Q1 2021 Halozyme Therapeutics Inc Earnings Call

No.

[music].

Good day and thank you for standing by while continue to handle volume first quarter 2021 financial results Conference call. At this time, all participants are in a listen only mode.

Operator: Good day, and thank you for standing by. Welcome to the Hadozine First Quarter 2021 Financial Results Conference call.

Operator: At this time, all participants are in list only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press Star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press Star Zero.

For the speaker's presentation, there will be a question and answer session to ask the question. During the session you will need to press star one on the telephone. Please be advised the today's conference is being recorded if you require any further assistance. Please press star Zero I would now like the end conference over to your Speaker today I'll Kill then vice President of Investor Relations.

Operator: I would like to hand the conference over to your speaker today, Al Kildanney, Vice President of Investor Relations and corporate communications. Thank you. Please go ahead. Thank you.

And corporate communications. Thank you. Please go ahead.

Thank you good.

Good afternoon, and welcome to our first quarter 2021 financial results conference call in.

Al Kildanney: Good afternoon, and welcome to our first quarter 2021 Financial Results Conference Call. In addition to our press release issued today after the close, you can find a supplementary slide presentation that will be referenced during today's call in the Investor Relations section of our website. Leading the call will be Dr. Helen Torley, Hale's president and chief executive officer, who will provide an update on our business, and Elaine Sun, our chief financial officer, who will review our financial results for the first quarter.

In addition to our press release issued today. After the close you can find the supplementary slide presentation that will be referenced on today's call in the Investor Relations section of our website.

Leading the call will be Dr. Helen Torley, <unk>, President and Chief Executive Officer, who will provide an update on our business and.

And the lane, our Chief Financial Officer, who will review our financial results for the first quarter.

On today's call, both GAAP and non-GAAP financial measures will be discussed the.

Al Kildanney: On today's call, both Gap and non-Gap financial measures will be discussed. The non-gap or adjusted financial measures are reconciled with the comparable gap financial measures in our earnings press release and slide presentations. During the call, we made forward-looking statements. I refer you to our SEC filings for a full listing of the risks and uncertainties. I'll now... Turn the call over to Helen.

The non-GAAP or adjusted financial measures are reconciled with the comparable GAAP financial measures in our earnings press release and slide presentation.

During the call we will be making forward looking statements I refer you to our SEC filings for a full listing of the risks and uncertainties.

I will now.

Now I'll turn the call over to Helen.

Thank you al I'm pleased to report that our first quarter results provided a strong start to 2021 for Amazon.

Helen I. Torley: Thank you, Al. I'm pleased to report that our first quarter results provided a strong start to 2021 for Halazine. We report his first quarter. Quarter revenues of $89 million, fueled by record quarterly royalties of $36.9 million, gap earnings per share of 19 cents, and non-gap, adopted earnings per share of 30 cents. Our partners made critical progress in the clinic with therapies used in the hands. In the first quarter, we achieved two of the expected four phase three trial starts for 2021, which is defined as the first patient enrolled.

We reported first quarter.

Quarter revenues of $89 million fueled by record quarterly royalties of $36 $9 million GAAP.

GAAP earnings per share of <unk> 19.

Non-GAAP adjusted earnings per share of 37%.

Our partners made critical progress in the clinic with therapies using of churn in the first quarter. We achieved two of the expected for a phase III trial starts for 2021, which is defined as the first patient enrolled and we also achieved two of the expected five phase one trial starts for 2021.

Helen I. Torley: And we also achieved two of the expected five phase one trial starts for 2021. Additionally, we completed a successful convertible note offering of $805 million on attractive terms and used a portion of the proceeds to retire a large portion of our existing convertible note and to repurchase $75 million worth of shares through an accelerated share repurchase, further demonstrating our commitment to capital returns.

Additionally, we completed a successful convertible note offering of the $805 million on attractive terms and use the portion of the proceeds to retire a large portion of our existing convertible note and to repurchase $75 million worth of shares through an accelerated share repurchase further demonstrating our commitment for capital return.

Don.

We keep the strong results against the backdrop of the ongoing global COVID-19 pandemic.

Helen I. Torley: We achieve these strong results against the backdrop of the ongoing global COVID pandemic. This has been accomplished by the stronger forms and hard work of our partners, our contract manufacturers and suppliers, and the entire HALAZM team. Let me not discuss our royalty revenue growth, which is illustrated on slide 3. We achieved our highest ever level of quarterly royalties during the first quarter at $36.9 million.

This has been accomplished by the strong performance and hard work of our partners, our contract manufacturers and suppliers and the entire human <unk>.

Let me now discuss our royalty revenue growth, which is illustrated on slide three.

We achieved our highest ever level of quarterly royalties during the first quarter at $36 9 million.

Helen I. Torley: This represented 119% growth year over year and 15% sequential growth, following what had previously been our record quarterly royalties. Its strong growth is primarily being driven by the successful ongoing global launches of Janssen's subcutaneous forms of Darzilex, which utilize Iron Hand technology. We continue to predict the doubling of royalty revenues for the full year 2021, primarily due to this continued growth of Darzilek Vec Fessi and also by growth in Roche's Fesgo. We're delighted with this robust growth and this high margin, and recurring revenue streams.

This represented a 119% growth year over year, and 15% sequential growth following what had previously been a record Fortunately royalties.

The strong growth is primarily being driven by the successful ongoing global launches of Janssen subcutaneous forms of Dar the lakes, which utilize our enhanced technology.

We continue to forget the doubling of royalty revenues for the full year 2021 true.

Primarily by the continued growth of <unk> and also by growth in most of the Fayetteville.

We're delighted with this robust growth in this high margin.

In return of recurring revenue stream.

Let me turn now to slide four where I'll provide highlights of our key commercialized products.

Helen I. Torley: Let me turn that to slide four, where I'll provide highlights of our key commercialized product. We have five products that are now approved in most major global markets using our enhanced technologies. Globally, more than 500,000 patients have received commercial products utilizing enhanced. And let's begin with the most recently launched products, which represent our Wage 2 launches, Darzolix S.P. and Fesgo. During the first quarter, Janssen's parent, Johnson & Johnson, reported worldwide sales of Darzilex, including both the IVMXC forms, of $1.37 billion, up 42% year-over-year on an operational basis. Jane Day does not provide a breakdown of Darzilex sales by indication or route of administration.

We have five products that are now approved in most major global markets using our enhanced technology flow.

<unk> more than 500000 patients have received commercial product utilizing enhanced.

I meant the game with the most recently launched products, which represent our wave two launches stars on the cash.

In fact, though.

During the first quarter Janssen as parents Johnson and Johnson reported worldwide sales of <unk>, including both the IV and the SEC forms of 1.3 dollars 7 billion.

Up 42% year over year on the operational basis.

J&J does not provide a breakdown of darts of like sales by indication of route of administration. However, they did comment of the impressive growth was attributable to share growth across all lines of therapy and increased penetration of the subcutaneous formulation in the U S and Europe and also continued <unk> penetration in the frontline.

Helen I. Torley: However, they did comment that the impressive growth was attributable to sheer growth across all lines of therapy and increased penetration of the subcutaneous formulation in the US and Europe, and also continued Darzalax penetration in the front-line setting. They did so by recently approved line extensions that penetrate new patient populations, posting nearly three points of sheer growth in front line in the U.S. this quarter. During the first quarter, Danston also reported several important achievements that are expected to support the future growth of subcutanese Darzilek.

Stenting aided by recently approved line extension the penetrate new patient population posting nearly three points of share growth in front line in the U S. This quarter.

During the first quarter dampened ultra reported several important achievements that are expected to support the future growth of subcutaneous dark legs.

Helen I. Torley: These include UFD Accelerated Approval and Health Canada Approval for the indication of newly diagnosed adults with light chain amylidosis for the use of Darzalexaspiro in combination with botasmid, cycloposomide, and dexometezone. I note that there were no previously approved therapies for this disease, and also approval from Japan's Ministry of Health, Labor, and Welfare for the Sepata Accordingly, Hila's unrecognized $5 million in milestone revenue.

