XOMA - NASDAQ

Ashleigh Barreto – Head-Investor Relations Frederick Kurland – Chief Financial Officer and Vice President-Finance John W. Varian – Chief Executive Officer Paul D. Rubin – SVP-Research and Development and Chief Medical Officer

Ted Tenthoff – Piper Jaffray & Co Ritu Baral – Canaccord Genuity Jason Kantor – Credit Suisse Adnan Butt – RBC Capital Markets. Biren Amin – Jefferies & Company, Inc. Matt Kaplan – Ladenburg Thalmann & Co. Inc.

Good afternoon, ladies and gentlemen, and welcome to the XOMA Corporation’s Corporate Update and First Quarter 2014 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. (Operator Instructions) As a reminder, this call is being recorded. I would now 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 and 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 cause actual results to differ. Please note that these forward-looking statements reflect our opinions only as of the date of this call. And we undertake no obligation to revise or publicly release results of any revisions to these forward-looking statements in light of new information or future events. Factors that could cause our actual results to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent filings on Form 10-K and other SEC filings. I’d now like to turn the call over to Fred.

Thank you, Ashleigh, and good afternoon everyone, and thanks for attending our call. For the three months ended March 31, 2014 we recorded total revenues of $3.4 million, compared with $9.5 million during the corresponding period of 2013. The revenues for the first quarter of 2014 reflects $6.1 million and lower reimbursements from SERVIER, compared to a year ago. There are two reasons for this. First, recall that under our agreement SERVIER paid the first $50 million of all non-infectious uveitis development cost, after which all cost would be shared equally between the two partners. We reached that $50 million spending levels during the third quarter of 2013, since that time each partner has incurred non-infectious uveitis costs that are approximately equal to each other, resulting in a reduction in reimbursements from SERVIER. Second, during the first quarter of 2013, we received a one time funding milestone payment of $3.9 million from SERVIER related to a product development program that we subsequently transferred to Symplmed. Our first quarter 2014 research and development expenses were $21.5 million compared to $16.6 million in the corresponding 2013 period. The first three months of this year had higher cost associated with gevokizumab clinical and other development activities, increased spending on pre-clinical development activities related to the XMet platform and $2.4 million in non-cash stock based compensation expense. Our selling, general and administrative expenses were $5.3 million and $4.1 million in for the 2014 and 2013 first quarters respectively. The increase primarily reflects an increase in charge for non-cash stock based compensation of $1.5 million. For the first quarter ended March 31, 2014, XOMA had a net loss of $4.7 million or $0.04 per share, which included a $20 million gain in the non-cash revaluation of contingent warrant liabilities, excluding the revaluation, our net loss for the first quarter would had been $24.7 million or $0.23 per share. In the quarter ended quarter ended March 31, 2013 we had a net loss of $24.9 million, or $0.30 of share including $12.8 million of non-cash revaluations of contingent warrant liabilities. So with that the revaluation, the 2013 first quarter loss would have been $12 million, or $0.15 per share. On March 31, 2014 we had cash, cash equivalents, and short-term investments of $93.7 million compared to $121.6 million at December 31, 2013. Our first quarter cash burn was on target with our internal expectations and we are on target with our full year guidance of an operating burn of $55 million to $60 million for the full year. This quarter contained a few below the line cash payments that are worth articulating. Two, our one-time items. In January we paid SERVIER $1.9 million of accrued interest on our loan of €15 million which was expanded back in January of 2011. This was the first interest payment since the loan was extended and covered interest own for a three year period. Going forward interest will be payable every six months until the loan is scheduled to be repaid in 2016. We also had received back in December a $7 million milestone payment from Novartis which triggered a clause in our in the loan agreement whereby government is obligated to pay 25% of clinical milestone payments received. Therefore in the first quarter we included a $1.75 million payment to Novartis which was applied to reducing the principle of our loan. These two one-time payments were in addition to our standard monthly payments of principle and interest to GE Capital Corporation which amount to $1.3 million per quarter. I also want to point out that our unchanged guidance of $55 million to $60 million of cash to be used in ongoing operating activities during 2014 includes the expectation that we will receive license and contract related revenues during the year. This expectation is consistent with our history of entering into such agreements regarding our assets and programs. I will turn the call over to John for an overview of our operating highlights for the first quarter. John?

