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): August 13, 2018

 

ISORAY, INC.

(Exact name of registrant as specified in its charter)

 

Minnesota
(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)

 

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 p r ovisions:

 

 

 

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))

 

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  1.01      Entry into a Material Definitive Agreement.

 

On August 15, 2018, IsoRay Medical, Inc. (“Medical”), a wholly owned subsidiary of IsoRay, Inc. (the “Company”), entered into a Professional Services Agreement (the “Global IR Agreement”) with J. Squared Partners, Inc., DBA Global IR Group (“Global IR”).

 

Pursuant to the Global IR Agreement, Global IR will provide investor relations services on behalf of Medical, including strategic counsel, editorial commentary on press releases and investor presentations, and interfacing with industry analysts, investors and shareholders.  The term of the Global IR Agreement is six months, subject to automatic renewals.  Either party may terminate the Global IR Agreement with or without cause with 30 days’ written notice.

 

As compensation for the services, Medical will pay Global IR a monthly stipend of $10,000, plus reimbursement for costs and expenses.  Additionally, Global IR will receive a success fee of $5,000 for each sell-side firm that initiates research coverage of the Company.  Services for activities related to mergers, acquisitions, spin-offs, divestitures, or financing activities with a value in excess of $3 million will be billed at a rate of $350 per hour.

 

Additionally, on August 13, 2018, Medical entered into a Services Agreement (the “Schultz Agreement”) with Schultz Public Relations, LLC, a Delaware limited liability company (“Schultz”).

 

Pursuant to the Schultz Agreement, Schultz will provide public relations services, including support of message development in concert with Medical, writing of press releases with input from Medical and additional parties as appropriate, and media relations.  The term of the Schultz Agreement is 12 months commencing August 15, 2018, subject to automatic six month renewals.  Either party may terminate the Schultz Agreement with or without cause with 90 days’ written notice.

 

As compensation for the services, Medical will pay Schultz a monthly retainer of $5,000, plus reimbursement for costs and expenses.  Services performed outside the defined scope of work will be billed at a rate of $250 per hour or a per-project task fee.

 

The foregoing summaries of the Global IR Agreement and the Schultz Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the agreements.  Copies of the agreements are attached hereto as Exhibits 10.1 and 10.2 and are incorporated herein by reference.

 

Item  1.02      Termination of a Material Definitive Agreement.

 

On September 24, 2018, Medical notified The Curators of the University of Missouri, a public corporation of the State of Missouri, contracting on behalf of its University of Missouri Research Reactor (“MURR”), of Medical’s decision to terminate the Irradiation Services Agreement dated November 29, 2016, between the parties (the “Agreement”).  The Agreement provided for the irradiation of natural or enriched barium to produce Ba-131, which is used by Medical to produce Cesium-131 for use in its product. The decision to terminate the Agreement was the result of a thorough review by Medical of the capacity and cost of isotope produced at the MURR facility.

 

The Agreement may be terminated by either party upon three months’ written notice.  Pursuant to the terms of the Agreement, the termination is effective three months following the notice.  There are no early termination penalties. 

 

Item  2.02      Results of Operations and Financial Condition .

 

On September 25, 2018, the Company issued a press release announcing its financial results for the fourth quarter and fiscal year ended June 30, 2018, 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, 2018.

 

 

 

 

Item  8.01      Other Events .

 

On September 10, 2018, 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, 2018, the text of which is attached hereto as Exhibit 99.2.

 

Additionally, the Company will hold its fiscal 2019 annual shareholder meeting on Tuesday, December 18, 2018, beginning at 11:00 a.m. local time, in Richland, WA.  The board of directors has established October 24, 2018, 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 July 6, 2018.  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 July 6, 2018, 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.

 

I tem 9.01       Financial Statements and Exhibits .

 

(d)       Exhibits

 

  10.1 Professional Services Agreement, dated August 15, 2018, between IsoRay Medical, Inc. and J. Squared Partners, Inc., DBA Global IR Group.
  10.2 Services Agreement, dated August 13, 2018, between IsoRay Medical, Inc. and Schultz Public Relations, LLC.
 

99.1

Press release issued by IsoRay, Inc., dated September 25, 2018.

