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AVINGER (AVGR)

A medical device expert friend wrote: "What Avinger is going after is one  of the holy grails of cardiovascular disease management."

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Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com

AVGR UPDATE  23 MAY 2020

AVGR

Corona hurt Avinger a lot, but as the world goes back to normal, Avinger's sales should ramp up. This week AVGR filed a 510(k) with FDA for pre-marketing clearance of Ocelaris, a next generation chronic total occlusion (CTO) crossing system utilizing Avinger's proprietary image-guided technology platform.

Very interesting science. Dr. Joe turned me on to AVGR. He also owes shares. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography.

I've spoken to AVGR's CFO. They're a very committed management team and are regularly buying shares in the open market.

Latest PR: https://finance.yahoo.com/news/avinger-announces-510-k-filing-123000751.html

MNLO

MNLO fair price using pre-merger metric:

If you held 100 shares of FOMX per-merger, and your cost basis was 4.30, today you own 180 shares and your cost basis is 2.40.

  • So 4.30 pre-merger = 2.40 today
  • and 4.50 = 2.50
  • and 4.10 = 2.28

Now, analyst average target for FOMX was $13.

Nothing has changed in the equation as far as I can see: MNLO's trials failed. FOMX got MNLO's cash and US footprint. So that $13 target is still valid. Translate that to post merger level (*.50 and +1.205...) that $13 = $7.24. However, Cowan upped that to $10. Today's price: 2.24. I think even a first grader can see MNLO is VERY VERY UNDERVALUED.

Also see new article: https://seekingalpha.com/article/4349547-should-fda-approve-menlo-therapeutics-latest-therapy-shares-should-well

ADXS

ADXS has a very advanced cancer treatment that extends the efficacy of the most widely used cancer drug (Merck's Keytruda). Dr. Joe turned me on to ADXS and he also owns shares. If the next couple of patients show the same positive response as the last two, ADXS's stock should do very well.

Latest PR: https://finance.yahoo.com/news/advaxis-announces-updated-positive-clinical-120010526.html




ARNA

ARNA is cooking. CEO Amit Munshi just cashed in around $3.5 million of stock options. Stock has gone to upper 50's due to a number of reasons including failure of competitor drug.


This is not an investment advice. Do your own research.

Best Regards

Reza Ganjavi

UPDATE 3 Feb 2020  TALK WITH CFO, MARK WEINSWIG

DISCLAIMER: This is not an investment advice -- just sharing my impressions and my research. Do your own research. Consult a professional investment advisor for advice. The statements below are NOT Avinger's -- they're based on notes I took, and my opinions and impressions, and may be inaccurate.  You can check out their website if you want to learn more about the technology : www.avinger.com

QUICK IMPRESSIONS

I enjoyed talking with Mark Weinswig, CFO of Avinger (AVGR). He sounded genuine, honest and competent. I like his background: Aside from being a CFO he was a equity research analyst, CPA, CFA, and has an MBA.

Also look at the 5 year chart. They were like $10,000 a share. Now 60 cents!! What happened? They were high flyers but the device had an issue so the stock tanked. They've fixed the device, brought new generation ones to the market, and new devices and area developing also.

Management buys company stock in open market - no discount - $25000 a year, each of them. The CFO owns over 80,000 shares.  He seems really decent and I liked what I heard.  They're laser focused on growing revenue, client based, gradually number of sales reps etc. - this is a specialized field with a special approach: the rep participates in each procedure on patients and makes a sale with each.

Other companies in this space traditionally make around 800k revenue per year per rep. AVGR is making 450k/year but it's because they're ramping up and new product went to market last quarter. Q4 earnings should be in March. Any traction can move the stock. The float is very small. They have a good IR guy (external) - responsive, knowledgeable. However, I'm a big fan of internal / dedicated IR when a company can afford it. CFO is big on cost control. I walked away from the call feeling good about my investment and comfortable to hold and give it time. Average analyst target is 5 times current price.

