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Sangamo Therapeutics, Inc. (SGMO)

Q2 2010 Earnings Call· Wed, Jul 28, 2010

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Transcript

Operator

Operator

Good afternoon and welcome to the Sangamo BioSciences Teleconference to discuss Second Quarter 2010 Financial Results. This call is being recorded. I will now pass you over to the coordinator of this event, Dr. Elizabeth Wolffe, Director of Corporate Communications.

Elizabeth Wolffe

Management

Thank you, Tiero [ph]. Good afternoon and thank you for joining Sangamo’s management team on our conference call to discuss the company’s second quarter 2010 financial results. Also present during this call are several members of Sangamo’s senior management, including Edward Lanphier, President and Chief Executive Officer; Ward Wolff, Executive Vice President and Chief Financial Officer; Dale Ando, Vice President of Therapeutic Development and Chief Medical Officer and Philip Gregory, Vice President of Research and Chief Scientific Officer. Following this introduction, Edward will highlight recent activities Ward will briefly review second quarter financial results for 2010. And Dale and Philip will update you on our ZFP-therapeutic and research program. Finally, Edward will summarize our current guidance and our goals for the rest of 2010. Following that we will open up the call for questions. As we begin, I’d like to remind everyone that the projections and forward-looking statements that we discuss during this conference call are based upon the information that we currently have available, this information will likely change over time. By discussing our current perception of the markets and the future performance of Sangamo with you today, we are not undertaking an obligation to provide updates in the future. Actual results may differ substantially from what we discuss today, and no one should assume at a later date that our comments from today are still valid. We alert you to be aware of risks that are detailed in such documents that the company files with the Securities and Exchange Commission, specifically our quarterly reports on Form 10-Q and our annual report on Form 10-K. These documents include important risk factors that could cause the actual results of the company’s operations to differ materially from those contained in our projections or forward-looking statements. Now, I’d like to turn the call over to Edward.

Edward Lanphier

President

Thank you, Liz. And thank you all for joining us for our conference call to discuss our second quarter results for 2010. We reported important progress in both clinical and preclinical program this quarter. Let me begin by briefly recapping a few of the highlights. At the American Diabetes Association or ADA Meeting in June, we and our collaborators at Johns Hopkins presented positive Phase 2 clinical data from our ZFP-therapeutic program to develop SB-509 as a disease modifying treatment for diabetic neuropathy or DN. The data from our SB-509-601 and SB-509-701B trial demonstrated that SB-509 treatment resulted in statistically significant and clinically beneficial improvement in subjects with moderate and severe DN as compared to placebo; and provided direct histological evidence of SB-509’s dual affect on both blood vessel and nerve growth and regrowth. As you will hear from Dale later in this call, these data provided direct evidence of both an angiogenic and neuroregenerative mechanism of action and further validates our strategy of using multiple endpoints to assess disease severity as we enrolled subjects with moderately severe diabetic neuropathy into our ongoing Phase 2b trial SB-509-901. In early July, we had an important paper published in the scientific journal, Nature Biotechnology, an exciting preclinical data from our stem cell therapeutic strategy for HIV/AIDS. This approach is based upon the use of our proprietary zinc finger nuclease or ZFN technology to permanently disrupt the CCR5 gene in human hematopoietic stem cells or HSCs. Disrupting the gene in HSCs enables us to make this permanent change in all cell types in the immune system and forms the basis for a very promising therapeutic strategy. The work was carried out by Sangamo scientists and collaborators at the Keck School of Medicine of the University of Southern California. You may recall that last…

