Source: Streetwise Reports   04/27/2020

Avadel Pharmaceuticals' shares traded 25% higher reaching a new 52-week high price after the company reported positive topline results from its Pivotal Phase 3 REST-ON trial of FT218 for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients.

Avadel Pharmaceuticals Plc (AVDL:NASDAQ) today announced "positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy." The firm pointed out that it met all three of the co-primary efficacy endpoints in the study for each of three dosage levels which it claims demonstrates "highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks."

The company's Chief Medical Officer Jordan Dubow, M.D., commented, "We are excited to see these positive topline data from the REST-ON study, where all three dose levels of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo...Once-nightly FT218 delivered a clinically meaningful response within three weeks of treatment initiation, which was sustained through each treatment period...We think once-nightly FT218, if approved, has the potential to be a meaningful contributor to patient care."

Avadel Pharma's CEO Greg Divis remarked, "The successful outcome of the REST-ON study strengthens our belief that, if approved, once-nightly FT218 has the potential to be a significant advancement for patients in the estimated $1.7 billion twice-nightly sodium oxybate market. Our proprietary market research with physicians and patients informs us that there is a strong interest in a once-nightly sodium oxybate formulation. We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy."

The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel's proprietary Micropump technology for extended-release oral suspension in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The company stated that 212 patients were enrolled in the study and result "showed that the 9 g dose of once-nightly FT218 demonstrated a highly significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints."

The company advised that FT218 has been granted Orphan Drug Designation from the U.S. FDA for the treatment of narcolepsy. The firm added that the designation was granted on basis that FT218 may be clinically superior to a formulation of sodium oxybate that is already approved by the FDA for the same indication.

Avadel Pharmaceuticals is biopharmaceutical company headquartered in Dublin, Ireland. The company's primary focus is on the development and potential FDA approval for FT218, which just completed its Phase 3 REST-ON clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. The firm also develops and markets sterile injectable drugs for use in hospital settings.

Avadel started off the day with a market capitalization of around $456.2 million with approximately 46.4 million shares outstanding and a short interest of about 14.00%. AVDL shares opened more than 34% higher today at $13.30 (+$3.37, +34.28%) over Friday's $9.83 closing price and reached a new 52-week high price this morning of $13.49. The stock has traded today between $11.90 and $13.49 per share and is currently trading at $12.27 (+$2.44 +24.82%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
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5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
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( Companies Mentioned: AVDL:NASDAQ, )

Source: Keith Schaefer for Streetwise Reports   04/28/2020

With telehealth becoming a rising star in the coronavirus era, Keith Schaefer discusses why one company rapidly expanding in Canada stands out.

An entirely new—and highly profitable—industry is being borne out in 2020—TeleHealth.

CloudMD Software & Services Inc. (DOC:CSE; DOCRF:OTCQB; 6PH:FSE) is my favorite way to play teleHealth. It's growing quickly with over 100,000 patients registered on its app and over 3000 doctors in 8 provinces in its Electronic Medical Records—EMR—system. It has MULTIPLE revenue streams and it just moved into Canada's largest market—Ontario—setting up an even faster growth rate.

The recent spread of coronavirus is only accelerating this. COVID-19 has forever changed how we all will think about visiting a hospital or seeing our doctor. We really don't want to do that at all, if possible. It will have a very positive and long lasting impact on teleHealth.

teleHealth companies in Canada are getting paid more money for services than bricks-and-mortar clinics, and have a fraction of the costs. Doctors want more of it, patients want more of it, government wants more of it—and the Market REALLY wants more of it. Everybody wins here; there is no downside.

The rapid scale-up and profitability is key for investors.

The stock market is now recognizing this trend—in spades. You can see it in the stock chart of the U.S. leader in teleHealth, Teladoc Health Inc. (TDOC:NYSE).

While the market plummeted Teladoc's business and share price soared.

Now that a firm trend is in place—and teleHealth is one that makes a lot of sense—I'm looking for the junior with the best leverage to this new long term trade.

CloudMD is established, growing quickly and trading at a fraction of its peers.