These include the U S at the accelerated approval and health, Canada approval for the indication of newly diagnosed adults with light chain amyloidosis for the use of <unk> in combination with Bortezomib Cyclophosphamide Index <unk> zone.

I'll note that there were no previously approved therapies for this disease.

And also the approval from Japan Ministry of Health Labor and welfare for the subcutaneous formulation of <unk> for the treatment of multiple myeloma.

Accordingly, <unk> recognized $5 million in milestone revenue.

With strong operational momentum expansion into new geographies and expansion into new indications. We continue to expect the <unk> will be of strong driver of royalty growth for hail event.

Helen I. Torley: With strong operational momentum, expansion into new geographies, and expansion into new indications, we continue to expect that Darzilex will be a strong driver of royalty growth for Halavan. The second product that was ways to launch as Fezgo, the fixed-dose combination of two of roach's antibodies, Progeta and Perceptin, administered in 5 to 8 minutes at subcutaneous injections compared to the administration time of several hours for the IV

The second product upper wait too long because the fact of the fixed dose combination of two of Roche of antibody project and for certain administered in a five to eight minutes at the peak.

These index and compared to the administration time for several hours for the IV.

<unk> was launched in the U S in the third quarter of 2020.

Helen I. Torley: SESCO was launched in the U.S. in the third quarter of 2020, and in the initial European Monch markets during the first quarter of 2021. The European launches followed regulatory approval in Europe in late December of 2020. In the first quarter, SESCO achieved sales of 29 million Swiss francs.

And in the initial European launch markets during the first quarter of 2021.

The European launches polo regulatory approval in Europe in late December of 2020.

In the first quarter Roche reported telco sales of 29 million Swiss francs.

We anticipate the continued adoption and use in the U S and additional long cycle of that Christie will continue to be the key driver of royalty revenue and royalty revenue growth for heelys line in 2021.

Helen I. Torley: We anticipate the continued adoption and use in the US, and additional long-stars like SREC will continue to be the key driver of royalty revenues and royalty revenue growth for Halalazine in 2021. Now we move now to the way one launches a product. Roche continues with its global commercialization of Naphtra S.C., also called Retire Drachin-Hisela, and subcaneus Herceptin and Herceptin Hylexa. We project continued decline in royalties from these mature products as a result of the ongoing impact of biosimilar competition. And he's just hiking.

Let me move notes of the wave one launch product.

Growth continues with its global commercialization of Mabthera SC also call for your time.

<unk> got some high Stella and subcutaneous herceptin and herceptin highlight them.

We project continued decline of royalties from these mature products as a result of the ongoing impact of Biosimilar competition.

And the heaters.

<unk> continues to post growth, albeit on a smaller base of revenue.

Helen I. Torley: Ticudia continues to show growth, albeit on a smaller base of revenue. Let me now move to slide five for a discussion of the enhanced development portfolios. I'll begin with an o... What is very exciting is that we project the expansion and maturing of our development pipeline to 16 products by the end of 2021, including an expectation that four products will be studied in Phase 3 clinical trials, and a total of 12 products will be in or will have completed Phase 1 clinical trials. I highlighted that on slide five.

Let me now moving to slide five and the discussion of the enhanced development portfolio.

I'll begin with of course.

What is very exciting is that we predict the expansion and maturing of our development pipeline to 16 products by the end of 2021, including an expectation that for our products will be studied in phase III clinical trial and the total of 12 products will be in or we will have completed phase one clinical trials.

As highlighted on slide five in the first quarter, we saw strong progress with for new clinical trial starts, including two phase III studies and two phase one.

Helen I. Torley: In the first quarter, we saw strong progress with four new clinical trial starts, including two phase three studies and two phase one. Today, we have two products that are in phase three, Agenix's F. Prodigamot and Roche's etisemizamamon. And we expect two additional phase three starts this year, one of which programs comprises our potential waste-re launches, based on The four phased tree products represent potential loans to in the 2020 to 2020. Time for it.

Today, we have two products that are in phase III of <unk>.

<unk> <unk> of modern Moshe's Etsy is the mismatch and.

And we expect two additional phase III start for here, one of which Graham's comprised of our potential waste to relaunch it.

Based on.

The for phase III products represent potential launches in the 2023 to 2020.

The five timeframe.

Helen I. Torley: As I mentioned, we have 12 products that we project will be in, or completing phase one by the end of 2021. These products form our potential wait for product launches, where if development continues, they could launch them in the time window of 2025 to 27. We believe that this advancing pipeline of products utilizing enhance is setting up the potential for multiple waves of future product launches that will deliver long-term growth in revenues, cash flow, and profitability. Now, let me provide a brief discussion by partner, and I'll begin with Bristamars Squibb.

And the mentioned we have 12 products that we predict will be in <unk>.

For completing phase one by the end of 2021 the.

The products form our potential way for product launches for a day.

Development continues the fifth launch within the time window of 2025 to 2027.

We believe that is advancing pipeline of products utilizing enhanced is setting up the potential for multiple waves of future product launches that will deliver long term growth in revenues cash flow and profitability.

Now let me provide the brief discussion by partner and I'll begin with Bristol Myers Squibb.

Bristol recently posted an overview of the design of its planned phase III study of subcutaneous Navona map for the treatment of clear cell renal cell carcinoma on clinical trials Gov.

Helen I. Torley: Bristel recently posted an overview of the design of its planned phase three study of subcutaneous nivonemone for the treatment of clear-cell renal cell carcinoma on clinical trials.gov. With a study start insight, accordingly, we recognize 25 million; we're very excited for this important next step for Sub-Supénymed as one of our potential wave-three launches. In parallel, Bristol is continuing with an exciting set of immunoncology target clinical studies, having publicly announced the selection of five of the available 11 targets. In addition to Nevolomab, Bristol has three ongoing or computed, Phase 1 studies within hand. These include studies of anti-CD-7K3, 103, and the fixedose combination of nevolomab and volatamab.

With the study start insight accordingly, we recognized 25 million.

We're very excited for this important.

Next step for subcutaneous Nikola map of one of our potential wave three launches.

In parallel Bristol is continuing with an exciting set of immuno oncology target clinical study, having publicly announced selection of five of the available 11 targets.

In addition to nibble on them for.

Still has three ongoing our completed phase one studies with enhance these include studies of MPC. The seventy-three 10, three and the fixed dose combination of Nevada the map.

Latin America.

Let me move now starting with partner Horizon Therapeutics, we are delighted to share the evidenced by horizon last week.

Helen I. Torley: Let me move now to our newest partner, Horizon Therapeutics. We're delighted to share that Agenz by Horizon, that week, not only has Horizon initiated a phase one study of the pair of equalizing in hands, but they've already completed patient dosing. The trial is a small, single-dose, Phase 1 pharmacokinetic trial evaluating the use of enhanced with tapaz up.

Not only have the initiated the phase one study of depends of utilizing enhanced but they've already completed patient dosing.

The trial of the small single dose phase one pharmacokinetic trial evaluating the use of <unk> with <unk>.

At the development of successful horizon hopes for potentially shorten drug administration time reduce health care practitioner time, and all for patient suffering from thyroid eye disease additional flexibility and convenience.

Helen I. Torley: If development is successful, Horizon hopes to potentially shorten drug administration time, reduce healthcare practitioner time, and offer patients suffering from thyroid eye disease additional flexibility and convenience. This development represents remarkably fast progress, given that we signed our collaboration agreement with Horizon in November of last year in this exciting program for a drug that has an anticipated peak sales potential of 3. $5 billion, according to Horizons, and you now move to Ergenics. Ergenics has two targets in development using in hand, F-Cartisanumas, and ERGX-117. Argenics continues with the execution of its four, three trials for four separate potential indications for FKertitimod S.C., utilizing the at hand. Let me briefly describe these four registration enabling studies.

This development represents remarkably fast progress given that we signed a collaboration agreement with horizon in November of last year.

And this exciting program for <unk>.

For drug that is anticipated peak sales potential of three five.

$5 billion according to horizon.