Ward Wolff

Management

Thank you, Edward, and good afternoon, everyone. As you know, after the close of the market today, we released our financial results for the second quarter ended June 30, 2010. And I am pleased to review the highlights of those results. Revenues in the second quarter of 2010 were $6.5 million compared to 4.7 million for the 2009 quarter. The second quarter 2010 revenues were primarily comprised of revenue from our collaboration agreements with Sigma-Aldrich and Dow AgroSciences, and agreements in protein production, as well as $315,000 of revenue from research grants. The increase in revenues was primarily due to the $15 million license payment that we received from Sigma in the fourth quarter of 2009 as part of our expanded agreement which we are recognizing radiably into revenue through the end of this month. Total operating expenses for the second quarter of 2010 were $10.4 million compared to 9.9 million for the same period in 2009. Research and development expenses were 7.1 million in the 2010 quarter and 6.9 million for the prior year quarter. General and administrative expenses were 3.3 million in the second quarter of 2010 compared to 3 million in the 2009 quarter. The increase in general and administrative expenses is primarily due to increased personnel cost including non-cash employee stock-based compensation. For the second quarter of 2010, we reported a consolidated net loss of 3.9 million or $0.09 per share compared to a net loss of 4.5 million or $0.11 per share for the second quarter of 2009. Turning to the balance sheet, we ended the second quarter of 2010 with 69.3 million in cash, cash equivalents and short-term investments. Our net cash used in operating activities was 7.5 million for the second quarter. I’m pleased to say that we are on track with respect to our operating plan for 2010 for the second quarter and we are maintaining our financial guidance, reiterated on the first quarter call in April of having at least $60 million in cash and investment balances on hand at the end of 2010. In our last call, we explained that the cash guidance and our usage estimate translated into anticipated GAAP revenues in the 18 million to 22 million range and GAAP operating expenses in the 43 to $47 million range for the full year 2010. These GAAP metrics remain in place supporting our year-end guidance of $60 million for cash. As you will recall this guidance assumes no new financings or partnerships, but it does include anticipated milestones in revenues in 2010 from our existing partnership agreement. Thank you. And I will now turn the call back over to Edward.

Edward Lanphier

President

Thanks Ward. Our partnerships with Sigma-Aldrich and Dow AgroScience continue to provide non-dilutive revenues which offset our ongoing investment in our ZFP-therapeutic programs. As such we are able to carefully manage our cash burn and with nearly 70 million in cash at the end of the second quarter, we are on track to meet our goal of ending 2010 with at least 60 million in cash and cash equivalents, all while prosecuting clinical trials in three different ZFP-therapeutic products. As I mentioned earlier, I have asked Dale to provide you with the summary of the SB-509 clinical data that were presented in three oral presentations at the ADA Scientific Sessions last month. Dale?

Dale Ando

President

Thank you, Edward. To start with some background, SB-509 is a zinc finger activator of the vascular endothelial growth factor A gene or VEGF-A, which has been shown to have significant effects on both nerve and blood vessel growth in preclinical and clinical studies. We are evaluating this product clinically in two indications, diabetic neuropathy and amyotrophic lateral sclerosis or ALS. Currently we have an ongoing on 150 subject randomized, double-blind, placebo controlled, Phase 2b study, SB-509-901 in subjects with moderately severe DN. The study is designed to finalize dose, schedule and primary and secondary end points for pivotal Phase 3 trials. And will accumulate data on a probable end points including nerve conduction velocity in the sural nerve or sural NCV neurological impairments score in the lower limbs or NIS-LL, as well as qualitative life assessments and intraepidermal nerve fiber density or IENFD. We have multiple inclusion criteria for this trial which are designed to exclude subjects with mild disease and select subjects with moderately severe DN to exhibit both neurologic and vascular disease. We believe that this group that will show the greatest benefits from the dual angiogenic and neurological effect of SB-509, and in a clinical trial demonstrate the greatest differences in disease outcome as measured by approval endpoints between treatment with drug or placebo. In June at the ADA’s Scientific Sessions we made three oral presentations. Two of the presentations focused on data from our Phase 2 trial, SB-509-601 in subject with mild to moderate DN. And the third presentation was on data from our Phase 2 trial SB-509-701 Part B in subject with at least one unmeasurable nerve conduction velocity. Collectively the data provided us with valuable confirmatory evidence for an angiogenic as well as a nerve regenerative mechanism action of this drug. And further…

Edward Lanphier

President

Thank you, Dale. As I mentioned earlier, this quarter has had some exciting news in two of our early stage ZFP-therapeutic development program. And HIV with the publication of an important paper in Nature Biotechnology, and in our preclinical Parkinson’s program with the renewal of funding support by the Michael J. Fox Foundation. I’ve asked Philip to give you a brief overview of these events and how they move these respective programs forward. Philip?

