Key Highlights and Product Updates from 15 Pharmaceutical Giants at J.P. Morgan Healthcare Conference

Source: PharmaCube Info

Last month, due to concerns about the omicron variant, the annual J.P. Morgan Healthcare Conference (JPM Conference) finally kicked off virtually online. This article will provide an overview of the "bold statements" made by leaders of various multinational pharmaceutical companies.

Merck: Confident that molnupiravir is highly effective against the omicron variant!

Last November, Merck announced that the final effectiveness of the COVID-19 oral antiviral drug molnupiravir in reducing hospitalization and death risk was 30%, a 20% decrease compared to the interim trial data. When Pfizer reported that Paxlovid's efficacy reached 89%, Merck’s highly anticipated small-molecule drug lost much of its luster.

At the conference, Dean Li, President of Merck 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 I can imagine."

Merck 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 products. In fact, in December, Merck had already supplied the U.S. government with approximately 950,000 treatment courses. By the end of January, 3.1 million treatment courses will be provided to the U.S."

Pfizer: Vaccine Specifically Targeting Omicron to Be Developed by March

Pfizer CEO Albert Bourla Says Two Doses of COVID-19 Vaccine "Not Enough" for Sufficient Protection Against Omicron Variant. He added that while the third dose "provides fairly good protection against death and decent protection against hospitalization," the duration of this protection remains a concern.

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 offer 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 Patent Cliff of Blockbuster Drugs

When discussing the loss of patent protection for key products, Takeda didn't break a sweat. 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, as well as the recently launched Exkivity and Livtencity, would sustain growth.

Meanwhile, 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 biosimilars 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 on the drug is valid until 2032, meaning any potential biosimilar competitor attempting to launch before then would need to overcome these patent barriers."

Gilead: Long-Acting HIV Prevention Drug Expected to Be Approved by 2025

Gilead CEO Daniel O’Day: HIV Business Won't Slow Down Soon; Biktarvy and Lenacapavir Poised for Sustainable Revenue Beyond 2030

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 single-agent therapy 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.

Meanwhile, Gilead is entering a new era in oncology. Back in 2019, the disease area accounted for just 5% of the company’s business. However, by 2030, it is expected to make up over a third, O'Day said. Gilead’s oncology segment is on track to exceed $1 billion in sales for 2021. This strong momentum is largely driven by 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 Proven Less Effective Against the Omicron Variant, but the Company is Actively Developing Cocktail Treatments for Other Potential Variants. Regeneron Believes These Antibodies Will Have a Long-Term Market, Particularly for Immunocompromised Populations.

Regeneron also reported that its macular degeneration drug Eylea generated $1.54 billion in sales in the U.S. during the fourth quarter, with full-year 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 treatment options requiring fewer injections.

Johnson & Johnson: Achieving $60 Billion Drug Sales Target by 2025

In a one-on-one interview with Chris Schott, senior analyst at J.P. Morgan, Joaquin Duato, the new CEO of Johnson & Johnson, stated that Johnson & Johnson is preparing to spin off its consumer health business late next year, after which he will continue to manage this healthcare giant comprising three divisions.

In terms of pharmaceuticals business, Johnson & Johnson is looking forward to achieving significant growth in the next decade. Thanks to the promotion of new indications and formulations for existing major brands such as Darzalex and Tremfya, Johnson & Johnson aims to achieve $60 billion in pharmaceutical sales by 2025, Duato said, excluding any potential revenue from mergers and acquisitions.

When talking about the upcoming products, Duato emphasized that the peak sales of five of these products might reach or exceed 5 billion US dollars. These include the CAR-T drug Carvykti 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 expects these drugs to experience greater growth in the latter half of the decade.

Moderna: A Pan-Respiratory Enhanced Vaccine to Be Launched Annually 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 an annual pan-respiratory booster vaccine that can protect against COVID, flu, and respiratory syncytial virus infections.

Novartis: Money talks! Keep buying!

Novartis CEO Vas Narasimhan said that Novartis will continue to maintain a "balanced" capital allocation. This Swiss pharmaceutical company recently sold its long-held shares of rival Roche for $20.7 billion and is currently conducting a strategic review of its generic drug division, Sandoz, which could also bring a large windfall. As a result, investors have repeatedly pressured the Novartis management to update its capital allocation strategy.

After selling its shares in Roche, Novartis announced a plan to repurchase up to $15 billion worth of shares 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 clinical trials. Novartis secured BeiGene’s anti-TIGIT drug ociperlimab with a $300 million upfront payment and committed to paying $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

Ahead 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 leading brand 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 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, while their patents are set to expire later this 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 keep 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 buyback plan worth up to $15 billion.

AbbVie: Aesthetics Business Shows Strong 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 is pleased to have been wrong and has made upward adjustments. The company now expects its aesthetics franchise business to maintain a compound annual growth rate 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 third-quarter conference call, our revenue reached $5.1 billion, so we have already seen significant growth potential."

AbbVie Expects Aesthetics Business Sales to Reach $9 Billion by 2029

Lilly: The GLP-1 track is wide and long.

Lilly CEO David Ricks described the landscape for the company's upcoming diabetes treatment drug, the GLP-1 receptor agonist tirzepatide, as having "a wide runway and a long runway." In the current treatment paradigm — 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 apply it to obesity as well.

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, the revenue from this segment will more than double.

At the same time, the company is about to launch a重磅生物类似药Amjevita, which is a Humira类似物, and is 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 the PD-L1 inhibitor Tecentriq and the ALK inhibitor Alecensa, aimed at perioperative treatment for early-stage tumors. Six of these trials are expected to yield results in 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 more data on other PD-1/L1 inhibitors in what is referred to as adjuvant therapy.

Merck recently announced that the Phase III Keynote-091 trial of Keytruda as an adjuvant treatment for non-small cell lung cancer met one of its two primary endpoints. In a broader population of patients with Stage IB-IIIA disease, regardless of PD-L1 status, the drug showed superiority over placebo in reducing the risk of disease recurrence or death. However, in patients with high PD-L1 expression, Keytruda did not demonstrate a statistically significant difference, a subgroup that has historically shown better responses to PD-1/L1 inhibition.

Sanofi: Missed the Opportunity, Still Working Hard!

Sanofi vaccine head Thomas Triomphe 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.

Two Companies Have Submitted Positive Interim Data for Booster Shots and Are Awaiting "Good" Final Results. Meanwhile, Phase III Efficacy Data for the Primary COVID-19 Vaccination Series is Expected 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 said that the company hopes to further develop on the basis of its own strengths. In the field of immunology, Sanofi's goal is to establish an industry-leading 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. The independent company will market 20 products with annual sales exceeding £100 million each, reaching consumers in 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 revenues of £33 billion ($44.8 billion) by 2031. To achieve this goal, the company is banking on strong growth in its vaccines and pharmaceuticals businesses.