Medicure Inc.

Q1 2021 Earnings Conference Call

5/11/2021

spk01: earnings conference call for the year ended December 31st 2020 and quarter ended March 31st 2021 my name is Colin and I'll be your conference operator for today's call at this time all participants are in listen-only mode before we proceed I would like to remind everyone that this presentation contains forward-looking statements related to future results events and expectations which are made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risk and uncertainties, which could cause the company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, those described in the company's most recent annual information form and Form 20F. Later, we'll conduct a question and answer session Please note that this conference call is being recorded and today's date is May 11th, 2021. I would now like to turn the conference over to Dr. Albert Friesen, Chief Executive Officer of Medicare Inc. Please go ahead, Dr. Friesen.
spk05: Thank you, Colin, and good morning to all of you on the call. We appreciate your interest and participation in today's call. Joining me today in the call is our Chief Financial Officer, James Kinley, and President and Chief Operating Officer, Dr. Neal Owens. This morning we'll be discussing the year ending December 31st, 2020 and the first quarter of 2021. The release of the financial statements for the year ending 2020 and the first quarter of 2021 were so close that we decided to present them at the same call. COVID has provided challenges to a lot of businesses, including Medicare. Despite the challenges, we are delighted with the positive trend of revenue and net income over the past few quarters. We experienced a modest but positive EBITDA for the first quarter of 2021, a positive change from the losses that had been reported in 2019 and the first half of 2020. The sales of Agristat have stabilized and we're pleased with the early stage performance of our December 2020 acquisition, Marley Drug. One of the reasons we acquired Marley Drug, a mail order pharmacy, was to expand our sales reach for Zypidemag. The focus of our business is the sales and marketing of Agristat franchise and growing the Zypidemag business with more direct marketing to patients. with the help of Marley Drug, as well as continuing the marketing to healthcare providers. The revenue for the first quarter of 2021 was $4.9 million, which is up substantially from the previous quarters due mainly to the added revenue from Marley Drug. Agristat revenue of $2.63 million is similar to previous quarters. Marley was $2.1 million and Zypinemag $161,000. Medi-Cure has transitioned away from the sales and marketing of the REDS device, which reduced significantly our operating expenses and associated losses, while retaining value in our sensible medical investment. As mentioned, the main focus at present is on the sales and marketing of Agristat, Zypinemag, and further leveraging Marley Drug Pharmacy, which combined provide great margins and potential. We believe the past several quarters investments in our programs and onboarding of products will provide their growth, revenue and profits for the coming quarters and years. It takes time and persistence to make this a reality. Medicare has good cardiovascular product portfolio, a track record of growing sales and a great team with energy, talent and experience to build a strong growing company. Now, before turning the call over to our Chief Financial Officer, James Kinley, as we've reported, he is taking new opportunity. I would like to express a special thank you for the hard work and many contributions to Medicare. James.
spk04: Thank you, Bert, and good morning, everyone. A couple of quick items to note before I start. All dollar figures are in Canadian dollars, unless otherwise noted by each presenter. And as a reminder, you can obtain a complete copy of our financial statements for the year ended December 31st, 2020, and the quarter ended March 31st, 2021, along with previous financial statements on the investors page of our website. And a copy of all financial statements and management's discussion and analysis can be obtained from CDAR.com. Starting with the 2020 annual results, revenues for 2020 totaled $11.6 million compared to $20.2 million from 2019. The decrease in revenues between the two years was primarily a result of decreased Agristat revenues from $19.4 million in 2019 to $10.6 million in 2020. as a result of further genericizing of the Integralin market, which has created pricing pressures on Agristat, combined with lower hospital demand for the product, including a reduction in procedures being performed as a result of COVID-19. Zypidemag revenues increased to 453,000 for 2020, compared to 183,000 in 2019. The increase in revenues from Zepidimeg resulted from increased demand and usage of the product experienced during 2020 as a result of the company's sales and marketing initiatives implemented since acquiring control of the product. As a result of the acquisition of Marley Drug, which was completed on December 17, 2020, the company recorded revenue of $340,000 during the year ended December 31, 2020, pertaining to the Marley Drug in-store and mail-order pharmaceutical business. Cost