Evidence traces the existence of bagels all the way back to ancient Egypt, but popular belief suggests our favorite ring-shaped doughy delights are a product of Poland. No matter the origin, the bagel is a thing of beauty: A chewy, golden brown sheen of the properly boiled-and-baked roll-with-a-hole. And Big Sky Country hosts a few very good artisan bagel shops. Here are our six favorites!
Really good bagels are hard to find outside New York, let alone across the continent in the Inland Northwest. Part of a welcome bagel-boom in the early 90s, founder Sue Thompson filled the void in Missoula, employing her son as the inaugural baker. Per the shop's focus on quality and the responsibly-sourced, these never-frozen morels are hand crafted and certified organic/non-GMO. A plethora of flavors ebb and flow with the seasons.
If an establishment is going to focus on only two things, they better do them right. And this couldn't be any more important than in the realm of bagels & coffee. This Bigfork institution grinds their beans fresh, in house, and serves hot and toothsome bagels from local Montana craftsmen. The savory combinations of breakfast and lunch sandwiches (on bagels, of course!) make Buzz a morning, or afternoon, necessity. A favorite formula is a simple one: Roasted turkey, pesto cream cheese, cranberry bagel.
Twenty-five years into their tenure, the bakers at the 'Works continue to crank-out house-made bagels, baked fresh daily. Warm and chewy bagels are sold by the each or dozen, coming in fourteen varieties, including cranberry and cheddar-jalapeno. The signage is certainly colorful, but it gets the point across: "fresh baked bagels" and "good coffee." Enough said.
This proudly diner-drab establishment is a solid breakfast and lunch stop, where all the focus is on the all-important bagel. Varieties are hand crafted: Soft and chewy, with just enough give. By the bag or mounded with toppings for a sandwich, Great American satisfies. There's the ubiquitous breakfast bagels, with bacon and melted cheddar, or the simply toasted with cream cheese. The Reuben melt and bagel-wrapped hot dogs are delicious in-house novelties, or add bacon to a cucumber-cream-cheese-laden roasted turkey.
This breakfast/brunch spot has a warming combination of freshly-baked bagels and morning cocktails. A full breakfast menu with pancakes and steak & eggs centers around "23 Kinds of Fresh Bagels." Alongside a refreshingly-spicy Bloody Mary, the bagel sandwiches enliven the spirit: that hallowed alchemy of bacon fat and chewy gluten, black pepper, tomato and the subtle sting of vodka. Supposedly, it's all healthy. Maybe, maybe not. But they only way to find out is to pay Bagels Etc. a visit.


...value land on the Melbourne side of Ballarat. As this estate has only a small number of lots on offer, be quick to select your ideal lot!
...rental assistance price with a Full Turnkey House and Land Package. Rental return for Investors is $350 a week, you will be positively geared.
...Take advantage of the below 400 K pricing in Ballarat. Invest now and reap the benefits! This is a turn key, Fixed price House and Land Package.


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Reinstated in - Idioms by The Free Dictionary
https://idioms.thefreedictionary.com/reinstated+in
(redirected from reinstated in)
To assign or elect one back into a particular position, role, or place that one previously held. Often used in passive constructions. The board has been directed by the president to reinstate Ms. Richards in her previous position. After Mr. Davis was cleared of all charges, protesters are demanding that the prime minister reinstate him in parliament.
reinstate someone in something
to put someone back into a certain office or position. If you will pay your dues, we will reinstate you in the organization. Fred was reinstated in office.
1FTR
reinstate (one) in (something)
On the day after, like the dogs again, he was reinstated in his privileges; and another change was introduced in the after-dinner formula.
My companions, no doubt, had been reinstated in their cabin, without having perceived it any more than I.
The viewers should demand that Brendan be reinstated in time for the next series in the autumn.
Strictly's lost one of its best in Cole; #Madeuthink; WHAT WE'RE ALL SAYING
The senator said some police officials felt that the hierarchy was bypassed when Marcos was reinstated in his post without asking their opinion.
De Lima: 'Bong' Go called Bato to reinstate Supt. Marcos
The Chief of the Main Criminal Investigation Department of the Interior Ministry, Tilekbai Alibaev, was reinstated in office, the press service of the Interior Ministry said today.
Chief of Main Criminal Investigation Department reinstated in office
Around 400 students had been reinstated in December, including students who are awaiting trial for felony crimes but have not yet been convicted.
Employees and students reinstated
Wouldn't it be neat if in August 2011 the RCN could be reinstated in lieu of Maritime Command--100 years later!
Why cant it be done?
The reinstated employees of OGDCL Hidayat Ullah, Abdul Sattar Lashari, Hussain Bakhsh and Shafiq Sial told that more than 200 employees who were sacked in Nawaz Sharif's regime have been reinstated in OGDCL but they have not been given their previous grades and posts.
OGDCL management refuses to reinstate sacked employees
reinstate one in
reinstate one into

redpajama_set_name: RedPajamaCommonCrawl


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The Treaty of Fort Stanwix was a treaty signed between representatives from the Iroquois and Great Britain (accompanied by negotiators from New Jersey, Virginia and Pennsylvania) in 1768 at Fort Stanwix. It was negotiated between Sir William Johnson, his deputy George Croghan, and representatives of the Iroquois.

The treaty established a Line of Property following the Ohio River that ceded the Kentucky portion of the Virginia Colony to the British Crown, as well as most of what is now West Virginia. The treaty also settled land claims between the Iroquois and the Penn family; the lands thereby acquired by American colonists in Pennsylvania were known as the New Purchase.

Treaty
The purpose of the conference was to adjust the boundary line between Indian lands and the Thirteen Colonies set forth in the Royal Proclamation of 1763. The British government hoped a new boundary line might bring an end to the rampant frontier violence between Native Americans and American colonists. Native Americans hoped a new, permanent line might prevent further encroachment of their lands from the colonists.

The final treaty was signed on November 5 with one signatory for each of the Six Nations and in the presence of representatives from the colonies of New Jersey, Virginia and Pennsylvania as well as Johnson. The Native American nations present received gifts and cash totaling £10,460 7s. 3d. sterling, the highest payment ever made from the British Crown to Native Americans. The treaty established a Line of Property which extended the earlier proclamation line of the Alleghenies (the divide between the Ohio and coastal watersheds), much farther to the west.  The line ran near Fort Pitt and followed the Ohio River as far as the Tennessee River, effectively ceding the Kentucky portion of the Virginia Colony to the Crown, as well as most of what is now West Virginia. The British government had recently confirmed ownership of the lands south and west of the Kanawha to the Cherokee by the Treaty of Hard Labour. During the Fort Stanwix proceedings, the British negotiators were astonished to learn that the Six Nations still maintained a nominal claim over much of Kentucky, which they wanted to be added into the consideration. In addition, the Shawnee did not agree to this treaty, contesting colonial Virginian settlements between the Alleghenies and Ohio until the 1774 Treaty of Camp Charlotte.

Although the Six Nations of New York had previously recognized colonial rights southeast of the Ohio River at the 1752 Treaty of Logstown, they continued to claim ownership (by conquest) over all land as far south as the Tennessee River. They had reserved this territory for decades as a hunting ground. They still considered the Tennessee their boundary with the Cherokee and other "Southern" tribes. Although representatives of the Indian nations who occupied these lands, primarily the Shawnee and Delaware, were present at the negotiations in 1768, they were not signatories and had no real role in the Iroquois' sale of their homeland. The Iroquois hoped that by releasing Ohio lands, they could take pressure off their own home territories in the New York and Pennsylvania areas. Rather than secure peace, the Fort Stanwix treaty helped set the stage for the next round of hostilities between Native Americans and American colonists along the Ohio River, which would culminate in Dunmore's War.

The treaty also settled land claims between the Six Nations and the Penn family, the proprietors of Pennsylvania, where the lands acquired in 1768 were referred to as the "New Purchase". Due to disputes about the physical boundaries of the settlement, however, the final treaty line would not be fully agreed upon for another five years. The final portion of the Line of Property in Pennsylvania, called the Purchase line in the State, was fixed in 1773 by representatives from the Six Nations and Pennsylvania who met at a spot called Canoe Place at the confluence of West Branch of the Susquehanna River and Cush Cushion Creek in what is now Cherry Tree, Pennsylvania.

American settlers pushing westward and opportunities for economic development turned the attention of investors and land speculators to the area west of the Appalachians. In response to demands by settlers and speculators, colonial authorities sought further land cessions from the Iroquois and Cherokee. The Treaty of Lochaber with the Cherokee followed in 1770, adjusting boundaries established in the Treaty of Hard Labour, whereby the Cherokee withdrew their claim to parts of the same country, encompassing the south part of present-day West Virginia.