Thank you, Fred. I would like to thank everyone for joining us today. This is an incredibly exciting time for us here at XOMA. We are very near to having the first data from our Phase 3 studies and our lead indication non-infectious uveitis. We also have a clear path forward in our next pivotal indication for gevokizumab, pyoderma gangrenosum. Before I touch on these near-term events, let me start with some of our other clinical efforts. You are well aware of the challenge we’ve been facing with enrollment in the EYEGUARD A and C studies. All the companies working in this indication have had similar difficulties. In our continuing effort to learn and adapt, we’ve launched a new push known as the EYEGUARD-C initiative. This most recent drive came about because in U.S. we were seeing steadily increasing and apparently predictable enrollment in EYEGUARD-C through February of this year. In March, we saw a slowdown in activity. EYEGUARD-C enrollment in the U.S. is the area on which XOMA can have the most direct impact. Patients with active disease who quality for EYEGUARD-A are harder to find in the U.S. as our investigators have to quote, “wait for them to show up”, with a qualifying vitreous haze score. These patients are rare here in the U.S. Now EYEGUARD-C is a different story, since we’re looking for patients who have NIU but are controlled corticosteroids. These patients exist and can be accessed at our 60 plus U.S. clinical site. Our investigators just have to continue to find them and enroll them in EYEGUARD-C. We put our EYEGUARD-C initiative in place based on a simple premise, if each of our open U.S. centers can find us approximately one more patient, we can at least hit our U.S. enrollment target fairly soon. We want each center to find a patient or two in the next two months. The key to achieving this simple goal is to demonstrate a commitment to a higher presence at the clinical sites. We want to make sure the investigators understand how important this program is to XOMA and the patients who suffer from NIU. We want to identify and address any issues that are preventing enrollment. As part of this initiative every member of our executive management team has or will be spending time with these physicians who are critical to the success of our Phase 3 program. I’ve been to Los Angeles and was in North Carolina yesterday, I’ll be back out on the road in the next couple of days. Fred was in New Jersey and Connecticut last week. Paul was at ARVO this weekend. He’s always communicating with and visiting the physicians. He applies our resource to support their progress. While we’re learning from this initiative is that there are patients who qualify for EYEGUARD-C, but they are hard to find. Some issues are structural, but the bulk are practical one, which we can deal with fairly directly. On the structural side, we’re seeing the standard of care is changing. With the move away from use of steroid as patient and physician acceptance of the side effects from steroid is diminishing. Medical data support this shift. EYEGUARD-C is a steroid tapering study, so patients need to be on steroid to qualify for the study. In the long run this ship bodes well for our steroids bearing therapy like gevokizumab. Now from a practical standpoint, we are restructuring the CRO relationship and are taking over the lead communication and site management efforts. We’re already beginning to see that there is renewed interest and commitment as the increased over site directly by XOMA provides site with an understanding of the importance of this trial to us. This includes using awareness of the enhanced EYEGUARD website, more focused on referring physicians, direct targeted uveitis patient reach and very importantly assistance with chart and data base review to more effectively identify potential candidates. Our efforts to partner with the study sites to customize the best approach has been successful, with an increase of subjects to be screened in the past several weeks. Growth operational over site and ongoing site interactions are key to continue to the full momentum due to this initiative that we’ve seen this past weeks. Simply put, during our visits were asking the investigators and their staff to review their patient records to find as at least one additional patient to enroll in EYEGUARD-C, that’s it. If this site list is a success, we should be able to meet our enrollment targets for U.S. patient in EYEGUARD-C. And by being even more visible to our clinicians, we may see a larger percentage of patients enroll in EYEGUARD-A coming from the U.S. than we anticipated or seen today. So while enrollment in EYEGUARD-A and C is what’s keeps us awake at night. We hope that by getting out into the field our expanded presence can help us speed up the enrollment process, it may not but we continue to take action. Ann Neale, our newly hired Vice President of Clinical Operations, has aggressively stepped in to lead this critical effort. She also just returned from a week with her counterpart SERVIER. While there, she and the SERVIER team worked to even further communicate to improve communications between the two companies and to identify additional way to enhance enrollment both EYEGUARD’s A and C. I worked with Ann in the past and we were very fortunate to bring here to XOMA. Paul has characterized these studies as the most difficult enrolled studies she is ever been part of with Ann driving our Kim’s efforts, Paul and I have full confidence at every thing that can be done is being done. Since our last call was only six weeks ago changes outside the U.S. were only beginning to take effect, so my update is to where we stand there will be brief. Our XOMA 60 plus U.S. center – study centers are opened and a majority have been opened for over nine months now. Today SERVIER has 15 of its targeted 23 countries with open site actively recruiting patients. SERVIER continues its work to open sites in these countries to expand the geographic reach and hope that