Q1 2021 Coherus BioSciences Inc Earnings Call

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Okay.

Welcome to the Q1 2021 co Harris Biosciences, Inc. Earnings Conference call. My name is Richard and I'll be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session. During the question and answer session. If you have a question. Please press Star then.

Operator: Welcome to the Q1, 2021 BioSciences, Inc. Ernie conference call. My name is Richard, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode.

Operator: Later, we will conduct a question and answer session. During the question and answer session, if you have a question, please press star, then one, on your touchstone phone. I'm now reaching the caller to McDavid-Stewell, Chief Financial Officer. Mr. Stilwell, you may begin. Thank you. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our 2021 first quarter results. This release can be found on Coharris Bioscience's website. Today's call includes forward-looking statements regarding Coheris' current expectations.

One on your Touchtone phone.

I'll now turn the call or to Mcdavid Stilwell, Chief Financial Officer, Mr. Stilwell, you may begin.

Thank you.

Good afternoon, everyone and thank you for joining us.

We issued a press release earlier announcing our 2021 first quarter results. This release can be found on the coherent biosciences website.

Today's call includes forward looking statements regarding regarding <unk> current expectations.

McDavid Stilwell: These statements include, but are not limited to, our ability to advance our biosimilar and immunol oncology product candidates through development and registration, as well as our commercialization of Eugenica and other potential products in the future. Our ability to meet our R&D and SG&A expense guidance for 2021, as well as our use of capital, all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ from these statements. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in documents that we file with the securities and exchange companies.

These statements include but are not limited to our ability to advance our biosimilar and immuno oncology product candidates through development and registration.

Our commercialization of <unk> and other potential products and the future of.

Our ability to meet our R&D and SG&A expense guidance for 2020, one as well as our uses of capital all of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ from these statements.

These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed and documents we file with the securities and Exchange Commission, specifically and our quarterly report on form 10-Q for the quarter ended March 31, 2021 that we filed earlier this afternoon.

McDavid Stilwell: Specifically, in our quarterly report on Form 10 Q for the quarter ended March 31st, 2021, that we filed earlier this afternoon. The forward-looking statements stated today are made as of this date, and we undertake no duty to update such information except as required under applicable law. With me today are our Coherst CEO, Jenny Lamphir, Paul Reeder, Executive Vice President of Commercial Operations and Market Access, Chris Thompson, Executive Vice President of Sales, and Dr. Shah Rahimian, Senior Vice President of Immunogy Clinical Development. I'll now turn the call over to Denny. Thank you, McDavid, and thank you all for joining me this afternoon.

The forward looking statements state of today are made as of this day and we undertake no duty to update such information, except as required under applicable law.

With me today are coherent CEO Denny Lanfear here.

Paul Reader executive Vice President of commercial operations of market access and Chris.

Chris Thompson Executive Vice President of sales and Doctor Shaw Rahimi on.

Senior Vice President of immuno oncology clinical development all day.

Now I'll turn the call over to Denny.

Thank you Mick David and thank you all for joining us this afternoon.

Denny: Today I'll provide updates on Eugenica commercialization, our biosimilar pipeline candidates, as well as Toropalem, the PD1 antibody we inlicensed from Juni-Bi biosciences earlier in the first quarter. We are making strong progress with Tora Palmet and our biosimilar product candidate. Over the next two years, we anticipate bringing four new products to markets in the United States, complimenting Eugenica in our commercial portfolio. The investments we are making in 2021 are expected to diversify and grow our revenues for years to come.

Today I'll provide updates on the identical and commercialization, our biosimilar pipeline candidates as well as to our Palmetto. The PD one antibody we in licensed from June She biosciences earlier on in the first quarter.

We are making strong progress before of palmette and our biosimilar product candidates.

Over the next two years, we anticipate bringing for new product to market and the United States.

Some of many of you've deneke and our commercial portfolio.

The investments, we're making and 2021 are expected to diversify and grow our revenues for years to come.

Denny: With clinical data and regulatory milestones over the next 12 months, we expect the key elements to come together in our unique strategy of leveraging the strong cash flows from our biosimilar products into the rapidly growing community oncology market. Today I'll start with a review of the performance of our first product, Eugenica, which maintains its position as the most prescribed hypograss can biosimilar, with 20% of the overall market, as reported by Icuvia.

But the clinical data and regulatory milestones over the next 12 months, we expect the key elements to come together and our unique strategy of leveraging the strong cash flows from our biosimilar products and so the rapidly growing immuno oncology market.

Today I'll start with the review of the performance of our first product eugenic, which maintains its position as the most prescribed pegfilgrastim biosimilar with 20% of the overall market as reported by <unk>.

Denny: In the first quarter of 2021, we recorded 83 million in net sales, as compared to 110 million in the fourth quarter of 2020 and 116 million in the year-ago quarter. Market share for Eugenica, at 20%, was relatively flat compared with the fourth quarter.

And the first quarter of 2021, we recorded $83 million and net sales of the tenneco.

As compared to $110 million and the fourth quarter of 2020 $116 million and a year ago quarter.

Market share for the Deneke, and 20% was relatively flat compared with the fourth quarter and within the type of 20% to 20% range of 22% range. We have experienced since the start of the COVID-19 epidemic.

Denny: And within the 20 to 20% range we have experienced since the start of the COVID pandemic. The overall Peggylastic market grew by 1% in the first quarter. Quarter-over-quarter revenue decline for Udenica and Q1 was driven primarily by two factors, inventory changes and prices. First, seasonal fluctuations in wholesale inventory had a significant impact on quarter-to-quarter ex-factory shipping.

The overall take the rest of the market grew by 1% and the first quarter.

Quarter over quarter revenue declined for the Zeneca and Q1 was driven primarily by two factors.

Inventory changes and pricing.

First seasonal fluctuations wholesale inventory and a significant impact on quarter to quarter ex factory shipments.

Denny: Wholeset inventory rose from 11 days on hand at the end of the third quarter of 2020 to 21 days on hand in the fourth quarter, and then came back down at the end of the first quarter to 12 Second, as we have signaled since the third quarter last year, pricing pressure has intensified across the Pagall Rest and Market. The SPs reported by CMS show the trends across the category. Price decline has been most significant for the originator, Elasta, which now has the lowest ASP at any type of class. I'd now like to introduce Paul Reeder, our executive vice president, commercial operations, and market access. Paul brings over 30 years of relevant commercial experience and oncology in other therapeutic areas to Cohereas, and will provide some additional color on the market dynamics we see going forward. Thank you, Denny.

Wholesale inventory rose from 11 days on hand at the end of the third quarter 2020.

Two of 21 days on hand, and the fourth quarter and then came back down at the end of the first quarter to 12 days.

Second as we have signaled since the third quarter of last year.

Pricing pressure has intensified cross the pegfilgrastim market.

The USPS reported by CMS and show the trends across the category.

Price the clients have been most significant for the originator Neulasta, which now has the lowest ASP any types of aircraft.

I'd now like to introduce Paul reader, our executive Vice President of commercial operations and market access.

Paul brings over 30 years of relevant and commercial experience in oncology and other therapeutic areas to call here and we'll provide some additional color on the market dynamics, we see going forward Paul.

Thank you Denny I'd.

Paul Reider: I'd like to make a few comments regarding the pricing actions taken by the originator, which is entirely unusual for the category leader with presumed differentiation and strong marketing capabilities to employ a value proposition of having the lowest price in the market. These actions by the originator, combined with the revenue impact and unsustainability of price declines in a buy and bill reimbursement model, create an attractive opportunity through Dudenica. Our strategy is to grow UDeneca at the expense of New Asthma while maintaining pricing discipline and overall long-term economic value for providers. As you know, Neelasta retained 67% of the Peggful Rasta market, with On Pro representing approximately 55% share. During COVID, physicians used the on-body device to minimize patient visits to clinics and hospitals.

And I'd like to make a few comments regarding the pricing actions taken by the originator.

It's highly unusual for the category leader with presumed differentiation and strong marketing capabilities to employ of value proposition, but having the lowest price and the market.

These actions by the originator and combined with the revenue impact and the Unsustainability of price declines and the volume build reimbursement model.

Great and attractive opportunity through the identical.

Our strategy is to grow the identical that's the.

The expense of Neulasta, while maintaining pricing discipline and overall long term economic value providers.

As you know you asked the retained 67% of depicts the rest of the market with on pro representing approximately 55% share.

During COVID-19 physicians use this on body device to minimize patient visits and to clinics and hospitals.

Paul Reider: Now that COVID is receding, the medical imperative to use Pro is greatly reduced. We believe Udenica is well positioned to gain share in this context for the following reasons. First, Udicate is the number one prescribed Peggol Grasm biosimilar with approximately 20% share. Second, Udicate is well positioned among commercial pairs, with over 90% of commercial medical lives covered. Thirdly, we've earned the trust of oncologists and have built a broad customer base, with over 2,400 accounts currently purchasing Udenica.

Now the COVID-19 is receding the medical imperative to use on probe is greatly reduced.

We believe you deneke is well positioned to gain share in this context for the following reasons.

