Lantheus Holdings Inc
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Lantheus Holdings Inc
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Good morning, ladies and gentlemen. Welcome to the Lantheus Holdings First Quarter 2021 Earnings Conference Call. This is your operator for today's call. [Operator Instructions] This call is being recorded for replay purposes. A replay of the webcast will be available in the Investors section of the company's website approximately 2 hours after the completion of the call and will be archived for 30 days.
I'll now turn the call over to your host for today, Mr. Mark Kinarney, Senior Director of Investor Relations. Mark?
Thank you, and good morning. Welcome to Lantheus Holdings First Quarter 2021 Financial Results Conference Call. With me on today's call are Mary Anne Heino, our President and CEO; and Bob Marshall, our Chief Financial Officer. Mary Anne will begin with some introductory remarks and a business update, and then Bob will cover our financial results. Mary Anne will conclude the call with closing remarks and then we'll open the call for Q&A.
This morning, we issued a press release which was furnished to the Securities and Exchange Commission under Form 8-K reporting our first quarter 2021 results. You can find the release in the Investors section of our website at lantheus.com. For those of you not on the webcast, you can find the slide presentation in the Investors section of our website under the Presentations tab.
Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. In particular, the continuing impact of COVID-19 on our business results and outlook is a best estimate based on the information available as of today's date. Please note that we assume no obligation to update these forward-looking statements, except as required by applicable law, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties.
Also discussions during this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is also included in the Investors section of our website.
With that, it is my pleasure to now turn the call over to Mary Anne.
Thank you, Mark. I hope this finds everyone healthy and vaccinated or well on the way to being so. During the first quarter, we continued to successfully execute against our financial and operational strategies while keeping the safety of Lantheus employees a top priority and I am pleased to update you on our progress today.
As we approach the 1-year mark of our acquisition of Progenics, I am proud of what our team has accomplished. You may recall, after announcing the transaction, we established a fully dedicated team to oversee the integration effort to achieve identified strategic and financial goals. The execution against these milestones is well advanced and we have been able to significantly invest in our business while overachieving on the targeted run rate savings. I cannot be more excited about what the future is that we are creating for this company.
While Bob will provide more detail later, I want to bring your attention to a change in our reporting segments that begins with this quarter. Going forward, we are changing our reporting segments from U.S. and international to a single reporting segment. Under that single segment, we will be grouping our reported revenue into 3 categories: the first is precision diagnostics; the second is radiopharmaceutical oncology; and the third is strategic partnerships and other. This better aligns with our corporate strategy into our current product portfolio and pipeline. I will structure my comments to be consistent with this new format.
In the first category, precision diagnostics, I'll be discussing the following products: DEFINITY, TechneLite and Xenon. I'll start with DEFINITY. If you recall, during the fourth quarter 2020, we noted that while results in October and November were in line with our expectations, we did see volume decline in non-urgent echocardiography procedures in late December in those geographic regions that experienced resurgence of COVID-19 infections and related hospitalizations.
Starting in early February, we began to see recovery, albeit with regional differences across the country. With steadily increasing availability of vaccines to broader segments of the population, we believe health care professionals and patients are becoming more comfortable in administering and receiving in-person care. And with that, we believe echocardiography utilization will continue to return to pre-COVID-19 volumes. Throughout the pandemic, we've engaged our DEFINITY customers through digital technology, including virtual training programs as direct promotional access to hospitals has been restricted.
In fact, we've conducted a record number of virtual programs in the past year. While virtual engagement continues, hospitals are now allowing in-person visits for our sales professionals in some areas. While in-person activities are highly geographically dependent and still limited, we are encouraged by the trend and, more importantly, the opportunity to engage with our customers in person. Experience gained over the last year with different forms of digital engagement will inform the full promotional mix of our approach to the echocardiography market going forward.
We are committed to the echocardiography specialty and believe these investments complemented by a return to normalized echocardiography levels and utilization dynamics will drive DEFINITY revenue growth for the balance of 2021 and beyond. Finally, regarding DEFINITY, our in-house manufacturing facility project remains on-track. We expect to submit the supplemental New Drug Application or sNDA later this year, with an FDA action date anticipated by year-end. During the first quarter, we successfully manufactured batches of DEFINITY that will be commercially salable upon FDA approval.
