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THOMSON REUTERS STREETEVENTS EDITED TRANSCRIPT DCTH - Delcath Corporate Update Webinar EVENT DATE/TIME: DECEMBER 05, 2012 / 10:00PM GMT 1 THOMSON REUTERS STREETEVENTS | www.streetevents.com | Contact Us 2012 Thomson Reut

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THOMSON REUTERS STREETEVENTS
DCTH - Delcath Corporate Update Webinar
DATE/TIME: DECEMBER 05, 2012 / 10:00PM GMT
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DECEMBER 05, 2012 / 10:00PM GMT, DCTH - Delcath Corporate Update Webinar
CORPORATE PARTICIPANTS
Gregory Gin EVC Group - IR
Eamonn Hobbs Delcath Systems Inc -
Graham Miao Delcath Systems Inc - EVP & CFO
Good afternoon, ladies and gentlemen, and welcome to the Delcath corporate update. At this time, all participants are in a listen-only mode and will
remain so for the duration of today s conference.
(Operator Instructions)
Please note that this conference is being recorded. I would now like to turn the call over to Mr. Gregory Gin of EVC Group. Please, go ahead.
Gregory Gin - EVC Group - IR
Thank you, Operator; and good
afternoon, everyone. Thank you for joining us for this webinar to provide an update on Delcath s recent corporate progress. An archived replay of the webinar will available approximately two hours after its conclusion, and it will be available
for seven days on the Company s website at www.delcath.com.
Before we begin, I would like to remind you that some of the statements made
during this webinar will contain forward-looking statements within the meaning of the Safe Harbor provision of the US Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and actual
results could differ materially from those projected in any forward-looking statements. Factors that could cause actual results to differ are discussed from time to time in the Company s filings with the SEC, including our Annual Report on Form
10-K and our reports on Form 10-Q and 8-K. These documents are available on the Investor Relations section of our website and we encourage you to review the material. The Company has no obligation to publicly update or revise these forward-looking
statements to reflect the events or circumstances after the date they are made.
Participating in today s webinar are Eamonn Hobbs,
President and Chief Executive Officer; and Graham Miao, Executive Vice President and Chief Financial Officer. Following their opening remarks, there will be in question-and-answer period. Questions can be submitted electronically via the webinar
interface, and questions will be summarized and addressed. Feel free to forward us your questions during the course of this webinar and we will summarize and address them at the end.
Now, I d like to turn the call over to Mr. Hobbs.
Eamonn Hobbs - Delcath
Systems Inc - President & CEO
Thank you, and good afternoon, everyone.
The purpose of today s webinar is to review the news we announced this afternoon after the market closed regarding our committed equity facility and
modification of our new drug application, or NDA, pending with the US FDA, as well to provide a brief update on other recent corporate developments. I will start with the NDA and other developments, and then turn it over to Graham to discuss the
committed equity financing vehicle.
Let s begin. We have had recent discussions with the FDA and are very appreciative of the FDA s
interest in our NDA and the progress that has been made to date towards our June PDUFA goal date. Although the Company s Phase 3 trial demonstrated a very positive signal in patients with unresectable liver dominant cutaneous melanoma, based on
the Agency s recommendation, we have decided to focus our NDA s indication for the treatment of patients with unresectable metastatic ocular melanoma in the liver. This is due to 90% of the patients enrolled in our Phase 3 trial having
ocular melanoma metastases to the liver and the statistically significant efficacy data generated in the trial for this disease.
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DECEMBER 05, 2012 / 10:00PM GMT, DCTH - Delcath Corporate Update Webinar
Additionally, FDA-approved treatment options have evolved significantly for metastatic cutaneous
melanoma over the past several years, while treatment options for unresectable metastatic ocular melanoma continue to be lacking. This evolution, since our SPA was approved, has raised the regulatory bar for new drug approvals for treatment of
cutaneous melanoma considerably. Given these facts, we believe that our data in metastatic ocular melanoma, coupled with the large unmet need for treatments in this disease, presents the most compelling case for our NDA, and the best opportunity for
FDA approval of our chemosaturation system. We hope that a timely approval of our chemosaturation system will represent an important step to bring benefits to those cancer patients afflicted with this disease.
It is important to note that the modification of the indication in our NDA submission has not impacted our June PDUFA goal date. Remember that the FDA
previously granted orphan-drug designation for melphalan in ocular melanoma, so assuming our NDA is approved, orphan-drug designation will provide Delcath with seven years of marketing exclusivity in this indication. Additionally, assuming our NDA
is approved, we believe the decision to focus the initial labeling for our proprietary chemosaturation system on ocular melanoma will have little impact on our revenue potential in the United States. We believe that this is due to the fact that
physicians in the United States typically prescribe any cancer treatment option based on clinical data and their professional medical experience.
While we are changing our request for labeled indication, the clinical data associated with our therapy remains the same and will continue to grow as we conduct further clinical trials. To that end, we
plan to initiate clinical studies in 2013 to study the use of our chemosaturation system in other tumor types that potentially represent significant commercial opportunities beyond the ocular metastatic melanoma market. Currently, we intend to
pursue studies to support label expansion for the use of our system to treat hepatocellular carcinoma and neuroendocrine cancer patients, and depending on feedback from the FDA, could potentially enroll our first patients before the end of 2013.
Before turning the call over to Graham, I d now like to provide a brief update on the European launch of CHEMOSAT, where we are making
steady progress. Physicians in Europe continue to treat patients with liver dominant metastases from a variety of tumor types, including both cutaneous and ocular melanoma, gastric cancer, breast cancer, and cholangiocarcinoma. We also have begun to
see first patients with HCC, or primary liver cancer, and NET neuroendocrine tumors treated with CHEMOSAT in the European Union. We believe this illustrates how clinical data and professional medical experience drives usage of new therapies, as well
as the broad potential that physicians see in using chemosaturation therapy to help patients suffering from wide varieties of cancers in the liver.
