NYSE:EBS Emergent BioSolutions Q1 2023 Earnings Report $10.35 -0.08 (-0.77%) As of 04/16/2025 03:58 PM Eastern Earnings HistoryForecast Goldman Sachs BDC EPS ResultsActual EPS-$3.17Consensus EPS -$1.67Beat/MissMissed by -$1.50One Year Ago EPS$0.18Goldman Sachs BDC Revenue ResultsActual Revenue$165.10 millionExpected Revenue$142.85 millionBeat/MissBeat by +$22.25 millionYoY Revenue Growth-46.30%Goldman Sachs BDC Announcement DetailsQuarterQ1 2023Date5/9/2023TimeAfter Market ClosesConference Call DateTuesday, May 9, 2023Conference Call Time5:00PM ETUpcoming EarningsGoldman Sachs BDC's Q1 2025 earnings is scheduled for Thursday, May 8, 2025, with a conference call scheduled on Friday, May 9, 2025 at 9:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Goldman Sachs BDC Q1 2023 Earnings Call TranscriptProvided by QuartrMay 9, 2023 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Good day and thank you for standing by. Welcome to the Emergent BioSolutions First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference call is being recorded. I would now like to hand the conference over to the company. Operator00:00:32Please go ahead. Speaker 100:00:35Thank you, Jada, and good afternoon, everyone. My name is Bob Burrows. I'm Vice President of Investor Relations for the company, thank you for joining us today as we discuss the operational and financial results for Q1 of 2023. As is customary, today's call is open to all participants and the call is being recorded and is copyrighted by Emergent BioSolutions. In addition to today's press release, there is a series of slides accompanying this webcast available to all webcast participants. Speaker 100:01:02Turning to slides 34, During today's call, we may make projections and other forward looking statements related to our business, future events, our prospects or future performance. These forward looking statements are based on our current intentions, beliefs and expectations regarding future events. Any forward looking statement speaks only as of the date of this conference Call. And as except as required by law, we do not undertake to update any forward looking statement to reflect new information, events or circumstances. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the SEC when evaluating our forward looking statements. Speaker 100:01:41During today's call, we may also refer to certain non GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding Emergent's operating performance. Please refer to the tables found in today's press release and in the slides regarding our use of adjusted net income and loss, adjusted EBITDA and adjusted gross margin and the reconciliations between our GAAP financial measures and these non GAAP financial measures. Turning to Slide 5, the agenda for today's call will include Bob Kramer, President and Chief Executive Officer, who will comment on the current state of the company Paul Williams, SVP and Head of the Products Business, who will comment on the state of the Milliken Nasal Spray franchise As we migrate to our non prescription form of this key medical countermeasure, Amrits Lindahl, EVP and Chief Financial Officer, who will speak to the financials for Q1 2023 and then pivot to our revised forecast for full year 2023 as well as Q2 2023 total revenues. This This will be followed by a Q and A session where additional members of the Jagged leadership team are present and available as needed. Finally, and for the benefit of those who may be listening to the replay of this webcast, This call was held and recorded on May 9, 2023. Speaker 100:02:48Since then, Emergent may have made announcements related to topics discussed during today's call. And with that, I would now like to turn the call over to Bob Kramer. Bob? Speaker 200:02:57Thanks, Bob, and good afternoon to everybody. Thank you for joining the call. My comments this afternoon begin on Slide 6. Our Q1 performance was generally in line with expectations As revenues came in above our guidance range, but were offset by higher than expected operating costs that had a bearing on our profitability for the period, and Rich will provide more detail in his prepared remarks. We continue to strengthen our core businesses and build the foundation for sustainable long term growth. Speaker 200:03:32And today, I'd like to walk you through some of the progress since the beginning of the year and where we're going to go for the rest of 2023 and beyond. First, we expect the sale of our travel health business to Bavarian Nordic to close as planned in the Q2 of this year. Upon closing, the deal will provide an upfront cash payment of approximately $270,000,000 and a potential additional $110,000,000 in sales and development based milestones. As I said when we made this announcement earlier this year, this deal achieved 2 significant outcomes. First, it allows us to further sharpen our focus on our core products and contract manufacturing services businesses, while allowing continued supply of these important vaccines to patients and customers. Speaker 200:04:252nd, and before discussing NARCAN nasal spray in more detail, I'd like to mention that today is Fentanyl Awareness Every day the opioid epidemic cuts short innocent lives. This epidemic shows no signs of abating And we remain committed to working with federal, state and local governments and advocacy groups across the nation to ensure more naloxone reaches communities, patients and those in need to help reverse the trend of increased opioid related overdose deaths. That's one reason why we view the FDA's approval of our application to make NARCAN nasal spray The first and only opioid reversal treatment approved for over the counter use is a significant step forward in our efforts to expand access and availability of this life saving medicine. Since acquiring the product In late 2018, we've consistently supported efforts to expand awareness of and access to naloxone. We've also maintained our commitment to affordability and support for public interest partners who often are We believe greater access to NARCAN nasal spray As a result of the OTC designation will help save countless lives. Speaker 200:05:50As we said following approval, we're targeting a late summer launch for the OTC product and are in discussions with potential retail partners to support this critically important initiative. We continue our commitment to making NARCAN nasal spray affordable, while pricing the OTC product in a sustainable manner to support our continuous manufacturing and unique distribution capabilities. As a result of the ongoing epidemic, We're seeing continued growth in demand from the U. S. Public interest channel as well as in Canada. Speaker 200:06:25Paul Williams, our Senior Vice President of the Products Business will join us today to provide more details about NARCAN following my remarks. 