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Executives

Carol DeGuzman – IR

Steven Engle – Chairman and CEO

Fred Kurland – VP, Finance and CFO

Analysts

Chris James

Jason Kantor – RBC Capital Markets

Matt Kaplan – Ladenburg Thalmann & Company

XOMA Ltd. (XOMA) Q1 2010 Earnings Conference Call May 6, 2010 4:30 PM ET

Operator

Please proceed.

Carol DeGuzman

Alright. Welcome to XOMA’s call. About half an hour ago, we issued a news release which included our financial results for the first quarter ended March 31, 2010 and a general business update. Our quarterly report on Form 10-Q was filed this afternoon with the Securities and Exchange Commission. Each document will be available on our website at xoma.com.

Today’s webcast can be accessed via our website and will be available for replay until the close of business on August 6, 2010. On today’s call will be Steven Engle, Chairman and Chief Executive Officer and Fred Kurland, Vice President and Chief Financial Officer. Also with us today is Dr. Alan Solinger, our Vice President of Clinical Immunology.

We wish to remind all listeners that certain statements concerning conduct or availability of results of clinical trials, entry into XOMA 052 development partnership or potential licensing and collaboration arrangements or other aspects of product developments, or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.

These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Among other things, the conduct or availability of results of clinical trials may be impacted by or delayed or may never occur as a result of unavailability of resources, actions or inaction by our present or future collaboration partners, insufficient enrollment in such trials or unanticipated safety issues, and a XOMA 052 may not be entered into in an timeframes indicated or at all.

These and other risks including those related to the inability to comply with NASDAQ’s continued listing requirements, the generally unstable nature of current economic conditions, the results of discovery research and preclinical testing, the timing or results of pending and future clinical trials, including the design and progress of clinical trials, safety and efficacy of the products being tested, action, inaction or delay by the FDA, European or other regulators or their advisory bodies, and analysis or interpretation by or submission to these entities or others of scientific data.

Uncertainties regarding the status of biotechnology patents, uncertainties as to the cost of protecting intellectual property, changes in the status of the existing collaborative and licensing relationships, the ability of collaborators, licensees and other third parties to meet their obligations, market demands for products, scale up and marketing capabilities, competition, international operations, share price volatility, XOMA’s financing needs and opportunities and risks associated with XOMA’s status as a Bermuda company, are described in more detail in XOMA’s most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in considering XOMA’s prospects.

I’ll now turn the call over to Steven Engle, XOMA’s Chairman and Chief Executive Officer.

Steven Engle

Thank you, Carol. Good afternoon everyone and thank you for joining our call today. XOMA today is in excellent position to ride the wave of increasing excitement in the scientific and medical communities for the roll of IL-1 targeting as an anti-inflammatory approach to a wide range of diseases.

For XOMA the leading edge of this wave is our Phase 2 trials in Type 2 diabetes which along with other cardio-metabolic diseases separates in very large clinical and market opportunity. I’m pleased to note that enrollment for both of our Phase 2 clinical trials remains on pace to complete enrollment in both trials this summer.

Our Phase 2a is an 80 patient extended safety study in patients on metformin therapy, the standard first line treatment for Type 2 diabetes. 60 of the patients will receive XOMA 052 and 20 will receive placebo. All the patients on XOMA 052 treatment will receive the same dose of XOMA 052 for the first three months, after three months patients will based on pre-randomization receive either the same or higher or a lower dose for another three months.

We planned to measure diabetic outcomes including hemoglobin A1c or HvA1c and fasting blood glucose and we will also evaluate inflammatory biomarkers including C-reactive protein or CRP. We anticipate an interim analysis from the first three months of treatment that we conducted in the fourth quarter of this year. As a reminder we’ve already announced positive results in HvA1C and fasting blood glucose and CRP in our Phase 1 trials.

