Q2 2021 Novo Nordisk A/S Earnings Call
Hello, and welcome to Novo Nordisk a S. First 6 months of 2021 results conference call.
Operator: Welcome to Novo Nordisk AS's first six months of 2021 results conference call. Throughout the call, all participants will be in a listen-only mode, and afterwards, there will be a question-and-answer session. Today, I am pleased to present Lars Jorgensen, CEO. Please go ahead with your meeting.
Throughout the call all participants will be in a listen only mode and afterwards, there will be a question and answer session. Today I am pleased to present loss Farooq RDR Hinson CEO. Please go ahead with your meeting.
Lars Fruergaard Jorgensen: Thank you very much and welcome to this Novo Nordisk earnings call for the first six months of 2021 and the outlook for the year. I'm Lars Jorgensen, the CEO of Novo Nordisk.
Thank you very much and welcome to this earnings call for the first 6 months of 2021 and your outlook for the year I'm, Josh will got Dragon King the CEO of Nordisk.
Lars Fruergaard Jorgensen: I'd like to start by thanking you for your scheduling flexibility today as we decided to advance this earnings call as a consequence of our earlier than anticipated release of our results following an upgrade of both sales and operating profit. With me today, I have our Chief Financial Officer, Karsten Knudsen, Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest, Executive Vice President and Head of North America Operations, Doug Lange, and finally, Executive Vice President and Head of Development, Martin Holst Lange.
To start by thanking you for your scheduling flexibility today actually we decided to advance this earnings call as a consequence of our earlier than anticipated release of our results. Following an upgrade of both sales and operating profit with.
With me today I have our Chief Financial Officer, Cosmos, collusion executive Vice President and head of commercial strategy and corporate affairs fast commuters list.
Vice President and head of North America operations to Atlanta, and finally, executive Vice President and head of development margin host Landon.
Lars Fruergaard Jorgensen: All presenters will be available for the Q&A session. Today's earnings release and the slides for this call are available on our website, www.noornois.com. Please note that this call is being webcast live and a recording will be made available on Novo Nordisk's website. The call is scheduled to last for one hour.
All percentages will be available for the Q&A session.
Today's earnings release, and the slides for this call available on our website Nordstrom com.
Please note that this call is being webcast live and a recording will be made available on Nordisk website.
Our call is scheduled to last for 1 hour. Please turn to the next slide.
Lars Fruergaard Jorgensen: Please turn to the next slide. The presentation is structured as outlined on slide 2. Please note that all shares, sales, and operating profit growth statements will be at constant exchange rates unless otherwise specified. The Q&A session will begin in about 25 minutes. Please turn to slide three.
The presentation is structured as outlined on slide 2 please note that all share sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.
The Q&A session will begin in about 25 minutes.
Please turn to slide 3.
As always I need to advise you that this conference call will contain forward looking statements such forward looking statements are subject to risks and uncertainty that could cause actual results to differ materially from expectations.
Lars Fruergaard Jorgensen: As always, I need to advise you that this conference call will contain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty that could cause actual results to differ materially from expectations. For further information on the risk factors, including the uncertainties around COVID-19, please see the company announcement for the first half of 2021 and the slides prepared for this presentation. Please turn to the next slide.
For further information on the risk factors, including the uncertainties around COVID-19, Please see the company announcement for the first half of 2021 and the slides prepared for this presentation.
Please turn to the next slide.
In the first half of 'twenty or 'twenty, 1 no noise cause progress on all 4 dimensions of our strategic aspirations I would like to highlight a few today.
Lars Fruergaard Jorgensen: In the first half of 2021, Novo Nordisk has progressed on all four dimensions of our strategic aspirations. I would like to highlight a few today. As a company, we're continuously working on being the best for the world and have progressed with purpose and sustainability. Under our Defeat Diabetes strategy that focuses on prevention, access, and affordability, and innovation, we have expanded the Changing Diabetes in Children Program by including Ghana as the 15th country.
As a company we're continuously working on being the best for the World and have progressed within purpose and sustainability.
Onto our defeat diabetes strategy that focuses on prevention access and affordability and innovation, we have expanded the changing diabetes and children program by including Ghana as of 15th country. This will support our exploration of reaching 100000 children and young people with type 1 diabetes in low resource settings by 'twenty.
Lars Fruergaard Jorgensen: This will support our aspiration of reaching 100,000 children and young people with type 1 diabetes in low-resource settings by 2030. An integrated part of being a sustainable business is to offer an inclusive and diverse working environment. In Novo Nordisk, a number of initiatives have been launched to achieve balanced gender representation across all managerial levels, but the reality is that progress has been slow. The current share of women in leadership positions defined as vice presidents and above is 35%.
30.
An integrated part of being a sustainable business is to offer an inclusive and diverse working environment.
<unk> noticed a number of initiatives have been launched to achieve a balanced gender representation across all many tier levels, but the reality is that progress has been slow.
The current share of women in leadership positions to find us way Vice presidents and above is 35%.
Lars Fruergaard Jorgensen: To underline our commitment to accelerate progress and ensure leadership accountability, we are launching a global gender diversity target. Specifically, our aspiration is to achieve a minimum of 45% women and a minimum of 45% men in leadership positions by the end of 2025.
To underline our commitment to accelerate progress and ensure leadership accountability, we are launching a global gender diversity targets.
Pacifically, our aspiration is to achieve a minimum of 45% women and a minimum of 45% women in leadership positions by the end of 2025.
Lars Fruergaard Jorgensen: Personally, I see this as an important step to create an inclusive culture with equal opportunities at Novo Nordisk. Martin will come back to key developments within R&D, but I wanted to touch on a few. We have reached a very important milestone with the approval of WGOI in the U.S. for the benefit of people living with obesity. Rigovi will be made available to US patients in June 2021, and Doug will share more about the details of the launch later.
Lastly, I see this as an important step to create an inclusive culture with equal opportunities in new enrollees.
Martin will come back to key developments within R&D, but I wanted to touch upon a few we have reached a very important milestone with the approval of <unk> in the U S to the benefit of people living with obesity.
We go where he was made available to U S patients in June 'twenty, 'twenty, 1 and talk with share more about the details of the launch later.
Furthermore, we expanded our pipeline within cardiovascular disease with the hot seat collaboration and acquisition of protein is a T T R and melodious doses program.
For commercial execution, we have progressed on all 3 strategic aspirations, which Camilla Doug will elaborate on later lastly, leaving the detailed forecast we are pleased with our sales growth of 12% and operating profit growth of 9% in the first half of 2021, both measured at constant exchange rates.
Lars Fruergaard Jorgensen: Furthermore, we expanded our pipeline within cardiovascular disease with the Heart-Seed Collaboration and acquisition of Proteinaz ATTR amyloidosis program. In commercial execution, we have progressed on all three strategic aspirations, which Camilla and Doug will elaborate on later. Lastly, leaving the details to Karsten, we are pleased with a sales growth of 12% and operating profit growth of 9% in the first half of 2020, both measured at constant exchange rates. With that, I give the word to Camilla for an update on commercial execution. Thank you, Lars.
With that I give the world to Camilla for an update on commercial execution.
Thank you Lasse and please turn to slide 5.
In the first half of 2021, our total sales increased by 12%. This increase was driven by both operating units with international operations growing 13% and North America operations growing by 11%.
All cap he areas contributed to growth with diabetes, Cathay is growing 11% driven by tier 1 sales call and broadly unchanged incidental.
Yeah. If you want to say has increased 30% driven by North America, growing 24% and international operations growing 46%.
Camilla Sylvest: Thank you, Lars, and please turn to slide 5. In the first half of 2021, our total sales increased by 12%. This sales increase was driven by both operating units, with international operations growing 13% and North America operations growing by 11%. All therapy areas contributed to growth, with diabetes care sales growing 11% driven by GLP-1 sales growth and broadly unchanged insulin. GLP-1 sales increased 30%, driven by North America growing 24% and international operations growing 46%.
The broadly unchanged incident were driven by 6% growth in connecting population, partly offset by an 11% decline in North America.
The U S sales decline.
Insulin sales declined by 11% driven by a decline in volume and realized prices, the latter driven by channel and payer mix as well as rebate enhancements.
Obesity, Cathay and <unk> grew 34% overall and now includes both the center and vehicles in the U S.
In International operations, <unk> sales grew 44% and in North America operations obesity care sales grew 27%.
Yeah.
Camilla Sylvest: The broadly unchanged insulin sales were driven by a 6% growth in international operations, partly offset by an 11% sales decline in North America. U.S. insulin sales declined by 11 percent, driven by a decline in volume and realized prices, the latter driven by channel and payer mix as well as rebate enhancement.
Biopharm sales increased by 7% driven by North America operations, growing 12% and international operations growing by 4%. Please.
Please turn to slide 6.
In line with our strategic aspirations of leasing 1 third of the diabetes value market by 2025 hour growth of 11% is faster than the overall market and hence we have improved our market share by half a percentage point to 29, 6%.
Camilla Sylvest: Obesity care sales grew 34% overall and now includes both Sex Center and WeGoWe in the U.S. In international operations, Saksanda sales grew 44%, and in North America operations, obesity care sales grew 27%. Biofarm sales increased by 7%, driven by North America operations growing 12% and international operations growing by 4%. Please turn to slide six.
This increase reflects Q1 growth of 30% and market share gains in both operating units.
Currently with Sandvik has been launched in 62 countries and we felt this in 18 countries.
Please turn to slide 7.
Yeah.
In international operations diabetes cafes increased by 13% in the first half of 2021, driven by all geographies.
The continued rollout of new generation incidents and focus on the T. O P..1 product portfolio have resulted in an increase diabetes market share in international operations, which is now 23, 9%, reflecting an increase of 1.4 percentage points compared to 1 vehicle.
Camilla Sylvest: In line with our strategic aspirations of reaching one-third of the diabetes value market by 2025, our growth of 11% is faster than the overall market, and hence we have improved our market share by half a percentage point to 29.6%. This increase reflects GLP-1 growth of 30% and market share gains in both operating units. Currently, USEMPIC has been launched in 62 countries and with BELTUS in 18 countries. Please turn to slide 7.
This is driven by share gains in both <unk> and insulin.
And in the last 12 months, our insulin volume market share has increased from 47% to 47, 3%.
Please turn to the next slide.
Biopharm sales grew by 7% in the first 6 months of 2021. This was driven by a 12% sales growth in North America operations, and 4% sales growth in international operations.
Where blood disorders grew by 11% driven by uptake of launch products escrow off and by Ccs and Novo 8 and over 7.
Camilla Sylvest: In international operations, diabetes care sales increased by 13% in the first half of 2021, driven by all... The continued rollout of new generation insulins and focus on the GLP-1 product portfolio have resulted in an increased diabetes market share in international operations, which is now 23.9%, reflecting an increase of 1.4 percentage points compared to one year ago. This is driven by share gains in both DLP 1 and in. And in the last 12 months, our interest in volume market share has increased from 47% to 47.3%. Please turn to the next slide.
Specifically hemophilia a products grew by 39% and <unk> by 30% and Novo 7 by 3%.
Well endocrine disorders grew by 2% driven by new indications and global rollout of the next generation device for Naughty children.
And now to a dog fight update on <unk>, 1 and obesity care.
Thank you Camilla please turn to the next slide.
The U S. <unk> volume market growth is around 25% comparing Q2.2021 to Q2.2020, driven by once weekly injectable <unk>, 1 as well as rebel says no.