3rd, we continue to sustain a strong partnership with the U. S. Government focused on preparedness in response and to helping provide medical countermeasures for the public health threats it has identified and prioritized. With respect to our smallpox franchise, we recently received a notice of intent to procure ACAM2000, Our smallpox vaccine for delivery in 2023. Speaker 200:07:02This follows a similar notice of intent to procure for our VIGIV therapeutic product. The exact details are not yet final, but the values for each are reflected in our guidance for smallpox. Similarly, we've also received a notice of intent to procure our botulosin antitoxin or BAT product, which is reflected in the other products guidance. These notices demonstrate our continued support of in partnership with the U. S. Speaker 200:07:32Government as they seek to address potential public health threats. These would be the second, 3rd and 4th contract awards in the last 6 months following the January contract announcement earlier this year with the U. S. Department of Defense to procure RSDL. With respect to the Biologics License Application or BLA For our anthrax vaccine candidate AV7909, we continue to have constructive engagement with the FDA and believe that we remain on track for the PDUFA date in July. Speaker 200:08:08We're working closely with the government to transition this product to post exposure or post approval procurement. As a reminder, in 2019, AB7909 was the subject of a pre emergency use authorization package submitted to the FDA and since then The U. S. Government has been procuring this product for placement into the strategic national stockpile. These actions are consistent with the repeated comments and budget recommendations from the Department of Health and Human Services and specifically the Assistant Secretary for Preparedness and Response about the necessity of maintaining America's preparedness and response capabilities. Speaker 200:08:53As we've noted previously, Government contracting does not always work on the schedule private industry sets or suggests. Understanding that, we remain confident in the value placed by the U. S. Government in maintaining domestic medical countermeasure manufacturing capabilities and the important role of public private partnerships in addressing known and unknown public health threats. 4th, we continue to implement our strategy of improving and strengthening Our quality and compliance infrastructure and culture, while not largely visible externally, This work is fundamentally critical to our success in delivering for our current customers and ensuring both our products and services businesses are positioned for sustained growth well into the future. Speaker 200:09:44And finally, we're actively managing our business and the balance sheet to improve efficiencies while securing and maintaining sufficient liquidity and access to capital. We've completed the organizational changes announced in January, which are expected to result in approximately $60,000,000 in annualized savings. The anticipated sale of the Treble Health business will provide an additional $270,000,000 in cash proceeds, And we're actively working with our lenders to restructure and extend our debt obligations. We expect to have an agreement in place by May 17 this year. I've said it before, but it bears repeating, while our strategy is already driving improvements, The full benefits of the actions we have taken and have planned will not be realized overnight. Speaker 200:10:35For 25 years, Immersion has been at the forefront of helping protect Americans from serious public health threats. Our intention is to continue doing so for another 25 years and more, and the actions we're taking will help make that a reality. With that, I will now turn the call over to Paul to speak briefly about our plans for NARCAN nasal spray before Rich shares more on our financial performance for the Q1 of this year. Paul? Speaker 300:11:06Thanks, Bob, and hello, everyone. My comments are summarized on Slide 9 and 10. As Bob noted, the ongoing toll of the opioid crisis remains top of mind for all of us at Emergent. We take seriously our responsibility to work with all stakeholders in developing solutions to help those who experience an opioid overdose get a second chance. That is why we see the approval of NARCAN nasal available through pharmacies, convenience stores, vending machines, online retailers and anywhere else OTC products can be found. Speaker 300:11:47This is a significant opportunity to expand access and build on our continued commitment to our public interest partners across the country. With our FDA approval, we can now move forward confidently with our plans. First, we are meeting with retail partners to finalize contracts and distribution plans. While I'm not in a position to share specifics at this time, suffice it to say these are the partners you'd expect. As we announced in April, We are targeting a consumer out of pocket price of less than $50 a box of 2 4 milligram doses. Speaker 300:12:21This is significantly lower than the currently available prescription wholesale price of $125 for a box of 2. 2nd, Currently, our supply chain manufacturing efforts are focused on supporting the new OTC configuration with the goal of having product on shelves by late summer. We are confident we have the capacity to fulfill demand across all channels. And importantly, as we transition our existing packaging and manufacturing to AQuart OTC use, 4 milligram NARCAN nasal spray will remain in readily available supply through current channels. 