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Sangamo Therapeutics, Inc. (SGMO)

Q4 2013 Earnings Call· Tue, Feb 11, 2014

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Transcript

Operator

Operator

Good afternoon and welcome to the Sangamo BioSciences Teleconference to discuss Fourth Quarter and Full Year 2013 Financial Results. This call is being recorded. I would now like to pass you over to the coordinator of this event, Dr. Elizabeth Wolffe, Senior Director of Corporate Communications.

Elizabeth J. Wolffe

Management

Thank you, Charlotte. Good afternoon and thank you for joining Sangamo’s management team on our conference call to discuss the company’s fourth quarter and full year 2013 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; Geoff Nichol, Executive Vice President of Research and Development; Philip Gregory, Vice President of Research and Chief Scientific Officer and Dale Ando, Vice President of Development and Chief Medical Officer. Following this introduction, Edward will highlight recent activities and the significant events from the past quarter; Ward will then briefly review fourth quarter and full year financial results for 2013, as well as our financial guidance for 2014; Philip will provide an update on our ZFP Therapeutic programs and finally, Edward will update you on our goals for 2014 and beyond. 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 market 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 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 factors that could cause the actual result for 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 O. Lanphier

Management

Thank you, Liz. And thank you all for joining us for our conference call to discuss our fourth quarter and full year results for 2013, as well as our near and mid-term plans for the development of our ZFP Therapeutics pipeline. The fourth quarter of 2013 was extraordinarily busy, which was a fitting and exciting end to a truly transformational year for Sangamo, a year in which we made significant progress in moving both our clinical and preclinical programs forward, bolstered our delivery core competencies with the acquisition of Ceregene, a company with valuable AAV and Neuroscience assets and completed a significant financing. Importantly, this momentum was carried through into the New Year setting the pace for an even more eventful 2014. As most of you are aware, we began this year by announcing an important partnership with Biogen Idec to take our hemoglobinopathies programs to clinical trials and into commercialization. Additionally, I’ve asked Philip to summarize one of our most important presentations at ASH, the proof of concept data in non-human primates for our In Vivo Protein Replacement Platform strategy. Like our approach to beta-thalassemia and sickle cell disease, this approach is also designed to cure, not just treat symptoms and is broadly applicable to a range of monogenic diseases that are currently treated by repeated administration of recombinant enzymes to replace those proteins that are defective or missing in patients with these diseases. The platform forms the basis of both our partnered program in hemophilia with Shire and our proprietary programs in lysosomal storage disorders or LSDs. As we have said before, our goal is to file two INDs on our partnered hemophilia program in 2014, and a further two for our proprietary LSD programs in 2015. In addition to a very busy ASH, another fourth quarter scientific…

Henry 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 fourth quarter and full year ended December 31, 2013, and I am pleased to review the highlights of those results. Revenues in the fourth quarter of 2013 were $6.9 million, compared to $8.9 million for the same period in 2012. Fourth quarter 2013 revenues were comprised of revenue from Sangamo’s collaboration agreements with Shire, Dow AgroSciences, and Sigma-Aldrich, as well as approximately $260,000 of revenue from research grants. As we mentioned in the press release, the decrease in collaboration agreement revenues from the year-ago quarter was primarily due to the timing of reimbursable research services from the company’s collaboration and license agreement with Shire. Pursuant to the agreement, Sangamo received an upfront payment of $13 million, which is being amortized on a straight line basis over the initial six-year research term of which the company recognized $500,000 as revenue for the fourth quarter of 2013. Sangamo also recognized $2.9 million of revenues related to research services performed under the collaboration agreement with Shire in the fourth quarter. Total operating expenses for the fourth quarter of 2013 were $15 million, compared to $12.3 million for the same period in 2012. Research and development expenses were $10.8 million in the fourth quarter of 2013 and $9.3 million for the prior year quarter. The increase was primarily due to increases in personnel-related expenses, including stock-based compensation, and external research expenses associated with our preclinical programs. General and administrative expenses were $4.2 million in the fourth quarter of 2013 and $3 million for the same period in 2012. The increase was primarily related to increases in personnel-related expenses, including stock-based compensation and professional services expenses related to the Biogen agreement…

