Q4 2021 Seagen Inc Earnings Call

Speaker 1: It think there that C.

Thanks, Doug.

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Thanks.

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Good day, and welcome to the fourth quarter and full year 2021 financial results Conference call.

Speaker 2: Good day and welcome to the CJUN fourth quarter and full year 2021 Financial Results Conference call.

All participants will be in listen only mode.

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Speaker 2: After today's presentation, there will be an opportunity to ask questions.

After today's presentation there'll be an opportunity to ask questions.

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Speaker 2: I would now like to turn the conference over to Peggy Pinkston, Senior Vice President, Investor Relations. Please go ahead. Thank you, operator, and good afternoon, everyone. I'm pleased to welcome you to CJIN's fourth quarter and full year 2021 Financial Results Conference call. This afternoon, we issued a press release with our results, and that press release and supporting slides are available on our website in the investor section, events and presentation space.

I would now like to turn the conference over to Peggy Pinkston Senior Vice President Investor Relations. Please go ahead.

You operator, and good afternoon, everyone I'm pleased to welcome you to <unk> fourth quarter and full year 2021 financial results Conference call. This afternoon, we issued a press release with our results in that press release and supporting slides are available on our website in the investors section and events and presentations page.

Speaker 2: Speakers on today's call will be Clay Segal, President and Chief Executive Officer, Chip Brump, Executive Vice President, Commercial U.S., Todd Simpson, Chief Financial Officer, and Roger Danz, the Chief Medical Officer.

Speakers on today's call will be <unk>, President and Chief Executive Officer Chip Romp Executive Vice President commercial U S. Todd Simpson, Chief Financial Officer, and Roger <unk>, Chief Medical Officer.

Speaker 2: Following our prepared remarks, we'll open the line for questions. We aim to keep this call to one hour and so ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A during our call today.

Following our prepared remarks, we'll open the lines for questions. We aim to keep this call to one hour and so ask that you limit yourself to one question to give everyone an opportunity to participate in Q&A during our call today.

Today's conference call will include forward looking statements regarding future or anticipated events and results, including the company's 2022 financial outlook anticipated product sales revenues costs and expenses and potential clinical and regulatory milestones, including data readouts regulatory submissions and potential marketing and reimbursement approval.

Speaker 2: Today's conference call will include forward-looking statements regarding future or anticipated events and results, including the company's 2022 financial outlook, anticipated product sales, revenues, costs, and expenses, and potential clinical and regulatory milestones, including data readouts, regulatory submissions, and potential marketing and reimbursement approval.

Yes.

Speaker 2: Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the difficulty in forecasting sales, revenues, and expenses, impacts related to the COVID-19 pandemic, and the uncertainty associated with the pharmaceutical development and regulatory approval process.

Actual results or developments may differ materially from those projected or implied in these forward looking statements factors.

Factors that may cause such a difference include the difficulty in forecasting sales revenues and expenses impacts related to the COVID-19, pandemic and the uncertainty associated with the pharmaceutical development and regulatory approval process.

More information about the risks and uncertainties based by CGM is contained under the caption risk factors included in the Companys quarterly report on Form 10-Q for the quarter ended September 32021 filed with the Securities and Exchange Commission and the company's subsequent reports filed with the SEC and now I will turn the call over to clay.

Speaker 2: More information about the risks and uncertainties faced by CGIN is contained under the caption risk factors included in the company's quarterly report on Form 10Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission and the company's subsequent reports filed with the SEC. And now I'll turn the call over to Clay.

Thank you peg and good afternoon, everyone.

Speaker 3: Today, we reported $1.4 billion in 2021 net product sales, a 38% increase over 2020, driven by solid growth across our commercial portfolio.

Today, we reported $1 4 billion in 2021 net product sales, a 38% increase over 2020.

Driven by solid growth across our commercial portfolio.

Speaker 3: Royalty revenues increased to $151 million in 2021, a 19% year-over-year increase, reflecting sales growth by our collaborators.

Royalty revenues increased to $151 million in 2021, a 19% year over year increase reflecting sales growth by our collaborators.

Speaker 3: Our total revenue guidance for 2022 is $1.67 to $1.75 billion, excluding...

Our total revenue guidance for 2022 is 167 to $1 75 billion.

Excluding Tim Dec.

Speaker 3: With a strong balance sheet and a cash position of $2.2 billion, we are well positioned to advance our pipeline through internal and external investments.

With a strong balance sheet and our cash position of $2 2 billion.

We are well positioned to advance our pipeline through internal and external investments.

Todd will walk us through our 2022 financial guidance, but first I'd like to begin by reflecting on another exceptional year procedure.

Speaker 3: Todd will walk us through our 2022 financial guidance. But first, I'd like to begin by reflecting on another exceptional year for C-Gen.

Speaker 3: We achieved important milestones in 2021 and continued to expand our global infrastructure and portfolio. I'll begin with our commercial products.

We achieved important milestones in 2021 and continued to expand our global infrastructure and portfolio.

Begin with our commercial products.

Et cetera.

Speaker 3: Et cetera. It's a US standard of care in frontline hot skin lymphoma and peripheral T cell lymphoma and forms the foundation of our core business of a revenue stamp.

The U S standard of care in frontline Hodgkin lymphoma, and peripheral T cell lymphoma and forms the foundation of our core business from a revenue standpoint.

Speaker 3: Et cetera has received approval in more than 75 countries, and we and our partner Takeda continue to provide this important drug to patients in need.

Et cetera has received approval in more than 75 countries and we and our partner Takeda continue to provide this important drug to patients in need.

Speaker 3: Notably, last week, we announced that the phase three echelon-1 clinical trial demonstrated a statistically significant improvement in overall survival in advanced Hodgkin lymphoma patients treated with et cetera plus chemotherapy in the frontline setting.

Notably last week, we announced that the phase III echelon, one clinical trial demonstrated a statistically significant improvement in overall survival in advanced advanced Hodgkin lymphoma patients treated with ADCETRIS plus chemotherapy in the frontline setting.

Over 30 years ago, ABVD was established as standard of care for treating Hodgkin's disease, and almost 15 years ago data regarding intensified via Cup was initially released.

Speaker 3: Over 30 years ago, ABVD was established a standard of care for treating Hodgkin's disease, and almost 15 years ago, data regarding intensified BIA coF was initially released.

Speaker 3: We are thrilled that ETCDRIS plus ABD has now improved overall survival and we believe these groundbreaking data further demonstrate ETCDRIS clinical value and importance in this disease.

We are thrilled that ADCETRIS plus ABVD has now improved overall survival and we believe these groundbreaking data further demonstrate et cetera clinical value and importance in this disease.

<unk> is a first in class ADC, which has become a standard of care in the U S for previously treated metastatic <unk> cancer.

Speaker 3: PADSEV is a first-in-class ADC, which has become a standard of care in the U.S. for previously treated metastatic urophilical cancer. PADSEV has been broadly adopted by U.S. oncologists to treat more than 6,500 patients to date.

That has been broadly adopted by U S oncologists to treat more than 6500 patients to date.

Speaker 3: Last year, tests have received regular U.S. approval and was also granted a cisplatin ineligible second-line indication.

Last year headset receive regular U S approval and was also granted a cisplatin eligible second line indication.

Speaker 3: Together with our partner, Estellas, in 2021, we secured approvals in Canada, Switzerland, Israel and Japan.

Together with our partner Astellas in 2021, we secured approvals in Canada, Switzerland, Israel and Japan.

Speaker 3: We are progressing regulatory submissions across Asia Pacific and the Americas.

We are progressing regulatory submissions across Asia Pacific and the Americas.

<unk> received a positive CHF <unk> opinion in December 2021 recently, the European Commission decision, making process was pause or additional CH MP questions related to severe skin reactions and a French compassionate access program.

Speaker 3: cats have received a positive CHMP opinion in December 2021. Recently, the European Commission decision-making process was paused for additional CHMP questions related to severe skin reactions in a French Compassionate Access program.

Speaker 3: This side effect is described in a USPI, and since launch has been well managed by US prescribing physicians.

This side effect as described in the USPI and since launch has been well managed by U S. Prescribing physicians, we bill.

Speaker 3: We believe that the risk benefit profile of PADSEB remains unchanged. We are committed to working with European authorities to get this important drug approved for urofelial cancer patients.

Please at the risk benefit profile of <unk> remains unchanged. We are committed to working with European authorities to get this important drug approved for Europe filial cancer patients.

Beyond these global regulatory activities, we are advancing a robust clinical development program with <unk> as monotherapy and in combination with Keytruda in earlier lines of therapy.

Speaker 3: Beyond these global regulatory activities, we are advancing a robust clinical development program with PASTEB as monotherapy and in combination with Keytruda in earlier lines of therapy.

We completed enrollment of EV 103, cohort K and <unk>.

Speaker 3: We completed enrollments of EV103 cohort K and expect data in the second half of this year, which could potentially support accelerated approval in the U.S. in 2023 for first-line metastatic neurofelial cancer.

<unk> data in the second half of this year, which could potentially support accelerated approval in the U S. In 2023 for first line metastatic <unk> cancer.

Speaker 3: We are also exploring earlier stages of bladder cancer, which represent larger market opportunities. In muscle invasive bladder cancer, we will report neo adjuvant monotherapy data at ASCO GU later this month. And we are now enrolling patients in a trial for non-muscle invasive bladder cancer.

We are also exploring earlier stages of bladder cancer, which represent larger market opportunities in muscle invasive bladder cancer. We will report new adjuvant monotherapy data at <unk>. Later this month and we are now enrolling patients in a trial for non muscle invasive bladder cancer.

Finally, we are conducting a basket trial evaluating concepts and other negative for expressing solid tumors.

Speaker 3: Finally, we are conducting a basket trial evaluating PADSEB and other NECTIN-4 expressing thymokineollywood.

Speaker 3: Tuqyza is a best-in-class HER2 tyrosine kinase inhibitor with broad potential in HER2 cancer.

To Kaiser is a best in class her two tyrosine kinase inhibitor with broad potential and her two cancers.

Speaker 3: Overall survival data and inclusion in key treatment guidelines reflects its clinical value in second and later line HER2-positive breast cancer patients with and without brain metastasies.

Overall survival data and inclusion in key treatment guidelines reflects its clinical value in second and later line her two positive.

Breast cancer patients with and without brain metastasis.

Because it is approved in 36 countries and we have commercially launched in the U S, Germany, France, Switzerland and Austria.

Speaker 3: Yukaisa is approved in 36 countries and we have commercially launched in the U.S., Germany, France, Switzerland and Austria.

We are working to secure reimbursement in our planning launches in additional European countries over the course of 2022.

Speaker 3: We are working to secure reimbursement and are planning launches in additional European countries over the course of 2022.

Speaker 3: We recently announced the appointment of Lee Heesen as Executive Vice President, Commercial International potatoes jillg.

We recently announced the appointment of Lee Houston as Executive Vice President commercial International.

Speaker 3: We look forward to Lee's contributions towards our continued XUS expansion.

We look forward to lease contributions towards our continued ex U S expansion.

Speaker 3: Our strategic partnership with Merck extends to Kaiser's reach outside of the US, Europe and Canada.

Our strategic partnership with Merck extends to kaiser's reach outside of the U S Europe and Canada.