of goods sold decreased from $7.3 million in 2019 to $6.5 million in 2020. Selling expenses for 2020 totaled $5.4 million compared to $13.4 million for 2019 as a result of cost reductions implemented during late 2019 and throughout 2020, particularly as it relates to the sales and marketing costs associated with REDS, as well as decreases in costs as a result of limitations to conference and travel-related costs due to COVID-19. Beginning with the acquisition of Marley Drug, which again was completed in December 2020, costs associated with the Marley Drug business are included in selling costs for the year ended December 31, 2020. General and administrative expenses for 2020 increased to $4.6 million from $3.4 million in 2019. The increase in G&A expenses during 2020 when compared to 2019 primarily relate to higher legal costs associated with the company's patent challenge, which was settled in the fourth quarter of 2020, partially offset by cost reductions implemented by the company during late 2019 and throughout 2020. Research and development expenses totaled $3.3 million for 2020 compared to $4.3 million for 2019. The decreased experience during 2020 is primarily a result of FDA refunds obtained by the company during 2020 resulting in a recovery of expenses of $677,000 pertaining to previously paid FDA fees as well as reducing the quarterly expense going forward and in addition to the timing of research and development expenditures resulting in timing of each development project. During 2019, the company recorded a loss of $3.6 million as a result of the revaluation of the holdback receivable from the APICOR transaction, as well as an impairment loss on the intangible assets pertaining to REDS of $6.3 million. There were no similar losses recorded during 2020. The company recorded finance income of $765,000 in 2020, compared to $1.1 million in 2019, and a foreign exchange gain of $497,000 in 2020 compared to a loss of $2.6 million in 2019. This resulted in a net loss for 2020 of $6.8 million or $0.64 per share compared to $19.8 million or $1.32 per share for 2019 due to the factors previously described. Adjusted EBITDA for 2020 was negative 3.9 million compared to adjusted EBITDA of negative 3.8 million for 2019. The change is primarily due to the decrease in revenues and increased G&A expenses partially offset by decreases in selling expenses when compared to 2019. As at December 31st, 2020, the company had cash totaling 2.7 million compared to 13 million as of December 31st, 2019. The decline primarily related to cash spent to acquire the Marley Drug business in December 2020. As at December 31st, 2020, the company had net working capital of $3.2 million compared to net working capital at December 31st, 2019 of $19.7 million. Turning to the quarter ended March 31st, 2021. Total revenue for Q1 2021 was $4.9 million compared to $3 million for Q1 2020. Net revenues from Agristat for the quarter ended March 31st, totaled $2.6 million, consistent with net revenues from Agristat for the same quarter of 2020 of $2.7 million. The company earned net revenues from Zepidemag for Q1 2021 of $161,000, Again, consistent with revenues from Q1 2020 of $163,000. The company continues to focus on Zepidemag and expects revenue to grow through the remainder of 2021 and beyond. The company recorded revenue of $2.1 million during the three months ended March 31st, 2021 pertaining to the Marley Drug in-store and mail-order pharmaceutical business. There were no revenues recorded from REDS during Q1 2021 compared to $89,000 in the same quarter of 2020 and the company earned $49,000 of revenue from Sodium Nitro Precide or S&P during Q1 2021 compared to $31,000 for the same quarter in 2020. Turning to cost of goods sold, Agristat cost of goods sold for Q1 2021 totaled $670,000 compared to $666,000 for Q1 2020, and this resulted in gross margins for the quarter of approximately 74%, a slight decrease from the approximately 76% margin for the same quarter in the prior year. Zepidemag cost of goods sold for Q1 2021 totaled $605,000 and included $28,000 related to products sold to customers, $573,000 from amortization of the Zepidemag intangible assets, and $5,000 relating to royalties on the sale of Zepeda Mag resulting from the acquisition of the product in September of 2019. Removal of the amortization would result in a strong gross margin from the product of approximately 80%. As a result of the acquisition of Marley Drug, the company recorded cost of goods sold of $602,000 during Q1 2021 pertaining to the cost of products sold by Marley Drug. And additionally, S&P cost of goods sold during the quarter totaled $50,000. Selling expenses totaled $2.7 million for Q1 2021, up from $2.1 million for Q1 of 2020. And the increase in selling expenses when compared to the same quarter in the prior year were primarily due to the acquisition of Marley Drug. General and administrative expenses totaled $585,000 for Q1 2021, down from $800,000 from the same quarter in the prior year. The decrease in G&A expenses is primarily related to lower legal costs associated with the company's patent challenge, which was settled in the fourth quarter of 2020, as well as cost reductions implemented by the company during 2020. Research