Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q4 2023 Earnings Call Transcript
Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q4 2023 Earnings Call Transcript February 20, 2024
Halozyme Therapeutics, Inc. reports earnings inline with expectations. Reported EPS is $0.82 EPS, expectations were $0.82. Halozyme Therapeutics, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Hello and Welcome to the Halozyme Fourth Quarter and Fiscal Year 2023 Financial and Operating Results Conference Call. [Operator Instructions] I will now turn the conference over to Tram Bui. Please go ahead.
Tram Bui: Thank you, operator. Good afternoon and welcome to our fourth quarter and full year 2023 financial and operating results conference call. In addition to the press release issued today after the market close, you could find a supplementary slide presentation that will be referenced during today's call in the Investor Relations section of our website. Leading the call would be Dr. Helen Torley, Halozyme's President and Chief Executive Officer, who will provide an update on our business; and Nicole LaBrosse, our Chief Financial Officer, who will review our financial results as well as our outlook. On today's call, we will be making forward-looking statements as outlined on Slide 2. I would also refer you to our SEC filings for a full list of risks and uncertainties.
During the call, both GAAP and non-GAAP financial measures will be discussed. Certain non-GAAP or adjusted financial measures are reconciled with the comparable GAAP financial measures in our earnings press release and slide presentation. I'll now hand the call over to Dr. Helen Torley.
Helen Torley: Thank you, Tram, and good afternoon, everyone. Moving to Slide 3. We're very pleased to report our strong financial and operating results in the fourth quarter and for the full year of 2023. These results are driven by our two leading differentiated drug delivery technologies ENHANZE and our auto-injectors, and also by our two commercial products, XYOSTED and Hylenex. Moving to Slide 4. For 2023, we delivered a 26% year-over-year increase in total revenue to $829 million and reached a record $448 million in royalty revenue, which represents a 24% year-over-year increase. Strong operational performance drove another year of double-digit earnings growth, with adjusted EBITDA increasing 19% to $426 million and non-GAAP diluted earnings per share growth of 25% to $2.77 for the full year 2023.
We also deployed $400 million to shareholders through share repurchases, reflecting strong cash flow and disciplined capital allocation priorities. Moving to Slide 5. Our achievements and our partner progress in 2023 contributed to the strong performance and paved the path for our strong long-term outlook. The total number of enhanced commercial products increased in 2023 from five to seven with the approval of argenx's VYVGART Hytrulo for generalized myasthenia gravis in the U.S. and Europe and the approval of Tecentriq subcutaneous in Great Britain. We also had multiple positive Phase 3 data readouts supporting regulatory submissions for approval of the enhanced subcutaneous formulations. Recall that we have a 100% success rate for approval of products delivered subcutaneously with ENHANZE when the Phase 3 trials have met their endpoints.
VYVGART Hytrulo Phase 3 data in CIDP was the first positive Phase 3 readout and upon approval, creates an expanded commercial opportunity in the condition where there is high unmet need today. argenx has already submitted the supplemental BLA for this indication using a priority review voucher which would support a potential approval by mid-year of 2024. We were also very excited with the positive data announcements from two additional Wave 3 products, Roche's Ocrelizumab subcutaneous ENHANZE and Bristol Myers Squibb's Nivolumab subcutaneous within ENHANZE, supporting global regulatory submissions and potential launch in 2024 for Ocrelizumab subcu and in 2025 for Nivolumab subcu. We also continued to advance and expand our pipeline. Johnson & Johnson presented data at ASCO from the Phase 1 amivantamab subcue with enhanced trial.
An important observation that was highlighted was the dramatically lower rate of infusion-related reactions with the subcutaneous at 16% compared to 67% reported with intravenous amivantamab, which is commercialized as Rybrevant. Infusion-related reactions can include mild symptoms such as chills, breathlessness and nausea, but can also be severe, making this reduction, if confirmed in the Phase 3 study, very meaningful to physicians. We are delighted that Johnson & Johnson recently announced strong progress with the Phase 3 study that they project will support submission of regulatory filings in 2024 for subcutaneous amivantamab with ENHANZE. Another significant achievement was ViiV advancing testing of their broadly neutralizing antibody, N6LS, for HIV.
