Coherus BioSciences (CHRS) Q1 2022 Earnings Call Transcript

Coherus BioSciences (CHRS 5.31%)
Q1 2022 Earnings Call
May 05, 2022, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, and thank you for standing by. Welcome to the Coherus Biosciences Inc. first quarter 2022 earnings conference call. [Operator instructions] I would now like to hand the conference over to your speaker today, McDavid Stilwell, chief financial officer.

Please go ahead.

McDavid Stilwell -- Chief Financial Officer

Thank you, operator. Good afternoon, everyone, and thank you for joining us. We issued a press release earlier announcing our financial results for the first quarter of 2022, and the results can be found on the 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, our revenue targets for 2026 and our ability to meet the same, our projections about the margin as well as our ability to draw down announcement of our recent credit facility and the timing of the resubmission and review of the toripalimab BLA. All these future events 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. And these statements are not guarantees of future performance and are subject to substantial risks and uncertainties that are discussed in our press release that we issued today as well as the documents that we file with the Securities and Exchange Commission, including those in our quarterly report on Form 10-Q with today's day. 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 Denny Lanfear, CEO of Coherus; Paul Reider, chief commercial officer; Theresa Lavallee, chief development officer; and Dr. Rosh Dias, chief medical officer. And I'll now turn the call over to Denny.

Denny Lanfear -- Chief Executive Officer

Thank you, McDavid, and good afternoon, everyone, and thank you for joining us today in our conference call to review recent business highlights and financial results for the first quarter of 2022. Today, we'll provide updates on our current business as well as our progress transforming Coherus into an innovative immuno-oncology company supported by revenues from a diversified portfolio of FDA-approved products. Now first, with respect to the complete response letter we received from the FDA pursuant to the toripalimab BLA for advanced nasal paranasal cancer, we are currently assembling the FDA meeting package, which will support an agency interaction to occur prior to the BLA submission. We expect mid-summer filing in the six months for due time line.

As we previously communicated, we believe the requested quality process change is straightforward and readily addressable. Further to the development side of the business, Dr. Theresa Lavallee, our chief development officer, will provide additional detail regarding toripalimab BLA as well as our work with our partner, Junshi Biosciences, on the development of toripalimab for other indications and in combination with CHS-006, our targeted antibody. On the commercial side of the business, Paul Reider, our chief commercial officer, will review recent Udencya performance in our preparation for the anticipated near-term commercial launches of first, toripalimab, which we plan to launch or MPC once approved.

Similarly, on the census biosimilar candidate, where the review of the BLA is proceeding well and progressing toward an August 2, 2022 action date. [Inaudible], our Humira biosimilar, where we are investing heavily in inventory build and a robust supply availability, is a key part of our market strategy, as well as Udencya on-body injector presentation. Significant market share growth opportunity for our Udencya franchise. Today, we're also announcing the termination of our license relationship with Innovent for the development of biosimilar [Inaudible] candidate IBI-305.

COVID commenced shortly after execution of this agreement and has caused significant delays to the development timeline. We have recently assessed the market dynamics. And given ongoing and projected COVID-related delays, we determined that this program no longer warrants our continued investment. Lastly, McDavid Stilwell, the company's chief financial officer, will review our first quarter financial results, provide an update on our operating expense guidance for the remainder of 2022.

We will then, of course, be happy to take your questions. And today, I want to introduce you to our new chief medical officer, Dr. Rosh Dias, who is with us, and we'll be happy to take your questions during the Q&A. Rosh has over 18 years' experience in oncology across medical affairs, development and commercialization.

And we welcome Rosh to our team. Now at our analyst day event, March 29, we introduced 2026 revenue guidance targets of $1.2 billion to $2.2 billion, and further describe how we will leverage our existing operational infrastructure to achieve our commercial and development objectives. With continued strong execution of regulatory approvals and commercial launches and the advancement of our novel immuno-oncology pipeline. We expect to transform Coherus into a rapidly growing and profitable and innovative immuno-oncology company.

Now I'll turn the call over to Dr. Lavallee for an update on the toripalimab BLA review and our early development programs. Theresa?

Theresa Lavallee -- Chief Development Officer

Thank you, Denny. As Denny referenced, the FDA issued a complete response letter for the biologics license application for toripalimab for NPC. The CRL requests a quality process change that we believe is straightforward and readily addressable. We plan to meet with the FDA to ensure our resubmission is complete and will submit the meeting request package in the next few days.

