Johnson & Johnson at Bank of America 2025: Strategic Pipeline Focus

On Tuesday, 13 May 2025, Johnson & Johnson (NYSE:JNJ) presented at the Bank of America 2025 Health Care Conference, outlining its strategic focus on innovation and pipeline development. The company emphasized its commitment to smaller acquisitions and highlighted its approach to regulatory challenges and product development. Despite a recent dip in stock price, Johnson & Johnson remains optimistic about its future prospects, particularly in therapeutic areas like immunology, neuroscience, oncology, and cardiovascular.

Key Takeaways

• Johnson & Johnson is prioritizing smaller, bolt-on acquisitions to drive innovation.
• The company is focused on several promising therapeutic areas, including immunology, neuroscience, oncology, and cardiovascular.
• Regulatory processes remain on track despite changes at the FDA.
• Johnson & Johnson is conducting rigorous clinical trials to differentiate its products.
• The company is optimistic about addressing unmet medical needs with its pipeline.

Operational Updates

Immunology:

• Icotrokinra, an oral IL-23 inhibitor, is being developed with Protagonist and shows promising phase 3 data.
• The drug aims to treat a large number of patients eligible for advanced therapy biologics, with ulcerative colitis being a significant opportunity.
• Johnson & Johnson plans a head-to-head trial to secure reimbursement, particularly outside the U.S.

Neuroscience:

• The acquisition of Intracellular Therapies for $15 billion focuses on CAPLYTA, approved for schizophrenia and depression.
• ITI-1284, a deuterated formulation of CAPLYTA, is in phase 2 trials for Alzheimer’s psychosis/agitation and generalized anxiety, with data expected in 2025.

Oncology/Hematology:

• Johnson & Johnson is advancing cell therapies and bispecifics, with Tekdaily and Telve showing successful launches.
• Ribrivant, a bispecific for lung cancer, is demonstrating significant survival benefits and is being tested for other cancers.

Cardiovascular:

• Moldexian, a Factor XI inhibitor, is in phase 3 trials for atrial fibrillation and stroke prevention, with strong enrollment numbers.

Regulatory Landscape

• Despite leadership changes at the FDA, Johnson & Johnson’s regulatory timelines have remained on schedule.
• The company is optimistic about potential FDA advancements in AI and data sharing to enhance regulatory processes.

Future Outlook

• Johnson & Johnson’s strategy includes conducting head-to-head trials to differentiate its products and secure reimbursement.
• The company’s pipeline is positioned to address unmet medical needs and improve patient outcomes.
• The focus on smaller acquisitions is expected to enhance the pipeline value, as seen with previous acquisitions like Momenta and TARS.

Conclusion

For a detailed account of Johnson & Johnson’s strategic insights and pipeline developments, please refer to the full transcript below.

Full transcript - Bank of America 2025 Health Care Conference:

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Okay, I think we’re live. Thank you for joining us and sorry for the few minute delay. I’m Tim Anderson, the LargeCap in US Pharma Analyst and biotech analyst Bank of America.

We’re excited to have Johnson and Johnson with us today, Doctor. John Reed, currently Executive Vice President, Innovative Medicines R and D, joined the company in 2023. Prior to that, he was in various leadership positions at Sanofi, as well as Roche, served on their respective executive committees. He was in academia for a long period prior to that. So John, thanks for joining us.

I thought we’d start off with some high level questions that are ones that a head of R and D can answer. So why we ask about tariffs? Please,

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: let’s stick with those.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: So let’s talk about FDA, HHS, there’s changes going on there, turmoil, change in leadership. I think there’s a sense that it could have an impact that’s kind of incalculable and it could manifest in various ways. Are you guys seeing anything at this point in terms of disruption to process?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Yeah, so far so good, knock on wood, despite the significant change there. I’m speaking of the FDA in particular, that, you know, all of our PDUFA dates and other regulatory deadlines and interactions have occurred on schedule requests for meetings of various sorts, have been honored. So far so good. You know, kudos to the professionals there for managing to keep the trains running. In terms of, HHS too early to, you know, beyond FDA too early, I think, to say, but at least with respect to adjudication of our various applications and whatnot with the FDA so far so good.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: So I’ve been covering this space for twenty six years. To me, this is absolutely unquestionably the biggest disruption we’ve seen where different views are being espoused on what the drug development pathway should look like, what the regulatory BARDA approval should be. Would you concur with that?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: I would say that I haven’t seen seismic shifts of this proportion at any other time in my career of being involved with this industry. So, yeah. But I still think there’s so much we don’t know in terms of where the dust will settle. I noticed, for example, the new commissioner had decided to, last I heard, to keep the FDA structure largely intact rather than breaking it into these different divisions. So let’s see where the dust settles as we get through the latter part of this year.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: If you look at FDA, so you’ve interacted with the agency for a very long time. Are there positives that could come out of this? I mean, I have frankly viewed FDA as being pretty objective, doing a pretty good job, and not really needing a lot of change. We tend to have pretty fast approvals relative to a lot of countries around the world. Launches often occur in The U.

