Novo Nordisk (NVO) Q1 2022 Earnings Name Transcript

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Novo Nordisk (NVO 3.46%)
Q1 2022 Earnings Name
Apr 29, 2022, 7:00 a.m. ET

Contents:

  • Ready Remarks
  • Questions and Solutions
  • Name Contributors

Ready Remarks:

Operator

Good day, and welcome to the Novo Nordisk Q1 2022 outcomes name. [Operator instructions] As we speak, I am happy to current Lars Fruergaard Jorgensen. Please go forward together with your assembly.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks very a lot. Welcome to this Novo Nordisk earnings name for the primary three months of 2022 and outlook for the 12 months. This name follows the early announcement and lift steerage printed earlier in the present day. As a consequence of securities rules, we needed to advance the discharge that was initially scheduled for Wednesday subsequent week.

My title is Lars Fruergaard Jorgensen, and I am the CEO of Novo Nordisk. With me in the present day, I’ve govt vp and head of business technique and company affairs, Camilla Sylvest; govt vp and head of North America operations, Doug Langa; govt vp and head of improvement, Martin Holst Lange; and eventually, chief monetary officer, Karsten Munk Knudsen. All of us will likely be accessible for the Q&A session. As we speak’s announcement and the slides for this name can be found on our web site, novonordisk.com.

Please observe that this name is being webcast stay and a recording will likely be made accessible on our web site as nicely. The decision is scheduled to final for one hour. Please flip to the subsequent slide. The presentation is structured as outlined on Slide 2.

Please observe that each one gross sales and working revenue progress statements will likely be at fixed alternate charges except in any other case specified. The Q&A session will start in about 25 minutes. Please flip to Slide 3. As at all times, I have to advise you that this name will include forward-looking statements.

Such are topic to dangers and uncertainties that might trigger precise outcomes to vary materially from expectations. For additional data on the danger elements, please see the corporate announcement for the primary three months of 2022 and the slide ready for this presentation. Please flip to the subsequent slide. Within the first three months of 2022, we delivered double-digit gross sales and working revenue progress which was — which has enabled us to lift our outlook for the complete 12 months.

I want to begin this name by going by the efficiency highlights throughout our strategic aspirations earlier than handing over the phrase to my colleagues. Inside goal and sustainability, we reached an vital milestone with a constructive scientific opinion from EMA on human insulin. This can enable for extra versatile storage with out refrigeration for 3 rigs if saved under 30 levels sensors. This constructive opinion will assist acquiring approval from native well being authorities in low and middle-income nations.

With this, we goal to enhance flexibility and comfort for many individuals residing in these nations who’ve restricted entry to dependable chilly storage and will stay distant from a clinic or pharmacy. Following Russia’s invasion of Ukraine, our key priorities have been to safeguard workers and proceed the availability of important medicines. As well as, we have now donated two months provide of diabetes and hemophilia drugs to the Ukrainian Ministry of Well being. In collaboration with humanitarian organizations, we proceed to observe the state of affairs to have the ability to present additional assist.

Inside R&D, we’re inspired by the primary Section 3 trial with once-weekly insulin icodec, displaying the potential to enhance glycemic management with better comfort and a decreased remedy burden for folks needing insulin remedy. This is a crucial step in assist of our exploration of additional elevating the innovation bar, for diabetes remedy and our dedication to insulin innovation. We’re additionally glad with the progress made within the first quarter with our late-stage pipeline in uncommon illness. Martin will come again to this and our general RD milestones later on this name.

Within the first three months of 2022, we delivered double-digit progress in gross sales, reflecting strong industrial execution throughout geographies and our remedy areas. Particularly, the expansion is pushed primarily by accelerated demand for our GLP-1 therapies, particularly — particularly — sorry, Ozempic, which has enabled us to extend the outlook. Concerning the availability state of affairs for Wegovy in weight problems, the CMO has restarted manufacturing and we count on to make all Wegovy doses energy accessible within the U.S. in the course of the second half of 2022.

Camilla and Doug will undergo the main points of the remedy space later. Lastly, Karsten will undergo the monetary particulars, however I am more than happy with the gross sales and working revenue progress of 18% within the first three months of 2022. With that, I am going to give the phrase to Carmila for an replace on industrial execution.

Camilla SylvestGovt Vice President and Head of Industrial Technique and Company Affairs

Thanks, Lars, and please flip to the subsequent slide. Within the first three months of 2022, our whole gross sales elevated by 18%, the gross sales enhance was pushed by each working models with worldwide operations rising 13% and North America operations rising by 24%. Our GLP-1 gross sales elevated 45%, pushed by North America, rising 38%, and worldwide operations rising 60%. Insulin gross sales decreased by 4%, pushed by 1% progress in worldwide operations, offset by a 15% gross sales decline in North America operations.

The U.S. insulin gross sales declined by 16%, pushed by decrease realized costs and a decline in quantity. Weight problems care gross sales grew 107% general. In worldwide operations, Saxenda gross sales grew 63% and in North America Operations, weight problems care gross sales grew 146%.

Within the U.S., weight problems care gross sales grew 158%, pushed by each Saxenda and Wegovy. Whole uncommon illness gross sales elevated by 3%, pushed by each working models rising 3%. Please flip to Slide 6. Our 16% gross sales progress inside Diabetes Care is quicker than the general diabetes market.

Which means we have now improved our market share by 1.2 share factors to 30.5% and that we proceed to be on observe to achieve one-third of the diabetes worth market by 2025. The rise displays a GLP-1 progress of 45% and market share good points in each working models. Please flip to the subsequent slide. In worldwide operations, diabetes care gross sales elevated by 13% within the first three months of 2022, pushed by all areas and primarily by TLP1 gross sales that grew by 60%.

Novo Nordisk stays the market chief in worldwide operations with the GLP-1 worth market share of 60.1%. That is pushed by share good points throughout geographies and Ozempic stays on observe to change into the GLP-1 market share chief with a 36.1% market share. And with that, I’ll hand over the phrase to Doug.

Doug LangaGovt Vice President and Head of North America Operations

Thanks for the replace, Camilla. Please flip to the subsequent slide. The U.S. GLP-1 market grew greater than 30%, evaluating Q1 of 2022 to Q1 of 2021.