We plan to resubmit the BLA by midsummer 2022. The agency also communicated in the CRL that the review time line for the BLA resubmission would be six months. As required, on-site inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China. The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission.

Toripalimab has demonstrated clinical efficacy in multiple tumor types, including in tumors with low PD-1 expression. This differentiated clinical activity may result from toripalimab high binding affinity to a unique epitope [Inaudible] PD-1 internalization. The next clinical milestone for toripalimab will be the readout of the PFS and OS co-primary endpoints from the small cell lung cancer study, Jupiter-08, which is expected this year. We recently obtained Orphan Drug Designation for this indication in the United States.

Jupiter-08 is a randomized double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating platinum chemotherapy plus etoposide alone, or in combination with toripalimab as the first-line treatment of extensive stage small cell lung cancer. This is an aggressive tumor characterized by rapid disease progression low expression of PD-L1 and low levels of tumor-infiltrating immune cells as well as a high degree of immunosuppression. Efficacy of cancer immunotherapy has been limited in small cell lung cancer and no PD-1 inhibitors are currently approved in the United States for this indication. Regarding additional potential indications in the United States, we announced at our recent analyst day event that we are working with Junshi to review possibilities to amend protocols of several studies to enroll patients in the United States to satisfy the FDA's needs for multiregional clinical trials.

We look forward to providing additional information on this topic in the future. At this time, we are not planning additional studies for toripalimab in combination with chemotherapy for first-line non-small cell lung cancer. However, we are planning to develop the dual I-O treatment of toripalimab in combination with our TIGIT CHS-006 for non-small cell lung cancer, leveraging the robust efficacy results reported in the CHOICE-01 study. An ongoing Phase I clinical trials evaluating CHS-006 and toripalimab is being conducted in China and is expected to read out next year, and IND is open in the U.S., and we expect to begin enrolling cohorts of U.S.

patients later this year or early next year. Blockage of the TIGIT pathway may be a crucial underlying mechanism for overcoming PD-1 resistance. We believe the dual immunotherapy approach TIGIT with PD-1 could enhance PD-1 efficacy with the potential to extend survival and create a new standard of care for multiple tumor types. We expect to see important clinical data from several competing to this programs and commitments.

And these data may inform the future direction of our CHS-006 development program. At our recent analyst day, we introduced several fully owned programs targeting ILT4 and CCR8 that are being developed by Coherus Sciences at our research center in Camarillo. We expect to submit an IND for our first of the CHS-1000 targeting ILT4 next year and to file at least one new IND per year going forward. On the biosimilar development and regulatory trends, we recently held the late-cycle review meeting with the FDA for the similarly BLA, and that review is advancing toward the August action date.

Upcoming in June, results of the PK/PD study evaluating our Udencya on-body injector device will be published in connection with the ASCO annual meeting. Recall that we previously announced that the study met all PK bioequivalence primary endpoints as well as the key secondary pharmacodynamic endpoint of ANC. I'll now turn the call to Paul Reider.

Paul Reider -- Chief Commercial Officer

Thank you, Theresa. Udencya net sales were $60 million in the first quarter, a decline from $73.4 million in the prior quarter. This was driven by a 12% decline in demand units as well as continued price erosion due to intense competitive pressures in the pegfilgrastim prefilled syringe market. On a unit basis, the overall pegfilgrastim market increased 1% in the first quarter, and we expect low single-digit market growth in the remainder of 2022, consistent with historical trends.

Neulasta retains 59% total market share within the class with Onpro holding 47% market share, based on an entrenched preference by customers reinforced by the COVID pandemic. Udencya market share erosion from 17.5% to 16% in the first quarter occurred largely in the hospital segment where competitive biosimilars have resorted to a strategy of offering irreversible significant price reductions in order to capture short-term market share. This is reflected in the quarterly ASP declines by these competitive products. With our on-body device in the pipeline, our strategy is to maintain a disciplined approach in managing price with a PFS format in 2022.

This will enable us to maximize long-term revenues for the Udencya franchise through significant share gains that we expect in 2023 and beyond within the on-body segment, which currently represents approximately $1 billion in untapped opportunity. We expect Udencya market share to grow next year once we introduce our Udencya on-body injector, if approved. Now I'd like to talk about commercializing our [Inaudible]. We are preparing for the launch of three new brands in the next 15 months.