Also in 2023, we reached an important milestone for our new high-volume auto-injector as we successfully demonstrated the feasibility of administering a subcutaneous injection of 10 milliliters of representative biologic immune globulin 10% with enhanced in approximately 30 seconds using our high volume auto-injector. And we were pleased to add a new ENHANZE partner Acumen Pharmaceuticals in the fourth quarter. We're delighted to be working with them to develop a subcutaneous delivery option for ACU193, bringing together Acumen's deep understanding of Alzheimer's and the amyloid beta oligomers with our enhanced platform. Moving now to Slide 6. With our strong track record of success and progress, as we look ahead, we have high confidence in the visibility of our revenue and we were delighted to recently share our 2024 guidance and our five-year financial outlook for the company.
For 2024, we're delighted to project continued strong growth of revenue with a guidance range of $915 million to $985 million, representing 10% to 19% year-over-year growth. Royalty revenue remains our top driver of our revenues and is projected to be $500 million to $525 million, representing growth of 12% to 17%. As a result of our disciplined approach to expense management and our business model, we are projecting adjusted EBITDA in the range of $535 million to $585 million, a remarkable 26% to 37% growth. I'll focus now on the five-year financial outlook. Total revenue is projected to reach $1 billion in 2025 and grow to greater than $1.5 billion in 2027 and 2028, with royalty revenue continued to be the key driver projected at $1 billion in 2027.
And impressively, we project adjusted EBITDA will grow faster than revenue in every year of the five-year outlook to an impressive $1 billion in 2028 with a five-year CAGR of 23%. I'll now turn to Slide 7 and review royalty revenue drivers in a bit more detail. Our Wave 2 products, DARZALEX/FASPRO and Phesgo, launched in 2020, have driven the impressive royalty revenues and growth illustrated on this chart and have many years of impressive growth ahead for them. Moving now to Slide 8 and to DARZALEX/FASPRO enabled by ENHANZE. With subcutaneous penetration in excess of 90% in the U.S., total brand growth has become the key driver for understanding subcutaneous performance for this product. In 2023, total DARZALEX sales continued to deliver strong growth for Johnson & Johnson, increasing approximately 23% year-over-year on an operational basis to $9.7 billion.
This strong growth was driven by share gains in all regions and continued growth in the first line setting. Supporting future growth in first line, it is notable to highlight that Johnson & Johnson recently submitted a supplemental BLA to the FDA to support a new indication for DARZALEX/FASPRO with ENHANZE for multiple myeloma in newly diagnosed adult patients who are eligible for autologous stem cell transplant. The results from their PERSEUS study, recently published in the New England Journal of Medicine supported this submission. The addition of DARZALEX/FASPRO to standard of care treatment resulted in a statistically significant and clinically meaningful improvement over today's standard of care alone in progression-free survival, complete response or better, and minimal residual disease negativity.
As we look forward, analysts continues to expect annual sales of DARZALEX to grow to approximately $17 billion by 2028, driven in large part by the first-line opportunity. I'll move now to Phesgo, which is illustrated on Slide 9. Phesgo offers the potential for patients with breast cancer to receive treatment as a simple subcutaneous injection over five minutes after the first dose and a total treatment and observation time of about 20 to 38 minutes, which compares to 2.5 hours to 7.5 hours total treatment and observation time for the IV. With this strong value proposition, Phesgo sales continued at an impressive rate of growth in 2023, increasing 64% to CHF1.1 billion for the full year as Roche continued to expand into additional markets while also driving global conversion rates higher.
Roche reported a 39% conversion rate in 46 launch countries. As we look at regional uptake, strong growth in contribution was reported for all regions. Us sales were CHF423 million growing at 48% and now representing close to 40% of total revenue. EU is growing at 52% and international was reported to be growing at greater than 150%. Roche stated that it expects continued growth of Phesgo with increasing conversion from the IV treatment Perjeta, which reported sales of CHF3.8 billion francs in 2023, with Roche projecting peak conversion of approximately 50%. We are excited to see the strong performance and the future growth that lies ahead for Phesgo. I'll now move to Slide 10 and our focus on our Wave 3 products and product candidates. What you see in the left panel are the 2023 launches and as you move across the slide to the right, the multiple product, regional and indication launches that are projected this year and next.
I will highlight that positive Phase 3 data and regulatory submission plans have been reported by our partners for all products with the exception of Amivantamab that has not yet reported its Phase 3 data. We are very excited with the large opportunity for the Wave 3, which is now comprised of five products that are projected by analysts to generate total sales of approximately $35 billion in 2028. I will start with VYVGART Hytrulo with ENHANZE which was approved in generalized myasthenia gravis in the U.S. in June of 2023 and in Europe in November. VYVGART Hytrulo with ENHANZE offers myasthenia gravis patients a new faster treatment delivery option delivered by healthcare practitioners in just 30 to 90 seconds. Notably, the European approval also allows for patient self-administration subcutaneously.