patients will be identified enrolled more quickly. By getting all 52 sites open in these countries we would be nearing the initial 70 targeted sites. At April, 30 an addition of four countries have given approval for EYEGUARD-A and C to be conducted. SERVIER’s planning 12 clinical sites in these countries. We continue to press SERVIER to expedited process but we try to press them in a limited impactful way rather than just waiting. As I said during our last call certain countries have a bigger impact than others between the two studies five countries Argentina, Mexico, Turkey, Armenia and Brazil are expected to deliver more than 125 patients. These countries are just starting the process of opening clinical sites, until the sites in these five countries began to show their ability to enroll patients quickly and consistently we cannot project when we will reach full enrollment in either study. We hope to have more clarity by now. As of today, since we don’t know the full impact of our U.S. EYEGUARD-C initiative, and because of the delays global in getting site up and rolling, we do not foresee EYEGUARD-C study being completed in 2014. You would have to be fully enrolled with all patients by June 30. We and Servier will get it done and will not compromise the study. Timing matters, but the results of the study matters a lot more. You are aware of the challenge we faced enrolling patients in EYEGUARD-A trial due to the entry criteria, particularly here in the U.S. We are even more dependent on ex-U.S. enrollment for this study. In the past few weeks we began to see a tick up in the pace of enrolling patients with acute non-infectious uveitis. The patients came from countries that were unexpected. South Korea continues to be the best enrolling country for EYEGUARD-A and Germany, Austria and Spain continue to identify patients that meet the protocol requirements and roll them in the study. For EYEGUARD-A to complete in 2014, we must have all 300 patients enrolled and dosed by the end of October. The primary endpoint in EYEGUARD-A is a comparison of the number of non-infectious uveitis patients who have responded treatment in day 56 between the gevokizumab and placebo. We need a significant influx of patients to fully enroll the study. If the enrollment numbers we have seen in the past couple of weeks accelerate, there is a chance we can meet the primary endpoint in 2014. Ultimately the timing of both studies continues to depend upon a significant bolus of patients from all the countries where the trials are being conducted. It is important mind you that we only need data from two of the three studies, EYEGUARD-A, B and/or C, in order to submit our BLA for the broad non-infectious uveitis indication. So, now let’s move to EYEGUARD-B, which is in patients with Behçet’s uveitis and continues to move well. SERVIER continues to believe that pre-specified number of exacerbation, which is the primary endpoint to unmask the EYEGUARD-B clinical trial will occur in June. Their projection is based upon the number of exacerbations that have taken place to this point and in extrapolation forward. The June day projection has been consistent for more than a quarter now. Today SERVIER is a handful event away from the pre-specified number of exacerbations. As a reminder SERVIER is a 100% responsible for conducting the EYEGUARD-B study. They will control when they lock the data base. They will take as much time as they need to review and clean the data to ensure all the patient information is included and any abnormalities investigated and resolve. This will all occur prior to unmasking the study and running the endpoint analysis. As a large pharmaceutical company with extensive standard operating procedures, we know it will take them longer to generate the top line data than typically it would take XOMA. With that said, they have communicated they will work hard to have the primary endpoint data within about six weeks after the final event. We receive a lot of request to walk through fiscal powering assumption of EYEGUARD-B, Paul will do this for you in a few minutes. While we wait the top line data in Behçet’s uveitis, our clinical team has been completing the protocol for a supplemental study, which is design to expedite a BLA filing for a Behçet’s uveitis only label in the U.S. As the patient population in U.S. is very small, less than 7,500 patients. We are identifying sites that have patients who would be eligible for enrollment. We want to identify where U.S. patients are available to us prior to launching the study. As a reminder, we have been granted orphan status for both Behçet’s disease and non-infectious uveitis. The other thing that is now clear, is our path forward in pyoderma gangrenosum. With the input from FDA which we received in March, we’ve been able to finalize the protocols for our Phase III program for this indicatation. I want to stop and complement our clinical and regulatory teams for outstanding work, which is result in a very doable couple of pivotal studies. I also want to thank our partner SERVIER for agreeing to allow us to sponsor these studies in several of the countries in SERVIER’s territories. These countries have patients being treated by investigators with whom we have relationship and confidence. To conclude my remarks, everyone at XOMA is focused on getting gevokizumab closer to a BLA filing, together with SERVIER we are doing everything we can to get EYEGUARD’S-A and C fully enrolled. We are rapidly moving towards the launch of our second Phase III program in pyoderma gangrenosum and we are conducting due diligence to identify sites with eligible patients who will be interested in participating a supplemental U.S. study in Behçet’s uveitis. So, while I may lay awake night, worrying about enrollment EYEGUARD’S-A and C, it is excitement that keeps me awake as we await the Behçet’s uveitis results and launch our newly defined studies in pyoderma gangrenosum. So with that said, I’ll turn the call to Paul. Paul?