The spending now move to organic organic that has true targets in development using the <unk> in particular in <unk> ex 117.

Again ex continues with the execution of its for phase III trials for for separate potential indications for <unk> SC utilizing of hands.

Let me briefly describe these for registration enabling studies.

In February of <unk> go decision for the share registration trial evaluating subcutaneous that predicted demand.

Helen I. Torley: In February, Argenics announced a Go decision for its such-year registration file, which is being subcontinious app corrected tomorrow, with an enhancement in chronic inflammatory denioliniating colonelopathy or CIDP. Agenics has continued enrollment after the plan safety and efficacy assessment and expects to include approximately 130 patients to support potential registration of SCF Vertigimon for the treatment of CIDP. In January, Argenics initiated its phase three address trial in Pempsis vulgaris and oliasis, two serious, in-baria diseases associated with painful blistering, and these studies continue to enroll. Moving back to the third risk, Rest restoration trial and potential indications

Mark within hands in chronic inflammatory demyelinating polyneuropathy of <unk>.

<unk> continue the enrolment after the plant safety and efficacy statement and expect to include the approximately 130 patients to support potential registration of etsy encouraging demand for the treatment of <unk>.

In January organic since initiated its phase III address trial in pemphigus, Vulgaris and polices to serious in barrier diseases associated with painful blistering and these studies continue to enroll.

Moving on to the third growth.

The rest of your strength in trial and potential indications.

Our <unk> met with the FDA in the first quarter to discuss the potential for a bridging study of <unk> in myasthenia gravis or Mg.

Helen I. Torley: Argenics met with the FDA in the first quarter to discuss the potential for a bridging study of SCF Gartismo in Mycena Gravis or MG. Following FDA feedback, Argenics has moved forward with the small..., in hand for immune thrombocytopinic purpura. Estridgment, which analysts project could have multibillion dollar potential, is one of... And we're delighted with the progress today. And lastly, in Ergenic, development continues with its second nominated target, ARGX117, which is being evaluated in a recently initiated phase one study in healthy volunteers. Let me now move to Roche's two products in development for the hen, Decentric and Okrave.

Following the FDA feedback organics as move forward with the small.

But the intent for immune thrombocytopenia sneak per branch.

At cricket month, which analysts projected of multibillion dollar potential is one of them.

And we're delighted with the progress to date.

Okay.

And lastly on organic development continues with the <unk>.

Second nominate the target Arg ex 117, which is being evaluated.

And our recently initiated the phase one study in healthy volunteers.

Let me now move to Roche Roche has two products in development, the Manhattan to centric and awkwardness.

Helen I. Torley: The phase three trial, evaluating centric SACC within hands in stage four non-small lung cancer is ongoing, which is already a multi-billion dollar franchise, also represents one of our wave three potential launch products. With the help of the donors, the donors also continue with this phase one study, evaluating SC-admated with Enchrovus with Enhance. Okervis is another approved lot-buster product, and it's indicated for patients with multiple sclerosis. Now I move on to Janssen.

<unk> III trial evaluating to center can see with enhanced in stage for non small cell lung cancer is ongoing.

Centric, which is already a multibillion dollar franchise also represents one of our wave three potential launch products with the growth also continues with its the phase one study evaluating <unk> book.

With enhanced.

<unk> is another approved blockbuster product and is indicated for patients with multiple sclerosis.

I'm looking at the Janssen. In addition to the successful launch of subcutaneous form the darn the legs Janssen continues with the phase one study of Amazon from a map of the Egfr and <unk> by specific antibody with enhanced and.

Helen I. Torley: In addition to the successful launch of subcutaneous forms of Darzilex, Ganssen continues with a phase one study of Amibhant, their EGFR and CMEX bi-specific antibody with enhanced activity against advanced solid tumors. We're pleased with progress; our partners are meeting and advancing therapies using our enhanced technology. All of this progress I've just described is setting up multiple ways for future potential approvals and launches that can drive long-term revenue growth for healing design.

In advanced solid tumors.

We're pleased with the progress our partners are making in advancing therapies using our enhanced technology. All of this progress Ive just described of setting up multiple ways of future potential approvals and launches that could drive long term revenue growth for Amazon.

Helen I. Torley: And just before I close on the enhanced partners, I'd like to report progress on the second program that entered Phase 1 clinical testing during the first quarter. In 2019, we announced the Cooperative Research and Development Agreement, or CREDA, with the National Institute of Allergy and the Texas Diseases Vaccine Research Center, or the BRC, which is part of the National Institutes of Health. CREDA enabled us to use our enhanced technology to develop subcunous forms of broadly neutralizing antibodies against HIV for the treatment of HIV.

And just before I close on the enhanced partners I would like to report progress on the second program that entered phase one clinical testing during the first quarter.

And do you know.

End of 2019, we announced the cooperative research and development agreement, our credo with the National Institute of allergy and infectious diseases vaccine Research center for the DRC, which was part of the National Institutes of health.

The creator enables us to use our enhanced technology to develop subcutaneous forms of broadly neutralizing antibodies against HIV for the treatment of HIV.

Helen I. Torley: I'm pleased to report that the program recently got the first patient in the enhanced arms of the DRC 609 phase one trial, which will investigate the safety, tolerability, dose, and pharmacokinetics of the broadly neutralizing antibody in 6LS, which will be administered intravenously and circuitaneously with insurance in healthy adults. As you have heard, our partners are making impressive progress across a broad development pipeline in diverse indications. And beyond this existing pipeline, there's also the potential for us to drive additional While I'm confident we will sign additional appeals, as ever, the timing is difficult to predict, and there's also the potential for growth with our current partners, nominating new targets and advancing them into the clinic.

I'm pleased to report that the program recently dosed the first patient in the <unk> hands arms of the BRC 609 phase one trial with <unk>.

Will investigate the safety tolerability dose and pharmacokinetics of the broadly neutralizing antibody and six out of that.

Which will be administered intravenously and subcutaneously within trends in healthy adults.

As you have heard our partners are making impressive progress across a broad development pipeline and diverse indications.

And beyond the existing pipeline. There's also the potential for us to drive at this one I am confident we will find additional mobile as ever of the timing is difficult to predict.

And there's also the potential for growth for our current partners, knowing anything new targets and advancing them into the clinic.

With more than 20 open slots available we're excited for the growth opportunity also exists here.

Helen I. Torley: With more than 20 open slots available, we're excited for the growth opportunity that also exists here. Let me move now to slide six to discuss how our pipeline progress drives revenues for halazine. We are reiterating our three-year outlets for projected revenue from milestones. You can see here that for 2021, we have $60 million in milestone revenue. Patients for Partner Upfront Development, The Blue Bar? represents arts for your outlook since 2000. The bars represent actual annual milestone revenues, demonstrating that we're proposing this near still...

Let me move now as the play fix the discussed how our pipeline progress drives revenues for Amazon.

We are reiterating our three year outlook for projected revenues for milestones.

The thing here that for 2021.

The million dollars in milestone revenues.

Patients for partner upfront development.

Yes.

The Blue bar.

This represents our three year outlook since June.

The bars represent actual annual milestone revenue demonstrating that we of course.

This near still.

The near term milestone revenue is an important from strong indicator for future royalty revenue.

Helen I. Torley: Near-term milestone revenue is an important and strong indicator for future royalty revenues. $1 billion in 27, based on non-risk-adjusted revenue projections for programs that we currently have a line of sites for and slim global sales in all indications. Turning now to slide seven, I'll review our approach to value creation and capital returns. We've been consistent regarding a three-year capital return priority. These include maintaining each strong balance and commitment to driving both internal and external growth.

Yeah.

$1 billion in 2027 based on the non risk adjusted revenue projections for programs that we currently have line of sight, the kind of been in global sales in all indications.

Turning now to slide seven I'll review, our approach the value creation and capital return.

We've been consistent regarding our three year, our three capital return priority.

These include maintaining a strong balance sheet because.

For the and commitment to driving growth.

The internal and external growth.

We have a strong balance sheet of cash and cash equivalents of $764 million. Following the successful completion of our 2027 convertible note offering in March.

