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Paysafe Limited (PSFE) CEO Philip McHugh on Q1 2021 Results - Earnings Call Transcript
May 11, 2021 2:11 PM ETPaysafe Limited (PSFE)
Paysafe Limited (NYSE:PSFE) Q1 2021 Earnings Conference Call May 11, 2021 8:30 AM ET
Company Participants
Will Maina - IR
Philip McHugh - CEO
Izzy Dawood - CFO
Conference Call Participants
Darrin Peller - Wolfe Research
Dan Perlin - RBC Capital Markets
Jamie Friedman - Susquehanna Financial Group
Josh Levin - Autonomous Research.
Mike Del Grosso - Compass Point
Timothy Chiodo - Credit Suisse
Operator
Greetings, and welcome to Paysafe's First Quarter 2021 Earnings Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host, Will Maina, Investor Relations with Paysafe. Please go ahead.
Will Maina
Thank you, and good morning. Welcome to the Paysafe first quarter 2021 earnings conference call. With me today are, Philip McHugh, Chief Executive Officer; and Izzy Dawood, Chief Financial Officer.
Before we begin, I'd like to remind everyone that this call will contain forward-looking statements, and should be considered in conjunction with cautionary statements contained in our earnings release and the company's most recent periodic SEC reports. These statements reflect management's current beliefs, assumptions and expectations and are subject to a number of factors that could cause actual results to differ materially from those forward-looking statements.
During today's call, management will provide certain information that will constitute non-GAAP financial measures under SEC rules. These reconciliations to GAAP measures and certain legal [ph] information are also included in today's earnings press release and company's supplemental earnings presentation, which are available in the Investor Relations section of our company website.
I'll now turn the call over to Phil.
Philip McHugh
Thanks, Will. Thanks for that. Well, first of all, welcome and thank you to everyone for joining our first public earnings announcement as Paysafe. Today, I'm going to cover some of the strategic highlights and key deliverables from our first quarter, and then turn it over to Izzy Dawood, our CFO, to review our financial performance.
To say the least it's been an eventful and successful quarter for Paysafe. First, we successfully listed on the New York Stock Exchange on March 31, following the successful SPAC with strong return to investors. We raised $2.1 billion, and successfully de-SPACed going public 114-days after our initial announcement. We were able to pay down more than a $1 billion of debt, strengthening our balance sheet and our credit rating along the way.
We also have a new board in place with Bill Foley as our Chairman, and we've already started our implementation, the fully transformation plan, lots of activity on that front. As a team, we've been able to execute against our strategy, driving growth and scale across the company and delivering on our key initiatives. We're starting this new chapter with strong momentum across the business, and the markets that we want to win.
From an overall market view, we continue to see lots of strong activity, online and e-commerce volumes continue to remain strong. We're seeing rapid growth and lots of market activity in North America iGaming, with the legalization of sports betting in four new states planned in 2021, and several other states not far behind.
We're also seeing the emergence of a strong recovery in the U.S. SMB market. We're in the first quarter, we saw 18% increase in volumes year-on-year in our U.S. acquiring business, and we're seeing much higher growth in April.
Finally, we're also seeing a continued adoption in consumer openness to using new payment methods, which has served Paysafe well over time. According to our recent proprietary research, nearly 60% of consumers have tried a new payment method in the last 12-months.
Moving on to our strategy, for anyone new to Paysafe and our story, I really encourage you to review our recent Analyst Day Presentation. We provided ample detail during that event back in March, which I won't repeat today, but I do think it's important to recap a few points.
First, Paysafe is a scaled and truly unique payments company, with our goal to be the leading specialized payment platform. What do I mean by that? We're a company with differentiated products on both the consumer and the merchant side, creating a powerful two sided network. Moreover, our powerful Skrill, Neteller and Paysafe card brands provide millions of consumers valuable ways to make payments and send money in all forms of digital commerce. We match our products with strong risk management expertise, it's very hard to replicate, along with scale, global technology platforms that allow us to deliver payment solutions in hundreds of markets.
Lastly, and very importantly, we like to approach the market focused in deep verticals like iGaming, requires knowledge of multiple ATMs, strong risk management and ease of integration. When that combination is required, we know that Paysafe has the right to win.
In terms of how we deploy that strategy, we really focus on four key growth pillars. First, we're positioned to be the true winner in iGaming, which includes online sports betting, casino and poker, fantasy and eSports. In particular, we have a strong position to win the fast emerging U.S. iGaming market.
Second, the strength of our products, including Skrill, Neteller and our eCash solutions, combined with our strong e-commerce capabilities, position as well to win beyond iGaming, including digital goods, trading and financial services, travel entertainment, and some select integrated verticals. With 75% of our revenues coming from online payments, and our folks in specific industry verticals, we're exposed to the fastest swimlanes of growth in the payments market.
The third pillar, which we spoke about in great detail during our Analyst Day, is our transformation plan, which is well underway and we are ready delivering rising operating leverage across all areas of the company. And finally, we see multiple consolidation opportunities in the market to enhance our position in North America iGaming, digital wallet expansion, and e-commerce verticals. So that's a bit of a summary of what we said during the last Analysts Day in terms of our strategy.
So, now let me move on to what we actually did in the first quarter. Let me first start with North American iGaming. At the Analyst Day, we talked a lot about the iGaming market, and how Paysafe is the de facto payments partner of choice, serving the majority of regulated iGaming industry, with more than 1,000 gaming operators who use one or more of our products around the world. We also talked about our strategy to grow the emerging U.S. market, where we already have integrations into approximately 75% of all operators.
So, let me provide some key updates in our activity in the first quarter. Revenues from North America iGaming grew 66% in the first quarter. Paysafe launched in both Michigan and Virginia in the first quarter. Now we are live in 15 states across the U.S. We also expanded and deepened our presence with a number of exciting wins during the first quarter an early second quarter.
Our U.S. lottery business has enjoyed significant growth, buoyed by our expanded partnership with Jackpocket, who recently launched in New York. In March, we expanded our U.S. partnerships with PointsBet in Michigan. We're also expanding our relationship with Parx Casino, leveraging our Playtech integration, where we are live in Michigan with plans to expand in other states.
In Virginia, we are going live with WinBet [ph] on the back of our relationship with BetBall [ph] which is powering their business. Additionally, we also expanded our strong presence in Colorado with our launch of PlayUp.
Moving on to Canada, we continue to have a dominant position, and as announced in our recent press release, we now support Alberta's only-regulated online gambling website.
In addition to expanding our payments integrations in multiple states, we also talked about making key product enhancements, specifically with our Skrill digital wallet. We focus on driving instant funding in the wallet, where we think there's a material gap in the market. The feedback from our product from early discussions with key merchants has been very positive, and we're on track for upcoming pilots with several major brands.
Overall, we're incredibly pleased with the traction here, both from an execution and a market perspective.
Now let me turn to how we're growing in emerging verticals. We have seen strong growth in trading and financial services, as well as in digital goods such as online gaming. Of particular note has been the overall strength of our eCash business, growing 60% year-on-year, as it expands to new markets as well as crypto trading in our Skrill wallet.
In online gaming, we continue to gain traction. We're live in 20 countries with Microsoft, and we continue to expand that relationship. And our presence as an active sponsor in eSports league continues to drive true user engagement. We've been very active in other emerging markets, particularly we're making good strides across crypto and trading, supporting neobanks and other financial services.
We saw strong Q1 growth in crypto and FX trading volumes within digital wallets. Of particular note, in March, we expanded our partnership with Coinbase to include the ability to trade cryptocurrencies in the U.S. market. We are live on 27 crypto sites and exchanges for digital wallets, with seven other sites also live for processing as well. A good example of the two sided network.
In eCash, we're becoming a meaningful player supporting financial services, including partnerships with banks and neobanks. It includes a pilot with TSB and Diebold Nixdorf, building on some of our prior announces, including Monese.
Additionally, we continue to see progress in integrated software verticals, with Ascend and CampMinder as two recent wins.
Now, let me move on from the emerging verticals into the transformation proof points. We've also made progress on our transformation initiatives, and fully playbook to accelerate global scale and unlock value. We are well on track to meet or exceed our target to migrate 70% of our business across Paysafe to the cloud by year-end, effectively having 100% migration by early 2022. We're seeing improvement across both risk and banking as a service. These actions are lowering our loss rates and bank fees, as we improve risk analytics in part with more Tier 1 banks.
We've also kicked off a number of initiatives to capture further cost savings across multiple functions. In Q1, our SG&A costs were down approximately 4% versus prior year, and we see a continued path to driving positive operating leverage.
Now, moving on to the last pillar, we remain active in the market regarding deals, assessing potential opportunities to enhance iGaming, consolidate digital wallet, and expand our e-commerce footprint.
Before we move on, I'll make a quick comment on the financial results, then Izzy will take you through the details. While we are seeing growth and strong underlying trends across the businesses in all the right places, this growth has been somewhat tempered by measures to improve the overall risk reward profile in certain markets and channels. As we mentioned during the Analysts Day, the majority of these actions took place in 2020, and we expect to truly lap these issues in the second-half of this year.
As a last point, I want to finally thank my Paysafe team members around the world. Our success to getting this moment is a true testament of the hard work and dedication from everybody. We're really pleased to have given all the employees equity in the company, really instilling an ownership culture across Paysafe, as we start this new chapter as a public company.
