Q3 2023 Coherus BioSciences Inc Earnings Call
which was approved last month, and the eudetica on-body injector following FDA potential approval.
This will bring our total number of marketed assets from 1 to 6 over an 18-month time period.
and will drive top-line revenue growth over the coming years.
For the third quarter, combine net product revenue with $74.4 million, an increase of 27% over Q2.
I'll now speed to each brand and we'll start with Simerly, or biosimilar to Lucendos.
Our strategic approach to the retina market is first to maximize the conversion of existing lice needle into the anatomy of the Medallion.
and second, to grow-share through new patient starts and the conversion from other anti-VEGF products.
Execution against this plan remains strong as we report net sales in Q3 of $40 million.
an increase of 50%, quarter over quarter, driven by strong demand.
Similarly market share within the random business class was 28.6% an increase of 11.6 market share points quarter over quarter.
We also announced it similarly passed a major milestone.
During the first year of launch, we sold over 100,000 doses to retinal specialists, which reinforces the retinal community's receptivity of biosimilars and a desire for a safe and effective similar option to leucentis.
summary
Total 2023 net sales for Simerly through Q3 are $73 million.
So we refer guidance.
and similarly net sales will exceed $100 million for 2023.
I will onto you Danica.
As stated previously, our strategy has been to fortify our base pre-filled syringe business while making price and share trade-offs in order to maintain a competitive ASP in advance at the largest.
both the auto-injector and on-body presentations, respectively.
We guided that Udetica Demand and Market Share will return to growth this year. Based on our strong execution of this plan, I'm pleased to now report two consecutive quarters of Udetica revenue and market share growth.
Two-three net sales were $33 million, an increase of 4% quarter over quarter, driven by increased demand partially offset by lower net selling price.
architecture grew 16.5%.
An increase of 4.3 market show points, quarter over quarter.
Both demand and market share gains were driven primarily from our core prefilled syringe presentation.
It occurred across all segments of the business.
Also in the quarter, we launched the innovative Udenica Auto Injector and are working with accounts on how to best position and operationalize the auto injector within their respective clinical process throws.
since commercial launch.
We've had over 300 accounts for the eudendica auto-injector and are seeing a consistent flow of new account ordering every week. We expect increases in eudendica auto-injectors to happen every week.
as the launch progresses.
Another positive development that occurred in the quarter is payer coverage.
which significantly increased as both the eudenic and pre-filled syringe and auto-injector presentations.
were newly added onto a number of commercial and Medicare Advantage plans.
Effective start dates of this expanded coverage varied and range from September 2023 to January 2024, but regardless of the start date, these contracts extend through calendar year 2024.
significantly expanding eudenicus access.
going into next year.
Regarding our novel, Eudenica OnBody Device, we are awaiting FDA approval and will launch directly thereafter.
The Denikit is now a franchise.
and following the anticipated approval, the Dedeca on-body injector, will be the only PECFEL grasp of brand.
The three presentations are.
becoming the total solution for oncology providers.
This will enable us to compete directly with glass to on-printer.
which retains 42% of the market.
Turning now to you, Simri, our biosimilar to Humira.
The high cost of Adalimumab treatment remains a problem for the health care system and for many patients. The high cost of Adalimumab treatment remains a problem for the health care system and for
for patient-centric strategy.
is to provide you savory at a single, transparent, low price.
We launched USIMRI on July 3rd and were the innovators of the load list price strategy.
launching at a list price of $995 per carton for two auto injectors.
representing a discount of more than 85% to Humira.
As part of our low-risk price strategy, we establish partnerships.
Mark Cuban, Cost Plus Drugs Company.
and through its Team Cubicard and independent retailers nationwide.
We also signed an agreement with Superior Biologics.
specialty pharmacy who services more than 1.5 million patients across the country.
We will continue to pursue partnerships with organizations who look for low-risk price alternatives as we build our USIMRI business from the bottom up.
In Q3, we sold 2,300 cartons of Ussimri, generating net sales of $1.4 million.
While the market formation period for biosimilar adeliminib is still in its early stages, Humira retains formulary position for nearly all PBM and health plan formularies in 2023.
and likely in 2024.
Therefore, we expect slower growth for Humira biosimilars through 2024 and then greater acceleration of biosimilar adelabimab adoption with the implementation of the Inflation Reduction Act 2025.
IRA will shift financial risk during the catastrophic phase of the benefit.
from the government to the Part D plans.
which could affect how plants consider their formulary selections.
