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Unfiltered Notes from SGMO 4Q2007 Earnings CC
* Liz Wolffe, IR
* Thank for joining 4Q2007 earnings CC
* Sr mgt Ed Lamphier, CEO, Ward Wolfe, CFO,
* Ed highlight 2007 and recent events
* Ward fin results
* Ed 2008 onj, then Q&A
* Safe harbor
* Ed Lamphier
* Thanks for joining us $q2007, YE2007
* Highlight accomplishments, ask Ward to update 4Q2007 and 2007 results, 2008 guidance
* 2007 sign milestones, adv clin into P II, strengthened thera pipelines, partnerships
* 1st topline data P Ib, lead ZFP SB509 in DN
* Demo ZFP transcription factor VEGF-A showed disease altering effects single dose at 6M
* Stat sign in QST, impr in NCV in range clin relevant in progressing degen nerve damage
* Presented in Jun at ADA and Soc N/S, go to P II in DN
* In Dec2007, compl SB509-601 enrollment, n=110
* Double blind until trial complete, data collected
* Expect data by 2H2008
* 2 addit P II, SB509, f/u on int observations
* SB509-701 init in Apr2007, mod to severe DN, Blocked Nerve, unmeasurable NCVs, expand on 3 of 3 in P I gained conduction velocity after single dose
* SB509-703 n=20, SC mobilization, SC thought to be imp in repair and regen
* Hope to compl accrual and Tx by Ye2008
* Signma Aldrich lab reagents, u/f 13.5M, eligible 24M research, dev and commercial milestones
* As reganets sold, royalties and share subst in any sublicense
* Imp strat partnership, lev IP and throughput w/mkt leader
* Dow Agro moved from strength to strength, commercially rel targets, growing confidence in DAS, featured in their public discussions re plans
* Monetized partnerships re ZFP in ZF nucleases in cell lines, protein MF, imp lic agreement w/Genetech, expect addit collabs in 2008
* 2007 event, 30M fin, plus u/f payments, sign inmpr B/S, 81.4M cash and eq
* 5Dec2007 Analyst Briefing, encourage listen to replay
* Great detail re programs and activity in plant genetics, Dow Agro President talk and enthusiasm re ZFP technology
* 2007 very busy and prod yr for SGMO
* Intro newest member of mgt team, Ward Wolfe, EVP, CFO
* Joins from Nuvelo, SVP Fin/CFO, formerly CFO at Abgenix until 2006 w/AMGN merger, Ward served for 18M prior as member of board
* One of most expd fin execs in biotech, extensive experience, bus dev, fin, capital strategies and move into next phase of dev
* Ward
* Thanks for intro. Really enjoyed 1st couple months transiton from BOD to mgt, exciting yr ahead
* Execute on company objs in 2008
* Release fin results 4Q2007, YE2007
* Highlights 4Q2007 2.8M vs 2.2M YoY, incr amort u/f payments re lab research reagent w/SA
* Op exp 10.4M vs 12M, R&S 7.9M vs 10.1M decr due to 1 time acq of Edwards Lifesciences ZFP angio program
* Incr in R&D of 3.7M outsde of 1 time due to expanded DN clin programs, preclin HIV, glioblastoma, incr personnel
* 4Q2007 consol net loss 6.7M (17 cents) vs 8.9 and 26 cent loss
* 2007 Net Loss 58 cents vs 55 cents loss
* B/S 81,4M cash and equiv
* Net cash used 4.9M used in 4Q2007, FY 15.9M
* Fin guidance
* Expect at least 55M at YE2008 cahs and equiv
* Strong B/S, adv clin and preclin programs, maintain fin discipline
* Ed – Ward welcome aboard
* We begin 2008 w/solid cash pos to puesue R&D
* Expect to end 2008 w/at least 55M cash and equiv, not including nay new agreements
* Does assume 2H2008 Dow Agro exercise commercial license
* 2007 exciting yr, 2008 even more so
* Thera programs, adv SB509 thru several P IIs, advance others
* 1H2008 Presnet data SB509 P Ib midl to mod
* Collected sign data, qual and quantit data, e.g. NCV
* Single Tx creates stat sign impr w/1 Tx after 6M
* Look forward to hsaring at relevant mtg in 1H2008