Turning to TechneLite. The product performed well in Q1 and we continue to see demand build back towards pre-COVID-19 levels. While the business posted flat revenues on a sequential basis, the recent fourth quarter of 2020 included about $1.9 million of opportunistic generator sales to ANSTO, which did not repeat to the same magnitude in the first quarter. While international transportation logistics for inbound Molybdenum-99 or Moly supply remain complex, we are hopeful that international flight patterns will return to more normal levels, which will minimize our need to support custom logistics for Moly delivery.
Our Xenon business, however, continues to be negatively impacted by limited utilization of in-hospital respiratory inhalation procedures as a result of COVID-19 transmission concerns. As we've said previously, we anticipate aerosol based studies of which Xenon is one may continue to be impacted, while hospitals maintain precautionary protocols to prevent possible COVID-19 transmission by patients who may be infected when undergoing aerosol-based procedures.
Switching now to discuss our radiopharmaceutical oncology products and product candidates, I will give an update on the following: AZEDRA, PyL and 1095, beginning with AZEDRA. In March, we announced that updated biochemical tumor marker data from our pivotal Phase II trial of AZEDRA were presented at the Endocrine Society's 2021 annual meeting, ENDO 2021. In the trial, AZEDRA demonstrated reduction in hyper secreted tumor markers in a majority of patients with advanced pheochromocytoma and paraganglioma tumors or PPGL.
In addition, the overall tumor biomarker response correlated significantly with both the primary and secondary endpoint responses in the study, underscoring the clinical utility and relevance of this important biochemical marker to evaluate response to therapy and reinforcing the therapeutic benefit of AZEDRA in patients with these life-threatening tumors. As a reminder, AZEDRA is the first and only FDA-approved treatment option for patients with advanced or metastatic PPGL.
During the quarter, we introduced new marketing initiatives to increase awareness of the disease and treatment options amongst the preferring physicians. We also developed a new medical affairs plan to facilitate peer-to-peer education, while also working with centers of excellence to expand availability of this treatment option for patients. To ensure ongoing adequate product supply, we have increased the manufacturing staff at our Somerset facility. We are also constructing an additional manufacturing suite to provide redundancy for AZEDRA manufacturing as well as increased overall future capacity of our iodine-based products.
While it will take some time to complete the qualification and obtain FDA approval of this suite, we believe that some of these activities will result in ensuring adequate manufacturing capacity for the increased demand we anticipate for AZEDRA during the balance of the year and moving forward.
Turning now to our product pipeline. I will discuss the product candidates highlighted here, beginning with PyL. PyL is a lead candidate in our prostate cancer portfolio and is a prostate-specific membrane antigen or PSMA-targeted PET imaging agent for prostate cancer. PyL enables clinicians to visualize both bone and soft tissue metastases in patients with locally advanced, recurrent and/or metastatic prostate cancer. The FDA accepted our new drug application for PyL and assigned priority review to the NDA with an action date of May 28, 2021.
In March, we announced the publication of the results of both pivotal studies for PyL. The OSPREY Phase II/III style results were published in the Journal of Urology and the CONDOR Phase III trial results have been published in the Journal of Clinical Cancer Research. We believe these data demonstrate PyL's clinical benefits and that PyL has the potential to play an important role in transforming the management of men with high-risk recurrent or metastatic prostate cancer. We are pleased our studies were published in these prestigious journals.
With the PDUFA action date and potential launch later this month, we're very busy with commercial preparation activities. Over the last several months, we have focused our efforts on scaling up our commercial, medical and manufacturing capabilities in support of PyL. We've added significant talent throughout our organization, including our commercial, medical, supply chain, quality and technical departments, to help facilitate a successful product launch. On the commercial front, we've been pleased with our ability to recruit professionals with strong backgrounds in urology and nuclear medicine to enhance our sales effort.
Our senior commercial leaders are in place, as are our salespeople and medical science liaisons in key markets against a hiring plan that matches our anticipated launch timing. For our medical team, in early April, we announced the addition of 2 top tier talents, Dr. Bela Denes and Dr. Iryna Teslenko. Dr. Denes, a board-certified urologist and Dr. Teslenko, board-certified in radiology diagnostics, both come with extensive experience in both clinical practice and industry, and we are thrilled to have them supporting both PyL and the entire Lantheus medical teams.
Our time line supports launching PyL as soon as we receive FDA approval. We are working on-site preparedness and activation with our PET manufacturing facility or PMF partners to ensure nationwide product availability by the end of the year. This timing aligns with the expected approval of our pass-through application with the Center for Medicare and Medicaid Services or CMS for Medicare coverage in the hospital outpatient setting. We are also engaging with key payers for appropriate reimbursement for patients with commercial insurance, all to optimize initial adoption of PyL by clinicians.