and development expenses for Q1 2021 totaled $581,000, compared to $858,000 for Q1 of 2020. The decrease is primarily a result of FDA fees expensed during Q1 2020, which were subsequently refunded after the company obtained a waiver of these fees, as well as timing of research and development expenditures resulting from the timing of each development project. Medicare is in the process of developing additional cardiovascular products consistent with our research and development strategy to focus on low-cost projects with higher probabilities for success and we don't expect our research and development costs to increase relative to this. The company recorded finance expense of $121,000 for Q1 2021. This relates to accretion on the company's Agristat royalty obligation, the Zepidemag acquisition payable and on the company's contingent consideration associated with the Marley drug acquisition. as well as finance expense related to the company's lease obligations and bank charges. This compares the finance expense for Q1 2020 of $73,000, which primarily related to accretion on the company's royalty obligation and acquisition payable, the lease obligations and bank charges, partially offset by interest on cash held by the company. The company recorded a nominal foreign exchange loss during Q1 2021 compared to a gain of $868,000 for Q1 2020. The change relates to changes in the U.S. dollar exchange rate during the respective periods, which led to foreign exchange gains and losses as well as a significant decrease in U.S. dollar cash balances held by the company. This results in a net loss for the quarter of $1 million or $0.10 per share compared to $1.5 million or $0.14 per share for Q1 2020. The change in net loss is due to increased revenue and reduced general and administrative and research and development expenses partially offset by increased selling expenses and a reduction in foreign exchange gains experienced during the three months ended March 31, 2021. Adjusted EBITDA for Q1 2021 was $31,000 compared to adjusted EBITDA of negative $1.3 million for Q1 2020. The change is primarily due to the increase in revenues and decreased G&A and R&D expenses. Again, partially offset by increases in selling expenses. As of March 31, 2021, the company had cash totaling approximately $2.9 million and compared to $2.7 million as of December 31, 2020. As of March 31, 2021, the company had net working capital of $3.1 million compared to net working capital of December 31, 2020 of $3.2 million. The company does not have any debt recorded on its statement of financial position. However, we are in the process of finalizing a loan with a commercial bank to replenish the cash expended through the Marley acquisition. I want to remind you there will be an opportunity at the end of today's call for you to ask questions regarding the financial results and the company as a whole. And with that, I'd like to turn the call over to our President and Chief Operating Officer, Dr. Neil Owens, for some additional commentary regarding our operations.
spk03: Thank you, James, and good morning, everyone. The COVID-19 pandemic continues to have an impact on businesses worldwide, especially in the healthcare industry. For Medicare, all meetings with healthcare professionals continue to be virtual. This has required adjustment by Medicare sales team, but also has resulted in reduced selling costs. Generally, prescribers are receptive to video meetings. This has been a greater impact on meeting with interventional cardiologists regarding Agristat in a hospital setting compared to meeting with primary care providers regarding Zipidimac. There have been no disruptions to manufacturing or distribution, and Medicare continues to have normal supply of Agristat and Zipidimac. Agristat has seen consistent monthly demand since April 2020 and remains the preferred glycoprotein 2B3 inhibitor in more than 1,200 US hospitals. However, price competition from generic heptafibotide has led to a decrease in net selling price of Agrisat in order to maintain market share. In Q4 2020, Medicare announced the settlement of a patent infringement action that led to the acknowledgement that Medicare 60 patent is valid, enforceable and infringed. The settlement of the litigation protects the Agrisat brand and its intellectual property. We continue to make selective investments in Agristat, including clinical research that we believe will help expand the market. We look forward to soon presenting the results of the SAVI PCI study, which demonstrates the clinical and safety profile of using Agristat with a shortened infusion. We think this study will provide important evidence to support use of Agristat. and patients who require protection from ischemic events while limiting risk of bleeding. We thank the steering committee for their efforts and contributions in seeing the study through to completion and publication. In Q1, we announced the early completion of the investigator-sponsored study i-SPASM, which was a randomized double-blind Phase I-IIa trial aimed at assessing the safety of Agristat administered over a seven-day period. for a treatment of a type of stroke called aneurysmal subarachnoid hemorrhage. The trial was led by Dr. David Hassan