Finally, let me reiterate our excitement about the approval and coming launch of Lachthorsey.
The first and only FDA approved treatment.
for patients diagnosed with relapse from metastatic MPC.
We've commenced launch activities and are working to ensure that patients and providers have access to Wauwatosa Torsey.
as soon as product is in the channel, which we estimate to be in the early Q1 timeframe.
Let me share with you now some more details about the NPC Market opportunity for log tours.
First, the NPC mark.
We estimate that approximately 2,000 relapsed metastatic NTC patients in the U.S. are diagnosed each year.
And the split is even between those in the first line versus second line plus.
With Lactorzia's broad indication, we can access all of these patients.
and promote across all lines of therapy, including first line.
Second, the prescriber base.
NPC is fairly concentrated, approximately 2,200 oncologists.
accounting for 80% of NPC treatment.
60% of the business is in the hospital setting, and 40% is in the clinic.
We know these doctors and our existing oncology team currently calls on all of the accounts for these doctors practice.
So the call points are highly efficient and synergistic with eudendica.
Third, the current treatment landscape for NPC.
Claims data suggest that chemo-only regiments are prescribed 60% of the time, which provides an immediate opportunity for locked doors.
will target these treating positions and position-locked torsion to be added to the existing chemo reg irrespective of the line of treatment.
For the 40% where a combination of chemo and PD-1 is used, we'll position lachorosae as the preferred PD-1 and the new standard of care regimen.
based on our approved indication and the totality of the evidence, which includes overall survival data.
Finally, patient engagement.
Through NPCFacts.com, we've enrolled a community of over 2,100 NPC patients or caregivers and will appropriately communicate branded information about Lacturze so they are informed and educated when speaking with their doctors about their individual treatment plans.
Patients will also be supported through Lactorzae Solutions.
for patient services.
It can be accessed via logtorsey.com.
These are planned to go live next week.
We look forward to updating you on our progress as the Lactorze launch progresses.
With that, I'll now hand it over to Teresa.
Thank you, Paul, and good afternoon, everyone.
I want to once again thank the FDA for asking so quickly to approve Lactorzae following completion of the overseas inspection.
With Torapalumab approval now secured, we are continuing to collaborate with the FDA to complete their review of our final outstanding BLA for the Eugenica on-body injector.
As previously disclosed, the eugenica OBI supplement received a complete response letter from FDA on September 21, 2023.
solely due to a third party fillers inspection status.
We were very pleased that our third-party manufacturer was able to resolve this with urgency.
And we were able to resubmit the Eudenica OBI supplement to FDA in under two weeks.
It is important to note.
Only deficiency in the CRL from FDA was the third-party manufacturer, indicating the clinical and manufacturing data were complete.
Given there isn't any new information for FDA to review, we anticipate approval this year or in the early part of 2024 and anxiously await the resource-constrained FDA to take action.
Based on PASUFA, the review would be given a six-month clock, however the agency has communicated to us that they expect to act significantly sooner.
I will now briefly review the data from Tora Palomar and our other IO candidates we recently presented at ESMO and FYSSE.
Boxorzi is a next generation PD-1 inhibitor with a potent activation of T cells, including demonstrating significant activity in tumors that are less inflamed, such as small cell lung cancer, as was recently highlighted in oral presentation at EDSCO.
Coherence has presented our preclinical mechanism of action studies at the ACR-ERQC-NCI triple meeting and last week at the CIFSI conference comparing torapalumab to pembrolizumab and demonstrated in multiple assays that torapalumab treatment resulted in statistically significantly higher T cell activation than pembrolizumab.
Morpalimath potency on T cell activation is consistent with a 12-fold higher binding affinity to PD-1 and PEMBRO.
Additionally, the unique epitope of torapalumab at the SG loop of the PD-1 may also contribute to entire potency.
Lactor is the foundation of our IO franchise and we are excited to explore clinical opportunities to extend patient survival with novel
Particularly with agents that target mechanisms of PD-1 resistance due to immune suppression in the tumor microlyphirotomy.
At the 50 conference last week, we also presented two additional posters characterizing the mechanism of action of CAS DOZAKI-TED, our IL-27 antibody, and of CHS-114, our cytolitic anti-CPR-8 antibody.
The Casco So Coaster highlighted the interference signaling life properties of IL-27, importantly described biomarkers that may be useful for evaluating cancer patient treatment with Casco So.