And with once-weekly injectable GLP-1s and Rybelsus as the principle drivers. From an NBRx perspective, we have now seen a step up in quantity progress in 2021 that has accelerated additional for the reason that starting of 2022, as proven on the left-hand aspect of this slide. Measured on whole scripts, Novo Nordisk stays the market chief of 54.2% market share. We’re additionally excited with the approval of Ozempic 2.0-milligram by the FDA in March that will likely be an possibility for kind 2 diabetes sufferers who could require each glycemic management.

We count on to launch our Ozempic 2.0 milligram within the U.S. within the coming weeks. The worldwide rollout of Rybelsus is progressing nicely, and it has now been launched in 34 nations. Within the U.S., Rybelsus whole prescription trajectory continues to steadily enhance, and it stays one of many key contributors to progress in Novo Nordisk.

Outdoors the U.S., Rybelsus in Japan has now reached a 4.2% worth share within the fashionable oral antidiabetics market after the 14-day prescription limitation was lifted in December of 2021. This compares to a 2.6% worth share once we launched our full 12 months’s leads to February. Please go to the subsequent slide. Globally, weight problems care gross sales elevated by 107%.

The with 146% progress in North America operations and 63% in worldwide operations. Within the U.S. alone, weight problems care gross sales grew 158%. We’re additionally excited to share the weight problems care cut up model.

To be particular, the entire weight problems care gross sales have been DKK 3.4 billion, with DKK 2 billion coming from Saxenda and DKK 1.4 billion coming from Wegovy within the U.S. Subsequent slide, please. As you realize, the demand for Wegovy has exceeded expectations. And in the course of the first quarter of 2022, weekly prescriptions within the U.S.

have been above the 20,000 stage that we communicated we may provide at — in reference to the complete 12 months leads to 2021. Our focus stays to make sure continuity of care to the sufferers which have already initiated remedy. We now have put gross sales and advertising actions on maintain. And to additional forestall new sufferers from initiating remedy, we stopped the availability of the primary Wegovy dose strengths, the 0.25 and 0.5 milligrams in March.

As Lars talked about earlier, the CMO filling syringes for Wegovy has restarted manufacturing, and our expectation stays to make all Wegovy dose strengths accessible within the U.S. in the course of the second half of 2022. On Wegovy market entry, I am completely happy to share that we have now added to the Division of Protection as a reimburse channel. As well as, we have now additionally progressed on industrial formulary entry, which is now round 80% for Wegovy.

And employer negotiations are progressing. Now again to Camilla for an replace on uncommon illness.

Camilla SylvestGovt Vice President and Head of Industrial Technique and Company Affairs

Thanks, Doug. And subsequent slide, please. Our uncommon illness gross sales grew by 3% within the first three months of 2022. This was pushed by a 3% gross sales progress in each North America operations and worldwide operations.

The place blood problems grew by 9%, pushed by NovoSeven in addition to the launch product, ESOP and Refixia. Particularly, hemophilia A merchandise grew by 10%, hemophilia B gross sales by 18%, and NovoSeven % by 8%. The place endocrine dysfunction gross sales declined by 8%. The decline in gross sales have been pushed by worldwide operations lowering by 2% and by North America operations lowering by 20%.

And now over to you, Martin, for an replace on R&D.

Martin Holst LangeGovt Vice President and Head of Improvement

Thanks, Camilla. Please flip to Slide 12. As to follow-up on Doug’s earlier feedback, we’re more than happy with the approval of Ozempic 2.0 milligram for the remedy of kind 2 diabetes in adults. The U.S.

FDA approval relies on the outcomes from the SUSTAIN FORWARD trial. Mirrored within the accredited label is a statistically important A1c discount of two.1 share factors at week 40, in comparison with Ozempic 1.0 milligram. Within the trial, Ozempic 2.0 milligram confirmed an identical variety of gastrointestinal unwanted side effects due Ozempic 1.0 milligram and general withdrawal charge from the trial was under 4%. All in all, each doses of Ozempic appeared to have a secure and well-tolerated profile.

As well as, Ozempic is indicated to cut back the danger of main cardiovascular occasions comparable to coronary heart assault, stroke, and cardiovascular demise in adults with kind 2 diabetes and identified coronary heart illness. The approval of the two.0 milligram dose permits extra folks with kind 2 diabetes to realize and preserve individualized glycemic targets and stay on the identical remedy for longer because the must evolve with out having to compromise on security and tolerability. Please transfer to the subsequent slide. Our once-weekly insulin to — sorry, our once-weekly insulin icodec is being developed to enhance glycemic management and permit for decreasing the variety of insulin injections from 365 to a mere 52 injections over the course of the 12 months.

Subsequently, we’re very excited to share the outcomes from the ONWARD 2 trial in the present day. Now earlier than sharing the outcomes from the trial, I wished to briefly contact upon the trial design and this system. ONWARD 2 is the primary of 6 trials within the international Section 3 onwards program for as soon as weekly into Lingotek that may all learn out in the course of the course of ’22. ONWARDS 2 was a 26-week efficacy and security trial evaluating once-weekly insulin icodec to as soon as day by day in degludec.

The trial included 526 folks with kind 2 diabetes, all beforehand handled with a basal-only insulin. The first goal of the trial was to show noninferiority of icodec versus degludec in decreasing A1c at 26 weeks. Superiority was additionally a part of the testing right here. Now let’s transfer to the thrilling half.

Subsequent slide, please. This 26-week trial achieved its main endpoint by demonstrating non-inferiority in decreasing A1c at week 26 with insulin icodec in comparison with insulin degludec. Moreover, from an general baseline of — baseline A1C of 8.13%, as soon as weekly insulin icodec achieved a statistically superior discount in estimated A1c of 9.3 share in comparison with — sorry, 0.9 share factors, in comparison with 0.71 share level for insulin degludec with an estimated remedy distinction of 0.22 share factors. As well as, the speed of extreme or clinically important hypoglycemia was low, and the distinction in estimated charges was not statistically important.

