BioNTech SE Stock Price: Quote, Forecast, Splits & News (BNTX)

Company Profile

BioNTech SE Price & Performance (BNTX)

Market Summary

Updated May 16, 8:00 PM UTC

BioNTech SE

$92.77USD

+$0.43 (+0.47%)

After Hours

-$0.72 (-0.78%)

Prev Close

$92.34

Market Cap

$22.30B

Day Range

$91.80 - $93.44

Open

$93.22

P/E Ratio

-26.1

52W Range

$76.53 - $131.49

24H Volume

$64.29M

Dividend Yield

0.00%

EPS

-3.56

Latest News

Acquisition Expands BioNTech's Oncology Pipeline and Global Reach
May 5, 2025
BioNTech has completed its acquisition of Biotheus, a Chinese biotech firm, securing full rights to the promising BNT327 bispecific antibody and other pipeline assets. This move enhances BioNTech’s manufacturing capabilities and research presence in China, positioning the company for broader global clinical development and future oncology product launches.123
Investor Sentiment Mixed as BioNTech Faces Regulatory and Revenue Challenges
May 7, 2025
BioNTech’s stock has seen volatility amid concerns over U.S. regulatory changes and declining COVID-19 vaccine revenues. Analysts remain cautiously optimistic, citing a strong oncology pipeline and robust cash reserves, but warn of risks tied to evolving vaccine policies and the need for new product approvals to sustain long-term growth.456
Leadership Changes at FDA Spark Uncertainty for BioNTech and Peers
May 7, 2025
The appointment of Vinay Prasad as head of the FDA’s vaccine division has unsettled investors, given his critical stance on vaccine approvals. While some analysts see potential for faster drug approvals, others highlight possible hurdles for BioNTech if new treatments lack clear clinical benefits, keeping the sector on alert.578

What's Happening

Peers

Earnings

Report Date

May 5, 2025

Reported Revenue

197.8M

Beat +32.85%

Avg 1d Change

3.38%

Report Period

Q1 2025

Reported EPS

-2

Beat +29.27%

Implied Move 1d

8.95%

Transcript

10m 34s

As a reminder, the slides we will be using during this call and the corresponding press release we issued this morning can be found in the Investor Relations section of our website.

10m 42s

On the next slide, you will see our forward looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U. S. Securities and Exchange Commission. Forward looking statements on this call are subject to significant risks and uncertainties, and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements. On slide three, can find the agenda for today's call. Today, I am joined by the following members of BioNTech's management team. Ugar Zahin, Chief Executive Officer and Co Founder, Ozem Toreci, Chief Medical Officer and Co Founder, Jens Holstein, Chief Financial Officer, Ryan Richardson, chief strategy officer. With this, I would like to hand the call over to Ugar.

11m 22s

Thank you, Michael. A warm welcome to all those joining us today. As BioNTech has grown and evolved significantly over the years, our vision has remained unchanged. To translate science into survival, by building an immunotherapy powerhouse, and becoming a fully integrated biopharmaceutical company with multiple approved products. In today's call, we will provide updates on key achievements from this quarter related to our strategic goals. In oncology, we presented new clinical data for our two pan tumor priority programs our bispecific immunomodulator BNT57 and our mRNA cancer immunotherapies at recent medical meetings. For BNT-three twenty seven, our bispecific anti PD L1 anti VGS antibody we've presented new phase two data in small cell lung cancer at the European Lung Cancer Congress with preliminary overall survival data in the first time setting. At AACR, we reported the first data from our Phase I trial evaluating BNT327 in combination with our top two targeting ADC BNT325, signaling that this combination appears to have a manageable safety profile and may have synergistic clinical efficacy. This data strengthened our conviction in BNT327 as a next generation IO back book. We will continue to drive its clinical with the aim to establish a new standard of care for cancer patients who are currently treated with approved checkpoint inhibitors and for some that are currently not.

13m 12s

For our mRNA cancer immunotherapies we reported data from ongoing phase one trial evaluating BNT116 our off the shelf fixed vac mRNA immunotherapy candidate in combination with cemiplimab combination cemiplimab in PD L1 positive failed patients with non cancer lung cancer.

13m 35s

Data indicate that our off the shelf mRNA immunotherapy may be synergistic with checkpoint inhibition. Likewise, we are progressing our individualized mRNA cancer immunotherapy pathogens [indiscernible] randomized Phase two trials. Early in 2025, we published two manuscripts [indiscernible] our insight from two Phase one trials which demonstrate the polyspecific induction of long term near antigen specific T cell responses and strongly support the anticipated mode of action of our individualized mRNA therapy approach in multiple cancer indications. We are also advancing towards commercialization in oncology with the first BLA submission for BNT22 three. Our HER2 ADC planned by the end of twenty twenty five pending regulatory feedback. Regarding our COVID nineteen vaccine franchise, we initiated preparations to be on track to roll out a variant adapted COVID-nineteen vaccine for the upcoming season.

14m 50s

During the quarter, we closed the BioNTech acquisition and now hold global control over BNC three sixty seven. We were able to achieve all this while maintaining a strong financial position. Leveraging our COVID-nineteen vaccine business and our strong financial position we are significantly investing in the clinical development of our priority oncology programs across key tumor indications. Before I continue with our strategy in oncology, I would like to provide an update regarding our management board. Today, we announced our new Chief Financial Officer, We will welcome Ramon Sapater on July 1, 2025. Ramon is an accomplished leader with deep finance experience who will be taking over from Jens an exciting phase. He will join BioNTech from Novartis Global Biomedical Research Organization where he has been serving as CFO since 2022. He will introduce himself in the next analyst and investor call in August. With this and as previously shared our current CFO Jens Holstein will retire at the end of his term at the June as tenth. [indiscernible] thank you for your excellent financial leadership and your significant contributions to BioNTech's successful trajectory. We wish you continued success and fulfillment in the next chapter of your journey. Now coming back to our oncology strategy, one of our first convictions for cancer immunotherapy is that we believe that future cancer treatment and particularly the desire to increase cure rates in human cancers will be driven by combination therapy exploiting compound classes is potentially synergistic mode of action.

