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| Statement |
|---|
| While it is still early in the launch, we are optimistic about the potential of Cortrophin Gel for this indication, which represents a unique opportunity to introduce Cortrophin to new prescribers |
| Our overall portfolio is strengthened by this high gross margin, low working capital and strong cash flow generation business |
| A strong fourth quarter tapped off a record year and we finished 2023 with $486.8 million in total revenue, an increase of 54% over 2022 |
| Adjusted non-GAAP EBITDA was a record $133.8 million, up 140% year-over-year, and adjusted non-GAAP earnings per share for $4.71, an increase of 246% from 2022 |
| So on pulmonology, as we had mentioned, we have seen traction, increased number of new patient starts, increased number of new cases initiated and positive physician response seeing the momentum that we have from the first region, right? We had added a smaller sales force in the second quarter of 2023 |
| Key factors driving these are further increase in effectiveness of our existing sales force, the record number of new patient starts and continued growth across specialties we targeted since launch and the new areas such as pulmonology, gout and now ophthalmology |
| And look, we see strength in both the therapy that we initially launched with nephrology, neurology, and rheumatology as well as the newer therapeutic areas that we have begun investing in, which is pulmonology, ophthalmology and gout |
| I continue to be tremendously pleased by the effort and output of our Rare Disease team in building our Cortrophin Gel franchise |
| New patient starts accelerated during Q4, with the strongest sequential quarter over quarter growth in revenue to date |
| So the outlook for the category remains robust |
| Contemplated in our guidance is increased investment in R&D to fuel generics growth through new product launches, along with further strengthening of the Cortrophin Gel franchise through the initiatives that Nikhil spoke of moments ago |
| Since the launch of portrayal Cortrophin Gel in the first quarter of 2022, the overall category, ACTH category has experienced seven consecutive quarters of year-over-year growth and the outlook for the category remains robust |
| The company continues to maintain a strong compliance track record with successful FDA audits across sites |
| For generics, we anticipate high-single digit to low-double digit revenue growth on top of our exceptionally strong performance of 28% year-over-year growth in 2023 |
| As to the prior three quarters, we were able to leverage ANI’s exceptional new product launch execution, operational excellence and U.S.-based manufacturing footprint to achieve this growth |
| Turning now to our genetics business, which delivered another strong quarter |
| We posted another strong quarter to close out 2023 with fourth quarter revenues of $131.7 million up to 40%, over the prior year period |
| We are adding a second geographical reason to our pulmonology sales force, given the strong traction we have seen so far in the therapeutic area |
| Second, our strong operational backbone and U.S.-based manufacturing footprint |
| We believe ophthalmology could be a meaningful growth contributor for profits |
| Revenues from Cortrophin Gel reported in our Rare Disease segment was $41.7 million, up 137% from the prior year, and 40% from the third quarter driven by increased volume |
| 2023 was a record year for ANI and we're already off to a strong start in 2024 |
| We generated $71.8 million in revenue during Q4, an increase of 24% over the last year, and 2% over the strong revenue we reported in Q3 |
| This is a specialty where ACTH prescribing has gained traction over the past few years |
| Look, we are optimistic about the potential for Cortrophin Gel for this indication |
| Overall, our generics business remains an established and reliable partner of choice for our customers |
| Within this segment, generic revenues for the quarter were $71.8 million, an increase of 24% over the prior year period, and 2% over the third quarter, driven by increased volumes in the base business and contributions for new products launched in both 2022 and 2023 |
| For established brands, given our performance in the first two months of the year, we believe that revenue in the first quarter of 2024 will be higher than that achieved in the fourth quarter of 2023 |
| And we see momentum |
| Cortrophin demand growth continued across our specialties targeted at the launch -- targeted at launch, which were rheumatology, neurology and nephrology |
| Statement |
|---|
| To continue with this segment, net revenues for established brands and other revenues were $18.1 million in the quarter, a decrease of 3% from the prior year period driven by lower volume |
| Non-GAAP gross margin was 59.6%, a decrease of approximately 200 basis points versus the prior year, primarily due to unfavorable product mix |
| A number of patients being treated with ACTH treatments of course, for appropriate patients is significantly lower than where it was a few years ago |
| Moving down the P&L, we expect total company non-GAAP gross margin between 62% and 63%, which reflects modest erosion relative to 2023, due in large part to product mix |
| While the number of patients being treated with ACTH therapy in the U.S., is significantly lower today than it was several years ago |
| Fourth quarter diluted GAAP earnings per share was four cents, as compared to a $0.28 loss in the prior year period |
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