  99.2 Press release issued by IsoRay, Inc., dated September 10, 2018.

 

 

 

 

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 25 , 2018

 

IsoRay, Inc., a Minnesota corporation

 

 

 

By: /s/ Lori A. Woods           

       Lori A. Woods, Interim CEO

Exhibit 10.1

 

J SQUARED PARTNERS. INC.

DBA ‘GLOBAL IR GROUP’

2931 Ridge Road

Suite 101-MB140

Rockwall, TX 75032

 

PROFESSIONAL SERVICES AGREEMENT

 

J SQUARED PARTNERS, INC. (“Consultant”) and ISORAY MEDICAL, INC. (“Client”) hereby agree that Consultant will provide investor relations services to Client on the terms set forth below (“Professional Services Agreement”) for a period of six (6) months,

 

1.     Effective Date. This Professional Services Agreement is effective August 15, 2018 and will automatically renew, unless notice is given per the terms in paragraph nine (9) hereof, at least sixty (60) days ahead of the expiration of the agreement.

 

2.     Nature and Scope of Services. Client hires Consultant to provide investor relations services (“IR Services’) on behalf of Client, including without limitation strategic counsel; editorial commentary on press releases and investor presentations; interfacing with industry analysts, investors and shareholders; advisement on Client analyst day events; conducting Client site tours; attending within reason industry conferences and investor events; and such other services as Client may request from time to time. Consultant will interface and communicate with those representatives of Client as designated from time to time by Client.

 

3.     Client’s Duties. Client understands that Consultant will rely upon the materiality and accuracy of the information provided by Client, including without limitation investor information, SEC filings, fiscal reports, accountings, projections, and other regulatory and financial information. Client agrees to use its best efforts to ensure the accuracy of all information provided to Consultant with the express understanding that Consultant will use such information in the performance of the IR Services, including without limitation the dissemination thereof to investors, analysts, industry trade groups, and members of the public. Client acknowledges that the accuracy of the information disseminated to Consultant is critical to the proper performance of the IR Services, and inaccurate information could impose legal liabilities on Consultant even in Consultant’s proper discharge of the IR Services. Consequently, Client agrees to defend, indemnify and hold Consultant harmless from and against any and all allegations, losses, claims, actions, demands, damages, liabilities or expenses (including attorney’s fees) arising from or relating to inaccuracies, omissions, or other deficiencies of any nature whatsoever in the information provided to Consultant.

 

4.     Professional Service Fees. Client agrees to pay Consultant a fixed monthly stipend of $10,000.00 (“Stipend”) for the performance of the IR Services. The Stipend does not cover costs and other charges identified in paragraph five (5) hereof. The Stipend shall be due and paid via direct deposit on the fifteenth of the month for each month or part thereof of this Professional Services Agreement, and Consultant shall deliver to Client a billing statement each month in accordance with paragraph six () for all expenses incurred hereof.

 

Success Fee Milestones: Client agrees to pay Consultant a “Success Fee” of $5,000.00 for each sell-side tirm that initiates research coverage on IsoRay.

 

Additional fees Consultant services do not include activities specifically related to “Mergers”. “Acquisitions”, “Spin-offs”, “Divestitures” or “Financing Activities” with a value in excess of S3 million. Work related to these activities will be billed incrementally at the rate of $350.00 per hour.

 

 

 

 

Should this contract be terminated by either party, all compensation will be prorated based on the termination date and paid to Consultant.

 

5.     Costs and Other Charges. Consultant may incur various costs and expenses in performing the IR Services. Client agrees to pay for all costs, disbursements and expenses in addition to the Stipend. The costs and expenses commonly include without limitation travel costs, hotel costs, printing, and other similar items. Consultant will seek the consent of Client before incurring any expenses in excess of $1,000.00 and all costs and expenses will be charged at Consultant’s actual cost.

 

6.     Billing Statements. Upon request, Consultant will send Client monthly statements for the Stipend plus additional costs incurred, if any. Each statement will be payable within 14 days of its mailing date.

 

7.     Termination. Either Client or Consultant may terminate this Professional Services Agreement upon thirty (30) days written notice with or without cause. Upon notification of termination of this Professional Services Agreement by Client to Consultant the “Stipend” for the thirty (30) day period will be due and payable within five (5) days. When Consultant’s services conclude, any additional charges incurred will immediately become due and payable.