The voice of the patient is critical in prostate cancer and our work with advocacy groups to build awareness of PSMA PET imaging continues. Most notably, our outreach includes working with organizations such as The Prostate Cancer Foundation and ZERO - The End of Prostate Cancer as well as a number of veterans groups. We are greatly encouraged by the interest we have seen from the health care and patient communities in recognition of this novel imaging agent.
Moving to 1095, our iodine-131 PSMA-targeted product candidate for the treatment of metastatic castration-resistant prostate cancer or mCRPC. In October 2020, we resumed patient enrollment in our Phase II ARROW trial. I am pleased to report that we now have 24 active clinical sites across the U.S. and Canada, and patient enrollment is progressing well. The ARROW trial is designed to evaluate the safety and efficacy of iodine-131 1095 radiotherapy in combination with enzalutamide as compared to enzalutamide alone in chemotherapy naive patients with PSMA avid mCRPC, who have progressed on abiraterone. Patient enrollment is progressing as planned and we are on target with our time milestones for this trial.
Now I will discuss our progress in our strategic partnerships and others business. In late March, we acquired the exclusive worldwide rights to develop, manufacture and commercialize NTI-1309, an innovative PET oncology imaging agent from Noria Therapeutics. NTI-1309 targets the fibroblast activation protein or FAP, a target with potential broad imaging applicability and targeting implications for precision oncology. FAP is overexpressed in the tumor micro environment, specifically in tumor-associated fibroblast, which are believed to modulate tumor progression and immune response.
Already a focus of significant research by academics and the pharmaceutical industry, a FAP biomarker has the potential to address unmet medical need and to impact the clinical management of stroma-dense tumors, such as breast, colon, lung and pancreatic cancer, as well as having broad potential to inform diagnosis and staging to guide patient selections for therapy and to monitor response to treatment across multiple tumor types.
Upon completion of the Phase I study, which we believe will start later this year, NTI-1309 will be integrated into Lantheus' portfolio of imaging biomarkers and will be included as part of our offering to academic centers and pharmaceutical companies for use in oncology drug development programs. Under this agreement with Noria, Lantheus also has the option to acquire the therapeutic rights of this agent. We are enthusiastic about this cutting-edge oncology agent while realizing it is early in its development. This partnership is another example of Lantheus' commitment to advancing innovative imaging biomarker solutions that find, fight and follow cancer.
In our microbubble franchise, last week we announced a strategic collaboration, which will use our microbubble with Allegheny Health Network or AHN's ultrasound-assisted non-viral gene transfer technology for the development of a proposed treatment to xerostomia. Xerostomia, a lack of saliva production leading to dry mouth, has a variety of causes, including radiotherapy and chemotherapy in certain diseases. It is also a common side effect of ionizing radiation used to treat head and neck cancer. Thousands of cancer patients suffer from radiation-induced xerostomia, which can cause severe oral and dental issues. Once xerostomia begins, it is a permanent condition. We're excited to support AHN in its efforts to progress this innovative development program.
Finally, yesterday we announced we received CE Mark clearance for aPROMISE. CE Mark gives aPROMISE approval in Europe, a milestone in the path to potential U.S. approval. aPROMISE is an artificial intelligence-based medical device software that is used in conjunction with individual reader interpretation and enables health care professionals and researchers to locate, detect and quantify disease in whole body PSMA PET CT. Our goal is to seek approval for aPROMISE in the U.S. and to add this tool to the portfolio of offerings we bring to the prostate cancer treating community.
With that, I will conclude my update on key commercial and strategic programs and turn the call over to Bob. Bob?
Thank you, Mary Anne, and good morning, everyone. I will provide highlights of the first quarter financials focusing on adjusted results unless otherwise noted. Before I begin, I would like to talk about several reporting changes we are making in our disclosures to better reflect our businesses going forward. First, we are evolving our segment reporting to a single reporting segment. You'll recall that we briefly had 2 segments, U.S. and international. The sale of our last international radio pharmacy operation in January of this year, previously disclosed as our Puerto Rico operation, together with our acquisition of Progenics last year were factors in prompting our segment analysis.