Within the trial, as soon as weekly insulin icodec seemed to be secure and well-tolerated profile. These outcomes are essential step in bettering insulin remedy for folks with diabetes, and we’re very excited to share extra outcomes of the ONWARDS program all through the remainder of ’22. Let’s transfer to the subsequent slide, please. Throughout our Capital Markets Day in March, I talked concerning the thrilling completion of the Section 3 trial with nicezumab.

Simply to recap, the Explorer 7 trial investigated subcutaneous concizumab prophylaxis remedy in folks with hemophilia A and B with inhibitors. The trial met its main endpoint by demonstrating that concizumab was efficient in decreasing the annual bleeding charge by 86% in comparison with no prophylaxis remedy in folks with hemophilia A and B with inhibitors. The general median annualized bleeding charge was zero, and this was additionally the case in every of the hemophilia A and B subgroups. As well as, the GST made a imply annual bleed charge was 1.7% for concizumab prophylaxis and 11.8% for folks not receiving prophylaxis remedy.

Total, concizumab appeared to have a secure and well-tolerated profile with no hassle embolic occasions reported after the restart of the Section 3 trial in August of 2020. We count on to submit concizumab for regulatory approval within the second half of ’22 and to report on the nonetheless ongoing Explorer trial in non-inhibitor sufferers later this 12 months. Please flip to the subsequent slide. Turning to the high-level R&D milestones.

2022 is a 12 months with many thrilling trial readouts and initiations throughout our faucet areas. Inside diabetes, we’ll see a number of readouts throughout all phases all through 2022, with essentially the most distinguished clearly being the ONWARD Section 3 trial program for as soon as weekly insulin icodec. In weight problems, we may probably have the interim evaluation from the SELECT trial within the third quarter of ’22, and we plan to provoke Section 3 with Kagoshima by the tip of this 12 months. Inside uncommon illness, we sit up for following the development of our late-stage pipeline with concizumab and Could-mid.

The latter, we count on to provoke Section 3 remedy in fourth quarter of 2022. We that, over to you, Karsten.

Karsten Munk KnudsenChief Monetary Officer

Thanks, Martin. Please flip to the subsequent slide. Within the first three months of 2022, our gross sales grew by 24% in Danish kroner and 18% at fixed alternate charges, pushed by each our working models. That is the strongest quarterly progress for greater than 20 years.

The gross margin elevated to 83.5%, in comparison with 82.8% in 2021, pushed by a constructive product combine on account of elevated GLP-1 gross sales, a constructive forex affect of 0.5 share factors, and productiveness enhancements. These results are countered by decrease realized costs, primarily within the U.S. Gross sales and distribution prices elevated by 23% in Danish kroner and 18% at fixed alternate charges. The rise is pushed by launch actions and promotional spend for Rybelsus and Ozempic in addition to market improvement actions for weight problems.

That is partially offset by decrease promotional spend in North America associated to insulin. Analysis and improvement prices elevated by 32% in Danish kroner and 29% at fixed alternate charges. The rise is pushed by just a few elements. Firstly, we have now the next variety of late-stage scientific trial actions in comparison with the primary three months of 2021.

Secondly, our ongoing pipeline enlargement and diversification efforts, together with development of the pipeline inside heart problems and NASH. And at last, it displays the working prices and amortizations associated to the acquisition of Dicerna Prescribed drugs. Administration prices elevated by 4% in Danish kroner and a pair of% at fixed alternate charges. Working revenue elevated by 28% in Danish kroner and by 18% at fixed alternate charges.

Web monetary gadgets for 2021 confirmed a loss for 2022 confirmed a lack of round DKK 1.2 billion, in comparison with a acquire of round DKK 1 billion in 2021. The losses on hedge currencies primarily associated to the U.S. greenback. The efficient tax charge for the primary three months of 2020 was 20.7%, in comparison with 20.8% in 2021.

Web revenue elevated by 13% and diluted earnings per share elevated by 14% to DKK 6.22. Free money stream was DKK 21.6 billion, in comparison with DKK 9.5 billion in 2021. The rise is pushed by greater internet revenue greater provisions, extra rebates within the U.S., and a constructive affect from change in working capital. Subsequent slide, please.

We entered 2022 with a strong progress momentum and now count on gross sales progress to be between 10% and 14% at fixed alternate charges. That is based mostly on quite a few assumptions as described within the firm bulletins. The speed steerage displays expectations for gross sales progress in each worldwide operations and North America operations and throughout remedy areas, however it’s primarily pushed by diabetes and weight problems care. The steerage incorporates an accelerated NBRx quantity development inside injectable GLP-1 within the U.S.

and that we count on to make all Wegovy strengths accessible within the U.S. in the course of the second half of 2022. Following higher-than-expected quantity progress on GLP-1-based merchandise, together with Ozempic, the outlook additionally displays anticipated periodic provide constraints. We now count on working revenue progress will develop between 9% and 13% at fixed alternate charges.

This primarily displays the gross sales progress outlook and continued investments in present and future progress drivers. We’re additionally allocating extra sources to each early and late-stage R&D pipeline actions. Our excision of Dicerna Prescribed drugs is negatively impacting working revenue progress by round three share factors on account of greater working prices and amortizations of intangible belongings. Given the present alternate charges, most notably a strengthening of the U.S.

greenback, we count on a constructive forex affect for 2022. Our reported gross sales are actually anticipated to be seven share factors greater than at CER, and working revenue progress is now anticipated to be 11 share factors greater than CER. The constructive forex affect on working revenue is partly offset by a internet loss on monetary gadgets. For 2022, we now count on that monetary gadgets will quantity to a internet lack of round DKK 4.1 billion primarily reflecting losses related to overseas alternate hedging contracts.

Capital expenditure remains to be anticipated to be round DKK 12 billion in 2022, which primarily associated to investments in extra API manufacturing capability at current manufacturing websites. Our free money stream is now anticipated to be between DKK 55 billion and DKK 60 billion, reflecting greater gross sales and internet revenue expectations. Based mostly on the elevated money stream era in 2022, the board of administrators has accredited an enlargement of the continued share repurchase program by DKK 2 billion to DKK 24 billion. That covers the outlook for 2022.