Novo Nordisk new to brand market share leadership is now 62, 6% driven by the continued uptake of <unk> and rebel Sis. Furthermore, I was epic has regained <unk> market share leadership within injectable GOP 1 in the first half of 2021.
Measured on total scripts Novo Nordisk remains the market leader with more than 50% market share.
Please turn to slide 10.
In the U S rebels has increased its volume market share both in terms of total scripts and new patient starts in the first half of 2021.
Camilla Sylvest: Biofarm sales grew by 7% in the first six months of 2021. This was driven by 12% sales growth in North American operations and 4% sales growth in international operations, where blood disorders grew by 11% driven by the uptake of launched products Espiroc and Rayfixia and Novo 8 and Novo 7. Specifically, Hemophilia A products grew by 39%, Hemophilia B sales by 30%, and Novo 7 by 3%, where endocrine disorders grew by 2% driven by new indications and the global rollout of the next generation device for Nordic. Now to Doug for an update on US GLP-1 and obesity care.
This should be viewed in light of the 2 COVID-19 related commercial lockdowns in the U S with no face to face interaction between Novo Nordisk and the prescribers.
Since mid May our sales force has been fully back out in the field.
Accordingly, leading indicators such as prescriber breadth HCP awareness and sourcing from outside of the GOP..1 class remains encouraging and we remain confident in the product and its long term potential.
In addition, the launch trajectory is broadly progressing in line with the average performance of major <unk> twos that were all launched in a non COVID-19 world.
Outside the U S. Rebel this has now been launched in 17 countries with 1 key market being Japan, where <unk> has reached a 0.7% modern OAD value market share while underlying parameters are on track. It should be noted that there continues to be COVID-19 lockdowns in Japan.
Doug Langa: Thank you, Camilla. Please turn to the next slide. The U.S. GLP-1 volume market growth is around 25%, comparing Q2 2021 to Q2 2020, driven by once-weekly injectable GLP-1 as well as rebellion. Novo Nordisk's new-to-brand market share leadership is now 62.6%, driven by the continued uptake of Ozempic and Rebellion. Furthermore, Ozempic has regained MBRX market share leadership within injectable GLP-1s in the first half of 2021. However, measured on total scripts, Novo Nordisk remains the market leader with more than 50% market share, Please turn to slide 10.
Which makes it difficult for patients and a sales force to reach doctors. Please go to the next slide.
With the U S approval of <unk> in June obesity care is now a portfolio consisting of 2 products.
Globally obesity care sales increased 34% with 27% growth in North American operations, and 44% and international operations.
As we have touched upon throughout 2020 in 2021 fewer patients have started treatment with <unk> due to COVID-19, lockdowns and reduced access to health care providers.
But thankfully the situation is now starting to improve.
In the U S. Since the start of the year, we have seen positive momentum in new patient starts on <unk>, which during the second quarter of this year, we're above pre COVID-19 levels.
The U S launch of <unk> has been extraordinarily fast.
Following a 6 month FDA review will go <unk> was approved on June 4th.
Doug Langa: In the U.S., Robels has increased its volume market share both in terms of total scripts and new patient starts in the first half of 2021. This should be viewed in light of the two COVID-19-related commercial lockdowns in the U.S., with no face-to-face interaction between Novo Nordisk and the prescribers. Since mid-May, our sales force has been fully back out in the field. Importantly, leading indicators such as prescriber breath, HCP awareness, and sourcing from outside of the GLP-1 class remain encouraging, and we remain confident in the product and its long-term potential.
Launched on June 10, and available to patients or excuse me, yes available to patients in pharmacies on June 18th.
Market access has progressed since launch and 2 national payers have unblocked will go from their national formulary.
The initial feedback from patients and prescribers has been encouraging.
5 weeks after launch more than 8000 will go will be prescriptions.
Prescriptions have been filled and more than 50% of these are new to the anti obesity medication class.
Now the overwhelming initial demand has put the supply chain is under pressure.
Leading to temporary shortages for the starting dose which is <unk> 5 milligram.
Novo Nordisk is committed to ensuring that any patient who has started on mobility will be able to continue on the product and production plans are being adjusted to satisfy the current demand.
Doug Langa: In addition, the launch trajectory is broadly progressing in line with the average performance of major SGLT-2s that were all launched in a non-COVID world. Outside the U.S., Robelsys has now been launched in 17 countries, with one key market being Japan, where Robelsys has reached a 0.7% modern OAD value market. While underlying parameters are on track, it should be noted that there continue to be COVID lockdowns in Japan, which makes it difficult for patients and the sales force to reach doctors. Please go to the next slide. With the U.S. approval of OGO Globally, obesity care sales increased 34%, with 27% growth in North American operations and 44% in international operations.
Now I'll review Martin for an update on R&D.
Thank you Doug Please turn to slide 12.
During the first half of 2021, we have progressed, our pipeline in diabetes, and obesity and biopharm as well as in other serious chronic diseases.
Based on the significant unmet need of millions of people as well as scientific evidence to the potential benefits with GOP, 1 based treatment of dementia.
Initiated in May 2 phase III trials, evoke and evolve plus investigating the efficacy and safety of all <unk> 14 milligram.
He also how much disease.
As discussed before we have in real world data as well as improve talk evaluations of our large scale our cities seeing the potential of clinically very meaningful impact of GBP, 1 treatment on the progress of dementia.
The mode of action is still being evaluated but based on preclinical data. Some magnetite is believed to work.
Doug Langa: As we have touched upon throughout 2020 and 2021, fewer patients have started treatment with sexenda due to COVID-19 lockdowns and reduced access to healthcare providers. But thankfully, the situation has now started to improve. In the U.S., since the start of the year, we have seen positive momentum in new patient starts on sexenda, which during the second quarter of this year were above pre-COVID levels. The U.S. launch of Agove has been extraordinarily fast.
By reducing neural inflammation as well as by impacting all the pathways and the all time, most pathophysiology, thus, reducing newark degeneration and slow the clinical decline in all time of disease.
Yes.
The duration of the 2 trials will be 3 years with a confirmatory readout after 2 years.
That <unk> hundred 40 patients in each trial and therefore, a total of approximately 3700 patients will be randomized the majority of whom are diagnosed with mild cognitive impairment or early dementia of yours, how much time.
Doug Langa: Following a six-month FDA review, Wlugovy was approved on June 4th, launched on June 10th, and available to patients in pharmacies on June 18th. Market access has progressed since launch, and two national payers have unblocked Wlgovi from their national formulas. Initial feedback from patients and prescribers has been encouraging. Five weeks after launch, more than 8,000 Wogovi prescriptions have been filled, and more than 50% of these are new to the anti-obesity medication class.
Oh in enable plus however, at least 20% of patients enrolled will have small basal pathology.
The primary endpoint for both trials is.
Is the change in the clinical dementia rating some of box score after 2 years of treatment.
If successful <unk> has the unique potential to become the worlds first oral disease modifying treatment for Alzheimer's disease with a very well established safety profile from across several indications.
Turning to the next slide.
Within cardiovascular disease Novo Nordisk, the cheek ambition is to have at least 1 dedicated compound to be launched between 24 and 28.
This should target either.
Doug Langa: Now, the overwhelming initial demand has put the supply chain under pressure, leading to temporary shortages for the starting dose, which is 0.25 mg. Novo Nordisk is committed to ensuring that any patient who has started Amulgovi will be able to continue on the product, and production plans are being adjusted to satisfy the current demand. Now, Martin, for an update on R&D.
Sclerotic cardiovascular disease or heart failure with a high highly innovative first to market products, serving a significant unmet need.
In support of this ambition, we have entered into a new stem cells R&D license agreement with Hotseat and further acquire Fresenius <unk> Amyloidosis program.
Let us start with the Hotsheet agreement.
Novo Nordisk has entered into an exclusive worldwide collaborations as well as license agreement for the development manufacturing and commercialization of heartsease lead acid Hs <unk>.
Martin Holst Lange: Thank you, Doug. Please turn to slide 12. Now, in the first half of 2021, we have progressed our pipeline in diabetes, obesity, biopharmaceuticals, as well as in other serious chronic diseases. Based on the significant unmet need of millions of people, as well as scientific evidence of the potential benefits of GLP-1-based treatment of dementia, we initiated in May two phase three trials, Evoque and Evoque Plus. Investigating the efficacy and safety of oral semaglutide 14 mg in early Alzheimer's disease. As discussed before, we have seen the potential for clinically very meaningful impact of GLP-1 treatment on the progress of dementia in real-world data, as well as in post-hoc evaluations of our large-scale RCTs.
H F series here, 1 is an investigational cell therapy, using purified cadre of myositis derived from induced pluripotent stem cells, which is currently under development by Hotseat for the treatment of heart failure.
<unk> expects to initiate a combined phase <unk> trial in Japan during the second half of this year.
The collaboration very nicely complements our own stem cell technology platform.
Further we've acquired protein has brought our <unk> amyloidosis program Andy.
In the phase II ready antibody P. R share shortfall for the rare heart disease <unk> cardiomyopathy.
More specifically this is a rare type of heart condition characterized by a buildup of amyloid deposits in the Cochin tissue.
This can cause both weakening and stiffening of the hot emotional and it is an often fatal disease with a very significant at mesquite.
Martin Holst Lange: The mode of action is still being evaluated, but based on preclinical data, semaglutide is believed to work by reducing neuroinflammation, as well as by impacting other pathways in the Alzheimer's pathophysiology, thus reducing neurodegeneration and slowing the clinical decline in Alzheimer's.
Yes. It P. Rx series fearful as an innovative mode of action with the potential to remove myocardial.
Myocardial amyloid, preventing further progression and to reverse the course of the disease in <unk> cardiomyopathy.
Martin Holst Lange: The duration of the two trials will be three years with a confirmatory readout after two years. There are 1,840 patients in each trial, and therefore, a total of approximately 3,700 patients will be randomized, the majority of whom will be diagnosed with mild cognitive impairment or early dementia of Alzheimer's. In Evoke Plus, however, at least 20% of patients enrolled will have small vessel pathology. The primary endpoint for both trials is the change in the clinical dementia rating sum of Boxer's score after two years of treatment. If successful, semaglutide has the unique potential to become the world's first oral disease-modifying treatment for Alzheimer's disease, with a very well-established safety profile across several indications. Turn to the next slide.
<unk> expects to initiate a phase II clinical trial in 'twenty 2.
Which is expected to be followed by a phase III cardiovascular outcomes trial.
These activities support and expansion of Novo nordisk activities and commitment within cardiovascular disease.
And as to the ongoing activities within the cardiovascular space such as our clinical development program for CK Bacon myth or P. C. S canine as well as our major cardiovascular outcomes trials, such as select for sure.
Please go to the next slide.
Turning to the high level of R&D milestones, we start with the second quarter of 'twenty 1.
Within diabetes, we resubmitted the label expansion application for simply 2 milligram for the treatment of diabetes to the FDA on May 28.
The standard review time by the FDA is 10 months.
This resubmission followed the refusal to file letter received 5 yesterday on March 22.
It's already been mentioned during this call, but within obesity, we have reached a very important milestone with the approval of week over in the U S.
This was based on the results from the step program and building on that in Q2, we completed the phase II freebies, sorry, the phase III trials.
Martin Holst Lange: Within cardiovascular disease, Novo Nordisk's strategic ambition is to have at least one dedicated compound launched between 24 and 28. This should target either atherosclerotic cardiovascular disease or heart failure with a highly innovative first-to-market product serving a significant unmet need. In support of this ambition, we've entered into a new stem cell R&D license agreement with and further acquired Prathena's ATTR amyloidosis program Let us start with the hardship.