With that introduction, I'll now turn it over to Izzy.
Izzy Dawood
Thanks, Philip. Now let's turn to Slide 6, and start with a brief summary of our performance versus our guidance for the first quarter. Revenue and EBITDA came in at the higher end of our guidance. Gross profit and expenses were right in line. Overall, we delivered solid performance versus our expectations for the quarter.
Now let's turn to Slide 7, volumes were up 8% year-over-year, driven by integrated processing and eCash. Total revenue for the first quarter was $377.4 million, up 5% year-over-year, driven by strong growth in our eCash segment. Excluding the impact of the Pay Later business, which was invested in July of 2020, revenue would have increased approximately 7%.
Further adjusting for the actions we have discussed in our Analyst Day and continued risk reward optimization in our business model, our revenue growth would have been in the mid to high teens.
Adjusted EBITDA for the quarter was $113.2 million, essentially flat compared to the prior year, resulting in an adjusted EBITDA margin of 30%, compared to 31.4% a prior year. The decrease in margin primarily reflects business mix and integrated processing and digital wallet, partially offset by eCash margin expansion.
Lastly, free cash flow was $109 million, or 96% conversion on an adjusted EBITDA basis, which included a $45 million benefit from the utilization of bank guarantees at the end of Q1. Next quarter, we expect free cash flow conversion in line with typical levels.
Moving to Slide 8, I will quickly touch on a few additional line items, including our GAAP results. Depreciation and amortization was $65.5 million, which is 6% lower than last year. Interest expense was $58.5 and 53% higher than last year, driven by the acceleration of deferred debt financing expense, as we paid down debt at the end of Q1. For Q1, 2021, our net loss was also impacted by share-based compensation charge, relating to the shares invested on the completion of the transaction.
Moved to Slide number 9 for a discussion of the segment results, starting with integrated processing. Volume growth was strong, up 17% in the processing business, led by the U.S. market. We saw increased volumes across most of our industry verticals, while travel and hospitality are still subdued relative to Q1, 2020.
Revenue for the first quarter was $176.9 million, a decrease of 5% compared to the prior year. Excluding the Pay Later business, revenue declined 1% as growth in the U.S. payments processing and iGaming was offset by lower revenue from our direct marketing channel.
Adjusted EBITDA was $44.9 million compared to $55.2 million in the prior year. Adjusted EBITDA margin of 25.4% decreased due to merchant and channel mix, partially offset by lower credit losses due to a one-time event in the prior year.
Excluding the impact of Pay Later and the discrete actions that we have taken to improve our risk reward profile, revenue in integrated processing would have increased approximately 5%.
Now let's turn to eCash on Slide 10. eCash revenue for the first quarter was $112.9 million, an increase of 63% compared to prior year, driven by extended lockdowns in Europe and associated increase in spending more online in all verticals. Adjusted EBITDA was $48.1 million more than double Q1 of 2020, resulting in an adjusted EBITDA margin of 42.6%, an increase of 950 basis points year-over-year.
Moving to Slide 11, we shift our focus to digital wallet. Revenue in digital wallet segment for the first quarter was $94.9 million, a decrease of 30% compared to the prior year, and performance was impacted by the targeted actions and country exits from last year, that we’ve discussed in our prior Analyst Dat.
Excluding this impact, digital wallets revenue would have grown approximately 6%, driven by higher iGaming and crypto and FX trading activity. Adjusted EBITDA was $37.8 million, compared to $53.7 million in the prior year. Adjusted EBITDA margin of 39.8% decreased year-over-year, driven by the changes in gross profit margin due to the business mix, and increase investment in marketing and operations.
Moving on to Slide 12, total debt outstanding at the end of the quarter was $2.1 billion as of March 31. And our net debt to last 12-month adjusted EBITDA ratio was 4.2x, reflecting repayment of approximately $1.2 billion of debt post-closing of the merger.
In April, Moody's upgraded our corporate and first lien rating to two notches, by two notches to be one. S&P also upgraded our rating by two notches to B+. We expect leverage to decrease to approximately 3.7x by year-end as well.
Finally, we continue to evaluate whether our current debt profile can efficiently be refinanced, which will further improve our leverage profile and create additional flexibility.
Moving on to Slide 13, we would now discuss our outlook for Q2. For Q2, 2021, we expect revenue in the range of $365 million to $385 million on a reported basis, with strong growth across all our businesses. Gross profit is expected to be between $225 million to $235 million, and adjusted EBITDA between $110 million to $120 million.
On Slide 14, we move on to the full year. Our expectations as a whole remain in line with guidance provided the Analysts Day. For revenue, however, we are lifting the low end of the guidance and now expect revenue in the range of $1.53 billion to $1.55 billion. This reflects year-over-year growth in the range of 9% to 10%, which excludes Pay Later from 2020.
In the second-half of the year, you will see our revenue growth reflect the strength of our business model, as we've lapped the legacy issues that impacted our growth in Q1. We continue to expect gross profit of $930 million to $970 million. For adjusted EBITDA, we continue to expect $480 million to $495 million.
With that, I'll now turn the call back over to, Philip, for closing remarks.
Philip McHugh
Thanks, Izzy. In summary, we're executing well against our strategy. We're lapping our key legacy issues. We're winning deals in the U.S. iGaming market at a rapid pace. We're expanding in high growth emerging verticals across digital wallets, eCash and e-commerce. We're seeing strong recovery in our U.S. SMB business. We're delivering against the transformation plan, and we're well-positioned for consistent, organic and inorganic growth.
With that said, I think we can now move to the Q&A session. Thank you very much.
Question-and-Answer Session
Operator
Thank you, sir. At this time, we'll be conducting a question-and-answer session. [Operator Instructions] Our first question today comes from Darrin Peller of Wolfe Research. Please proceed with your question.
Darrin Peller
All right. Hey, guys. Good morning. Thanks. When we look at your results, and you called out that revenue growth would have been, I think you said, mid to high teens, if you were to back out the impacts from the network partners, the referral partners and the digital side, and then merchant obviously had a portfolio change to derisk. Can you just touch on, is that the normalized growth we should expect as we start to grow in the next couple of quarters?
Obviously, you have comps that impact a lot. But just remind us, on a segment basis perhaps, and then overall, what do you guys see this company growing at? Again, per segment, more normalized, when you anniversary these changes on a per segment basis as well as company-wide?
Philip McHugh
Hey, Darrin, it's Philip. Good to talk as always, good chat. Yeah, look, so in terms of the change there are basically three components worth calling out that Izzy laid out. So one is the disposal of Pay Later last year and that's a simple kind of pro forma math. The second one is, as he called out was on digital wallets, where we were very consistently talking about that through the pipe rates on Analysts Day. We exited segments of kind of channels and markets, which we didn't think were good for our clients or for us. Those were kind of Q2 and Q3 actions of last year. And we see ourselves starting to lap that in Q2 and Q3 of this year.
And then in the direct marketing vertical, we are a significant player there. And more recently, at the end of the year, we strategically took a decision to anticipate some upcoming scheme rules and views on that market. As a result of that, we wanted to get out ahead and we exited discrete set of clients. It's a very ring-fenced piece. We did that in late December, and we worked through that, basically through kind of early Q1.
As we stand here today, we're very well-positioned in that business. We have one of the broadest sets of capabilities and capacity to manage direct marketing volumes. Trading in May is strong and going the right direction. And we'll lap that specific issue in Q3 of this year. So, those are the three components.
They were all going to capture the impacts of those decisions were all in our -- broadly in our March 9 guidance. And as you kind of call out what we've highlighted, we're really happy with the growth trends of the business and then the right place. So, we see ourselves lapping those issues through Q2 and Q3.
We won't have the very high Paysafe card growth as well. So that will taper down a little bit on year-on-year. When that all kind of blends through, we definitely see ourselves in that kind of 11%, 12%, 13% range of growth as a consistent business.
But, let me turn it over to Izzy, if you want to add anything else to that.
Izzy Dawood
Sure. Thanks, Philip. Hey. So, Darrin, putting a finer point on Q1, specifically, to help you guys kind of do the math and how we get to the mid-teens. So specific to some of the scheme changes that Philip talked about, we believe in Q1 that's roughly a $10 million impact year-on-year. And the network accounts and those channels that we exited year-on-year is roughly $20 million.
So if you add the two, it's about $30 million impact year-on-year. And if you wanted to adjust for those, that's how you see how we get to the mid-teens growth overall for the company.
Philip McHugh
Yeah. And I just wanted to reiterate, yes, as folks said, these are items we have obviously discussed, talked. We feel comfortable with -- enough uncomfortable where we're reaffirming our full year guidance. So these are things we're aware of. And you'll see their real performance kind of starts taking shape as we would lap these legacy issues in the second-half of the year.
Darrin Peller
Okay. So that partly explains the yield compression you're seeing in the integrated side also. We're just getting some questions on the bottom [multiple speakers].
Philip McHugh
Yeah. Exactly.
Darrin Peller
When we look at -- and then just my follow-up is really around the strategy on the digital wallet side, I mean, revisiting all the new initiatives you build out. I mean, it's a lot of what I know investors are excited about what the stock and the story overall. So if you could just update us on what kind of progress has been made over, whether it's the expansion into areas like crypto? How that's going or remittance?
And then, any progress on partnerships with the U.S. gaming, specifically to bring the wallet more to the U.S. market. Thanks again, guys.