Our conclusion reflects the company's focus on both the performance of the business and resource allocation to be on a consolidated worldwide basis. You will see this reflected in our 10-Q to be filed today. In addition, to the new revenue categories noted by Mary Anne, we will now present rebates and allowances within each relevant grouping and individual product as appropriate. You can find within the Investor Relations section of our website under supplemental financial information, a listing of each product within its respective revenue grouping as well as historic gross and net revenue for both DEFINITY and TechneLite to aid with evaluating growth rates going forward.
Turning to the quarter. Revenue for the first quarter was $92.5 million, an increase of 2% over the prior year quarter, the comparison that included run rate revenues from our Puerto Rico operation now divested. Beginning with precision diagnostics, revenue of $85.8 million were 2.9% lower from the prior year quarter. Sales of DEFINITY, net of rebates and allowances, were $56 million, 6.6% higher as compared to the prior year quarter, driven by sequentially higher volumes.
TechneLite net revenue was $22.8 million net, up 0.1% from the prior year quarter. Within other precision diagnostics, Xenon's performance has continued at similar levels to previous sequential 3 quarters. Radiopharmaceutical oncology contributed $1.5 million of sales, down 23.8% from the prior year quarter due mainly to the loss of revenue tied to the divestiture of the Puerto Rico operation in comparison. In the future, in addition to AZEDRA and QUADRAMET, assuming approval by the FDA, PyL will reside within this revenue category. Lastly, strategic partnerships and other revenue was $5.3 million, driven primarily by the RELISTOR royalty.
Gross profit margin for the first quarter was 50.3%, a decrease of 89 basis points from the first quarter of 2020 on a similar basis. The decrease is due mainly to product mix and expanded manufacturing footprint acquired from Progenics on a year-over-year comparable basis as well as increased Moly distribution and logistics costs due to the COVID-19 pandemic. Operating expenses were 1,314 basis points unfavorable to the prior year at 40.5% of net revenue, driven primarily by the continued annualization of expenses from Progenics, offset in part by synergy achievement.
Additionally, as noted by Mary Anne, we have made good progress in our PyL commercialization prepared efforts, along with ongoing patient enrollment in the 1095 Arrow study. Together, expenses were slightly favorable to our expectations while hitting our intended quarterly objectives. Operating profit for the quarter was $9 million or a decrease of 58.2% over the same period prior year. Total adjustments in the quarter totaled $7.8 million gain before taxes. Of this amount, $3.3 million and $4.7 million of expense is associated with noncash stock and incentive plans and acquired intangible amortization respectively.
Also in the quarter, we recorded $15.3 million of gain on the sale of our Puerto Rico operation as well as a gain of $900,000 on extinguishment of debt. The remainder is related to acquisition, integration and other nonrecurring expenses. Our effective tax rate was 49.7% in the quarter. As has been the case in prior periods, our tax rate includes certain entries to account for uncertain tax positions from which we are indemnified and doesn't have a direct correlation with profit before tax. The resulting reported net income for the first quarter was $9 million and $3.3 million on an adjusted basis, a decrease of 76.9%. GAAP fully diluted earnings per share were $0.13 and $0.05 on an adjusted basis, a decrease from the prior year of 86.3%.
Now turning to cash flow. First quarter operating cash flow totaled $9.8 million as compared to $9.4 million in Q1 2020. Capital expenditures totaled $2.5 million, down slightly from the prior year quarter. Free cash flow, which we define as operating cash flow less capital expenditures, was $7.3 million, an increase of $0.6 million over the prior year period. Also at the end of the quarter, we utilized $30.9 million of cash to pay off the RELISTOR royalty-backed loan in full. In doing so, we've reduced our overall net leverage ratio used in our bank facility covenants to 2.5x, achieving one of our initial deal goals ahead of schedule. Cash and cash equivalents, net of restricted cash now stand at $68.9 million. We continue to have access to our $200 million undrawn bank revolver and are comfortable with our strong liquidity position.
Turning now to guidance for Q2 and the full year. We forecast revenue to be in a range of $93 million to $97 million for the second quarter of 2021, an increase of 41% and 47% over the second quarter of 2020 respectively. We are updating our full year view to take into consideration actual Q1 performance relative to our initial views of revenue impact stemming from the COVID-19 uncertainty, which had informed the lower end of our original range. Therefore, we will now forecast the full year revenue to be in a range of $390 million to $400 million from our prior range of $385 million to $400 million.