* Present followup of SB509-601 DB PC safety and clin effects SB509 in mid to mod DN in 2H2008
* Single blind SB509-701 in mod to severe Blocked Nerve comple accrual and finish
* Desnity of sensory nerves and pot changes after SB509 using skin bipsies
* Compl accrual SB509-703 re SC mobilization
* Conducted in mild to mod DN, look at class of cells, mark adehyde dehydroogenase, bright cells post SB509, highly enriched, mediate in cell repair hemato, mesenchymal, endothelial,
* Look for correl re incr SC #s and symptoms
* SC mobilization may be PK biomarker after SB509 admin
* After completing presentation of P II, 3 new trials
* P II SB509 ALS, have more to say when initiated
* Dale described type of study in Analyst Briefing by Dale Ando
* 1st INDs for ZFNs, init P I glioblastoma and HIV/AIDs, more info in future calls
* Adv ZFP pipeline
* Preclin SCI, TBI, Parkinsons, neuropathic pain, ZFN modified
* Depth and breadth of ZFP platform
* Establish strat collabs, monetize techn platform in non-strat areas
* Expect in 2008 new in ZFN protein engineering and DAS re commercial program
* DAS and parent Dow have big plans internally and sublicensing
* Also, research reagent collab w/SA
* See NT launch of producs, from sales and sublicensing later this yr
* Addit strat partnerships core to our strategy
* Done in plant agriculture, labe reagents, prtein M/F
* Well-positioned for corp collab
* Own 100% of our thera programs, always assumed partner when reach sign value inflection pt
* P II should represent that pt
* Expect activity on all fronts in 2008
* From fin persp, strong pos in 2008
* Begn 81.4M cash and equiv
* Carefully manage expenses, build value, est strat collabs
* Expect end yr at least 55M cash and equiv
* In conclusion, 2007 exciting yr, 1st top line clin data, compl enrollment 1st P II, progress to est ZFP as new, highly diff human Tx
* Accomplishments position very well for likely most imp yr in our corp history
* Never entered yr w/optimism and enthusiasm as enter 2008
* Addit updates Bio Ceo next week, Cowen in Mar2008
* Q&A
* Q1: Leanna, Pacific Growth Equity
* When data from -701?
* A1: As you know, single blind trial (blocked nerve). Expect data in 2008. Dale: 1st opp as late breaker at ADA.
* Q2: When from SC mobilization? On track P I for HIV and glioblastoma P I? ALS P II?
* A2: SC mobilization started in Jan2008. Begin accrual.. More specifics re data as see accrual (Dale agrees). Re glioblastoma, CCR, on track to begin 2008. On track to start ALS in 2008.
* Q3: Charles Duncan, JMP
* Congrats on good Q of progress. Q re industrial use of platform. Specifically, Dow Agro, visibility re collab. Will that be done by Oct2008 or any time. What drives that?
* A3: Discussed by Jerome at AD, license expires Oct2008. We believe they have intent to exercise commercial license, up to them. Don’t expect them to exercise sign earlier than 3Q2008 but could happen at any time.
* Q4: Regular interactions?
* A4: Daily. Jerome did excellent job talking about differential aadvs using techn in plant agriculture. Great enthusiasm here in Richmond and Indianapolis. Fair to think Dow and SGMO present data from collab.
* Q5: Re Sigma Aldrich, research prod go to mkt, timing, incr visibility?
* A5: See throughout the yr. Leave specifics re prod launches, prods to our partners. Have clear sense receive prod royalties from sales, research funding, milestones from SA. From SA mktg persp, expect incr visibility to research community.
* Q6: Joe, Canaccord Adams
* Couple SB509 Qs, single dose expr of plasmid and resultant ZFP transient, assessed at 6M. Why multi-dosing advantageous?