References

Further reading
 Billington, Ray A. "The Fort Stanwix Treaty of 1768," New York History (1944), 25#2 pp. 182–194 in JSTOR
 Halsey, Francis Whiting. The Old New York Frontier, New York; Charles Scribner's Sons, 1901 (Part 3, Chapter 2: "The Fort Stanwix Deed, and Patents that Followed It (1768–1770)," pp. 99–105)
 Marshall, Peter. "Sir William Johnson and the Treaty of Fort Stanwix, 1768." Journal of American Studies (1967) 1#2 pp 149–179.

Primary sources
 Complete Text of the Treaty of Fort Stanwix, 1768
 The Documentary History of the State of New York, by E.B. O'Callaghan, M.D.; Albany: Weed, Parsons & Co., 1850 (Vol. 1 pp. 379–381 text of treaty of 1768; also extensive correspondence of Sir William Johnson)

External links

1768 Boundary Line Treaty of Fort Stanwix

Legal history of Canada
Pre-statehood history of Pennsylvania
Fort Stanwix
Fort Stanwix
1768 in the Thirteen Colonies
1768 treaties
Rome, New York
Iroquois
Native American history of Pennsylvania

redpajama_set_name: RedPajamaWikipedia


Sibling to the Scottish Fold, the Scottish Straight shares the same relaxed, sociable character, meaning they settle easily into many different home environments.
With the same origins as the Scottish Fold, and born in the same litters, the only difference between the two cats are the ears.
While a Scottish Fold's ears lie forward against their head, the Scottish Straight has medium-sized upright ears. As well as enjoying their sleep, Scottish Folds are playful characters and will get along well with both children and, once properly introduced, other family pets.


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Q: Get Views Of A Facebook Video Using Public API If I want to download statistics on a Facebook video, I can use https://developers.facebook.com/docs/graph-api/reference/video to get almost all the public information about a video expect for its view count. Is there someway to get the view count from videos on Facebook page from the API without having access to pages insights?

A: Video in a Fan Page is treated as a POST, you can check the following link for the documentation

Permissions
Any valid access token can be used for publicly available metrics
  (currently page_fans_country or page_storytellers_by_country).
  access token with read_insights permission can retrieve metrics for
  all pages and domains owned by this user. A page access token with
  read_insights permission can retrieve all metrics for that Page.A user

So the answer to your question is, it's not possible without the "read_insights permission".

redpajama_set_name: RedPajamaStackExchange


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Splitting Up Ownership to Ride Out a Rough Spot
June 20, 2012 March 7, 2018
It is not obvious from the names on the deeds, but 655 Madison Avenue. the Backer Building at 136 Madison Avenue and 304 Fast 45th Street in Manhattan share a new owner.
All three office buildings still belong to the joint ventures that have owned them for years, but in January a real estate private equity company, Madison International Realty, paid nearly $80 million to acquire ownership stakes in those partnerships. Madison bought the positions from the Irene Diamond Fund, which needed to liquidate its part in the portfolio to support its philanthropic activities.
Such 'partial Interest' deals, as they are known. are becoming more common in Manhattan. as they allow landlords to retain some control over properties that might otherwise revert to lenders through default and foreclosure when the final, balloon mortgage payment conies due. (Commercial loans are typically not self-amortizing.)
"Most of the real estate business is about ego and control, and if you talk to most of the usual suspects, they want to go out and buy buildings," said Ronald Dickerman. Madison's president and founder. 'But we've created a really interesting business out of buying these partial interests in a private and under-exposed niche of the commercial real estate business."
Partial-interest deals accounted for $9.9 billion, or 63 percent. of the $15.7 billion in Manhattan office transactions in 2011. according to Real Capital Analytics, a market researcher based in New York. That percentage is up sharply since the height of the market in 2007, when partial-Interest deals made up less than $5.7 billion, or 19 percent. of Manhattan's $30.3 billion in office deals for the year.
Many of today's transactions are recapitalizations, in which the property owner uses an outside investor's capital and credibility to persuade the lender or lenders to restructure the property's debt. In exchange, the new investor typically gains equity, or an owning interest in the property. Often requiring lengthy negotiations among lenders and other stakeholders, the resulting deals usually bring the new investor into the existing ownership structure.
That is how Vornado Realty Trust acquired its 49.5 percent stake in the office part of 666 Fifth Avenue late last year. Kushner Companies had bought the 1.45 million-square-foot 39-story property for $1.8 billion in January 2007, but by the spring of 2010 Kushner was already negotiating with a special servicer to Make the debt more manageable. Last December, Kushner and tornado announced a joint venture that modified the $1.215 billion mortgage and extended its term until February 2019. In addition to taking on the debt. Vornado reported that it had invested PIO million in the venture. The growing frequency of partial-Interest transactions also explains why many so-called vulture investors, which have amassed funds to snatch up office buildings from distressed owners forced to fell at a lOSS, are still waiting on the sidelines for properties to show up on the auction block.
"These recapitalizations are the reason there isn't blood on the streets," Madison International has acquired stakes in three Manhattan buildings, including 655 Madison Avenue, above, and the Backer Building, below. said Dan Fasulo, the managing director at Real Capital Analytics. and all this is taking place behind the scenes. That's going to be a template going forward." Other recent examples include the purchase in May by Crown Acquisitions of a 49.9 percent interest in the Olympic Tower complex at 641 Fifth Avenue. In March. the Paramount Group, a privately held real estate investment manager. bought out Investa Office Fund of Australia's 49 percent stake in 900 Third Avenue to consolidate Paramount's ownership of the 604.000.square-foot office building Of the 98 Manhattan office transactions that have closed since the beginning of 2010 for properties valued at $100 million or more, 40 involved partial-interest deals or recapitalizations. Real Capital's data shows.
Three distinct market forces will keep the recapitalization fees burning for at least the next few years. said Jay Neveloff, a partner at Kramer Levin Naftalis & Frankel in New York One is the plentiful supply of capital that investors are eager to place in New York's promising real estate properties. The other two are maturing commercial mortgages, which must be paid off and replaced with new financing, and conservative lending practices In 2006 and 2007. lenders were commonly financing as much as 90 percent of an office property's value, but both loan-to-value ratios and asset values have come down since then. This creates shortfalls as investors seek financing to replace debts obtained before the financial crisis.
"It's hard to find new lenders that will refinance buildings at the same level today." Mr. Neveloff I said. "The lender might say, 'We will consider extending the loan, but we want the principal reduced.' That's a great opportunity for some of the abundant money on the sidelines to come in and invest in the property." Investors might prefer to buy office buildings outright, but few Manhattan owners are marketing their properties for sale. One possible deterrent to conventional sales is transfer tax, which the seller must pay upon selling 50 percent or more of a property.
The combined city and state transfer tax in Manhattan is 3.023 percent, one of the highest rates in the nation. The frequency of 49 percent office trades in re. cent months suggests that sellers are well aware of this tax trigger and are taking steps to avoid that cost through partial-interest transactions.
At a time when governments are facing deficits, the increase in partial-interest transactions means that millions of dollars invested in the New York office market this year will not be subject to transfer tax, said J.D. Parker, a vice president and regional manager in the Manhattan office of Mamas & Millichap Real Estate Investment Services. "A lot of people will buy up to 49 percent of a deal so they won't be subjected to that tax: Mr. Parker said. 'That's a legitimate concern for the local and state economy.
Yet the situation is temporary, he believes. Once job growth brings increased demand for Off lee space, rents and property values will begin to climb, making it easier for owners to finance their buildings or gamer healthy sale prices. At that point, most investors will abandon the complexities of partial-interest investments and return to the rel. awe simplicity of buying and selling entire properties. 'It's a necessary form of rapes/ event that is required right now in the market-place.' Mr. Parker said, "but the market would prefer. at anoints in the cycle, to be less complicate."
Madison, the new part owner of 655 Madison and the other assets it bought stakes in earlier this year, has invested millions of dollars in partial-interest real estate transactions around the globe, and plans to keep doing so. But Mr. Dickerman, the company's president, agrees that the herd of investors making similar transactions today will ditch the partial-interest investment model one market conditions change. "They'd rather own the buildings than buy partial interests in buildings," he said. "so 1 believe it's a bit of a passing fancy."
June 20, 2012 New York Times


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redpajama_set_name: RedPajamaGithub