Speaker 3: to Kaiser's broad clinical development program includes HER2-positive breast cancer, colorectal cancer, gastric cancer, and other HER2 amplify or mutant tumors.

Two kinds of broad clinical development program includes her two positive breast cancer colorectal cancer gastric cancer and other her two amplify or mutant tumors.

Speaker 3: Notably, we expect data from the phase two Mountaineer trial in the second half of this year, which could potentially support accelerated FDA approval in colorectal cancer in 2023.

Notably, we expect data from the phase III mountaineer trial in the second half of this year, which could potentially support accelerated FDA approval in colorectal cancer in 2023.

Speaker 3: CGEN's fourth approved product is TIDAC, which we launched in collaboration with GenMap.

<unk> fourth approved product as tip deck, which we launched in collaboration with Genmab.

Speaker 3: TIVDAC, which is a tissue factor targeted ADC, was approved for recurrent or metastatic cervical cancer patients with disease progression on or after chemotherapy.

<unk>, which is a tissue factor targeted ADC was approved for recurrent or metastatic cervical cancer patients with disease progression.

Or after chemotherapy.

Speaker 3: It represents an important new drug in a disease that is characterized by low objective response rates and poor outcomes.

It represents an important new drug in a disease that is characterized by low objective response rates and poor outcomes.

Speaker 3: TIV-DEX Clinical Development Program is designed to support global regulatory applications and maximize its future potential in cervical cancer and other solid tumors.

<unk> clinical development program is designed to support global regulatory applications and maximize its future potential and cervical cancer and other solid tumors.

As we look to expand <unk> cervical cancer. We recently presented promising combination data in earlier lines of treatment, which could lead to use and much larger patient populations.

Speaker 3: As we look to expand TIB-DAC in cervical cancer, we recently presented promising combination data in earlier lines of treatment, which could lead to use in much larger patient populations.

Speaker 3: In 2021, we also drove key advancements across our deep and diverse pipelines. For example, we in-licensed the late-stage novel ADC, decidimab-badotin, which utilizes a high affinity HER2 antibody with enhanced internalization compared to trastuzumab.

In 2021, we also drove key advancements across our deep and diverse pipeline for.

For example, we in licensed the late stage novel ADC, The cinema, the dotan, which utilizes a high affinity her two antibody with enhanced internalization compared to Trastuzumab.

Speaker 3: DV received conditional approval in China for third line gastric cancer and recently in second and later lines of metastatic urofelial cancer.

DB received conditional approval in China for third line gastric cancer and recently in second and later lines of metastatic <unk> cancer.

Speaker 3: Our clinical development program prioritizes model therapy and combination approaches in breast, bladder, gastric, and other cancers. DV utilizes our Vadodin-based ADC technology and leveraging our expertise, we are working to maximize its development, potential value, and global reach.

Our clinical development program prioritizes monotherapy and.

<unk> approaches in breast bladder gastric and other cancers.

DB utilizes our <unk> based ADC technology and.

And leveraging our expertise we are working to maximize its development potential value and global reach.

Speaker 3: Turning to our earlier stage work, we recently initiated two trials for two novel ADCs, SGN-PDL1V and SGN-V7H4V. And we have also submitted an INDA which just cleared for SGN-ALPV. We are developing new ADC technologies in order to widen the therapeutic window of this exciting class of drugs with a focus on improving tolerability.

Turning to our earlier stage work, we recently initiated two trials for two novel Adcs.

STM PDL one and.

In STM these seven each for the and.

And we have also submitted in R&D, which just cleared.

For STM.

We are developing new ADC technologies in order to widen the therapeutic window of this exciting class of drugs with a focus on improving tolerability.

Speaker 3: In addition, we have four programs that use our proprietary sugar-engineered antibody technology. Overall, we are advancing more than 17 programs across our pipeline and approved products in a range of solid tumors and hematologic malignancies.

In addition, we have four programs that use our proprietary sugar engineered antibody technology overall, we are advancing more than 17 programs across our pipeline.

And approved products in a range of solid tumors and hematologic malignancies.

Speaker 3: Next, I want to provide a brief update on the Daichi Senkyou litigation.

Next I want to provide a brief update on the Daiichi Sankyo litigation.

Speaker 3: Recently, the arbitration hearing record was reopened by the arbitrator to consider additional evidence.

Recently.

Arbitration hearing record was reopened by the arbitrator to consider additional evidence.

Speaker 3: As a result, the decision may occur after the first quarter of 2022, as previously anticipated.

As a result, the decision may occur asking the first quarter of 2022 as previously anticipated.

Our 2021 achievements have helped to bolster our resilient core business and the solid foundation, we continue to build upon.

Speaker 3: Our 2021 achievements have helped to bolster our resilient core business and the solid foundation we continue to build upon.

Speaker 3: We expect to achieve many milestones in 2022, including important clinical data readouts, global regulatory and commercial progress, and advances across our pipeline, which will help drive future growth.

We expect to achieve many milestones in 2022, including important clinical data Readouts global regulatory and commercial progress in advancements across our pipeline, which will help drive future growth as.

Speaker 3: As we look to deliver continued innovation and develop transformative therapies, we remain focused on three key areas. First, we are working to maximize the potential of our approved portfolio through exceptional commercial execution, clinical development, and strategic partnership.

As we look to deliver continued innovation to develop transformative therapies. We remain focused on three key areas first we are working to maximize the potential of our approved portfolio through exceptional commercial commercial execution clinical development and strategic partnerships.

Speaker 3: We've expanded our commercial portfolio from one to four products in under two years and have treated over 110,000 patients to date.

We've expanded our commercial portfolio from one to four products in under two years and have treated over 110000 patients to date.

Speaker 3: Global development programs will generate the potential for future label expansions and opportunities.

Relative programs will generate the potential for future label expansions and opportunities.

Speaker 3: Second, we are advancing our deep and diverse type six and seven to market in the coming years. We believe our ABC leadership.

Second we are advancing our deep and diverse type six and seven to market in the coming years, we believe our ADC leadership.

Speaker 3: and R&D expertise in empowered antibodies provides us with a competitive advantage when it comes to expanding and progressing our pipeline.

And R&D expertise and empowered antibodies provides us with a competitive advantage when it comes to expanding and progressing our pipeline.

Speaker 3: Finally, we are well positioned for continued innovation and growth, having built and optimized our infrastructure and capabilities.

Finally, we are well positioned for continued innovation and growth, having built and optimize our infrastructure and capabilities.

Speaker 3: Our expanding geographic footprint and over 50 strategic partnerships maximize our ability to reach patients across the globe.

Our expanding geographic footprint and over 50 strategic partnerships maximize our ability to reach patients across the globe.

Speaker 3: Our strong corporate development team and significant financial strength allows us to execute upon deals that will further accelerate our trajectory.

Our strong corporate development team and significant financial strength allows us to execute upon deals that will further accelerate our trajectory.

Speaker 3: Next, I'll turn the call over to Chip, who will provide an update on our commercial performance. Then, Todd will discuss our findings. After that, Roger will detail our clinical development activities and pipeline. Chip? spirit

Next I will turn the call over to chip to provide an update on our commercial performance then Todd will discuss our project after that Roger will detail, our clinical development activities and pipeline.

<unk>.

Speaker 3: Thanks, Clay. The commercial team delivered another strong quarter to close out a very successful year for CJ.

Thanks, Blake the commercial team delivered another strong quarter to close out a very successful year for <unk>.

Speaker 3: We've effectively scaled and executed in our efforts to maximize the potential of our commercial portfolio of four products.

We've effectively scaled and executed in our efforts to maximize the potential of our commercial portfolio of <unk> products.

Speaker 3: At Sefrit's fourth quarter 2021 sales were $176 million, an 8% increase over the fourth quarter of 2020.

Et cetera, <unk> fourth quarter 2021 sales were $176 million.

An 8% increase over the fourth quarter of 2020.

Speaker 3: Our focus remains on driving share in frontline stage three and four Hodgkin-Linto.

Our focus remains on driving share in frontline stage III and for Hodgkin lymphoma.

Speaker 3: We were pleased to see the recent update to the NCCN treatment guidelines that recognize the significance of the five-year echelon 1 data. We are excited to now...

We were pleased to see the recent update to the NCC and treatment guidelines that recognize the significance of the five year echelon one data.

We are excited to now have overall.

Speaker 3: survival data from the echelon-1 phase 3 study, and we will continue to monitor uptake in the frontline setting.

While survival data from the echelon, one phase III study and we will continue to monitor uptake in the frontline setting.

Speaker 3: Moving on to pad set. Fourth quarter 2021 US sales were.

Moving on to pads.

Fourth quarter 2021 U S sales.

Speaker 3: for $93 million, a 34% increase over the fourth quarter of 2020. We have now seen broad adoption of checkpoint inhibitors as maintenance therapy for patients in the frontline metastatic setting, which has helped pad therapy continue to represent a meaningful option and a modest incremental growth opportunity.

The $93 million.

<unk> hundred 34% increase over the fourth quarter of 2020.

We have now seen broad adoption of checkpoint inhibitors as maintenance therapy for patients in the frontline metastatic setting, which has helped pad therapy continues to represent a meaningful option and a modest incremental growth opportunity.

Speaker 3: We expect growth in 2022 to be driven by existing indications and look forward to potentially promoting to an additional US pass-up label in the frontline metastatic urotherial cancer setting next year.

We expect growth in 2022 to be driven by existing indications and look forward to potentially promoting June additional U S patent label and the frontline metastatic your female cancer setting next year.

Speaker 3: Moving on to the Kaiser fourth quarter 2021 sales were $94 million, a 53% increase over the fourth quarter of last year.

Moving on to the <unk> fourth quarter 2021 sales were $94 million, the 53% increase over the fourth quarter of last year.

Speaker 3: with growth coming from both the US and Europe . So Kaiser remains the most utilized product in second and later lines in the US in patients with brain.

With growth coming from both the U S and Europe .

So Chris it remains the most utilized product in second and later lines in the U S in patients with brain Mets.

Speaker 3: updated overall survival data in these patients that recently was presented at the San Antonio Breast Cancer Symposium has been well received and is a promotional photo.

<unk> overall survival data in these patients that recently was presented at the San Antonio breast cancer Symposium has been well received and easy promotional focus.

Speaker 3: We are monitoring the evolving HER2 metastatic breast cancer treatment landscape, and we have incorporated this into our annual revenue guidance, which Todd will detail shortly.

We're monitoring the evolving <unk> metastatic breast cancer treatment landscape and we have incorporated this into our annual revenue guidance, which Tom will detail shortly.

Speaker 3: The CAISA sales in Europe for the quarter continue to grow, and we look forward to gaining reimbursement in additional countries in 2022.

The cadence of sales in Europe for the quarter continued to grow and we look forward to gaining reimbursement in additional countries in 2022.

Speaker 3: We are pleased with Tivdak sales of $6 million for the first full quarter since approval. And launch is going as planned.

We are pleased with Tyvek sales of $6 million for the first full quarter since approval.

And launch is going as planned.

Speaker 3: We are navigating the eye care requirements and have gained valuable insights that are allowing us to enhance our educational efforts.

We are navigating the Ikea requirements and have gained valuable insights that are allowing us to enhance our educational efforts.