MORE DETAILED NOTES FROM THE CALL

  • Company does not provide guidance. The $12m revenue in 2020 is an analyst projection. Company states drivers of revenue and growth as listed in the corporate presentation.
    • Drive Utilization
    • Open New Markets
    • Launch New Devices
    • Expand Salesforce
    • Advance Clinical Data
  • It's industry standard practice to be present in every procedure. CSI has 200 people in the field. Avinger doesn't have a lot of products -- it's a pure play. Larger companies sell balloons etc. as well. It means a higher burn rate because the sales force is there but not a lot of other products to sell.
    • The company has the objective to significantly improve revenue per rep by addressing the opportunities.
    • Goal is increasing shareholder value.
    • They are very focused on increasing their product portfolio through a variety of means -- for products that can be bundled and offered to the same call points.
  • Company sells a solution including a console and various disposable products. Company's reps get engaged in supporting the doctors in the procedures and at the end, sell the disposable unit used.
    • Each procedure takes less than an hour. A vascular surgeon may do for example 5 procedures in a given day.
    • Depending on the type of blockage the doctor determines which company's tool he will use, and which product.
    • QUESTION: what is your competitive advantage? why would a doctor chose your product over another company's?
      • Avinger offers what we believe to be superior clinical outcomes through its intravascular guided atherectomy devices, resulting in higher luminal gain, reduced disruption of the adventitia and lower TLR / restenosis incidence in patient cases. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
    • Our salesrep gets the device going. The doctor performs the procedure with help from Avinger person.
    • The device is sold in advance of the procedure. After the procedure there's an automatic re-order of the device which costs about $2000 to $3000. 
    • In majority of cases doctors want a rep in the room with them. It's always been like this for every company in this industry. The reason for this is not clear, it's just been that way, so the doctors are expecting it.  If your person is not there, you can can lose the sale.
    • As of September they had 28 sales positions in the US: 1 VP, 3 regional sales directors, 14 territory sales and 10 clinical clinical specialists. International sales are by way of 1 sales VP and distributors.
    • Sometimes patients don't show up, sometimes doctor chooses another product because of the type of lesion (Avinger focus is not on highly calcified lesions). Out of 5 cases, we could get 1 or 5 or 3 -- so it makes it difficult to predict sales.
  • Revenue per rep is $450,000 per rep per year. In larger companies a rep could do $800,000 / year.
    • Company introduced a new product last year. This year applying for FDA clearance for new device. Etc.
    • Company is working on increasing number of hospitals that use its technology so as to more fully utilize each rep and increase average revenue per sales position.
  • As of last quarterly report + recent raise , $18.5m cash -- they don't want to raise money all the time -- they want to have enough capital to invest on a number of things, e.g., R&D -- 1 product this year, 1 new product next year (a smaller cheaper, portable version of the console). Three current clinical programs, to help the sales, get new indications from FDA, boost doctor confidence, better demonstrate efficacy and safety, show how Avinger device is better than competing technology. Multiple studies are ongoing. Each study takes less than 1.5 years to complete. 
    • Where can these studies be seen on the website? Answer: on the company presentation and SEC filing [that's not adequate -- why not have a section on the website listing your studies?!].  Company noted:
      • This is not entirely correct. The Healthcare Professionals link on the site has case studies and summaries of the key clinical data. More complete data is provided as part of the sales process to new accounts, as is standard in the industry. For investors, we typically refer them to the slides, PRs and SEC filing data as those sources are easy and familiar to those audiences.
        • My note: Noted, however, I disagree. You guys are too technical, and seem to lose sight of "macro" level to quote yourself. You can't expect all investors to be techies. They need things rolled up for them in a high level (and honest) presentation / phrasing, and the main go-to place is the website which is terrible. Your website needs to be totally redone, including the entire navigation / interface as well as organization. I sent Matt a note on this already. Doing the right things is not enough. History is full of great products that failed because of poor management / promotion. AVGR is an investment product. The website is the brochure, and it's a disaster, from the moment you try to navigate it , to the verbiage , to the organization.
  • YESTERDAY & TODAY: Company was a high flyer, spending some 14m / quarter, stock about $10,000 / share. Its device had an issue, it went into lab, revenues dropped significantly, but the device problems were resolved, and turn-around started. New product introduced, expenses down to a quarter of what they were, sales up 20% year over year on quarterly basis, new products being introduced. While there's more work ahead to complete this turnaround, the company seems to be on the right path to make that happen.
    • 2015 had huge first year in revenue growth. Had 66 sales reps.
    • 2016, device had issues.
    • 2017, company restructured, went back in the lab. Revenue fell 65%
    • 2018, Pantheris Next Gen product announced. Revenue has been increasing.
    • 2019, Pantheris SV (second new product) announced (below knee). Third new product, Ocelaris (third new product), received CE marking, targeted for FDA announcement in 2020.
    • Going forward, continue strategic plan to grow, and keep expenses low.
    • Sales headcount has gone up 30%. 7 news customers in 3Q2019 (biggest growth in number of hospitals per quarter).
    • European sales should ramp.
    • 2020 is a pivotal year with lots of milestones.
    • Plan is to increase sales headcount gradually (around 5 to 8 per year).
  • Because of the market cap, many institutions cannot buy the stock. So the majority of shareholders are retail. As the turnaround happens, and financials improve, with proper, effective, active investor relations efforts, the market cap should grow, and more institutions come on board. Lots of investors know Avinger from 2015. No reason for the company to not be promoting itself more actively to past and prospective investors.
  • They have 8.6m debt, due by 2023. It's by a strategic partner. A Board observer. They own a lot of equity. They're a partner which helps the company with finding clients etc. etc., and have restructured the debt before. The interest rate is 12.5%.
  • The Preferred stock is held by the same person who holds the debt. They own equivalent of 2.2m shares of stock.
  • The company does not charge insurance companies or Medicare. They bill the hospitals. A procedure gets reimbursed for $10k to $16k.
  • Company realizes that some longer-term investors are upset and are determined to improve the business to increase shareholder value and turnaround shareholder sentiments in the process.
  • Management buys shares every other week in a non-discounted stock purchase plan, in the open market ($25,000 per year each person). Form 4s are released.
  • With the anticipated release of the new device in 2020, assuming 510k clearance, the company will have launched 3 new devices (totally refreshed the product line). This allows them to do the sales calls with all new products/technologies and a more comprehensive solution to address more potential patient cases.
  • 2020 goals: Release new devicel; Complete additional clinical trials, Grow sales force and revenue, Make progress on the new Lightbox.
  • Stock was down under a dollar in September but it bounced back to over a dollar by itself due to progress. Company is optimistic executing to plan will reflect positively on the stock.

References:  Company Website

Reference: Corporate Presentation

References:  Company Fact Sheet




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