Technology

Pulmonx: FDA Accepted Expertise However Adoption Points (NASDAQ:LUNG)

Pulmonologist doctor, lungs specialist. Aesthetic handdrawn highlighted illustration of human lings. Neutral grey background, studio photo and collage.

mi-viri/iStock by way of Getty Photographs

The most effective factor to do throughout an fairness bear market is to not hand over and stick to one’s analysis course of in looking for the leaders of the following bull market. For that purpose, I’ve been spending numerous time researching new and attention-grabbing corporations, to attempt to discover the following Google (GOOG) (GOOGL) or Intuitive Surgical (ISRG).

Whereas Pulmonx Company (NASDAQ:LUNG) does have an attention-grabbing know-how treating an underserved medical situation, I believe the enterprise is struggling to ramp up adoption for its Zephyr Valves know-how and traders are finest served to attend on the sidelines.

Introduction To Pulmonx

Pulmonx Company is a industrial stage medical system firm that sells the Zephyr Endobronchial Valve and related screening and administration software program. The Zephyr Valve is a minimally invasive remedy for sufferers with extreme emphysema, a type of power obstructive pulmonary illness (COPD). Pulmonx estimates its resolution is appropriate for 1.2 million sufferers world wide, representing a $12 billion market alternative.

Zephyr Valves have been clinically confirmed to alleviate affected person signs, with over 100 scientific articles revealed within the New England Journal of Medication, The Lancet, and the American Journal of Respiratory and Crucial Care Medication.

Pulmonx acquired FDA approval in 2018 for its Zephyr Valve know-how and launched industrial manufacturing shortly afterwards. So far, over 100,000 valves have been used to deal with 25,000 sufferers. Zephyr Valves are commercially out there in over 25 nations and have been included in COPD remedy pointers worldwide (Determine 1).

slide depicting Zephyr availability

Determine 1 – Zephyr Valves out there in 25 nations (Pulmonx investor presentation)

What Is Emphysema?

Emphysema, a type of COPD, is a debilitation lung situation characterised by the affected person’s shortness of breath. Emphysema progressively destroys lung tissue and reduces a affected person’s capacity to breath and interact in primary each day actions. Globally, it’s estimated that 175 million sufferers undergo from COPD as of 2015, and a couple of quarter of them is because of emphysema.

In sufferers with emphysema, the air sacs within the lungs are broken. Over time, the internal partitions of the air sacs weaken and rupture – creating bigger air areas as a substitute of many small ones (Determine 2 reveals wholesome vs. emphysema lung tissue). The diseased areas of the lung develop into over-inflated and crowd out the more healthy tissue. This reduces the floor space of the lungs and the quantity of oxygen that reaches the bloodstream.

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Determine 2 – Wholesome vs. emphysema lung tissue (Pulmonx 2021 10K)

The lung harm from emphysema is irreversible. Remedy for emphysema normally begins with remedy to scale back irritation and airway obstruction however doesn’t handle the underlying lung tissue harm. Because the illness progresses, sufferers could also be prescribed supplemental oxygen and pulmonary rehabilitation workout routines. In extreme circumstances, sufferers could require lung transplants or lung quantity discount surgical procedure (LVRS) to alleviate their breathlessness. These invasive surgical procedures contain excessive threat of issues, lengthy hospital stays, and excessive threat of demise (Determine 3).

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Determine 3 – Remedy choices for Emphysema (Pulmonx investor presentation)

The Pulmonx Zephyr Valve is designed to supply bronchoscopic lung quantity discount with out invasive surgical procedure and its related dangers. Throughout a minimally invasive bronchoscopic process that usually lasts just one hour, Zephyr valves are positioned in airways to shut off essentially the most diseased components of the lung which have develop into hyperinflated. Trapped air is allowed to flee, which shrinks the diseased lung tissue. This enables more healthy components of the lung to develop and soak up extra air. Sufferers who’ve acquired the Zephyr Valve report improved respiratory and the higher high quality of life.

Sizeable Market Alternative

Pulmonx believes that of the worldwide inhabitants of COPD sufferers, roughly 8.5 million have extreme COPD and three.2 million have extreme emphysema. Of that 3.2 million extreme emphysema inhabitants, Pulmonx believes 1.2 million (500k within the US, 700k worldwide) would high quality for Zephyr Valves, representing a $12 billion market alternative.

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Determine 4 – Zephyr market alternative (Pulmonx investor presentation)

Pulmonx IPO and Worth Motion

Primarily based on the promising know-how and sizeable market alternative, Pulmonx accomplished a profitable IPO in 2020. Initially, the corporate needed to lift $86 million in recent capital at $13 per share. Nevertheless, as a consequence of robust demand, the corporate raised $190 million as a substitute by issuing 10 million shares at $19 a share. The inventory opened at $40 on day 1, and shortly galloped to nearly $70 a share (Determine 5). Nevertheless, Pulmonx, together with different speculative equities, quickly cooled off. From the height in January 2021, LUNG has steadily declined by nearly 80%.

stock price chart of LUNG

Determine 5 – Pulmonx inventory chart (writer created with value chart from stockcharts.com)

Gross sales Traction Curtailed From COVID-19

The primary difficulty with the Pulmonx story is that its gross sales ramp-up failed to achieve important traction as gross sales have been impacted by the COVID-19 pandemic. Determine 6 reveals quarterly US and Worldwide revenues for Pulmonx.

bar chart of sales data

Determine 6 – Quarterly gross sales for Pulmonx (writer created from information offered by Pulmonx 10Q and S1)

In reality, when COVID-19 initially appeared, Pulmonx noticed a 55% YoY lower in models bought in Q2/2020. As hospitals have been speeding to deal with sufferers with COVID-19, many elective surgical procedures resembling Pulmonx’s Zephyr Valves have been delayed. Furthermore, the pandemic additionally severely impacted the corporate’s capacity to draw and practice surgeons on the Zephyr Valves remedy.