With the VYVGART Hytrulo subcutaneous launched just six months ago, argenx's focus has been on broadening commercial coverage and securing the data growth which was accomplished in January of this year. With this, we project growing adoption for VYVGART Hytrulo. The successful launch of VYVGART with $1.2 billion in revenue in 2023 supports the unmet need that exists for the treatment of generalized myasthenia gravis and the attractiveness of the VYVGART clinical profile. VYVGART Hytrulo adds the potential to expand the number of physicians using VYVGART and to expand use in the earlier lines of treatment. I'll now move to an exciting additional opportunity for VYVGART Hytrulo in that CIDP, or chronic inflammatory demyelinating polyneuropathy.
Based on Organics's research and recent comments, 42,000 patients receive treatment today for CIDP. It's a condition where there is a high unmet need. Just 20% of patients get remission on the current standard of care treatment and 50% of patients report that they remain dissatisfied with the current burden of symptoms. The 61% reduction in risk of relapse with VYVGART Hytrulo versus placebo shown in the ADHERE study would upon approval offer an important new option for patients. And I'll highlight that this indication will be available only as a subcutaneous treatment enabled by ENHANZE. With the recent submission and use of their priority review voucher, argenx projects the possibility of approval for this new indication in the United States in mid-2024.
Moving now to Tecentriq. Tecentriq as an IV remains a key growth driver for Roche, with revenue growing 9% year-over-year to CHF3.8 billion in 2023. Tecentriq subcutaneous with ENHANZE was granted regulatory approval in Great Britain last year and in the European Union in January of 2024, for all of the approved IV indications. It is given as an approximately seven-minute subcutaneous delivery, which compares to 30 minutes to 60 minutes for the IV infusion. With U.K. conversion already reaching 18% essentially in one quarter, Roche believes that the opportunity for subcutaneous adoption remains significant. The US approval is projected in September of this year. Moving now to Ocrevus. Ocrevus as an IV is the leading treatment in the U.S. and EU5 for multiple sclerosis, with more than 300,000 patients treated globally and a higher retention rate than other multiple sclerosis medicines.
For the full year, Ocrevus generated an impressive CHF6.4 billion, which we estimate to be about $7 billion in revenue for Roche, which represents 13% year-over-year growth. ocrelizumab subcutaneous with ENHANZE creates a possibility for people living with multiple sclerosis to receive their treatment in just 10 minutes twice a year, which compares to 3.5 hours to 6.5 hours for the IV treatment and observation time. Roche commented on their recent quarterly call that they project the addition of availability of ocrelizumab subcu, which is enabled with ENHANZE to create a standalone blockbuster opportunity. As we have seen with DARZALEX subcutaneous, the availability of the subcutaneous delivery option can result in or accelerate market growth.
We project the availability of ocrelizumab subcutaneous with ENHANZE can create increased growth in two key ways: firstly, by allowing current multiple sclerosis centers to increase the number of patients treated as a result of improved throughput based on shorter time needed for each patient occupying an infusion chair; and secondly, by expanding the number of treatment centers by enabling multiple sclerosis centers that do not have IV infrastructure today to start administering ocrelizumab subcutaneously. Following the completed regulatory submissions in the U.S., EU and U.K. in 2023, we project the approval of ocrelizumab subcutaneous to represent our eighth ENHANZE royalty revenue generating product in 2024. Our next Wave 3 product is Bristol Myers Squibb's nivolumab subcutaneous with ENHANZE, which is the brand name Opdivo as the IV.
Opdivo IV sales were $9 billion in 2023, increasing 9% year-over-year, showing continued strong growth. In January, Bristol Myers Squibb presented the detailed result results of CheckMate-67T, the Phase 3 IV versus subcutaneous registration enabling study at ASCO-GI. As announced previously, the trial met the primary endpoint of non-inferiority of the two co-primary endpoints, C average over 28 days and C min, a key powered secondary endpoint of overall response rate was also reported. Non-inferiority was also demonstrated with the overall response rate of 24.2% for the subcutaneous and 18% for the IV. Given in just five minutes, nivolumab subcutaneous has the potential to be practice-changing and to improve the patient's treatment experience.