Now again to you, Lars, for ultimate remarks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Karsten. Please flip to the ultimate slide. We’re more than happy with the double-digit gross sales progress within the first three months of 2022. We Gross sales progress was pushed by all geographical areas inside worldwide operations in addition to North America operations and by all remedy areas.

Particularly, the gross sales progress was pushed by a continued robust demand for our portfolio of GLP-1 therapies for diabetes and weight problems care, and we proceed to achieve much more sufferers. The robust monetary efficiency within the first three months of 2022 has enabled us to lift our outlook for the complete 12 months. From an R&D perspective, the readout of the primary Section 3 trial with a once-weekly insulin icodec on the strains that we’re nonetheless dedicated to additional elevating the innovation bar in diabetes. We sit up for sharing outcomes from the opposite trials within the onwards program throughout 2022.

With that, we now open and prepared for Q&A. [Operator instructions] Operator, we’re now able to take the primary questions.

Questions & Solutions:

Operator

Thanks. [Operator instructions] Our first query comes from the road of Wimal Kapadia from Bernstein. Please go forward.

Wimal KapadiaAllianceBernstein — Analyst

Properly, nice. Thanks very a lot for taking my questions. Nice. Wimal Kapadia from Bernstein.

So first, can I simply ask on icodec, please. So clearly, a really robust end result demonstrating the prevalence versus placebo. However how do you actually take into consideration industrial potential and urge for food from payers particularly. That does HA1 superiority present Novo with a possibility to cost the drug at a premium within the commoditized market? Or ought to we actually be desirous about quantity upside? After which my second query is on yesterday’s Lilly replace on tirzepatide.

Now the GI charges in weight problems weren’t what we have been anticipating and among the placebo charges behave in a different way to what we noticed with Wegovy step 1. So I am simply curious if you happen to may touch upon how baseline traits affect GI. So I recognize — I am not asking you to touch upon the Lilly trial itself, however it’s extra of a broader query. What elements influenced GI outcomes in overweight sufferers that enable us to essentially take into consideration the security information extra precisely? Thanks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Wimal. And so two questions. First, Camilla on icodec and the industrial potential quantity worth technique. And Martin, you may speak to the final views about what to anticipate in weight problems on GI.

So Camilla?

Camilla SylvestGovt Vice President and Head of Industrial Technique and Company Affairs

Sure. Thanks for that, Lars. Sure. Thanks, Wimal.

We consider that icodec has the potential to redefine basal insulin remedy and, in fact, assist quite a few folks. There are roughly 30 million sufferers within the basal phase in the present day. You additionally know that Novo Nordisk has a market share round 35%, slightly extra in worth rather less in quantity. So additionally right here, there’s a potential for us.

Just a few of the traits of icodec are essential. To start with, it gives better comfort, but additionally better due price management that Martin was simply speaking to and a major one in comparison with what we have now seen earlier than. And that with a once-weekly injection that is also anticipated to cut back the remedy burden for folks residing with diabetes requiring basal insulin remedy. After which I additionally wish to point out, on the identical time that it does scale back the variety of injections from roughly 365 a 12 months to 52 a 12 months.

And that, in fact, can even haven’t only a aid remedy burden, but additionally a really constructive environmental affect. So all in all, the entire package deal of icodec could be very promising, and we consider it has the potential to redefine how achievement is finished in basal incline remedy. Then in the case of pricing, in fact, all of those belongings taken collectively is one thing that payers will likely be taking a look at. However for us, it is too early to speak on how precisely that may play out.

However the nice proof on the ONWARDS trial is a really nice first step for us to see the proof of icodec.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Camilla. And Martin?

Martin Holst LangeGovt Vice President and Head of Improvement

Sure. And on the gathering and reporting on gastrointestinal unwanted side effects, I feel you convey up an excellent level. Clearly, that is precisely why we ought to be very, very cautious evaluating throughout France, the very best comparability is clearly inside trial as a result of, to your personal level, each the inhabitants investigated. However actually additionally the way you gather information, which questions are being requested and the way typically do you gather information will drive the reporting on not solely gastrointestinal however any unwanted side effects.

So, subsequently, all of this ought to be interpreted slightly bit with a warning. A method of making an attempt to objectify it could be slightly bit is clearly to have a look at both discontinuation or withdrawal charges as a result of there, it is mainly a extra direct comparability. However nonetheless, higher to match inside trials than between trials.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Martin. Thanks, Camilla. Thanks, Wimal. Subsequent set of questions, please.

Operator

The following query comes from the road of Elizabeth Walton from Credit score Suisse. Please go forward.

Elizabeth WaltonCredit score Suisse — Analyst

Hello. Thanks very a lot for taking my questions. I’ve two. It is a follow-up on the Tirzepatide information that we had yesterday, actually clearly spotlight the on-treatment efficacy information that they noticed notably to your information, it is the intent-to-treat inhabitants that’s messaged and in addition on the FDA label.

So I am curious if that was a Novo selection or if that is what’s mandated by the FDA? After which simply on the GLPs extra broadly, you’ve got seen some very robust progress this quarter. I might be curious to grasp that that is actually being pushed by new sufferers beginning remedy or if you happen to’re additionally seeing a rise of keep time for sufferers on remedy. You was once form of neck and neck with Trulicity. What do you assume has modified over the previous 12 months that is meant you’ve got persistently gained the additional share.

Thanks very a lot.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Elizabeth. So Martin, first, once more, on say, trial design, and information with out with the ability to remark a lot on aggressive debt.

Martin Holst LangeGovt Vice President and Head of Improvement

So very, very clear. Within the U.S., with the U.S. FDA, there is a requirement for reporting and in addition in labels reporting what they name remedy coverage estimate, which is mainly taking into consideration all sufferers which have participated within the trial and in addition receiving slightly little bit of a penalty from a statistical perspective on sufferers both withdrawing from remedy or from the trial. That is particularly why we have reported on that each in most of our publications, but additionally in our label.

And we count on that the Tirzepatide label may even replicate the remedy coverage.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Martin. Camilla, on the clearly very robust GLP-1 progress? How would you characterize that?

