Dynavax Technologies - Q2 2023

Transcript

Operator (participant)

Good day, ladies and gentlemen, welcome to Dynavax Technologies' second quarter 2023 financial results. As a reminder, this conference is being recorded. At the end of the company's prepared remarks, we will open the call for questions and provide specific instructions at that point. I would now like to turn the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications. You may begin.

Paul Cox (VP, Investor Relations, and Corporate Communications)

Thank you all for participating in today's call. Joining me today from Dynavax are Ryan Spencer, Chief Executive Officer; Donn Casale, Chief Commercial Officer; Rob Janssen, Chief Medical Officer; and Kelly Macdonald, Chief Financial Officer. Earlier today, Dynavax released financial results for the second quarter ended June 30th, 2023. Copies of the press release and a supplementary slide presentation are available on Dynavax's website. Before we begin, I advise you that we will be making forward-looking statements today based on our current expectations and beliefs, including, but not limited to, potential market sizes, market segmentation, effective marketing efforts, future expected market share and related growth rates, and related ACIP recommendation impact on each.

Financial guidance and trends, including revenue, profitability, cash flow, and sufficiency of current capitalization, timing and results of FDA submissions, clinical trial starts and data readouts, and potential future uses of or demand for our CpG 1018 adjuvant. These statements involve risks and uncertainties, and our actual results may differ materially. These risks are summarized in today's press release and detailed in the Risk Factors section of our SEC filings, including today's quarterly report on Form 10-Q. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements. With that, I will now turn the call over to Ryan.

Ryan Spencer (CEO)

Thanks, Paul. Good afternoon, everyone, and thank you for taking the time to join us to review Dynavax's results for the second quarter of 2023. We are pleased to share the results of yet another impressive quarter for Dynavax, including outstanding progress for HEPLISAV-B, our adult hepatitis B vaccine, which delivered $56 million in quarterly net product revenue. These results reflect our team's success in driving the expansion of the adult hepatitis B vaccine market and capturing market share. As a result of the strong HEPLISAV-B performance in the first half of 2023, along with the growing enthusiasm that we see in the market, we are significantly raising our revenue expectations for the full year.

We now expect HEPLISAV-B net product revenue to be in the range of $200 million-$215 million, compared to the prior range of $165 million-$185 million. Last year, HEPLISAV-B revenue doubled compared to 2021, and with our increased guidance range, we now expect growth of 58%-70% this year. Based on our exceptional commercial execution, we have strengthened our financial proposition, with cash and investments increasing to $682 million at quarter end, and we expect positive free cash flow for 2023 in total. This position enables us to support our efforts to maximize the HEPLISAV-B opportunity while making the appropriate investments to advance our clinical portfolio. We continue to make progress in advancing our clinical pipeline of three vaccine candidates for Tdap, shingles, and plague.

Rob will walk through our achievements and expectations for our clinical programs in a few minutes. Additionally, we continue to identify and review strategic opportunities to help accelerate our growth and further diversify our product portfolio and future commercial opportunities. We are focusing on prioritizing external opportunities in the following two categories: First, commercial or late-stage assets in the vaccine space to leverage our expertise in the field and our fully integrated capabilities. Second, high-synergy commercial assets within the infectious disease space that would broaden our focus to include therapeutic modalities outside of vaccines. We remain focused on disciplined capital allocation strategy in our efforts to generate significant value and accelerate growth, and we look forward to providing updates on this front in the future. I'll now turn the call over to Donn, so he can provide more details on the tremendous HEPLISAV-B performance in the second quarter.

Donn Casale (Chief Commercial Officer)

Thank you, Ryan. I'm excited to share more details about another very strong quarterly performance for HEPLISAV-B and our continued progress in driving overall market growth, as well as capturing market share within what we believe is the best-in-class hepatitis B vaccine. The hepatitis B market continues to grow in the U.S. following the ACIP's universal recommendation for hepatitis B vaccination, which now represents a large and growing market opportunity. We believe this recommendation will be a significant catalyst for growth and estimate the hepatitis B market opportunity in the U.S. could grow to over $800 million by 2027. We continue to see indicators of market expansion, with hepatitis B vaccine market growth of approximately 40% year-over-year in Q2. HEPLISAV-B continues its positive trend towards securing a majority market share within the expanding hepatitis B market.