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HomeworldAdele with her boyfriend Skepta does shopping.
Adele with her boyfriend Skepta does shopping.
Abu Zar July 12, 2021
Adele has net worth approximately $190 million, making her more famous and became one of the richest female singers ever. But presently, she still loves to do a bargain.
Sources revealed that shoppers at the Cabazon Outlets, a discount mall just outside San Bernardino, Calif., were amazed to see the famous singer in the discount Prada store there.
she looks to be on dating with the famous rapper she said she was not on date.
After source reports last October,2020 that she was being watched with British rapper Skepta, 38, Adele was in difficult to tell she was not in contact. After the 33-year-old hosted "Saturday Night Live," she shared a message on account of Instagram that she ended that she is going back to her cave now to be the single cat lady that she is.
But our source says she was assisting a British guy resemblance with Skepta — and with the same kind of tattoos — picking out clothes.
It's no wonder the famous superstar is spending as little money as possible. After all, she did just spend $10 million on her next-door neighbor Nicole Richie's Beverly Hills mansion. She now have 3 homes in the ultra-luxe neighborhood, according to famous Architectural Digest.
The singer was seen with ex-husband Simon Koneck, previously. Both got married secretly in 2017, but became separate in 2019 after 7 years together. Their divorce got final in March 2021. They contacted with court for sharing physical and legal custody of their 8-year-old son, Angelo.
Every fan wants to know that how old is Adele:? Adele is celebrating her 33rd birthday.
Adele then ended the birthday post with an image of herself in mid-twirl, wearing a beautiful printed dress.
Adele weight loss experiences stunned every fan and every body wanted to know that how did Adele lose weight? She had an art to be in news and everyone can see and read her in news.
Last week, Adele who have lost about 100 pounds by eating the sirtfood diet — resurfaced in a rare public sighting to celebrate pal Daniel Kaluuya's Oscars win.
Adele dating with Skepta Adele Shopping with Skepta International news world


How can I help prevent bullying at my child's school?
Schools can work to prevent bullying by creating policies supported by a mission statement, a code of conduct and a reporting system that allows people to assess how often bullying happens and the responses to it. Schools have to work to establish a culture of respect, tolerance and inclusiveness, which can take a while to take effect and needs to be reinforced often.
View the Bullying report page.
How can I raise awareness of bullying prevention in our school?
Some approaches taken to raise awareness include social media campaigns, morning or assembly announcements, posters and student surveys.
Bullying can be verbal, physical, or virtual (online). It can be racially, sexually or socially motivated, or in some other form.
People who are bullied are negatively affected in a number of ways. They often lose confidence in themselves and become insecure. If subjected to chronic and severe bullying, some people even take their own lives.
Who is more at risk of being bullied?
How do I respond to a bully in the workplace?


The demands placed on the automated production lines of vehicle manufacturers are always on the rise. Purchasers want exclusive, high quality, and individually tailored solutions. New materials, production technologies, and levels of automation require automation solutions to be constantly updated. For welding and assembly processes in its Chinese production plants, FAW-VW found a versatile and reliable solution in the Uprox+ sensors from Turck.
In order to ensure the efficient production of high quality automobiles like VW's new Sagitar or the Magotan vehicle lines, FAW-VW Automobile Co., Ltd. – a joint venture between the Chinese government-owned First Automotive Works, Germany's Volkswagen AG, Audi AG and Volkswagen Automobile (China) Investment Co., Ltd. – relies on sensor technology from Turck.
During the course of the rapid development in the Chinese automobile industry, customer demands have risen with regard to quality, functionality and efficiency. This has led FAW-VW – like all automobile manufacturers in the end – to use new materials and technologies in order to facilitate the flexible production of different vehicle types and models at one location. Equally high were the automobile manufacturer's requirements with regard to the sensor technology used. In order to be able to detect workpiece positions in the various stages of automated production, such as stamping, painting, welding and final assembly, the sensors have to be robust, versatile, and cost-efficient – requirements that the Factor 1 sensors from the uprox+ product line fully meet.
Thanks to multi-spule technology, the sensors designed to meet the IP68 protection class detect all metals without a reduction factor – regardless of whether it is iron, stainless steel, copper, aluminum or brass. Not only that, in comparison to conventional ferrite core sensors, uprox+ made it possible for FAW-VW to detect all metals used in the production lines with considerably higher switching distances up to 50 mm (FAW-VW uses the Ni50U-CK40 series) – thus offering high degrees of freedom for installation and area of application. A further advantage of the Factor 1 sensors that are sold by Turck (Tianjin) Sensor Co., Ltd. (TTS) in China is the fact that with the few sensor types that are suitable for many applications within the production line, the automobile manufacturer was able to set up simple and cost-efficient warehousing.
One of the hardest areas of application in the FAW-VW plants is welding assembly. In the overall production line, the individual parts of the various sedan models run through up to 5,000 spot welding steps. For monitoring the automated motion sequences, FAW-VW relies on the sensors from Turck's MT series. Mounted on the robot arms, the special sensors coated with teflon continuously check the position of the robotics in relation to the workpieces. In welding assembly, not only high switching distances are required in order to be able to detect the position of the workpieces early on and, if necessary, correct them, but also excellent shielding against external environmental conditions. Because uprox+ sensors do not contain ferrite core, they are equally insensitive to strong magnetic fields, like those that develop during the welding process, as they are to flying sparks or mechanical wear.


