
Pharmaceutical R&D and Manufacturer
Last month, due to concerns about the omicron variant, the annual J.P. Morgan Healthcare Conference (JPM Conference) finally kicked off virtually online. Next, let's take a look at the "bold statements" from the leaders of various multinational pharmaceutical companies.
MSD: Confident that Molnupiravir is Highly Effective Against Omicron Variant!
Last November, MSD announced that the final efficacy of its COVID-19 oral antiviral drug molnupiravir in reducing hospitalization and death risks was 30%, a 20% drop from the interim trial data. When Pfizer reported that Paxlovid had an efficacy rate of 89%, MSD's highly anticipated small-molecule drug lost much of its luster.
At the conference, Dean Li, President of Merck & Co., Inc. Research Laboratories, stated, "We are confident that molnupiravir is highly effective against the omicron variant. This mechanism-based drug can reduce mortality by 90% and is applicable to omicron as well as any other variants that may emerge."
MSD CEO Rob Davis said, "We produced 10 million courses of this drug last year and plan to produce 20 million courses this year. We have not changed our revenue forecast for molnupiravir in 2022, which is $5 billion to $7 billion."
Davis said that, based on the contracts signed, we believe this forecast value is reasonable. More importantly, we are delivering the products. In fact, in December, MSD has already provided approximately 950,000 treatment courses to the U.S. government. By the end of January, 3.1 million treatment courses will be supplied to the United States."
Pfizer: Vaccine Specifically Targeting Omicron to Be Developed by March
Pfizer CEO Albert Bourla said that two doses of the coronavirus vaccine are "not enough" to provide sufficient protection against the omicron variant. He added that while a third dose "offers fairly good protection against death and decent protection against hospitalization," the duration of this protection remains questionable.
The company will develop a vaccine specifically targeting Omicron by March. Pfizer will also launch a combination vaccine that will protect against Omicron and other COVID-19 variants. At that time, the company will decide which vaccine can provide the best protection.
Bourla said Pfizer plans to produce 120 million courses of Paxlovid next year. This is a significant increase from the company's initial estimate of 50 million courses in 2022.
Takeda: Existing Products Fully Capable of Addressing Blockbuster Patent Cliff
When discussing the loss of patent protection for key products, Takeda is not sweating. Takeda CEO Christophe Weber stated that once Vyvanse, Velcade, and Azilva fall off the patent cliff, the support from 14 branded products, including Takhzyro, Natpara, and Entyvio, along with the recently launched Exkivity and Livtencity, will sustain growth.
At the same time, the threat from biosimilars to Entyvio seems less imminent. Entyvio, which is used to treat Crohn's disease and ulcerative colitis, is one of Takeda’s blockbuster drugs. Weber stated, "First, so far, we have not identified any biosimilar to Entyvio currently in clinical development; second, it would take at least 4-5 years for a biosimilar to complete all clinical studies and file for market approval; furthermore, Takeda’s patent for this drug is valid until 2032. Therefore, any potential biosimilar competitor attempting to launch before that would need to overcome these patent barriers."
Gilead: Long-Acting HIV Prevention Drug Expected to Be Approved by 2025
Gilead CEO Daniel O’Day stated that Gilead Sciences' HIV business will not slow down anytime soon. The once-daily Biktarvy and long-acting lenacapavir are expected to generate sustainable revenue "through 2030 and beyond."
O’Day stated that lenacapavir is the "cornerstone" of the company's long-acting plan for HIV treatment and prevention. Last year, the company launched two Phase III prevention trials to evaluate the efficacy of lenacapavir as a monotherapy administered every six months. Regulatory authorities are expected to make an approval decision on this indication around 2025. If approved, Gilead believes that the six-month dosing regimen of lenacapavir will provide sufficient convenience advantages to help expand the overall HIV prevention market.
At the same time, Gilead is entering a new era in oncology. As early as 2019, this disease accounted for only 5% of the company's business. However, by 2030, it is expected to account for more than one-third, O'Day said. Gilead’s oncology business is expected to exceed $1 billion in sales in 2021. This strong momentum is largely due to Trodelvy and Yescarta, which reported sales of $262 million and $632 million respectively in the third quarter.
Regeneron: Full-Year Sales of COVID-19 Cocktail Therapy Reach $5.82 Billion
Before Regeneron's conference presentation, the company disclosed unaudited Q4 sales of its COVID-19 neutralizing antibody at $2.29 billion, bringing its total annual revenue to $5.82 billion.
Regen-Cov therapy has been shown to lack effectiveness against the omicron variant, but the company is actively researching cocktail therapies for other potential variants. Regeneron believes that this antibody will have a long-term market, particularly for immunocompromised populations.