Regarding adjusted earnings per share, we continue to invest in commercial readiness for PyL. Additionally, enrollment in our Phase II ARROW study with 1095 has been steady and is expected to continue at its current pace. As such, Q2 will carry an expense burden slightly higher than actuals in Q1, but in line with prior guidance on average. Taken together, adjusted EPS should be in the range of 3.6 -- excuse me, adjusted to be in the range of $0.03 to $0.06 for the second quarter. We are raising our full year adjusted EPS to account for relative Q1 outperformance and interest savings from a fully repaid RELISTOR royalty-backed loan, offset in part by incremental investments to advance our pipeline assets. We now expect adjusted EPS to be in a range of $0.36 to $0.41 per share versus the prior range of $0.34 to $0.39.
With that, let me turn the call back over to Mary Anne.
Thank you, Bob. The balance of 2021 will be a pivotal period for Lantheus. In just a few short weeks, we may have the opportunity to bring a truly important product to market that will have an impact on the lives of prostate cancer patients. Reaching this important milestone would not be possible without the work of everyone at Lantheus and their dedication to the clinicians and patients we serve. Before I open the call to questions, I would like to express my sincere thanks to all Lantheus employees and to the patients, customers and shareholders who trust us to serve you.
With that, Bob and I are now ready to take your questions. Operator, Please go ahead.
[Operator Instructions] And our first question comes from the line of Richard Newitter of SVB Leerink.
Congrats on the progress you made during the quarter. Maybe just a couple here to start on the PyL, just given that that's such a exciting and important focus for you guys coming up here. Can you -- understanding that the FDA has just been a little more unpredictable lately, I'm just wondering if there's anything you can offer us in what you're seeing with respect to their inspections of your PET manufacturing facilities? And are things generally tracking on time as far as you can tell for the PDUFA at the end of May here?
So obviously, Rich, since we're now within 3 weeks of our action date, we are kind of constraining the comments we can offer. But I will say we are on track with all our milestones with the FDA. I will also note the PMF or third-party partners, they will be individual manufacturers of the product. So we do not own them. We obviously work very close with them to ensure that they are on track with their own milestones and especially as regards to any potential FDA inspections. But I can confirm that we remain on track with all our milestones related to FDA submission and review.
Got it. And just based on the way we're modeling PyL, we don't really model any material revenue until 2022. We feel like we've built in some cushion. I think the Street seems to me on modeling similarly. I'm just curious if there were some delays here, can you just talk to how you feel about the commercialization time lines that you kind of laid out in the past irrelative if there were to be some delays here with the pass-through submission and what it would take for you to build out a commercial infrastructure to still kind of meet some of those targets even if there were a delay by a few months?
So Rich, there's actually 3 different time lines that run concurrently. And what we spoke to today is we feel we have them very strongly aligned. The first is our own internal commercial preparedness. And as I mentioned, we are ready, willing and very capable and eager to launch this product as soon as it's FDA approved, and that comes from commercial build-out of all of our internal functions. So you heard me speak to quality, sales, medical, technical, manufacturing. So that's been something that we've been on top of for several months now. And as I mentioned, we are also very pleased with our hiring progress there. We're really attracting great talent to the organization.
The second is the time line for CMS pass-through. Now CMS pass-through, let's all remember, this only applies to reimbursement for the procedure in the Medicare patients, in the hospital outpatient setting. And CMS does have some time lines that are related to when you can submit the application and when the application can be approved. They accept applications on the last month of each quarter and they approve applications in a timely fashion on the first month of the subsequent quarter.
So if you submit say on September of a quarter, you would then expect approval by January of that subsequent quarter, although there have been exceptions where CMS has accepted the application after the last month of the quarter and in some cases has approved before the first day of the first subsequent quarter. But the way that we've lined up our time frame here is assuming that we have approval on May 28, which is our action date, and that allows us then because of some of the other inclusion items of the application, we would anticipate submitting our application on September 1 and having pass-through approval for January 1.
The third time line that runs along with that is availability of the product out in the market among the PMF network. And this is the opportunity to build out your network. So essentially, you have broad availability across the United States. And the analogy that I'm encouraged to use, although it's not one that's totally familiar to me, is football cities. And where you say that if you had good PMF coverage in what are the current football cities in United States, that would represent broad availability to the treatment centers that are close to there and represent broad availability across the prostate cancer patient population.
