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Valuation Reports

Basilea Valuation Report
"Return to anti-infectives and profits"
2022 prelims beat guidance - Zevtera US filing imminent

Basilea has delivered on its new strategy to become a pure-play anti-infectives company. 2022 preliminary revenues beat guidance thanks to the continued strong performance of Cresemba and substantial proceeds from oncology asset transactions. Zevtera's revenue should get a considerable boost on contracting a US commercialization partner and the approval and launch in the lucrative US market. US NDA filing in three indications (SAB, ABSSSI and CABP) is planned for March/April 2023. Basilea reduced its debt level and targets sustainable profits from 2023 onwards.

Key catalysts include:
1. FY 2022 results release and call (14 February 2023)
2. US NDA filing of Zevtera for severe bacterial infections (March/April 2023)
3. US commercialisation partner for Zevtera (2023)
vL Basilea Valuation Report 23JAN23.pdf
Adobe Acrobat Document 1.9 MB
Newron Valuation Report
“Back to pivotal”
Evenamide data provides a brilliant start to the New Year

Despite exciting 6-month interim results of the first 100 patients enrolled in “Studies 014/015” of evenamide in TRS, Newron trades just above its cash value. Xadago, its marketed drug for Parkinson’s disease, and its key driver, evenamide for schizophrenia, are virtually free. Further clinical progress of evenamide in schizophrenia and starting the PD-LID label extension trial for Xadago should add significantly to the value while reducing the clinical development risk. Moreover, the exciting “Studies 014/015” interim data might trigger a potential global partnering deal with a major CNS player earlier than expected, providing further equity upside.

Key catalysts include:
1. Full results “Study 014” trial of evenamide in TRS (March 2023)
2. Start new label trial Xadago in PD-LID (H1 2023)
3. Results pivotal “Study 008A” trial of evenamide in non-TRS (H2 2023)
vL Newron Valuation Report 3JAN23.pdf
Adobe Acrobat Document 2.3 MB
Relief Therapeutics Valuation Report
“Play ACE!”
Christmas came early: ACER-001 approved in the US

ACER-001 (branded "Olpruva" in the US by Acer) was approved in UCDs ahead of its 15 January 2023 PDUFA date with US launch in early 2023. The US launch of PKU GOLIKE and upcoming US launch of Olpruva in UCDs, provide a boost to near-term revenues. Successful development of Relief’s diversified pipeline including RLF-100 in rare respiratory diseases, RLF-OD032 in PKU, and RLF-TD011 in EB, are future revenue generators. Relief has a cash runway through Q3 2023. An estimated CHF 30 mn additional funding, needed to reach breakeven guided for late 2024, should primarily be raised through non-dilutive regional product out-licensing agreements.

Key catalysts include:
1. US launch of Olpruva (ACER-001) in UCDs (early 2023)
2. EU filing of Olpruva/ACER-001 in UCDs (early 2023)
3. RLF-100 INHALED “Leuppi Study” topline results (Q1 2023)
vL Relief Therapeutics Valuation Report
Adobe Acrobat Document 1.4 MB
Santhera Valuation Report
“Against all odds”
Vamorolone close to launch triggering huge upside

US and EU approval of vamorolone with peak sales of CHF 650+ mn in DMD alone will be transformational for Santhera. The equity upside should be a multiple of the potential share dilution to raise an estimated CHF 40 mn to build up a US and EU specialist sales force to commercialize vamorolone and maximize its long-term profitability. Out-licensing agreements for vamorolone outside rare diseases or Santhera territories add to the potential and may reduce potential share dilution.

