Q4 2021 Coherus BioSciences Inc Earnings Call

Operator: Good day and thank you for standing by. Welcome to the fourth quarter and full year 2021 Coherus BioSciences earnings conference call. At this time, all participants are in a listen-only mode.

Good day, and thank you for standing by welcome to the fourth quarter and full year 2021 quarters Biosciences earnings Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star one on your telephone please be advised that today's.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star one on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then zero.

Conference May be recorded if you require any further assistance. Please press Star then zero I would now like to hand, the conference over to your host today Mcdavid Stilwell Chief Financial Officer. Please go ahead Sir.

McDavid Stilwell: I would now like to hand the conference over to your host today, McDavid Stilwell, Chief Financial Officer. Please go ahead, sir. Thank you, operator. Good afternoon, everyone. And thank you for joining us. We issued our press release earlier announcing our 2021 fourth quarter and full year results. This release can be found on the Coherus BioSciences website. Today's call includes forward-looking statements regarding Coherus' current expectations about future events. These statements include, but are not limited to, our ability to advance our product candidates through development and registration, the status of our product candidate clinical profile, our timing and ability to commercialize our products and product candidates in the future, our R&D and SG&A expense guidance for 2022, and our ability to meet the same, our projections about margin, as well as our ability to draw down amounts under our new credit, All of which involve substantial risks and uncertainties that are beyond our control and could cause actual results. Performance or Achievements to differ from the results, performance or achievements complied by the forward-looking statement.

McDavid Stilwell: These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in our press release that we issued today, as well as in the documents that we file with the Securities and Exchange Commission, including those in our annual report on Form 10-K and quarterly reports on Form 10-Q. The forelooking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forelooking statements.

Thank you operator, good afternoon, everyone and thank you for joining us.

We issued our press release earlier announcing our 2021 fourth quarter and full year results.

Release can be found on the coherent biosciences website.

Today's call include forward looking statements regarding <unk> current expectations about future events.

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

<unk> of our product candidate clinical profile, our timing and ability to commercialize our products and product candidates in the future our R&D and SG&A expense guidance for 2022, and our ability to meet the same our projections about margin as well as our ability to drawdown amounts under our new credit facility all of <unk>.

Which involve substantial risks and uncertainties that are beyond our control and could cause actual results.

Performance or achievements to differ from the results performance or achievements implied by the forward looking statements.

These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in our press release that we issued today.

As well as in the documents that we file with the Securities and Exchange Commission, including those in our annual report on Form 10-K , and quarterly reports on Form 10-Q .

The forward looking statements provided on the call today are made as of this date and we undertake no duty to update or revise any forward looking statements.

McDavid Stilwell: With me on today's call are Dennis Lanfear, CEO of Coherus, Paul Reider, Chief Commercial Officer, and Theresa Lavallee, Chief Development Officer. I will now turn the call to bidding. Thank you, McDavid, and thank you all for joining us this afternoon.

With me on today's call are getting Lanphier, CEO Erez, Paul Reeder, Chief Commercial officer, and Theresa Modality, Chief Development Officer.

I will now turn the call continuing.

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

Dennis Lanfear: Today I'll describe how, over the past year, we've delivered on our objective to transform Coherus into an innovative immuno-oncology company. Supported by income from a diversified portfolio of FDA approved products. I'll begin today with a brief review of our achievements toward our strategic initiative in the immuno-oncology, detailing the progress of our foundational assets, or PowMED, and of our pre-clinical and clinical-stage innovative combination agents. General Review recent progress to grow and diversify our commercial portfolio.

Today I'll describe over the past year, we've delivered on our objective to transform coherence and to an innovative immuno oncology company supported by income from a diversified portfolio.

The approved products.

I'll begin today with a brief review of our achievements towards our strategic initiatives in immuno oncology.

E tailing the progress of our foundational assets of our Belmont.

And of our preclinical and clinical stage innovative combination agents.

Dan will review recent progress to grow and diversify our commercial portfolio.

Dennis Lanfear: Now, with respect to our immuno-oncology programs, you may recall that in November, we announced the FDA-granted priority review for the BLA for TOR-PALMAP for the treatment of nasal pharyngeal carcinoma, an indication for which TORP-LMAB has breakthrough therapy and orphan drug designation, and the BLE review is progressing well towards the target action date of April 30th, which is about 10 weeks from now.

Now with respect to our immuno oncology programs you may recall that in November we announced the FDA granted priority review the BLA for <unk>.

Treatment of nasopharyngeal carcinoma.

And indications with no FDA approved cancer immunotherapy options and for which <unk> has breakthrough therapy and orphan drug designation.

The BLA review is progressing well towards the target action date of April 30.

About 10 weeks from now.

Dennis Lanfear: Toropallimab's clinical profile continues to strengthen across indications. In December, we announced that Toropallimab plus chemotherapy demonstrated a statistically significant overall survival benefit, in a pre-specified interim analysis of the CHOICE-1 clinical trial for the first-line treatment of advanced non-small cell lung cancer. This builds on other first-line indications in esophageal squamous cell carcinoma and nasal pharyngeal carcinoma where we have seen a robust benefit in both the progression-free survival and overall survival.

Sure Palomas Coca profile continues to strengthen across indications in December we announced the <unk> plus chemotherapy demonstrated a statistically significant overall survival benefit.

A prespecified interim analysis in the choice one clinical trial for the first line treatment of advanced non small cell lung cancer.

This builds on other first line indications and esophageal squamous cell carcinoma, and nasopharyngeal carcinoma, where we have seen a robust benefit both the progression free survival and overall survival.

Dennis Lanfear: We've also made progress with our clinical stage. Mid-Stage IO Asset Strategy, In January, we initiated the process to exercise our option license, JS006. A TIGID-targeted antibody developed by Jun-Chi Biosciences, our partner, which they are evaluating in a study combination with Toropalmib.

We've also made progress with our clinical stage.

Stage Io asset strategy.

In January we initiated a process to exercise our option and license.

006.

<unk> targeted antibody developed by June <unk> Bioscience as a partner.

Which they are evaluating study combination with propel map.

Theresa Lavallee: Dr. Theresa Lavallee, our new Chief Development Officer, will provide additional details about JS006 and our development plans for you in just a moment. Our immunology preclinical research and development team is proving to be highly productive. In January, we announced that we're advancing an internally generated pipeline of PD-1 combination candidates, and we expect to file the first IND, in mid-2023. With Tora Palmev nearing its first potential approval, a tiget-targeted immune checkpoint blocker entering mid-stage development, and our in-house, early-stage immuno-oncology candidates successfully advancing towards human clinical trials, Coherus is evolving into an innovative immuno-oncology company with a broad pipeline of product candidates and the potential to drive long-term growth over this decade.

Dr. <unk> <unk>, our new Chief Development Officer, who will provide additional details about <unk> and our development plans for you just a moment.

Our immuno oncology preclinical research and development team has proven to be highly productive.

In January we announced that we are advancing an internally generated pipeline a PD one combination candidates and we expect to file the first R&D.

In mid 2023.

With tour Palmetto nearing its first potential approval.

Target an immune checkpoint blocker and are in mid stage development and our in house early stage immuno oncology candidates.

Hopefully advancing towards human clinical trials.

<unk> is evolving into an innovative immuno oncology company with a broad pipeline of product candidates and the potential to drive long term growth over this decade.

Theresa Lavallee: I'd now like to introduce Dr. Theresa Lavallee, a recently appointed Chief Development Officer who brings more than 25 years of drug discovery and development experience and is recognized for her immuno-oncology expertise. Most recently, Dr. Lavallee was Vice President of Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy, where she provided scientific leadership for the clinical strategy for development of novel gynecology therapies and helped establish the Institute's translation and regulatory organization. Prior to that, from 2008 to 2013, Dr. Lavallee was a member of the immunology team developing checkpoint inhibitors and related diagnostics at MedImmune in AstraZeneca. Thank you, Demi.

I'd now like to introduce Dr. <unk> <unk>, our recently appointed Chief Development Officer, who brings more than 25 years of drug discovery and development experience and is recognized for her immuno oncology expertise.

Most recently Dr. The Valley was vice President of translational Medicine, and regulatory affairs at the Parker Institute for cancer Immunotherapy, where she provided scientific leadership for our clinical strategy for development of novel immuno oncology therapies and help establish institutes translation.

And regulatory organization.

Part of that from 2008 2013, Dr. <unk> was a member of immuno oncology team developing checkpoint inhibitors and related diagnostics at Medimmune and Astrazeneca.

Theresa Lavallee: It is exciting to join Coherus as the company gains momentum in its transition to an innovative immuno-oncology leader. I believe our broadening product portfolio with early, mid, and late-stage complementary I.O. products is well-positioned to clinically succeed in immuno-oncology. Commercially, our oncology-focused organization has proven that Coherus can be very successful in highly competitive fields. Coherence has both the in-house expertise and assets needed to support a successful transformation. Antibody development for BD1 combinations and co-formulations requires world-class analytics, protein science, and bioinformatics capabilities. We have that at our Camarillo, California site, a 25,000 square foot facility we moved into two years ago.

Teresa.

Thank you Kenny.

It is exciting to join.

Okay.

In addition to an innovative immuno oncology either.

I believe our broadening product.

Early.

And late stage complementary.

<unk> is well positioned to clinically.

Oncology.

Commercially our oncology focused organization.

Suzanne.

This can be buried.

And the competitive field.

So here it has both the India, Turkey and asset needed to support a successful.

Transformation.

Antibody development for PD, one combination in California.

We acquired World class analytics printing.

And for Matt Bioinformatics capability.

We have that at our Canton, Ohio, California site, and 25000 square foot facility, we moved in Q2 years ago.

Theresa Lavallee: On the development side, our clinical and regulatory teams have repeatedly demonstrated the ability to develop drugs that gain FDA approval. Our scientific advisory board of recognized I-O experts from academia and industry is actively involved in our target and moiety selection, playing a key role, for example, in selecting Tora Palamab from a due diligence review of more than 10 PD-1 product candidates, as well as vetting the Tidget asset from Junxi. Oh, for Coherus, these investments are paying off.

On the development side.

Clinical and regulatory teams have repeatedly.

Demonstrating the ability you can develop tret.

FDA approval.

Our scientific Advisory Board is recognized.

From academia and industry.

Secondly involved and our target selection.

A key role for example, when selecting our talent.

<unk> more than 10, PD, one can't product candidates as well as bad in the kitchen.

Tianjin.

These investments are paying off.

Theresa Lavallee: Tora Palamab, our foundational immuno-oncology asset, is establishing an excellent safety and efficacy profile in the ongoing clinical trial. The torepalumab BLA for nasopharyngeal carcinoma and unmet medical need with no approved immunotherapy is under priority review by the FDA with an action date of April 30th. Denny mentioned earlier that Tora Palamab's clinical profile continues to strengthen across indications. Case in point, the positive progression-free survival in overall survival data from the Jupiter-6 study in a sausage yield swaying the cell carcinoma, which showed a significant overall survival benefit, even in low PDL-1 patients.

<unk> Allomap, our foundational immuno oncology asset.

Establishing an excellent safety and efficacy profile and the ongoing clinical trials.

The Torah talent BLA for nasopharyngeal carcinoma.

Unmet medical need with no approved.

<unk> therapy is under priority review by the FDA with an.

Action date of April 30th.

Danny mentioned earlier at toward Palomar.

<unk> continues to strengthen across indications.

Case in point, a positive progression free survival overall survival data from the <unk> study and esophageal squamous cell carcinoma, which showed a significant overall survival benefit even in low PD lone patients.

Theresa Lavallee: We have and will continue to engage the FDA on the potential for submission later this year of a supplemental BLA for Tauropalumab in combination with chemotherapy for first-line treatment of ESCC. Another important immune-responsive tumor type is hepatocellular carcinoma, which also is highly prevalent in patients of Asian descent, and which the FDA has said could warrant regulatory flexibility for new PD-1.

We have and will continue to engage the FDA on the potential for submission later this year.

Supplemental BLA for <unk> in combination with chemotherapy.

First line treatment of <unk>.

<unk>.

Another important immune responsive tumor types, it's a patent cellular carcinoma, which also is highly prevalent in patients of Asian descent.

And which the FDA has been good.

<unk>.

Regulatory and flexibility for new PD one.

Theresa Lavallee: We are conducting two pivotal clinical trials evaluating toropalumab and HCC, including a frontline trial randomizing approximately 520 advanced HCC patients to limbatinib and placebo versus limbatinib plus toropalumab. In adjuvant therapy, we have a trial with approximately 400 HCC patients randomized to toropalumab or placebo following resection. Initial clinical data from these studies are expected later this year. The February 10th ODAC meeting discussing the Inovent Glyly PLA for non-small cell lung cancer provided helpful insights into the FDA's expectations for sponsors seeking approval for PD-1s for indications with available immunotherapy options.

We are conducting two pivotal clinical trials evaluating <unk> in HCC, including a frontline trial randomized approximately 520 <unk> and <unk>.

HCC patients to lend that placebo versus lift that NIM plus <unk>.

And adjuvant therapy, we have a trial with approximately 400 HCC patients randomized to <unk> or placebo following resection.

Initial clinical data from these studies are expected later this year.

The February 10th.

In discussing the event Lilly BLA for non small cell lung cancer provided helpful insights SBA expectation for sponsors seeking approval for PD, one for indications with available immunotherapy options.

Theresa Lavallee: We believe it is wise to fully engage with the FDA early and prior to submission decisions to fully understand their views. We are continuing to meet with the FDA frequently for toropalumab for multiple potential indications, and we'll discuss with them this year the pathway for toropalumab in combination with chemotherapy for first-line treatment of non-small cell lung cancer. Although there are FDA-approved checkpoint inhibitors for non-small cell lung cancer, new and more effective treatment options are needed as the majority of patients still die rapidly from this deadly disease.

We believe it is wise to fully engage with the FDA early and prior to submission decision fully understand their views.

We're continuing to meet with the FDA frequently for tomorrow.

Potential indications.

We'll discuss with them this year the pathway for Allomap in combination with chemotherapy for first line treatment of non small cell lung cancer.

Although there are FDA approved checkpoint inhibitors for non small cell lung cancer, new and more effective treatment options are needed at the majority of patients still die rapidly.

Theresa Lavallee: We are focused on addressing unmet patient needs. The non-small cell lung cancer will be the first tumor type we pursue for the combination of toropalumab with JS006. We are excited about the development of this TIGID antibody. TIGID is emerging as an important checkpoint to enhance PD-1 anti-tumor immunity. After a decade of translational research with IO, the field understands better how PD-1 inhibitors work and why they have been foundational for IO treatment.

Deadly disease, we are focused on addressing unmet patient need to non small cell lung cancer will be the first tumor type we pursue for the combination of <unk> with <unk>.

We are excited about the development of a kitchen antibody.

Ticket is emerging as an important checkpoint to enhance PD, one anti tumor immunity.

After a decade of translational research with IL the field to understand better how PD, one inhibitors work and why they have been foundational for I O treatment.

Theresa Lavallee: Cancers trick attacking T cells into shutting off prematurely. A subset of T cells that exhibit stemness have the potential to be reactivated by the unique crosstalk between PD-1 and TIGIT pathways. All of this is consistent with the observed improved clinical activity with PD-1 and TIGID inhibitors in the clinic and specifically in non-small cell lung cancer. In preclinical studies, JS006 has demonstrated excellent binding affinity and strong inhibition of the TIGIT pathway, as well as enhanced anti-tumor activity in combination with toropalumab in preclinical mouse models. A clinical study evaluating JS006 as monotherapy and in combination with toropalumab in patients with advanced pellet tumors is ongoing.

Panther strengths attacking T cells into studying prematurely a subset of T cells that exhibit 10 minutes at the potential to be reactivated by the unique cross talk between PD, one and ticket pathways.

All of this is consistent with the observed in previous clinical activity with PD, one and <unk> inhibitors in the clinic and specifically in non small cell lung cancer.

In preclinical studies <unk> has demonstrated excellent binding affinity and strong inhibition of strategic pathway as well as enhanced anti tumor activity in combination with <unk> or about <unk>.

Taliban in preclinical mouse models, a clinical study evaluating <unk> as monotherapy and in combination with <unk> in patients with advanced solid tumors on belly.

Theresa Lavallee: The IND for JS006 is open in the United States, and we are planning to advance JS006 in combination with toropalumab in a clinical trial in the U.S. later this year. Clinical data news flow will continue this year as results come in from trials evaluating tumor polymaths for first-line treatment of small cell lung cancer and two additional non-small cell lung cancer studies, one in the neoadjuvant setting, as well as a trial in patients with EGFR mutations who have failed prior TKAI therapy. And also pivotal studies in triple negative breast cancer, hepatocellular carcinoma, and interhepatic phalangeal carcinoma.

Indeed for gas.

Opened in the United States, and we are planning to advance Jan.

In combination with <unk> in a clinical trial in the U S. Later this year.

Clinical data needed to play will continue this year as results come in from trials evaluating all of that.

First line treatment in.

Small cell lung cancer and two additional non small cell lung cancer study one in the neo adjuvant setting as well as a trial in patients with Egfr mutations who have failed prior <unk> therapy and also pivotal studies in triple negative breast cancer, a patent cellular carcinoma.

A man and.

Interest hepatic cholangiocarcinoma.

Dennis Lanfear: Depending on clinical outcomes and conversations with the FDA, these studies could lead to additional indications for toropalumab in the United States. I will now turn the call back to Denny. Thank you, Theresa. It's great to have you on the team directing our mid to late stage IO development effort. Now, let me briefly summarize our recent accomplishments with respect to our commercial stage portfolio and our goal to grow and diversify our commercial portfolio of FDA approved products.

Pending on clinical outcomes in conversations with the FDA. These studies could lead to additional indications for <unk> in the United States.

Ill now turn the call back to Denny.

It's great to have you on the team directly on our mid to late stage I O development efforts.

Now let me briefly summarize our recent accomplishments with respect to our commercial stage portfolio and our goal to grow and diversify our commercial portfolio FDA approved products.