And that is about -- and I told about 31 -- I'm sorry, that I don't know this, 31 or so teams. And in those -- I guess, in some of those cities, it's actually more than 1 team, which I find amazing, but hats off to them. And so we are aligning that. We anticipate that we could have that type of coverage build out by the end of the year, which then aligns with our pass-through application approval and gives us all of that time beforehand with our commercial preparedness to go out, drive name awareness and also to work on commercial insurance availability, which is also very important for some of the major commercial insurers. So I hope that answers your question.
Yes. No, no, it definitely does. And maybe just to switch here. You're clearly breaking out, from a segment reporting standpoint, the partnerships that you have and there are many and some really interesting ones more recently that were announced. So I'm just curious, how do we think about the contribution from some of these -- your recently-announced initiatives? It seems like RELISTOR is probably the main contributor right now in that segment. But when can we start to think about contribution from some of these newer areas?
So you're right on spot there with RELISTOR being a very kind of called out and very noticeable contributor right now because that's an ongoing royalty stream. The others are very strategic in nature, and you'll continue to hear me talk about how we are working with our pharma services team to really keep our eye on and ahead of what is emerging as far as technology and targets in the fields that we're interested in. And a lot of the partnerships you see us signing are somewhat, I would say, mutually valuable partnerships both ways in that we are providing what is a very, very valuable service, which will have revenue associated, but not revenue that was really significant.
But more importantly, we're providing a service of needed almost manufacturing capacity and availability for the biomarkers into clinical trials and into academic centers. And in exchange, we get early insight into the progress and performance of these biomarkers. And as you heard with me with the Noria announcement, we get first right of refusal for what could be a very important therapeutic target that we're very excited about going forward, which obviously then any revenue associated, especially with that therapeutic target would be down the road.
And our next question comes from the line of Anthony Petrone of Jefferies.
Congrats on a strong start to the year here. And Mary Anne, hopefully this year is your first year as a big fan of football on Sundays and best to share [ dry fix ] on next year's go around. Maybe to start with the core business on DEFINITY and you touched on ECG volumes. I'm just kind of wondering, just to kind of splice through the comments, where ECG volumes are versus pre-COVID levels? It sounds like they're approaching normal levels, but perhaps you're not quite there yet. So maybe just to quantify that a bit. And is there any backlog to speak of as we think of DEFINITY volumes just as we sit at the current phase of the pandemic? And then I'll have a couple of follow-ups on PyL and one on TechneLite.
Sure. Welcome, Anthony. I can't say that I'll be sitting on the couch on Sundays because I'm not really a sitter, but I'll try to learn a little bit more about this American sport of football that everyone loves so much. To echocardiography, I'm happy to share some insights with you, but I need to caveat it by saying that these are drawn from market research and from survey data. And so they need to be accepted as that is. And therefore, I would accept them as trending and not absolute data points. We do not have access to actual claims databases. And so that's why I caveat my comments that way. But we are seeing -- at this time, we are seeing activities that suggest that the volume of echocardiography procedures in the United States has returned to what we were at pre-COVID-19.
And if you remember back to that time with my comments, that's a market of approximately 35 million procedures on an annual basis, then growing at a few low percentage points, you can call it like 2 to 3 percentage points on an annual basis. And so that is something that most recently -- and you heard in our comments that we did really begin to see that at the end of first quarter, that is something that we believe is true about the marketplace. And there's still a recovery to be had because echocardiography procedures are used in many different ways. And I'm not sure that all those different ways are backed up to full volume. And why I say that is one of the many ways is as part of a regular physical. And so different patients, depending on their age, category and their risk factors as part of their physical cardiac workup, might include an echo exam and that echo exam might have a rest in stress part to it. I'm not sure that, that level of procedures is truly back it, but it's coming.
To your other question about comments from the field, we are also seeing hearing comments from during our market research about echocardiography suites having to deal with backlog. And this is, again, from -- and we talked about this through the pandemic, what would constitute backlog during -- of echocardiography procedures. But we are hearing some comments about that. It comes back to us around scheduling and around needing to extend hours into weekends and the like. So all good signs of what I referenced in my comments, which is that I think we're getting to a point with vaccination levels and with hospital protocols, the wonderful protocols that hospitals are able to put in place, that caregivers and care seekers are both more open to and willing to have that interaction happen in person. And I think that's a great thing for the larger health care environment.