Regeneron also stated that the company's macular degeneration drug Eylea achieved sales of $1.54 billion in the U.S. during the fourth quarter, with annual sales reaching $5.79 billion, showing robust growth compared to $4.95 billion in sales for 2020. The company is currently evaluating the efficacy of a higher dose of the product to provide patients with a treatment option that requires fewer injections.
Johnson & Johnson: To Achieve $60 Billion Pharmaceutical Sales Target by 2025
In a one-on-one interview with Chris Schott, senior analyst at J.P. Morgan, newly appointed Johnson & Johnson CEO Joaquin Duato stated that Johnson & Johnson is preparing to spin off its consumer health business late next year, after which he will continue to lead the healthcare giant comprising three divisions.
In terms of pharmaceuticals business, Johnson & Johnson is looking forward to achieving significant growth in the next decade. Driven by the expansion of existing major brands such as Darzalex and Tremfya into new indications and formulations, Johnson & Johnson aims to reach $60 billion in pharmaceutical sales by 2025, Duato said, excluding any potential revenue from mergers and acquisitions.
When discussing the upcoming products, Duato emphasized that the peak sales of five of these products could reach or exceed $5 billion. These include the CAR-T drug Carvykti developed in collaboration with Legend, the anti-FcRn monoclonal antibody nipocalimab, the lung cancer drug Rybrevant, the potential first-in-class oral XIa inhibitor milvexian, and the potential bladder cancer treatment platform Taris. Duato stated that Johnson & Johnson anticipates greater growth for these drugs in the latter half of the decade.
Moderna: A Pan-Respiratory Enhanced Vaccine for Once a Year to Be Launched in 2022
Moderna announced at the conference that the company has raised its sales forecast for the COVID-19 vaccine from $17 billion in 2022 to $18.5 billion. This is because the company recently signed contracts with the UK, Switzerland, and South Korea to provide coronavirus vaccines this fall.
Moderna CEO Stéphane Bancel also outlined the company's 2022 product strategy. This mRNA expert aims to bring to market a once-a-year pan-respiratory booster vaccine that can protect against COVID, flu, and respiratory syncytial virus infections.
Novartis: Rich! Keep Buying!
Novartis CEO Vas Narasimhan stated that Novartis will continue to maintain a "balanced" capital allocation. The Swiss pharmaceutical company recently sold its long-held shares in rival Roche for $20.7 billion and is currently conducting a strategic review of its generics division, Sandoz, which could also result in a significant windfall. As a result, investors have repeatedly pressured Novartis management to update its capital allocation strategy.
After selling its Roche shares, Novartis announced a plan to repurchase up to $15 billion of its stock from investors by the end of 2023. The company has paid $800 million upfront to acquire UK biotech firm Gyroscope Therapeutics, gaining access to a gene therapy drug for ophthalmic diseases currently in Phase II trials. Novartis secured BeiGene’s anti-TIGIT drug ociperlimab with a $300 million upfront payment and a commitment to pay $700 million upon exercising the option. Following encouraging clinical data, the Swiss pharmaceutical giant announced on Monday a purchase agreement worth 150 million Swiss francs ($163 million) to obtain Molecular Partners’ COVID-19 antiviral drug ensovibep.
BMS: 7 New Products to be Launched
On the eve of the 2019 JPM conference, BMS stole the spotlight with its large-scale acquisition of Celgene. At this conference, BMS executives stated that despite facing competition from generic drugs and biosimilars, the company aims to achieve growth by expanding its key branded products and advancing its pipeline. The executives noted that BMS's new product portfolio could generate $25 billion or more in revenue by 2029, while the company is planning to bring seven products in mid-to-late stage development to market.
As Revlimid is about to lose its exclusive marketing rights, BMS anticipates that blockbuster products like Opdivo and Eliquis will continue to thrive in the coming years, achieving billions of dollars in sales growth by 2025, with their patent periods arriving later in the decade. Reblozyl, a first-in-class anemia treatment approved in 2020, could generate $4 billion in revenue by 2029—although other competitors may emerge in this space.
In terms of deals, BMS said it plans to continue looking for small to medium-sized "bolt-on" transactions that can complement its pipeline. At the same time, the company is working to pay down debt and has just authorized a stock repurchase program of up to $15 billion.
AbbVie: Aesthetic Business Shows Promising Growth
When acquiring Allergan, AbbVie did not have high expectations for the aesthetics business that the deal would bring, predicting only single-digit growth. However, less than two years later, AbbVie was pleased to find itself mistaken and made upward adjustments. The company now anticipates that its aesthetics franchise will maintain a compound annual growth rate (CAGR) of around 10% through 2029.