We are demonstrating gains in market share and estimate that HEPLISAV-B's total market share increased to approximately 39%, compared to approximately 32% at the end of the second quarter last year. As Ryan stated, HEPLISAV-B's performance in the second quarter exceeded expectations. In the quarter, net product revenue for HEPLISAV-B grew 73% year-over-year. These quarterly results were once again driven by HEPLISAV-B's strong performance in two critical market segments: retail pharmacy and integrated delivery networks, or IDN. For IDN, at the end of the second quarter, HEPLISAV-B's market share increased to approximately 53%, compared to approximately 39% at the end of the second quarter last year.

In the IDN segment, we are seeing strong conversion from large customers that have started to adopt the universal recommendation, driving meaningful increases in their hepatitis B vaccine purchases and vaccination in appropriate patients that exceeded 2019 pre-pandemic levels. We are working with these large health systems and others to drive ongoing adoption of the universal recommendation during the second half of the year. In the retail pharmacy segment, we continue to make tremendous progress. During the quarter, HEPLISAV-B dose volume increased 78% year-over-year. We are excited about this result, as market growth is the number one indicator that retail pharmacy customers are adopting the universal recommendation. Driving market growth and retail will be our primary sales and marketing focus moving forward.

Although our market share for the quarter remained consistent at 45% year-over-year as a result of buying patterns of several top retail chains, we are extremely confident in our ability to be the market leader within this critical segment. We have well-established, strong collaborative relationships across the top retail chains and have launched key headquarter-sponsored marketing initiatives and tactics across the segment. Given this, we will be optimizing our sales force to expand our promotional reach in the segment to drive market expansion. This expanded sales force reach will call on headquarters, divisional, regional, and district leaders across the top retail chains. In addition to increasing our sales force reach, we are also excited to see the full impact of the collaborative marketing initiatives launched at the end of the second quarter.

We anticipate these headquarter-sponsored initiatives, plus our expanded sales force reach, will enable continued strong market growth and market leadership within this important segment. We are focusing our efforts on the retail pharmacy and IDN segments, as we expect to see most of the anticipated market growth from the ACIP universal recommendation in these segments. Both segments have the required institutional control, infrastructure, capabilities, and patient volume that can help drive universal uptake. We expect these two segments will represent approximately 60% of the hepatitis B market by 2027, compared to approximately 44% in 2022. We are well positioned in both segments, with HEPLISAV-B now capturing approximately 50% of the market share in these segments combined. In summary, we had an outstanding quarter, reaffirming our confidence in HEPLISAV-B becoming the market leader in the expanding hepatitis B vaccine market.

We are encouraged by our progress and momentum in the key segments of retail pharmacy and IDN, both of which significantly contributed to the performance of HEPLISAV-B exceeding expectations for the second quarter. This quarter's record HEPLISAV-B revenue results reflects the continued expansion of the hepatitis B vaccine market and growing demand from physicians, pharmacists, and patients for our best-in-class hepatitis B vaccine, both made possible by our team's strong commercial execution. I will now turn the call over to Rob to take you through our clinical pipeline.

Rob Janssen (Chief Medical Officer)

Thank you, Donn. Over the second quarter, we made important progress on our pipeline, I'm pleased to provide our recent advancements and our plans for continued execution throughout 2023. I'll start with our shingles vaccine program, Z-1018. In June, we presented the results from a phase I randomized, active-controlled, adjuvant dose escalation trial to evaluate the safety, tolerability, and immunogenicity of Z-1018 at the 2023 Annual Conference on Vaccinology Research. In the study, we demonstrated that Z-1018 showed favorable tolerability without observed safety concerns in healthy adults aged 50-69 years. All Z-1018 groups demonstrated high antibody and CD4+ T cell responses. These results demonstrate the opportunity to develop a shingles vaccine with improved tolerability and comparable efficacy, They support the continued development of Z-1018.