<unk> 5 and 8.
The 5 demonstrated a sustained weight loss.
Of 16, 7%.
What period, a full 2 years of treatment.
Almost a little bit repetitive, but very consistently to the profile step 8 demonstrated a similar 17, 1% statistically significant weight loss business to be compared to the 6.7% achieved 4.6%.
In the second half of 'twenty, 1 we expect phase 1 results for our glucose sensitive insulin.
Martin Holst Lange: Novo Nordisk has entered into an exclusive worldwide collaboration, as well as a license agreement, for the development, manufacturing, and commercialization of Hartz's lead asset, HS001. HS001 is an investigational cell therapy using purified cardiomyocytes derived from induced pluripotent stem cells which is currently under development by HeartSeat for the treatment of heart failure. HeartSeat expects to initiate a combined Phase 1-2 trial in Japan during the second half of this year.
As well as several trial initiations across all therapy areas, such as the fishery initiation of Orissa magnetite in obesity.
And the shipyard construction facility.
The shares chronic diseases.
Towards the turn of the year, we expect a decision from the EU to Magnetek, 2 port 4 milligram in obesity and <unk>.
Simply to share a milligram and diabetes.
Within Biopharm, we expect results from the Phase III program for Soma Pashtun in growth hormone deficient children.
And results from cohort of the ongoing combined phase 1.2 trial with <unk>.
Over to you guys.
Thank you Martin please turn to slide 15.
And the first 6 months of 2021 sales grew by 5% in Danish kroner and by 12% at constant exchange rates.
Martin Holst Lange: The collaboration very nicely complements our own stem cell technology platform. Further, we've acquired Prathina's broader ATGI amyloidosis program and Phase 2 ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy. More specifically, this is a rare type of heart condition characterized by a buildup of amyloid deposits in the cardiac duct.
The gross margin declined to 83 points your percent compared to 84, 1% in 2020.
The decline reflects a negative currency impact of <unk> 7 percentage points.
Lower realized prices in the U S and amortization of intangible assets related to the acquisition of atmosphere technologies in 2020.
These factors were partly offset by positive product mix driven by increased just 1 sales and continued productivity improvements.
Martin Holst Lange: This can cause both weakening and stiffening of the heart muscle, and it is often fatal disease with a very significant odds. The acid PRX004 has an innovative mode of action with the potential to remove myocardial amyloid, preventing further progression and to reverse the course of the disease in ATTR cardiomyopathy. Novo Nordisk expects to initiate a phase 2 clinical trial in 2022, which is expected to be followed by a phase 3 cardiovascular event.
Sales distribution costs increased by 8% in Danish kroner, and 50% at constant exchange rates.
The increase is driven by investments in our key strategic priorities, most notably launch activities and promotional spend for <unk>.
And <unk>.
Market development investments for obesity as well our sales force expansion in China.
Research and development costs increased by 12% in Danish krone, and 15% at constant exchange rates.
Martin Holst Lange: These activities support an expansion of Novo Nordisk activities and commitment within cardiovascular disease and add to the ongoing activities within the cardiovascular space, such as our clinical development program for Cytivegamab and PCSK9, as well as our major cardiovascular outcomes plans, such as SELECT and SOUL. Please go to the next slide.
The cost increase is driven by increased investments associated with more patients enrolled in clinical trials as we progress the early pipeline within cardiovascular disease, and Nash as well as the ongoing cardiovascular outcome trials, so and select.
Furthermore, we increased our investments in our research platform technologies.
Martin Holst Lange: Turning to the high-level R&D milestones, we start with the second quarter of 2020. Within diabetes, we resubmitted the label expansion application for SEMPIC 2.0 mg for the treatment of diabetes to the FDA on May 28. The standard review time by the FDA is 10 months.
Administration costs increased by 5% in Danish kroner, and 8% at constant exchange rates impacted by low spent in the first half of 2020.
Operating profit increased by 1% in Danish kroner and increased by 9 decreased by 1% in Danish krone and increased by 9% at constant exchange rates.
The negative currency impact on operating profit is partly offset by around 1 billion Danish kroner in hedging gains on our net financial items.
Martin Holst Lange: This resubmission follows the refusal to file letter received by the FAA on March. It's already been mentioned during this call, but within obesity, we've reached a very important milestone with the approval of WeCovi in the U.S., which was based on the results of the STEP program. And building on that, in Q2, we completed the Phase 3B trials, Step 5 and Step 8. Step 5 demonstrated a sustained weight loss of 16.7% over a period of full two years. Almost a little bit repetitive, but very consistently to the profile.
This compares to a loss of $1.7 billion Danish kroner in 2020.
The gains on his currencies, primarily relate to the U S. A.
Net profit increased by 10% and diluted earnings per share increased by 12% to 10 kroner and 71.
Free cash flow was $32.7 billion Danish kroner, compared with 33 billion Danish kroner in 2020.
The increase reflects the higher net profit and the favorable impact from changes in working capital.
Further cost positively impacted by within timing of U S rebate payments.
Next slide please.
A key priority for <unk> is to ensure attractive capital allocation to shareholders and over the past 3 years, our average customer interest ratio has been around 80%.
Martin Holst Lange: Step 8 demonstrated a similar 17.1% statistically significant weight loss. This is to be compared to the 6.7% achieved for Saxen. In the second half of 2021, we expect phase one results for our glucose-sensitive insulin, as well as several trial initiations across all therapy areas, such as the phase 3 initiation of all semaglutide inoculations and the CBI outcomes trial for Seltzer-Werke map in other serious conditions. Towards the turn of the year, we expect a decision from the EU on magnifying 2.4 milligrams and Osempe 2.0 mg in diabetes.
In may the share repurchase program for 'twenty to 'twenty..1 was increased by 1 billion kroner to a total of 18 billion kroner.
It should be noted that the program may be reduced in size, if significant business development opportunities arise during towards tranche 1.
For 2 inch trench 1 the board of directors has decided to pay out an interim dividend of treat Corona and 50 per share which will be paid out in August this year.
This is an increase of 8% compared to the 2020 interim dividend.
Now in orders because consistently returned its free cash flow to investors through both share buybacks and dividends with dividends per share increasing for 25 consecutive years.
Martin Holst Lange: Within Biopharm, we expect results from the Phase 3 program for somatopacetam in growth hormone deficient children, and results from cohorts of the ongoing combined Phase 1-2 trial will probably be. With that, over to you, Karsten. Thank you, Martin.
Finally in Q2, we executed a 3.7 year eurobond issuance in an aggregate amount of $1.3 billion Euro.
The 2 trenches were issued with a coupon of 7% and 012, 5% respectively.
Europe onshore issued under a 5 billion MTN program.
Karsten Munk Knudsen: Please turn to slide 15. In the first six months of 2021, sales grew by 5% in Danish kroner and by 12% at constant exchange rates. However, the gross margin declined to 83.0% compared to 84.1% in 2020. The decline reflects a negative currency impact of 0.7 percentage points.
Please turn to the next slide.
Yeah.
We now expect towards tranche, 1 sales growth to be between 10 and 13% at constant exchange rates.
This is based on the performance in the first half of the year across therapies and geographies, including the strong initial uptake.
Uptake in the U S.
Increasing global obesity market growth.
Pacific growth acceleration as well as a reduced likelihood of a negative impact from volume based procurement in China in 2021.
The guidance reflects growth across therapy areas, but it's mainly driven by tier 1 product centric and resources as well as for beauty care.
Karsten Munk Knudsen: Lower realized prices in the US and amortization of intangible assets related to the acquisition of hemisphere technologies in 2020. However, these factors were partly offset by a positive product mix driven by increased year-to-month sales and continued productivity improvement. Sales and distribution costs increased by 8% in Danish kroner and 15% at constant exchange rates. The increase is driven by investments in our key strategic priorities, most notably launch activities and promotional spend for Rebelsis and Ocempic, Market Development Investments for BC as well as Salesforce Expansion in China.
Also embedded as it says intensifying competition within both diabetes care and Biopharm and continued pricing pressure, mainly within diabetes care in the U S.
Operating profit is now expected to grow between 9 and 12%, reflecting the sales growth outlook and continued investments in current and future growth drivers.
This includes the continued rollout of <unk> and Roberto was the launch of <unk> and associated market development investments.
Furthermore, additional resources being allocated to R&D pipeline activities, such as the many phase III clinical trial activities.
Given the current exchange rates, most notably a strengthening of the U S. Dollar, we expect less negative currency impact for the full year compared to 3 months ago.
Consequently, our reported sales and operating profit growth is now expected to be 4 and 5% lower than at constant exchange rates respectively.
Karsten Munk Knudsen: Research and development costs increased by 12% in Danish kroner and 15% at constant exchange rates. The cost increase is driven by increased investments associated with more patients enrolled in clinical trials as we progress the early pipeline within cardiovascular disease and NASH, as well as the ongoing cardiovascular outcome trials SO and SELECT. Furthermore, we increased our investments in our research platform technology.
For twice the tranche 1 financial items are now expected to be a gain of around <unk> 6 billion Danish kroner, mainly reflecting gains associated with foreign exchange hedging contracts.
Capital expenditure is still expected to be around $7.5 billion Danish kroner entrance to which 1.
Lastly, free cash flow has increased by 2% in Danish kroner, and now expected to be between 39, and 44 billion Danish kroner.
That covers the updated outlook for transfer Wenchuan now back to <unk> for final remarks.
Thank you Carsten, please turn to slide 18.
Karsten Munk Knudsen: Administration costs increased by 5% in Danish kroner and 8% at constant exchange rates, impacted by a low spend in the third half of 2020. Operating profit decreased by 1% in Danish kroner and increased by 9% at constant exchange rates. The negative currency impact on operating profit is partly offset by around 1 billion Danish Kroner in hedging gains on the net financial item. This compares to a loss of 1.7 billion Danish Kroner in 2020. The gains on hedge currencies primarily relate to the US dollar.
Firstly, we are proud of our progress within purpose and sustainability with introduction of a concrete gender diversity targets to continue to build an inclusive culture with equal opportunities in oil Nordisk.
We're also pleased with our sales growth in the first 6 months of 2021.
Sales growth was driven by all geographical areas within insertion of operations as well as North America operations and by all therapy areas in particular, our portfolio of tier 1 treatments.
The strong financial performance in the first 6 months of 2021 and the initial substantial demand for V. Go has an envelope that has enabled us to raise our outlook range for the full year.
We recent important milestone with the approval and very fast launch if we go away in the U S was encouraging initial feedback from both patients and prescribers.
Karsten Munk Knudsen: Net profit increased by 10%, and diluted earnings per share increased by 12% to 10,71 kroner. Free cash flow was 32.7 billion Danish kroner compared with 30.3 billion Danish kroner in 2020. The increase reflects higher net profit and the favorable impact from changes in working capital, further positively impacted by the timing of U.S. rebate payments. Next slide, please.
Finally, the license agreement with hot seat and the acquisition of Prettiness ATT Amyloidosis program is fully aligned with our ambition within cardiovascular disease.
We're now ready for the Q&A, where I kindly ask you to limit yourself to maximum of 2 questions.
Operator, we're now ready to take the first questions.
Thank you and just as a reminder, if you do wish to ask a question. Please press <unk> 1 on your telephone keypad.
If you wish to withdraw your question you may do so by pressing zero too.