Toripalimab, our PD-1 inhibitor or nasal pharyngeal carcinoma, similarly, our Lucentis biosimilar, and Yusimry, our Humira biosimilar. Nasopharyngeal carcinoma or NPC, is a rare cancer, where there are currently no PD-1 inhibitors approved for use by the FDA. Toripalimab not only has the potential to be the first and only PD-1 inhibitor indicated for this tumor type, but also to establish a new first-line standard of care. Our oncology commercial capabilities have been built to scale, and there is significant overlap between our current Udencya customers and toripalimab-targeted prescribers.

Therefore, the launch of toripalimab will be efficiently integrated into our existing oncology commercial infrastructure. In addition, the NCCN guidelines committee for NPC has added as a reference to the guidelines, the citation for the Jupiter-02 trial, which was published in Nature Medicine last year, further validating the importance and quality of the clinical trial. Commercial launch preparations are on track, and the field-facing teams have been fully trained. We will be ready to launch toripalimab if approved by FDA.

With respect to -- similarly, our FDA action date is August 2, 2022, which if approved, will allow us to launch in the early biosimilar market formation period of the $7 billion anti-VEGF market. This is a clinic-based buy-and-build model, which is very similar to oncology and the core competency of ours. And we look forward to competing in this large, attractive market. Recently conducted market research confirms the opportunity exists to penetrate the entire VEGF market.

Since our last call, we've continued to engage with [Inaudible] thought leaders, built out additional marketing expertise, and hired the head of our ophthalmology sales team, an experienced sales executive with over 15 years building and leading sales teams in the ophthalmology therapeutic area. Retinal specialists opinion leaders expressed positive to receptivity is Coherus entering this market, and our track record of success in oncology gives them confidence that Coherus understands the dynamics of a buy-and-bill market and that we will deliver a safe and effective alternative to Lucentis with a compelling value proposition. Now regarding Yusimry, a Humira biosimilar. Yusimry was approved by FDA last December, and we are preparing for a launch in July 2023.

Humira's U.S. net sales were $17 billion in 2021, and we look forward to competing in this large market. We believe payers and PBMs will drive biosimilar, toripalimab adoption and have completed extensive market research with national regional payers as well as PBMs. The insights gleaned from this market research confirmed that Coherus can deliver on the attributes most important to payers, which include a highly competitive price, robust and reliable supply and an auto-injector presentation that has a non-stinging citrate-free formulation.

User will have both a prefilled surge and an auto-injector presentation and the Yusimry device will include our proprietary non-stinging citrate-free formulation and a 29-gauge needle, all comparable to the originators. We also plan to introduce a high concentration presentation post launch. We need our expectations to win at least 10% unit market share, we have invested more than $45 billion of large-scale manufacturing and expect to be a high-volume, low-cost manufacturer, well-positioned to compete on supply guarantees and price. Our first year manufacturing capacity exceeds 1 million units or about 10% of the overall adalimumab market, and we have the potential to triple that capacity in the current facility.

Unlike other players in the adalimumab market, we have no portfolio of branded alternatives to Humira that we need to protect from adalimumab cannibalization. Our positioning for Yusimry is perfectly aligned with that of the payers and PBMs. We want to make the adalimumab market as large as possible and as quickly as possible. We see this as a source of competitive advantage.

In short, we are confident that we will deliver a compelling value proposition and that we can achieve our objective to win at least 10% mid market share at peak. I'll now turn the call to McDavid for a review of the quarter's financial results.

McDavid Stilwell -- Chief Financial Officer

Thanks, Paul. I'll focus on just a few financial highlights since the details are in the press release and in the 10-Q that we filed earlier this afternoon. For the first quarter of 2022, we reported a $96.1 million net loss on a GAAP basis. On a non-GAAP basis, we reported a net loss of $77 million.

GAAP to non-GAAP reconciliation included two items: $12.9 million in noncash stock-based compensation expense and a $6.2 million loss on the extinguishment of debt. Cash used in operating activities was $54 million for the first quarter of 2022. As detailed earlier in the call, net product revenues were $60.1 million, a decline from the prior quarter and the year-ago quarter. The decline was primarily attributable to a decline in demand units as well as lower net realized price.