Camilla SylvestGovt Vice President and Head of Industrial Technique and Company Affairs

Sure. Thanks rather a lot. So typically, we have now seen an acceleration in GLP-1 progress, each within the U.S. but additionally exterior the U.S., and particularly, additionally on new sufferers begin a major enhance.

And a part of that, in fact, is said to GLP-1 remedy being extra acknowledged being remedy pointers, but additionally, in fact, the attention of the a number of advantages that Ozempic and reversal tab and Ozempic particularly, we all know that 80% of persons are in good management. actually in a mix of discount of blood sugar discount of weight and in addition a confirmed discount in cardiovascular threat profile. And this triad of advantages is, in fact, one thing that’s clearly being acknowledged. And that is why we see increasingly more new sufferers beginning on GLP-1.

So it’s undoubtedly an impact of that. In the case of keep time then that is one thing that we measure extra at a form of a degree stage. So it is doubtless that there’s a continued enhance in state time. However the principle impact that we have seen within the final 4, 5 months has clearly been pushed by MPIX.

Then simply when it comes to acknowledged in GLP-1 remedy. We have additionally seen in China that after we have had Ozempic accredited and in addition on the reimbursement checklist, the NDRL, we have now seen that the scale of the GLP-1 market has now expanded from just a few years again being simply 1% of the market now being round 6.8% of the entire diabetes market. So additionally right here, we see the identical impact of the enlargement of the GLP-1 phase pushed by the advantages of the sort of remedy.

Elizabeth WaltonCredit score Suisse — Analyst

Thanks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks. Subsequent set of questions, please.

Operator

The following query comes from the road of Peter Verdult from Citi. Please go forward

Peter VerdultCiti — Analyst

Thanks. Peter Verdult, Citi. Two questions. Simply with the Clayton plant coming on-line this 12 months, I assumed the GLP-1 API state of affairs wouldn’t be an issue.

So the periodic provide constraints you are flagging throughout the portfolio, are all of them nonetheless and end associated? I suppose what I am driving at is simply whenever you may hope to be in a provide unconstrained whenever you may be in a provide unconstrained place to your GLP-1 portfolio? My second query, Martin, are you able to simply remind us what your modeling of the Section 2 20-week class weight problems information out to 72 weeks, Predix when it comes to anticipated share weight reduction? I feel you mentioned 25% to 29% within the CMD. Simply wished to make clear that. Thanks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Pete. So beginning on the availability state of affairs. So going again to the prior query, we’re clearly actually, actually happy with the unprecedented progress we see within the GLP-1 class. And it is also what leads us to improve right here after the primary quarter already.

So actually, actually, actually robust dynamics. We noticed on the Capital Markets Day, how we have now been increasing capability over the latest years and the way we’re ongoing doing that. There are, say, short-term optimizations one can do. You may, for example, see in our accounts that we have now elevated our variety of workers by 9%.

A lot of these are literally going into prolonged shifts in manufacturing you allude to investments. We’re additionally guiding that we’re investing DKK 12 billion in capex. So we have now each API capability coming in line, and we have now additionally a serious new fill end line coming in line in Denmark within the close to future. So we’re very targeted on with the ability to drive a progress technique with the ability to ship on our strategic aspirations.

However we’re additionally in a state of affairs the place the fundamental success of our molecules, the 70% of — 70% progress of Ozempic doubling weight problems, and many others., creates a major demand. In order we construct and ramp up that capability we’ll brief time period need to steadiness this, say, from a place of energy. And I am going to not be guiding on a selected date or future enterprise. And once we are unconstrained as we do not know precisely what the demand will seem like.

However we’re fairly assured that we are able to handle this — however we additionally simply wish to underline that the very profitable momentum we see proper now requires us to make these short-term costs — and we consider we are able to try this in a means the place we are able to each be there for the affected person and maintain progress of no Nordisk. After which there was a second query to you, Martin.

Martin Holst LangeGovt Vice President and Head of Improvement

Sure. Thanks very a lot. That was [Inaudible] and our modeling. I am going to simply remind us what we have now a 20-year — sorry, 20-week examine on the mix remedy of cagrilintide and semaglutide.

And in that examine, we noticed a 17% weight reduction over 20 weeks with out compromising on security and tolerability, so security profile much like that of semaglutide in monotherapy. After we mannequin that, we count on in a 68-week mannequin to see a weight reduction within the share of 25% physique weight reduction. It might be slightly extra. It might be rather less, however roughly 25% physique weight reduction.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Martin. Subsequent set of questions, please.

Operator

The following query comes from the road of Michael Novod from Nordea. Please go forward.

Michael NovodNordea Markets — Analyst

Yeah. Thanks rather a lot. It is Michael from Nordea. Perhaps simply making an attempt to quantify affect from the tight provide on — throughout your merchandise.

So may you say how a lot it truly is included in your steerage when it comes to share factors of top-line progress that isn’t going to be there due to the sort of provide. After which secondly, additionally to Rybelsus, it looks as if now you’ve got had three quarters the place you’re beating expectations. Do you simply see that doctor notion is altering on each the GLP-1? Or is it only a results of you higher with the ability to come out into the market and clarify the benefits of an oral GLP-1 in comparison with different oral therapies. Thanks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Michael. I am going to begin out on the availability state of affairs, then Doug can comply with on on Rybelsus efficiency and the way we see that. So we have now made a steerage which is reflecting the development change that Doug alluded to when it comes to variety of scripts. So we have now baked in considerably stronger GF-1 efficiency into our forecast.

So I feel that is a fairly daring outlook for our firm. And we really feel assured that we are able to provide that. So you may say we are literally leaning in and taking the newest, say, market dynamics into our forecast and may ship on that. So I do not assume it is actually attainable or related for us to invest what else there may have been of alternative as a result of we’re truly taking the newest development of the market into consideration.

And naturally, additionally reflecting how we consider this 12 months will unfold. So in our view, it is a actually, actually robust momentum we see. And we’re additionally leaning in, when it comes to carrying that momentum ahead within the 12 months. After which, Doug, are you able to speak a bit by Rybelsus efficiency within the U.S.

and the way we see the dynamics round that?