Thanks, John. And good afternoon, everyone. I am going to review the primary end point for EYEGUARD-B and provide with a statistical powering assumptions. Then I’ll give you an update of our plans for pyoderma gangrenosum and our progress related to XMetD, a compound which blocks the action of insulin and its receptor. And let you know about the presentations we’re going to make in the coming months that maybe of interest to you. EYEGUARD-B is being conducted exclusively in uveitis patients with underlying Behçet’s disease and are being treated with oral corticosteroids. It’s design to compare the difference in the time to first acute ocular exacerbation between the gevokizumab and placebo arms. Patients being treated with prednisone 20 milligrams per day or an equivalent steroid and our randomized one-to-one to receive either gevokizumab 60 milligram subcutaneously once monthly oral placebo. After dosing these patients have their steroids tapered in a consistence step wise approach down to 5 milligrams per day using the jobs protocol. The study is designed to analyze the primary end point after a pre-specified number of initial exacerbations have occurred in the study. Now it’s important to understand how the protocol to find in exacerbation. EYEGUARD-B defines an exacerbation as a worsening in Vitreous Haze with or without two year Behçet's involvement by two units and its front scale or a 15 or greater later ETDRS decrease in best collected visual acuity score that is not explained by a cause other than ocular information secondary to disease or the emergence of new retinal infiltrates or acute retinal vasculaters. Now I’ll explain the statistical assumptions for this portion of the EYEGUARD-B study. Power assumptions for EYEGUARD-B will derive from the review of the literature and in console patients with the Type 2 diabetes key opinion leaders on a worldwide basis. The sample size was based upon a hazard ratio of 0.3 or 0.3 exacerbations in the gevokizumab group for each exacerbation in the placebo treated group. The primary end point will be reported as the difference in time to first acute ocular exacerbation between the placebo and gevokizumab groups. This difference will be estimated from the statistical comparison of the curves generated show the number of non-exacerbating patients over time or survival herbs using a toxic proportional hazard model. Our assumption will provide 90% power and a P value of less than or equal to 0.05. So once the prescribed number of exacerbations is reached, all patients will participate in the one-year double blind masked portion of the study. Servier will be making further clinical assessments when all the patients have completed the second double-masked period. As John said, we are very excited to get the results from the study, so we can be forward with our regulatory plans. Our supplemental U.S. study in Behçet’s uveitis patients is in the lead planning stages and will be implemented soon. Due to the very small number of patients in the U.S. optimum slide selection is crucial. Turning to our next Phase 3 program, let’s quickly talk about the progress we have made with getting gevokizumab into a pivotal program in patients with pyoderma gangrenosum. In March, our team conducted a meeting with the dermatology division at FDA regarding gevokizumab and our desire to pursue a Phase 3 program in patients with pyoderma gangrenosum or PG. PG is a rare necrotic condition of painful expanding sterol skin ulcers. We submitted the data from our six patient pilot study and discussed the agency’s requirement to consider a gevokizumab BLA indication. The two most important outcomes from this meeting with the agency’s acknowledgement with PG is an area of unmet medical need and the second was the very specific input into the requirements for pursuing a PG label, which have helped to refine our clinical program. Our clinical and regulatory teams rapidly integrated the comments into a final set of protocols. We will submit the protocols with responses to the agency’s questions in the next week or two. The Agency has 90 days to file any additional comments. Based on the inputs we’ve received, the PG phase program we are submitting includes two clinical trials that are designed to enroll up to 60 patients each. Participants will receive gevokizumab 60 milligrams or placebo once monthly. The primary endpoint is a responder analysis of patients who achieved complete wound closure of the target ulcer in approximately four months. We’ve also elected to make time to closure and improvement in pain scores secondary endpoints. We will let you know when the studies have been launched. While we await any additionally feedback we have been preparing to launch the study, as John said, SERVIER has given us authorization to conduct our Phase III studies in countries within their development and marketing territory. XOMA retains 100% control for the combatants program and will be wholly responsible for the Phase III program. SERVIER retains the option to acquire the rights to our data after we complete the studies. We will contract the clinical research organization with expertise running rare dermatologic Phase III clinical study and together we will conduct pre-study activities in North America and several other countries. Our goal is to have the investigators and their staffs ready to enroll patients as soon as possible after we receive final concurrence with FDA. Now, lets turn the XMet platform. We continue to take steps during submitting an IND for XMetD, our allosteric modulator that deactivates the insulin receptor this year and the Phase I study should begin prior to the end of 2014. We are excited to be presenting an abstract on the in-vivo animal proof-of-concept at Endo in June. XmetA which we intend to license for clinical commercial development to a large pharmaceutical company will be the focus of an oral presentation at the American Diabetes Association meeting in June. The presentation describes the beneficial effects of the XMetA compound in spontaneously diabetic monkeys. Additionally, we have had or will have a presence at the American Academy of Dermatology, The American Association for Cancer Research and The Association for Research and Vision and Ophthalmology universally known as ARVO. Our team will be spending more time with these conferences as both the gevokizumab programs advance in a broader base of clinical indication and as the XMet platform moves into the early stages of clinical development. Now I’ll turn the call back to John for final comments.

