Halozyme Therapeutics, Inc. (HALO) Earnings Call Transcript & Summary

Good morning. I am Helen Torley, President and Chief Executive Officer of Halozyme Therapeutics, and I'll be chairing this Annual Meeting of Shareholders. I'd like to call the meeting to order. This meeting is being held pursuant to the notice of the annual meeting, which was mailed to all of the company's stockholders on or about March 26, 2021. The polls are now open. At this time, any stockholders who are present and who would like to vote their shares at this meeting may do so by clicking the Voting button that's on your screen. Otherwise, the proxy holders will vote your shares as indicated on the proxy. [Operator Instructions] Mas Matsuda, who is Halozyme's Senior Vice President, General Counsel and Corporate Secretary, has been appointed secretary for this meeting to record the minutes, and he has taken the oath to serve as Inspector of elections. Mr. Matsuda has previously provided Halozyme with a certificate indicating the number of votes represented by proxy at this meeting. At this time, I'd also like to thank members of the Board of Directors and officers of the company who are participating on the call. And while he's not on today's call following his recent resignation, I'd also like to take a moment to thank Ken Kelley for his 17 years of service as a member of Halozyme's Board of Directors. Now I'd also like to introduce Doug Rein from DLA Piper, our outside legal counsel, who's participating on today's call. And finally, I'd also like to introduce Sarah Lichtman and Chad Whitefield (sic) [ Chad Whitehead ] of Ernst & Young, the company's independent registered public accounting firm. Ms. Lichtmann and Mr. Whitehead will be available to answer stockholder questions during the question-and-answer period following adjournment of the meeting. Let me now ask Mas Matsuda, secretary for the meeting, for his report.

Thank you, Helen. Only holders of record of common stock on the record date are entitled to vote at this meeting. A copy of the notice of this meeting together with a declaration as to the mailing of a copy of the notice to stockholders who were holders of record at the close of business on March 8, 2021, will be made part of the record of this meeting. The holders of a total of 127,617,860 shares are represented at the meeting. Since there were 143,301,550 shares of common stock outstanding at the close of business on March 8, 2021, the record date of the meeting, a majority of the outstanding common stock is present and represented here today. A quorum is therefore present. The meeting is authorized to transact business. Helen?

All right. At this time, we will address the items of business that were set forth in the notice of this meeting. And I'll just say that after the formal business portion of the meeting has been adjourned, I'll provide a brief corporate update and answer any stockholder questions relating to the company. The matters to be considered at the meeting today, which are further described in the proxy statement dated March 26, 2021, which was mailed to all stockholders of record with the notice of the meeting will be; firstly, the election of 2 Class 2 Directors to hold office for a 3-year term and until their successors are elected and qualified. Class 2 consists of 2 directors and the Board of Directors has nominated those persons set forth in the proxy statement for the meeting. The Class 2 nominees are; Jean-Pierre Bizzari and James Daly. These nominations need no second. Since the company's bylaws require advance notice of additional Board nominations and no such advance notice was given to the Corporate Secretary, the nominations are closed. The second matter to be considered at the meeting is an advisory vote on the company's executive compensation. The third matter to be considered at the meeting is the approval of Halozyme Therapeutics, Inc. 2021 Stock Plan. The fourth matter to be considered at the meeting is the approval of Halozyme Therapeutics, Inc. 2021 Employee Stock Purchase Plan. And the fifth matter to be considered at the meeting is a proposal to ratify the selection of Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2021. We'll give the stockholders another minute to complete their voting if they wish to do so at this time. [Voting]

All right, the polls are now closed, and we'll now hear the report of the inspector of elections regarding the results of the elections. Mas?

Thank you, Helen. As the inspector of elections, I'm pleased to report on the results of the meeting as follows. Jean-Pierre Bizzari and James M. Daly have each been elected as Class 2 Directors for the company to hold office for a 3-year term and until a successor is elected and qualified. The compensation of the company's named executive officers has been approved by a nonbinding advisory vote. The Halozyme Therapeutics, Inc. 2021 Stock Plan and 2021 Employee Stock Purchase Plan have both been approved. And lastly, the selection of Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2021, has been ratified. The final voting results for each of these matters will be reported on a Form 8-K, which the company will file with the SEC.

