Utilico Insights - Jacqueline Broers assesses why Vietnam could be the darling of Asia for investors. Watch the full video here.
Thanks Clio, and I have always been sure it was not but just imagine how very different the market reaction would have been if Stuart had made it crystal clear in the RNS using those very words. At least this BB can now appreciate the potential of this announcement and how it changes the roi calls that TW has used to declare the acquisition is not accretive when it is odds on that it most certainly will be. Let's hope for one of those glorious RNS's a few months down the line that revenues from the Dermatonics acquisition will be materially more than market expectationd
Couldn't agree more elrico. I have demonstrated the size of the Indian market alone for the once heel foot balm in previous posts. What people need to consider is that Modi have paid for the manufacturing capability and will ensure marketing spend and targeting is aimed at maximising the return on investment they have made. TW has taken the line that because of the wording in the RNS infering no change to current market expectations as meaning it is already in the recent Cavendish projections, overlooking the fact that it may it likely came out of the blue and they have not had time to properly consider the actual impact. Well look at the Cavendish projections yourselves and see whether you can see a large uptick to represent a major breakthrough in this huge Indian market already there. My only criticism of SA is this is not the first poorly worded RNS that leaves investors to speculate what it actually means in terms of future prospects, just a pity we have to wait a couple of months for the next investor meets to gain clarity when previously elrico or TW could have taken swifter action on behalf of us all to resolve.
Had wondered about the language used in the Asia link "In the end, what stands out is not just the promise of improved foot health but the broader implications of such partnerships in the healthcare sector. By combining expertise and resources, SkinBioTherapeutics and the Umesh Modi Group are not just launching products; they are setting a precedent for international collaboration aimed at solving pressing health issues. As we watch the ripple effects of this launch unfold, it's clear that the journey towards better health care is a shared one, fortified by the bonds of innovation and compassion."
Until I came across these facts and realised the potential impact of manufacturing in India an affordable (for low income families) product to help prevent Diabetic Foot Ulcers and subsequent amputations if not prevented and treated:
"Globally, an estimated 463 million adults are living with diabetes; India, with 77 million patients, has the second-highest number of patients after China [1]. Diabetic foot disease represents a real challenge to national health systems and healthcare providers in general [2]. The lifetime risk of a person with diabetes having a foot ulcer has been reported to be as high as 25%, with foot ulcers being the most frequent reason for hospitalization of patients with diabetes (about 30%) [3]. Moreover, treating diabetic foot ulcers is costly, accounting for 20% of total healthcare costs for diabetes, which is more compared to the cost for any other diabetic complication [3]. In India, the numbers of diabetic foot patients are increasing in both urban and rural settings, with 85% of amputations preceded by foot ulcers. Almost 75% of these amputations are performed on neuropathic feet with secondary infection, which is potentially preventable. In India, neuropathic lesions account for 80% of foot ulcers, with neuroischemic making up the remaining 20% [4]. The prevalence of the peripheral arterial disease is 3.2% in diabetic patients aged 80 years, with the increase being associated with both age and the duration of diabetes [5]. In India, approximately 100,000 legs are amputated every year, and the numbers are increasing [3]."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7364422/
The view from Asia of the deal
"The choice of markets for this launch is no mere coincidence. Regions like India, Bangladesh, Sri Lanka, and Nigeria are not only densely populated but also exhibit high prevalence rates of diabetes, making them ripe for innovative solutions like Pheet and Dermatonics Once Heel Balm. This strategic expansion is a testament to the partners' commitment to addressing unmet needs in dermatology and diabetes management, setting a new standard in healthcare access and quality. Looking Ahead: Prospects and Expectations
As SkinBioTherapeutics and the Umesh Modi Group embark on this venture, the eyes of the world are on them, awaiting the impact of their breakthrough products on the foot care industry. With a total addressable market of over £5bn at their fingertips, the stakes are high, but so are the expectations. The successful rollout of Pheet and Dermatonics Once Heel Balm could not only redefine foot care standards but also pave the way for further innovations in healthcare, benefiting millions of people across Asia, the Middle East, and Africa.
