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Basilea Pharmaceutica

BASILEA PHARMACEUTICA: Derazantinib shown to be effective in a broader iCCA population at ESMO 2019 | BUY | CHF73(+70%)

BASILEA PHARMACEUTICA - BUY | CHF73(+70%) Derazantinib shown to be effective in a broader iCCA population at ESMO 2019 FGFR2 mutations and amplifications patients benefit from Dera Competitors do not address those patients Extension of the ongoing clinical trial

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  • 30 Sep 19
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Pharmaceuticals: Hot topics at ESMO 2019

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  • 25 Sep 19
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Pharmaceuticals: Drug prices in the US: a new bill proposed by House Speaker Nancy Pelosi

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  • 20 Sep 19
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Basilea Pharmaceutica

Cresemba on track, oncology pipeline advances

Concerns about a potential revenue decline due to the absence of deferred revenue related to divested asset Toctino were allayed when Basilea reported H1/2019 revenue growth of 5.5% YoY, driven by strong contributions from antifungal Cresemba. Our 2019E estimates are broadly unchanged and in line with tightened financial guidance. Changes for 2020E and beyond reflect multiple adjustments including the impact of Pfizer taking over manufacturing of Cresemba in its territory during 2020E. We trim our target price to CHF105 (from CHF108) and maintain our OUTPERFORM recommendation, as the shares only appear to be pricing in Cresemba revenues in marketed regions. We anticipate multiple news flow items in the next 12-18 months – largely related to Basilea’s oncology pipeline – which coupled with steady revenue growth should drive share price performance. A key event in the longer term is Phase III data for ceftobiprole in S. aureus bacteraemia (“SAB”).

goetzpartners securities Limited

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  • 29 Aug 19
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Basilea Pharmaceutica

Basilea Pharmaceutica - Data-driven catalysts ahead

Basilea has reported good momentum in 2019, with positive clinical data from key studies on Zevtera/Mabelio and derazantinib. Cresemba sales have continued to grow, benefiting from international launches by partners in new markets and growth in existing markets. Despite significant R&D investment, operating losses have narrowed to CHF13.2m (H118: CHF20.4m). Basilea is well funded, with gross cash and investments of CHF177.9m sufficient to fund operations beyond 2020 to multiple R&D inflection points. Pivotal data in 2020/21 could lead to filings for derazantinib (oncology) and Zevtera (US NDA for the treatment of resistant bacterial infections). We value Basilea at CHF1,077m.

Edison

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  • 22 Aug 19
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Basilea Pharmaceutica

Revenue growth drives robust H1/2019 results

Basilea reported H1/2019 revenues of CHF63.2m, 10% ahead of our estimate, driven by robust performance from marketed products Cresemba (antifungal) and Zevtera (MRSA antibiotic). The latter more than offset the lack of deferred revenue from Toctino (vs. CHF18.8m in H1/2018), leading to revenue growth of 5.5%. Total operating expenses, which declined by 5% YoY, were in line with our forecasts, resulting in a smaller than expected operating loss of CHF13.2m vs. our CHF19.5m forecast and CHF20.4m in the prior year. Management updated its financial outlook for FY2019. Since our forecasts are in line with the tightened ranges, we expect limited changes to our estimates. With the shares trading well below our sum-of-the-parts derived target price ("TP") of CHF108 per share, suggesting the shares are only pricing in revenue from Cresemba in marketed regions, we maintain our OUTPERFORM recommendation.

goetzpartners securities Limited

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  • 20 Aug 19
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Basilea Pharmaceutica

Basilea Pharmaceutica - Ceftobiprole hits its TARGET

Basilea has announced positive top-line data from the Phase III TARGET trial which is evaluating Zevtera/Mabelio (ceftobiprole) in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Ceftobiprole, a broad spectrum antibiotic, met primary and secondary efficacy endpoints including non-inferiority to standard of care vancomycin plus aztreonam in the intent-to-treat population. While this news is positive, TARGET is one of two cross-supportive Phase III trials required for the US filing; top-line data from the second study in Staphylococcus aureus bacteraemia (SAB) bloodstream infections (ERADICATE) is expected in H221. A US launch date of 2022/23 for ceftobiprole could be feasible, with a focus on SAB and ABSSSI. We value Basilea at CHF1,082m or CHF100/share.