In the second half of 2023, we plan to assess the regulatory pathway with the FDA to support the initiation of a phase I trial in early 2024. Let's turn to our Tdap-1018 program. It's an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis, or Tdap. We're focused on improving the durability and protection against pertussis by leveraging our CpG 1018 adjuvant in a novel Tdap booster vaccine. We recently completed a pertussis challenge study in the non-human primate model, which demonstrated protection from disease and robust Th1 responses. We also recently received Type B pre-IND meeting feedback from the FDA on the Tdap-1018 clinical development and regulatory pathways. Together, results from our phase I study and our non-human primate study, as well as feedback from FDA, support proceeding to a human challenge study....

We expect to submit an Investigational New Drug Application to FDA in the fourth quarter of 2023 to support the initiation of the human challenge study. Moving on to the plague program. We're conducting a phase II trial evaluating the immunogenicity, safety, and tolerability of a two-dose plague vaccine candidate that is adjuvanted with CpG 1018. This is a collaboration with and funded by the U.S. Department of Defense. The CpG 1018-adjuvanted vaccine candidate's mechanism of action has the potential to speed up time to protection with fewer doses, compared to the three-dose alum-adjuvanted vaccine under development by the Department of Defense. Earlier this year, we completed enrollment in part two of the phase II program, with top-line data expected in 2024.

In July, Dynavax and the Department of Defense executed a contract modification to support advancement into a non-human primate challenge study, with the agreement now totaling $33.7 million through 2025. We look forward to continuing to make progress across these programs during the rest of this year. In addition, we're excited to announce the establishment of our scientific advisory board, comprised of renowned leaders in vaccine research and development and infectious diseases. We look forward to working with this advisory board in advancing our pipeline, as well as supporting the evaluation of internal and external opportunities. I'll now turn the call over to Kelly to review our financial results.

Kelly Macdonald (CFO)

Thank you, Rob. I'm thrilled to report on another strong quarter. I'll review the key financial results for the second quarter and then review our updated guidance for the full year. Please note that all financial comparisons are versus the prior year period, unless otherwise noted. Please also refer to our press release and Form 10-Q for the detailed financial information. Starting with revenue. Total revenues for the second quarter of 2023 were $60 million, driven by HEPLISAV-B net product revenue of $56 million. Compared to the second quarter of last year, HEPLISAV-B net product revenue grew by 73%.

We're excited about the uptake trajectory for HEPLISAV-B, including our continued growth in key market segments, therefore raising our HEPLISAV-B net product revenue guidance for the full year to $200 million-$215 million, compared to the prior guidance of $165 million-$185 million. This represents an almost 20% increase at the midpoint, reflecting our confidence in the continued product growth this year. We are also pleased with the continued trend in the margin profile for HEPLISAV-B, with gross margins of approximately 76% in Q2, compared to about 69% last year, we continue to expect gross margins to average in the mid-70s for the full year.

Other revenue was $4 million for the second quarter, representing revenue related to the plague vaccine program in collaboration with, and fully funded by the U.S. Department of Defense. Now turning to our research and development expenses for the quarter. These increased to $13 million, compared to $10 million for the prior period. The increase was driven by continued advancement in our clinical pipeline program. Selling, general, and administrative expenses for the quarter were $37 million, compared to $36 million for the prior period. The increase was primarily driven by higher personnel-related costs and an overall increase in targeted marketing efforts to drive HEPLISAV-B market share and drive market expansion in key segments that we believe will disproportionately benefit HEPLISAV-B. Now, turning to net income.

We recorded GAAP net income of $3 million, or $0.03 per share, basic and diluted in Q2, compared to GAAP net income of $129 million, or $1.02 per share basic, and $0.87 per share diluted for the prior year period. Moving to the balance sheet. We ended the second quarter with cash, cash equivalents, and marketable securities of approximately $682 million, an increase compared to our year-end balance of $624 million. Based on our current operating plan, we continue to expect to finish 2023 with a positive free cash flow for the year.