Karsten Munk Knudsen: A key priority for Novo Nordisk is to ensure attractive capital allocation to shareholders, and over the past three years, our average cash-to-earnings ratio has been around 80%. In May, the share repurchase program for 2021 was increased by 1 billion kroner to a total of 18 billion kroner. It should be noted that the program may be reduced in size if significant business development opportunities arise during 2021. For 2021, the Board of Directors has decided to pay out an interim dividend of 3.50 kroner per share, which will be paid out in August this year. This is an increase of 8% compared to last year.
First question is from Emmanuel Papadakis from Deutsche Bank. Please go ahead.
Thanks for taking the question maybe I'll take 2 of them will go to the place.
If you could just give us a little bit of insight into what proportion of these chrome initial prescription uptake is.
Where are you versus paid put up on when you expect pay downs.
For that only if we put out.
Referring to the 25 day.
Thanks, Paul.
Let's say the product you subsidizing.
And the second question would be around your anticipation based on initial discussions or coverage rates.
2022.
So we think we had reasonably strong technical and commercial insurance companies.
But a lot of talents and less than half of that was effective.
You're expecting something similar on 1 guy that you with your initial discussions lead you to believe that there'll be more opt into commercial employers and to what extent.
Well that also.
<unk> utilization management.
Such as well since that guidance. Thank you.
Thank you Manuel.
I'll hand over to Dr questions on.
How we see the split.
The initial scripts on recovery.
It's based on commercial access or support.
Support programs and.
Maybe you could talk a bit to how we are building access.
Karsten Munk Knudsen: 2020 Interim Dividend
With the caveat that we're not at this call going into guidance and guidance on an excess of the like when it comes to 2022. So it's a bit about how we are progressing as we speak so to Utah.
Karsten Munk Knudsen: University, Interim Dividend. Novo Nordisk has consistently returned its free cash flow to investors through both share buybacks and dividends, with dividends per share increasing for 25 consecutive years. Finally, in Q2, we executed a 3 and 7 year euro bond issuance in an aggregate amount of 1.3 billion euros. The two tranches were issued with a coupon of 0% and 0.125%, respectively. The Eurobonds were issued under a 5 billion euro EMGN program. Please turn to the next slide.
Yes, Thank you Lars and thank you Emmanuel for the questions. So for your first question I would say, it's roughly 50.50 in terms of where we are seeing coverage today, and where we need to assist as an organization secondly to your question on coverage I think that we've been pleased initially with the work that the team has done and the receptivity from major Pbms.
As well as local health plans and employers.
As I stated in my opening 2 major Pbms did unlock the blocking of <unk> early on almost at launch. So that's a promising sign and I think the receptivity and the feedback from the clinical conversations has been extremely strong and.
We have communicated that we believe that we'd like to see some extended like access in 2022, moving on and I'd say. These early indicators are a good sign that we're well on our way.
Thank you Doug and thank you Emmanuel and the next set of questions. Please.
Karsten Munk Knudsen: We now expect 2021 sales growth to be between 10 and 13% at constant exchange rates. This is based on the performance seen in the first half of the year across therapies and geographies, including the strong initial Vigovi uptake in the US, increasing the global obesity market growth. [inaudible] The guidance reflects growth across therapy areas, but it's mainly driven by GLP-1 products, ozempic and rubelsis, as well as obesity care. Also embedded is intensifying competition within both diabetes care and biopharm and continued pricing pressure, mainly within diabetes care and biopharm.
And our next question is from Matthew Weston from Credit Suisse. Please go ahead.
Thank you very much 2 questions for me please.
The first on the rebels us if we look at the U S prescription trends versus revenue Doug It would suggest a significant step down in revenue per unit.
And I'll just be very interested to understand whether that's a real increase in rebating and patient support of the sales force comes back online or has there been a significant change in mix in the U S market.
Would you expect.
Or would you expect that to progress over the course of the year.
And then secondly, a general question on guidance.
Significantly raised revenue expectations, but you've also kept operating margin growth below sales I realize that was the guidance and your previous setting because it was all about investing in R&D.
Now that you've added incremental sales I'd be very interested to know what you're spending the extra money on is it R&D or is it more incremental sales support for the launch it. Thank you.
Karsten Munk Knudsen: Operating profit is now expected to grow between 9% and 12%, reflecting the sales growth outlook and continued investments in current and future growth drivers. This includes the continued rollout of FOSEMPEG and REBELSIS, the launch of BIGOVI, and associated market development initiatives. Furthermore, additional resources are being allocated to R&D pipeline activities, such as the Manifest-3 clinical trial activities. Given the current exchange rates, most notably a strengthening of the US dollar, we expect a less negative currency impact for the full year compared to three months ago.
Thank you Matthew so 2 questions 1 on rebels as a prescription and how do we see the.
Revenue per script, I think that looks okay for customer can cover that and also causing you can cover.
The guidance that we are keeping intact, you can say the ratio between topline and bottomline.
Yep measure Matthew Thanks for this question. So so first of all.
As to a robust value prescript in the USA.
That basically very limited changes to what we're reporting for the first quarter. We are now at the tail end of some of the initial launch a copay program said, we saw them run out in the middle of the second quarter. So so that's pretty much the only change.
The rebels as.
Karsten Munk Knudsen: Consequently, our reported sales and operating profit growth is now expected to be 4 and 5% lower than at consular exchange rates, respectively. For 2021, financial items are now expected to be a gain of around $0.6 billion.
Value prescript.
And then we have a competitive.
The co pay program vis vis the oral competition, they're down to $10 per prescription and we have achieved 1 like pricing from there so pretty much nothing new from from Q1.
In terms of.
Of investments with the with the increased sales outlook then of course, that's something that we carefully consider and I would put it in and rather simple buckets. So so first of all we continue to invest in our in our tier 1 portfolio between repulsive endocentric both in the U S. But also.
Karsten Munk Knudsen: [inaudible]
Karsten Munk Knudsen: Capital expenditure is still expected to be around 7.5 billion Danish Kroner in 2021. Lastly, free cash flow has been increased by 2 billion Danish Kroner and is now expected to be between 39 and 44 billion Danish Kroner. That covers the updated outlook for 2021. Now back to you Lars for final remarks. Thank you, Karsten. Please turn to slide 18.
On a global basis.
Then secondly, our obesity franchise with the market development required to clearly is an area. It's a focus area of investments.
On a global scale. This is a this is a market that we have to build out on our own. So so so clearly a lot of investments going into both building internal capabilities, but also working a lot on market development.
Large.
Lars Fruergaard Jorgensen: Firstly, we are proud of our progress in purpose and sustainability, with the introduction of a concrete gender diversity target, and we will continue to build an inclusive culture with equal opportunities at Novo Nordisk. We are also pleased with the sales growth in the first six months of 2021. Sales growth was driven by all geographical areas within international operations, as well as North America operations, and by all therapy areas, in particular our portfolio of DLV-1 treatments.
Thirdly reinvest in the in the specific emerging markets based on the on our growth opportunities and portfolio in those markets and then finally, I'd say as I've been commenting on before clearly.
We have.
Our strategy to increase our R&D to sales ratio gradually over time.
Thereby increasing our all R&D pipeline and diversifying our R&D pipeline and that is exactly what you also see in the patient numbers.
Yeah portfolio that Martin was talking to.
Thank you Carsten. Thank you Mathieu next question please.
And our next question is from <unk> <unk> from Bernstein. Please go ahead.
Lars Fruergaard Jorgensen: The strong financial performance in the first six months of 2021 and the initial substantial demand for WeGoWe has enabled us to raise our outlook range for the full year. We reached an important milestone with approval and a very fast launch of WeGoWe in the U.S., with encouraging initial feedback from both patients and prescribers. Finally, the license agreement with HeartSeat and the acquisition of Progena's ATTR amyloidosis program are fully aligned with our ambitions within cardiovascular disease. We're now ready for the Q&A, where I kindly ask you to limit yourself to a maximum of two questions. Operator, we are now ready to take the first question.
Great. Thanks, so much for taking my questions I wouldn't like apart from bad things. So just first on <unk> doses.
I just wanted to know whats novo preference in terms of volumes between doses and Olympic given that <unk> seems to have a higher net price, but a short to IP duration that doesn't have the same level of lifecycle management as well, but just curious given there's nothing seems to be beating market expectations, but life products. It seems to be coming in a little bit lower and then.
My second question I, just wanted to ask about the broader growth of the broader obesity market in the U S.
If I look at volumes over the last 5 years in the U S. So we actually see flat absolute volumes in but I'm just.
How youre thinking about market volume growth from here do you expect will go the to drive market growth.
To what extent do you think that they can they can do that over the majority of volume is actually come from generic products on the market I appreciate the initial volumes.
Operator: Thank you. And just as a reminder, if you do wish to ask a question, please press 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02. Our first question is from Emmanuel Papadasky from Deutsche Bank. Please go ahead.
It's 50.50 like you outlined in your slide, but just curious how you think that will play out moving forward.
Okay.
So first the community if you can talk to a bit whether we have a preference for 1 of the other rebel source vessels for simpler in terms of driving growth and then talk can talk to what we see in terms of obesity market growth in the U S.
Emmanuel Papadakis: Thanks for taking the question. Maybe I'll take two and we'll go, if you please.
Emmanuel Papadakis: If you could just give us a little bit of insight into what proportion of the strong initial prescription uptake is, and Mark Burr, Simon Baker, Emmanuel Papadakis, Eric Berrigaud, Benjamin Yeoh, Rajesh Kumar, Harry Sephton, Lars Jorgensen, Michael Novod, Thomas Bowers, Harry Sephton, Lars Jorgensen, Martin Lange, Douglas Langa, Andres So I think we had reasonably strong technical commercial insurance coverage rates, but there were a lot of opt-outs, so less than half of that was effective. Are you expecting something similar from Mugabe, or do your initial discussions lead you to believe that there'll be more opt-ins from commercial employers, and to what extent? Will that also involve equalization management? Thank you.
Yeah. Thank you lasse and so in a sense.
Thanks.
The approval of the buses all has long been our strategy to expand into the OLED market and from the pioneer program. We saw that they have with US. This is the most efficacious OID.
Our plans and strategies to expand the use of DSP 1 being in the injectable segment <unk> segment, where we historically have never been questioned so so that's basically the strategy that we've been following and that'd be executing on.
Thank you Camilla, that's very clear and I think we are we've seen some good success. So Doug what can you say about your expectations to the obesity market growth in the U S.
Thanks I appreciate the question. So what I would say is as I said in my opening comment that we did see in the second quarter.
Sex and Theyre coming back and then Additionally, and importantly will go the adding to the growth of the category and importantly, we saw within that over.
Over 60% of that coming from naive patients. So the expectation is that we'll go there will continue to add to the glass and its growth.
Thanks, Doug and when we compare to Io, we can see that there is a very nice uptick in the beauty market in I O and obviously, we are not even close to getting a we go beyond the market. There. So I think it's a very strong sign that.
Lars Fruergaard Jorgensen: Thank you, Emmanuel. So I'll hand over to Doug the questions on how we see the split of the initial scripts on WeGoWe, whether it's based on commercial access or its support programs. And maybe Doug, you can talk a bit about how we are building access, with the caveat that we're not on this call going in and giving guidance on access or the like when it comes to 2022. So it's a bit about how we are progressing as we speak. So, over to you, Doug.
44% growth.
In Io.
Sign that the obesity market is back and you could say that is maybe coming back even stronger because during a lockdown and many people have developed an even larger needful obesity medicines. So we're quite confident and told on the future growth of nutrition market globally.