 

8.     Disclaimer of Guarantees and Estimate of Fees. Consultant will strive to provide quality IR Services for Client. Client has not, and reasonably cannot, guarantee any particular result in the handling of Client’s matters, as the ultimate outcome of Consultant’s services are influenced by the market and other forces outside of the direct control of Consultant. Consultant will endeavor to explain the potential ramifications associated with decisions made in the course of rendering the IR Services, however, any comments concerning the outcome of any matter are expressions of Consultant’s opinion only. Consultant will strive to provide cost-effective IR Services for Client and may provide Client with estimates for extraordinary services and associated costs outside the scope of the IR Services Stipend Any estimate of such fees given by Consultant shall not be a guarantee, and actual costs may vary from estimates given.

 

9.     Notices. All notices and other communications called for or contemplated hereunder shall be in wnting and shall be deemed to have been duly given when delivered personally or three (3) calendar days after the dated and mailed by First Class United States Mail, postage prepaid, addressed to the parties or their successor in interest at the following address or such other addresses as the parties may designate from time to time.

 

 

If to Client:

Lori Woods

IsoRay Medical, Inc

350 Hills Street

Suite 106

Richland, WA 99354

     
  If to Consultant:

Gar Jackson

J Squared Partners

2931 Ridge Road

Suite 101-1V1B140

Rockwall, TX 75032

 

10.     Entire Agreement . This Professional Services Agreement contains the entire agreement of the parties. No other agreement, statement, or promise made on or before the effective date of this Agreement will be binding on the parties.

 

2

 

 

11.     Negotiated Agreement. This Professional Services Agreement, in its final form, is the result of the combined efforts of the parties hereto and that should any provision of this Professional Services Agreement be found to be ambiguous in any way, such ambiguity shall not be resolved by construing this Professional Services Agreement in favor of or against any party herein but rather by construing the terms of this Professional Services Agreement fairly and reasonably in accordance with their generally accepted meaning and the purposes for which this Professional Services Agreement is made.

 

12.     Severability in the Event of Partial Invalidity. If any provision of this Professional Services Agreement is held in whole or in part to be unenforceable for any reason, the remainder of that provision and of the entire Professional Services Agreement will be severable and remain in effect.

 

13.     Modification by Subsequent Agreement. This Professional Services Agreement may be modified by subsequent agreement of the parties only by an instrument in writing signed by both of them.

 

14.     Counterparts. This Professional Services Agreement may be signed in counterparts, and signatures transmitted by facsimile or scanned electronic copies of the parties’ signatures are permitted and are deemed effective.

 

 

ISORAY MEDICAL, INC.

 

 

 

 

 

 

By:

/s/  Lori A. Woods

 

 

 

Lori Woods, Interim CEO

 

 

 

J SQUARED PARTNERS, INC.

 

 

 

 

 

 

By:

/s/  Gar Jackson

 

 

 

Gar Jackson, President

 

 

 

3

Exhibit 10.2

 

SCHULTZ PUBLIC RELATIONS, LLC

Services AGREEMENT

 

This Agreement (“Agreement”) is made between Schultz Public Relations, LLC, a Delaware Limited Liability Company (“SPR”) and, IsoRay Medical, Inc. (“Corporation” or “Client”), with respect to the following:

 

RECITALS

 

WHEREAS, SPR is in the business of providing public relations and media relations/communications services to privately held and publicly held corporations; and

 

WHEREAS, the Client is a legal corporation, and wishes to retain the services of SPR the following Agreement is offered.

 

AGREEMENT

 

CONSIDERATION of the mutual promises made by SPR and the Client, and the terms and conditions hereafter set forth, the receipt and adequacy of such consideration being mutually acknowledged, SPR and the Client therefore agree to the following:

 

1.

TERM AND TERMINATION:

 

The initial term of this agreement shall be for a twelve-month period commencing on August 15th, 2018. This agreement will automatically renew every six months following the initial contract period absent any other action. Contract may be cancelled by either party by providing a 90-day written notice of intent to terminate. In the event of notification of intent to terminate, payment will immediately be due for any outstanding invoices including expenses and payment will continue for the 90-days prior to date of termination. In the event of nonpayment, the cost of collection, including attorney fees and the cost of time spent by SPR seeking payment, shall be borne by Client.