Additionally, we continue to believe this level of capital is sufficient to support our core business, enabling us to drive sustainable growth in HEPLISAV-B to capture a majority market share and bring our R&D portfolio of vaccine candidates forward without needing to return to the capital markets. We are also pleased to update our full year 2023 financial guidance expectations. As mentioned, we are raising our HEPLISAV-B net product revenue expectations to be between $200 million-$215 million. We are maintaining our operating expense guidance of R&D expenses between $55 million-$70 million, as well as SG&A expenses between $135 million-$155 million.

We do expect to come in at the lower end of our R&D expense range due to the timing of Tdap program clinical trial startup activities taking place later this year and into early 2024. In closing, we are proud of another successful quarter marked by continued HEPLISAV-B outperformance, further strengthening of our financial position and pipeline progress, progress. We also continue to be extremely thoughtful in how we allocate our capital to accelerate growth and build beyond our current base business. Our strong capital position and commercial execution have provided us with strategic flexibility to identify and pursue external opportunities to complement our organic growth as we strive to deliver long-term value to our shareholders. We are excited about our progress to date, and we look forward to continuing to deliver on our goals for 2023. Thank you everyone for your attention today.

Operator, we would now like to open the Q&A portion of today's call.

Operator (participant)

Thank you. To ask a question, you'll need to press star one one on your telephone. To withdraw your question, please press star one one again. Please wait for your name to be announced. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question comes from the line of Matthew Phipps with William Blair. Your line is now open.

Matthew Phipps (Group Head of Biotechnology Equity Research)

Good afternoon. Just really congrats on a great quarter for you guys. Great to see. I guess first for Donn, given what some of the commentary you had around, kind of retail growth and just where your market share is, is the overall market expanding as you expected, or is it maybe even a little bit faster than you expected to get to that $800 million? I guess I would have thought it'd be a little bit slower in this first year, picking up a little bit later. Curious where you think you are in that kind of trajectory to get to $800 million.

Ryan Spencer (CEO)

Hey, Matt, hi, thanks for the question. Regarding market growth, as I mentioned on the comments, you know, market growth is so critical, obviously, in retail and IDN, but specifically to answer your question, market growth is actually accelerating more so than we forecasted. We're really pleased to see the uptake with the recommendation in both segments, both retail and IDN. So that's something that we're really excited about in those segments.

Matthew Phipps (Group Head of Biotechnology Equity Research)

Great, thanks. curious, on the Tdap non-human challenge study, did that study include a control arm such as Boostrix?

Ryan Spencer (CEO)

It, it did.

Matthew Phipps (Group Head of Biotechnology Equity Research)

Can you comment on any of that, or do you plan to present that at some meeting coming up?

Ryan Spencer (CEO)

We don't have, we don't have any plans to present that non-human primate data at a meeting, on its own. In, in general, we saw strong T cell responses, which with the adjuvant, compared to Boostrix, compared to the control arm. We were, we were pleased with the results compared to the, compared to the comparator.

Matthew Phipps (Group Head of Biotechnology Equity Research)

Yep. Awesome.

Ryan Spencer (CEO)

Just to put a finer point on, on, on Donn's question before, Matt, just, just so you're clear. As he mentioned, it's accelerated faster than we projected. We haven't, at this point, changed the overall time on our long-term guidance around the, the, the peak. We're going to have to watch that and see how that, how that kind of continues to evolve over time, to see if it, if it's accelerated or the shape of the curve just got a little steep on the front end.

Matthew Phipps (Group Head of Biotechnology Equity Research)

Yep, understood. Thank you all, and congrats again.

Ryan Spencer (CEO)

Thank you so much.

Operator (participant)

Thank you. One moment for our next question, please. Our next question comes from the line of Ernesto Rodríguez-Dumont with Cowen. Your line is now open.

Ernesto Rodriguez Dumont (VP and Biotech Equity Research Analyst)

Hi, congratulations on a great quarter. Thank you for taking my question. One question on Hep B. You have guided previously for gross margins in the low 70s. Now you've reported margins on the mid, high, 70s. Is that something that we should consider looking forward, maybe improvement in your estimate in the growth margins, or is that something more short-term?