Edward O. Lanphier

Management

Thank you, Ward. As you have heard, we ended 2013 with approximately $132 million, well above our guidance of at least $125 million. With the Biogen $20 million upfront payment, our cash position is very strong relative to our historic and projected burn rate. We believe that our balance sheet provides a very solid basis from which to work and will enable us to complete our ongoing clinical trials and to bring up to eight new products to IND by the end of 2015. These programs include our programs partnered and funded by Shire and Biogen, as well as our proprietary programs in LSDs that have significantly benefit from – that have significantly benefited from our partner funded work. As Ward mentioned, while we are guiding the higher operating expenses, as we ramp up our activities to move these programs to IND. we are guiding to ending 2014 with a higher cash balance than the end of 2013, at least $135 million in cash, making 2014 a cash flow positive year for the company. This assumes no additional agreements or financing activities only that we maintain our historically thoughtful control of expenses and meet our goals of filing INDs for our two Shire programs by the end of the year, which will trigger a total of $8.5 million in milestones for each program. These payments along with the research funding provide our – provided by our collaborations will ensure us to achieve these development and financial goals. So let’s turn these – let’s turn to those programs. I’ve asked Philip to outline the approach that we have – we will be taking forward with Biogen and to summarize, the data we presented at ASH in December and at SFN in November, and to highlight, why we believe our approach – approaches to treatment of these diseases has significant advantages over currently available therapies. Philip?

Philip D. Gregory

Management

Thanks Edward. Before I go into detail, as to our approach and the data that we presented at ASH, let me provide a formal background on the diseases that we are addressing in our collaboration with Biogen. Both sickle cell disease and beta-thalassemia are results of mutations in the gene encoding beta-globin, a subunit of the hemoglobin protein that is found in red blood cells or RBCs and enables them to carry oxygen from the lungs to the tissues. In sickle cell disease, the beta-globin gene defect results in abnormal hemoglobin, which causes the red blood cells to develop a sickle or crescent shape. These abnormal red blood cells are stiff and sticky, can block blood flow in the small blood vessels of the limbs and organs resulting in painful episodes called crises, progressive organ damage and an increased risk of infection, all of which result in a shortened life expectancy. The current standard of care is to manage and control symptoms and to limit the number of crises; current treatments including blood transfusions, iron chelation therapy and administration of hydroxyurea, pain medications and antibiotics do not address the underlying cause of disease. The gene defect responsible for beta-thalassemia while still associated with the beta-globin gene results in poor production or excess destruction of red blood cells leading to life-threatening anemia, enlarged spleen, liver and heart, and bone abnormalities. Beta-thalassemia major is a severe form of thalassemia that requires regular, often monthly, blood transfusions and subsequent iron-chelation therapy to treat the resulting iron overload. Both diseases have been treated by a bone marrow transplant hematopoietic stem cells or HSCs from a matched donor or so called allogeneic transplant. However, this therapy is quite limited due to the scarcity of matched donors and the significant and serious risk of Graft versus…

Edward O. Lanphier

Management

Thanks, Philip, great update. Let me follow-up with a quick summary of our agreement with Biogen. As we announced, we have granted Biogen an exclusive worldwide license to our technology platform and intellectual property for the treatment of hemoglobinopathies, specifically beta-thalassemia and sickle cell disease. For beta-thalassemia, Sangamo will be responsible for all research and development activities through the first clinical trial and patients. For the sickle cell program both companies will perform activities to enable submission of an IND application. Biogen is responsible for subsequent worldwide clinical development, manufacturing and commercialization of products arising from our alliance. Importantly, Sangamo has retained an option to co-promote beta-thalassemia and sickle cell disease products in the United States. As part of the agreement, Sangamo received a $20 million upfront payment and we will be reimbursed by Biogen for our internal and external research and development costs. We’ll also receive additional payments of approximately $300 million, based upon the achievement of certain development, regulatory, commercial and sales milestones, as well as tiered escalating double-digit royalties on product sales. The nearest term milestone payments will be the Phase I related milestones of $7.5 million for each program. To state the obvious, this is a significant relationship for us and will enable us to move this program and the rest of our pipeline forward much more efficiently. We also expect to make significant progress in delivering on the promise of ZFP Therapeutics. We will complete our Phase II clinical trials in our SB-728-T HIV/AIDS program with positive data from these studies; we will partner this program for further development and commercialization. As I mentioned earlier, you can expect an update on our ongoing trials at CROI, as well as additional guidance on the overall program. We’ll also continue to aggressively prosecute our partnered programs in…