MGC Pharmaceuticals (ASX: MXC) is an Australia-headquartered specialist medical cannabis biopharma company, which has most of its operations based in Europe. Management has many years of technical, clinical and commercial experience in the medical cannabis industry.
MGC Pharmaceuticals is developing cannabis-based pharmaceutical products, initially in Australia and Europe. It has cannabis-growing operations in Europe and plans to supply cannabis-based active pharmaceutical ingredients (API), as well as developing registered pharmaceutical products for refractory epilepsy and dementia. MGC has signed a binding term sheet for the sale of its MGC Derma cannabis-based cosmetics business to Cannaglobal for up to C$15m (A$16m). We arrive at an initial valuation of A$140m or A$0.11 per share.
MGC is already growing medicinal cannabis crops in the Czech Republic and has established in Slovenia one of the few fully GMP-certified resin extraction and separation plants in Europe, in order to produce cannabis resins for use in its own pharmaceutical products, and for sales to drug and cosmetics manufacturers. The company plans to establish larger-scale cannabis-growing and processing operations in Malta under a contract awarded by the Maltese government in April.
The company intends to develop CannEpil and CogniCann as registered pharmaceutical treatments for refractory epilepsy, and to improve quality of life in dementia patients, respectively. It plans to conduct randomised, placebo-controlled Phase II crossover studies to generate high-quality evidence to support further development of these pharmaceutical products. It has received Therapeutic Goods Administration (TGA) authorisation for CannEpil to be prescribed as an Investigational Medicinal Product in Australia.
MGC has signed a binding term sheet for the sale of its MGC Derma business to the unlisted Canadian cannabis investment company, Cannaglobal, for up to C$15m (A$16m), subject to shareholder approval. Consideration includes C$9m of Cannaglobal shares up front, up to C$3.5m of potential milestones (payable as shares), eventual repayment of a C$2.5m working capital loan and a five-year supply agreement. The sale will allow MGC to focus fully on the pharmaceutical business.
Our initial valuation is A$140m or A$0.11/share, based on a risk-adjusted net present value (rNPV) analysis. The sales of flowers and resin from the cannabis-growing operations contributes over 60% of our valuation, with the CannEpil and CogniCann registered pharmaceutical products providing potential upside. Current cash of A$9.9m should support operations into FY20.
MGC Pharmaceuticals is an Australia-listed company with operations in central and southern Europe. Its key focus is supplying cannabis-based API and finished medicines in Australia and Europe. It has already established licensed growing operations in the Czech Republic and Slovenia, and has built a resin extraction plant in Slovenia, which has received full GMP certification. The Maltese government recently gave the company approval to establish a full medical cannabis cultivation and production facility in that country. The company intends to conduct Phase II studies of is lead products, CannEpil and CogniCann, for the treatment of refractory epilepsy and dementia, respectively. These trials represent the first step towards seeking approval as registered pharmaceutical products in Europe and Australia. It has signed a binding term sheet to sell its MGC Derma cosmetics business to Canadian cannabis investment company, Cannaglobal, for up to C$15m (A$16m).
We arrive at an initial valuation of A$140m or A$0.11 per share, based on a risk-adjusted net present value (rNPV) analysis. The sales of cannabis flowers and resin from the cannabis-growing operations contribute over 60% of the enterprise value, with the CannEpil and CogniCann registered pharmaceuticals providing potential upside. Our valuation assumes that the company will increase its cannabis-growing greenhouse space tenfold to 10,000m2 by 2022. We model A$6m of additional funds being required in FY20 to support construction in Malta.
MGC faces the typical risks of a development-stage biopharma company, including the unpredictable outcome of trials, regulatory decisions, success of competitors, financing and commercial risks, coupled with unique regulatory risks associated with its medicinal cannabis focus. The investment case hinges on establishing expanded, GMP-certified, medicinal cannabis growing and processing facilities in Malta. Obtaining regulatory approval for CannEpil in refractory epilepsy and CogniCann in dementia will be crucial to its ability to drive additional sales growth in the competitive medicinal cannabis space. GW Pharmaceuticals (GW) recently gained FDA approval in two severe epilepsy syndromes for Epidiolex, which is a highly purified formulation of cannabidiol (CBD), the main ingredient in CannEpil. It has also filed for approval in Europe. If CannEpil's efficacy is not comparable to Epidiolex, it may be difficult to capture a significant market share. GW has an extensive patent estate, which affects the extraction, purification and use of CBD in refractory epilepsies. While the company's advice is that the GW patents will not impinge on its freedom to operate, there is a risk that GW could pursue legal action if it believes that its patents have been infringed. Finally, the company could potentially face competition from supplies of synthetic CBD from API manufacturers in South Asia.
MGC has been loss making since its re-listing in February 2016, reporting losses of A$6.2m in FY16, A$8.5m in FY17 and A$9.0m in FY18. We forecast smaller PBT losses of A$5.7m and A$6.6m in FY19 and FY20 respectively, as it commences commercial sales of API in Europe and of CannEpil as an Investigational Medicine in Australia. We assume that expansion of cannabis-growing and API extraction capacity to support 10,000m2 of greenhouse space, to be constructed by 2021 and fully operational in 2022, will require capital expenditure of A$10m. The company raised net proceeds of A$10.5m from stock issues in FY16, A$9.8m in FY17 and A$4.7m in FY18. We estimate that additional funds of A$6m will be required in FY20, which we model as long-term debt.
MGC Pharmaceuticals (MGC, ASX:MXC) is an Australian Securities Exchange-listed company, headquartered in Perth and with its principal operations in the Czech Republic, Slovenia and Malta. Its main product lines are cannabis-based active pharmaceutical ingredients and cannabis-based finished medicines, including CannEpil for the treatment of severe refractory epilepsy.
MGC listed on the ASX in February 2016 via a reverse takeover of the mining exploration company Erin Resources. At the time of listing, its business strategy was to develop and supply high-quality, non-psychoactive cannabidiol (CBD) to the growing European and international cosmetics and medical market; the CBD resin was to be manufactured from hemp crops (low THC cannabis sativa strains) grown outdoors in Slovenia. However, in order to access wider market opportunities, it has revised the business strategy to include growing cannabis that contains high levels of the psychoactive compound tetrahydrocannabinol (THC) in secure greenhouse facilities in the Czech Republic and Malta, establishing a GMP-certified cannabis resin extraction and separation facility for API production, and developing finished cannabis-based medicines. As part of this revised strategy it intends to seek approval for its cannabis-based CannEpil formulation for the treatment of refractory epilepsy, initially for children and young adults in Europe and Australia, with the option to pursue US approval later. It also intends to seek approval for CogniCann in dementia patients.
The strategy of producing cannabis-based medicines from seed to finished registered medical products, as well as being a supplier of cannabis-based APIs, differentiates MGC from the majority of companies operating in the medical cannabis market. One key differentiator is that few companies are seeking to achieve regulatory approval for their cannabis-based medicines as registered pharmaceutical drugs.
In addition to its strategy of seeking registration of CannEpil and CogniCann as pharmaceutical products, the company plans to generate near-term revenues from the sale of CannEpil and other medical cannabis products in markets where regulations allow their sale without obtaining registration. As part of this strategy, it has entered into a supply and distribution agreement with Lenis covering 12 European countries, and has signed a definitive exclusive supply agreement for the distribution of CannEpil under an import licence in Australia. MGC recently obtained authorisation from the TGA for CannEpil to be available for prescription in Australia as an Investigational Medicinal Product through specialist prescribers under the Authorised Prescriber Scheme. It expects sales in Australia to commence by December.
Cannabis, also known as marijuana, is usually recognised by two main types, cannabis sativa, which originated in the western hemisphere and cannabis indica, which originated in central and south Asia.
The cannabis plant contains a complex blend of more than 70 compounds called cannabinoids. The two principal components believed to be the key contributors to the medicinal properties attributed to cannabis are the psychoactive compound tetrahydrocannabinol (THC), which is principally responsible for the cannabis 'high', and the non-psychoactive cannabidiol (CBD). However, other minor cannabinoids may also contribute to the medicinal properties.
The core strategy of MGC's Botanic division is to produce high-quality, cannabis-based products at a competitive price. The low cost of goods produced will be a key driver of the ongoing profitability of the company. As a first step towards this goal, it has established cannabis-growing operations in the Czech Republic and Slovenia and has constructed a GMP-approved cannabis resin extraction facility in Slovenia. The next phase will be to establish larger-scale cannabis-growing and processing operations in Malta under a binding letter of intent signed with the government of that country in April 2018.
MGC has established research collaborations in the Czech Republic, Slovenia and Australia in order to maximise yields, to develop high-yielding strains, to optimise growing conditions and to identify new cannabis-based products for treating additional medical conditions.
MGC harvested 400kg of medicinal cannabis biomass from 1,100m2 of outdoor greenhouse space at its Panax operation in Prague in 2017, as shown in Exhibit 1. A second crop was planted in early Q218, and is expected to be harvested in the current quarter.
MGC acquired 80% of Panax Pharma (Panax) in February 2017 in exchange for a commitment to fund the first year of operations, capped at €0.7m. MGC has an option to acquire the remaining 20% of Panax for €0.6m of shares in MGC. Panax has a strategic partnership with the Institute of Experimental Botany at the Academy of Sciences of the Czech Republic (IEB) in Prague, which holds a medical cannabis breeding licence and provides access to 1,100m2 of dedicated greenhouse growing space.