 

2.

Public Relations Services

 

As requested by Client, Schultz Public Relations, LLC will provide the following services.

 

 

1.

Support of message development in concert with marketing, investor relations, and C-suite

 

 

2.

Writing of press releases with input from C-suite and additional parties as appropriate

 

 

3.

Media relations

 

 

A.

Provision of Information

 

 

1.

SPR will utilize and disseminate information based on the information provided by Client and Client directed staff and consultants. Client maintains responsibility and accountability for the accuracy of information provided to SPR.

 

 

2.

Ability to create media opportunities is predicated on provision of viable content by Client for story development.

 

 

 

 

3.

Fees

 

A monthly retainer in the amount of $5,000 per month will be paid for the defined services. SPR will provide a monthly invoice for expenses and retainer. Any services and work product requested outside the defined scope of work will be considered in discussion with Client and if agreed to will be billed at a rate of $250 per hour or a per project task fee.

 

 

A.

Client will be billed for vendor services and supplies including, but not limited to, press release distribution services, press release and interview tracking and acquisition of clippings/dubs of interviews, camera crews, editing services, print services, DVDs, and any other expenses incurred in behalf of the client. Expenses will be documented. No mark-up or additional charges will be added to any of these services.

 

 

B.

Client agrees to pay all travel costs including airfare, ground transportation, mileage, lodging, meals and related expenses incurred by SPR for Client business initiatives and efforts.

 

a.            Retainer payment of $5,000 per month for services rendered is due in accordance with the date of services commencement. First retainer payment is due upon execution of contract.

 

b.             LATE PAYMENTS

 

There will be a 5% monthly late charge assessed after 10 business days elapse without payment of invoice for retainer and expenses and all work will cease until payment is received. Invoice for retainer and expenses will be delivered to Client by email.

 

 

C.

EXTENSIONS AND RENEWALS: This Agreement may be extended “Extension Period”) upon mutual agreement,

 

4.

Confidentiality

 

 

A.

CONFIDENTIAL INFORMATION

 

 

1.

“Confidential Information” shall include but is not limited to SPR’s personal and professional contacts and any and all reports, guidebooks, training manuals, and tip sheets prepared by SPR.

 

 

2.

Client agrees not to use any of SPR’s confidential information for its own uses or purpose except to carry out discussions or a business understanding between Client and SPR.

 

 

3.

Client agrees not to disclose any of SPR’s confidential information to any third party and, and that they will take all reasonable and proper measures to protect the secrecy of and avoid disclosure or use of SPR’s confidential information.

 

2

 

 

5.

Remittance Failure and Breaches

 

B.          FAILURE TO REMIT PAYMENT: The continued lack of payment by Client to SPR for a period of 30 continuous days pursuant to Section 1(C) shall be considered a breach of this Agreement and shall, at SPR’s option, be valid grounds to terminate this Agreement.

 

C.         COSTS DUE UPON BREACH: Notwithstanding the breach of this Agreement by Client, SPR shall be entitled to receipt of all fees, hard costs, compensation and expenses incurred for actual work performed, time spent seeking payment, and legal fees associated with recovery of outstanding debt.

 

6.

CONTROLLING LAWS OF AGREEMENT:

 

 

A.

BEST EFFORTS BASIS: SPR agrees that it will at all times faithfully, to the best of its experience, ability and talents, perform all the duties that may be required of and from SPR pursuant to the terms of this Agreement. Client understands and acknowledges that the success or failure of SPR’s efforts will be predicated on Client’s performance, assets, sales, operating results and management decisions.

 

 

B.

BINDING LAW: This Agreement shall be subject to all valid applicable laws, rules and regulations of the State of Delaware and of the United States. In the event that this Agreement, any of its provisions, or its outlined operations are found to be inconsistent with or contrary to any such laws, rules or regulations, the latter shall control. Furthermore, if commercially practicable, this Agreement shall be considered modified accordingly and shall continue in full force and effect as so modified.

 

 

1.