Edison

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  • 06 Aug 19
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Basilea Pharmaceutica

Ceftobiprole succeeds in first US Phase III trial

Basilea reported positive top-line results for the Phase III TARGET trial testing broadspectrum MRSA antibiotic ceftobiprole in severe skin infections. This is one of two Phase III trials required for the filing of a new drug application ("NDA") with the US FDA, both conducted under Special Protocol Assessment ("SPA") agreements. The second study (ERADICATE) in blood poisoning is on track to read out in H2/2021E. Although ceftobiprole is already marketed for pneumonia (HAP and CAP) in many European and RoW countries, the US is the key market for MRSA antibiotics and accounts for 56% of our peak sales estimate for the drug. We forecast launch in 2022E and peak sales of $225m in 2029E. Since ceftobiprole was designated Qualified Infectious Disease Product ("QIDP") by the FDA, we anticipate up to 10 years of market exclusivity from the date of launch. The ceftobiprole US opportunity accounts for c.10% of our CHF108 target price ("TP") for Basilea. We maintain our OUTPERFORM recommendation.

goetzpartners securities Limited

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  • 06 Aug 19
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Basilea Pharmaceutica

Astellas reports robust Cresemba sales

In its recent financial results, Basilea's partner Astellas reported Cresemba (isavuconazole, antifungal) Q2/2019 US sales of $37m, taking H1/2019 US sales to $67m (+26% YoY), slightly above our $65.5m forecast. The company also stated that it projects FY2019E (April 2019 - March 2020) sales to reach $143m, in line with our estimate for Astellas's fiscal year. This increases our confidence in our peak sales forecasts for Cresemba of nearly $230m in the US and $645m globally by 2026E, of which we expect Basilea to receive close to 40% over the life of the agreements with commercialisation partners. Basilea shares are trading well below our sum-of-theparts ("SoTP") derived fair value of CHF108 per share, of which Cresemba in marketed regions including the US and Europe accounts for CHF49 (46%). Hence, we feel that the shares are undervalued and see room for upside as the company continues to achieve upcoming milestones, including first Phase III data for anti-MRSA antibiotic ceftobiprole in the US in H2/2019E. We reiterate our OUTPERFORM recommendation.

goetzpartners securities Limited

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  • 01 Aug 19
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  • 31 Jul 19
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  • 18 Jul 19
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Basilea Pharmaceutica

Basilea Pharmaceutica - Executive interview – Basilea Pharmaceutica

Basilea Pharmaceutica is a Switzerland-based biopharmaceutical company established in 2000 as a spin-out from Roche with the divestment of its anti-infective portfolio. Basilea was listed on the SIX Swiss Stock Exchange in 2004 and is well funded through its key near-term milestones. Revenue growth will be driven from its two marketed anti-infectives: Cresemba (antifungal – for invasive mould infections) and Zevtera (antibiotic – for hospital infections), which are commercialised globally through partners such as Pfizer and Astellas. It has several oncology assets in clinical development, which represent the next pillar of growth, including derazantinib, a pan-FGFR kinase inhibitor, which is currently in a registrational Phase II study for bile duct cancer. In this video, CEO David Veitch introduces the company, its assets and sets out the key near-term milestones.