16m 57s

Driven by our vision, we want to address the full continuum of cancer across different states. From resected cancers which are in the adjuvant stage and have a higher risk for relapse to early stage metastatic cancer as well as the late stage cancers which are refractory to different types of treatment. We have built a pipeline of compounds from different RAC classes that are well suited to achieve this. Following novel novel combinations of immunomodulators with targeted therapies and mRNA cancer immunotherapies. With a clear focus we will continue to invest in our technologies and drug candidates that have the potential to improve outcomes for patients across wide range of tumor types. We believe that our two priority pan tumor programs our mRNA cancer immunotherapies, fixed fact and INEST, and our bispecific anti PDS. L1 anti VG [indiscernible] have disruptive potential and are aligned well with our vision. It's successfully developed and approved we believe these programs could establish a new standard of care and enhance patients outcome in multiple cancer indications globally. We are significantly investing in the clinical development of this program across various cancer types building up commercial functions for the future commercialization in key markets, and enhancing manufacturing capabilities to support both clinical trials and commercial supply.

18m 39s

I will turn the call over to Estem to provide more details on SELECT. Clinical programs.

18m 47s

Thank you, Ugur. Glad to be speaking with everyone today. Our first oncology programs are moving towards commercial stage. We continue to advance toward our first BLA submission in oncology with BNT323 in HER2 expressing second line endometrial cancer.

19m 7s

Alongside BNT323 and our mRNA cancer immunotherapies, BNT327 is a key program in our development pipeline. With first global pivotal clinical trials in triple negative breast cancer small cell, and non small cell lung cancer. BNT327 by co localizing the blockade of PD L1 and VEGF A signaling to the tumor is being developed with the aim to deliver superior antitumor immunomodulatory and anti angiogenic effects compared to individual targeting of PD L1 and VEGF A and with the potential to minimize adverse events associated with systemic anti VEGF A therapy.

20m

We now have data from over one thousand patients across indications, which further strengthens our conviction in this asset. With the NTAPDL1, and anti VGFA mechanisms, being validated across numerous tumor types and in some cases in combination we have a clear roadmap for development. The first wave is focused on small cell and non small cell lung cancer, and TNBC, as key indications to establish BNT327 combined with standard of care chemotherapy with first approvals then for the first line settings of these indications. We have made continuous progress over the past month in researching these indications.

20m 53s

Our second wave of development with BNT327 reflects that IO plus ADC combos are an emerging treatment paradigm in oncology. We have started exploring combinations of PNT321 with novel ADC candidates informed by single agent data for these ADCs. The last wave aims at further broadening our global clinical development program with BNT327 through additional novel combinations across tumor types. As mentioned, triple negative breast cancer is a priority indication for BNT327 based on unmet need we see for patients and based on the clinical profile observed to date. Stage IV TNBC patients face poor prognosis with a five year survival rate around ten percent. [indiscernible] depending on their PD L1 status, are either treated with checkpoint inhibitor combination with chemotherapy or with chemotherapy alone. PD L1 positive patients have a median overall survival of twenty three months while PD L1 negative patients have a median overall survival of fifteen point two months, as observed in the KEYNOTE-three 55 study. Data from a study in first line metastatic triple negative breast cancer showed that BNT327 in combination with chemotherapy has an encouragingly high objective response rate of seventy three point eight percent irrespective of PD L1 status. We also observed in the trial encouraging landmark overall survival rates, such as sixty nine point seven percent at eighteen months for BNT327 in this setting, suggesting that effect control of disease can translate into improved overall survival.

22m 57s

In addition to the encouraging efficacy data, the manageable safety profile was observed. With no new safety signals beyond those typically described for standard of care chemotherapy, anti PD-onePD L1 and [indiscernible] Based on these data, we believe that BNT327 has the potential to become a first line treatment option for triple negative breast cancer patients, including those not currently treated by existing IO therapies. We also plan to start a Phase III trial later this year in the first line setting. Moving to extensive stage small cell lung cancer an immunologically cold tumor for which high unmet need remains. With current standard of care treatment, the durability of responses is quite short and five year survival rate is only three percent. Today, patients are treated with a combination of atezolizumab and chemotherapy. And experienced a median overall survival of twelve point three months as observed in the EMPOWER 133 clinical trial. Based on our emerging data, we believe that BNT327 has the potential to improve clinical outcomes for patients with small cell lung cancer. At the European Lung Cancer Congress, we disclosed interim data from the Phase two clinical trial evaluating BNT327 in combination with chemotherapy as a first line treatment for patients with extensive stage small cell lung cancer.

24m 37s

Beyond the response rate of eighty five point four percent and median progression free survival of six point nine months, but ELCC data also included for the first time median overall survival data with a median overall survival of sixteen point eight months. In addition, a manageable safety profile was observed with no new safety signals beyond those typically described for chemotherapy agents and anti PD L1 and anti VEGF monotherapies. Are these data still immature? We are encouraged by the findings. These data support our decision to evaluate BNT327 in combination with chemotherapy in the ongoing global randomized Phase three clinical trial Rosetta, ZAN-one. We view non small cell lung cancer as one of our indications as it's not the one most prevalent cancers globally. Over eighty percent of patients are diagnosed at late stages. Long term outcomes depend on PD L1 status and histology but overall remain poor despite improvements in care. By checkpoint inhibitors. At the ASCO Annual Meeting last year, we presented data from the Phase I trial evaluating BNT327 as a monotherapy first line treatment in metastatic PD L1 positive non small cell lung cancer. BNT327 monotherapy treatment resulted in an overall response rate of forty seven percent the DCR of one hundred percent and the MPFS of thirteen point six months.