Dennis Lanfear: As you may recall, in December, the FDA approved our second product, eSimer, or you might have heard about eSimer. All will address our planning for this important launch in 2023 and some of the key issues we are considering to ensure that we reach our market share objective. Thankful grass the market continues to be very important to us and has only about 50% biosimilar penetration in terms of presentation segment mix. We have had good success with additional presentation and development to address all the psych... In October, a Udenica on-body injector demonstrated pharmacokinetic and pharmacodynamic similarity in a randomized clinical trial, enabling the submission this year of a prior approval supplement to the Udenica BLA.

You may recall in December the FDA approved our second product <unk>.

Thank you Myra Biosimilar.

Paul will address our planning for this important launch in 2023 and some of the key issues. We are considering to ensure that we reach our market share objectives.

Thank you congrats to market continues to be very important to us and is only about 50% biosimilar penetration in terms of presentation segment mix.

We've had good success with additional presentations in development to address all of the segments.

In October you Danica on body injector demonstrated pharmacokinetic and pharmacodynamic similarity in a randomized clinical trial.

The submission this year of a prior approval supplement to the authentic a BLA.

Paul Reider: If it is approved, we project that 2023 launch of the Eugenica OnBody Injector, which would compete directly with Nuance Design Pro, which would provide a second wave of growth for Eugenica. Identica and the prefilled syringe format continue to provide a significant source of funding for our pipeline investments and support upcoming commercial launches. Net sales of Eugenica declined to $73 million in the fourth quarter within the context of increasingly competitive tech-focused markets.

If it is approved we project that in 2023 launch zeneca on body injector, which would compete directly with nuance designed probe.

Which would provide the second wave of growth pretty identical.

<unk> in the pre filled syringe format continues to provide a significant source of funding for our pipeline investments and support upcoming commercial launches.

Net sales to be deneke declined to $73 million in the fourth quarter.

Within the context of increasingly competitive pegfilgrastim market.

Dennis Lanfear: We anticipate Ugenica net revenue in 2022 will decrease relative to the $327 million of net revenue generated in 2021. Our strategy is to balance price and market share to optimize long-term revenues with the PFAS format in 2022 and then gain significant share through the accessing the untapped bond buying segment in 2023. In October 2021, the FDA accepted for review DVLA for similarly our Lucentis biopsy. Mid-cycle review meeting occurred recently, and the BLA is progressing well towards the target action date in August this year.

We anticipate <unk> net revenue in 2022 will decrease relative to the $327 million of net revenue generated in 2021.

Our strategy is to balance price and market share to optimize long term revenues.

Format in 2022.

And then getting significant share through the accessing untapped on by these segments in 2023.

In October 2021, the FDA accepted for review the BLA.

For Kimberly.

Our Lucentis biosimilar.

Mid cycle review meeting occurred recently and the BLA is progressing well towards the target action date in August this year.

Dennis Lanfear: As Paul will elaborate, we plan to launch similarly in the second half of this year, assuming approval. We are also planning for the launch of ToroPalMab and MPCMaker, further diversifying our product portfolio. These two launches in 2022 should be followed by the two 2023 launches of USIMRIC and the Udenica OnBody Injector. Accelerating the Revenue Growth. We expect these four new products to mark an inflection point for revenues, fueling top line growth starting later this year.

Paul will elaborate we plan to launch similarly in the second half of this year assuming approval.

We are also planning for the launch of Torre <unk>.

Further diversifying our product portfolio in 2022.

These two launches in 2022 should be followed by the to 2023 launches of your summary, deneke on body injector accelerating our revenue growth.

We expect these four new products to market inflection point for revenues fueling top line growth starting later this year.

Paul Reider: We expect growth to continue with the potential expansion of the Toropalumab label and project longer-term growth with the JS006-Toropalumab combination and our Innovative IO Pipeline to be discussed. I'll now turn the call over to Paul Reider, our Chief Commercial Officer, and Paul will review EDENICA's fourth-quarter performance and update you on the launch preparation for ToroCalMED, Simili, and Yose Paul.

We expect growth to continue with the potential expansion towards <unk> label and project long longer term growth with the Chaz Jones zero six propelling <unk> combination.

And our innovative Io pipeline, we discussed.

I'll now turn the call over to Paul Reader, our Chief Commercial Officer, and Paul will review <unk> fourth quarter performance and update you on the launch preparation for palmette, Similarly, and Zimmer Paul.

Paul Reider: Thank you, Danny. As Denny indicated previously, UdeticaNet sales were $73 million in the fourth quarter, down 12% from the prior quarter. This was driven by a 4% decline in demand units, as well as continued price erosion due to intense competitive pressures in the PEG progressive pre-purchase surge market. Our share declined slightly from 18% to 17.5% in the fourth quarter. Market share gains in the clinic segment were offset by declines in both 340B and non-340B hospitals. On a units basis, the overall Pennsville grass-to-market declined modestly in the fourth quarter, period in which historically we've seen slight market growth.

Thank you Debbie.

As Denny indicated previously <unk> net sales were $73 million in the fourth quarter down 12% from the prior quarter.

This was driven by a 4% decline in demand units as well as continued price erosion due to intense competitive pressures in the paid progressed deeply search firm.

Our share declined slightly from 15% to 17, 5% in the fourth quarter.

Market share gains in the clinic segment were offset by declines in both <unk> and non 300 <unk> hospitals.

On a units basis, the overall pegfilgrastim market declined modestly in the fourth quarter.

A period in which historically, we've seen slight market growth.

Paul Reider: We expect to return to low single-digit market growth in 2022. Until COVID recedes more broadly, there will continue to be a short-term advantage favoring the originators on body to body. Retains approximately 50% share of the overall market. As Denny indicated, we expect Udenica's sales to grow again once we introduce our Udenica on-body injector next year, if approved. Our strategy is to balance price and market share to optimize long term revenues with the PFS format in 2022, and then gain significant share through accessing the untapped on-body segment in 2023.

We expect to return to low single digit market growth.

In 2022.

Until COVID-19 receipts more broadly there.

It will continue to be a short term advantage favoring the originators on body device, which retains approximately 50% share of the overall market.

As Tony indicated we expect to Delek us sales to grow again, which we introduced our identical on body injector next year if approved.

Our strategy is to balance price and market share optimize long term revenues with the PSS PFS format in 2022.

<unk> gained significant share through accessing the untapped on body segment in 2023.

Paul Reider: Now I'd like to talk about commercializing our pipe. We are preparing for the launch of three new brands in the next 18 months. For palimab or PD-1 inhibitor for nasal pharyngeal carcinoma, Simmerly or Lucentis Biosimilar, and Eucimbry or Humira Biosimilar.

Now I'd like to talk about commercializing a pipe.

We are preparing for the launch of three new brands in the next 18 months towards <unk>, our PD one inhibitor for nasopharyngeal carcinoma. Similarly, our Lucentis biosimilar.

<unk>, our Humira biosimilar.

Paul Reider: Regarding Tor Palma, Papal pharyngeal carcinoma, where NPC is a rare cancer, where there are currently no PD-1 inhibitors approved for use by the FDA, where Palomav not only has the potential to be the first and only PD-1 inhibitor indicated for this tumor type, but has the potential to also establish a new first-line standard of care. Our oncology commercial capabilities have been built to scale and the Tor Pellimab launch effort will be efficiently integrated into our existing commercial infrastructure.

Regarding to propel them.

Nasal pharyngeal carcinoma NPC is a rare cancer.

There are currently no PD one inhibitors for use by the FDA.

Hello, Matt not only has the potential to be the first and only PD one inhibitor indicated for this tumor type.

Has the potential to also establish a new first line standard of care.

Our oncology commercial capabilities built to scale and the tour Pelham launch effort will be efficiently integrated into our existing commercial infrastructure.

Paul Reider: Commercial Launch Preparations and Proceeding on Track. I'd also like to note that the NCCN guidelines for nasal pharyngeal carcinoma recently added the Jupiter 02 study of torepalumab for the first line treatment of NPC as a reference, serving to validate the significance of this important clinical trial.

Commercial launch preparations are proceeding on track.

I'd also like to note that the NCC guidelines for nasal pharyngeal carcinoma.

Recently added the Jupiter's two study of towards element for the first line treatment of MPC as a reference which serves to validate the significance of this important clinical trial.

Paul Reider: And with respect to Simmerly, our FDA auction date in August 2022 will allow us to launch into the 1.4 billion Lucentis market in the early stages of biosimilar market formation, and we look forward to competing in the retina therapeutic area. Retinal specialist opinion leaders have expressed positive receptivity to Coherus entering this market, and our documented track record of success in oncology give them confidence. Coherus understands the dynamics of the buy and build market and that we will deliver a safe and effective alternative to Lucentis, along with a compelling value proposition.

But with respect to similarly, our FDA action date in August 2022.

Will allow us to launch into the one 4 billion. We sent this market in the early stages, the Biosimilar market formation, and we look forward to competing in this therapeutic area.

Retinal specialist opinion leaders have expressed positive receptivity to careers entering this market.

That are documented track record of success in oncology gives them confidence that coheres understands the dynamics of the biofuel market.

And that we will deliver a safe and effective alternative lucentis.

Along with a compelling value proposition.

Paul Reider: Similar to our playbook with Udenica, we plan to launch a similar education campaign to the retina community in the second quarter. We've also completed our account segmentation work and intend to launch with a focused and dedicated ophthalmology sales, while at the same time leveraging our commercial organization's existing key account, market access, and patient support capabilities. Now on to Yosemite.

Similar to our playbook with Utica, we plan to launch a similar education campaign to the retina community in the second quarter.

We've also completed our account segmentation work and intend to launch with a focused and dedicated ophthalmology sales team while.

While at the same time, leveraging our commercial organization's existing key account market access and patient support capabilities.

Paul Reider: We're preparing for the launch in July 2023. Primera has been the top selling drug in the United States with net sales of $17 billion in 2021, and we look forward to competing in this market. While we expect significant competition, our commercial goal is to achieve at peak at least 10% share of the overall Aluminum AdMark.

Now onto your summary, with preparing for the launch in July 2023.

Humira has been the top selling drug in the United States with net sales of $17 billion in 2021, and we look forward to competing in this market.

While we expect significant competition, our commercial goals to achieve a peak at least 10% share of the overall and I believe in that market.

Paul Reider: We believe PAIRS will drive biosimilar adalumumab adoption and have completed extensive market research with national and regional PAIRS as well as PBM. The insights gleaned from this research confirm that Coherus can and expects to deliver on all of the payers' critical expectations. These include a competitive price that delivers value to key stakeholders. Robust and reliable supply with high quality manufacturing, a non-stinging, citrate-free formulation. Pre-filled syringe and auto-injector presentations with high-gauge needles that are comparable to the reference product and that are comfortable, reliable, and easy for patients to use.

We believe payers will drive biosimilar out a little bit amount of adoption.

Completed extensive market research with national regional peers as well as Pbms.

The insights gleaned from this research confirmed that coheres can and expect to deliver on all of the payers critical expectations. These include a competitive price that delivers value to key stakeholders robust reliable supply with high quality manufacturing.

A non speaking citrate free formulation.

Pre filled syringe, a auto injector presentations with high gauge needles that are comparable to the referenced product and that are comfortable reliable and easy for patients to use.

Paul Reider: Robust patient support services to facilitate access and to address patient out-of-pocket. Also, according to our research, interchangeability was regarded as a nice-to-have action. But not essential, since payers already have the mechanisms to drive product selection based on their formularies and utilization management tools that they use routinely today in multiple product categories. So to meet these expectations, Coherus has previously invested in large scale manufacturing and expects to be well positioned to compete on supply guarantees and price. We will have quality pre-filled syringe and auto-injector presentation. Our Yosemite device uses a 29-gauge needle comparable to the originators, and we also use our proprietary non-stinging citrate-free formulation.

Robust patient support services to facilitate access and to address patient out of pocket costs.

Also according to our research interchange ability was regarded as a nice to have but not essentially since peers already have the mechanisms to drive product selection based on their formulary and utilization management tools that they use routinely today in multiple product categories.

<unk>.

So to meet these expectations procure as previously invested in large scale manufacturing and expects to be well positioned to compete on supply guarantees and price.

We will have quality pre filled syringe and the auto injector presentations or.

Or are you simply device used 2009 gauge needle comparable to the originators and we also will use our proprietary non stinging to treat three formulations.

Paul Reider: In addition, through Coherus Complete, which is our patient and provider services that are considered best in class among the Pectoral Grasping classes today, we have an established and high-tech service offering to facilitate access and affordability. Some large competitors may position their Adalumin map somewhere within a portfolio offering to payers. Coherus, by contrast, will have a singular focus.

In addition through coheres complete which is our patient and provider services.

Consider best in class among the Pegfilgrastim class today, we have an established and high touch service offering to facilitate access and affordability.

So some large competitors may position their adalimumab biosimilar within our portfolio offering to Peters coheres by contrast behaviors will have a singular focus.

Paul Reider: Repeating successfully in the Adeluva Memoir. Without the constraints, trying to minimize, Lateral impacts of price erosion on a portfolio of premium priced branded products. Our interest is in seeing the overall adalumumab market become as large as possible. We believe this is also in the best interest of payers and patients. In short, we are confident we can deliver a compelling overall value proposition and expect results consistent with our market share forecast with you. I'll now turn the call to McDavid for a review of the quarter's financial... Thank you, Paul.

<unk> successfully in the <unk> in that market.

Don't think constraints trying to minimize the collateral impacts of price erosion on a portfolio premium priced branded products.

Interest is it seen the overall evolution that bar to become as large as possible.

We believe this is also in the best interest of payers and patients.

In short we are confident we can deliver a compelling overall value proposition and expect results consistent with our market share forecast with you soon.

I'll now turn the call to Vic David for a review of the quarter's financial results.

Thank you Paul.

McDavid Stilwell: The details of our financial results are in the press release. So I'll focus now on a few highlights. For the fourth quarter and full year 2021, we reported net losses of $46 million and $287 million, respectively, on a gap. Cash used in operating activities was $52 million for the fourth quarter and $37 million for the full year 2021. As detailed earlier in the call, net revenue was $73 million for the quarter and $327 million for the year.

The details of our financial results are in the press release.

So I'll focus now on a few highlights.

For the fourth quarter and full year 2021, we reported net losses of $46 million and $287 million, respectively on a GAAP basis.

Cash used in operating activities was $52 million for the fourth quarter and $37 million for the full year 2021.

McDavid Stilwell: This is a decrease for both periods, reflecting lower unit volumes and lower net realized price. Whole family inventory remained within the normal range at year end. Cost of sales was $12 million for the quarter and $58 million for the year, resulting in gross margins of 84% and 82% respectively.

As detailed earlier in the call net revenue was $73 million for the quarter and $327 million for the year.

This was a decrease for both periods, reflecting lower unit volumes and lower net realized price.

Wholesaler inventory remained within the normal range at year end.

Cost of sales was $12 million for the quarter and $58 million for the year, resulting in gross margins of 84% and 82% respectively.

McDavid Stilwell: Recall that in the first quarter of 2021, we depleted the inventory manufactured and expensed prior to approval. And since then, per unit acquisition costs are fully reflected within COPS. Accordingly, cost of goods as a percentage of net revenues has increased since 2020. In the long run, starting in 2024, we expect Udenica pre-filled syringe gross margins to return to 90% or higher as we realize the benefits of a significant manufacturing process improvement and also royalty expiration. Research and development expenses were $51 million for the quarter and $363 million for the year.

Recall that in the first quarter of 2021, we depleted the inventory manufactured and expense prior to approval and since then per unit acquisition costs are fully reflected within Cogs.

Accordingly cost of goods as a percentage of net revenues has increased since 2020.

In the long run starting in 2024, we expect eugenic pre filled syringe gross margins to return to 90% or higher as we realize the benefits of our significant manufacturing process improvement and also loyalty exploration.

Research and development expenses were $51 million for the quarter and $363 million for the year.

McDavid Stilwell: This is an increase over 2020 and includes the $136 million upfront payments to Jun-Chi for the Tor Panamab license, as well as costs to advance our late-stage pipeline. Activities such as regulatory affairs and manufacturing scale-up for Yosemite, clinical development and BMA filings for Toropanelmeb, a clinical trial for the Eugenica on-body injector, as well as the ongoing three-way peak case study evaluating CHS305 via bastion biosimilar, spending general and administrative expenses were $50 million for the quarter and $170 million for the year, an increase that was primarily driven by higher eugenics commercialization activities, as well as stock based compensation, We ended the year with $417 million in cash and cash equivalents.

This is an increase over 2020 and includes the $136 million upfront payment to June sheet for the tour coming out license as.

As well as cost to advance our late stage pipeline activities, such as regulatory affairs and manufacturing scale up for use in clinical.

Clinical development and BLA filings for toward a clinical trial for the identical on body injector as well as the ongoing <unk> PK study evaluating CHF <unk> five the Avastin biosimilar.

Selling general and administrative expenses were $50 million for the quarter and $170 million for the year, an increase that was primarily driven by higher U deneke commercialization activities as well as stock based compensation expense.

We ended the year with $417 million in cash and cash equivalents.

McDavid Stilwell: Recall that subsequent to year end. We entered into a credit facility agreement with Pharmacon Advisors for a $300 million term loan payable across four tranches. We drew the first $100 billion tranche at closing and simultaneously paid off a $75 million term loan.

Recall that subsequent to year end.

We entered into a credit facility agreement with Pharmacon advisors for a $300 million of term loan payable across four tranches.

Through the first $100 billion tranche at closing and simultaneously paid off $75 million term loan.

McDavid Stilwell: Prior to April 1st, we plan to draw a second $100 million tranche and simultaneously pay off the convertible notes that come due at the end of March. Two additional tranches of $50 million each will become available to us upon the FBA approval of Toropanamab and of Simrami. We are introducing full year 2022 guidance for R&D and SG&A expenses of $415 million to $450 million, not including the $35 million upfront fee to Chunchi Biosciences we expect to pay later in the first quarter for rights of JS006 or the $25 million milestone payment that will become due on approval of Toropalamat for NPC. This guidance range includes approximately $55 million to $60 million in non-cash, stock-based compensation expenses.