Nonetheless we think that these current studies will actually have even better information in terms of the way the trials are run, in particular that we’re looking at these trials in comparison between the Phase 2 and the Phase 1 trials that we’re talking about 60 patients on drug and 20 of placebo versus in the Phase 1 studies for a single does level of five patients versus that.

Also that everyone in these studies is on the same background medication that is monotherapy of metformin whereas in the Phase 1 study there were variable levels of medications and types of medications being given to patients. And third, we think another reason why these studies will be more indicative of the drugs ability to have a positive efficacy effect is that the four doses in these studies are given within a 56 day period with the measurement on day 84, versus there were only three doses given within a 28 day period and the measurements were taken at days 56, and 84.

The larger Phase 2b trial will enroll 325 patients also on metformin, so my previous comments apply, will be randomized to one of four doses of XOMA 052 or placebo and dosed monthly or six months. The primary endpoint of the study will be mean change in hemoglobin A1c levels at six months from baseline. Secondary outcomes will include additional diabetic and inflammatory cardiovascular disease markers. We anticipate the topline results will be available in the first quarter of next year.

There is a large and growing need for new therapies replacing for diabetes. A University of Chicago study released late last year has stated the number of diabetics in this country will nearly double from 23.7 million people at present to 44 million by 2034. Further the direct medical costs of treating diabetes are estimated triple over that period from a 113 billion to 336 billion.

We believe that XOMA 052 has the potential to address this large growing public health crisis by modifying the course of the disease, something that current diabetes medications do not do. Not only that, but such a medicine also has chance to transform patients lives. In addition to advancing XOMA 052 in clinical development, we have a growing intellectual property portfolio in the field. Notably in April, we were issued two new US patents for methods of treating Type 2 diabetes and inflammatory diseases using IL-1 beta antibodies.

With these patents we now have four issued US patents, one granted European patent and more than 40 additional applications pending in the US and other countries. Since we spoke to you last, there has been progress in the use of the IL-1 in addition approach in cardiovascular disease. Inflammatory mechanisms in the particular IL-1 has been shown in preclinical studies that would up regulated in several models of cardiovascular disease.

For example a heart attack patient’s inflammation induced by access IL-1 secretion contributes to adverse cardiac remodeling. This remodeling is a hard tissue and can result in congestive heart failure. The first clinical trial to evaluate IL-1 inhibition in cardiac remodeling in humans was presented in March at the American College of Cardiology meeting by Dr. Antonio Abbate of Virginia Commonwealth University. He demonstrated that heart attack patients treated with Anakinra or Kineret, one of the approved IL-1 targeting agent showed positive results of reduced advised cardiac remodeling compared to placebo.

At that same meeting Dr. Abbate presented results with murine XOMA 052 in mouse model stimulating heart attack. Also showing favorable effects of 052 treatment on cardiac remodeling. These results were in addition to those we previously reported in mouse model of a serial transformation and growth. In that study we showed that mice treated with murine XOMA 052 has typically significant reduction in the formation of atherosclerosis causing plaque in the aorta and trends toward improved lipid profiles compared to mice receiving the controlled antibody.

This is yet another demonstration of the potential for IL-1 inhibition and for XOMA 052 in cardiovascular disease. The leading cause of death worldwide according to the World Health Organization. As a next step in this area, we noted that a clinical trial with Kineret in cardiovascular disease patients and enrolled approximately 185 patients in the UK has recently been completed.

This year and next we expect substantial news flow around clinical trials with IL-1 targeting agents for indications including gout, diabetes and juvenile rheumatoid arthritis. We look forward to the publications of these and other results as we evaluate our further development plan for XOMA 052.

Oncology is another large unmet need, that could be addressed by IL-1 targeting. New data were reported by researches that the Mayo Clinic using XOMA 052 to significantly reduce IL-6 production in human myeloma cells. This is important because IL-6 is supposed growth factor for myeloma cells. Myeloma is a type of cancer that originates in the plasma cells. The data we reported last month at the American Association of Cancer Research meeting.