26m 27s

In summary, BNT327 indicated encouraging antitumor activity and manageable safety in this patient population. Safety events were consistent with those described for anti PD L1 and anti VEGF monotherapy. These data support our decision to start our global phase three trial non small cell lung cancer which is named Rosetta Lung O2. Rosetta Lung-two is designed to evaluate the potential of BNT327 dosed in combination with chemotherapy to survival outcomes when compared to standard of care pembrolizumab in combination with chemotherapy as a first line therapy for non small cell lung cancer patients without actionable genomic alterations. This trial is enrolling both non squamous and squamous histologies in two separately powered [indiscernible] And each sub study will enroll patients across all PD L1 status. The study includes a Phase two part with 40 patients seeking to establish the dose for the phase three randomized part in nine forty two patients. The co primary endpoints are progression free survival and overall survival. Today, are enrolling patients in the Phase two part and expect to progress to the phase three part [indiscernible] We will present the complete trial design for our two ongoing BNT 327 global phase three studies Rosetta Lung-one and Rosetta Lung-two, which are evaluating BNT327 dosed in combination with chemotherapy in first line small cell and non small cell lung cancer at the ASCO Annual Meeting at the end of this month.

28m 21s

We plan to have a significant presence at the ASCO Annual Meeting, including five clinical data updates, across our oncology pipeline, featuring not only our immunomodulator BNT327, but also our anti CTLA-four, BNT316, our B7 H3 targeting ADC, BNT324, and BNT142, our Claudine six T cell engager, We look forward to this and other conferences this year during which we plan to share more data updates across our investigational oncology pipeline as we continue our progress toward becoming a multi product oncology company.

29m 6s

To conclude, as I highlighted at the beginning of my section, we remain strongly convinced that our combination based pipeline offers this potential to positively impact the future outcomes for patients in key indications such as in breast and lung cancer. With that, I will now pass the presentation to our CFO, Jens Holstein.

29m 31s

Thank you, Eslem, and a warm welcome to everyone who has dialed in today's call.

29m 36s

Let me begin my section with our Q1 twenty twenty five financial results. In the first quarter of twenty twenty five we reported total revenues of approximately €183,000,000 driven mostly by the sale of our COVID-nineteen vaccines. Compared with €188,000,000 for the first quarter of twenty twenty four. This revenue figure is consistent with our expectations and reflects the seasonality we expect in an endemic COVID-nineteen environment. Research and development expenses reached €526,000,000 for the first quarter of twenty twenty five compared to $5.00 €8,000,000 for the comparative prior year period. The increase was mainly driven by progressing late stage clinical studies for pipeline candidates, including BNT327 in our ADC portfolio. SG and A expenses amounted to approximately €121,000,000 in the first quarter of twenty twenty five, compared to 133,000,000 in the comparative prior year period. The decrease was primarily driven by reduction in external services. For the first quarter of twenty twenty five, we reported a net loss of $416,000,000 compared to a net loss of EUR $315,000,000 for the comparative prior year period. Our basic and diluted loss per share for the first quarter of twenty twenty five was €1.73 compared to a basic and diluted loss per share of EUR €1.31 in the comparative prior year period.

31m 7s

As indicated in our full year earnings call in March 2025 will be a year of transition for BioNTech with the aim of becoming a multi product oncology company. We will continue to invest with discipline in our long term growth strategy namely by advancing BNT327 our mRNA cancer immunotherapies.

31m 28s

We believe that these two programs have disruptive and tumor potential. We ended the quarter in a strong financial position with €15,900,000,000 in total cash plus security investments. Among other things, the reduction compared to the year end figure is due to the payment of approximately US800 million dollars as part of the BioNTech acquisition.

31m 51s

It also reflects the payment made in connection with the settlement of a contractual dispute with NIH of about $792,000,000 We expect an additional payment of $400,000,000 associated with the settlement with the University of Pennsylvania to be reflected in our second quarter twenty twenty five financial position. With respect to both these settlements, we expect to be reimbursed partially by our partner Pfizer during 2025 and 2026. Building on our strong cash position and track record of financial discipline, we will continue to invest in our pan tumor oncology programs which we believe position us well to achieve sustainable growth. Turning to the next slide, we're confirming the company's financial guidance for the 2025 financial year with revenue expected to be in the range of 1.7 to EUR 2,200,000,000.0. R and D expenses expected to be in the range of €2,600,000,000 to €2,800,000,000 SG and A expenses expected to be in the range of EUR650 million to EUR750 million, and capital expenditures expected to be in the range of €250,000,000 to €350,000,000 Our revenue guidance assumes relatively stable vaccination rates, pricing and market shares compared to 2024. We anticipate a revenue facing similar to last year with the last three to four months of the year driving the full year revenue figure.

33m 17s

Please note that potential changes in law or government policy including tariffs and public health policy, and evolving public sentiment around vaccines and mRNA technology worldwide could further negatively impact our anticipated COVID-nineteen vaccine revenues and expense. While it is premature to comment specifically on the potential impact of tariffs, on the pharmaceutical industry at this stage, actively monitoring the situation and evaluating potential risk mitigation strategies. In addition, we estimate some inventory write downs other charges in the range of roughly 15% of BioNTech's share of gross profit from COVID-nineteen vaccine sales in the Pfizer territory. We also expect revenues related to our service businesses as well as revenues from the German pandemic preparedness agreement to contribute to our overall group revenues. We continue to diligently invest in our long term growth strategy. While maintaining financial discipline. We remain focused on achieving long term sustainable growth and generating value for patients and shareholders.

34m 23s

Today, I will close my section on a personal note. As Ugo mentioned, I will retire from my executive role at BioNTech at the June, and will focus on non executive board roles in future. As this is my last earnings call as CFO of BioNTech, I would like to take this opportunity to thank the investor and analyst community for their trust.

34m 46s

I'll also thank my colleagues on the Supervisory and Management Board, as well as my teams for their dedication and collaboration during this remarkable growth journey. It has been a privilege to be part of the development of BioNTech into one of the largest global biotechnology companies. I'm confident that BioNTech is well positioned for continued success. And with that, I would like to turn the call over to our Chief Strategy Officer, Ryan Rich for our strategic outlook and concluding remarks. Thank you. Thank you, Jens.

