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Susquehanna Financial Group, LLLP, Member FINRA Biotechnology Friday, September 05, 2008 Refer to Appendix for important disclosure information Susquehanna Financial Group, LLLP, Member FINRA Biotechnology Jason Kolbert SciClone Pharmaceuticals Rating: Neutral 212-514-4875 - [email protected] SCLN: $1.42 Price Target: N/A Brian Skorney SPIL Creates a Valuation Floor, but Can Zadaxin Succeed? 212-514-4897 - [email protected] Initiating Coverage with a Neutral Rating SciClone Pharmaceuticals We are initiating coverage of SciClone Pharmaceuticals with a Neutral rating. Our rating is SCLN $1.42 driven by our concerns for the outcome of the Sigma Tau EU trial for Zadaxin. We do Rating Neutral believe that the existing value of SPIL (SciClone Pharmaceutical International China Price Target N/A Limited), where Zadaxin is expected to reach $50 mln in top-line revenue this year, does 52-Week Range $1 - $3 justify a higher valuation; however, we believe investors are ignoring the value in SPIL in Mkt Cap $* $65.3 front of the Zadaxin outcome expected soon. Based on our analysis of the data, we Enterprise Value $* $49 believe that if statistical significance is reached, it will be only minimally so, and as such, Shares Outstanding* 46 we are not very enthusiastic for the outcome. We do believe a positive outcome opens the Avg Daily Vol 51 door for commercialization in Europe by Sigma Tau (SciClone picks up a manufacturing Net Cash Per Share 0.47 margin) and creates a partnership opportunity for U.S. rights. The problem we face with * mln the current Sigma Tau trial is that just a few patients can sway the outcome of the trial either way. We conclude that the therapeutic effect of Zadaxin in HCV (Genotype 1, non- FY Ends: December responders) is minimal, at a time when treatment options are expanding dramatically with EPS ($) 2007A 2008E Prior 2009E Prior direct-acting antivirals. We believe the better opportunity for the company is the pursuit of 1Q (0.01) (0.12) (0.07) 2Q (0.06) (0.01) (0.06) Zadaxin in metastatic melanoma, where Phase II results show potential, as well as 3Q (0.07) (0.07) (0.06) developing its earlier stage pipeline products and building its SPIL subsidiary. Based on 4Q (0.08) (0.08) (0.06) these latter events, shares may appear undervalued, but we believe investors should wait FY (0.22) (0.27) (0.25) until Zadaxin EU data is available before building a position in the stock. FY Rev* 37 51 64 HIGHLIGHTS * $ mln • $50 million plus in sales in 2009, mostly from SPIL. Zadaxin is currently sold in SCLN Share Price (LTM) more than 35 countries worldwide, but the bulk (>90%) of its sales comes from SciClone’s subsidiary in China, SPIL. We estimate net margins are close to 50%. Zadaxin is approved in China for Hepatitis B and a variety of other indications (such as surgical prophylaxis and others). Of interest is that generic Zadaxin is available at one- fifth its price in China, yet it still shows strong growth (15-20% CAGR) based on brand recognition and the quality message created by the SPIL sales force. We view Zadaxin’s China sales as an engine to fund U.S. development of the product. We also note the impressive patient experience base (Zadaxin has been prescribed for ~100,000 patients to date), and it is widely considered a safe and active agent/immunomodulator. We believe the current value of the SPIL franchise limits the downside risk against a negative outcome for the current EU trial (Sigma Tau trial in indicates split Hepatitis C). Positive Factor Source: SFG Research and company reports • Zadaxin – a TLR9 plus. Zadaxin is believed to operate partly through a TLR-9 mechanism and partly through another channel that we review in this report. Zadaxin is currently being developed for both Hepatitis C and metastatic melanoma with development partner Sigma Tau. Results of Sigma’s Phase III EU trial are expected this fall. We review our concerns regarding the current trial in the bullets below, but suffice it to say that the outcome of the Zadaxin trial is going to be very close and will hang on a few patients. There appears to be zero margin for error. Regardless of the outcome of the Sigma Tau trial, we believe the company’s best options lay in the pursuit of a pivotal trial in metastatic melanoma. Neutral Factor • 2008: a pivotal year for the company. The outcome of the European (Sigma Tau) trial for Zadaxin is around the corner and represents the next milestone for the company. Zadaxin has failed two prior U.S. trials, but we believe the trial design was at fault (based on incorrect Interferon treatment assumptions and a changing SOC environment). The bad news is that we still have reservations regarding the current