We remodeled our next set of questions. Please.
And our next question is from Steve Scala from Cowen. Please go ahead.
Doug Langa: Yeah, thank you, Lars. And thank you, Emmanuel, for the question.
Thank you so much to 1 we go the first curious if versus your expectations more physicians have prescribed <unk>, so far or among the physicians who have prescribed it you were seeing more prescriptions for COVID-19.
Doug Langa: So, for your first question, I would say it's roughly 50-50 in terms of where we're seeing coverage today and where we need to assist as an organization. Secondly, to your question on coverage, I think that we've been pleased initially with the work that the team has done and the receptivity from major PBMs as well as local health plans and employers. As I stated in my opening, two major PBMs did unlock the blocking of Wachovia early on, almost at launch, so that's a promising sign, and I think the receptivity and the feedback from the clinical conversations have been extremely strong. We have communicated that we believe that we'd like to see Saxenda-like access in 2022 moving forward, and I'd say these early indicators are a good sign that we're well on our way.
Uh huh position than expected so the former might suggest a bigger opportunity there.
Might suggest quicker saturation and then secondly have commercial insurers mandated any stopping or discontinuation conditions on will go views. Thank you.
Thank you Steve so.
2 questions 1 on <unk>.
So the first 1 to kind of breath.
Just in terms of the prescriber universe, and then whether there are any say conditions to how our commercial plans can can we go.
Doug Langa: Thank you Doug and thank you Emmanuel, and next set of questions, please.
Campaign, So Doug can you talk to that please.
Yeah.
Yes, Thanks, Steve for the question so for US what's critically important is both breadth to the <unk>.
Operator: And our next question is from Matthew Weston from Credit Suisse. Please go ahead.
Number of prescribers as well as depth and those prescribers prescribing more so we're hard at work at both of those and I'd say, it's early days to tell you know we're 5.6 weeks into the launch.
Matthew Weston: Thank you very much. Two questions for me, please. So first on Rebelsis, if we look at the U.S. prescription trends versus revenue, Doug, it would suggest a significant step down in revenue per unit, and I'd just be very interested to understand whether that's a re-increase in rebating and patient support as the salesforce comes back online, or has there been a significant change in mix in the U.S. market, and how would you expect us, how do you expect that to progress over the course of the year?
What we have been pleased with is that we've seen 8000 prescriptions in less than a month.
If you compare that to <unk> that took approximately 4 years to achieve that so I think that it's a combination of both as far as your payer question right now we're seeing the same traditional components on SEC centre in the payer community as we are with <unk>, but we're working very hard to hear.
This treated like a standard listed product, we think that's critically important not only for patients, but the overall success of the brand. So that's where we're hard at work and again early indications are good receptivity of the Pbms.
Matthew Weston: And then secondly, a general question on guidance. You've significantly raised revenue expectations, but you've also kept operating margin growth below sales. I realize that was the guidance in your previous setting, because it was all about investing in R&D. Now that you've added incremental sales, I'd be very interested to know what you're spending the extra money on. Is it R&D, or is it more incremental sales support for the launches? Thank
Thank you Doug and thank you Steve next set of questions. Please.
And our next question is from Peter <unk> from Citi. Please go ahead.
Thank you Pete <unk> Citi, just a quick clarification for Doug and then my 2 questions just like what you Doug when do you expect the supply situation on the starts that you still would there be to result.
A very quick clarification.
Just on the 2 questions maybe the constant.
Just give us some sort of ballpark quantification.
Matthew Weston: Thank you, Matthew. So two questions, one on Robelso's prescription and how do we see the, you know, revenue per script? I think that looks okay, but Karsten can cover that.
It was the guidance this year for <unk>.
Interesting in China.
Coming to cost in 2021.
Any sort of Intel or insight you can give us about potential scope.
Right.
Karsten Munk Knudsen: And also, Karsten, you can cover, you know, the guidance that we are keeping intact; you can say the ratio between top line and bottom line. Yeah, Matthew, thanks for these questions. So first of all, as to the rebels' value prescription in the U.S., there are basically very limited changes to what we're reporting for the first quarter. We're now at the tail end of some of the initial launch co-pay programs. We saw them run out here in the middle of the second quarter.
For 2022.
With the recent meeting with the government and industry players.
And then Martin just a quick update on the key outcome studies.
So hello.
Any comments.
These trials are lives Congress too much but.
Can you say about event rates, whether they are running in line.
Thank you.
So thank you Peter I will deal with the supply issue because that's not really on the dock service possibilities, where it's clear we have seen a very very strong uptake.
Oh the Kobe.
And I think we have to admit it's been stronger than what we had planned for so when you launch you obviously in a ramp up phase for manufacturing. So we have some bottlenecks right now, but you can rest assure that we're working hard to make sure that we can ramp up our manufacturing as fast as possible and.
Karsten Munk Knudsen: So that's pretty much the only change vis-Ã -vis rebel values prescripts. Then we have a competitive co-pay program vis-Ã -vis the oil competition down to $10 per prescription. And we have GF1-like pricing from there. So pretty much nothing new from Q1.
These are standard manufacturing processes that we know how to handle their wells. So we know what needs to be done to get the supply.
Back on track and as Dr. <unk> mentioned, all key concerns of course to make sure that those who start on treatment can kind of continue on treatment.
On DPP in China.
Karsten Munk Knudsen: In terms of investments with the increased sales outlook, then of course, that's something that we carefully consider, and I would put it in rather simple terms. So, first of all, we continue to invest in our GF1 portfolio, between Rebelsis and Ocempic, both in the US but also on a global basis. Then, secondly, our obesity franchise, with the market development required, clearly is a focus area of investments on a global scale. This is a market that we have to build on our own, so clearly, a lot of investments are going into both building internal capabilities but also working a lot on market development at large.
You know caution you could talk a bit to how it's baked into the guidance, but I can just say that there was recently a consultation meeting in China with the absorptions women infectious participated based on that we now believe it is.
And it's likely that there'll be an impact this year.
If an instrument bvt's implemented, which we believe will eventually happen.
It's.
Probably not going to take place before 2022.
And we if you put a bit of caveats around it.
It had been issued to do most likely it would be done so I think I've commented before that the experience.
That is already in the market is in the small molecule space and if you. If you wanted to have EVP for a biologic and not least lifesaving.
Lifesaving medicine like like an instrument.
No this is not.
This is not a trivial thing to do to secure both volumes and quality of those volumes. So for now we think it's unlikely for for this year and if it happens it could be next year, so cost and you can talk to how we have.
Karsten Munk Knudsen: Thirdly, we invest in specific emerging markets based on growth opportunities and our portfolio in those markets. And then finally, I would say, as I've been commenting on before, clearly we have a strategy to increase our R&D to sales ratio gradually over time, thereby increasing our whole R&D pipeline and diversifying our R&D pipeline. Thank you, Karsten. Thank you, Matthew. Next set of questions, please.
Baked that into the guidance, we have we again.
Yeah, absolutely and thanks for that question Pete So so based on what the last just explained around the status of EVP that AR that was part of enabling us to narrow the breath of our guidance range for our top line and and lift the floor, but of course, the key driver behind us lifting the old.
Range, what's what's what we've just discussed in terms of our performance in within obesity care, both recovery and the old obesity market growth as well as the exploration and th 1 and the strong.
Operator: And our next question is from Vimal Kapadia from Bernstein. Please go ahead.
<unk> biopharma pumps in the first half.
Thanks Carsten.
Vimal Kapadia: Oh great, thanks so much for taking my questions; I will mark a few from Bernstein. So, first on Rybel's... I just wanted to know, what's Novo's preference in terms of volumes between ribelsis and ozempic? You know, given that ozempic seems to have a higher net price but a shorter IP duration and does not have the same level of lifespan.
So I think this was actually 2 questions marching very shortly on the stages on the outcome trials yeah. Thanks very much Pete.
Things are going well, we managed to secure a recruitment of all 3 trials on time in fact selected flow, we're a little bit ahead of time.
And what we see right now is despite of COVID-19, really good retention in all trials, so more than 95% of patients still being in trial.
Can't really speak to the event rate, but maybe just saying that that what we see right now is very close to what we anticipated when initiating the trials.
Vimal Kapadia: I'm just curious, you know, given that Zempig seems to be beating market expectations, but rice products seem to be coming in a little bit lower. And then my second question: I just want to ask about the broader growth of the broader obesity market in the US. And if I look at volumes over the last five years in the US, we actually see flat absolute volumes for AOMs. So I'm just curious how you're thinking about market volume growth from here.
Thank you Martin good to hear that it is well on track. Thank you Pete for the 2 questions and a.
Set of questioners.
Our next question is from Martin <unk> from Danske Bank. Please go ahead.
Yes, multiply that times the bank actually also are on <unk> or older 2 questions.
Just on the supply side or will you say that you of course, the advisor is to make sure that the pace with which all video on the dwarf could continue.
Does that mean that we can.
Vimal Kapadia: Do you expect us to go the to drive market growth? And to what extent do you think that they can, you know, they can do that over the majority of volumes actually coming from generic products on the market? I appreciate the initial volumes, just 50-50, like you outlined in your slides. We're just curious how you think that will play out moving forward.
Think about script count because you have it's happened enormous.
The growth in script over last 5 reached.
Newsgroups actually your new brand store, because you can actually not have supply to stop replacements mall.
Should we see the dynamics and then secondly, maybe this is onto a 222 door.
I guess that.
A lot of the.
The demand has.
Driven by patients.
About this new want those logs in lithium and stuff like that.
Camilla Sylvest: Thank you very much. First, Camilla, if you could talk a bit about whether we have a preference for one or the other, rebels versus conservatives, in terms of driving growth, and then Doug can talk about what we see in terms of obesity market growth in the UK.
Are there a risk that it is not the right patients did not the patients that you actually like to have it.
To make to make sure that this will be yet.
Strong long term upside off of the floor and also maybe you can talk about because we also saw many years ago that that comes off actually had a quite nice thought not to the magnitude like this but.
Camilla Sylvest: Thank you, Lars. So, since we got the approval of REBELSUS, it has always been our strategy to expand into the OAD market. And from the Pioneer Program, we saw that REBELSUS is the most efficacious OAD. So, our plans and strategies are to expand the use of DLP1, being in the injectable segment and being in the OAD segment, where we historically have never been present. So that's basically the strategy that we've been following and that we are implementing.
<unk>.
Uh huh.
Other risks that you actually end up getting the right patients on bolt.
Thank you imagine I'll start on the supply.
So we have seen here initially that we were out of the stopped dose low dose but of course, our manufacturing is running constantly so yes, we can start the new patients.
But.
The initial uptake we have seen is significantly higher than what we had the painful and it's.
Doug Langa: Thank you Camilla, that's very clear, and I think we've seen some good success. So Doug, what can you say about your expectations for obesity market growth in the US?
If not is it always quite common that when you launch a new product you are ramping up manufacturing.
As you launch and we're doing that so we will we.
Doug Langa: Thanks. I appreciate the question. So, what I would say is, as I said, my opening comment that we did see in the second quarter sex end up coming back. And then additionally, and importantly, we'll go the added to the growth of the category. And importantly, we saw within that that over 60% of that coming from naive patients. So the expectation is that we'll go over it, and we'll continue to add to the class and its growth.
We will eventually be able to cover the full or default.
Demand.
But it's not that we cannot start new patients further for the rest of the year, So don't need to worry about that.