35m 16s

I will close our prepared remarks with a brief summary of our 2025 strategic priorities. We are continuing to focus on executing against two pan tumor product opportunities, BNT327 and our mRNA cancer immunotherapies six pack and nine. Both of these programs are currently in multiple ongoing phase two and three trials reflecting our strategy to bring novel combinations to patients. We expect to generate additional meaningful data for these programs throughout this year. We are also continuing to build out our commercial capabilities in oncology to support our goal of becoming a fully integrated biopharmaceutical company. These include a U. S. General manager and broader global leadership team with the goal of commercial readiness to support our transition to the commercial stage in oncology, starting with the potential launch of BNT323 early as 2026, if approved. In infectious diseases, we will continue to invest to maintain our advisors global leadership position in the COVID-nineteen vaccine market. While advancing next generation and combination vaccines in the clinic. We expect to provide multiple updates from our early stage infectious disease pipeline this year. In closing, I would like to highlight on the next slide important investor events we will be holding this year.

36m 30s

Our Annual General Meeting will take place on May 16. We also plan to hold our innovation series event in the fall. And we'll share more details later in the year. With that, we would like to open the floor for questions. Thank you. You. Wait for your name to be announced. Please make sure you ask your question loudly and clearly into your microphone and please limit yourself to one question only. To withdraw your question please press star 11 again. We will now go to your first question. And your first question comes from the line of Tazim Ahmed from Bank of America. Please go ahead.

37m 18s

Hello, good morning. Thank you for taking my question. As you prepare for your first launch for endometrial cancer can you talk to us about how you say do you think that particular addressable population is And then related to that, can you remind us where manufacturing of three twenty seven is expected to take place? And if you expect any impact from those tariffs. Thanks.

37m 44s

Yeah, thank you Tazeen. So we estimate that the second line market in endometrial cancer about ten thousand patients. In The US and Europe. So it is a sizable potential market opportunity. In regards to manufacturing, so we've licensed this program, ENT323, as you know, from Duality Biologics. Manufacturing is currently currently supplied [indiscernible] And we are in the process of diversifying our supply base and our plans over the next couple of years are to establish multiple supply nodes, including outside of China. But for the time being, it is we're reliant on a China based CDMO Thank you.

38m 28s

I'll just say that maybe Jens you can say a few things about tariffs for our broader business, but we don't anticipate at the current time significant impact financial impact, from the tariffs that have been announced.

38m 42s

Obviously, we're continuing to track policies and responses to US policy. In that regard.

38m 54s

Thank you.

38m 58s

We will now take the next question. And your next question comes from the line of Akash Tewari from Jefferies. Please go ahead.

39m 7s

Hey, thanks so much. So this is more long term In NSCLC, let's say five years down the road, what do you think is the more likely outcome The you know, VEGF bispecific change standard of care in chemo combo or you really needed a novel ADC along with the bispecific to beat pembro chemo? Then kind of as an add on, how do you expect the safety profile of three twenty seven to evolve in chemo combo versus some of the early data you've seen with the trope to ADC? Thanks. Yeah, thanks Akash. So I think you're asking yeah, just to clarify the question. So you're asking in five years, how do we see the NSCLC market evolving? Do we see this evolving where an ADC will be a necessary component on top of next generation immunomodulator. Is that fair? We'll go with that.

40m 5s

That was the question. Akash, we think that actually both will be the case. On the one hand, we, as you know, are developing our bispecific three twenty seven in combination with chemotherapy to to replace first generation. CPIs in non small cell lung cancer. However, we expect that the clinical benefit threshold. To be reached will be moving over time. And therefore, also ADCs in combination with our bispecifics or with such PD-onePDI1, BGS bispecifics will also have a role.

40m 54s

That's the reason why we are following both streams of development. In a sort of sequential manner.

41m 6s

And if we got And with regard to the ADC, as you know, we have several ADCs that in principle can be combined. In the non small cell lung cancer indication. Including our TOP2 ADC B7 H as well as our HER3 ADC BNT326.

41m 30s

Thank you.

41m 33s

Your next question comes from the line of Dana Greibosh from Leerink Partners. Please go ahead.

41m 41s

Hi. CDC's ACF is going to have a vote in June on the recommendation of COVID boosters.

41m 49s

And my interpretation of their pre meeting was there is a likelihood that they narrow The U. S. Recommendation to a risk base And I wonder if you could talk about that meeting, what you anticipate the vote will be. And if they do narrow it, what that might how that might impact your COVID-nineteen vaccine sales in The U. S? Thank you. Yes. Thanks for the question, Dana. Indeed, we the world, not just in The United States, but also in other regions. And we are expecting actually the first wave of decisions regarding strain selection and policy for COVID for the COVID season in 2025, to take place actually in the next couple of weeks in May. Already in regions. We're going be tracking that very closely. So I think we'll have within the next four to six weeks, we'll already have some additional clarity in terms of the picture. I think in regards to The US policy specifically, it's already been the case that the majority of vaccinations in The United States have gone into the older 65 populations along with the immunocompromised. Which together account for about twenty percent of The US populations, about eighteen percent of the population is 65, and there's a couple more percent that take into account the immunocompromised.

43m 12s

So that's and that's already been the majority of vaccinations in The US for the last last couple of years. So while, of course, we're gonna track the outcome of the meeting that you mentioned, We think that the market's already oriented in that direction. And so, you know, our base scenario here is that we think that the vaccination rates in The US around twenty percent that we've seen over the last couple of years is still our sort of base scenario going into the end of this And in addition, Dana, to just add, we've seen such a development in other jurisdictions before as well. So it's nothing new. What we experienced is, of course, the recommendation goes for the bone population, goes for the immunosuppressive population, and there will be a chunk of people that will, and that's difficult to predict, chunk of people that will get vaccinations nonetheless independent of the recommendation on the age That's the experience that we had in the past to a great extent. We got to it has to be seen how the implications will will look like.