clinical trial design and execution, which we review in great detail in this report. We believe that if Zadaxin does meet its primary endpoint with statistical significance it could play a modest role in the physician’s HCV treatment armamentarium and, more importantly, opens up a partnering window for U.S. rights. Neutral Factor • Success with the current EU trial leads to a U.S. trial. We believe that, short of an overwhelmingly clear signal (which we absolutely do not expect), the FDA will request a confirming U.S. pivotal trial (one trial if the Sigma Tau trial succeeds, likely two if the current trial misses its primary endpoint). The earliest we would expect to see Zadaxin Susquehanna International Group, LLP (SIG) is comprised of affiliated entities, including Susquehanna Financial Group, LLLP (SFG), a provider of research, investment banking, and execution services. SFG does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Biotechnology 2 in the U.S. marketplace for Hepatitis C would be in 2012. However, we note that Zadaxin could be approved in the EU based on the one Sigma Tau trial alone. SCLN benefits from Sigma Tau’s approval, as the company stands to receive what is essentially a manufacturing royalty (we assume ~15%), which will further contribute resources to the development of Zadaxin in the U.S. Neutral Factor • We are hopeful for a favorable outcome for Zadaxin, but success hinges on a handful of patients. We recently learned as part of our diligence effort that the current EU HCV non-responder trial (all patients have failed a pegylated IFN + Ribavirin) was designed to be all genotype 1 patients; however, the trial includes a significant number of non-genotype 1 patients (we estimate 75 out of 478). The problem is that the re-treatment response rate for non-genotype 1 patients is significantly higher vs. genotype 1, and the treatment effect for Zadaxin may be lower in genotypes 2/3. In essence, this new variable raises the trial risks of failure. Should Zadaxin fail in the Sigma Tau trial, we believe it becomes folly for the company to continue to pursue U.S. approval in HCV. Negative Factor • We have undertaken our own statistical analysis of the most recent interim data set; it will be a “close call” either way. Based on the company’s February interim data, 65 SVRs reported across both trial arms (patients population = 553), we see the outcome as being close. We are concerned that the trial may be underpowered to see a small therapeutic effect. Figures 20A and 20B review our analysis of a few scenarios: SVRs by drug vs. control arm and by genotype 1 vs. genotype 2/3, aggregate SVR percentages, and associated probabilities of success. We conclude from this analysis that based on our assumptions of what to expect for control SVR rates, the trial outcome has a slight positive skew of reaching statistical significance (see Scenario 1A, Figure 20A). This conclusion is based on a patient population in the trial that includes ~14% genotypes 2/3, which have historically significantly higher background SVR rates with SOC vs. genotype 1 patients. The assumptions that we make regarding which re-treatment response rate to use for genotype 1 vs. 2/3 is critical to the analysis. Based on three sources, Schering-Plough’s own review of the EPIC 3 study, the EMEA review of that same study, and the Jacobsen 2005 study, we see a wide range of baseline response rates: genotype 1: 2-8% (EASL), 4% (EASL audit), and 8.6% (Jacobson), and genotypes 2/3: 0-57% (EASL), 10% (EASL audit), and 27.3% (Jacobson). If the SVR rate for the control considering all genotypes (1, 2, and 3) is less than 9%, which in turn demands that the SVR rate for genotype 1 patients only in the control is less than 6.7%, we can conclude that Zadaxin is showing a statistically valid therapeutic effect. However, if these thresholds are exceeded, the Zadaxin Sigma Tau trial is unlikely to meet statistical significance (see Figure 20A, 20B). Negative Factor • Hepatitis C: Zadaxin could be a factor in changing the standard of care . We believe immunomodulation therapy without side- effects could become a key ingredient to future SOC in Hepatitis C that will include direct acting antiviral therapies (DAAV). In previous industry reports, we have discussed the efforts of other companies in this direction, such as Anadys, Romark, GlobeImmune, and Scynexia. However, SciClone/Sigma Tau is now engaged in a pivotal trial, and we consider SciClone the frontrunner in the immunomodulation field for HCV. We believe that with stakes so high in Hepatitis C, a variety of pharma partners could show interest to partner Zadaxin as part of an overall HCV product strategy.
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