Youre right.
There's a lot of excitement around goby and talk what can you. What can you talk to the type of patients we get and obviously, it's early days, but what are you what is your intelligence from the field.
Thanks, a lot Martin. Thank you for the question, let me first start by saying we have a there's a when we think about an unmet need in the 650 million patients in the world with 100 million patients in the U S.
I need help and they've been and a lot of ways, maybe waiting for a drug like this so.
Doug Langa: Thanks, Doug. And when we compare it to IO, we can see that there's a very, very nice uptick in the obesity market in IO. And obviously, we are not even close to getting Wicovi on the market there. So I think it's a very strong sign that, you know, a 44% growth in IO is a sign that the obesity market is back. And you could say that it's maybe coming back even stronger because during a lockdown, many people have developed an even larger need for obesity medicine. So we're quite confident and bold on the future growth of the UBC market globally. Thank you, Vimal. Next set of questions, please.
There is certainly a significant patient pool I would say it's early days when we look at the patient level data that we see it with <unk> typically the patients are aged between 40 and 60 with a BMI of 35 or less with comorbidity. So.
I think there is a significant unmet need and now is the right time to unlock the potential.
And what were the main prescribers.
The primary windows weight loss centers.
Yeah, So what we're seeing and again this is really based on what we've seen for <unk> and anticipate is that the primary care physician in the interim medicine nurse practitioners peers, that's going to be the bulk of the per script writers that we're going to see in this space right now it's less about specialty is comparatively.
We would see in say diabetes, but.
Based on what we see in <unk> and what we anticipate is a PCP in MPS.
Okay. Thank you.
Thank you Doug Thanks, so much and it's clearly exciting times and I think we've all been talking through that would go away is the first time, there is a real solution to the pump and being obesity and I think the sign received from the monitors that that's well understood and significant demand for this so we're very encouraged with what we see.
Operator: And our next question is from Steve Scala from Cowan. Please go ahead.
Steve Scala: Thank you so much. Two on Wigovi. First, curious if, versus your expectations, more physicians have prescribed Wigovi so far, or among the physicians who have prescribed it, you are seeing more prescriptions per physician than expected. So the former might suggest a bigger opportunity. The latter might suggest quicker saturation. And then secondly, have commercial insurers mandated any stopping or discontinuation conditions on Wigovi use?
Next set of questions. Please.
Our next question is from <unk> <unk> from Seb. Please go ahead.
Yeah.
Thank you very much I'll, just jump on a little bit into the tier 1 diabetes.
What we saw here in Q2 was that you.
Significantly also June sort of a market share gain trajectory in the U S. Market. Then you had another very strong quarter in terms of market share gains.
Steve Scala: Thank you.
Lars Fruergaard Jorgensen: Thank you, Steve. So two questions on WeGoWe. So the first one is about kind of breadth or depth in terms of the prescriber universe, and then whether there are any, say, conditions on how commercial plans can, you know, join the WeGoWe Campaign. So Doug, can you talk about that please?
And it came after that period, maybe Lilly has put a little bit of a push out in here with a high dose it relates to loans.
What have you changed have you changed anything in your marketing message or your go to market strategy for <unk> in particular, because it seems to be the driving force.
Doug Langa: Yes, thanks, Steve, for the question. So for us, what's critically important is both breadth, so the number of prescribers, as well as depth, and those prescribers prescribing more. So we're hard at work on both of those, and I'd say it's early days to tell. You know, we're five, six weeks into the launch. What we have been pleased with is that we've seen 8000 prescriptions in less than a month. If you compare that to Saxenda, it took approximately four years to achieve that. So I think that it's a combination of both, as far as your payer question is concerned. Right now, we're seeing the same traditional components in Saxenda in the payer community as we are in with Wogovi.
And then secondly on the <unk>.
What's your expectations for timing of use interchangeable version of Milwaukee, and what do you think will happen once the product hits the market.
Okay.
Thank you Carsten and I think the first the first question on the on Yours is 1 dynamics clearly very very strong performance no. I think we are all long and very excited about something but can you can you say anything about.
Any changes in techniques or anything or is it just pull through and then.
Secondly, I don't know timing about interchangeability for Norwalk, whether you have a view on that.
Thanks for the question and what I would say is if you just remember we started the phase in our sales reps in mid February and then got them fully back in the field by May. So there was a component of us reentering into the market I would also suggest that magnetite has become a well known molecule <unk> itself.
Doug Langa: But we're working very hard to have this treated like a standard listed product. We think that's critically important, not only for patients but the overall success of the brand. So that's where we're hard at work. And again, early indications are that PBMs are well receptive to the medicines.
As highly recognized its excellent efficacy if you think back to the numbers of patients in the sustain program, 80% of them, reaching HBA when sea of less than 7 so.
It's a great product and I think that we haven't necessarily changed our strategy. We're still deploying what we've communicated is semi synergy wishes to be effective and successful with both.
Doug Langa: Thank you, Doug. Thank you, Steve. Next set of questions, please.
Operator: And our next question is from Peter Vettel from Citi. Please go ahead.
<unk> and <unk> in the category.
Okay and on the second question on interchange ability in the U S. I think our perspective is that to a large degree we already see that the market seem from a manufacturing point of view is a model that works like interchangeable market in the way P. P M.
Peter Verdult: Thank you, people of Old City. Just a quick clarification for Doug and then my two questions. Just very quickly, Doug, when do you expect the supply situation on this data to go till we go V2 resolve? Just a very quick clarification. Just on the two questions, maybe for Karsten, can you give us some sort of ballpark quantification of what the uplift was for guidance this year from GDP and Brett for the plans for 2022 in light of the recent meeting with the government and industry payers? And then, for Martin, just a quick update on the key outcome studies, select
Buy from us.
It might not be fully.
The benefit of that not might not fully be going to the patients but in terms of the contract and we do that is largely of an inch.
Interchangeable in nature.
Thank you Doug and thank you Carsten so we take the next set of questions. Please.
And our next question is from Michael <unk> from the BMO. Please go ahead.
Yes, Thanks a lot.
2 questions as well so.
On <unk> first.
So how should we sort of foresee growth going forward.
It seems to have been able to completely stabilized. It then if you could first half year you're up around.
Lars Fruergaard Jorgensen: So thank you, Pete. I will deal with the supply issue because that's not really the DOC's responsibility. So it's clear we have seen a very, very strong uptake of GOVI, and I think we have to admit it's stronger than we had planned for. So when you launch, you're obviously in a ramp-up phase for manufacturing. So we have some bottlenecks right now, but you can rest assured that we're working hard to make sure that we can ramp up manufacturing as fast as possible.
To 919% and in the U S. So are we through this.
Market share erosion from Hilli, Brian and what should we expect going forward.
And then secondly tube business dynamics in Io.
Quarter over quarter decline in sales is that due to the aforementioned lockdowns in Japan going on or what is what is sort of the drivers of this or is it just that you don't really get the traction that you wish fall with Bill says in Io.
Lars Fruergaard Jorgensen: These are standard, say, manufacturing processes that we know how to handle very well, so we know what needs to be done to get the supply back on track. And as Doug mentioned, our key concern is, of course, to make sure that those who start treatment can continue treatment on BBP in China. You know, you could talk a bit about how it's baked into the guidance, but I can just say that there was recently a consultation meeting in China with the authorities, where manufacturers participated.
Yes, Thank you Michael.
Yes, Indeed, no 7 performance is a is very strong in a rather competitive arena. So karsten can you talk a bit to 2 <unk>.
We see growth there and then Camilla you can touch upon rebels just performance in Central relations. Yeah. Yeah, I think we've seen a lot of pandemic activity going on the first day.
Yeah Michael.
I fully concur, we were we were very satisfied with it with 3% growth in the first half.
7 after a number of years, where the branches has been significantly under competitive pressures.
Lars Fruergaard Jorgensen: Based on that, we now believe it is [inaudible] And if you put a bit of caveats around it, had it been easy to do, most likely it would have been done. So I think I've commented before that the experience that is already in the market is in the small molecule space. And if you want to do a VPP for biologics, and not least a life-saving medicine like insulin, you know, this is not a trivial thing to do to secure both volumes and quality of those volumes. So for now, we think it's unlikely for this year. And if it happens, it could be next year.
Say that that couple of aspects to it. So so first of all then there as you know then demand for number 7 is somewhat stochastic and in nature linked to the number of fleets and surgery center and so on and and we did we did see some some significant events in the second quarter in the U S are positively impacting you.
<unk> sales.
And on top of that.
Without having a firm data on it then of course with the society and health care systems opening up 1 could speculate that increased activity levels could lead to increased bleeding episodes.
Requiring it 7 treatments.
As to the commercial impact on the brand.
Karsten Munk Knudsen: So Carsten, you can talk about how we have, you know, baked that into the guidance we have given. Yeah, absolutely. And thanks for that question, Pete. So, based on what Lars just explained about the status of EVP, that was part of enabling us to narrow the breadth of our guidance range for our top line and lift the floor. But, of course, the key driver behind us lifting the overall range was what we have just discussed in terms of our performance within obesity care, both with Govee and the overall obesity market growth, as well as the acceleration in GLP-1 and the strong biopharm performance in the first half.
Then.
We're not fully through with that.
A set of emerging markets that have yet to.
Sure don't see competition, but but to a large extent we're through it.
And some of the.
The more developed markets.
Thank you Carsten.
Camilla on the doses performance.
And we've also seen IL and we are continuing to see increasing market share performance in key countries.
But of course in the light of COVID-19 that continues to impact, especially in EU countries and also in Japan, and we don't see in 17 countries.
And Japan being the country with the biggest potential has been impacted by multiple states of emergency.
And that of course impacts our ability for the sales force to retail customers.
Karsten Munk Knudsen: Thank you, Karsten. And since I think this was actually two questions, Martin, very briefly on the status of the outcome trials. Yeah, thanks very much, Pete. Things are going well. We managed to secure recruitment for all three trials on time. In fact, Select and Flow were a little bit ahead of time. And what we see right now is, despite COVID-19, really good retention in all trials. So more than 95% of patients are still in trials.
Nevertheless, the underlying parameters such as number of activity prescribing physicians and source of business and also launch uptake the hospital, good encouraging and Oh I think the U S. We also in the rest of the world continuing to expand the number of subscribers of course.
The number of scripts, what he called box prescriber Aswell.
Thank you Camilla and thank you Michael.
Next set of questions. Please.
Our next question is from Sacha.
John from Bank of America.
Uh huh.
Hi, Sachin Jain Bank of America, just too long, we gave me please and just trying to.
Karsten Munk Knudsen: We can't really speak to the event rate, but maybe just say that what we see right now is very close to what we anticipated when initiating the trials. Thank you, Martin. It is good to hear that it is well on track. Thank you, Pete, for the two questions. And on to the next set of questions.
Trying to get the excitement on scripts into our numbers the extent you're able to firstly is it fair to assume that the biggest single element of the sales go Andres he is going to be of the various factors.
But even if it is implying.
Implying we gave me sounds instead of 1 and a half to 2 billion Danish kroner for this year and then secondly, again, Doug you mentioned that scripts are matched.
Martin Holst Lange: Our next question is from Martin Parkhoi from Danske Bank. Please go ahead.
8 weeks.
If something is then converted to paid drug into next year.
