Q4 2024 Omeros Corp Earnings Call
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Speaker Change: Good afternoon, and welcome to todays earnings call for own Narrows Corporation.
Speaker Change: At this time all participants are in listen only mode. After the company's remarks, we will conduct a question answer session. Please be advised that this call is being recorded at the company's request and a replay will be available on the company's website for one week from today alter.
Speaker Change: I'll turn over the call to Jennifer Williams Investor Relations for Omer OS.
Jennifer Williams: Good afternoon, and thank you for joining the call today.
Jennifer Williams: To remind you that some of the statements that will be made on the call today will be forward looking.
Jennifer Williams: Payments are based on management's beliefs and expectations as of today, only and are subject to change.
Jennifer Williams: All forward looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special note and the risk factor section regarding forward looking statements in the company's annual report on Form 10-K, which was filed today with the SEC.
Greg: Now I would like to turn the call over to Dr. Greg <unk>, Chairman and CEO of Alero.
Jennifer Williams: Thank you Jennifer and good afternoon, everyone.
Greg: Joining me on today's call by David <unk>, Our Chief Accounting Officer.
Greg: Delek, our chief commercial officer, Andreas Grauer, our Chief Medical Officer, Cathy Melfi, our Chief regulatory officer, and Steve would occur our vice president of political.
Greg: Today I'll start with an overview of our 2024 financial results and provide updates across our development programs.
Greg: David will go through our financials in more detail and then we'll open the call for questions.
David: Let's begin with the financials.
David: Our net loss for the fourth quarter of 2024 was 31 $4 million or 54 cents per share compared to a net loss of $32 2 million or <unk> <unk> per share in the third quarter of 2024 for the full year 2024 net loss.
David: <unk> was $156 8 million or $2.70 per share.
December 31, we had over $90 million in cash and investments on hand.
David: Now that we have resubmitted, our BLA for <unk> in Ta TMA, which we'll discuss in just a bit our focus is on restructuring the balance sheet, having substantially reduced the amount of the 2026 convertible notes last June.
David: Now are in preliminary discussions with certain remaining holders of the 'twenty six notes.
David: To retire or refinance them to extend their maturity.
David: As part of this debt restructuring, we intend to add substantial capital for operations.
David: In addition discussions are underway regarding potential partnerships, primarily around our complement franchise, which includes in our supplement.
David: So I'll kind of art LMS $10 29.
David: Additional discussions directed to our deeper pipeline.
David: Other possible options of course include royalty monetization, our debtor equity transactions, including through the use of our existing at the market offering facility, which provides for the sale of up to $150 million of our common stock at prevailing market prices.
David: We're confident in our ability to leverage these opportunities to strengthen our financial position.
David: While driving long term growth and near term shareholder value.
David: We will provide an update on our progress at such time as a definitive announcement can be made.
David: With that let's move on to an update on our development programs, starting with our complement franchise in our supplement our first in class inhibitor targeting matched to the effector enzyme of the lectin pathway of complement.
David: As we announced today there has been a tremendous amount of activity moving us toward approval of <unk> for hematopoietic stem cell transplant associated thrombotic microangiopathy or Ta TMA.
David: Both in the U S and in Europe.
David: We expect that our first approved indication for <unk> will be Ta TMA, a serious often rapidly fatal condition that occurs frequently in children and adults who undergo stem cell transplantation.
David: Earlier this month, we resubmitted to FDA, our biologics license application or BLA for <unk> in the treatment of Ta TMA.
David: Over the past year, we've been working closely with FDA to complete the Resubmission. This concludes our meeting with the agency last September to finalize the content to be included in the Resubmission and the subsequent receipt in November of FDA.
David: Final comments on both the protocol and statistical analysis plan to compare survival in our supplement treated ta TMA patients to that of an external control population.
David: The independent Statistics Group, then incorporated all of Fda's comments and ran the analysis results of these analyses, which we have shared publicly and are included in the BLA demonstrate in our Sop <unk> significant and clinically meaning.
David: Full survival benefit.
David: Submissions have no filing period with the six month review clock starting on the date.
David: Two FDA setting in this case <unk>.
David: <unk> date in September of this year.
David: We do not expect that recent or anticipated changes add FDA will affect the review of our Resubmission.
David: Let's spend a little more time on those results are in our supplement of analysis, which I expect will be instructive as previously reported the primary and all primary related sensitivity analyses were agreed with FDA and include propensity.
David: The matching which further enhances the matching between the patients and then our <unk> pivotal trial and the controlled patients.
David: At Fda's request.
Analyses were also adjusted for potential immortal time bias.
David: The primary analysis shows a more than threefold improvement in survival associated with <unk> treatment.
David: With a P value of less than 0.00001.
David: The related sensitivity analyses recommended by FDA. We're also conducted.
David: With results strongly and consistently supporting that same survival benefit.
David: The FDA further requested that we conduct analysis to assess even the effect of unmeasured can founders on our results recommending that we use a measure called an expectation value worry value.
David: The value for our primary analysis was five 7% demonstrating that the possibility of our results being affected by unmeasured, Ken founders is vanishingly small in other words the results of the statistical comparison of <unk> versus a well matched.
David: And rigorous external control group.
David: Our robust <unk>.
David: Assistant statistically significant and highly clinically meaningful.
David: Uniformly demonstrating compelling evidence of improved survival for in our supplement.
David: Ta TMA.
David: The BLA Resubmission also presents analysis of survival and our global expanded access program or EAP, often referred to as compassionate use with 136 adult and pediatric Ta TMA patients at time of database lock.