In early November, we reported the first national reimbursement mechanism for CHEMOSAT procedures in Europe under an existing Italian diagnostic-related group code, or DRG code. Establishing reimbursement
across our targeted EU markets is critical to our commercialization efforts, and we are pursuing additional supplemental new technology payment programs in Italy, as well as conducting a concentrated effort to establish reimbursement in Germany and
the UK, where we hope to receive positive reimbursement determinations in the first quarter of next year.
In Germany, a new cancer center at
Gottingen University successfully performed its first CHEMOSAT procedure last week, bringing us to seven CHEMOSAT-trained launch centers in Europe so far this year. Gottingen University has also submitted a reimbursement application to a major
private insurance carrier in Germany and received reimbursement. This is an interim mechanism we will attempt to leverage elsewhere in Germany until an expected decision by the NUB is rendered in the first quarter next year.
Also, we intend to build clinical experience with CHEMOSAT through investigator-initiated clinical trials by leading EU opinion leaders in tumor types
where there is a large need. We believe these small trials will help build a growing body of evidence to support the clinical case for CHEMOSAT and help drive clinical adoption at key centers, which we hope will facilitate wider usage, once
reimbursement mechanisms become available. In addition, these studies, if positive, will provide support of data for future US-registration trials in indications with a large need. Together with our reimbursement efforts, and with additional centers
coming online in the next few weeks, we are building momentum for growth in Europe during 2013.
With that, I would like to have Graham Miao
provide a review of the committed equity financing facility that we announced this afternoon, and then we will take questions. Graham?
Graham Miao - Delcath
Systems Inc - EVP & CFO
Thank you, Eamonn. Good afternoon, everyone.
As part of our ongoing efforts to strengthen our balance sheet, we have established a committed equity financing facility, or CEFF, under which we may
sell up to $35 million of our registered common stock to Terrapin Opportunity Fund over a 24-month period. This CEFF is a common financing resource that has been successfully used by late-stage development biotechnology companies. The new facility
provides Delcath with the ability to potentially raise capital more efficiently by issuing shares at the time of our choosing. When, and if, we elect to use the facility, a modest discount would be applied to the purchase price, ranging between 3.6%
and 5.8% to the volume weighted average price of Delcath s common stock over a preceding period of trading days. We are not obliged to utilize any of the $35 million facility, and we are free to enter into other equity and debt financing
transactions, subject to certain restrictions. It is important to emphasize that no warrants are associated with this committed equity financing facility.
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DECEMBER 05, 2012 / 10:00PM GMT, DCTH - Delcath Corporate Update Webinar
As you may know, in late December of last year, we established an At-The-Market, or ATM, financing
program to sell up to $40 million in shares of our common stock from time to time. This new CEFF differs from the ATM by providing Delcath the ability to raise a larger amount of capital at one time as compared to the ATM. The CEFF also enables the
Company to know where the shares are being held initially. In the Terrapin Fund, the investor has a successful track record with investments in the life sciences space. At the same time, the equity financing facility offers certain advantages over
other financing strategies, including the ability to raise capital quickly, at a competitive cost, and it may allow us to manage dilution more effectively by issuing shares in multiple tranches at times of our choosing over the next 24 months.
This flexible financing facility is an important component of our portfolio of financing options. Combined with our $28 million in cash on
hand at September 30, 2012, and an additional $21.5 million currently available under our At-The-Market program, we believe that the CEFF provides our Company with additional resources and flexibility required to execute our operation plan
through our June 15, 2013 PDUFA goal date and well beyond. We continue to expect our average monthly cash expenses of $3 million to $4 million in the fourth quarter and anticipate maintaining this level in 2013.
That concludes our prepared remarks. We will be happy to take your questions online.
Gregory Gin - EVC Group -
As a reminder, questions can be submitted electronically via the webinar interface, and questions will be summarized and addressed.
(Caller Instructions)
The first question is why did you choose to modify the label
indication? Actually, this first questioner has two questions. The second question is won t this narrower indication diminish the sales opportunity?
Eamonn Hobbs - Delcath
Systems Inc - President & CEO
Thanks, Greg. I ll take a shot at that. Although our Phase 3 trial demonstrated a very
positive signal in patients with unresectable liver dominant cutaneous melanoma, based on the FDA s recommendation, we have decided to focus our NDA s indication solely for the treatment of patients with unresectable metastatic ocular
melanoma in the liver. As we mentioned earlier, this is due to the fact that our data is strongest in ocular melanoma, in that 90% of the patients in our Phase 3 trial were ocular melanoma patients, and the data is most compelling in that area.
Additionally, and very importantly, the world moved on during the course of the seven-plus years since the SPA was negotiated and approved by
the FDA. When the SPA was agreed to with the FDA back in 2005, there were no treatments approved by the FDA for melanoma metastases of any kind, including cutaneous and ocular. So, the trial that was conducted by the Company agreed to under the SPA,
really did not was not designed to provide discrete data for each type, and the two types of melanoma were grouped together. I was not there at the time in 2005, but I would suggest that if I had been there I might have believed that there
was no preassumption that there was any difference between how melanoma would react in the liver to a treatment, regardless of where it came from. And in fact, that still permeates the clinical mindset that melanoma is melanoma with regard to a
cytotoxic agent in the liver. Since that time, multiple drugs have been approved by FDA to treat cutaneous melanoma, and the bar has risen significantly for what FDA is going to require to get a new an additional cutaneous melanoma product
approved and labeled for that.
Ocular, on the other hand, has not progressed. There are still no FDA-approved treatments for unresectable
Last updated: Dec 10, 2012