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| In addition to YUPELRI and ampreloxetine, we’re in a strong financial position with over $100 million in cash, as well as the potential to accrue significant value through milestones and royalties on YUPELRI and TRELEGY over time |
| As a result, we are well positioned to achieve milestones in 2024 and beyond |
| that is delivering consistent growth |
| Third, we’ll maintain a strong capital structure as we work to deliver value for shareholders |
| On slide 25, I’ll provide an update on our potential to earn milestones from TRELEGY, noting that GSK delivered another excellent quarter of growth |
| We grew hospital volumes an outstanding 46% for the year and set the business up for continued momentum in 2024 |
| This is achieved by gaining forming -- gaining support for formulary inclusion, implementation of hospital protocols involving all nebulization strategies and therapeutic interchanges, and equally important high touch transition of care programs |
| Turning to our corporate progress, I’m proud we delivered on our promise of reaching non-GAAP profitability in the fourth quarter, which involves significant efforts on the part of the entire Theravance team |
| In addition, we completed our $325 million capital return program within the first few days of January while maintaining a strong financial profile |
| Moving to slide 16, I’m also very pleased to share with you the exceptional finish to the year our hospital team was able to deliver |
| We set ambitious goals for our hospital business in 2024, which we believe will translate into future share gains in the long-acting nebulization market |
| Although quarter-to-quarter results can vary depending on the timing of shipments and other seasonal factors, we remain optimistic for YUPELRI’s continued growth based on the success we are delivering in the hospital channel, as well as several key performance indicators we track across the business |
| Fourth quarter net sales reached $60.6 million and full year sales reached $221 million, with YUPELRI recording its highest level of profitability since launch |
| Turning to our 2024 financial outlook, we expect annual collaboration growth to remain strong and for our quarterly financial results to improve as the year progresses |
| Beginning on slide 15, I’m pleased to report that the Theravance and Viatris commercial partnership finished the year strong, having driven YUPELRI net sales growth of 9% for the full year of 2023 |
| Moreover, as the first novel therapy in years, we are optimistic we will be able to build a case for a broad access and significant adoption in the population for which it is indicated, should ampreloxetine be approved |
| Based on the choices we’ve made regarding YUPELRI, ampreloxetine and TRELEGY, we believe we’re at the crossroads of Theravance’s evolution, where we stand poised to deliver significant incremental value through operational assets, as well as near-term milestones and royalties, while making limited incremental investments and managing risk |
| We attribute both segments share growth to the increasing traction of our concomitant therapy messaging |
| I’m pleased to report that our team delivered on these objectives |
| We’re pleased with the accomplishments of 2023 and look forward to what we can accomplish in 2024, both through effective financial management of the business, as well as the growth of YUPELRI and the execution on the CYPRESS study in order to bring what we believe will be an important medicine to patients with MSA and nOH |
| In May, we were granted orphan drug status, which confers important financial advantages such as tax credits and user fee exemptions and shields ampreloxetine from price negotiation associated with the Inflation Reduction Act |
| So we’re really excited about the opportunity and the economics there |
| It was great to see a positive outcome from your Phase 3 trial of YUPELRI in China back in November |
| We’re very excited about the opportunity for ensifentrine |
| We plan to limit cash utilization and we believe we’re in a strong position to achieve the $25 million TRELEGY sales milestone in 2024 and possibly the higher $50 million milestone |
| While we don’t comment specifically on enrollment, we continue to make excellent progress activating sites, including many outside of the United States |
| One, we see such significant opportunity in ampreloxetine and the execution of the CYPRESS study and the preparatory work over the next year, both on the regulatory side, as well as some very early commercial preparation work that any distraction from anything else as they could be net harmful where we are right now |
| So we’re quite excited about, obviously, continuing to progress with the study, the investor event that we have in quarter two, which I think will fill in some more information and then continue to provide additional information as we work towards closing the study and data, so |
| Looking ahead, we expect to achieve continued growth and value creation for YUPELRI, driven both by continued penetration of the U.S |
| We’re making very good progress there and I think if you split that, we got this is really about -- is a little bit tilted towards patients as opposed to sites and that’s where our focus will be |
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| Not surprisingly, a significant majority of patients with symptomatic nOH report that they have a reduced ability to perform daily activities, while many also expressing a loss of independence |
| And more recently, based on data reported on clinicaltrials.gov, it failed to demonstrate a benefit in the confirmatory study requested by the FDA known as RESTORE |
| While realized sales this quarter closely tracked with demand generation, we have traditionally experienced seasonal dips in reported net sales as we transition from the fourth quarter to the first quarter of the following year |
| MSA patients experience a progressive loss of autonomic function, as well as challenges with standing, walking, speaking and swallowing |
| This is due to an expected decrease in collaboration revenue in Q1 from Q4 of 2023, driven by typical seasonality for YUPELRI net sales, as mentioned by Rhonda, combined with a temporary increase in R&D spend due to the expected rapid patient enrollment and site initiation for the CYPRESS study |
| During the first year, we expect to report losses on a non-GAAP basis |
| And then just, Rick, as a follow-up, obviously, you have now brought yourself and the company to expense management and some difficult choices to a point where your cash burn is pretty minimal |
| Lastly, we may continue to incur non-cash income tax expense of several million each quarter |
| In terms of our non-GAAP metric, we expect we will turn from a non-GAAP profit in Q4 2023 to a non-GAAP loss in early 2024 |
| Unfortunately, most epidemiology research was conducted decades ago on Parkinsonism, more generally using survey techniques with significant limitations |
| For share-based comp, we are expecting between $18 million and $22 million, the midpoint reflecting a year-over-year reduction of approximately 20% |
| Compared with 2023 actuals, we need only 5% growth in annual net sales to achieve the first $25 million milestone and 17% to achieve the second $50 million milestone |
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