Lori A. Woods, CEO

Exhibit 99.1

 

Isoray Announces Third Quarter Fiscal 2021 Financial Results

 

Revenue Increased 10% Sequentially 
Record Non-Prostate Brachytherapy Revenue Increased 20% Year-Over-Year

 

RICHLAND, Wash., May 13, 2021 (GLOBE NEWSWIRE) --  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 third quarter fiscal 2021 ended March 31, 2021.

 

Revenue for the third quarter of fiscal 2021 declined 10% to $2.60 million versus the record $2.88 million in the prior year comparable period. Revenue increased 10% sequentially from the fiscal second quarter ended December 31,2020. The company’s core prostate brachytherapy revenue declined 16% versus the record third quarter of fiscal 2020 as procedure volumes continued to be impacted by the COVID-19 pandemic. However, third quarter prostate increased 7% sequentially from the second quarter of fiscal 2021. Prostate brachytherapy represented 78% of total revenue for the third quarter of fiscal 2021 compared to 84% in the prior year comparable period. Record non-prostate brachytherapy revenue increased 20% versus the prior year comparable period. The majority of non-prostate brachytherapy revenue in the quarter was comprised of sales to treat brain and lung cancers.  

 

Gross profit as a percentage of revenues for the three months ended March 31, 2021 was 52.4% versus 59.2% in the prior year comparable period. Third quarter gross profit decreased 20% to $1.36 million versus $1.71 million in the record third quarter of fiscal 2020.

 

Isoray CEO Lori Woods said, “Despite the pandemic, we are more optimistic than ever before about our future path and the success of our efforts. We are encouraged by the sequential growth we experienced in our core prostate brachytherapy business as well as our growing strength in adoptions for the treatment of other cancers. Going forward, we remain focused on executing our strategic plans for continued growth. We believe that Isoray’s enhanced capital position will be pivotal in allowing us to capitalize on growth opportunities.”

 

Total operating expenses for the third quarter of fiscal 2021 declined 6% to $2.13 million versus $2.25 million in the prior year comparable period. Total research and development expenses increased 23% versus the prior year comparable period. The increase in total research and development expenses was primarily the result of increased payroll, benefits, and share based compensation and increased protocol expenses which were 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 28% versus the prior year comparable period. The decrease in sales and marketing expenses was driven primarily by 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 increased 2% versus the prior year comparable period, primarily the result of increased director and officer insurance expense, increased payroll, and IT consulting expenses, which were partially offset by decreased travel costs due to COVID-19 restrictions as well as decreased employee hiring costs and legal fees.

 

The net loss for the three months ended March 31, 2021 was $0.75 million or ($0.01) per basic and diluted share versus a net loss of $0.55 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 122.6 million for the three months ended March 31, 2021 versus 67.6 million in the comparable prior year period.

 

 

For the first nine months of fiscal 2021 ended March 31, 2021, revenue decreased modestly to $7.34 million versus $7.40 million in the prior year comparable nine-month period. Prostate brachytherapy represented 79% of total revenue for the first nine months of fiscal 2021 compared to 87% for the first nine months of fiscal 2020. Total operating expenses for the first nine months of fiscal 2021 decreased 3% to $6.13 million, versus $6.34 million in the prior year comparable nine-month period. The net loss for the first nine months of fiscal 2021 was $2.33 million, or ($0.03) per basic and diluted share, compared to a net loss of $2.26 million, or ($0.03) per basic and diluted share, in the prior year comparable nine-month period. Basic and diluted per share results are based on weighted average shares outstanding of approximately 91.3 million for the nine months ended March 31, 2021, versus 67.4 million in the comparable prior year nine-month period.

 

Cash, cash equivalents, and certificates of deposit at the end of the third quarter of fiscal 2021 totaled $64.8 million and the company had no long-term debt. Stockholders’ equity at the end of the third quarter of fiscal 2021 totaled $68.1 million.