Prior to April one we plan to trial, our second $100 million tranche and simultaneously pay off the convertible notes that come due at the end of March.

Two additional tranches of $50 million each will become available to us upon the FDA approval for our Panamax and a similarly.

We are introducing full year 2022 guidance for R&D, and SG&A expenses of $415 million to $450 million.

Not including the $35 million upfront fee to <unk> Biosciences, we expect to pay later in the first quarter for rights of chance zero-zero, six or the $25 million milestone payments that will come to an approval for Palomar for MPC.

This guidance range includes approximately $55 million to $60 million and noncash stock based compensation expense.

McDavid Stilwell: Let me provide some additional color on these anticipated operating expenses, much of which is investment that will convert back to cash quickly with a high IRR. This year, we will spend approximately $50 million manufacturing inventory for new product launches. Now recall that one lesson from our successful Udenica launch is that going to market with ample supply is a critical success factor. Also recall that low-cost inventory manufactured and expensed prior to FDA approval subsequently delivers P&L benefit in the form of lower cost.

Let me provide some additional color on these anticipated operating expenses.

Each of which is investment that will convert back to cash quickly with a high.

Our.

This year, we will spend approximately $50 million manufacturing inventory for new product launches.

You'll recall that one lesson from our successful <unk> launch is that going to market with ample supply is a critical success factor.

Also recall that low cost inventory manufactured and expense prior to FDA approval subsequently delivered P&L benefit in the form of lower Cogs.

McDavid Stilwell: Another $40 to $50 million of operating expense this year will fund completion of development of additional presentations of products we expect to introduce over the next two years, as well as manufacturing scale-up projects that will deliver ongoing benefits in the form of significantly lower cost of goods. Finally, on the investor relations front, we will present and host investor meetings in March at two conferences, the Cowen Conference and also the Barclays Conference, and we are planning to host the Coherus Analyst Day event in late March in New York City, hopefully in person. And I will now turn the call back to Denny for closing remarks. Thank you, McDavid.

Another 40% to $50 million of operating expense. This year, we will fund the completion of development of additional presentations of products, we expect to introduce over the next two years as well as manufacturing scale up projects that will deliver ongoing benefits in the form of significantly lower.

Our cost of goods.

Okay.

Yes.

Finally, let me Investor Relations front, we will present and host investor meetings in March at two conferences, the Cowen Conference and also the Barclays Conference.

And we are planning to host a <unk> analyst day event in late March in New York City hopefully in person.

And I will now turn the call back to Denny for closing remarks.

Dennis Lanfear: A year ago, we told you that our vision for Coherus was to become an innovative immuno-oncology company with commercial I.O. assets, promising clinical stage programs, and novel in-house preclinical pipelines. With the potential approval of Toropalmab in April, the initiation of a clinical trial evaluating Fidget in combination with Toropalmab later this year, and the advancement of the first of our in-house IO assets towards IND, we are delivering on this vision that we laid out to investors a year ago. The levers of success are now in our own hands.

Thank you David.

A year ago, we told you that our vision for coherent supposed to become an innovative oncology company with commercial Io assets promising clinical stage programs.

And how its preclinical pipeline.

With the potential approval of <unk> in April initiation of a clinical trial evaluating <unk> in combination with <unk> later this year and.

And the advancement of the first of our in house asset towards A&D, we are delivering on this vision and we laid out to investors a year ago.

The levers of success right now in our own hands.

Operator: I am proud of the execution of my team and confident that we will fulfill the promise of our strategy. On the commercial side, we are uniquely positioned to launch multiple new products in the next 18 months. With these launches, the total addressable market opportunity of our product portfolio will increase tenfold, from about $2.5 billion to more than $25 billion. Our commercial opportunity will continue to expand as additional TORO-PALMAP indications are added and as our immuno-oncology pipeline candidates advance to commercialization.

I am proud of the execution of my team and confident that we will fulfill the promise of our strategy.

On the commercial side, we are uniquely positioned to launch multiple new products in the next 18 months.

With these launches the total addressable market opportunity of our product portfolio will increased tenfold from about $2 5 billion to more than $25 billion.

Our commercial opportunity will continue to expand as additional probe palmette indications are added and as our immuno oncology pipeline candidates advance to commercialization.

Operator: This growing product portfolio will fund our continued growth in immuno-oncology through the end of this decade. Operator, we're ready for the questions. Thank you. If you have a question at this time, please press star then one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.

This growing product portfolio will fund our continued growth in immuno oncology through the end of this decade.

Operator, we're ready for the questions.

Thank you if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

Operator: And our first question comes from the line of Salim Seed with Mazuho. Your line is open. Please go ahead. Hey, good afternoon, guys. Thanks so much for the color.

And our first question comes from the line of Slim seat with Mizuho. Your line is open. Please go ahead.

Salim Seed: A couple for me, if I can. One on torepalumab. So, I would like to understand a little bit more about the strategy here in lung post and assumed NPC approval late April. Specifically, the prospects of getting torepalumab listed as a Category 2B medication on NCC guidelines and the prospects of a subsequent Medicare reimbursement off-label uptake in lung. Or, do you really think you'll need an additional trial in lung that's head-to-head versus a PD-1 and how those costs would be allocated or shared? And then the second question is on the Udenica guidance for 22.

Hey, good after noon guys. Thanks, so much for the color a couple from me if I can.

Operator: So, Denny, I appreciate that it's going to be lower. Transcripts provided by Transcription Outsourcing, LLC. Thank you for that, Salim. I would ask that follow-on questions limit themselves to one question so we can work through them, and then if your question is not answered, we're happy to go through them again.

One on <unk>.

So I would like to understand a little bit more about the strategy here in lung posting assumed MPC approval late April specifically.

Prospects.

The prospects of getting towards <unk> with it as a category to be medication on the NCC guidelines and the prospects of a subsequent Medicare reimbursement off label uptake in lung.

Or do you really think you'll need an additional trial in lung head to head versus the PD, one and how those costs would be allocated are shared.

And then the second question is on the <unk> guidance for 'twenty two.

So Denny I appreciate that it is going to be lower.

Then revenues will be lower than 'twenty one.

But how are you thinking about ASP declines in 'twenty, two 2021 by my math had roughly about a 20% to 30% ASP decline. So this is now the fourth year post launch should we be thinking about that moderating in 'twenty. Two and then also with Covid cases, largely declining here.

And on personal having 50% of the Pegfilgrastim market.

Just maybe you could speak about qualitative here your your views on units. Please thanks so much.

Thank you for that Selim I would ask that.

Follow on question is limit themselves to one question so.

So we can work through and then a few questions not answered we're happy to go through so let me direct the question of the non small cell regulatory strategy that you posed to Dr. La valid to say do you want answer that one yes finian. Thanks for that question.

Dennis Lanfear: So let me direct the question of the non-small cell regulatory strategy that you posed to Dr. Lavallee. Theresa, do you want to answer that one? Yeah, thanks, Denny, and thanks for the question. I mean, for non-small cell lung cancer, we haven't had any meetings with the FDA since the ODAC, and look forward to discussing the path forward with them. We continue to be impressed with the data, and I think for the overall tone of how the FDA is reviewing these data, they've kind of given some bookends between the MPC indication and non-small cell lung cancer. So our strategy is to have frequent and often conversations with them and align on the packages. Thank you, Theresa. Any additional comment with respect to the endpoints of our study or other aspects to Céline's question?

For non small cell lung cancer, we haven't had any meetings with the FDA.

And look forward to discussing our path forward with them.

Continue to be impressed with the data and I think the overall.

And how the FDA is reviewing data and kind of given again between the mtc indication in non small cell lung cancer. So our strategy is to have frequent and often conversations with him and aligned.

Packages.

Thank you for any additional comment with respect to endpoints of our study or other aspects to <unk> question.

Theresa Lavallee: The endpoints that we have are for overall survival with a pre-specified secondary endpoint and was part of the statistical analysis plan, which was designed to meet FDA filings. Thank you. Thank you for that.

And the endpoints that we have are overall survival with a pre specified secondary endpoint and it's part of the statistical analysis plan.

Our ankeny FDA filing.

Theresa Lavallee: And I think your second question, Salim, was with respect to second half of the year sales or 2022 sales. Paul, can you offer Salim any additional color on what we see for Udenica through the rest of this year? Yeah, thanks for your question, Saleem. Yeah, so, you know, I think it's reasonable to expect continued price declines in this market, you know, throughout 2022, as it's becoming increasingly competitive. And, you know, I think if you look at our ASPs, you know, we've been averaging mid single digits over the last three quarters.

Thank you thank you for that.

And I think your second question Selim was with respect to.

Second half of the year sales were 2022, So Paulo can you offer assume any additional color on what we see for Ya deneke through the rest of this year.

Thanks for your question. So yes, so I think it's reasonable to expect continued price declines in this market.

Throughout 2022 is becoming.

Increasingly competitive and I think if you look at our Asp's.

Paul Reider: And our strategy has really been to balance price and market share, you know, as we look to optimize longer term revenues for Unetica. In 2022, it's going to be within the context of the prefilled syringe segment. But we're, you know, we're going to be ready to go with the launch of an on-body device in 2023, if approved, you know, to go after that, you know, remaining 50% of the on-pro market that's, you know, I think just been able to entrench itself through for the persistence of COVID.

We've been averaging mid single digits over the last three quarters and our strategy has really been too.

Is balanced price and market share.

We look to optimize longer term revenues for <unk>.

In 2022, it's going to be within the context of the pre filled syringe segment.

But where we are.

We're going to be ready to go with the launch of an on body device in 2023 are approved.

To go after that.

Remaining 50% of the <unk> market I think just been able to entrench itself through.

The persistence of Covid so.

That's what we're thinking.

Paul Reider: So, you know, that's what we're thinking. Hope that answers your question, Salim. We'll be happy to loop back with you if we have a little more follow on to that. Operator, can we have the next question?

I hope that answers your question does lean we'll be happy to loop back with you.

You have a little more.

I'll answer that.

Operator can we have the next question.

Operator: And our next question comes from the line of Ken Cacciatore with Cowan. Your line is open. Please go ahead. Hello, Ken. Ken, your line might be on mute.

And our next question comes from the line of Ken Cacciatore with Cowen. Your line is open. Please go ahead.

So Ken Ken your line might be on mute.

Yeah.

Operator: Okay, we'll move to our next question, which is Georgie Yordanoff with Cowen & Company. Your line is open. Please go ahead.

Right.

Well move to our next question with Joe Giorgi Giordano with Cowen <unk> Company. Your line is open. Please go ahead.

Operator: Thank you, guys. Thank you so much for taking our questions. We're going to limit to one.

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

Georgie Yordanoff: So on the recently announced partnership for the TIGIT asset, could you maybe talk about how these are being differentiated from the more advanced TIGIT antibodies that are in later stages of development out there? And then you mentioned your intentions to run trials here in the U.S. in combination with TORI, as well as in my therapies. Could you remind us of the expected R&D costs for that associated with that development and what percentage of that you're responsible for?

We're going to limit to one so on the recently announced partnerships with the pigeon asset could you maybe talk about how do you see as being differentiated from the more.

Advanced tissue antibodies that are.

In later stages of development out there and then you mentioned.

Your intentions to to run trials here in the U S. In combination with <unk> as long as the monotherapy could you remind us.

R&D costs for that associated with that development.

What percentage of that you're responsible for it.

Georgie Yordanoff: Let me take the last part first with respect to cost, and then I'll let Theresa describe our strategy around the tigent. With respect to cost, you may recall that the agreement, with Jun Shi, limits our shared clinical cost to $25 million per year per product. That is the same for Toropalmat as it is for the opted-in product. JAS 006 is 1.

Now let me take the last part first with respect to cost and then I'll let <unk>.

Describe our strategy around the tissue.

In respect to cost you may recall that the agreement.

With June sheet.

Limits, our shared clinical cost you $25 million per year per product that is at the same point towards palmette as it is for the opt in product, which tissue Chaz Zero-zero six is one so we presume that this will be done under the auspices of the joint steering committee of the partnership and such.

Dennis Lanfear: So we presume that this will be done under the auspices of the Joint Steering Committee of the Partnership and subject to those caps. Now if there's additional work that we want to do outside of that, that may be some additional things that is not paid for through the Partnership and then Jun-Chi has the opportunity to opt back into that data later. Given that this asset, however, will be developed internationally, globally, across all markets, it's probably safe to assume that this will be primarily developed through the Joint Steering Committee of the Partnership.

To those caps now if theres additional work that we want to do outside.

Outside of that that may be some additional things that it's not important to the partnership and then June she has the opportunity to opex into that data later given that this asset however will be developed internationally globally across all markets.

It's probably safe to assume that.

We'll be primarily developed through the joint steering committee of the partnership.

With respect to tissue development potential differentiation in our strategy of going into <unk>.

Dennis Lanfear: With respect to tigent development, potential differentiation, and our strategy of going into line, Theresa, would you like to make a few comments on that? Yeah, and I think the data we've seen from our partner Junxi on the TTIP antibody is it has significant potency in preclinical models. And we look to develop it in tumor types, such as non-small cell lung cancer, obviously to establish proof of principle in combination with toropalumab with a translational strategy to really understand where we see activity and not activity to advance it with urgency. The only other additional color I would provide with respect to the Tidget is we have developed co-formulated approaches to the product, which would be single vials.

It's on that.

And then I think the data we've seen from our partner <unk> antibody it had significant hesitancy in preclinical models.

We love to develop Ed in tumor types.

<unk> non small cell lung cancer, obviously establish.

The following combination makes for a pilot with a translational strategy to really understand where we see activity.

Got activity can advance it with urgency.

Do any other additional color I can provide with respect to the ticket, but as we have developed co formulated approaches to the product which would be single aisle.

Theresa Lavallee: Operator, we're ready for the next call. And our next question comes from the line of Chris Schott with J.P. Morgan. Your line is open. Please go ahead. Great. Thanks so much.

Operator, we're ready for the next call.

And our next question comes from the line of Chris Schott with Jpmorgan. Your line is open. Please go ahead.

Chris Schott: I'm going to slip a one and a half questions in. I just come back to the Tor Palomar discussion earlier. Would you run a U.S.-based head-to-head study in non-small cell lung cancer if FDA required it, or is that kind of a non-starter as you think about, I know you still need to meet with the FDA, but if that's what they're asking for, is that something that makes sense for Coherus or not?

Alright, great. Thanks, so much.

Wanted to ask questions and I'll just come back to the tour Palomar discussion earlier would you run a U S based head to head study in non small cell lung cancer. After you acquired it.

Or is that kind of a nonstarter or as you think about I know you still need to meet with the FDA, but if thats. What they are asking for is that something that makes sense for coherent or not.

Chris Schott: My core question was coming back to biosimilar Humira. I think there's been a lot of debate about how much volume AbbVie is going to be able to contract here and how many biosimilars each payer is going to cover. So can you just elaborate a little bit more on how you think that plays out as you look out to 2023 and beyond? Do you think it's going to be in a situation where there's multiple biosimilars and it's kind of a jump ball and it's about commercial execution, or do you expect the payers to kind of focus in on one or two biosimilars, and do you expect that AbbVie is going to be able to retain a sizable portion of the market, or do you expect that a lot of the volume in this space is going to be available to the biosimilar players? Thanks so much.

Quick question was coming back to Biosimilar Humira I think there's been a lot of debate about how much volume abbvie is going to be able to contract here and how many biosimilar as each payer is going to cover. So can you just elaborate a little bit more on how you think that plays out as you look out to 2023 and beyond.

Do you think it's going to be in a situation, where there's multiple biosimilars and it's kind of a jump ball.

Commercial execution or do you expect the payers to kind of focusing on like one or two biosimilars.

And do you expect that Abbvie.

Going to retain a sizable portion of the market or do you expect that a lot of the volume in this space is going to be available to the biosimilar players. Thanks, so much.

Dennis Lanfear: Thanks. Thank you for your one and a half questions. I think you have one and three quarters questions there, Chris, but that's okay. I'm going to call first to trust the Yosemite. You know, he might have a similar question for you, and then we'll move back on to our panel.

Thank you for your.

Wanted to have I think one of the three quarters questions there, Chris but that's okay Paul.

First the trustee.

The summary.

The Humira Biosimilar question for you and then we'll look back on.

Tori comment Paul.

Paul Reider: Yeah, thanks for your question. So, you know, at the time of our launch in July 2023, you know, we will expect to be one of a number of biosimilars entering the market at that same time. And what we'll be prepared to do at that time is to bring, you know, a value proposition, You know, that includes those those factors that I mentioned in my prepared remark. A very competitive price, substantial. Supply Guarantees, and all of the pre, full, syringe and auto injector types of presentations. The non-stain citrate-free formulation will be another differentiator.

Yes. Thanks for your question so.

At the time of our launch in July 2023.

We'll expect to be won a number of biosimilars entering the market at the same time.

And what will be prepared to do at that time is to bring.

<unk> proposition.

That includes those those factors that I mentioned in my prepared remarks.

We're very competitive price substantial.

Supply guarantees.

And all of the Prefilled syringe and the auto injector types of presentations.

The non <unk> formulation will be another differentiator and so I think we expect to happen.

Paul Reider: And so I think what we expect to happen is, you know, we're going to through our payer segmentation not look at them all as a one size fits all but to fit their particular objectives based on their plans, their covered lives, and their businesses, and to deliver the value proposition that, depending upon the control level of the plan, might be a single biosimilar in a rapid conversion away from the innovator or, in the short term of launch, you know Either way, we'll have, you know, a portfolio of value propositions that will meet their needs, and we will expect to be one of the most compelling high volume, low cost providers at the time of commercialization mid-year.

As we're going through our payer segmentation as <unk> looked at them all as a one size fits all but to fit their particular objectives based on their plants or covered lives and their businesses.

And to and to deliver the value proposition that.

Depending upon the control level of the plan might be.

A single Biosimilar in a rapid conversion away from the innovator for the in the short term of launch.

Humira, plus <unk>, plus <unk> in which case that will be a slower transition overtime either way we will have.

A portfolio of value proposition that will meet their needs and we will expect to be one of the most compelling high volume low cost providers at the time of commercialization midyear, we expect to that we expect to do very well.