Helen I. Torley: We have a strong balance sheet of cash and cash equivalence of $764 million following the successful completion of our 2007 convertible note offering in March. We anticipate the strong and projected free cash flow driven by enhanced will support both our ongoing commitments to capital return as well as our longer-term strategies. We've made strong progress with a three-year, $560 million share repurchase program, with approximately $426 million completed to date at an average price of $21.99.

We anticipate the strong from projected free cash flow driven by enhanced will support both our ongoing commitments of capital return as well as our longer M&A strategy.

We've made strong progress with their three year $550 million share repurchase program with approximately $426 million completed to date and average price of $21 99.

Helen I. Torley: And, in addition to supporting the ongoing growth of our enhanced technology franchise, we continue to evaluate the potential for new technology platform expansion and acquisition, with the goal of accelerating and extending long-term revenue growth. We see the opportunity to create incremental value for other platform technologies. Highland is proven Partnership and Commercialization capabilities. With a handful early in its growth cycle, we have the opportunity to be highly selective here. With that update, I'm going to turn the call now over to Elaine for a discussion of the first quarter financial results. Thank you, Helen.

And in addition to supporting the ongoing growth of our enhanced technology franchise, we continue to evaluate the potential for new technology platform expansion through acquisition with the goal of accelerating and extending long term revenue growth.

When you see the opportunity to generate incremental value for other platform technologies.

<unk> proven partner and commercialization capabilities.

With enhanced still early in its growth cycle, we have the opportunity to be highly selective here.

And with the updates I'm going to turn the call now over to Elaine for a discussion of the first quarter financial results the length.

Okay.

Thank you Helen.

Before I begin I'd like to note that with this quarter's results, we'll begin reporting key measures on both a non-GAAP adjusted as well as the GAAP basis, and we will also provide financial guidance on a non-GAAP basis.

Na Sun: Before I begin, I'd like to note that with this quarter's results, we'll begin reporting key measures on both a non-gap adjusted as well as a gap basis, and we will also provide financial guidance on a non-gap basis. We consider these non-gap financial measures to be important because they provide useful measures of our operating performance, exclusive of factors that do not directly affect what we consider to be our core operating performance, such as stock-based compensation, amortization, as well as non-occurring or unrecurring or unusual events, and I'd ask you to refer to our press release and filings for a reconciliation of gaps and non-gap net income and earnings per share.

We consider the non-GAAP financial measures to the important because they provide useful measures of our operating performance exclusive of factors that do not directly affect what we consider to be our core operating performance such as stock based compensation amortization as well as nonrecurring.

Unusual events and I'd ask you to refer to our press release and filings for a reconciliation of GAAP to non-GAAP net income and earnings per share.

So with that let me now turn to slide eight for a review of our first quarter revenues.

Na Sun: So with that, let me now turn to slide eight for a review of our first quarter revenues. Total revenue for the first quarter was $89 million, compared to $25.4 million in the prior year period. In terms of revenue composition, we saw growth from all three sources of revenue in the first quarter. Revenue from royalties for the quarter was $36.9 million, a 119% increase over the prior year period. This was driven primarily by the continued strong uptake of subcutaneous Garzilex in the hands by our partner, Jansen.

Total revenue for the first quarter was $89 million compared to $25 4 million in the prior year period.

In terms of revenue composition, we saw growth from all three sources of revenue in the first quarter revenue.

Revenue from royalties for the quarter was $36 9 million a 100.

<unk> of 19% increase over the prior year period. This was driven primarily by the continued strong uptake of subcutaneous <unk> utilizing enhanced by our partner of the Ensign.

Na Sun: Product sales were $21.8 million in the quarter, up 167% from the prior year period product sales of $8.1 million. Growth in Product Sales was driven by higher Bulk API sales to our enhanced partners, Janssen, Roche, and Argenic, demonstrating continued progress by our partners' collaboration revenue in the quarter totaled $30.3 million, up from $0.4 million in the prior year period. And during the quarter, we recognized $25 million in milestone revenues from Bristol Myers related to the upcoming start of their phase three trial for subcutaneous nevolumab was enhanced. In addition, the approval of Dargalax was in hand in Japan, and its anticipated launch resulted in $5 million in Mousin Revenies to Halazine.

Product sales were $21 8 million in the quarter up 167% from the prior year period product sales of $8 1 million.

Growth in product sales was driven by higher bulk API sales to our enhanced partners and Finn Roche and organic.

Demonstrating continued progress by our partners collaboration revenue in the quarter totaled $33 million up from <unk> 4 million in the prior year period.

And during the quarter, we recognized $25 million in milestone revenues from Bristol Myers related to the upcoming start of their phase III trial for subcutaneous <unk> with enhanced.

In addition, the approval of <unk> within hands in Japan and can you competed launch resulted in $5 million in milestone revenue to handle line.

Na Sun: Turning to slide 9, you'll find a more detailed breakdown of our first quarter P&L. Let me begin with total operating expenses, which were $38.3 million in the first quarter, 34% from $28.6 million in the prior year period. The overall increase in total operating expenses resulted from higher cost of product sales, which were $18.2 million compared with $5.8 million in the prior year period, and this increase in COGS was attributable to the markedly higher level of API sales versus the prior year period in support of our partners' products and programs in the first quarter. Research and Development expenses of $9 million decreased 11% from $10.2 million in the prior year period.

Turning to slide nine you'll find a more detailed breakdown of our first quarter of P&L.

Let me begin with total operating expenses, which were $38 3 million in the first quarter up 34% from $28 6 million in the prior year period.

The overall increase in total operating expenses resulted from higher cost of product sales, which were $18 2 million compared with $5 8 million in the prior year period.

And the increase in Cogs was attributable to the markedly higher level of API sales versus the prior year period in support of our partners products and programs in the first quarter.

Research and development expenses of $9 million decreased 11% from $10 2 million from the prior year period, and SG&A expenses were $11 1 million.

Na Sun: And SG&A expenses were $11.1 million, down 12% from $12.6 million in the prior year period. Total operating expenses excluding COGS were $20.1 million for the first quarter, compared with $22.8 million in the prior year period, consistent with the expectations we laid out as part of our annual guidance last quarter. Gap operating income for the quarter was $50.7 million compared to a gap operating loss of $3.2 million in the prior year period, reflecting our strong growth in revenues and leverageable business model. On a GAAP basis, net income for the quarter was $27.9 million, or 19 cents per diluted share. This compares with a net loss of $6.1 million, or $0.4 per share, in the prior year period.

Down 12% from $12 6 million in the prior year period.

Total operating expenses, excluding Cogs were $20 1 million for the first quarter compared to $22 8 million in the prior year period, consistent with the expectations, we laid out as part of our annual guidance last quarter.

GAAP operating income for the quarter was $50 7 million compared to a GAAP operating loss of $3 2 million in the prior year period.

<unk>, our strong growth in revenues and leverage of our business model.

On a GAAP basis net income for the quarter was $27 $9 million or <unk> 19 per diluted share this compared with the net loss of $6 $1 million or for per share in the prior year period.

As I mentioned, we will now also be reporting <unk> results, such as net income and diluted earnings per share on a non-GAAP adjusted basis.

Na Sun: As I mentioned, we'll now also be reporting key results such as net income and diluted earnings per share on a non-gap-adjusted basis. In the first quarter of 2021, the largest adjustment made to arrive at non-gap net income and diluted earnings per share was for a $21 million one-time inducement expense related to the repurchase of a significant portion of our 2024-convertible notes This is also a non-cash expense.

In the first quarter of 2021, the largest adjustment made to arrive at non-GAAP net income and diluted earnings per share was for a $21 million one time investment expense related to the repurchase of a significant portion of our 2020 for convertible notes.

This is also a non cash expense.

On a non-GAAP adjusted basis net income was $54 $3 million for 37 per diluted share compared to net income of $1 9 million for approximately <unk> <unk> per diluted share in the prior year period.