Edison

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  • 29 May 19
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Basilea Pharmaceutica

Derazantinib has potential in iCCA and beyond

The in-licensing of fibroblast growth factor receptor (“FGFR”) inhibitor derazantinib in April 2018 marked a turning point for Basilea: it brought in a late-stage oncology asset with potential across multiple cancers, thus complementing earlier-stage pipeline assets BAL101553 (Ph II) and BAL3833 (Ph I). The demonstration of proof-of-concept in intrahepatic cholangiocarcinoma (“iCCA”), a rare cancer of the bile duct, paved the way for the pursuit of larger indications. A Ph I / II trial in urothelial carcinoma (“UC”) (the most common form of bladder cancer, “BC”) in combination with anti-PD-L1 Tecentriq is due to start in mid-2019E. In this research report, we take a deep dive into the FGFR inhibitor landscape to elucidate derazantinib’s potential positioning compared to other molecules in the same class. We conclude that the compound’s profile should allow it to capture at least 25% market share in each iCCA and UC. Since our forecasts only reflect limited value for derazantinib in iCCA, we see upside from adding sales in UC as we gain more clarity on the design of the pending Ph I / II trial. We maintain our OUTPERFORM recommendation and nudge up our target price (“TP”) to CHF108.

goetzpartners securities Limited

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  • 23 Apr 19
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Basilea Pharmaceutica

Basilea Pharmaceutica - Cresemba driving top-line growth

Basilea continued to build on its foundations for growth in 2018, reporting FY18 revenues of CHF132.6m (+31%) and an operating loss of CHF24.1m (+41%), beating guidance for the year. Revenues benefit from the multitude of global licensing/distribution deals for launched assets Cresemba and Zevtera. The main revenue driver is Cresemba, whose sales growth has accelerated in the US and EU. R&D investment in the oncology pipeline continues. This represents the next pillar of growth and we anticipate further progress in 2019. We expect further in-licensing opportunities given the strength of the balance sheet (cash and financial investments CHF223m). We value Basilea at CHF1082m or CHF100/share.

Edison

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  • 06 Mar 19
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Basilea Pharmaceutica

Cresemba on track, pipeline expanding

Basilea reported FY2018 revenue growth of 31% to CHF133m, driven by antifungal Cresemba. We expect limited revenue growth in 2019E, but note that there will be a shift towards cash-generating revenues, since deferred revenue of CHF23.9m related to Toctino will be replaced by contributions from Cresemba and antibiotic Zevtera (we forecast +30% YoY), translating to a reduction in net cash burn. With the commercialisation of Cresemba and Zevtera handed over to partners, Basilea is fully focused on its pipeline, particularly oncology asset derazantinib, which will enter additional clinical trials this year. We trim our target price (“TP”) to CHF107 (from CHF112), reflecting a lower cash balance by YE2019E and delay of a potential US licensing deal for ceftobiprole by one year, and retain our OUTPERFORM recommendation. We believe that the share price neither reflects continued strong growth from marketed products nor attributes value to clinical-stage pipeline assets.

goetzpartners securities Limited

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  • 28 Feb 19
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Basilea Pharmaceutica

Derazantinib to enter combo trial with Roche's Tecentriq

Basilea announced a clinical trial supply collaboration with Roche to explore the combination of its in-licensed oncology drug candidate derazantinib with Roche’s PDL1 immune checkpoint inhibitor ("ICI") atezolizumab (Tecentriq) in urothelial cancer ("UC"), the most common type of bladder cancer and sixth largest cancer in the US. A Phase I/II biomarker-driven study is projected to start in mid-2019E. Derazantinib has already demonstrated activity as a single agent in shrinking tumours of patients with intrahepatic cholangiocarcinoma (“iCCA”) and, based on its mechanism of action, is expected to enhance the effect of PD-1/PD-L1 immune checkpoint inhibition. A successful outcome for the planned trial could lead us to include sales in bladder cancer to our valuation, which currently only includes a small contribution for derazantinib based on sales in iCCA. The deal underpins Basilea's commitment to the oncology space, in our view. We reiterate and maintain both our OUTPERFORM recommendation and CHF112 target price.

goetzpartners securities Limited

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  • 25 Jan 19
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Basilea Pharmaceutica

Basilea Pharmaceutica - Derazantinib interim iCCA data promising

Basilea has reported positive interim results from the derazantinib Phase II registration trial in intrahepatic cholangiocarcinoma (iCCA, bile duct cancer). The promising efficacy shown highlights the potential for the product in FGFR-driven solid tumours, an unmet need. Full data are expected to be available once the study has completed (mid-2020). Basilea in-licensed derazantinib from ArQule in April 2018. The asset is a complementary addition to its oncology portfolio and the company now has three diversified, early/mid-stage clinical assets targeting cancer resistance in its portfolio. We anticipate increased investor focus on the oncology strategy at Basilea. We value Basilea at CHF115/share.