at the University of Iowa, and the study results were recently accepted for publication in the journal Stroke. The results paved the way for a phase two trial focused on efficacy in this clinical space, for which Agristat does not currently have an approved indication. Turning to another significant development, Medicare was pleased to announce the acquisition of Marley Drug on December 17, 2020. It is a pharmacy located in North Carolina with national distribution of prescription medications, known for its excellent customer service, home delivery, and very competitive prices. Marley Drug has been successful in marketing directly to consumers, providing access to medications without the need for insurance and building a nationwide customer base of more than 30,000. One of the key aspects of marketing products through Marley Drug and part of the appeal for the acquisition, in addition to an existing customer sales base, is it is truly an innovative approach. Through Marley, branded products can be accessible to all customers where they can avoid requirements of insurance companies for step-through therapy, prior authorizations, and no requirement of a copay discount card. It is also very appealing for healthcare providers who pay overhead for processing insurance claims and the reaction to the simplicity and certainty of filling these epidemic prescriptions through Marley has been extremely positive. The addition of Marley Drug brings more than 20 experienced staff who fill over 100,000 prescriptions per year. Sales through Q1 have remained consistent with previous quarters and with an expanded marketing approach, are expected to grow. Above all, Marley provides simplicity and certainty for access to Zypidematic. We are already seeing double-digit growth in sales month-over-month, and our sales and marketing team is pushing hard to continue that trend. We continue to focus on adding new prescribers, new patients, and having a high refill rate. Through Q4 2020 and into Q1 2021, We increased our focus on digital and social media advertising to consumers to explain the benefits of Zipidimeg over other statins and its accessibility in terms of price and home delivery. Our team remains motivated and driven to increase sales and fulfill Zipidimeg's market potential. We continue to evaluate branded products and products with high market share potential to add to Medicare's product portfolio. and those that would align well with our focus and contacts in the US market, especially those that can be sold through Marley Drug. In terms of our generic products, the sales of sodium nitroprusside increased through the end of 2020 and into Q1. Medicare continues to develop additional cardiovascular abbreviated new drug applications, or ANDAs, for in-hospital use. However, the regulatory review process has resulted in a delay in approval of one of our ANDAs, due to deficiencies reported in Medicare's contracted manufacturing partner. Medicare is working with its partner on resolving these issues to obtain necessary approvals. In Q4 2020, Medicare announced the filing of an IND for a pivotal Phase III study to find the first FDA-approved therapy for patients with PNPO deficiency, which is a rare pediatric disease leading to seizures and is ultimately fatal if untreated. If successful, use of Medicare's legacy product, MC1, could lead to a priority review voucher, which can be redeemed to obtain priority review for any subsequent marketing application. In summary, although there have been challenges presented by COVID-19, there remains significant opportunity for Agristat, Zephyrime, and Marley Drug. Because of control of spending, we are pleased to report small positive EBITDA in Q1. Our team wants our investors to know that we are driven and dedicated to growing revenue and making Medicare a long-term success. As noted, James will be moving on to another opportunity and I'd like to thank James for his contributions and we wish him the very best. With that, I'd like to turn the call back to Dr. Friesen for final comments.
spk05: Thank you, Neil. 2019 was a year in transition with a sales and marketing focus on two products which were added in 2018 for diversification to our main cardiovascular drug, Agristat. There was considerable learning. 2020 was a drive to reduce investment losses and further learning to the marketing of Zypinime. This learning led us to the acquisition of Marley Drug as a more efficient way to provide a great product at a very affordable price. We are thankful for Agristat, the additional cardio assets, and the addition Marley Drug, a mail order specialty pharmacy. We continue to focus on growing the business with a pipeline of cardiovascular products that will further diversify our revenue and asset base, carefully investing to grow our future profitability. My goal, the goal of our team, the goal of our board management staff is to continue to build this business with a stable long-term outlook to generating value for our shareholders. And as always, I want to express my appreciation to the outstanding team of employees we have been blessed with. Thank you, our shareholders, for your continued support and interest. Now, Colin, I'll turn it back to you to lead us through the Q&A.