In addition just last week, one of the internationally recognized leaders in the IL-1 field Dr. Charles Dinarello published a very interesting paper titled “Why not treat human cancer with interleukin-1 blockade”. In which sets forth rationale for using IL-1 as an add-on to antiangiogenic therapy for metastatic cancer. That revenue of investigations based on studies that have shown that elevated levels of IL-1 are associated with greater diversity disease – severity excuse me, in cancers including colorectal, ovarian, pancreatic cancer and breast cancer.

And due to the known association between the inflammation and angiogenesis. IL-1 inhibition is particularly interesting to cancer researches because unlike most current cancer treatments the approved IL-1 targeting agents have not been associated with organ toxicity. The clinical research with IL-1 inhibition in cancer is relatively new. And one of the first trials Dr. John Lust with the Mayo Clinic reported on 47 patients with myeloma, a cancer of the plasma cells. His results showed that IL-1 blockade with Anakinra in combination with standard therapy improved progression free survival.

Another academic collaborator who is also evaluating concepts of IL-1 inhibition is Mark Donas [ph] who led the ground breaking study of Anakinra in patients with Type 2 diabetes and who headed the European arm of our Phase 1 clinical trial. Dr. Donas recently began enrolling patients in a Phase 2 study of XOMA 052 in Type 1 diabetes patients.

This trial is designed to evaluate effects of XOMA 052 on beta cell function and insulin production. Funding for the trial is being provided by the Juvenile Diabetes Research Foundation. Now I’d like to discuss progress in other business areas. We continue to pursue opportunities in biodefense and advancing our XOMA 3AB anti anti-botulism antibody for biodefense in pre-IND studies.

As we’ve previously noted, we anticipated significant increase to biodefense funding of approximately $20 million which is more than three times the biodefense revenue we are in this 2009. And we continue to develop our proprietary preclinical pipeline in autoimmune, cardio-metabolic, inflammatory and oncology diseases.

Recently we announced that we had received a $1 million milestone payment as part of our continuing antibodies discovery in development collaboration with Takeda. We continue to pursue technology licensing and antibody development collaboration, because we have a leading position in antibody technologies that offers significant value to others.

With this brief summary, I will turn the call over to Fred to review our financials.

Fred Kurland

Thanks, Steve. Good afternoon everybody and welcome to the XOMA call. XOMA had total revenues of $7.2 million in the first quarter of 2010 compared with $39.7 million in the first quarter of 2009. The decrease in revenues in the 2010 period compared with the same period in 2009 was primarily due to an expansion fee of $27.5 million recognized in the first quarter of 2009 related to our collaboration with Takeda.

In addition, royalty revenue decreased by $4.4 million in the first quarter of 2010 compared with the first quarter of ‘09 primarily due to the sale of our royalty interest in LUCENTIS in the third quarter of 2009 and the withdrawal of Raptiva from the market earlier in the year. XOMA had a net loss of $21.8 million or $0.09 a share in the 2010 first quarter compared with net income of $6.2 million or $0.04 a share in last year’s first quarter.

Research and development expense for the first quarter of 2010 was $17.6 million compared with $16.5 million in the same period last year. The increase was principally due to the initiation of our Phase 2 XOMA 052 clinical trials in diabetes. Selling, general and administrative expenses in the first quarter of 2010 were $5.6 million compared with $6.1 million for the same period last year.

Interest expense for the first quarter of 2010 was $100,000 compared with $1.8 million in the same period of 2009. This decrease is primarily due to the repayment of the Goldman Sachs loan in September 2009. Other expense was $5.8 million in the 2010 first quarter compared with nominal income in last year’s first quarter. This increase in other expense was primarily related to the $4.5 million paid in the first quarter of 2010 to hold the warrants issued in June 2009 upon the modification of warrant terms.