David: <unk>.
David: This includes a comparison of survival in the EAP versus survival in the same external control group views for the primary analysis.
David: And the related sensitivity analyses.
David: The results of these EAP comparisons were consistent with those of the pivotal trial primary analysis.
David: Hazard ratios P values, Andy values all consistent.
David: The EAP data also assess survival in adults and children with Ta TMA, who have failed treatment with other complement inhibitors, namely <unk> and peg sheet, a coke plant as well as <unk> tied prior to receiving in our supplement.
David: These refractory Ta TMA patients showed one year survival in excess of 50%.
David: More than two five fold higher than historically reference survival in these refractory patients of less than 20%.
David: Two months prior to resubmitting, our BLA, we had shared with FDA all data from the primary analysis and the primary related sensitivity analysis and over the following several weeks also sent and completed portions of their.
David: <unk> submission these.
David: These submissions were provided at the agency's request to allow FDA reviewers to begin their review prior to receipt of the <unk> submission by the FDA made clear that the review clock would not start until the fall submission was received which is.
David: Then occurred.
Earlier this month.
David: Concurrent with preparing and submitting the BLA, we've been compiling our marketing authorization application or MAA for submission to the European medicines agency or EMA.
David: <unk> planned for the coming quarter.
David: In anticipation of our upcoming submission the EMA has appointed rapid tours to Shepherd, our application through Ema's committee for medicinal products for human use or see HMP.
Speaker Change: And our <unk> to our country is Germany.
Speaker Change: The co rapid tour is Austria.
Speaker Change: <unk> met previously with regulatory authorities in multiple RMA member countries, including Germany regarding in our supplement for Ta TMA and scientific advice from these meetings has been incorporated into the upcoming MAA.
Speaker Change: Okay.
Speaker Change: Upcoming meetings are scheduled between <unk> and representatives from both rapid tour countries at which we will Orient the representatives to the AAM to the MAA.
Speaker Change: <unk> data.
Speaker Change: Rather than requiring separate national approvals across Europe, and our <unk> MAA is eligible for submission under <unk> centralized review procedure.
Speaker Change: This allows us to submit a single MAA that if approved authorizes marketing of the product and all 27 European Union member States, plus Iceland, Norway and Liechtenstein.
Speaker Change: <unk> has orphan drug designation from the EMA for treatment.
Speaker Change: Amount of poetic stem cell transplantation.
Speaker Change: In preparation with our efforts on <unk>.
Speaker Change: La and MAA submissions to manuscript authored by groups of international transplant experts have been drafted and are under review once finalized both manuscripts will be submitted for publication in premier peer reviewed journals.
Speaker Change: First.
Speaker Change: Consistent with our primary endpoint for regulatory approval compares survival of patients and then our <unk> pivotal Ta TMA trial with the same external control used for our submissions.
Speaker Change: Second manuscript details the survival data from our global expanded access program in the 50 <unk> treated children.
Speaker Change: Last month, two presentations reporting real world outcomes from Ta TMA patients treated under then our supplement EAP were featured at the 2025 tandem meetings in Honolulu.
Speaker Change: The first a podium presentation reported on the impressive survival in both adult and pediatric high risk Ta TMA patients, including those who had failed another ta TMA directed therapy prior to receiving their supplement.
Speaker Change: The second reported on high risk Ta TMA patients, who had failed <unk> and were subsequently treated with <unk> achieving an over three fold increase in <unk>.
Speaker Change: Our survival compared to the reported less than 20% survival in <unk> refractory patients.
Speaker Change: Preparations for the market launch of our supplements are going well.
Speaker Change: Our commercial team is well prepared and eager.
Speaker Change: To launch the drug.
Speaker Change: Transplant experts continue to express their patients need for in our supplement basking how quickly it will be approved.
Speaker Change: As an increasing volume of data are made public regarding the safety concerns surrounding the currently used off label therapies for Ta TMA the need becomes increasingly acute.
Speaker Change: There are 174 transplant centers in the U S 40 of those centers perform 60% of the transplants and 80 sites perform 80.
Speaker Change: Percent.
Speaker Change: We effectively have relationships across these centers and anticipation for the launch of <unk> as high.
Speaker Change: Recall also that we in collaboration with leading U S transplant specialists and professional associations were responsible for establishing an ICD 10 diagnostic code and a CPT procedure code essential for billing.
Speaker Change: The treatment of Ta TMA.
Speaker Change: Once approved in our supplement would be the only drug specifically linked to these codes.
Speaker Change: <unk> reimbursement for use of nurse thoughtful amount, while creating reimbursement barriers for off label treatments not approved for Ta TMA.
Speaker Change: Now, let's turn to our resolve turnabout programs <unk> <unk> also known as <unk> 906 is our lead masks <unk> inhibitor has shown to block activation of the alternative pathway of complement.
Speaker Change: Pathway that is therapeutically validated and involved in a wide range of diseases.
Speaker Change: So I'll turn of our treatment has several important characteristics that positively differentiate it from treatment with other complement inhibitors.
Speaker Change: These differentiators, including enhanced efficacy.
Speaker Change: Convenient and reliable dosing and potential safety advantages are related both to those all 10 of our molecule.
Speaker Change: And its target masked period.
Speaker Change: We continue making good progress in developing data demonstrating <unk> potential to be the preferred choice for the treatment of alternative pathway related diseases.