Doug LangaGovt Vice President and Head of North America Operations

Sure. Thanks, Michael, for the query. Actually, as we talked about final quarter, the trajectory of Rybelsus has been persevering with to develop. It is now has reported the third largest contributor to progress.

What we’re seeing particularly is we’re seeing a greater recognition or continued recognition of the semaglutide molecule. And particularly for Rybelsus, we’re seeing the breadth of latest writers, so roughly 1,100 writers per week are being added. After which whenever you take a look at month-to-month writers, we’re over 50,000. So we’re persevering with to see a rise in HCP consciousness of not solely the molecule, however particularly the model in Rybelsus, and we’re happy with the aggressive nature of what we’re doing in a really crowded area.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Doug. Thanks, Michael. Subsequent set of questions, please.

Operator

The following query comes from the road of Martin Parkhoi from SEB. Please go forward.

Martin ParkhoiSkandinaviska Enskilda Banken — Analyst

Sure. Martin Parkhoi from ESB. Two questions. Only a query to worldwide operations and the Q1 improvement.

We present this chart on Slide 7 that Ozempic now could be up on the identical market share and an acceleration as dulaglutide, and it is — very tough for me to grasp as a result of if you happen to take a look at the reported numbers, then Ozempic gross sales in worldwide relations this quarter was about 50% greater than the quantity that they reported yesterday on Trulicity exterior U.S. So what’s the distinction? Are these information right here ineffective or — are you — are the sell-in greater than what goes out to the sufferers? Simply clarify to me what the distinction is? Is it pricing or no matter? After which second query on gross sales and distribution. You are still guiding this 12 months for slight decline to the margin regardless of the very robust top-line progress, given the availability constraints that you simply possibly flag slightly bit as a possible threat. Are you eradicating slightly little bit of the strain additionally on SNP and why is that not mirrored? Is it the case mirrored within the margin?

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Martin. I am unsure on the IO TF1 gross sales. Karsten, are you able to — do you have got a perspective on that and maybe additionally SNP.

Karsten Munk KnudsenChief Monetary Officer

So if I begin out on SNP, then what we have now been pursuing all alongside is to drive top-line progress extra so than then the working margin enchancment, given the place we’re in our working margin above 40%. And we’re creating extra worth by driving top-line progress which is strictly what we’re benefiting from now with the enticing progress from our GLP-1 portfolio in diabetes in addition to market improvement. After which, in fact, we’re adjusting our industrial investments to no matter constraints there may be on particular merchandise or particular markets. However for now, we proceed to drive investments in industrial to be able to proceed to drive enticing top-line progress.

And so there isn’t any change to the method in that respect. And to the graph, I feel it ought to be considered that the graph we have now on Slide 7 is just not all of IO. It is a market the place we have now market statistics. In order that may be the explanation margin why there is a distinction.

However we are able to look additional into that. I am going to get again to you.

Martin ParkhoiSkandinaviska Enskilda Banken — Analyst

Thanks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Martin. Subsequent set of questions, please.

Operator

Subsequent query comes from the road of Mike Nedelcovych from Cowen. Please go forward.

Mike NedelcovychCowen and Firm — Analyst

Thanks for the query. I’ve two. First, on Section 3 SELECT, if the trial is constructive and relying on what label we do the finally garners, is it attainable that we go may change into eligible for Medicare Medicaid protection within the U.S. based mostly on the cardiovascular profit alone with out being for statutory change round protection of weight-loss medication.

That is the primary query. After which the second query is on Cagri Sea’s Section 3 program. Are you able to remind us of the quantity and kind of Section 3 trials which are required for U.S. submitting for a weight reduction indication? And can the Cagrisema Section 3 program basically be the identical as we go or completely different? If completely different, in what means? Thanks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Michael. So first, on Section 3 SELECT if there is a constructive end result. And the query was whether or not we may have protection in Medicare, sorry, based mostly on the CV information. I do not know, Doug, do you have got a perspective on that? .

Doug LangaGovt Vice President and Head of North America Operations

Sure, Lars. Thanks, Mike, for the query. This is able to nonetheless require legislative change. So actually, it will be useful, however it will nonetheless require a legislative change for Medicare.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Good. After which margin on the Cagrisema.

Martin Holst LangeGovt Vice President and Head of Improvement

So typically, the U.S. FDA would require not less than well-powered, randomized, and managed trials for a sure remedy interval for the approval of a drug, particularly in an weight problems indication. So not less than trials. Particularly for Kagoshima, that is precisely what we do or plan on this area, a targeted improvement program residing as much as the regulatory necessities, whereas on the identical time, demonstrating the efficacy and security of the calcemic mixture.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Martin. Thanks, Mike. Subsequent set of questions, please.

Operator

The following query comes from the road of Richard Vosser from J.P. Morgan. Please go forward.

Richard VosserJ.P. Morgan — Analyst

Hello. Thanks for taking my query. Two, simply going again to the onwards trial, please? And simply desirous about the upper charge of hypoglycemia. Simply your perspective on that and whether or not by striving for greater or superiority in HBC, that is dragged admittedly a low charge of hypoglycemia slightly bit greater.

And whether or not KOLs would try to take into consideration possibly decreasing the dose to try to scale back the hyperglycemia. So simply your views on how physicians will see that a part of the info. After which secondly, simply again to Cagrisema. I imply there’s been some suggestion by Lilly that they could try to file early.

Is there any likelihood of beginning the Cagrisema Section 3 trials slightly bit earlier? Or is that also certain up with getting the capability on-line for the pen? Any ideas there?

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Richard. I feel two questions for you, Martin.

Martin Holst LangeGovt Vice President and Head of Improvement

Sure. So on the onwards hypoglycemia, I feel it is vital to recall that on this state of affairs by regulatory requirement, we do what we name treat-to-target. So mainly, each insulins are titrated to the identical stage of fasting plasma glucose and that additionally occurred within the ONWARD 2 trial. Now in that setting, truly, and we did that efficiently.