Speaker 3: Although the initial indication represents a modest opportunity, TIBEC is an important treatment option and early feedback has been positive. With that, I'll turn it over to Dr.

Although the initial indication represents a modest opportunity <unk> as an important treatment option in early feedback has been positive.

With that I'll turn.

Speaker 3: Thanks Chip and thank you everyone for joining us on the call this afternoon.

Thanks, Chip and thanks to everyone for joining us on the call. This afternoon.

Speaker 3: Our financial results reflect significant advances made across the business in the past year. Today, I'll summarize our financial results for 2021 and then discuss our outlook for 2022.

Our financial results reflect significant advances made across the business in the past year today I'll summarize our financial results for 2021, and then discuss our outlook for 2022.

Speaker 3: Total revenues were $430 million in the fourth quarter and $1.6 billion for the full year in 2021. This included net product sales of $369 million in the fourth quarter and $1.4 billion for the full year, representing an increase of 38% over the year in 2020.

Total revenues were $430 million in the fourth quarter and $1 6 billion for the full year in 2021.

This included net product sales of $369 million in the fourth quarter and $1 4 billion for the full year, representing an increase of 38% over the year end 2020.

Speaker 3: This reflects growth in product sales across our portfolio, and particularly for to Tachai's and PEDS.

This reflects growth in product sales across our portfolio and particularly for <unk> and pads.

Speaker 3: Royalty revenues were $46 million in the fourth quarter and $151 million for the year in 2021. The 19% year-over-year annual growth in royalty revenues is primarily driven by increasing sales of its cephras by Takeda, and to a lesser degree, sales of PolaB by Roche and Blendwrap by GSK, both of which are ABCs that utilize cGen technology.

Royalty revenues were $46 million in the fourth quarter and $151 million for the year in 2021.

The 19% year over year annual growth in royalty revenues is primarily driven by increasing sales of ADCETRIS by Takeda.

And to a lesser degree sales of <unk> by Roche and one rep by GSK, both of which are adcs utilize CGM technology.

Speaker 3: Collaboration revenues were $15 million in the fourth quarter and $38 million for the whole year in 2021.

Collaboration revenues were $15 million in the fourth quarter and $38 million for the full year in 2021.

Speaker 3: 2021 collaboration revenues decreased as a result of $250 million recognized in the fourth quarter, and $975 million recognized for the full year in 2020.

2021 collaboration revenues decreased as a result of $250 million recognized in the fourth quarter and $975 million recognized for the full year of 2020.

Speaker 3: These amounts related to the Lidiratum Avidotin and Taqisa collaborations with Merck that we entered into in 2020.

These amounts related to the <unk> and <unk>.

<unk> collaborations with Merck that we entered into in 2020.

Speaker 3: cost of sales for the $87 million in the third quarter and $312 million for the full year in 2021.

Cost of sales for the $87 million in the third quarter and $312 million for the full year in 2021.

Speaker 3: This included product cost of sales and royalties for each of our brands, the gross profit share due to our collaborators, and non-cash amortization of acquired technology costs for Chicago.

This included product cost of sales and royalties for each of our brands. The gross profit share due to our collaborators and noncash amortization of acquired technology costs were too high.

Speaker 3: R&D expenses were $304 million in the fourth quarter and $1.2 billion for the full year in 2020.

R&D expenses were $304 million in the fourth quarter and $1 2 billion for the full year in 2021.

Speaker 3: This is an increase over 2020 and included the $200 million upfront payments to Remagen for in-licensing the Cidimapidotin, as well as continued investment across our early and late stage pipeline.

This is an increase over 2020 and included the $200 billion upfront payment to rent the gym for in licensing dissident methadone move as well as continued investment across our early and late stage pipeline.

Speaker 3: SGA expenses were $211 million in the fourth quarter and $716 million for the full year in 2021.

SG&A expenses were $211 million in the fourth quarter and $716 million for the full year in 2021.

Speaker 3: These are increases over 2020, reflecting investments to support the ongoing launches up to Kaiser across Europe , and more recently, the launch of Tivdak in the U.S.

These are increases over 2020, reflecting investments to support the ongoing launches up to Kaiser across Europe , and more recently the launch of tip back in the U S.

Speaker 3: Next, I'll turn to our financial outlook for 2022, beginning with our revenue guide.

Next I'll turn to our financial outlook for 2022, beginning with our revenue guidance.

Speaker 3: Across our three key commercial brands, we are guiding to product sales of $1.48 to $1.55 billion, representing an increase of 7 to 12% over 2021.

Across our three key commercial brands, we are guiding to product sales of $1 48 to $1 $55 billion, representing an increase of 7% to 12% over 2021.

Speaker 3: The CEFRA sales are expected to be in the range of $730 to $755 million, reflecting modest growth while we advance a broad clinical development program intended to secure additional labels.

The tougher sales are expected to be in the range of $730 to $755 million.

Shifting modest growth, while we advanced a broad clinical development program intended to secure additional labels.

Speaker 3: Past-step sales are projected to be in the range of $435 to $455 million.

<unk> sales are projected to be in the range of $435 million to $455 million.

Speaker 3: We expect growth in 2022 to be driven primarily by continued utilization within its two current indications.

We expect growth in 2022 to be driven primarily by continued utilization within the two current indications.

Speaker 3: While we expect to report data from co-work K-103 trial in the second half of this year, our guidance does not include the impact of a potential label expansion.

While we expect to report data from cohort K, but 103 trial in the second half of this year. Our guidance does not include the impact of a potential label expansion.

Speaker 3: Chikayah sales are expected to be in the range of $315 to $335 million. And as Chip mentioned, our guidance reflects the ongoing evolution of the treatment landscape.

Two kinds of sales are expected to be in the range of $315 billion to $335 billion and as chip mentioned our guidance reflects the ongoing evolution of the treatment landscape.

Speaker 3: While we expect to report data from the mountaineer trial later this year in colorectal cancer, we do not anticipate label expansion in 2022. We continue to engage with individual country authorities to secure broader European reimbursement, which can take up to two years post-EMA approval.

While we expect to report data from the Mountaineer trial later this year in colorectal cancer, we do not anticipate the label expansion in 2022 weeks.

We continue to engage with individual country authorities to secure broader European reimbursement, which can take up to two years post EMEA approval.

Speaker 3: And since we are still early in the launch of TIBDAQ, we are not including fail vestments in our 2022 guidance at this time.

And since we are still early in the launch of Tyvek, we are not including sales estimates in our 2022 guidance at this time.

Speaker 3: Next, we expect Royalty revenues to be in the range of $160 to $170 million, primarily reflecting sales of its set for site to cater in its territories, along with contributions from Starcraft.

Next we expect royalty revenues to be in the range of $160 million to $170 million, primarily reflecting sales of ADCETRIS by Takeda in its territory, along with contributions from <unk> and <unk>.

Speaker 3: Finally, we expect collaboration revenues to be in the range of 25 to $30 million. As a reminder, collaboration revenues include our profit share from Stellis' sales of PEDSA in its territory. This now includes royalties from sales in Japan, and in future years is expected to include a profit share from the EU5. Now Weight Banking, Part six, involves our

Finally, we expect collaboration revenues to be in the range of $25 million to $30 million. As a reminder, collaboration revenues included our profit share from Astellas are sales of capstone in its territory.

This now includes royalties from sales in Japan and in future years is expected to include a profit share from the EU five.

Now I'll turn to 2022 expense guidance.

Speaker 3: Cost of sales is expected to be in the range of $380 to $420 million. This is driven by increased product sales across all brands and the higher profit share payments to our collaborators. Cost of sales also reflects third party royalties owed, as well as non-cash amortization.

Cost of sales is expected to be in the range of $380 million to $420 million. This is driven by increased product sales across all brands and the higher profit share payments to our collaborators cost of sales also reflects third party royalties owed as well as noncash amortization.

Speaker 3: R&D expenses are expected to be in the range of $1.2 to $1.3 billion, primarily related to two items. First, investment in clinical trials to further expand, et cetera, heads up to Kaiser and Tivdak into additional indications.

R&D expenses are expected to be in the range of one two to $1 3 billion.

Primarily related to two items first investment in clinical trials to further expand et cetera.

<unk> into additional indications and second increased investment to advance our earlier stage agents, including <unk> 13 other programs in the pipeline.

Speaker 3: Second, increase investment to advance our earlier stage agents, including more than 13 other programs in the pipeline.

Speaker 3: We believe that these investments are important to our long-term growth.

We believe that these investments are important to our long term growth.

Speaker 3: SGA expenses are expected to be in a range of $780 to $860 million as we continue to focus on commercial execution to drive growth of our approved products.

SG&A expenses are expected to be in a range of $780 to $860 million as we continue to focus on commercial execution to drive growth of our approved products.

Speaker 3: The guidance also includes investment to support the global infrastructure for the continuing launches of Tchaikovsky's in Europe .

The guidance also includes investments to support the global infrastructure for the continuing launches of <unk> in Europe .

Speaker 3: Non-cash expenses are expected to be in the range of $280 to $310 million, the majority of which is stock-based compensation.

Noncash expenses are expected to be in the range of $280 to $310 million the.

City of which is stock based compensation.

Speaker 3: Taken together, our guidance reflects our strategy to expand the commercial opportunity of our portfolio into advanced new product candidates.

Taken together our guidance reflects our strategy to expand the commercial opportunity of our portfolio and to advance new product candidates now I will turn the call over to Roger who will highlight our development activities.

Speaker 3: Now we'll turn the call over to Roger, who will highlight our development.

Speaker 4: Thank you, Todd, and good afternoon, everyone. I'm happy to share recent clinical development updates for both our approved medicines and our pipeline. I'll begin with the setters. We are extremely pleased that a setter in combination with ABD has significantly improved overall survival compared with ABVD in newly diagnosed patients with advanced Hodgkin lymphoma.

Thank you Todd and good afternoon, everyone I am happy to share our recent clinical development updates for both our approved medicines and our pipeline.

I'll begin with ADCETRIS, we are extremely pleased that a texas in combination with ABB has significantly improved overall survival compared with ABVD in newly diagnosed patients with advanced Hodgkin lymphoma.

Speaker 4: A textual shown to reduce the risk of death by 41% with a hazard ratio of 0.59 and a p value of 0.009.

Texas was shown to reduce the risk of death by 41% with a hazard ratio of <unk> nine and a P value of 0.009.

Speaker 4: These data further demonstrate the meaningful difference that a tekrus brings to patients. And we look forward to presenting the results at an upcoming medical meeting.

These data further demonstrate the meaningful difference that <unk> brings to patients and we look forward to presenting the results at an upcoming medical meeting.

Speaker 4: In addition, we were recently informed that a phase three study of a Tetris in newly diagnosed pediatric patients with high risk Hodgkin lymphoma, defining the stages 2B with bulk, 3B and 4 has met the primary end point of event three survival, as reported by the Data Safety and Monitoring Committee.

In addition, we were recently informed that a phase III study of <unk> in newly diagnosed pediatric patients with high risk Hodgkin lymphoma defined the stages <unk> with both <unk> and full has met the primary endpoint of increase survival as reported by the data safety monitoring Committee.