S. First. So are there some positives that could happen? Or if you, even a year ago, if I asked you, were there certain things FDA could do better? Do you think rise to the surface or would you agree that it’s generally a pretty well functioning agency?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Well, I guess one thing that comes to mind for me, and again, I’m totally speculating, but this administration seems to be, very enamored with AI and data at scale. And so there certainly are opportunities to have data sharing with the regulatory authorities occur in more robust ways where primary data could be uploaded directly, where analyses could be conducted, in more automated ways or more consistent ways. So I think there’s some opportunities there, but, you know, to be determined. Tim, I was hoping we’d talk about the pipeline and not too much about these ecosystem changes, which again, it’s hard to speculate exactly where things will land.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Well, yeah, you’ll be getting these questions from others, not just me, I’m sure, unfortunately. Okay, so with that, yes, we’ll shift to tariffs next, I’m joking. Let’s shift to immunology. A newer product that’s in the pipeline is Icotrokinra. So this is an oral IL-twenty three, your partner is a biotech company protagonist, and we’ve seen some phase three data that looks quite compelling.

It’s complimentary to some of the current products you have because you have an injectable IL-twenty three that does quite well. So how do you think this kind of layers into your immunology portfolio? And what about possible cannibalization of your injectable IL-twenty three?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Well, a couple of things. First, I just wanna, for those who aren’t that familiar with the story, this is a oral targeted peptide inhibitor of the IL-twenty three receptor, very potent once a day dosing. I think it’s an example of J and J at its best. We started with a collaboration with Protagonist by making an equity investment in the company to help nurture along this peptide drug discovery platform they had, Licensed the lead candidate from them, it quickly failed in the clinic. And then our chemists went to work, synthesized more than 700 of these complex cyclic peptides, more than 20 crystal structures got the optimized lead.

And then the real work started because we had to find a way to manufacture this at a commercially viable way. And so we went from a 20 plus synthesis, solid state, very expensive to a completely solution phase conversion synthesis that we can make this now a multi kilogram scale that cost of goods more than a hundred fold lower than what we started with. So it’s a great story. So now the data coming out have shown biologics like efficacy with IL-twenty three like very pristine safety profile. And where it fits in is that, you know, if you look across autoimmune diseases and you look at the percentage of patients who are eligible for an advanced therapy biologic, in no matter what disease you look at, it’s only a minority of patients that have taken that plunge and have agreed to go on a biologic.

So we see huge, parts of these markets, whether it’s psoriasis, psoriatic arthritis, IBD, where more than two thirds of patients on average are not getting an advanced therapy, even though they’re eligible. So this will have efficacy and safety that should make them comfortable once a day convenient dosing and, you know, really give patients that choice. I think one indicator of how much demand there is for this on our psoriasis studies, for example, our phase threes, they enrolled at one third the time that it normally takes us to do these studies. So we had so much demand from patients and investigators. So we’re really excited about potential Vicodrokinra.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Okay, so let me ask you a commercial question. Just like you liked it when I asked you policy questions, I’m sure you’ll like me asking a commercial question. So we have had another oral out there in the last few years from Bristol, SATIQ2. It really struggled to gain traction, frankly. Different class of drugs, your data, I think indisputably is better.

You do though have one structural impediment, it’s a peptide, an oral peptide. So you have to not eat, think for thirty minutes before you take the pill, that’s a little bit cumbersome. But why would your product in psoriasis do better than Bristol’s in as much as the commercial team and you talked

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: about this principally because the efficacy is so much better. We haven’t yet disclosed the difference between the TYK2 inhibitor and our molecule that’ll be presented at a future medical meeting. But just to give you a preview, think, Eagles versus Chiefs in the last Super Bowl. It is not a trivial difference. It is really head and shoulders efficacy on par with biologics.