First the delicate as the number one prescribed pegfilgrastim biosimilar with approximately 20% share.

Second <unk> is well positioned among commercial peers with over 90% of commercial and medical lives covered.

Thirdly, we've earned the trust of oncologists and ability of broad customer base with over 2400 accounts currently purchasing new deneke.

For the.

Paul Reider: Fourth, the majority of our field team has now been vaccinated and has resumed in-person sales. And lastly, patient out-of-pocket costs for Eudenica are on average $200 lower per syringe compared to the new last, according to Sympanee's data for the last half of 2020.

The majority of our field team has now been vaccinated and his resumed in person and sales calls.

And lastly patient out of pocket costs would you deneke is on average $200 lower per syringe compared to Neulasta. This according to symphony data for the last half of 2020.

Therefore, it's COVID-19 receipts, and we expect <unk> will resume market share growth.

Paul Reider: Therefore, as COVID receives regulatory approval, we expect Udenica will resume market share growth. That product revenue, of course, will be a function of both volume and price. While our strategy is to maintain disciplined management of Udica ASP, within the context of the competitive pegful grass to market, prices, the variable over which we have the least control as we pursue our strategy of growing Udenica penetration and making inroads into the on-pro market. We expect revenue growth in the second half of the year. Let me now hand it back over to Denny to discuss the progress of our biosimilar plan. Thank you, Paul.

Net product revenue of course will be a function of both volume and price while on.

Our strategy is to maintain disciplined management of you dedicate asps.

Within the context of the competitive pegfilgrastim market prices the variable over which we have the least control.

As we pursue our strategy of growing <unk> penetration and make inroads into the on per market, we expect revenue growth and the second half of the year.

Let me now hand, it back over to Denny to discuss the progress and our Biosimilar pipeline.

Thank you Paul together with the Deneke, our Biosimilar, Lucentis, Humira, and Avastin addressed and aggregate and 28 billion and the market opportunity.

Denny: Together with Eugenica, our biosimilars, Sos, Umair, and Abaston, addressed an aggregate 28 billion market opportunities. We've already demonstrated our ability to use our branded marketing and other commercial capabilities to penetrate the competitive areas without similar. We believe we will experience similar success taking a significant share in these new markets. Our strategy is to take at least 10% of each of these markets. And in some cases, as with Eudenica, even a significantly greater market share.

We've already demonstrated our ability to use our branded marketing and other commercial capabilities to penetrate the competitive areas for the biosimilar.

We believe we will experience similar success, taking significant share and these new markets.

Our strategy is to take at least 10% of each of these markets and in some cases as with the deneke, even significantly greater market share.

By 2023, we expect all four of the Biosimilars will be on the market generating significant cash per coherence.

Denny: By 2023, we expect all four of these biotsimilars will be on the market, generating significant cash for coherence. How some of our products play a critical role in our corporate strategy Cash flows from this portfolio will create a diversified source of funding that we will redeploy as we enter the rapidly growing $25 billion immunol oncology market. Having this core economic engine allows us to pursue high growth, high return opportunities while limiting the illusion to our shareholders.

Biosimilar products and play a critical role of our corporate strategy.

Cash flows from this portfolio will create and diversified source of funding that we will be deployed as we entered the rapidly growing $25 billion oncology market.

Having this core economic engine allows us to pursue high growth high return opportunities, while limiting the dilution to our shareholders.

Let me start with our next expected bump some of our large CHF 201 of.

Denny: Let me start with our next expected POS Similar launch, CHS 201, which are the census biosimilar candidates. Our partner, BioWAC, continues to target mid-year 2021 for the submission of the PLA filing. As we previously reported, BioWAC held a supportive PVLA meeting with the FDA during the first quarter of 2021. We're very excited about the potential approval of this product in 2022 and have begun commercial planning activities preparation for launch next year. We believe we could be among the first file similar companies who send us candidates to market, and this could become another significant revenue opportunity for Coiris.

Are the such as Biosimilar Kennedy.

Our partner biotech continues to target the fifth year of 2021, the submission BLA filing.

As we previously reported biotech held the support of pre BLA meeting with the FDA during the first quarter of 2021.

We're very excited about the potential approval of this product in 2022 and have begun commercial planning activities and preparation for launch next year.

We believe we could be among the first biosimilar lucentis candidates to margin and this can become another significant revenue opportunity for clarus.

Ophthalmology is of similar buying pulp business model to oncology.

Denny: Optomology has a similar buy-end built business model to oncology, with analogous critical success factors that our commercial team understands very well. We plan to leverage much of our existing commercial infrastructure to gain significant share of the overall $6 billion anti-bedge ophthalmology market. Now, respect to our Humair, about similar, CHS 1420. The FDA has accepted our BLA for review for the December 2020-2021 action date and is making good progress. In March, the FDA conducted the on-site portion of the pre-approval drug substance CMC inspection, with no 43s reported.

And I will just critical success factors that our commercial team understands very well.

We plan to leverage much of our existing commercial infrastructure the gained significant share of the overall segment.

And keep that Jeff ophthalmology market.

And with respect to our Humira, Biosimilar and CHS 14 and funny.

And the FDA has accepted our BLA for review of the December 2020, one action date and is making good progress.

And March the FDA conducted the on site portion of the pre approval drug substance and CMC inspection with no 40 Three's reported.

The anti TNF market represents a substantial commercial opportunity for coherent <unk>.

Denny: The NETNF market represents a substantial commercial opportunity for Coheris. After years of double-digit price increases with Humair, there is clearly significant pent-up demand for the type of out-similar value that Coheris will deliver in this market, where lower costs of alternatives can bring down the overall cost of health. A product, a patient-focused offering, and our manufacturing scale will match what the partners are looking for. We are making manufacturing and supply investments to support our objective of capturing greater than 10% of the market.

After years of double digit price increases, but tomorrow, and there's clearly significant pent up demand for the type of biosimilar value of that coherent and still deliver and this market were lower cost alternatives and bring down the overall cost of health care.

Our product of patient focused offering.

And our manufacturing scale and match with the parents are looking for.

We are making manufacturing and supply investments support our objective of capturing greater than 10% market share.

With respect to CHF 305, our vast and Biosimilar. We're currently conducting of three waves PK study required to support the BLA filing.

Denny: With respect to CHS 305, our Vast and biosimilar, we're currently conducting a three-way PK study required to support the BLA file. COVID has impacted the recruitment, and we now expect to receive data toward year-end and file the BLA in the first part of 2022.

COVID-19 has impacted the recruitment and we now expect to receive data towards year end and the file the BLA. The first part of 2022.

Denny: Once approved, Vastom Commercial Opportunities will provide additional scale to our oncology commercial efforts, with nearly identical sales call points as Utenica and Tora Palomaph. By 2023, we anticipate this diversified portfolio of four biosimilar products, plus Tora Palomad, our first innovative product, will be approved, marketed, and generating significant cash flows to fund our growing immunol oncology franchise. The next topic I'd like to cover with you today. Now, as you know, in February, we executed the transformational first step of our strategy and a large and growing amino oncology market with our collaboration with Juni Bioscibiens, an innovation-driven biotech company, for Tora Palem, their PD1 inhibitor antibodies.

Once approved the vast and commercial opportunities will provide additional scale of our oncology commercial efforts with nearly identical sales call points as you've kind of cut to our Palomar.

By 2023, we anticipate the diversified portfolio of four biosimilar products plus to our parliament of innovative product will be approved marketed and generating significant cash flows of the fund our growing of immuno oncology franchise. The next topic I'd like to cover with you today.

Now as you know in February we executed the transformational first step on our strategy and the large and growing immuno oncology market with our collaboration with <unk> Biosciences.

And the innovation driven biotech company for.

<unk> the PD one inhibitor antibody.

Denny: We spent two years conducting a rigorous assessment of the global checkpoint and the, and define the optimal preclinical properties for our investment in a PD1 blocking antibody. We search for a molecule that would ideally deliver near-term revenue for monotherapy indications but would also provide us with a clinical profile that would be ideal as a foundational asset for future combination therapy, since that is where the mental oncology field is heading.

We spent two years conducting a rigorous assessment of the global checkpoint inhibitor landscape.

We define the optimal preclinical and clinical properties for our investment and the PD one blocking the antibody.

We searched for a molecule that would ideally deliver near term revenue for monotherapy indications, but would also provide us with the clinical profile that would be ideal as a foundational asset for future combination therapies.

And since that is where the oncology field and setting.

We reviewed over and it doesn't PD ones the depths.

Denny: We reviewed over a dozen PD1 detectable molecules. Torpalmab demonstrated high potency and unique molecular properties, which appear to translate favorably across a broad, pivotal clinical development program. Toropalab has been in development since 2015 and is being evaluated in 15 registrational clinical trials across a broad range of rare and highly prevalent tumor types.

Tore palomas demonstrated high potency and unique molecular properties, which appears to translate favorably across a broad and pivotal clinical development program.

Tour of Palomar has been and development since 2015 is being evaluated and the 15 registrational clinical trials across the broad range of rare and highly prevalent tumor types.