Speaker 4: Trial AHOD1331 is sponsored by the National Cancer Institute and run by the NCI funded Children's Oncology Group. The study compared an atypical containing chemotherapy regimen to a chemotherapy regimen that included bromycin. We thank the Children's Oncology Group for their efforts and we look forward to their presentation of this exciting data at an upcoming medical meeting.

Trial.

<unk>.

<unk> one <unk> three one is sponsored by the National Cancer Institute and run by the NCI funded childrens oncology group with steady compared an ADCETRIS containing chemotherapy regimen to a chemotherapy regimen that included.

We think the children's oncology group for their efforts and we look forward to the presentation of these exciting data at an upcoming medical meeting.

Speaker 4: At ASH, we presented initial data of a combination of the Tetris plus novolumab, adromycin, and dacarbazine in frontline advanced Hodgkin lymphoma, which shows an objective response rate of 93 percent and a complete response rate of 88 percent at the end of therapy. We believe these promising results could form the basis in the future for testing this novel regimen in the frontline.

At Ash, we presented initial data on the combination of the Texas personal volume Ed Adriamycin Dacarbazine in frontline advanced Hodgkin lymphoma, which showed an objective response rate of 93% and the complete response rate of 88% at the end of therapy. We believe these promising results could form the basis.

In the future with testing as novel regimen in the frontline setting.

Speaker 4: Later this year, we plan to share results describing a set of potential utility as an immunomodulator in combination with Keytruda in solid tumors. We are also testing at Tetris in a phase two study in HIV patients, which will begin enrolling this quarter.

Nathan this year, we plan to share results, describing it such as potential utility as an immuno modulator in combination with Keytruda in solid tumors we are.

We're also testing ADCETRIS in the phase II study in HIV patients, which will begin enrolling this quarter.

Speaker 4: Turning to pad says, we remain focused on moving this important product into earlier lines of your urefibular cancer. In the frontline metastatic setting, we are evaluating pad says and Keytruder in two studies, EB103 cohort K in patients who are ineligible for cisplatin therapy and EB302, which includes both cisplatin eligible and ineligible patients.

Turning to <unk>, we remain focused on using this important product into earlier lines of <unk> cancer in the frontline metastatic setting we are evaluating <unk> and keytruda in two studies EV 103, cohort K and patients who are eligible to statin therapy and <unk>.

<unk>, which includes both cisplatin eligible and ineligible patients.

Speaker 4: EV103 COVID-K has completed enrollment and we expect to report top line results in the second half of 2022. The phase three EV302 global trial is assessing PADSEV plus Keytruda compared to platinum-containing chemotherapy. And we are pleased that this trial is projected to complete enrollment this year. EV302 is intended to be a confirmatory trial for COVID-K as well as supporting global marketing applications.

EV 103 cohort K has completed enrollment and we expect to report topline results in the second half of 2022.

Phase III EV 302, global trial is assessing paths <unk>, plus keytruda compared to platinum containing chemotherapy and we are pleased that this trial is projected to complete enrollment this year.

<unk> is intended to be a confirmatory clinical cohort K as well as supporting global marketing applications.

Speaker 4: In muslin days of bladder cancer, we, together with Estelles and Merck, are advancing two phase three trials that are testing PADCEV in combination with Keytruda as perioperative treatment in different populations. The keynotes B15 or EV304 trial is enrolling cisplatin eligible patients and keynote 905 or EV303 trial is enrolling cisplatin ineligible patients.

In muscle invasive bladder cancer, we together with its Denison are.

Advancing to phase III trials that are testing <unk> in combination with Keytruda as peri operative treatment in different populations. The keynote <unk> <unk> or EV 300, full trial is enrolling cisplatin eligible patients and keynote nine of five <unk> three trial is enrolling cisplatin.

Eligible patients later.

Speaker 4: Later this month that ASCOGU, we plan to present the results of the EV 103 exploratory cohort H. In this cohort, passive monotherapy was given as near-angirling treatment of cisplatin ineligible muscle invasive gut accounts for patients with three cycles prior to suspecting me.

Later this month at <unk>, we plan to present the results of the EV 103 exploratory cohort H in this cohort pets at monotherapy was given as neo adjuvant treatment of cisplatin ineligible muscle invasive bladder cancer patients with key cycle's prior to cystectomy.

Speaker 4: Furthermore, we are pleased to announce that we have begun an involvement into the EV 104 trial of single-agent PADSET in non-mustle invasive platic cancer. In this study, PADSET is administered intraversically in BCG non-responsive patients. We are also studying...

Furthermore, we are pleased to announce that we have begun enrollment into the EV 100 full trial of single agent <unk> in non muscle invasive bladder cancer. In this study <unk> administered intravenously and BCG nonresponsive patients.

We are also studying pets a mono.

Speaker 4: Pyrnics and poor expressions for the tumors, including laminopressed, hedonic, gastric, and esophageal cancer. This study continues to enable data this year to inform our next set.

<unk> four expressing solid tumors, including non based hidden they could gastric and esophageal cancer. This study continues to close later this year to inform our next steps.

Speaker 4: Turning to Tukasa, we continue to advance our broad development program in breast and GI malignancies, as well as other father tumours.

Turning to two kinds of we continue to advance our broad development program embraced in Gi malignancies, as well as other solid tumors.

Speaker 4: Today I will highlight a new study, HER2-CLIMB-05, which will evaluate to Kaiser in the frontline maintenance setting of HER2-positive metastatic breast cancer.

I will highlight a new study.

Claim of five which will evaluate <unk> in the frontline.

Maintenance setting of such a positive metastatic breast cancer.

Speaker 4: Standard of care for these patients typically include six to eight cycles of ataxane with the sepsum and progeta, otherwise known as THP. Once the chemotherapy is complete, the sepsum and progeta are...

Standard of care for these patients typically includes six to eight cycle of a taxane with a symptom agenda otherwise known as THP. Once the chemotherapy is complete the <unk> agenda.

Speaker 4: Despite the excellent results obtained with THP, patients remain at risk of relapse and death, including the risk of relapse in the brain. Her2Clim-05 randomizes patients who have completed THP to receive trichyza, perceptin, and pajeta, or perceptin and pajeta alone. The primary endpoint is progression-free survival, and we expect to treat the first patients in this corner.

Despite the excellent results obtained with THP patients remain at risk of relapse and did including the list because we <unk> in the brain.

To climb of five randomized patients who had completed th T to receive two kinds of persistent Jana August kicks in and pitch it alone.

Primary endpoint is progression free survival, and we expect to treat the first patient this quarter.

Speaker 4: In GI cancers, we are waiting results of a phase two mountain-year study, which are expected in the second half of this year. The study assesses to Kaiser anticeptin as treatment for patients with previous et cetera to positive colororectal cancer. Additional trials are studying to Kaiser in combination with a scully platen-based chemotherapy in first-line GI cancers, as well as in combination with the Hoseptin in a basket trial 3rd test.

In Gi cancers, we are awaiting results of the phase III Mountain study.

Which are expected in the second half of this year.

The study assesses to Kaiser and his symptom as treatments for patients with previously treated her two positive colorectal cancer additional trials studying <unk> in combination with expanded testing based chemotherapy in first line Gi cancers as well as in combination with herceptin in the basket trial for solid tumors with cell.

Observations.

Speaker 4: I'll turn now to Tudek, which received accelerated approval in the United States for the treatment of patients, which are...

I'll turn now to tip deck, which received accelerated approval in the United States for the treatment of patients with <unk>.

Speaker 4: with disease progression on or after chemotherapy.

Okay with disease progression <unk> asked the chemotherapy.

Speaker 4: A global phase 3 trial in cervical cancer, Innovative 301, is currently enrolling in the EU and Asia including Japan with plans to expand to other regions.

A global phase III trial in cervical cancer innovative 301 is currently enrolling in the EU and Asia, including Japan with plans to expand to other needs.

He just simply gets at.

Speaker 4: This study is intended to serve as the conformity trial in the United States and importantly, to support global regulatory applications.

This study is intended to serve as a confirmatory trial in the United States and importantly to support global regulatory applications.

The engine combination data from the Internet.

Speaker 4: innovative 205 trial in the first and second line setting at ESMO 2021. This study will be expanded to further investigate additional.

Two of five trial in the first and second line setting and is now 2021.

This study will be expanded to further investigate additional.

Speaker 4: including TIFFDAQ combined with carbon-classen and intruder with or without their system. The results from these new combinations will inform further

Leading tik-tik combined with Carboplatin and <unk>.

With or without Bevacizumab there.

Results from these new combinations will inform further.

Okay.

Speaker 4: Beyond cervical cancer, we continue to study the potential for tib-dak in other malignancies through an ongoing phase 2 trial inivated 207. Preliminary data evaluating tib-dak as treatment of head and neck cancer is being presented later this month at the astro head and neck cancer symposium in Arizona.

Beyond cervical cancer, we continue to study the potential for Tuesday in other malignancies to an ongoing phase two trial innovative <unk> seven.

Preliminary data evaluating <unk> as treatment of hidden neck cancer is being presented later this month at the Astro head and neck cancer Symposium in Arizona.

Speaker 4: Turning now on to the Citramar Beduken or DB in the second screen.

Turning now to the system at the dosing OTV and the ticket.

Speaker 4: enrolling our Monotherapy trial in Eurothelial Cancer. We are also focusing on the development of DV and Fertilow Breast Cancer based on encouraging Monotherapy data generated by a partner remedy.

Enrolling a monotherapy trial in Europe any okay.

We are also focusing on the development of DB and <unk> low breast cancer based on encouraging monotherapy data generated by imaging.

Speaker 4: I'd like to now briefly mention our early stage pipeline. We are evaluating multiple products in phase one clinical trials across a range of solid tumors and hematologic malignant.

I'd like to now briefly mentioned our early stage pipeline, we are evaluating multiple products in phase one clinical trials across a range of solid tumors.

Nick Malignancies, we recently reported first clinical data from two novel programs.

Speaker 4: We recently reported first clinical data from two novel SCA programs at ASH, we disclosed the initial SCA BCMA monotherapy data that demonstrated

Programs at Ash, we disclosed initial cib's TMA monotherapy data that demonstrates it.

Speaker 4: an encouraging early safety and efficacy profile in the first line plus multiple mile almost hitting. In addition, we recently shared SDACD 40 data in combination with chemotherapy and an anti-PD1 in metastatic pancreatic cancer in which we demonstrated evidence of immune activation in patients with an acceptable safety profile and encouraging anti-trimic activity.

And the encouraging early safety and efficacy profile in the first line plus multiple myeloma <unk>. In addition, we recently shared <unk> 40 data in combination with chemotherapy and an anti PD one in metastatic pancreatic cancer in which we demonstrated evidence of immune <unk>.

<unk> and patients with an acceptable safety profile and encouraging anti tumor activity.

Speaker 4: Follow-up for survival is ongoing and will inform future development decisions. We are also enrolling a basket trial to assess SACA 40 combinations in other solid treatments, including melanoma and non-small cell lung caps.

A follow up for survival is ongoing and will inform future development decisions we are.

Also in rounding a basket trial to assess it.

40 combinations in other solid tumors, including melanoma and non small cell lung cancer.