spk01: Thank you. Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press star followed by one on your touchtone phone. You'll hear a three-tone prompt acknowledging your requests. and your questions will be polled in the order they're received. Should you wish to decline from the polling process, please press star, followed by two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment for your first question. Okay, so your first question comes from Kara Manages from Carl M. Henning, Inc. Kirk, please go ahead.
spk00: Thank you. You guys talked about some other businesses that might be interested in Marley. And I'm just wondering if you could expand on different opportunities other than ramping sales, which obviously is positive, but other opportunities for Marley.
spk03: I can add a little bit of color to that. I think in terms of other companies or other products being marketed through Marley Drug, I believe that was the question. It's been interesting to see the response from other companies because they also have branded products that they feel like have a lot of market potential but have struggled to actually gain that market share or at least work through the PBMs and the insurers. So we actually are continuing our discussions with other companies. We think that there are definitely opportunities to work with them on marketing their product. And I think the success we've had so far with Marley in terms of the response from providers gives us a good leverage point in terms of negotiation with them. So I think it's still pretty early to say exactly what that partnership would look like, but we have been approached by multiple companies and continue discussing with them.
spk00: Do you see something in 2021 or is that maybe not even until next year?
spk05: It's hard to say. I think Dr. Owens did a good job of describing the interest, but in negotiating agreements, we've learned in the past that sometimes it can go very rapidly in weeks and months, like we did with Marley. Sometimes it can take a year or two. So it's hard to predict. I understand your interest in knowing, but We're pursuing a number of avenues, and it's hard to say what the timing is going to be.
spk00: Okay, great. Good to know there's that opportunity. Do you see sales trajectory throughout the year? Because you're new with Marley, ramping through the year. Is there seasonality? How do you kind of see, do you see us exiting? If we're at a 5 million run rate, do you see us exiting the year at, five and a half, six million, just kind of in general, how should we look at the quarters as you're building through the year?
spk05: Again, Curt, I understand the interest, but we've made a practice not to provide guidance. As we said in our report, we do believe that there will be growth. The growth is hard to predict. Our prediction that there is growth is because we've seen, even in the first few months, a little bit of growth and a lot of interest. So if that interest does translate to sales, we see a steady growth over the year.
spk00: Okay. And then, am I right in thinking that you've got real good leverage to the bottom line as your sales increase with the margin profile? Does that make sense?
spk05: Yeah. As we described, you know the margin's on these products are high, 70%, 80%. Not so much on the generics, although even some of the generics in Marley are very high, and it depends which product it is. But one of the reasons – Red's is a great product. One of the reasons we dropped it was that it was a ticket marketing push. It cost us money, but the margins weren't there, and so what we focused on is trying keep our eye on the ball of making money and profit. And so looking at high-margin products, the three that we're focusing on are very good margins.
spk00: Okay, great. And finally, are you able to measure your advertising? I know you're doing targeted micro-advertising. How are you feeling about that? Are you able to measure with the advertising from earlier in the Zepidimag and that kind of thing?
spk03: Yeah, we can track and measure the return on ad spend through multiple channels. As you may have heard, Marley actually has a call center as part of their team, so we actually get a lot of direct customer calls. And it's one of the ways that we can actually track our different marketing spend through different channels is to tie it back to the original ad. But it also gives us pretty great insight into their response to being able to order through Marley, either for Zepidemag or other products, which helps us kind of tune our marketing. So there is a combination of different approaches we're taking, and that we can all track either digitally or actually just listening to them, how did they hear about Marley and how did they hear about Zepidemag. Interestingly, we do get calls from customers, but also physicians and other pharmacists who are interested in Marley.
spk00: Okay, great. I appreciate it. Sorry, I thought of one more. That PNPO deficiency drug, can you give us kind of a timeline on that voucher? What kind of timeline where you might know if things go well, when you might get that voucher or not? Is that a year and a half out, or what do you think in there?
spk05: Again, it's hard to predict, Kurt, but the trial itself is a 12-month treatment, and we expect to start shortly. So I would say probably a two-year kind of window by the time you get enrollment going and then doing the analysis and submission.
