Johnson & Johnson (JNJ) SEC Filings & Earnings Calls

Talc Litigation Overhang

“The fiscal third quarter of 2026 includes a charge of approximately $5.5 billion related to the proposed talc ovarian litigation resolution.”

Biosimilar Competition for STELARA

“In the fiscal nine months of 2026, the negative impact of the STELARA sales decline, due to biosimilar competition, on worldwide operational sales was approximately 4.7%.” · word for word

Generic Entry for Key Products

“There are potential generic entrants in 2027 in the U.S. and Europe which will likely result in a reduction in future sales.” · word for word

MedTech Margin Pressure from Separation

“Orthopaedics separation related costs of $0.7 billion in 2026” · word for word

China Volume-Based Procurement Impact

“The Advanced Surgery operational decline was primarily driven by China volume-based procurement” · word for word

Large litigation/other charge of $5.78B severely impacted GAAP earnings; ongoing legal exposure.

“Other (income) expense, net $5,780 million vs ($478 million) prior year; GAAP EPS $0.09.”

R&D expense growth of 26.7% outpacing sales growth, pressuring margins.

“R&D expense $4,652 million, +26.7% YoY; gross margin declined 150 bps.”

Leadership transition in key pharmaceutical segment could cause temporary uncertainty or strategic shifts.

“Retirement of EVP, Worldwide Chairman of Innovative Medicine”

Near-term EPS dilution from acquisitions and collaborations, with FY2026 adjusted EPS reduced by $0.64 and FY2027 by ~$1.36.

“The combination of these two transactions is expected to reduce the Company’s adjusted operational earnings per share... by approximately $0.64 in 2026... approximately $1.36 in 2027” · word for word

Sail Biomedicines collaboration includes milestone-dependent payments that could increase future costs.

“assumes Sail’s achievement of certain development milestones and the Company’s option grant, if exercised” · word for word

Litigation resolution contingent on participation of at least 95% of remaining claims; failure to meet threshold could result in continued litigation.

“conditioned upon, among other things, the express participation of at least of 95% of the remaining claims.” · word for word

Significant cash outflow of $5.5 billion over multiple years, impacting liquidity and cash flow.

“The agreement calls for per claim payments, with a $5.5 billion commitment by the Company, and the first payment of no more than $3 billion to be made in 2027 and no additional payments due before 2028.” · word for word

Biosimilar Competition Risk

“The Company expects STELARA biosimilars to continue to negatively impact the Company’s sales of STELARA.” · word for word

Generic Competition Risk

“Generic competition for OPSUMIT entered the U.S. market late in the second quarter of 2026, which will likely result in a reduction in future sales.” · word for word

Talc Litigation Risk

“The fiscal six months of 2026 include charges for talc matters of $0.8 billion.” · word for word

Tariff Risk

“Impact of tariffs in the MedTech business” · word for word

SIMPONI Biosimilar Risk

“Biosimilars for SIMPONI have entered the European market in the second quarter of 2026, with a potential U.S. entrant later in 2026. This will likely result in a reduction in future sales.” · word for word

Currency headwind partially offset by operational growth; international sales growth of 5.7% total vs 3.4% operational indicates currency benefit of ~2.3%.

“International sales $10,777M vs $10,199M; operations growth 3.4%, currency 2.3%”

GAAP net earnings flat YoY due to higher tax rate (18.0% vs 14.7%) and increased other expense.

“Net earnings $5,534M vs $5,537M; effective tax rate 18.0% vs 14.7%”

STELARA biosimilar erosion

“the negative impact of the STELARA sales decline, due to biosimilar competition, on worldwide operational sales was approximately 5.4%.” · word for word

SIMPONI biosimilar risk

“Biosimilars are pursuing regulatory approval for SIMPONI, which would likely result in a reduction in future sales, potentially in the first half of 2026 in Europe and second half of 2026 in the U.S.” · word for word

OPSUMIT generic competition

“The Company expects generic competition for OPSUMIT in the U.S. in the second half of 2026, which would likely result in a reduction in future sales.” · word for word

IRA Drug Pricing Negotiation

“While the impact of the IRA on our business and the broader pharmaceutical industry remains uncertain, as litigation filed by Janssen and other pharmaceutical companies remains ongoing, CMS has publicly announced the maximum fair price for each of the selected drugs and has recently begun implementing the program.” · word for word

Talc litigation

“The fiscal first quarter of 2026 includes charges for talc matters of $0.3 billion.” · word for word

GAAP net income down 52.4% due to prior year gain from divestitures; adjusted earnings slightly down.

“Net earnings $5,235M -52.4%; adjusted net earnings $6,614M -1.4%.”

SG&A expense increased 18% YoY, pressuring margins.

“Selling, marketing and administrative expenses $6,034M, 25.1% of sales vs 23.3% prior year.”

Litigation liability pressure

“The Company reversed an accounting charge of $7.0 billion related to talc matters in 2025.” · word for word

Loss of exclusivity headwinds

“Delivered strong growth by accelerating existing brands and launching multiple new products, overcoming our most significant loss-of-exclusivity event in more than a decade.” · word for word

Biosimilar Competition

“STELARA sales declined 41.3% due to biosimilar competition. The Company expects continued launches of biosimilar versions of STELARA globally which will continue to negatively impact the Company’s sales of STELARA.”

Patent Expiry and Generic Competition

“The Company expects generic competition for OPSUMIT in 2026, which would likely result in a significant reduction in future sales.” · word for word

Medicare Part D Redesign Impact

“Growth of ERLEADA was primarily due to continued share gains and market growth partially offset by the impact of Medicare Part D redesign.”

Litigation Risk (Talc)

“The fiscal year 2025 includes the reversal of approximately $7.0 billion, a significant portion of the previously accrued talc reserve and an expense of $0.8 billion for the Auris shareholder litigation.” · word for word

Currency fluctuations impacted international sales; Europe had 8.6% currency tailwind.

“Europe currency impact +8.6%; Western Hemisphere ex-U.S. currency impact -5.0% for full year.”