Full Press Release Details
CytoSorbents 2017 - Propelling
the Company to the "Next Level"
Targeting significant annual sales growth,
near-term operating profitability, a U.S. pivotal trial, and greater investor awareness and ownership
MONMOUTH JUNCTION, NJ - April
19, 2017 - CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb
blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, issues
a stockholder letter from its 2016 Annual Report from its Chief Executive Officer, Dr. Phillip Chan.
Dear Fellow Stockholders and Friends,
We spoke last year of driving towards the
inflection point. After achieving record CytoSorb sales of $8.2 million last year, helping to save many lives in more than
20,000 treatments, and numerous accomplishments through the first quarter of this year, we believe we are now well-positioned to
drive the next phase of our evolution into a potentially very profitable and visible, high margin disposables pure play that can
transform medical care. Specifically, we are targeting the following major milestones.*
In 2016, we more than doubled our product
sales and CytoSorb treatments from the prior year. Direct sales were particularly strong, with broad increases in usage and one
hospital already exceeding $1 million in sales, confirming our assertion that large hospitals can be multi-million dollar accounts.
Several major recent developments give us visibility and confidence on future growth. The first is the recent achievement of a
dedicated reimbursement code for CytoSorb in Germany, the largest medical device market in Europe and third largest in the world,
accounting for approximately 60% of our 2016 revenue. Importantly, this new code was initiated and supported by many major German
medical societies, providing yet more validation of our technology. The new reimbursement is expected to cover the full cost of
the device and procedure, significantly improving upon the previous reimbursement, and eliminating a significant bottleneck in
usage. German hospitals are completing government negotiations for their annual operating budgets, which includes procedures like
our CytoSorb therapy. We are already seeing solid increases in reimbursement rates. Once these rates are more widely established,
they are expected to progressively enhance CytoSorb sales over time.
Our expanded agreement with Fresenius Medical
Care ("FMC"), the largest dialysis company in the world, is expected to be another major catalyst going forward. Exclusive
critical care distribution rights for CytoSorb were extended by three years in France, Poland, Denmark, Sweden, Norway and Finland,
with FMC increasing its commitment to guaranteed quarterly purchases. More importantly, we entered into a co-marketing agreement
where FMC's sales force will co-market CytoSorb as a preferred critical care therapy on its industry-leading multiFiltrate
and multiFiltratePRO dialysis machines, with a written endorsement that can be used worldwide. This will effectively increase the
number of sales reps in each country marketing CytoSorb, where we (or our partners) will record the sale of CytoSorb, and FMC's
sales reps will gain sales on all ancillary disposable products (e.g., blood lines, fluids, dialysis filters) and dialysis machines.
We believe this win-win scenario will drive greater usage of CytoSorb while maximizing utilization of FMC's acute care dialysis
machine infrastructure and growing the overall ICU market. We are in the training and preparation stage with FMC, and plan to start
in major countries later this year.
We have strong expectations for our other
strategic partners as well. In December 2016, our partner Terumo Cardiovascular, a global leader in cardiac and vascular surgery,
launched CytoSorb for cardiac surgery applications in six countries - France, Denmark, Sweden, Finland, Norway, and Iceland.
We may potentially expand this agreement to other countries, such as Japan, where Terumo is the market leader. Biocon, the largest
biopharmaceutical company in India, is also expanding steadily in India and Sri Lanka after establishing a specially focused CytoSorb
sales division. Furthermore, the addition of Dr. Reddy's Laboratories, a $2 billion in sales global pharmaceuticals company,
for South Africa shows the broad interest of our platform across all types of international healthcare partners. Meanwhile, we
continue to grow our international sales team, adding reimbursement support and regional sales managers, by way of example, to
drive the success of our distribution network worldwide.
New CytoSorb growth opportunities abound
in the $100 billion in product sales immunotherapy market, even beyond critical illness and cardiac surgery. For example, the recent
addition of cancer immunotherapy pioneer, Dr. Carl June, to our advisory board highlights the potential of CytoSorb and related
technologies in the massive cancer and immuno-oncology fields.
