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| Statement |
|---|
| The team has a clear roadmap for execution and I remain confident that we are on track to unlock the tremendous value in the company |
| We are very excited and we are actually the investigators who are doing this study are very excited about the data and encouraged by it |
| I am happy to report that we are now fully ramped up and seeing strong customer engagement |
| Overall, these anticipated data updates are especially exciting as we see the current approved indication in third-line plus DLBCL as a stepping stone to expanding the potential of ZYNLONTA to earlier lines of therapy and combination in DLBCL and across other lymphomas |
| To summarize, we're confident that we have the right team and strategy in place to progressively drive them onto growth |
| Our pipeline has several potential meaningful catalysts over the next 12 months, and we believe our expected cash runway provides us with the ability to execute our business plan |
| The potential catalyst in 2024 will shape the company's future to further serve patients and be able to create additional value |
| Before I get into the financials, I would like to reiterate our continued progress in achieving operational efficiencies throughout the business |
| We understand the challenges, and I am confident that we have the right team and the right strategy in place to effectively position ZYNLONTA now as a monotherapy and in the future, as we look to move to earlier lines of therapy in combination |
| This explains why we felt the brunt of the restructuring in the third quarter, and also why we expect to see a return to growth over the coming quarters, particularly as we look into 2024 |
| So investigators are very excited about it |
| I am confident that we are now set up to most effectively reach treaters in the community, where increasing awareness and trial is a top priority |
| To conclude, we are confident we have a clear roadmap as well as the capabilities to execute on our strategy to drive future value creation for all our stakeholders |
| As you see on this chart, call volume has recovered to pre-restructuring levels with an approximate 40% increase in August and September compared to the prior four months |
| I would like to highlight that beyond our own clinical studies, we are encouraged to see substantial interest in the investigator community to explore ZYNLONTA in novel combinations and across multiple types of B-cell malignancies |
| For physicians in the community setting, ZYNLONTA represents a highly effective monotherapy with a manageable safety profile that can be administered in the outpatient setting |
| We're confident in keeping operational expenses in both 2023 and 2024 below 2022 levels |
| We continue to focus our efforts and resources on the programs, which we believe have the highest potential to drive value |
| We're set up better to enable the leveraging of advocacy from the medical experts in the academic setting to the community treaters |
| We continue to believe that restructuring in the commercial model was necessary to fully capture the longer term value of ZYNLONTA, and we expect to see progressive growth in the coming quarters |
| We're also actively pursuing partnership opportunities and will continue to drive our productivity initiatives to enable capital allocation toward the most promising, nearer term value drivers |
| The study of LOTIS-7 is progressing very well |
| And we also overall improve the collaboration between the teams |
| One of the key advantages that we have with this new model is that we have one world that is fully dedicated to driving demand in the community |
| As we keep getting encouraged by the positive data that we start seeing in combinations in these other settings |
| Lastly, I want to highlight our continued progress in increasing operating efficiencies throughout the organization |
| And that is what opens up the opportunity for a product like ZYNLONTA in the community where it is an off-the-shelf option that is accessible and provides a rapid response for patients who need it |
| While it's important we maintain a solid base and influence in the academic setting, we continue to see the majority of the growth opportunity for ZYNLONTA in the community and we are focusing our resources and efforts accordingly |
| And then finally we had higher growth to net, especially when you look year-over-year, there's quite a bit higher growth to net in this quarter versus the prior year |
| And a treatment like ZYNLONTA is about, a cleaner safety profile and also very fast action, a very fast time to assess response is critical for those patients |
| Statement |
|---|
| Third quarter net sales of ZYNLONTA decreased by 33% year-over-year, impacted by disruption from the field force restructuring and the evolving competitive environment, particularly with the launch of bispecific |
| Starting with ZYNLONTA, we had a challenging quarter with net sales of $14.3 million, down 33% year-over-year |
| We also faced growth to net headwinds from the Medicare Part B discarded drug policy |
| But again, while it is increasing, we also continue to hear from physicians that is still a challenge for patients to get access to these complex therapies |
| What we do know is that the majority of the decline was due to the prolonged disruption from the field force restructuring |
| The decline was attributable to the extended disruption following the field force restructuring and increasing competitive environment, and higher gross to net deductions |
| You know, one was of course the disruption, as we had mentioned before, the time and depth of which we disrupted the field force to get to the right commercial model was longer |
| One of the major obstacles we face is that prescribing behavior in the community is slow to change due to the entrenchment of older and/or less effective agents |
| And the second one is in Medicare Part B discarded drug policy, which we said it would be between mid to high single-digits, that those two elements are going to impact every quarter and have impacted the year-to-date numbers as well as Q3 numbers |
| On an IFRS basis, we reported a net loss of $47.8 million for the third quarter, or $0.58 per basic and diluted shares |
| There's always a lag between activity and getting a new team and a new model up and running |
| As of August, our call volumes have returned back to normal |
| Moving down the P&L, our combined operating expenses on a non-IFRS basis, which excludes stock based compensation, were down 23% compared to the same period in 2022 |
| And when you're working independently, very tough to penetrate a more rare disease like third-line plus DLBCL, if you're working in isolation |
| And so we expected and saw a disruption happened in Q3 |
| Importantly, the maximum tolerated dose has not yet been reached |
| So it's difficult to quantify the impact from each |
| We feel that we felt the brunt of that in Q3 |
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