3rd, we remain committed to working with our public interest partners, including providing innovative solutions for organizations lacking large scale logistical support to ensure NARCAN is available to the underserved communities who need it. Speaker 300:13:13Public interest partners are critical to maintaining the broad access to NARCAN nasal spray. And lastly, we continue to seek new ways to serve markets outside the United As Bob stated, NARCAN nasal spray is the 1st and only opioid overdose reversal medicine approved for over the counter. While we expect competitive entrants in the market, we don't expect those until early to mid-twenty 24. Since its introduction in February of 2016, more than 44,000,000 doses of NARCAN have been distributed in the U. S. Speaker 300:13:52And Canada, and as a result, they're giving countless people a second chance. Sadly, the need for naloxone continues to grow. We believe Immersion is in a strong position to continue meeting that need based on our record of reliable service to our customers. We are excited about the opportunities to expand awareness of and access to NARCAN that the OTC designation creates. And we look forward to providing additional details regarding our pricing and our go to market strategy closer to launch in late summer. Speaker 300:14:23With that, I'll turn it over to Rich. Speaker 400:14:26Thank you, Paul. Good afternoon, everyone. We appreciate you joining the call. I'll start on Slide 12 and touch on a few key financial highlights before walking through the Q1 details. First, As Bob noted, we anticipate closing on the divestiture of the Travel Health business in the Q2, which will provide an infusion of upfront cash while furthering our stated objective of sharpening our strategic focus. Speaker 400:14:51The impact of the sale is now incorporated into our updated guidance for 2023 and enables us to better align our cost structure with our current revenue trajectory. 2nd, as you heard from both Bob and Paul, We continue to see robust demand for NARCAN nasal spray in both the U. S. Public interest and Canadian markets, and that is reflected in our Q1 results. These trends are leading us to significantly increase our NARCAN revenue guidance for this year. Speaker 400:15:19In addition, our NARCAN guidance also continues to reflect our assumptions Regarding the impact of over the counter sales, which we are planning to initiate beginning in late summer. 3rd, the U. S. Government has recently provided us with notices of intent to procure quantities of ACAM, BAT and VIG that all align with our prior expectations. 4th, we are adjusting down our CDMO revenue guidance, driven principally by recent changes to customer requirements for COVID related products we were manufacturing. Speaker 400:15:52These impacts, along with continued remediation costs and other investments to improve quality and compliance across our entire manufacturing network, negatively affected Q1 adjusted gross margin and have a corresponding ripple effect on our updated full year adjusted gross margin forecast. Calendar 2023 will continue the process of rebuilding this business, readying our manufacturing capacity and positioning it for growth in the future. Lastly, we are in the final stages of reaching agreement with our bank group to amend certain terms of our credit facility, including an extension of the October 2023 maturity date. We anticipate closing this amendment on or before May 17, and we'll provide additional details at that time. With that, let's now turn to a review of our financial results, which can be found on Slides 13, 14, and 15. Speaker 400:16:44Highlights include Total revenues of $165,000,000 a decrease over the prior year driven by lower sales of our key medical countermeasure products Our key profitability measures declined versus the prior year with net loss of $183,000,000 adjusted net loss of $159,000,000 and adjusted EBITDA of negative $101,000,000 Notable revenue elements in the quarter include AnFrac's MCM sales of $22,000,000 lower than the prior year due to timing of deliveries of AB7909 and BioFrac The U. S. Government's strategic national stockpile offset by increased sales of Anthrasil. NARCAN sales of $100,000,000 higher than the prior year demonstrating the continuing durability of this product driven by consistently strong demand from the U. S. Speaker 400:17:44PIP channel and the growing market in Canada. Smallpox MCM sales of $7,000,000 lower than the prior year due to timing of ACAM2000 international sales. Other product sales of $14,000,000 slightly higher year over year reflecting increased sales of Baxcora and Bivotif as well as the timing impact of several other products and combined CDMO service and lease revenues of $15,000,000 Significantly lower than the prior year due to lower production activities in certain of our sites as we continue to support existing customers and rebates on the business following our COVID-nineteen response. Turning to operating expenses, cost of product sales in the quarter were $103,000,000 higher than the prior year and driven primarily by lower overhead absorption combined with higher allocations of product COGS at our Bayview facility, offset by lower period costs at our burn facility and lower NARCAN royalty costs. Cost of CDMO was $52,000,000 Significantly lower than the prior year due to reduced production across the CDMO network, partially offset by higher costs at the Camden site, resulting from additional investments in quality improvement initiatives. Speaker 400:18:59R and D expense of $41,000,000 Lower than the prior year due primarily to lower spending on the Chick program and SG and A spend of $101,000,000 Higher than the prior year largely due to professional services supporting transformation activities and one time costs related to the previously announced employee reductions. With that, let's move to slide 16 and review segment performance during the quarter. In the product segment, revenues were $143,000,000 A decrease in the prior year as strong performance from NARCAN was offset by lower contribution from both anthrax MCM and smallpox MCM sales. And adjusted gross margin was $44,000,000 or 31%, both decreases over the prior year reflecting lower sales volume, a less favorable product mix and the higher cost of product sales I just discussed. As for the Services segment, revenues were $15,000,000 A significant decrease from the prior year and adjusted gross margin was negative $37,000,000 a decrease versus the prior year driven primarily by declining services revenues related to the COVID-nineteen response, coupled with incremental costs associated with facility remediation efforts and investments in quality and compliance across our manufacturing Moving on to Slide 17, I'll touch on select balance sheet and cash flow highlights. Speaker 400:20:21We ended the Q1 with $430,000,000 in cash, down sequentially from December 31. Operating cash flow was negative in the quarter due primarily to lower MCM and CDMO revenues. As we said previously, we expect the contribution of revenues, earnings and operating cash flow to be weighted to the second