Edison

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  • 10 Jan 19
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Basilea Pharmaceutica

Derazantinib interim data in line with expectations

Basilea reported encouraging interim data for the derazantinib registrational Phase II trial in intrahepatic cholangiocarcinoma ("iCCA"), a few months earlier than we had anticipated. The overall response rate ("ORR") of 21% is in line with the efficacy observed in a previous Phase I/II trial and clinically relevant given the poor prognosis of the disease and the lack of 2nd line therapies, thus paving the way for a potential accelerated approval upon completion of the study in mid-2020E. The data supports clinical development of derazantinib in other fibroblast growth factor receptor ("FGFR") driven solid tumour indications, and one new trial is expected to start in mid-2019E. We conservatively forecast approval and launch in Q4/2023E based on Phase III data and peak sales of c.$70m in iCCA alone, with Basilea paying partner ArQule single-digit milestones related to iCCA. We maintain our OUTPERFORM recommendation and CHF112 target price ("TP"), of which derazantinib accounts for c.CHF1 per share, based on a 25% chance of success in iCCA.

goetzpartners securities Limited

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  • 10 Jan 19
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Basilea Pharmaceutica

Basilea Pharmaceutica - Cresemba growth, pipeline expansion

Basilea reported a strong set of interim 2018 results; H118 total revenues grew to CHF59.9m (+30%, H117 CHF46.2m). Notable is Cresemba’s (invasive mould infections) performance; its revenue contribution increased 30% to CHF26.3m (H117 CHF20.3m), which includes royalties on sales of CHF10.8m (H117 CHF5.3m) received from partners. Zevtera (severe bacterial infections) sales remain lacklustre; however, the US opportunity is key and the two required registration ceftobiprole trials (SAB and ABSSSI) are now underway. We value Basilea at CHF1,239m.

Edison

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  • 21 Aug 18
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Basilea Pharmaceutica

Cresemba shines in H1/2018 results

The key update at the H1 results was an upgrade to 2018E revenue guidance to reflect stronger than expected sales growth of antifungal Cresemba (isavuconazole) in the US and Europe, prompting us to lift 2018E - 2020E revenues by up to 17%. While its commercialisation partners continue to grow sales of Cresemba and antibiotic Zevtera (ceftobiprole) in existing and new regions, Basilea has been focused on advancing and expanding its pipeline to pave the way for sustained long-term growth. We increase our target price per share to CHF112 (from CHF108) and reiterate our OUTPERFORM recommendation, as the current share price does not reflect the full potential of both marketed and clinical-stage pipeline assets, in our view.

goetzpartners securities Limited

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  • 17 Aug 18
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Basilea Pharmaceutica

Basilea Pharmaceutica - Oncology product portfolio to drive future growth

Basilea has successfully brought two anti-infective drugs to the market: Cresemba (severe mould infections) and Zevtera (bacterial infections). With the commercialisation of both assets largely in the hands of partners and Zevtera’s Phase III US clinical programme underway, we turn our focus to the next pillar of growth, the oncology portfolio. The recent deal with ArQule (in-licensing of Phase II product, derazantinib) means Basilea now has three diversified, early/mid-stage clinical assets targeting cancer resistance in its portfolio offering. We value Basilea at CHF119/share.

