MGC Pharmaceutical (ASX: MXC) is a global biotech company that is looking to revolutionize the modern healthcare industry using cannabis-derived medicine.
MGC Pharmaceutical has a number of cannabis-based medicinal products currently under development that are intended to treat a variety of different conditions, including epilepsy, various forms of cancer, dementia and Alzheimer's.
However, MGC Pharmaceutical's most important assets are its research and manufacturing facilities in Slovenia and Malta, which allow it to harness a vertically integrated business model that can handle every level of the cannabis supply chain.
In fact, the Slovenian Facility was one of the first in the European Union's to receive approval to extract and develop phytocannabinoid active pharmaceutical ingredients (API) in July 2018, giving MGC Pharma a considerable head-start on the competition.
We are confident in the future growth of MGC Pharma and the opportunity that our business offers investors in providing exposure to the fast-growing market utilising cannabis for medical use and our unique 'Seed to Medicine' strategy.MGC Pharma Co-Founder and Managing Director, Roby Zomer
Meanwhile, the Malta Facility—which is currently in the process of being constructed—is set to become the company's primary operations hub going forward. This site is also expected to receive permission to produce APIs in house, which will significantly lower the cost of producing medicinal cannabis products.
While MGC Pharmaceutical has continued to build its Australian patient base over the course of 2019, the company also began targeting the European market, which could be worth as much as €123 billion by 2028, according to a recent report by Prohibition Partners. In aid of this, MGC is currently pursuing a listing on the London Stock Exchange (LSE) and has engaged the services of Cannacord Genuity to guide them through the process.
Additionally, the company's products are already generating revenue in the UK and Irish market— with countries such as Austria, Germany and Switzerland expected to soon follow suit—and a deal was recently negotiated that will see MGC's products distributed in Brazil and Latin America.
Investors can look forward to significant movement from the share price during the next 12-24 months, as the company reaches the upcoming 5,000 patient milestone. During this time MXC also expects to complete construction on the Malta site—while the Slovenian Facility will have reached maximum capacity—substantially improving the company's revenue growth and capability to support larger patient groups.
CannEpil – MGC Pharmaceutical's epilepsy drug
CannEpil is a phytocannabinoid product developed for the treatment of drug-resistant epilepsy that is currently being sold in Australia, South America and parts of Europe.
The drug is delivered using an oral oil solution of cannabidiol (CBD) and tetrahydrocannabinol (THC), which has been produced from two proprietaries, preselected, specifically bred genotypes of the cannabis plant with a stable and specific ratio of cannabinoids
Aside from CannEpil's efficacy and price point—which will make it a strong alternative to current medicines once registration is complete—it also offers a large addressable market for the company to target, as studies estimate that the UK and Australia have more than 500,000 and 250,000 epilepsy patients, respectively.
MGC Pharma has made terrific progress in 2019, having grown from just 100 prescriptions starting in August 2019, to more than 2,000 by the start of the calendar year. I am confident that this rapid growth trajectory will continue in 2020 as our products are now available on three continents and the prescription numbers are projected to increase as the knowledge of MGC Pharma's medicines improves amongst healthcare professionals.MGC Pharma Co-Founder and Managing Director, Roby Zomer
While the drug is currently being provided to patients in Australia and the UK via the early access schemes, it has still shown an impressively fast patient uptake. Over the course of the year, the company's prescription numbers have rapidly jumped from milestone to milestone, going from 200 to 400, before eventually jumping past 1000 in October 2019.
According to Zomer, the increased momentum of new prescriptions, "is a testament to the effectiveness of our phytocannabinoid medicines and growing recognition from, and use by, the medical community."
"I believe that this is just the beginning of our market penetration and we will be able to sustain this attractive growth trajectory."
"With our unique EU-GMP production and key market distribution infrastructure now established, we can meet this increasing demand for our offering of phytocannabinoid derived medicines in our existing and future markets in both Europe and Australasia," he said.
The company has confirmed that prescriptions are now expected to begin growing at an exponential rate, following the recent receipt of purchase orders worth more than $485,000.
At the start of the December 2019, the company also announced that it had successfully completed its entry into the Irish market, after it secured formal approval for the sale of CannEpil in Ireland, following a recommendation from the Health Products Regulatory Authority (HPRA).