The company completed the construction of a clean room and CO2 extraction facility in Ljubljana in Slovenia in April 2017. In July it was formally granted full GMP certification of the processing facility and a manufacturing licence for the production of cannabis-based medicines. Receipt of the licence enables the commercial-scale production of GMP-grade medical cannabis pharmaceutical products. It will enable MGC to be licensed for distribution of CannEpil, CogniCann and other medicinal cannabis products.
In October 2017 MGC harvested 4,000kg of biomass from a low-THC cannabis strain (hemp) crop at its open field farm on leased farmland in Slovenia. A proportion of the hemp crop will be processed to produce food-grade CBD for use in the company's nutrient and MGC Derma cosmetics products, with the remainder sold in the European market as Aquiol.
In April 2018 MGC received a binding Letter of Intent granting approval and a contract by Malta Enterprise Corporation to establish a medical cannabis production and cultivation facility on 4,000m2 of land. MGC is in the process of obtaining a formal contract to commence construction of the facility, which will also house a research hub and, once approved, a GMP-certified production and manufacturing facility. Under the terms of the contract, MGC will be obliged to spend a minimum of €4.3m (A$6.5m) over the first three years on the construction and operation of the facility, and to employ at least 25 Maltese people as part of the local workforce.
Thanks to its warm Mediterranean climate, the Maltese facility should produce high-yielding cannabis crops with a relatively low cost of production.
The establishment of the facility in Malta will be a key part of the company's plan to expand its greenhouse growing capacity to around 5,000 m2 over the next three years. While we model a further expansion of growing capacity to 10,000 m2 by 2022, at this stage it is not clear whether this further expansion would take place in Malta or in another location.
conducting preclinical studies of the use of cannabinoids to treat a range of medical conditions, including cancers such as melanoma.
MGC has started putting in place supply and distribution agreements as it prepares for commercial sales of its pharmaceutical-grade cannabis products.
The first agreement was an exclusive regional distribution deal with Mikro+Polo for the sale in Slovenia, Croatia and Bosnia of the API material that will be produced from MGC's extraction facility in Slovenia.
Separately, the company has entered into a five-year supply and distribution agreement with the European pharmaceutical distribution company Lenis in eight countries in central and eastern Europe; in addition, Lenis and MGC will jointly market the products into Germany, Croatia, Greece and Italy. Lenis will distribute MGC's medicinal products, which include cannabis flower products and its CannEpil epilepsy medicine. The flower products will be available in pharmacies in select countries for use in a variety of medical conditions such as nausea, vomiting, pain, Tourette's syndrome, multiple sclerosis, severe uncontrollable epilepsy and inflammatory bowel diseases. In addition, the agreement covers the future supply of MGC's finished pharmaceutical products once they have been registered in the EU for sale.
Furthermore, in November 2017 MGC signed a definitive exclusive supply agreement with HL Pharma, a specialist Australian pharmaceutical distributor, to bring CannEpil to the Australian market for treating epilepsy patients. The company plans to sell CannEpil in Australia as a 50ml bottle containing 100mg/ml of CBD, 5mg/ml of THC (ie a total of 5,000mg CBD and 250mg THC) plus small amounts of other cannabidiols. A 50ml bottle will retail for less than A$800, which is significantly lower on a price per mg basis than the most similar current competing product in the market, which is supplied by the privately owned Canadian company, Tilray.
In Australia, certain cannabis-based Investigational Medicinal Products can be dispensed by pharmacies for treatments prescribed by doctors who are registered under the Authorised Prescriber Scheme (APS). The TGA has approved an initial group of doctors as authorised prescribers of CannEpil, who will provide access to a pool of more than 100 patients. The formal TGA authorisation follows endorsement from the St Vincent's Hospital Melbourne Human Research Ethics Committee for the use of CannEpil in the treatment of adults with drug-resistant epilepsy.
The company has already established links with the patient support group, Epilepsy Action Australia (EAA). The EAA estimates that up to 240,000 people are currently living with epilepsy in Australia. However, we base our forecasts on an estimate of 154,000 Australians with active epilepsy, based on the estimated global prevalence of active epilepsy of 6.4 cases per 1,000 people (see pages 8-9 for details).
MGC anticipates the initial base of 100 patients generating revenues of A$1m; we conservatively model a more modest uptake, with sales of CannEpil as an investigational product in Australia assumed to reach A$1.0m in FY21. We will look to revise our forecasts as MGC establishes a track record of sales in Australia.
MGC has announced that it intends to undertake a Phase II safety and efficacy study of six weeks of treatment with the company's CannEpil medicinal cannabis formulation in children and adolescents with treatment-resistant epilepsy at the University Children's Hospital Ljubljana, Slovenia. CannEpil is a whole plant extract-based medicinal cannabis formulation with a high (20:1) CBD/THC ratio. Over 65 volunteers have been identified to participate in the study, which aims to recruit over 100 subjects. The Phase IIa crossover study will compare the response to six weeks of treatment with CannEpil to treatment of the same individuals with a pure synthetic CBD that has already been studied at the hospital. The primary endpoint of the study will be a reduction in the frequency of seizures. The company has received ethics approval for the study, but it is awaiting final sign-off from the regulators in Slovenia before the trial can commence.
A positive outcome to the study would potentially lead to a Phase III pivotal study to support an application to register the product in the EU and Australia.
The company's near-term strategy does not include plans to seek regulatory approval in the US market as it focuses its resources on the European development programme. However, if the efficacy of CannEpil in the planned trials in children and young adults with refractory epilepsy is in line with expectations, we see a potential opportunity to subsequently commence a development programme to support an application for approval in the US. We do not expect the company to make any plans to seek approval in the US until it has evaluated CannEpil in a Phase III trial in Europe. We do not currently include any sales in the US in our model, so this represents a potential upside opportunity.
As cannabis is considered to be an illicit drug in most jurisdictions, its medical use is highly regulated. However, following recent changes, regulations in Australia and all countries in the EU now permit clinical treatment with cannabinoids and other medicinal cannabis products under defined conditions. In some jurisdictions, this is limited to products that contain CBD but not THC, or allow only low levels of THC in the products.
Countries with more liberal regulations that allow doctors to prescribe medical cannabis products containing higher levels of THC include Germany, Italy, Switzerland, the Netherlands, Croatia, the Czech Republic, Macedonia and Greece.
However, despite the relaxation of some restrictions, the growth and processing of cannabis products remains tightly regulated to reduce the risk that products may be diverted to the illicit drug market or for recreational use. For example, the growth of cannabis in Slovenia is regulated under the Production of and Trade in Illicit Drugs Act (referred to as the ZPPPD act). MGC will require a licence from the governments of Slovenia and the Czech Republic to export the cannabis products that it produces.
In addition to the regulations that apply specifically to cannabis products, the company will face the typical regulatory challenges of gaining pharmaceutical drug approval and GMP certification (which it has already obtained for its Slovenian facility). However, if MGC can successfully negotiate the regulatory hurdles to produce and sell pharmaceutical-grade cannabis products, these same regulations would become barriers to entry that may limit the number of competitors that it faces in the marketplace.
MGC intends to seek regulatory approval for CannEpil as a treatment for severe, refractory epilepsy in Europe and Australia. Epilepsy is a common and devastating neurological disorder characterised by repeated unprovoked seizures. Antiseizure drugs are routinely used to control seizures, but about one-third of epilepsy patients are drug-resistant and continue to suffer from uncontrolled seizures despite pharmacotherapy.2 Commonly used anti-epileptic drugs include clobazam, valproic acid, levetiracetam, lamotrigine and rufinamide.
The company's expectation that CannEpil will be effective at reducing seizure frequency in refractory epilepsy is supported by the fact that GW Pharmaceuticals has already demonstrated in well-controlled clinical studies that Epidiolex, a highly purified plant-derived CBD extract, is effective at reducing seizures in treatment-resistant patients with the severe epilepsy disorders Dravet syndrome and Lennox-Gastaut syndrome (LGS). The FDA approved Epidiolex for these two disorders in June 2018. The company has also filed for approval in Europe.
GW has reported positive results from three Phase III studies in Dravet and LGS patients, as shown in Exhibit 2. The average reduction in seizure frequency for Epidiolex doses of 10-20mg/kg in the three studies ranged from 37-44%, compared to 13-22% for placebo.
Despite the proven efficacy of CBD in severe forms of epilepsy, the failure of Zynerba's CBD gel in adult epilepsy shows there is no certainty that a particular product or clinical trial will deliver a positive result.
Zynerba, which has been developing ZYN002, a synthetic transdermal cannabidiol gel for adult epilepsy patients with focal seizures, announced that the compound failed to show significance in any of the primary or secondary endpoints in its Phase II trial (known as STAR 1). Whereas Epidiolex was able to show a ~40% reduction in seizure frequency in its three Phase III trials, ZYN002 was only able to show an 18.4% reduction at the lower dose (195mg daily total) and a 14.0% reduction at the higher dose (390mg daily total).
In September 2017, Zogenix announced positive Phase III results for ZX008 (fenfluramine) in treatment-resistant Dravet Syndrome. The responder rate (at least 50% reduction in seizures) was 75% for the high dose, 41% for the low dose and 7.5% on placebo. In a confirmatory Phase III reported in July 2018, the responder rate for an intermediate dose was 54% for ZX008 vs 7% for placebo. If it is approved ZX008 is likely to compete with cannabinoid drugs for market share.
Ngugi et al. Incidence of epilepsy: a systematic review and meta-analysis. Neurology (2011) 77:1005–12. doi:10.1212/WNL.0b013e31822cfc90.
Following a review of the epidemiology of epilepsy in Europe, Forsgren et al reported that ~20-30% of patients experience at least one seizure per month.5 Combining the higher 30% estimate of patients with frequent seizures with the fact that one-third of patients have treatment-resistant epilepsy (due to likely overlap between the two groups), we estimate that 10% of all patients with active epilepsy have frequent seizures that are resistant to antiseizure drugs.