Though COVID-19 has develop into much less of a difficulty, it continues to have a unfavourable influence, with administration commenting within the newest Q1-2022 quarterly that…

“…COVID shut us down for roughly half of the primary quarter.”

– Quote from Glendon French, CEO, throughout Q1/2022 earnings name

For the total yr, administration solely guided to $55 to 60 million in prime line revenues, a modest 13-24% YoY progress fee that isn’t typical for an rising know-how assembly robust affected person demand.

Monetary Mannequin Challenged

Whereas the gross sales ramp up has been disappointing, the corporate has not slowed down its infrastructure buildout. Pulmonx grew SG&A 26% YoY within the newest quarter, far above the 17% income progress. In reality, administration expects full yr bills of $100-105 million, a 23% progress fee YoY on the midpoint.

The online result’s that the corporate isn’t anticipated to interrupt even within the close to time period. Even when we assume working bills have been to be held fixed at $24 million (Q1/2022 ranges), income should develop to $131 million to interrupt even, assuming a secure 75% gross margin. Except Pulmonx can obtain a step change in its gross sales adoption curve, the corporate is extremely unlikely to interrupt even in 2023 both.

Valuation

How ought to we take into consideration a rising firm however struggling to interrupt even? Pulmonx at present has a market cap of $570 million, with $20 million in debt and $170 million in money. This provides an enterprise worth of $420 million. On the midpoint of steerage, this interprets to 7.3x EV/Income.

The next is a presentation I discovered on valuation multiples for the medical units trade from Cogent Valuations, a valuation and monetary advisory specialist agency.

table of valuations

Determine 7 – Valuation multiples for medical units trade (Cogent Valuations)

Whereas the information is a little bit dated as it’s from Q2/2021, I believe it’s nonetheless very helpful. As we are able to see from the determine, EV/Revenues for the trade peaked at 5.0x in Q1/2021, principally the time when Pulmonx’s valuation additionally peaked at $2.5 billion. Since Pulmonx’s present valuation a number of of seven.3x is increased than the height trade median a number of of 5.0x, I believe Pulmonx’s shares are nonetheless too richly valued.

Insiders Agree With My Evaluation?

Insiders seem to agree with my evaluation that the inventory value is overvalued. Over the previous two years, insiders, from the administrators to C-level executives, have bought a collective $194.6 million in shares. The CEO has personally bought $13.4 million in inventory, together with his most up-to-date sale on June 1st.

summary table of insider sales

Determine 8 – Pulmonx insider gross sales (writer created with information from dataroma.com)

Key Dangers

Competitors

One of many key threat to the Pulmonx story is competitors. Whereas the corporate claims its Zephyr Valves are a novel remedy for extreme emphysema, they do point out that there are different therapies and units available on the market competing with Zephyr.

The closest competitor is the Spiration Valve (Determine 9) from Olympus Medical. A quick examination of the know-how reveals that the 2 units are very comparable and performs primarily the identical perform. Each valves are implanted utilizing a versatile bronchoscope and occludes the broken airways whereas permitting trapped air to go by means of. Even their info movies are almost equivalent (Determine 9 vs. Determine 10).

screenshot of spiration valve

Determine 9 – screenshot of Spiration Valve process (Olympus Medical)

Zephyr valve procedure

Determine 10 – Zephyr Valve process (Pulmonx)

The issue for Zephyr is that Olympus Medical is a part of Olympus Corp. (OTCPK:OCPNY), a $25 billion Japanese conglomerate with much more monetary assets and sells an entire suite of medical gear along with the endo-bronchial valves.

Endemic COVID-19 Could Proceed To Disrupt Adoption

One other threat is that because the COVID-19 pandemic turns into endemic, it periodically flares up and causes sufferers to keep away from elective surgical procedures. Some scientists warn of additional mutations and outbreaks because the western world enters fall this yr.

Furthermore, it’s clinically proven that sufferers with COPD have a a lot increased mortality fee from COVID-19 (15% vs. 4%). So sadly, repeated outbreaks of COVID-19 could dramatically cut back the affected person inhabitants of these with extreme emphysema.

Pulmonx May Be Offered

One upside threat to my evaluation is that it makes far more strategic sense for the Zephyr Valve to be half of a bigger medical units firm like Olympus. It does not make strategic sense for a devoted gross sales drive promoting a single product. In order Pulmonx’s valuation continues to lower, it turns into more and more probably a bigger firm snaps it up and places the Zephyr valve into its product portfolio.

Conclusion

Whereas Pulmonx has a really attention-grabbing valve know-how to deal with extreme emphysema, I believe it’s nonetheless too richly valued relative to the demonstrated progress fee. I’m additionally involved that its product isn’t materially totally different from the Spiration Valve bought by Olympus Medical, an organization backed by a a lot bigger conglomerate with a collection of medical merchandise to promote/bundle. Lastly, I don’t like the truth that insiders have been constantly dumping inventory. I’d fairly take a wait and see strategy with Pulmonx.

One potential upside is that it makes far more strategic sense for Zephyr Valve to be a part of another firm’s portfolio, so a sale might be sooner or later.

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