Approval for CannEpil was officially granted by the Irish Ministry of Health, making it one of the first cannabinoid-based medicines approved for prescription and sale under Ireland's Medical Cannabis Access Programme.
CogniCann – MGC Pharmaceutical's dementia drug
CogniCann is MGC Pharmaceutical's second GMP certified, investigative medicinal cannabis product, which comes in the form of an oral spray that utilizes a specific THC:CBD ratio and is intended to relieve dementia symptoms.
It is produced using two preselected, proprietary genotypes of the cannabis plant with a stable and specific ratio of cannabinoids. The drug was developed based on longitudinal research conducted in Israel and is available to patients in Australia and the UK under early access schemes.
Clinical observations recorded by the company over the last three years have already demonstrated an improvement in the quality of life in a sample size of 1,000 patients. This could potentially prove to be hugely valuable from an investment perspective, as dementia and Alzheimer's has a huge addressable market, with the company identifying a potential patient base of 2.5 million sufferers in Europe and Australia alone.
The company is currently in the process of completing Phase IIb trials for CogniCann—which are being conducted by the University of Notre Dame in Western Australia (WA)—and are on track for completion in Q2 2020.
At this rate, the drug has an expected time to marketing authorization of four years, with its current trials proceeding approximately 12 months ahead of schedule due to unprecedented demand from potential applicants.
The volume of applications has meant that the recruitment process will not take as long as originally anticipated and will result in a considerable time saving for the completion of the study which we now look to complete in Q2 2020, significantly ahead of schedule.MGC Pharma Co-Founder and Managing Director, Roby Zomer
CogniCann will also soon be making its way into the German, Austrian and Swiss markets, as MGC Pharmaceutical, recently signed a deal with MedVec—a subsidiary of Mexacare—to distribute the company's two flagship drugs.
The two-year agreement will see MGC's products sold as a white label product under its own name and will be used as an entry-point into the wider European market. According to the Managing Director of MGC Pharma, Roby Zomer, the company views Germany and the associated regions as representing, "a key emerging market within the wider European market."
"I am confident that this agreement with Mexacare will enable us to capitalize on this extraordinary market opportunity as we effectively commercialize MGC Pharmaceutical's products in the region via Mexacare's established network of pharmacies and medical professionals alongside its diagnostic technology that is expected to result in faster, cost-effective, prescriptions."
"As investors will recognize from the recent volume of news that we are focused on expanding MGC Pharma's global presence and connecting patients with our products," Zomer said.
Mercury Pharma 100 – MXC's CBD product
MGC Pharma took another huge leap forward in January 2020, when it unveiled the launch of its new brand of affordable cannabinoid products known as Mercury Pharma.
The proprietary affordable prescription medicine line is currently available exclusively in Australia and New Zealand, with "Mercury Pharma 100" (MP100)—a 100mg/mL CBD solution available for prescription from healthcare professionals—being the first product set to launch.
The launch of Mercury Pharma brand and "MP100" so early in 2020 bodes well for the year ahead as MGC Pharma continues to follow its agenda to provide cost effective affordable standardised phytocannabinoid based medicines to patients globally.Co-founder and Managing Director of MGC Pharma, Roby Zomer
MGC has already secured purchase orders for MP100 of more than 2,000 units, which are set to be distributed in January and February by logistics specialist, Cannvalate Pty Ltd, while additional orders from Health House International are also expected in the coming weeks.
MP100 was developed in response to feedback from patients and prescribing physicians concerning the access issues regarding the price point of medicinal cannabis products. The company expects the revenue generated from the purchase orders to produce in excess of $270,000, which will have a positive and immediate effect on short term revenues.
According to the Managing Director of MGC Pharmaceutical, Roby Zomer, the Mercury Pharma brand, "brings an alternative affordable high CBD prescription medicine to the Australian and New Zealand markets only, as well as adding a new product line to MGC Pharmaceutical's offering."
"We have already seen a positive response to MP100 with purchase orders totalling over AU$270,000, which will have an immediate and positive effect on our revenues in Q1 2020."
"With ever-increasing prescription numbers for our pharma-grade products, we expect to see a further significant increase inpatient and prescription numbers in the short term as MP100 is increasingly available in Australia and New Zealand, and as we continue to develop additional formulations for the Mercury Pharma brand," Zomer said.
