David Elkins
Executive Vice President and Chief Financial Officer at Bristol-Myers Squibb
Thank you, Giovanni, and thank you all again for joining our call today. I know this is a busy morning for all of you. As Giovanni mentioned, 2022 was another solid year of execution for Bristol-Myers Squibb. Let's get started with our top line performance on Slide 11. Unless otherwise stated, all comparisons are made versus the same period in 2021, and sales performance growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. We delivered on our full-year commitments with sales of approximately $46 billion, with growth of 3%. Demand for our diversified in-line and new product portfolio was strong, with revenue growth of 13% for the year, more than offsetting the loss of exclusivity for Revlimid in the first year of generic entry.
Let me dive deeper now into fourth quarter and full-year performance of our new product portfolio on Slide 12. Global revenues in the quarter were $645 million, up 87%, while full-year revenues topped over $2 billion, nearly doubling over 2021. With nine new product approvals and multiple additional indications coming to fruition, we have an increasingly de-risked new product portfolio. This provides us confidence that we are on track to deliver the potential of our new product portfolio with $25 billion of non-risk adjusted revenue, expected at the end of the decade.
Moving to Slide 13, to discuss our performance of our solid tumor portfolio. Global Opdivo sales reflect strong demand for our newly-launched and core indication, with double-digit growth in the fourth quarter and the full year. In the U.S. fourth quarter revenue saw full year sales growth strong, growing 13% and 15% respectively. This growth was primarily driven by demand for our new metastatic and adjuvant indications, partially offset by declining second-line eligibility, as well as some use of Opdualag in first-line melanoma.
Internationally, revenues grew 20% in the fourth quarter and 14% for the full year. Fourth quarter revenue growth was largely driven equally by demand and timing of shipments. Demand was primarily driven by new indications, particularly first-line lung and upper GI cancers. As we look through this year, we expect growth of Opdivo to continue. This growth will come from an expanded indications, in both early and late-stage cancers.
Now turning to our first-in-class LAG-3 inhibitor Opdualag, which had an impressive first year on the market. Approved in the U.S. in late March, Opdualag generated sales of $252 million in 2022. Sales in the fourth quarter had strong sequential growth of 24% versus quarter three. With first-line melanoma market share now in the high-teens. We continue to see room for growth of Opdualag in first-line melanoma, where PD1 monotherapy share still is approximately 20%. And further potential with pivotal studies in adjuvant melanoma and second-line plus colorectal cancer underway.
On Slide 14, let's discuss our growing cardiovascular portfolio, starting with Eliquis, which had another great year. Global revenues in the fourth quarter and the full year grew 6% and 14% respectively. In the U.S. fourth quarter sales increased 15% driven primarily by demand and favorable gross-to-net adjustments. Internationally, Eliquis is the leading OAC in many countries. Given high market shares across these countries, demand growth has been offset by pricing measures, as well as generic entry in Canada, the UK and Netherlands.
Now, turning to our first-in-class myosin inhibitor Camzyos. Sales in the fourth quarter were $16 million. We are pleased with the progress we've made since the launch in May of 2022. We laid a strong foundation of REMS certified over 2,600 healthcare professionals and enabled key centers to get operationally ready to make Camzyos available to patients. We also significantly increased the number of patients on commercial dispensed drug, which provides strong momentum, heading into this year. We look forward to continuing this momentum, as well as bringing Camzyos to European patients with approval expected by midyear.
Moving to our hematology portfolio on Slide 15, starting with Revlimid. Global sales for the full year were approximately $10 billion, impacted by generic entry. As we noted last year, we expect a variability quarter-to-quarter. And in 2022 we saw slower than anticipated utilization of generic lenalidomide in the U.S. With favorability in 2022 and anticipated increase in generic volume this year, we expect Revlimid revenues to be approximately $6.5 million -- $6.5 billion in 2023, We continue to expect an average $2.5 billion annual step-down as a reasonable assumption for 2024 and 2025.
Pomalyst global revenues continue to grow in the fourth quarter and for the full-year, driven primarily by demand for triplet based regimens in earlier lines of therapy and extending duration of treatment for patients. As usual, in the first quarter, I would like to remind you of the typical seasonality Revlimid and Pomalyst experienced, due to patients entering the Medicare coverage gap early in the year.
Now moving to Reblozyl, our first-in-class EMA. Demand for Reblozyl was strong, with fourth quarter and full-year sales, growing over 30%. In the U.S., revenues grew over 20%, in both the fourth quarter and full year. We have made great progress since launch, by increasing patient adherence, extending treatment durations, and accelerating switches when ESAs fail. Internationally, Reblozyl continues to launch in different markets across the globe, with launches now in 16 markets outside the U.S.
Growth continues to be driven by demand in both MDS and beta thalassemia-associated anemia and obtaining reimbursement in additional countries. Turning to our differentiated cell therapy portfolio Abecma and Breyanzi. Our first-in-class BCMA cell therapy Abecma continued its robust performance. Global revenues for the full year were $388 million versus $164 million in 2021. This represents strong growth year-over-year, reflecting significant patient demand and the work that the company has done to increase manufacturing capacity. Remain focused on continuing to ramp up capacity and believe this will enable us to get Abecma to more patients with highly refractory myeloma, as well as preparing to move into earlier lines of therapy.