Operator

Operator

(Operator Instructions) Our first question comes from the line of Charles Duncan from Piper Jaffray. Your line is open. Charles C. Duncan – Piper Jaffray, Inc.: Hi, Edward. First of all, congratulations on a great year of progress and thanks for taking my questions.

Edward O. Lanphier

Management

Sure, Charles. Charles C. Duncan – Piper Jaffray, Inc.:

Edward O. Lanphier

Management

Well, I’ll go first and Geoff and Dale are both here. in terms of the broad versus narrow, Charles, the fundamental hypothesis that we’re pursuing in terms of acute viral load control is really predicated on the observation that maximizing the engraftment of biallelically modified cells can lead to a significant impact on viral load, and the strategy that we’re pursuing, I’ll use the word narrow in discussing the CCR5 delta-32 heterozygote is focused on that population and we’ve seen activities there including the patients that we’ve discussed, as well as several other patients who have had one to two log reductions and those correlate again, directly to engraftment levels of biallelically modified cells. but for the broader population, the strategy in really pushing towards a threshold of biallelically modified cells with a Cytoxan preconditioning, I think speaks to the ability – if successful to apply this to the entire population. Why don’t I stop there, come back in a moment to the financials and see if Geoff or Dale want to add or subtract in it into the issue of the application of this approach to a narrow or broader population.

Geoffrey M. Nichol

Analyst

Charles, this is Geoff here. I think it’s a little early to be sort of pinning our flag to a particular patient group or approach as Edward has described. we have taken a broad view, I think the heterozygotes are a narrower group although that’s roundabout plus or minus 10% of the U.S. HIV population, but that's still a substantial group that allowed us to move forward to test up this proof of concept and we do have the Cytoxan strategy for broadening the approach. So a little too early to say where we’re going, I think we’ve got several ways to win here and we are moving forward to see whether in deed we can win. I’ll turn it back to Edward in terms of investments and other activities, but broadly, we’ve guided to certainly – this year up to 12 more patients in the program.

Edward O. Lanphier

Management

Yes. and then that’s what I was going to say, I think Charles, if you look at where we are what we’ve completed the accrual of the additional six subjects in the dose escalation component and we’ve guided to another 12 subject. So the investment this calendar year really is relatively modest at this point. I don’t want to quantify around any specific program, but I can tell you relatively overall OpEx budget, it’s a relatively modest number and the goal really is to, as I said in the script, use the data that we’ve generated to-date in terms of the responder analysis. Those baseline characteristics with the optimized Cytoxan dose, in these additional 12 subjects to achieve the clinical proof of concept around functional control, and based upon that, our plans to partner in the program. So I think there is a – well there is, I don’t have to think there is a finite and it’s a relatively modest percentage of – a very modest percentage of our OpEx this year that we plan to invest to move to a partner or not in the HIV program. Charles C. Duncan – Piper Jaffray, Inc.: It’s helpful. Edward, one quick question on monogenic diseases or IVPRP platform, I know lots of people have asked you about timing of INDs and four INDs is pretty substantive piece of work, but I’m wondering if you could at least touch on one of them in terms of the triggers to the timing or to that filing of the IND and if you think that that could occur in the next, call it six months.

Edward O. Lanphier

Management

Well, the guidance Charles and I updated the slide for this on, at JPMorgan, I don’t think I spoke directly to it here is that the HIV stem cell IND is likely to be in the midyear type of timeframe, and the guidance we’ve given related to beta-thal Factor VIII and Factor IX are definitely by the end of the calendar year, but I would certainly suggest everyone that they – it’s very close to the end of the year versus the middle of the second half. Charles C. Duncan – Piper Jaffray, Inc.: Okay, last question, on technology regarding a fair amount of noise that we’ve been hearing on this CRISPR technology. I’m just wondering if you could explore that for a second and tell us what you think zinc fingers you may have over the CRISPR technology?