Denny: As a reminder, our portion of the development cost is limited to $25 million per year, giving us rights to an extremely high-quality molecule at a reasonable and predictable cost. The Torropalament collaboration is already exceeding our expectations. They are pleased that the progress being made, now the clinical data are beginning to read out, and the first regulatory submission in the U.S. is underway. The accumulation and external validation for Tora Palomad concludes the selection of the nasal pheromaryngeal abstract for ASCO's plenary session and press program.

As a reminder, our portion of the development costs and limited to $25 million per year.

Given us rights to an extremely high quality molecule and a reasonable and predictable cost.

The <unk> collaboration is already exceeding our expectations.

And we're pleased with the progress being made now the clinical data and became the readout and the first regulatory submission and the U S is underway.

Yeah, accumulating and external validation of our tour of Parliament includes the selection of the nasopharyngeal carcinoma abstract for <unk> plenary session and press program.

Breakthrough therapy designation from FDA and the additional recent approvals in China for Mtc and your theory of cancer supplementing.

Denny: Breakthrough Therapy designation from FDA, and the additional recent approvals in China for NPC and your arterial cancer supplement the original approval there for second-line melanoma, We expect Tora Palomab's emerging clinical validation of a potent PD1 inhibitor to drive partnership discussions with third parties seeking to combine their portfolio with a high-quality PD1 backbub. We are already making progress towards registration in the United States with the initiation of the rolling submission, BLA, or metastatic or recurrent MPC.

Supplementing the original approval there for the second line melanoma.

We expect tour of Palo <unk> emerging clinical validation of a potent PD one inhibitor to try and partnership discussions with third parties seeking to combine their portfolio with a high quality PD went back book.

We are already making progress towards registration and the United States with the initiation of a rolling submission BLA for metastatic or recurrent MPC.

Denny: We're also working closely with our partner on the registration strategy for multiple additional tumor types, which we will outline subsequently, and we expect to meet with FDA to discuss our registrational strategy for some of these key programs. We expect several near-term Toropalmat catalysts in areas of high unmet need, including NPC, lung cancer, Sopageal cancer, triple negative breast, and urethrial carcinoma. Now, let me introduce you to Dr. Shaw Rahamian, our senior vice president in Immunoancology, who is leading Cohes' TORPalem Development Program, and will provide you with an overview. Sean?

We're also working closely with our partner on the registration strategy for multiple additional tumor types, which we will outline subsequently.

And we expect to meet with FDA to discuss our Registrational strategy for some of these key programs.

We expect several near term toward Palomar and catalyst and the areas of high unmet need, including MPC lung cancer esophageal cancer.

The triple negative breast and Youre on cereal carcinoma.

Now let me introduce you to Dr. Shah Rahimi of our senior Vice President and immuno oncology, who is leading the coheres towards Alabama development program and will provide you with and Oregon, Sean. Thank.

Unknown Executive: Thank you, Danny. I'm excited to speak today about a number of Torah Formal Studies for which we expect clinical detail the next time. Let me start with Nevaferengal Carcinoma or NPR. FDA has granted Ticoma breakthrough therapy designation for recurrence for metastatic and, As a reminder, this is granted when preliminary clinical evidence should be used by the agency indicates that the drug may demonstrate substantial improvement or available therapy on a clinically, But keeping that in mind, we expect the BLA submission for this indication to be completed here.

Thank you Denny I'm excited today on a number of sort of format. The studies for which we expect clinical detail over the next year.

Let me start with nasopharyngeal carcinoma NPC.

FDA has granted a breakthrough.

Breakthrough therapy designation per occurrence limits of aesthetic and ads.

The reminder, this is granted and preliminary clinical evidence review by the agency indicated that the drug we demonstrate substantial improvement over available therapy on a clinically significant endpoint.

And with keeping that in mind, we expect the BLA submission for this indication to be completed here.

The first FCC BLA submission based on the Polaris to CPO five clinical trial. The study of the rule of 190 patients recurrent or metastatic mtc refractory to standard chemotherapy.

Unknown Executive: The first NPCBLA submission was based on the Polaris O2, Ct O5, clinical trial of all 190 patients with current or metastatic NPC refractory to standard chemotherapy. Results of this study were published in the Journal of Clinical Encollege in January. Tori Palom could have approval for this indication come as soon as the first half of 2022. We also expect to submit a BLA supplement for first-line NPC based on results from the randomized tributor O2 CT15 trial with 289 treatment naifes.

Of this study were published and the journal of clinical oncology and junior.

The Tory pulling out of the approval of this the Acacia as soon as first half of 'twenty.

We also expect the submit the BLA to supplement first on MCC based on results from the randomized Jupiter.

Two of CPA 15 trial with 289 treatment nave patients.

Unknown Executive: Tripiter O2 is a based-tree study in first-time, and we're excited that the study results will be featured by ASCO as a late-breaking abstract in the plenary program on Sunday, June 6th, and in ASCO's official press program.

Jupiter owed to the phase III study and the first thing the NPC and.

And we're excited that the study results will be the picture at basketball as the.

Late breaking abstract and the plenary program on Sunday June six.

And in Africa was the official press book.

We look forward to the meeting and the opportunity to introduce sort of parliament and the odd.

Unknown Executive: We look forward to the meeting and the upper-exmany to introduce our Apollo to a column to the audience of US positions and investors. We expect our Apollo to become the first PID1 inhibitor approved for these two NPC indications in the UN. Recurrence or metastatic NPC is an orphan indication in the United States. Because Toripolomab has the potential to be the first PD1 approved for the treatment of NTC and to address an unmet need, we see this indication as an excellent opportunity to educate opinion leaders, community oncologists, and pairs on Tori Polymian leaders.

And he has the fewest positions and testers.

We expect to reap all of them to become the first PD one inhibitor approved with these two and <unk> indications.

The current or metastatic npcs and orphan indications.

Because of Torrey point of the map has the potential to be the first P would improve for the treatment of MPC and to address an unmet need.

See this indications and the excellent opportunity to educate opinion leaders community oncologists and the peers and commentary.

Now, let me review, our lung cancer program, which compromises for the tourist trap.

Unknown Executive: Now, let me review our long cancer program, which comprises four pivotal, As you know, lung cancer presents over 60% of the immunoncology market opportunity, and we believe these trials will support comprehensive label to thoroughly address this dominance. I'll let me briefly comment on each of the studies in some, Choice O1 or CT19 is a randomized first-line non-smobile long capture study with 465 patients. The primary endpoint of this study is progression-free survival, and the key secondary end points are overall survival and objective for summary.

As you know lung cancer represents over 60% of immuno oncology Mark of temperature and we believe these trials and the support comprehensive label the thoroughly address the dominant segment.

And let me briefly comment on each of the studies and some day.

Yep.

Choice one we're seeking 19 is the randomized first line non small cell lung cancer the study.

With 465 patients the primary endpoint. The study is progression free survival and the key secondary endpoint of overall survival and objective.

This is study is progressing well and.

Unknown Executive: This study is progressing well. In December 2020, an interim analysis showed that the primary end point of progression-free survival had been met. And this will be presented later. We expect the final data read out of this study to be available by year. The second study, 25, is a randomized trial with 250 patients and TGFR mutations or failed prior treatment; the tyros and kindness are here. Enrollment is expected to be completed by the end of the year, with final data expected in 2020. The third non-smolone cancer study, CT18, is a randomized trial with 450 patients comparing to a polymer versus placebo in the new study.

In December 2020, and interim analysis showed that the primary endpoints of progression free survival has been mix.

And this will be presented later this year.

We expect the final data readout, the study to be available and Gary.

The second of the study 25 is the randomized trial of the 260 patients with Egfr mutations on a scale of prior treatment and the tyrosine kinase inhibitors.

The enrollment is expected to be completed by the end of the year, which funded with final data expected to be between.

The third non small cell lung cancer for the <unk> is a randomized trial of the 450 patients.

<unk> two of polymer versus placebo and <unk>.

The new adjuvant and.

Unknown Executive: Enrollment is expected to be completed by the end of the year, with final data expected in 2020. The Board's study of the program is in small cell long, Dripur 08, DT28, a randomized first-line study with 420 patients with primary endpoints, progression-free survival, and overall survival, and is expected to be completed in 2020. We believe this comprehensive program will support registration paths in lung cancer, being dignitary. The next indication I will discuss today is alpha Jill's screen with cell car. After 18,000 patients in the United States diagnosed with pathageal cancer each year, approximately one-third have a squamous cell histology, which is an unmet medical need, and approximately 95% of patients with ducetic disease die with the inviagris effect. Last month, in the terminal of Jupiter O6, CT21, a randomized phase-tree study with 500 patients met both primary and was progression-free survival and overall survival.

Enrollment is expected to be completed at the end of the year with final data expected in 2022.

For the study of the program and small cell lung kids distributor of eight <unk> 28.

Is the randomized first line study with 420 patients with primary endpoints of progression free survival and overall survival and is expected to be completed and 22.

We believe this comprehensive program will support registration paths and the lung cancer seem to get it.

The next indication and I'll discuss the day of the Geo squamous cell carcinoma of.