Lastly, moving to our best-in-class CD19 cell therapy Breyanzi. Global sales for the year were $182 million, more than doubling over 2021. Sales in the quarter reflects strong demand and hard work of our teams to expand supply. Looking to this year, we continue to expect growth driven by demand for Breyanzi and second-line plus large B-cell lymphoma. And we will remain focused on continuing to build manufacturing capacity, to further support the uptake and prepare for additional indications.
Now let's move to our expanded immunology portfolio on Slide 16. Starting with our first-in-class S1P agonist Zeposia. Fourth quarter sales grew 69%, while full-year global sales nearly doubled, driven by increased demand in multiple sclerosis and ulcerative colitis. Our strategy to expand volume and to improve commercial access is materializing. We've made progress with several plans, with either zero or one-step at it, which will meaningfully expand access as we move in 2023. We expect continued growth of Zeposia to evolve, primarily from MS today to UC over time.
And remember, as with any new immunology medicine, heading into the first quarter, the typical dynamics of co-pays we set in each year tend to impact the first-quarter performance, as additional co-pay supports affects gross-to-net adjustments. Internationally, we are continuing to focus on securing reimbursement in additional markets, to get Zeposia to more patients living with MS and UC.
Finally, turning to our first-in-class TYK2 inhibitor for moderate-to-severe plaque psoriasis Sotyktu. We're extremely pleased with U.S. launch so-far. Still early days, but physician feedback has been outstanding. As of December, we had over 2,000 script equivalents on bridge and commercial drug. Since then, we continue to make progress in new scripts and see that the use of Sotyktu is roughly evenly split across systematic naive patients, Otezla switch patients and biologic switch patients.
We remain focused on driving demand for this new medicine as the oral choice and ensuring as many patients as possible get Sotyktu to enable broader formulary positions in 2024. Internationally, we are now approved in Japan and Canada with expected European approval by midyear.
Switching gears to our fourth quarter P&L on Slide 17. Having just covered sales performance, let me walk you through a few non-GAAP key line items. As expected, fourth quarter gross margin was impacted primarily by product mix and higher manufacturing costs. For the full year, gross margin was in-line with our prior guidance, at approximately 79%.
Excluding acquired in-process R&D, fourth quarter and full-year operating expenses decreased primarily due to reallocation of investments behind our growth opportunities, and the impact from foreign exchange and dilution from the Turning Point acquisition. Acquired in-process R&D in the quarter was $52 million, which was partially offset by $16 million of licensing income, that benefited OI&E in the quarter.
Fourth quarter effective tax rate was approximately 11%, driven by earnings mix and one-time items with the full-year tax rate of approximately 15%. Overall, fourth quarter earnings per share was $1.82. From a full-year perspective, we ended the year at the upper end of our guidance range at $7.70, representing 8% over previous year.
Moving to the balance sheet and capital allocation on Slide 18. Cash flow from operations in the fourth quarter was $3.3 billion. The company's balance sheet remains strong with approximately $9 billion of cash and marketable securities on hand as of December 31st. Our capital allocation priorities are unchanged. Business development remains a top priority to further renew and diversify our portfolio and strengthening our growth outlook. We're also focused on balance sheet strength and returning capital to shareholders. We have executed several early-stage business development deals, as well as acquiring Turning Point Therapeutics last year. Our strong balance sheet allows us to be size agnostic on deals. As it relates to balance sheet strength in 2022, we reduced debt by over $5 billion and we are committed to maintaining a strong investment-grade credit rating.
And finally, as it relates to returning capital to shareholders, we have a longstanding track record of paying dividend for 91 consecutive years, and recently grew the dividend for the 14th consecutive year. We remain committed to growing the dividend, subject to Board approval and continue to be opportunistic on share repurchases, with approximately $7 billion remaining in our share repurchase authorization.
Let me close with our 2023 non-GAAP guidance on Slide 19. Due to unpredictable macroeconomic factors and large swings in foreign-exchange last year, we are providing guidance on a reported basis, as well as on underlying basis, which assumes currency remains consistent with prior year. We expect 2023 revenues to grow approximately 2% on a reported and constant-currency basis. This reflects our confidence that our in-line and new product portfolios will more than offset the LOE impact from Revlimid and Abraxane.
We expect Revlimid sales to be approximately $6.5 billion, which assumes additional step-up to generic manufacturers later in Q1, as well as continued variability quarter-to-quarter. With the momentum of our new product portfolio, we expect it to roughly double versus last year, and will be approximately $4 billion.
As it relates to our line-item guidance for the year, we expect our gross margin to be approximately 77%, which reflects a shift in product mix. We do not predict acquired in-process R&D, so, excluding this, we expect our total operating expenses to decline in the low-single-digit range. This reflects a reallocation of cost and efficiency initiatives in MS&A as we continue to invest in our new launches.
R&D expenses are expected to be largely in line with last year, due our dynamic portfolio of studies reading out and new study starts. We project our tax rate to be approximately 17%, reflecting changes to Puerto Rico tax laws and product mix.
Finally, we expect to grow our non-GAAP earnings per share, with a range of $7.95 to $8.25. This represents growth of approximately 5%. Excluding prior year acquired in-process R&D, adjusted EPS would grow approximately 2%. So before we move over to Q&A, I want to thank our colleagues around the world for the strong performance in 2022. Our strong execution in 2022 and our commitments for 2023 reflects the resiliency of our business and the renewal of our product portfolio. The performance in the year positions us well for long-term growth.
I'll now turn the call-back over to Tim and Giovanni for questions and answers.