* A6: Dale – eval neuron benefits, QST, NCV, 30, 60, 90, 180 days, rationale 3 doses, anticipate get maximal difference from baseline in that regimen.
* Q7: Corporate, parner DN SB509. Is P II, starting clock or already discussed?
* A7: All of the above. View data from P II as tsrating clock, Ichigawa and Dale busy with many companies, educating w/P Ib interim data, prepare, inform in anticipation of P II. Rest assured, active from bus dev to prepare field for it.
* Q8: Pamela, Cantor Fitzgerald
* Congrats. Look forward to 2008. You and Ward spent considerable time in BT and pharma. Views on how pharma changing, macro changes re big pharma, impact on SGMO.
* A8: That is thesis topic, thought about a lot. Clear trend, even more than trend, pharma looking for IND engines. Tech platforms gen novel INDs into clin trials in broad, predictable way. Rationale behind targets and partnerships. I can be wrong, I think sit in bulls-eye of where pharma is going. Demp breadth and validity of platform, take adv of huge need for big pharma. May be more long winded, but that is my view.
* Q9: Piper Jaffray
* Never say you are long-winded. Thinking back to init work re vasc of VEGF. SC recruitment work out of work from Yale. Broaden SB509 program beyond nerve and DN. What are initial thoughts re revascularization.
* A9: From preclin work and clin work, concept or premise activation of VEGF-A new blood vessels, true, collect some of that data. Where go from new clin program is TBD item. Having, not overstate, very enthusiastic re neuroprot, possibly nuero regen, highly differentiated. Not only outcome unique, commercial opp dwarfs peripheral vasc. Dale: In neuron disease, lucky than measurement of severity in DN very quant, electrical and speed. In peripheral, no single test correlates really well w/outcome, disease. Seeing pos pro-angiogenesis. Submitted abstract, maybe present mid-yr. Trying to accrue second study.
* Q10: As assemble SB509 data package for pot partner, how encapsulate disparate vale opps?
* A10: Two parts, Ted. We are transparent w/partners and breadth of data. From ceommercial, licensing, value retention persp, likely link DN and peripheral artery indications.
* Q11: Brian, Janney Montgomery
* As step back get -601 and -701 data, clin rel improvement in new Tx. Expand on what hope to see, max at neg table.
* A11: A little color. Very clear what drive, criteria for partner, what FDA wants in clin benefit, very quantitative. Have quant bar to jump over. In P Ib, above that bar. Dale: In terms of what prev precedents in P III, no drug approved in peripheral regen, but in prev P III trials, QST >8%. We achieved 25-30% in P Ib. NCV diff 1 m/sec, TNS diff of 1 unit. In that magnitude or better, if stat sign. These are 3 areas. Ed: Correlate back to pot collaborators.
* Q12: Glioblastoma and HIV/AIDS, work done as asked by FDA to proceed?
* A12: Working on those animal studies in both for final product.
* Q13: John Sullivan, Leerink Swann
* Couple of quick Qs. Anti-HIV program. Seen progress by other companies blocking CCR5, incl oral. How think of ZFP program?
* A13: In bulls-eye of rationale. Dale: LFE has oral prod for blocing CCR5. Need high concentration in blood to block. ZFP synergistic. Incr efficacy of CCR5 strategy, decr escape mutants. Not mutually exclusive. May make CCR5 inh/blocking more potent.
* Q14: As grow closer to imp Dow Agro, particular crops more imp re ZFP? Get some sense of breadth of appeal?
* A14: 2 beyond tobacco, maize and canola. Application of technology indifferent to crops.
* Q15: Any candidates ruled out?
* A15: No. Exactly the opposite. Data not rule out any.
* Q16: Leanna, Pacific Growth
* Ward, break-out collabs and research?
* A16: Ward, of 2.8M, 2.3M collab, 500K research grants.
* Thanks for joining us. Look forward to 1Q2008 CC. |
