EXHIBIT 99.2
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IMMEDIATE RELEASE |
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March 19, 2008 |
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CONTACTS: |
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Brent Larson, |
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Tim Ryan, |
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Vice President / CFO |
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The Trout Group |
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614 822.2330 |
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646.378.2924 |
NEOPROBE LETTER TO THE SHAREHOLDERS
DUBLIN, OHIO March 19, 2008 Neoprobe Corporation (OTCBB: NEOP), a diversified developer of
innovative oncology and cardiovascular surgical and diagnostic products, today released the text of
its annual Letter to Stockholders from Neoprobe Chairman, Carl J. Aschinger, Jr., and President and
CEO, David C. Bupp.
The letter highlights Neoprobes business and financial activities in 2007 and early 2008 and
outlines planned business initiatives for the remainder of 2008. The text of the stockholder
letter follows.
Dear Fellow Stockholders,
Since you received our last shareholder letter, Neoprobe Corporation has completed a period of
significant commercialization and development activities and achievements. Our corporate
accomplishments during this period have paved the way for the achievement of additional
commercialization and development milestones for our medical device and drug products over the
coming months. Neoprobe is in the process of surmounting the development and regulatory hurdles
associated with the commercialization of our biomedical products. When we began 2007, we set the
stage for development advancements that we believed would provide significant milestone
achievements during the year. This proved to be the case with the attainment of accomplishments in
our medical device product portfolio and in our drug development programs. We are currently
executing a two-pronged commercial strategy comprised of building on a solid foundation of medical
device products while we develop a platform of recurring revenue drug and biologic products led by
Lymphoseek® and RIGScan® CR. During 2007, commercial and development
milestones were achieved in all of the key areas of our business strategy.
The achievements that were realized in the past fifteen months are the result of the efforts of the
dedicated and experienced personnel, management and advisors of Neoprobe. We have employed a
successful virtual business model that maintains core competencies internally while outsourcing
capital and resource intensive activities such as manufacturing and marketing. During 2007, we
enhanced a key internal advisory resource by adding Dr. Owen Johnson to our board of directors. Dr.
Johnson provides valuable experience regarding the evaluation of new medical products for
reimbursement as the head of technology assessment for United Health, Inc. In 2008, we augmented
our staff with a Director of Clinical Research and we will be contracting with several experienced
clinical research associates to oversee the domestic and international Phase 3 studies planned for
2008. The efforts of the employees of Neoprobe are supported by a group of regulatory and
biostatistics experts to assist in the completion of our regulatory submissions and clinical trial
designs. All of the employees at Neoprobe are dedicated to providing the highest quality products
that meet the healthcare needs of the patients they help treat.
Our 2007 loss from operations decreased from 2006 despite our continued investment in research and
development activities associated with our drug and biomedical product initiatives. Margin
contribution from our medical device businesses continued to be strong and to cover a significant
portion of our public company corporate overhead costs. The gamma detection device margin
contribution allowed us to devote our financial resources to the development of the drug technology
platforms that we expect to provide rewarding future returns on our investment. Our
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net loss for the year was $5.1 million and included $2.9 million in non-cash charges related to the
accounting treatment for our financing activities and amortization of our intellectual property. In
addition, 2007 cash flow expenditures included $675,000 to repurchase and retire 10 million
warrants to purchase Neoprobe common stock related to a 2004 financing.
Neoprobes core gamma detection device business continued to perform well in 2007. Our
neo2000® system continues to be recognized as the market leader among gamma detection
devices. In 2007 gamma device product revenues increased by $1.3 million or 24% versus 2006
revenues. The revenue and margin growth was led by our first probes with Bluetooth®
wireless technology. The new wireless probes incorporate increased probe sensitivity, further
improving the already superior gamma detection capability and performance of the neo2000. The
introduction of the wireless probes demonstrated the flexibility that is a key competitive aspect
of our neo2000 system, since all models of the neo2000 can be simply and easily upgraded to permit
the use of the wireless probe. The wireless probes have solidified the market leadership position
of our gamma detection device products in 2007. We expect the positive impact of the wireless
probes to continue in 2008 and beyond.