Speaker Change: So <unk> is now in phase III development for paroxysmal nocturnal hemoglobinuria or <unk>, a life threatening hematologic disorder or.
Speaker Change: <unk> Phase III program is comprised of two studies.
Speaker Change: One in <unk> patients, who are not receiving treatment with our complement inhibitor.
Speaker Change: And the other following a switchover design and which is all kind of art is administered to <unk> patients who have a suboptimal response to treatment.
Speaker Change: With a C five inhibitor, either <unk> or <unk>.
Speaker Change: These study designs in populations are very similar to those of our successful phase III trials.
Speaker Change: <unk> substantially de risking our ongoing phase III program.
Speaker Change: Both of our phase III clinical trials directly compare the efficacy and safety of <unk> monotherapy to that of the C. Five inhibitors <unk> and <unk>.
Speaker Change: And both FDA and European regulators have agreed with the trial designs.
Speaker Change: This is the first time.
Speaker Change: That both trials evaluating an alternative pathway inhibitor in a phase III program are being run with an active comparator.
Speaker Change: So both of our trial designs provide head to head comparisons with <unk> and <unk> and should provide data demonstrating superiority of <unk> over the therapeutic class of <unk> inhibitors.
Speaker Change: His head to head comparisons are important.
Speaker Change: For several reasons first these data could form the basis for comparative superiority claims for promotion.
Speaker Change: This would also allow our sales and marketing teams to discuss zao <unk> superiority oversee five inhibitors with treating physicians greatly accelerating health care provider awareness of Zao <unk> advantages.
Speaker Change: The comparative data can also enhanced market access and support pricing appropriately reflective of.
Speaker Change: All 10 of Bart's advantages over other agents.
Also to support market access and pricing.
Speaker Change: With the German Federal Joint Committee that committee determines availability of reimbursement from German statutory health insurance funds and as specialized expertise in patient reported outcome measures.
Speaker Change: Their recommended measures were incorporated into these all 10 of our phase III design and are expected to help further secure.
Speaker Change: Brokerage pricing.
Speaker Change: Looking at trial logistics and execution, we have completed all settled pannenberg manufacturing needed for our phase III program. We are also identified in source active comparator drug.
Speaker Change: <unk> trials include a total of 120 clinical investigative sites across 30 countries, which were carefully evaluated and chosen for clinical trial participation based in large part.
Speaker Change: Their respective abilities to conduct well run clinical trials.
Speaker Change: And to contribute substantial enrollment.
Speaker Change: Pools of PIH patients ready to participate in the two trials have been identified and efforts continue to locate additional patients. We anticipate all data needed for submission of the BLA on global approval dossier is first of all 10 of our <unk> to be available.
Speaker Change: In the fourth quarter of next year.
Speaker Change: The market size for <unk> is large and growing.
Speaker Change: Our reported <unk> three $9 billion in 2023 and projected at over $10 billion in 2032.
Speaker Change: We believe that is all 10 of our clinical program will position <unk> to capture.
Speaker Change: A substantial portion of that market.
Speaker Change: In addition to the phase III clinical program, we have two other ongoing <unk> clinical trials. One trial is an extension study to provide long term safety and efficacy data.
Speaker Change: This trial enrolled patients who have completed other <unk> clinical trials.
Speaker Change: The other clinical trial is the previously reported evaluation of <unk> in patients who are naive to complement inhibitor treatment.
Speaker Change: Data from this trial have previously been presented at the American Society of Hematology and Europe European Hematology Association annual meeting.
Speaker Change: This study has been amended to treat patients with our phase III dose.
Speaker Change: <unk> milligrams per kilogram of intravenous all 10 of our treatment. Once every eight weeks further derisking our phase III program.
Speaker Change: This study shows strong efficacy.
Speaker Change: That's the last available time point, all patients achieved an increase in hemoglobin of at least two grams per deciliter from their study.
Speaker Change: Entry baseline.
Speaker Change: One component of our phase III primary endpoint.
Speaker Change: 12 of 13 patients without Myelodysplastic syndrome, which is a disease that suppresses bone marrow function and the generation of blood cells on which you would not expect an alternative pathway inhibitor to be effective.
Speaker Change: <unk> achieved.
Speaker Change: In absolute hemoglobin of greater than 12 grams per deciliter.
Other component of our primary endpoint.
Speaker Change: These data are very encouraging for our phase III outcomes no safety signal a concern has been observed.
Speaker Change: <unk> okay.
Speaker Change: We have submitted two abstracts for the upcoming conference of the International PSNH interest group, both were accepted and will be presented at the conference occurring in mid May in Paris.
Speaker Change: We also have submitted abstracts to the 30th European Hematology Association annual Congress acceptance notifications will be sent by the Congress organizers by April 24.
Speaker Change: Given the strength of our <unk> data and the established validation of the alternative pathway and <unk>. Our commercial team has already begun planning for market launch.
Speaker Change: We conducted an advisory board in parallel with the American Society of Hematology annual meeting in December.
Speaker Change: The advisors were PSNH experts from academic and community settings.
Speaker Change: And we've learned that both are critical meaning academic and community physicians and <unk> patients diagnosis and treatment journey.
Speaker Change: The experts uniformly underscored the unmet treatment needs remaining in <unk>, specifically, the patient problems, resulting from extra vascular hemolysis caused by <unk> inhibitors.
Speaker Change: And compliance concerns with newer oral therapy.
Speaker Change: There was significant discussion about the experts.
Speaker Change: Concerns regarding robust compliance mechanisms required with current oral therapy is to prevent treatment gaps that could lead to breakthrough hemolysis and life threatening thrombotic events.