Bristol Myers Squibb commented that the subcutaneous could potentially extend the franchise through the end of this decade and into the early 2030s, with the subcutaneous approval projected to cover up to 75% of the IV indications. And lastly, we were excited to have recently added Johnson & Johnson's amivantamab subcutaneous with ENHANZE into our Wave 3 potential launches with the potential for launch in 2025. Johnson & Johnson recently indicated that they expect Phase 3 data from the PALOMA 3 trial for amivantamab with ENHANZE plus lazertinib in 2024, supporting U.S. and European regulatory filings also in 2024. Amivantamab is already approved as an IV under the brand name RYBREVANT with Johnson & Johnson projecting, RYBREVANT will become a multi-billion dollar brand.
Let me now move to Slide 11 where I'll provide an update on our Wave 4 pipeline which is projected to support our future growth trajectory with potential launches in the 2025 to 2027 timeframe. We currently have a robust pipeline with seven exciting products in development. This reflects amivantamab moving to Wave 3 based on the updated potential launch timing and Amgen's decision to not move forward with a subcutaneous version of TEPEZZA with ENHANZE. Johnson & Johnson has also made the decision to not proceed with rilpivirine subcutaneous. The Wave 4 portfolio comprises of products across a range of therapeutic areas, including oncology, neurology, immune disease and HIV. We have two products in Phase 3 development. This includes Bristol Myers Squibb's nivolumab with relatlimab with ENHANZE where the Phase 3 study is underway.
The IV version of [Opdualag] is projected by analysts to be a multi-billion dollar brand in 2028. The goal with the subcutaneous version is to offer a shorter, simpler treatment option, reducing patient burden and healthcare resources. Takeda's TAK-881, which is a 20% IGG with ENHANZE for primary immune deficiency, is the second Phase 3 development program. This would be the second 20% IGG to launch and will expand at Takeda's immune global offering for patients, creating a lower volume and potentially shorter treatment schedule. Last year, our ViiV collaboration also progressed with subcutaneous delivery of N6LS enabled by ENHANZE. N6LS is a broadly neutralizing antibody for HIV and it is advanced into a Phase 2b study in combination with Cabotegravir as a two drug regimen for HIV treatment.
Because of the rapidly changing nature of HIV and its potential to develop resistance to certain treatments, ViiV based on HIV community feedback has stated that there continues to be a need for medicines with unique mechanisms of action like the broadly neutralizing antibodies, which may open up a completely new approach to treating HIV. Separately, we continue to be pleased to collaborate with our argenx on ARGX-117, now named Empasiprubart. And in addition, we have two remaining programs in Wave 4 that are confidential at the request of our partners. I'll move now to Slide 12. Let me now spend a moment on our high volume auto-injector. We were excited last year to demonstrate delivery of 10 mLs of a representative biologic co-formulated with ENHANZE in just 30 seconds with our innovative new high-volume auto-injector.
ENHANZE is the key ingredient that makes this possible. For patients, this can offer the option for home delivery or rapid delivery in the physician's office. Our goal with the high-volume auto-injector offering is to expand upon establishing ENHANZE collaborations and add new collaboration partners. I'm pleased to announce that one of our current partners is initiating a human factors test of the high-volume auto-injector to evaluate device usability. This test is scheduled to start this quarter. I'll turn now to new enhanced deals. We continue to have strong and expanding interest by existing and new partners. While we were disappointed by the slow progress in decision-making by companies in 2023, we remain confident in our ability to expand our pipeline in 2024.
This year started with expanded interest from potential new partners with a busy schedule of meetings in January and February already with partners expressing interest in ENHANZE, the high volume on auto-injector, and in some cases, the small volume auto-injector technology. I look forward to providing updates and progress on new agreements throughout the year. I'll now turn to our commercial portfolio, XYOSTED sales achieved $100 million in 2023, demonstrating strong growth. This sales attainment met our target revenue for the year and breakeven in the fourth quarter. This performance reflects successful execution of our three-pronged strategy, which includes targeting the switch of patients who are not achieving their treatment goals with intramuscular injections, enhancing adherence with specialty pharmacies executing educational programs to support patients staying on treatment, and continued actions to improve the net sales price.
With a market of more than 9.5 million scripts a year and our share approaching 5%, we see a clear path for continued growth in revenue and EBITDA contribution in 2024 with a CAGR projection of 25% through 2028. Let me now turn the call over to Nicole who will discuss our financial results in more detail.