As a result of the successful introduction of the wireless probes, our marketing partner for the
gamma device products, Ethicon Endo-Surgery, Inc. (a Johnson and Johnson company) entered into
discussions with us about extending our marketing agreement which was originally scheduled to
terminate in December 2008. In the fourth quarter of 2007, we announced a five-year extension of
the marketing agreement (the new agreement expires in December 2013) that provides a number of
enhanced terms to Neoprobe. Commencing in January 2009, Neoprobes portion of the revenue derived
from the sales of gamma device products will improve by 15 20% assuming product selling prices
remain consistent with current selling prices. In addition, a new mechanism has been established
for the review and approval of new gamma device product initiatives. The mechanism reflects the
cooperative nature of our relationship with Ethicon and provides for a return on investment to each
of us in recognition of our respective contributions to new product initiatives including potential
financial contribution from Ethicon to defray some of the cost of future product development
activities. In recognition of our past investment in product development and as an incentive to
extend the marketing agreement, Ethicon paid us $500,000, which covered the majority of the
development costs associated with the wireless probes. We are currently reviewing several product
development initiatives with Ethicon for products that could be introduced in 2008 and 2009.
Finally, the new agreement established annual product sales levels that must be achieved in order
for Ethicon to maintain distribution exclusivity in future years.
While the gamma device business had a successful year, the commercialization efforts for our blood
flow measurement devices continue to be a challenge. However, several development and evaluation
activities that were initiated in 2007 provide some basis for cautious optimism. The
Quantix® blood flow measurement system was originally envisioned as a means to provide
mechanical blood flow measurement in the cardiovascular arena. While the Quantix system employed an
innovative measurement approach, the clinical setting of the cardiovascular procedure presented
certain challenges. During 2007, we completed some minor measurement algorithm modifications and
began evaluating the technology in vascular assessments with very encouraging results. The vascular
applications address a growing problem with dialysis patients. We are assessing the commercial
opportunity that may be available with the vascular access business. During 2007, we recognized
$351,000 in Quantix product revenue, which represented a decline of 42% from 2006. Almost all of
the product sales occurred as a result of device placements in Europe and Asia. We still believe
Europe and Asia represent viable markets for the Quantix device in both the cardiovascular and
vascular assessment markets. However, we have begun exploring separate distribution channels for
the vascular applications of the Quantix products in the United States.
On an overall basis in 2007, revenue from sales and service of our medical devices increased to
$7.1 million or approximately 18%. This increase was driven by the 24% increase in revenues from
our gamma detection devices which increased from $5.4 million in 2006 to $6.8 million in 2007. The
gross margin from our medical devices totaled $4.0 million or 56% of sales in 2007.
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In 2007, our research and development expenses totaled $2.9 million, a decrease of 25% compared to
the prior year. The primary reason for the decrease was that our Lymphoseek development expenses
were lower in 2007 from 2006 with the reductions in preclinical testing and manufacturing-related
drug development costs being less than completely offset by the costs associated with our Phase 2
human clinical trials. Lymphoseek drug development costs during 2007 were also offset by savings
related to curtailing our activities associated with the Quantix device products and reduced gamma
radiation detection device development costs following the launch of the wireless probes. Also, we
continued to effectively manage our general and administrative overhead structure in an
increasingly complex business environment for public companies.
We closed 2007 with cash and securities of approximately $1.5 million. Upon achieving previously
announced milestones, we have access to an additional $5.7 million; net of placement costs, through
the Platinum-Montaur Life Sciences LLC financing that was closed in December 2007. Our cash on hand
at December 31, 2007 and the capital available through Platinum-Montaur provide us with sufficient
funds to complete the development of Lymphoseek and fund our initial development efforts for our
other device and biologic product initiatives.