In the end, what stands out is not just the promise of improved foot health but the broader implications of such partnerships in the healthcare sector. By combining expertise and resources, SkinBioTherapeutics and the Umesh Modi Group are not just launching products; they are setting a precedent for international collaboration aimed at solving pressing health issues. As we watch the ripple effects of this launch unfold, it's clear that the journey towards better health care is a shared one, fortified by the bonds of innovation and compassion."
https://bnnbreaking.com/world/asia/skinbiotherapeutics-and-umesh-modi-group-gear-up-to-revolutionize-foot-care-in-asia-middle-east-and-africa
Pretty sure that this was not factored in to the recent Cavendish forecast for Dermatonics when calculating just how accretive it would be for Skinbio. There was a reference to Asia and Eastern Europe in the Cavendish forecast As follows "Revenues – We expect ‘Dermatonics’ to launch a range of its products in the US via the Amazon
platform and for this to be a key driver of revenue growth in FY25E. Such growth is expected
to be supported by growth in Asia and Eastern Europe and on-going growth in the domestic
market, particularly to the NHS and podiatrist clinics." but that I would suggest purely refers to existing exports to Vietnam and the Baltics, there is no mention of the Middle East and Africa which the modi partnership will cover in addition to the wider Asia Market so suggest Cavendish and TW will both need to revisit their calculators for FY's 25 and 26 and that's excluding the benefits that may well drop for Axis and Skinbiotix products from this new partnership.
Well said Disco and Med. When Stuart was appointed by the Skin Board it came with this reason
"Prior to Onbone, Stuart was President/CEO of Andover Healthcare Inc., a US-based wound management manufacturer, and before then, was President/CEO of TI Group, a UK-based medical/engineering company. Stuart also served as Senior VP, Global Sales & Strategic Marketing, BSN Medical (Biersdorf, Smith and Nephew) and was Director of Sales & Marketing at Smith & Nephew Plc, in its Woundcare, Casting & Bandaging division. In these roles, Stuart gained extensive experience of both direct sales management across multiple geographies, and of business to business selling. He has also been involved in M&A transactions and has achieved considerable commercial success in both small and large companies.
Prior to his career in industry, Stuart served in the armed forces. He has an MBA and a BSc in Business & Management.
Martin Hunt, Non-Executive Chairman of SkinBioTherapeutics, commented:
"On behalf of the Board of SkinBioTherapeutics, I look forward to welcoming Stuart to the team and for his transition into the CEO role. His proven track record with both SMEs and larger public companies in Europe and the US will be essential in driving the Company forward as we progress our first product towards commercialisation. He has a considerable network within the medtech and life science industries and he has the experience and drive to take us forward on the next stage of the Company's development."
Note the M&A mention and the need to drive the Company forward not passively wait for revenue to come our way which most certainly would not warrant paying big bucks, so do nothing was never really a credible option. Only time will tell whether the acquisition made and to come will lead to the sum of the parts turning the Company profitable by the Year End, but as Disco said it is far too early to judge success or failure at this juncture.
Disco, beat me to the punch on that one. Bubs other short term announcements expected:
From the Results RNS
- AxisBiotix for Acne
- The study involves 300 UK-based participants with acne-prone skin, 150 randomly selected participants will receive product 1, the other half of the group will receive product 2. Online recruitment of participants will start via a pre-qualification questionnaire form.
The products will be mailed to participants who are expected to record their experience of using the product in a weekly questionnaire over eight weeks, over which they are expected to take the product daily. A follow-up questionnaire will be provided one month after the participants stop taking their allocated product. The study is expected to be completed and results reported by the end of Q1 2024.
Oral Health Care Study
Three different actives, and a number of components have been investigated with differentiated activities that offer a route to oral care products with different protective actions on the hard and soft tissues of the oral cavity. This current phase of the programme ends in January 2024 and the company will work with the University to publish relevant findings in H1 2024, and the remainder of the details of the next phase programme through to commercialisation. This lysate is different to that of SkinBiotix.
From the Update on Transactions RNS
Further Acquisition
The Company is also in advanced due diligence on another target which is a manufacturer within the dermatology market in the UK. The management believes that this acquisition also has the potential to be completed in early 2024.