The CHS 114 studies support that free clinical treatment with an anti-CBR-8 antibody used to depletion a T-ray cell in the tumor in conversion of cold tumors to hot.
These data position as well for clinical development oppose of these programs with locked doors.
Our third program targeting immune-suppressive mechanisms in the tumor microenvironment is our CHS 1000 ANSI IL-T4 antibody program.
We continue to progress our I&D directed studies and plan to file the I&D in the first quarter of 2024.
And now turn the call to rush.
Thank you, Teri Tha. Good afternoon, everyone.
With the approval of not-tall-D, we're delighted to be able to bring the first and only FDA approved treatment for nasopharyngeal cross-nomer patients in the US living within PC.
across all lines of therapy.
The approval in both frontline patients with a metastatic or recurrent locally advanced disease in combination with splatine engines, genocytes, and also as a single agent for patients with recurrent, unreceptible or metastatic disease progression after platinum containing chemotherapy marks a real step change in the treatment of these patients where up until now, standard of care can be...
will stay at home on our website.
As a reminder, the approval is based on strong efficacy dates from two welcome doctor studies data published in Nature Medicine and JTO and presented at both AACR and AFCO.
Firstly, in Juveda 2, October's in combination with chemotherapy and baseline patients showed that it had the ratio of 0.52 for progression fee survival and 0.63 for overall survival with benefit seen across four PDR1 expression levels with the results being both statistically significant as well as clinically meaningful.
Secondly, in Polaris II and Second Line and beyond, single-agent Lahtorzi met its primary endpoint with an overall response rate of 20.5% and also demonstrated a median overall survival of 17.4 months.
The advanced event profile in both files demonstrated that the safety profile, which was consistent with the drop class.
Positive data sets across additional human types continue to demonstrate the consistency of effect of the block tool of the, for example, at ASCO, the Neo-Torch data in the perioperative non-small-for-lunk cancer space showed a statistically significant benefit favoring the Tori Palomad farm with a hazard ratio of 0.4, but event-free survival, demonstrating the potential of Tori Palomad in earlier stage non-small-for-lunk cancer.
We're working with the FDA to export potential avenues to bridge the data to the US.
Also, at ESMA a few weeks ago, positive data was reported for an uptool in both. Reemless our car's no more as well as small cell lung cancer.
The additional rich data sets that have continued to emerge across several human sites here will continue to view the local authorities as a pivotal backbone for future combination in particular with other novel agents and we continue to explore both internal combinations with our own pipeline agents as well as external partnerships for the local authorities.
Key to this is that acquisition of Surf some Colossary, which, as Theresa mentioned, provided us with two early stage assets, Casdogo, Festing Class, and OG Clinical Stage R27, and CHS 114, RCTRA.
But with respect to CalGervo, as a reminder, this asset has shown monetary activity to phase one study in PDL-1 refractory non-smortal lung cancer and also combination activity with a T-Zo and Bev in Hepat's Serginocardtenoma, data that was disclosed earlier this year.
Updates and days from these patients are anticipated to be presented in the coming month, both for non-smorthal lung cancer and the bad of cellular cancer.
We will be taking this early indication of activity forwards with a Phase 1 B combination study of Casdosa with Torre Palomab, which is currently in startup and which we anticipate being active in the coming months.
With respect to CHS114, this asset is currently in the clinic in dose finding, and we have safely proceeded through several dose levels without come towards safety concerns. We will continue dose escalation before moving on to dose optimization, and further studies in head and neck across the knowa, a tumor type where the disease link is just strong.
Regarding our TIGIT, our phase 1-2-8 study looking at the Torre Palomac TIGIT combination has completed the enrollment of its initial cohort of subject to the US. This is an acceptable thank you profile.
We will hold further enrollment into this trial while we analyze the data from the ongoing patient call and assess the evolving data from expected trials in order to be able to complete a robust portfolio prioritization while at the same time continuing our clinical development effort with the LoptoreZ in combination Casanovo and THS114 together with continued development of our ILP4 which now gives us the opportunity to target not only the T-cell with LoptoreZ but also the T-MIMICER environment in a potentially synergistic fashion.
And now I'll turn the call over to the first paper.
Thank you, Robert.
I will briefly review third quarter results before discussing our updated 2023 guidance.
As Paul detailed earlier, today we are reporting a 27% increase in net sales across our three marketed products.