We assume that this 10% of patients with severe refractory epilepsy represent the main target market for CannEpil. Applying this 10% factor to the prevalence of 6.4 patients with active epilepsy per 1,000 head of population, we estimate the addressable patient population with severe, treatment-resistant epilepsy to be ~69,000 young people aged less than 20 years and 260,000 adults aged over 20 in Europe, 3,900 young people and 11,600 adults in Australia, and 56,000 young people in the US.
MGC has announced plans to conduct a Phase II clinical trial of CogniCann in patients with mild dementia and Alzheimer's disease (AD). CogniCann is MGC's GMP-certified medical cannabis pharmaceutical product, which has been specifically formulated for the treatment of key dementia symptoms and improving specific cognitive functions. Each 10m bottle of CogniCann contains 250mg THC and 170mg CBD. The trial leverages IP secured through the company's Medical Advisory Board, led by Professor Uri Kramer, which is based on experience gained through the use of medicinal cannabis products in Israel.
Ethics approval has been received to conduct the study in partnership with the Institute for Health Research at the University of Notre Dame in Western Australia. The trial, which will recruit a total of 50 subjects aged 65 years and older, is expected to commence in early 2019, subject to TGA approval. The 16-week trial will use a randomised, double blind, crossover, placebo-control design to evaluate behavioural changes, quality of life, level of discomfort and pain in dementia patients living in residential aged care facilities (Exhibit 3).
CogniCann's impact on dementia symptoms will be assessed by validated questionnaires such as the Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Cohen-Mansfield Agitation Inventory, Quality of Life – Alzheimer's Disease (QoL-AD) and the Abbey Pain Scale.
Source: MGC Pharmaceuticals announcement. Note: *Adverse events (AE) will be recorded with each dose in the titration phase and on the last dose of the intervention phase.
Cannabis targets a system in the brain known as the endocannabinoid system, which comprises receptors called CB1 and CB2. The endocannabinoid system is involved in memory, appetite regulation and response to stress. Memory loss is a key feature of AD, and agitation and aggression are commonly observed symptoms in AD and other forms of dementia. This has prompted a number of investigators to explore the potential for cannabis and cannabinoids to ameliorate dementia symptoms.
Several studies in cell culture and animal models have shown that cannabinoids can reduce oxidative stress, neural inflammation, and the formation of amyloid plaques and neurofibrillary tangles, the key hallmarks of AD.6 Some studies have shown that cannabinoids appear to remove the amyloid plaques that are a hallmark of AD from nerve cells grown in the lab.7 A study in an animal model of AD found that a combination of THC and CBD preserved memory, reduced learning impairment and decreased levels of soluble beta amyloid1-42, a key component of amyloid plaques found in the brains of patients with AD.8 Some researchers believe that targeting the CB2 receptor (eg with CBD) could control the activity of microglia cells, preventing the potentially harmful overactivation of the immune system in the brain seen in AD.
Aso et al 2015. J. Alzheimers Dis. 43, 977–991.
In contrast to the negative findings from the van den Elsen study, in July 2018 the synthetic cannabinoid nabilone (Cesamet, Mylan/Meda Pharmaceuticals) successfully met its primary endpoint of reducing agitation and aggression in a randomised 39-patient Phase II/III study in AD patients (NCT02351882).10 Nabilone is a synthetic cannabinoid analogue of THC that causes minimal euphoria. In addition to meeting the primary endpoint of improving agitation as measured by the Cohen-Mansfield Agitation Inventory, nabilone also improved quality of life, cognition and overall neuropsychiatric symptoms. Although the treatment was well tolerated, there was an increase in sedation (drowsiness/sleepiness, 45% on nabilone vs 16% on placebo).
Despite the fact that the results of the investigator-sponsored Phase II/III study of nabilone are positive, larger trials and replication would be needed to make recommendations that would change clinical practice.11 Nabilone is currently approved in the US and certain European countries for the treatment of chemotherapy-related nausea and vomiting. The study was sponsored by the Sunnybrook Research Institute in Canada, and we could not find any evidence that Mylan plans to conduct a confirmatory study of nabilone in dementia.
In addition to the completed trials above, our search of clinicaltrials.gov identified two ongoing studies of cannabis or cannabinoids in dementia. The first was a 60-patient randomised Phase II study in dementia-related agitation and aggression (NCT03328676). This study, which is being conducted by TO Pharmaceuticals, a subsidiary of Tikun Olam, is investigating the effect of Avidekel, a low THC cannabis oil (THC:CBD 1:20). The study commenced in December 2017 and is expected to complete in November 2019.
The second study is an investigator-sponsored, 160-patient Phase II pilot study of dronabinol for the treatment of agitation in AD (NCT02792257). The trial, which commenced in March 2017, is expected to report top-line results in August 2020. Dronabinol (Marinol, AbbVie), a synthetic oral formulation of THC, is FDA-approved for anorexia/weight loss in AIDS and for nausea/vomiting associated with chemotherapy.
The successful nabilone study and the ongoing studies of dronabinol and Avidekel raise the possibility that CogniCann could face competition from an established cannabinoid-based therapy for dementia-related AD symptoms by the time MGC generates efficacy data for CogniCann for this indication.
Neither the FDA nor EMA has approved any drugs to treat neuropsychiatric symptoms such as agitation in dementia patients. Non-pharmacological interventions are suggested as first-line treatment, but are not effective for every patient. Currently, these symptoms are treated by off-label use of psychotropic medications such as antipsychotics, antidepressants, benzodiazepine sedatives and anti-convulsants. These drugs have modest efficacy and their use can produce harmful side effects.
A number of candidate drugs are in Phase III development for the treatment of agitation in dementia, including the antipsychotic brexpiprazole, the antidepressant citalopram, and the novel compounds AVP-786 (deuterated-dextromethorphan/quinidine combination) and Lumateperone (ITI-007).12 These drugs could be potential competitors for CogniCann (if approved).
As we do not have data on the proportion of dementia patients living in care facilities, we conservatively assume that the addressable market of patients with agitation or other neuropsychiatric symptoms that are not adequately controlled by non-pharmacological interventions represents 10% of dementia patients. This represents 550,000 patients in North America, 950,000 patients in Central and Western Europe and 40,000 patients in Australia.
The market research group EvaluatePharma estimated that the market for AD drugs was valued at ~US$2.4bn in 2018 and forecasts it to grow to US$5.7bn by 2024. The approved AD drugs fall into two drug classes. Cholinesterase inhibitors, such as donepezil, galantamine and rivastigmine, slow down the breakdown of the neurotransmitter acetyl choline, which is involved in memory and judgement. Memantine helps control a different brain chemical needed for learning and memory. Namzaric is a combination of memantine and donezepil. These drugs have been shown to improve cognition and behaviour in people with AD, but do not slow down disease progression.
The market research group Grand View Research recently estimated that the global medical marijuana market was worth US$11.4bn in 2015, and forecasts it to grow to US$55bn by 2025 due to the increasing number of territories that have legalised the use of medical cannabis and the increasing demand for cannabis in medical applications. It estimated that North America accounted for a 49% share of the current global market, with chronic pain the largest indication, accounting for a 40% revenue share.
We use the current experience of medical cannabis use in Israel as the basis to estimate the underlying potential demand for cannabis resin in Europe for use in investigational medicinal products. Sales of medical cannabis are licensed by the Israeli Ministry of Health for a number of indications, including oncology-related pain and side effects of chemotherapy, phantom pain and pain related to multiple sclerosis, diabetic neuropathy, post-traumatic stress disorder, intractable epilepsy, intractable Crohn's disease and severe fibromyalgia. In 2016, there were 23,500 active licences in the Ministry of Health registry,16 representing ~0.3% of the total population.
We use the 0.3% uptake of medical cannabis products in Europe as a guide to the potential underlying demand that is likely to exist in Europe. If uptake in the EU was to reach a similar level to that seen in Israel, and assuming a low average dose of 1mg/kg/day (the lowest dose used in the Tzadok et al epilepsy study in Israel), we estimate the potential demand for cannabis in the EU of approximately 37,000kg of cannabis resin equivalent each year.
At the wholesale price of €50 per gram of CBD resin that we model in our forecasts, this would be worth €1.9bn per year. In practice, this demand would likely be met by a combination of cannabis resin and cannabis flower products.
At present, the medical cannabis regulations in most countries in Europe are more restrictive than those in Israel. If we restrict the analysis to the 195 million people in the eight European countries with more liberal medical marijuana laws (listed on page 7), we estimate the underlying demand for medical cannabis in those countries to be equivalent to 14,000kg of resin per year. We model MGC's API production in 2023 to be equivalent to 500kg of resin, which is approximately 3% of estimated underlying demand in these eight countries.
MGC has signed a binding term sheet for the sale of its MGC Derma business to the unlisted Canadian cannabis investment company Cannaglobal for up to C$15m (A$16m), and a five-year CBD and cosmetic materials supply agreement. The supply agreement includes an upfront order and payment of C$1m for the purchase of raw materials from MGC. The sale is subject to shareholders voting to approve the sale at the AGM in early November, and there being no material adverse change in either MGC or Cannaglobal.
Consideration for the sale comprises C$9m in ordinary shares in Cannaglobal at settlement, C$3.5m of shares payable on the achievement of certain revenue milestones, plus the future repayment of the existing C$2.5m working capital loan owed to MGC by MGC Derma. As Cannaglobal is an unlisted entity, we are unable to independently confirm the value of their shares.
MGC Derma (previously known as Ananda Cosmetics) is a joint venture company that was owned 51% by MGC and 49% by the Slovenian cosmetics manufacturer Dr M Burstein (Burstein). To complete the Cannaglobal transaction, MGC has acquired the 49% of MGC Derma held by Burstein for C$1.25m (Burstein's share of the MGC Derma working capital loan). In turn, Burstein will benefit from the five-year cosmetic materials supply agreement that is part of the transaction.