Speaker 4: In closing, we continue to make meaningful progress with our pipeline and we look forward to providing you with updates on future calls. Now I'll hand the call back over to play.

In closing, we continue to make meaningful progress of our pipeline and we look forward to providing you with updates on future calls now ill hand, the call back over to clay.

Speaker 3: Thank you, Roger. I'm proud of the important milestones we have achieved in the past year, which have set the stage for our future. Our portfolio, proven to be a success.

Thank you Roger.

I'm proud of the important milestones we have achieved in the past year, which have set the stage for our future.

Our portfolio proven commercial engine.

Speaker 3: expanded international infrastructure and strategic partnerships increase our global competitiveness and maximize the value of our approved medicine.

Expanded international infrastructure and strategic partnerships increased our global competitiveness and maximize the value of our approved medicines.

Speaker 3: We believe our significant financial strength, active corporate development, robust clinical development, and key 2022 catalyst will continue to bolster our deep and diverse pipeline. We are well-positioned for future innovation and growth. At this point, we'll turn to Q&A operator. Please open the line for questions. yes hopefully without any information, I'mologicdivisionony.ru and I will definitely thank you for having been work today really hard. the

We believe our significant financial strength.

<unk> corporate development robust clinical development and key 2022 catalysts will continue to bolster our deep and diverse pipeline we.

We are well positioned for future innovation and growth.

At this point, we'll turn to Q&A operator, please open the line for questions.

Speaker 2: Thank you. Thank you. We will now begin the question and answer session. To ask a question, you may press star, then one on your co-zone, EPAT.

Thank you. Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.

Speaker 2: If you're using a speaker phone, please pick up your hand before cupping the keys. Please draw your question, please press.

If youre using a speakerphone, please pick up the enhanced cutting that Keith.

Thanks, John Your question. Please press Star then two.

Speaker 2: At this time, we will pause now materially to fund the law doctor. That first question comes from...

At this time, we will pause momentarily to assemble our box.

Our first question comes from.

Jeff <unk> with Bank of America. Please go ahead.

Hey, guys. Thanks for taking my question.

Speaker 5: I guess the real obvious one is, you guys have talked a lot about all the trends in the fourth quarter in last year and the guidance for the three main products.

I guess the real obvious one is you guys have talked a lot about all the trends in the fourth quarter and last year.

And the guidance for the three main products.

Speaker 5: You know, one is down year on year and the other two are just marginally, essentially flat line with fourth quarter. So is it, I get the need to be conservative, but is there something that we should be aware of as it relates to the competitive backdrop for all of your products or the market itself? Just give us a little bit more detail on kind of the idea behind the guidance and maybe any individual kind of nuances that you don't want to point out. Thanks.

One is down year on year and the other two are just marginally essentially flat line looks fourth quarter. So is it I guess the need to be conservative, but is there something that we should be aware of as it relates to the competitive backdrop for all of your products for the market itself.

Give us a little bit more detail on kind of the idea behind the guidance and maybe any individual kind of nuances that you'd want to point out.

Speaker 3: Sure, thanks, Jeff. So first of all, we like where we are positioned on all our brands. You know, we have OS data in three of these brands. Don't know when we don't kid back, cause they're new with drug. And that's something especially for the future.

Sure. Thanks, Jeff So first of all we like where we are positioned on all our brands we have.

OS data.

Three of these brands to Illinois, we don't <unk>, our newest drug and Thats something potentially for the future.

Speaker 3: These are real drugs. These are not incremental drugs. They really help patients.

These are real drugs. These are not incremental trucks, they really help patients and as you know building brands.

Speaker 3: And you know, building brands and take time to build them up. And we have tons of great catalysts coming out for 2022, which we certainly could go over. You know, our revenue guidance for 2022 is, you know,

Takes time to build them up.

And we had tons of great catalysts coming out for 2022.

We certainly can go over.

Our revenue guidance for 2022.

As you know.

Yes.

Speaker 3: uh... is seven to twelve percent growth over 2021 so we're certainly not hiding that the company we're going down

Is 7% to 12% growth over 2021, so we're certainly not guiding and as a company we are going down.

Speaker 3: You know the one point about Kaiser that you know if you

Yes.

The one point about Kaiser.

If you want to talk about.

Speaker 3: The guidance is flat to slightly down, it's pretty pizza.

Hi.

The guidance is flat to slightly down.

And.

Speaker 3: not for that. And really how we're thinking about it is in brain mets, tachysis is the most utilized drug for patients with her positive breast cancer.

Built for that.

And really how we're thinking about it is in brain Mets two cases to most utilized drug for patients with <unk> positive breast cancer.

Speaker 3: in second and later lines. And the product is growing in Europe . But it's an evolving and dynamic marketplace. And with the advent of the NHRP2-DB03 trial, it's likely to have a near-term effect on our growth, and that's reflected in our guidance. But we do expect non-near data in the second half of the year to support regulatory submission with potential labels.

And second or later lines and product is growing in Europe .

It's an evolving and dynamic marketplace.

With the advent of the <unk> trial.

It's likely to have a near term effect on our growth and that's reflected in our guidance, but we do expect now near data in the second half of the year to support regulatory submission.

Potential label.

Speaker 3: in, you know, in the, uh, in 2023. So there's a lot that, uh, we can do. You know, there's so many other things we're doing with TuKyza. Uh, we have Her2Clim 02, as Roger mentioned, soon to start Her2Clim 05 in frontline maintenance, uh, continued contributions from Europe as we secure reimbursement. So I think the future is very bright for TuKyza. Okay, thanks.

And.

<unk>.

'twenty three so theres a lot.

We can do that.

So many other things we're doing with Pfizer.

We have.

To climb up 2% as Roger mentioned soon to start to climb over $5 in frontline maintenance.

<unk> contribution from Europe , as we secure reimburse.

And so I think the future is very bright for <unk>.

Okay. Thanks.

Yes.

Please go ahead.

Good afternoon, Thanks for taking my question.

Speaker 6: Could you frame the pads of muscle invasive bladder cancer?

So could you frame the pad SaaS muscle invasive bladder cancer.

Speaker 6: H data that's coming up in terms of how we should think about what's meaningful here.

Alright H data.

Coming up in terms of how we should think about.

What's meaningful here.

Speaker 3: Sure. We're really excited about what we can see with the, what we're going to be presenting at ASCO to you. Roger, can you outline a little bit what we are looking at and the context?

Sure.

We're really excited about what we can see with the.

What we're going to be presenting at the <unk> <unk> Roger can you outline a little bit.

We are looking at.

The context.

Speaker 4: Sure, thanks, Claire. So the data that we'll be presenting from EV103 cohort H is passive monotherapy in the near adjuvant setting. And these are folks who are cisplatin ineligible with MIBC. And so they're not yet undergone any surgery.

Sure. Thanks Clay so the date of it will be presenting from EV 103 cohort H is Ted says mono therapy in the Neo adjuvant setting. When these are folks who are cisplatin ineligible within might be C and so theyre not yet undergone any surgery.

Speaker 4: So what this will do, and when the data is presented publicly, you will have a better understanding and a better indicator of what Pat said was the monotherapy that he's able to achieve in this disease state.

So what this will do and when the data is presented publicly you will have a better understanding.

A better indicator of what Ted said as a mono therapy.

Was able to achieve in this disease states.

Speaker 4: We're excited to have the data presented, but it is important to just note that the ongoing registration trials that are being run, which were mentioned in the prepared remarks, are focusing on the combination of Keytruda plus PADFED. You know, Keytruda has already shown meaningful activity in this population. When we've shared the PADFED data, there will be an understanding of what PADFED can do, and then some idea of potentially what a combination could produce.

We're excited to have the data presented but it is important to note that.

The ongoing registration trials.

Being one which I mentioned in the prepared remarks, all focusing on the combination of Keytruda plus <unk>.

Keytruda has already shown meaningful activity in this population when we shared the pads have data there will be an understanding of what <unk> can do and then some idea of potentially what a combination could produce.

Speaker 7: Our next question comes from Corey Caspian with JP Morgan. Please go ahead.

Our next question comes from Cory <unk>.

J P. Morgan. Please go ahead.

Speaker 3: Hey, good afternoon, guys. Thank you for taking my question. Wanted to ask about the significance of the arbitrator reopening the Daiichi litigation to consider additional evidence. Can you talk about kind of what this means, a precedent there? And are you able to say what parties submitted the additional evidence? Thank you.

Hey, good afternoon, guys. Thank you for taking my question.

Wanted to ask about the significance of the arbitrator reopening the Daiichi litigation to consider additional evidence can you can you talk about kind of what this means a precedent there and are you able to say what parties submitted the additional evidence. Thank you.

Speaker 3: Thanks for the question. So as we said, the arbitration hearing was reopened. I just want to repeat this and by the arbitrator to consider additional evidence. As a result, the decision may occur.

Thanks for the question. So as we said the arbitration hearing was reopened I'm just want to repeat this in.

By the arbitrator to consider additional evidence.

As a result.

A decision may occur.

Speaker 3: after the first quarter. We don't know exactly at this point. And, you know, what's important is for us to say is that legal matters are confidential and they're pending and it's not appropriate for us to discuss them in detail. However, what I will say is that we have to be clear about what's going on. And we have to be clear about what's going on. And we have to be clear about what's going on.

After the first quarter, we don't know exactly at this point.

And.

Whats important is for us to say is that legal matters are confidential and the pending and its.

It's not appropriate for us to discuss them in detail. However, what I will say is.

Speaker 3: We believe that our case is strong. We continue to believe that. We have no change whatsoever in our belief in our case. And this delayed resolution does not change our view that we have a great case.

We believe that our case is.

Strong we continue to believe that we have no change whatsoever in our belief in our case and this delayed resolution does not change our view that we have a great case.

Okay. Thank you.

Yes.

Speaker 7: Our next question comes from Kenan McKay with RBC Capital Markets. Please go ahead.

Our next question comes from Kennan Mackay with RBC capital markets. Please go ahead.

Speaker 3: Hi, maybe just thinking about the product revenue guidance for 2022, can you talk a little bit about net price assumptions here? We've heard more and more that revenue growth is going to rely much more on volume growth than pricing growth, which is a little bit different from some of the trends for the last 15 years or so. I'd just love to hear how you're thinking about that for 2022 and beyond. Thanks.

Maybe just thinking about the product revenue guidance for <unk>.

22 can you talk a little bit about net price assumptions there we've heard.

More and more of that.

Revenue growth has been relying much more on.

Volume growth than pricing.

Pricing growth, which is a little bit different from.

Some of the trends for the last 15 years.

<unk>, So I'd just love to hear how you're thinking about that for 2022 and beyond.

Speaker 3: Sure. Thank you, Ken, for the question. Todd, would you like to comment? Yeah, thanks, Ken. I'll try to jump in here. I think, you know, when you look across the brands, we are projecting volume growth. We have, as you know, historically done price increases, although today we're not commenting on, you know, which prices we have or will or won't do. Yeah, but what we've tried to do with our guidance is really kind of look across each of the brands.

Sure.

Sure. Thank you Kevin for the question Todd would you like to comment yes, Thanks, Kevin I'll try to jump in here I think when you look across the brands we are projecting volume.

Growth.

As you know historically that the price increases although today, we are not commenting on which prices, we have or will or won't.