Characterized compliance as multi factorial not just remembering to take a pill or a subcutaneous injection.
Speaker Change: <unk>, which physicians cannot monitor.
Speaker Change: But with PIL self administered injections another primary.
Speaker Change: Pharmacy benefit products.
Speaker Change: A significant issue is whether the patient can even afford to pick up their <unk> prescription are instead choose to delay the refill due to other bills that need to be paid.
Speaker Change: This type of delay could be quickly life threatening. These experts are convinced that <unk> offers unique benefits improved hemolysis control with convenient dosing that health care providers administer only four to six times per year, giving both a physician.
Speaker Change: The patient confidence that effective treatment is onboard.
Also emphasized is all 10 of bard's expected improvement in the patients experience in life.
Speaker Change: Limiting the time that the patients are required to sink about treatment with <unk> <unk> two only a few occasions each year.
Speaker Change: Really giving the patients a sense of empowerment over their disease by reducing.
Speaker Change: <unk> visibility and enabling those patients to almost forget about <unk> between infrequent. So all 10 of our treatments.
Speaker Change: We're also advancing <unk> <unk>, an ultra rare kidney disease, commonly affecting children dosing is ongoing in our phase II study in this indication.
Speaker Change: We recently amended the protocol to expand the study population we've added a treatment cohort of patients with normal plasma <unk> levels. A group that is a substantial portion of the total <unk> population.
Speaker Change: The phase two <unk> trial requires enrollment of a relatively small number of patients.
Speaker Change: And assuming strong evidence of efficacy.
Speaker Change: Look forward to initiating our phase III program in <unk>.
Speaker Change: As a reminder, all tenant Bart received rare pediatric disease designation from FDA for the treatment of <unk>. This designation can allow us to request a priority review voucher that can be used for a different product.
Speaker Change: It's reviewed time to six months the.
Speaker Change: The vouchers can also be transferred or sold and have had a recent market value of over $100 million.
Speaker Change: Our voucher.
Speaker Change: We are very excited about the potential for <unk> inhibition in Pn HC three gene a number of other indications involving the alternative pathway and we are confident.
Speaker Change: That solid tenant bart's anticipated advantages specifically.
Speaker Change: Consistent efficacy better safety and superior dosing compliance and convenience with significantly lower treatment burden.
Speaker Change: Can effectively differentiate <unk> from other alternative pathway targeting therapeutics on the market or in development.
Speaker Change: Let's now look quickly at RMS $10 29, our next generation long acting <unk> two inhibitor phase one clinical trial data made clear that RMS $10 29 can readily be dosed subcutaneously. Once every three months providing.
Speaker Change: Providing a very convenient dosing regimen for chronic indications admins.
Speaker Change: Administered either in health care centers or at home.
Speaker Change: While our recent focus has been on our supplement Enzo panel Bard and deciding on next indications for each we're also honing in on the first indication for phase II development of <unk> $10 29.
Speaker Change: The product has already been manufactured and the quantity stored should be more than sufficient to support a phase III trial.
Speaker Change: In addition to our antibody inhibitors of <unk> II <unk> III.
Speaker Change: Progress continues on the development of potential drug candidates in our small molecule orally available mask to en masse for inhibitor programs.
Speaker Change: To conclude our discussion on our franchise of complement therapeutics. Our studies continue with masked two inhibition in acute respiratory distress syndrome or <unk>.
Speaker Change: We've generated compelling data in established animal models across all forms of severe rds bacterial viral and chemical a rds and are awaiting completion of one additional study ongoing in animals infected with H five N one avian.
Speaker Change: Influenza or bird flu.
Speaker Change: <unk>.
Speaker Change: Many experts believe will become the next life threatening global pandemic.
Once the results from the <unk> study are available we will submit the already drafted manuscript.
Speaker Change: Broadly directed to our supplemental benefits in there.
Speaker Change: For publication.
Speaker Change: A high level peer reviewed journal.
Speaker Change: Another publication, we expect.
Speaker Change: Will be coming soon from Weill, Cornell, which is focused on mass to inhibitions effects in long COVID-19.
Speaker Change: I'll turn now briefly to all of them as five to seven or <unk> seven inhibitor program aimed at treating addictions and compulsions and movement disorders.
Speaker Change: It's five to seven is being developed for the treatment of cocaine use disorder at the request of and with funding from the National Institute on drug abuse or Nader.
As recently announced we successfully completed a drug drug interaction safety studies, where <unk> five through seven showed no enhancement of cocaine detrimental effects instead.
Speaker Change: As five to seven was beneficial to cocaine administered animals.
Speaker Change: In view of the success in either committed to fund to $4 million for the upcoming year, which will fund the planned randomized double blind parallel group inpatient phase one b clinical trial, comparing the safety and efficacy of <unk> five to seven to placebo and the treatment of adults with <unk>.
Speaker Change: Cocaine use disorder.
Speaker Change: The preclinical clinical and mechanistic data generated to date suggests that our <unk> seven inhibitor program could be effective in treating not just cocaine use disorder, but a broad range of addiction and compulsion.
Speaker Change: Work on the Phase <unk> program is underway in our preliminary data readout is targeted for year end.
Speaker Change: We'll conclude today's review with our first in class therapeutic platform.
Speaker Change: Killer and cellular programs targeting a wide range of therapeutic areas, including cancer.
Speaker Change: Building on our understanding of immunity both on eight.