Dennis Lanfear: The other the other point I would make with respect to that, Chris, is we think with the number of competitors in the market, there's going to be tremendous cost pressure all around. And we would be surprised if, if AbbVie, you know, two or three years into the market, did not have a relatively small share of that market as opposed to a majority greater than 50% share. So we think they'd probably get down to the 20-25% type of share gain.

The other the other point I would make with respect to that Chris.

I think with the number of competitors in the market there is going to be tremendous cost pressure all around.

And we would be surprised if it.

Abbvie.

Two or three years into the market.

It did not have a relatively small share of that market as opposed to a majority of greater than 50% share. So we think theres, probably get down to the 20, 25%.

Type of share gain with respect to your question onto our Allomap and the potential.

Dennis Lanfear: With respect to your question on Torop LMAB and the potential Regulatory Pathway there in Lung, it's, we believe it's probably prudent for us not to preempt our conversations, you know, that we haven't had yet with the FDA. As Theresa said, we haven't really had a chance to interact with FDA post the ODAC. And we look forward to doing that.

Regulatory pathway there.

We believe it's probably prudent for us not to preempt our conversations.

We haven't had to do with the FDA as Teresa said, we haven't really had a chance to interact with FDA post the <unk>.

And we look forward to doing that we were convinced that we have a very high quality molecule is demonstrating significant efficacy and safety across a number of indications, including lung. So we're very enthusiastic about talking to the FDA about that.

Dennis Lanfear: We were convinced that we have a very high quality molecule demonstrating significant efficacy and safety across a number of indications, including lung. So we're very enthusiastic about talking to the FDA about that. But, you know, we really think it's probably not prudent to, talk about what sort of studies they might require and when and that type of thing.

But we really think it's probably not.

Prudent too.

Talk about what sort of studies they might require in wind and other types of things that being said, we are planning on moving into lung.

Dennis Lanfear: That being said, though, we are planning on moving into lung with with the TIGIT asset in conjunction with TORC Palmet. And you'll be hearing more of that later in her remarks. Theresa, of course, talked about that and how we're going to move in towards the end of this year. So stay tuned on that one. Thank you. Thanks, Chris.

With the ticket asset in conjunction with towards development and Youll be hearing more of that later in her prepared remarks, <unk> talked about that and how we're going to move in towards the end of this year. So stay tuned on that one.

Thank you.

Thanks, Chris.

Operator: And our next question comes from the line of Balaji Prasad with Barclays. Your line is open. Please go ahead. Thank you. Hi, good evening, everyone.

And our next question comes from the line of <unk> Prasad with Barclays. Your line is open. Please go ahead.

Balaji Prasad: So, firstly, getting back to Biosimile Myra, can you quantify better the non-stinging citrate-free formulation and what kind of an advantage it provides to you? And also, probably importantly, do you expect to be the only citrate-free formulation on the market next year? One.

Thank you hi, good evening.

So firstly getting back to <unk>.

Can you quantify a bit of the nonstick exit rate same formulation on what kind of my bond agent for lifestyle and also probably importantly, do you expect to be the only suite.

Dennis Lanfear: And two, if you can just also quantify with your clinical trials, with the multiple trials going on with $417 million in cash, if you need to prioritize your clinical trials, what would be the top one or two ones that are going to advance next year? Thank you. Thank you, Balaji. Let me, let me first address the issue of the formulation. It's very important from the viewpoint of patient comfort upon injection, that the formulation does not stain, that it's not unduly uncomfortable.

Great free formulation on the market next year.

Until if you can just help us quantify any clinical trials with multiple trials going on with $417 million of cash.

If you need to prioritize clinical trials, what will be the top one or two ones I can think of advanced next year. Thank you.

Thank you Hi, Brian So let me let me first address the issue of the formulation is very important from the viewpoint of patient comfort upon injection that the formulation.

Dennis Lanfear: And there's anecdotal data that patients found the previous low concentration formulation of AbbVie very uncomfortable because it does have, So several years ago, when we approached the Humira Biotech, which was 1420 at that time, we developed a proprietary, non-stringing, citrate-free formulation.

That is not unduly uncomfortable and there is anecdotal data that patients.

The <unk>.

Previous low concentration formulation of Abbvie very uncomfortable because does exit rate. So several years ago. When we approach the humira Biosimilar, which was $14 20 at that time, we developed a proprietary non stinging citrate free formulation no I won't speak for others, but I.

Dennis Lanfear: Now I won't speak for others, but I think this is very, very important from the viewpoint of patient comfort and being able to penetrate the markets, as Paul said. Now, with respect to the clinical trial. In 2022 and various costs and guys, you know, as, as McDavid pointed out to you, there are significant spins on matters such as manufacturing. One of the ways that we succeeded with eugenics, and you may recall, we stockpiled, 100,000 syringes prior to launch at significant manufacturing expense. It was it was $25 or $35 billion when we did it.

This is very very important from the viewpoint of patient comfort and being able to penetrate the markets.

As Paul said.

Now with respect to the clinical trials.

In 2022 at various cost guidance.

As as make David pointed out too there are significant spins.

On matters, such as manufacturing one of the ways that we succeeded with your Deneke as you may recall, we stockpiled.

Hundreds of thousands syringes prior to launch at significant manufacturing expense it was 25 or $35 million when we did it.

Dennis Lanfear: And however, I think that served us very, very well post launch. We were able to do supply guarantees and did very well in that market, while others were not able to do so. And I think that was one of the reasons why we achieved in excess of 20 percent market share in that market. We think that very same formula applies here, for example, with Humira.

However, I think that served us very very well post launch we were able to do supply guarantees and did very well in that market while others.

We're not able to do so and I think that was one of the reasons why we achieved in excess of 20% market share in that market. We think that very same formula applies here for example, with Humira, we have gone to large scale, we've made those investments.

Dennis Lanfear: We have gone to large scale, we've made those investments. We will be prepared, for example, for fierce competition in price that we have to. But we think that we want to be the team that has the inventory and the supply guarantees to be able to go in the market for that. And that's where I think some significant parts of our spend go. But on the other hand, we think that's very wise. And as McDavid indicated in his remarks, that pays back later. That goes into COGS, it's expense now, but that gives you an advantage. And there's a significant IRR.

We will be prepared for example for a fierce competition in price. So we have to but we think that we wouldn't be we wouldn't be the team that has.

The inventory in the supply guarantees to be able to come to market for that and that's where I think.

Some significant parts of our spend go but on the other hand, we think thats very wide and as Mick David indicated in his remarks that pays back later that goes that goes into Cogs expense now, but that gives you an advantage and there is a significant IRR.

Dennis Lanfear: I hope that answers your question. Thank you. And our next question comes from the line of Jason Gerberry with Bank of America. Your line is open. Please go ahead.

Hope that answers your question.

Thank you and our next question comes from the line of Jason <unk> with Bank of America. Your line is open. Please go ahead.

Jason Gerberry: Hey guys, thanks for taking my question. Mine is on the NPC US market opportunity. Can you talk a little bit about your expectations here with this? Do you expect it to be used more frontline with the chemo combination or second line monotherapy? How many of these patients are really addressable? Is it going to be hard to find these patients because it's a pretty small population? And it seems like there's a pretty big swing factor if you're frontline versus second line.

Hey, guys. Thanks for taking my question.

Mike on the MPC U S market opportunity.

Can you just talk a little bit about your your expectations here with this you expect it to be used more frontline with the chemo combination or second line monotherapy.

Many of these patients are really addressable is.

Is it going to be hard to find these patients because it's a pretty small population and if you think theres a pretty big swing factor for your frontline for a second line I think the interim PFS was 12 months for frontline, but I think in like second line is much much shorter so just trying to get a sense. If you can kind of frame the key parameters of an oncology forecast.

Dennis Lanfear: I think the interim PFS was 12 months for frontline, but I think in like second line, it was much, much shorter. So just trying to get a sense if you can kind of frame the key parameters of an oncology forecast. Thanks. Thanks for the question on that. Of course, we expect to get frontline with NPC.

Thanks. Thanks for the question on that of course that we expect to get frontline with MPC I'll, let Paul Phil.

And the rest of your question with respect to the market size and so on.

Paul Reider: I'll let Paul fill in the rest of your question with respect to the market size and so on. Yeah, thanks for your question, Jason. So, Yeah, as a rare cancer, you know, The data suggests that, you know, there's a couple thousand patients treated with NTC annually, and about a third of those patients, you know, are cycled through in the in the first line setting. And so, you know, as the we expect, if approved to be the first and only.

Yes, Thanks for your question Jason So.

Yes, it's a risk.

Cancer.

The data suggests that there is a couple of thousand patients treated with MPC annually.

And about a third of those patients.

Through in the in the first line setting and so.

As the <unk>.

Expect if approved to be the first and only.

Paul Reider: P1 antibody approved for MPC, including first line, you know, that's where we believe we have the potential to establish a new standard of care, and really, in combination with chemotherapy, plus torpellumab, you know, be the standard of care in frontline patients. The patients are treated with chemotherapy only in first line.

PD, one antibody approved for MPC, including first line.

That's where we believe we have the potential to establish a new standard of care and really in combination with chemotherapy plus towards element.

The standard of care in frontline patients and patients who are treated with chemotherapy only first slide slightly they're going to progress and then we've got the data in later lines of therapy that we.

Paul Reider: It's likely they're going to progress. And then we've got the data in later lines of therapy that we'll, you know, we'll expect to pick them up later lines. But we want to, we want to get these patients treated frontline. Yeah, so there's not a lot of them, Jason, but, you know, we, you know, looking at our data with about 1,500 HCPs that we see are using PD-1s for NPC, and they account for over half of the patient volume, and we've got significant overlap with our current, you know, Udenica base, and so we'll have high overlap, very synergistic at the time of launch to drive share voice and the, The fact that the data has already been widely presented by ASCO Plenary in 2021, the study was published in Nature Medicine last year, and of course now NCCN Guidelines has added it, you know, provides a real tailwind for us going into a potential launch here.

We'll expect to pick them up later lines, but we want to we want to get these patients treated frontline.

Yes, so theres not a lot of them, Jason but we.

Looking at our data with about 500 Hcp's.

We see youre using PD ones for MPC, they account for over half of the other patient volume and we've got.

Significant overlap with our current <unk>.

<unk> base and so we will have high overlap very synergistic launched.

To drive share of voice.

The tour Pelham.

MPC story, there and the fact that the data has already been widely presented <unk> plenary in 2021.

Study was published in nature Medicine last year and of course now.

<unk> guidelines is that additive.

Provides a real tailwind for us going into <unk>.

Paul Reider: Jason, the other thing we would add here, of course, we'll also get second and third line, and so we're going to pursue MPC quite holistically, and as Paul indicated, you know, we think we have a very strong case therapeutically with the ASCO Plenary session and Nature Medicine and so forth. So, after we get the approval under our belts and we get into the market for a few months, I think your questions fair game with respect to forecasts and so on.

Potential launch here just in the other the other thing we would add you are of course I will also get second and third line and so we're going to pursue mtc quite holistically and.

As Paul indicated we think we have a very strong case therapeutically with ESCO plenary session in nature medicine.

So forth after we get the approval under our belts and we get into the market for a few months I think your question is fair game with respect to forecasts and so on we'll be happy to loop back.

Paul Reider: We'll be happy to loop back. Can you just remind me, in the frontline setting, what the PFS was? And when you say one-third cycle through first line, so basically of a couple thousand, only a third of them make it to second line, was that the point? Or only a third of a couple thousand ultimately get treated in the frontline setting? Theresa, do you want to grab that one?

Can you just remind me in the frontline setting what the PFS was.

Say, one third cycle first line. So basically of a couple of thousand only a third of them make it to second line was at the point, where only a third of a couple of thousand ultimately get treated in the frontline setting.

Right.

But tracey do you want take that.

Theresa Lavallee: Yeah, the PFS in first line was 11.7 months, with a one year PFS of 49%. Yeah, Jason, and then of the couple thousand patients treated annually, about a third get treated in the in the first line setting. Okay. All right. Thanks so much.

Yes, the PFS are flying like 11 seven months.

With a one year PFS of 49%.

Jason and then of the couple of thousand patients treated annually about a third.

Get treated in the first line setting.

Okay, alright, thanks, so much.

Thanks, Susan.

Operator: Thank you. And our next question comes from the line of Douglas Tsao with HC Wainwright. Your line is open. Please go ahead, now added sort of your own internal R&D capabilities, discovery and I.O. I'm just curious.

Thank you and our next question comes from the line of Douglas Tsao with H C. Wainwright. Your line is open. Please go ahead.

Now added sort of your own internal R&D capabilities discovery in IL I'm just curious.

Douglas Tsao: Well, forgive me, Doug, I think we missed the first part of your question. Could you restart? Oh, yeah, sorry. You've, you've now started your sort of own internal discovery efforts in IO, it sounds. And, I'm just curious, as you sort of add to your own capabilities, you know, how do you see your vision for growing the business, you know, versus business development? Obviously, you're going to be launching a number of products, your cash flow should be quite significant. Do you have a sort of bias towards now focusing on sort of internally developed assets versus ones that you might want to acquire?

But forgive me Doug.

We missed the first part of your question could you restart.

Oh, yes, sorry.

You've now started your sort of own internal discovery efforts Nio it sounds.

And.

I'm just curious as you sort of add to your own capabilities.

How do you see your your vision for growing the business.

Versus.

Business development, obviously, you're going to be launching a number of products. Your cash flow should be quite significant do you have a sort of a bias towards now focusing on it.

Sort of internally developed.

<unk> assets versus ones that you might want to acquire and as that cash flow comes in do you potentially think about business development and M&A more aggressively. Thank you.

Operator: And as that cash flow comes in, do you potentially think about, you know, business development and M&A more aggressively? Thank you. That's a great question, Doug.

Dennis Lanfear: It's very important to us that we have a portfolio that's balanced across all three stages of development. Preclinical, early stage development, mid-stage development, represented by, for example, the TIGI-TORP-LMF combinations, and then late stage, of course, with the potential approval of TORP-LMF. I'll let Theresa talk a little bit about our early stage development efforts. But to cut to the chase and answer your question directly, we certainly would be open for business development opportunities with IO.

Okay.

Thats great question.

It's very important was that we have a portfolio that is balanced across all three stages of development preclinical early stage development mid stage development Representatives by for example, the <unk> combination and then late stage of course with the potential approval.

<unk>.

<unk>.

I'll, let <unk> talk a little bit about our early stage development efforts, but to cut to the chase and answer your question directly we certainly would be open for business development opportunities with Io Theres a lot of opportunities out there and we have.

The number of folks who approach us from time to time with various assets, we haven't locked in and anything so far but we continue to look at them to say you want to say a few things about our early stage pipeline.

Dennis Lanfear: There's a lot of opportunities out there, and we have a number of folks who approach us from time to time with various assets. We haven't locked in on anything so far, but we continue to look at them. Theresa, you want to say a few things about our early stage pipeline? Yeah, and I think having recently joined, one of the things that really attracted me to Coherus was the people and the talent.

Yes.

Having recently joined one of the things that really attracted me just kind of curious what the key following the talent.

Theresa Lavallee: And in addition to having great assets, what surprised me was how strong the science was and the preclinical aspects and looking at the early pipeline and how well it's been put together. And really targeting important aspects of the tumor microenvironment that, you know, the field is really going after broadly. To think about, you know, we have starting on the T cell with, you have to have a PD1, so toropalumab is an excellent molecule. And then coming in with the TGIT as an important way to really get the T cell activated and have that anti-tumor immunity. But if you have a suppressed microenvironment, an active T cell still is hindered.

In addition, kid, having great assets might surprise me you might have.

From Cyan plant and the preclinical last act and looking ahead.

Our lead pipeline and how well put together and really targeting important aspects of the tumor micro environment.

<unk> Israeli gallium.

Rightly so think about we have starting on the T cell you have to have a PD one <unk> is an excellent molecule.

And then coming in with a T J as an important way to really get the T cell.

Activate it and have that anti tumor immunity.

If you have it.

Suppress micro environment and active T cell.

Theresa Lavallee: So I think the portfolio really looking at that is going to be exciting. And as we advance the stages, I mean, I'm really looking forward to getting an in-house IND next year and starting an in-house clinical trial. The other comment I would offer you, Doug, is we will be covering our in-house assets in more detail at our investor meeting. I think David indicated it's going to be around the end of March in New York.

So I think the portfolio.

That is it going to be exciting MSP at HSN.

<unk> temporarily.

I'm really looking forward to getting our <unk> next year and starting the clinical.

Clinical trials the other comment I would offer you Doug.

We will be covering our in house assets in more detail.

At our Investor meeting I think David indicators around whether it'd be around the end of March in New York and will bring us. Some some of the key personnel that were working on this and explain the mechanism of action a few things that we're doing so I think you'd find it interesting.

Dennis Lanfear: And we'll bring out some of the key personnel as we're working on this and explain the mechanism of action, a few things that we're doing. So I think you'll find it interesting. Okay, great. Look forward to the event. Thank you. Thank you and I'm showing no further questions at this time and I would like to turn the conference back over to Denny Lanfear for any further remarks. Thank you.

Okay, Great look forward to the event.

Thank you Doug.

Thank you and I'm showing no further questions at this time I would like to turn the conference back over to Kenny Lam for any further remarks.

Dennis Lanfear: We want to thank you all for joining us today for our end of the year in our fourth quarter conference call. We look forward to seeing you at the upcoming conferences and so on and so forth. And we also look forward to talking to you in more detail at our Investor Day event at the end of March. Thank you.

Thank you we want to thank you all for joining us today for end of the year.

Fourth quarter conference call.

We look forward to seeing you at the upcoming conferences and Cohen and so forth and we also look forward to talking to you in more detail at our Investor day event in March. Thank you.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

This concludes today's call. Thank you for participating you may now disconnect.

Okay.

[music].

[music].

Operator: .. .. .. .. .. .. .. .. Copyright © 2021 Mooji Media Ltd. All Rights Reserved.

Operator: No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. Recording © 2021 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. Recording © 2021 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. Recording © 2021 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.