Philip McHugh
Yeah, I'll make a couple of comments on digital wallets. One is, in regards to Skrill and Neteller, and the other ones to our eCash business too, which has a very strong wallet profile, it's effectively emerging as another wallet business. And both those are driving growth and a lot of upside for us going forward.
So in terms of initiatives, we've certainly been really pleased with crypto trading. As we said in our announcement, we're live in 27 sites. We get very strong and consistent signups now, not just from gambling operators, but from FX and crypto trading sites. With our partnership in Coinbase, in March, we expanded our ability to trade crypto in the U.S. and 27 states. So today, we could do multiple functions of free up the [ph] crypto, crypto to crypto trading, we could do advance orders. We could trade 15 currencies in 90 countries now.
So, we think we are building a wall that can really enable crypto trading. And over time, we'll be looking at expanding crypto to merchant capability on a limited basis. We'll go slow on this as your crypto to fund the wallet, but those will take some changes and some [Indiscernible] for us to build that out.
We have a roadmap where we think we can be a player not only in gaming, but in trading that's strong. Remittance continues to be strong, especially as we move up to Tier 1bank relationships. Our cost to serve goes down and that creates more kind of tailwind for us in that business.
And then most importantly, in Skrill and Neteller is the U.S. market. We've been really focused on driving instant funding in the wallet. And we mean literally on the spot instant funding with a focus on the VIP client base. That's a gap in the U.S. market. We built the product. We have pilot setup with four or five very large brands, that we plan to test over the summer in anticipation of the NFL season.
So we're really pleased with that. We're pleased with how we've developed that product. We're very pleased with how partners have reacted to it, and reaffirmed the view that a gaming-focused wallet, focused on their VIP players who drive a large part of the cashier volume is a need in the market. And that Paysafe is really uniquely placed as a company to solve that.
So, those are some of the flavors when we think about the wallet and the trajectory. We're working through some of these legacy issues. They are painful. We've spoken about that before. So we think we're well-positioned there.
Also, just to call out on our eCash business, that business we called this out Analyst Day as well, we started really moving to the paysafecard app, where you can store the funds on an app, right. So it's no longer stay a pre or postpaid transactional account, but it's a stored value APM. Once we have that done then we will be expanding in IBAN account, and other payment forms into that app. It's effectively a digital wallet.
We've gone from a standing start on that progress, to where we'll have 80% of our revenues will go through my paysafecard app by the end of this year. So we also see that as one of the drivers of eCash growth, as it becomes another wallet serving more Gen Z and millennial type customers, versus the more sophisticated digital traders and gamers on Skrill.
Darrin Peller
Alright, that's great. Thanks again, guys.
Philip McHugh
Thanks, Darrin.
Operator
The next question is from Dan Perlin of RBC Capital Markets. Please proceed with your question.
Dan Perlin
Thanks and good morning, guys. I wanted to just talk a bit about, it looks like within the digital wallet, so you just explained a bunch of these things, so this might be the reason. But the take rate there versus the integrated place where we saw little more degradation, here we saw it actually expanding quite substantially.
And so, I'm wondering, a couple things. One is, just making sure we understand how to reconcile that lift on a year-over-year basis? And then secondly, is this kind of the run rate that we should be modeling? Is there any cadence as we think about it? I know you talked about the second-half you will having some lapping effects. So could you just speak to that point first? Thank you.
Philip McHugh
Sure. Hey, Dan, nice to hear from you. So I'll turn it over to Izzy talk about the take rate mix and what's going on there.
Izzy Dawood
Yeah, so let's start Dan, with digital wallets. Yeah, pretty meaningful, we think meaningful, uplift in take rates and the combination of two factors. Again, we love the fact that, our users or consumers use the wallet for multiple things.
So first, the exit of the channels we discussed which impacted revenue, also kind of impacted take rate on a downward basis. But on the flip side, the increased crypto volume, FX trading volume that we saw, combined with call it a crypto FX volume, actually increased take rates for digital wallets, because that's a big, big driver. I mean, higher take rates that lead general wallet transaction, so that explains kind of the take rate bump versus the revenue decline in digital wallets. So again, just a mix of how our consumers are using the wallet to do their activities.
On the integrated processing, it really is pretty simplistic. The scheme rules and the likes that Philip mentioned earlier, really in our direct marketing business, which have higher cake rates. As a matter of fact, if you saw our volumes and integrated processing group were pretty solid year-on-year, and here's primarily e-commerce driven, with lower take rates. So a combination of the decline and the direct marketing piece add to see general e-commerce growth contribute to the take rate difference on the integrated processing side.
So overall, as a company, I believe our take rate was impacted by roughly 10 basis -- actually it was kind of flat year-on-year for the most part and to kind of balance those two out.
Dan Perlin
Okay. That's really helpful. And then my follow-up question is on U.S. iGaming. There's a lot of things that are taking place there. It sounds like you've gone into some additional markets, and there's others that are expected to open up.
I'm wondering, if you could just kind of help us understand how you're envisioning that playing out, throughout the year, the amount of investments that are necessary to truly drive brand awareness. You mentioned, some of the things you're doing in the Skrill and Neteller wallets, but I'm just trying to make sure I understand the cadence of how that is expected to roll out and then the investments behind that.
And then just secondarily, on the transformation piece, where do you guys stand? I know, we're early in the year. But where do you stand on achieving that, I think it was $26 million of kind of cost takeout that you were expecting in '21? Thank you.
Philip McHugh
Thanks, Dan. So on the U.S. iGaming piece, let me break out to two pieces. So one is, in terms of what we expect to happen, when in terms of the market, obviously, anyone that follows can see there's a tremendous amount of activity, both from online and casino players, but also from state. So we currently see 10 states with real activity. We see Arizona, Maryland, New York and Wyoming, all with pretty advanced legislation and plans to go live as early as the second-half of this year.
But also Florida, Louisiana, Ohio, Connecticut, Massachusetts and Maine, also with the active legislation with plans to go live at sometimes some as early as this year, if not early 2022. So, we see a path where you can have up to 25 of the 50 states opening up gaming. So that's a very nice tailwind.
To the playbook that we consistently talked about, is one, integrate, integrate now. You have to integrate with the online gaming players. You have to integrate with a player account management platforms like Scientific Games and Playtech.
And you're gaining that ground by servicing the processing side, so that's debit and credit card processing, plus ACH conductivity. So we're winning in that space, right. We have a large share of the players, as they open up states where there we mentioned Parx, which is a big Playtech play. We mentioned WinBet and BetBall. So we are live in those states in multiple states. So we'll be well-positioned there. So that's the first part of the formula is drive that and grow.
The second part of the formula, which we've seen in other markets is to really develop the digital wallet play over time. Now that's a second follower. In our view, to attack that VIP segment that's why the instant funding capability that we've done. We've got an integration on the backing with Plaid to the power that. We pilot through the summer. We start to see pick up on that piece as we go into the fall. And that becomes a second engine of growth on top of the payment processing growth, where we really are integrating and leading the market there. So that's a little bit how we see that playing out.
In terms of marketing dollars, we will be doing some thesis, but as Skrill takes off and the pilot takes off, you'll see us start to ramp up some of the marketing on the Skrill brand towards the end of the year and into 2022. So, that's a little bit there. We feel really good about that.
And then the last part, in terms of the cost takeouts, we have had a strong program. We've also worked with all the kind of Foley family of companies on the kind of transformation projects they have and specific incentives. So we've implemented a lot of pieces to follow the Bill Foley playbook. We have $30 million of cost of repeatable cost takeout in our kind of guidance numbers for this year. That's about a $45 million exit run rate for next year. And there are several other activities that we're building in the pipe to augment that into 2022.
So, we do expect EBITDA margins to expand in the back-half of the year to continue that like have a steady drumbeat going into next year as well. So, it's a lot of focused activity there.
Dan Perlin
That's great. Thank you so much.
Operator
The next question is from Jamie Friedman of Susquehanna Financial Group. Please proceed with your question.
Jamie Friedman
Hi, good morning. Let me echo the congratulations. Philip, I wanted to ask, in your prepared remarks you had commented about strength in April, I think I was wondering if you could elaborate that rather qualitatively or quantitatively?
Philip McHugh
No, we're definitely seeing, as we look at the early results for April, and even some very early results in May. We continuously to be pleased with where the top-line trends are going. We've had some actual record days in e-commerce processing, historical records, not just recovery records, but historical records. As we've expanded our e-com into some crypto trading sites, we're seeing travel come back. So we're seeing some really nice proof points across the board.
eCash continues to remain very strong, not only in terms of online adoption, but also the move to the my Paysafe app as well.
I don’t know, Izzy, if you want to add anything to that.
Izzy Dawood
Yeah, I'll just add, and then numerically, love to say some things. But, I'll tell you April, last year was probably very depressed. April this year has been incredibly solid. So, we have, I'll say pretty significant growth, at least in the month of April and our volumes. How that will play into May and June? We'll see, fingers crossed, as the world goes through different speeds of COVID recovery.
But, so far, April off to a really solid start from all the metrics that we track and see.
Jamie Friedman
Alright. And then as my follow-up. So Phil, in the beginning, I think in your prepared remarks, you had observed that 75% of the volume is online. Can you dimensionalize the growth of the online versus the offline, at least qualitatively again?