Net revenue was $74.6 million, during the three months in the September 30 of 2023.
and included $33 million of net sales of Utenica, $40 million of net sales of Simmerley, $1.4 million of eSimmering net sales.
as well as approximately $200,000 in royalties we received from a license to our Anilima Math formulation.
Cost of good sold for the three months in December 30th, 2023, was $32.7 million.
And grows margin was 56%.
Recall the eugenica COGS includes a mythical digit royalty on net sales paidable through the first half of 2024. And similarly COGS includes a low to missed 50% royalty-grossed profits.
We continue to focus on keeping tight control of our operating costs.
And research and development extends for the three months in the September 30, 2023 and 2022, for $25.6 million and $45.8 million, respectively.
The significant decline in R&D expense compared to the prior year quarter, primarily resulted from the reduction in scope of the Torre Palomao Collaboration Agreement.
The capitalization of certain new silvery costs in inventory in 2023, they were expense as R&D prior to mid-2022, as well as $5.2 million in personnel and stock-based compensation expense due to lower headcounts.
Selling General and administrative expense increased by $3.4 million compared to the Uricoke of $48.2 million.
The increase was attributable to an increase in professional services piece of $4.7 million driven by the surface acquisition.
and third-party processing fees for multiple products being commercialized.
Portually offset by a $1.9 million reduction in employee and consultant costs.
due to a lower average head count as we continue to realize savings from the cost cutting program in Elston March.
As we launch new products, we are carefully controlling and criminal spending to ensure the investment is appropriate for the opportunity. And then we realize the efficiency is inherent in our portfolio.
For example, are you summary strategy to build a business with customers attracted to our lowest price at a limit amount of offering?
And we have very low operating expenses associated with use of marine.
For a panel map, we'll be efficiently launched using the same commercial infrastructure of marketing utility.
As our product revenues increase and we continue to constrain operating expenses, we expect operating losses will continue to moderate.
For the third quarter of 2023, we recorded a lower net loss, $39.6 million for 41 cents per share, compared to a net loss of $86.7 million, or $1.11 per share for the same period in 2022.
Cash, cash equivalents, and investments in marketable securities were $131 million as of September 30th, 2023. We've compared to $192 million at December 31st, 2022.
We are projecting continued sales growth and expect fourth quarter net sales of $85 to $95 million.
For the full year 2023, we are reducing our earlier revenue to a range of $250 to $260 million.
Primarily, as a result of the delay in approval of utenica on body injector.
which we now expect a launch in the early part of 2024 following potential approval.
We continue to tightly manage our expenses.
And we are today reducing our combined RD-STNA expense guidance from the earlier range of 315 to $335 million to a new range of 300 to $310 million.
including 40 to $45 million of stockpaste compensation expense.
This range also includes the addition of service on college related operating expenses since the closing of the acquisition in September . And it excludes any upfront or milestone collaboration payments.
closing costs of the service on college access.
Although we are not yet introducing revenue or expense guidance for 2024, we do expect lower expenses in 2024 compared to 2023, as well as continued growth in net product revenues.
as we continue to execute on our product launch plans.
We're focused on ensuring the success of our commercial launches.
We will continue to maintain tight control over our operating expenses as we manage cohera's back to being cashflow positive over the course of May 24.
I'm now having the call to DINI for closing remarks prior to questions.
Thank you, McDavid. Well, here is now one of the small number of biocompes with improved carceral stage PD-1 inhibitor and a competitively positioned development program.
We believe these are the two critical success factors for any company aspiring to lead their IO. We hope these are the two critical success factors for any company aspiring to lead their IO.
We're now a revenue generating, you know, on College of Company with growing sales across a number of products.
with an increasingly diversified revenue balance.
We look forward to keeping you surprised of our progress.
Operator, we're ready for the question.
Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced.
To withdraw your question, please press star one one again.
Please stand by with how the CUNY roster.
Our first question comes from the line of Robin Karnaski's with true security, so your line is now open.
Hi guys, thanks for taking my question. I mean, given the stock reaction, I think you'll be able to focus on consensus.
So, two questions for you on that. For a demo cub. Congrats.
scripts were up actually and then you noted on the prepared marks, you took, you know, I think pricing sessions, help us understand some of the dynamics when you're on the dinner cup. On similarly, it seems like on the, we're generally on call like where are you taking share? It doesn't seem like you're taking share from them. Did you have any impact from them? And my last question is like a big picture question. You guys have guided to like being cash-al-positive next year, which is like a big thing for you. Is that still on track or do you want to see with hold that guidance? Thank you.