But what we've tried to do with our guidance was really kind of look across each of our brands.

Speaker 3: um you know look at where we are for example with etc this is a drug that's been on the market you know for 11 years it's an incredible drug that has helped a lot of patients

So look at where we are for example, with et cetera, because the drug has been on the market.

Our 11 years incredible broadband has helped a lot of patients.

Speaker 3: And we're projecting growth this year because we think we can continue to increase adoption. And, you know, we commented on the call with the O.S. data that we presented last year. You know, I'll point out that those data are only out in top-line form right now. We're looking forward to presenting the full dataset at a medical conference.

And were projecting growth this year, because we think we can continue to <unk>.

Increased adoption.

We commented on the call with.

Oh, that's data that we presented last year, Joe I'll point out that those data are only out in topline for right. Now we are looking forward to presenting the full data set at a medical conference later in the year. So we haven't tried to assume uptake of our guidance based on that but its certainly positive handset.

Speaker 3: later in the year. So we haven't tried to assume uptake in our guidance based on that, but it's certainly positive. I think, you know, pad said we'll see is a nice growth here. We continue to see patients that are completing checkpoint inhibitor maintenance therapy in the frontline setting that, you know, fall really nicely into the current labeled indications. And of course, we've got clinical trials underway to continue to broaden the way.

Handset, we'll see a nice growth year.

We continue to see patients that are completing.

Checkpoint inhibitor maintenance therapy in the frontline setting haul really nicely.

The current labeled indications and of course, we've got clinical trials underway to continue to broaden the label is the longer term goal and then what.

Speaker 3: did the longer term goal. And then with the Kaiser, you know, we've been on the market now approaching two years in the US.

<unk>.

And then on the market now approaching two years in the U S. We're starting to.

Speaker 3: We're starting to reach a steady state there. Europe continues to grow.

Reach step.

Europe continues to grow.

Speaker 3: But as Chip mentioned in the call, we're also aware that nicely for patients.

As chip mentioned in the call. We're also aware that nicely for patients.

Speaker 3: the treatment landscape continues to evolve here. So we think that Kaiser is going to continue to be an important drug.

The treatment landscape continues to evolve here. So we think the cadence is going to continue to be an important drug and as Roger mentioned, there's a lot of work underway to move it into earlier lines combination setting with translate kept silos.

Speaker 3: And as Roger mentioned, there's a lot of work underway to move it into

Speaker 3: earlier line combination settings with drugs like Sunrise's Passpoint?

And the Hershey <unk> five.

Speaker 3: trial setting as, you know, maintenance therapy and then of course the colorectal data and hopefully that leads to a label next year out of the down year trial. So you know we're really bullish on the drugs. This is a little bit of a year of executing on clinical trials which is what you've got to do to generate data to support label expansions and you know that's been a stated goal of ours for a long time.

Trial setting.

Maintenance.

Therapy, and then of course.

In colorectal data and hopefully that leads to a label next year out of the trial. So we're really bullish on the drugs, which is a little bit of a year of executing on clinical trials, which is why you got to do to generate data to support label expansion.

That's been our stated goal of ours for a long time.

Speaker 7: Our next question comes from Matthew Harrison with Morgan Stanley . Please go ahead.

Our next question comes from Matthew Harrison with Morgan Stanley . Please go ahead.

Speaker 5: Great. Good afternoon. Thanks for taking the question. Thanks for all the comments on the product guidance you've already provided. I guess I was just hoping on two kinds of to ask a bit more specific question. So could you comment so far in 2021 what impact you've seen from the destiny of three results for in her two and and you know have you seen share loss you know off label share loss

Great. Good afternoon, thanks for taking the question.

Thanks for all the comments on on the product guidance, you've already provided I guess I was just hoping on to cause it to ask.

A bit more specific questions. So could you comment.

So far in 2021, what impact you've seen from the Destiny <unk> results for her to end and how do you see share loss off label share loss from from in her two being used there and then.

Speaker 5: from an HER2 being used there and then.

Speaker 5: Can you give us some sense of how much of an impact you're thinking this is going to cause in 2022? That would be very helpful. Thanks.

Can you give us some sense of how much of an impact youre thinking this is going to cause.

In 2022 that would be very helpful. Thanks.

Speaker 3: Right, well, you know, in 2021 is not really where we're predicting the impact. It's really in 2022. Chip, do you want to give a little bit of color on that?

Right.

In 2021 is not really where we're projecting the impact is really in 2022.

Chip do you want to give a little bit of color on that.

Speaker 3: Sure Clay, absolutely. It is early to see impact of new data. Moving forward, we do expect to see changes as the market digests the data more thoroughly. As far as the adjustments, those are reflected in the guidance that we put forth for 2022.

Sure absolutely. It is early to see impact of new data moving forward, we do expect to see changes in the market as the market digests the data.

We're steadily.

As far as the adjustments those are reflected in the guidance that we've put forth for 2022.

Speaker 7: Our next question comes from Andrew Barents with SVB Leering. Please go ahead.

Our next question comes from Andrew Baum.

<unk> Leerink. Please go ahead.

Speaker 4: Hi, thanks and appreciate all the color you guys have given. Maybe one on the EMA pause of the pads of review. You mentioned that there was a positive CHMP decision. Didn't this include a consideration of the skin rash and Stevens-Johnson syndrome as we've seen previously? Just trying to understand what's new about what was seen in the French Compassionate Use Program that caused EMA to pause the review.

Hi, Thanks, I appreciate all the color you guys have given.

Maybe one.

PMA pause of the pads are reviewed.

Mentioned that there was a positive <unk> decision.

This include a consideration of the skin rash and Stevens Johnson syndrome.

In previously just trying to understand what's new about what was seen in the French compassionate use program that causes them to pause some of you.

Speaker 3: Yeah, thanks for the question. So we had some severe skin reactions in a, as you pointed out, but as we stated, a French compassionate active program. This is a well-documented side effect, and it's very consistent with our USPI. Well, safety is our highest priority.

Yeah. Thanks for the question. So we had some severe skin reactions.

As you pointed out as we stated that French compassionate access program. This is a well documented side effects and it's very consistent with our USPI.

Safety is our highest priority.

Sure.

Speaker 3: for patients, but we believe fully that the benefit-risk profile is unchanged for pad sessions.

For patients, but we believe fully that the benefit risk profile is unchanged for bad debt.

Speaker 3: And we're excited with this drug. It's used in many, many thousands of patients in the US. Docs use it well in the US, understand how to use it. And it's important for docs around the world to use it according to the label. Roger, do you want to add any additional color?

And.

We're excited with this drug.

It used in many many thousands of patients in the U S.

Dax.

Use it well in the U S understand how to use it in.

It is important too.

For docs around the world to use it according to our label Roger do you want to add any.

Any additional color.

Speaker 4: Yeah, and Andy, I think that this is the European regulatory process, you know, that we're going through.

Yes, yes.

Andy I think that this is the European regulatory process.

But we're going through.

Speaker 4: The exact reason why a decision is made to pause on an approval is really for the regulators to make that call. Just to reiterate what Clay is saying, there's nothing in the data that we're aware of that we see that is any different from what we've generated elsewhere and what is currently reflected very clearly in the USPIs.

And the exact the exact reason why a decision is made a decision is made to pause.

On an approval is really for the regulators to make that call, but just to reiterate.

Rates, what players, saying, there's nothing in the data that we are aware of it we see it as any different from what we've generated elsewhere and what is currently.

Reflected very clearly in the USPI.

Thank you.

Speaker 7: Our next question comes from Michael Schmidt with Bugenein. Please go ahead.

Our next question comes from Michael Schmidt with.

Please go ahead.

Speaker 8: Hey, guys. Thanks for taking my questions. And congrats on the nice fourth quarter, actually. But I had another one on the 2022 product guidance. Specifically, along to Kaiser, when we talk to breast cancer docs, they really tell us that they use the drug predominantly in patients with brain mass. And that would really not change based on the new and her two data. So just wondering what your market research there says.

Hey, guys. Thanks for taking my question and congrats on the nice quarter actually but I had another one on the <unk> product guidance.

Specifically around <unk>, when we talk to breast cancer docs there really.

Tell us that they used to drag predominantly in patients with brain Mets that would really not change base.

Based on <unk> data so just wondering.

What your market research there.

Speaker 8: And then on the other hand, you know, Pat's guidance for 2022, it was actually higher than what we expected, especially since you have stated in the past that you already have, you know, very high market penetration in bladder cancer in the US. And so just wondering, you know, how you see the market evolving there in the near term that, you know, and what the growth drivers could be for past 2020.

<unk>.

And then on the other hand path that guidance for 2022 is actually higher than what we expected, especially said.

<unk> stated in the past that you already have very high market penetration and data content and AOS until just wondering how you how you see the marketing logging there in the near term that.

And what the growth drivers could beef up access into 2022.

Speaker 3: So first of all, we'll start with PAS-7. You know, our guidance shows about a 30% growth over 2021. So we believe PAS-7 is really helping patients.

So first of all I will start with <unk>.

And our guidance shows about a 30% growth.

Over 2021, so we believe.

Pat.

Really helping patients.

Speaker 3: And, you know, there's a lot we could talk about with this, but we believe it's still a growth opportunity, post-checkpoint in eligible patients, which is reflected in our guidance. And so, you know, checkpoint inhibitors have grown the market for past setbacks.

And.

There's a lot we should talk about.

With this but we believe it's still a growth opportunity.

Post checkpoint.

Post checkpoints and post checkpoint ineligible patients, which is reflected in our guidance.

And so.

Checkpoint inhibitors.

Grow the market for Pat actually.

Speaker 3: And so we're excited with that. But we're also excited from we're going to get data in cohort K this year. It's not in our guidance because we're going to get, we expect the data in the second half of the year. And so we think that based on the timing for submitting that and everything, the approval wouldn't happen until 2023. So obviously, we couldn't put that into 22 guidance.

And so we're excited with that but we're also excited we're going to get data in cohort K. This year, it's not in our guidance because we're going to get we expect the data in.

In the second half of the year and so we think that based on the timing for submitting that and everything we approval wouldn't happen until 2023. So obviously, we could put that into 'twenty two guidance we.

Speaker 3: We do expect to complete enrollment of EV302 this year, which is to support global submissions in first line.

We do expect to complete enrollment.

302, this year, which is to support global submissions in first line.

Speaker 3: urofelial cancer, regardless of whether you're cis eligible or ineligible.

<unk> cancer, regardless of whether youre eligible or ineligible and we're going to have presentations very soon on.

Speaker 3: And we're going to have presentations very soon on.

Speaker 3: muscle invasive bladder cancer, which is a bigger opportunity than metastatic disease.

Muscle invasive bladder cancer, which is a bigger opportunity in metastatic disease and then.

Speaker 3: And then trials are under way, not only in muscle evasive, but in non-muscle evasive.

Trials are underway.

Not only in muscle invasive, but a non muscle invasive which is a much bigger.

Speaker 3: which is a much bigger opportunity. And we also have basket trials enrolling. So expect data this year for initial data on basket trials. So when you look at Patsep, you look at our guidance of a 30% growth.

Opportunity and we also have basket trials enrolling so expect data this year for initial data on a basket trial. So when you look at pad.