From the Investor Meets Presentation:
Dermatonics Once Heel Balm
The results for the New Cross Hospital trial for the Dermatonics Heel Pressure Ulcer trial are expected imminently
Certainly ties in with Cath's research Toyin, this from the EOY Results RNS; "The inflammation study is still underway. It is looking at how the microbiome can influence and balance the body's response to inflammation specifically related to harmful UVR (sunlight) light. Several first-in-class findings have been made on the effects of bacterially derived components and their ability to regulate the cytokine mediated inflammatory response associated with exposure to UVR. These results strongly support the use of bacterial actives in protecting the skin from sun exposure and a breakout patent filing has been made by the company on a lead active.
The company continues to work with the University of Manchester in further validating these and other findings and in advancing the technology toward human trials. The programme has delivered very encouraging results and has been expanded and extended to allow for the actives identified to be validated in propriety human skin models. The programme will run until June 2025. "
Hi PG, yes accept that the labelling is the final outcome from the regulatory review. My interpretation of the progress reported in the RNS's is that the US Partner Mogroside based products have completed scale-up, undergone independent taste and structure analysis and hence the granulated version is ready for regulatory evaluation and classification for the Country a launch is aimed at. The fact that the initial launch is as a standalone product rather than as an ingredient incorporated in someone else's end product will simplify matters. Firmenich have yet to complete the optimised scale-up of their Stevenol based sweetbiotix products which I suspect will also need to undergo independent taste and structural tastes prior to any regulatory submissions.
Mol, read the 19th July RNS meeting the market need section and you will see mention of both the nutrional label and sweetbiotix as dietary fibers, all I have done is research the US label classifications to conclude what lies ahead once sweetbiotix are incorporated into suppliers products in the US
Mol the labelling mention is nothing to do with lemmings and if you have read the same RNS's and seen the Investor Meets presentations over the years you would be aware of the differently SOH has spoken of in terms of sweetbiotix being classified as sweet fibers rather than sugars. Also, the US nutritional labelling with added sugars has occurred relatively recently. All I have done is try and join the dots up for people once the penny dropped for me, perhaps with your unwarranted reaction I should not of bothered sharing my thoughts
Ensuring not insurance
Mol, the importance of insurance the structure, as opposed to just the flavour, had not been impacted by scale-up by an independent panel was so that it still qualified as an innovated dietary fibre. Hence part of the regulatory clearances that each finalised sweetbiotix product is subjected to, will include FDA labelling for the US market
Post 3 end
So bearing in mind Optibiotix Health recently announced that discussions are ongoing but are likely to involve a phased introduction of SweetBiotix® products as a direct bulk sugar substitute and the importance the FDA place on scientific evidence in classifying new products under the Innovative Dietary Fiber definition, the significance of the recent Independent verification of the structure and taste of scaled-up sweetbiotix from the US Partner, and the Optibiotix Health Commercial and Scientific Update RNS on 22nd July 2022 in supporting the Sweetbiotix application, cannot be understated.
“SweetBiotix® Publication: The Company is pleased to announce the publication of a study on the prebiotic activity and sweetness of one of its SweetBiotix® products in a peer reviewed journal (see https://pubs.acs.org/doi/10.1021/acs.jafc.2c01363). The study reports that enzymatic synthesis of modified mogroside and galacto-oligosaccharides (GOS) from lactose was able to generate products which positively modulated the microbiome with a sweetness profile similar to sugar. The products sweetness, bulking and prebiotic fibre properties could make it a suitable replacement to sugar in everyday products. This is one of a number of SweetBiotix® products developed for different application types in food, beverages, and dairy. Publications by independent authors in peer reviewed journals are critical in establishing industry awareness and credibility in the Company's products and provide valuable marketing assets to support product launches. “
https://pubs.acs.org/doi/10.1021/acs.jafc.2c01363
Post 3 continued
What evidence does the FDA use when determining whether an ingredient is classed as an innovative dietary fibre?
The FDA (U.S. Food and Drug Administration) evaluates evidence carefully when classifying a new ingredient as an innovative dietary fiber. Here are the key steps and considerations:
1. Scientific Research: The FDA reviews scientific articles that assess the physiological effects of the proposed ingredient. Researchers study how the ingredient interacts with the human body and its impact on health.