In the event of dispute resolution, disputes, differences, or controversies shall be heard in the venue of the State of Delaware as designated by SPR.

 

 

C.

ENTIRE AGREEMENT: This Agreement supercedes and replaces any and all agreements, whether oral or in writing, and shall constitute the entire Agreement between the parties unless modified by a written amendment signed by all of the parties or their successors in interest. There are no other Agreements, undertakings, restrictions, representations or warranties among the parties other than those described and provided for in this Agreement and expressly signed by the parties therein.

 

 

D.

WAIVER; Client agrees that SPR’s failure to enforce any provision or provisions of this Agreement shall not in any way be construed as a waiver of that provision or provisions, nor shall such failure prevent SPR from thereafter enforcing each and every provision of this Agreement.

 

AGREED TO this 13th day of August, 2018.

 

 

 

Schultz Public Relations, LLC.

 

 

 

 

 

 

 

/s/  Sharon L. Schutz

 

 

 

Sharon L. Schultz, President

 

 

 

Schultz Public Relations, LLC

 

       
    Isoray Medical, Inc.  
       
    /s/ Lori A. Woods  
   

Lori Woods, Chief Executive Officer

IsoRay

 

 

3

Exhibit 99.1

 

 

 

IsoRay Announces Fourth Quarter and Full-Year 2018 Financial Results

 

Year over year fourth quarter revenues increased 17%
Sixth Consecutive Quarter of Year-Over-Year Revenue Increases
Full year revenues increased 24%

 

RICHLAND, Wash., Sept. 25, 2018 (GLOBE NEWSWIRE) -- IsoRay (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 fiscal fourth quarter and full-year ended June 30, 2018.

 

Revenue for the fourth quarter ended June 30, 2018 grew 17% to $1.60 million versus $1.37 million in the prior year comparable period. The revenue increase was driven by an increase in both new and existing accounts. Prostate brachytherapy represented 87% of total revenue for the fourth quarter of 2018 compared to 88% in the prior year comparable period. Gross profit as a percentage of revenues declined to 27.3% for the three months ended June 30, 2018 versus 36.4% in the prior year comparable period. The decrease was primarily due to an increase in raw material costs in anticipation of sales growth.

 

“I am excited to rejoin the company and bring new ideas and develop key opportunities for existing and new products. With the recent growth trajectory of the core business, the expected launches of Blu-Build™ delivery system and GammaTile™ Therapy along with our increasing progress in expanding applications for Cesium-131, we see promise on many fronts. We look forward to building on these important achievements to expand our market presence and fuel continued growth,” IsoRay Interim CEO Lori Woods said.

 

Total operating expenses in the fourth quarter increased 19% to $2.81 million compared to $2.36 million in the prior year period. Increases in research and development and general and administrative expenses were partially offset by decreases in sales and marketing expenses. General and administrative expenses of $1.56 million included $0.36 million attributable to the executive severance agreement of the former CEO during the quarter. The increase in research and development expense was related to new product development and collaborative research and development expenses related to GT Medical Technologies and the pending launch of GammaTile™ Therapy. 

 

The net loss for the three months ended June 30, 2018 was $2.36 million or ($0.04) per basic and diluted share versus a net loss of $1.85 million or ($0.03) per basic and diluted share in the comparable prior year period.

 

Revenue for the full year ended June 30, 2018 increased 24% to $5.92 million versus $4.76 million in the prior year comparable period. Prostate brachytherapy represented 86% of total revenue for fiscal 2018 compared to 88% for the fiscal year 2017. Fiscal 2018 sales growth was driven by the revitalized sales and marketing strategy that included significant investments in website design, product support literature and social media and public relations which are increasing the awareness of the Company in the prostate brachytherapy treatment markets. Additionally, IsoRay’s Cesium-131 isotope received increasing interest from clinicians primarily focused on brain and pelvic cancers which resulted in other brachytherapy revenue growing faster than prostate brachytherapy revenue for the full fiscal year ended June 30, 2018. The Company realized a balance of overall revenue growth from both new and existing accounts. Gross profit as a percentage of revenue improved to 31.1% for the year ended June 30, 2018 versus 17.6% in the prior year comparable period. The improvement was driven by leveraging the manufacturing facility, personnel and better utilization of the isotope.