We did see the prevalence of A1C, however we additionally noticed the numerical distinction. However as you level out, with a really low charge. And I feel it is vital to level out that there’s that very low charge, and that is particularly why we do not see a distinction between the 2 therapies, neither from a statistical or a scientific perspective. sufferers with these numbers on icodec could be on remedy for one and a half 12 months earlier than having a not extreme hypoglycemic episode.

I feel it is vital, even on this pretty massive Section 3 trial, we noticed no occasions of extreme hypoglycemia. So from a security perspective, we do not assume that there will likely be any restrictions neither within the clinic or from a regulatory perspective, not less than if we are able to repeat these information within the following 5 trials. I feel it is also vital to level out could also be that once we do form of sensitivity evaluation, the affect of hypoglycemia is mainly not registerable mainly, once more, reflecting very, very low charges of hypoglycemia, which are literally the bottom that we have seen within the improvement program thus far. On the time strains on Cagrisema, clearly, we’re taking a look at these intently — we intend to provoke the trial as deliberate within the second half of this 12 months.

After which clearly, we consider that we have now a observe file for not solely quick recruitment but additionally quick finalization and regulatory submission of our applications. And subsequently, we’re pretty assured that we are going to not be late with the Cagrisema trial conduct and regulatory approval subsequently.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Martin. Perhaps enable me so as to add a industrial perspective to Cagrisema and our alternative already based mostly on Wegovy. Within the first quarter, we bought SEK 1.4 billion price of Wegovy with out promotion and with very restricted provide capability. So I feel there is a bit an excessive amount of deal with, say, evaluating two trials.

And what I feel is a comparatively modest distinction in weight reduction — and if you happen to take a look at the inhabitants of individuals residing with weight problems and what we are able to present them of weight reduction in a secure method, in a simple remedy setting for a doctor to begin and a affected person to take there is a large alternative. And if you happen to simply take into account concerning the market dimension, all of us thought-about just a few years again in comparison with what it’s now. That is an incredible alternative. And we’re not nervous about competitors right here in any respect as a result of the variety of sufferers in want of remedy is admittedly, actually important probably one of many largest alternatives round — so this isn’t a market share recreation.

That is about getting sufferers on remedy, and we’re actually assured that we’ll get a major a part of these based mostly on what we have now and what we have now seen thus far. We’re simply getting going with the merchandise we have now, and we’re actually thrilling that we have now, say, a third-generation possibility that has potential to be even higher than something seen on the market in the present day. So for me, that is actually, actually thrilling. Thanks, Richard.

Subsequent set of questions, please.

Operator

[Operator instructions] The following query comes from the road of Colin White from UBS. Please go forward.

Colin WhiteUBS — Analyst

Good day. Colin right here. Two for me, please. To start with, why has the ego quantity of quantity modified a lot within the first quarter? Is that a listing impact? And might you quantify that? And secondly, it has been talked about previously about when GLP-1 market may decelerate, however that does not seem like taking place.

So I simply was questioning if you happen to may focus on newest assumptions on once we may begin to see the GLP-1 market progress begin to sluggish? Thanks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks. Karsten, may you give a perspective on maybe each questions right here. Worth, quantity Q1 and when will it decelerate.

Karsten Munk KnudsenChief Monetary Officer

Sure. So to start with, on Wegovy gross sales within the first quarter and — and which now could be the primary time we’re disclosing the quarterly restoration gross sales. And yow will discover on the IR aspect additionally the previous quarters of final 12 months. So we have now the complete development accessible.

And as with all launch product, there will likely be some volatility within the quantity worth numbers whenever you do implied worth prescripts. And there are mainly two key parts to it. So to start with, when you have got a launch product, there will likely be a variety between the recorded, name it IQVIA or Symphony script numbers after which our manufacturing facility gross sales as a result of ramping up a product means additionally constructing inventories at each the retail and wholesale a part of the availability chain. So there’ll usually be 10%, 20%, 30%, even 40% hole relying on the quarter on — within the so-called reality ratio as one a part of the reason.

And the opposite half is is linked to the truth that once we launched — we go together with final 12 months, we have been doing an early expertise program known as a Bridge program, the place we’re mainly offering co-pay insurance coverage. So we’re shopping for down the scripts to a standard co-pay no matter whether or not sufferers had full insurance coverage, whereas we’re negotiating to ascertain insurance coverage. And as a consequence, then there are a selection of the scripts over the quarters will likely be tapping into this bridge program, which was discontinued for brand spanking new initiations as of finish of final 12 months. In order this bridge program runs out, the worth per script may even be altering.

So some very traditional launch impacts on merchandise that we see throughout most product launches within the U.S. When it comes to and progress momentum and whether or not it slows down, then I am going to say the GLP-1 class has quite a few traits that are very enticing. So to start with, the product traits cater extraordinarily nicely for for the affected person viewers and the prescriber viewers that we’re mainly promoting the product into each when it comes to efficacy on blood glucose. It is a kind 2 product, proper? So on blood glucose, on weight, and cardiovascular security parameters, and it is easy and secure to prescribe.

So whenever you then take a look at the expansion trajectory and as we introduced at our Capital Markets Day, then as of in the present day, solely to the tune of three% of worldwide diabetes scripts, H1. So the runway when it comes to G1 penetrating the diabetes class has a really, very lengthy runway most notably in rising markets. So for example, once we take a look at Q1 this 12 months and the ramp-up of Ozempic in China, after reimbursement simply drives extra progress. After which come on high of that, that the GLP-1 class in kind 2 diabetes is admittedly being acknowledged for the traits.

In order we see within the first quarter within the U.S. Clearly, there is a massive demand and an acceleration of latest affected person initiations linked to these product traits. And a part of enabling that can also be that the product is being prescribed earlier and earlier. So beforehand being an injectable GLP-1 was prescribed solely after sufferers have failed on all therapies.

And increasingly more, we see Ozempic and GLP-1 remedy being moved early on into the remedy cascade towards, say, metformin failure and thereby being positioned a lot earlier on.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Karsten. Thanks, Colin, for these questions. Subsequent set of questions, please.

Operator

Subsequent query comes from the road of Kerry Holford from Berenberg. Please go forward.