The average multiple of competitors in the sector trade at 5-7x revenue, and CloudMD is trading way below that at 2.5x per revenue. I'll have more on those comps in a moment.

But realize that the Canadian use of telemedicine is still just a fraction of where it is in the U.S—so the quick, early upside is even bigger.

Literally the Canadian Version of Teladoc Health

The story with this stock is very simple. CloudMD is literally the Canadian version of Teladoc Health—just at an earlier stage in the growth curve.

The market desperately wants to own teleHealth right now (see also the stock charts of LVGO-NASD and CATS-NASD). I see CloudMD as the best way to do that in the junior sector (where the leverage is!).

For this stock to have a major run all that needs to happen is for institutional investors to wake up to the fact that the company exists. That's happening now with the company entering the province of Ontario—which has 14.5 million people, over one-third of Canada's population.

CloudMD is a fully integrated health care company—kind of like a hospital-in-the-sky. They do have five bricks-and-mortar clinics, but they also own their own EMR—Electronic Medical Records—system that operates in eight provinces and is used by over 3,000 doctors and is supported by an in-house 25 person development team. They have their own CloudMD app—which has over 100,000 registered patients already.

Folks, we really are in front of the institutions on this one. I don't have room in this article to even talk to you about the depth and credibility of CEO Dr. Essam Hamza, but after several conversations with him I can say that shareholders are in very good hands.

The EMR gives CloudMD a recurring monthly revenue stream, which The Street loves. The app gives them high margin fees from doctors, specialists and groups like massage therapists and counselors. These people are revenue, not costs. As I said, full hospital-in-the-sky. Multiple revenue sources with lower costs.

To schedule a virtual doctor's appointment all that a patient has to do is download the free CloudMD app and then arrange an appointment with one of the doctors. There is zero charge for the patient and they can see a doctor very quickly.

CloudMD can scale up the number of patients VERY quickly—and they are.

Every aspect of healthcare that's very fractured and disjointed will now be in the one CloudMD ecosystem.

Everyone wins with this system. Patients, doctors, the medical system, society, even investors. Everyone.

TeleHealth Is MUCH More Profitable Than Clinics

Doctors who have signed up with CloudMD work remotely from home or wherever they are (like their winter home down south). The rapid scale-up potential excites me. CloudMD can add in unlimited number of doctors and patients—so it has a virtually unlimited ability to scale quickly with little incremental cost.

Profit margins are wide and there is no cap on the number of customers that can be handled.

After a patient has an appointment, CloudMD bills the government directly just like every bricks-and-mortar clinic in Canada does. CloudMD records 100% of the revenue and gets to keep 30% of the billing for every patient that is seen through telemedicine, which is actually 10% more than what a bricks-and-mortar clinic receives. That is because the governments are trying to push teleHealth.

The doctor gets the other 70% and doesn't have to deal with any headaches of commuting or running a business.

Without the overhead of a bricks-and-mortar clinic, AND more revenue—CloudMD will be much more profitable than traditional health care stocks.

Faster scale, more cash flow. And they just entered Canada's largest market. This is the right stock in the right market at the right time.

When CloudMD goes from one doctor to 10 doctors to 100 doctors working at the same time, they don't have to build more clinics. They don't have to create more rooms for them or hire more staff. They just sign them on. That's it.

And we are not just talking about family doctors. They are also adding specialists and third party services like counseling and physiotherapists to the platform—and again, all these people are revenue, not costs.

That's the great thing about this business model. It's very scalable, very easy, and it grows very quickly.

CloudMD has been growing its recurring SAAS (Software-as-a-Service) revenue by 30% YoY with its EMR system. But this year the company is expecting that doctor growth to be much much higher—with a new full time sales team and the coronavirus pandemic. SaaS revenue is highly lucrative!

Consumer growth (patients) using the CloudMD app is growing even faster. And the recent COVID-19 situation will only turbocharge that.

Another Revenue Stream, Another Win-Win

There's another angle here—pharmacies. CloudMD says they will partner with more than 150 pharmacies in 2020 alone who are afraid of losing prescription business to Amazon (AMZN-NASD).

