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XOMA Ltd. (XOMA)
Q2 2013 Earnings Conference Call
August 07, 2013 04:30 pm ET
Ashleigh Barreto – Head-Investor and Media Relations
John W. Varian – Director and Chief Executive Officer
Paul D. Rubin – Senior Vice President-Research and Development and Chief Medical Officer
Fred Kurland – Secretary Vice President and Chief Financial Officer
Charles C. Wells – Vice President-Human Resources and Information Technology
Simos Simeonidis – Cowen & Company
Adnan Butt – RBC Capital Markets
Ritu Subhalaksmi Baral – Canaccord Genuity Inc.
Jason Kantor – Credit Suisse Group
Bert Hazlett – Roth Capital Partners
Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.
Previous Statements by XOMA
» XOMA Corp. Management Discusses Q2 2013 Results (Webcast)
» XOMA Management Presents at Credit Suisse 2013 Antibody Day (Transcript)
» XOMA Corp CEO Discuses Q1 2013 Results - Earnings Call Transcript
» XOMA's CEO Discusses Q4 2012 Results - Earnings Call Transcript
And now I’d like to turn the conference over to your host for today, Ashleigh Barreto, Investor Relations at XOMA. You may begin.
Thank you, operator and good afternoon everyone. Joining us on the call today are John Varian, Chief Executive Officer; Paul Rubin, Senior Vice President- Research & Development, and Chief Medical Officer; and Fred Kurland, Vice President-Finance and Chief Financial Officer. Before we begin, I’d like to remind everyone that this conference call will contain forward-looking statements about the Company.
These statements are subject to risks and uncertainties that could cause actual results to differ. Please note, these forward-looking statements reflect as opinions only as of the date of this presentation, and we undertake no obligation to revive and publicly released results of any revisions. These forward-looking statements in light of new information or future events.
Factors that could cause actual results and outcome to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent filings of Form 10-K and other SEC filings.
Now I’d like to turn the call over to John.
John W. Varian
Hello everyone and thanks for joining us. It’s hard to believe that during the second quarter of last year we were managing just the acne proof-of concept study. At the end of that quarter, we announced the launch of the first of three EYEGUARD Phase 3 studies, and the Phase 2 proof-of concept trial in patients with inflammatory erosive osteoarthritis of the hand.
In contrast, we ended the second quarter of this year with gevokizumab and six clinical trials that we are managing directly. The global Phase 3 EYEGUARD-A and EYEGUARD-C clinical trials in patients with acute and controlled non-anterior non-infectious uveitis are scheduled to enroll 600 patients collectively.
The Phase 2 study in EOA patients, we have elevated CRP, has completed enrollment with those data to be delivered in October.
We’ve initiated enrollment in our pilot study of pyoderma gangrenosum. In this quarter we launched a supplemental study in EOA patients who do not have elevated CRP. It will enroll 90 patients and is already two-thirds enrolled.
In addition, our partner SERVIER has initiated or is about to initiate a number of complementary clinical trials in its proof-of-concept program. Paul will provide you with a detail of several other studies in which we are testing gevokizumab’s ability to modulate inflammatory diseases.
Between SERVIER and XOMA, gevokizumab is currently being evaluated in over a dozen trials involving 10 different indications. The data reads from these studies have begun and will continue to rollout.
This past January we announced very encouraging results in moderate to severe inflammatory acne. As we’ve shared our results with experts in the field, we become increasingly convinced that there is a clear development path going forward for gevokizumab in this most severe subset of acne.
Our initial commercial analysis has also been positive. The dermatologists we surveyed see a need for a product that might be effective in patients with failed treatment with systemic antibiotics. This is the patient population we studied in our Phase 2 trial. The physician survey would like another option available to them before having to resort to Accutane for these patients. Our commercial assessment is ongoing and is directed to identifying the best positioning for gevokizumab enacting.
Another important event on our path to choosing the next Phase 3 indication for gevokizumab will be the results from our Phase 2 study in erosive osteoarthritis of the hand. We anxiously wait these results, which we’ll have in October. Our commercial analysis of this indication is also underway, but I think we are already in a position to say the commercial potential for gevokizumab in EOA is clear and significant.
With the results of the EOA study and the ongoing commercial analysis in acne and EOA, we will be in a position to choose the next indication for gevokizumab to follow the ongoing EYEGUARD studies into pivotal trials.
Paul will provide you with a detailed update on the ongoing EYEGUARD studies. What you’ll here is the team here at XOMA has done a good job managing the piece of the global effort over which we have the most control, getting the centers for EYEGUARD-A and EYEGUARD-C open in U.S.
On our first quarter call, we shared that 51 centers of our originally targeted 60 U.S. sites were up and running. As of today we have 63 sites opened, which reflects our plan to expand a number of U.S. sites to total of 70. Of the 63 open U.S. sites, 53 were opened after February 15 of this year.
The increase in planned U.S. centers from 60 to 70 is in response to a couple of factors. First, we are not seeing the initial rate of enrollment and open new centers at the pace we would like. It is still early since as I said, 53 of the 63 sites have been opened for less than six months. It may be self correcting, but we are taking some additional steps beyond adding centers to accelerate the pace of enrollment, particularly through the use of social media, ongoing review of protocol requirements, exploring ways to streamline screening and reaching out to other investigators for referral.