Edward O. Lanphier

Management

Well, I would say it’s not an easy subject just to be – give you too short sound bites on, but it is a topic of which we’re extremely well versed. Philip, maybe you could try and be succinct on this.

Philip D. Gregory

Management

Sure. So I think, I’d say, Charles, there is an enormous amount of interest in CRISPR in the academic world. obviously, we have demonstrated how powerful genome-editing can be in cells, in animals and in the dish. and this is another tool that achieves that outcome, and so it’s obviously getting a lot of – developing a lot of interest, largely because it is extremely simple to deploy, uses a – essentially a guide RNA, which can be designed essentially based on sort of Watson and Crick base pairing rules, as well as makes it very simple for people to design their own in a CRISPR/Cas9 system for a specific site. There is a difference however between the application of this technology in the context of research application and in the context of the clinic. and we continue to believe that the ZFP approach is the appropriate one for therapeutic use. we think it has both the specificity that’s necessary, we think it has the potency on efficacy that’s necessary and of course, it’s a system developed from a – from man – it’s a system developed from the mammalian zinc finger proteins, not from bacteria. And these are the types of difference that make the zinc finger protein platform in our view, a superior at this stage for therapeutic use. Charles C. Duncan – Piper Jaffray, Inc.: Thanks for the added color.

Edward O. Lanphier

Management

Thanks, Charles.

Operator

Operator

Thank you. (Operator Instructions) Our next question comes from the line of Heather Behanna from JMP Securities. Your line is open. Heather A. Behanna – JMP Securities LLC: Hi, and congratulations on a great year and a great start to 2014.

Edward O. Lanphier

Management

Thanks, Heather. Heather A. Behanna – JMP Securities LLC: I just wanted to get a little bit of color from you guys as far as medical meetings this year, we should expect or where we might expect to see some more potentially non-human primate data or any other data throughout the year to sort of support the INDs moving forward in either the end of this year and the ones for next year.

Edward O. Lanphier

Management

Sure. Heather, I’ll take a shot at it, and then obviously Philip or Geoff can comment. I’ll start with 30,000 feet, our practice in the past has been to discuss meetings where we have a) submitted abstracts, and b) those abstracts have been accepted. So I was going to say rarely, I do recall the time about six, seven years ago, when I talked about a meeting, the abstract wasn’t accepted and that was a good learning experience for me. So we do try and learn from our mistakes, my mistakes. and so we are not going to guide to any specific meetings. With that said, we have a pretty consistent track record of presenting at various meetings. I had mentioned several of them on this call in addition to that; we usually have a dozen plus kinds of presentation at the American Society for Cell and Gene Therapy. but at least at this point, I don’t want to get as – since we’re in the Olympic moment, too far out, over our sties here and guide any particular meetings at this time. Geoff and Philip, I’m sure you have nothing to add to that.

Philip D. Gregory

Management

That’s correct.

Geoffrey M. Nichol

Analyst

Yes, absolutely, absolutely right. Heather A. Behanna – JMP Securities LLC: Fair enough.

Edward O. Lanphier

Management

I mean expect perhaps, to add that, clearly, several of these INDs are with partnered programs. so we have partners whose interests will need to be reflected in our communication activities. Heather A. Behanna – JMP Securities LLC: Okay. and for CROI coming up, is it too early for us to expect any data on the Cytoxan dose ranging, should we just expect a more general update or can you give any color on that?

Edward O. Lanphier

Management

Give color on that, well, will we present data on the Cytoxan work? Yes, should I at this point, go into what cohorts and what dose levels and so on and so forth, I should probably wait three weeks and then comment extensively based upon on what we present. Heather A. Behanna – JMP Securities LLC: Fair enough. Okay, thank you so much.

Edward O. Lanphier

Management

Thank you, Heather.

Operator

Operator

Thank you. (Operator Instructions)

Edward O. Lanphier

Management

Hearing none. We’d like to thank you for joining us and we look forward to speaking with you again, when we release our first quarter 2014 financial information. We will be available later today if you have any follow-up questions. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may all disconnect. Everyone, have a great day.