That's helpful background. Maybe to shift gears a little bit to PyL, a couple here. First one, maybe just kind of thinking about the entirety of the sales effort, just sort of headcount where it is today? And where is it sort of going once it's fully staffed? That would be the first question. And then, Mary Anne, you mentioned reimbursement and sort of that goes into pricing. Is there anything that you can share just on your expected levels of reimbursement, whether that's Medicare and then private and how that translates to pricing going forward? And then one last one I could squeeze in for Bob would just be, as we look at the new reporting structure and sort of think about new products coming into the fold, specifically within the radiopharmaceutical oncology segment, how should we think about the progression of gross margin going forward, perhaps over the next several years?
You're very welcome. With respect to hiring and more importantly the hiring levels, what I would say about that is you -- we have now -- we have one company we're in the market that's been targeting PET imaging for prostate cancer. We have ourselves entering the market and there's a third company fairly close behind us. And while I won't speak to relative size, I will very confidently say that we will be at the largest or very much competing for the voice that we will bring into the market across both commercial and medical with the prostate cancer treating community. We feel it's very important because this is a new class PSMA based PET imaging agents, are a new class. And any time you introduce a new class, there is an obligation and we feel that as a commitment to educate and to bring awareness to what the different aspects and value are of the agent you're bringing to the market. So we're very, very committed to that.
From an insurance and coverage perspective, you heard me speak to CMS, and CMS will cover very specifically with pass-through outpatient coverage. But then there's also some other classes of patient coverage would have to do with ambulatory centers and the like, which kind of come along with that. I guess the other big group is the commercially-insured group. And included among the commercially-insured group are also those patients who are CMS eligible, but Medicare Advantage covered. So they are a very important group for us. And as you can appreciate prior to any launch, this is work that starts long before launch and continues long after. And for some of these insurer groups, their policy is such that they will really not entertain you as a product for coverage until after you were approved. You can imagine what their dockets would look like if they allowed presentations from every product that was under evaluation by the FDA. So it is a process, Anthony, and we anticipate that total coverage will build over time.
I will though say that in the -- before coverage is in place, every insurer has a process by which you can ask for prior authorization or special clearance or special approval for a procedure. And with something as, I would say, novel as PSMA-based PET imaging, we would anticipate that, that would be the case. And that is, we believe, a great way to build data, a data set around the value of these procedures and the ability to really use this type of imaging as an ability to change patient management for patients and therefore, describe and demonstrate the value of this type of imaging.
Your question around gross margin progression. So as I look at the different categories, you did ask specifically about the radiopharmaceutical oncology. But even as I look at precision diagnostics, which is a reflect on the products in there, it's largely the legacy of Lantheus business, which also has gross margin expansion opportunity in the sense of our on-campus manufacturing as an opportunity as well as, as we recover through the COVID-19 impacts on gross margin, those will abate as we go through the year. So there is still opportunity to go there.
With regard to radiopharmaceutical oncology, when we set out along this journey in terms of looking to add strategic assets to the portfolio, we did so with a sort of our own internal mandate to find assets that would be margin accretive, so as is the case with what is PyL and AZEDRA. While initially, they're going to be at gross margin levels probably on par with the company averages quickly with scale, these products will be appreciative and will accrete to our company average. And we have every confidence that in doing -- as we drive volume, we will certainly be able to achieve the 100s of basis points of it margin expansion that we fully expect within sort of the near to medium term. So from that perspective, we're very focused on driving that kind of level of profitability and then ultimately free cash flow.
Strategic partnerships and other, our royalty stream is 100% gross margin. So there's not much more you can say. That's a very highly accretive, although much smaller bit of the overall business, but it is additive. But again, I do have sort of an eye on ramping our gross margin and profitability over the next years.
Sorry, Anthony, but I didn't answer one of your questions and I probably won't know. But other than to say that neither Bob or I will ever speak specifically to pricing of the products. It's just something that we have taken the stand that we do not do.
[Operator Instructions] Our next question comes from the line of Larry Solow of CJS Securities.
Just a couple -- piggyback on Anthony's question there. Just on PyL, forgetting headcount, can you maybe -- and I'm sure you won't be able to quantify it exactly, but in terms of the build out on the infrastructure of costs and whatnot, I assume the R&D phase is probably going to sort of bleed more into the manufacturing side of it. But just in terms of your sales force, in terms of dollars, do we still need a significant jump up? I know you've been investing in that. But should we expect over the next 2, 3 quarters if all goes well with commercialization that you'll have to invest significantly more marketing dollars and sales dollars? How should we look at that over the next several quarters, several years, wherever you want to discuss it?