44m 11s

Could have a negative implication.

44m 13s

It's very difficult to predict at this point in time.

44m 18s

Thank you.

44m 20s

Your next question comes from the line of Cory Kasimov from Evercore.

44m 25s

Please go ahead.

44m 28s

Hey, good morning, guys. Thank you for taking my questions. And again, congratulations on your retirement. So I wanted to, I recognize it's difficult to comment on programs that another company, but I'd be interested in your perspective on a case of preliminary overall survival data. That recently came out? I mean, is this something that's in line with your expectations and maybe more specifically as it relates to the 03/27, does it have any impact at all in how you think about designing own trials in non small cell lung cancer? Thank you.

45m

Yes, thank you, Corey, for the question. You know, we are also strong believers of VEGF PD-onePD L1 bispecific concept Therefore, we find the data which has been reported from Harmony too very encouraging. The PFS, which was the primary endpoint, speaks for itself.

45m 25s

The OS trend, which is based on a premature analysis of an immature information fraction with very low alpha. Also this is encouraging. It has not direct impact on our program. Rosetta lung O2 is in different population. It's and it's in combination with chemotherapy. However, as I said, seeing that the concept as such is producing encouraging data and clinical benefit is also very positive for us.

46m 16s

Thank you.

46m 19s

Your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead.

46m 25s

Great. Thanks for taking the question. A two part for me on 03/27. Thanks for the details on the ROSETTA Lung-two study. I was just wondering if you could elaborate in terms of doses that are being studied exactly in the Phase two portion and when we might see some of the Phase II data? And then can you just powering of the Phase three portion of that trial? Thank you.

46m 49s

We cannot comment at this point on the doses. We are exploring. You might get more information on that later this year when we will present trial design on conferences?

47m 11s

The second question was can you repeat the second question?

47m 18s

The timing of the data for phase two and the powering of the phase three portion?

47m 23s

Yeah, so the data for phase two, we will see some data later this year, beginning of next year. And the powering for the Phase III portion is to to accommodate co primary PFS OS.

47m 45s

Thank you.

47m 47s

Your next question comes from the line of Jessica Fey from JPMorgan. Please go ahead.

47m 54s

Hey, guys. Good morning. Thanks for taking my question. Ryan, I think earlier in the call, you mentioned minimal impact from current tariffs. But can you speak to how the potential implementation of future biopharma tariffs in The U. S. Might impact BioNTech, Is commercial you know, for The US market made in The US? And second, can you just recap what you guys see as the key similarities, or maybe more importantly, the key areas of differentiation of your development plans for 03/27 relative to the iminezumab development program? Thank you.

48m 33s

Yeah, sure. Thanks Jessica. So, the tariff point, my reference to limited near term financial impact was related mainly to the fact that we've got one commercial stage product in Commerity. Currently where we have production infrastructure and capability through our partnership with Pfizer on both sides of The Atlantic. So we've got the ability, we have the ability to produce that vaccine in The United States. We also have the ability to produce it in Europe. And we have sufficient capacity to manage that accordingly. I don't know, Jens, would you add anything?

49m 3s

No, I just you know, there are existing tariffs already for China, you know, 20% at this point in time. That we got to cover, and the financial implications so far have been really minor. For us going forward. That makes life a little bit difficult in terms of predictions. Of course, how that will evolve over time and if pharmaceuticals will be challenged, then costs could go up for clinical trials for research work but overall, at this point in time, we would estimate that as as not being really critical for us, we can't talk for anyone else. Of course. I mean, you've seen a lot of statements from other companies terms of the tariffs. We've got to wait how things are evolving over time in how severe financial implications can be. Look like.

49m 51s

And with regard to your second question, Jessica, on ENT327 development strategy, I would just note that our strategy is based on a couple of key pillars the first of which is to establish BNT327 as an approved therapy in a number of solid tumor indications We've announced publicly three of those indications. A couple of those where we think we're positioned we can execute well, to be potentially first to market. So TNBC and small cell lung cancer being two of those potential indications. Those first wave of trials are with chemotherapy backbones.

50m 25s

We think that's the fastest path to market. But the the broader and longer term strategy is to combine ENT327 with other agents, including ADCs, and there we think we have a differentiated strategy by virtue of our broad pipeline and the ADCs and therapies that we have in house that could be combined with it.

50m 46s

Don't have much to add, thank you. Ryan. I think that summarizes our differentiation strategy.

50m 56s

Thank you. Your next question comes from the line of Evan Weigerman from BMO Capital Markets. Please go ahead.

51m 7s

Hi, all. Thank you so much for taking my question. I wanted to take a higher level question With varying views on mRNA technology, are you thinking about the potential of your therapeutic vaccine franchise? There's a lot of resistance building up in The United States. You still see this as a core component of your strategy? Are you more focused on the bispecifics? Thank you so much.

51m 33s

Definitely. We have we have a core interest in our mRNA therapeutics, As we have alluded today, we have a two pan tumor opportunities. This is BNT327, which gives the opportunity to develop the product as potential new IO backbone in multiple indications. And the same is true for the pan tumor potential for [indiscernible] Based on our neoantigen as well as our fixed back approach. We believe that this approach approaches have a huge potential, particularly in the patient populations with a higher risk of relapse. Either in the adjuvant setting or in the minimal residual disease setting. But we also believe that the combination of both both compounds BX-two twenty seven as well as our mRNA therapeutics vaccine provide a huge opportunity. So the science is clearly stating that mRNA therapeutics going to be a disruptive platform of the future, and we believe it's even even more the time to invest into the technologies and further leverage our strengths here.

53m 4s

Thank you.

53m 7s

Your next question comes from the line of Yaron Werber from TD Cowen. Please go ahead.