Edison

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  • 16 Jul 18
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Basilea Pharmaceutica

Derazantinib deal adds third oncology asset

Basilea has signed an in-licensing agreement with ArQule for late-stage oncology asset derazantinib (ARQ 087), a small molecule that targets the fibroblast growth factor receptor (“FGFR”) family of kinases. Derazantinib is in Phase II development for second-line intrahepatic cholangiocarcinoma (“iCCA”), a rare cancer with limited treatment options and a poor prognosis. Under the terms of the deal, Basilea will pay $10m upfront and up to $326m in milestones. We estimate that only c.$5m are related to iCCA and the remainder to large, non-orphan solid tumour indications being assessed. We forecast launch in Q4/2023E and peak sales of c.$70m in iCCA, with Basilea paying ArQule an estimated 8% royalty rate. There could be upside to our forecasts if derazantinib receives accelerated / conditional approval in late 2021E based on data from the ongoing Phase II trial. We nudge our target price (“TP”) to CHF108 per share and maintain our OUTPERFORM recommendation.

goetzpartners securities Limited

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  • 04 May 18
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Basilea Pharmaceutica

Reaping the rewards of an intense BD period

We initiate coverage on Basilea, a commercial-stage Swiss biotech company focused on treatment-resistant infections and cancers, with an OUTPERFORM recommendation and target price of CHF107/share, which is c.60% above the share price. Basilea recently completed a busy period during which it signed commercialisation agreements with global and regional leaders for its two marketed hospital anti-infectives, antifungal Cresemba (isavuconazole) and MRSA antibiotic Zevtera (ceftobiprole), in most key markets. We expect revenue from these deals to fuel a 2018E-2023E revenue CAGR of c.18% (based on 2018E revenues of CHF109m) and lead to profitability from 2020E, driving share price upside, in our view. We see increasing visibility on the de-risked ceftobiprole US programme and clinical milestones for Basilea’s early-stage oncology pipeline as additional share price drivers.

goetzpartners securities Limited

 View

  • 19 Mar 18
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Basilea Pharmaceutica

Strength in numbers

Basilea reported a definable FY17, as a multitude of licensing/distribution agreements announced in 2016/17 for launched anti-infective drug assets Cresemba (isavuconazole) and Zevtera (ceftobiprole) aided reported product sales, royalty and milestone income. Total revenues grew 54% to CHF101.5m, of which CHF16.3m related to product sales and CHF15.0m to royalty income. Operating losses declined by 68% to CHF14.1m. For 2018, we expect operating losses to reduce further as higher R&D costs are offset by growth in total revenues. We value Basilea at CHF1,231m.

Edison

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  • 08 Mar 18
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Basilea Pharmaceutica

Pfizer Cresemba deal extended to Asia and China

Basilea has announced an extension to its licence agreement with Pfizer (PFE) for Cresemba (for invasive fungal infections). The original deal granted PFE exclusive commercialisation rights to the product in Europe (ex-Nordics), Russia, Turkey and Israel and the new amendment includes China and 16 countries within Asia Pacific. The extension of Cresemba’s global footprint at this stage highlights PFE’s commitment to the product in areas outside of Europe. Concomitantly Basilea has updated its guidance for FY17 to a reduced operating loss of CHF1m per month vs CHF2m per month. Our valuation rises slightly to CHF1,222m.

Edison

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  • 07 Dec 17
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Basilea Pharmaceutica

The future looks bright

Basilea’s prognosis looks good. Multiple licensing/distribution agreements announced for launched assets Cresemba and Zevtera should drive top-line growth faster than we had expected. Major deals include; Cresemba in Europe (ex Nordics), Russia, Turkey and Israel with Pfizer (CHF70m upfront plus up to $427m in regulatory and sales milestones and mid-teen royalties), Zevtera in China with CR Gosun, and in Europe with Cardiome. These licensing and distribution deals validate the commercial potential for both assets and enable the financial fire power to bolster Basilea’s existing, innovative R&D pipeline (with a focus on cancer and anti-infective drug resistance). Our upgraded valuation is CHF1,188m or CHF110/share (excluding treasury shares) vs CHF1,048 previously.