And so we are really excited that ICO can become a go to therapy. In terms of the food effect you mentioned, indeed, one takes it for half an hour before eating. We are doing studies just to verify that you can take, you know, black coffee, black tea, and just so you can go ahead and enjoy your morning coffee or tea before you have your breakfast. So, but that’s probably the only thing that’s, sort of a convenience factor with this. Again, once a day oral dosing otherwise.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: So early data, or not early, but phase two data in ulcerative colitis looked quite good. So very different setting of inflammatory bowel disease. Is that likely to be the bigger opportunity for this product where there’s more of an established paradigm, I think, with oral therapies?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: If you just look at our biologics like Stellara, it very well could be about seventy percent of Stellara sales. That’s non selective IL-twenty three inhibitor biologic for those who don’t know. Although it’s approved for psoriasis, psoriatic arthritis, and Crohn’s and colitis, about seventy percent of the sales are coming from IBD. So it very well could be that in this IL-twenty three class, that is gonna be the biggest of the opportunities.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Last question on IBD for this product, competitive space, not a regulatory requirement, but effectively do you need to run head to head trial in phase three against an active drug to really kind of find a home for this problem?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: We intend to do that. You know, we did that with TREMFYA where we went head to head against our STELARA in a rigorous double blind, controlled study, unlike the way some others have done head to heads. And we will do the same with this molecule. That is important outside The U. S.

In particular for sometimes for reimbursement, particularly now that STELARA has gone biosimilar. So we will need to have some data of that sort for the payer conversations, especially overseas.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Okay, I wanna pivot to neuroscience. Sure. So the company recently paid about 15,000,000,000 to acquire a company, Intracellular Therapies. And really the cornerstone product there is CAPLYTA, which is for schizophrenia and other indications. There’s a follow on molecule and it’s really hasn’t gotten much attention.

You guys didn’t really highlight it at the time you did the transaction, it’s called ITI-twelve eighty four and it’s a deuterated formulation. So a slight tweak to the chemical structure. So what excites me about this is that when I look at the development program, you’re running quite a few number of phase two trials in Alzheimer’s psychosis and Alzheimer’s agitation. You’re also running trials in generalized anxiety. So you take phase two, okay, long pathway to approval.

When I look at these phase twos, they’re randomized trials. They’re large, large enough. They’re running duplicate. So to me, feels like it’s registrational. So is this a phase two product that’s actually a phase three product that could get into market a lot quicker than folks are thinking.

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Yeah, Ted, you’re very astute. First, let me just back up a little bit and say we’re super excited to have brought the Intracellular colleagues and their pipeline and products into J and J. J and J is number one in psychiatry. And so, you know, this, the marketed product, CAPLYTA, is a great fit for our portfolio approved for schizophrenia, approved for depression in the context of bipolar I and II. It’s the only drug approved in both I and II.

And then the thing that sort of tipped us over the edge to take the plunge was their phase III data in adjunctive treatment of major depressive disorder. That’s sort of your more garden variety depression. There are more than a quarter billion people around the world struggling with depression today. That’s been submitted, the PDUFA dates later this year, but those data are just outstanding. So we see broad utility and then twelve eighty four, as you said, is sort of son of CAPLYTA to slightly chemically modified.

And those studies that you mentioned are indeed of a size that normally could constitute grounds for the equivalent of a Phase III for the regulators that want to see two independently independent well controlled studies. So let’s see what the data look like. They are technically exploratory sometimes, you know, one is adjusting what your final endpoints will be in other patient and patient eligibility requirements based on the data. We’ll see what we learn from it. If, but if the data sets are rock solid and the FDAs and other health authorities agree, yes, this can count as one of the two required studies, then we’ll be one step further to approval.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: And that would take the product into areas potentially that CAPLYTA is not in, things like Alzheimer’s psychosis, and that’s relevant to products like Bristol’s Covenfi, which is trying to get there as well. Okay, so timing of news flow for these data sets, it’s not 25, it looks like it’s maybe 26 or even 27.

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: That’s correct, well, think we’re next year on the twelve eighty four readouts that you mentioned.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Okay, and I’d ask you, so we did one of our pipelines unplugged call with you a while back where we covered lots of things. And I’d asked at the time, 15,000,000,000 purchase price, how much was ascribed to this product? Couldn’t answer at the time, deal hadn’t closed. Do you have an answer now?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: No, I mean, most of value obviously was the marketed product, although we do see a lot of potential for $12.84. I would say though, although, yes, that was a big acquisition and J and J has the largest balance sheet in the industry, so we can certainly do those. It’s pretty atypical for us that we do big acquisitions. We tend to go in much earlier, do small bolt ons, and from that we tend to really, that’s really where a lot of the value in our pipeline comes from. You can see that in recent examples, like the Momenta acquisition where nipocalimab just got approved, our FcRn inhibitor for a broad diversity of autoantibody driven diseases, or TARS platform for bladder cancer that’s gaining a lot of interest.