The 18000 patients and the United States diagnosed with average yield accounts.

Accounts for each year, approximately one third of scoop.

Painless.

This is an unmet medical need and approximately 95% of pieces of the studies of the die within five years of effect.

Last month. The interim analysis is attributable was six <unk> and 'twenty, one randomized phase III study with 500 patients met both primary endpoints of progression free survival and overall survival.

Unknown Executive: We expect the presentation of Jupiter 06 data later in 2021 and the potential supplemental VLA-5 support labeled indications in 2020. Triple negative breast cancer is another high unmet medical need. It accounts for approximately 10 to 15% of all breast cancers in the United States, and nearly 90% of these patients with the synthetic disease die within five years of diagnosis.

We expect the presentation of Jupiter of it was 62 on later in 2021 and the potential customers with DLA Piper supports the labeled indications in 2000.

Triple negative breast cancer of clear high on.

The the belief it accounts for approximately 10% to 15% of all breast cancers, and the United States and nearly 90% of these patients.

And I think disease died and five years effective.

And.

The report site.

Unknown Executive: This report slide for the CT26 study is enrolling 600 to 0 negative breast cancer; data from this study are expected in 2020. The URUL carcinol program is just two, The first study is Polaris 12, a phase two study which supported communication approval in China earlier. Second study, CT38, a large phase three, evaluating tpola or placebo in combination of standard of care chemotherapy as first line treatment, which is fungo.

<unk> 2006, the study is enrolling 600 and triple negative breast cancer patients.

Data from the study are expected.

<unk> and 2020 two.

The U S. D level of personal program consists of two things the first of the studies players with two six and 12.

<unk> II study, which supported indication approval in China earlier this year.

Second the B C.

<unk> 38.

The large phase III evaluating true polymer or placebo and combination of standard of care therapy.

First line treatment.

The phone call.

Unknown Executive: I'll turn the call back to Dave. Thank you, Sean, for that very exciting review. In the second half of 2021, together with June Shee, we plan to engage with FDA to discuss the filing strategy for these and the other indications. We look forward to providing you future updates on both the clinical data and the regulatory progress program. I only see a few words about the Torpalmath combination.

I'll turn the call back to David.

Thank you Sean for the very exciting and redo.

And the second half of 2021, together with <unk>, we plan to engage with FDA to discuss the filing strategy for these and the other indications we look forward to providing new future updates on both the clinical data and the regulatory progress of these programs.

Let me say a few words about tour of Palmetto combinations.

Denny: As previously disclosed, the Junci transaction also includes options to their anti-tigid antibody and engineered IOTEin, as well as certain negotiation rights with respect to additional assets. For the anti-tigid antibody, we expect phase one studies to begin later this year. We have the opportunity to review the data and make our opt-in decision when the study is complete. Together with Jun Xi or other partners, we expect to explore and develop synergistic combinations with Tora Palmet, particularly given its emerging strong efficacy profile and the market's direction toward combinations.

As previously disclosed the Juicy transaction and also includes options for anti <unk> antibody and engineered IL, two cytokine as well as sort of negotiation rights with respect of traditional assets.

For the anti attention of antibody, we expect the phase one study to begin later this year, we'll have the opportunity to review the data and make our opt in decision on the studies. Please.

And together with June scheme, or other partners, we expect to explore and develop synergistic combinations with tour of Palmetto.

Particularly given its emerging strong efficacy profile and the market's direction towards the combinations.

Launch planning is well underway and our commercial team is excited and Toro pound average of our oncology product portfolio.

Denny: Launch planning is well underway, and our commercial team is excited to add a pound to our oncology product portfolio. There's significant overlap with our established footprint of over 2,400 accounts, and inbound customer comments suggest they are eager to support competition in the anti-PD1 market. We believe displacing entrenched competitors is one of our demonstrated commercial competences; I look forward to market entry in 2022. Now, I'll turn the call over to McDavid for a review of the quarter's financial results. David

There is significant overlap with our established footprint of over 2400 accounts and inbound customer comments suggest they are eager to support competition and the anti PD one market, we believe displacing entrenched competitors one of our demonstrated the commercial competencies and look forward to the market entry of 2022.

Now I'll turn the call over to make David per reviews of the quarter's financial results and David Thanks Denny.

McDavid Stilwell: Thanks, Danny. The details of our financial results are in the press release and in the 10Q we filed this afternoon, so all focus now, only on a few highlights. The first quarter of 2021, we reported a $173 million net loss on a gap-based, On a non-gap basis, we reported net income of $400,000, or about a penny a share on a fully-deluded, The translation from Gap to non-Gap included three items, the $145 million upfront payment to Junchi Phi The $11.5 million in charges related to the termination of the CHS 2020 program as part of a strategic realignment of R&D resources toward immunoncomology, and $16.9 million in non-cash stock-based compensation.

The details of our financial results are in the press release and on the 10-Q, we filed this afternoon. So I'll focus now only on a few highlights the.

The first quarter of 2021, we reported of $173 million net loss on a GAAP basis.

On a non-GAAP basis, we reported net income of $400000 or about a penny a share on a fully diluted basis.

The translation from GAAP to non-GAAP included three items the one.

$145 million upfront payments and specie biosciences, the $11 $5 million and charges related to the termination of the CHS 2020 program as part of our strategic realignment R&D resources toward immuno oncology.

And $16 9 million and noncash stock based compensation.

McDavid Stilwell: Cash flow from operating activities was $1.4 million for the first quarter of 2021. As detailed earlier in the call, net product revenue was $83 million, a decline from the prior quarter and the year ago. The decline was primarily attributable to seasonal fluctuations in wholesale inventory, as well as increased allowances and discounts to customers.

Cash flow from operating activities was $1 $4 million for the first quarter of 2020 one.

As detailed earlier and the call net product revenue was $83 million of.

The decline from the prior quarter and the year ago quarter the.

The decline was primarily attributable to seasonal fluctuations and wholesale inventory as well as increased allowances and discounts to customers.

Research and development expenses for the first quarter of 2021 for $203 5 million compared to $33 $1 billion for the same period and 2020.

McDavid Stilwell: Research and development expenses for the first quarter of 2021 were $203.5 million, compared to $33.1 billion for the same period in 2020. The increase was mainly due to the $145 million upfront payment to Juncibe Viastines, and the $11.5 million charge related to the termination of the CHS 2020 program, as well as development costs in support of the advancement of Toropalamab and the biosimilar pipeline product. Selling general and administrative expenses were $39.4 million in the first quarter of 2021, as compared to $35.4 million in the year-ago quarter. The increase was primarily driven by higher stock-based compensation expense.

The increase was mainly due to the $145 million upfront payment to <unk> biosciences.

$11 $5 million charge related to the termination of the CHS 2020 program as well as development costs to support of the advancement of tour on the map and the Biosimilar pipeline product candidates.

Selling general and administrative expenses were $39 $4 million and the first quarter of 2021, as compared to $35 4 million and the year ago quarter and.

The increase was primarily driven by higher stock based compensation expense.

McDavid Stilwell: We ended the quarter with cash, cash equivalence, and marketable securities of $399.5 million, compared to a balance of $541.2 million at year-end 2020. Subsequent to the quarter end, Goheris received $50 million from Juncibioc Sciences' acquisition of approximately 2.5 million shares at a price per share of $20. For financial guidance, now that we have closed the Juni Biosciences collaboration, we are increasing our expected operating expenses for the year to a range of $370 million to $400 million, excluding the $145 million upfront payment to June Shee biosciences in the first quarter. The expense guidance includes approximately $50 million to $55 million in stock-based compensation.

We ended the quarter with cash cash equivalents and marketable securities of $399 $5 million compared to a balance of $541 2 million at year end 2020.

Subsequent to quarter and go Harris received $50 million from <unk> Biosciences acquisition of approximately $2 5 billion shares at a price per share of $20.06.

Of course financial guidance now that we have closed the two and she biosciences collaboration we are increasing our expected operating expenses for the year to a range of 370 million to 400 million <unk>, excluding the $145 million upfront payment to <unk> biosciences, and the first quarter.

<unk>.

The expense guidance includes approximately 50 million to $55 million and stock based compensation expense.

McDavid Stilwell: Our external R&D spending is focused on manufacturing-related activities in preparation for the potential launch of Toropalamab and CHS 1420 and development activities for CHF 305 and for additional presentations of Udenica. Increases in SG&A spending in 2021 are primarily driven by marketing activities and headcount to support Eugenica and the potential launches in 2022 of Tora Palomab and CHS 201. In the first quarter, we exhausted the remaining inventory that was manufactured and fully expensed prior to Udenica approval.

External R&D spending is focused on manufacturing related activities and preparation for the potential launch of tour of upon the map and.

And the CHF $14 20.

And development activities for CHF 305.

And for additional presentations of the deneke.

Increases in SG&A spending and 2021 are primarily driven by marketing activities and head count to support the deneke and the potential launches in 2022 of tour of Perm about and CHS two of one of them.

And the first quarter.

And we exhausted the remaining inventory that was manufactured and fully expensed prior to your deneke approval.

