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IsoRay Announces Fourth Quarter Fiscal 2017 Revenue of $1.37 Million, 22% Fourth Quarter-over-Fourth Quarter Increase Gross Margin Expands to 36% on Continued Process Improvements and Expense Reduction

Key Takeaway: IsoRay Announces Fourth Quarter Fiscal 2017 Revenue of $1.37 Million, 22% Fourth Quarter-over-Fourth Quarter Increase Gross Margin Expands to 36% on Continued Process Improvements and Expense Reduction RICHLAND, Wash., September 28, 2017 -- IsoRay, Inc. (NYSE MKT: ISR), a me

Full Press Release Details

IsoRay Announces Fourth Quarter Fiscal
2017 Revenue of $1.37 Million, 22% Fourth Quarter-over-Fourth Quarter Increase
Gross Margin Expands to 36% on Continued
Process Improvements and Expense Reduction
RICHLAND, Wash., September 28, 2017
-- IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications
for the treatment of prostate, brain, lung, head and neck and gynecological cancers, today announced its final financial results
for the fourth quarter and fiscal year ended June 30, 2017.
Revenue for the fourth quarter of fiscal
2017 was $1.37 million, a 22% increase compared to $1.12 million revenue for the fourth quarter of fiscal 2016 and
a 7% increase compared to revenue of $1.28 million in the third quarter of fiscal 2017. The increase in revenue is primarily due
to a growing customer count from new and returning practitioners. Prostate brachytherapy represented 88% and 85% of
total revenue for the fourth quarter of fiscal 2017 and 2016, respectively and 89% of total revenue for the third quarter of fiscal
2017. Gross profit for the three months ended June 30, 2017 was $0.50 million compared to a loss of $0.05 million in the prior
year period and $0.29 million in the third quarter of fiscal 2017. The increase is primarily due to expense reductions and process
and manufacturing improvements put in place over the past year. Gross profit margin was 36% in the current period compared to a
negative gross margin in the fourth quarter of fiscal 2016 and 23% in the third quarter of fiscal 2017.
Operating expenses were $2.36 million compared
to $1.21 million in the fourth quarter of the last fiscal year. The increase is primarily due to continued investment
in research and development and implementation of the company's new sales and marketing initiatives. In addition to these
investments, during the fourth quarter the Company completed the settlement of a class action lawsuit for $0.195 million and had
expenses related to a special shareholders' meeting. These one-time expenses were recorded in the fourth quarter. In 2016,
fourth quarter expenses were reduced by an asset retirement obligation adjustment of $0.456 million primarily related to an extension
of the lease term for the manufacturing facility. Operating loss was $1.86 million compared to a $1.25 million loss
in the fourth quarter of fiscal 2016. The net loss was $1.86 million, or ($0.03) per basic and diluted share, for the fourth quarter
of fiscal 2017 compared to a net loss of $1.19 million, or ($0.02) per basic and diluted share, for the fourth quarter of fiscal
2016. Basic and diluted per share results are based on weighted average shares outstanding of approximately 55.0 million for both
periods. IsoRay had cash and cash equivalents and certificates of deposit of $9.0 million as of June 30, 2017, and
For the fiscal year ended June 30, 2017,
revenue was $4.76 million, consistent with revenue of $4.77 million for the fiscal year ended June 30, 2016. Prostate brachytherapy
represented 88% and 86% of total revenue for fiscal 2017 and 2016, respectively. Operating expenses were $7.15 million for fiscal
2017 compared to $5.21 million for the year ended June 30, 2016. Gross profit was $0.84 million compared to $0.13 million for the
prior year. Increased investments in research and development and sales and marketing accounted for the majority of the increase.
Operating loss was $6.31 million for fiscal 2017, compared to a $5.08 million operating loss for fiscal 2016. The net loss was
$6.16 million, or ($0.11) per basic and diluted share, for fiscal 2017 compared to a net loss of $4.71 million, or ($0.09) per
basic and diluted share, for fiscal 2016. Basic and diluted per share results are based on weighted average shares outstanding
of approximately 55.0 million for both periods.
"Our fourth quarter results reflect
the momentum that has begun to build for IsoRay," said Thomas LaVoy, Chairman and Chief Executive Officer of IsoRay, Inc.
"Sales increased 22% year-over-year in the fourth quarter after increasing 7% year-over-year in the third quarter of this
year. These increases come after the transition in our sales and marketing team during the second half of fiscal 2016 which continued
into early fiscal 2017, as well as the revamping of our entire sales and marketing strategy with a renewed focus on marketing that