half of the year. Capital expenditures in the period were $15,000,000 and as of March 31, our net debt position was $975,000,000 Please turn to slides 18 and 19 for a review of our 2023 forecast and associated assumptions. As announced in our press release this We're updating our guidance for full year 2023 as follows. Speaker 400:21:03Importantly, our revised guidance reflects the impact of the previously announced sale of our Travel Health to the Varian Nordic, which we anticipate to close in the second quarter. Total revenues of $1,100,000,000 to $1,200,000,000 unchanged from prior guidance. Anthrax NCM sales of $260,000,000 to $280,000,000 also unchanged from prior guidance. NARCAN nasal spray sales of $360,000,000 to $380,000,000 an increase over the prior guidance, primarily reflecting robust demand from the U. S. Speaker 400:21:35Public interest channel and the Canadian market. Smallpox MCM sales of $235,000,000 to $255,000,000 unchanged from prior guidance. Other product sales of $120,000,000 to $140,000,000 lower than prior guidance, primarily reflecting the removal of travel health products following the anticipated completion of the divestiture. CDMO Services revenue of $90,000,000 to $110,000,000 A decline from the prior guidance range for the reasons I highlighted earlier. Adjusted net loss of $85,000,000 to $35,000,000 slightly lower versus the prior range, reflecting the impact of higher NARCAN sales and the impact of the Travel Health divestiture, offset by lower CDMO revenues and an increase to our tax valuation allowance. Speaker 400:22:24Adjusted EBITDA of $100,000,000 to $150,000,000 higher than the prior range, primarily reflecting the impact of the Travel Health business divestiture as well as the upward revision to NARCAN, offset by the ongoing process of rebaselining the CDMO business and adjusted gross margin of 39% to 42%, slightly lower than the prior range and reflecting the impact of overall revenue mix. Finally, we are guiding to 2nd quarter revenues of $210,000,000 to 230,000,000 Further emphasizing our anticipation that revenues and profits in 2023 will be more heavily weighted towards the second half of the year. To conclude, please turn to slide 20 for some summary comments. Our results in the Q1 once again reflect a mix of strong performance in certain core areas of our business, offset by ongoing challenges in other aspects of our business. We are committed to sustaining revenue growth and improving profitability, We are addressing near term challenges to our credit profile. Speaker 400:23:21Finally, as always, we remain confident in the impact we are having on patients and customers focused on health security and pandemic preparedness. That completes my prepared remarks. And I'll now turn the call over to the operator so that we can start the question and answer session. Operator? Operator00:23:37Thank you. At this time, we will conduct a question and answer session. Our first question comes from Jessica Fye of JPMorgan, your line is now open. Speaker 500:24:06Hey, guys. This is Nick on for Jess. Thanks for taking our questions. I had a A clarification question on the NARCAN guidance. You guys talked about the increase in that guidance from $290,000,000 to $310,000,000 to $360,000,000 $380,000 Is that I know you talked about some of the push and pulls there and what drove that increase, but can we talk a little bit about how If it's primarily due to an increase in demand from the public interest market, Canadian markets? Speaker 500:24:33Or is there also kind of more When thinking about OTC as well, just thinking about those 3 together, kind of what drove that increase? Speaker 200:24:43Yes, Nick, this is Bob. Thanks for the question and thanks for joining the call. I'll invite in a minute here, Paul, to weigh in. But When as we announced our guidance initially for 2023, we made it clear that Our plans included an OTC switch sometime in Q3 of this year. So the guidance that we initially provided that $290,000,000 to $310,000,000 number already had kind of Consideration for OTC switching it, I think what you see in our upgraded guidance now of $360,000,000 to $380,000,000 is primarily driven by What we see is increased demand in the 2 channels that we're distributing product today, primarily driven by, again, the public interest market in the United States as well as Canada. Speaker 200:25:37But Paul, weigh in here with some additional color. Speaker 300:25:41Yes. Thanks, Bob. And Nick, Sure. Yes. No, the increase in guidance is directly attributable to both the U. Speaker 300:25:49S. PIP segment as well as the Canadian segment. I think for the The public interest segment in the U. S, obviously, given they serve just the many vulnerable at risk populations with the obviously continued The increase of the opioid crisis, the demand flowing through that channel continues to grow and expand. And similarly, in Canada, we're seeing expanded access to meet the demand in Canada as well. Speaker 300:26:15So obviously, the update in the guidance, I think reflects the trends that we are seeing as we start the year this year. Speaker 500:26:25Great. Thank you. And just maybe a quick follow-up. Could you provide a bit color on some of the conversations you've been having regarding potential insurance coverage for Medicare and Medicaid patients for OTC NARCAN? Speaker 200:26:37Yes. Paul, you want to take that one? Speaker 300:26:40Right. So I think for us access is critical. I think that's what moving NARCAN to over the counter is I think will really help and assist. But I think our conversations and working with whether that's CMS or private payers to understand how they're going to think about Potential coverage for NARCAN OTC continues. I don't think we've landed anywhere with any one particular payer or CMS yet, but we know that this is Top of mind for them, we continue to work with them and other stakeholders to ensure that we're able to balance the access With the affordability as we bring NARCAN OTC to market. Speaker 500:27:21Great. Thanks so much. Operator00:27:24Thank you. Please as a reminder, please limit yourself to one question and one follow-up. One moment for our next question. Our next question comes from Brandon Folkes of Cantor Fitzgerald. Your line is now open. Speaker 600:27:47Hi. Thanks for taking my question and thank you for the update. Maybe just firstly staying on NARCAN, how Speaker 300:27:54How do you think about potential for a Speaker 600:27:55non profit player to come into the OTC market there, both