Speaker Change: And complement mediated and adaptive meaning b cells as well as CD four and CDA T cells. Our objective is to move beyond existing targeted biologics such as antibody drug conjugates, which have small therapeutic index.
<unk> and limited tissue penetrance.
Speaker Change: And to advance engineered cellular therapies such as.
Speaker Change: Car T cells, which are expensive and time consuming. These again, we are planning to move beyond.
Speaker Change: To achieve this.
Speaker Change: We're developing a portfolio of next generation biologics to treat cancer consists of a new modalities of targeted drug conjugates with better therapeutic indexes and better tissue penetration.
Speaker Change: Which we expect will eventually sideline the current ADC technology.
Speaker Change: Our portfolio includes an addition of adoptive T cell technology combined with an immuno stimulator that is easier faster and cheaper than current cellular therapy approaches.
Speaker Change: Our technology also maintains an enhanced anti cancer immune response through subsequent repeat and simple therapeutic administrations.
Speaker Change: We're rapidly advancing our oncology programs in stealth development, while we continue to build our intellectual property position.
Speaker Change: Over the past several months, we've sought the input and guidance of therapeutic area experts and advisers under confidentiality.
Speaker Change: And have received a uniformly positive response.
Speaker Change: Our oncology platform is not our only stealth program. We're also developing and have created broad intellectual property around our program targeting the increasingly life threatening challenges and infectious disease.
Speaker Change: We expect to be able to share our success publicly across both our oncology and infectious disease programs and.
Speaker Change: In the very near future.
David: So with that I will turn the call over to David.
David: Thanks, Greg.
David: Our net loss for the fourth quarter of 2024 was 31.
David: 31, 4 million or 30, or 54 per share compared to a net loss of $32 2 million or <unk> 56 per share in the third quarter of 2024.
David: For the full year 2024, our net loss was $156 $8 million or $2 70 per share.
David: As of December 31, 2024, we had over $90 million of cash and investments on hand.
David: Yeah.
David: Costs and expenses from continuing operations for the fourth quarter before interest and other income were $35 $7 million, which was an increase of just $253000 from the third quarter of this year.
David: Research and development expenses in the fourth quarter were heavily focused on their <unk> and <unk>.
David: Interest expense for the fourth quarter was $3 $2 million, which was $1 million lower than in the third quarter of this year.
David: The primary components of interest expense are the 2026 notes.
David: <unk> royalty obligation and the secured term loan in the fourth quarter, we recorded a $4 $1 million noncash remeasurement adjustment to interest expense related to changes made to the omidria royalty obligation. This credit was $700000 higher.
David: Then a similar adjustment reported in the third quarter and is a primary driver of the decrease in interest expense for the fourth quarter.
David: Interest and other income totaled $2 3 million in both the fourth and third quarters.
David: Income from discontinued operations in the fourth quarter was $5 $2 million down just $300000 from the third quarter. The fourth quarter. Total includes two primary components first a $4 $1 million of interest turned on omidria contact royalty asset.
David: And $600000 of re measurement adjustments to the omidria contract royalty assets.
David: As previously discussed royalties earned are recorded as a reduction of the omidria contact royalty asset on our balance sheet.
David: Rather than recognized in our income statement.
David: Imagery of royalties for the fourth quarter totaled $10 $1 million based on Omidria net sales of $33 6 million.
David: This compares to royalties of $9 3 million on third quarter net sales of $31 million, representing an increase of $762000 in royalties and $2 5 million and net sales quarter over quarter.
David: Compared to the fourth quarter of 2023.
David: Fourth quarter 2020 for imagery of royalties decreased by 631000 corresponding to a $2 1 million decline in net sales.
David: As a reminder, in February 2024, we entered into an amended agreement with <unk> under which they acquired the right to receive all U S imagery of royalties payable by Rainer through December 31, 2031.
David: <unk> retains all royalty rights to ex U S sales of Omidria and we are entitled to receive all U S royalties on Omidria sales from and after January one 2032.
David: In other words, all global royalty payments will accrue to <unk> beginning January one 2032.
David: Now, let's take a look at our expected first quarter 2025 results.
David: We anticipate that overall operating expenses from continuing operations in the first quarter of 'twenty five will be comparable to the fourth quarter of 2024.
David: Interest and other income for the first quarter is expected to be approximately $1 $1 million.
David: Interest expense, including any noncash adjustments related to the omidria royalty obligation should be around $7 $2 million <unk>.
David: This represents a noncash increase of $4 1 million from the fourth quarter, primarily reflecting the absence of a significant noncash adjustment tied to the omidria royalty obligation.
David: And as a reminder, the senior term loan transaction, we closed in June 2024, and included a $29 $8 million gain resulting from repurchasing a portion of our 2026 convertible notes.
David: Under GAAP, we're unable to recognize that gain immediately.
David: $29 8 million gained is deferred and amortized over the term of the senior loan reducing interest expense and.
David: Inclusive of the deferred gain we calculate the annual effective interest rate to be one 5% and we expect to incur roughly 400000 in interest expense for the first quarter of 'twenty five related to the senior loans.
David: And finally income from discontinued operations is expected to be in the $7 million to $8 million range, excluding any noncash remeasurement adjustments to.
David: So the imager contract asset.
Greg Alero: With that I'll turn it back over to Greg.
Greg Alero: Thanks, David.
Greg Alero: Operator would you open the call to questions. Please.
Greg Alero: Okay.
Speaker Change: As a reminder to ask a question. Please press star one one on your telephone.