Operator: Yes, Martin Parkhoi, Danske Bank, actually also on the go, all the two questions. Just on the supply side, Lars or Karsten, whoever, you say that you, of course, prioritize to make sure that the patients who are already on the drug can continue. Does that mean that we can, what should we think about script count? Because we have had an enormous growth in scripts over the last five weeks? Can, you know, new scripts actually or new brands stall because you do not actually have supply to start new patients now? Or how should we view the dynamics? And then secondly, maybe this is on to Doug.
Is it fair to think that you could potentially see view midterm obesity aspiration of doubling sales.
22 itself. Thank you.
Thank you Sachin so.
We are not going into a simulation is about 2022.
Yet, but oh, we have limited amount of <unk>.
Sales in the books, so far customer about what can you tell us about.
What we are seeing without going into guidance on individual branch.
Yeah Sachin is S house covering before then then obesity cat large it's 1 of the key drivers for US are upping our guidance for the full year and that is a combination of COVID-19.
Martin Parkhoi: I guess that a lot of the demand for COVID has maybe been driven by patients seeing about these new wonder drugs in the media and stuff like that. But is there a risk that it's not the right patients, they're not the patients that you actually want to have to make sure that this will be a strong, long-term uptime for the drug? And also, maybe you can talk about, because we saw many years ago that Contrav actually had a quite nice start, not to the magnitude of this, but it died out. So, are there risks that you're actually not getting the right patients on board? Thank you, Martin.
And the all market growth.
Benefiting section that both in the U S and in international operations. So.
So sort of the Golar is part of it.
But only 1 segment. So the 2 main chunks of the upgrades is these 2 care and exploration of <unk>.
<unk> business.
Okay.
Thank you.
So we'll take the final set of questions.
And our next question is from Seamus Fernandez from Guggenheim Securities. Please go ahead.
Alright, great. Thanks for the question so.
Couple of questions first on the select trial and the current obesity market uptake in opening up access.
Just hoping in the past you generally commented that the select trial would be critical.
Lars Fruergaard Jorgensen: I'll start on the supply. So, initially, we have seen here that we were out of the start dose, the low dose, but, of course, manufacturing is running constantly. So, yes, we can start new patients, but the initial uptake we've seen is significantly higher than what we had planned for. And it's not It's always quite common that when you launch a new product, you are ramping up manufacturing as you launch, and we will be doing that.
Critically important.
I think 1 investor earlier this week characterized it as biblically important.
2 a real opening up of the obesity market. Just wondering how you are feeling given the strong early launch if we go the.
Relative to the importance of our successful select trial, and then incremental to the select trial opportunity.
We've had many questions on an 833.
Lars Fruergaard Jorgensen: So we will eventually be able to cover the full demand. But it's not that we cannot start a new patient for the rest of the year. So you don't need to worry about anything, and you're right that there's a lot of excitement around Wigobi and Doug. What can you do? What can you talk about? You know, the type of patients we get in, obviously, it's early days, but what is your intelligence from the field?
And the acceleration of your combination program there just hoping.
You could provide a little bit of context of the pace.
Of a switch there.
Potentially and how quickly.
You would want to drive patients to that is it optimized for obesity or do you really view that combination as a.
No preferred diabetes, plus obesity and Nash market opportunity product. Thanks.
So thank you if I, if I started by giving it.
Shot on how we see the importance of select and then Martin you can cover the second question. So.
Doug Langa: Thanks, Lars and Martin. Thank you for the question. Let me first start by saying, you know, we have a, there's an, when we think about the unmet need of 650 million patients in the world, with 100 million patients in the US, you know, they need help. And they've been, in a lot of ways, maybe waiting for a drug like this. So there's certainly a significant patient pool. I would say it's early days, when we look at the patient-level data that we see with sexenda, typically, patients are aged between 40 and 60 with a BMI of 35 or less and have comorbidities. So I think there is a significant unmet need, and now is the right time to unlock the potential.
We have when we I spoke to you a bit of changes we are sort of spoken about the importance of mobilizing.
No patients living with obesity, the importance of getting physicians to prescribe and the importance of getting pay us to to reimburse and you can see the you know.
Based on the initial signs proceed here, we do see that patients mobilized we do see that physicians are willing to prescribe based on what the Doc mentioned in terms of 2 national.
Payoffs are.
Having it removed block we also see that there's a willingness to.
To pay for it.
So I think it's I think we're off to a very exciting stuff and it seems like the profile of the product and the market productivity as we have done, especially eating well and I think that's quite encouraging.
Marching on.
<unk>.
Doug Langa: And who are the main prescribers? Primary care, endos, weight loss centers?
Yeah.
Very briefly.
Grilling type between friends to be combined was magnified and we've shared the data showing that with the combination of <unk> titled Tomato side, we can see.
Doug Langa: Yeah, so what we're seeing, and again, this is really based on what we've seen for Sex End and Anticipate, is that the primary care physician, the interim medicine nurse practitioners, PAs, that's going to be the bulk of the prescribing writers that we're going to see in this space right now. It's less about specialty as compared to, say, diabetes, but based on what we see in Sex End and what we anticipate are PCPs and MPs.
And approximately 17% weight loss, but it a matter of 2 weeks and with a safety profile that is comparable to that of some Atlas I Didnt monotherapy, obviously that has made us very excited and we intend to initiate phase III already next year.
I think the question was more about the positioning of the combination product towards.
And maybe that's too early to speculate on.
Thank you Martin and Thats since we are on a good roll to take 1 final question.
Doug Langa: Thank you, Doug. Thank you, Martin.
And our next question is from <unk> Parekh from Goldman Sachs. Please go ahead.
Lars Fruergaard Jorgensen: It's clearly exciting times, and I think we've all been talking about how this is, you know, the first time there's a real solution to the problem of obesity. And I think the sign we see from the market is that that's well understood, and there is a significant demand for this. So we're very encouraged with what we see. Next set of questions.
Hi, Thank you for fitting me in 2 questions. If I may please first 1.
Doug as we think about the launch for <unk> ex U S. If my memory is correct kind of this extended loans ex U S was actually more successful then this external launch in the U S.
Think about Vega relaunch ex U S is there a reason why that might be different or should we expect a similar enthusiasm to ww launch ex U S. That's question number 1.
Operator: Our next question is from Karsten Lundberg from SEB. Please go ahead.
Karsten Lundberg: Thank you very much. I will just jump a little bit into the GLP1 diabetes segment. What we saw here in Q2 was that you significantly altered your sort of market share gain trajectory in the U.S. market, and you had a very, very strong quarter in terms of market share gains. And it came after a period where maybe Lilly had put a little bit of pressure on you with the high-dose Trulicity loans.
And then question number 2 Boston you kind of made an oblique reference to the risk to the stock buyback in the event that you want to pursue a sizable transaction.
Clearly raising your free cash flow guidance you have done a couple of transactions would you do with your balance sheet capacity is still meaningful. So I'm just wondering kind of what is the size of transaction that might need you to rethink your stock buyback and is that something we should be anticipating.
Karsten Lundberg: What have you changed? Have you changed anything in your marketing message or your go-to-market strategy for, in particular, Osembic? Because it seems to be Osembic that's the driving force, and then secondly on the What are your expectations for the timing of a US interchangeable version of Novolock and what do you think will happen once such a product hits the market? Thank you, Karsten. And I think the first the first question on you is just one dynamics: clearly, a very, very strong performance.
Over the course of the next few months. Thank you.
Thank you Okay U S. So on and on we go we ex U S. You know we have plans to get the European approval by the end of the year. So it's a bit early for us to start speculating on how it might look like.
I think it's quite dynamic.
<unk>.
In Io, it's typically our out of pocket paid whereas in the U S. It's reimbursement.
And clearly now in the U S. It seems like we are now hitting.
Our weight loss profile, where it becomes meaningful meaningfully for payers to reimburse.
Karsten Lundberg: You know, I think we have all along been very excited about the Olympics, but Doug, can you share anything about, you know, any, you know, change in tactics or anything, or is it just going to pull through? And then, secondly, I don't know the timing about interchangeability or no lock, whether you have an overview of that?
And I can only.
You know protect.
Protect that individuals who are paying out of pocket today when they see the profile of we go we are at.
Similar pricing.
It's very robust demand for that also outside of the U S chicken.
The encouraging prospects based on the profile of the product and the price point, we have set.
Doug Langa: Thanks, Karsten, for the question. And what I would say is, if you just remember, we started to phase in our sales reps in mid-February and then got them fully back in the field by May. So there was a component of us reentering the market. But I would also suggest that Smagatot has become a well-known molecule. Ozempic itself is highly recognized for its excellent efficacy. If you think back to the numbers of patients in the SUSTAIN program, 80% of them reached an HbA1c of less than seven.
You raised a good point in terms of our capital location in the context of of deals. So karsten can you talk a bit to that you have you have.
Introduced tipped financing in Illinois.
At a Super Center.
Coupons, which obviously isn't attractive.
Right. So so what can you tell about that.
Thank you Lasse and thank you for your yeah. So so first of all it's interesting.
Finance company. It was 40 years ago that were listed on the New York stock exchange at a p/e at around 15.
At the end and now we are issuing bonds at a zero coupon.
Doug Langa: So, it's a great product, and I think that we haven't necessarily changed our strategy. We're still deploying what we've communicated as Semir Synergy, which is to be effective and successful with both Ozempic and Rebelsis in the category.
This year so.
So just to wind back and we basically have.
The 3 core pieces to our toolbox in terms of capsule allocation. So we have the you know the cash we have on our balance sheet.
Then the then we have adjustments to our to our share buyback and then we have to have leverage.
Additionally, it means probably but that's kind of 3 core.
Doug Langa: and on the second question on interchangeability in the U.S. I think our perspective is that, to a large degree, we already see that the market scene from a manufacturer's point of view is a market that works like an interchangeable market, you know, in the way PPMs buy from us. It might not be fully, the benefit of that might not fully be going to the patients, but in terms of the contracting we do, that is largely, you know, of an interchangeable nature. Thank you, Doug, and thank you, Karsten. So we will take the next set of questions, please.
The tools, we use and what you saw last year, just just to baseline us in that is that the that the COVID-19. Your transaction. We did last year with an upfront of $725 million that we were actually able to finance through our financial reserves or the cash on balance sheet without impacting our share buyback.
Our racing depths, whereas the MSP acquisition at $1.8 billion.
In rare diseases.
Mainly linked and finance from me from the bond issuance, we adjust it. So so we are very focused on continuing to provide an attractive capital return to shareholders and to and thereby continuing.
Operator: And our next question is from Michael Novod from DMR Kids. Please go ahead.
Our track record on increasing dividends for 25 years, but also continuing our share buyback program. So of course it depends on the exact yield and so on how we finance it between 3 means.
Michael Novod: Thanks a lot, two questions as well, perhaps on Nov. 7 first. So how should we sort of foresee growth going forward? It seems you have been able to completely stabilize it, and if you look at the first half year, you're up around 19% in the US. So are we through this market share erosion from Hemlibra, and what should we expect going forward? And then secondly, to Rebelsys Dynamics in IO, where you see a quarter over quarter decline in sales. Is that due to the aforementioned lockdowns in Japan still going on?
And the magnitude of the deal.
Thank you Carsten. Thank you can you would that would close the call and again. Thank you for your flexibility and rescheduling. This earnings call. We were excited about our hockey ever something I wanted to share their insights with you as fast as possible. So thanks, a lot for dialing in and have a great day and a great evening wherever you are thank you very much.
[music].