MP100 is also expected to help drive total Australian and New Zealand prescription numbers, due to the product lines affordability and the large distribution network of Cannvalate. And it already seems to be taking effect, as news of the product's launch caused MGC Pharma stock to climb in value by 6.25%.
The COO of Cannvalate, Darryl Davies, lauded the company's new product line, saying that they are, "delighted to introduce MGC Pharmaceutical's latest range across our network."
"MP100 is a high-quality, cost-effective medication option that we expect to be extremely well received by both prescribing physicians and patients."
"MXC continue to work towards lowering barriers for Australian patients and we expect this will be the start of significant growth in patient numbers for 2020," Davies said.
Slovenia – MGC's EU-GMP certified production facility
Although MGC Pharma remains dedicated to staying on the forefront of research and product development, an equally important part of its broader commercialization strategy is its' "seed to medicine" approach to the cannabis supply chain.
While other cannabis companies often rely heavily on assistance from outside service providers—to assist in cultivation, extraction or distribution operations—MGC Pharmaceutical is capable of managing the entire process in-house. This allows the MGC stock to commercialize its products via a vertically integrated model that makes use of the company's full R&D capabilities.
And one of the most crucial elements of this model is its Slovenian Facility, which serves as the company's current multi-national base of operations. The facility is also European Good Manufacturing Practices (EU-GMP) certified, which is a hugely valuable asset—as it allows the company to develop its own APIs—significantly reducing the cost of producing Phytomedicine products.
This is the main function and the main uniqueness of the facility, in order to be also cost effective, we have also the approval to do our own API and to control the whole value chain. In the future to create our own unique APIs, because we believe and one of our studies also demonstrate it, it's not just the THC and CBDR, the API that need to be in our medication, but other cannabinoids.Co-founder and Managing Director of MGC Pharma, Roby Zomer
The facility houses the company's GMP Class D non-sterile manufacturing set-up, which is currently licensed to produce Investigational Medicinal Products (IMPs) for both human use and clinical trials and is also used to refine processes and develop new methods for the development of cannabis-based medicines.
In August 2019 the Slovenian Facility was granted a first of its kind approval from the Slovenian Ministry of Health, which will see it conduct a wide-ranging large scale research project—to be conducted in collaboration with the Institute of Hop Research and Brewing (IHPS)—studying the cultivation of cannabis for medicinal purposes.
MGC Pharmaceutical's management has confirmed that the study will also have a heavy focus on standardizing post-cultivation production processes, covering everything from genetics to API production.
The company then intends to use this research to create defined standards—in an industry first—for commercial cultivation, extraction and production, ensuring it remains at the forefront of cannabis research.
During this period the company kicked off a Phase IIb double-blind, placebo-controlled crossover study of CannEpil with the Institution for Children's Neurology Paediatric Clinic. The trial will be overseen by Professor David Neubauer—a member of MGC Pharmaceutical's Scientific Advisory Board—and will be used to assess whether CannEpil provides a meaningful reduction in seizures for patients suffering from drug-resistant epilepsy.
MGC Pharma has also partnered with Slovenia's National Institute of Biology (NIB) and the University Medical Centre Ljubljana, to study the efficacy of cannabis-derived medicines on glioblastomas.
If successful, this could be a huge development for the company, as glioblastomas are one of the most aggressive—and unfortunately treatment-resistant—forms of brain tumour. Luckily, data from the trial has been highly encouraging thus far, confirming that cannabinoid preparations can successfully inhibit tumour viability and cause a reduction in the number of glioblastoma cells.
More importantly, MGC's cannabis formulations were also shown to target glioblastoma stem cells—which are viewed as being the root of the disease—making them a highly viable treatment option for future oncology therapy.
Malta – MGC Pharmaceutical's future cultivation and manufacturing facility
MGC Pharmaceutical is in the process of constructing a new facility in Malta—which is expected to be fully operational by mid-2021—that will be substantially larger than their current Slovenian Facility and serve as MGC's primary operations hub going forward.
Once complete, the facility will allow MGC to achieve a fully integrated supply chain along with easy access to the European market through the FDA Mutual Recognition agreement, which includes the UK, Austria, Croatia, France, Italy, Spain, and Sweden.