McDavid Stilwell: As a result, we estimate that the cost of goods sold as a percentage of net product revenue will be in the range of mid to high single digits, excluding a mid-single-digit loyalty on net product revenue that we owe through July 1st, 2024. As Paul noted earlier, we expect Eugenica revenue and market penetration to rise in the second half of 2021, assuming treatment patterns normalize as the COVID-19 pandemic received, and subject to pricing trends in the overall pectalgrast market.

As a result, we estimate that the cost of goods sold as a percentage of net product revenue will be and the range of mid to high single digits.

Excluding a mid single digit royalty on net product revenue.

We owe through July one 2024.

As Paul noted earlier, we expect Utica revenue and market penetration to rise and the second half of 2021, assuming treatment patterns normalize as the COVID-19 pandemic receipts.

And subject to pricing trends and the overall pegfilgrastim market.

McDavid Stilwell: Finally, on the investor relations project, we'll be participating in the Bank of America Healthcare Conference next week with our presentation scheduled for May 12th at 1.15 p.m. Eastern Time. And I'll now turn the call back to Denny for closing remarks. Thank you, David. As you can see, we're making strong progress with Eugenica on a similar pipeline in our strategic alignment towards immunol oncology. On a financial side, we were focused on optimizing the cash flow potential of our biosimilar product candidates, fueling our IEL growth and Clinical Data announcements, medical and scientific presentations, and regulatory milestones for Toropal Map and our biosimilar product candidates. We expect frequent important news flow for the remainder of the year.

Finally on the Investor Relations front we.

And we'll be participating and the bank of America Healthcare Conference next week with our presentation scheduled for May 12 at $1 15 P M Eastern time.

And I'll now turn the call back to Denny for closing remarks, Thank you David.

And you can see we're making strong progress with the deneke about similar pipeline and our strategic realignment towards immuno oncology.

On a financial side, we are focused on optimizing cash flow potential of a biosimilar product candidates to fill our Io growth engine.

The clinical data announcements medical and scientific presentations and regulatory milestones for <unk> and our Biosimilar product candidates. We expect frequent of important news flow for the remainder of the year.

McDavid Stilwell: We look forward to engaging with you through these announcements and also at our analyst event day later this year. I'll ask the operator to open the line for your questions. Thank you. We will now begin the question and answer session. If you have a question, please press star then one on your touchtone phone. If you wish to be removed from the queue, please press the pound sign or the hash key. If you're using a speaker phone, you may need to pick up the handset first before pressing the numbers.

Look forward to engaging with you through these announcements and also to our analyst day later on this year.

And I'll ask the operator to open the line for your questions.

Yeah.

Thank you.

We'll now begin the question and answer session. If you have a question. Please press Star then one on your Touchtone phone if you wish to be removed from the queue. Please press the pound or the husky.

If youre using a speakerphone you may need to pick up the handset first before pressing the numbers. Once again if you have a question. Please press Star then one on your Touchtone phone and we're standing by for questions.

Operator: Once again, if you have a question, please press Star Than 1 on your touchtone phone. And we're standing by for questions. And our first question online comes from Mohit Vensel from City. Please go ahead. Good, thanks for taking my question. Another contributing factor in the first quarter was the severe weather in some parts of the country. I think you are not mentioning that. So the question is, is it a smaller part than previously anticipated, and pricing and inventory are the bigger parts for us?

And our first question on line comes from Mohit Bansal from Citi. Please go ahead.

Okay. Thanks for taking my question.

And Oh.

Yeah.

Okay.

And another contributing factor in first quarter of that was the Cvs and rather than and some part of the country I think I'm not managing that so the question is is it the smaller box and then.

The anticipated and then.

And on pricing and and make the us through the big on Fox.

Operator: And then as you think about the demand, so if I think about the fourth-quarter number and take out that monetary move, I calculate roughly $100 million was the demand. Is this a fair number of demand to think about for the first quarter and beyond because obviously flies is an important point, but how should we think about demand? Yeah, hi, Mohi, thank you.

And then as you think about that and Matt.

So if I think about fourth quarter number and take out net making book I calculate roughly 100 million looked at the map is this the fed state and number of the Mag.

To think about for first quarter net and beyond because our policy of the sizes and the players like like how should we think of like tobacco.

Yes.

Unknown Caller: I think you cut off with the first part of your question. Could you repeat the first part of your question, please? Sorry, I just wanted to get some color on the severe weather in some parts of the country, which you kind of mentioned earlier in the quarter, but you are not mentioning it today. So was it a smaller portion of the total number in terms of impacting the quarter number?

Hi, Mohit. Thank you I think you cut out the first part of your question could you repeat the first part of your question. Please.

And I just wanted to get some color on the sandbox against that that and some part of the kind of feedback that you kind of mentioned Eylea and.

The quarter, but getting on making it two days on was it the smaller portion of the in terms of impacting the quarter number.

Yeah, I mean, David do you want address that sure.

Unknown Caller: Yeah, David, do you want to address that? Sure. Moki, it's hard to measure the effect of the weather.

Okay.

It's hard to measure of the effect of the weather.

McDavid Stilwell: So we're focusing today on the two aspects of inventory and pricing. And so, you know, the way to think about it, as we said in the script, is that at the end of the third quarter of 2020, we had about 11 days on hand in inventory, which jumped in the fourth quarter to the high end of the normal range at 21 days on hand due to seasonal buy-ends from customers. And then in the first quarter, this extra inventory was depleted, and now we're back into the normal range of 12 days ago. Additionally, Udenica ASP declined 6% in the first quarter versus the fourth quarter, which indicates how pricing changed in the market.

And so we're focusing today on on the two aspects of inventory and.

Pricing and so and the.

McDavid Stilwell: So this decrease, I think, accounts for the remainder of the decrease in net sales. Thanks, David. Lombe, did you have a follow-on question? So, you are mentioning other formulations or other presentations of Ciderica in this Peslis.

Unknown Caller: So now that you seem to be working on that, is there anything you can disclose in terms of timelines or how you are thinking about it? We have made no formal disclosures, as you know, with respect to these additional formulations. Okay, God.

Unknown Executive: However, you know, as soon as we have a material development, we will, of course, disclose it. Thank you. Our next question online comes from Jason Gherpury from Bank of America. Please go ahead.

Yeah.

Thank you. Our next question online comes from Jason <unk> from Bank of America. Please go ahead.

Hey, guys. Thanks for taking my question.

Unknown Caller: Hey, guys, thanks for taking my question. First, just on Torpalimab, just the positive interim data in lung cancer, just wondering, do you think that's a sufficient basis for a BLA? Or I know a number of competitors are saying that they're going to need phase one, PK bridging data in U.S. subjects. So just sort of curious if that's a gating item or something in the final top line update that you're looking to see. And then just on Peg Philgrasum, A.S. SP Dynamics called out in its prepared remarks.

First just on top of Poly, Matt just the.

And the positive interim data in lung cancer. Just wondering do you think that's sufficient basis for a BLA or I know of number of competitors are saying that they're going to need phase one PK bridging data and U S. Subjects. So just sort of curious if that's the gating item or something and the final Todd.

Top line update that you are looking to see and then just on the Pegfilgrastim ASP dynamics called out in the prepared remarks do you have a sense of what proportion of oncology providers participated and like capitate or value based.

Unknown Caller: Do you have a sense of what proportion of oncology providers participate in capitated or value-based payment pilot programs? I'm just trying to get a rough sense of, you know, what proportion of the market Amgen might be trying to cater to with the lowest net cost offering. Thank you. Thank you, thank you for your question, Jason. With respect to your first question, which, you know, strikes the issue of the lung studies and the interim analysis, I don't believe that you want to conflate that with the issue of any additional studies that others might be doing to supplant their indications. That being said, I'll let Shaw make some remarks about the lung study, the interim analysis, and the patient population there. Sean?

The payment pilot programs and I'm, just trying to get a rough sense of when and what proportion of the market Amgen might be trying to cater to with the lowest net cost offering. Thanks.

Thank you think of your question, Jason with respect to your first question, which strikes to the issue of the lung studies and the interim analysis.

And I don't believe the you want to conflate the with the issue of any additional studies that others might be doing to supplant or indications.

That being said I'll, let's try and make some remarks about the lung study of the interim analysis and the patient population there Sean.

Unknown Executive: Understanding, and thanks for the question. Really, the short answer is that we believe that the study is well designed, is well powered, and was conducted within industry and international rules and regulations. And we believe that this study is sufficient for a BLA submission. Of course, once the study is presented to the agency, the agency has, The other point that I would make here, Jason, is that other people's studies may not have included the appropriate subset of patients. And one thing about this study, I believe, is that it includes both squamous and non-screamless histologies, which I think is very important.

And we're studying and thanks for the question.

It's really the short answer is that he believes that the.

The team is well designed well powered and.

What's the conducted within the industry and international rules and regulations and we believe that the study is sufficient for a BLA submission of course.

Once the study is.

Presented at the ACC and the agency has the last.

The other point that I would make your chase and is that other people studies may not have included of the appropriate subset of patient histology and.