from perhaps the price Ability to supply and satisfaction. And if they do come to market, do you think it's a big Become a bigger player in the retail and first responder market there and then along the line, staying on that line of questioning. What can you say about a 4 milligram naloxone intranasal compared to perhaps a 3 milligram? Any data out there suggesting there are different Speaker 200:28:29Yes. Thanks, Brandon. So again, I'll start and then invite Others to join in there as well. So as it relates to your question about a potential nonprofit Player in the nasal naloxone mix. I'm not going to speculate, Brandon, on Who might be out there and what they might be doing? Speaker 200:28:50Again, our focus continues to be as it has for the last 5 years, Continue to look for opportunities to expand awareness, expand access and as Paul indicated, Continue to work with both public and private insurance companies to make this as affordable as possible. So I think the moves that we're making We'll make a big dent in that. In terms of a non profit, again, I think we won't speculate on what they might do. In terms of the 4 milligram formulation, I don't know that there are any exact studies comparing 3 versus 4 milligram, I think it's pretty widely accepted that again given the work The FDA did on this product to approve it back in February of 2016. The 4 milligram presentation is widely accepted as a very Safe and effective dose. Speaker 200:29:51So Paul, if you want to add some more additional color, please do so. Speaker 300:29:56I think you got that one, Bob. Speaker 600:30:00Great. Thanks. And if we can count that as one question, just one follow-up. So just the intent to procure ACAM2000, can you just and I apologize if you did explain this in the call and pop into the future. What does that mean versus the actual excise of the contract option? Speaker 600:30:19Are there any additional steps between the 2nd to secure and the excise of the contract option? That's it for me. Thank you very much. Speaker 200:30:26Yes. Thanks, Brandon. So the notice of intent to procure is What the government typically uses as the next logical step, so after they do a request for information And after they do a request for a proposal and a contractor responds to that RFP, Then negotiations ensue. And after those negotiations are pretty much done, Brandon, You would typically see a notice of intent to procure. So while the exact details of the potential procurement That we refer to under the notice of intent to procure, we're not detailing now. Speaker 200:31:14They have been pretty much heavily negotiated, And we expect that contract modification to be executed in a fairly reasonable time period. And As such, it's now baked into our smallpox franchise guidance for 2023, which is unchanged from earlier this year. Should we go on to the next question, Jada? Operator00:31:48Yes, of course. Thank you. One moment for Speaker 200:31:53the next question. Operator00:31:59Our next question comes from Boris Peaker of TD Cowen. Your line is now open. Speaker 700:32:05Hi. Thanks for taking the question. This is Nick on for Boris. Just a quick one for me. But how does the closing of the deal with Bavarian affect the income statement? Speaker 700:32:14I know that you guys raised EBITDA guidance without really changing too much else directly affecting it. So I was just wondering how this deal with the variant will Affect that? Speaker 200:32:24Yes. Thanks for the question, Nick. Rich, you want to take that one? Speaker 400:32:28Sure. Happy to. So we have we've incorporated the impacts into Our guidance assuming again a Q2 closing, the main impacts are that the other products revenue will decrease Because the existing VEXCOR and Vivotif products will come out of our sales channel and move to Bavarian Nordic. In addition, there will be a positive impact on adjusted EBITDA driven primarily by lower R and D expense As the Chick program spend will also transition over to Bavarian Nordic as well. So those are the contours Of what the impacts are going to be, we do not disclose the components of adjusted EBITDA below the total company level Or the components of other product revenue, but those are the categories that are impacted. Speaker 700:33:24Got it. Thanks. And then just a quick follow-up on that. So once the if assuming the deal closes in 2Q, well then everything related to ChickVVLP be sent over to them, there will be no more R and D costs from you guys on that? Or will you still have to finish out Phase III trial for on your expense and then Varian takes up from there? Speaker 400:33:44They'll assume responsibility for the trial going forward. Speaker 700:33:49Got it. Thanks very much. Operator00:33:52Thank you. One moment for our next question please. Our next question comes from Christopher Sakai from Singular Research, your line is now open. Speaker 800:34:11Thanks. This is Asim for Chris. I see that you have increased the guidance on NARCAN to 93,000,000 in Win 10,000 to 360,380,000 And maybe coincidentally, there is also a decrease in gross margins, 41, 44 to $239,42,000 And obviously, to an extent, you can give us color, how much Of the decrease in gross margin is due to NARCAN because I also see that another major development Is Travel Health divestment? Speaker 200:34:52Yes. Thanks for the question. Rich, you want to field that one? Speaker 400:34:56Sure. Yes. And you're right, there's several moving parts. I would say, the biggest influence On gross margin guidance change is the change in CDMO revenue guidance and the impact there, As well as, as I referred to on the call, just the impact in the Q1 itself of some of the activities there. So those are really the things that are driving the change to full year adjusted gross margin guidance. Speaker 800:35:26And as a follow-up between now and quarterly call 4th quarter, Depending on your conversations with the different channel partners and pricing and volume variables, It looks like and correct me if I am wrong that your expectations in terms of what You would be able to charge for NARCANZA retail price versus what would be at your end has probably not changed. Do you think that assumption is correct? Speaker 200:36:09So Paul, you want to weigh in on that one? Speaker 300:36:13Sure. So I think as and thanks for the question by the way. Because as we've communicated, we've targeted a consumer out of pocket price for OTC to be slightly less than $50 And I would say that is consistent with the price in the public interest