Philip McHugh
What we've seen is outside of the course, the direct marketing vertical, we've seen very strong double digit growth, generally speaking in our e-commerce businesses. Now, obviously, the iGaming business is an e-commerce business sort of us calling it extremely high double digits. But across the board, we're very happy with our e-commerce business, and we've been investing in sales and capacity on that front.
Jamie Friedman
Got it. I'll jump back in the queue. Thank you.
Philip McHugh
Thanks, Jamie. It's good to hear from you.
Operator
The next question is from Josh Levin of Autonomous Research. Please proceed with your question.
Josh Levin
Hi, good morning. I have two questions. Number one, you called out 66% growth in North America iGaming. Can you tell us how much came from processing versus digital wallet versus eCash?
And then the active users for digital wallet 3.5 million, that number looks unchanged from the last report. Is that a current number? Or is it dated? Or, if it is a current number, why has it not changed? Thank you.
Philip McHugh
Do you want to grab that one?
Izzy Dawood
Yeah. Hey, Josh, good to hear from you as well. Hey, on the North America iGaming predominantly all the volume right now is gateway or e-commerce related. The wallet really doesn't roll out in full force till the second-half of the year. And this is the common around the instant funding of a program that we're rolling out in concert with Plaid supporting us. So pretty much all the growth is an e-commerce activity, which kind of pretty much is in line about kind of what the market would have expected, maybe a little better as well.
In terms of 3.5 million active users, no it's static, it's unchanged from the end of Q4. So it's an updated number as we're still outside, we're still lapping through the channel exits and the like. Obviously, the muted in Q1 -- impact in Q1, '21 is less, but there's still some impact. And then we'll continue to update that as the quarters go along.
Josh Levin
Thank you.
Operator
[Operator Instructions] Our next question is from Mike Del Grosso of Compass Point. Please proceed with your question.
Mike Del Grosso
Good morning. Thanks for taking my question. A question on the integrated processing volume growth this quarter 17%, I know there was some channel exits in there. But, could you kind of help us out as far as some of the other verticals, how those performed relative to your expectations, whether it's SMB or travel or some of the other segments? Thanks.
Philip McHugh
Hey, Mike, thanks for the question. So, generally across the board, what we're seeing is a really, really robust recovery across our SMB portfolio and that's strong. That tends to be on the smaller side of SMB, which is where we like to operate. There's a lot of kind of a restaurant and retail in that space, which has been very good.
Two, we have a Petro business which is also continues to perform extremely well on that front. But across the board, the U.S. SMB recovery is a nice tailwind for us across. Two, we are seeing some return to travel. We actually had a decent amount of health and wellness, actually camps as well. So, those are other sectors which we see continued emerging tailwinds.
And then finally, we did mention that while we're available on 27 crypto trading sites with a digital wallet, we're also processing on seven of those sites. And, that's a great story of Paysafe working together, really. We've got a client, you get to hook in with a product and be able to introduce the wider relationship. And that's really worked in both FX trading, and crypto trading, where we've been working very closely, the teams, they're working very closely in grabbing not only wallet share, but processing share. And we see that as a really nice growth engine for us that will continue to develop. Izzy, I think you want to add to that?
Izzy Dawood
Yeah. Mike, one of the quick things that is interesting, as Phillip mentioned, really good strength across multiple sectors. The travel and hospitality piece is really interesting, because we really start seeing that pick up more in April. Some of the state restrictions came down and things start to opening up. So that kind of also supports the strong growth in April as retail and restaurants and petro, health and wellness continue into Q2 as well.
So far, I mean, knock on wood here, but we see really strong green shoots across our integrated processing business, almost across everywhere, vertical.
Mike Del Grosso
Great. Thanks. And then, I guess my follow-up is on the U.S. iGaming opportunity. I know, you've had a lot of qualitative comments today on it, and then you've got the 66% revenue growth in Q1. But, just stepping back, as we think about the incremental state legalizations, I think you mentioned 25 of the 50 maybe legalized here in the next 12 to 18-months. Like, how does that compare to your initial presentation last March, and kind of your existing expectations relative to what they were then? Is this upside to the story?
Philip McHugh
I think there are two ways to answer that. Generally speaking, it's happening better and faster than when we spoke about kind of you look back at kind of Q3, and Q4, or Q4, when we were talking about it initially. So, generally, it's going at a strong cliff. We did believe that COVID and state budgets might be an accelerating force. We think we're seeing that happen. New York is a great example of that. So overall, that's a positive trend and slightly more optimistic than what we would have said.
The only caveat as we go through on a state by state basis, not every state opens up the same way. Some are opening up for multiple operators, some will open up for lottery first, and then sports betting second. Some states like New York will be very specific and only allow a very select few of operators. So if you're integrated into that operator, that's great. If you're not, you might miss out on more of a chance of that state.
So there's a little bit of a nuance, and Mike as you drilled down on it. But generally speaking, we are very well integrated across the big important player account management systems. We're very well integrated with all the big names or the majority of the big names. So, that does serve us well as these states open up at a more accelerated pace.
Mike Del Grosso
Great. Helpful color. Thank you.
Philip McHugh
Thanks, Mike.
Operator
The next question is from Timothy Chiodo of Credit Suisse. Please proceed with your question.
Timothy Chiodo
Great. Thanks for taking the question this morning. On SMB, within integrated processing, roughly half or so of the segment revenue. Maybe you could just talk about the component there that is the Clover business. I understand you guys are one of the largest resellers of Clover. Maybe just talk about the relationship there? How large that business is for you? And how that grew maybe compared to the overall and compared to the rest of the SMB portfolio?
Philip McHugh
Thanks, Tim. No, we've definitely talked in the past that we're definitely one of the larger resellers of Clover Smart devices in the country. It's a great relationship with First Data, which we continue to have. So that's been a strength. I don't have to hand the exact cut of Clover terminals and the share. We can certainly follow-up in an assessment call and get you that breakdown.
Where the real focus for us has been, we've really been focusing on driving scale and operational efficiency, improving auto serve. And we're very focused on having a single boarding capability, where you can auto board onto the backend of either TCIS, first state of North or Omaha. That's actually a pretty powerful capability in this market, it drives an extra pop. It attracts lots of agents in [indiscernible] there.
Two, we're also working closely with our e-commerce gateway of integrating that more and more into our SMB offering, as well. So there's a couple of nice developments happening on that front beyond the Smart POS sales, but we can follow up on that.
Timothy Chiodo
Okay. Great. And then, just related to the yield on the Clover business, in general, would you describe that as relative to the overall segments yield? Would you describe that as roughly in line, slightly higher, slightly lower?
Philip McHugh
Tim, I'm sorry, you said the yield on which business? I didn't pick that up. Apologies.
Timothy Chiodo
The Clover portion of the SMB business.
Philip McHugh
Oh, is there a higher yield on the Clover portion? We have to double check. But I would suspect there's not a meaningful delta in yield aside between selling POS [ph]. What's going to really drive the yield is the size of the merchant and the vertical more, than the actual POS at the end of the day. So, that's certainly the way we approached from pricing. But, we can come back with a confirmation of that.
Timothy Chiodo
Okay. Great. Thanks so much for taking the questions.
Philip McHugh
Thanks, Time. It's good to hear from you.
Operator
There are no additional questions at this time, I would like to turn the call back to Philip McHugh for closing remarks.
Philip McHugh
Thanks. We have a large crowd on the phone, so thank you for everyone for joining. Thanks for the questions. We look forward for some follow-up sessions and to updating on the performance and growth of where we're taking Paysafe. Thanks, everybody.
Operator
This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
There are hundreds of immuno-oncology products in the pipeline. Each one of those technologies is built on at least one biomarker like MAGEA4. But, what makes MAGEA4 stand out of the crowd of biomarkers? The value of a biomarker as a target is determined by three critical factors. First, how much normal expression is going on in the body or what is the likelihood of off-target effects? The most valuable biomarkers are those with the least natural expression in non-tumor tissues. This lesson was learned in a fatal clinical trial involving MAGEA3. MAGEA4 only expresses in the testes and placenta making it a high-value biomarker. Especially because not everyone has testes. The second factor of importance is the patient population size. MAGEA4 is found in many different cancer types making it doubly valuable. Third, researchers consider if immuno-oncology treatment, targeting the biomarker, can improve treatment over existing therapeutics. MAGEA4 is present in many malignant tumors or those hardest to treat today. Thus, MAGEA4 is a triple threat biomarker.
Melanoma-associated antigen A (MAGEA) subfamily proteins are members of cancer/testis antigens (CTAs), whose normal expression is limited to germ cells, but ectopic expression can be observed in tumor cells of different origins. The MAGEA genes were initially identified as tumor antigens that can be recognized by cytotoxic T-lymphocytes in melanoma patients. The MAGEA subgroup of CTA family comprises eleven genes that show striking homology with each other and are encoded as a cluster at the Xq28 region. Their normal expression is restricted to the testis, trophoblast and placenta. MAGEA expression in somatic cells is silenced by promoter DNA methylation, but in tumor cells genome-wide epigenetic reprogramming can result in promoter hypo-methylation, leading to aberrant expression of one or more of these genes.