And one thing about this study I believe is that include both squamous and non squamous histology.

I think is very important so I don't think it's really the apples to apples comparison when you look at all the studies, but so far no. We don't believe that we will have to do any supplemental studies and with the caveat that we will be talking to the agency. Later this year with June Chi to validate that and lastly, what I would point out is that there is of three basketball.

Unknown Executive: So I don't think it's really an apples-to-apples comparison when you look at other studies. But so far, no, we don't believe that we will have to do any supplemental studies with the caveat that we will be talking to the agency later this year with June Shee to validate that. And lastly, what I would point out is that there are three non-small studies in the lung and one small style study.

On the studies.

And lung and one small cell studies. So we think there's going to be a plethora of data and the indication now.

Unknown Executive: So we think there's going to be a plethora of data in the indication. Now with respect to the ASP question, Paul Reeder, perhaps, or Chris Thompson may address that, Chris. Thanks, Denny.

And now with respect to the ASP question, Paul reader of perhaps or Chris Thompson and May address that Chris.

Thanks, Denny Thanks for your question Jason.

Chris Thompson: Thanks for your question, Jason. You asked us, do we have an idea how many customers participate in value-based incentives? And I would have to say I don't have an exact number, but many customers do.

And you had asked US about do we have an idea of how many customers participate and value based incentives and.

I'd have to say I don't have an exact number but many of the customers do that's what they tell us they participate both on the commercial side as well as on the Medicare side.

Chris Thompson: That's what they tell us. They participate both on the commercial side as well as on the Medicare side, with the Medicare side sometimes going in and out of programs. But let's say this: although they are participating in value-based incentives, they evaluate not only the cost of the product but also the revenue derived from the product, and they try to balance that in their decision-making.

With the Medicare side, sometimes going in and out of programs, but let's say this on.

Although they are participating and value based incentives.

They evaluate not only the cost of the product.

But also the right revenue derived from the product and they try to balance that and their decision, making we believe that we made the right decisions as it relates to being good stewards of ASP.

Chris Thompson: We believe that we've made the right decisions as it relates to being good stewards of ASP, and we'll continue to do so. I hope that answers your question. Thank you. We're ready for the next question, operator. Thank you. Our next question online comes from Chris Schott from J.P. Morgan. Great, thanks for the questions. On Nulasta, just directionally, are you seeing signs of either normalized pig-filgrastum usage or willingness to switch away from On Pro over to biosimilars as we've kind of moved from this environment we were in in January, February to where we're sitting today in April and May?

And we'll continue to do so and hope that answers your question.

Thank you.

We're ready for the next question operator.

Thank you. Our next question on line comes from Chris Schott from J P. Morgan.

Oh, great. Thanks for the questions on.

On the Neulasta just directionally are you seeing signs of either normalized pegfilgrastim usage or willingness to switch away from on Peru over to Biosimilars as we've kind of moved from this environment. We're in and January February to where were sitting today in April and May I guess, directionally, you're starting to see that or is that still.

Chris Thompson: I guess directionally, you're starting to see that, or is that still TBD in terms of when that transition is going to start to happen? And then, just a second one on Peggful Grasdom, just on pricing. You talked about a 6% erosion in one queue. Has pricing stabilized at this point, or are you still seeing some erosion on the pricing front? And I just have one follow-up after that.

TBD in terms of when that transition is going to start to happen.

And then just the second one on Pegfilgrastim just on on pricing and you talked about of 6% of erosion in <unk>.

The pricing stabilized at this point or are you still seeing some erosion on the pricing front and Miss of one follow up after that.

Oh, great. Thanks, Chris So I'll, let Paul reader address your first question with respect to Neulasta and so forth Paul.

Unknown Caller: Okay, thanks, Chris. So I'll let Paul Reader address your first question with respect to New Last and so forth. Paul?

Paul Reider: Yeah, hi, Chris, thanks for your question. Yeah, I mean, I think with respect to the shareship with On Pro and New Asta, you saw that in the first quarter. And so, you know, we do expect as COVID recedes, as we laid out, the opportunity for the market in that On Pro opportunity to open up to greater, greater opportunities. We believe we're well positioned there for that, protecting the market.

Yeah.

Chris Thanks for your question, Yeah, I mean, I think with respect to the.

The share shift with on pro and Neulasta.

Sort of in the first quarter and so we do expect as COVID-19 receipts as we laid out the opportunity for the market and that on pro.

The opportunity to open up to greater and greater opportunity, we believe we're well positioned there.

Paul Reider: And as it relates to pricing, you know, I think we expect prices to continue to erode as new competitors enter the marketplace. I think if you look at, you know, what's happened in the last quarters, the steep decline, it's really fueled by, you know, the new, continued decline but also the pandemic where these new entrants, the biosimilar entrants, were forced to compete for share in that smaller pre-filled syringe segment.

And for that protecting the market and as it relates to the pricing I think we expect prices to continue to erode and as new competitors enter the marketplace. I think if you look at what's happened in the and the last quarters of the steep decline you really fueled by.

On the Neulasta declined but also the pandemic, where these new entrants of the Biosimilar entrants were forced to compete for share and that smaller pre filled syringe segment.

Paul Reider: So now, again, as COVID is receding, you know, we feel we're well positioned that that entire market opportunity will open up for more competition as the need for On Pro, you know, becomes more diminished, and price decreases will matter. We do believe price decreases will be moderate over time, yes. Thank you, Chris. Did you have a follow-up question? Yeah, I just had a quick one on Torpabab

So now again as COVID-19 receding.

And we feel we're well positioned at the entire market opportunity and we will open up for more competition as the need for on pro.

It becomes more diminished.

And and price decreases will moderate.

We do believe create price decreases and the water overtime, yes.

And Chris did you of a following question Yeah, I'd sort of quick one on on and on <unk> is there any thoughts or need and your view to think about doing a head to head against Keytruda and just given they are obviously dominant and and many of these indications you're pursuing over time do you think that does that would that help at all from a commercial standpoint or do you think the data will be comparable.

Unknown Caller: Is there any thought or need, in your view, to think about doing a head-to-head against Ketruda, just given they are obviously dominant in many of these indications you're pursuing over time? Do you think that would help it all from a commercial standpoint, or do you think the data will be comparable enough that you won't need that type of data? No, we don't think so.

<unk> enough that that you won't need that type of data.

No we don't think so.

Unknown Executive: It is an issue that we took a look at earlier on. However, our research studies and our conversations with customers, and particularly with providers, indicated that they would really look at the data generated with the particular PD1, and if that data compared favorably, that would be fine to generate utilization. This is why we're very pleased with the data that's being generated with Tora Palomab so far. It's showing very strong efficacy in each of the indications that it's been put into.

It is it is an issue that we took a look at earlier on however, our and our research studies and our conversations with the customers and particularly with the providers and indicated that really they would look at the data generated with the particular of PD, one and if that data.

And compared favorably that would be fine to generate utilization. This is why we are very pleased with the data that's being generated with toured Palo maps, so far and it's showing very strong efficacy and each of the indications that it has been put in so we're feeling that.

Unknown Executive: So we feel that this will continue and will have excellent data to go forward, particularly in some of these breasts and some of these other indications. So no, we don't think there's a need to go forward with a head-to-head trial in that.

We'll continue and we will have excellent data forward, particularly in the lung and some of these breast and some of these other indications. So no. We don't we don't think there is a need to go forward with the head to head and that.

Unknown Executive: We have seen nothing in the market that indicates that. Okay, perfect. Thanks so much. Thank you. Our next question online comes from Salim Siat from Missou Hill. Please go ahead. Hi, this is Venet on behalf of Salim. Thank you for taking our questions. A couple, if we may, although both are related. We found last month on the site Clinicalhero.com two trials listed, one for Eugenica administered with an auto-injector and another one using a non-body injector, but we haven't seen similar trials on clinicaltrials.com.

And we have seen nothing and the market starting to kick butt okay. Perfect. Thanks, so much.

Okay.

Yeah.

Thank you. Our next question on line comes from selling Scott from Mizuho. Please go ahead.

Hi business by net on behalf of Selim. Thank you for taking our questions. A couple of weeks and we may have the most of our related.

With all of last month, and the Si team because the comp to try on that.

One for you of any cash and strictly with announcing check put on another one using a non bobby and sector, but we haven't seen similar trials in clinical trials of the above it.

Unknown Caller: If we could get some color regarding this, please. And also, if you could comment on the type of studies that are needed when developing an auto and an own-body injector. I mean, is only a phase-1 PKPD study needed, or do you think of pivotal studies eventually in this as well? Thank you. Thank you. As I indicated previously, we haven't made any formal announcements or disclosures with respect to alternative dosage forms for Eugenica. With respect to the requirements, I would direct you to the studies that Amgen performed when they brought forward their on-body system, which were pharmacokinetic studies. That is to say efficacy studies are probably not required.

We could get some color regarding this claim and.

Also if you could comment on the type of studies that have neither when developing on outdoor and and on body injector. I mean, it is only a phase one PK PD study any of those or do you think of people at those kind of use of eventually the nims and as well. Thank you.