Hey Robin, thanks very much. So first question, what respect to...
UDeneca is a script sub, but what was the impact of pricing? And then with respect to similarly, where's the share coming from and last day, the guy, I'll pull first and trust the dynamics of the UDeneca market and trust question where the similarly shared came from.
Thanks, Danny. Thanks for your question, Robin. Yeah, the Udenica business, Robin, as we, uh, as we've guided, um, with the launches and our, uh, and our strategy that market share and demand growth will increase 2023. We reported, um, that increase today. That's driven by 30% increase in demand, quarter over quarter. Um, what we've always guided to was, was the price impact, which was always, you know, a little bit harder to predict the competitive markets. In the third quarter, we saw net selling price decline of about 9%.
So that's the puts and take. We do expect continued market share and demand growth occurring over the fourth quarter in the mid 2024. Driven by two things, the first is the enhanced pair of coverage, which is increased substantially for the brand, as well as the expected launch of our on-body device.
So between the auto injector and the on body of approved, we'll have two shots on goal to go after that on-pro sure, which is a 42%
Regarding similarly, we're executing on our strategy of targeting the Lucentist business. And that's the first part of our strategy.
So the majority of our businesses coming from a combination of a share from Lucentus, but also with Ashton, which is also a target for us, that's, represents 40% of unit share. We're getting business from both of those. In addition to new patient starts, those represent the largest source of our business.
in line with our strategy.
Can I?? Recruits with insect? You can't click the answer, indeed?
And your last part of your question. With respect to returning to profitability and being casual positive next year, they indicated my over-reward remarks. We were very cognizant of bringing our expense structure in line with our revenue structure. This quarter also lead.
We've kind of downward with respect to our impacts and expenses.
and we will continue to see reduced expenses next year, even as revenues grow. We have now offered formal guidance of becoming profitable for next year. And once we get past, I think our first quarter call and we look at the launches are going potentially of on-body and of life towards the, we'll be happy to revisit that for you. But we are very, very focused on driving the business back to cashful positive and back to profitability as you've seen expenses are found and failed throughout.
Super helpful and just a follow up on our denica like as we think about on body device launching
just to make sure we're all in the same realm. How do you think about the impact of pricing when you launch that? Could we see continued price declines? And shout out to Theresa, like last, like last call you did. Again, 10 grads on Tori. I'm not asking one on Tori, but Congrats, but maybe just like, maybe delve deeper into a dentist so that we can all model it better.
Next quarter and for next year.
Yeah, thanks, Robin. So, you know, our focus here is we're going to be going into 2024 and year six of the Hedeneca, you know, life cycle is maximizing the long-term revenue and profitability of this franchise.
So if and when the on-party device is approved.
We will launch that into each of the segments of the business.
We believe we'll have a competitive value proposition, but also you'll be able to maintain discipline with our pricing so that we can drive profitability for this franchise.
So we're going to be looking at every segment, but clearly be watching the market dynamics that occur in each of those segments, whether it's the clinic or the hospital, and approach or large accordingly.
Robin, I would also add that we expect a significant market share gain with Eudenica next year, and we're very cognizant of the margins in obtaining those gains. As you've seen, the bear coverage has significantly increased over the past quarter. We expect to see that next year. But the overarching message for the Eudenica franchise is that the long-term strategy is succeeding. As Paul indicated, we're in your five or six on this franchise. We were very, very careful with our pricing in order to have a strong price upon which to launch our additional presentations.
that has been successful and even as other competitors who gave away more price have now fallen away we are emerging in this market.
Do you think you can have to lower price further? Just out of curiosity, I'm just trying to make sure that all the analysts are on the same page. Make sure we watch script growth and then if you miss on price.
could we predict a window, another line for each of the terms.
We would seek to protect price even as we go forward having all three presentations.
Great, thanks so much.
Congrats guys, thank you and goud.
Thank you.
Our next question comes from the line of Yigal Nakumov.
with Citigroup. Your line is now open.
Hi, Betty and team. Thank you for taking the questions. Just a quick housekeeping question. At one point, you had discussed having an R&D day during the fourth quarter. I just curious if that is still the calendar. And then you'd also discussed additional monopathy data for the AL27 program. Is that happening this year? And then more generally, with regards to liver cancer, obviously, there was data from most early in the year. And then, more recently, the Beijing abstract related to the Pigeot in combo with the Tezo and Bev. I'm just wondering how you're thinking about developing for HUC, given those data points, for the combo for your Pigeot and IL27. Thanks.