Greg Alero: Wait for your name to be announced.
Greg Alero: Sure. Your question. Please press star one one again.
Greg Alero: Please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of Steve Brozak from W. BB Securities.
Speaker Change: Steve Brozak. Your line is now open.
Speaker Change: Please check your mute button.
Speaker Change: Sorry about that can you hear me.
Speaker Change: Hello.
Speaker Change: Yes, hi.
Speaker Change: Congrats on the submission of the BLA and thanks for taking the questions.
Speaker Change: Simply put one question Hugh.
Speaker Change: Given us details on the Resubmission.
Speaker Change: Can you tell us why you believe and go into as much detail as possible that the submission is that strong and what are the implications and anything else you want to add on that and I'll hop back on the queue. Thank you.
Speaker Change: Okay.
Speaker Change: That could take a while let me let me do this at a high level.
Speaker Change: Look.
Speaker Change: What we did in the analysis and remember that the statistical analysis plan and associated protocol.
Speaker Change: Were created.
Speaker Change: With Fda's agreement.
So what we really did was what FDA asked us to do.
Speaker Change: And the result of those analyses I think can be characterized as nothing else.
Speaker Change: But <unk>.
Speaker Change: Impressively strong right right down the line, whether it's the primary.
Speaker Change: Or the primary related sensitivity analysis or the analyses that we conducted with the expanded access program.
Speaker Change: Not only descriptive analyses on the EAP, but also taking the EAP population and comparing it to the same external control.
Speaker Change: Group, which.
Speaker Change: Frankly, I don't believe we were even asked to do.
Speaker Change: We took it one step further and ran those analyses as well.
Speaker Change: Yes.
Speaker Change: It would be wonderful to be able to share our forest plots from all of those analyses because it tells those really tell the story.
Speaker Change: One quick glance, but really.
Speaker Change: Everything.
Speaker Change: Is favoring nurse thoughtful map all the way down the line and with the P values and the hazard ratios that we generated and I'll just I know everybody heard it but I'll just remind that the primary hazard ratio was <unk> 32.
Speaker Change: Meaning the likelihood of survival in the <unk> treated group was more than three fold higher than in the control group and then you look and that had a P value of.
Speaker Change: Well less than 0.00001.
Speaker Change: Any way that you look at these squeeze these push on these the.
Speaker Change: Data are impressive they are statistically significant and clinically meaningful.
Speaker Change: And all of those numbers that I just gave you are really aligned.
Speaker Change: And supported by those same comparisons we did with the EAP population in comparison to the external control.
Speaker Change: All consistent so when you're asking why we're confident about the data.
Speaker Change: The data speak for themselves, we've put the data out publicly.
Speaker Change: Folks I'm sure have seen those.
Speaker Change: Tried to make those very available.
And I think.
Speaker Change: Sure.
Despite all I've just said the data really speak for themselves, let me ask Kathy.
Speaker Change: You have anything you'd like to add to that.
Speaker Change: Yes.
Speaker Change: PL.
Speaker Change: Very strongly that we've got.
Speaker Change: Solid package, we had a meeting with FDA back in September of an in person meeting very productive.
Brad: As Brad mentioned.
Brad: Got a well matched external control group.
Brad: With Fda's input into agreement adjusted for MRO time bias is propensity matching and then pushed on the model every which way to see if it would budge and consistently we're getting very strong resolve themselves.
Brad: Yes, both with the FDA collaborations and the strength of the results I think we've got a strong package.
Steve Brozak: That answer the question Steve.
Steve Brozak: I'm sure everyone I appreciate the detail you just went into so obviously good luck on the.
Steve Brozak: The.
Steve Brozak: On the <unk>.
Steve Brozak: And I will hop back in the queue. Thank you.
Steve Brozak: Thank you. Thank you.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of Olivia Brayer from Ken Taylor.
Speaker Change: Hey, good afternoon, thanks for taking the questions.
Speaker Change: Sure.
Speaker Change: Greg how you Doin' can you comment at all on how Youre thinking about pricing for <unk> now that you are officially in launch prep mode or at least anything directional would be really helpful. And then on <unk>.
Speaker Change: Can you just talk about the level of confidence you have in the clinical profile, we've seen to date and.
Speaker Change: And whether there's anything you are doing in the phase III to help mitigate for liver toxicity.
Speaker Change: And then I've got one follow up.
Speaker Change: Sure.
First let me answer about the pricing and then I'll hand that over to.
Speaker Change: But I think we have not disclosed.
Speaker Change: Pricing plans for in our supplement.
Speaker Change: But I think one would be safe to assume that there is a range within that pricing would fall and thats probably similar.
Speaker Change: Two other complement inhibitors that are used in <unk>.
Speaker Change: TMA, but at present, we have not yet disclosed, but let me see not Ed do you want to comment on that as well.
Speaker Change: Agree with you Greg.
Speaker Change: The way I look at it as pricing is never final until we're literally publishing it and launching we're looking at it from every angle. The uniqueness here is that nothing is approved <unk> will be the first approved Ta TMA treatment.
Speaker Change: And as Greg just explained the efficacy at threefold benefiting overall survival is drive significant value and so we're taking that into consideration as payers will look at those along with physicians and the last aspect Thats really critical is that we believe that it will.
Speaker Change: Be administered it has the potential to be administered both in the inpatient and outpatient setting and so there could be numerous payers. There. So we look at it as cost within the inpatient setting cost within the outpatient setting.
Speaker Change: These are all the parameters that the bottom line is we believe that <unk>.