So these are just a few examples. So tend to do a lot of these little bolt ons and rather than the big product based companies like Intracellular.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Okay, let’s move to oncology and hematology. So in multiple myeloma, you guys have really charted the course more than any other company and really making a meaningful difference to this disease over the years with a host of products. Newer ones include cell therapies like Carvicti and then bispecifics like Tekdaily and Telve. So I wanted to kind of talk about those last two products. So bispecifics versus CAR T.

So CAR T gets kind of held back in terms of usage because of certain toxicities like cytokine release syndrome, but the bispecific T cell engagers also share some of these toxicities. And the feedback that we sometimes get is that community hematologists are reluctant to engage with those products because of that safety profile. CAR T gives you great efficacy, these other products like TEKHNEDA give you good efficacy, they are off the shelf, they’re easier to use. But what is J and J doing to kind of massage those concerns and better define the safety profile such that there’s a better commercial future for those products?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Yeah, no, with any of these new therapies and the regimens in which they’re included, there’s always a journey in really devising the most convenient and best tolerated ways to get there. I mean, is not unlike the journey we went through with good old DARZALEX where in the beginning it was pretty much limited to the academic community. And then over time we figured out how to manage things like infusion reactions and other issues, and they became more and more integrated in the community practice. We’re going through that same journey right now. We’re doing a lot with community oncology groups.

We just got, to ameliorate the cytokine release syndrome. As you know, many times one uses an IL-six receptor inhibitor, namely Tosi. We recently, have that now in the NCCN guidelines to be used together with the bispecifics so that it ameliorates the cytokine release syndrome and are now working with community practices to make that part of the routine that the TOSI is reimbursed as well in this country. So, we’re certainly getting there. Then I think what’s more exciting is that of course we start as always at late line and our overall response rates were groundbreaking.

These are first in class bispecifics and the launches have been the most successful of any bispecifics in the industry. So take that into account as well. But now we’re moving into frontline and earlier lines of treatment in combinations. So at the last hematology meetings, American Society of Hematology, we showed, for example, if you take our DARZALEX and pair it with either TEC or Tau in patients with just one to three fire lines therapy, we were getting 100% minimal residual disease negativity in these studies. MRD is now recognized by the FDA as a bona fide surrogate for disease free survival, based on, pronouncements they had last year.

So, I mean, we’re seeing this now, the ability to take combinations of molecules from our portfolio and bring them to the early line is literally going to define the next regimens of the future. And we’ll work with community practices to teach them how to use them and make them, well tolerated.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Let’s move to Ribrivant, which is a newer product for you. This is your EGFR c Met bispecific used partly in conjunction with a small molecule EGFR in frontline lung. It’s notable because J and J has high views. You guys have given peak sales that are at least 5,000,000,000 and the street is a fraction of that. So there’s a discrepancy in how the street views it.

One of the reasons is the safety of that regimen going up against the current gold standard, is Astra’s Tagrisso, which is only just a single pill. It’s quite easy to use. How is this being used in frontline now? It’s more of a commercial question, but what are you seeing as the uptake in the frontline setting versus the second line setting?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Yep, no, ever since we shared our overall survival data in the frontline setting, we’re seeing the uptake really increasing exponentially. Just a few months ago at the European Lung Cancer Meetings, we showed that going head to head against the standard of care, that we were delivering, this combined drug regimen of Ribrovant plus Lascluse, a chemo free regimen is able to extend survival by more than a year. And the other thing that is really insightful is that if you look at the Kaplan Meier curves, as time goes on, the curves between standard of care and Reibbrandt Lascludes are actually diverging even more. It’s what we call kind of a fishtail type of shape, as opposed to what you might see with the standard of care protein tyrosine kinase inhibitor, OZ, together with chemo, where the curves initially diverge, but then they converge and you get more of this banana shape type of thing. So we really like what we’re seeing in the data.

And then on top of that, mind you that those data were not an optimized regimen. That was our first shot, but now we have a sub q rather than an IV, which looks to be not only more convenient, but also safer in terms of injection site reactions, also more efficacious. And we also have learned a lot about how to ameliorate the side effects related to skin thrombosis, etcetera. And so we now have an optimized protocol that we’re testing in community oncology centers, particularly in this country to gather more data. But we feel that we’re really on the right trajectory with this.