In addition to the improvements in our gamma detection device business, we advanced the clinical
development of our first recurring revenue product, Lymphoseek, to complement and expand our gamma
detection device product businesses. The following are some of the research and development
milestones achieved in 2007 related to our drug, biomedical and medical device product initiatives:
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Completion of patient enrollment in a Phase 2 multi-center clinical evaluation of
Lymphoseek in patients with either breast cancer or melanoma. |
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Conducted successful end of Phase 2 and pre-Phase 3 meetings with FDA for Lymphoseek |
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Submitted Phase 2 data to FDA for clinical study completed in patients with breast
cancer or melanoma and provided responses to FDA to drug formulation and clinical
questions |
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Initiated regulatory review process for Lymphoseek in European Union |
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Completed exclusive U.S. marketing and distribution agreement for Lymphoseek with
radiopharmaceutical division of Cardinal Health, Inc. |
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Received notification of the allowance of a concept of matter patent covering the
chemical construct of Lymphoseek in Japan |
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Received second lot of cGMP-produced final drug product that was used in the Phase 2
clinical study. |
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Introduced an updated blood flow measurement algorithm and initiated evaluations for
the measurement of blood flow in vascular assessment and dialysis applications. |
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Took initial steps to add a third prong to our business strategy by seeking external
financing for our oncology and viral disease products utilizing our proprietary activated
cellular therapy (ACT) technology. |
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Completed extension of marketing agreement with Ethicon for the global marketing and
distribution of Neoprobes gamma detection devices. |
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Received regulatory clearance to commence patient enrollment in a third Phase 1
clinical study of Lymphoseek using prior day injection imaging and intraoperative
detection in patients with breast cancer. |
With the completion of enrollment in the Phase 2 clinical study, we began the process of reviewing
the efficacy and safety data from the study and preparing submissions to FDA for the design and
conduct of the pivotal Phase 3 clinical studies to support the product registration of Lymphoseek
as a sentinel lymph node targeting agent. The Phase 2 clinical study was conducted in 80 evaluable
patients with either breast cancer or melanoma. Some the nations most prestigious cancer treatment
centers participated in the study and the results were presented at the Society of Surgical
Oncology in March. The primary objective of the study was to demonstrate that Lymphoseek accurately
and safely identified lymphatic tissue in the study subjects. Our clinical objective was a
pathology confirmed accuracy or efficacy rate of 90%. Once we analyzed the data, we found that we
had achieved a pathology confirmed accuracy rate of 99%. In addition, we did not observe any
drug-related safety issues in the Phase 2 study patients.
Based upon the successful completion of the Phase 2 study, we held an end of Phase 2 meeting with
FDA in the fourth quarter of 2007 and we completed responses to questions raised by FDA regarding
our clinical and drug development program for Lymphoseek. All of our responses to the questions and
the final report for the Phase 2 were filed with FDA in January of 2008. After the completion of
the responses, we filed with the agency our final version of the first of two pivotal studies to be
conducted to support the registration of Lymphoseek as a sentinel lymph node targeting agent. The
first clinical study is proposed to be conducted in approximately 200 patients with either breast
cancer or melanoma. The trial design is similar to the successfully conducted Phase 2 study, except
that we will be monitoring the concordance of Lymphoseek uptake in lymph nodes with the uptake of a
vital blue dye in the same lymph nodes. In addition, we have provided FDA with the outline of a
second Phase 3 study to be conducted in patients with head and neck squamous cell carcinoma. This
second Phase 3 study is designed to validate Lymphoseek as a sentinel lymph node targeting agent.
We have begun the process of contracting with approximately 20 investigational sites in the United
States while we await FDA clearance to commence patient enrollment in the first Phase 3 study. Some
of the investigational sites have begun the process of internally reviewing the protocol, the
informed consent and investigator brochure to obtain institutional clearance to enroll patients in
the study while we await FDA clearance to commence enrollment in the first Phase 3. In addition, we
have begun to contact domestic and international investigators regarding the conduct of the second
Phase 3 study.
Our regulatory strategy for Lymphoseek has evolved in response to questions and guidance from FDA,
but the overall scope of the pivotal clinical studies has remained relatively constant. Based upon
the current clinical pathway we are planning to submit a new drug application (NDA) for Lymphoseek
in the first half of 2009. The NDA will cover three tumor types: breast cancer, melanoma and head
and neck squamous cell carcinoma, rather than the two originally envisioned. The addition of head
and neck squamous cell carcinoma has resulted in an expanded initial market potential for
Lymphoseek.
As we have completed the activities associated with the Phase 2 study and prepared for the first
Phase 3 study in the United States, we began the process of exploring the registration requirements
for Lymphoseek in the European Union (EU). In this regard we have filed an
application with the centralized drug evaluation agency for the EU, the EMEA, for a formal review
of our regulatory strategy and clinical trial design for Lymphoseek to support the registration of
the drug in the EU. We anticipate the formal review process will be completed by the EMEA by mid
2008.
In preparation for the commercialization of Lymphoseek in the United States, we completed a
marketing and distribution agreement with the dominant domestic radiopharmaceutical firm
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Cardinal Health, Inc. The exclusive agreement with Cardinal provides us with a marketing arrangement that
provides access to all of the nuclear medicine and nuclear pharmacies in the United States.