Speaker Change: <unk> will deliver significant value and we're taking that into consideration with pricing determination.
Speaker Change: Okay. Thank you and then with respect to your second question around how we characterize sultana bar.
Speaker Change: As I mentioned in the prepared statements, we have not seen a safety signal of concern with Zelle tunnel Buck that includes.
Speaker Change: Lefties or lipid profile changes have not seen it and I think that's what you're referencing since those have been identified.
Speaker Change: With other agents.
Speaker Change: Yes.
Speaker Change: I'll hand, this over to Steve Whittaker, who is here but.
Speaker Change: I also would expect that very likely those changes.
Speaker Change: People have seen around <unk>.
Speaker Change: And lipid profiles very.
Speaker Change: It very well may not be target.
Steve Brozak: Related but I'll, let Steve comment on that.
Excuse me thanks, Greg.
Speaker Change: We haven't seen anything that we think is just.
Steve Brozak: To deliver safety signal with <unk>.
Steve Brozak: Not in our Southland Salten apart and obviously, we look at this just like every other company looks that liver.
Steve Brozak: Potential liver toxicity with every drug.
Steve Brozak: We have done a couple of things to mitigate can founders and let me emphasize that that was a confound or not a liver toxicity issue, but as you know <unk> patients can have elevated <unk> or liver function test because they can get biliary disease from the hemolysis, they get a lot of transfusions and they can get hemochromatosis.
Steve Brozak: We have excluded prospectively patients who have significant liver disease pre existing liver disease. So we don't have to worry about that confounding interpretation of the clinical trials, but we do not expect to see evidence of liver toxicity in the trials and we don't think we've seen it to date.
Speaker Change: Okay got it. Thanks, guys. That's helpful. And then last question is just around cash runway and managing balance sheet from here.
Speaker Change: I guess more broadly what's the strategy for funding you guys have a lot going on this year with a commercial launch in multiple phase III trials kicking off. So just how are you thinking about that broader kind of balance sheet management strategy and then specifically how youre thinking about your current cash runway from here.
Speaker Change: You guys.
Speaker Change: Sure. Thanks, Olivia obviously, we're very aware of that we're on top of it.
Speaker Change: We.
Speaker Change: We commented about discussions that are ongoing.
Speaker Change: Our objective here would be as I think I made clear to restructure.
Speaker Change: The converts.
Speaker Change: And bring in additional capital in so doing.
Speaker Change: There are a lot of other levers that we have to Paul.
Speaker Change: Weather.
<unk> be partnering whether those be other debt instruments, whether that be royalty monetization or even equity all of those are levers that we can pull but.
Speaker Change: We're quite aware of what needs to be done.
Speaker Change: And we wanted to turn some of these cards over which I think we've now done.
Speaker Change: Perhaps perhaps more coming.
Speaker Change: And what we will see is how to first let's let's take care of what's right in front of us and move on from there. So we're quite confident that we've got this well enhanced.
Speaker Change: Okay, great. Thank you guys.
Speaker Change: Alright. Thanks.
Speaker Change: Thank you one moment for our next question.
Serge Belanger: Our next question comes from the line of Serge Belanger, Zhang from Needham and company.
John: Hi, Good afternoon. This is John on for change today, and thanks for taking my Josh.
Speaker Change: So pending pending a potential approval in September for our Sop or Matt just curious where the company stands on any manufacturing scale abilities required to adequately support market demand.
Speaker Change: Secondly is that potentially the first product approved in this category have you begun or plans to begin making any inroads on increasing awareness for <unk> treating physicians.
Speaker Change: Yes, let me answer first and then I'll hand, it to <unk>.
Speaker Change: And in terms of manufacturing, we have all the drug supply necessary.
Speaker Change: To launch and to support our sarcoma.
Speaker Change: Through the first three years.
Speaker Change: Several years.
Two to three years.
Speaker Change: <unk> of utilization, so we're well set there John.
Speaker Change: That drug product drug substance and drug product are available.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Remember that we would expect.
Speaker Change: To be launching that product.
Speaker Change: Very soon after approval.
Speaker Change: Our commercial team.
Speaker Change: One of the.
Speaker Change: A few benefits of having this approval.
We expect.
Speaker Change: So long.
Speaker Change: The initial Carl is that certainly our commercial team has been able to.
Speaker Change: To interact with experts.
Speaker Change: There has been a tremendous amount of education.
Speaker Change: I've done a vacation.
Speaker Change: Ta TMA patients and identification of high risk.
Speaker Change: Ta TMA patients and also.
Speaker Change: With respect to their treatment, so let me hand that over to <unk>.
Let's see.
Speaker Change: Can you provide any additional color.
Speaker Change: Built on Greg's comments, we had a small but very targeted team in the field that has been working as Greg said earlier.
Speaker Change: Not only our top 40 accounts that drive 60% of the allogeneic transplant volume, but.
Speaker Change: All the way up to 80 accounts that drive 80% of the allogeneic transplant volume and they are building what we consider the first phase of the prelaunch and launch its that awareness of Ta TMA.
Speaker Change: Dara is over.
Speaker Change: Rewind historically, there has not been a lot of harmonization of understanding of how to diagnose and treat th.
Speaker Change: Ta TMA that awareness has increased significantly a lot due to the efforts in the field also with our MSL on the medical side and at a recent conference and Thats important transplant conference in the U S. In February.
Speaker Change: We have been engaging we engaged with over 100 physicians and the Ta TMA topic is mainstream that's being raised by the physicians and they want a solution.