Ryan Spencer (CEO)

Kelly, you want to take that one?

Kelly Macdonald (CFO)

Sure. Hi, Ernie. Thanks for the question. As you know, and as you've seen sort of in the lumpiness over the last couple of years in COG, we've made pretty meaningful investments in our manufacturing facility over in Germany. We're really excited to see some of the yield improvement translating to improved margins, especially in this quarter. To answer your question directly, we would expect margins in this level to continue here on out, with mid-70s% margins for the year on average.

Ernesto Rodriguez Dumont (VP and Biotech Equity Research Analyst)

Got it. Thank you. That's helpful. If I may, on the shingles vaccine, on the presentation, any feedback that you got from the presentation from physicians? In particular, have you disclosed also the Grade 3 or Grade 4 AEs that were presented, in particular, the one that led to the discontinuation of treatment?

Ryan Spencer (CEO)

Rob, do you mind answering that one?

Rob Janssen (Chief Medical Officer)

Yeah, we did. The grade two, three, and four were similar between the two groups, and the ones that led... There was one that led to discontinuation in the lowest Z-1018 group, but it wasn't related to vaccine. It was thought to be related to vaccine from, pardon me, by the investigator, but by the sponsor, we would not consider it to be related.

Ernesto Rodriguez Dumont (VP and Biotech Equity Research Analyst)

Got it. Okay. Thank you. Appreciate it. Congrats again.

Ryan Spencer (CEO)

Thank you.

Operator (participant)

Thank you. One moment for our next question, please. Our next question comes from the line of Roy Buchanan with JMP Securities. Your line is now open.

Roy Buchanan (VP and Equity Research Analyst)

Thanks for taking the question. Great, great quarter. First one, I guess on, on the plague, the new grant, just how much was left in the original part of the grant? Do you have access to that entire amount? Then how far does the new total get you? I think the PR says, starting the non-human primate challenge trial, but seems like it probably gets you quite a bit beyond that. I guess help us understand what the load from the non-human primate challenge trial are as far as getting you to an approval? Thanks.

Ryan Spencer (CEO)

Alright, thank you. If you recall, the, the original contract was about $22 million. We still have full access to that contract. That was to, to focus on the, completion of the, of the phase II trial. There's a there's a number of amendments that expanded the contract by, about $11 million in total, with the largest piece being the non-human primate study, which is, I think, to get you a the, the crux of your real question is how far does that get us? That's one component of a longer-term pathway, to support eventual approval that would leverage, non-human primate challenge studies. That's the first step in that process, which is covered by, this particular contract expansion.

Roy Buchanan (VP and Equity Research Analyst)

Okay, great. Then just a quick one on shingles. I know you guys still need to talk to the FDA and probably will have more to say after that. I guess, I'm just curious your thoughts around if you have to go ex-U.S. for the next trial, is that leverageable for a U.S. approval, or is it, is a base, base assumption that you might have to forgo the U.S. market? If the latter is the case, does it make the most sense to license the candidate out? Thanks.

Ryan Spencer (CEO)

Yeah, our, our current strategy is definitely to include the U.S. market. As, as you indicated, we'll have to still talk to the agency about our opportunities for a pathway in the U.S. Anything, any sort of strategy that took us into ex-U.S. markets for efficacy would be part of a, of a, a plan to utilize that data to support a U.S. licensure.

Roy Buchanan (VP and Equity Research Analyst)

Okay. Thank you.

Operator (participant)

Thank you.

Ryan Spencer (CEO)

Thanks.

Operator (participant)

One moment for our next question, please. Our next question comes from the line of Jon Miller with Evercore ISI. Your line is now open.

Jon Miller (Equity Research Associate and Managing Director)

Hey, guys. Thanks so much for taking my question. I guess I'll join everybody else in congratulating you on a great quarter. As a new analyst covering the story, I can only assume every quarter will be as exciting as this one.

Ryan Spencer (CEO)

Thanks. We appreciate that.