Michael Novod: Or what is sort of the driver of this? Or is it just that you don't really get the traction that you wish for with Rebelsys in IO? Yeah, thank you, Michael. Yes, indeed, No7's performance is very strong in a rather competitive arena. So, Karsten, can you talk a bit about how we see growth there? And then, Camilla, you can touch upon Rebels' performance in international relations, where, yeah, I think we've seen a lot of pandemic activity going on. Michael, I fully concur.
Yeah.
[music].
Yeah.
Yeah.
Yeah.
Yes.
Karsten Munk Knudsen: We were very satisfied with the 3% growth in the first half for Novo7 after a number of years where the brand has been significantly under competitive pressures. I'd say there are a couple of aspects to it. So, first of all, then, as you know, the demand for Novo 7 is somewhat stochastic in nature, linked to the number
Okay.
Uh huh.
[music].
Okay.
[music].
Okay.
[music].
Okay.
Okay.
Yeah.
Yes.
Yes.
[music].
Karsten Munk Knudsen: and so on. And we did see some significant events in the second quarter in the U.S., positively impacting U.S. sales. And on top of that, without having firm data on it, then, of course, with society and healthcare systems opening up, one could speculate that the increased activity levels could lead to increased bleeding episodes requiring O7 treatment. As to the commercial impact on the brand, we are not fully through with that.
Yes.
[music].
Sure.
Yes.
Karsten Munk Knudsen: You know, a set of emerging markets that have yet to launch competition, but to a large extent, we're through it in some of the more developed markets. Thank you, Karsten. And Camilla on the Rebels' performance in Iowa.
Yeah.
[music].
Okay.
Yes.
Yes.
[music].
Camilla Sylvest: So, on reversals in I.O., we are continuing to see increasing market share performance in key countries, but it is, of course, in the light of COVID-19 that continues to impact, especially E.U. countries and also Japan. We've launched in 17 countries, and Japan, being the country with the biggest potential, has been impacted by multiple states of emergencies, and that, of course, impacts our ability with the sales force to reach our customers. But nevertheless, the underlying parameters, such as the number of actively prescribing physicians and sources of business, and also launch uptake, do look good and encouraging. And as in the U.S., we also, in the rest of the world, are continuing to expand the number of prescribers and, of course, the number of scripts, what we call deaths per prescriber, as well.
Okay.
Yeah.
Okay.
[music].
Yes.
[music].
Yes.
Camilla Sylvest: Thank you, Camilla, and thank you, Michael. Next set of questions, please.
[music].
Operator: Our next question is from Sasheen Jain from Bank of America. Go ahead.
Okay.
[music].
Sachin Jain: Hi there, Pat from Jane Bank of America. Just two on Wigovi, please. I'm just trying to try and get the excitement on Scripps into numbers to the extent you're able to. So firstly, is it fair to assume that the biggest single element of the sales guide raise is Wigovi, of the various factors that you've listed, implying Wigovi sales are sort of 1.5 to 2 billion Danish kroner for this year? And then secondly, you know, again, Doug, you mentioned that Scripps matched Saks Fender within eight weeks. And if that is converted to a paid drug into next year, is it fair to think that you could potentially have your midterm obesity aspiration of doubling sales by 22 itself? Thank you. Thank you.
Okay.
Yeah.
Sure.
[music].
Yes.
[music].
Okay.
[music].
Sachin Jain: Thank you, Satyen. So, you know, we are not going into speculations about 2022 just yet. But, you know, we have a limited amount of We go with sales in the books so far, Karsten, but what can you tell us about... what we are seeing without going into guidance on individual brands? Yes, Sachin, as I mentioned before, obesity care as a whole is one of the key drivers for us upping our guidance for the full year, and that is the combination of Vigovi and the overall market growth benefiting Stuxnet, both in the U.S. and in international operations.
Okay.
Okay.
Yes.
Okay.
[music].
Okay.
Okay.
Okay.
Sure.
[music].
Sachin Jain: So Vigovi is part of it, but only one segment. So the two main chunks of the upgrade are obesity care and acceleration of our GF21 business. Thank you, Karsten. Now we take the final set of questions.
Karsten Munk Knudsen: And our next question is from Simas Fernandes from Guggenheim Securities. Please go ahead.
Okay.
Okay.
[music].
Operator: All right. Great. Thanks for the question. So, a couple of questions.
Unknown Executive: questions first on the select trial and the current obesity market uptake and opening up of access just hoping in the past you've generally commented that the select trial would be you know critically important I think one investor earlier this week characterized it as biblically important to a real opening up of the obesity market just wondering how you're feeling given the strong early launch of WeGoV relative to the importance of a successful select trial and then incremental to the select trial opportunity I don't think we've had many questions on AM 833 and the acceleration of your combination program there just hoping you could provide a little bit of context of the pace of of a switch there potentially and how quickly you would want to drive patients to that is it optimized for obesity or do you really view that combination as a you know preferred diabetes plus obesity and NASH market opportunity product [inaudible]
Okay.
Okay.
[music].
Yes.
Okay.
Okay.
[music].
Yes.
[music].
Okay.
Okay.
[music].
Okay.
Yes.
[music].
Okay.
[music].
Lars Fruergaard Jorgensen: Thank you. If I start by giving it a shot on how we see the importance of select, and then, Martin, you can cover the second question. So, we have, when we spoke about the obesity opportunity, we spoke about the importance of mobilizing, you know, patients living with obesity, the importance of getting physicians to prescribe, and the importance of getting payers to reimburse. And you can see that, based on the initial signs we see here, we do see that patients are being mobilized. We do see that physicians are willing to prescribe, and based on what Doug mentioned in terms of two national payers having removed the block, we also see that there's a willingness to pay for it.
Okay.
Okay.
Okay.
Okay.
Okay.
Yes.
[music].
Okay.
[music].
Okay.
Yes.
Martin Holst Lange: So I think we're off to a very exciting start. And it seems like the profile of the product and the market build activities we have done is resonating well. And I think that's quite encouraging, and Martin on AMH. Yeah, very briefly, cagrelian type between friends to be combined with semaglutide and we've shared the data showing that with the combination of cagrelian type and semaglutide we can see.., and approximately 17% weight loss, but in a matter of 20 weeks and with a safety profile that is comparable to that of semaglutide and monotherapy, obviously that has made us very excited and we intend to initiate phase three already next year.
Okay.
Yeah.
Okay.
Yes.
Okay.
[music].
Okay.
Sure.
Okay.
Right.
Yes.
Okay.
Yes.
Martin Holst Lange: I think the question was more about the positioning of the combination product towards semaglutide, and maybe that's too early to speculate on. Thank you, Martin. And let's, since we are on a good roll, take one final question.
Okay.
Okay.
Alright.
Yes.
Okay.
Yes.
[music].
Okay.
Right.
Okay.
Okay.
Okay.
Okay.
Yes.
Yes.
Okay.
Okay.
Yeah.
Okay.
Okay.
Okay.
Okay.
[music].
Yes.
Yes.
[music].
Yes.
Great.
Yes.
Uh huh.
Yes.
Okay.
Okay.
Yes.
Yeah.
Okay.
Okay.
Yes.
Yes.
Okay.
Okay.
Okay.
[music].
Yes.
Yes.
Okay.
Thank you.
Yes.
Okay.
Okay.
Yes.
Okay.
Yes.
[music].
Okay.
Okay.
Lars Fruergaard Jorgensen: And our next question is from Kayo Park from Goldman Sachs. Please go ahead.
Operator: Hi, thank you for putting me in. I have two questions, if I may, please. First one, Doug, as we think about the launch for the VW XUS, if my memory is correct, the Succenda launch XUS was actually more successful than the Succenda launch in the US. So as we think about the Volkswagen XUS, is there a reason why that might be different or should we expect a similar enthusiasm to the Succenda launch? That's question number one.
Okay.
Yes.
Okay.
Yeah.
Okay.
[music].
Okay.
Okay.
Mhm.
Sure.
Richard Parkes: And question number two, Karsten, you kind of made an oblique reference to the risk of the stock buyback in the event that you were to pursue a sizable transaction. You're clearly raising your free cash flow guidance. You have done a couple of transactions, but your balance sheet capacity is still meaningful. So I'm just wondering what the size of the transaction that might need you to rethink your stock buyback. And is that something we should be expecting over the course of the next few months?
Okay.
Yes.
Okay.
Okay.
Okay.
[music].
<unk>.
Thank you.
Okay.
Okay.
Okay.
Okay.
Richard Parkes: Thank you. Thank you, K. Ewer. So on WeGoWe x US, you know, we have plans to get European approval by the turn of the year. So it's a bit early for us to start speculating on how it might look.
Okay.
Okay.
[music].
Okay.
[music].
Lars Fruergaard Jorgensen: I think it's a quite dynamic position that, you know, in I.O., it's typically out of pocket paid, whereas in the U.S., it's reimbursable. And clearly, now, in the U.S., it seems like we are now hitting a weight loss profile where it becomes meaningful, meaningful for payers to reimburse. And I can only, you know, Project You raise a good point in terms of capital allocation in the context of deals, so Karsten, could you talk a bit about that? You have introduced debt financing in Novo Nordisk at a 0% coupon, which obviously is an attractive rate, so what can you tell me about that?
Okay.
Okay.
Okay.
Yes.
Okay.
Yes.
Yes.
Yes.
Okay.
Okay.
Yeah.
Yes.
Okay.
Okay.
Okay.
Okay.
Lars Fruergaard Jorgensen: Yeah, thank you, Lars. Thank you, Keyur. Yeah, so first of all, it's interesting, you know, how to finance a company. It was 40 years ago that we actually listed on the New York Stock Exchange at a PE of around 15. And now we are issuing bonds at a zero coupon this year. So just to wind back, we basically have, you know, three core pieces to our toolbox in terms of capital finance through our financial reserves or the cash on the balance sheet without impacting our share buyback or raising debt.
Okay.
Okay.
Okay.
Okay.
Okay.
Sure.
Yes.
Okay.
Yes.
Yes.
Okay.
Okay.
Lars Fruergaard Jorgensen: Whereas the MSB acquisition at $1.8 billion is, in reality, mainly linked to and financed from the bond issuance we just did. So we are very focused on continuing to provide an attractive capital return to our shareholders and thereby continuing our track record of increasing dividends for now 25 years, but also continuing our share buyback program. So, of course, it depends on the exact deal and so on, how we finance it between three means and the magnitude of the deal.
Okay.
[music].
Okay.
Okay.
Yeah.
Okay.
Yes.
Thank you.
Yes.
Karsten Munk Knudsen: Thank you, Karsten. Thank you, Keyur. With that, we'll close the call. And again, thank you for your flexibility in rescheduling this earnings call. We were excited about our half-year response and wanted to share the insights with you as fast as possible. Thanks a lot for dialing in, and have a great day and a great evening wherever you are. Thank you very much.
Yes.
Yes.
Okay.
Yeah.
[music].
Yeah.
[music].
Okay.
Lars Fruergaard Jorgensen: , Peter Welford, Simon Baker, Emmanuel Papadakis, Eric Berrigaud, Benjamin Yeoh, Rajesh Kumar, David Evans, Harry Sephton, Lars Joergensen, Martin Lange, Martin Jorgensen, Marco Webster, Daniel Bohsen, Martin Jorgensen, Lars Joergsen, [inaudible] Welcome to Pittsburgh, Philadephia! [inaudible] , , , , , , , , , , , , , , , , , , , , , , , , , , , , ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? ??? [inaudible]
Okay.
Okay.
Okay.
Okay.
Okay.
Yes.
Okay.
[music].
Yeah.
Yeah.