53m 13s

Yes. Hi. Thanks for taking my question. I have a couple interrelated questions. The first one is, you've been very clear and everything you said made a lot of sense on how you're going to develop three twenty seven small cell TNBC non small cell What about second line EGFR mutant? Any thoughts on that indication? Obviously, we're waiting for the Phase III from the competitor. And then secondly, can you just remind us for three twenty three for second line endometrial, What data are we expecting this year in filing? For accelerated approval is going to be based on which endpoints specifically, and if you can, just the powering for that study? Thank you.

53m 56s

Yeah. For second and non small cell lung cancer, I believe you refer to the EGFR mutant population, right? We have recently published data [indiscernible] population, including response and PFS data based also with differentiation into patient populations with PD L1 positive and PD L1 negative populations. The data are very encouraging. We have currently also also running 27 in the subpopulation of of EGFR mutant tumors based on on their PD L1 positivity.

55m 17s

I think in regards to your second question, which I believe was what are the endpoints in the data package that we expect for BNT323 later this year. Allison, do you want yes. So, you're referring to our second line endometrial cancer trial, which is a single arm trial which comes basically out of our basket trial across solid cancers, which we are conducting have conducted together with Duality, and the end point is objective response rate. We are in discussion with regulatory authorities to better understand the expectations for a BLA and are progressing in these discussions.

56m 11s

Thank you.

56m 13s

I might also add, I forgot to say that, the population is across all HER2 positivity scores, so it's a broader second line endometrial cancer population.

56m 28s

Thank you.

56m 29s

Your next question comes from the line of Mohit Bansal from Wells Fargo. Please go ahead.

56m 36s

Thank you very much for taking my question and congrats on all the progress. I have two questions. So one is is Rosetta LUN two, could you give us some timeline of when should we expect Phase two portion of the study to be over? And you're moving forward into phase three? And second one, we get a lot of questions around the differences between different bispecifics for yours, summits, and and Merck's, And the key key difference I see, like, one is that you are the only one you using a PD L1.

57m 11s

And you also have the the very, very heavy chain. So VHH could you talk a little bit about these differences and how much could they matter in the real world, especially PD L1 given that the experience with PD L1 antibodies has not been that fruitful. Thank you.

57m 34s

Okay, so I think the first question was, when do we expect the phase two trial phase two portion of the Rosetta lung trial to be complete?

57m 43s

The phase two portion of ROSETTA will be completed later this year, or we will have data to inform, to put it in this way, to inform the phase three portion of the trial, defining the dose, which will be then used in the phase three portion, which will start this year. The other question I think was about the The difference between PD L1.

58m 9s

Yeah, the molecular differentiation.

58m 12s

Between different bispecific molecules with this mode of action We cannot comment on other molecules, obviously. We have deliberately chosen when we were assessing different external opportunities, bispecific with a PD L1 versus the PD-one portion, because we expect from PD L1 that it might be superior to PD L1 in anchoring, in particular in the tumor microenvironment where we want to have the bispecific. That was one of the reasons. And also the molecular format [indiscernible] VEGF, anti VEGF portion. And VHH PDI1 portions, was compelling to us because we think that we get the right pattern of cross ligation in the tumor microenvironment environment.

59m 28s

Thank you.

59m 30s

Your next question comes from the line of Geoff Meacham from Citigroup. Please go ahead.

59m 38s

Hey, guys. This is Nishan on for Geoff, and thanks for the question. So on 03/27, you also highlight potential to kind of combine with other modalities, including ADCs and cell therapies. So wanted to ask, what are the key factors driving the selection of this specific combinations? And what is the overall kind of rationale for this kind of combinations? Thank you. [indiscernible] I can take the question. I think with regard to the combination of [indiscernible] portfolio, anti and the content portfolio has three categories products which are all suitable as combination therapies. First of all, our IO pipeline So we have multiple additional bispecifics. Particularly also after acquisition of [indiscernible] In the pipeline, including for example TJPV IgG antibody, bispecific antibody and other bispecific antibody. So these are, we were engaged in the clinical trials. We have preclinical context mode of action synergy for this compound, the second class. Which we find very exciting is our mRNA vaccines. And mRNA immunotherapies. We believe that this modality could have the advantage not only to delay PFS, and improve OS, but also have to completely eradicate residual tumor cells, which which remain after checkpoint blockade we have been engaging into a number of preclinical studies.

1h 1m 33s

And our first clinical cohorts are going to start later this year.

1h 1m 41s

And we have recently demonstrated preclinical proof of concept of combinations of BNT-four twenty seven with our our ADC portfolio. Which provides the opportunity to reduce tumor burden with ADCs to benefit from the immunogenic cell death mediated by ADCs and based on the superior effect of the bispecific combining VEGF anti VEGF, and PDL activities.

1h 2m 21s

Thank you.

1h 2m 23s

Your next question comes from the line of Atika Gunavadhana from Truist Please go ahead.

1h 2m 33s

Hi, this is Karina Fostiker. Thanks for taking the question. I have the question on the initial ACR data for BNT327. Which was combined with TROP2 ADC, there was notable rate of stromatitis which included grade three events How do you plan to manage this toxicity going forward? And was this also observed with other [indiscernible] Actually, the stomatitis rate in the combination was very comparable to the stomatitis rate that is observed with this [indiscernible] is very encouraging that we don't see additional additive toxicity.

1h 3m 25s

Thank you.

1h 3m 26s

Your next question comes from the line of Harry Gillies from Berenberg. Please go ahead.

1h 3m 34s

Thank you very much for taking the questions. Could you please comment on the extent of global Phase II BNT327 data you've seen internally that informs your decision for phase three entry and small cell lung and TNBC. And then related to that, is Phase III entry in TNBC still contingent on any Phase II global data And finally, when could we expect the phase two global data for for BNT327 in small cell or TNBC this year? Could could we see it at ESMO or worldwide lung? Thank you.

1h 4m 11s

Yeah, yeah, as you might see from the clinical trial database, we are doing now our clinical trials in this indication in a global manner, The US, in Europe, in multiple centers in Turkey. And decapitulating data previously presented from China patients we are very confident that the findings of the China type will be more or less fully vacapitulated in this global time.