MGC foresees great things for Malta, which is why we are here. The ease of access to Europe places Malta at the center of a global supply chain and the foresight and forethought of the government has ensured that the country can take advantage of that.Co-founder and Managing Director of MGC Pharma, Nativ Segev
Additionally, Malta has one of the Mediterranean region's main seaports, along with land access to Italy, making it an ideal logistical hub for MGC's European operations.
The climate in Malta is also ideal for large scale cannabis cultivation, allowing for three crop cycles each year. The Malta site will feature a 10,480m2 combined manufacturing facility—including GMP certified processing and production—as well as a 5,240m2 greenhouse on the roof for cultivation purposes.
In fact, the Maltese Facility is expected to become the world's biggest GMP certified phytocannabinoid manufacturing site thanks to its unmatched capacity. This will allow MGC to produce thousands of units of pharmaceutical-grade medicine per hour, making them a global leader in the pharmaceutical market.
The Managing Director of MGC Pharmaceutical, Roby Zomer, said that the company will split its manufacturing efforts between Slovenia and Malta until GMP certification is achieved at the new site, allowing for large-scale production that will cut its costs significantly.
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"Slovenia will do half manual and semiautomatic manufacturing, but with more variation to get the product through the clinical studies. But once we have a finish dose form (FDF), in Slovenia, this recipe—or what you call the SOP of the product—will go with the dossier to Malta, and then it's just large scale production that reduces our costs dramatically."
"Then we become much more cost-effective, meaning on the other side we will be more affordable, and maintain our low cost to the patient, relative to other products in the market," Zomer said.
Once the site is fully operational—and primary operations switches over to Malta—the Slovenian Facility will become the company's new research hub.
The construction of the Malta Facility will be funded by the company's capital raising upon listing on the London Stock Exchange (LSE), which is currently expected to cost approximately $20 million.
While this may seem steep, once the facility is fully operational it will be able to handle everything from cultivation to production, compounding, extraction and isolation, allowing the company to "produce 8,000 units of a product such as CannEpil in an hour."
According to the Co-founder and Managing Director of MGC Pharmaceutical, Nativ Segev, the growth of the cannabis industry over the coming years "is difficult to project, but it will be significant, and the simple fact is this: demand is growing for these products all over the world, and there is a lack of facilities, and personnel, to fill this need."
"Malta is ensuring it can offer both, and with other considerable benefits to a company with vision and a need to expand such as ours," Segev said.
MGC Pharmaceutical's Distribution Pipeline
MGC Pharmaceutical is a truly global operator in every sense of the word, and this includes the markets that the company is targeting.
Naturally, the MGC stock maintains a strong focus on the Australian market, while also supplementing its preexisting local distribution channels—which are handled by Cannvalate and Health House International—with clinical partnerships that have been established with both Cannabis Access Clinics (CAC) and Tetra Health.
Both companies are supplied with medicinal cannabis products as part of MGC's agreement with Cannvalate, while Health House International handles the offtake for all other clinics. This makes it a highly advantageous arrangement, as Cannvalate already has an established network of prescribing clinics ensuring continuous demand, while Health House gives the company access to the rest of the market.
And this demand only seems to be building, with Cannvalate recently reporting increased interest in the company's products. The CEO of Cannvalate, Sud Agarwal, stated that patients have shown a spike in interest in MGC cannabis products, thanks to their high quality and affordable pricing.
"We are delighted to see that MGC Pharmaceutical's product range has been so well received by the medical community. Each week, there are hundreds of patients that are accessing MGC range medication via our network," Agarwal said.
"The spike of interest has been due to superior quality (EU-GMP), competitive pricing and individually designed condition-specific medications."
At the same time, the company has also begun targeting the European market, with the UK and Ireland being the company's first port of call.
MGC made its initial entry into the UK market last year when its first shipment of CannEpil reached Britain in May 2019. Grow Biotech and IPS Specials are currently handling distribution, giving MGC stock access to a combined commercial network of 5,500 pharmacies.
According to the company, the UK is a highly lucrative area to target, as it has a medicinal cannabis market that is expected to be worth €8.8 billion by 2028. As a result, MGC Pharmaceutical sees the market as a "huge opportunity" for the commercialization of cannabis-based medicinal products.
The company also received formal approval for the sale of CannEpil in Ireland in December 2019, making it one of the only medicinal cannabis products currently available to patients under the country's Medical Cannabis Access Programme.
