• Lack of benefit from acquisitions
• Share loss
That said, Cardiac Surgery also accounts for only a small fraction of EPS, with single-digit operating
margins in most year, largely driven by higher SG&A costs. In 2019 EPS was $3.08, of which I estimate
Cardiac to be about 50c or 16-17%.
Neuromodulation (~40% of revenue)
Neuromodulation, on the other hand, is much more exciting at LIVN. The business came from the
combination of Sorin and Cyberonics in 2015 which included these assets.
LIVN’s core neuromodulation product is vagus nerve stimulation (VNS) therapy, which involves
implanting a small device with a lead that attaches to the vagus nerve on your spine. Using small
electrical shocks, VNS therapy stimulates the nerve, generating a variety of effects. The therapy has
been used since the prior decade for treatment-resistant epilepsy. After an epileptic patient has tried 4-
5 drugs, they are able to be put on VNS therapy, either separately or in addition to the drugs for an
incremental effect. The results of the therapy are well-understood and this has been a high-growth
business for LIVN. The product itself generates high gross margins at a $32k price point (25k device, 7k
for the leads). The segment as a whole has reached operating margins as high as 50% in previous years.
There is also platform potential for LIVN’s therapy. In 2005, researchers, noticed that patients
experience better moods on the therapy, ultimately leading to a trial for treatment-resistant depression
(TRD). The results were strong enough for an FDA approval, but CMS refused to cover the therapy since
the trial that was done to show data was not a randomized, controlled trial. As such, very few patients
ever got VNS for TRD.
That changed in 2018 when after a long-term study (still not randomized controlled but against
treatment-as-usual) was released, as well as a quality of life analysis showing that incremental
improvements from the therapy made a different, even if clinically they weren’t considered that
significant. CMS agreed to revisit its non-coverage decision, and eventually demanded an RCT (CMS
covers the trial implants) with a transition to a registry (therapy is covered outside trial with follow-up
data required). The key difference with an RCT is that the control group is getting sham therapy instead
of treatment at all, implying that results for those patients are likely to be much worse (which bodes
well for the VNS study) unless a placebo can last 1+ years. This trial is currently underway and LIVN is
expecting a transition to a registry in 2022.
TRD is a huge opportunity for LIVN. Roughly 7% of the US population has clinical-grade depression, and
anywhere from 10-33% of these are determined to be drug-resistant. At the low end, this could mean a
target population of 1.6M patients, which implies a revenue opportunity around $48 billion. LIVN is also
examining VNS’s effects in heart failure patients, which several neuromodulation companies are also
trying to do with different nerves (CVRx is one such company which targets the carotid baroreceptor
with a similar device).