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| Statement |
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| As seen on the left panel of this slide, disciplined execution has resulted in an impressive year-over-year growth in NUZYRA's core commercial business, evidenced by the 32% increase in net revenue from Q1, 2023 versus Q1, 2022 |
| Over the first four years of NUZYRA’s US launch, its commercial success continues to clearly differentiate its core commercial performance as one of the most successful IV oral antibiotic launches in the last decade |
| Strong demand, coupled with disciplined execution, resulted in consistent year-over-year growth in NUZYRA’s core commercial business |
| So we continue to feel good about our NTM program and our phase two study, which is why we're doing it |
| Encouragingly, we saw momentum in overall sales growth in the latter half of the first quarter that has continued through April |
| We feel very confident in our full year guidance, and we're able today to reiterate that guidance with approximately 25% to 35% year-over-year growth projected for this year |
| As you can see on the right side of this slide, we are pleased to report that our trailing 12-month net revenue has now surpassed the $100 million threshold, an important milestone in the evolution and consistent upward trajectory of NUZYRA’s commercial growth |
| And while it's too early to comment on whether we think these trends are sustainable through 2023, we are encouraged with the progress that we've seen to date |
| These positive trends allow us to have confidence in reiterating our full year 2023 revenue guidance of $143 million to $158 million as captured on this slide |
| I'm pleased to report that we are actually seeing these improving trends continue, actually not just in the back end of the last quarter, but they seem to have carried over into the second quarter |
| I can tell you that we're quite pleased with the progress that's been happening in the first quarter of this year, and we remain on target to plan to make our enrollment completion by the end of this year |
| NTM represents a promising future growth opportunity in the orphan disease space |
| This trend is a good signal for new growth in the hospital business after the headwinds of the last two quarters |
| In addition to these early and positive trends in the hospital business dynamics since February, we're also seeing a steady increase in new hospital prescribers as shown in the dark blue bars on this slide |
| With the investment to date in the community expansion, we're seeing an acceleration in the share of prescription days of therapy generated by this team |
| We think that that's actually a function of staffing conditions in the hospitals, along with improved patient flow in addition to the data I've shown |
| As we think about our business, we see operational efficiencies and opportunities here to consider places where we could be more efficient |
| The hospital and community segments have both contributed significantly to the year-over-year growth in the NUZYRA core commercial business |
| Having both once daily oral and IV formulations enables NUZYRA to have clinical utility in every setting of care |
| We continue to believe that the expansion of the community sales team and the associated medical support will maximize long-term growth for NUZYRA |
| Is that still a long term goal, and can you outline some major factors in order to achieve that goal? Evan Loh Yes, look, I think that when we look at our business, we continue to remain extremely pleased with our current upward trajectory in terms of our core commercial business |
| As seen on this slide, we continue to see growth across both the hospital and community sectors of our core commercial business |
| As you can see on slide 17, in contrast to the headwinds we've seen during the last half of 2022, there appears to be potential early signals of an emerging recovery in the hospital setting which is both encouraging and welcomed |
| First, an improving macroenvironment regards recruitment and staffing within the hospital setting and second, a subtle but important change in our messaging within the hospital |
| On the right panel of this slide, first quarter gross demand, the leading indicator of future sales growth, increased year-over-year by 50% over the same quarter in the prior year |
| And Randy could speak to this also that we will be actually, we're in the process of getting off the ground with a similar regulatory process where we have high confidence that we'll be able to, number one, achieve orphan disease designation |
| In addition, we have seen some early signals of a potential improvement in the overall hospital business environment |
| I also obviously mentioned the encouraging trends that we've seen in the hospital, and I put those, obviously, in my prepared remarks |
| As a result of this quarter's performance, combined with the sales momentum we have seen through April, we maintain our confidence in achieving the growth required to meet our full year revenue guidance for the core commercial business of $125 million to $135 million |
| NUZYRA net US sales of $26.2 million, a 32% increase from $19.9 million for the same period in the prior year |
| Statement |
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| Consistent with past performance expectations, we saw a modest decrease in net sales in the first quarter of this year compared to the fourth quarter of last year, which is likely due to the annual insurance resets that occur at the beginning of each year |
| As Evan noted earlier, we saw a modest reduction in first quarter net sales compared with the fourth quarter of last year, primarily due to annual insurance resets |
| Government contract, service and grant revenue earned from cost reimbursement under the BARDA contract of $3.8 million, a 12% decrease from $4.3 million for the same period in the prior year |
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