Nicole LaBrosse: Thank you, Helen. The fourth quarter marked a strong end to 2023. We delivered double-digit revenue growth and achieved another record quarter of royalty revenue. Adjusted EBITDA and diluted earnings per share growth outpaced the top line, reflecting the significant leverage we generate as we grow royalty revenue. Let me start with capital allocation on Slide 13. We remain committed to our three capital allocation priorities of investing in the business to maximize revenue growth and durability, returning capital to shareholders through share repurchases and adding new growth opportunities through M&A. In November 2023, we initiated a $250 million Accelerated Share Repurchase, or ASR. This will operate to repurchase our shares for a number of months into 2024.
This brings our total share buyback since the inception of the first program in 2019 to $1.3 billion. I am also pleased to announce that our Board authorized a new $750 million repurchase program, reflecting our continued commitment to balanced capital allocation and a focus on driving value for shareholders. Turning now to Slide 14 for our detailed financial results for the fourth quarter of 2023. Revenue for the fourth quarter grew 27% to $230 million, compared to $181.5 million in the prior year period. Royalty revenue for the quarter was $122.1 million, an increase of 15% compared to $106 million in the prior year period, driven by continued strong performance of Wave 2 products, subcutaneous DARZALEX/FASPRO. Note that Q4 of 2022 reflected a measurement period adjustment to amortization of intangibles to our current run rate of $17.8 million a quarter.
Other operating expenses remained relatively flat period over period due to our leverageable business model, resulting in adjusted EBITDA growth of 47% to $121.7 million from $83 million in the prior year period. Our cash, cash equivalents and marketable securities were $336 million as of December 31, 2023, compared to $483.3 million as of September 30, 2023. The reduction is due to the use of $250 million for the ASR offset by positive cash generation in the quarter. We ended the quarter with a net leverage ratio of 2.5 times and we expect to decrease net leverage each quarter with EBITDA growth. Turning now to Slide 15 for our detailed financial results for the full year 2023. I will briefly touch on some highlights here with more details available in our press release and the 10-k filed with the SEC today.
Recall that we closed the Antares acquisition on May 24, 2022, and therefore the year-over-year comparison is impacted by a full year versus a partial year of contribution from the Antares business. Total revenue grew 26% year-over-year to $829.3 million in 2023, off in an already substantial revenue base in 2022 of $660.1 million. The main contributor to this increase was higher revenue from royalties of $447.9 million, reflecting growth of 24%, as well as higher ENHANZE product sales in XYOSTED sales growth. Also note that the revenue growth was offset by the timing of milestones recognized in the prior year. Recall that the timing of a milestone for Tecentriq SC in the U.S. was planned for the third quarter of 2023 and is now expected in September 2024.
Research and development expenses were $76.4 million compared to $66.6 million in 2022, primarily due to increased compensation expenses resulting from the addition of a new platform, our device platform, as well as plan investments in ENHANZE. Selling general and administrative expenses were $149.2 million compared to $143.5 million in 2022, primarily due to the addition of resources in sales and marketing with the addition of our commercial products, XYOSTED, offset by one-time transaction costs related to the Antares acquisition that occurred in the second quarter of 2022 of approximately $38 million. Adjusted EBITDA increased 19% to $426.2 million from $358.9 million in the prior year period. GAAP diluted earnings per share was $2.10 and non-GAAP diluted earnings per share was $2.77.
This is compared with GAAP diluted earnings per share of a dollar and Non-GAAP diluted earnings per share of $2.21 in 2022. Turning now to Slide 16, in our 2024 guidance, we are reiterating our top-line adjusted EBITDA and non-GAAP diluted EPS guidance for the full year 2024 that was provided in January. We are projecting another year of double-digit revenue growth to $915 million to $985 million. With milestones and API sales to be substantially weighted in the second half of the year. Royalties are growing to $500 million to $525 million, with a flattening in the first and second quarter and growth sequentially thereafter. With royalty revenues for the year greater than 50% of total revenue, this directly impacts gross margin expansion, resulting in adjusted EBITDA growth of 26% to 37% to $535 million to $585 million.
And when coupled with our 2023 share repurchases, non-GAAP diluted EPS growth is outpacing the top-line growth at 28% to 41% to $3.55 to $3.90. With that, I'll now turn the call back over to Helen.
Helen Torley: Thank you, Nicole, and thank you to all of the Halozyme team, our partners and collaborators, on a strong 2023. I'm very excited for the opportunities that lie ahead for Halozyme. Our disruptive drug delivery technologies continue to demonstrate strong value to our partners and to patients. As the market leader, we are well-positioned to capitalize on the significant market opportunities ahead for subcutaneous delivery technologies and to deliver strong, durable revenue and EBITDA growth. And with that, operator, we're pleased to open the call for questions.
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