NEW YORK – Sales of Novartis' precision oncology drugs like Kisqali and Tafinlar/Mekinist continued to grow during the second quarter, and the Swiss drugmaker said it has resolved access issues affecting its radiopharmaceutical Pluvicto.
During the three months ending June 30, the Basel, Switzerland-based Novartis brought in $13.62 billion in overall revenues, up 7 percent from $12.78 billion during Q2 2022, and above the $13.19 billion that analysts predicted on average. On a constant currency basis, Novartis' revenues increased 9 percent versus Q2 2022.
Novartis' Kisqali (ribociclib) was among the top-selling drugs in Q2. The CDK4/6 inhibitor, which Novartis markets for hormone receptor-positive, HER2-negative metastatic breast cancer, contributed $493 million during Q2 2023, up 60 percent compared to the same quarter last year.
The Swiss drugmaker is actively trying to expand Kisqali's indication into a broader population of early-stage breast cancer patients, including those with stage II or III disease. During the American Society of Clinical Oncology's annual meeting in June, Novartis presented data from the Phase III NATALEE trial in which adjuvant Kisqali plus endocrine therapy resulted in a 25 percent reduction in invasive disease-free survival versus adjuvant endocrine therapy alone. The benefit was seen across all patient subgroups, including patients with node-positive and node-negative disease.
"Those consistent results give us confidence that we'll be able to achieve a broad label in the early breast cancer setting," Narasimhan said, pointing out that Novartis saw a positive overall survival trend in the interim analysis within the NATALEE trial. The firm plans to present updated invasive disease-free survival and overall survival data from this study during the second half of this year. Narasimhan further said Novartis anticipates submitting its application for adjuvant Kisqali treatment based on this data to European regulators in the third quarter of this year and to the US Food and Drug Administration during the fourth quarter of this year.
Meanwhile, Novartis' prostate-specific membrane antigen (PSMA)-targeted radioligand therapy Pluvicto (Lu 177 vipivotide tetraxetan) brought in $240 million in sales during Q2 2023. The treatment, which is marketed for previously treated PSMA-expressing metastatic castration resistant prostate cancer (mCRPC), netted FDA approval in March 2022, and Novartis didn't provide an estimate for how much Pluvicto sales increased compared to the year-ago quarter. That said, Narasimhan pointed out that Pluvicto's sales did climb 14 percent versus Q1 2023, exceeding the company's expectations. Novartis had previously projected that Pluvicto sales this quarter would be about the same as Q1, thanks to a manufacturing capacity issue that temporarily stopped new patients from starting the treatment.
Now, according to Narasimhan, Novartis is "fortunately at a situation where [Pluvicto] supply is no longer constraining the ability to grow this brand." This is due to recent regulatory signoffs on two new radiopharmaceutical manufacturing sites — one in Millburn, New Jersey, and one in Zaragoza, Spain — allowing Novartis to ramp up Pluvicto's commercial production.
"This has allowed us to start adding new patients as well as adding new centers," Narasimhan said, noting that in coming months, Novartis aims to ensure that 100 new centers have the capability to administer Pluvicto. He said he expects regulators to approve a third Pluvicto manufacturing site in Indianapolis, which would further increase production capacity, though he didn't share when this approval might come through.
Looking ahead, Novartis is planning to present data from the PSMAfore study on the use of Pluvicto in mCRPC patients who have not previously received a taxane-based chemotherapy. The drugmaker aims to both present these data and file for regulatory approval during Q4 of this year as well as present data on Pluvicto's efficacy in hormone-sensitive prostate cancer from the Phase III PSMAddition trial in 2024.
Narasimhan predicted that Pluvicto sales will exceed $1 billion this year.
The firm is also trying to develop radioligand therapies against other targets and in different cancer indications. Recently, Novartis acquired a fibroblast activated protein (FAP)-targeting radioligand, FAP-2286, from now-bankrupt Clovis Oncology. Novartis is evaluating that therapy in patients with FAP-positive solid tumors, as determined by the gallium-linked FAP PET imaging agent 68Ga-FAP-2286, in the Phase I LuMIERE trial.
Additionally, during Q2 2023, sales of Novartis' BRAF-MEK inhibitor combination, Tafinlar and Mekinist (dabrafenib and trametinib) were $496 million, up 10 percent compared to Q2 2022.
Novartis recorded net income of $2.32 billion in Q2 2023, or $1.11 per share, compared to $1.70 billion, or $.77 per share, in Q2 2022. Its core EPS was $1.83, which beat analysts' average estimate of $1.67 per share.
The firm is raising its full-year guidance based on its strong performance. Now, the drugmaker expects its innovative medicines business to grow in the high-single digits in 2023, whereas it previously projected growth in the mid-single digits.
Novartis also announced on Tuesday that it will buy back $15 billion of its shares by the end of 2025, after having completed a $15 billion share buyback in June, through which Novartis repurchased a total of 170.7 million shares.