Na Sun: On a non-gap-adjusted basis, net income was $54.3 million, or 37 cents a share, compared to net income of $1.9 million, or approximately two cents a share, in the prior year period. With that, let me now turn to slide 10 for a discussion of our 2021 financial guidance. Our guidance is based on the latest information from our partners and our planned expenses for the year. Consistent with the strong growth we're seeing for our business, we are reiterating our guidance for total revenues of $375 to $395, which would represent year-over-year growth of 40 to 48%. Moving to the components of revenues, we expect revenues from rural areas to double from 2020 levels.

With that let me now turn to slide 10 for a discussion of our 2021 financial guidance.

Our guidance is based on the latest information from our partners and our planned expenses for the year.

Consistent with the strong growth, we're seeing for our business. We are reiterating our guidance for total revenues of $375 million to $395 million, which would represent year over year growth of $40 to 48%.

Moving to the components of revenue, we expect revenue from royalties to double from 2020 levels. We expect product sales to increased 50% for 60% from 2020 levels driven primarily by bulk API sales to our enhanced partners.

Na Sun: We expect product sales to increase by 50% to 60% from 2020 levels, driven primarily by bulk API sales to our enhanced partners. We further expect revenue under collaborations to be in a similar range as these significant milestone revenues generated in 2020, driven by new clinical trial starts and commercial milestones of our partners, and reflecting our leverageable business model. We also continue to expect Gap operating income for 2021 to be in the range of $215 million to $235 million, which would represent 49% to 63% growth over 2020.

We further expect revenue under collaborations to be in a similar range as the significant milestone revenue generated in 2020, driven by new clinical trial starts and commercial milestones of our partners.

And reflecting our leverage of our business model. We also continue to expect GAAP operating operating income for 2021 to be in the range of $215 million to $235 million, which would represent 49% to 63% growth over 2020.

Moving to net income, we expect GAAP net income of $190 million to $210 million and non-GAAP net income of $235 million to $255 million.

Na Sun: Moving to net income, we expect gap net income of $190 million to $210 million and non-gap net income of $235 million to $255 million. Moving to earnings per share, we are projecting GAAP EPS of between $1.25 and $1.40, representing growth of 37% to 54% over 2020 GAAP EPS, and non-gap earnings per share of $1.55 to $1.70, which would represent 38% to 52% growth over 2020 non-Gap BPA.

Moving to earnings per share were projecting GAAP EPS of between $1 25, and $1 40.

Representing growth of 37% to 54% over 2020 GAAP EPS.

And non-GAAP earnings per share of $1 55 to $1 70.

Which would represent 38% to 52% growth over 2020 non-GAAP EPS.

As Helen reviewed we remain committed to returning capital to shareholders. We continue.

Na Sun: As Helen reviewed, we remain committed to returning capital to shareholders. We continue to expect to repurchase up to $125 million of our shares this year, pending market conditions and other factors, which would leave $75 million worth of shares available for share repurchases remaining under our current authorization. In support of our financial and capital return goals, we completed the sale of $805 million of convertible senior notes due 2027. Reflecting the strong cash flow and growth prospects for the company, we were able to secure highly attractive terms with a 25 basis point coupon and a 50% conversion premium. Additionally, we retired 80% of the previous convertible note, which was deeply in the money. And in doing so, we were able to mitigate dilution that we would otherwise face from the outstanding 24 convertible senior notes.

For you to expect to repurchase up to $125 million in our shares this year pending market conditions, and other factors, which would leave $75 million worth of shares available for share repurchases remaining under our current authorization.

In support of our financial and capital return goals, we completed the sale of $805 million of convertible senior notes due 2027.

Reflecting the strong cash flow and growth prospects for the company, we were able to secure highly attractive terms with a 25 basis point coupon and 50% conversion premium.

We retired 80% of the previous convertible note, which was deeply in the money and in doing so we were able to mitigate dilution we would have otherwise space from the outstanding 2020 for convertible senior notes.

We also use some of the proceeds to complete a $75 million accelerated share repurchase.

So with that I'll now turn the call back to Helen.

Thank you Elaine.

And you just heard the developing pipeline coupled with our financial outlook places halos line in the strongest position ever as a company.

Na Sun: We also used some of the proceeds to complete a $75 million accelerated share repurchase. So with that, I'll now turn the call back to Helens. Thank you, Elaine. As you just heard, the developing pipeline, coupled with our financial outlets, places Halalzine in the strongest position ever as a company. We look forward to strong growth and revenues, profitability, and cash flow in the coming quarters and years, which will allow us to deliver on our commitment to return capital to our shareholders, maintain long-term sustainable growth, and maximize shareholder values. As summarized on slide 11, we continue to expect multiple important value-driving events throughout 2021.

We look forward to strong growth in revenue profitability and cash flow in the coming quarters and years, which will allow us to deliver on our commitment to return capital to our shareholders maintain long term sustainable growth and maximize shareholder value.

As summarized on slide 11, we continue to expect multiple important value driving event throughout 2021.

We expect our continued launch momentum for <unk> SV in Fayetteville, with broadening adoption and use of in the already launch market and through additional global launches.

Two new products are expected to enter phase III development, resulting in a total of four ongoing phase III programs across seven indications recall. These of the next wave of potential launches wave three for the time window for a launch of 2023 to 2025.

Na Sun: We expect a continued launch momentum for Darzolik SD and Fezgo, with broadening adoption and use in the already launched market and through additional global launches. Additionally, two new products are expected to enter Phase 3 development, resulting in a total of four ongoing Phase 3 programs across seven indications. Recall, these are the next wave of potential launches, Wave 3, with a time window for launch of 2023 to 2025. We reject 5-E phase-1 starts, resulting in a total of 12 products in or having completed phase one testing by the end of the year.

We project by the Phase one starts resulting in a total of 12 product in our having completed phase one testing by the end of the year.

These represent of development continues our wave for potential launches with the potential for lunch in the window of 2025 to 2027.

And we will work to create new revenue growth opportunity by seeking to sign new collaboration agreements and advanced new targets into development or fade or week five.

Helen I. Torley: These representatives development continues the way for potential launches, with the potential belonging in the window of 2025 to 2027, and we will work to create new revenue growth opportunities by seeking to sign new collaboration agreements and advance new targets into development our phase, our phase, our wave five. As a result of all of this progress, we're in a position to return capital to shareholders, aiming to complete the planned $125 million share purchase for 2021. And finally, we'll continue to seek to identify and acquire a platform that can add to our long-term revenue growth. None of these results would have been possible without the amazing team we have at Kayla Zine.

The result of all of this progress for in a position to return capital to our shareholders aiming to complete the planned $125 million share repurchase for 2021.

And finally, we'll continue to seek to identify and acquire a platform that can add to our long term revenue growth.

None of these results would have been possible without the amazing team, we haven't halos line I'd like to what they might sincere thanks to each and every one of you for these terrific results and thank you to everyone for your attention to day, we'd now be delighted to take your questions from operator would you. Please open the call up for questions.

At this time I'd like to remind everyone in order to ask the question crush the star one on the telephone.

Withdraw your question, perhaps for the pound key.

Sandbox the compile the Q&A roster.

Your first question comes from do Kim from BMO.

Hi, good afternoon, Thanks for taking my question.

Helen I. Torley: I'd like to say my sincere thanks to each and every one of you for these terrific results. And thank you to everyone for your attention today. We'd now be delighted to take your questions, operator. Would you please open the call up for questions?

A question on Opdivo for.

First of all of US moving forward with the phase III in renal cell carcinoma.

Can you talk about what the clinical strategy is to as I shared that with you and are they looking for the phase three in RCC of the anchor study in June other tumor types of phase twos.

Operator: At this time, I'd like to remind everyone, in order to ask a question, press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from Doquim from VMO. Hi, good afternoon.

Yeah. Thanks, Bill for the question.

Aware of the strategy, but BMS hasnt publicly commented on it. So unfortunately, we can't we can't share any details.

I think we can talk about is the fact that of the rituxan the hiseq la <unk> the <unk>.

Unknown Attendee: Thanks for taking my question. A question on Opdivo, Bristol is moving forward with phase three in renal cell carcinoma. Can you talk about what their clinical strategy is, have they shared that with you, and are they looking for this phase three in RCCC as an anchor study and other tumor types in phase twos?

