NexMed, Inc. (NEXM)
Q2 2010 Earnings Call
August 13, 2010, 12:00 PM ET
Ed Cox - VP, IR and Corporate Develoment
Bassam Damaj - President and CEO
Rob Wasserman - Dawson James
Greetings, and welcome to the NexMed Inc. second quarter 2010 results conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host, Ed Cox, Vice President of Investor Relations and Corporate Development for NexMed Inc. Thank you. Mr. Cox, you may begin.
Good morning. I am Ed Cox, Vice President of Investor Relations and Corporate Development here at NexMed. On the call with us today are Dr. Bassam Damaj, Chief Executive Officer; Mark Westgate, Chief Financial Officer; and Vivian Liu, our Executive Vice President.
Before we begin, I will read the forward-looking language statement, and then turn the call over to Bassam for an update on the business and financial condition of the company. Following Bassam’s remarks, we will open the call for your questions and comments.
As a reminder to everyone, during the course of the call the management team will make forward-looking statements regarding the future events or the future financial performance of the company. Please keep in mind that such statements are predictions based on current expectations, and actual results could differ materially.
You should refer to our most recent filings with the Securities and Exchange Commission for additional discussions on factors affecting our business.
Now, I will turn the call over to Bassam.
Thank you, Ed, and thank you all for joining us today to discuss the second quarter 2010 and our plans going forward. I'm eager to bring you up to date on the company's progress since we last spoke on our first quarter call.
The advancement we made on all fronts of the company in the second quarter demonstrates NexMed's continued success in executing our fourth acquisition and transformation of the company.
We are now halfway through our first full year as a combined company. Already we are seeing positive signs of what can be achieved. I am very pleased with what our team has accomplished. We remain focused on driving revenue growth, maintaining our NASDAQ full compliance, reducing our cost structure, advancing our clinical products, aggressively pursing partnerships for the NexACT delivery platforms and licensing our pipeline, all of which are allowing us to make good progress towards making NexMed a leader in the pharmaceutical industry.
We have an excellent multi (inaudible) drug delivery technology and capabilities that can be applied within both the pharmaceutical and biologic arena. When you look at the face of our activities, since the beginning of 2010, especially during the second quarter, you will see that our progress in this area has been substantial.
As the versatility of the NexACT technology continues to reveal itself in both pre-clinical and clinical settings we have been aggressively pursuing licensing deals while also maintaining a keen focus on monetizing our existing late-stage product pipelines via out licensing and commercial partnership opportunities.
Our goal is to conclude at least one partnership on the clinical products side and one partnership on the NexACT technology side this year. Now let's take a few moments to update you more sophistically on our operations.
I'd like to start with our clinical pipeline. Starting with Vitaros, as you know, in the beginning of the second quarter we submitted our response to Health Canada, which is part of the review process for our new drug submission for the product.
In June, Health Canada confirmed the acceptance of our [CMP] response for review which triggered a new 150 day review cycle by the NDS reviewers for a final approval or rejection of our marketing application. Based on the rate of acceptance we anticipate a final approval decision by the end of November.
In parallel we have undertaken an aggressive strategy in the registration of Vitaros in international markets. We expect to file our [MNA] for Europe in the first quarter of 2011. We are also preparing for filing for [AMEA] countries.
In terms of our partnering efforts for Vitaros, we remain in active discussions with potential partners in Canada, Europe and other international markets. Several of these discussions are characterized at later stage now. Please be assured that we will continue to keep you updated of the progress of the [process].
We are also very close to choosing a manufacturer for Vitaros, which will be in place in time for the approval decision by Health Canada in late 2010.
In the US we are still awaiting a decision from the FDA. We will provide you updates as they become available.
In terms of intellectual property, we continue to be notified of new patent issuance in key international markets which continue to add to and strengthen our IT portfolio. Meanwhile, we continue to assess new product opportunities for Vitaros based on clinical results for [more] (inaudible) easy indications and the data that shows that the active ingredient in Vitaros, which is prostaglandin E1 or Alprostadil, is clinically effective in multiple diseases.
Towards that end, we announced the second quarter that the FDA granted NexMed an IND application for our Alprostadil-based treatment for Raynaud's syndrome ahead of our [pre-R&D] meeting which occurred in mid-July to discuss our [preferred] Phase II, Phase III protocols.