Thank you and.

As I indicated previously we haven't made any formal announcements.

With our disclosures with respect to.

Alternative dosage forms of <unk> deneke.

With respect to the requirements I would direct you to the studies that and Amgen.

<unk> when they brought forward the on body system of which were pharmacokinetics studies.

And as I say thank you.

The same efficacy studies are probably not required.

Unknown Executive: I see. Good. Thank you, man.

Okay got it thank you very much.

Unknown Caller: Thank you. Our next question online comes from Georgie Jordonov of Cohen and Company. Please go ahead.

Thank you. Our next question online comes from Georgie Giordano from Cowen and company. Please go ahead.

Hey, guys. Thank you so much for taking our questions.

Unknown Caller: Hey guys, thank you so much for taking our questions. I guess, first, if you could talk about the opportunity for the incentives and the anti-vege-f market. Do you believe that having only one of the two products as a biosimilar could allow you to have access to the whole anti-vege-f market? And then, maybe, you could talk about your expectations for the competitive dynamics at the time of launch and the time of launch and thereafter.

I guess first if you could talk about the opportunity for Lucentis and the anti VEGF market.

Do you believe that having only one of the two products.

And the Biosimilar could allow you to have access to the whole of anti VEGF market.

And then maybe if you could talk about your expectations for the competitive dynamics of the type of law and the time of launch and thereafter and.

Unknown Caller: And then I have a quick follow-up. Thank you. I'll let Paul Reader offer some additional insights into Lucentus, but the short answer to your question is, yes, we think that the entire market, that is approximately $2 billion for Lucentus and $4 billion for Ilya, is addressable to some degree with a Lucentus file similar.

And then I have the eclipse all of them.

Thank you I'll, let Paul the reader offer some additional insights of the incentives, but the short answer to your question is yes, we think that the entire market that is the approximately 2 billion per lucentis and 4 billion of Eylea is addressable.

And some degree.

Our lucentis Biosimilar and as you know that market is stratified.

Denny: As you know, that market is stratified from reformulated to Vastin at the low end all the way up to a very long duration, and Moides at the top end, with Ilya and Lucentis in between. So we feel that Lucentis is an ideal entry point for this. And we further think that it'll be a couple of years before Ilya biosimilars actually get on the market. So we look forward to market formation with the Lucentis Biosimilar starting sometime next year, and we are now working on our launch for next year, as we said.

Denny: Paul, do you have any additional comments with respect to Lucentis? I don't think I have much to add, Denny. I think that was very comprehensive, so nothing more to add. Thank you so much. Thank you. And then just a quick follow-up on Nudenaica. What are your sales we're seeing in terms of marketing activity from Pfizer's competitor product? And are there any other Udenica competitors that are not yet on the market that you expect will be coming up in the next six to 12 months? Great question. I'll add Chris Thompson, our executive vice president of sales, on that one. How does the competitive set look?

Chris Thompson: Thanks for your question. So, you know, you're seeing activity amongst all of the competitors that are out there. As Paul mentioned earlier, though, you know, with COVID being here, it's a smaller competitive set we all have to compete with, which probably attributed to some of the price. But now, with COVID receding and everybody getting vaccinated and my salespeople able to get into these accounts, I think what we're going to see here is, you know, the pie gets bigger, right?

Compete with which probably.

Attributed to some of the price declines.

And now with COVID-19, receding and everybody getting vaccinated and myself hoarse.

Able to get into these accounts I think what we're going to see here is the pie gets bigger right. The the opportunity to compete for the on pro business that 55 per cent of the business.

Chris Thompson: The opportunity to compete for the on-pro business, that 55% of the business really gives us an opportunity to expand as well as the competition to expand. But we're pretty confident that, based on our past history, we're going to do a pretty good job there.

Really gives us an opportunity to expand as well as the competition to expand but we're pretty confident that the based on our past history of we're going to do a pretty good job there. Thanks.

Chris Thompson: Thanks. Thank you so much. Thank you. Our next question online comes from Greg Gilbert from Truist Securities. Please go ahead. Thank you. It's Greg Fraser on behalf of Greg Gilbert.

Thank you so much.

Okay.

Thank you.

Our next question on line comes from the Great Gilbert I'm sure of Securities. Please go ahead.

Thank you that's great Fraser on for Greg Gilbert the expectation for any day of the sale to write and the second half and that relative to the first half or is that on a year over year basis.

Unknown Caller: The expectation for identical sales to rise in the second half, is that relative to the first half, or is that on a year-over-year basis? Would you like to take that one, Paul? It's based on the first half, correct?

[laughter].

And would you like to take that one book this based on the first half correct.

Okay, and the operating expense guidance change how much of that was related to the junkie and.

Paul Reider: Okay, and the operating expense guidance change, how much of that was related to the Junchi collaboration versus higher spending in other areas? Sure, so for the Junchi collaboration, as you might recall, we have a $25 million per molecule per year R&D expense contribution, and so that's already kicking in. And then we are also preparing for commercialization there, which involves some tech transfer activity. Got it. Okay. And then

Collaboration versus higher spending and other areas.

Sure so for the for the insurance she'd collaboration and see.

You might recall, we have a <unk>.

$25 million per molecule per year, R&D expenses contribution and.

And so that's already kicking in and.

And then we're also of preparing for commercialization narrow which involves some.

The transfer activities.

Got it Okay and then.

Unknown Caller: You mentioned that you could potentially do better with some of your future biosumer launches than you did with Edenica. Is the Census one that you put into that category where you could perhaps do better than 20, 25% share? Thank you. Yeah, let me, so let me just correct that. What we indicated was that for any Bows similar launch, we would do at least 10%, and that would include, for example, the 14-20, the Umair Bout similar launch, certainly the Lucentus launch. We're very proud of the Eudenica launch.

You mentioned that you could potentially do better with some of your future Biosimilar launches then you've done with the den and cut is the census, one that you put into that category, where you the perhaps the better than 2025 per cent sure. Thank.

Thank you.

Yeah, Let me so let me just the correct that.

And what we ended when we indicated and was that we felt that for any file similar lines you would do at least 10% and that will include for example of the 14th of why I need neumeyer about some of our large certainly and the incentives launch and we're very proud of the deneke launch we did 20% of the first year, which was actually.

Denny: We did 20% of the first year, which was actually 50% of the syringe segment. So we did quite well there. I'd be very, very happy to replicate that success with Humira or Lucentis. But we are optimistic that our proficiency in file similar commercialization will be demonstrated with the Lucentis launch, the Avastan launch, the Humira Vowelan launch, and so on. We feel this is our home field, and we're the folks who have demonstrated specific competencies in these areas without resorting to extraordinary price cuts.

Denny: Got it. Thank you. Thank you. And thank you. Our next question online comes from Douglas Fow from H.C. Wainwright. Please go ahead.

Unknown Caller: Hi, good afternoon; thanks for taking the questions. Just, Danny, you know, so much of the strategy, certainly in the success that you've enjoyed, both with Eannica and hopefully with some of the other biasmuch as they come to market, has been driven by their sort of outreach to payers. I'm just curious, you know, since you've moved ahead in the PD1 market and immunolology, have you engaged with payers extensively and talked to them about this sort of opportunity to sort And what are they looking for and what is their receptivity, given the significant increase in spend in the immune oncology category?

Denny: Thank you. Thanks for the question, Doug. You know, I think that the first thing that we're going to do is get Tora Palmaab approved as an orphan indication. It's got breakthrough status. And so we don't see a need to position it as a value brand, per se, given this indication going forward. How things roll out in the future will be dealt with in the future as they come. But I think the main thing to focus on here, though, is that Tora Pelamab really is being extraordinary.

And it's going to get sort of upheld and have approved and it's an orphan indication, it's kind of a breakthrough status and so we don't we don't see.

And the need to position it as the value brand per se given the syndication going forward, how things roll out of the future of will handle and the future as they come but I think the main thing to focus on here, though is that tour of Palomas really has been extraordinarily validated and the number of way.

Denny: It is nearly validated in a number of ways. You know, it got breakthrough status from the FDA, the selection at ASCO for the plenary session, the additional approvals in China, uh, Juni-Bio Sciences distribution agreement with AZ in China, and so on. And so, we feel that we have a very, very strong molecule on our hands.

Got.

Got breakthrough status from the FDA the selection of the Azgul for the plenary session. The additional approvals in China.

And Junichi Biosciences, the distribution agreement with a Z and China and so on and so we feel that we are of very very strong molecule on our hands, we'll be able to address each of these indications as they come up.

Denny: We'll be able to address each of these indications as they come up. Okay, great. Thank you. Thank you. And our next question online comes from Jason McCarthy for Maxim Group. Hey, this is Michael Cunwich on the line for Jason.

Yeah.

Okay, great. Thank you.

Yeah.

Thank you and our next question on line comes from Jason Mccarthy from Maxim Group.

Hey, this is Michael accumulates on the line per Jason. Thank you for taking my question.

Unknown Caller: Thank you for taking my question. So I'd like to see on Eugenica if you could provide a bit more color on how the pricing and reimbursement breaks down between Udenica and Nulastin now. I know you touched on that a bit before, but could you provide a bit more color?