Speaker Change: There is very.
Speaker Change: Very strong relationships, a strong foundation of awareness, but those effort tap to continue.
Speaker Change: We're very excited to be able to provide a solution.
Speaker Change: In short order here.
Speaker Change: Thanks.
Speaker Change: Any other question Olivia.
Speaker Change: John Tim.
Speaker Change: John sorry.
Speaker Change: I'm all set thanks for all the color.
Speaker Change: Alright.
Speaker Change: Thank you.
Speaker Change: One moment for our next question.
Our next question comes from the line of Brandon Folkes from Rodman and Renshaw.
Brandon Folkes: Alright, Thanks for taking my question and congratulations on the progress in the Resubmission.
Speaker Change: Hey, Greg maybe for you can you just talk sort of a high level. How do you think about it very strategically longer term.
Speaker Change: Now listen I'll start from that being resubmitted.
Speaker Change: The ability to obviously self commercialized today, but yes.
Speaker Change: Some of these opportunities.
Speaker Change: Large market opportunity and do you have it.
Speaker Change: <unk> deep and broad pipeline, how do you think about partnering commercially in future.
We think if I'm Mira says.
Speaker Change: Taking its pipeline.
Speaker Change: Commission itself.
Speaker Change: The combination of seeking partnerships, where they make sense.
Speaker Change: I'd, just love to get your view, especially given sort of.
Speaker Change: History right within the Adrian kind of having seen by some of it will play out. Thank you.
Speaker Change: Thanks Brendan.
Speaker Change: Look.
Speaker Change: Certainly in our supplement we are planning to launch in the U S independent.
Speaker Change: We have the team ready to do that we have the relationships with the transplant centers with the trans planners and is nodding his head a tremendous amount of work has gone in on the front end of that to make sure that we have a very successful launch with respect to ex U S. Absolutely.
Speaker Change: We are we are expecting to partner in our <unk> Similarly as alternative book.
Speaker Change: That can be regional.
Speaker Change: That could be X U S writ large.
Speaker Change: A lot of opportunities and we just need to figure out what makes the most sense for us when.
Speaker Change: When you say long term.
Speaker Change: There are a number of products coming.
Speaker Change: <unk> <unk> and Zelle tunnel Barton.
Speaker Change: And certainly at some point in the future, we would love to be able to manage ex U S commercialization independently as well I don't see that currently.
Speaker Change: Or either in our supplement horizontal tunnel book so.
Speaker Change: No.
Speaker Change: Very very much focused on partnering those programs again regionally or or internationally ex U S.
Speaker Change: Broadly.
Speaker Change: But that is the plan you do see a deep pipeline.
Speaker Change: I think theres going to be a lot coming I really feel like.
Speaker Change: <unk> with the Resubmission of the BLA.
Speaker Change: Things changed.
Speaker Change: The <unk>.
Speaker Change: I think the tenor of the company the complexion of the company has significantly changed we're moving back to being a.
Speaker Change: A commercial entity, we've done it once with Omidria and remember.
Speaker Change: We were able to commercialize that I think extremely well there were a lot of folks questioning what we could do with that program.
Speaker Change: Imagery are brought in and net revenues to <unk> north of $1 billion through sales through through the partnerships and royalty sales that we did there. So we're very excited about this next.
Speaker Change: Phase.
Speaker Change: No.
Speaker Change: <unk>, which means commercial on our supplement and then coming up really right behind that Zao <unk>.
And when you look at the data from Zao <unk>.
Speaker Change: And the difference here is with <unk>.
Speaker Change: We are the first right there was no playbook for us to follow for the development and the regulatory strategy.
Speaker Change: Around in our supplement that's a very different set of circumstances for resolve tenant.
Speaker Change: We're really able to follow where others are going doing very similar things to what they've done.
Speaker Change: But with what we believe is a.
Speaker Change: Meaningfully better molecule.
Speaker Change: And a meaningfully better target and out of that we would expect that.
Speaker Change: We're very eager to get solid tenant borrowed in the market and be generating revenues not only from our supplement but from zao <unk> tena BARDA as well.
Speaker Change: The boy.
Speaker Change: That we all look forward to we expect very much that we will get there you cant look at those all 10 of our data and really I think rationally come to the conclusion that that product is going to have a lot of difficulty getting approved I think Conversely.
Speaker Change: We are very confident that subtenant, Bart will be approved as we are for in our supplement.
Speaker Change: In our supplement we had to go through a lot of extra steps.
Speaker Change: But we've completed those and the data look really strong. So we're looking forward to September and our launch very soon thereafter, and revenue generation and being right back as a commercial company.
Speaker Change: Great. Thanks, so much Greg.
Speaker Change: Yeah, and I would I would not forget.
The pipeline programs.
Speaker Change: So I would pay very much attention to what's happening in our oncology programs.
Speaker Change: And the other programs that we mentioned.
Speaker Change: Thank you I would now like to turn the conference back over to Doctor Demopoulos for closing remarks.
Okay. Thank you operator.
Speaker Change: I'd like to thank everyone for joining us today.
Speaker Change: Before we close I just wanted to acknowledge the entire <unk> team.
Speaker Change: That continues to build a series of truly cutting edge programs.
Speaker Change: That will likely change the landscape in their respective fields.
Speaker Change: Look forward to sharing more with you.
Speaker Change: In the very near future all of US at <unk>. Appreciate your continued support have a good evening. Thank you.
Speaker Change: Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
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