<unk> said that moving forward because of the more broad experience with our EPS of 28 separate Jack controlled clinical study might not be needed for each and every indication and we certainly saw that with the approvals of dark likes bass pro and sales go while in the same tumor types, we saw broader indications from the studies conducted.

Helen I. Torley: Yeah, thanks, though, for the question. We are aware of the strategy, but BMS hasn't publicly commented on it, so unfortunately, we can't share any details. What I think we can talk about is the fact that for retoxone and Hysela Odeck, the FDA said that moving forward, because of the more broad experience with REPH20, a separate controlled clinical study might not be needed for each and every indication. And we certainly saw that with the approvals of Darzolix Fast Pro and Fresgo.

Income do we think about this though is the I believe the if the FDA would feel that the state of need there were no safety question. It would be of possibility of a broader label than simply renal cell carcinoma, but it really is going to be based on the discussion between the sbe and Bristol Myers Squibb on the data generated and Amy out.

Spanning safety questions that might exist.

Any particular reason why they chose renal cell is the first tumor indications.

Helen I. Torley: While in the same tumor type, we saw a broader indication than the studies conducted. So I think the way to think about this, though, is I believe that if the FDA would feel that the say any, there were no safety questions, there would be a possibility of a broader label than simply winnow carcinoma, but it really is going to be based on the discussion between the XDA and for some Mars squib on the data generated and any outstanding safety questions that might exist. Any particular reason why they chose renal cell therapy is there?

None that I can share, though okay understand.

On the commercial side of things it looks like the launch of FESCO is much slower than the SaaS growth could you talk about what's driving that difference whether it's the different cancer markets breast cancer versus multiple myeloma or how your sales.

The partner is executing on the launches.

Yes.

In terms of the differences between the market. There are several what we don't have is of specific cause and effect, but.

One of the key things is is timing for Darko its fast growth. It was approved both in the U S and Europe in June of last year, whereas <unk> was approved in the.

Unknown Attendee: is their first tumor indication?

Helen I. Torley: None that I can share, though. Okay, I understand.

Unknown Attendee: Okay, understand. And on the commercial side of things, it looks like the launch of Fesgo is much slower than fast pro. Could you talk about what's driving that difference, whether it's the different cancer markets, breast cancer versus multiple myeloma, or how your associated partner is executing on the launches?

The third quarter in the U S and the only in December and it's only now launching in Europe, and so I do think we're going to see some strong growth of sales go, particularly as it starts to rollout and European launch markets.

I like from other differences, though of multiple myeloma in older population more Medicare covered whereas the breast cancer patients, perhaps more of a skew towards commercial payer. So the two of being a little bit of more time taken to get on formulary for the commercially focused breast cancer patients, perhaps further leading to a flow and done.

Helen I. Torley: In terms of the differences between the markets, there are several. What we don't have is a specific cause and effect.

Unknown Attendee: But, you know, one of the key things is timing. For Darzolix FastPro, it was approved both in the U.S. and in Europe in June of last year, whereas Fesgo was approved in the third quarter of the U.S., and not only in December, and it's only now being launched in Europe. And so I do think we're going to see some strong growth of FESCO, particularly as it starts to roll out in the U.S. European launch markets.

With Fayetteville.

I'll leave you with the takeaway, but yes that certainly very strong start to fast growth at certainly exceeded our expectations for last year. As you know I think Fayetteville, having kept the setup for all of the reimbursement on logistics in 2020 is going to start to show good growth in the U S and we're particularly excited about the launch.

Unknown Attendee: You highlight some other differences, though, multiple myeloma and the older population, more Medicare covered, whereas the breast cancer patients, perhaps more of a skew towards commercial pairs, so there could have been a little bit of more time taken to get on formulary for the commercially focused breast cancer patients, perhaps further leading to a slowing down with FESGO. But I'll leave you with the takeaway that, yes, that certainly very strong start to FASPRO certainly exceeded our expectations for last year, as you know.

During that we hope to see in Europe, particularly given the demonstrate the success. They showed with her set since the Q a number of years ago. So.

There will be a good growth out of happening from first of the here, but as we stated Starwood SSD will continue to be the dominant driver of our royalty revenues for 2021.

Great. That's helpful. Congrats on the quarter and all of the progress.

Unknown Attendee: I think FESGO, having had to set up for all of the reimbursement and logistics in 2020, is going to start to show good growth in the U.S. And we're particularly excited about the launch trajectory that we hope to see in Europe, particularly given the demonstrated success they showed with her sept and sub Q a number of years ago. So there'll be good growth from FESCO this year, but as we've stated, Starzolix SSE, SSE, and C will continue. to be the dominant driver of our wealthy revenues for 2021.

I appreciate that thank you.

Your next question comes from Jessica Fye from Jpmorgan.

Good afternoon, and thanks for taking my questions.

The first of all of you when you look at the street models, which potential royalty stream. We can see is most underappreciated by the strength.

Yeah, Let me turn that one over to Elaine to see which drove the true do you feel is the most underappreciated the link.

Sure. So I think just the I think for that question I think well I think we are.

I think the street has largely focused on on <unk> fast pro which given helens comments in our public comments I think is.

Unknown Attendee: Great, that's helpful. Congratulations on the quarter and all the progress.

Unknown Attendee: I appreciate that, Jill. Thank you. Your next question comes from

Certainly.

<unk>.

Unknown Attendee: Your next question comes from Jessica. I'm from K.P. Morgan.

Driven by the strong one thing that.

We'd like folks to appreciate over time is the breadth of our royalty portfolio.

Unknown Attendee: When you look at street models, which potential rural can stream do you see as most underappreciated by the street? Yeah, let me turn that one over to Elaine to see which world you feel is most underappreciated, Elaine.

We have 10 parks.

Rguest underlying those different partnerships.

Na Sun: Sure, so Jessica, thanks for that question. I think, look, I think we, I think the street has largely focused on Darzlex Fast Pro, which, given Helen's comments and our public comments, I think, is certainly, you know, driven by the strong. One thing that we'd like folks to appreciate over time is the breadth of our royalty portfolio. We have, you know, 10 parts, targets underlying those different partnerships and that diversity of programs of our partners, waves of launches over time, that should drive strong royalty growth beyond Darsalax, FESCO, et cetera, as being larger contributors.

And that diversity of programs of our partners.

Sales of launches over time.

Of that should drive strong royalty growth beyond <unk>.

Et cetera as the as.

The larger contributors I think certainly I'd love.

Welcome to our wave three product launches in particular.

As being though the next drivers and as Helen indicated certainly with the continued progress of erosion for centric.

The.

Until a significant drivers as well as the subcutaneous nivola map with Bristol.

Okay.

Okay, great thanks for that and with respect to the share repo.

Na Sun: I think certainly I've learned, look to our Wave 3 product launches in particular as being those next drivers. And, as Helen indicated, you know, certainly with the continued progress of Roche's Decentric, potential significant drivers, as well as subcutaneous nevolumab with birth. Okay, great. Thanks for that.

Oh, just given how much you've already completed.

In the first quarter is there any chance that you'll pull some of the remaining of repo on the plan forward into 2021 and are there any other uses of cash beyond repos are looking for.

Unknown Attendee: And with respect to the share repo, Just given how much you've already completed in the first quarter, is there any chance that you'll pull some of the remaining repo on the plan forward into 2021? And are there any other uses of cash beyond repo that look increasingly appealing?

Increasingly appealing.

Yes, let me ask the line to address that.

Sure. So as you know we have a balanced capital allocation strategy.

And that support of both capital return as well as funding internal and external growth via M&A.

Na Sun: Yes, let me ask for a loan to address that. Sure, so as you know, Jessica, we have a balanced capital allocation strategy and support both capital return as well as funding internal and external growth via M&A. We've certainly been very focused on capital return, and I think we're just over 75% of our way through the $550 million three-year buyback plan, which would leave $75 million remaining through the end of 2022.