Operator: Christopher Schott, Yigal Nochomovitz, [music] Good day and thank you for standing by. Welcome to the fourth quarter and full year 2021 Coherus BioSciences earnings conference call. At this time, all participants are in a listen-only mode.

[music].

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star one on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then zero.

Good day, and thank you for standing by welcome to the fourth quarter and full year 2021 course Biosciences earnings Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone please be advised.

Today's conference May be recorded if you require any further assistance. Please press Star then zero I would now like to hand, the conference over to your host today Mcdavid Stilwell Chief Financial Officer. Please go ahead Sir.

McDavid Stilwell: I would now like to hand the conference over to your host today, McDavid Stilwell, Chief Financial Officer. Please go ahead, sir. Thank you, operator. Good afternoon, everyone, and thank you for joining us. We issued our press release earlier announcing our 2021 fourth quarter and full year results. This release can be found on the Coherus BioSciences website. Today's call includes forward-looking statements regarding Coherus' current expectations about future events. These statements include, but are not limited to, our ability to advance our product candidates through development and registration, the status of our product candidate clinical profile, our timing and ability to commercialize our products and product candidates in the future, our R&D and SG&A expense guidance for 2022, and our ability to meet the same, our projections about margin, as well as our ability to draw down amounts under our new credit, All of which involve substantial risks and uncertainties that are beyond our control and could cause actual results. Performance or Achievements to Differ from the Results, Performance or Achievements Complied by the Forward-Looking Statement.

Dennis Lanfear: These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in our press release that we issued today, as well as in the documents that we file with the Securities and Exchange Commission, including those in our annual report on Form 10-K and quarterly reports on Form 10-Q. The forelooking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forelooking statements. With me on today's call are Dennis Lanfear, CEO of Coherus, Paul Reider, Chief Commercial Officer, and Theresa Lavallee, Chief Development Officer. I will now turn the call to Denny.

Thank you operator, good afternoon, everyone and thank you for joining us.

We issued our press release earlier announcing our 2021 fourth quarter and full year results.

The release can be found on the coherent biosciences website.

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

These statements include but are not limited to our ability to advance our product candidates through development and registration the status of our product candidate clinical profile, our timing and ability to commercialize our products and product candidates in the future, our R&D and SG&A expense guidance for 2022, and our ability to meet the same.

Our projections about margin as well as our ability to drawdown amounts under our new credit facility all of which involve substantial risks and uncertainties that are beyond our control and could cause actual results.

Performance or achievements to differ from the results performance or achievements implied by the forward looking statements.

These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are discussed in our press release that we issued today as well as in the documents that we file with the Securities and Exchange Commission.

<unk> notes in our annual report on Form 10-K , and quarterly reports on Form 10-Q .

The forward looking statements provided on the call today are made as of this date and we undertake no duty to update or revise any forward looking statements.

With me on today's call are getting Lanphier, CEO Erez, Paul Reeder, Chief Commercial officer, and Theresa Modality, Chief Development Officer.

I will now turn the call continuing.

Dennis Lanfear: Thank you, McDavid, and thank you all for joining us this afternoon. Today I'll describe how, over the past year, we've delivered on our objective to transform Coherus into an innovative immuno-oncology company. Supported by income from a diversified portfolio of FDA-approved products. I'll begin today with a brief review of our achievements toward our strategic initiative in immuno-oncology, detailing the progress of our foundational assets to our pilot meds, and of our pre-clinical and clinical stage innovative combination agents.

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

Today I'll describe how over the past year, we've delivered on our objective to transform coherence and to an innovative immuno oncology company supported by income from a diversified portfolio.

<unk> products.

I'll begin today with a brief review of our achievements towards our strategic initiatives and immuno oncology.

The progress of our foundational assets, where a problem yet.

And of our preclinical and clinical stage innovative combination agents.

Dennis Lanfear: General Review recent progress to grow and diversify our commercial portfolio. Now, with respect to our immuno-oncology programs, you may recall that in November, we announced the FDA-granted priority review for the BLA for torepalmat for the treatment of nasopharyngeal carcinoma. An indication with no FDA-approved cancer immunotherapy options, and for which TORP-ALMAD has breakthrough therapy and orphan drug designation. The BLE Review is progressing well towards the target action date of April 30th. This is about 10 weeks from now.

I'll review recent progress to grow and diversify our commercial portfolio.

With respect to our immuno oncology programs you may recall that in November we announced the FDA granted priority review the BLA for <unk> for the treatment of nasopharyngeal carcinoma.

An indication with no FDA approved cancer immunotherapy options and for which <unk> has breakthrough therapy and orphan drug designation.

The BLA review is progressing well towards the target action date of April 30, which is about 10 weeks from now.

Dennis Lanfear: Toropallimab's clinical profile continues to strengthen across indications. In December, we announced that Toropallimab plus chemotherapy demonstrated a statistically significant overall survival benefit in a pre-specified interim analysis of the CHOICE-1 clinical trial for the first-line treatment of advanced non-small cell lung cancer. This builds on other first-line indications in esophageal squamous cell carcinoma and nasal pharyngeal carcinoma where we have seen a robust benefit in both the progression-free survival and overall survival.

Sure Palomas Coca profile continues to strengthen across indications in December we announced that to our Palomar plus chemotherapy demonstrated a statistically significant overall survival benefit.

<unk> specifies the interim analysis in the choice one clinical trial for first line treatment of advanced non small cell lung cancer.

This builds on other first line indication and esophageal squamous cell carcinoma, and nasopharyngeal carcinoma, where we have seen a robust benefit both the progression free survival and overall survival.

Dennis Lanfear: We've also made progress with our clinical stage. Mid-Stage IO Asset Strategy, In January, we initiated the process to exercise our option license, JS006. A TIGID-targeted antibody developed by Jun-Chi Biosciences, our partner, which they are evaluating in a study combination with Torpelmeth.

We've also made progress with our clinical stage.

Mid stage Io asset strategy.

In January we initiated a process to exercise our option to license <unk> zero six.

<unk> targeted antibody developed by June <unk>, our partner, which they are evaluating study combination with <unk>.

Theresa Lavallee: Dr. Theresa Lavallee, our new Chief Development Officer, will provide additional details about JS006 and our development plans for you in just a moment. Our immunology preclinical research and development team is proving to be highly productive. In January, we announced that we're advancing an internally generated pipeline of PD-1 combination candidates, and we expect to file the first IND, in mid-2023. With Toropal and Avnerian's first potential approval, a tiget-targeted immune checkpoint blocker entering mid-stage development, and our in-house early-stage immuno-oncology candidates successfully advancing towards human clinical trials, Coherus is evolving into an innovative immuno-oncology company with a broad pipeline of product candidates and the potential to drive long-term growth over this decade.

Dr. <unk> <unk>, our new Chief Development Officer, who will provide additional details about <unk> and our development plans for you just a moment.

Our immuno oncology preclinical research and development team is proving to be highly productive.

In January we announced that we are advancing an internally generated pipeline of PD, one combination candidates and we expect to file the first AMD and <unk>.

Mid 2023.

With tour palmette nearing its first potential approval contingent target an immune checkpoint blocker enter in mid stage development and our in house early stage immuno oncology candidates successfully advancing towards human clinical trials.

<unk> is evolving into an innovative immuno oncology company with a broad pipeline of product candidates and the potential to drive long term growth over this decade.

Theresa Lavallee: I'd now like to introduce Dr. Theresa Lavallee, a recently appointed Chief Development Officer who brings more than 25 years of drug discovery and development experience and is recognized for her immuno-oncology expertise. Most recently, Dr. Lavallee was Vice President of Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy, where she provided scientific leadership for the clinical strategy for development of novel gynecology therapies and helped establish the Institute's translation and regulatory organization. Prior to that, from 2008 to 2013, Dr. Lavallee was a member of the immunology team developing checkpoint inhibitors and related diagnostics at MedImmune in AstraZeneca. Thank you, Denny.

I would now like to introduce Dr. <unk> <unk>, our recently appointed Chief Development Officer.

More than 25 years of drug discovery and development experience and is recognized for her immuno oncology expertise.

Most recently Dr to the Valley was vice President of Translational Medicine, and regulatory affairs at the Parker Institute for cancer immunotherapy.

She provided scientific leadership for our clinical strategy for development of novel immuno oncology therapies.

And help establish institutes translation and regulatory organization.

Part of that from 2008 to 2013, Dr. <unk> was a member of immuno oncology team developing checkpoint inhibitors and related diagnostics at Medimmune and Astrazeneca.

Theresa Lavallee: It is exciting to join Coherus as the company gains momentum in its transition to an innovative immuno-oncology leader. I believe our broadening product portfolio with early, mid, and late-stage complementary I.O. products is well-positioned to clinically succeed in immuno-oncology. Commercially, our oncology-focused organization has proven that Coherus can be very successful in highly competitive fields. Coherence has both the in-house expertise and assets needed to support a successful transformation. Antibody development for BD1 combinations and co-formulations requires world-class analytics, protein science, and bioinformatics capabilities. We have that at our Camarillo, California site, a 25,000 square foot facility we moved into two years ago.

Lisa.

Thank you Kenny is.

It is exciting to join in Turkey.

All trends.

In addition to an innovative immuno oncology meter.

I believe our broadening product portfolio, but it's early.

H complementary.

<unk> is well positioned to clinically succeed in immuno oncology.

Commercially our oncology focused organization.

<unk> can be very successful and highly competitive.

<unk> appeal.

Coherent has bode the income ex Turkey, and the asset needed to support our successful transformation.

Antibody development for PD, one combination and co formulation require world class analytics pricing.

And in for Matt Bioinformatics capability.

We have that at our Canton, Ohio, California site, and 25000 square foot facility, we moved in Q2 years ago.

Theresa Lavallee: On the development side, our clinical and regulatory teams have repeatedly demonstrated the ability to develop drugs that gain FDA approval. Our Scientific Advisory Board of recognized I-O experts from academia and industry is actively involved in our target and moiety selection, playing a key role, for example, in selecting Tora Palamab from a due diligence review of more than 10 PD-1 product candidates, as well as vetting the Tidget asset from JumeSheet. Oh, for Coherus, these investments are paying off.

On the development side, our clinical and regulatory teams.

<unk> demonstrated the ability to develop drugs.

FDA approval.

Our scientific advisory Board recognized Io expertise.

Academia and industry is actively involved in our target and ladies collection claim.

Playing a key role for example, when selecting our talent from a due diligence for a deal of more than 10, PD, one product candidate as well as betting the ticket from Tianjin.

Foreign coherent these investments are paying off.

Theresa Lavallee: Tora Palamab, our foundational immuno-oncology asset, is establishing an excellent safety and efficacy profile in the ongoing clinical trial. The torepalumab BLA for nasopharyngeal carcinoma, an unmet medical need with no approved immunotherapy, is under priority review by the FDA with an action date of April 30th. Denny mentioned earlier that toropalumab's clinical profile continues to strengthen across indications. Case in point, the positive progression-free survival and overall survival data from the Jupiter-6 study in esophageal squamous cell carcinoma, which showed a significant overall survival benefit even in low PD-L1 patients.

<unk>, our foundational immuno oncology asset.

Establishing an excellent safety and efficacy profile and the ongoing clinical trials.

The Torah Palomar BLA for nasopharyngeal carcinoma.

Unmet medical need with no approved immunotherapy is under priority review by the SEC.

With an action date of April 30.

Danny mentioned earlier at Tora Palomas clinical profile continues to strengthen across indications.

Case in point.

Pivoted progression free survival and overall survival data from the <unk> study and esophageal squamous cell Carcinomas, which showed a significant overall survival benefit even in low PD lone patients.

Theresa Lavallee: We have and will continue to engage the FDA on the potential for submission later this year of a supplemental BLA for Tauropalumab in combination with chemotherapy for first-line treatment of ESCC. Another important immune responsive tumor type is hepatocellular carcinoma, which also is highly prevalent in patients of Asian descent, and which the FDA has said could warrant regulatory flexibility for new PD-1.

We have and will continue to engage the FDA on the potential for submission later this year as a supplemental BLA for <unk> in combination with chemotherapy.

First line treatment of SEC.

Another important immune responsive tumor types, it's a patent cellular carcinoma, which also is highly prevalent in patients of Asian defense, and which the FDA has said could warrant.

Regulatory flexibility for new PD one.

Theresa Lavallee: We are conducting two pivotal clinical trials evaluating toropalumab in HCC, including a frontline trial randomizing approximately 520 advanced HCC patients to linfatinib and placebo versus linfatinib plus toropalumab. In adjuvant therapy, we have a trial with approximately 400 HCC patients randomized to toropalumab or placebo following resection. Initial clinical data from these studies are expected later this year. The February 10th ODAC meeting discussing the InnoVent Lily VLA for non-small cell lung cancer provided helpful insights into the FDA's expectations for sponsors seeking approval for PD-1s for indications with available immunotherapy options.

We are conducting two pivotal clinical trials evaluating <unk> in HCC, including a frontline trial randomized Inc. Approximately 520 advanced HCC patients to lend back nandan placebo versus lift that NIM plus to our Palomar.

And adjuvant therapy, we have a trial with approximately 400 HCC patients randomized to <unk> or placebo following intersection.

Initial clinical data from these studies are expected later this year.

The February 10th Kodak meeting discussing the in event Lilly BLA for non small cell lung cancer provided helpful insights into the fda's expectations for sponsors seeking approval for PD, one for indications with available immunotherapy options.

Theresa Lavallee: We believe it is wise to fully engage with the FDA early and prior to submission decisions to fully understand their views. We are continuing to meet with the FDA frequently for toropalumab for multiple potential indications, and we'll discuss with them this year the pathway for toropalumab in combination with chemotherapy for first-line treatment of non-small cell lung cancer. Although there are FDA-approved checkpoint inhibitors for non-small cell lung cancer, new and more effective treatment options are needed as the majority of patients still die rapidly from this deadly disease.

We believe it is wise to fully engage with the FDA early and prior to submission decision to fully understand their views. We are continuing to meet with the FDA frequently for tomorrow palomas multiple potential indications and we'll discuss with them. This year the pathway for <unk>, Inc.

Combination with chemotherapy for first line treatment of non small cell lung cancer.

Although there are FDA approved checkpoint inhibitors or non small cell lung cancer, new and more effective treatment options are needed as the majority of patients still die rapidly from this deadly disease. We are focused on addressing unmet patient needs to non small cell lung cancer will be the first tool.

Theresa Lavallee: We are focused on addressing unmet patient needs. The non-small cell lung cancer will be the first tumor type we pursue for the combination of toropalumab with JS006. We are excited about the development of this TIGID antibody. TIGID is emerging as an important checkpoint to enhance PD-1 anti-tumor immunity.

<unk> eight <unk> for the combination of <unk> with J F.

<unk>.

We are excited about the development of fifth Gen antibody ticket is emerging as an important checkpoint to enhance PD one anti tumor immunity.

Theresa Lavallee: After a decade of translational research with IO, the field understands better how PD-1 inhibitors work and why they have been foundational for IO treatment. Cancer's trick attacking T cells into shutting off prematurely, a subset of T cells that exhibit stemness, have the potential to be reactivated by the unique crosstalk between PD-1 and TIGIT pathways. All of this is consistent with the observed improved clinical activity with PD-1 and TIGID inhibitors in the clinic and specifically in non-small cell lung cancer.

Decades of translational research with IL.

And understand better how PD one inhibitors work.

Why they haven't been foundational for I O treatment.

Cancers trend attacking T cells into studying be materially a subset of T cells that exhibit seven is at the potential to be reactivated by the unique cross talk between PD, one and ticket pathways.

All of this is consistent with the observed in previous clinical activity with PD, one and <unk> inhibitors in the clinic and specifically in non small cell lung cancer.

Theresa Lavallee: In preclinical studies, JS006 has demonstrated excellent binding affinity and strong inhibition of the TIGIT pathway, as well as enhanced anti-tumor activity in combination with toropalumab in preclinical mouse models. A clinical study evaluating JS006 as monotherapy and in combination with toropalumab in patients with advanced pellet tumors is ongoing.

In preclinical studies J S. 006 has demonstrated excellent binding affinity and strong inhibition of the ticket pathway as well as enhanced anti tumor activity in combination with <unk> or about.

Hello, Ma'am in preclinical mouse models.

Clinical study evaluating <unk> as monotherapy and in combination with <unk> in patients with advanced solid tumors is ongoing.

Theresa Lavallee: The IND for JS006 is open in the United States, and we are planning to advance JS006 in combination with toropalumab in a clinical trial in the U.S. later this year. Clinical data news flow will continue this year as results come in from trials evaluating duropalumab for first-line treatment of small cell lung cancer and two additional non-small cell lung cancer studies, one in the neoadjuvant setting, as well as a trial in patients with EGFR mutations who have failed prior TKI therapy, and also pivotal studies in triple negative breast cancer, hepatocellular carcinoma, and interhepatic phalangeal carcinoma. Depending on clinical outcomes and conversations with the FDA, these studies could lead to additional indications for toropalumab in the United States. I will now turn the call back to Denny.

The IND for <unk> opened in the United States and we are planning to advance Jan 006 in combination with Toro power map in a clinical trial in the U S. Later this year.

Clinical data news flow, we will continue this year as results come in from trials evaluating <unk> for.

For first line treatment of small cell lung cancer and two additional non small cell lung cancer studies, one in the neo adjuvant setting as well as a trial in patients with Egfr mutations who have failed prior <unk> therapy and also pivotal studies in triple negative breast cancer.

Our our patent cellular carcinoma and interim capacity Cholangiocarcinoma.

Spending on clinical outcomes in conversations with the FDA feed studies could lead to additional indications for <unk> in the United States.

I will now turn the call back to Denny.

Dennis Lanfear: Thank you, Theresa. It's great to have you on the team directing our mid to late stage IO development effort. Now, let me briefly summarize our recent accomplishments with respect to our commercial stage portfolio and our goal to grow and diversify our commercial portfolio of FDA-approved products. As you may recall, in December, the FDA approved our second product, eSimer. You might have heard about eSimer.

It's great to have you on the team directly on our mid to late stage I O development efforts.