As well as $1.3 million in non-cash expense related to the reevaluation of our warrant liabilities during the period. Cash used in operating activities during the first quarter of 2010 was $16.4 million compared with cash provided by operating activities of $15.3 million during the first quarter of 2009. The decrease in cash provided by operating activities in this recent period was primarily due to the receipt in the first quarter of last year of $23.2 related to the expansion of the Takeda collaboration. $5.5 million in contract manufacturing revenue and $4.4 million in royalty revenue.

In March 2010, we had cash, cash equivalence and short term investments of $28.4 million compared with $23.9 million at March 31, 2009. In January and February of 2010, excuse me $23.9 million on December 31, 2009. in January and February of 2010 we received approximately $21 million in net proceeds from financing transactions after underwriting discounts, expenses and the amendment fee to certain existing warrant holders.

Consistent with last year, we will not be providing guidance on revenues or cash receipts for 2010, so at the best manage our ongoing negotiations for XOMA 052 and technology licensing. The company expects the cash used in operating activities may range from $45 million to cash neutral or positive. Based on our cash reserves and anticipated spending levels, revenues government and other funding from other sources we believe will be available, we estimate that we have sufficient cash resources to meet our anticipated net cash needs through the next 12 months.

Regarding our NASDAQ status, as previously announced we received a staff determination letter from NASDAQ indicating that the company regarding – indicating regarding compliance with the minimum $1 per share requirement for continued inclusion on the NASDAQ global market. As a result our shares would have been subject to delisting from the NASDAQ global market unless we requested a hearing before the NASDAQ listing qualifications panel to present its plan, our plan for regaining compliance which we have done. We intent to announce the panel’s decision when it is available.

I’ll now turn the call back to Steve for some final comments.

Steven Engle

Thanks Fred. As you can see we have completed several important milestones in our XOMA 052 program and we have many key events coming up later this year and into next year. With our continued efforts to build other areas of the business, we believe at 2010 we’ll see continued growth for the company and we look forward to keeping you up to-date on our progress.

Operator, this concludes our prepared remarks. Please open the call for questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) Thank you and our first question comes from Chris James.

Chris James

Hi good afternoon guys and congratulations on our progress made during the quarter especially with respect to 052, and thanks for taking my questions.

Steven Engle

Absolutely, thank you Chris.

Chris James

I guess my first question has to do with the patents, recently issued for 052. For those of us who are nowhere close to being an expert on patent laws, just help us understand the scope of the coverage? How broad are the claims made in both patents? And could these patents potentially cover other compounds?

Steven Engle

Chris, I appreciate the respect in your comments but say I am not expert either and in fact in the particular case unlike some cases, the legal situation such with patents that we’re not really allow to say very much beyond what is already in the press release that we put out a few weeks ago regarding these. So I am sorry at this point, but because of that we just can’t say much.

Chris James

Okay. Maybe I can ask a different way, which compounds or characteristics of compounds maybe with respect to high affinity or inhibition of IL-1 beta, do you think these compounds would not cover, if that makes it easier to?

Steven Engle

It doesn’t and again I apologize and normally we’re very force coming but this is the one where the our panels have been pretty well tied up in terms of what I can say.

Chris James

Sure. With respect to the Phase 2 studies, will you.

Steven Engle

Maybe I could just say Chris we’re very excited about that.

Chris James

Okay, good. Just moving on then to the Phase 2 studies, will you be able to control for physicians adding therapy such as DTP 4s in either the 052 arm or control?

Steven Engle

Yes Alan, would you like to speak to that?

Alan Solinger

Certainly. Yes, Chris the way these studies are designed, all the patients in these studies are on a stable background dose of metformin which is really the primary first line of therapy in these patients. So addition of other agents would basically be considered a protocol violation and the patients would be out of the trial.

Chris James

That’s great, thank you. Maybe just moving a little bit back to the patents. How are your partnership discussions progressing and have the patent issuances had any meaningful impact in either bringing more players to the table or increasing the attractiveness of the deal terms?