"Not only does it allow MGC Pharmaceutical's GMP certified medical products to reach more patients in need, but can be seen as a catalyst for fast-tracking follow-on approval applications to prescribe in other EU member state countries such as Germany, Austria, Italy and France," Managing Director Roby Zomer said.
"With distribution agreements already in place across Europe, we are well-positioned for a quick entry to these markets following receipt of the required approvals."
Now that they have also secured permission from the Irish government to begin distribution, they will begin pursuing entry into additional markets such as Austria, Switzerland and Germany through mutual recognition between EU member states.
This should allow the company to quickly capture a significant segment of the market share, as MGC Pharmaceutical already has distribution and the sales force on the ground, along with a growing network of doctors, clinicians and pharmacists.
In November 2019 the company also signed a binding term sheet with BRASILINVEST, to create a Joint Venture company aimed at the development of dedicated retail sales and marketing channels for MGC Pharmaceutical's products in key Brazil and Latin American markets.
The Brazil and Latin American markets for the use of cannabis-based medicines is developing rapidly and emerging as a key region in the global marketplace; this JV Co will provide MGC Pharma with a strategic position to capitalize upon this and become a key supplier into this growing market.Co-Founder and Managing Director of MGC Pharma, Roby Zomer
Under the terms of the deal, the joint venture company will be incorporated with 50/50 ownership structure, with MGC's first product shipment to Brazil expected in early December.
BrasilInvest's established network is expected to be used to promote MGC's products to medical professionals—and potential distribution partners—across key markets in the region. This will significantly assist the joint venture company's efforts to launch a sales distribution network in Brazil and other Latin American markets.
The deal represents another huge win for the company, as the Latin American medicinal cannabis market is expected to reach a valuation of $5.8 billion by 2028.
The company's management believes that the agreement will produce significant "material economic benefit" for the MGC stock, by facilitating new sales and revenues pipelines for its phytocannabinoid based medicines.
This is understandable, as the deal adds another major sales stream for the company in the Brazilian and Latin American market, outside of its wholesale distribution channel.
According to the Co-Founder and Managing Director of MGC Pharma, Roby Zomer, the binding agreement "with BrasilInvest represents a key milestone towards establishing MGC Pharma as a leading international producer of phytocannabinoid based medicines."
"Capturing a 50% share of the retail margin for our Company in the huge market of Brazil, and other Latin American markets under our JV Co, is a very commercially significant development for MXC," Zomer said.
Canndeo Supply Agreement
The company scored another home run in January 2020, after MGC announced a new agreement with THC Global Group Limited to produce and supply white label pharmaceutical grade Canndeo branded phytocannabinoid products in Australia and New Zealand.
News of the deal—which will provide a substantial new revenue stream for the company—sent stock in MGC Pharma climbing by 5.41%, and as of midday it was trading at 0.039 apiece.
The Supply Agreement with THC Global for the white label production and supply of pharma grade Canndeo branded products demonstrates MGC Pharma's reputation, high quality and cost competitiveness in the ever-growing use of phytocannabinoids for medicinal purposes.MGC Pharma Co-Founder and Managing Director, Roby Zomer
The supply agreement—which is set to run for a minimum of 18 months—has already generated €25,000 for the company from initial purchase orders, while all subsequent orders will have a minimum value of €50,000.
Under the terms of the deal, MGC will handle the production and supply of white label pharma grade Canndeo branded products with a variety of different cannabinoid formulations, including high CBD + low THC, balanced CBD + THC, and high THC low CBD.
The Co-Founder and Managing Director of MGC Pharma, Roby Zomer, also confirmed that THC's Global's range of Cannadeo products will not be targeting the same area of the market as MGC Pharma's cannabis-derived medicines, which should contribute significantly to increasing sales revenue in 2020.
"This new, and immediate, revenue stream will contribute to increasing revenues from Australia and New Zealand going into 2020, and we expect that further discussions between MGC Pharma and THC Global on mutual exports of product to respective international markets will be beneficial to the Company going forward, particularly as we develop our ~15,000m2 multipurpose GMP certified pharma production and research facility in Malta," Zomer said.
Canndeo's three oral liquid formulations will initially be manufactured at MGC Pharma's Slovenian production facility, before being imported to Australia and New Zealand for prescription under the respective countries' prescriber access schemes.