segment as we go forward. So, again, we are in the process of finalizing our Our contracts with our retail partners, I would say stakeholders in this, they're as committed to affordability as we are. And once those contracts are finalized, we can provide specific clarity on where the actual consumer Out of pocket price will end up. Speaker 300:36:58But I think our goals are aligned in terms of affordability. Operator00:37:04Thank you. Thank you. We see no further questions at this time. And I will now turn it back over to the company. Speaker 100:37:15Thank you, Jada. And with that, ladies and gentlemen, we now conclude the call. Thank you for your participation. Please note an archived version of today's webcast as well as PDF version of the slides used during today's call will be available later today and accessible through the Investors landing page on the company website. Once again, thank you, and we look forward to speaking to all of you in the future. Speaker 100:37:34Have a good night. Operator00:37:37Thank you for your participation in today's conference. This does conclude the program. You may nowRead moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallGoldman Sachs BDC Q1 202300:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Goldman Sachs BDC Earnings HeadlinesGreat Southern Bancorp, Inc. Reports Strong First Quarter 2025 Earnings with Increased Net Income and Interest MarginApril 16 at 6:57 PM | quiverquant.comGreat Southern Bancorp, Inc. 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There are 9 speakers on the call. Operator00:00:00Good day and thank you for standing by. Welcome to the Emergent BioSolutions First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference call is being recorded. I would now like to hand the conference over to the company. Operator00:00:32Please go ahead. Speaker 100:00:35Thank you, Jada, and good afternoon, everyone. My name is Bob Burrows. I'm Vice President of Investor Relations for the company, thank you for joining us today as we discuss the operational and financial results for Q1 of 2023. As is customary, today's call is open to all participants and the call is being recorded and is copyrighted by Emergent BioSolutions. In addition to today's press release, there is a series of slides accompanying this webcast available to all webcast participants. Speaker 100:01:02Turning to slides 34, During today's call, we may make projections and other forward looking statements related to our business, future events, our prospects or future performance. These forward looking statements are based on our current intentions, beliefs and expectations regarding future events. Any forward looking statement speaks only as of the date of this conference Call. And as except as required by law, we do not undertake to update any forward looking statement to reflect new information, events or circumstances. Investors should consider this cautionary statement as well as the risk factors identified in our periodic reports filed with the SEC when evaluating our forward looking statements. Speaker 100:01:41During today's call, we may also refer to certain non GAAP financial measures that involve adjustments to GAAP figures in order to provide greater transparency regarding Emergent's operating performance. Please refer to the tables found in today's press release and in the slides regarding our use of adjusted net income and loss, adjusted EBITDA and adjusted gross margin and the reconciliations between our GAAP financial measures and these non GAAP financial measures. Turning to Slide 5, the agenda for today's call will include Bob Kramer, President and Chief Executive Officer, who will comment on the current state of the company Paul Williams, SVP and Head of the Products Business, who will comment on the state of the Milliken Nasal Spray franchise As we migrate to our non prescription form of this key medical countermeasure, Amrits Lindahl, EVP and Chief Financial Officer, who will speak to the financials for Q1 2023 and then pivot to our revised forecast for full year 2023 as well as Q2 2023 total revenues. This This will be followed by a Q and A session where additional members of the Jagged leadership team are present and available as needed. Finally, and for the benefit of those who may be listening to the replay of this webcast, This call was held and recorded on May 9, 2023. Speaker 100:02:48Since then, Emergent may have made announcements related to topics discussed during today's call. And with that, I would now like to turn the call over to Bob Kramer. Bob? Speaker 200:02:57Thanks, Bob, and good afternoon to everybody. Thank you for joining the call. My comments this afternoon begin on Slide 6. Our Q1 performance was generally in line with expectations As revenues came in above our guidance range, but were offset by higher than expected operating costs that had a bearing on our profitability for the period, and Rich will provide more detail in his prepared remarks. We continue to strengthen our core businesses and build the foundation for sustainable long term growth. Speaker 200:03:32And today, I'd like to walk you through some of the progress since the beginning of the year and where we're going to go for the rest of 2023 and beyond. First, we expect the sale of our travel health business to Bavarian Nordic to close as planned in the Q2 of this year. Upon closing, the deal will provide an upfront cash payment of approximately $270,000,000 and a potential additional $110,000,000 in sales and development based milestones. As I said when we made this announcement earlier this year, this deal achieved 2 significant outcomes. First, it allows us to further sharpen our focus on our core products and contract manufacturing services businesses, while allowing continued supply of these important vaccines to patients and customers. Speaker 200:04:252nd, and before discussing NARCAN nasal spray in more detail, I'd like to mention that today is Fentanyl Awareness Every day the opioid epidemic cuts short innocent lives. This epidemic shows no signs of abating And we remain committed to working with federal, state and local governments and advocacy groups across the nation to ensure more naloxone reaches communities, patients and those in need to help reverse the trend of increased opioid related overdose deaths. That's one reason why we view the FDA's approval of our application to make NARCAN nasal spray The first and only opioid reversal treatment approved for over the counter use is a significant