Brief Healthcare: Biosimilar Battlefield: Unpacking Celltrion and more

In this briefing:

1. Biosimilar Battlefield: Unpacking Celltrion
2. Amarin Q4 2018 Conference Call–Strong Sales & High Confidence
3. CStone Pharma (基石药业) Post-IPO: Strong Debut but Lacks near Term Catalysts
4. HK Connect Discovery Weekly: Geely, Great Wall Motor and Sands China (2019-02-22)
5. Celltrion Healthcare: Well, We Were Warned

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

3. CStone Pharma (基石药业) Post-IPO: Strong Debut but Lacks near Term Catalysts

CStone Pharma’s IPO was priced at HKD 12.00/share and started trading today. In this insight, we summarize the allocation, the use of proceeds and recap our view on our valuation. We also look at past few biotech listings and discuss our thoughts on the market sentiments. We are of the view that despite a strong debut performance, CStone lacks near term catalysts that can continue to drive performance after the first day. 

Our Previous Coverage of CStone

• CStone Pharma (基石药业) IPO: Strong Assembly and Backing (Part 1)
• CStone Pharma (基石药业) IPO: Thoughts on Valuation (Part 2)

4. HK Connect Discovery Weekly: Geely, Great Wall Motor and Sands China (2019-02-22)

In our Discover HK Connect series, we aim to help our investors understand the flow of southbound trades via the Hong Kong Connect, as analyzed by our proprietary data engine. We will discuss the stocks that experienced the most inflow and outflow by mainland investors in the past seven days.

We split the stocks eligible for the Hong Kong Connect trade into three groups: component stocks in the HSCEI index, stocks with a market capitalization between USD 1 billion and USD 5 billion, and stocks with a market capitalization between USD 500 million and USD 1 billion.

In this week’s HK Connect Discovery, we highlight the strong inflow to automobile stocks and Sands China. 

5. Celltrion Healthcare: Well, We Were Warned

Celltrion Healthcare (091990 KS) reported preliminary 2018 results that were dramatically short of expectations as the company cut shipments to reduce distributors’ inventories. Management had announced plans to shift to a direct sales model to get better control over pricing decisions, but the magnitude of Q4’s shortfall (94% decline in revenue) raises questions about the role of “channel stuffing” in boosting prior periods’ results. In addition, we expect some spillover effect on Celltrion Inc (068270 KS)‘s Q4’s results. This Insight discusses the results in brief and contrasts Celltrion Healthcare’s results with those of Samsung Bioepis. 

We continue to avoid these stocks.