This is Mary. And I'll start and then I'm going to pass to Bob for actual numbers. But I'll just put some context on my comments where I said that we intended to be competitive with voice and with our presence in the specialty or to the specialty. And I do intend that to be true. However, let me also share that luckily, it is a fairly efficient way to do this with this voice. This community, and when you're talking about PET imaging, you can focus on PET imaging centers, which is where the -- all of these studies flow through and where all of the orders for these studies come through and then the -- from a demand creation, the source of demand into it. So unlike some markets that are very broad or have a very diffused, I'd say, demand outreach, this is a very efficient and very concentrated market and that's reflected in some of the investment profile, and I'll let Bob explain.
Yes. So Larry, my prior -- if you recall back in February, I had said that we would expect sort of OpEx to sort of be in that $40-ish million range per quarter, which is still -- I would still point you at that sort of level. So when I look at the numbers, even the first quarter, which, if I look over year-over-year, it's about a $12.5 million increase in overall spend. What's important to think about though is that the addition of Progenics. Progenics was running at a run rate per quarter of about $21 million or so of OpEx. So what we've been able to do is invest in the business and we have made significant progress, but do so in a way that we're actually able to do this within the achieved synergies and drive what will ultimately be good leverage in the P&L as that product takes off.
So I would still point you to the numbers that I had -- I think that's what I was trying to get at in my comments around saying, while we may have been slightly favorable, some of that had to do a little bit of phasing within the quarter based on initial indications. But as we move into Q2 specifically, that's when I was saying you would sort of go back to sort of what I was talking about as our average run rate in the remaining portions of the year. Could it be slightly higher than that? I think that all depends on timing of things. But certainly, it would be not materially different than what I had sort of outlined from a dollars perspective.
Okay. And then sticking to that theme and I know you had sort of gave some high-level sort of gross margin targets on a consolidated pro forma basis when you announced the Progenics acquisition. Now that's coming up on, I guess, over 18 months ago, time has gone there. But obviously, there's been a lot of noise, COVID, big noise there. But has anything significantly changed in terms of your sort of accretion time lines and whatnot? Obviously, some things were delayed a little bit, but in terms of closing the acquisition, but has anything really materially moved to the right?
I would say, one, it's been only 12 months. I know the [ journey go ], but it feels like 18. But no, I mean, our -- one of the things that happened here that was somewhat fortunate in the sense that [ P vial ] and its ability to get to where it is today wasn't impacted but from a COVID perspective in the sense that the studies were completed prior to the shutdown and then it was able to be submitted within a very short window of when we had expected. And then with priority review, it's actually going to be able to hit in the time line that will help us actually hit these numbers. You're referring to the fact that I had said we would expand by 800 basis points. And I'll go back to my comments even from Anthony's question that we still feel that that's extremely achievable.
Particularly, if you go back and look at 2019 as sort of maybe a true base because when I look at gross margin progression over the last 4 quarters, prior to this one, we hit 50 again. And you kind of have to go back to Q1 of last year where we were at 51.1, so sort of the pre-COVID numbers. I think that's sort of your baseline from which I would have you think about that margin expansion and it certainly is achievable. And as is our ability to hit the other financial metrics because it's not just about gross margin, it's about driving a levered P&L and delivering on EBITDA and cash flow, but more importantly, quite honestly, there has to be more to do with a sustainable top line growth rate that we think can be very healthy over the next number of years.
Okay. Great. And then just last question on DEFINITY and in-house production. It sounds like things are progressing well there. Could you maybe discuss sort of the longer term outlook? I assume you will dual source for some time period, but do inevitably, you think you could bring majority of that in-house? And any thoughts on how that could improve benefit margin?
So obviously, Larry, there is a benefit margin value for us going forward based on mix of how we source DEFINITY. But the strategy here originally, and you haven't been with us long enough to know, but several years back, we struggled with the security from just the total capacity perspective of our DEFINITY supply. So our in-house project serves a very important benefit of redundancy for us. And so we would anticipate continuing to maintain dual supply so that we have that redundancy.
Now to ratio and to taking advantage of what is obviously will be a better margin on the product's COGS margin for utilizing the larger ratio from our in-house manufacturing plant, that's something that we'd absolutely point to in the future. And you'll hear Bob speaking to that as we move forward over the quarters, how that will come into play. But a big milestone for us this quarter, the PET batches we produced. We produced on the commercial process. And for having done so, they sit and having siting there, they can be used for a salable merchandise once our plant is approved.
[Operator Instructions] And we are showing no further questions at this time. Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect, and have a wonderful day.