step forward in our efforts to expand access and availability of this life saving medicine. Since acquiring the product In late 2018, we've consistently supported efforts to expand awareness of and access to naloxone. We've also maintained our commitment to affordability and support for public interest partners who often are We believe greater access to NARCAN nasal spray As a result of the OTC designation will help save countless lives. Speaker 200:05:50As we said following approval, we're targeting a late summer launch for the OTC product and are in discussions with potential retail partners to support this critically important initiative. We continue our commitment to making NARCAN nasal spray affordable, while pricing the OTC product in a sustainable manner to support our continuous manufacturing and unique distribution capabilities. As a result of the ongoing epidemic, We're seeing continued growth in demand from the U. S. Public interest channel as well as in Canada. Speaker 200:06:25Paul Williams, our Senior Vice President of the Products Business will join us today to provide more details about NARCAN following my remarks. 3rd, we continue to sustain a strong partnership with the U. S. Government focused on preparedness in response and to helping provide medical countermeasures for the public health threats it has identified and prioritized. With respect to our smallpox franchise, we recently received a notice of intent to procure ACAM2000, Our smallpox vaccine for delivery in 2023. Speaker 200:07:02This follows a similar notice of intent to procure for our VIGIV therapeutic product. The exact details are not yet final, but the values for each are reflected in our guidance for smallpox. Similarly, we've also received a notice of intent to procure our botulosin antitoxin or BAT product, which is reflected in the other products guidance. These notices demonstrate our continued support of in partnership with the U. S. Speaker 200:07:32Government as they seek to address potential public health threats. These would be the second, 3rd and 4th contract awards in the last 6 months following the January contract announcement earlier this year with the U. S. Department of Defense to procure RSDL. With respect to the Biologics License Application or BLA For our anthrax vaccine candidate AV7909, we continue to have constructive engagement with the FDA and believe that we remain on track for the PDUFA date in July. Speaker 200:08:08We're working closely with the government to transition this product to post exposure or post approval procurement. As a reminder, in 2019, AB7909 was the subject of a pre emergency use authorization package submitted to the FDA and since then The U. S. Government has been procuring this product for placement into the strategic national stockpile. These actions are consistent with the repeated comments and budget recommendations from the Department of Health and Human Services and specifically the Assistant Secretary for Preparedness and Response about the necessity of maintaining America's preparedness and response capabilities. Speaker 200:08:53As we've noted previously, Government contracting does not always work on the schedule private industry sets or suggests. Understanding that, we remain confident in the value placed by the U. S. Government in maintaining domestic medical countermeasure manufacturing capabilities and the important role of public private partnerships in addressing known and unknown public health threats. 4th, we continue to implement our strategy of improving and strengthening Our quality and compliance infrastructure and culture, while not largely visible externally, This work is fundamentally critical to our success in delivering for our current customers and ensuring both our products and services businesses are positioned for sustained growth well into the future. Speaker 200:09:44And finally, we're actively managing our business and the balance sheet to improve efficiencies while securing and maintaining sufficient liquidity and access to capital. We've completed the organizational changes announced in January, which are expected to result in approximately $60,000,000 in annualized savings. The anticipated sale of the Treble Health business will provide an additional $270,000,000 in cash proceeds, And we're actively working with our lenders to restructure and extend our debt obligations. We expect to have an agreement in place by May 17 this year. I've said it before, but it bears repeating, while our strategy is already driving improvements, The full benefits of the actions we have taken and have planned will not be realized overnight. Speaker 200:10:35For 25 years, Immersion has been at the forefront of helping protect Americans from serious public health threats. Our intention is to continue doing so for another 25 years and more, and the actions we're taking will help make that a reality. With that, I will now turn the call over to Paul to speak briefly about our plans for NARCAN nasal spray before Rich shares more on our financial performance for the Q1 of this year. Paul? Speaker 300:11:06Thanks, Bob, and hello, everyone. My comments are summarized on Slide 9 and 10. As Bob noted, the ongoing toll of the opioid crisis remains top of mind for all of us at Emergent. We take seriously our responsibility to work with all stakeholders in developing solutions to help those who experience an opioid overdose get a second chance. That is why we see the approval of NARCAN nasal available through pharmacies, convenience stores, vending machines, online retailers and anywhere else OTC products can be found. Speaker 300:11:47This is a significant opportunity to expand access and build on our continued commitment to our public interest partners across the country. With our FDA approval, we can now move forward confidently with our plans. First, we are meeting with retail partners to finalize contracts and distribution plans. While I'm not in a position to share specifics at this time, suffice it to say these are the partners you'd expect. As we announced in April, We are targeting a consumer out of pocket price of less than $50 a box of 2 4 milligram doses. Speaker 300:12:21This is significantly lower than the currently available prescription wholesale price of $125 for a box of 2. 2nd, Currently, our supply chain manufacturing efforts are focused on supporting the new OTC configuration with the goal of having product on shelves by late summer. We are confident we have the capacity to fulfill demand across all channels. And importantly, as we transition our existing packaging and manufacturing to AQuart OTC use, 4 milligram NARCAN nasal spray will remain in readily available supply through current channels. 