Philip D. Gregory

Management

Thanks Edward. Earlier this month, we published a significant paper in the scientific journal Nature Biotechnology. The work provides crucial concept for a stem cell therapy for human immunodeficiency virus, HIV based on our Zinc Finger Nucleases or ZFN technology. The cells that we are using are human hematopoietic stem cells or HSCs, self-renewing cells that that give rise to all of the different types of immune cells in the body. Our ZFNs for this program are designed to permanently modify the DNA sequence in coding CCR5, a co-receptor that enables HIV to infect cells of the immune system. We know that from several observations that disrupting this receptor makes cells resistant to infection with the R5 strains of the virus, the most commonly transmitted strains of HIV. Firstly, it is well documented that individuals carrying a naturally occurring mutation, which results the disruption of the CCR5 gene, a variant known as CCR5-delta32 are resistant to HIV infection. In addition, a study published in the New England Journal of Medicine 2009 reported a potential “cure” when an AIDS patient with leukemia known as the Berlin patient received a bone marrow transplant from a matched donor with this disrupted delta32 CCR5 mutation. Transfer of the HSCs residing in the bone marrow from the delta32 donor provided a self renewable and potentially lifelong source of HIV resistant immune cells. After transplantation, this patient was able to discontinue all anti-HIV drug treatments, his CD4 counts increased and his viral load dropped to an undetectable level, demonstrating effective transplantation of protection from HIV infection with CCR5 disruptive stem cells. The data reported in our Nature Biotechnology publication replicate these findings for a ZFN based treatment in a preclinical model. We demonstrate that a one-time exposure to our CCR5-specific ZFNs resulted in permanent genetic disruption…

Edward Lanphier

President

Thanks, Philip. In conclusion, our second quarter activities demonstrate our progress and continued focus and execution on our goal of establishing ZFP-therapeutics as a new and highly differentiated class of human pharmaceuticals. And we look forward to keeping you informed of our progress in the second half of this year. In addition to data presentations for our ALS program at the Society for Neuroscience in November, we will be presenting at two Investor Conferences in September, UBS Global Life Sciences Conference and the JMP Securities Healthcare Conference, which are both being held in New York City. This completes our prepared comments. We’d now like to open up the call for your questions. Charles Duncan – JMP Securities: Hi, guys, thanks for taking my questions and congratulations on a nice quarter of progress.

Edward Lanphier

President

Thanks, Charles. Charles Duncan – JMP Securities: First question that I had was perhaps for Dale. First of all, thank you for that thorough overview of what was presented at ADA, but what we’d like to hear some more color on is perhaps what we didn’t see and that was maybe your impressions of meetings that may have been had with clinicians and their interest in this program and our corporate partners, could you let us know if you had any corporate interest that, not definitive but perhaps good point to an interest in the program as it matures?

Edward Lanphier

President

Charles, I’ll jump in first. Dale I think we’ll comment on the corporate partnering discussions or interest. However, accept to say that ADA was well attended by a lot of groups that follow this program very closely. But I think it is a good question to Dale in terms of the clinician and investigator and real key opinion leaders who do attend the conference and Dale maybe give a sense of the response to that population.

Dale Ando

President

Yeah, I think, people were quite excited in that, a lot of the findings that we showed really moved this product in two side [ph] the neuroregenerative type of product which is quite unique; most of the other parts being studied in diabetic neuropathy are really treat symptoms and the only other – when there is any effect on the nerve process is aldose reductase inhibitors; so, I think this sets us out as a very, very unique product in this field. And also, I think, the fairly comprehensive analysis of the multiple end points at baseline, I think for the first time we have a truly very, very accurate view point of what comprises a moderate severity or severe diabetic population. I think this supports our Phase 2 efforts in using these multiple baseline endpoints to select a patient population responsive. Charles Duncan – JMP Securities: So you’re saying that you had pretty good interest from investigators, do you think that that could result in or at least cannot clinicians, do you think that could result in interest in enrolling patients in the program?