Those pharmacies are paying $500 a month for CloudMD kiosks to be in their pharmacies—where customers can get a prescription from a doctor on demand.

This keeps the customer in the pharmacy for their prescription—not out to see a doctor and then off to Costco to get it filled.

Pharmacies that don't see the writing on the wall will become the blockbusters of the industry and get left behind.

With the kiosk in the pharmacy, a person can just see a doctor right away, within 10 minutes, and walk the prescription back to the pharmacist.

Buy-outs Are Happening at High Valuations

We know that these businesses are worth.

Grocery giant Loblaws purchased QHR—another Canadian based EMR company—for $3.10/share or 7.5X revenue. Note that QHR's former Chairman Mark Kohler recently joined CloudMD's Board of Directors.

Teladoc bought a company out of Quebec just two months ago called InTouch for about US$600 million, which again is about 7.5X revenue. Teladoc itself trades at more than 10X revenue.

CloudMD trades at 2.5X revenue, less than a third of recent transactions. Meanwhile the company is poised to grow revenues at a high double digit rate for the foreseeable future.

TeleHealth is the future of how our healthcare is delivered.

Everyone has always expected that the growth would be just like what Netflix experienced with streaming, shaped like a hockey stick. The hockey stick shape is slow at the start as early adopters move and then straight up as the mainstream catches up with plot.

The demand for teleHealth from COVID-19 just took the flat part of that hockey stick out of the equation and instead took the industry directly to the exponential growth curve.

The jumping off point for teleHealth is here and I think CloudMD is the best pure-play teleHealth stock right now.

TeleHealth is to healthcare what streaming was to video rentals, and what Amazon was to retail. IT IS THE FUTURE.

Now is the time for investors to get on board, especially in Canada where virtual healthcare only accounts for 0.15% of the market and the growth curve will be much steeper.

And for me, that's CloudMD. It's the new normal. I'm long.

Keith Schaefer is editor and publisher of the Oil & Gas Investments Bulletin. He has a degree in journalism and has worked for several Canadian dailies but has spent over 15 years assisting public resource companies in raising exploration and expansion capital.

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Disclosure:
1) Keith Schaefer: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: CloudMD. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: CloudMD. My company has a financial relationship with the following companies mentioned in this article: None. Additional disclosures are listed below.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with CloudMD. Please click here for more information.
3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
4) This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of CloudMD, a company mentioned in this article.

Keith Schaefer Disclosures:

CloudMD has reviewed and sponsored this article. The information in this newsletter does not constitute an offer to sell or a solicitation of an offer to buy any securities of a corporation or entity, including U.S. Traded Securities or U.S. Quoted Securities, in the United States or to U.S. Persons. Securities may not be offered or sold in the United States except in compliance with the registration requirements of the Securities Act and applicable U.S. state securities laws or pursuant to an exemption therefrom. Any public offering of securities in the United States may only be made by means of a prospectus containing detailed information about the corporation or entity and its management as well as financial statements. No securities regulatory authority in the United States has either approved or disapproved of the contents of any newsletter.

Keith Schaefer is not registered with the United States Securities and Exchange Commission (the "SEC"): as a "broker-dealer" under the Exchange Act, as an "investment adviser" under the Investment Advisers Act of 1940, or in any other capacity. He is also not registered with any state securities commission or authority as a broker-dealer or investment advisor or in any other capacity.

Charts provided by the author.

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Shares of Energous Corp. skyrocketed after the company reported that it received certification from the FCC for its new, "groundbreaking" over-the-air, power-at-a-distance wireless charging WattUp® technology.

Adopting the Green Economy approach will reap greater environmental, social and economic benefits, compared with a society that focuses on economic growth as the measure for future development, according to a recent UN report. Using two per cent of global GDP to ???green??? key sectors could be enough to trigger the transition towards a green economy.

There is a common assumption that plant species are more inclined to thrive in a non-native community than a native one, sometimes becoming 'invasive'. However, this behaviour is likely to be quite unusual and invasive alien plants are actually an important exception, according to a new study. Much can be learned from the population of a species 'at home' and should be included in official assessment criteria.