Let me briefly summarize our recent accomplishments with respect to a commercial stage portfolio and our goal to grow and diversify our commercial portfolio FDA approved products.

You may recall in December the FDA approved our second product <unk>.

Dennis Lanfear: Paul will address our planning for this important launch in 2023 and some of the key issues we are considering to ensure that we reach our market share objective, thankful grass the market continues to be very important to us and has only about 50% biosimilar penetration in terms of presentation segment mix, We have had good success with additional presentation development to address all the segments. In October, a Udenica on-body injector demonstrated pharmacokinetic and pharmacodynamic similarity in a randomized clinical trial, enabling the submission this year of a prior approval supplement to the Udenica BLA.

Myra Biosimilar.

Paul will address our planning for this important launch in 2023 and some of the key issues. We are considering to ensure that we reach our market share objectives.

Take progressive market continues to be very important to us and is only about 50% biosimilar penetration in terms of presentation segment mix.

We've had good success with additional presentation development to address all of the segments.

Tober deneke on body injector demonstrated pharmacokinetic and pharmacodynamic similarity in a randomized clinical trial.

Enabling the submission this year of a prior approval supplement to the <unk> BLA.

Dennis Lanfear: If it is approved, we project that 2023 launch of the Eugenica on-body injector, which would compete directly with the last design probe, which would provide a second wave of growth for Eugenica. Identicating the prefilled syringe format continues to provide a significant source of funding for our pipeline investments and support upcoming commercial launches. Net sales of Eugenica declined to $73 million in the fourth quarter within the context of increasingly competitive typhographic markets.

If it is approved we project that in 2023 launch of the tanker on body injector, which would compete directly with nuance designed probe.

Which would provide the second wave of growth for <unk>.

<unk> in the pre filled syringe format continues to provide a significant source of funding for our pipeline investments and support upcoming commercial launches.

Sales of <unk> declined to $73 million in the fourth quarter within the context of increasingly competitive pegfilgrastim market.

Dennis Lanfear: We anticipate Udenica net revenue in 2022 will decrease relative to the $327 million of net revenue generated in 2021. Our strategy is to balance price and market share to optimize long-term revenues with the PFAS format in 2022 and then gain significant share through the accessing the untapped non-binding segment in 2023. In October 2021, the FDA accepted for review the VLA for similarly, our Lucentis BioSciences. Mid-cycle review meeting occurred recently, and the BLA is progressing well towards the target action date in August this year.

We anticipate <unk> net revenue in 2022 will decrease relative to the $327 million of net revenue generated in 2021.

Our strategy is to balance price and market share to optimize long term revenues. The two best format in 2022, and then getting significant share through the accessing.

On by these segments in 2023.

In October 2021, the FDA accepted for review the BLA for similarly, our Lucentis Biosimilar.

Mid cycle review meeting occurred recently and the BLA is progressing well towards the target action date.

Dennis Lanfear: As Paul will elaborate, we plan to launch similarly in the second half of this year, assuming approval. We are also planning for the launch of ToroPalMab and MPCMaker, further diversifying our product portfolio. These two launches in 2022 should be followed by the two 2023 launches of UCIMRI and the Udenica on-body injector. Accelerating the Revenue Growth. We expect these four new products to mark an inflection point for revenues, fueling top-line growth starting later this year.

August this year.

As Paul will elaborate we plan to launch similarly in the second half of this year assuming approval.

We are also planning for the launch of tour appellate Mab in MPC Victor further diversifying our product portfolio in 2022.

These two launches in 2022 should be followed by the 2023 launches of your summary.

Deneke on body injector accelerating our revenue growth.

We expect these four new products to market inflection point for revenues fueling top line growth starting later this year.

Dennis Lanfear: We expect growth to continue with the potential expansion of the Tauropalumab label and project longer term growth with the JS006-Tauropalamab combination, and our Innovative I.O. pipeline we've discussed. I'll now turn the call over to Paul Reider, our Chief Commercial Officer, and Paul will review EDENICA's fourth quarter performance and update you on the launch preparation for Toropalmat, Simmerling, and Yosemite. Thank you, Danny. As Denny indicated previously, Udetica Net sales were $73 million in the fourth quarter, down 12% from the prior quarter.

We expect growth to continue with the potential expansion the <unk> label.

Project long longer term growth with these chaz Jones zero six propelling <unk> combination.

And our innovative Io pipeline you've discussed.

I'll now turn the call over to Paul Reader, our Chief commercial officer.

Paul will review <unk> fourth quarter performance and update you on the launch preparation for <unk>.

Similarly, and Zimmer Paul.

Dennis Lanfear: This was driven by a 4% decline in demand units, as well as continued price erosion due to intense competitive pressures in the Pegpro-Grass Company post-surge market. Our share declined slightly from 18% to 17.5% in the fourth quarter.

Thank you Denny.

As Denny indicated previously <unk> net sales were $73 million in the fourth quarter down 12% from the prior quarter.

This was driven by a 4% decline in demand units as well as continued price erosion due to intense competitive pressures in the pipe progressed deeply storage market.

Our share declined slightly from 18% to 17, 5% in the fourth quarter.

Paul Reider: Market share gains in the clinic segment were offset by declines in both 340B and non-340B hospitals. On a units basis, the overall Penn Philgrasta market declined modestly in the fourth quarter, period in which historically we've seen slight market growth. We expect to return to low single digit market growth in 2022. Until COVID recedes more broadly, there will continue to be a short-term advantage favoring the originators on body to body, obtains approximately 50% share of the overall.

Market share gains in the clinic segment were offset by declines in both 340, <unk> and non 340 <unk> hospitals.

On a unit basis, the overall pegfilgrastim market declined modestly in the fourth quarter.

A period in which historically, we've seen slight market growth.

We expect to return to low single digit market growth in 2022.

Yeah.

Until COVID-19 receipts more broadly there will continue to be a short term advantage favoring the originators on body device, which retains approximately 50% share of the overall market.

Paul Reider: As Denny indicated, we expect Udenica's sales to grow again once we introduce our Udenica on-body injector next year, if approved. Our strategy is to balance price and market share to optimize long term revenues with the PFS format in 2022, and then gain significant share through accessing the untapped on-body segment in 2023. Now I'd like to talk about commercializing our pipe. We are preparing for the launch of three new brands in the next 18 months. Toropalumab, or PD-1 inhibitor for nasal pharyngeal carcinoma, Simerly, or Lucentis biosimilar, and Usimri, or Humira biosimilar.

As Tony indicated we expect <unk> sales to grow again, which we introduced our identical on body injector next year if approved.

Our strategy is to balance price and market share to optimize long term revenues with the PSS PFS format in 2022.

<unk> gained significant share through accessing the untapped on body segment in 2023.

Now I'd like to talk about commercializing our pipeline.

We were preparing for the launch of three new brands in the next 18 months.

<unk>, our PD, one inhibitor for nasopharyngeal carcinoma.

Similarly, our Lucentis Biosimilar and.

<unk>, our Humira biosimilar.

Paul Reider: Regarding TORPALIMENT, Papal pharyngeal carcinoma, where NPC is a rare cancer, where there are currently no PD-1 inhibitors approved for use by the FDA, where Palomav not only has the potential to be the first and only PD-1 inhibitor indicated for this tumor type, but has the potential to also establish a new first line standard. Our oncology commercial capabilities have been built to scale and the Tor Pellimat launch effort will be efficiently integrated into our existing commercial infrastructure.

Regarding toward Palomar.

Nasal pharyngeal carcinoma, or NPC is a rare cancer.

There are currently no PD one inhibitors for use by the FDA.

<unk> not only has the potential to be the first and only PD one inhibitor indicated for this tumor type.

It has the potential to also establish a new first line standard of care.

Our oncology commercial capabilities have been built to scale and the tour Pelham launch effort will be efficiently integrated into our existing commercial infrastructure.

Paul Reider: Commercial launch preparations are proceeding on track. I'd also like to note that the NCCN guidelines for nasal pharyngeal carcinoma recently added the Jupiter-02 study of torpalumab for the first line treatment of NPC as a reference, serving to validate the significance of this important clinical trial.

Actual launch preparations are proceeding on track.

I'd also like to note that the NCC and guidelines for nasopharyngeal carcinoma recently added the Jupiter's Euro two study of towards element for the first line treatment of MPC as a reference which serves to validate the significance of this important clinical trial.

Paul Reider: Now, with respect to SEMRelief, our FDA auction date in August 2022 will allow us to launch into the 1.4 billion lucentis market in the early stages of biosimilar market formation. And we look forward to competing in the retina therapeutic area. Retinal specialist opinion leaders have expressed positive receptivity to Coherus entering this market, and our documented track record of success in oncology give them confidence. Coherus understands the dynamics of the buy and build market and that we will deliver a safe and effective alternative to Lucentis, along with a compelling value proposition.

So with respect to similarly, our FDA action date in August 2022 will allow us to launch into the one four.

<unk> 4 billion, we sent this market in the early stages, the Biosimilar market formation, and we look forward to competing in the retina therapeutic area.

Retinal specialist opinion leaders have expressed positive receptivity to careers entering this market.

Documented track record of success in oncology gives them confidence that coheres understands the dynamics of the biofuel market.

That we will deliver a safe and effective alternative to lucentis.

Along with a compelling value proposition.

Paul Reider: Similar to our playbook with Udenica, we plan to launch a similar education campaign to the retina community in the second quarter. We've also completed our account segmentation work and intend to launch with a focused and dedicated ophthalmology sales, while at the same time leveraging our commercial organization's existing key account, market access, and patient support capabilities. Now on to Yosemite.

Similar to our playbook with Utica, we plan to launch a similar education campaign to the retina community in the second quarter.

We've also completed our account segmentation work and intend to launch with a focused and dedicated ophthalmology sales team while.

While at the same time, leveraging our commercial organization's existing key account market access and patient support capabilities.

Paul Reider: We're preparing for the launch in July 2023. Camira has been the top-selling drug in the United States with Nedelcovych, 17-glam in 2021, and we look forward to competing in this month. While we expect significant competition, our commercial goal is to achieve at peak at least 10% share of the overall Adalimum AdMark. We believe PAIRS will drive biosimilar adalumumab adoption and have completed extensive market research with national and regional PAIRS, as well as PBM. The insights gleaned from this research confirm that Coherus can and expects to deliver on all of the payers' critical expectations. These include a competitive price that delivers value to key stakeholders.

Now onto your summary, with preparing for the launch in July 2023.

Humira has been the top selling drug in the United States with net sales of $17 billion in 2021, and we look forward to competing in this March.

While we expect significant competition, our commercial goals to achieve a peak at least 10% sure. The overall <unk> market.

We believe payers will drive biosimilar at aluminum app adoption and.

We have completed extensive market research with national regional peers as well as Pbms.

The insights gleaned from this research confirmed that coheres Chan and expects to deliver on all of the payers critical expectations. These include the competitive price that delivers value to key stakeholders.

Paul Reider: Robust and reliable supply with high quality manufacturing, a non-staining, citrate-free formulation. Pre-filled syringe and auto-injector presentations with high-gauge needles that are comparable to the reference product and that are comfortable, reliable, and easy for patients to use. Robust patient support services to facilitate access and to address patient out-of-pocket, Also, according to our research, interchangeability was regarded as a nice-to-have attribute. But not essential, since payers already have the mechanisms to drive product selection based on their formularies and utilization management tools that they use routinely today in multiple product categories.

Robust reliable supply with high quality manufacturing.

A nonspeaking citrate free formulation.

Pre filled syringe of auto injector presentations with high gauge needles that are comparable to the referenced product and that are comfortable reliable and easy for patients to use.

Robust patient support services to facilitate access and to address patient out of pocket costs.

Also according to our research interchange ability was regarded as a nice to have.

Not essentially since <unk> already have the mechanisms to drive product selection based on their formulary and utilization management tools that they use routinely today in multiple product categories.

Paul Reider: So to meet these expectations, Coherus has previously invested in large-scale manufacturing and expects to be well positioned to compete on supply guarantees and price. We will have quality pre-filled syringes and auto-injector presentation. Our Yosemite device uses a 29-gauge needle comparable to the originators.

So to meet these expectations coherence has previously invested in large scale manufacturing and expects to be well positioned to compete on supply guarantees and price.

We will have quality pre filled syringe in auto injector presentations are you simply device used 2009 gauge needle comparable to the originators and we also will use our proprietary non stinging to treat three formulations.

Paul Reider: And we also use our proprietary non-stinging citrate-free formulation. In addition, through Coherus Complete, which is our patient and provider services that are considered best in class, among the Pectoral Grasping class today, we have an established and high-tech service offering to facilitate access and affordability. Some large competitors may position their Adalumin map somewhere within a portfolio offering to payers. Coherus, by contrast, will have a singular focus.

In addition through coheres complete which is our patient and provider services are considered best in class among the Pegfilgrastim class today.

We have an established and high touch service offering to facilitate access and affordability.

So some large competitors they position their adalimumab biosimilar within our portfolio offering to Payors coherent by contrast behaviors will have a singular focus on competing successfully and the evolution of that market without the constraints trying to minimize the collateral impacts of price erosion on.

Paul Reider: Without the constraints, trying to minimize, Unknown Executive, Ashwani Verma, McDavid Stilwell, Paul Reider, Rosh Dias, and Billal Jahangiri, our interest is in seeing the overall development of that bark to become as large as possible. We believe this is also in the best interest of payers and patients. In short, we are confident we can deliver a compelling overall value proposition and expect results consistent with our market share forecast with you. I'll now turn the call over to McDavid for a review of the quarter's financial...

A portfolio premium priced branded products.

Our interest is in seeing the overall adalimumab bar to become as large as possible we.

We believe this is also in the best interest of payers and patients.

In short we are confident we can deliver a compelling overall value proposition and expect results consistent with our market share forecast with you simmer.

I'll now turn the call to David for a review of the quarter's financial results.

Thank you Paul.

McDavid Stilwell: The details of our financial results are in the press release. So I'll focus now on a few highlights. For the fourth quarter and full year 2021, we reported net losses of $46 million and $287 million, respectively, on a gap. Cash used in operating activities was $52 million for the fourth quarter and $37 million for the full year 2021. As detailed earlier in the call, net revenue was $73 million for the quarter and $327 million for the year. This is a decrease for both periods, reflecting lower unit volumes and lower net realized price. Wholesaler inventory remained within the normal range at year end.

The details of our financial results are in the press release.

So I'll focus now on a few highlights.

For the fourth quarter and full year 2021, we reported net losses of $46 million and $287 million, respectively on a GAAP basis.

Cash used in operating activities was $52 million for the fourth quarter and $37 million for the full year 2021.

As detailed earlier in the call net revenue was $73 million for the quarter and $327 million for the year.

This was a decrease for both periods, reflecting lower unit volumes and lower net realized price.

Wholesaler inventory remained within the normal range at year end.

McDavid Stilwell: Cost of sales was $12 million for the quarter and $58 million for the year, resulting in gross margins of 84% and 82% respectively. Recall that in the first quarter of 2021, we depleted the inventory manufactured and expensed prior to approval. And since then, per unit acquisition costs are fully reflected within cost. Importantly, cost of goods as a percentage of net revenues has increased since 2020. In the long run, starting in 2024, we expect Udineka pre-filled syringe gross margins to return to 90% or higher as we realize the benefits of a significant manufacturing process improvement and also royalty expiration. Research and development expenses were $51 million for the quarter and $363 million for the year.

Cost of sales was $12 million for the quarter and $58 million for the year, resulting in gross margins of 84% and 82% respectively.

Recall that in the first quarter of 2021, we depleted the inventory manufactured and expense prior to approval and since then per unit acquisition costs are fully reflected within Cogs.

Accordingly cost of goods as a percentage of net revenues has increased since 2020.

In the long run starting in 2024, we expect <unk> pre filled syringe gross margins to return to 90% or higher as we realize the benefits of our significant manufacturing process improvement and also loyalty exploration.

Research and development expenses were $51 million for the quarter and $363 million for the year.

McDavid Stilwell: This is an increase over 2020 and includes the $136 million upfront payments to Jun-Chi for the Tor-Palomar license, as well as costs to advance our late-stage pipeline. Activities such as regulatory affairs and manufacturing scale-up for Yosemite, clinical development and BMA filings for Toropanelmeb, a clinical trial for the Eugenica on-body injector, as well as the ongoing three-way peak case study evaluating CHS305 via bastion biosimilar. Spending general and administrative expenses were $50 million for the quarter and $170 million for the year, an increase that was primarily driven by higher eugenics commercialization activities, as well as stock based compensation. We ended the year with $417 million in cash and cash equivalents.

This is an increase over 2020 and includes the $136 million upfront payments to June sheet for the <unk> license as well as cost to advance our late stage pipeline activities, such as regulatory affairs and manufacturing scale up for <unk> clinical development and BLA filings for tour Panamax.

Our clinical trial for the Utica on body injector as well as the ongoing <unk> PK study evaluating CHF <unk> five the Avastin biosimilar.

Selling general and administrative expenses were $50 million for the quarter and $170 million for the year, an increase that was primarily driven by higher U deneke commercialization activities as well as stock based compensation expense.

We ended the year with $417 million in cash and cash equivalents.

McDavid Stilwell: Recall that subsequent de-year-in. We entered into a credit facility agreement with Pharmacon Advisors for a $300 million term loan payable across four tranches. We drew the first $100 billion tranche at closing and simultaneously paid off a $75 million term loan.

Recall that subsequent to year end.

We entered into a credit facility agreement with Pharmacon advisors for a $300 million term loan payable across four tranches.

Through the first $100 billion tranche at closing and simultaneously paid off $75 million on our term loan.

McDavid Stilwell: Prior to April 1st, we plan to draw a second $100 million tranche and simultaneously pay off the convertible notes that come due at the end of March. Two additional tranches of $50 million each will become available to us upon the FDA approval of Toropanamab and of Simrami. We are introducing full year 2022 guidance for R&D and SG&A expenses of $415 million to $450 million, not including the $35 million upfront fee to Jun-Chi Biosciences we expect to pay later in the first quarter for rights of JS006 or the $25 million milestone payment that will become due on approval of Toropalmat for NPC. This guidance range includes approximately $55 million to $60 million in non-cash, stock-based compensation expenses.