Steven Engle

So the conversation continued to progress and I – one way to reflect it is that everybody was very interested to have conversations with us when the press release went out on the path.

Chris James

That’s great color, I guess can you comment on the enrollment of the pace of the Phase 1, I’m sorry the Phase 2 study in Type 1 diabetes, and what are your expectations for timing of data there?

Steven Engle

So this is on the 2a and 2b for Type 2.

Chris James

No, this is Type 1 diabetes for smaller studies.

Steven Engle

Alan, do you want to say?

Alan Solinger

Yes, certainly. This is a much longer trial than our Type 2 diabetes trials, because the nature of the disease. So based on enrollment rates and the fact that patients are in the study for a longer period of time. We don’t anticipate having any data to present until some time in 2011.

Chris James

Great guys. I’ll jump back in the queue.

Steven Engle

Okay, thank you Chris.

Operator

Thank you. Our next question comes from Jason Kantor of RBC Capital. Your line is open.

Jason Kantor – RBC Capital Markets

Thanks a lot, could you give us some idea of what you would consider in this design this Phase 2a study. What you would consider a clinically meaningful or a good level of reduction of HbA1c at this first interim?

Steven Engle

Yes Jason, thanks for asking the question. It’s always hard to predict these things but as you might guess we’re thinking that we’ll do as well or better by that point in time as we did with the Phase 1 study and the reason we think that has to do with some of my comments about the idea that we have 60 patience on drug on versus five in the last study, so we’re very much dealing with a lot of small numbers when we’re doing the Phase 1.

Also that everyone as Alan indicated is on the same background medication that is metformin and nothing else versus the situation with the Phase 1 were people are on a number of things or not on anything. And then the third reason we think that we’ll do that is because we think that the four doses are being given within a 56 day period with the measure on day 84 in the current studies versus what we were doing with Phase 1 when we did that original multi-dose sub queue approach which was three doses were given within 28 days and then the results were measured at day 56 and 84.

So our thinking is we’ll do as well are better because of those three things and of course we always we hope we do better but I think the other side is in the end you’re looking for the effect over a longer period of time. We frankly wouldn’t want to go too fast with patients because that always leads you to this question of hypoglycemia, that is taking them down too soon, so what we’re thinking is given the data we’ve got right now that we’ll be aiming for those kinds of results.

Jason Kantor – RBC Capital Markets

Yes and in terms of the partnership discussions, I would imagine that you were running these trials to get to a certain data set that could drive the kind of valuation that you were hoping for, I mean is that still a reasonable assumption that these first looks at these two trials are going to be gating factors for a deal and that we shouldn’t necessarily anticipate something coming before that?

Steven Engle

If I can just a little preamble to that, make sure that we’re clear. On the 2a what we’re looking at is results after the three month period and the 2b will be getting topline results after six months. So we of course see the 2b results not like because its 325 patients, as more definitive because it’s all the way out to the six months point, whereas the 2a we’ll be getting that three month look through the interim analysis.

So anyway I just want to make share it’s crystal clear. So what we’ve said before and I think it continues to be true in our conversation is there are some companies that are going to look for additional data. There are some companies we’re talking to right now and some of those companies that want additional data may wait to see the Phase 2a data or they may wait to see the Phase 2b data. But I think our feeling overall is between those points if we will have enough data to be able to move forward with conversation.

Jason Kantor – RBC Capital Markets

Got you. Thanks.

Operator

Thank you. And our final question comes from Matt Kaplan of Ladenburg.

Matt Kaplan – Ladenburg Thalmann & Company

Hi good afternoon guys, thanks for taking my question.

Steven Engle

Hi Matt, thanks.

Matt Kaplan – Ladenburg Thalmann & Company

Just following up on some of the partnership questions. In your partnering discussions, I guess did the patents, the issuance of the new patents bring any new parties to the discussions that weren’t there before?