Looking forward to these events:
Upcoming Events
May 11, 2021 8:00 am EDT – 10:00 am EDT
Adaptimmune to Present First Preclinical Data from its HLA-independent TCR (HiT) Platform at ASGCT
Abstract Title: In vitro selection and engineering of a human leukocyte antigen-independent T-cell receptor recognizing human mesothelin (Abstract # 641)
Poster Presentation: Tuesday May 11, 2021 8:00 AM - 10:00 AM EDT during the Cancer - Immunotherapy, Cancer Vaccines Session
Jun 4, 2021 1:30 pm EDT – 4:30 pm EDT
Adaptimmune Oral Presentation at ASCO 2021 Annual Meeting
Abstract Title: SPEARHEAD-1: A phase 2 trial of afamitresgene autoleucel (Formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma
Session Title: Sarcoma
Teleconference dial-in information will be shared closer to the presentation date
https://www.adaptimmune.com/investors-and-media/news-events/ir-calendar
This week looking forward to:
Sio Gene Therapies Announces Four Upcoming Oral Presentations At 24th Annual Meeting Of American Society Of Gene And Cell Therapy
Sio Gene Therapies Inc. (NASDAQ:SIOX), a clinical-stage company focused on developing gene therapies to radically transform the lives of patients with neurodegenerative diseases, today announced four upcoming oral presentations at the 24th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), to be held virtually between May 11th to May 14th, 2021.
The AXO-AAV-GM1 presentation will include a review of patient-level data on safety and efficacy at 6 months follow up from the low-dose cohort of the Company's ongoing clinical study. Additionally, Dr. Cynthia Tifft, the lead investigator for the study, will present 6-month biomarker data from cerebrospinal fluid (CSF) in the 5 children who received intravenous AAV9 gene therapy.
Oral Presentation Details:
Presentation Title: AXO-AAV-GM1 for the Treatment of GM1 Gangliosidosis: Preliminary Results from a Phase I-II trial
Abstract Number: 162
Session: Clinical Trials and Advanced Preclinical Studies for Neurologic Diseases
Presenting Author: Cynthia Tifft, MD, PhD, Deputy Clinical Director, National Human Genome Research Institute
Presentation Date and Time: Thursday, May 13, 2021 6:15 PM – 6:30 PM EDT
Presentation Title: AXO-Lenti-PD gene therapy for Parkinson's disease: efficacy, safety, and tolerability data from the second cohort in open-label dose evaluation study SUNRISE-PD at 6 months post administration
Abstract Number: 163
Session: Clinical Trials and Advanced Preclinical Studies for Neurologic Diseases
Presenting Author: Gavin Corcoran, MD, Chief R&D Officer
Presentation Date and Time: Thursday, May 13, 2021 6:30 PM – 6:45 PM EDT
Presentation Title: Immune Modulation Preceding AAV9-GLB1 Gene Therapy Preserves the Possibility for Re-Dosing in Children with GM1 Gangliosidosis
Abstract Number: 179
Session: Immunotherapy and Vaccines
Presenting Author: Precilla D'Souza, DNP, MSN, CRNP, National Human Genome Research Institute
Presentation Date and Time: Thursday, May 13, 2021 7:00 PM – 7:15 PM EDT
Presentation Title: A GLP Safety and Biodistribution Study of AXO-Lenti-PD Manufactured via Two Processes Delivered at a Higher Volume and Flow Rate
Abstract Number: 256
Session: Pharmacology/Toxicology Studies or Assay Development
Presenting Author: Thomas Pack, PhD, Sio Gene Therapies
Presentation Date and Time: Friday, May 14, 2021 from 1:45 PM – 2:00 PM EDT
About AXO-AAV-GM1
AXO-AAV-GM1 delivers a functional copy of the GLB1 gene via an adeno-associated viral (AAV) vector, with the goal of restoring ß-galactosidase enzyme activity for the treatment of GM1 gangliosidosis. The gene therapy is delivered intravenously, which has the potential to broadly transduce the central nervous system and treat peripheral manifestations of the disease as well. Preclinical studies in murine and a naturally-occurring feline model of GM1 gangliosidosis have supported AXO-AAV-GM1's ability to improve ß-galactosidase enzyme activity, reduce GM1 ganglioside accumulation, improve neuromuscular function, and extend survival.
AXO-AAV-GM1 has received both Orphan Drug Designation and Rare Pediatric Disease Designation from the Food and Drug Administration and is the only gene therapy in clinical development for both Type I and Type II GM1 gangliosidosis.
In 2018, Sio licensed exclusive worldwide rights from the University of Massachusetts Medical School for the development and commercialization of gene therapy programs for GM1 gangliosidosis and GM2 gangliosidosis, including Tay-Sachs and Sandhoff diseases.
About AXO-Lenti-PD
AXO-Lenti-PD is an investigational gene therapy for the treatment of Parkinson's disease that is designed to deliver three genes (tyrosine hydroxylase, cyclohydrolase 1, and aromatic L-amino acid decarboxylase) via a single lentiviral vector to encode a set of critical enzymes required for dopamine synthesis, with the goal of reducing variability and restoring steady levels of dopamine in the brain. The investigational gene therapy aims to provide patient benefit for years following a single administration. Axovant expects to dose the first patient in EXPLORE-PD, a randomized, sham controlled study in 2021.
© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Also TDA has this:
Analyst Actions
All Buy Hold Sell
Analyst
Target Price
Stock Rating
Action
Latest Report
News
TipRanks Analyst Ratings Sorted by date: ascending
Analyst
Daniel Perlin
RBC Capital target $19.00
Ranking Buy
Analyst Action
Initiated date
13 days ago
Analyst
Darrin Peller
Wolfe Research target $19.00
Ranking Buy
Analyst Action
Initiated date
a month ago
Analyst
Michael Del Grosso Compass Point target $19.00
Ranking Buy
Analyst Action
Initiated date
a month ago
Has data for 3rd program adRP later this year, pivotal LCA10 data 1H 22
Sports betting legislation advances in key areas
The developments on sports betting legislation continue to trend very favorably.
Morgan Stanley analyst Thomas Allen points to numerous reports indicating that Florida could legalize online sports betting this year with a deal with the Seminole tribe.
Allen also says a recall vote in California on Governor Newsom bodes well for sports betting. He thinks a referendum to legalize retail sports betting at tribal casinos get pushed up to November of 2021 from 2022 . That means action could flying as early as 2022.
Morgan Stanley thinks Connecticut, Louisiana and Ohio are likely to formally legalize sports betting this year. Across the border, a bill in Canada allowing single event wagering is advancing.
Opening up new states for sports betting even in incremental stages is expected to give established casino operators and iGaming operators an edge as partnerships explode.
Wells Fargo Says
Affimed is an immune-oncology researcher in the biopharma world, looking into new therapies for cancer patients. The company’s ‘redirected optimized cell killing’ (ROCK) platform is used to develop innate cell engagers capable of reactivating the patient’s own immune cells to combat tumors. The company has 6 separate programs in its development pipeline, most in the preclinical stage of research. The company’s focus is on the treatment of hematological and solid tumors.
Of Affimed’s drug candidates, AFM13 is the first to have reached the clinical trial stage. The candidate has trials ongoing for the treatment of peripheral T cell lymphoma and CD30-postive T cell lymphoma, as well as transformed mycosis fungoides. Other lines of research are in earlier phases of development. AMF13 is a CD16A-based innate cell engager, and has shown promise of some therapeutic efficacy as well as a favorable safety profile.
In March, Affimed announced that it will be continuing REDIRECT, a Phase 2 study of AFM13 as a treatment for CD30-postivie T cell lymphoma. So far, the study has shown some anti-tumor response in both Cohort A and Cohort B of the patient base. Affimed’s recent program update also showed significant progress with AFM24, the company’s second most advanced program, now in a Phase 1 trial of its efficacy against solid tumors.
In his report on Affimed for Well Fargo, analyst Nick Abbott gives the stock an Overweight (i.e. Buy) rating and a $18 price target that indicates a potential for 62% upside in the year ahead.
Backing his stance, Abbott writes, “Our Overweight rating on AFMD reflects our view on AFMD’s approach to immuno-oncology (IO) with focus on the ROCK platform of innate cell engaging bispecific antibody development as a monotherapy, in combination with checkpoint inhibitors and in combination with cell therapy. Positive interim analysis of the registration-directed REDIRECT trial of AFM13 provides validation of the ROCK platform, in our view.”
Wall Street’s analysts are unanimous here, giving the stock 5 positive reviews in recent weeks for a Strong Buy consensus rating. The shares are priced at $10.42 and their $14 average target implies ~25% one-year upside.
https://www.tipranks.com/news/article/wells-fargo-says-these-2-stocks-could-spike-over-60-from-current-levels
Analysts Say ‘Buy the Pullback
Cardiff Oncology (CRDF)
The first stock we’re looking at, Cardiff Oncology, is a clinical stage biopharma company with a laser-focus on cancer treatment. Specifically, the company focuses on the development of medication options for cancer patients whose current treatment has lost efficacy. Cardiff is developing onvansertib, a first-in-class, third generation Polo-like Kinase 1 (PLK1) inhibitor, designed to work in combination with existing medications to overcome treatment resistance, improve patient response, and increase survival rates.
Cardiff’s current research pipeline features onvansertib in three separate clinical programs, in combination with different existing drugs to combat three different cancers. The programs are a Phase 1b clinical trial of onvansertib plus Folfiri/Avastin for the treatment of KRAS-Mutated Metastatic Colorectal Cancer (mCRC), and two Phase 2 trials, one in combination with Zytiga to treat Metastatic Castration-Resistant Prostate Cancer (mCRPC) and one to treat Relapsed/Refractory Acute Myeloid Leukemia (AML) in combination with Decitabine.