Scientists involved in a pan-European project to develop better methods of risk assessment say maps that show such cumulative risks geographically are easy to interpret and should be considered as practical tools for conveying risk information to decision makers and the general public.

A recent study has assessed the lifecycle environmental impact during the production and use phase of three battery types for plug-in hybrid (PHEV) and full performance battery electric vehicles (BEV). The study indicates that newer lithium-ion (Li-ion) technologies outperform current nickel-metal hydride (NiMH) batteries and identifies processes contributing to 13 environmental impacts

By ranking the ???hazard potential??? of a wide range of chemicals used to make common plastics, Swedish researchers have highlighted which plastic polymers are made from the most hazardous chemicals. These should be prioritised for assessing the risk of causing human or environmental harm.

Heat waves are predicted to become more frequent under climate change, and are likely to be particularly severe in cities and towns due to the Urban Heat Island effect (UHI). A recent UK study of UHI mitigation strategies has demonstrated that even a small urban river can result in a cooling effect of 1??C during temperatures higher than 20??C, and that these cooling effects can be improved by careful urban design of the surrounding areas.

Researchers in Berlin have demonstrated that urban wasteland areas can be used as suitable habitats for a range of grassland species. Using simple and cost-effective measures to sow grassland seed mixtures, they found that such areas flourished despite poor soil conditions and high levels of impact from people.

Using data gathered by satellites, scientists have monitored changes in fishing activity around Italy in the Mediterranean Sea for the period 2007-2010. From this, they developed new ecological indicators that gave a more detailed pattern of fishing activity in the Italian seas. In addition, the new indicators suggest that fish stocks on the seabed around Italy are continuing to decline.

A recent study has described a simple method to screen the toxicity of materials used in consumer products. Using utility meter products as examples, the study found, for example, that stainless steel and polyvinyl chloride (PVC) had high toxicity potentials and suggests less toxic, but equally effective and priced, alternatives that could be used instead.

A recent study has revealed how water use has changed across the world over the last 60 years. Growing populations and economic development, particularly in newly-emerging countries, have increased water demand, but technological developments have led to water efficiencies and savings, which moderate these demands.

Covering walls with plants can significantly reduce the temperature of building walls during hot summer months. A recent study of three different types of these ???living walls??? in Italy suggests that they can be 20??C cooler than a bare wall on sunny days. An added advantage is that living walls can be retrofitted to existing buildings.

Trees form a valuable part of green infrastructure in cities by helping reduce surface water runoff, recent research finds. Together with grassy areas, significant reductions in surface water flows can be achieved by planting trees, reducing the risk of floods.

Density in the urban environment can encompass a multitude of factors such as population or dwelling density or the density of green areas. A new study surveyed professionals regarding how decisions on urban density are made, and has revealed that many feel that developers make most of these decisions, but that local authority planners should have more influence.

Increases in the amount of CO₂ in the atmosphere can be beneficial to crops, by providing a source of carbon for growth. However, very high levels of CO₂ have the reverse effect, decreasing the yield and quality of vegetable crops, a new study has shown. The researchers say atmospheric CO₂ concentration should be kept below 5 000 ppm to enhance the yield of leafy vegetables such as cabbage and lettuce.

Invasions of alien species are rising at an alarming rate, largely due to growing global trade and transport routes. Preventing the successful establishment of alien species by better understanding the factors determining success is a step toward limiting the threat of future biological invasions. Statistical modelling using observed bird invasion data — including location, event and species-level factors showed which factors were key to successful establishment by the alien species.

A circular economy, in which waste is minimised and resources are kept within the system, relies upon inventive ways of turning waste into a resource. A new study explored the possibility of using the microalga Scenedesmus obliquus to refine and process brewery wastewater. The alga efficiently removed pollutants from the effluent, produced biomass and biofuels in a range of different forms — and with different bioactive compounds — and encouraged waste barley and wheat to germinate at increased rates. This is especially important for breweries, as barley seeds are one of the main feedstocks for the industry — and thus are key to increasing its sustainability and circularity.