Prior to April one we plan to draw our second $100 million tranche and simultaneously pay off the convertible notes that come due at the end of March.

Two additional tranches of $50 million, each will become available to us upon the FDA approval for our Panamax and similarly.

We are introducing full year 2022 guidance for R&D, and SG&A expenses of $415 million to $450 million.

Not including the $35 million upfront fee to <unk> Biosciences, we expect to pay later in the first quarter of rights of <unk> 006, or the $25 million milestone payment that will become too on approval look toward Palomar for MPC.

This guidance range includes approximately $55 million to $60 million and noncash stock based compensation expense.

McDavid Stilwell: Let me provide some additional color on these anticipated operating expenses, much of which is investments that will convert back to cash quickly with a high IRR. This year we will spend approximately $50 million manufacturing inventory for new product launches. And recall that one lesson from our successful Udenica launch is that going to market with ample supply is a critical success factor. Also recall that low-cost inventory manufactured and expensed prior to FDA approval subsequently delivers P&L benefit in the form of lower costs.

Let me provide some additional color on the anticipated operating expenses.

Each of which is investment that will convert back to cash quickly with a high IRR.

This year, we will spend approximately $50 million manufacturing inventory for new product launches.

You'll recall that one lesson from our successful <unk> launch is that going to market with ample supply is a critical success factor.

Also recall that low cost inventory manufactured and expense prior to FDA approval subsequently delivers P&L benefit in the form of lower Cogs.

McDavid Stilwell: Another $40 to $50 million of operating expense this year will fund the completion of the development of additional presentations of products we expect to introduce over the next two years, as well as manufacturing scale-up projects that will deliver ongoing benefits in the form of significantly lower costs of goods. Finally, on the investor relations front, we will present and host investor meetings in March at two conferences, the Cowen Conference and also the Barclays Conference, and we are planning to host the Coherus Analyst Day event in late March in New York City, hopefully, in person. And I will now turn the call back to Denny for his closing remarks. Thank you, McDavid.

Another 40% to $50 million of operating expense. This year, we will fund the completion of development of additional presentations of products, we expect to introduce over the next two years as well as manufacturing scale up projects that will deliver ongoing benefits in the form of significantly lower.

Our cost of goods.

Okay.

Finally on the Investor Relations front, we will present and host investor meetings in March at two conferences, the Cowen Conference and also the Barclays Conference.

We are planning to host the <unk> analyst day event in late March in New York City hopefully in person.

And I will now turn the call back to Jenny for closing remarks.

Dennis Lanfear: A year ago, we told you that our vision for Coherus was to become an innovative immuno-oncology company with commercial I.O. assets, promising clinical stage programs, and novel in-house preclinical pipelines. With the potential approval of Toropalmab in April, the initiation of a clinical trial evaluating Tidgit in combination with Toropalmab later this year, and the advancement of the first of our in-house IO assets towards IND, we are delivering on this vision that we laid out to investors a year ago. The levers of success are now in our own hands.

Thank you David.

A year ago, we told you that our vision for <unk> is to become an innovative oncology company with commercial Io assets promising clinical stage programs and novel and how its preclinical pipeline.

With the potential approval of <unk> in April initiation of a clinical trial evaluating <unk> in combination with <unk> later this year.

And the advancement of the first of our in house Io assets towards AMD, we are delivering on this vision and we laid out to investors a year ago.

The levers of success are now in our own hands.

Dennis Lanfear: I am proud of the execution of my team and confident that we will fulfill the promise of our strategy. On the commercial side, we are uniquely positioned to launch multiple new products in the next 18 months. With these launches, the total addressable market opportunity of our product portfolio will increase tenfold, from about $2.5 billion to more than $25 billion. Our commercial opportunity will continue to expand as additional ToroPALMAP indications are added and as our immuno-oncology pipeline candidates advance to commercialization.

I am proud of the execution of my team and confident that we will fulfill the promise of our strategy.

On the commercial side, we are uniquely positioned to launch multiple new products in the next 18 months.

With these launches the total addressable market opportunity of our product portfolio will increased tenfold from about $2 5 billion to more than 25 billion.

Our commercial opportunity will continue to expand as additional <unk> indications are added and as our immuno oncology pipeline candidates advance to commercialization.

Dennis Lanfear: This growing product portfolio will fund our continued growth in immuno-oncology through the end of this decade. Operator, we're ready for the questions. Thank you. If you have a question at this time, please press star then one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.

This growing product portfolio will fund our continued growth in immuno oncology through the end of this decade.

Operator, we're ready for questions.

Thank you if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

Operator: And our first question comes from the line of Salim Seed with Mazuho. Your line is open. Please go ahead. Hey, good afternoon, guys. Thanks so much for the color.

And our first question comes from the line of Slim seed with Mizuho. Your line is open. Please go ahead.

Salim Seed: A couple for me, if I can. One on torepalumab. So, I would like to understand a little bit more about the strategy here in lung post and assumed NPC approval late April. Specifically, the prospects of getting torepalumab listed as a Category 2B medication on NCC guidelines and the prospects of a subsequent Medicare reimbursement off-label uptake in lung. Or, do you really think you'll need an additional trial in lung that's head-to-head versus a PD-1 and how those costs would be allocated or shared?

Hey, good after noon guys. Thanks, so much for the color a couple from me if I can.

One on <unk>.

I would like to understand a little bit more about the strategy here and long posting assumed MPC approval late April specifically the.

The prospects for <unk>.

Aspects of getting towards <unk>, the category to be medication on the NCC guidelines and the prospects of a subsequent Medicare reimbursement off label uptake in lung.

Or do you really think you'll need an additional trial in lung.

The head versus the PD, one and how those costs would be allocated for shared and.

Salim Seed: And then the second question is on the Udenica guidance for 22. So, Denny, I appreciate that it's going to be lower. Transcripts provided by Transcription Outsourcing, LLC. Thank you for that, Salim. I would ask that follow-on questions limit themselves to one question so we can work through, and then if your question is not answered, we're happy to go through.

And then the second question is on the <unk> guidance for 'twenty two.

So Denny I appreciate that it is going to be lower.

Then revenues will be lower than 'twenty one.

But how are you thinking about ASP declines in 'twenty, two 2021 by my math had roughly about a 20% to 30% ASP decline. So this is now the fourth year post line should we be thinking about that moderating in 'twenty. Two and then also with Covid cases, largely declining here.

And on personal having 50% of the Pegfilgrastim market.

Just maybe you could speak about qualitative here your your views on units. Please thanks so much.

Thank you for that Selim I would ask that.

Follow on question is limit themselves to one question. So we can work through and then a few questions not answered we're happy to go through so let me direct the question of the non small cell regulatory strategy that you posed to Dr. La valid trees.

Dennis Lanfear: So let me direct the question of the non-small cell regulatory strategy that you posed to Dr. Lavallee. Theresa, do you want to answer that one? Yeah, thanks, Denny, and thanks for the question. I mean, for non-small cell lung cancer, we haven't had any meetings with the FDA since the ODAC, and look forward to discussing the path forward with them. We continue to be impressed with the data, and I think for the overall tone of how the FDA is reviewing these data, they've kind of given some bookends between the MPC indication and non-small cell lung cancer. So our strategy is to have frequent and often conversations with them and align on the packages. Thank you, Theresa.

Did you want to answer that one yes, thanks, Danny and thanks for that question I mean for non small cell lung cancer, we haven't had any meetings with the FDA since the DAC and look forward to discussing our path forward with them.

And to be impressed with the data and I think part of the overall tone of how the FDA is reviewing the data.

Kevin again between the MPC indication in non small cell lung cancer. So our strategy is to have frequent and often in conversations with and then aligned.

The packages.

Theresa Lavallee: Any additional comment with respect to the endpoints of our study or other aspects to Colleen's question? The endpoints that we have are for overall survival with a pre-specified secondary endpoint and was part of the statistical analysis plan, which was designed to meet FDA filings. Thank you. Thank you for that.

Thank you choose any any additional comment with respect to the endpoints of our study or other aspects to <unk> question.

And the endpoints that we have are overall survival with a prespecified secondary endpoint and was part of the statistical analysis plan, which is that our <unk> S.

Paul Reider: And I think your second question, Salim, was with respect to second half of the year sales or 2022 sales. Paul, can you offer Salim any additional color on what we see for Udenica through the rest of this year? Yeah, thanks for your question, Salim. Yeah, so, you know, I think it's reasonable to expect continued price declines in this market, you know, throughout 2022, as it's becoming increasingly competitive. And, you know, I think if you look at our ASPs, you know, we've been averaging mid single digits over the last three quarters.

Finally.

Thank you thank you for that.

And I think your second question Selim was with respect to <unk>.

Second half of the year sales in 2022, So Paulo can you offer assume any additional color on what we see for Ya deneke through the rest of this year.

Thanks for your question <unk>, yes.

I think it's reasonable to expect continued price declines of this market throughout 2022 is becoming.

Increasingly competitive.

I think if you look at our Asp's.

Been averaging mid single digits over the last three quarters and our strategy has really been too.

Paul Reider: And our strategy has really been to balance price and market share, you know, as we look to optimize longer term revenues for Udenica. In 2022, it's going to be within the context of the prefilled syringe segment. But we're, you know, we're going to be ready to go with the launch of an on-body device in 2023, if approved, you know, to go after that, you know, remaining 50% of the on-pro market that's, you know, I think just been able to entrench itself through the persistence of COVID.

As balanced price and market share.

As we look to optimize longer term revenues for you Detica in 2022, it's going to be within the context of the pre filled syringe segment.

But where we are.

We're going to be ready to go with the launch of an on body device in 2023 are approved.

To go after that.

Meaning 50% of the <unk> market.

I think just been able to entrench itself through.

The persistence of Covid so.

That's what we're thinking.

I hope that answers your question does lean we'll be happy to look back with you.

Have a little more.

I will answer that.

Operator can we have an expression.

Paul Reider: So, you know, that's what we're thinking. Hope that answers your question, Salim. We'll be happy to loop back with you if we have a little more follow-on to that. Operator, can we have the next question? And our next question comes from the line of, Can Ketchatory with Cowan. Your line is open, please go ahead. Ken, your line might be on mute.

And our next question comes from the line of Ken Cacciatore with Cowen. Your line is open. Please go ahead.

So Ken Ken your line might be on mute.

Operator: Okay, we'll move to our next question, which is Georgie Yordanoff with Cowen & Company. Your line is open. Please go ahead.

Okay.

Well move to our next question with Josh Giorgi Giordano with Cowen <unk> Company. Your line is open. Please go ahead.

Operator: Thank you guys. Thank you so much for taking our questions. We're going to limit to one.

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

Georgie Yordanoff: So on the recently announced partnership for the TIGIT asset, could you maybe talk about how these are being differentiated from the more advanced TIGIT antibodies that are in later stages of development out there? And then you mentioned your intentions to run trials here in the U.S. in combination with TORI as well as in monotherapies. Could you remind us of the expected R&D costs for that associated with that development and what percentage of that you're responsible for?

We're going to limit to one so on the recently announced partnership for the digit asset could you maybe talk about how do you keeping differentiated from the more.

Advanced <unk> antibodies that are.

In later stages of development out there.

And then you mentioned.

Your intentions to to run trials here in the U S in combination with <unk> as well as in mono therapies could you remind us of.

The expected R&D costs for that associated with that development.

What percentage of that you're responsible for it.

Georgie Yordanoff: Let me take the last part first with respect to cost, and then I'll let Theresa describe our strategy around the tiget. With respect to cost, you may recall that the agreement with Jun Shi limits our shared clinical costs to $25 million per year per product. That is the same for Toropalmat as it is for the opted-in products. JAS 006 is 1.

Now let me take the last part first with respect to cost and then I'll, let Teresa described.

Describe our strategy around the tissue.

With respect to costs, you may recall that the agreement.

With June sheet.

Limits, our shared clinical cost you $25 million per year per product that has the same point towards that as it is for the opted in products, which tissue jazz 006 is one so we presume that this will be done under the auspices of the joint steering committee of the partnership and such.

Dennis Lanfear: So we presume that this will be done under the auspices of the Joint Steering Committee of the Partnership and subject to those caps. Now if there's additional work that we want to do outside of that, that may be some additional things that is not paid for through the Partnership, and then she and she has the opportunity to opt back into that data later. Given that this asset, however, will be developed internationally, globally, across all markets, it's probably safe to assume that this will be primarily developed through the Joint Steering Committee of the Partnership.

To those caps now if theres additional work that we want to do.

Outside of that that may be some additional things that is not important to the partnership and then June she has the opportunity to up back into that data later.

Even at this asset however will be developed internationally globally across all markets.

It's probably safe to assume that this will be primarily developed through the joint steering committee of the partnership.

With respect to Tianjin development potential differentiation in our strategy of going into <unk> would you like to make a few comments on that.

Dennis Lanfear: With respect to tigent development, potential differentiation, and our strategy of going into line, Theresa, would you like to make a few comments on that? Yeah, and I think the data we've seen from our partner Jun-Shi on the TTIT antibody is it has significant potency in preclinical models. And we look to develop it in tumor types, such as non-small cell lung cancer, obviously to establish proof of principle in combination with TOR-PAL-MM with a translational strategy to really understand where we see activity and not activity to advance it with urgency. The only other additional color I would provide with respect to the Tidget is we have developed co-formulated approaches to the product, which would be single vial.

And then I think the data we've seen from our partner <unk>.

It's an antibody.

<unk> potency in preclinical models.

We love to develop bed in tumor types, such as non small cell lung cancer, obviously established principle in combination with <unk>.

But the translational strategy to really understand where we see activity.

Activities to advance it with urgency.

Do any other additional color I can provide with respect to the ticket, but as we have developed co formulated approaches to the product which would be single aisle.

Theresa Lavallee: Operator, we're ready for the next call. And our next question comes from the line of Chris Schott with KP Morgan. Your line is open. Please go ahead. Great. Thanks so much. I'm going to slip a one and a half questions in. I just come back to the Tor Palomar discussion earlier.

Operator, we're ready for the next call.

Chris Schott: Would you run a US-based head-to-head study in non-small cell lung cancer if the FDA required it or is that kind of a non-starter as you think about, I know you still need to meet with the FDA, but if that's what they're asking for, is that something that makes sense for Coherus or not? My core question was coming back to biosimilar Humira. I think there's been a lot of debate about how much volume AbbVie is going to be able to contract here and how many biosimilars each payer is going to cover.

And our next question comes from the line of Chris Schott with Jpmorgan. Your line is open. Please go ahead.

Great. Thanks, so much I wanted to ask questions and I'll just come back to the tour Palomar discussion earlier would you run a U S based head to head study in non small cell lung cancer. After you acquired it.

Is that kind of a nonstarter or as you think about I know you still need to meet with the FDA, but if that's what they're asking for is that something that makes sense for coherent or not in my core question was coming back to Biosimilar Humira I think there's been a lot of debate about how much volume abbvie is going to be able to contract here and how many biosimilar as each payer is going to cover. So can you just elaborate a little bit more on how you.

Chris Schott: So can you just elaborate a little bit more on how you think that plays out as you look out to 2023 and beyond? Do you think it's going to be a situation where there's multiple biosimilars and it's kind of a jump ball and it's about commercial execution or do you expect the payers to kind of focus in on like one or two biosimilars and do you expect that AbbVie is going to be able to retain a sizable portion of the market or do you expect that a lot of the volume in this space is going to be available to the biosimilar players? Thanks so much.

Think that plays out as you look out to 2023 and beyond.

Do you think is going to be in a situation, where there's multiple biosimilars than it's kind of a jump ball is about commercial execution or do you expect the payers to kind of focusing on like one or two biosimilars.

And do you expect that Abbvie is going to retain a sizable portion of the market or do you expect that a lot of the volume in this space is going to be available to the biosimilar players. Thanks, so much.

Dennis Lanfear: Thanks. Thank you for your one and a half questions. I think you have one and three quarters questions there, Chris, but that's okay. I'm going to call first the trustee of the Yosemite Trust, you know. They might have a similar question for you, and then we'll move back on to our panel.

Thank you.

For Europe .

Wanted to have I think one of the three quarters questions there, Chris but that's okay with me on the call for <unk>.

Rusty.

The summary.

The Humira Biosimilar question for you and then we'll move back.

And that's where I'll comment Paul.

Paul Reider: Yeah, thanks for your question. So, you know, at the time of our launch in July 2023, you know, we will expect to be one of a number of biosimilars entering the market at that same time. And what we'll be prepared to do at that time is to bring, you know, a value proposition, You know, that includes those those factors that I mentioned in my prepared remark, a very competitive price substantial Supply Guarantees, and all of the pre, full syringe and auto injector types of presentations. The non-stain citrate-free formulation will be another differentiator.

Yes. Thanks for your question so.

At the time of our launch in July 2023.

We will expect to be want to number of biosimilars entering the market at the same time.

And what we will be prepared to do at that time is to bring our.

Our value proposition.

That includes those those factors that I mentioned in my prepared remarks.

We were very competitive price substantial.

Supply guarantees.

And all of the Prefilled syringe and the auto injector types of presentations.

The non <unk> things to treat <unk> formulation will be another differentiator and so I think we expect to happen.

Paul Reider: And so I think what we expect to happen, is you know we're going to through our payer segmentation is not look at them all as a one size fits all but to fit their particular objectives based on their plans their covered lives and their business and to deliver the value proposition that, depending upon the control level of the plant, might be a single biosimilar in a rapid conversion away from the innovator or in the short term of launch, you know, Humira plus Yosemite, in which case it'll be a slower transition over time. Either way, we'll have, you know, a portfolio of the value proposition that will meet their needs and we will expect to be, you know, one of the most compelling high volume, low cost providers at the time of commercialization mid-year. We expect to do very well.

As we're going through our payer segmentation is not look at them all as a one size fits all but to fit their particular.

<unk> objectives based on their plans their covered lives and their businesses.

And to and to deliver the value proposition that.

Depending upon the control level of the plan might be.

A single Biosimilar in a rapid conversion away from the innovator.