Hi, thanks for your questions. With respect to our D-Day, given the delay and the approval of on-body, we're going to move that into Q1 from Q4. We want to have on-body, approved, and ready to go on the market, because that's going to be an important part of the story. So we're going to move that out into Q1, with respect to I-27, and a liver, I'll add Dr. LeValley and the post-request.
And so, Heidi, you think we're super excited about the clinical development plans. And in terms of presentations, we do have a abstract submitted on both the Mono therapy.
and the 850 data.
to give the full data set and a more mature data set. So it would anticipate that later this year in early next year, and once the abstracts are accepted.
We'll make sure to add.
and publicize VEI.
In terms of how its positions were very excited about the data to date, having a patient population more similar to the Atezo-Bez-Tijid.
CCC data and the Beijing program.
and think about the data.
Should be comparable within that realm.
Okay, thanks. And then just one on the guidance, Ms. Gavelet, I think you said for 4,3,2,3,8,5 to 95 million, in any way you could just elaborate a little bit more in terms of the relative, the country we've been from the three market of products as to how that will get you into that range. Thank you.
Sure. So earlier in the year, Denny provided insight into how we feel that the Adam and the Map market is shaping up and that we expect total USIMRI sales for the year in the single digits. And so that's important to note as you think about where the portfolio guidance would go for the fourth quarter. So we expect most of the revenue growth in the fourth quarter to come fromudica and Simerly. OK.
Well.
Got it. Okay. Appreciate it. Thank you.
Thank you.
Our next question comes from the line of Michael Nadekovich with TD Cowan. You want to go open.
Thank you for the questions. I have two. My first is given the shift in timing of revenues
in the lowering of your top-line guidance.
Has that impacted your development plans at all? I know we'll learn more on the Q1.
pipeline day call, but I'm curious if this has affected the scope of development for your pipeline portfolio as of where we stand right now.
Or, for example, would you perhaps replace
anticipated revenues with other types of financing to more fully develop your pipeline. And then my second question relates to you Simri. I'm curious to distribute AbbVie's ability to hold on to such high share for so long. Would you point to supply, the label, or perhaps price?
Thank you.
Thank you. Thank you for the question, Michael. First of all, with respect to the development plans, as I indicated in my opening remarks, we are significantly constraining all R&D expenses from to the middle of 2024. Because of the revenue picture, we are very, very cognizant that we need to bring our R&D expenses and our overall spend into alignment with our revenue.
We have made very, very deliberate efforts to revise our development spend and minimize it, and I would say, into a myth next year. And no, we won't be going to alternative forms of a finance can to support that. We think that's really very, very important to move the company back to cash flow positivity and profitability, right? And so that's something we'll have to do until we get greater movement on the revenue.
With respect to USIMRI, Humira has been able to hold on to a significant portion of the revenues there. I believe about 99 percent all might have a little further color for you on the Humira and USIMRI revenue picture as a function of $2.5 million.
the placement on the part of the areas and so forth.
Thanks for your question, Michael. I think, you know, based on what Abby reported that it was really the lower price that's driving their ability to maintain these formulary positions. So that's which driving it. And again, I reiterate our strategy was very different.
We intended to bring the summary to market for a segment of the business, the desires of low affordable, transparent price. And we're going to build that business from the bottom up.
And that's working, our partners with Mark Q. And are really helping with that. So it's two different strategies. We're approaching this strategy, setting ourselves up for then the IRA in 2025 when we believe. There'll be a lot of different considerations by the EVMs and the pairs when the cost shifts and during the catastrophic phase from the government to the pairs themselves.
Michael, the other point that I would make to you is I would just direct you to McDavid Stilwell's comments. While we reduced the revenue guidance for $15 million for 2023, we also reduced the spend by $15 million. And I think this illustrates that being very, very responsible with respect to revenues and expenses are coming into alignment.
And that's the next question.
Thank you. Our next question comes from the line of Douglas Sow with HC Wainwright. Your line is open.
Hi, good morning. Thanks for taking the questions.
So.
I guess, Paul, congrats on the progress that we've seen with Simerly. When we think about the trends into the fourth quarter, we see that the trend is going up
Should we expect to see some further acceleration or do you think that we'll see sort of a little bit more of a linear trend in terms of adoption now that we have the J code and you know you've had the J code in place and for some time.