The most comprehensive glacier assessment yet reveals that glacier melt was responsible for 27mm of sea level rise between 1961 and 2016. Ice loss from glaciers is now the second biggest contributor to rising sea levels after warming water. If glaciers continue to melt at current rates, most — including many in central Asia, central Europe, western Canada and the USA — will vanish during the second half of this century.

Polycyclic aromatic hydrocarbons (PAHs) are a large group of toxic molecules produced by forest fires, industrial processes and the incomplete combustion of fossil fuels. The airborne particles containing these molecules are often washed into watercourses, where they can persist. This study uses long-term monitoring data from the Elbe river, Saxony, Germany, to show how changes in PAH sources affect both the concentrations of these chemicals and the corresponding environmental risks. The researchers suggest that controlling PAHs is the best prevention of harm to aquatic and human health.

While cities worldwide are expanding so is the significant carbon dioxide footprint of urban transport. Consequently, there is an urgent need for sustainable urban mobility solutions. A thorough analysis of the variables and dynamics of urban mobility in cities can aid in planning sustainable mobility policy. This study used a new system of classification by type (typologisation) relevant to urban mobility in global cities, with data from 331 cities in 124 countries covering 40% of the global urban population (as of 2016).

A survey of over 600 private boats docked in marinas throughout the Mediterranean showed that 71% are carrying non-indigenous species. In certain cases, non-indigenous species can become ‘invasive’ and have enormous and long-lasting impacts on ecosystems. The findings suggest that a common monitoring strategy may be necessary to prevent further disruptions to natural ecosystems.

Organisations are increasingly applying green business principles. According to a recent study, electronics manufacturing companies in Taiwan that practice green supply chain management (GSCM) have a better business performance than companies that do not. Those with a strong green marketing focus performed the best, successfully competing with their rivals.

Promoting the personal benefits of sustainable consumption, such as more free time and less stress, could play an important role in encouraging more sustainable living, according to a recent study. The researchers interviewed people who lived greener lifestyles and found that self-interest influenced their decision to consume less and buy sustainable products.

Scientists in the US have found a way to make a 'biorenewable' plastic from wood by-products. Their fossil fuel-free plastic is similar to polyethylene terephthalate (PET) - a material used to make plastic bottles and packaging. Such green chemistry approaches could help reduce reliance on dwindling fossil fuel resources.

A recent study has concluded that the green infrastructure concept has been successful in integrating green space policy with economic development policies in the north-west region of the UK, by emphasising the links between the economic benefits of green spaces and growth policies.

The EU Joint Research Centre has produced a new part of the handbook that provides guidelines for developing and using Life Cycle Assessments (LCA), which evaluate the environmental impacts of products, focusing specifically on life cycle impact assessment (LCIA). It recommends that assessments should be comprehensive, accessible and easy to apply in order to make LCA a more mainstream concept in decision-making.

Building Information Modelling (BIM) can enhance the design of a building, reduce costs and save energy. However, little research has been carried out on its impact on sustainable practices. A US survey illustrates that many practitioners do not see sustainability as a primary application, suggesting that more effort is needed to encourage the integration of ‘green’ design and construction into BIM.

A new study of attitudes towards transport and mobility has identified five groups of travellers. The groups differ significantly in their choice of transport, distance travelled and the impact their transport choices have on the environment in terms of greenhouse gas (GHG) emissions.

A new study finds that a quarter of fish products labelled as ‘cod’ or ‘haddock’ in Dublin, Ireland, are in fact completely different species of fish. This indicates that fish consumers are being misled by inaccurate labels, which could compromise sustainable fishing and consumption efforts.

The public can help assess the human impact on wild birds through amateur ‘citizen science’ networks, according to new research. Scientists evaluated the suitability of data collected by amateur bird-watchers for long-term monitoring of European bird populations. Their findings suggest that citizen data may significantly improve the accuracy of existing official survey methods, as well as help increase public awareness of wild bird conservation.