Jon Miller (Equity Research Associate and Managing Director)

That's my question. No. Maybe, maybe just one or two from, from me. When you say you're optimizing your commercial efforts for retail and IDN segments as, as the fastest growing segments, can you maybe give me a little more color on what levers are available to you there from versus other segments? Maybe what the biggest drivers of share growth there will be. Given the rapid growth you've seen since the ACIP rec, are you seeing any signs that a pushback from payers, price sensitivity or anything like that in the retail segment that may be influencing further growth there?

Ryan Spencer (CEO)

Why don't I, why don't we break this up? I'll take the second question quickly, and then let Donn provide some more insight around the optimization within retail. But in general, and this is really important as it relates to the vaccine business, there's very little payer involvement or engagement in the vaccine business. It's, it's generally good medicine and, and seen as being, you know, it's welcomed by payers typically. So we have not seen any pushback as it relates to the recommendation from a payer or pricing perspective. So and I don't-- we don't expect that would, would, would, would have any impact on the ability for the market to, to grow. That really comes down to physician recommendation and patient acceptance.

As it relates to the operational changes within, the field team and, and the marketing, I'm sorry, the retail segment, why don't I turn it over to Donn?

Donn Casale (Chief Commercial Officer)

Yeah. Hey, Jon. So yeah, regarding the optimizing of sales force, optimization of sales force, mainly as it relates specifically to retail, as I mentioned on the call, you know, the targets will be around not only headquarters, which is where we've been quite a bit for, for quite some time, establishing relationships that allows us to deploy marketing initiatives, but also engaging at the regional, the divisional, and the district levels of these retail chains, which is so critical to pull through initiatives and education, whatever it may be, to increase identification and recommendation of hepatitis B vaccine. So the whole point there is to really engage the retailer at those different levels, and that's part of this process, ensuring we have the right sales force attack to allow us to drive forward the recommendations throughout the top chains.

At the same time, within the hospital segment, IDN segment, we've gone to a more vertical structure that allows account executives to own the decision-makers at the top, as well as pull through at the clinic level, to drive the recommendation. We feel really good about where we're at, and a lot of it's based upon a lot of the learnings we've been able to gather over the last several years, in launching HEPLISAV-B.

Jon Miller (Equity Research Associate and Managing Director)

Great. That, that makes sense. Maybe on the Tdap program, do you have any more color on, on that challenge study that you're planning on starting by the end of the year? How big it's gonna be and, and how that'll support further development of that program?

Ryan Spencer (CEO)

Yeah, we haven't commented on, on actual size just yet, but as far as the, how it fits into the whole picture, obviously demonstrating that the product can be protective, in humans is critical, and it'll allow us to then have a immunogenicity endpoint that we can use to bridge back to in larger studies. This is a, an initial, challenge study. It's likely and expected that we would have to do larger challenge studies, in, in addition to this, this one, as part of a longer-term development plan. It's important to also recognize this is a new, study design that hasn't really been done before with a vaccine for pertussis.

We're working with an investigator now to help support his, his development of a challenge model, where we can use a vaccine and allow the disease to progress to identify and test efficacy in humans. You know, this pilot study is important on a number of fronts, one, for our product and also to establish the model.

Jon Miller (Equity Research Associate and Managing Director)

That makes sense. Thanks so much.

Ryan Spencer (CEO)

Absolutely. Thank you for the question.

Operator (participant)

Thank you. We have no further questions at this time. I would like to hand the conference back over to Mr. Ryan Spencer, Chief Executive Officer, for closing remarks. You may begin.

Ryan Spencer (CEO)

Thank you, operator, and thank you all for joining us today. We appreciate your interest in Dynavax. We are very excited about our continued progress and the strength of our position, which we believe allows us to focus on executing our long-term objectives to drive value through advancement of meaningful products to help protect the world from infectious diseases. We look forward to updating you on our progress. Operator, you may end the call.

Operator (participant)

Thank you. Ladies and gentlemen, thank you for joining us today. This concludes today's conference call. You may now disconnect. Everyone, have a wonderful day.