In this briefing:
- Biosimilar Battlefield: Unpacking Celltrion
- Amarin Q4 2018 Conference Call–Strong Sales & High Confidence
1. Biosimilar Battlefield: Unpacking Celltrion
Both Celltrion Inc (068270 KS) and Celltrion Healthcare (091990 KS) have reported preliminary 2018 results with some MD&A. As suspected, Q4’s results for both companies reflected factors beyond distributors’ destocking: retroactive price adjustments played a major role. This Insight includes updated end market sales forecasts by product. Remsima should grow in the US and decline moderately in the EU (the latter is a best-case scenario). Both Herzuma and Truxima will launch in the US this year with Truxima the largest contributor. Capacity expansion programs should keep margins under pressure near-term.
2. Amarin Q4 2018 Conference Call–Strong Sales & High Confidence
Q4 2018 Revenues Stronger Than Pre-Announcement on January 4th: Amarin released its Q4 2018 results today and held a conference call. Results of $77m in sales (+44% YoY), were stronger than the January 4th pre-announced range of $72m and $76m. 2019 revenue guidance of 50% growth to $350m was left unchanged, but management sounded very confident on the conference call (see details below).
Q1 2019 Revenue Growth Appears Stronger than Expected: On the conference call, Amarin was asked whether Q1 revenues were tracking the prescription data, which indicates +50% YoY growth so far. Management said that sales looked about the same, despite revenues tending not to track prescriptions that closely in Q1 normally.
FDA May Fast-Track Vascepa Label Expansion: While Amarin’s CEO, John Thero, is usually very conservative with guidance, today he explored the possibilities of fast-track treatment by the FDA for Vascepa’s label expansion for the first time. Amarin is still on course to file for this with the FDA by March-end. Fast-track treatment by the FDA would speed up the approval process to 6 months, versus 10 months, and if favorable, could have significant upside impact on 2019 revenues.
Approval for Vascepa in Europe to be Sought This Year: Amarin disclosed for the first time that it would seek approval for Vascepa in Europe this year. This is highly significant because the cardiovascular disease (CVD) patient population is 22% higher than the US. Amarin confirmed that FDA approval for label expansion would speed up the approval process in Europe.
Next Catalyst is the ACC Conference on March 18th: Amarin will be announcing “late-breaking” data from the Reduce-It clinical trial at the American College of Cardiology on March 18th. Because the Reduce-It trial results themselves were so powerful, we expect the ACC event to be of high interest among CVD specialists and investors.
Amarin Remains an Attractive Take-Over Candidate: Given the high efficacy of Vascepa in the treatment of CVD patients, Amarin continues to be one of the most highly attractive take-over candidates in the pharmaceutical world. Management’s confidence on today’s call appears to be linked to a stronger than expected response to Vascepa among doctors since its block-buster trial results were announced last September. For details about our outlook on Amarin, please refer to our deep-dive report published last month: Amarin–2019’s Biggest Buyout Target for Big Pharma
Get Straight to the Source on Smartkarma
Smartkarma supports the world’s leading investors with high-quality, timely, and actionable Insights. Subscribe now for unlimited access, or request a demo below.