Key catalysts include:
1. Vamorolone FDA “acceptance of filing” (January 2023)
2. Vamorolone US approval in DMD (Q2 2023)
3. Vamorolone EU approval in DMD (Q4 2023)
vL Santhera Valuation Report 19DEC22.pdf
Adobe Acrobat Document 1.8 MB
Cosmo Valuation Report
"Back to the roots"
Strong H1 - Winlevi is off to a flying start in the US

Cosmo reported its best half-year in terms of revenues with new key drivers such as Winlevi off to an excellent start in the US, attracting additional partnering agreements, while legacy products such as Lialda, Uceris, and Cortiment rebounded strongly, adding to the company’s operating cash flow. Cosmo’s investments to move towards large markets over the past years with major players such as Medtronic are starting to pay off, with a full franchise in artificial intelligence (GI Genius) and dermatology (Winlevi) just beginning to gain traction.

Key catalysts include:

1. Start phase III trial Breezula in male alopecia (Q4 2022)
2. Start phase III trial Aemcolo in IBS-D (Q4 2022)
3. Start confirmatory Lumeblue phase III trial for US approval (Q4 2022)
Cosmo Valuation Report 16SEP22.pdf
Adobe Acrobat Document 2.4 MB
Spexis Valuation Report
“Catching breath in lung disease”
ColiFin US phase III CF trial to start in H1 2023

Spexis provides a unique, low clinical risk, high reward investment, yet, dependent on securing sufficient funding. Lead drug ColiFin (branded inhaled colistin), approved in the EU for cystic fibrosis (CF), needs only a single positive phase III trial to gain US approval. In the US, generic versions of inhaled colistin are prescribed “off label” by physicians at their own risk to treat CF patients, given its favorable profile. Following US approval, the roughly 36% of CF patients on generic colistin could be rapidly switched to branded ColiFin, while gaining traction in new patients and enjoying 12 years of US market exclusivity from FDA approval. We forecast CHF 300+ mn US peak sales for ColiFin.

Key catalysts include:
1. Strategic decision on balixafortide (H2 2022)
2. Start of ColiFin “COPILOT” dosing trial in CF (H1 2023)
3. Start of ColiFin single pivotal US phase III “COPA” trial
vL Spexis Valuation Report 17AUG22.pdf
Adobe Acrobat Document 1'023.4 KB
Addex Valuation Report
“Back to the future - fast forward”
USD 339 mn Indivior deal highlights pipeline potential

The USD 339 mn strategic agreement with Indivior to accelerate development of ADX71441 in addiction highlights the underlying value of Addex’ allosteric modulator pipeline and extends it cash runway into 2021. The company plans to raise sufficient funds in 2018 to finance pivotal development of dipraglurant in PD-LID and dystonia, both with blockbuster peak sales potential. Successful funding is the last step in Addex' development strategy to unlock the value of its key pipeline projects.

Key catalysts include:
1) Start phase IIa POC trial of dipraglurant ER in dystonia (H2 2018)
2) Start phase I trial of ADX71441 in addiction (H2 2018)
3) Start 1st pivotal phase III trial of dipraglurant IR in PD-LID (H2 2018)
vL Addex Valuation Report 8JAN18.pdf
Adobe Acrobat Document 1.3 MB
Kuros Valuation Report
"Fit for Growth"
KUR-023, the first product to reach the market in 2017

Kuros’ key projects target sizable market opportunities in surgical sealants with KUR-023 (dural membrane sealant); and orthobiologics with KUR-111 (bone graft substitute) and KUR-113 (bone fracture healing), with combined peak sales of more than CHF 1.5 bn. With cash of CHF 18 mn (June 30, 2016), the company has sufficient funds to launch KUR-023 in the EU in 2017, and prepare KUR-111 and KUR-113 for phase III development. Additional financing will be needed to bring KUR-111 and KUR-113 successfully to market. Legacy Cytos collaborations (not in our forecasts) provide significant upside potential without any further funding requirements.

Key catalysts include:
1. Filing CE marking dural membrane sealant KUR-023 (~end 2016)
2. Start US PMA clinical trial KUR-023 in spine patients (2017)
3. EU approval, partnering agreement, and launch of KUR-023 (2017)
vL Kuros Valuation Report 27JUN16.pdf
Adobe Acrobat Document 1.3 MB