- New technologies in diagnostics and tools are driving growth: NexGen sequencing, molecular and “point-of-care” testing platforms and veterinary testing.
- M&A and consolidation should continue.
- The sector is a laggard due to slowing sales and earnings growth vs forecasts.
Rayno Clinical Diagnostics Portfolio Update
We initiated coverage of Clinical Diagnostic and Life Science Tools stocks in 2009 with five stocks :
Abaxis (ABAX), Alere (ALR), GenProbe, now owned by Hologic (HOLX), Illumina (ILMN) and Sequenom (SQNM). Since then we added several stocks, dropped a few, but kept most of our picks on the focus list. Despite all the volatility in the market holding positions over the long-term has been the best portfolio strategy. Several of our companies were acquired. Keep in mind that this sector has experienced slower growth and is more dependent on M&A and new technology. Most of these stocks are off their highs and down YTD.
The hot stock sector in the life sciences is biopharmaceuticals and clinical diagnostic stocks are lagging for several reasons:
- Sales growth is slowing except for the hot DNA sequencing and genetic testing markets.
- Overall market growth for most routine clinical diagnostic tests is slowing at 3% but molecular and genetic diagnostic tests are growing at 11%.
- Reimbursement is tight with little pricing power.
- Competition is increasing even in molecular assays with overlapping test menus.
- Valuations are on the high side by Price/Sales, PE and PEG measures.
- Many small cap emerging companies still do not have reliable earnings but revenue growth is expected from new products.
Stocks that outperformed over one year are in breakthrough technologies like DNA sequencing JPMorgan On Next Gen Sequencing 1/19/15 or have hot products/platforms (ABAX) or are acquirers (TMO) and consolidators.
- Alere (ALR) was a “value play” with a ‘roll-up” strategy but now will undergo restructuring.
- Hologic (HOLX) and Thermofisher (TMO) are doing well with great strategies and acquisitions.
- Exact Sciences (EXAS) has done well with anticipation of the “roll-out” of its DNA screening test for colo-rectal cancer.
For review here is a summary of 2014 Rayno Diagnostics and Tools with winners and key points.
Based upon prices as of 6/10/15 here are the top winners YTD in the portfolio :
- Foundation Medicine, Inc.(FMI) Up 58.8%
- Hologic, Inc. (HOLX) Up 38.8%
- Alere, Inc. (ALR) Up 32.3%
- Illumina, Inc. (ILMN) Up 16.8%
- Vermillion, Inc. (VRML) Up 12.6%
- Benchmark (IWO) Russell 2000 Growth Up 9% YTD
There are plenty of losers-see chart below.
The drivers for future stock appreciation continue to be new products, new technology like DNA sequencing and molecular tests and M&A. We have written extensively on sequencing plays which is still the only near term product theme in the sector. A few of the growth companies have stalled due to marketplace changes and slowing product sales. Nonetheless the emergence of molecular medicine and need for biomarkers will bring more clinical diagnostic opportunities. Synergies with biopharmaceuticals offer a growth path with companion diagnostics and biomarkers that target therapy.
Currency was an issue with some companies that have a global presence as we saw with Q1 revenues. This will be a significant headwind going forward as the dollar is forecasted to remain strong. Here is our March 2015 Update- Rayno Diagnostics and Tools post on the sector.
Here are a few companies not on our focus list that are potential emerging growth stocks. We mentioned two in the past Accelerate Diagnostics (AXDX) Inc. (AXDX) and Genmark Diagnostics, Inc. (GNMK). Two companies that recently went public are Invitae (NVTA), a genetic testing Company and more recently HT Molecular Diagnostics, Inc. (HTGM) an NGS platform for tumor profiling with a platform technology utilizing a reduced sample size. We will track these technology platform players for revenue growth.
A good source of detailed news and data on the diagnostics industry see IVDNews-Clinical Dx Info Services provided by McGrath & Associates, Inc.
Stock summary: Despite recent earnings shortfalls there are plenty of opportunities ahead for the sector. Molecular medicine and synergies between targeted therapies and companion diagnostics are one example. The explosion in genomics will migrate to the consumer level and genetic testing is already on a growth path.
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