Steven Engle

Yes its getting close to where we’re crossing the line, we’re willing to say and not say about the process, because it’s unfortunately if we introduced the idea of either new competition or not then it becomes something that could potential fuse by one of the partner in the conversation. I’m sure they would never do it, but I mean it’s just – it’s blocking a little bit too far out there. What I can say is that when you start a process like this they’re always interested in what kind of coverage you’re going to get. It has a direct impact on how certain they are that even if you get your clinical results you think you’re going to get that you protect your property and again as I said a little bit earlier that there were everybody was interested in talking about these patents. So it was a very, in our minds very helpful event.

Matt Kaplan – Ladenburg Thalmann & Company

Alright, and just a couple other questions, in terms of your licensing collaborated fees that you received, this quarter looks to be a lot lower than prior recent quarters. Can you give us a sense in terms of what you expect and what your visibility is for the remainder of 2010 for this part of the revenue stream?

Steven Engle

Sure, Fred do you want to speak to that?

Fred Kurland

Well sure, hi Matt, let me first make a rather general comment and then I’ll try to be more specific. And it’s just as general statement about cash, our cash reserves and when combined with our spending levels and the expectation of revenue from technology licensing, from collaborations and government funding as well as other sources give us a great deal of confident that we’ve got enough cash to meet our operating needs for the next 12 months and so embedded within that statement is an expectation of revenue from technology licensing.

We’d not been specific about the dollar amounts but by way of background then I realized that you, Matt, know this but for perhaps other people listening, last year we had $43 million from antibody technology licensing which proves to be very helpful and as well we’ve had over the last year a good track record of monetizing assets in the way of bringing in cash and so while not being able to specifically answer your question about what kind of technology licensing we’re having to do expect in calendar 2010.

We do expect technology licensing to continue and take advantage of the asset that we continue to build as we increase our technology base.

Matt Kaplan – Ladenburg Thalmann & Company

Right, and it seems as though you have got some reasonable visibility on the contract revenue side on the biodefense program, is that correct?

Fred Kurland

That is correct and of course I differentiate that because it’s with one customer that has already signed on and so we’re considerably more comfortable talking about the fact that we were able to triple the size of the revenue we expect in 2010 versus 2009 from approximately six or seven last year to about 20 this year.

Matt Kaplan – Ladenburg Thalmann & Company

Alright, and then along those lines if you look at your non-cash expenses during the quarter, could you break those out for us, and then also what you think those the non-cash charges I guess are expenses during 2010 as well.

Fred Kurland

Sure. Understood for those who might have a had a chance in the last few moments to look at our 10-Q which was just filed, there are two major elements of non-cash expense in the first quarter and by the way we would expect this to continue through the course of the year and then they’re not surprising they are pretty much what you would see in most development stage companies. We had about $1.5 million in depreciation expense clearly non-cash in nature and not quite a $1 million in share based compensation expense.

So approximately $2.5 million in the quarter in the if you look below the line to other expense we see $1.3 million and I had mentioned in my prepared remarks, in non-cash expense associated with the reevaluation for warrants and the accounting rules requires us to effectively mark-to-market each quarter with our warrants and so what we would expect is in quarters in which and by the way the primary mechanism to see the direction what for a reduction in expense or an increase is to see how we moving of stock price has goes, when the stock price goes up its more expenses, when the stock price goes down (inaudible) this quarter we have $1.3 million non-cash expense for reevaluating the warrants.

But (inaudible) and so those adds to the three components of non-cash expense.

Operator

And that now concludes our question and answer session. And I’ll turn the program back over to Carol DeGuzman for closing remarks.

Carol DeGuzman

Thank you, Nova. Well we’d like to thank you all for joining us today. As I mentioned before replay of this call be available starting later today on our website and we look forward to seeing many of you at the American Diabetes Association meeting, other meetings that will be held over the summer and of course at the Investor Conferences. Operator this concludes our call.

Operator

Thank you for participating in today’s XOMA first quarter financial results conference call. You may now disconnect.

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Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

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