we rolled out last fall. We believe that IsoRay's growing customer count from both new and returning practitioners validates
the strategic changes that we've made. For the full fiscal year, revenue was flat year-over-year, with the stronger second
half offsetting the approximate 14% revenue decline of the first half of the fiscal year when the new sales team and strategies
were being implemented. Process and manufacturing improvements, as well as expense reductions, contributed to the sustainable expansion
of the gross margin to 36% in the fourth quarter."
"Increasing evidence of Cesium-131's
efficacy and lower side effect profile as reported in a growing list of studies is supportive of our two-pronged growth strategy
focused on prostate brachytherapy and brachytherapy for other parts of the body including brain and gynecological cancers. In prostate
brachytherapy, emerging clinical data demonstrates sustained clinical outcomes with rapid patient return to baseline recently published
in a study by the University of Pittsburgh Medical Center. Another recent study reported durable positive outcomes for Cesium-131
in prostate cancer patients followed over nine years, the longest data ever available."
Mr. LaVoy continued, "In other cancers,
a growing number of leading institutions are performing brain brachytherapy with Cesium-131. There are multiple publications from
Weill Cornell Medical College that demonstrate high rates of brain cancer control when Cesium-131 brachytherapy is combined with
surgery. And IsoRay's collaboration with GammaTile LLC to develop and commercialize a custom delivery system is in development
with a filing for FDA clearance and reimbursement code assignment in process. In gynecological cancers, a new study was recently
accepted for publication in the highly respected International Journal of Radiation Oncology, Biology, Physics (the "Red Journal")
on Cesium-131's use in recurrent pelvic malignancies. The study found that the use of Cesium-131 has the ability to control
local disease, avoid radical surgery, and provide an improved quality of life for these patients."
"IsoRay is in a unique position as
the only manufacturer in the world of Cesium-131, which we believe is the "next" generation brachytherapy isotope that
delivers a faster, more consistent treatment. The combination of improvement in IsoRay's strategic focus and execution, as
seen in our fourth quarter results, supported by the growing evidence of Cesium-131's efficacy in treating multiple types
of cancers, gives us confidence in our outlook for growth in fiscal 2018 and beyond," concluded Mr. LaVoy.
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
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 increase sales, whether
the changes to the sales staff will 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
increase revenue, whether we obtain and the timing of obtaining our FDA application for 510(k) clearance and favorable reimbursement
codes, our ongoing relationship with GammaTile LLC, whether further automation of production processes will be completed or will
result in lower costs, whether revenue will increase and costs decrease in the upcoming quarters, 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 and 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, agreements we ultimately negotiate with
third parties related to distribution of GammaTile products, 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.
Stephanie Prince, Managing Director
IsoRay, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except shares)
June 30, June 30,
2017 2016
ASSETS
Current assets:
Cash and cash equivalents $ 5,932 $ 10,139
Certificates of deposit (Note 3) 3,039 2,247
Accounts receivable, net of allowance for doubtful accounts of $26 and $30, respectively 726 605
Inventory 323 334
Prepaid expenses and other current assets 271 304
Total current assets 10,291 13,629
Property and equipment, net 1,054 577
Certificates of deposit, non-current (Note 3) - 2,973
Restricted cash 181 181
Inventory, non-current 513 591
Other assets, net of accumulated amortization 230 151
Total assets $ 12,269 $ 18,102
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 630 $ 612
Accrued protocol expense 75 122
Accrued radioactive waste disposal 125 177
Accrued payroll and related taxes 138 72
Accrued vacation 138 111
Total current liabilities 1,106 1,094
Long-term liabilities:
Warrant derivative liability - 27
Asset retirement obligation 561 580
Total liabilities 1,667 1,701
Commitments and contingencies (Note 15)
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;
55,017,419 and 55,010,619 shares issued and outstanding 55 55
Additional paid-in capital 83,151 82,788
Accumulated deficit (72,604 ) (66,442 )
Total shareholders' equity 10,602 16,401
Total liabilities and shareholders' equity $ 12,269 $ 18,102
Last updated: Sep 28, 2017