Research and development expenses for the first quarter of 2022 were $82.9 million, compared to $203.5 million for the same period in 2021. This year's first quarter included a $35 million payment to Junshi BioSciences for the license of CHS-006, our TIGIT targeted antibody. Last year's first quarter R&D expense included the $145 million upfront payment to Junshi for the toripalimab collaboration. Selling, general and administrative expenses were $48.8 million in the first quarter 2022 as compared to $39.4 million in the year-ago quarter.

The increase was primarily driven by activities in preparation for the launches of multiple new commercial products anticipated in 2022 and 2023. We ended the quarter with cash and cash equivalents of $326 million, compared to a balance of $417 million at year-end 2021. Recall that in January, we entered into a credit facility agreement with Pharmakon Advisors for a $300 million term loan payable across four tranches. We gained the first $100 million tranche at closing and simultaneously paid off a $75 million term loan.

At the end of March, we drew a second $100 million tranche and simultaneously paid off the 2022 convertible notes. Two additional tranches of $50 million each will become available to us upon the approval by the FDA of toripalimab and similarly. As for our expectations for full year operating expenses, with the discontinuation of the CHS-305 Avastin biosimilar program and the delay in the toripalimab launch, we're lowering our projected range for full year R&D and SG&A expenses by $20 million to $395 million to $430 million. This guidance excludes both the $35 million upfront fee to Junshi BioSciences that we paid for rights to CHS-006 and a $25 million milestone payment that will become due on approval of toripalimab for nasopharyngeal carcinoma.

This range also includes approximately $55 million to $60 million in noncash stock-based compensation expense. Let me provide some additional color on these anticipated operating expenses, a significant portion 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. Recall that one lesson from our Udencya 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 approval subsequently is expected to deliver P&L benefit in the form of lower cost of goods sold. Another $40 million 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 COGS. I'll close by saying that on the Investor Relations front, we'll be participating in the Bank of America healthcare conference in Las Vegas next week on May 12 and in the UBS conference in New York on May 24, and the HCW conference in Miami on May 25. And I'll now turn the call to Denny for closing remarks.

Denny Lanfear -- Chief Executive Officer

Thank you, McDavid, and thank you all once again for joining us today. This is an exciting time in our company as we prepare for as many as four product launches in 2022 and 2023 and continue to make strong progress transforming Coherus into an innovative new oncology company supported by our diversified commercial portfolio of revenues. With our sharp focus on execution of the strategic transformation, the leveraging of our commercial capabilities with new products, and the advancement of our novel immuno-oncology pipeline while keeping a critical eye on our cost structure. I believe we are in excellent position to create significant shareholder value in the coming years.

Operator, we're ready to take any questions.

Questions & Answers:

Operator

[Operator instructions] Your first question will come from the line of Salim Syed with Mizuho. Please proceed with your question.

Unknown speaker -- Mizuho Securities -- Analyst

Hey, guys. This is [Inaudible] on for Salim.Thanks for taking our questions. Regarding toripalimab submission beyond MPC, are you still planning to submit for ESCC and non-small cell lung cancer this year? Or should we expect this to happen after potential pre-approval for [Inaudible]? And also, if you could provide a little...

Denny Lanfear -- Chief Executive Officer

I'm sorry, I'm sorry, let's just do one question at a time, and then we'll provide you with the opportunity for a follow-on question. So I'll let Dr. Theresa Lavallee address the question about the submissions. Did you hear the question clear?

Theresa Lavallee -- Chief Development Officer

Salim, hi. Thanks for the question. Just to make sure I heard. You were asking about submission for non-small cell lung cancer.

Unknown speaker -- Mizuho Securities -- Analyst

And for -- yes, and for ESCC as well, if you're planning to do it this year as well? Or you want to expect first to get approval in MPC?

Theresa Lavallee -- Chief Development Officer

So as mentioned during the discussion, we don't anticipate following up with toripalimab in non-small cell lung cancer and for filing based on the TRACE-1 data. We'll leverage that data to look at dual immunotherapy combinations with an TIGIT, [Inaudible] CHS-006. In terms of other filings, I think at this time, we're in focused with engaging with the FDA on MPC, and we'll continue to have discussions about where else the clinical data really warrant regulatory flexibility.