2. Elimination Process: Studies that do not provide clear scientific conclusions about the ingredient are eliminated from consideration. Only robust research is taken into account.
3. Beneficial Effects: The FDA evaluates the strength of evidence to determine whether the ingredient demonstrates beneficial physiological effects on human health. These effects must be relevant to dietary fiber.
4. Health Claims: If there is sufficient scientific support, the FDA may issue health claims related to the ingredient. For example, diets high in fiber-containing foods have been associated with reduced risk of certain cancers1.
5. Recent Additions: Over time, the FDA has added several isolated or synthetic non-digestible carbohydrates to the definition of dietary fiber. For instance:
◦ In December 2021, acacia (gum arabic) was included.
◦ In January 2020, glucomannan was added.
◦ In March 2019, cross-linked phosphorylated RS4 was recognized.
◦ In June 2018, the FDA responded to citizen petitions and identified eight fibers for potential inclusion2.
Remember, this process ensures that innovative dietary fibers meet rigorous scientific standards before being classified as such
Post 3 continued
So what does the FDA Class as Innovative Dietary Fibers?
The FDA defines innovative dietary fibers based on specific criteria. Let’s break it down:
1. Intrinsic and Intact Fibers:
◦ These are naturally occurring fibers found in plants, such as whole grains, fruits, and vegetables.
◦ They must be intrinsic (part of the plant’s structure) and intact (not significantly processed).
◦ Examples include cellulose, hemicellulose, and lignin.
2. Added Isolated or Synthetic Non-Digestible Carbohydrates (NDCs):
◦ These are non-digestible carbohydrates that are intentionally added to food products.
◦ To be considered dietary fiber, they must meet two criteria:
▪ Have at least 3 monomeric units (building blocks).
▪ Demonstrate beneficial physiological effects on human health.
◦ Companies must provide evidence of these health benefits to the FDA.
3. Examples of Added NDCs Recognized by the FDA:
◦ Acacia (gum arabic): Recently added to the list of dietary fibers 1.
◦ Glucomannan: Also recognized by the FDA 1.
◦ Cross-linked phosphorylated RS4: Another recognized fiber 1.
◦ These fibers contribute to the total dietary fiber content on nutrition labels.
4. Enforcement Discretion:
◦ While awaiting formal rulemaking, the FDA exercises enforcement discretion for certain fibers.
◦ Manufacturers can include the recognized fibers when calculating the amount of dietary fiber to declare on labels.
◦ For instance, polydextrose (a recognized fiber) is assigned a caloric value of 1 kcal/g 1.
In summary, the FDA classifies dietary fibers as either naturally occurring intrinsic fibers or added NDCs with proven health benefits. So, when you see “dietary fiber” on a label, it encompasses these diverse components!
Post 3 continued
Why Are Added Sugars Listed on the Nutrition Facts Label?
The Dietary Guidelines for Americans recommends limiting calories from added sugars to less than 10 percent of total calories per day. For example, if you consume a 2,000 calorie daily diet, that would be 200 calories or 50 grams of added sugars per day. Consuming too much added sugars can make it difficult to meet nutrient needs while staying within calorie limits. Added sugars are listed on the Nutrition Facts label so that you can make informed choices, based on your individual needs and preferences.
Coca Cola with Corn Syrup Sweetener
For example, a 12 fl oz can of Coca Cola that includes high-fructose corn syrup contains 39 grams of added sugar which is most of the recommended added sugar daily allowance in just one can, little wonder Coca Cola has been engaged with Optibiotix Health to tailor a version of sweetbiotix to meet their needs over a number of years
What does the FDA classify as low added sugars
Nutrition Facts Label:
◦ On food labels, the number of grams and the percent Daily Value (%DV) for added sugars are listed within the Nutrition Facts label.
◦ If a product contains added sugars, the label will explicitly state it. For example:
▪ “Includes 7 grams of added sugars” in a container of yogurt with added sweeteners.
▪ The %DV helps you understand how much the product contributes to your daily added sugar intake.
4. Low vs. High:
◦ Low source of added sugars: If a food provides 5% DV or less of added sugars per serving, it is considered low in added sugars.