 

Total operating expenses for the 2018 fiscal year increased 20% to $8.57 million compared to $7.15 million in the prior year period. General and administrative expenses included $0.36 million attributable to the executive severance agreement of the former CEO during the fourth quarter. The increase in research and development expense was primarily related to new product development, specifically Blu-Build™, and collaborative research and development expenses related to GT Medical Technologies and the pending launch of GammaTile™ Therapy. The increase in sales and marketing expenses was related to travel and compensation for new employees and support for revenue growth.

 

The net loss for the fiscal year ended June 30, 2018 was $6.70 million or ($0.12) per basic and diluted share versus a net loss of $6.16 million or ($0.11) per basic and diluted share in the comparable prior year period. 

 

Cash, cash equivalents, and certificates of deposits at the end of fiscal 2018 totaled $3.43 million versus $8.97 million in the prior year comparable period and the Company had no debt. During the fiscal first quarter of 2019 the Company closed a public offering of 11.0 million shares of its common stock at a price of $0.75 per share. Gross proceeds, before underwriting discounts, commissions and estimated offering costs, were approximately $8.25 million.

 

 

 

 

Conference Call Details
The Company will hold an earnings conference call today, September 25, at 4:30 p.m. ET/1:30 p.m. PT to discuss operating results. To listen to the earnings conference call, please dial (877) 407-8031. For callers outside the U.S., please dial (201) 689-8031.

 

The conference call will be simultaneously webcast and can be accessed at http://www.investorcalendar.com/event/37451 by clicking on the link. The webcast will be available until December 25, 2018 following the conference call. A replay of the call will also be available by phone and can be accessed by dialing (877) 481-4010 and providing reference number 37451. For callers outside the U.S., please dial (919) 882-2331 and provide reference number 37451. The replay will be available beginning approximately 1 hour after the completion of the live event, ending at midnight eastern on October 2, 2018.

 

Contacts
Investor Relations: Mark Levin (501) 255-1910
Media and Public Relations: Sharon Schultz (302) 539-3747

 

About IsoRay, Inc.
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. 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/IsoRay . Follow us on Twitter @IsoRay .

 

Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems, whether interest in and use of our products will increase or continue, whether the new marketing strategy will continue to increase sales, whether the changes to the sales staff will continue to result in increased sales, whether the additional resources being added to IsoRay's online presence will increase patient or clinician engagement and interest, 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, the advantages of Cesium-131 over Iodine-125, whether our market presence and growth will continue, the timing of launch of Blu-Build TM and GammaTile TM Therapy, the positive industry data fueling renewed interest in brachytherapy, strong patient results, the perception by patients of quality of life outcomes, 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, our ability to successfully manufacture, market and sell our products, 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) clearance 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
(In thousands, except shares)

 

   



June 30,
2018

   



June 30,
2017

 

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 2,600     $ 5,932  

Certificates of deposit

    825       3,039  

Accounts receivable, net

    1,192       726  

Inventory

    516       323  

Prepaid expenses and other current assets

    335       271  
                 

Total current assets

    5,468       10,291  
                 

Property and equipment, net

    1,311       1,054  

Certificates of deposit, non-current

    -       -  

Restricted cash

    181       181  

Inventory, non-current

    297       513  

Other assets, net of accumulated amortization

    198       230  
                 

Total assets

  $ 7,455     $ 12,269  
                 

LIABILITIES AND SHAREHOLDERS' EQUITY

               
                 

Current liabilities:

               

Accounts payable and accrued expenses

  $ 1,391     $ 630  

Accrued protocol expense

    77       75  

Accrued radioactive waste disposal

    37       125  

Accrued payroll and related taxes

    155       138  

Accrued vacation

    175       138  
                 

Total current liabilities

    1,835       1,106  

Long-term liabilities:

               

Warrant derivative liability

    -       -  

Asset retirement obligation

    590       561  
                 

Total liabilities

    2,425       1,667  

Commitments and contingencies

               
                 

Shareholders' equity:

               

Preferred stock, $.001 par value; 7,001,671 shares authorized:

               