Denny Lanfear -- Chief Executive Officer

We'll be happy to provide you with the opportunity for a follow-on question then. Did you have a second one?

Unknown speaker -- Mizuho Securities -- Analyst

Yes. Thank you. Well, you could provide a little bit more color on the reasons behind today's announced discontinuation of CHS-305.

Denny Lanfear -- Chief Executive Officer

[Inaudible] If you can provide more color on the discontinuation of CHS-305.

McDavid Stilwell -- Chief Financial Officer

Yes, we're happy to, of course. First of all, let me say that we have a very positive relationship with [Inaudible]. I have a very good relationship with their Innovent CEO, Michael Yu. We signed this agreement and directly thereafter ramped to Chinese leaders, you can recall, COVID struck.

And COVID basically impaired the progress of this product development, I think, significantly. It was very difficult, and it was impossible actually for us to travel to China. The clinical trials were difficult in a number of things. So we lost a substantial amount of time with the product really as a function of that.

And when we took a look during our product review period, currently, it was simply a matter that the commercial case for the product and the market had moved on from our prior assumptions. And given these costs that were in hand in front of us, we felt that it was the best interest strategically for us to discontinue it and there's really nothing more else to it. Again, we have nothing but good things to say about our friends at Innovent and it's unfortunate that this particular product cannot move forward. But it was simply a business decision.

Unknown speaker -- Mizuho Securities -- Analyst

Thank you very much.

Operator

Your next question will come from the line of Balaji Prasad with Barclays. Please proceed with your question.

Balaji Prasad -- Barclays -- Analyst

Hi, good evening. And just -- a couple of questions from my side. Firstly, on FDA inspections. Are there any pending for either Humira or Yusimry? I'll stick to one question.

Thanks.

Denny Lanfear -- Chief Executive Officer

Yeah. Theresa, do you want to answer that one with respect to Yusimry inspections?

Theresa Lavallee -- Chief Development Officer

Yeah. We feel that we're complete at this time.

Balaji Prasad -- Barclays -- Analyst

I'm sorry, complete?

Denny Lanfear -- Chief Executive Officer

Yeah. Yusimry inspections have been completed, and there are no issues impairing the approval.

Theresa Lavallee -- Chief Development Officer

And Yusimry is approved.

Denny Lanfear -- Chief Executive Officer

Yusimry is already approved.

Balaji Prasad -- Barclays -- Analyst

Thanks.

Operator

Your next question will come from the line of Jason Gerberry with Bank of America. Please proceed with your question.

Jason Gerberry -- Bank of America Merrill Lynch -- Analyst

Hey, guys. Thanks for taking my questions. I guess my first would just be -- just looking at the run rate that you have for Udencya right now, 1Q, do you see any reason why that would get better for the remainder of the year before you have the OBI launch, which will be a 2023 event. So just curious, do you see that run rate improving? I know there was some commentary about, I think, sort of market unit volume trends growing.

But I'm just curious, specifically your own run rate, how that pans out through the rest of the year?

Denny Lanfear -- Chief Executive Officer

Well, I think, Jason, for that. Paul, do you want to take that one?

Paul Reider -- Chief Commercial Officer

Sure. Thanks for your question, Jason. So yes, as we indicated during our Q4 call, where we stated that our Udencya sales in 2022 will be less than the sales in 2021. We're not offering any updates to that guidance at this time.

The market grew 1%, remaining relatively stable. So we're expecting that to pick up, but that's where we're at right now. No further updates on guidance.

Jason Gerberry -- Bank of America Merrill Lynch -- Analyst

OK. And then I guess if I can get a follow-up question. Just based on the commentary about sort of the maybe irrational competitor pricing behaviors in the Udencya market, thinking ahead to Humira, just given the sheer volume of players, do you see this as a profitable market beyond 2024? Like I think most people could probably say 2023 and 2024 could be interesting, but there's sort of an expectation among the investors that perhaps pricing could get so compressed in that category that it might be not particularly profitable beyond 2024. So curious if you guys have a view there based on your learnings from the Udencya, I guess, market launch.

Denny Lanfear -- Chief Executive Officer

I'm going to let Paul add some additional remarks. But I would point to two things. First of all, we've already made previous investments that we outlined in order to be the high-volume, low-cost producer. We made significant progress in driving the cost down to fully loaded and released auto-injector, which I think the price will be significantly larger than.