Preliminary data on these studies shows positive responses to onvansertib in combination with existing therapies. In the mCRC program, 86% of evaluable patients have shown a clinical benefit, while in the mCRPC program 54% of patients across three cohorts showed a radiographic stable disease. In the AML program, 20% of patients achieved a complete remission. These early data are considered significant, and the company has plans to initiate further trials later this year.
This background, along with the stock’s 50% fall year-to-date, have combined to catch the attention of 5-star analyst Jason McCarthy of Maxim Group. McCarthy points out that the shares have retreated recently due to profit-taking and broader market changes.
“While valuation has pulled back since reaching a 52-week high in late 4Q, from a KRAS perspective, CRDF is not alone… and we view Cardiff as potentially having the more attractive asset in mCRC which continues to be supported with emerging data… we still see a KRAS space that will continue to be active and is of potential high value given the unmet need, a company in Cardiff that is well-financed ($130M in cash as of YE20), and a drug in onvansertib that has multiple opportunities. Combined, we see this as an opportunity to buy CRDF shares on the weakness,” McCarthy opined. McCarthy puts a Buy rating on CRDF, and his $30 price target implies a robust upside of 242% from current levels.
https://www.tipranks.com/news/article/analysts-say-buy-the-pullback-in-these-3-stocks-2/
Agenus 1181 New Cancer Response Data Adds To Conviction
https://seekingalpha.com/article/4419058-agenus-1181-new-cancer-response-data-adds-to-conviction
ProQR's sepofarsen shows promise in blindness study
Apr. 13, 2021 4:34 PM ETProQR Therapeutics N.V. (PRQR)By: Aakash Babu, SA News Editor
ProQR Therapeutics (NASDAQ:PRQR) highlights case study describing durable vision improvement after treatment with sepofarsen in a clinical trial for CEP290 mediated Leber congenital amaurosis 10 (LCA10), in the scientific journal Nature Medicine.
Sepofarsen (QR-110) is being evaluated in the pivotal Phase 2/3 Illuminate trial and is a first-in-class investigational RNA therapy designed to address the underlying cause of Leber congenital amaurosis 10 due to the c.2991+1655A>G mutation in the CEP290 gene.
Leber congenital amaurosis (LCA) is the most common cause of blindness due to genetic disease in children.
"Treatment with sepofarsen resulted in substantial, concordant and enduring improvement in more than a dozen different subjective and objective measurements of visual function as well as retinal structure," lead author Professor Artur V. Cideciyan said.
Published results highlight a patient who is homozygous for the c.2991+1655A>G mutation in CEP290 and was part of a larger cohort in the Phase 1/2 clinical trial. The patient was studied for 15 months after intravitreal treatment with sepofarsen.
Concordant measures of visual function and retinal structure including visual acuity, light sensitivity and visual fields, reached a substantial efficacy peak near three months after injection and remained better than baseline at 15 months.
Shares up more than 2% post market.
https://seekingalpha.com/news/3681528-proqr-highlights-publication-in-nature-medicine-for-sepofarsen-in-blindness-study
Bought a couple 100 more shares @$13.81 and may be the low in this for awhile. Glad to buy more if the market will keep selling this gem down...
https://www.barchart.com/stocks/quotes/PSFE/cheat-sheet
Here's Why Shares of Affimed Skyrocketed Today
https://www.fool.com/investing/2021/04/09/heres-why-shares-of-affimed-skyrocketed-today/?source=iedfolrf0000001
AACR: Germany's small NK cell player Affimed makes a big splash with early lymphoma data
https://endpts.com/aacr-germanys-small-nk-cell-player-affimed-makes-a-big-splash-with-early-lymphoma-data/
Agenus Inc. (NASDAQ: AGEN) reported earlier this year that it has entered into a clinical collaboration with Nelum Corp. to evaluate the safety and efficacy of zalifrelimab, Agenus' anti-CTLA-4 antibody, in combination with NLM-001, Nelum's small molecule hedgehog inhibitor, and chemotherapy for first-line advanced pancreatic cancer. "This collaboration with Nelum is an exciting next step in our partnership strategy to broaden combinations and indications with our late-stage checkpoint antibodies," said Julie DeSander, Vice President of Business Development and Alliance Management. "Zalifrelimab, our first generation anti-CTLA-4 antibody, shows promising results alone and in combination with balstilimab, our anti-PD-1 antibody, and offers the potential to expand therapeutic benefit in novel combinations."
Kinross Gold Co. (NYSE:KGC) (TSE:K) has been assigned an average rating of “Buy” from the fourteen brokerages that are presently covering the stock, MarketBeat Ratings reports. Two research analysts have rated the stock with a hold rating, nine have assigned a buy rating and one has assigned a strong buy rating to the company. The average twelve-month price objective among brokerages that have updated their coverage on the stock in the last year is $11.57.
https://www.tickerreport.com/banking-finance/7261866/kinross-gold-co-nysekgc-receives-11-80-consensus-pt-from-brokerages.html
04/08/2021
Hookipa Pharma initiated with an Overweight at Morgan Stanley Morgan Stanley analyst Vikram Purohit initiated coverage of Hookipa Pharma with an Overweight rating and $19 price target. Hookipa is developing candidates for cancer and infectious disease using its arenavirus platform and its initial clinical data for HB-201 in HPV16+ cancer provides early proof-of-concept, Purohit tells investors. The analyst estimates peak product sales of HB-201 in HPV16+ head and neck cancer of about $400M in 2030, assuming a launch in 2024 and assigning the program 75% odds of success. Overweight and $19 PT.
An End to This Rare Syndrome Could Be an Opportunity for Investors
https://www.fool.com/investing/2021/04/07/an-end-to-this-rare-syndrome-could-be-an-opportuni/?source=iedfolrf0000001
Scholar Rock weakness overdone after TOPAZ results, says JPMorgan
JPMorgan analyst Anupam Rama noted that Scholar Rock shares are down about 15%, which Rama views as "overdone," after the company announced update 12-month results from the phase 2 TOPAZ study in the treatment of Type 2/3 Spinal Muscular Atrophy. The 12-month data showed relatively consistent functional benefit compared to six-month interim data reported in October, noted Rama, who added that "there were no major concerns" on the safety front. The analyst, who sees the "totality of data as a probability of success increase lever," reiterates an Overweight rating on Scholar Rock shares.
Exactly and always a given the SP will come down on an offering, the smart money buys on a selloff when the fundamental have not changed.
Large blocks are bought by the institutions wanting a higher percentage of the company shares rather than buying in the open market, driving up the share price.
Wells Fargo Biotech Cell and Gene Therapy Companion o Newsletter. This week's themes include: continued fund-raising for cell and gene therapy; regulatory actions including first BCMA CAR-T product approval, a first CAR-T filing for adult acute lymphoblastic leukemia, IND approval for pre-loaded NK cells, Orphan Drug designation in TTR-amyloidosis; optimization of cell therapy including point-of-care, reversal of exhaustion; further exoneration of AVV as a driver of cancer, but caution over long-term toxicity from AAV9-SMN in mice with spinal muscular atrophy; funding of an academic CRISPR trial in sickle cell disease and pre-clinical data for a gene therapy addressing hemophilia A & B.
Highlights of the week include: 1) Applied Genetic Technologies Corporation (AGTC) partner, Bionic Sight disclosing positive data for BS01 in retinitis pigmentosa. 2) Emergence of potential point-of-care cell therapy competitor, Avalon GloboCare - relevant for Precigen (PEGN) and Ziopharm (ZIOP). 3) Gracell Biotechnologies (GRCL) agreement with Lonza to manufacture dual CD19/BCMA FasCAR-T, GC-012F.4) Announcement by uniQure (QURE) that independent investigation finds it highly unlikely that the case of hepatocellular carcinoma was caused by AAV. 5) Publication with senior author Guangping Gao that natural AAV sequences in tumors and adjacent tissue are not different from each other - relevant for QURE and Sangamo Therapeutics (SGMO). 6) IND approval for Affimed's (AFMD) first IND for pre-loaded NK cell therapy. 7) Autolus Therapeutic's (AUTL) obe-cel received PRIME designation for relapsed/refractory acute lymphoblastic leukemia (ALL). (8) Filing of an sBLA by Gilead for TECARTUS in adult ALL highlights obe-cel's superior safety profile. 9) FDA approved bluebird bio (BLUE) and BMY's BCMA CAR-T, ABECMA in a more restricted patient population than studied - relevant for AUTL, Cellectis (CLLS), Celyad Oncology (CYAD), Fate Therapeutics (FATE), GRCL. 9) Intellia Therapeutics (NTLA) received Orphan Drug designation in Europe for NTLA-2001 in TTR-amyloidosis. 10) CIRM will fund a CRISPR gene therapy trial in sickle cell disease at 3 University of California institutions - relevant for Beam Therapeutics (BEAM), BLUE, CRISPR Therapeutics (CRSP) & SGMO. 11) UCLA publishes pre-clinical data supporting clinical development of CD4 CAR-T for HIV; NIH publishes less encouraging data [this is science]. 12) Clinical vignette from Chinese glioblastoma patient treated with a B7H3 CAR-T published - relevant for FATE. 13) Columbia University publish pre-clinical data suggesting gain of toxic function data in mice receiving AAV9 SMN treatment for spinal muscular atrophy - relevant for Ionis Pharmaceuticals (IONS) if there is read through to NVS's ZOLGENSMA. 14) Pre-clinical gene therapy with a platelet restricted factor Xa is effective in hemophilia A & B - relevant to QURE/SGMO. 15) CAR-T exhaustion can be reversed in pre-clinical models with a single dose of dasatinib - relevant for all companies developing CAR-T using a high affinity/avidity scFv.