Thank you....
Yeah, thanks Doug. Yeah, we're real pleased with the with the uptake. You know, I think looking at the you know the ramp
projecting the same level of growth quarter over quarter, probably too optimistic at this point. We're going to continue to see demand growth driven from the current book of business and the patients coming back in, but also new business that we get in. So again, we haven't guidance as to what the final similarly number is, but we still maintain guidance that sales are going to exceed $100 million for the year. And Paul, do you think the opportunity just improving your volume within your existing similarly accounts, or are you still picking up new accounts?
Yeah, Doug, in the third quarter, we increased the number of ordering accounts by 70%. So we've got about 550 accounts now.
that have ordered similarly 80%
We have reordered at least one time.
So it's really this breadth and depth. We want to go deeper into the.
into the accounts that are ordering, convert that still and set this.
unit volume that's available. Rob has asked him.
where they've completed their step edits.
And at the same time, then continue to broaden out for those
you know, those accounts that maybe have been a little bit slower on the, on the Simerly adoption with biosimilars. What's really pushing that new account, acceleration though, Doug, is the fact that, you know, we've got now the Q code well established, but also real world evidence, you know, that was just presented at the ASRS meeting, uh, demonstrating that Simerly is safe and effective in delivering on their clinical profile for leucenthus. We just hit 139,000 overBBT Um I think it's in all sort of the few different takedowns changing, uh, we've started talking about the important goals,
unit shift now. I know we pressed released in the third quarter was a hundred but that's now 139,000. So we're going to bring along those new rule but slower on the biosimilar adoption curve.
And final question, Paul, on similarly, is there a type of account that you're really doing well in, is it the private equity back practices, or is it smaller practices? Just any color would be interesting to hear. Thanks.
It's been a mix of everything, Doug, you know, it's really just been once a retinal specialist, you know, understands that biosimilar to licentious, you know, is a great option for them. They get on board, they trial it, they get reimbursed, and we start to see more rapid adoption there. So, it's really across the board.
Okay, great. Thank you all. How bad are the queue?
Great. Thanks so much. Just two questions for me. I guess first, just coming back to the biosimilar Humira market, can you maybe just elaborate a little bit more on the priorities for you, Sumari, as we head into 2024, given it sounds like 25 is really the key year for the market opening up. And maybe just as part of that, I know you did a couple million this quarter and sales sounds like not a huge step up in 4Q, but should we think about a meaningful step up of sales in this product in 2024, or does this remain a relatively small business until we get out to 25 and more of the volume comes through? And I said one follow up after that.
All right, thanks for the.
Big question, Chris. The issue with the Humira biocimilar market is really the position of Humira on the formular areas. And we don't see significant growth in this market until 2025, until the Inflation Reduction Act comes into play, and then sort of the pricing dynamics.
a little bit. So we're projecting shallow but steady growth throughout that time, but with the inflection in 25. Okay, okay. That's helpful. And then just on eudenica, just any color of how much of the sales this point is coming from the auto injector versus the traditional presentation? As I just think about that auto injector piece of it, do you expect any sort of inflection as I guess just the ecosystem gets more educated on the product, or is coverage really the key here? And I know you've talked about some progress on that front. I'm just trying to get a sense of what the key factors that might lead to that auto injector seeing broader uptake would be.
Yeah, thanks, Chris. So in the third quarter, the pre-filled syringe represented the vast majority of the eudenica volume.
And it was coming from all segments of the business.
So when we launched the auto injector in the quarter, it was really the first of its kind, a new innovation that the marketplace delved into this year.
you know, had never, you know,
implemented into the system. So we had to get better coverage set up.
At the same time, we then had to educate the providers.
and particularly the nurses and the pharmacists.
get it on the formularies, the order sets. So there's a lot of operational work that had to get done to
to get this set up. We've had about 300.
accounts order, auto injector, since it's been approved. So they're looking for the places where it can fit in the system. We expect that as the launch progresses, we're going to see continued demand increases. And that will be buoyed as we move into 2024 as payer coverage continues to expand.
And once we then have the on-body, we'll then be the only brand, you know, Chris, with all three presentations.
being a total solution meeting the needs of the patients and the providers. So we had two shots on goal then with the auto injector and the OVI to go after that on pro market which has been named fairly resilient at 42% share.
Thanks so much.
Thank you.