Kerry HolfordBerenberg Capital Markets — Analyst

Thanks very a lot. A few questions, please. Firstly, on Ozempic, clearly spectacular progress first quarter. I ponder if you happen to can speak concerning the elements of that, notably within the U.S.

Does this replicate solely demand in diabetes? Or maybe is there some aspect of off-label use in greatest given these could be provide constraints simply thinking about your perspective there. After which secondly, on GLP-1 capability in PCT. Beforehand, you spoke of delivering round 20,000 wave provide with by change for per week when you’ve been constrained in provide. I ponder if you happen to may speak about roughly what your capability is within the second half of the 12 months between you — with you and your CMO again on-line and what number of scripts per week you may be capable of present within the second half of the 12 months.

Thanks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Kerry. So Doug, may you begin giving a perspective on, as was talked about, the spectacular progress within the U.S. and the way we are able to categorize that. After which Karsten, you may speak to the capability for Wegovy now that we’re again and having our CMO producing.

First you, Doug?

Doug LangaGovt Vice President and Head of North America Operations

Sure. Thanks, Kerry, for the query. Actually, we’re happy with the efficiency of Ozempic. It is actually been one thing we’re very happy with.

It is change into the No. 1 branded product whenever you take a look at NBRx. Semaglutide additionally, as I mentioned earlier, has change into a well known molecule and its potential to enhance each HbA1c, CV in addition to weight. And really, very importantly, Novo Nordisk, we promote Ozempic and Megoviin accordance with their indications and label interval.

Now within the U.S., there may be particular person physician expertise after which they prescribe drugs based mostly on their discretion. However for us, we nonetheless implement strong insurance policies and procedures to be sure that we’re monitoring the state of affairs and that our promotion, once more, is in line inside accordance with indications and labels. We’re happy with the efficiency. It is change into the No.

1 requested model in NBRx. And positively, we predict that momentum is powerful.Lars Fruergaard JorgensenThanks, Doug. Over to you, Karsten, on capability.Karsten Munk KnudsenYes. So capability on Wegovy is clearly a spotlight at Novo Nordisk.

And as we mentioned at our final name, then we had a sure capability across the 20,000 TRx and to the tune of three,000 inbox. And as you’ve got seen, although we have not been selling, we go within the U.S. market, demand has been constructing and exceeding these numbers. In order a consequence, the three lowest dose strengths of Wegovy are presently not accessible within the U.S.

market. In order that signifies that you must count on for the approaching quarters that the variety of TRx will likely be steadily taking place for the reason that three low strengths account for to the tune of fifty% of whole scripts if we take a look at it in Q1. After which, in fact, we’re very targeted on earlier than we make the product accessible in the course of the second half that we constructed ample inventories to be able to to make sure that there is a good expertise for each sufferers and prescribers when the product is out there out there once more. And there, we’re not defining the precise capability however hopefully, that shouldn’t be a priority.

After all, that is additionally a query of demand. However for positive, we is not going to make it accessible till we have now ample inventories in place.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Karsten. Thanks, Kerry. And we have now time for one ultimate query and a fast reply.

Operator

The ultimate query comes from the road of Simon Mather from BNP Paribas. Please go forward.

Simon MatherBNP Paribas — Analyst

Thanks. I will be as fast as I can. And simply casting rapidly, I imply, may you possibly assist us perceive after an outstanding first quarter and enhance in steerage, why there’s nonetheless a margin decline elements into your two steerage ranges, I do count on numerous working leverage to drive no margin contraction. After which simply secondly, simply on pricing.

I do not know if it has been disclosed, however when it comes to Ozempic 2.0, how is the pricing stacking up? I am simply considering on this as a possible technique to defend in opposition to apatite if certainly they do resolve to cost the identical throughout all doses and there is clearly going to be off-label use in weight problems. Thanks.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Simon. And Karsten, first on margin. After which, Doug, what you may say on pricing for two.0.

Karsten Munk KnudsenChief Monetary Officer

Thanks for that query, Simon. That is in fact one thing which could be very, very near my coronary heart to take care of the margin of the corporate being at an already very enticing stage north of — the important thing driver behind the margin dropping this 12 months is the truth that we purchased Dicerna Therapeutics late final 12 months, which has an affect of three% on working earnings. And as you realize, we’re not adjusting our numbers into varied varieties of core earnings. So that is type of the clear set of numbers.

And as you see, — once we began out the 12 months, we had a two share level hole between gross sales progress and OP progress ranges. And now we’re tightening that to just one share level linked to the margin advantages of the upper progress charges.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks, Karsten. And Doug, on pricing for two.0.

Doug LangaGovt Vice President and Head of North America Operations

Sure. Merely put, it is in alignment with Ozempic or flat pricing throughout all doses.

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Thanks. With that, I might similar to to conclude the Q&A session and once more say how happy we’re with our efficiency. We’re out to — off to a very, actually robust begin, and we sit up for have a continued robust progress for this 12 months, as we have now guided based mostly on the robust momentum we see. So thanks all for taking part on this name and be happy to achieve out to our investor relations officer, ought to you have got extra questions.

Thanks, and have a very good day.

Operator

[Operator signoff]

Length: 64 minutes

Name members:

Lars Fruergaard JorgensenPresident and Chief Govt Officer

Camilla SylvestGovt Vice President and Head of Industrial Technique and Company Affairs

Doug LangaGovt Vice President and Head of North America Operations

Martin Holst LangeGovt Vice President and Head of Improvement

Karsten Munk KnudsenChief Monetary Officer

Wimal KapadiaAllianceBernstein — Analyst

Elizabeth WaltonCredit score Suisse — Analyst

Peter VerdultCiti — Analyst

Michael NovodNordea Markets — Analyst

Martin ParkhoiSkandinaviska Enskilda Banken — Analyst

Mike NedelcovychCowen and Firm — Analyst

Richard VosserJ.P. Morgan — Analyst

Colin WhiteUBS — Analyst

Kerry HolfordBerenberg Capital Markets — Analyst

Simon MatherBNP Paribas — Analyst

Extra NVO evaluation

All earnings name transcripts

The post Novo Nordisk (NVO) Q1 2022 Earnings Name Transcript appeared first on India Express Online.

Source: Around the Globe

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