We believe CytoSorbents has significant
operating leverage as a high value, high margin "therapeutic razorblade" pure play. We are able to achieve this leverage
throughout our business model: from a highly scalable and robust manufacturing process requiring only modest capital expenditures
for major production gains; to our R&D program that is nearly fully-funded by external grants and contracts; to our mixed direct
and distributor-based sales model where blended gross margins are expected to approach 80% with volume manufacturing and economies
of scale. Because of these dynamics, we expect to achieve operating profitability (excluding clinical trial costs and non-cash
expenses) within the next one to two years at approximately $20 million in sales. At 2016 year end, we had already achieved a $10
million sales run rate. Once $20 million in sales is achieved and clinical trial costs are offset, we expect to generate significant
amounts of cash and income, where approximately 50 cents on every dollar in sales could drop to the bottom line. This would be
further enhanced by using our sizeable net operating loss carryforwards to offset corporate taxes. We believe this is why our company
is unlike many other medtech companies who often incur increasing losses, as sales and marketing expenses skyrocket to drive machine
sales. We also believe our high margin disposables model is why we have such strong partnership interest. We appear to fit perfectly
with their acute care sales models of selling machines and disposables, while giving them the ammunition to out-innovate and out-compete
The expected initiation of our U.S. cardiac
surgery REFRESH 2 trial in the second half of 2017, pending FDA protocol approval, would establish a timeline for U.S. approval
(potentially as early as 2020) for the first time. This would be a major milestone for investors. Last year we successfully completed
the 40-patient, 8-center randomized, controlled REFRESH (REduction of FREe Hemoglobin) I feasibility and safety trial which demonstrated
that CytoSorb was safe when used intra-operatively during on-pump complex cardiac surgery. The trial also identified complex cardiac
surgery procedures with the highest levels of plasma-free hemoglobin (which will be used to enrich REFRESH 2 for those at greatest
risk of organ injury), and demonstrated statistically significant reductions of key inflammatory mediators in this group. An abstract
of our REFRESH I data was submitted and accepted for podium presentation to the "Late Breaking Abstracts" tract of
the American Association for Thoracic Surgery conference on May 1, 2017. Selection of abstracts by AATS is very competitive, while
podium presentation selection is even more so. We feel this represents encouraging validation of our strategy to control excessive
inflammation during cardiac surgery.
We recently announced the completion of
an $11.5 million financing that was led by Cowen and Company ("Cowen"), one of the top U.S. healthcare investment banks,
and co-managed by our existing investment banking syndicate including Aegis Capital Corp. and HC Wainwright & Co., as well
as B. Riley & Co., Maxim Group, LLC, and Northland Capital Markets. We are pleased that Cowen, following its own due diligence,
sought to work with us to introduce a new tier of fundamental institutional investors to our story. This complemented meetings
organized by our existing banking syndicate, with a broad range of smaller fundamental investors in non-deal roadshows over the
past year. We are also delighted that many other well-known healthcare focused investment banks also want to work with us.
We accomplished several important goals
in this financing. First, we strengthened the balance sheet, eliminating the financing "overhang" and enabling us to
fund our anticipated growth without interruption, including the build-out of a new CytoSorb manufacturing facility and the financing
of REFRESH 2, pending discussions with the FDA. Second, we have garnered the support of Cowen and other major investment banks
and plan to continue working with them on non-deal roadshows to increase our exposure and spread our story to a new universe of
investors. Third, we met with a large number of fundamental investors, some of whom we knew, and many of whom we met for the first
time, with a number of such investors participating in this deal. These investors form the beginning of a core base of fundamental
institutional stockholders that is intended to drive sustained, increased liquidity of the stock.
Improving the daily trading volume and
liquidity of our stock is one of our main priorities. Increasing liquidity would allow our stock to respond more appropriately
to good news. It would allow large investors to begin taking open-market positions in the stock, where previously they could not.
And future financings, if needed at all, would not need to "bake in" a liquidity discount for larger investors. This
discount contributed to a greater than expected 17% discount to our stock price in this most recent financing, but was still slightly
better than the approximate 20% mean and median discounts for most comparable life science and medical device follow-on financings
done in the past two years, and below the approximate 23% discount on financings for medical device companies with revenue of $5-20M.
That said, this financing with Cowen and
our existing banks, the participating core investors, and the marketing we did around the deal, were central to our goal of propelling
the company to the "next level" with greater visibility and institutional sponsorship that is intended to benefit all
stockholders in the longer term. In the coming months, we will work to build upon this progress, and bring in new institutional
and retail investors from both the U.S. and Europe. We will complement these efforts with a newly focused PR and IR effort specifically