Thank you, Mas. That concludes the formal business of the meeting. I'd really like to thank everyone for your continued interest and participation today. This part of the meeting is now adjourned. And now I'd like to provide an update on Halozyme's recent activities and our plans for the future. And following this, we'd be happy to address any questions from the stockholders. So it really is a pleasure to provide this update today on an update on our strategy and our progress. I'll move to Slide 2 now. In the course of this presentation, I will be making forward-looking statements, and I refer you to our SEC filings for full listing of risks and uncertainties. Moving to Slide 3. Let me begin just with summarizing our business. We are the sole owners of a unique technology, which is the only FDA-approved recombinant human hyaluronidase that when is combined with certain medicines that today need to be given into the vein, can enable them to be given underneath the skin or what we call subcutaneously. With 5 products utilizing ENHANZE now approved in the U.S., Europe and other regions around the world, the ENHANZE technology is significantly de-risked both by regulators and also by payors. The 5 approvals we have today already represent a significant and growing revenue opportunity for Halozyme. Expectation for the total sales of the 5 approved payor products utilizing ENHANZE today is $18 billion, but this is projected to grow to $22 billion in the next 4 years. Now Halozyme receives on average a mid-single-digit royalty on net sales that are converted to subcutaneous use, and you can see how this clearly represents substantial near-term opportunity. This really is just the beginning. And by the end of 2020, we had 11 products in development with ENHANZE. And it's projected that this is going to increase to 16 by the end of 2021. And all of this is resulting in the potential for our royalty revenues to reach $1 billion in 2027, which represents substantial growth over the next multiple years. Now let me move to Slide 4 and briefly describe how ENHANZE works. Today, many major medicines need to be administered into the vein, and this is causing a lengthy intravenous infusion and it's because of the large volume of fluid they need for administration. ENHANZE is our proprietary and wholly owned enzyme, which is also called rHuPH20, which when it's combined with these medicines can allow them to be given subcutaneously or under the skin in a shorter and simpler injection. Now let's just move to Slide 5 now and talk about what this can mean for patients. Instead of spending multiple hours in the infusion suite receiving the treatment into the vein, which is what's shown on the left, patients can receive the same therapy into the abdomen or the thigh, enabled by ENHANZE in just minutes. And you can see an illustration here that they can go from a multi-hour infusion to a multi-minute infusion. You can imagine this is a very different experience for the patient. But it's also important, we've been shown to reduce the use of health care resources and thus costs to the health care system. Now let me move to Slide 6, and we'll review why our partners want to license access to ENHANZE. It really is because our partners are excited by the multiple ways that ENHANZE can provide meaningful differentiation and true value creation for their drugs and for their portfolios. If we begin at the top, I've just shown you ENHANZE reduces the treatment burden for patients and can reduce health care costs. And this was a focus that Roche had in developing a subcutaneous version of Herceptin and Rituxan in advance of the expected launch of biosimilar products. Today, as is shown on the next row, the most common reason for partners wanting to access ENHANZE is for competitive differentiation, either with the goal of maintaining a leading market position or indeed to create that leading market condition in the face of multiple competitors. On the third row, we have also demonstrated the potential to deliver 2 different compatible therapeutic antibodies in a single subcutaneous injection, potentially simplifying and streamlining treatment for patients. And this obviously has recently just been demonstrated with Roche's Phesgo. On the fourth row, while we mostly focus on IV to subcutaneous drug enablement, we can also extend the dosing interval for drugs that are already subcutaneous, meaning less frequent dosing and less frequent injections for patients. And this has been demonstrated with the approved drug, HyQvia. And then finally, and very importantly, there's also the potential for new intellectual property to be granted to the co-formulation product, providing exclusivity for 20 years for that co-formulated product from when the application was filed. Now we have been on Slide 7, showing momentum in ENHANZE really for the last 15 years. I can say that today we have more than 500,000 patients who've been treated commercially with ENHANZE-enabled drugs. Beginning on the left are what we call our Wave 1 products. These really were the products that demonstrated both regulatory and commercial success and have established the strong foundation we have with ENHANZE today. And these include HyQvia, Herceptin and MabThera. If I move now to the middle panel, in the end of 2019 we repositioned the company, we restructured and we sharpened our focus on our ENHANZE drug delivery technology. In 2020, we supported the launch of 2 Wave 2 launch products. These include DARZALEX SC, which is also known as DARZALEX FASPRO; and Phesgo, which is the fixed-dose combination of Herceptin and Perjeta. With, as an example, DARZALEX FASPRO gaining 40% share of total sales of DARZALEX in the U.S. in just 5 months after the launch, these products are off to a very strong start and they are the basis for strong relative revenue growth for the next several years beginning now. And if we move to the right-hand column, based on the broad development pipeline that we have and that I will review in just a moment, we predict multiple additional potential new launches in the coming years that will form Wave 3, Wave 4 and we also see a path to Wave 5 launches. And it is this growth in the portfolio and the multiple waves of launches that [Audio Gap]. I'll move to Slide 8. Today, we're already partners with 10 leading pharma and biotech companies who together have the option to use ENHANZE with up to 57 different types of treatments or targets. Our partners today are focused on a diverse range of diseases. We've seen most of our launches to date be in oncology. But as we'll review the pipeline, you'll see that we have partners now working in neurology, autoimmune disease, rare disease. ENHANZE can enable products across a very wide range of different diseases and conditions. And a great example of this, I wanted to highlight, is the deal we just signed at the end of 2020 with Horizon. We're working together to develop a subcutaneous form of TEPEZZA with ENHANZE, which is for a greater autoimmune disease called thyroid eye disease. This