Look at our guidance of a 30% growth and where we are with the new labels for the year, yes, the products still doing really well. So I appreciate you pointing that out as far as <unk> goes.

Speaker 3: and where we are with no new labels for the year. Yeah, the product's still doing really well. So I appreciate you pointing that out. As far as Jukaija goes,

Speaker 3: uh... you know we we have that we have discussed you know

We have been.

Yeah.

Speaker 3: everything here. We believe it will still be used and doctors rely on it in terms of brain mets. And so that's something that we're really happy about. The other thing is, one of the things that's kind of been interesting is docs use, the duration of use of tukyazu had been strong. So we're really pleased with that. And I don't know if you found that out in your market assessment, but docs, often you see a drug that you do a clinical trial.

Everything here, we believe it will still be used and doctors rely on it.

In terms of brain Mets and so that's something that we're really happy about the other thing as well.

One of the things that's been interesting is docs use the duration of use of two guys that had been strong. So we're really pleased with that and I don't know if you found that out in your market assessment, but.

<unk>.

Often you see a drug that you have.

Speaker 3: and you see a shorter duration in the real world. That's not what we're seeing in the real world. We're seeing something that's very good. But we do, we are including our guide.

Clinical trial.

And you see.

A shorter duration in the real world.

What we're seeing in the real World, we're seeing something that's very good but we do we are <unk>.

Including in our guidance.

Speaker 3: some effect of the DB03 trial. You know, it's not just, to characterize it, it's not just used in brain nut patients.

Perfect.

<unk> D B III trial.

Not just it's not just used in brain met patients. Although that's a very big area. It's also used in patients with visceral disease.

Speaker 3: Although that's a very big area. It's also used in patients with visceral disease.

Speaker 3: And Chip, do you want to give any color on that part of patients and a little bit about our guidance on what we're thinking?

Chip do you want to give any color on that part of patients and go a little bit about our guidance.

Speaker 3: So, you know, as I mentioned in past calls, we've seen uptake in both patients with and without brain metastasis. St. Louis has strong data in both those patients' subsets, so we need some really broad utilization.

What we're thinking.

Shortly so.

Mentioned in past calls, we've seen uptake in both patients with and without brain metastasis.

<unk> has strong data in both of those patient subsets.

Really broad utilization.

It has established has established itself as an important treatment option.

Especially for patients that do have brain metastasis.

Speaker 3: So our thinking around this is that we're going to continue to get utilization. We're going to continue to work to make sure that every eligible patient has an option that is available to them that physicians, quite frankly, have anchored to since its launch. But we look forward to continuing to promote the product. The guidance recommendation that we have is our best current thinking on how the marketplace and the landscape is going to change.

So our thinking around this is that we're going to continue to get utilization, we're going to continue to work to make sure that every eligible patient.

As an option that is available to them.

Physicians on quite frankly have anchor too since it was launched but we look forward to continuing to promote the product the guidance recommendation that we have is our best current thinking on how the marketplace and the landscape is going to change.

Okay. Thank you.

Speaker 7: Our next question comes from Boris P. Kerr with Cohen. Please go ahead.

Our next question comes from Boris <unk> with Cowen. Please go ahead.

Speaker 8: I just want to follow up on to Kaiser and the new HER-2 CLIMA 5 study that you announced earlier today. Just thinking, given the relatively good prospects for these patients, how large will this trial be? How long do you think it will take? And based on that kind of estimated time of completion, how much exclusivity do you think it will be left on to Kaiser at that point?

Great I just wanted to follow up on <unk>.

Her to climb all five study that you announced earlier today.

Thinking given the relatively good prospects for these patients how large will this trial be how long do you think it will take some based on that kind of estimated time of completion, how much an exclusivity do you think there'll be left onto Kaiser at that point.

Speaker 3: You know, we haven't outlined everything. Roger, can you give a little color and context on Tukai's O5 trial?

We haven't outlined everything Roger can you give a little color and context on.

<unk>.

<unk> trial.

Speaker 4: Yeah, sure. So as you heard us in our prepared remarks, you know, outlining what this trial will do is from a medical perspective, it's very appealing. Yes, the frontline therapy with, you know, PHP is successful, but there are still patients who relapse.

Yes sure.

As you've heard us compared remarks.

Outlining what this time, we will do is from a medical perspective, it's very appealing.

Frontline therapy with.

THP is successful, but there are still patients, who relapse and using <unk> in a maintenance mode like this to us and to exit your positions as well.

Speaker 4: and using to Kaiser in a maintenance mode like this trust and actually positions as well has a lot of appeal and

A lot of appeal and makes a lot of sense the size of the trial the assumptions of achieving the fixed the rates of events. So all things.

Speaker 4: The size of the trial, the assumptions of the treatment effect, the rates of events are all things that will influence timing. But we decided to move ahead with the trial, so we believe that based on its size, based on how long it will take, and based on when we expect to read out, that we will have a meaningful opportunity, if the trial is successful, to commercialize that indication.

Will influence timing.

We decided to move ahead with the trial so we believe.

Based on its size based on how long that will take.

And based on when we expect to read out that we will have a meaningful opportunity.

Trial is successful.

To commercialize that indication.

Speaker 3: We think this is the appeal of the trial, as Roger says. It goes to the fact of how quickly you can enroll. And as far as timing goes, the faster you can roll, the faster you can have the data and go toward helping patients on the commercial market. So we're really excited with the trial. We believe it's strongly positive from a financial standpoint. And we're excited and going forward.

We think this is.

The appeal of the trial as Roger says.

It goes to the factor of how quickly you can enroll and.

As far as timing goes fast few corolla passenger you can have the data.

And go toward.

Helping patients on the commercial market. So we're really excited with the trial. We believe is strongly positive from a financial standpoint, and we're excited and going forward.

Great. Thanks for taking my question.

Speaker 7: Our next question comes from Stephen Willie with CIFIL. Please go ahead.

Our next question comes from Stephen Willey with Stifel. Please go ahead.

Speaker 7: Hi, this is Bonnie. I just had a quick question for your top line results that we anticipate this before cohort K and EV103. Are there any expectations that you can frame for us in terms of what types of data and how much data we can anticipate now that enrollment is complete?

Hi, This is Bonnie quach on for Bobby.

I just had a quick question following a topline results.

We anticipate this supplier.

Cohort came easy one Anthony.

Any expectations that you can frame for us in terms of what type of data on how much data. We can anticipate now that enrollment is complete.

Speaker 3: Well, you know, we have said we'll have data in the second half of this year.

Well.

We have said we will have data in the second half of this year.

Speaker 3: uh... you know i i think that the specifics of what we expect or what it will look like we'll just have to wait till the data come out

I think that is.

Specifics of what we expect or what it will look like we'll just have to wait until the data come out.

Speaker 3: And you know our intention is with this these type of data. We put out top line, but we'd also presented at a conference and you know as fast as we can.

And our intention is.

These type of data, we put out top line, but we'd also presented at a conference.

Speaker 3: and obviously write up publications. That's what we usually do, and we would continue to do that. But as soon as possible, after gaining, you know, allowing the time to go on to really watch the trial and make sure that we see the appropriate data and duration and everything, you know, safety and all the different features that you need to see, we will put out the top line data at our soonest appropriate timing. So, and that's not gonna happen this year.

As fast as we can.

And obviously right up publication Thats, what we usually do.

We would continue to do that but as soon as possible.

After gaining.

Allowing the time to go on to really watch the trial and make sure that we see the appropriate data and duration and everything safety and all different feature sets.

We will put out topline data are soonest.

Appropriate timing so that's the second half of this year.

Sure.

Speaker 7: Our next question comes from Jenna Waring with Barclays. Please go ahead. Thank you. Just one quick question, clarification question regarding arbitration reopen for additional evidence. Just want to make sure, like with the additional evidence already submitted or arbitrator is asking for additional evidence. If the latter, is there a deadline to submit the data?

Your next question comes from Gena Wang with Barclays. Please go ahead.

Can you just one quick question clarification question regarding the arbitration, we opened four additional evidence just wanted to make sure.

Additional evidence already submitted or opportunity is asking for additional efficacy. It's the latter.

Headline to submit the data.

Speaker 3: Well, thank you very much for the question. Evidence doesn't come from arbitrators in this case. They come from the companies. So that's all I'll say about that. It's not from the arbitrator.

Alright, well, thank you very much.

Sure.

Evidence of income from arbitrators indicate that come from the companies. So that's all I'll say that it's not from the arbitrator.

Speaker 3: And there, you know, I can't give you details on deadlines or things like that. I want to be very respectful of that this is a pending legal matter and it's inappropriate to give you more in-depth color than I'm allowed to at this point. But I want to remind everyone on the call that we believe our case...

They are.

I can't give you details on <unk>.

Deadlines or things like that I want to be very respectful of that this is a pending legal matter and it's inappropriate.

More in depth color than I'm allowed to at this point.

To remind everyone on the call that we believe our case.

Speaker 3: is strong, it's been strong, it continues to be strong, and this has no bearing on the strength of our case whatsoever.

Is strong it's been strong and continues to be strong and this has no bearing on the strength of our case whatsoever.

Speaker 7: Our next question comes from Jay Oldman with Oppenheimer. Please go ahead.

Our next question comes from Jay Olson with Oppenheimer. Please go ahead.

Speaker 3: So hey, thanks for the update and thanks for taking the question. I want to follow up on your clinical development strategy in breast cancer.

Hey, Thanks for the update and thanks for.

Thank you for your questions I wanted to follow up on your clinical development strategy in breast cancer based on the work Youre doing with to Kaiser in combination with <unk> and also considering the evolving standard of care in her two positive breast cancer that you mentioned would you consider studying in her two as an active comparator in first line breast cancer.

Speaker 3: based on the work you're doing with Tukkiza in combination with NhR2 and also considering the evolving standard of care in HER2-positive breast cancer that you mentioned, would you consider studying NhR2 as an active comparator in first-line breast cancer and or adjuvant treatment setting? And then related to that, how are you thinking about the potential to add

<unk> and or.

Adjuvant treatment setting and then related to that how are you thinking about the potential to add.

Speaker 3: the SIDEMAB, the DOTIN, and your breast cancer portfolio as a either as a standalone agent or in combination with Kaiser. Thank you.

<unk>.

Breast cancer portfolio is it.

There is a standalone agent or in combination with two kinds of thank you.

Speaker 3: Sure. Thank you for the question. Some of this, you know, we've talked about some of it is not publicly released yet and information we're not ready to talk about. But Roger, can you give a little more color on Tkiza in first and adjuvants and then maybe just a little color on DB and what we're thinking.

Sure. Thank you for the question some of this we've thought about and we've talked about some of it is not publicly released information we're not ready to talk about but Roger can you give a little more color on.

<unk> and.

First an adjuvant and then maybe just a little color on <unk> and what we're thinking.

Speaker 4: So, the trachizo development program as we present and as it's laid out does cover almost all aspects of breast cancer, including this new trial, which is a true front line trial. And the approach we've taken, because trachizo is a drug that is appropriate for combinations. It's a small molecule, VIRTU-TKI. It profoundly inhibits the pathway. We've shown now with HER2-CLIMB.

