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Research

Santhera Valuation Report
“All-in on DMD” - Sufficient funds to reach turning point in 2020

The license agreement with Chiesi for the global rights (ex. North America) of Raxone in LHON marks Santhera’s exit from neuro-ophthalmology. The proceeds will be reinvested in the current pipeline to bridge a funding gap until the 2020 turning point with the anticipated EU conditional approval of Puldysa (80% filing success rate) in DMD and the readout of the vamorolone pivotal "VISION-DMD" trial (35% phase IIb success rate) in DMD. The peak sales potential of both DMD drugs are 26 times higher than the peak sales potential of Raxone in LHON (ex. North America). Given the relatively high success probability of Puldysa EU conditional approval, we believe the sale of the Raxone LHON rights to Chiesi should pay out nicely.

Key catalysts include:
1. POL6014 phase I MAD trial results (H2 2019)
2. Puldysa EU conditional approval (mid 2020)
3. Vamorolone “VISION-DMD” pivotal trial results (mid 2020)
vL Santhera Valuation Report 6JUN19.pdf
Adobe Acrobat Document 2.1 MB
Cosmo Valuation Report
"Seeing is believing"
AI-ing big profits with Medtronic

At the 2019 R&D Day, Cosmo revealed the AI Smart Box (CB-17-08), a revolutionary artificial intelligence enhanced device for colonoscopy alongside a global distribution agreement with Medtronic; a novel online DTC business model for Aemcolo directly targeting travelers; a new exclusive agreement for Eleview with Medtronic in the US, China and South America replacing the Olympus agreement; and last but not least, announced a new proprietary compound CB-03-10, a novel androgen receptor that will start phase I development in cancer patients in Q4 2019 and on positive results will be partnered to a strong oncology player. In 2019 a net loss of EUR ~12 mn is expected with Cosmo returning to profitability in 2020.

Key catalysts include:

1. Activity started for 2nd confirmatory phase III trial MethyleneBlue (2019)
2. AI Smart Box (CB-17-08) European launch (mid 2019)
3. US launch Aemcolo (June/July 2019)
Cosmo Valuation Report 3JUN19.pdf
Adobe Acrobat Document 1.5 MB
Basilea Valuation Report
"Partners paving way to profitability"
Strong Cresemba boosts 2018 results and 2019 outlook

LATEST UPDATE: Basilea beat its increased 2018 guidance thanks to strong Cresemba (fungal infections) sales leading to a significant reduction in the operating loss, despite higher costs to obtain the global rights (excluding China, Hong Kong, Macau and Taiwan) for derazantinib, a promising oral panFGFR inhibitor for treating solid tumors, from Arqule. Strong growth of Cresemba is expected to continue. Basilea should approach profitability in 2020/2021 with sufficient cash, revenues from Cresemba and Zevtera (lung infections), and external funding (e.g. BARDA) to develop its key pipeline projects up to next value inflection points.

Key catalysts include:
1. Start derazantinib/Tecentriq POC trial in urothelial cancer (mid 2019)
2. Results phase III “TARGET” trial of Zevtera in skin infections (H2 2019)
3. Results POC trial of BAL101553 in brain & ovarian cancer (end 2019
vL Basilea Valuation Report 30APR19.pdf
Adobe Acrobat Document 1.5 MB
Newron Valuation Report
“STARS on the horizon”
Sarizotan in Rett syndrome a potential game changer

Newron has a pipeline with multiple catalysts on the horizon consisting of a nice mix of products targeting large disease areas such as Xadago that already generates revenues in Parkinson’s disease, and evenamide in schizophrenia; and products targeting rare diseases such as sarizotan in Rett syndrome, Xadago in PD-LID and evenamide in CTRS. Newron’s valuation is currently based on (low) royalties and milestones from Xadago in Parkinson’s disease. Substantial value will be unlocked with the approval and launch of sarizotan in Rett syndrome (a potential game changer sold through an own specialist sales force), Xadago in PD-LID, and evenamide in schizophrenia and CTRS.

Key catalysts include:
1. Start new label trial Xadago in PD-LID (Q2 2019)
2. Start potentially pivotal program of evenamide in schizophrenia/CTRS (Q2 2019)
3. Top line results sarizotan “STARS” trial in Rett syndrome (Q4 2019)
vL Newron Valuation Report 29APR19.pdf
Adobe Acrobat Document 1.7 MB
Cassiopea Valuation Report
"Winlevi spot on"
Breezula moves into phase III in alopecia in Q4 2019

Cassiopea made excellent progress with its key pipeline projects including, Winlevi (acne) that successfully completed phase III and will be filed for US approval in Q2 2019, and Breezula (alopecia/hair loss) that successfully completed phase II and will start pivotal phase III trials in Q4 2019. Cassiopea plans to build up an own specialist dermatology sales force in the lucrative US market and seek commercialization partners outside the US. We assume a NASDAQ listing around US approval of Winlevi to fund US operations and fully develop its remaining pipeline projects. Cosmo provided a credit line of up to EUR 20 mn to bridge a short-term funding gap and avoid considerable share dilution at the current low share price.

Key catalysts include:
1. US NDA filing Winlevi in acne (Q2 2019)
2. Start POC trial of Breezula (alopecia/hair loss) in women (Q3 2019)
3. Start phase III trials of Breezula in male alopecia (Q4 2
Cassiopea Valuation Report 23APR19.pdf
Adobe Acrobat Document 1.4 MB
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