spk00: Great. Thank you, guys. Appreciate it. Look forward to the coming quarters.
spk06: Thank you.
spk01: Your next question comes from Sam Robotsky from SER Asset Management. Sam, please go ahead.
spk02: Yeah. Good morning, Bert. Morning. I am surprised to see I looked at my records. I've been involved since 2004, and... I'm interested in knowing what's going on with Reliable, the Indian company, and do you have something you could do with India with the COVID? Is there anything that you thought of doing there?
spk05: Not really. Thanks, Sam. We have a relationship and agreement with Reliance Life Sciences. Reliance is the largest Indian company, and we certainly feel for them. They are going through a credible, difficult time. We communicate with them on a reasonably regular basis. But if your question is, do we have a COVID focus, no. Now, we mentioned COVID, which you probably remember, that there were some physicians that were using Agristat to inhibit the clots that sometimes are associated with COVID. And it is very effective. It's a small number of patients that were treated. But the cost of getting that label for AgriStat would be very expensive and take a long time. And so we didn't see it as an immediate commercial opportunity. Now, having said that, some physicians will be using AgriStat for that treatment on their own as a physician-directed treatment. But we don't see that as a big market opportunity.
spk02: And as far as you're looking to raise some funds, do you have a dollar amount? And with your account financial gentleman leaving, who are you working with to raise funds?
spk05: We're not raising funds for equity, but we do have a... or working on a bank line, sort of bank rate interest rates, and that is just to replenish some of the cash that we had. So it will be probably less than the $8 million we spent, but something to increase our working capital a bit. So it's a bank loan.
spk02: Okay. And the drug company, Pharmacy, there seems to be some smaller pharmacies that are raising funds in New York. Do you see the expansion or a basis for expanding your pharmacy?
spk05: We look at the... pharmacy that we acquired has several advantages which Dr. Owens described fairly well and that is it enables patients to buy very easily at a very low price and it bypasses the cost of the PBMs and insurance. People think because they have insurance they have a lower cost but there are many examples where even coverage costs you more with co-pays, with minimals, and where your insurance runs out and you now end up paying more money for drugs. The approach that we're using with Marley Drug is a very low cost, the lowest cost, direct-to-patient mail order. You get your prescription within 48 hours, mailed to your house. The doctor's convenient. That process... is a huge opportunity for us and I think will be a revolutionary change in the U.S. And that's what we're looking towards building on with the existing Marley drug operation. And others are seeing it, but in conferences where Dr. Owens has participated, the industry is starting to recognize Medicare's leadership in this area. and a huge opportunity.
spk02: And what amount of your purchase of the companies that you have bought, are you using a brokerage firm? to find a business for you? And has the company bought any stock in the open market? And what is the nature or size of stock that anybody has bought?
spk05: Okay, there's two questions. One is we have the... a normal course issue bid and we've pretty much purchased that. There might be a little bit left, I'm not sure. And so we haven't bought recently because we've had this reporting and then blackout. So that's – we haven't purchased more recently but we have purchased in this year I believe, haven't we? Not in 2021.
spk04: I think there's about 100,000 left that we can buy under the normal course issuer bid.
spk05: The other question you asked is do we use a broker? Well, the broker approached us, so we don't have an agent that works for us, but there are agencies that have approached us about potential opportunities.
spk02: Has the offices or is the period open for the offices to buy stock In the open market, is that allowable? And if it is, when is it?
spk05: Well, I don't know when the blackout is going to come out, but we have some other transactions that we're looking at. So it's hard to predict when a blackout will come out.
spk02: Okay. Well, since being a stockholder, since 2004, The size of my investment has increased pretty significantly, and I think it would be nice to show some positive results as is going on now. Good luck, Bert.
spk05: Thank you, Sam. Appreciate your interest and your support.
spk02: Okay, thank you.
spk01: Ladies and gentlemen, as a reminder, should you have a question, please press star followed by one. Okay, it appears there are no further questions at this time. Please proceed.
spk05: Thank you again all on the call. We appreciate your interest and we look forward to sharing next quarter's results in the coming months. Thanks again. Wish you all the best. Be safe and well.
spk01: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.
Disclaimer

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