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| Statement |
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| We believe that the positive net income reported in the fourth quarter and for the full year 2023 reflects these expense reductions |
| We have continued to reduce our internal expenses to account for these factors, as we recognize our fiscal responsibility to the shareholders and continue to be net income positive in 2024 |
| In Q4, we were pleased to see enrollments continue to improve from Q3, and we saw Q4 enrollments grow 12% sequentially |
| As I mentioned during the third quarter earnings call, we did see the enrollment trend improve as the third quarter progressed |
| We are pleased to report positive net income for the fourth quarter of 2023 and for full year 2023 |
| The expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that the company is guiding to for full year 2024 |
| We have seen a fairly steady increase in the adoption of dose escalation over the last several years, and I am pleased with the feedback that we receive from customers |
| The company remains committed to continuing to achieve this positive net income, and we'll continue to reduce expenses if needed to achieve this |
| We are pleased to announce that in late Q3, NERLYNX received regulatory approval in Mexico in the metastatic setting and also received regulatory approval in the United Arab Emirates in the extended adjuvant setting |
| Because again, the thesis we have is that alisertib is an aurora kinase inhibitor, so the biomarkers that are involved in the euro kinase pathway is where we should see the best efficacy |
| We at Puma are committed and passionate about finding more effective ways at helping these patients during their journey, and we will continue to strive to achieve that goal |
| Our SD business did grow 10% quarter-over-quarter and about 4% year-over-year |
| We truly appreciate all the efforts put forth by our partners to make NERLYNX available to more patients around the world |
| This team is committed to finding ways to be more efficient and effective and adapting to the changing needs of the business |
| We are hopeful that this increase in non-personal promotion was a contributor to this enrollment growth |
| As Alan mentioned it, net product revenue from NERLYNX sales was $53.2 million, an increase from the $51.6 million reported in Q3 2023 |
| Higher medicare share, particularly from patients in Puerto Rico, the higher government charge backs were the main drivers of the increase versus Q3 2023 |
| Please note that I will make comparisons to Q3 2023 which we believe is a better indication of our progress as a commercial company than year-over-year comparisons |
| Finally, as a commercial organization, we remain committed to being more efficient and effective with our resources |
| In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operational cash flows |
| And so we're anticipating we're going to have a good number of patients to talk about |
| NERLYNX's net revenue in Q4 2023 was $53.2 million, which is a $1.6 million increase from the $51.6 million we reported in Q3 of 2023, and about a $500,000 reduction from the $53.7 million, we reported in Q4 of 2022 |
| Product revenue net was $53.2 million in the fourth quarter of 2023, which was an increase from the Q3, 2023 and slightly below $53.7 million reported in Q4 2022 |
| Puma senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends in 2024 and beyond and recognizes the fiscal responsibility to shareholders to continue to maintain positive net income |
| In addition to pure call activity, we are using internal and external data to try and improve our abilities to engage with clinicians at the right time, given the various treatment decisions and duration of therapies |
| Most notably, a recent biomarker analysis from this trial has demonstrated a subgroup of patients with a biomarker where the aurora kinase pathway plays a role, where alisertib appears to have much greater efficacy when added to osimertinib at the time of progression on osimertinib |
| ACP calls in the fourth quarter increased about 12% year-over-year with about 80% of those calls being live interactions |
| Due to those items, we are forecasting a net loss in Q1, but anticipate that we will be net income positive for the remainder of 2024 as well as for the full year |
| More specifically, we anticipate SG&A expenses to decrease by 8% to 12%, and R&D expenses to increase 17% to 20% year-over-year |
| I think the clear signal we're looking for is both response rate and PFS, but to see something that's better in the group that has the biomarker that doesn't from the early data |
| Statement |
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| As Alan mentioned, Q4 performance was negatively impacted by several factors |
| Soft Q3 enrollments had a negative impact on fourth quarter new patient starts TRx and overall demand |
| Q4 performance was negatively impacted by the decline in enrollments we saw in Q3 and discussed during the Q3 earnings call |
| NERLYNX sales were negatively impacted by the decline in enrollments that we mentioned in our third quarter earnings call, a lower than anticipated rate of conversion from enrollment to commercial new patient starts and a higher than expected gross to net |
| The second factor that negatively impacted our Q4 performance was the conversion rate from enrollments to commercial new patient starts |
| Overall demand decreased 3.1% quarter-over-quarter and about 12.8% year-over-year |
| As investors are aware, Q1 usually represents the lowest net product revenue for the fourth quarter due to the burn-off from inventory build from Q4 |
| We do see quarterly fluctuations in these conversion rates, but in Q4, we had this metric move in a negative direction |
| In Q4 of 2023, new prescriptions or NRx, were down approximately 9% compared to Q3, 2023, and total prescriptions, TRx, were down approximately 7% compared to Q3, 2023 |
| As we have discussed with investors in prior earnings calls, we typically see a decline in enrollments in the fourth quarter as patients delay starting therapy until after the holidays |
| In Q4, we saw new patient starts or NRx declined about 9% quarter-over-quarter and about 25% year-over-year |
| In terms of total prescriptions, or TRx, we saw about a 7% quarter-over-quarter decline and about a 17% decline year-over-year |
| Q4 net sales were impacted by lower enrollments in Q3 as well as a higher gross to net in Q4 |
| Inventory buildup by our distributors, was approximately $2.1 million in Q4, which was lower than expected versus approximately $0.6 million of buildup in Q3 2023 |
| In Q4 of 2023, NERLYNX ex-factory bottle sales were 2,881, which represents a slight increase of about 0.2% quarter-over-quarter and a 13% decline year-over-year |
| In Q4, we saw a decrease in a percent of patients converting from enrollments to new patient starts with the majority of that being driven by an increase in PAP or free goods |
| We believe NERLYNX continues to be promotionally sensitive |
| Puma anticipates a Q1 net loss of between $10 million and $12 million |
| Puma anticipates a Q1 net loss between $10 million and $12 million |
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