Series A: 1,000,000 shares allocated; no shares issued and outstanding

    -       -  

Series B: 5,000,000 shares allocated; 59,065 shares issued and outstanding

    -       -  

Series C: 1,000,000 shares allocated; no shares issued and outstanding

    -       -  

Series D: 1,671 shares allocated; no shares issued and outstanding

    -       -  

Common stock, $.001 par value; 192,998,329 shares authorized; 56,331,147 and 55,017,419 shares issued and outstanding

    56       55  

Treasury stock

    -       -  

Additional paid-in capital

    84,322       83,151  

Accumulated deficit

    (79,348

)

    (72,604

)

                 

Total shareholders' equity

    5,030       10,602  
                 

Total liabilities and shareholders' equity

  $ 7,455     $ 12,269  

 

 

 

 

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

 

   

Three Months Ended

June 30, 2018

   

Three Months Ended

June 30, 2017

   

Twelve Months Ended

June 30, 2018

   

Twelve Months Ended

June 30, 2017

 
   

Q4 2018

   

Q4 2017

   

2018

   

2017

 
                                 

Product sales, net

  $ 1,603     $ 1,370     $ 5,923     $ 4,761  

Cost of product sales

    1,166       872       4,081       3,923  

Gross profit

    437       498       1,842       838  
                                 

Operating expenses:

                               

Research and development

                               

Proprietary research and development

    437       283       1,351       771  

Collaboration arrangement, net of reimbursement

    135       33       395       194  

Total research and development

    572       316       1,746       965  

Sales and marketing

    680       760       2,660       2,310  

General and administrative

    1,555       1,285       4,165       3,918  

Change in estimate of asset retirement obligation

    -       -       -       (48

)

Total operating expenses

    2,807       2,361       8,571       7,145  
                                 

Operating loss

    (2,370

)

    (1,863

)

    (6,729

)

    (6,307

)

                                 

Non-operating income:

                               

Interest income

    12       29       29       118  

Change in fair value of warrant derivative liability

    -       -       -       27  

Financing and interest expense

    -       (20

)

    -       -  

Non-operating income, net

    12       9       29       145  
                                 

Net loss

    (2,358

)

    (1,854

)

    (6,700

)

    (6,162

)

Preferred stock dividends

    (3

)

    (3

)

    (11

)

    (11

)

                                 

Net loss applicable to common shareholders

  $ (2,361

)

  $ (1,857

)

  $ (6,711

)

  $ (6,173

)

                                 

Basic and diluted loss per share

  $ (0.04

)

  $ (0.03

)

  $ (0.12

)

  $ (0.11

)

                                 

Weighted average shares used in computing net loss per share:

                               

Basic and diluted

    55,463       55,017       55,159       55,016  

 

 

 

Exhibit 99.2

 

 

IsoRay To Announce Fourth Quarter and Year End 2018 Financial Results on September 25, 2018

 

Conference Call is Tuesday, September 25, 2018, at 4:30 p.m. ET/1:30 p.m. PT

 

Richland, Wash., Sept. 10, 2018 (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 that it will host a conference call to discuss its financial results for the fourth quarter and fiscal year ended June 30, 2018 on Tuesday, September 25, 2018, 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, 2018 after the close of the U.S. stock markets on September 25, 2018.

 

To listen to the conference call, please dial (877) 407-8031. For callers outside the U.S., please dial (201) 689-8031.

 

The conference call will be simultaneously webcast and can be accessed at  http://www.investorcalendar.com/event/37451 by clicking on the link. The webcast will be available until December 25, 2018 following the conference call. A replay of the call will also be available by phone and can be accessed by dialing (877) 481-4010 and providing reference number 37451. For callers outside the U.S., please dial (919) 882-2331 and provide reference number 37451. The replay will be available beginning approximately 1 hour after the completion of the live event, ending at midnight eastern on October 2, 2018.

 

You will note a change in contact information for this announcement. The Company recently retained the services of the Global IR Group for investor relations services and Schultz Public Relations for public relations services.

 

About IsoRay

 

IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of Cesium-131 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-131 by visiting www.isoray.com. Join us on Facebook and follow us on Twitter @Isoray.

 

Contact

Investor Relations: Mark Levin (501) 255-1910

Media and Public Relations: Sharon Schultz (302) 539-3747