These products are expected to become available for patients in Q1 2020 and will serve as a stopgap solution for THC Global until the company can commence production at its Southport Facility.
The CEO of THC Global, Ken Charteris, also stated that both companies are currently pursuing the possibility of developing further global export opportunities, with plans to target "the North American, South American, European, Asian, and Oceanic markets" by providing competitively priced, high quality pharmaceutical products.
"As THC Global transitions into a large-scale Australian manufacturer of a full range of medicinal cannabis, we will seek further supply agreements with MGC Pharma that take advantage of quality and cost leadership in our respective operations, and competitively address the needs of multiple international markets," Charteris said.
The latest news relating to MGC Pharmaceutical
MGC Pharma Hits the 2,000 Prescription Milestone – The company has confirmed that the increase is being driven largely by patients in Australia and the United Kingdom.
MGC Launches Affordable Cannabinoid Product Line – The first product unveiled under the brand, MP100, is expected to drive additional prescription numbers in the short term.
MGC Commences Distribution of CannEpil in Ireland – The company expects the approval to expedite the licensing process in further EU member states.
MGC Provides London Stock Exchange Listing Update – The planned dual-listing is currently set to take place in February 2020 and is being overseen by Canaccord Genuity.
Reasons to invest in MGC Pharmaceutical stock
MGC Pharma is about to experience exponential patient growth,
- The company's prescription numbers increased rapidly last year, climbing from 200 to 1,000 by October 2019, before doubling again to 2,000 by the beginning of 2020.
- MGC Pharma entered into several new markets—including Brazil, Ireland and the UK—during 2019, with additional EU markets such as Austria, Switzerland and Germany expected to soon follow.
- The company recently secured purchase orders worth more than $485,000 for CannEpil alone.
The launch of the Malta Facility is expected to drive considerable value for investors.
- Once fully operational the Malta Facility is set to become the world's biggest GMP-certified phytocannabinoid manufacturing site.
- The Malta site will be able to manufacture 8,000 product units in an hour, giving it an unmatched production capacity.
- MGC will also enjoy easy access to the EU market through the FDA Mutual Recognition agreement, which includes the UK, Austria, Croatia, France, Italy, Spain, and Sweden.
MGC is targeting highly lucrative diseases with huge addressable markets.
- MGC Pharma's epilepsy drug, CannEpil, has a combined patient base of more than 750,000 in the UK and Australia.
- CogniCann could become a treatment option for up to 2.5 million dementia and Alzheimer's sufferers.
- The company's glioblastoma drug has shown impressive preliminary results in early clinical trials, while its oral CBD solution MP100 has already generated more than $270,000 in purchase orders.
Disclaimer: Past performance is not an indicator of future performance.
The forward outlook for MGC Pharmaceutical
The MGC stock put on a powerhouse performance in 2019, as it rapidly expanded patient numbers and hit several key milestones.
The company's products are now being distributed in multiple global markets—including Australia, New Zealand, Brazil, Ireland and the UK—while the upcoming launch of the Malta Facility will ensure that MGC remains one of the largest phytocannabinoid medicine manufacturers in the world.
These are also highly valuable areas for MGC to target, as the Latin American medicinal cannabis market is expected to reach a valuation of $5.8 billion within the next decade, while the UK is predicted to rise to €8.8 billion in value by 2028.
Last year we laid a very solid foundation for the company and in 2020 we shall build on it as we plan to continue to grow product sales, expand distribution to new territories, advance our clinical trials and commence construction at our production facility in Malta. We expect a lot of near-term positive news flow and I look forward to updating our shareholders on our progress.Co-founder and Managing Director of MGC Pharma, Roby Zomer
Additionally, the launch of its new CBD oral solution, MP100, is expected to drive considerable patient uptake, while the company's planned listing on the LSE remains on track for Q1 2020.
As a result, investors will see an increase in near term revenue over the course of the year as patient numbers experience further growth—with 262 new patients being added in December 2019 alone—and the level of repeat prescriptions continue to rise.
During the next 12-24 months, the market can expect to see significant movement from the share price, as the MGC stock completes its LSE listing, officially opens its cutting-edge Malta Facility and reaches the upcoming 5,000 patient milestone.
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