<unk> certainly been very focused on capital return and I think we're just over 75% of our way through the $550 million three year of buyback plan, which would leave $75 million remaining through the end of 2022 to that three to the timing of repurchases as is <unk>.

Just on different factors, including market conditions et cetera, but.

But we continue to be focused on capital return I think beyond capital return, we continue to think of it there. It is appropriate as part of that balanced capital allocation strategy to continue to fund the substantial internal growth drivers that we have fueled by enhanced as well as potential to bring in.

Na Sun: The specific timing of repurchases is based on, you know, different factors, including market conditions, et cetera, but we continue to be focused on capital return. I think beyond capital return, we continue to think that it is appropriate, as part of that balanced capital allocation strategy, to continue to fund the substantial internal growth drivers that we have fueled by enhanced, as well as the potential to bring in another external platform technology that could leverage our existing capabilities and experts. Peace, to drive additional value long-term for shareholders.

Another external platform technology that can leverage our existing capabilities and an expertise.

To drive additional value long term for shareholders.

Thank you.

Sure.

Your next question comes from Jason Butler from JMP Securities.

Unknown Attendee: Your next question comes from Jason Butler, from

Unknown Attendee: Hey, I just want to make sure I was clear on the Goders-elect's first line, multiple mile on the 3% market share, is that the overall market, or is that the additional portion that's converted to sub-tukes? That was the overall market, I believe, that was being referred to right.

Okay.

Yes.

Hey, it's Roy on for Jason I, just wanted to make sure of.

The first line multiple myeloma, 3% market share of the overall market of the buffer.

Additional of portion of that is converted to the subcutaneous.

That was the overall market I believe that was being referred to arrive.

They didn't break <unk> sales overall EBIT as part of it.

Helen I. Torley: They didn't break by sub-tube, but it's overall. They've never broken about. They didn't break it, break-in. I don't know if they're up the two. Okay, they've never broken out sub-few. They haven't, they haven't, day and day have not.

For me.

They didn't broke at breakeven levels with a mixture of it too.

So the as I've never broken out of the deal.

They haven't J&J has not.

Okay, Great and then can you remind us what the the light chain amyloidosis.

Helen I. Torley: Okay, great. And then can you remind us what the light chain ameladosis, um, Total Market Opportunity is in their view? Yeah, the epidemiology around this is there's about 4,500 incident Tia amyloidosis patients in the US annually, and it's a similar number in Europe. So think about the total opportunity, I think, globally, of being about 10,000 to approval, Roy, and specifically there are some conclusions based on cardiac disease, so you need to take that 10,000 and reduce it to get the opportunity. So incremental add, as this indication is only approved; it's a sub-2, not an IV.

Total market opportunity is.

Yes.

Epidemiology around business, there's about 4500 incident light chain amyloidosis patients in the U S annually and it's a similar number in Europe. So think about the global opportunity I think globally of being about 10000. After the approval ROI and there's specifically there are some exclusions based on cardiac disease. So you need to take that.

10000, and reduce it them to get the opportunity so the incremental add as the syndication is only approved as a sub Q.

As an IV.

Okay. Thank you.

Unknown Attendee: Your next question comes from Anita Deshant from Bloomberg Capital Markets.

Your next question comes from the attrition from Bloomberg travel markets.

Unknown Attendee: Hi, good afternoon. Congratulations on the progress, and thanks for taking the time to answer my questions. I was just wondering, Helen, on the last call you mentioned that you were kind of re-engaging with your partners to sort of have them revisit their portfolios and see if they will be able to identify new targets that could move forward into the clinic. I was just wondering how many new targets we are likely to see this year or next into the clinic.

Hi, good afternoon, congrats on the progress and thanks for taking my questions on the morning Han.

And the last call you had mentioned about you know all.

But the <unk>.

Re engaging with our partners at <unk> for <unk>.

We will have the portfolios.

They will be able to identify new targets that could move all items of the panic.

I was just wondering how the how many sort of new targets that.

We're likely to see them with the.

The net come.

Unknown Attendee: As we entered this year, Anita, as you know, we said five new phase one starts, which represent the line of sight new targets we had coming in, and we've already started two of those. I can tell you our discussions with partners are ongoing, and the number of new starts this year, or perhaps some of them could take into next year to actually start, just depending on where those targets are in development, or next year, just based on the discussion; we can't be absolutely sure yet based on timelines that anyone can start on any additional ones will start in 2021 yet. Okay, good. Thank you.

In the clinic.

As we entered the here and you guys. You know we set five new phase I starts which represent the line of sight, new new targets, we had coming in and we've already started two of those I can tell you our discussions with partners are ongoing the number of new starts this year or perhaps some of them could take get into net.

Year to actually start just depending on where those targets are in development.

For next year, just based on the discussions.

Once we have can't be absolutely sure yet based on timelines the annual ex star in any additional ones.

We'll start in 2021 yet.

Okay, great. Thank you and the.

One more question.

Helen I. Torley: And just one more question, on Dard's Electics Health. So I think from what J&J had against it, and I talked about it before, there were about 40% of the patients that converted to the subcue form. So eventually, we would expect, like, the majority of the population to adopt the subcube version. We could kind of think about that for the other candidates using enhanced.

You know on a darn good ex itself so.

So I think from what J&J had.

Again, and I talked about it before.

About 40% of the patients that.

Converted to the sub Q form.

So eventually we would expect the majority of the population to adopt the subsidy of version.

With the kind of think about that for the.

The other.

The candidates easing in hand.

Yes.

I do think dark like for them as you mentioned is off to a strong start and I think of the comment on the 40% equity of Big was made by US based on data last October that showed that this was from symphony. They showed that 40% of use in the U S was with that was with the sub Q. We certainly are delighted with the performance. We know that just based on our royalty revenue.

Unknown Attendee: I do think Dargo, like the, as you mentioned, is off to a strong start. And I think the comment on the 40% was actually made by us based on data last October that showed that this was from Symphony. They showed that 40% of use in the US was with this sub-Q. We are certainly delighted with the performance. We know that just based on our royalty revenues, it's even higher than that now in the U.S., and we're seeing good penetration around the world as well.

Use of the even higher than that now in the U S and we're seeing good penetration around the world as well I think as you think about all of the other products in the portfolio.

Unknown Attendee: I think if you think about all of the other products and the performance, the portfolio. It really will be dependent on the value proposition that positions see, and there's no doubt that GAR's elects is a very strong value proposition, but we've got very strong value propositions in the rest of our portfolio. And what we do is we take a look at what we think they're offering versus the competition and per patient, and we do a range around as to what we think the peak penetration will be. So you're absolutely right. There's a great opportunity in the U.S.

Really will be dependent on the value proposition that positions, the and that Theres no doubt that the ars elect of the very strong value proposition, but we've got very strong value propositions and the rest of our portfolio in the well.

What we do is we take a look at what we think the offering brings versus the competition on per patient and we do do a range of range as to what we think the peak penetration will be so.

Youre absolutely right.

A great opportunity when the U S.

Okay. Thank you.

Yes.

Your next question comes from Greg for now.

Unknown Attendee: Your next question comes from Greg, from Golden Sack. Great, thank you for taking my question. Congratulations on all the great progress.

<unk> from Goldman Sachs.

Great. Thank you for.

Taking my question Congrats on all of the great progress.

Unknown Attendee: I've got two questions, if I could. My first just has to do with the broader portfolio, in particular the 16 products that you list on slide five. We're just wondering if you could maybe remind us if there are certain products where the current IV infusion times are perhaps, considered longer, perhaps than others that might facilitate greater conversion over to any potential subpoe that might get eventually improved. And then my second question, I just wanted to revisit the company's prior comments around looking, you know, after some of the top several quarters. I'm curious if there have been any changes in the BD Thanks very much.

Got two questions if I could.

First just has to do with the broader.

The portfolio in particular, the 16 products, but true list on slide five.

Just wondering if you could maybe remind us first.

Certain products, where the current IV infusion time or for.

Perhaps.

The longer.

Perhaps from others that might facilitate.

Greater conversion over 'twenty, particularly for Q.

My Kid of entry.

For the improved.

