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Basilea Pharmaceutica Ltd. (BSLN.S) Initiation Report

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Basilea Pharmaceutica Ltd. (BSLN.S) Initiation Report Initiating Coverage December 13, 2016 Basilea Pharmaceutica Ltd. (BSLN.S) Initiation Report LifeSci Investment Abstract Basilea Pharmaceutica (SIX: BSLN.S) is a commercial stage biopharmaceutical company with Analysts two marketed anti-infective products and two early stage oncology assets. CRESEMBA is a Jerry Isaacson, Ph.D. (AC) potent antifungal with activity against multiple clinically relevant species that is approved in (646) 597-6991 both the US and Europe. Basilea has a commercialization agreement with Astellas for the drug [email protected] in the US. Zevtera, a broad-spectrum antibiotic, has been approved in over a dozen European countries for the treatment of community acquired and hospital acquired pneumonia. It has QIDP status and BARDA funding for a US Phase III program, which is expected to begin in Market Data the first half of 2017. BAL3833 is a kinase inhibitor indicated for melanoma and other small Price $69.97 tumors that is currently being evaluated in a Phase I study for the treatment of refractory solid Market Cap (M) $826 tumors. BAL101553 showed early signs of efficacy in Phase I/IIa study and an oral study is EV (M) $762 ongoing. Shares Outstanding (M) 11.8 Key Points of Discussion Fully Diluted Shares (M) 14.4 52-week Range: $57.62 - $95.60 ■ CRESEMBA is Partnered with Astellas. CRESEMBA (isavuconazole) is an anti- Cash (M) $255.7 fungal targeting invasive mold species. CRESEMBA is available in oral and intravenous Net Cash/Share $5.46 formulations and is approved in the US for the treatment of invasive aspergillosis and Annualized Cash Burn (M) $48.7 invasive mucormycosis in adults and in the EU for the treatment of adult patients with Years of Cash Left >2.0 invasive aspergillosis and for the treatment of adult patients with mucormycosis for Debt (M) $195.1 who amphotericin is inappropriate. Basilea entered into licensing, co-development, and Financials commercialization agreement for the drug with Astellas (OTC: ALPMY) in February of 2010. This agreement stipulated that Basilea would receive an initial payment of CHF 75 FY Dec 2014A 2015A 2016A million (approximately $77 million), followed by an additional payment of CHF 42 million EPS H1 (1.87)A (3.00)A (2.76)A predicated on attainment certain regulatory milestones. Under the current agreement, H2 NA NA NA Astellas has commercial rights to CRESEMBA in the US and in addition to royalties Basilea FY (4.17)A (6.09)A NA is still eligible for up to CHF 290 million in milestone payments related to sales. The Company also recently entered an agreement with Asahi Kasei Pharma (TSE: 3407) for the development and commercialization of this asset in Japan. Expected Upcoming Milestones ■ H2 2016 – Expansion of Phase I/IIa oral study of BAL101553 to include glioblastoma patients. ■ H1 2017 – Completion of Phase I study for BAL3833. ■ H1 2017 – Initiate Phase III study of Zevtera in S. aureus bacteremia and ABSSI under SPA. Page 1 For analyst certification and disclosures please see page 44 December 13, 2016 . Growing Need for Efficacy Against Emerging Invasive Species. Invasive fungal infections are a growing medical concern, especially for immunocompromised patients. These infections are associated with high rates of morbidity and mortality, with some infections having mortality rates as high as 80%. Furthermore, the proportion of these infections caused by emerging invasive fungal species has also grown. The increasing prevalence of fungal infections caused by apergillosis and mucorales strains necessitates the incorporation of antifungals with efficacy against these species in clinical practice. Because patients are usually treated empirically, before the infection is identified, there is a need for therapies with broad spectrum activity. With both a favorably safety and tolerability profile and potency against these species, CRESEMBA is poised to play a critical role in the antimicrobial armamentarium whenever a fungal infection is suspected. CRESEMBA is Broadly Active with Good Safety. Basilea has conducted three Phase III studies that demonstrated the pharmacokinetics, safety, and efficacy of CRESEMBA for the treatment of different fungal infections in patients with and without renal impairment. The VITAL and SECURE Phase III trials demonstrated the efficacy of CRESEMBA for the treatment of IFI’s caused by mucormycosis and aspergillosis, respectively. The ACTIVE Phase III study of CRESEMBA in Candida infections revealed safety profile is comparable to that of caspofungin. CRESEMBA was found to be a good IV to oral option for these patients. Fungal infections most often affect vulnerable populations, such as patients undergoing treatment for cancer, or those who are faced with other immune-system compromising conditions. The myriad of associated co-morbidities in many patients with fungal infections underscores the importance of an amenable tolerability and safety profile. In a Phase III study evaluating the outcome of Aspergillosis