05-June-2020:  Clinuvel Pharmaceuticals Presentation at the Jefferies Global Healthcare Conference

27 Feb 2020:  From Moelis Australia:  CLINUVEL PHARMACEUTICALS LTD (BUY)

"European summer still to come" - http://research.moelis.com.au/ResearchPortal/DownLoad?E=bheikdfij

Price Today (28-Feb-2020):  $17.77.  

Moelis Target Price:  $32.15.  (Implying potential upside of +80.9% from here).  

Excerpts from the Moelis Report:

EVENT

Revenue in-line but costs higher than expected: Revenue was $10m (+11%), EBITDA was $0.9m (-77%) and NPAT was $1.1m (-74%). While the topline result was largely as expected, earnings were weaker than expected due to significantly higher than expected costs. Operating cashflow was $4.7m (34.5%) as expected. Balance sheet position remains strong with net cash of $57.4m (FY19 $54.3m). No interim dividend as expected (in line with pcp) and no quantified guidance was provided.

IMPACT

• Volume growth softer than expected. While revenue grew +11%, volumes growth was closer to 7.5% as CUV benefitted from the weaker AUD in the period. Softer than expected growth was attributed to stocking orders in the pcp ahead of supply concerns related to Brexit. Despite this CUV continued to reach new patients in the period. We expect 2H earnings to continue at a similar growth rate, as penetration increases in existing markets.
• New EU market launches expected over the next 6 months. Whilst there were no new EU market launches in 1H20, CUV are close to launching in 2 small EU markets. These market launches, as well as continued market uptake in Germany will support +15% revenue growth in FY21. Our FY22 estimates assume sales in the USA and a major EU market launch.
• Coronavirus could impact 2H. While to date CUV has not had any impact from the virus,  given Italy is the 4th largest EU market for CUV we note there could be a short term drop-off in doses as Italian patients may be less inclined to travel to a hospital to receive treatment for EPP.
• Cost base significantly higher than expected. Following FDA approval in Oct-19, it was always the plan that CUV would invest in R&D in order to expand SCENESSE into other indications. However, the quantum and the timing of the increase was larger and faster than expected. While we see investment in R&D to increase the addressable market as sensible, we note the majority of the cost increases were in the G&A line. Our cost base in FY21 increases to capture this for the full 12 months, as well as additional costs around clinical trials for vitiligo.
• US launch on track with payer negotiations underway.  

INVESTMENT VIEW

EPS downgrades of 10-30% reflect the slower EU ramp up and higher costs. TP moves to $32.15 and while we believe the EU ramp up will be slower, we believe any success in the US will be well-received. BUY retained. 

1st August 2019:  From Moelis Australia:  CLINUVEL PHARMACEUTICALS LTD (HOLD)  
 "More cash in the bank" - http://research.moelis.com.au/ResearchPortal/DownLoad?E=bfcakccbd

Price Today (03-Aug-19):  $30.84

Moelis New Target Price:  $31.58. (implied upside of circa +2.4%)

Disclosure:  I don't hold.

23rd December 2019:  From Moelis Australia:  CLINUVEL PHARMACEUTICALS LTD (BUY - upgraded from HOLD previously)  

"Examining the NDA" - http://research.moelis.com.au/ResearchPortal/DownLoad?E=bghbkdfij  

Price Today (11-Jan-2020):  $28.18.  

Moelis Target Price:  $44.42.  (Implying potential upside of +57.6%).  

Excerpts from the Moelis Report:

Examination of the FDA analysis on CUV’s new drugs application for SCENESSE. We have examined the data provided and analysis undertaken by the FDA and while we have not found any material additional analysis performed by the FDA, it did agree with the rationale that it is better to look at the relative increase in exposure rather than the absolute numbers.  

AGM update:  Whilst no formal guidance or outlook commentary around the core EPP business was provided, CUV did announce its intention to develop a new product targeting the prevention of UV-induced skin cancer (by promoting DNA repair).  Clearly it is early days, however it highlights further optionality for the business and has increased chances of regulatory approvals post the SCENESSE FDA approval. 

IMPACT  

• EU roll-out tracking in line with expectations.  We understand that uptake in existing EU markets continues to grow, with short term growth driven by increasing market penetration as new EPP treatment clinics are added in Germany. In the medium term we see upside potential from the EMA relaxing the maximum 4 doses p.a. and moving to continuous coverage (in line with the US).  
• FDA analysis does not materially increase the probability of achieving EU reimbursement.  Since examining the NDA and FDA analysis of CUV’s application we were not able to identify any meaningful incremental analysis performed by the FDA, we believe achieving reimbursement for new EU nations will likely be elongated. 
• Preparations for the US launch is underway.  CUV is currently: (1) finalising the protocol for the post-marketing patient safety follow-up; (2) setting up a US office on the West Coast that will employ 11 people in 18 months; and (3) in discussions with US insurers. Once completed, CUV will be able to launch in the US. We expect first sales in 2H21.   
• New product development provides optionality.  CUV had identified skin cancer prevention as a new target indication. Whilst still early days the addressable market is large, and given that SCENESSE has achieve FDA approval, we believe the probability of regulatory approval for the new indications are higher. 

INVESTMENT VIEW

FY20-22 EPS estimates remain unchanged. Our TP moves to $44.42 (from $50.91), and we upgrade to a BUY rating. 

-------------------------------------------------------------

Disclosure:  I don't hold.

4th June 2019:  From Moelis Australia:  CLINUVEL PHARMACEUTICALS LTD (HOLD)  
 "Minimal concerns over FDA delay" - http://research.moelis.com.au/ResearchPortal/DownLoad?E=behbkccbd

Price Today (07-Jun-19):  $31.69.

Moelis Target Price:  $26.43.  (Lower than current SP).

Disclosure:  I don't hold.