In the short term of launch.

Humira, plus <unk>, plus <unk> in which case that will be a slower transition overtime either way we will have.

A portfolio of the value proposition that will meet their needs and we will expect to be one of the most compelling high volume low cost providers at the time of commercialization midyear, we expect to that we expect to do very well.

Dennis Lanfear: The other the other point I would make with respect to that, Chris, is we think with the number of competitors in the market, there's going to be tremendous cost pressure all around. And we would be surprised if, if AbbVie, you know, two or three years into the market, did not have a relatively small share of that market as opposed to a majority greater than 50% share. So we think they'd probably get down to the 20-25% type of share gain.

The other the other point I would make with respect to that Chris.

I think with the number of competitors in the market, there's going to be tremendous cost pressure all around.

And we would be surprised if it.

Abbvie.

Two or three years ended the market.

It did not have a relatively small share of that market as opposed to the majority of greater than 50% share. So we think they are probably get down to the 25%.

Dennis Lanfear: With respect to your question on Torop LMAB and the potential Regulatory Pathway there in line, it's, we believe it's probably prudent for us not to preempt our conversations, you know, that we haven't had yet with the FDA, as Theresa said, we haven't really had a chance to interact with FDA post the ODAC. And we look forward to doing that. We were convinced that we have a very high quality molecule demonstrating significant efficacy and safety across a number of indications, including lung.

Type your share gain with respect to your question onto our Allomap and the potential.

Regulatory pathway there.

We believe it's probably prudent for us not to preempt our conversations.

We haven't had to deal with the FDA as Teresa said, we haven't really had a chance to interact with FDA post the <unk>.

And we look forward to doing that we were convinced that we have a very high quality molecule is demonstrating significant efficacy and safety across a number of indications, including lung. So we're very enthusiastic about talking to the FDA about that.

Dennis Lanfear: So we're very enthusiastic about talking to the FDA about that. But, you know, we really think it's probably not prudent to, Talk about what sort of studies they might require and when and that type of thing.

But we really think it's probably not.

Prudent too.

Talk about what sort of studies they might require in wind and other types of things that being said, we are planning on moving into lung.

Dennis Lanfear: That being said, though, we are planning on moving into lung with with the TIGIT asset in conjunction with Toracalumab. And you'll be hearing more of that later in her program remarks. Theresa, of course, talked about that and how we're going to move in towards the end of this year. So stay tuned on that one. Thank you. Thanks, Chris.

With the <unk> asset in conjunction with toward Palmette and Youll be hearing more of that later in her prepared remarks, <unk> talked about that and how we're going to move in towards the end of this year. So stay tuned on that one.

Thank you.

Dennis Lanfear: And our next question comes from the line of Balaji Prasad with Barclays. Your line is open. Please go ahead. Thank you. Hi, good evening, everyone.

Thanks, Greg.

And our next question comes from the line of <unk> Prasad with Barclays. Your line is open. Please go ahead.

Balaji Prasad: So, firstly, getting back to Biosimile Myra, can you quantify better the non-stinging citrate-free formulation and what kind of an advantage it provides to you? And also, probably importantly, do you expect to be the only citrate-free formulation on the market next year? One.

Thank you hi, good evening.

So firstly getting back to <unk>.

Can you quantify a bit of the nonstick exit rates being formulation on what kind of my bond agent for lifestyle and also probably importantly, or do they expect to be the only suite.

Trade free formulation on the market next year.

And two if you can just help us quantify it with your own clinical trials with multiple trials going on with $417 million of cash.

Dennis Lanfear: And two, if you can just also quantify with your clinical trials, with the multiple trials going on with $417 million in cash, if you need to prioritize your clinical trials, what would be the top one or two ones that are going to advance next year? Thank you. Thank you, Balaji. Let me let me first address the issue of the formulation. It's very important from the viewpoint of patient comfort upon injection, that the formulation does not stain, that it's not unduly uncomfortable.

If you need to prioritize clinical trials, what would be the top one or two are ones that have linked advanced next year. Thank you.

Thank you Bob Let me, let me first address the issue of the formulation is very important from the viewpoint of patient comfort upon injection that the formulation does not state that is not unduly uncomfortable and there is anecdotal data that patients found.

The preview.

Previous low concentration formulation of Abbvie very uncomfortable because does etcetera. So several years ago. When we approach the humira Biosimilar, which was 14.

Dennis Lanfear: And there's anecdotal data that patients found the previous low concentration formulation of AbbVie very uncomfortable because it does have, So several years ago, when we approached the Humira Biotech, which was 1420 at that time, we developed a proprietary, non-stringing, citrate-free formulation.

<unk> 2000, and at that time, we developed a proprietary non stream citrate free formulation no I won't speak for others, but I think this is very very important from the viewpoint of patient comfort and being able to penetrate the markets.

Dennis Lanfear: Now I won't speak for others, but I think this is very, very important from the viewpoint of patient comfort and being able to penetrate the markets, as Paul said. Now, with respect to the clinical trial, in 2022 and various costs and types. As McDavid pointed out to you, there are significant spends on matters such as manufacturing, one of the ways that we succeeded with Utanaka that you may recall as we stockpiled. 100,000 syringes prior to launch at significant manufacturing expense. It was it was $25 or $35 billion when we did it.

As Paul said.

With respect to the clinical trials.

In 2022 at various cost guidance.

As Mick David pointed out too there are significant spins on matters such as manufacturing one of the ways that we succeeded with you Dennis as you may recall, we stockpiled.

<unk> thousand syringes prior to launch at significant manufacturing expense it was $25 $35 billion when we did it.

Dennis Lanfear: And however, I think that served us very, very well post launch. We were able to do supply guarantees and did very well in that market, while others were not able to do so. And I think that was one of the reasons why we achieved in excess of 20 percent market share in that market. We think that very same formula applies here, for example, with Humira.

However, I think that served us very very well post launch we were able to do supply guarantees and did very well in that market while others.

We're not able to do so and I think that was one of the reasons why we achieved in excess of 20% market share in that market.

We think that very same formula applies here for example, with Humira, we have gone to large scale, we've made those investments.

Dennis Lanfear: We have gone to large scale, we've made those investments. We will be prepared, for example, for fierce competition in price that we have to. But we think that we want to be the team that has the inventory and the supply guarantees to be able to go in the market for that. And that's where I think some significant parts of our spend go. But on the other hand, we think that's very wise. And as McDavid indicated in his remarks, that pays back later. That goes into COGS, it's expensed now. But that gives you an advantage, and there's a significant IRR.

We will be prepared for example for a fierce competition in price that we have to but we think that we wouldn't be that we wouldnt be the team that has.

The inventory in the supply guarantees given the global market for that and that's where I think.

Some significant parts of our spend go but on the other hand, we think thats very wide and as mcdavid indicated in his remarks that pays back later that goes that goes into Cogs as expense now, but that gives you an advantage and there is a significant IRR.

Dennis Lanfear: I hope that answers your question. Thank you. And our next question comes from the line of Jason Gerberry with Bank of America. Your line is open. Please go ahead.

Hope that answers your question.

Thank you and our next question comes from the line of Jason <unk> with Bank of America. Your line is open. Please go ahead.

Jason Gerberry: Hey guys, thanks for taking my question. Mine is on the NPC US market opportunity. Can you talk a little bit about your expectations here with this? Do you expect it to be used more frontline with the chemo combination or second line monotherapy? How many of these patients are really addressable? Is it going to be hard to find these patients because it's a pretty small population? And it seems like there's a pretty big swing factor if you're frontline versus second line. I think the interim PFS was 12 months for frontline, but I think in like second line, it was much, much shorter.

Hey, guys. Thanks for taking my question.

Maybe on the MPC U S market opportunity.

Can you just talk a little bit about your expectations here with this you expect it to be used more frontline with the chemo combination or second line monotherapy. How many of these patients are really addressable if.

Is it going to be hard to find these patients because it's a pretty small population and if you think theres a pretty big swing factor for your frontline <unk> second line I think the interim PFS was 12 months for frontline, but I think in like second line is much much shorter so just trying to get a sense. If you can kind of frame the key parameters of an oncology forecast.

Dennis Lanfear: So just trying to get a sense if you can kind of frame the key parameters of an oncology forecast. Thanks. Thanks for the question on that. Of course, we expect to get frontline with MPC. I'll let Paul fill in the rest of your question with respect to the market size and so on. Yeah, thanks for your question, Jason. So, Yeah, it's a real cancer, you know, we- The data suggests that, you know, there's a couple thousand patients treated with NPC annually and about a third of those patients, you know, are cycled through in the in the first line setting.

Thanks. Thanks for the question on that of course that we expect to get frontline with MPC I'll, let Paul drilling the rest of your question with respect to the market size and so on.

Yes, Thanks for your question Jason So.

<unk> is a rare cancer.

The data suggests that there is a couple of thousand patients treated with MPC annually.

And about a third of those patients or site.

Through in the in the first line setting and so.

Paul Reider: And so, you know, as we expect, if approved to be the first and only. P1 antibody approved for MPC including first line, you know, that's where we believe we have the potential to establish a new standard of care and really in combination with chemotherapy plus torpellumab, you know, be the standard of care in frontline patients. Patients are treated with chemotherapy only in first line, it's likely they're going to progress and then we've got the data in later lines of therapy that we'll, you know, expect to pick them up later lines, but we want to get these patients treated frontline.

As the <unk>.

<unk> if approved will be the first and only.

PD, one antibody approved for MPC, including first line.

That's where we believe we have the potential to establish a new standard of care.

Really in combination with chemotherapy plus towards element.

The standard of care in frontline patients and patients who are treated with chemotherapy only in first line slightly they're going to progress and then we've got the data in later lines of therapy that we will win.

We'll expect to pick them up later lines, but we want to we want to get these patients treated frontline.

Paul Reider: Yeah, so there's not a lot of them, Jason, but, you know, we, you know, looking at our data with about 1,500 HCPs that we see are using PD-1s for NPC, and they account for over half of the patient volume, and we've got significant overlap with our current, you know, Udenica base, and so we'll have high overlap, very synergistic at the time of launch to drive share voice and the, The fact that the data has already been widely presented by ASCO Plenary in 2021, the study was published in Nature Medicine last year, and of course now NCCN Guidelines has added it, you know, provides a real tailwind for us going into a potential launch here. Jason, the other thing we would add here, of course, we'll also get second and third line, and so we're going to pursue MPC quite holistically, and as Paul indicated, you know, we think we have a very strong case therapeutically with the ASCO Plenary session and Nature Medicine and so forth.

So theres not a lot of them, Jason but we.

Looking at our data is with about 500, hcp's, but we see youre using PD ones for MPC. They account for over half of the other patient volume and we've got.

Significant overlap with our current <unk>.

<unk> base and so we will have high overlap very synergistic AGA launched.

To drive share of voice.

The tour Allomap and.

MPC story, there and the fact that the data has already been widely.

<unk> <unk> <unk> in 2021. This study was published in nature Medicine last year and of course now NCC guidelines is that it added it.

Provides a real tailwind for us going into potential launch here, Jason the other the other thing we would add you're of course, we'll also get second and third line and so we're going to pursue mtc quite holistically and.

As Paul indicated we think we have a very strong case therapeutically with ESCO plenary session in nature medicine, and so forth. After we get the approval under our belts and we get into the market for a few months I think your question is fair game with respect to forecast until I will be happy to look back.

Paul Reider: So, after we get the approval under our belts and we get into the market for a few months, I think your questions fair game with respect to forecasts and so on. We'll be happy to loop back. Can you just remind me, in the frontline setting, what the PFS was? And when you say one-third cycle through first line, so basically of a couple thousand only a third of them make it to second line? Was that the point?

Can you just remind me in the frontline setting what the PFS was.

Would you say one third cycle first line for basically of a couple of thousand only a third of them make it. The second line was up a point or only a third of a couple of thousand ultimately get treated in the frontline setting.

Chris: Or only a third of a couple thousand ultimately get treated in the frontline setting? Chris, did you want to grab that one? Yeah, the TFS and first line were 11.7 months, with a one year PFS of 49%. Yeah, Jason, and then of the couple thousand patients treated annually, about a third get treated in the first line setting. Okay. All right. Thanks so much.

But curious if you want to cover that one.

Yes, the PFS in first line with 11 seven months.

With a one year PFS of 49%.

Jason and then of the couple of thousand patients treated annually about a third.

Get treated in the first line setting.

Yes.

Okay, alright, thanks, so much.

Theresa Lavallee: Thank you. And our next question comes from the line of Douglas Tsao with HC Lainwright. Your line is open. Please go ahead, now added sort of your own internal R&D capabilities, discovery, and I.O. I'm just curious. Well, forgive me, Doug. I think we missed the first part of your question. Could you restart?

Thanks, Susan.

Thank you and our next question comes from the line of Douglas Tsao with H C. Wainwright. Your line is open. Please go ahead.

Now added sort of your own internal R&D capabilities discovery in IL I'm just curious.

Well forgive me Doug.

I think we missed the first part of your question could you restart.

Operator: Oh, yeah, sorry. You've, you've now started your sort of own internal discovery efforts in IO, it sounds. And, I'm just curious, as you sort of add to your own capabilities, you know, how do you see your vision for growing the business, you know, versus business development? Obviously, you're going to be launching a number of products, your cash flow should be quite significant.

Oh, yes, sorry.

You've now started your sort of own internal discovery efforts Nio it sounds.

And.

I'm just curious as you sort of add to your own capabilities.

Do you see your your vision for growing the business.

Versus.

Business development, obviously, you're going to be launching a number of products. Your cash flow should be quite significant do you have a sort of a bias towards now focusing on sort of internally developed.

Douglas Tsao: Do you have a sort of bias towards now focusing on sort of internally developed assets versus ones that you might want to acquire? And as that cash flow comes in, do you potentially think about, you know, business development and M&A more aggressively? Thank you. That's a great question, Greg.

Assets versus ones that you might want to acquire and as that cash flow comes in do you potentially think about.

Business development and M&A more aggressively thank you.

Dennis Lanfear: It's very important to us that we have a portfolio that's balanced across all three stages of development. Preclinical, early stage development, mid-stage development, represented by, for example, the TIGI-TOR-PALMF combinations, and then late stage, of course, with the potential approval of TOR-PALMF. I'll let Theresa talk a little bit about our early stage development efforts, but to cut to the chase and answer your question directly, we certainly would be open for business development opportunities with I.O.

Okay.

Thats Great question Gregg.

It's very important was that we have a portfolio that is balanced across.

All three stages of development preclinical early stage development mid stage development Representatives by for example, the digital vintages of ophthalmic combinations and then late stage of course with the potential approval of.

<unk>.

I'll, let <unk> talk a little bit about our early stage.

<unk> efforts, but to cut to the chase and answer your question directly we certainly would be open for business development opportunities with Io Theres a lot of opportunities out there and we have.

A number of folks who approach us from time to time with various assets, we haven't locked in and anything so far but we continue to look at them to say you want to say a few things about our early stage pipeline.

Theresa Lavallee: There's a lot of opportunities out there, and we have a number of folks who approach us from time to time with various assets. We haven't locked in on anything so far, but we continue to look at them. Theresa, you want to say a few things about our early stage pipeline? Yeah, and I think having recently joined, one of the things that really attracted me to Coherus was the people and the talent.

Yeah, No I think Gavin recently, joining one of the things that really attracted me just kind of curious what the key following the talent and in addition, kid having great assets.

Theresa Lavallee: And in addition to having great assets, what surprised me was how strong the science was and the preclinical aspects and looking at the early pipeline and how well it's been put together. And really targeting important aspects of the tumor microenvironment that, you know, the field is really going after broadly. To think about, you know, we have starting on the T cell with, you have to have a PD-1, so toropalumab is an excellent molecule. And then coming in with the TGIT as an important way to really get the T cell activated and have that anti-tumor immunity. But if you have a suppressed microenvironment, an active T cell still is hindered.

Surprisingly.

Strong said Cheyenne plant and the preclinical aspect and looking at the early pipeline and how well it would be put together and really targeting important aspects of the tumor micro environment.

<unk> Israeli galleon after broadly to think about we have starting on the T cell would you have to have a PD Wang <unk> pallet math isn't it.

Excellent molecule.

And then coming in with a T J as an important way to really get the T cell.

Activate it and have that anti tumor immunity, but if you have.

As the press micro environment and active T cell still hindered.

Theresa Lavallee: So I think the portfolio really looking at that is going to be exciting. And as we advance the stages, I mean, I'm really looking forward to getting an in-house IND next year and starting an in-house clinical trial. The other comment I would offer you, Doug, is we will be covering our in-house assets in more detail at our investor meeting. I think David indicated it's going to be around the end of March in New York.

So I think the portfolio, let me, let's see.

That is it going to be exciting MSP Exelon is Asia.

I'm really looking forward to getting them in house R&D next year and starting clinical.

Clinical trials the other comment I would offer you Doug is.

We will be covering our in house assets in more detail.

At our Investor meeting I think David indicators around whether it be around the end of March in New York and will bring us. Some some of the key personnel that were working on this and explain the mechanism of action and a few things that we're doing so I think you'll find it interesting.

Dennis Lanfear: And we'll bring out some of the key personnel as we're working on this and explain the mechanism of action, a few things that we're doing. So I think you'll find it interesting. Okay, great. Look forward to the event. Thank you. Thank you and I'm showing no further questions at this time and I would like to turn the conference back over to Denny Lanfear for any further remarks. Thank you. We want to thank you all for joining us today for our end of the year in our fourth quarter conference call.

Okay, Great look forward to the event.

Thank you Doug.

Thank you and I'm showing no further questions at this time I would like to turn the conference back over to Denny Lanfear for any further remarks.

Dennis Lanfear: We look forward to seeing you at the upcoming conferences and so on and so forth. And we also look forward to talking to you in more detail at our Investor Day event at the end of March. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Thank you we want to thank you all for joining us today for our end of the year and our fourth quarter conference call.

We look forward to seeing you at the upcoming conferences and Cohen and so forth and we also look forward to talking to you in more detail at our Investor day event in March. Thank you.

This concludes today's call. Thank you for participating you may now disconnect.