AbbVie President Michael Severino stated: "Our initial sales forecast for the aesthetics business in 2021 was $4.5 billion." "During the Q3 earnings call, our revenue reached $5.1 billion, so we have already seen significant growth potential."
AbbVie Expects Aesthetics Sales to Reach $9 Billion by 2029
Lilly: The GLP-1 track is wide and long.
Regarding the company's upcoming diabetes treatment drug, the GLP-1 receptor agonist tirzepatide, Eli Lilly CEO David Ricks stated that "the runway is wide, and the runway is long." In the current treatment landscape, which is between "oral medication intolerance" and "before insulin therapy," this class of drugs is expected to see gradual growth over "quite a long period of time."
At the same time, Eli Lilly is "quite optimistic" about the potential of GLP-1 to revolutionize the field of weight management. Tirzepatide is currently seeking approval for use in type 2 diabetes, but Lilly aims to extend its application to obesity.
Amgen: Biosimilar Business Establishes Its Own Brand
Amgen has already regarded its biosimilar business as "an industry-leading franchise," said CEO Robert Bradway. This is not without good reason, as the company has launched five biosimilars so far, with total sales of these drugs reaching approximately $2 billion in the first nine months of 2021. Bradway stated that by 2030, revenue from this segment will more than double.
Meanwhile, the company is about to launch a blockbuster biosimilar, Amjevita, which is a Humira analog, expected to debut in the United States on January 31, 2023.
In terms of business development, "External innovation has been and will continue to be an important part of our strategy," Bradway said. Just this morning, Amgen invested $75 million to partner with Arrakis Therapeutics to research targeted RNA degraders for difficult-to-drug targets.
Roche: Aiming at the Early Stages of Cancer, a Lot Can Be Achieved!
Roche CEO Bill Anderson stated that a key strategy in Roche's development of anti-cancer drugs is to target diseases at an early stage to achieve potential therapeutic effects. This Swiss pharmaceutical company has currently launched nine Phase III clinical trials for PD-L1 inhibitor Tecentriq and ALK inhibitor Alecensa, aimed at perioperative treatment for early-stage tumors. Six of these trials are expected to yield results by 2022.
Recently, Tecentriq has been approved by the FDA for adjuvant treatment post-surgery in patients with stage II to IIIA non-small cell lung cancer (NSCLC) expressing PD-L1. However, doctors have stated that they will await further data on other PD-1/L1 inhibitors in what is referred to as adjuvant therapy.
MSD announced a few days ago that the Keytruda adjuvant non-small cell lung cancer Phase III Keynote-091 study achieved one of its two primary endpoints. In a broader population of patients with Stage IB-IIIA, regardless of PD-L1 status, the drug demonstrated superiority over placebo in reducing the risk of disease recurrence or death. However, in patients with high PD-L1 expression, Keytruda did not show a statistically significant difference, despite this group historically responding better to PD-1/L1 inhibitors.
Sanofi: Missed the Opportunity, but Still Trying Hard!
Thomas Triomphe, head of Sanofi's vaccine division, said that although Sanofi and GlaxoSmithKline, as global vaccine giants, have not yet become the mainstay of vaccine supply in this COVID-19 pandemic, the two partners are still making steady progress in this field.
Both companies have submitted positive interim data for the booster shot and are expecting "good" final results for the booster. Meanwhile, Phase III efficacy data for the primary COVID-19 vaccination is set to be released in the first quarter of 2022.
As for Sanofi's capital allocation and transaction priorities, Sanofi Chief Financial Officer Jean-Baptiste Chasseloup de Chatillon stated that the company aims to further build on its strengths. In the field of immunology, Sanofi’s goal is to establish a leading industry franchise.
GSK: "Breakup" for Better Growth
After announcing last summer that it would spin off its consumer healthcare group by mid-2022, GSK CEO Emma Walmsley stated at the conference that the British pharmaceutical giant is ready to embrace "a landmark year." Following the spin-off, GSK's consumer healthcare group will become the world's largest integrated consumer healthcare company, with annual sales of £10 billion (£13.58 billion) and 23,000 employees worldwide. This independent company will market 20 products with annual sales exceeding £100 million, serving consumers across 100 countries.
As for the remaining profit growth after the spin-off, the new GSK aims to achieve 5% annual sales growth by 2026 and more than 10% operating profit growth during this period. The pharmaceuticals and vaccines group is targeting annual revenue of £33 billion ($44.8 billion) by 2031. To achieve this, the company is banking on strong growth in its vaccines and pharmaceuticals businesses.