Our next question comes from the line of ash verma with UBS your line is open
Thanks for taking my question. I have two. So the first one, I believe you have a milestone payment due to Junxi for the NPC approval. Can you remind us what's the timeline and the amount for that? And then second, I saw there was an 8K file earlier that noted a smaller leave space going forward. Is there a new reduced workforce as a part of this? I'm just surprised to see the space is now cut into half.
and any implications that you can mention for that to your cash bond. Thanks.
Hi, Yash. Thanks for the question. Let me take the last one first. We were able to reduce the footprint on the leaves. Primarily that came up because we were in a period where there was a renewal period. So we were opportunistic and being able to do some consolidation.
We have team members that work from home and then go back and forth. So we've done some sequencing with people in and out of the office. We're able to consolidate some space. And as I indicated in my remarks before, we're always looking for opportunities to reduce our expenses, and this is one where we could do so. With respect to the milestone and its timing from Chin-Shee, I'll let McDavid Stilwell comment on that. Thanks, Ash. So it's a $25 million milestone payment, and it will be paid in March 2024.
Great, thanks.
Thank you.
Our next question comes from the line of Balaji Prasad with Barclays. The line is open.
Good afternoon. This is Xiao An for Bellagio. Thanks for taking our question. Our question is about partnership opportunity for Tori Palimap. You mentioned that you received a lot of partnership interest from outside partners. Could you add some color on what therapeutic areas or what type of agents that you will be prioritized for future combo trials? And what type of collaboration and economy will you adopt for those partnership agreements for a combo trial in order to achieve lower R&D costs next year? Thank you.
Thank you. Great question. I'll let Raj pass.
Just that rush.
Thanks very much for the question.
As we look at the partnership space, I think the first thing I'll say is that
the wealth of data and the robustness of the data a lot towards the across different tumor types and indications.
really sets us up well for partnerships together with it.
pretty unique mechanism of action as well. I think for a lot towards the partnership opportunities and incomings that we're receiving are essentially, and mainly in terms of novel combinations and the kind of avenue that we're taking with that.
will be more in terms of drug supply agreements and supplying drugs.
for partnership studies. We also of course have our novel assets that came in with the surface acquisitions of Cazdozo and CHS 114 and I think one of the important points I'd like to stress today is we do have global rights so you know we'll be looking for potential opportunities with these two novel assets to maybe ex-US find partnership opportunities for for central revenue that.
Thank you.
Thank you.
We have time for one last question. Our last question comes from the line of Douglas Sow with the HC Wayne, right? You're on it's open.
Hi, thanks for taking the follow up. I just wanted to touch on Eudanica a little.
And I'm just curious from your perspective on the broader environment within the text progress and category as a whole where we've seen you really have success for maintaining shares or gaining some share while maintaining your AST and others have continued to see the AST fall. So what do you think has been the sort of the driver of your success and your perspectives on what the next step is for this market? Thank you. You listen to my students' stories more thanON NOVACE
I'll let Paul dive into that a bit before he talks.
I think that we bring
and the core competency of the commercial team.
A very deep and nuanced understanding of Medicare Part B space.
As you know, our policy for a long time has been to be good guardians of ASP and not to rely simply on discounting to drive sales.
The other issue I think here is that we have deployed
very successfully a strategy to maintain price and share for the long term as a basis upon which to launch our presentation and we are now successfully deploying that strategy. Our average selling price is well above the other competitors in the class, significantly above the innovator for example, but I think that we're very competent in terms of our ability to
to understand price and really to execute our value proposition strategy without simply resorting to price in the market.
Paul has some additional comments.
I think that's exactly right, Denny. Doug, you look at what the competitors' strategies have been, and we've always viewed Udenica as a franchise. And so we applied the strategies that we needed to do in order to maximize the long-term revenue, but also profitability of the brand. What we've seen with other competitors, Similars in particular, that just had a pre-filled syringe, is to just use deep discounting for short-term market share gains. And you've seen examples of what happens to that strategy.
So we really have just taken the long-term view. We've been disciplined with it. We're bringing the new presentations to market, and we're going to position, you know, eudendica, you know, as the person-only franchise with three presentation offerings, because these patients still need the echograspin support. Whether they're getting it at the office, whether they're getting it at home, we're going to have a solution for the patient, the provider, to meet those needs. So it really comes down to that.
And we're delighted that our strategy is paying off and that you're seeing it now in consecutive quarters.