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| Statement |
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| The transaction is expected to deliver a very high return on investment and was a terrific strategic fit with our metabolic genetics presence |
| The product continues to outperform our original estimates, and we're continuing to reap the benefits of our expanded sales force as well as the recent launch of Betaine Anhydrous |
| Sales of ALKINDI SPRINKLE continue to be strong, delivering significant growth over the prior year period of Q2 2023 |
| So I am pleased that our strong revenue growth and disciplined cost structure allowed us to reach this critical mark a whole quarter ahead of schedule |
| Before we wrap up, I just wanted to acknowledge and thank our dedicated employees, building the business to reach cash flow positivity is an impressive milestone that is the result of years worth of hard work from our dedicated employees |
| This was a very strong quarter for the company, and in fact, our 11th straight quarter of sequential product revenue growth |
| This underscores the very attractive operating leverage in our business, and we expect to be able to continue to deliver rapid revenue growth, both from existing products and new product launches, while seeing only minimal increases in expenses |
| Having our business reach a cash flow positive state also means that our significant cash balance, which finished the quarter at more than $22 million is largely excess cash that can be invested in additional rare disease products to expand our portfolio and increase our revenue and earnings growth even further |
| We believe our commercial advantages, existing relationships with prescribers and experienced sales force will allow us to capture a meaningful percentage of the $50 million market |
| I hope it is clear that our existing commercial products in our late-stage pipeline has us very well positioned to deliver strong organic growth for many years to come |
| We believe the sampling program will have a positive impact on the products growth in the quarters to come |
| Adding on the potential from our numerous late-stage pipeline candidates and the attractive business development environment, I remain very confident in our ability to reach our goal of having 10 commercial rare disease products on the market by the end of 2025 |
| Our strong balance sheet has put us in a very advantageous position relative to many industry peers that are overleveraged, unprofitable or struggling to raise capital |
| We are very pleased to close the acquisition of Nitisinone in October, which was acquired out of a bankruptcy, but on a very attractive terms |
| Betaine is still early in its commercialization, but we are already seeing good adoption and have received positive feedback from patients and prescribers |
| We believe there is a significant opportunity for us to leverage our resources and grow even faster through additional business development |
| More importantly, though, we achieved a critical milestone for the company by delivering positive cash flow from operations |
| This was posted this positive cash flow from operations is solely on product sales and royalty revenue |
| Yes, since Q3 was a big turning point for us, positive operating cash flow, we do expect that to continue in normal first quarter seasonality |
| We expect continued product sales growth moving forward, and ALKINDI SPRINKLE revenue will likely trigger a onetime sales-related milestone payment of $1.0 million under the terms of the ALKINDI SPRINKLE licensing agreement from 2020 |
| The meeting went very well, and we believe the agency is supportive of the program |
| We will have milestone payment in Q1 and with normal kind of seasonality issues in the beginning of the year, but we do expect positive operating cash flow outside of that going forward, certainly for full year 2024 |
| Moving on to Carglumic Acid, which also had a strong quarter |
| Our third quarter revenue was $7.0 million compared to $3.2 million in the third quarter of 2022, or a 118% increase driven by increased sales volume for ALKINDI SPRINKLE and Carglumic Acid |
| With both products, we believe we would be able to offer a compelling portfolio that addresses the full spectrum of unique preferences among the estimated 5,000 children under the age of 10 that suffer from this disease |
| However, we look forward for even larger opportunities, preferably branded, patent-protected assets where we can add value with our sales infrastructure and expertise |
| The product has a long runway for growth ahead of it throughout the 2034 patent In fact, we are in the midst of launching ALKINDI SPRINKLE sampling program, which I expect to go live in the coming weeks |
| I think our recent results are proving that to investors, while our revenue this quarter increased an impressive 118% year-over-year, our selling, general and administrative expenses increased by only 4% year-over-year |
| We remain confident that our cash position is sufficient to allow us to execute our plan and continue pursuing bolt-on transcends and new product developments |
| We are growing rapidly and expect that to continue for the foreseeable future, but we are also committed to profitable growth |
| Statement |
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| Total company net loss for the third quarter of 2023 was $0.6 million or $0.02 per basic and diluted share, compared to a net loss of $3.0 million or $0.12 per basic and diluted share in the prior year period |
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