Notable Corporate Events
AGTC partner Bionic Sight reported initial data from a phase 1/2 study of BS01 in advanced stage retinitis pigmentosa (RP). The data demonstrated that all four patients, who were complete or near-completely blind, can now see light and motion. Additionally, 2/4 patients can now detect the direction of motion. Bionic expects to report additional data later in 2021. Recall, AGTC has the option to pick up the program when the phase 1/2 data are available.
Avalon GloboCare Corp and strategic partner Arbele, are collaborating with the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center to advance the clinical development of point of care RNA-based autologous cell therapies using FLASH CAR technology. Avalon’s first FLASH CAR product candidate, AVA-011 targets CD19 and CD22 is on track to initiate a clinical study in B-cell leukemia and non-Hodgkin’s lymphoma – relevant for PEGN and ZIOP who use on-site point of care CAR-T manufacture leveraging Sleeping Beauty. PEGN and ZIOP use conventional DNA-CARs which integrate into the T cell genome while Avalon is using an RNA CAR which may be episomal and shorter lived.
GRCL signed an agreement with Lonza to manufacture FasTCAR products to support IND filing of dual BCMA/CD19 FasTCAR, GC-012F. Separately, GRCL announced enrollment of the first acute lymphoblastic leukemia patient into the registration-directed trial of GC007g in China. GC007g is an HLA-matched donor-derived allogeneic CD19 CAR-T product.
QURE announced the results of an independent investigation into the case of hepatocellular carcinoma (HCC) diagnosed in a patient in the HOPE-B trial. QURE noted that the independent investigation found it highly unlikely the HCC was caused by the company's AAV gene therapy etranacogene dezaparvovec (etra-dez).
Notable Regulatory/Clinical News
AFMD and partner NKMax America announced FDA IND clearance for a co-sponsored phase 1/2a dose escalation and expansion study evaluating AFMD’s EGFR/CD16A innate cell engager AFM24 in combination with NKMax America’s autologous NK-cell product SNK-01, currently in phase 1 testing, in patients with advanced/metastatic EGFR-expressing solid tumors.
AUTL announced receipt of PRIME designation for Obe-cel (AUTO1) in relapsed/refractory B-acute lymphoblastic leukemia (B-ALL) as well as recent listing of the MCARTY trial (NCT04795882) evaluating a modular CAR-T targeting BCMA alone or BCMA with CD19.
AUTL – Filing of an sBLA by GILD for TECARTUS highlights the superior safety profile of obe-cel (AUTO-1). With 1/4 and nearly 1/2 of TECARTUS-treated adult acute lymphoblastic leukemia patients suffering grade 3 or higher cytokine release syndrome (CRS) and neurotoxicity / immune cell associated neurotoxicity syndrome (ICANS) respectively at the 1M cell dose of ZUMA-3. By contrast, in 20 patients treated with obe-cel, AUTL reported no grade 3 or higher CRS and ICANS was limited to 4/20 patients, of which 3 cases were grade 1 and resolved within 24 hours.
AUTL – Chinese academics listed a phase 1 trial of a TRBC1 CAR-T in TRBC1+ve relapsed/refractory T cell leukemia. AUTL is conducting the LIbrA T1 trial of AUTO4 in TRBC1+ve T cell leukemia with interim data expected 2H21; AUTL expects to initiate clinical development of AUTO5 in TRBC2 T cell leukemia 2H21.
AUTL/CLLS/CYAD/ FATE & GRCL - we see the approved label for bluebird bio/ Bristol Myers Squibb's BCMA CAR-T, ABECMA for relapsed/refractory multiple myeloma setting a low bar for competitors. While ABECMA was studied in 4th line plus myeloma FDA gave the product a 5th line plus label. ABECMA’s blackbox warning includes hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) which occurred in 4% of patients overall increasing to 8% at the 450MM dose; approved CD19 CAR-T do not have an HLH/MAS blackbox warnings. In more recent BCMA trials, we note use of the IL-1 receptor antagonist, ANKINRA, potentially for HLH/MAS with 19% use in JNJ/Legend Biotech's cilta-cel CARTITUDE-I trial.
NTLA announced receipt of orphan drug designation from European Commission (EC) for Regeneron-partnered in vivo editing program NTLA-2001 for TTR amyloidosis (ATTR). The decision follows the initiation of the phase 1 study of NTLA-2001 in hereditary ATTR with polyneuropathy (hATTR-PN).
BEAM/BLUE/CRSP/EDIT - California Institute of Regenerative Medicine will support a phase 1 trial of CRISPR engineered SCD gene therapy to be conducted at The University of California, San Francisco (UCSF), UC Berkeley (UCB) and UC Los Angeles (UCLA).The 4-year study will include six adults and three adolescents with severe sickle cell disease. It is planned to begin this summer in Oakland and Los Angeles.
Notable Peer Reviewed Publications
FATE/CLLS – With both companies expected to announce programs outside of oncology we note UCLA scientists publish data for a 2nd generation anti-HIV1 CAR-T. UCLA’s use of engineered hematopoietic stem cells could be replaced by FATE’s induced pluripotent stem cells in our view. UCLA modified hematopoietic stem cells with a truncated CD4 CAR to target HIV envelope, that unlike the first gen CAR prevented HIV transmission as well as prevented IL-16 binding and potential non-specific CAR signaling while maintaining similar cytotoxicity against Env+ve cells. The use of 41BB as a costimulatory domain of the CAR, versus CD28 was essential for successful differentiation and improved anti-viral function. Suppression of viremia in untreated mice by the 2nd gen CAR was enhanced by combination treatment with ART which increased CAR-T persistence. The authors believe the 2nd gen CAR-T should be pursued as a clinical candidate. Separately we note an NIH manuscript describing the development of CAR-T against SIV. The studies failed to protect or gain control of viral spread. The authors identified optimal targets noting that while minimally expanded T cells were the most potent, generating large numbers was a challenge, one we note would not be an issue for an iPSC/allogeneic CAR-T. In addition, the authors observed that virus infected cells expressed Env protein for a relatively small fraction of the rapid viral lifecycle, and only towards the end when virus may be about to be released, an observation we interpret as requiring CAR-T persistence or the ability to re-dose.
Wells Fargo Biotech Cell and Gene Therapy Companion o Newsletter. This week's themes include: continued fund-raising for cell and gene therapy; regulatory actions including first BCMA CAR-T product approval, a first CAR-T filing for adult acute lymphoblastic leukemia, IND approval for pre-loaded NK cells, Orphan Drug designation in TTR-amyloidosis; optimization of cell therapy including point-of-care, reversal of exhaustion; further exoneration of AVV as a driver of cancer, but caution over long-term toxicity from AAV9-SMN in mice with spinal muscular atrophy; funding of an academic CRISPR trial in sickle cell disease and pre-clinical data for a gene therapy addressing hemophilia A & B.
Highlights of the week include: 1) Applied Genetic Technologies Corporation (AGTC) partner, Bionic Sight disclosing positive data for BS01 in retinitis pigmentosa. 2) Emergence of potential point-of-care cell therapy competitor, Avalon GloboCare - relevant for Precigen (PEGN) and Ziopharm (ZIOP). 3) Gracell Biotechnologies (GRCL) agreement with Lonza to manufacture dual CD19/BCMA FasCAR-T, GC-012F.4) Announcement by uniQure (QURE) that independent investigation finds it highly unlikely that the case of hepatocellular carcinoma was caused by AAV. 5) Publication with senior author Guangping Gao that natural AAV sequences in tumors and adjacent tissue are not different from each other - relevant for QURE and Sangamo Therapeutics (SGMO). 6) IND approval for Affimed's (AFMD) first IND for pre-loaded NK cell therapy. 7) Autolus Therapeutic's (AUTL) obe-cel received PRIME designation for relapsed/refractory acute lymphoblastic leukemia (ALL). (8) Filing of an sBLA by Gilead for TECARTUS in adult ALL highlights obe-cel's superior safety profile. 9) FDA approved bluebird bio (BLUE) and BMY's BCMA CAR-T, ABECMA in a more restricted patient population than studied - relevant for AUTL, Cellectis (CLLS), Celyad Oncology (CYAD), Fate Therapeutics (FATE), GRCL. 9) Intellia Therapeutics (NTLA) received Orphan Drug designation in Europe for NTLA-2001 in TTR-amyloidosis. 10) CIRM will fund a CRISPR gene therapy trial in sickle cell disease at 3 University of California institutions - relevant for Beam Therapeutics (BEAM), BLUE, CRISPR Therapeutics (CRSP) & SGMO. 11) UCLA publishes pre-clinical data supporting clinical development of CD4 CAR-T for HIV; NIH publishes less encouraging data [this is science]. 12) Clinical vignette from Chinese glioblastoma patient treated with a B7H3 CAR-T published - relevant for FATE. 13) Columbia University publish pre-clinical data suggesting gain of toxic function data in mice receiving AAV9 SMN treatment for spinal muscular atrophy - relevant for Ionis Pharmaceuticals (IONS) if there is read through to NVS's ZOLGENSMA. 14) Pre-clinical gene therapy with a platelet restricted factor Xa is effective in hemophilia A & B - relevant to QURE/SGMO. 15) CAR-T exhaustion can be reversed in pre-clinical models with a single dose of dasatinib - relevant for all companies developing CAR-T using a high affinity/avidity scFv.