Thanks, Paul. Before we take questions I’d be remiss if I didn’t address Dr. Servier’s passing. We have a very strong connections with SERVIER and very much feel part of an extended family. We are on regular contact with people and highest levels of the organization, particularly Dr. Emmanuel Canet and Pascal Touchon both of whom sit on the executive committee. We do not know the succession plan for leadership at this point, but we know gevokizumab is one of the company’s highest priorities and they have communicated this to us. Dr. Servier had a foresight to plan for the long-term durability of SERVIER as a company. In the 1980s he organized the company as a research foundation and all the company’s profits are reinvested. His passing will not create a change of control event. The research foundation will continue to own SERVIER, the company. Dr. Servier was an extraordinary man who dedicated his life to pursuing his passion to improve human health. With that said, Operator we’ll be glad to take questions.

Okay. Yeah, so to be clear, SERVIER expects the final exacerbation to happen in June, and they have indicated to us which we appreciate them being as clear as they have that it will take them about six weeks or so, they’ve given us the schedule of how long it would take to them deliver the results to us and then immediately to you. There’s actually a very good chance to be part of that data analysis. The XOMA team part of that also, we intend to. So, that’s just clear as we can be. And just one thing to say, there’s a prediction about when the last exacerbation will happen. It’s based upon number that have happened so far and rate of expectations for the remainder. So, it will happen when it happens. And we what the events to fall as they should between the placebo and the treatment groups and so when the event happens, again, they’ve indicated to us it will be about six weeks and again, we appreciate them giving us at least an indication of how long they think it would take, because it’s important for you and investors to have an idea of soon we can deliver that result.