Sure. So the <unk> development program as we presented it as it's laid out does cover almost all estimate based accounts, including this new trial, which is which is a true frontline trial and the approach we've taken because <unk> is a drug that is appropriate for combinations such as <unk>.

Small molecules go to T K.

It profoundly inhibits the pathway, we've shown now with decline.

Speaker 4: you know, inhibiting hernia signaling both from outside the cell and inside the cell is a right sort of medical strategy to follow.

Ed.

Inhibiting virtue signaling both from outside the cell and inside the cell is a right set of medical strategies follow and so in principle combined in Chicago and hopes it makes complete sense to very active agent same type of principal with chemotherapy.

Speaker 4: And so in principle, combining two kinds of inhersing makes complete sense to a very active agent.

Speaker 4: Same type of principle with the chemotherapy delivery and a transducer map finder.

Chemotherapy delivery and a chance to cement binder and that applies also to the system at <unk>, which is a an optimized antibody with a dozen payloads aimed so two and two kaisers obviously in that space for the hitch over expressing over here to emphasize so we haven't disclosed.

Speaker 4: And that applies also to the system of the Doton, which is an optimized antibody with a Vadartan payload and just for two.

Speaker 4: And to Kaiser is obviously in that space for the HER2 overexpressing or the HER2 amplified. So we haven't disclosed plans but it's an obvious question that we're looking at very carefully which is what is the synergy between those two products.

Those plans, but it's an obvious question that.

Looking at very carefully which is what is the synergy between those two products.

Speaker 4: and how would we develop those two as a combination. So that's under serious consideration. Beyond that, the concepts like head-to-head against in HER2, it's not an obvious thing I think that they're not thinking, but of course we wouldn't exclude any possible trial if it made sense.

Howard we develop those too.

As a combination so thats under serious consideration.

And that the concepts like head to heads against into two it's not an obvious thing I think that's in our thinking but of course, we wouldnt exclude any possible trial.

Tim.

Great. Thanks.

Speaker 7: Our next question comes from Andy Shea with William Blair. Please go ahead.

Our next question comes from Andy Shay with William Blair. Please go ahead.

Oh, great. Thanks for squeezing me in.

Speaker 9: So two questions. So regarding etc.

So two questions regarding <unk>.

Speaker 9: Congratulations on the OS win. Just wondering if you mind sharing with us about how that 40% plus reduction in the risk of death would change perception and prescribing pattern.

Etc. Congratulations on the OLED win just wondering if you mind sharing with us about how that 40% plus reduction in the risk of death could change perceptions and prescribing patterns and the second question is really on the tour.

Speaker 9: And the second question is really on the method for expression in lung cancer. So the 202 study, you're looking at lung cancer, but it's not biomarker selected. Just curious about, you know, what kind of data informed that decision.

<unk> expression in lung cancer.

202 study youre looking at lung cancer.

But it's not biomarker selected just just curious about what kind of data inform that decision.

Speaker 3: or one part would be a centrist for

Yes.

Sure, let's start with the centers.

Speaker 3: data. Look, we're thrilled at the OS. I mean this is a long time coming and it's in a disease, hospital diploma, which takes a long time to watch and monitor and look at this. But it's very clear to us that this is a great regimen and we're excited to present the data in full detail, not just top line at a conference by the investigator.

Data look we're thrilled at the OS initiatives.

Long time coming and it's in a disease Hodgkin lymphoma, which takes a long time to watch and monitor and look at this but it's very clear to us.

This is a great regimen.

And we're excited to present that data in full detail not just top line at Congress by the investigators.

Speaker 3: And so Roger, can you talk a little bit about the impact of the risk of death and what we can do about this with regulators, etc.? Sure. So, as I said, this is a great result because, you know, historically it has been...

And so Roger can you talk a little bit about <unk>.

The impact of the risk of death.

<unk>.

But.

And what we can do about this with regulators.

Et cetera sure. So as I said. This is this is a great result, because historically it has been.

Speaker 4: It's been very difficult to improve overall survival in Hodgkin-Lepoma. I mean that's good news because patients have good outcomes.

It's been very difficult to improve overall survival in Hodgkin lymphoma, I mean, that's good news because patients have good outcomes.

Speaker 4: But E1, after multiple years of...

Its E. One after multiple years of supply.

Speaker 4: follow-up has actually reached the point, and it's a pre-specified outcome. So this is an endpoint that was defined in the protocol in terms of how many events one needs and such. And so it has the potential, you know, once you've presented the data publicly and worked through all of the information that we will get, it has the potential to be, to form part of things such as regulatory submission because of the nature of, you know, the way the trial was conducted.

Follow up has actually reached the point and its a pre specified outcomes. So this is an endpoint that was defined in the protocol.

In terms of how many against one needs and such and so it has the potential.

Once we presented the data publicly.

And work through all of the information that we will we will get it has the potential to be to form part of things such as regulatory submission because of the nature of the way the trial was conducted.

Speaker 4: So I think the first sort of data point is to present it publicly, let everyone see the full data set as Clay mentioned. And we're obviously thinking about all those other components as well.

The first set of data points as to presented publicly.

It won't see the full data set and as clay mentioned and we're obviously thinking about all those other components as well.

Speaker 4: to biomarker expression, what I would say, and we haven't disclosed the information, but the trial is moving along and we are clearly at some point in the next, in a while, we'll start to talk about some data and present. I can't comment on which particular cohort we'll look at, but in general, from a biomarker perspective, clearly we measure and we evaluate Neptune-4 in all cohorts.

Two biomarker expression, what I would say and we haven't disclosed the information, but the trial is moving along and we are clearly at some point in the mix in a while we will start to talk about some data and present.

I can't comment on which particular cohorts will look at it but in general from a biomarker perspective.

Clearly, we measure and we evaluate it Nixon for an old cohorts.

Speaker 4: We enroll all comments, but we evaluate the biomarker. And so if it was appropriate to enrich a population, you know using a biomarker, that's something we would do. Again, I'm not saying that is what we're doing, but if that is found compelling, we would be able to do that.

We enrolled all comers, but we evaluate the biomarker and so if it was it was appropriate to them.

Richard population.

Using a biomarker that's something you would do again I'm not saying that is what we're doing.

Is that sounds compelling we would be able to do that.

Great. Thanks, so much.

Speaker 3: Our next question comes from Ren Benjamin with JMP Securities. Please go ahead. Hey, good afternoon, guys. Thanks for taking the questions. Just one, can you talk a little bit more about SEA-CD40? You know, the update at ASCO GI we thought was pretty compelling. The response rates looked pretty good. So just trying to think about next steps. What are the gating steps, I guess, to pursue a Phase II trial? I don't know.

Our next question comes from Ren Benjamin.

JMP Securities. Please go ahead.

Hey, good afternoon, guys. Thanks for taking the questions.

Just one can you talk a little bit more about <unk> 40.

The update at <unk> Gi without was pretty compelling response rates look pretty good. So just trying to think about next steps what are the gating steps I guess.

Pursue a phase two trial and then a registrational study.

Speaker 3: Yeah, thank you for the question, Ron. You know, SCA40 continues to be a drug we're very interested in. You know, I think you're asked about next steps in pancreatic cancer after the data we put out on ASCO-GI.

Yes. Thank you for the question.

SCA 40 continues to be a drug we're very interested in.

I think youre asking about next steps in pancreatic cancer. After the data we put out at <unk> Gi.

Okay.

Speaker 3: You know, certainly there was encouraging anti-tumor activity in a disease that's arguably one of the worst cancers. There are incredibly difficult to treat disease in general.

Certainly there was encouraging anti tumor activity in a disease that's.

Arguably one of the worst cancers, there are incredibly difficult to treat disease in general.

Speaker 3: But for what we're looking at, we want to make sure these stand the test of time. And we need to evaluate the survival curves.

But for what we're looking at we want to make sure.

These stand the test of time, and I want to we need to evaluate to survival curves over a little bit of a longer period of time. He gets important it's hard to know.

Speaker 3: over a little bit of a longer period of time. I think it's important. It's hard to know.

Speaker 3: until you really see the durable data. You know, even if you're going forward, it's like how do you size this?

Until you really see the durable data.

Going forward, it's like how do you size this.

Speaker 3: what are the statistics you need to study, what are the right data set? So I'm very proud of the work we're doing on this horrible disease.

What are the statistics you gave to this study.

Alright dataset, so I'm very proud of the work we're doing on this horrible disease.

Speaker 3: You know, the initial data was, you know, encouraging, but we have been very clear that we want to see the full Kaplan-Meier curves and how they compare to what we think that some of the best regimens of the day, of today, would work. So stay tuned on that. It's something we talk about regularly, and it's just a little premature to give you any more definitive data. Yes, stay tuned.

The initial data was encouraging.

We have been very clear that we want to see the full.

Capital Meier curves and how they compare to what we think.

The best regimen of the day of today.

So.

Stay tuned on that.

We talk about regularly.

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It's a little premature to give you any more definitive data yet so stay tuned.

Speaker 10: Thanks.

Great. Thanks.

Speaker 7: Our next question comes from Zhi Zheng Qiu with Spandberg. Please go ahead.

Our next question comes from Jason <unk> with Baird.

Please go ahead.

Speaker 4: Great. Thank you very much for taking my question. I want to ask about TAT-SAV EV-104 in a non-muscle basis.

Great. Thank.

Thank you very much for taking my question I want to ask about patents.

Alright.

<unk> 104 in non muscle invasive.

Speaker 4: of bladder cancer. Given PAMBRO is approving this indication on single-arm maxillary approval, what do you expect this trial to achieve? Do you think the data could be sufficient for approval?

Bladder cancer.

Given <unk> proving this case.

This indication on single arm back Saturday approval and what do you expect this challenge to achieve do you think the data could be sufficient for approval.

Thanks very much.

Speaker 3: Yeah, thanks for the question. Roger, do you want to address that? Sure. So we have just begun. I think we're very excited. And

Yes. Thanks for the question, Brian do you want to address that sure. So.

We have we have just begun I think we're very excited.

Speaker 4: The potential to use pad-cev installed directly into the bladder is a pretty compelling argument if indeed the product is post-faced and effective.

The potential to use <unk>.

To use <unk>.

Install directly into the data is a pretty compelling argument.

If indeed, the product is both safe and effective.

Speaker 4: And provided there's an accelerated approval path available for BCG non-responsive population, again, without saying that we would or we wouldn't do it, that in at least in theory is a potential approach. So I would say we are still working out whether, you know, PANSIV will produce the type of efficacy we hope to see. And we could potentially move forward with the late-line population. That is, you know, one possible outcome.

And provide the visit an accelerated approval path available for BCG nonresponsive population.

Without saying that we wouldnt, we wouldnt do that in at least in theory is a a potential approach. So I would say we are still looking out where the tensive will produce the type of efficacy we hope to see.

And we could potentially move forward with a late line population that has one possible outcome.

Great. Thank you very much.

Speaker 2: This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks.

This concludes our question and answer session I would now.

Like to turn the conference back over to management for any closing remarks.

Speaker 2: Thank you, operator, and thanks everybody for participating and joining us on our call this afternoon. Have a wonderful evening.

Thank you operator, and thanks, everybody for participating and joining us on our call. This afternoon and have a wonderful evening.

Speaker 7: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.