And I'd like to see.

On your Denny cause if you could provide a bit more color on how the pricing and reimbursement breaks down between you Denny kind of on new left and now I know you touched on out of it before but could you provide a bit more color.

Unknown Caller: Thank you for the question. Perhaps Paul or Chris have the actual ASP numbers for Eugenica. One of those has recently been published, Udenica versus Nelasta.

Yeah.

And thank you for the thank you for the question.

All of our crews have the.

The actual ASP numbers for you of Deneke and of that very simple punish you don't cut versus the last of the Paul do you have the.

Paul Reider: Paul, do you have those? Yeah, how are you doing, Michael? Yeah, I think, you know, the second quarter published prices will be coming out soon. But, you know, looking at Q1, which was publicly available, New Lasta had, you know, the lowest ASP published price amongst all of the biotechs, the Peggill Grasdom set, just a little over $2,900. So, you know, as Chris mentioned, many of these segments are cost recovery sensitive, so, you know, they look at both cost and reimbursement on that.

How are you doing Michael Yes, I think.

The second quarter of published price as well.

Be coming out soon but looking at Q1, which were publicly available new line.

The.

The lowest asps published price.

Amongst all of the bar on the Pegfilgrastim set and just little over $2900. So.

And so from a as Chris mentioned.

Many of these segments are.

Quite a recovery sensitive so they looked at the cost and and.

And the reimbursement on that so.

Paul Reider: So, but, you know, I'll refer you to Amgen's earnings report, you know, for specifics around their specific or specific ASP declines year over year-over-year-a-quarter report. But we, I think it's fair to say that we have exercised ASP in pricing discipline. We've talked about that a lot, that's showing up in the numbers, and our ASP is well aware of that. All

But the.

I'll refer you to amgen's.

Earnings reported for specifics around the specific ASP declines year over year and quarter over quarter.

But I think it's fair to say that we have exercised on.

The ASP and pricing discipline, we've talked about that a lot that's showing up in the numbers and our.

Our ESP is well above that of Amtrust.

Yeah.

Yeah.

Thank you and then.

Unknown Caller: And then... On the competition in the biosimilar space, historically, you know, the idea has been that new entries come in, and they're going to take share from New LESTA rather than from each other. However, with Amgen taking the, you know, ASP leadership position, does that change the calculus at all when looking at the competitive dynamics? Yeah, Paul, do you want to take that one?

On on the competition and the Biosimilar space, historically and I'm. The idea has been that new entries come in and they're going to take share from new left the rather than from each other however, with Amgen and taking the <unk>.

ASP leadership position does that change the the.

And the calculus at all when looking at the competitive dynamics.

Yeah.

Yeah, Paul do you want to take that one yeah sure Michael Yeah, I mean.

Paul Reider: Yeah, sure, Michael. Yeah, I mean, it's pretty expected that a lot of these biosimilars will compete for the overall share. But, you know, I think with COVID and the pandemic favoring the on-body device, it caused this competition for the segment that was really for pre-filled syringes.

And.

With its pretty expected with a lot of these.

Biosimilars to compete for the overall share of it I think with COVID-19 and.

And the the pandemic favoring the on body device with the.

Cause of this competition for the.

And the segment, which was really for Prefilled syringes.

Paul Reider: And we own that second. We're the number one Peggfield Grasthan Biosimilar. And now that COVID's receding, you know, we believe that's why we're in the strongest position to be able to go after that 54% on pro share, which is available to the market. So, you know, that's our focus; we're not, you know, focused on the newer entrance. Our focus is on taking a share from the originator, who has two-thirds of the business.

And we do not something we're the number one pegfilgrastim biosimilar and now the COVID-19 receding. We believe that's why we're and the strongest position to be able to go after the 54% on pro share, which which is.

Book to the market so.

So that's our standard where we're not.

Focused on the.

The newer entrants our focus is on taking share from the originator who is two thirds of the business.

Alright, Thank you very much.

Paul Reider: All right, thank you very much. Thank you. Thank you. And our last question comes from Greg Gilbert from Truest Security. This is the other Greg Gilbert from Truist, with a follow-up here.

Okay.

Thank you.

And our last question comes from Gregg Gilbert from true of Securities.

Yes, Hi, this is the other Greg from trust with the follow up here on two part question and one is on revenue.

Unknown Caller: Two-part question. One is on revenue. Do you want investors to take away that you expect to sell more than four times the Q1 level of Edenica? I just want to make sure you have the opportunity to kind of set the stage here and reduce variability of estimates. But it sounds like a second half higher than the first half means, most likely, that your sales would be higher than Q1's sort of run rate.

Do you want investors to take away that you expect to sell more than four times. The Q1 level of Atlantica I just wanted to make sure you have the opportunity to kind of set the stage here and reduce variability of estimates, but it sounds like second half higher than first half means most likely that your sales would be higher than Q1's sort of run rate. So that's part one per.

Unknown Caller: So that's part one. Part two is, Denny, about interchangeability. We may see for the first time ever, well, the biggest drug ever to see biosimilar competition, but you may also see a mix of interchangeable biosimilars and many that are not. Are you pursuing interchangeable status? I think you're not, but I'm curious about your views as to whether you would consider it and whether you think it matters. Thank you so much. That's a great question.

Two as Denny about interchange ability.

We may see for the first time ever well the biggest drug ever seen by some of the competition, but you may also see of mix of interchangeable biosimilars and many of that or not.

Are you pursuing and or are you pursuing interchangeable status I think youre not but I'm curious on your views as to whether you would consider it and whether you think it matters. Thank you so much.

And that's a great question, let me ask let me answer the second question before the first.

Denny: Let me answer the second question before the first. First, I think it's important to keep in mind that interchangeability has thus far not been a requirement at all to support biosimilar adoption. Secondarily, what we would say is that our payer research indicates that interchangibility will not be a major impediment to biosimilar adoption, specifically in the Humira market. We expect the players to be very, very active in that market, but we don't expect the requirement to be interchangeability or not.

First I think it's important to keep in mind that interchange ability. Thus far has not been a requirement at all of the support and Biosimilar adoption.

Secondarily, what we'd say is that our payer research indicate that entered the pain changeability will not be of major impediments to biosimilar market Biosimilar adoption, specifically and the Humira market and we expect the parent to be very very active and that market, but we don't expect and they were.

Requirement.

To be interchange ability or are not.

Denny: And the third thing I would say is, you know, there are no interchangeability requirements in Europe, and that has impeded biosimilar adoption there whatsoever. So, you know, we don't really think so, and no, we are not seeking biosimilar requirements, or an interchangeability study or investing in such. We don't believe it's required. With respect to first half versus second half revenues, I'll let McDavid comment on that. Yeah, I think another way of phrasing your question is whether or not you can take your first quarter revenue and multiply it by four.

And the third thing I would say as you know theres not interchange ability of requirements in Europe and that hasn't impeded biosimilar adoption there whatsoever.

I don't we don't really think so and now we are we are not seeking the biosimilar.

The interchange ability study or to invest and such we don't believe its required with respect to first half versus the second half revenues and I'll, let Nick David to comment on that.

I think another way of phrasing. Your question is whether or not we can you can take first quarter revenue and multiply it by four and I would say no. We expect that the second half will have higher revenues as we penetrate into the on from market.

McDavid Stilwell: And I would say no, we expect that the second half will have higher revenues as we penetrate the pro market. Of course, that's dependent on the overall pricing environment, but we believe that revenues will rise in the second half. Thank you. Is that fine?

Of course, that's dependent on on the overall pricing environment, but we believe the revenues will rise and the second half.

Yeah.

Yeah.

Yeah.

Yeah.

Yeah.

Definitely the great. Thank you.

Denny: Okay, great. We've no further questions at this time. I'd like to turn the call over to Denny Landpair for closing comments. Thank you all very much for joining us today on our Q1 call. As you can see, I think we're making excellent progress with respect to Malapah, and I think the Juni-She transaction going forward will turn out to be a very positive one for the company, particularly since it is now apparent that we have a very high-quality asset, which I think will give us a lot of readouts with respect to clinical programs over the next six to 12 months.

The good great. Thank.

We have no further questions at this time I'd like to turn the call over to <unk> for closing comments.

Thank you all very much for joining us today on our Q1 call and.

As you can see I think we're making excellent progress with respect to our Malibu and I think the the June she transaction going forward will turn out to be a very positive one for the company, particularly since we are now parent and we have a very high quality assets and.

Which I think well and.

Give us a lot of readouts with respect to the clinical programs over the next six to six and 12 months and we look forward to seeing you all on our next call will be at Bank of America and also will have a few things to say on our R&D day, which will be towards the end of the year, most likely in Q4 and well give you some additional Colorado.

Denny: And we look forward to seeing you all on our next call. We'll be at Bank of America, and also we'll have a few things to say on our R&D day, which will be towards the end of the year, most likely in Q4. We'll give you some additional context around a few things.

Few things thank you.

Denny: Thank you. And thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.

Yeah.

And thank you ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.