1h 4m 59s

Thank you. We will now take our final question for today. And the final question comes from the line of John Newman from Canaccord Genuity. Please go ahead.

1h 5m 11s

Hi, thanks very much for taking my question.

1h 5m 14s

I'm just curious regarding the development of the COVID-nineteen vaccine. At Pfizer. I wonder if you have any thoughts on some of the recent comments coming out of FDA regarding the possibility of looking at randomized studies for the yearly strain updates. I'm wondering if you think that feasible or likely if it were to move forward, what your strategy might be best.

1h 5m 42s

Yeah. Thanks, John.

1h 5m 44s

So I I think that I would note that the COVID-nineteen vaccine was first approved after a study of 43,000 participants, very large global study, where we demonstrated efficacy in that study. And obviously we're continuing to track all policy, potential policy data FDA, but we don't expect that that that talk is going to have a near term impact on our COVID vaccine franchise, given it's been approved for multiple years. Our expectation is that there's going to be multiple regions selecting strains for the fall twenty five-twenty six season, and that's our focus at the moment. [indiscernible] Thank you.

1h 6m 28s

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

Key Insights

BioNTech reported Q1 2025 revenues of approximately €183 million, primarily from COVID-19 vaccine sales, with a net loss of €416 million; the company ended the quarter with €15.9 billion in cash and securities, despite significant acquisition and settlement payments.
The company is advancing its oncology pipeline, highlighting BNT327 (a bispecific anti-PD-L1/anti-VEGF antibody) and mRNA cancer immunotherapies as pan-tumor opportunities, with multiple ongoing Phase 2 and 3 trials in indications such as triple negative breast cancer (TNBC), small cell lung cancer, and non-small cell lung cancer.
BNT327 showed encouraging efficacy and manageable safety in early trials, including a 73.8% objective response rate in first-line metastatic TNBC and a median overall survival of 16.8 months in small cell lung cancer; Phase 3 trials (Rosetta Lung-one and Rosetta Lung-two) are underway, with additional data expected later this year and early next year.
BioNTech confirmed 2025 financial guidance: revenues of €1.7–2.2 billion, R&D expenses of €2.6–2.8 billion, SG&A expenses of €650–750 million, and capital expenditures of €250–350 million; revenue is expected to be back-weighted to the last 3–4 months of the year.
The company is preparing for its first oncology BLA submission (BNT323 for second-line endometrial cancer) by end of 2025, expanding manufacturing outside China, and expects minimal near-term impact from tariffs or potential changes in U.S. COVID-19 vaccine policy; BioNTech remains committed to mRNA therapeutics as a core strategy despite evolving public sentiment.

Recent Transcripts

BioNTech advances oncology pipeline with strong cash position despite Q1 net loss.

BioNTech met 2024 revenue guidance amid lower COVID vaccine demand, prioritizing oncology pipeline and late-stage trials.

Income Statement

Revenue

	2020	2021	2022	2023	2024
Revenue	€482M	€19B	€17B	€3.8B	€2.8B
Cost of Revenue	€59M	€2.9B	€3B	€600M	€541M
Gross Profit	€423M	€16B	€14B	€3.2B	€2.2B
Gross Profit %	88%	85%	83%	84%	80%
R&D Expenses	€645M	€949M	€1.5B	€1.8B	€2.3B

2020

2021

2022

2023

2024

Revenue

€482M

€19B

€17B

€3.8B

€2.8B

Cost of Revenue

€59M

€2.9B

€3B

€600M

€541M

Gross Profit

€423M

€16B

€14B

€3.2B

€2.2B

Gross Profit %

88%

85%

83%

84%

80%

R&D Expenses

€645M

€949M

€1.5B

€1.8B

€2.3B

Cash Flow

Net Income

	2020	2021	2022	2023	2024
Net Income	-€146M	€15B	€13B	€1.2B	-€678M
Dep. & Amort.	€39M	€75M	€123M	€183M	€298M
Def. Tax	€0	-€3.8B	€0	€0	€0
Stock Comp.	€32M	€94M	€109M	€51M	€101M
Chg. in WC	-€93M	-€11B	€4.5B	€5.6B	€1.2B

2020

2021

2022

2023

2024

Net Income

-€146M

€15B

€13B

€1.2B

-€678M

Dep. & Amort.

€39M

€75M

€123M

€183M

€298M

Def. Tax

€0

-€3.8B

€0

Stock Comp.

€32M

€94M

€109M

€51M

€101M

Chg. in WC

-€93M

-€11B

€4.5B

€5.6B

€1.2B

Balance Sheet

Cash

	2020	2021	2022	2023	2024
Cash	€1.2B	€1.7B	€14B	€12B	€9.8B
ST Investments	€137M	€382M	€189M	€4.9B	€7B
Cash & ST Inv.	€1.3B	€2.1B	€14B	€17B	€17B
Receivables	€166M	€12B	€7.1B	€2.2B	€1.5B
Inventory	€64M	€503M	€440M	€358M	€283M

2020

2021

2022

2023

2024

Cash

€1.2B

€1.7B

€14B

€12B

€9.8B

ST Investments

€137M

€382M

€189M

€4.9B

€7B

Cash & ST Inv.

€1.3B

€2.1B

€14B

€17B

Receivables

€166M

€12B

€7.1B

€2.2B

€1.5B

Inventory

€64M

€503M

€440M

€358M

€283M

Go Deeper

Financial information provided by Financial Modeling Prep. Options data provided by Unusual Whales. Live transcripts provided by Quartr. Reported revenue and EPS data from Earnings powered by FinChat.io. All data is provided for informational purposes only, and is not intended for trading purposes or financial, investment, tax, legal, accounting or other advice. · See all tickers.