On 20 October 2017, the company announced that its MGC Derma division had signed a binding terms and conditions supply agreement for the supply of A$40m per year of white-label (unbranded) cosmetic products to the Korean cosmetics manufacturer Varm Cosmo. Ten days later, it signed the first binding sales agreement with Varm Cosmo, for a minimum contracted volume of A$8m of product.
However, Varm Cosmo failed to meet its commercial obligations under the agreement, including the payment of a A$1m deposit. On 25 September 2018, MGC issued a formal contract default notice to Varm Cosmo and will seek a minimum of A$0.5m from the company as restitution, plus additional damages.
MGC Derma has developed a range of CBD-based cosmetic products, including the Derma Plus range of dermatologically tested products that have shown efficacy in improving a range of highly irritated or inflamed skin conditions. The Derma Plus range includes products for the relief and prevention of psoriasis, acne and seborrheic conditions, including its CBD Herbal Repair Cream, Herbal Balm and Herbal Replenish Cream. Successful safety studies have allowed the company to register the products with the European Cosmetic Products Notification Portal (CPNP), allowing them to be sold in Europe as 'dermatologically tested' products.
MGC Derma is marketing its mgc derma range of CBD-based cosmetic products through its online shop and through wholesale reseller agreements in Spain, Italy, Romania and the Czech Republic. It has signed supply agreements with leading online retailer Cult Beauty and the prestigious department store Harvey Nichols to sell the range of cosmetic products internationally.
MGC faces the typical risks of a development-stage biopharma company, including the unpredictable outcome of trials, regulatory decisions, success of competitors, financing and commercial risks, coupled with unique risks associated with its medicinal cannabis focus.
The investment case hinges on establishing expanded, GMP-certified, medicinal cannabis growing and processing facilities in Malta. The ability to obtain regulatory approval for CannEpil for the treatment of refractory epilepsy will be crucial to its ability to drive additional sales growth in the competitive medicinal cannabis space.
Due to the highly regulated nature of the medicinal cannabis market, the company is vulnerable to regulatory changes that either restrict its ability to operate or alternatively leave it open to increased competition from new entrants.
We note that the inclusion of low levels of psychoactive THC in CannEpil could potentially increase the incidence of side effects such as drowsiness or nausea in patients.
GW Pharmaceuticals has gained FDA approval and is currently seeking approval in Europe for Epidiolex in two severe epilepsy syndromes. Epidiolex is a highly purified formulation of cannabidiol (CBD), the main ingredient in CannEpil. If the efficacy of CannEpil is not comparable to Epidiolex, it may be difficult to capture a significant market share. GW has an extensive patent estate, which affects the extraction, purification and use of CBD in refractory epilepsies. While the company's advice is that the GW patents will not impinge on its freedom to operate, there is a risk that GW could pursue legal action if it believes that its patents have been infringed.
Finally, the company could potentially face competition from supplies of synthetic CBD from API manufacturers in South Asia.
We arrive at an initial valuation of A$140m, based on a 15-year, sum-of-the-parts risked DCF valuation model of the company's CannEpil product for epilepsy and CogniCann for dementia in Europe and Australia, as well as API sales of cannabis flowers and resin. We assume 3% annual market growth but do not include any terminal value. We include a valuation of MGC Derma based on the proposed sale consideration. Taking into account the 1,213m shares in issue and 100m performance shares, our valuation is equivalent to A$0.11 per share. On a fully diluted basis our valuation is A$0.10 per share, after taking into account 95m performance rights and options that would be in-the-money if the stock traded in line with our basic valuation. Exhibit 4 summarises the key assumptions and constituent parts of our valuation. We use a 12.5% discount rate and apply an average tax rate of 10% from 2022 onwards. The company does not currently have patent protection for its product pipeline.
As described earlier, we estimate the number of patients with severe, refractory epilepsy who make up the main target market for CannEpil to be ~69,000 young people aged less than 20 years and 260,000 adults aged over 20 in Europe, 3,900 young people and 11,600 adults in Australia, and 56,000 young people in the US.
We give the programme to develop CannEpil as a registered pharmaceutical product for epilepsy in Europe and Australia a 20% probability of success, supported by the positive results reported for a similar formulation in Israel and the fact that GW Pharmaceuticals has already demonstrated in Phase III studies that CBD, the main component in CannEpil, significantly reduces seizure frequency in children with two different, severe refractory epilepsy syndromes. Although MGC has announced plans for a Phase II trial in Slovenia, it has not yet commenced recruiting patients. We include modest pre-approval sales of CannEpil as an investigational medicine in our model with a probability of 100%.
We do not include CannEpil for juveniles in the US in our valuation at this stage, as we do not expect the company to decide whether to commence development for this indication in the US until it has completed a Phase III study in Europe.
We assume that the company will commence sales of CannEpil in Europe and Australia during the current financial year as an investigational medicine. We expect it to achieve penetration of 0.5% to 1% of the addressable market for young people as an investigational medicine in select countries including Australia, Germany, Italy, Croatia, Greece, Macedonia and the Czech Republic, and penetration of 10% in young people and 5% of adults if it is approved as a registered pharmaceutical. We model a launch price as an Investigational Medicinal Product equivalent to €4,800 per year and A$8,900 per year for children in Europe and Australia respectively (assuming 90% compliance). This compares to the list price for GW's Epidiolex for children in the US of US$32,500 (A$43,000) per year. For the higher dose of CannEpil required for adults, we assume Investigational Medicinal Product pricing of €8,000 per year and A$14,900 per year in Europe and Australia respectively. We assume a modest 10% price increase if relaunched as a registered pharmaceutical.
We model clinical trials and regulatory submissions in Europe and Australia to cost €7.0m for juvenile epilepsy and €6m for adults.
We model clinical trials and regulatory submissions for CogniCann in Europe and Australia to cost A$15m.
For both CannEpil and CogniCann we model the company earning an average gross profit margin of 35% on sales, after allowing 35% for COGS and a 30% average distributor margin.
The company intends to sell a proportion of cannabis flowers and THC and CBD resins produced at its facilities in Malta, the Czech Republic and Slovenia as APIs in addition to using the resin to manufacture CannEpil and other finished products, and for the supply of food-grade CBD resin to MGC Derma and other customers for the manufacture of cosmetic products. It is currently growing cannabis in 1,100m2 of greenhouse space in the Czech Republic and has received full GMP certification for its resin extraction facility in Slovenia.
We expect the company to expand its greenhouse space to 5,000m2 by 2020 and 10,000m2 by 2022 and increase its resin extraction capacity at a total cost of ~A$10m. This would allow it to grow 5,000kg of cannabis flowers (on a dry matter [DM] basis) from two crops per year by 2023. We assume that by 2023, 90% of the crop will be used for the production of resin and flowers for sale as API, and 10% will be used for the production of food-grade CBD for cosmetics and other products.
We assume that the flowers for API production contain 7% THC and 7% CBD, and that the company achieves an 80% extraction efficiency. We model cannabis flower sales priced at €3.5 per gram with a growing cost of €0.7 per gram and a 30% distributor margin. According to the company, at present in Europe API-grade, GMP-certified CBD resin is selling for €45-50/g and GMP-certified THC resin is selling for €200/g. We assume that the prices will decrease over time as supply increases, and conservatively model all API-grade resin sales at an average price of €50/g, with a cost of production of €25/g.
We assume that food-grade CBD resin is sold for €25 per g. The lower-purity requirement for food-grade resin results in a lower cost of production. This is due to both the lower expenditure on quality assurance testing and the higher extraction yields that result from a wider proportion of the CBD profile being collected during flash chromatography separation. We assume cost of production of €16 per g for food-grade resin.
We assume that shareholders will approve the sale of MGC Derma, and that the transaction is completed according to the announced terms. We value the Cannaglobal shares to be issued as upfront consideration at face value of C$9m, and include the C$2.5m working capital loan, which is to be repaid in the future as cash or shares. At this stage, we do not include the C$3.5m of shares payable on the achievement of certain revenue milestones; we will review this once we have more visibility as to the sales trajectory.
Source: Edison Investment Research. Notes: *Financial year of product launch; #sales of investigational CannEpil begin in FY19 at 100% probability, registered pharmaceutical in FY23 at 20% probability; **peak sales estimates rounded to nearest A$10m; ***risk-adjusted R&D costs are offset against income for each drug development project.
MGC has been loss making since listing in February 2016, reporting losses of A$6.2m in FY16, A$8.5m in FY17 and A$9.0m in FY18. We forecast smaller PBT losses of A$5.7m and A$6.6m in FY19 and FY20 respectively, as it commences commercial sales of API in Europe and of CannEpil as an Investigational Medicinal Product in Australia. We forecast R&D expenses of A$1.3m in FY19 and A$5.8m in FY20.
We assume that expansion of cannabis-growing and API extraction capacity to support 10,000m2 of greenhouse space by 2021 will require capital expenditure of A$10m. The company raised net proceeds of A$10.5m from stock issues in FY16, A$9.8m in FY17 and A$4.7m in FY18. The current cash balance of A$9.9m should be sufficient to support operations into FY20. We estimate that additional funds of A$6m will be required in FY20 to support construction of the new facilities in Malta, which we model as indicative long-term debt.
Mr Zomer joined Mr Segev as co-founder of MGC Pharma and then as the executive director and CTO, following 10 years' experience in the biotech and agrotech sectors, alongside running large-scale projects. Mr Zomer brings his extensive list of business contacts, and scientific and engineering expertise to ensure the company is positioned as a leader in research and development, in addition to guaranteeing top performance from global operations.