And that’s why we have high hopes for the molecule in both first and second line lung. But beyond that, Tim, we’re now in phase three in colorectal cancer, two different phase threes there in first and second line, as well as we’ve achieved POC or moving into phase three with head and neck squamous cell carcinoma. So there’s more to the Riborfan story than lung cancer.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: And early stage lung, my guess is the subQ formulation, better tolerability probably allows you to go into early stage like Astra did with Truprisso.

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Yeah, that’s certainly on the list of things to explore is getting even into adjuvant, etcetera.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: So just admittedly, we used to be pretty skeptical of that program, but that survival data does actually look quite compelling. Do you have any idea, is that actually preventing the emergence of MET formation and MET resistance? Is that why the shape of the curve looks like?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: We do know that. We actually did that analysis. For those who aren’t following this, so Ribrovant is the world’s first bispecific antibody ever approved for a solid tumor indication. One arm neutralizes the EGF receptor, which is commonly mutated in lung cancers and the other CMET, which is another growth factor receptor, often called HGF receptor, that becomes overexpressed as a resistance mechanism when you block the EGF receptor. And, so we did do, analysis in the Mariposa study and looked at how often did c Met overexpression occur in the Ripervant lens glue arm compared to the OZ and we significantly suppressed the emergence of CMAT overexpression.

We also suppressed the emergence of additional mutations in the EGF receptor as well.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Okay, let’s finish up in the cardiovascular space with Moldexian. This is your partnered product, World Factor XI in three different indications in phase three, the biggest of which is atrial fibrillation. So it’s been a class kind of marked by some setbacks here and there. Some companies have dropped out, others are pushing ahead. Just your updated level of confidence, some totality of all the industry data and where things are today, would you describe this as a low risk, medium risk, or high risk program?

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Well, I won’t do it pronounce, but maybe just say, look, we’re very dedicated to the program. We’ve already completely enrolled the AF, the atrial fibrillation study, more than 20,000 patients. We think we got the pharmacology right, in collaboration with BMS in that the molecule has been really well behaved. It, was well tested in phase two studies using, total knee replacement as a sort of playground in which you can adjust and define doses that have historically translated to the AF situation. In fact, all oral anticoagulants that are approved for AF went through that phase two testing.

We’re actually the only factor 11 that has done that at this point that’s still in the hunt for AF. So we think we got the dose right. You know, as my mentors always told me, dose matters. And so that’s what we’ve put a lot of emphasis on that. Some companies not as much, and we feel that we’ve got a molecule where for the AF indication, which is more like a venous stasis type of, situation for coagulation rather than an arterial side, where we know from our experience was Xarelto, the factor ten inhibitor, we know you have to push the dose.

What we’ve got with MILVAXAN is a molecule that is safe enough that we can push the dose and get it to the right level for that AF indication. So we’re very bullish on, the study. It’s, you know, it addresses a huge unmet need, particularly as our populations become more aged. And, while I’m at it, maybe I put in a plug for the med tech colleagues who do a lot with ablations in AF for those patients who prefer not to, stay on a medicine forever, they can have the option of trying an ablation.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Okay, last question on this end of the session here. So would you say that secondary stroke, which is one of your trials is riskier than atrial fibrillation? It’s a relevant question in my opinion, because we’ve got the Bayer stroke data coming up at the end of the year, and that’s naturally people are gonna look at that as read across to the mechanism, whatever the indication.

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Yeah, I think just by the nature of the more heterogeneous kinds of mechanisms that can lead to stroke, you’d probably say it is higher risk than the AFib. But again, there we’re, you know, we feel confident that we’ve got a great mechanism in factor 11. For those who haven’t followed it, there’s great genetics where people are sometimes born without factor 11. They have been decreased risk of thrombosis, but they don’t have major bleeding problems. So we feel like we’ve got that shot at both efficacy and safety.

And when it comes to a disease like stroke, so many patients are not on therapy because of the risk of bleeding in the brain. So this will be able to address an unmet need due to the safety of factor eleven inhibition, which is believed to block the formation of, of, pathologic clots that might block a vessel, but still allow the clotting mechanisms that prevent bleeding. So we’re, we’re excited about the stroke prevention as well. And this new mechanism we think fits right there where, you know, the current anticoagulants are thought to be not safe or, enough for that kind of an indication in many cases.

Tim Anderson, LargeCap in US Pharma Analyst and biotech analyst, Bank of America: Great. Okay. Well, we’re gonna call it there. Thanks so much, John, for joining us today and for participating in our conference this year.

John Reed, Executive Vice President, Innovative Medicines R and D, Johnson and Johnson: Hey, Tim, thank you. Thanks.

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