is a very important advance for patients. It has a strong commercial potential with peak sales projected at $3.5 billion. And we're very excited to be working on a subcu version of TEPEZZA with Horizon. Let me move to Slide 9 now and just review our business model. Just as an example I used with TEPEZZA, we focus on targeting large attractive markets and through ENHANZE, our goal is to provide meaningful competitive differentiation and benefits to our partners. Moving around the circle, as a result of this differentiation, we receive diverse revenue streams, both through receiving milestones and also through the royalty revenues, which is resulting in growing cash flow for Halozyme, which we then use to return cash to our shareholders. Now with that, let me transition to give a brief update on our portfolio, beginning with the marketed products, which is shown on Slide 10. The Wave 1 and 2 products that we have reviewed are shown on the left-hand side. We've already discussed those, so I won't provide any more details. But where I want you to focus is on the right-hand panel. You can see here shown in blue is the total revenue potential shown in 2020 and 2024 for the Wave 2 products, so FASPRO and for the Phesgo products. You can see this is projected to double between 2020 and 2024. And what's important for Halozyme is how much of this market and use we can convert to subcutaneous us, because recall, we receive on average a mid-single-digit royalty on the net sales. Let me turn now to the near-term royalty revenue growth that has really been driven by these Wave 2 products, and this is shown on Slide 11. For 2021, we project a doubling of our royalty revenue from the 2020 number, which was $88.6 million. And this growth you're seeing here, this doubling and the strong momentum is really driven by these Wave 2 launches, predominantly by the growth we're projecting in DARZALEX FASPRO and DARZALEX SC outside the U.S. And this is because these products are continuing to penetrate into the already launched markets. But throughout 2021, we're also expecting launches in multiple additional markets. Now on Slide 12 is an overview of our development pipeline shown by the phase of development. At the end of 2020, we had 11 products in development, and we expect 5 new products to enter development in 2021, which will result in 16 products. At the bottom of the slide, you can see our most advanced products. Those are the ones that are in Phase III development. This includes efgartigimod, which is argenx' product, which is already in 4 Phase III clinical studies; and also, Roche's atezolizumab, which is also called Tecentriq. Now what's important about the products we have that are in Wave 3 development is that based on standard development times we've seen for development of ENHANZE, which is 4.5 to 5 years, these could be potential launches in the '23 to 2025 time frame. So Wave 3 launches, 2023 to 2025. And we actually, on this list of the Phase I studies, expect 2 additional products to enter Phase III development in 2021. So to summarize, we'll have 4 Phase III products in 2021, all with the potential to launch in that time frame, 2023 to 2025. For the 7 remaining Phase I products plus the 5 new starts, those would have the potential to launch in '25 to '27 based on standard development time lines and assuming those products move forward too, and those from the Wave 4 potential launches. I think you can agree based on the products we're showing here, we have an exciting portfolio and an exciting dynamic with these multiple waves of future potential launches based on what we have line of sight of in development today. But if I turn to Slide 13, I can also talk about the potential for Wave 5, which is really driven by the far right-hand column, where we see that all of our current partners, they have 20 currently open slots that they can move forward and bring new products into development that we don't know about today. And we also continue an active dialogue with a number of companies with regard to signing new ENHANZE collaboration and licensing agreements. And this really is the beauty of ENHANZE and the beauty of our ENHANZE business model, this potential to be adding multiple new products into development, which will have the potential to result in future waves of launches and with that, continued growth and evolution of our royalty revenue stream. Now let me move to Slide 14 and just review our capital allocation strategy. With the attractive and growing cash flow, we have as our first priority ensuring we maintain a strong balance sheet. As of the end of the fourth quarter of 2020, we had $368 million in cash and cash equivalents. In addition, we have also halved the convertible debt as is described here. Moving to the second part of this, the share repurchases. Based on our projected free cash flow and align to with the goal of returning capital to our shareholders, in 2019, we announced and initiated a 3-year, $550 million share repurchase program. As of the end of the fourth quarter of 2020, we had already repurchased $350 million of that $550 million target. The average price for this $350 million repurchase was $19.88. And with our share price today exceeding $40, I think you would agree that the share repurchase is an excellent way of returning capital to our shareholders. And the final part of our strategy is our focus on both internal and external growth. We're going to continue to fund ENHANZE growth and consider an acquisition of an additional platform that could drive incremental revenue growth for Halozyme. Our goal here with this acquisition would be to apply our demonstrated expertise in building a multi-partner, high-value, lean, scalable business, and with our expertise accelerate the growth and potential of that platform. I can tell you that I certainly could not be more excited for the progress we have demonstrated, but also for the potential we have for Halozyme. And on Slide 15, let me just close on our commitment to ESG. Halozyme is committed to the highest standards of ESG, and I'm very excited to say that in 2020, we increased our focus on communication of this and published our first annual ESG report that you can find in the Investor Relations section of the website. The successful position we've seen of Halozyme to -- we are today would not have been accomplished without our exceptional team of employees and without the support of our Board of Directors. I have absolutely no doubt that the strong diversity of our team across many dimensions has been absolutely key to this success. Thank you for your attention. Thank you for your support of Halozyme. And with that, I'm happy to take any questions. We'll pause a moment. The operator so far has told me we have received no questions today. I'll just give it a minute more and see if there is any questions coming in. All right. With that, it doesn't appear there are any questions. Thank you, again, for your support and attention to Halozyme. And that concludes the meeting for today. Thank you.