And then my second question just wanted to revisit the company's prior comments around looking for.

Okay rochus over the past several quarters.

I'm curious if there had been any changes.

And the BD environment.

Whether it is the.

The number of potential assets of the.

The quality of the assets or or protection of the prices of the assets.

It really changed.

Thanks very much.

Alright.

Helen I. Torley: All right. So turning to slide 5, thank Greg, as we're taking a look at the products that are listening here, there is a whole range of infusion times, as you point out. And obviously, some of them are perhaps 30-minute IV infusions, some of them more range towards the one and a half to two hours. What I think is important is, you know, duration of infusion is one aspect. But what we're seeing with our partners is not simply reducing the time of administration; there are other, I think important strategic plays that they are pursuing here.

Turning to slide five thank Greg.

Taking a look at the products that are listed here there are a whole range of infusion times as you point out in the ABL.

Obviously some of them are perhaps 30 minute IV some of them more range towards the one and a half to two hours what I think is important is.

The duration of infusion is one aspect, but what we're seeing with our partners is not simply reducing the time of administration that are other I think important strategic plays.

That they are pursuing here, if we think about some of the products for the goal might be to get the patients to be able to use the product from at home more easily.

Helen I. Torley: If we think about some of the products where the goal might be to get patients to be able to use the product at home more easily, a sub-Q is a significant advantage, obviously, over an IP. We've got other partners who are working to develop drugs in combination, so similar to what Roche succeeded with Fesgo, using two antibodies together.

They're a sub Q is a significant advantage all of US stay overnight, Inc. We've got other partners, who are working to develop drugs in combination. So similar to what Roche succeeded with the with Fayetteville of two antibodies together and that was all al mentioned that Bristol Myers Squibb. When they started working with us have a vision for being able to.

Helen I. Torley: And that was, I'll mention that some of our squibb partners when they started working with us had a vision to be able to take care more into the community oncology sector, I think, to make it easier for patients. And so as you think about what the value proposition is, I think there are the strategies, there's the duration of administration. All very important, and for each of the products that you see listed here as well as the side that we expect to start this year, there is a compelling value proposition that is why this will bring competitive differentiation for each partner for them to take it to the market. If I could move to the question of BD, yes, as we mentioned, our goal is to seek to find another platform that we can do what we've done with in hands, which is licenses to multiple I would say the environment has got a good number of assets.

Take care more into the community oncology setting to make it easier for patients and so as the as you think about what the value proposition is I think the strategies of the duration of the Ministry.

Strength in all very important and for each of the product that you see listed here as well as the five that we expect the start this year. There is a compelling value proposition of the supply of Chris will bring competitive differentiation for each partner for them to take it to the market.

If I could move to the question of BD, yes.

As we mentioned the goal is to seek to find another platform that we can do what we've done with enhanced which is licensed to multiple partners and be able to grow revenues, perhaps beyond for the at originator of was able to do and so we are very actively look.

King at different from opportunities at the moment great.

I would say the environment has got the a good number of assets.

Pricing is perhaps a little bit down as to what it was perhaps for five months ago. So that that is a bit of of positive.

Helen I. Torley: Pricing is perhaps a little bit down as to what it was perhaps four or five months ago, so that is a bit of a positive. But, you know, I would say there has been no major change in the overall environment of the assets that we are looking at. And, you know, we will take our time. We have the luxury of time based on the strong growth we're projecting for enhanced, so we're not rushing into this. We're looking for something that we feel is a great fit for our capabilities and our business model, and we'll complement that effectively. So we're going to find the right thing. Okay.

But.

I would say no major change in the overall environment of the assets that we are looking at any of the we will take our time, we have the luxury of time based on the strong growth for projecting for <unk> hand, So we're not rushing into this we're looking for something that we feel is of great fit for our capabilities and our business model and we'll complement that effect.

Of late so we're going to we're going to find the right thing.

Okay. That's great. Thank you so much.

Unknown Attendee: Okay, that's great. Thank you so much. Thank you, Greg. As a reminder, to ask a question, press Star 1. Your next question comes from Joe Kenton Tower, from Piper Samar.

Thank you Greg.

Okay.

As a reminder to ask the question press the star one.

Your next question comes from John kind of in terms of Piper Sandler.

Okay.

Unknown Attendee: Hey, guys, thanks so much for taking my questions here. Just do something somewhat related. I'm wondering if you could help.

Hey, guys. Thanks, so much for taking my questions here, just just two somewhat related I'm wondering if you could help.

Helen I. Torley: Also, somewhat related. I'm wondering if you could help contextualize how much of the growth of Fast Pro is due to your products, and then somewhat related. I think Gemmaab said some Nordic countries are seeing 90% fast pro conversions, while others are around 30%. If you guys have any sense around the overall conversion rates across the full European geography, and can you actually back into that number based on the royalty you received? Thank you.

<unk> realized how much of the growth of SaaS pro that your products and then somewhat Relatedly I think Jim Babb said, some Nordic countries are seeing 90% cash broke conversions, while others are around 30.

Steve.

You've got sort of any sense around the overall conversion rates across the full European geography, and can you actually backing for that number of based on the royalty you received thanks.

Yeah, I would say, let me take the second part.

Helen I. Torley: I would say, let me take the second part first. We heard the comments from Gen Mab and really echo the Chief Commercial Officer there to say it is very difficult to get detailed penetration data from Europe, so we can't really comment on that by geography. We have a general sense from our royalties shows how much overall share in Europe versus the U.S., but we certainly don't know on a market-by-market basis, unfortunately.

Yeah, when we heard the comments from.

From Genmab and really echo of the Chief commercial officer, there to say it is very difficult to get detailed penetration data from Europe. So we can't really comment.

On that by geography, we have a general sense from royalties Joe is true overall share in Europe versus the the U S. But we certainly don't know on a market by market basis. Unfortunately, although obviously the core messages that we're delighted with the strong uptake.

Unknown Attendee: But obviously, the core messages that we're delighted with the strong uptake that we're seeing in the US, where our last reported data was 40%, obviously that has continued. And this sense that they talked about about the Nordic markets being at 90% and other markets at 30% obviously shows that the value proposition is being well received around the world. With regard to the growth of Fasbro, we certainly are seeing a contraction, to your question on the legacy product, so the ongoing impact of biosimilars on perception and ulcerotoxin is muting it modestly.

Being in the U S work of our last reported data was the 40% that obviously that has continued and the same but they talked about the boat some of the Nordic markets being at 90% in other markets of 30%, obviously shows that the value proposition is being well received around the around the world.

With regard to the growth of Fas per week.

We certainly are seeing a contraction of two to your question on the legacy products. So the ongoing impact of Biosimilars.

Perfect.

And also rituxan.

<unk> is meeting eight modestly so we did predict them state of this year somewhat mute the $1 of electric bass pro.

Unknown Attendee: So we did predict and state this year that Darzolx Faspro would somewhat mute, but on a... Relatively modest basis, we're obviously very pleased with the growth that we're seeing in Fasco this year. Okay, got it. Thanks for taking.

But on a net.

The relatively modest basis, we're obviously very pleased with the the growth that we're seeing and fast per this year.

Okay got it thanks, thanks for the sake.

Unknown Attendee: Okay, got it. Thanks for taking it. Ask my question. Thank you. That was our last question at this time. I will now turn to call back over to the presenters.

Taking my question.

Thank you.

That was our last question at this time of ill now turn the call back over each of the presenters.

Why global of really appreciate everyone for your support and for your attention as you've heard we continue to execute very well against our strategy and we're excited with the progress that our partners are showing of their development of more enhance enables that product when it for to feature launches of waste.

Helen I. Torley: Right, well, we really appreciate everyone's support and for your attention. As you've heard, we continue to execute very well against our strategy, and we're excited with the progress that our partners are showing in their development of more enhanced products. We look forward to future launches of Waste 3 and 4, following on from the great success we're seeing with our, and we look forward to seeing you next quarter. See you later. Bye now.

Three and for following all of the Great success, we're seeing with our and we'll look forward to seeing the next quarter Goodbye now.

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

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

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