Edward Lanphier

President

Certainly this has been very, very useful in of getting investigators and sites interested in the program.

Dale Ando

President

And that Charles we absolutely know to be true. Charles Duncan – JMP Securities: Okay. Then my next question was with regard to HIV, first of all thanks for the kind of overview on the rationale on that again, what’s your sense of data timing and secondly, have you ever given some thoughts I don’t know even of this is technologically feasible to basically doing trades stacking within their program and being able to look at putting several targets or upping the number of targets that you could target within an HIV oriented product?

Edward Lanphier

President

So Charles I’ll just repeat the guidance on the SB-509-728-T trial to say that we plan to... Charles Duncan – JMP Securities: Yeah.

Edward Lanphier

President

Present interim data from that work in late this year or early next year, but a day an appropriate scientific or clinical meeting for those data. As it relates to the ability to use the events to do as you say trade stacking or plant term perspective, but multiple targets I’ll ask Phil to speak to that we have actually quite a bit of data around that.

Philip Gregory

Management

Sure. So Charles we actually presented at the ASGCT meeting data demonstrating the ability to add genes in a size specific manner to, it’s the same cell type HSCs and so... Charles Duncan – JMP Securities: Yeah.

Philip Gregory

Management

And so it’s quite clear that one could, users approach to add genetic methods at least for further restriction of HIV entry. So yes this is an area of active research.

Edward Lanphier

President

And as you know Charles in other mammalian systems we have shown the ability to do one, two and even three knock-outs in this case in CHO cells when we publish that work and collectible last year with Genentech.

Philip Gregory

Management

Genentech, yeah. Charles Duncan – JMP Securities: And that presentation you mentioned you mentioned, could that be at the annual HIV meetings which are held in December or don’t you know yet?

Edward Lanphier

President

Well, again, I think, well as soon as we have clear confirmation on that we will announce that and we’ll notify people on the call. Charles Duncan – JMP Securities: Okay. Good. Thanks for taking my questions.

Edward Lanphier

President

Sure. Charles Duncan – JMP Securities: I’ll hop back in the queue. Operator: And a question or comment is from Chad Messer of Piper Jaffray. Your line is open. Chad Messer – Piper Jaffray: Hi, thanks for taking my question. So you mentioned you reiterated that your guidance were greater than $60 million cash at year-end and said that that includes some milestone payments. I was wondering if you could just remind us what milestone payments remain outstanding from your various collaborations?

Edward Lanphier

President

Well, I think what we said in the past, Chad is that milestones will be achieved based upon commercial activities from Sigma as well as Dow, and then in the Dow collaboration there are annual and minimum sub-license payments. Beyond that, I don’t think we have a whole lot of additional specificity to add. Ward is there anything else we can add to that?

Ward Wolff

Management

No, I think that’s right Edward and Chad if this depends when in the calendar year did some of these kick in terms of minimums and those kinds of things. So that’s why our cash guidance is what it is in terms of expecting some increase from the first six months.

Edward Lanphier

President

Right, second half of that.

Ward Wolff

Management

Right. Chad Messer – Piper Jaffray: Thank you very much.

Edward Lanphier

President

Thanks Jeff. Operator: (Operator Instructions). Our next question is from Liana Moussatos of Wedbush Securities. Your line is open. Liana Moussatos – Wedbush Securities: Thank you. What was the stock-based compensation in Q2 and can you review the clinical data releases coming up again?

Edward Lanphier

President

Sure. Hi Liana, let’s start award with stock-based compensation or do you want me to jump into the guidance?

Ward Wolff

Management

Yeah, why don’t you jump in and I’ll come back.

Philip Gregory

Management

Okay. So I think the two guidance, in terms of additional clinical data are the data set from the ALS trial we presented at the Society for Neuroscience meeting in November and it will present interim data from the SB-509 728 T trial at an appropriate meeting either late this year or early next year.