And if we can do again, we’re not being exactly specific, but what we have said, is that if we can get about one per center here in the U.S., in these next few months, we’ll be okay in U.S., right. So, not to be too specific, but it’s not that big of hurdle we think. We look at it and say, can each center deliver us one patient and by going out and actually again I was in North Carolina yesterday meeting with the extremely good investigator and just spending the time with them and talking about ways to find their extra one or two patients for each of the center that we go out and talk – that we go out and talk to, it’s a very doable thing. So, file a station, getting them enrolled its not that you know, its an effort, but its not that big of amount for us to climb. So, we’re really focused on getting this done.

Thank you.

I think, that certainly the magnitude of the study that we intend to do is on a relative scale is not very quick. So, our plan is to initiate that trial as soon as we could get it going. To give us the option of submitting, there should be any additional voice in either of the other trials. So, this gives us flexibility in terms of submitting the BLA should either be – we continue, or we see some additional hurdles and getting this complete, or the one that’s positive takes a little bit longer than we thought it might. Yeah, so we’ll start it sooner or rather than later and just to say, Jason, what the clinical team has been doing is exactly the right thing, which is there are certain investigators here in the U.S. for the key to being able to get this small U.S. study done. What we’ve been doing is actually spending time directly with them to actually have them have some input on the protocol. So, they are going to be willing to and wanting to foot their Behçet’s uveitis patients into our study. So, it’s not a process where we’re sitting around drafting a huge protocol that we’re just going to hand out and see if people like it. We’re working with the four, five, six enters here in the U.S., so we think should be part of this study. We’ll have the patient, but make sure we have a protocol that they want to be part of.

Like we’re spending time now identifying the patients.

Okay. It’s a good question Jason. I think what we’ve said at the very beginning is that we believe that we could submit a EOA with any two of the three trials and at least obviously this is we won’t know until we submit a label and negotiate with FDA, but existing labels for uveitis all they say is for the treatment of non-infectious uveitis. So our assumptions at this point and we have no reason to spec otherwise is with any two to three trials, the label would be comparable to other labels that are being getting.

So just to be very specific with that you may not remember it’s history, but in October two years ago of all FDA when the only two studies we plan to do were EYEGUARD-A and B and got agreement with FDA that A and B would be enough for the broad label non-infectious uveitis treatment, okay. We added see if you remember it was supposed to be just the safety expansion study and we actually turned it into a third pivotal study later on. So the fact that FDA has said to us directly A and B would be enough for the broad NIU indication, makes us very comfortable that any combination of A, B and C would do the same because B would the one you would have the most, we have the most concern about it getting agreement of that counting as one of two.

Yeah. As we said, we’ve already had a conversation with FDA and we’ve essentially come to agreement as to what the study should look like. But we are putting together the final protocol exactly to what was discussed and we just starting to get their final seal at approval before we initiate. So we don’t anticipate any significant input but we don’t want to initiate until they’ve seen the final protocol.

Yes, this is completely the normal process where we ask for input we’ve got the input we’ve now put together protocols that we think incorporate all that input into agreement from the conversations. But if they have any last little tweaks like that we would like to know that before we finalize it. And...

You’re welcome.

Welcome.

I can’t say much except to say that I think all these studies are active in enrolling patients.

Yeah. We shouldn’t say more than that.

I mean, that’s really all we can say.

Yes.

Yes. Thank you.

And I’m not showing any further questions at this time. I’d like to turn the call back over to John Varian for closing comments.

Thank you, operator, and thanks everyone for joining us. It is really an exciting time for us right now at XOMA. The results from our Phase III study of gevokizumab in EYEGUARD-B, which we’ve been talking about, are right in front of us. In this study, what’s really exciting to us is this is the study in a specific patient population from which we’ve generated our most consistently compelling data. So we can’t wait to get these results on hand, so we can put in place our final clinical, regulatory and our preparatory commercial steps to aggressively pursue that indication. So very exciting time, and we look forward to sharing more data with you as we get them. Thanks very much.