Notable Corporate Events
AGTC partner Bionic Sight reported initial data from a phase 1/2 study of BS01 in advanced stage retinitis pigmentosa (RP). The data demonstrated that all four patients, who were complete or near-completely blind, can now see light and motion. Additionally, 2/4 patients can now detect the direction of motion. Bionic expects to report additional data later in 2021. Recall, AGTC has the option to pick up the program when the phase 1/2 data are available.
Avalon GloboCare Corp and strategic partner Arbele, are collaborating with the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center to advance the clinical development of point of care RNA-based autologous cell therapies using FLASH CAR technology. Avalon’s first FLASH CAR product candidate, AVA-011 targets CD19 and CD22 is on track to initiate a clinical study in B-cell leukemia and non-Hodgkin’s lymphoma – relevant for PEGN and ZIOP who use on-site point of care CAR-T manufacture leveraging Sleeping Beauty. PEGN and ZIOP use conventional DNA-CARs which integrate into the T cell genome while Avalon is using an RNA CAR which may be episomal and shorter lived.
GRCL signed an agreement with Lonza to manufacture FasTCAR products to support IND filing of dual BCMA/CD19 FasTCAR, GC-012F. Separately, GRCL announced enrollment of the first acute lymphoblastic leukemia patient into the registration-directed trial of GC007g in China. GC007g is an HLA-matched donor-derived allogeneic CD19 CAR-T product.
QURE announced the results of an independent investigation into the case of hepatocellular carcinoma (HCC) diagnosed in a patient in the HOPE-B trial. QURE noted that the independent investigation found it highly unlikely the HCC was caused by the company's AAV gene therapy etranacogene dezaparvovec (etra-dez).
Notable Regulatory/Clinical News
AFMD and partner NKMax America announced FDA IND clearance for a co-sponsored phase 1/2a dose escalation and expansion study evaluating AFMD’s EGFR/CD16A innate cell engager AFM24 in combination with NKMax America’s autologous NK-cell product SNK-01, currently in phase 1 testing, in patients with advanced/metastatic EGFR-expressing solid tumors.
AUTL announced receipt of PRIME designation for Obe-cel (AUTO1) in relapsed/refractory B-acute lymphoblastic leukemia (B-ALL) as well as recent listing of the MCARTY trial (NCT04795882) evaluating a modular CAR-T targeting BCMA alone or BCMA with CD19.
AUTL – Filing of an sBLA by GILD for TECARTUS highlights the superior safety profile of obe-cel (AUTO-1). With 1/4 and nearly 1/2 of TECARTUS-treated adult acute lymphoblastic leukemia patients suffering grade 3 or higher cytokine release syndrome (CRS) and neurotoxicity / immune cell associated neurotoxicity syndrome (ICANS) respectively at the 1M cell dose of ZUMA-3. By contrast, in 20 patients treated with obe-cel, AUTL reported no grade 3 or higher CRS and ICANS was limited to 4/20 patients, of which 3 cases were grade 1 and resolved within 24 hours.
AUTL – Chinese academics listed a phase 1 trial of a TRBC1 CAR-T in TRBC1+ve relapsed/refractory T cell leukemia. AUTL is conducting the LIbrA T1 trial of AUTO4 in TRBC1+ve T cell leukemia with interim data expected 2H21; AUTL expects to initiate clinical development of AUTO5 in TRBC2 T cell leukemia 2H21.
AUTL/CLLS/CYAD/ FATE & GRCL - we see the approved label for bluebird bio/ Bristol Myers Squibb's BCMA CAR-T, ABECMA for relapsed/refractory multiple myeloma setting a low bar for competitors. While ABECMA was studied in 4th line plus myeloma FDA gave the product a 5th line plus label. ABECMA’s blackbox warning includes hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) which occurred in 4% of patients overall increasing to 8% at the 450MM dose; approved CD19 CAR-T do not have an HLH/MAS blackbox warnings. In more recent BCMA trials, we note use of the IL-1 receptor antagonist, ANKINRA, potentially for HLH/MAS with 19% use in JNJ/Legend Biotech's cilta-cel CARTITUDE-I trial.
NTLA announced receipt of orphan drug designation from European Commission (EC) for Regeneron-partnered in vivo editing program NTLA-2001 for TTR amyloidosis (ATTR). The decision follows the initiation of the phase 1 study of NTLA-2001 in hereditary ATTR with polyneuropathy (hATTR-PN).
BEAM/BLUE/CRSP/EDIT - California Institute of Regenerative Medicine will support a phase 1 trial of CRISPR engineered SCD gene therapy to be conducted at The University of California, San Francisco (UCSF), UC Berkeley (UCB) and UC Los Angeles (UCLA).The 4-year study will include six adults and three adolescents with severe sickle cell disease. It is planned to begin this summer in Oakland and Los Angeles.
Notable Peer Reviewed Publications
FATE/CLLS – With both companies expected to announce programs outside of oncology we note UCLA scientists publish data for a 2nd generation anti-HIV1 CAR-T. UCLA’s use of engineered hematopoietic stem cells could be replaced by FATE’s induced pluripotent stem cells in our view. UCLA modified hematopoietic stem cells with a truncated CD4 CAR to target HIV envelope, that unlike the first gen CAR prevented HIV transmission as well as prevented IL-16 binding and potential non-specific CAR signaling while maintaining similar cytotoxicity against Env+ve cells. The use of 41BB as a costimulatory domain of the CAR, versus CD28 was essential for successful differentiation and improved anti-viral function. Suppression of viremia in untreated mice by the 2nd gen CAR was enhanced by combination treatment with ART which increased CAR-T persistence. The authors believe the 2nd gen CAR-T should be pursued as a clinical candidate. Separately we note an NIH manuscript describing the development of CAR-T against SIV. The studies failed to protect or gain control of viral spread. The authors identified optimal targets noting that while minimally expanded T cells were the most potent, generating large numbers was a challenge, one we note would not be an issue for an iPSC/allogeneic CAR-T. In addition, the authors observed that virus infected cells expressed Env protein for a relatively small fraction of the rapid viral lifecycle, and only towards the end when virus may be about to be released, an observation we interpret as requiring CAR-T persistence or the ability to re-dose.
AFMD should keep investors engaged over the next 15 months.
https://mattbiotech.substack.com/p/8-afmd-should-keep-investors-engaged?token=eyJ1c2VyX2lkIjoyMzUwODI2MywicG9zdF9pZCI6MzMzMTY4MjUsIl8iOiJONGVucyIsImlhdCI6MTYxNzYyMjA1OCwiZXhwIjoxNjE3NjI1NjU4LCJpc3MiOiJwdWItMjQ3MDA3Iiwic3ViIjoicG9zdC1yZWFjdGlvbiJ9.Wn2srFGmTJsw4Rvh-vNoCUNi_7YX9uNopW8OF6oOyGk&utm_source=substack&utm_medium=email&utm_content=share
Your most welcome. (-;
Kinross Gold: New Bullish Trend May Have Just Begun
https://seekingalpha.com/article/4417417-kinross-gold-new-bullish-trend-may-just-begun
A single injection reverses blindness in patient with rare genetic disorder
https://medicalxpress.com/news/2021-04-reverses-patient-rare-genetic-disorder.html
SPAC Market Has Dried Up, Bill Foley Says
Paysafe Chairman Bill Foley and CEO Phil McHugh discuss Paysafe going public via SPAC. They speak with Bloomberg's Matt Miller on "Bloomberg Markets."
https://www.bloomberg.com/news/videos/2021-03-31/spac-market-has-dried-up-bill-foley-says-video
Paysafe Interview TD Ameritrade
UPDATE: Compass Point Starts Paysafe Group Ltd. (PFSE) at Buy (Prior Ticker BFT)
March 30, 2021 4:22 PM EDT
(Updated - March 30, 2021 4:26 PM EDT)Compass Point analyst Michael Del Grosso initiates coverage on Paysafe Group Ltd. (NYSE-PFSE
VIDEO 07:18 minutes
Bill Foley on taking Paysafe, Alight Solutions public via SPAC video from Monday.
https://www.cnbc.com/2021/03/29/bill-foley-online-payments-company-paysafe-makes-spac-debut-tuesday.html
The Prognosis For Precision BioSciences
https://seekingalpha.com/article/4416084-prognosis-for-precision-biosciences
Paysafe $SAFE
To bad they could not get that ticker, it would be perfect....
May hear further strong points from the presentation.
Agenus to Present New Clinical Data on AGEN1181 at AACR 2021
https://www.globenewswire.com/fr/news-release/2021/03/10/2190840/0/en/Agenus-to-Present-New-Clinical-Data-on-AGEN1181-at-AACR-2021.html
A must read: Analyst Day Presentation "Paysafe"
https://www.paysafe.com/fileadmin/content/pdf/Analyst_Day_presentation_March_9__2021.pdf
ADC Therapeutics SA
Cowen healthcare conference: March 4th, 2021
https://wsw.com/webcast/cowen81/adct/1925484