Importantly the agreement affords Neoprobe with the opportunity to share in the revenue derived
from each patient dose of Lymphoseek delivered by Cardinal. As a result of the structure of the
agreement, Neoprobe should be able to recognize pharmaceutical margins on Lymphoseek with little
incremental support cost.
Our drug development activities have not been confined to Lymphoseek. We have continued to evaluate
clinical approaches for RIGScan CR to meet a continuing medical problem with the treatment of
colorectal cancer. A clinical protocol has been developed that would supplement the clinical
efficacy and safety data that has been accepted by FDA for the registration of the product. We have
submitted a request to EMEA to review this protocol to determine if it would address questions
asked by the EU reviewers with the original RIGScan dossier. If the response from the EMEA is
positive it is our intention to complete a strategic alliance with a development partner to conduct
the new clinical evaluation of RIGScan CR.
What do we see in the coming months for Neoprobe Corporation?
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Initiate patient enrollment in the first of the Phase 3 clinical studies of Lymphoseek
at cancer research centers in the United States before the end of April. |
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Provide interim efficacy results from the first Lymphoseek Phase 3 clinical study
within 30 days of enrollment of the first 100 patients. |
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Initiate patient enrollment in a global multi-center Phase 3 clinical study of
Lymphoseek in patients with head and neck squamous cell carcinoma around mid-year. |
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Analyze and report the results of the Phase 3 studies to support the filing of a NDA
for the drug in the United States and to support clinical development and product
registration activities in Europe. |
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Continue the clinical evaluation of Lymphoseek in prostate, lung, gastric and colon
cancers with the goal of expanding the application of lymphatic mapping to these and other
tumor types. |
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Maintain our leadership position of our gamma detection device business to provide
consistent financial contribution as compared to 2007. |
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Evaluate our blood flow measurement products to determine the appropriate strategic
focus for the products to maximize their near and long term potential to Neoprobe. |
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Complete the regulatory evaluation of RIGScan CR in the EU by initiating any
non-clinical or clinical comparability studies, and commence manufacturing transfer with
the assistance of a development partner. |
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In conclusion, we believe that as a result of the activities and initiatives outlined above, the
future of Neoprobe has been significantly enhanced in the past fifteen months. Lymphoseek has met
each of its clinical milestones and its continued successful development will dramatically change
the financial prospects for Neoprobe. In addition, the potential of our biomedical RIGScan and ACT
technology initiatives may provide significant incremental revenue opportunities to complement our
device and Lymphoseek businesses. All of our products are focused to fulfill our mission of
developing and commercializing innovative biomedical products that enhance patient care and improve
patient outcome. With your continued assistance and support, we will work to make Neoprobe an
innovative and successful biomedical company.
Sincerely,
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Carl J. Aschinger, Jr.
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David C. Bupp |
Chairman
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President and CEO |
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by
meeting the critical intraoperative diagnostic information needs of physicians and therapeutic
treatment needs of patients. Neoprobe currently markets the neo2000® line of gamma
detection systems that are widely used by cancer surgeons and is commercializing the
Quantix® line of blood flow measurement products developed by its subsidiary,
Cardiosonix Ltd. In addition, Neoprobe holds significant interests in the development of related
biomedical systems and radiopharmaceutical agents including Lymphoseek® and
RIGScan® CR. Neoprobes subsidiary, Cira Biosciences, Inc., is also advancing a
patient-specific cellular therapy technology platform called ACT. Neoprobes strategy is to
deliver superior growth and shareholder return by maximizing its strong position in gamma detection
technologies and diversifying into new, synergistic biomedical markets through continued investment
and selective acquisitions. www.neoprobe.com
Statements in this news release, which relate to other than strictly historical facts, such as
statements about the Companys plans and strategies, expectations for future financial performance,
new and existing products and technologies, anticipated clinical and regulatory pathways, and
markets for the Companys products are forward-looking statements The words believe, expect,
anticipate, estimate, project, and similar expressions identify forward-looking statements
that speak only as of the date hereof. Investors are cautioned that such statements involve risks
and uncertainties that could cause actual results to differ materially from historical or
anticipated results due to many factors including, but not limited to, the Companys continuing
operating losses, uncertainty of market acceptance of its products, reliance on third party
manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding,
dependence on limited product line and distribution channels, competition, limited marketing and
manufacturing experience, risks of development of new products, regulatory risks and other risks
detailed in the Companys most recent Annual Report on Form 10-KSB and other Securities and
Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any
forward-looking statements.