Mr Mitchell is a corporate finance executive with over 20 years' experience in the finance, technology and resources industries. He has been the co-founder of a number of ASX and private companies across these sectors, and holds executive and non-executive directorship roles with his key business interests. His executive management responsibilities cover capital markets, corporate finance, new business strategy and treasury for these companies.
Mr Segev founded MGC Pharma in 2014 with the goal of expanding into international markets and raising the quality of medicinal phytocannabinoid products, in addition to making them accessible to patients all over the world. Prior to establishing MGC Pharma, Mr Segev was leader in the medical cannabis industry with a sizeable patient-base.
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Annetta Texas Population Charts
According to the most recent demographics data available from the Census Bureau released in December of 2019, Figure 1 Annetta illustrates it has 3,014 population which isthe 4th ranked in population out of 10 total in the area. The city with the highest population in the area is Weatherford Southeast with a population of 33,611 is appreciably bigger. Figure 3 compares the population change from 2010 to 2018 and we can see Annetta indicates an increase of 1,726 (134%).
The population percent change for all areas for 2010 to 2018 is shown in Figure 4 and for Annetta shows it has 134.0% Population Change which is the largest of all placesin the area. Comparing Population Change to the United States average of 6.2%, Annetta compares as substantially bigger. Also, measured against the state of Texas, Population Change of 10.9%, Annetta is substantially bigger.
Looking at population density in Figure 5 Annetta shows it has 1,298 population density which is the 2nd most of all the places in the area. The next lower population density is Willow Park measures approximately three-fourths the size with population density of 785. The city with the highest population density in the area is Aledo with a population density of 1,476 is 13.7% larger. Figure 6 shows the median age of the people and Annetta shows it has 37.9 overall median age of all people which isthe 6th ranked in overall median age of all people out of 10 total in the area. The city with the highest overall median age of all people in the area is Annetta North with an age of 52.4 is 38.3% larger. Comparing the median age of men versus women in Figure 7 we find that Annetta shows median age of men compares as about 9.8% smaller than median age of women. Figure 10 shows the Hispanic or Latino population of the area with Annetta shows it has 6.4% people who are Hispanic or Latino which isthe 5th ranked in people who are Hispanic or Latino out of 10 total in the area. Figure 11 is the ratio of the population of men to women and shows total male population is 15.0% larger than total female population.
Annetta Texas Marriage and Families Charts
Figure 14 is the average size of a typical family. Annetta shows it has 3.4 average family size which is the 2nd most of all the places in the area. The city with the highest average family size in the area is Aledo with a size of 4.0 is 18.8% larger.
Figure 15 shows the ratio of families to total households and that Annetta illustrates it has 86% percent of people who are in a family which is the largest of all placesin the area.
Looking at husband and wife headed families as a percent of all families in Figure 16, Annetta shows it has 96% percent of people in a husband and wife family which is the 2nd most of all the places in the area. The city with the highest percent of people in a husband and wife family in the area is Annetta South with a percent of 99% is only about 3.2% larger.
Annetta Texas Mothers and Babies Charts
The next section of charts look at mothers and baby births over the last 12 months. Figure 18 shows the rate of women aged 15 to 50 years old who have given birth. Annetta shows it has 10.0% percent of women who gave birth which is the highest of all placesin the area.
Annetta Texas Singles Charts
Figure 28 compares the total single people in each area. Annetta shows it has 29% percent of people who are single for any reason which isthe 6th ranked in percent of people who are single for any reason out of 10 total in the area. The city with the highest percent of people who are single for any reason in the area is Aledo with a percent single of 41% is 43.6% larger. Comparing percent of people who are single for any reason to the United States average of 50%, Annetta measures approximately half the size. Also, in contrast to the state of Texas, percent of people who are single for any reason of 49%, Annetta is approximately three-fourths the size.
Figure 30 compares the single people in each area broken down by never married, divorced, and widowed. Annetta shows it has 20% percent of people never married which isthe 4th ranked in percent of people never married out of 10 total in the area. The city with the highest percent of people never married in the area is Annetta South with a percent never married of 29% measures 47.3% larger. Comparing percent of people never married|percent of people divorced|percent of people widowed to the United States average of 33%, Annetta is approximately half the size. Also, measured against the state of Texas, percent of people never married|percent of people divorced|percent of people widowed of 33%, Annetta is approximately three-fourths the size. Figure 31 shows the single men in each area. Annetta illustrates it has 24% percent of men who have never been married which is the 2nd most of all the places in the area. The city with the highest percent of men who have never been married in the area is Aledo with a men who have never been married of 26% is 7.1% larger. Comparing percent of men who have never been married|percent of men who are divorced|percent of men who are widowed to the United States average of 36%, Annetta is approximately three-fourths the size. Also, benchmarked against the state of Texas, percent of men who have never been married|percent of men who are divorced|percent of men who are widowed of 36%, Annetta is approximately three-fourths the size.
Figure 33 shows the single men between the age of 18 and 65, in each area, broken down by age group. Annetta has the largest proportion of percent of Single Men 18 to 24 at 53% of the total and is ranked #1. Second, it has the largest proportion of percent of Single Men 45 to 49 at 21% of the total and is ranked #1.
Annetta Texas Citizenship Charts
In Figure 37, the percentage of the population who was not born in the United States is shown (i.e. Percent Foreign Born.) Annetta shows it has 1.6% percent of population who was born in another country which isthe 5th ranked in percent of population who was born in another country out of 10 total in the area. The city with the highest percent of population who was born in another country in the area is Aledo with a percent born outside United States of 2.8% measures 76.4% larger. Comparing percent of population who was born in another country to the United States average of 13.5%, Annetta measures approximately a tenth the size. Also, compared with the state of Texas, percent of population who was born in another country of 17.0%, Annetta is approximately a tenth the size.
Figure 39 shows the age break down of non citizens. Annetta has the largest proportion of percent of non citizens under 18 years old at 58% of the total and is ranked #1. Figure 40 shows the median age of non citizens and it has 16.9 median age of non citizens which is the 3d most of all other places in the area. The city with the highest median age of non citizens in the area is Weatherford Southeast with a median age of 39.9 is approximately 2.4 times bigger. For non citizens, Figure 41 shows the year that they entered the United States and it has the largest proportion of percent of non citizens who entered the US between 1990 to 1999 at 23% of the total and is ranked #1.
For all foreign born people who have gone through naturalization (the process of becoming a citizen), Figure 42 shows when they became naturalized. it has the largest proportion of percent of people Naturalized 2005 to 2009 at 88% of the total and is ranked #1.
Annetta Texas Birthplace Charts
Figure 45 is a table that breaks out all the foreign born people by where they were born. Annetta has the largest proportion of percent foreign born in Europe-Northern at 8.5% of the total and is ranked #1.
Annetta, Texas Demographics Data
Marriage and Families
Figure 1: Annetta, TX and Area 2018 Population Data
Figure 2: Map of Annetta, TX and Area
Figure 3: Annetta, TX Population Change 2010 to 2018
Figure 4: Annetta, TX 2010 to 2018 Population Percent Change
Figure 5: Annetta, TX People per Sq. Mile
Figure 6: Median Age in Annetta, TX
Figure 7: Median Age by Gender in Annetta, TX
Figure 8: Annetta, TX and Area Age by Generation
Figure 9: Annetta, TX and Area Racial Makeup
Figure 10: Annetta, TX Hispanic Population
Figure 11: Male vs. Female Population
Figure 12: Annetta, TX Marriage Status
Figure 13: Advertisement
Figure 14: Annetta, TX Average Family Size
Figure 15: Families as % of All Households
Figure 16: Husband and Wife Families as Percent of All Families
Figure 17: Annetta, TX Head of Household
Figure 18: Annetta, TX Birth Rate (Last 12 months)
Figure 19: All Births Age of Mother
Figure 20: Annetta, TX Teenager Birth Rate
Figure 21: Annetta, TX Unwed Mothers as % of All Births
Figure 22: Annetta, TX Unwed and On Public Assitance
Figure 24: Annetta, TX Unwed Mother Births By Age Group
Figure 25: Annetta, TX Unwed Mother Birth Rate By Race
Figure 26: Annetta, TX Unwed Mother Births By Poverty Level
Figure 27: Unwed Births and Education Level
Figure 28: Total Single People
Figure 30: Annetta, TX Single People Broken Down By Reason
Figure 31: Annetta, TX Single Men in Area
Figure 32: Annetta, TX Single Women in Area
Figure 33: Single Men by Age Group
Figure 34: Single Women by Age Group
Figure 35: Annetta, TX Citizenship Status
Figure 36: Citizen Place of Birth for Annetta, TX
Figure 37: Annetta, TX Percent of Population Foreign Born
Figure 39: Annetta, TX Non Citizen Age Breakout
Figure 40: Non Citizen Median Age
Figure 41: % Non Citizen Year of Entry into USA
Figure 42: Year of Naturalization
Figure 43: Annetta, TX Foreign Born People are From What Region
Figure 44: Annetta, TX Foreign-Born World Region of Birth
Figure 45: Annetta, TX Foreign-Born Sub-Region of Birth
Figure 46: Foreign-Born Country of People Living in Annetta, TX
Figure 47: Foreign-Born Country for all people in the United States
Cities marked with an asterisk ("*") should resemble a city or town but do not have their own government (i.e. Mayor, City Council, etc.) These places should be recognizable by the local community but their boundaries have no legal status. Technically these include both Census Designated Places (CDP) and Census County Divisions (CCD) which are defined by the Census Bureau along with local authorities. (For more information, see: Census Designated Place or "CDP") and Census County Division "CCD".)
For comparison purposes, the US and state value are provided as well as in some areas a "Combined Statistical Area" or CSA. These are large groupings of adjacent metropolitan areas identified by the Census Bureau based on social and economic ties. (See: Combined Statistical Area)
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