Ward Wolff

Management

And Liana on the stock comp it was 1.9 million in the quarter which was the same as Q1. So 3.8 million for the first six months. Liana Moussatos – Wedbush Securities: Thank you very much.

Ward Wolff

Management

Thanks Liana. Operator: Thank you. We have a follow up from Charles Duncan of JMP Securities. Your line is open, Sir. Charles Duncan – JMP Securities: Thanks for taking my follow-up. My question is related to the industrial use of the technology platform specifically Dow agriculture collaboration [ph], I know you don’t usually talk much about that but do you have a sense of what particular crops maybe in the lead in their development program, is it tomato or is it another one and when we might see increased visibility on that, Edward?

Edward Lanphier

President

Charles, I’m going to largely duck the question, but I’ll ask Philip if he wants to add to it and I really mean if there is more to add. I’ll go based upon what Dale [ph] said publicly and that’s maize and canola being the major internal efforts that they’ve talked about. I will also refer to some license agreements that they’ve done both in the vegetable space, tomatoes and vegetables as well as in the forest products space. And they’ve also announced, what I think is interesting although it’s an academic collaboration in neurobiology and biofuels. Philip, anything to add to that?

Philip Gregory

Management

No, that’s pretty much the visibility that we have, yeah.

Edward Lanphier

President

But I do think well again, Dow AgroSciences is being a wholly owned subsidiary of Dow Chemical and Dow Chemical obviously being Fortune 50 type company it’s difficult to get a whole lot of visibility from a required disclosure perspective. But I think if you look at their website and you look at the number of presentations, publications and activities that are going on there you get a real sense of the centrality of word, okay centrality of this technology to their research and development and future commercial efforts. Charles Duncan – JMP Securities: Yeah, that makes sense and I understand why you can’t say a lot, you don’t – there is a lot on that website. But what I guess one question that you could perhaps answer is, has there been any change in the interaction over the course of last call like a year or so in terms of the frequency or call it the group that you’re interacting with and how do you feel about that partnership at this point?

Philip Gregory

Management

Hey, Charles, I think I can address that I mean, I can tell that the interaction has changed substantially since Dale took out the commercial license, that the – we interact with a much broader range of folks within the organization at this point, as the technology is deployed in different areas of their business. And so, there has been a material change I think, and so there was very, a very much focused project team initially and now it’s a much broader group.

Edward Lanphier

President

And Charles one thing I’ll kind of expand your question in terms of industrial applications just for a moment, because I think it’s important to note, I don’t how many people have had a chance to listen to or even normally would follow Sigma-Aldrich. But on their July 22nd call, both in their prepared remarks and in some questions at the end, I think there is good information there and good emphasis in terms of the role of the zinc fingers and zinc finger nucleases. In their internal and strategic development they put emphasis on the new P53 rat which has just been launched and coming out in the first half of this year. And spoke directly to the role of zinc finger nucleases in their SAFC division. One thing that I think is perhaps not completely understood about our royalty income from Sigma, is that the income that we report for instance in the second quarter is derivative of the revenues that they have in the quarter before, so royalties from income or revenues that they generated in this case in the first quarter. As you can hear or read from the Sigma transcript, there has been a great deal of activity in building up multiple models which are just really commercialized in the first part of this year. So – and fully back to, a full circle back to Chad’s question, we do expect to see a ramp up of both milestones and royalty revenues in the second half of this year. Charles Duncan – JMP Securities: Excellent, that’s good news. Thanks for the added color guys.

Edward Lanphier

President

Yep, thanks Charles. Operator: Thank you. And I’m showing no further questions or comments at this time. I would like to now turn the call over to Edward Lanphier for any closing remarks.

Edward Lanphier

President

We’d like to thank you for joining us, and we look forward to speaking with you again, when we release our third quarter financial information. We will be available later today, if you have any follow-up questions. Thanks very much. Operator: Ladies and gentlemen thank you for your participation in today’s conference call. This concludes the program. You may now disconnect. Have a wonderful day.