 

Conference Call Details
The company will hold an earnings conference call today, May 13, 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/2199/40855. The webcast will be available until August 13, 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. Join us on Facebook. Follow us on Twitter.

 

Safe Harbor Statement
Statements in this news release about Isoray’s future expectations, including: the anticipated growth in revenues in the remainder of fiscal year 2021, 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 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 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) 

 

		March 31,				June 30,
		2021				2020
ASSETS
Current assets:
Cash and cash equivalents		$	64,841			$	2,392
Accounts receivable, net			2,019				2,044
Inventory			731				645
Prepaid expenses and other current assets			483				426
Total current assets			68,074				5,507
Property and equipment, net			1,885				1,735
Right of use asset, net			830				1,001
Restricted cash			182				181
Inventory, non-current			192				137
Other assets, net			117				138
Total assets		$	71,280			$	8,699
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses		$	992			$	654
Lease liability			249				236
Accrued protocol expense			115				35
Accrued radioactive waste disposal			99				94
Accrued payroll and related taxes			221				352
Accrued vacation			240				204
Total current liabilities			1,916				1,575
Non-current liabilities:
Lease liability, non-current			589				769
Accrued payroll and related taxes, non-current			77				55
Asset retirement obligation			600				577
Total liabilities			3,182				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; 141,465,266 and 68,897,779 shares issued and outstanding			141				69
Additional paid-in capital			158,221				93,592
Accumulated deficit			(90,264	)			(87,938	)
Total stockholders' equity			68,098				5,723
Total liabilities and stockholders' equity		$	71,280			$	8,699

 

 

Isoray, Inc. and Subsidiaries
Consolidated Statements of Operations (Unaudited)
(Dollars and shares in thousands, except for per-share amounts)

 

		Three months ended								Nine months ended
		March 31,								March 31,
		2021				2020				2021				2020
Sales, net		$	2,600			$	2,880			$	7,343			$	7,401
Cost of sales			1,238				1,174				3,568				3,348
Gross profit			1,362				1,706				3,775				4,053
Operating expenses:
Research and development:			362				294				959				804
Sales and marketing			581				805				1,781				2,286
General and administrative			1,183				1,155				3,379				3,323
Loss on equipment disposal			2				-				9				-
Gain on change in estimate of asset retirement obligation			-				-				-				(73	)
Total operating expenses			2,128				2,254				6,128				6,340
Operating loss			(766	)			(548	)			(2,353	)			(2,287	)
Non-operating income:
Interest income, net			21				3				27				29
Non-operating income			21				3				27				29
Net loss			(745	)			(545	)			(2,326	)			(2,258	)
Preferred stock dividends			-				(3	)			(3	)			(8	)
Net loss applicable to common stockholders		$	(745	)		$	(548	)		$	(2,329	)		$	(2,266	)
Basic and diluted loss per share		$	(0.01	)		$	(0.01	)		$	(0.03	)		$	(0.03	)
Weighted average shares used in computing net loss per share:
Basic and diluted			122,566				67,558				91,277				67,444

 

 

Exhibit 99.2

 

 

Isoray To Announce Third Quarter Fiscal 2021

Financial Results on May 13, 2021

 

Conference Call is Thursday, May 13 at 4:30 p.m. ET/1:30 p.m. PT

 

RICHLAND, WASHINGTON – April 29, 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 third quarter fiscal 2021 ended March 31, 2021 on Thursday, May 13, 2021, at 4:30 p.m. Eastern Time. The Company will issue a press release announcing its financial results for the third quarter fiscal 2021 after the close of the U.S. stock markets on May 13, 2021.

 

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/2199/40855. The webcast will be available until August 13, 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. Join us on Facebook. Follow us on Twitter.

---

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

---

You May Also Be Interested In

• Interactive Strength Inc. (Nasdaq: TRNR) Strengthens Balance Sheet by Partially Converting Senior Loan to Equity and Extending the Maturity
• Form 8.3 - Lok’n Store Group PLC
• Form 8.3 - ABRDN European Logistics