Edison

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  • 11 Oct 17
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Basilea Pharmaceutica

Hat trick

Basilea announced a hat trick of positive news flow in June. This includes two separate licensing deals covering Cresemba (for invasive mould infections) and Zevtera, as well as triggering the allocation of $54.8m reimbursement funding from the Biomedical Advanced Research and Development Authority (BARDA) relating to the advancement of Zevtera’s US phase III clinical programme for bacterial infections (trials to initiate H217). Most notable is the major licensing deal with Pfizer for Cresemba in Europe, Russia, Turkey and Israel; Pfizer is the partner of choice given its long-standing expertise in this market. Additionally, Avir Pharma has licensed both Cresemba and Zevtera for the Canadian market. Our forecasts and valuation are under review; we will update both post further disclosure on the PFE deal at the interim results on 10 August.

Edison

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  • 11 Jul 17
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Basilea Pharmaceutica

Steady as she goes

Basilea reported a solid set of 2016 numbers ahead of guidance, driven by higher than expected product sales in H216 combined with lower than expected operating costs. Cresemba (for invasive mould infections), in particular, continues to pick up momentum both in the EU and the US through US partner Astellas. Zevtera’s US pivotal Phase III clinical trial programme for bacterial infections remains on track to initiate in mid-2017. Multiple distribution and commercialisation agreements signed in H216 should lead to international launches starting from 2018 for both products. We value Basilea at CHF1,048m or CHF97/share.

Edison

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  • 01 Mar 17
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Basilea Pharmaceutica

Licensing double act

Basilea continues to make good partnering progress with key assets Cresemba for mould infections and Zevtera for bacterial infections. Both drugs will be developed and marketed across Latin America by Grupo Biotoscana (GBT), while Cresemba will be developed and marketed by Asahi Kasei Pharma in Japan. Basilea will receive a total upfront of CHF18m (to be treated as deferred revenue over a number of years), plus additional payments on reaching regulatory and commercialisation milestones (up to CHF60m from Asahi plus royalties, undisclosed amounts from GBT). We value Basilea at CHF1,091m.

Edison

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  • 16 Sep 16
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Basilea Pharmaceutica

Moving on up

Basilea has made a solid start to the first half of 2016, with anti-microbial agents Cresemba and Zevtera continuing their respective European roll-outs. Ongoing dialogue with the FDA on the SPA protocol for Zevtera’s Phase III US clinical trial programme means US trials should initiate in H117. Together, these underpin the current valuation with upside potential from further partnering deals for Cresemba, Zevtera and the early-stage oncology pipeline, which in itself is making progress, albeit at an early stage. We value Basilea at CHF1,091m or CHF101/share.

Edison

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  • 30 Aug 16
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Basilea Pharmaceutica

Zevtera US development full steam ahead

Basilea has announced that BARDA, a division of the US Department of Health & Human Services Office, has awarded a contract of up to $100m for the Phase III development of antibacterial agent ceftobiprole (Zevtera) for the US market. Critically, this means that the Phase III trials in skin and bacteraemia (blood) infections could start as soon as late 2016/early 2017 once the company has agreed the Phase III study Special Protocol Assessments (SPAs) with the FDA. The BARDA contract now removes the uncertainty in timing for the Phase III clinical trial programme that would support Zevtera’s US regulatory filing. We value Basilea at CHF1,114m or CHF103.2/share.

Edison

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  • 22 Apr 16
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Basilea Pharmaceutica

Riding the crest of the novel antimicrobial wave

Basilea is one of the few standalone European companies focused on developing novel antimicrobial drugs. It has two approved hospital-based products: Cresemba for severe mold infections and Zevtera for bacterial infections. Together these underpin the current valuation with upside potential from a US partnering deal for Zevtera and the early-stage oncology pipeline. A US Zevtera deal and potential sales progression for the antimicrobial portfolio are key near-term share price drivers. We value Basilea at CHF1,114.0m or CHF103.2/share.

Edison

 View

  • 23 Mar 16
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