9/24/2024 Skull Session Management Morning Briefing with Craig Mull, CEO of Cipher Pharmaceuticals (CPHRF) (CPH.TO)

We caught up with Cipher Pharmaceuticals, Inc. (OTC:CPHRF) (CPH.TO) CEO Craig Mull for a Skull Session Management Briefing to specifically address its partner Moberg Pharma Ab (STO:MOB.ST) update on September 13, 2024 in which Moberg lwered its expectations on the primary endpoint for its nail fungus treatment (MOB-015)

Our conversation with Craig revolved around the following topics/questions that we hoped he would expand on..

1. Reassessing Impact on Canadian Approval: Moberg mentioned that the European dossier can be used for Canadian approval. Given the preliminary U.S. trial's issues, do you foresee any need to adjust your strategy or communication with Canadian regulators based on this new data?

2. European Study’s Role in Canada: Moberg highlighted the reliance on the European study for approval in Canada. How confident are you in this approach, and are there any additional steps Cipher might take to support this submission, considering the U.S. results?

3. Communication and Strategy for Canadian Market: While Moberg stated that the U.S. study doesn’t impact approval in Europe or Canada, the news has created market uncertainty. How is Cipher managing communication with investors and stakeholders about the Canadian launch, given this potential misunderstanding?

4. Long-Term Viability of MOB-015 in Canada: With the projected 2026 launch in Canada, and Moberg’s admission of increased risk in the U.S., what steps is Cipher taking to ensure long-term success in the Canadian market if FDA approval in the U.S. faces hurdles?

5. Risk Management and Licensing Agreement: Moberg indicated that further analysis will follow in December when top-line data is available. Should the data continue to disappoint, what options does Cipher have with respect to the licensing agreement for MOB-015 in Canada? Are there any provisions for reconsideration or withdrawal?

6. Timeline Adjustments Based on U.S. Data: Given the delay in U.S. approval, how has Cipher adjusted its internal timelines or expectations for launching MOB-015 in Canada? Are you prepared for potential pushback from Canadian regulators if the U.S. data doesn’t improve?

7. Contingency Plans for Market Expectations: Investors might be concerned that negative U.S. data could overshadow the Canadian opportunity. How is Cipher preparing to address these concerns and reassure stakeholders about the product's potential success in Canada?

8. Preparation for 2026 Launch: Given the long lead time before the anticipated 2026 launch, what steps is Cipher taking now to ensure a successful entry into the Canadian market? Are there any interim milestones or strategic partnerships you are pursuing to build market presence before then?

9. Integration of ParaPRO's Natroba Operations: With the acquisition of ParaPRO’s Natroba assets now in full swing, how is the integration progressing, and how does it derisk the company? Will this shift in focus allow Cipher to balance its reliance on the potential of MOB-015 with its other business lines/legacy products?