Rajiv Malik
President at Viatris
Thanks, Scott, and good morning, everyone. As Scott mentioned, we had another strong start to the year and a strong quarter of operational performance across various segments as well as product categories. Let me now begin by sharing our commercial segment highlights from the quarter. As I do, I will be making certain comparisons on an operational basis which excludes the negative impact of foreign currency rates versus the plan that supports our financial guidance as it relates to Q1 '22 results, which also excludes the results from the divested biosimilars business from Q1 '22.
Our well-balanced business of developed markets where brands make up close to 60% of our net sales delivered another strong quarter. Europe performed ahead of our expectations with France and Italy driving the strong performance. The region grew low-single-digits in Q1 compared to the prior year on an operational basis, making it our fifth consecutive quarter of year-over-year growth. Our key brands like Dymista, Creon, and Brufen, as well as our generics portfolio continued to perform strongly in Q1. Our North America business also performed ahead of expectations, driven by better-than-expected performance in our generics portfolio including lenalidomide and our injectables portfolio. Our brand business was led by stronger performance of YUPELRI. We look forward to launching several new products in North America this year including Breyna, our generic to Symbicort. We and our partner, Kindeva Drug Delivery, have settled the patent litigation with AstraZeneca, and expect to launch the product after expiration of regulatory exclusivity. We anticipate launching Breyna with 180 days first-to-file generic exclusivity to FDA's future determination of the issue, if and when, another ANDA filer becomes eligible for final approval. For the remainder of the year, in developed markets, we expect to meet or exceed our expectations of both North America and Europe.
Moving to emerging markets. Korea, Malaysia, Thailand, as well as Middle East delivered strong performance. Lipitor, Norvasc, and Viagra performed better than expected. Generics also performed ahead of expectations driven by solid ARE performance. We remain confident for this segment to deliver mid-single-digit growth for the full year, primarily driven by our brand category of this region.
In Jan, the brand category fell slightly behind expectations primarily due to customer buying patterns in Japan. We remain confident in our overall outlook for the year due to the projected strong performance of our generics, including authorized generics as well as our brands like Creon, Amitiza, and Effexor. Greater China performed better than expected with 5% year-over-year growth on an operational basis. We expect another strong year of operational performance in line with our expectations as we continue to focus on the retail segment and growing the self-pay patient base while navigating the evolving policy environment. I'm also pleased to confirm that we have 10 regulatory submissions under review with the SFDA in China.
Moving to eyecare. Tyrvaya's launch continued to progress as planned in its first quarter as a part of Viatris. March delivered Tyrvaya's the highest launch-to-date monthly prescriber count and total prescriptions. Furthermore, we remain excited about Tyrvaya's opportunities ahead, including driving prescriptions from the recent Medicare Part D coverage win, leveraging Viatris' commercial infrastructure, and launching its first direct-to-consumer marketing campaign in Q4, which together provides confidence in our current full-year outlook for Tyrvaya as to as beyond that. We have made significant progress in stabilizing our base business, which we believe is one of the key elements to the successful execution of our Phase 2 strategy in '24 and beyond.
One of the primary drivers through our expected stabilization is the effective management of our brand portfolio which spawns approximately two-thirds of our overall base. I'm pleased to report that for the last several quarters, our branded business has consistently performed at or above our expectations across the various geographies. This continued strong performance of our branded category as well as generics across the segments combined with our anticipated 500 million-plus of new product launches in '23 gives us tremendous confidence that our base business, excluding the positive impact of our eyecare division, will return to growth in the second half of the year versus the prior year. We believe we are headed into the final stages of completing all aspects of our Phase 1 commitments and we'll deliver another strong year that we expect will put the company in a very solid position to execute Phase 2.
Let me now switch to provide noteworthy updates on our pipeline with a focus on the three key buckets we highlighted at the beginning of the year. I will begin with our portfolio of complex injectable products. We secured a sole first-to-file position for Wegovy, a weight-loss treatment. In addition, we can also confirm that we have achieved a sole first-to-file status for Ozempic 8 milligrams strength. As we have previously disclosed, we have a shared first-to-file position on the other strengths of Ozempic. In addition, we have strengthened this portfolio and submitted our ANDA for ABRAXANE used in the treatment of breast cancer as well as advanced our MR-151 product, an anticoagulant, into its clinical phase of development. Finally, we have also submitted another first-to-market ANDA to FDA for MR-204 which is indicated for chronic dry-eye disease.
Within our select, novel, and complex products pipeline, I'm really excited to announce that we filed our NDA for Glatiramer Acetate once-monthly to FDA. As we have previously noted, our GA once-monthly product has met its primary endpoint of reduction in annual relapse rate in a placebo-controlled Phase 3 study. GA once-monthly demonstrated a 30% reduction in ARR as compared to placebo. In addition to this, GA once-monthly when compared to placebo demonstrated clinically relevant spirality on the Expanded Disability Status Scale Score that was statistically significant. For Meloxicam, we have completed our end-of-Phase 2 meeting with FDA on May 1 with positive outcomes and we look forward to initiating our Phase 3 clinical trials in the second half of this year. Finally, we are progressing our IND-enabling study for our BOTOX program and remain on track to making our IND filing this year.
Our eye care pipeline is also advancing as planned. We are pleased that we have received positive top-end results for Tyrvaya in China. We along with our partner are now tracking our submissions in China to August of this year. Our clinical program for MR-142 for night vision disturbances is progressing well. We also submitted our IND and are Phase 3 ready for our MR-148 for dry eye disease. In addition, we aligned with FDA on the Phase 3 study design for our Blepharitis program which will get initiated later this year. Finally, we are executing IND-enabling studies for our nerve growth factor product, MR-146, which we hope to progress to treat all stages of neurotrophic keratitis.
Before I hand it over to Sanjeev, I want to recognize that our execution has been and continues to be a team effort and I would like to thank our colleagues around the globe for delivering another strong quarter.
With that, I will now hand the call over to Sanjeev.