infections in patients treated with voriconazole or CRESEMBA, patients in the CRESEMBA treatment arm experienced fewer adverse events. This difference was statistically significant, and positions CRESEMBA to become the treatment of choice for these infections. Zevtera is the First Broad-Spectrum Anti-MRSA Cephalosporin Approved for Hospital and Community Acquired Pneumonia. With demonstrated efficacy against MRSA and other clinically relevant strains, Zevtera has been approved for the treatment of community acquired and hospital acquired bacterial pneumonia in 13 European countries. In Phase III studies, it was effective against both gram positive and gram negative bacterial species, and many of the most common clinical strains. Zevtera was also found to have a favorable safety and tolerability profile, similar to that of other antibiotics in its class. Basilea has a distribution agreement with Unimedic Pharma AB (private) for the Nordic countries including Sweden, Denmark, Norway, and Finland for CRESEMBA and Zevtera. Zevtera is in Phase III with QIDP Status and BARDA Funding. Basilea’s broad-spectrum antibiotic Zevtera has received Qualified Infectious Disease Product status from the FDA for the potential treatment of community acquired pneumonia, Staphylococcus aureus bacteremia, and acute bacterial skin and skin structure infections. While Zevtera is not yet approved in the US, Basilea has a contract with BARDA for up to $100 million to support Phase III programs that will evaluate Zevtera’s use in these conditions. In addition to activity against MRSA and many other clinically- relevant gram positive and gram negative species, Zevtera has exhibited a favorable safety profile in both European clinical trials, and in practice. Basilea plans to initiate US Phase III trials for Zevtera in the first half of 2017. Basilea has two Oncology Assets for Drug Refractory and Other Advanced Solid Tumors. In addition to the commercial stage anti-microbial programs, Basilea has two oncology assets. BAL3833 is being studied in melanoma and other advanced solid tumors and BAL101553 is being developed for drug-refractory tumors. Both programs are differentiated for their use of biomarkers to stratify the potential patient population and optimize tumor selection. The Company has completed a Phase I/IIa trial with an intravenous formulation of BAL101553, and it was well Page 2 December 13, 2016 tolerated. Oral and continuous infusion formulations of this compound are currently in Phase I/IIa trials. BAL3833 is in development for melanoma and other advanced, solid tumors. An oral formulation of the drug is currently in a Phase I study that is being conducted by a group of UK institutions that includes the Institute of Cancer Research, London, and the Royal Marsden. This dual acting kinase inhibitor has the potential to be used in patients with tumors that are resistant to BRAF inhibitors. Financial Discussion First Half 2016 Results. Basilea reported total revenues of CHF 29.7 million ($30.6 million) in the first half of 2016, as compared to CHF 25.0 million ($26.5 million) for the same period in 2015. Product revenues were CHF 1.9 million ($1.9 million) in the first half of 2016, and there were no product revenues during the same period of 2015. Contract revenues were CHF 27.8 million ($28.6 million) in the first half of 2016, as compared to CHF 24.4 million ($25.9 million) during the first half of 2015. The increase in contract revenues was related to the licensing agreement for isavuconazole with Astellas Pharma (Other OTC: ALPMY). Total operating expenses were CHF 54.6 million ($55.9 million) for the first half of 2016, as compared to CHF 55.0 million ($58.3 million) for the first half of 2015. The Company reported a net loss of CHF 27.9 million ($28.7 million) in the first half of 2016, down from CHF 30.1 million ($31.9 million) in the first half of 2015. Total cash and cash equivalents was CHF 310.9 million ($320.2 million) as of June 30, 2016. Full Year 2016 Guidance. The Company has provided product sales guidance of approximately CHF 5.1 million ($5.0 million) for full year 2016. Basilea has provided operating expense guidance of CHF 9-10 million ($8.8-9.8 million) on average per month in 2016, which annualizes to CHF 108-120 million ($105.8-117.6 million) for full year 2016. Basilea provided operating loss guidance of CHF 4-5 million ($3.9-4.9 million) per month in 2016, which annualizes to CHF 48-60 million ($47.0-58.8 million) for full year 2016. Product Revenue. A nascent source of revenue for Basilea is from their two approved products being commercialized in EU markets, CRESEMBA and Zevtera/Mabelio. The proportion of revenue attributed to these products is presented in Figure X. The Company launched CRESEMBA in select EU territories beginning in March 2016, and the product is currently available in Germany, Italy, the United Kingdom (UK), and Austria. Page 3 December 13, 2016 Table of Contents Company Description ...................................................................................................................................................................
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