The second issue, though, I think, Paul, Mike, why don't you go ahead and address.

Paul Reider -- Chief Commercial Officer

Yeah. I think Denny, articulated very well, Jason. This is -- there's a two-pronged approach to success with adalimumab biosimilar entry: it's price and it's supply. And so we're going to be coming to market offering supply guarantees, and we'll react to whatever price is going to be in the market at that particular time.

And we're very prepared to compete on that price to gain rapid adoption on the formularies in the second half of 2023 with real acceleration occurring in 2024 and beyond. So we see the opportunity for significant revenue growth in this Yusimry.

Denny Lanfear -- Chief Executive Officer

But we expect that our cost structure to remain profitable for a number of years on this product, given our high volume and low-cost capabilities, Jason. And the fact that we [Inaudible] and we also don't expect to build a sales force.

Jason Gerberry -- Bank of America Merrill Lynch -- Analyst

Yeah. OK, guys. Thanks.

Operator

Your next question will come from the line of Georgi Yordanov with Cowen and Company. Please proceed with your question.

Georgi Yordanov -- Cowen and Company -- Analyst

Hey. Thanks for taking our questions. So I guess for the first one, regarding the review process for biosimilar Lucentis, are there any additional updates or color you could provide around the interactions with the agency? And specifically, have you been part of these discussions? And has your partner received clearance around the manufacturing issue that was identified in the previous CRL? And then if I could have a follow-up.

Denny Lanfear -- Chief Executive Officer

Yes. To be clear, and I'll let Dr. Lavallee address this in more detail. To be clear, yes, we are confident that the previous issues with respect to manufacturing CRL have been fully addressed.

There has been an inspection of the facility and the manufacturing inspection, we do not believe or any pediment to approval whatsoever. Theresa, do you have any additional comment with respect to some of the approval?

Theresa Lavallee -- Chief Development Officer

Yeah. We just completed the late-cycle meeting, and I am optimistic of continued engagement with the FDA through the review process for the August PDUFA date.

Georgi Yordanov -- Cowen and Company -- Analyst

Great. And then just around the opportunity for biosimilar Lucentis. Do you know if there are any other competitors except Biogen and Samsung that might be launching in the near term? And given that limited competition, could you potentially see a similar ramp-up as we saw with Udencya over the next two to three years?

Denny Lanfear -- Chief Executive Officer

Well, I would say that our understanding is Biogen will probably be in a position to come into market before us. Just how much we're uncertain, but perhaps a bit. But as you point out, we were second to market with Udencya, did very, very well with that launch, with that product, and dominated that biosimilar market up until this point. So I think that we're fairly optimistic about how well Paul and his team will perform with a similar launch based on our demonstrated expertise.

Paul, any additional points you want to make on some of [Inaudible] on the launch?

Paul Reider -- Chief Commercial Officer

I don't think so, Denny. I think -- I mean we're in the market formation period, and that's key for short, long-term success with biosimilars. So we're going to be prepared to come in, get to have our probation period with our track record of our expertise and clinic-based buy-and-bill markets and our expertise with contracting, with discipline there as well as AST management, and delivering that retinal specialists a very compelling value proposition.

Denny Lanfear -- Chief Executive Officer

So just one note, the first assembly filing did not receive a complete response letter. There was additional manufacturing data requested by the agency. That data was subsequently developed in conjunction with the agency, they were conferred with , that was submitted. It was accepted, and now we look forward to approval from them.

Georgi Yordanov -- Cowen and Company -- Analyst

Thank you so much.

Operator

And at this time, there are no further questions in queue. I would now like to turn it back over to the panel for closing remarks.

Denny Lanfear -- Chief Executive Officer

Thank you, operator, and thank you, everybody, for joining us today.

Operator

[Operator signoff]

Duration: 39 minutes

Call participants:

McDavid Stilwell -- Chief Financial Officer

Denny Lanfear -- Chief Executive Officer

Theresa Lavallee -- Chief Development Officer

Paul Reider -- Chief Commercial Officer

Unknown speaker -- Mizuho Securities -- Analyst

Balaji Prasad -- Barclays -- Analyst

Jason Gerberry -- Bank of America Merrill Lynch -- Analyst

Georgi Yordanov -- Cowen and Company -- Analyst

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