Overview
Latest News
Earnings
Income Statement
Cash Flow
Balance Sheet
Related

Earnings

Report Date

May 5, 2025

Reported Revenue

197.8M

Beat +32.85%

Avg 1d Change

3.38%

Report Period

Q1 2025

Reported EPS

-2

Beat +29.27%

Implied Move 1d

8.95%

Transcript

10m 34s

As a reminder, the slides we will be using during this call and the corresponding press release we issued this morning can be found in the Investor Relations section of our website.

10m 42s

11m 22s

13m 12s

13m 35s

14m 50s

16m 57s

18m 39s

I will turn the call over to Estem to provide more details on SELECT. Clinical programs.

18m 47s

19m 7s

20m

20m 53s

22m 57s

24m 37s

26m 27s

28m 21s

29m 6s

29m 31s

Thank you, Eslem, and a warm welcome to everyone who has dialed in today's call.

29m 36s

31m 7s

31m 28s

31m 51s

33m 17s

34m 23s

34m 46s

35m 16s

36m 30s

37m 18s

37m 44s

38m 28s

38m 42s

Obviously, we're continuing to track policies and responses to US policy. In that regard.

38m 54s

Thank you.

38m 58s

We will now take the next question. And your next question comes from the line of Akash Tewari from Jefferies. Please go ahead.

39m 7s

40m 5s

40m 54s

That's the reason why we are following both streams of development. In a sort of sequential manner.

41m 6s

41m 30s

Thank you.

41m 33s

Your next question comes from the line of Dana Greibosh from Leerink Partners. Please go ahead.

41m 41s

Hi. CDC's ACF is going to have a vote in June on the recommendation of COVID boosters.

41m 49s

43m 12s

44m 11s

Could have a negative implication.

44m 13s

It's very difficult to predict at this point in time.

44m 18s

Thank you.

44m 20s

Your next question comes from the line of Cory Kasimov from Evercore.

44m 25s

Please go ahead.

44m 28s

45m

45m 25s

46m 16s

Thank you.

46m 19s

Your next question comes from the line of Terence Flynn from Morgan Stanley. Please go ahead.

46m 25s

46m 49s

We cannot comment at this point on the doses. We are exploring. You might get more information on that later this year when we will present trial design on conferences?

47m 11s

The second question was can you repeat the second question?

47m 18s

The timing of the data for phase two and the powering of the phase three portion?

47m 23s

Yeah, so the data for phase two, we will see some data later this year, beginning of next year. And the powering for the Phase III portion is to to accommodate co primary PFS OS.

47m 45s

Thank you.

47m 47s

Your next question comes from the line of Jessica Fey from JPMorgan. Please go ahead.

47m 54s

48m 33s

49m 3s

49m 51s

50m 25s

50m 46s

Don't have much to add, thank you. Ryan. I think that summarizes our differentiation strategy.

50m 56s

Thank you. Your next question comes from the line of Evan Weigerman from BMO Capital Markets. Please go ahead.

51m 7s

51m 33s

53m 4s

Thank you.

53m 7s

Your next question comes from the line of Yaron Werber from TD Cowen. Please go ahead.

53m 13s

53m 56s

55m 17s

56m 11s

Thank you.

56m 13s

I might also add, I forgot to say that, the population is across all HER2 positivity scores, so it's a broader second line endometrial cancer population.

56m 28s

Thank you.

56m 29s

Your next question comes from the line of Mohit Bansal from Wells Fargo. Please go ahead.

56m 36s

57m 11s

57m 34s

Okay, so I think the first question was, when do we expect the phase two trial phase two portion of the Rosetta lung trial to be complete?

57m 43s

58m 9s

Yeah, the molecular differentiation.

58m 12s

59m 28s

Thank you.

59m 30s

Your next question comes from the line of Geoff Meacham from Citigroup. Please go ahead.

59m 38s

1h 1m 33s

And our first clinical cohorts are going to start later this year.

1h 1m 41s

1h 2m 21s

Thank you.

1h 2m 23s

Your next question comes from the line of Atika Gunavadhana from Truist Please go ahead.

1h 2m 33s

1h 3m 25s

Thank you.

1h 3m 26s

Your next question comes from the line of Harry Gillies from Berenberg. Please go ahead.

1h 3m 34s

1h 4m 11s

1h 4m 59s

Thank you. We will now take our final question for today. And the final question comes from the line of John Newman from Canaccord Genuity. Please go ahead.

1h 5m 11s

Hi, thanks very much for taking my question.

1h 5m 14s

1h 5m 42s

Yeah. Thanks, John.

1h 5m 44s

1h 6m 28s

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

Key Insights

BioNTech reported Q1 2025 revenues of approximately €183 million, primarily from COVID-19 vaccine sales, with a net loss of €416 million; the company ended the quarter with €15.9 billion in cash and securities, despite significant acquisition and settlement payments.
The company is advancing its oncology pipeline, highlighting BNT327 (a bispecific anti-PD-L1/anti-VEGF antibody) and mRNA cancer immunotherapies as pan-tumor opportunities, with multiple ongoing Phase 2 and 3 trials in indications such as triple negative breast cancer (TNBC), small cell lung cancer, and non-small cell lung cancer.
BNT327 showed encouraging efficacy and manageable safety in early trials, including a 73.8% objective response rate in first-line metastatic TNBC and a median overall survival of 16.8 months in small cell lung cancer; Phase 3 trials (Rosetta Lung-one and Rosetta Lung-two) are underway, with additional data expected later this year and early next year.
BioNTech confirmed 2025 financial guidance: revenues of €1.7–2.2 billion, R&D expenses of €2.6–2.8 billion, SG&A expenses of €650–750 million, and capital expenditures of €250–350 million; revenue is expected to be back-weighted to the last 3–4 months of the year.
The company is preparing for its first oncology BLA submission (BNT323 for second-line endometrial cancer) by end of 2025, expanding manufacturing outside China, and expects minimal near-term impact from tariffs or potential changes in U.S. COVID-19 vaccine policy; BioNTech remains committed to mRNA therapeutics as a core strategy despite evolving public sentiment.

BioNTech SE Price & Performance (BNTX)

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