◦ High source of added sugars: If a food provides 20% DV or more, it is considered high in added sugars.
So this is the relatively small win that Tagatose are left with and highlights the advantage Optibiotix seek to hold with a classification of Innovative Dietary Fibers rather than Added Sugars and the excitement that will generate.
Post 3 - FDA Labelling What Does it Mean for Sweetbiotix?
https://www.fda.gov/food/nutrition-facts-label/added-sugars-nutrition-facts-label
What Are Added Sugars and How Are They Different from Total Sugars?
1. Total Sugars
Total Sugars include sugars naturally present in many nutritious foods and beverages, such as sugar in milk and fruits as well as any added sugars that may be present in the product. There is no Daily Value* for total sugars because no recommendation has been made for the total amount to eat in a day.
2. Added Sugars
Added sugars include sugars that are added during the processing of foods (such as sucrose or dextrose), foods packaged as sweeteners (such as table sugar), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices. They do not include naturally occurring sugars that are found in milk, fruits, and vegetables. The Daily Value for added sugars is 50 grams per day based on a 2,000 calorie daily diet.
For most Americans, the main sources of added sugars are sugar-sweetened beverages, baked goods, desserts, and sweets.
Post 2 continued
*Post receiving the answer a bit more digging through the additional large investor route, revealed that Hershey subsequently tried to persuade the FDA that Tagatose should be classified as a rare sugar so avoiding the dreaded added sugar label but this was rejected by the FDA on the following grounds ”In its seven-page response, the FDA agrees with the health research submitted by Bonumose, but says tagatose has too many calories to be exempted from the label designation. Tagatose has 1.5 calories per gram, while allulose — another rare sugar that the FDA has exempted from the Added Sugars designation — has 0.4 calories or less per gram. “
https://www.thehersheycompany.com/en_us/home/newsroom/blog/bonumose-groundbreaking-advancing-rare-and-innovative-sugars-for-betterforyou-snacking.html
https://www.fooddive.com/news/fda-tagatose-added-sugar/624410/#:~:text=Tagatose%20has%201.5%20calories%20per,calories%20or%20less%20per%20gram.
So noting the residual albeit subdued excitement surrounding Tagatose (see links), because despite being classified as added sugars, it attracts the label “low added sugars”, what does this mean for the opportunity afforded to Sweetbiotix on launch?
Post 2 – Tagatose – Rival to Sweetbiotix?
Having come across a Company, Bonumose who appeared to have a similar product to Sweetbiotix I posed the following question via Lemmings:
“Bonumose who list ASR Group amongst their backers (took over Tate & Lyle Sugars) seem to have a sweetbiotix like product derived from Mogroside using a similar one-step process to produce Tagatose. That said it has not been exempted from listing as “added sugars” on the label by the FDA despite the company claiming they are fibres, has sweetbiotix cleared this hurdle with the FDA or will Opti suffer a similar fate and have to settle for lean on the labels in which case this appears to be a serious competitor?”
https://www.foodnavigator-usa.com/Article/2022/07/14/IFT-First-Bonumose-gears-up-for-commercial-production-of-rare-sugar-tagatose-this-fall-It-really-does-stand-apart-in-terms-of-its-taste-and-its-functionality
https://www.foodnavigator-usa.com/Article/2021/02/18/Sugar-reduction-game-changer-Hershey-ASR-Group-invest-in-startup-paving-way-for-mass-market-adoption-of-allulose-tagatose
Lemmings duly forwarded the question to SOH who with impressive knowledge of the product especially as he was abroad, and hence out of office at the time, having presented at the Probiota event in Milan, responded “‘Tagatose is not classified as a fibre as it is predominantly disaccharide, which is where the problem lies.’
The key differentiator was the largest technical challenge, as fibres are long-chain oligosaccharides. The other point is that it is a prebiotic fibre, i.e., a fibre that produces a health benefit. The technology allows us to build different types of fibre chains. This family of products is based on a platform technology that enhances its value.
These effects are all validated independently by Universities and industry. They are outlined in the published articles we have shared, one of which concludes, ‘This new ingredient could provide health benefits when evaluated in human studies by combining sweetness and prebiotic fibre functionality.”