3rd, we remain committed to working with our public interest partners, including providing innovative solutions for organizations lacking large scale logistical support to ensure NARCAN is available to the underserved communities who need it. Speaker 300:13:13Public interest partners are critical to maintaining the broad access to NARCAN nasal spray. And lastly, we continue to seek new ways to serve markets outside the United As Bob stated, NARCAN nasal spray is the 1st and only opioid overdose reversal medicine approved for over the counter. While we expect competitive entrants in the market, we don't expect those until early to mid-twenty 24. Since its introduction in February of 2016, more than 44,000,000 doses of NARCAN have been distributed in the U. S. Speaker 300:13:52And Canada, and as a result, they're giving countless people a second chance. Sadly, the need for naloxone continues to grow. We believe Immersion is in a strong position to continue meeting that need based on our record of reliable service to our customers. We are excited about the opportunities to expand awareness of and access to NARCAN that the OTC designation creates. And we look forward to providing additional details regarding our pricing and our go to market strategy closer to launch in late summer. Speaker 300:14:23With that, I'll turn it over to Rich. Speaker 400:14:26Thank you, Paul. Good afternoon, everyone. We appreciate you joining the call. I'll start on Slide 12 and touch on a few key financial highlights before walking through the Q1 details. First, As Bob noted, we anticipate closing on the divestiture of the Travel Health business in the Q2, which will provide an infusion of upfront cash while furthering our stated objective of sharpening our strategic focus. Speaker 400:14:51The impact of the sale is now incorporated into our updated guidance for 2023 and enables us to better align our cost structure with our current revenue trajectory. 2nd, as you heard from both Bob and Paul, We continue to see robust demand for NARCAN nasal spray in both the U. S. Public interest and Canadian markets, and that is reflected in our Q1 results. These trends are leading us to significantly increase our NARCAN revenue guidance for this year. Speaker 400:15:19In addition, our NARCAN guidance also continues to reflect our assumptions Regarding the impact of over the counter sales, which we are planning to initiate beginning in late summer. 3rd, the U. S. Government has recently provided us with notices of intent to procure quantities of ACAM, BAT and VIG that all align with our prior expectations. 4th, we are adjusting down our CDMO revenue guidance, driven principally by recent changes to customer requirements for COVID related products we were manufacturing. Speaker 400:15:52These impacts, along with continued remediation costs and other investments to improve quality and compliance across our entire manufacturing network, negatively affected Q1 adjusted gross margin and have a corresponding ripple effect on our updated full year adjusted gross margin forecast. Calendar 2023 will continue the process of rebuilding this business, readying our manufacturing capacity and positioning it for growth in the future. Lastly, we are in the final stages of reaching agreement with our bank group to amend certain terms of our credit facility, including an extension of the October 2023 maturity date. We anticipate closing this amendment on or before May 17, and we'll provide additional details at that time. With that, let's now turn to a review of our financial results, which can be found on Slides 13, 14, and 15. Speaker 400:16:44Highlights include Total revenues of $165,000,000 a decrease over the prior year driven by lower sales of our key medical countermeasure products Our key profitability measures declined versus the prior year with net loss of $183,000,000 adjusted net loss of $159,000,000 and adjusted EBITDA of negative $101,000,000 Notable revenue elements in the quarter include AnFrac's MCM sales of $22,000,000 lower than the prior year due to timing of deliveries of AB7909 and BioFrac The U. S. Government's strategic national stockpile offset by increased sales of Anthrasil. NARCAN sales of $100,000,000 higher than the prior year demonstrating the continuing durability of this product driven by consistently strong demand from the U. S. Speaker 400:17:44PIP channel and the growing market in Canada. Smallpox MCM sales of $7,000,000 lower than the prior year due to timing of ACAM2000 international sales. Other product sales of $14,000,000 slightly higher year over year reflecting increased sales of Baxcora and Bivotif as well as the timing impact of several other products and combined CDMO service and lease revenues of $15,000,000 Significantly lower than the prior year due to lower production activities in certain of our sites as we continue to support existing customers and rebates on the business following our COVID-nineteen response. Turning to operating expenses, cost of product sales in the quarter were $103,000,000 higher than the prior year and driven primarily by lower overhead absorption combined with higher allocations of product COGS at our Bayview facility, offset by lower period costs at our burn facility and lower NARCAN royalty costs. Cost of CDMO was $52,000,000 Significantly lower than the prior year due to reduced production across the CDMO network, partially offset by higher costs at the Camden site, resulting from additional investments in quality improvement initiatives. Speaker 400:18:59R and D expense of $41,000,000 Lower than the prior year due primarily to lower spending on the Chick program and SG and A spend of $101,000,000 Higher than the prior year largely due to professional services supporting transformation activities and one time costs related to the previously announced employee reductions. With that, let's move to slide 16 and review segment performance during the quarter. In the product segment, revenues were $143,000,000 A decrease in the prior year as strong performance from NARCAN was offset by lower contribution from both anthrax MCM and smallpox MCM sales. And adjusted gross margin was $44,000,000 or 31%, both decreases over the prior year reflecting lower sales volume, a less favorable product mix and the higher cost of product sales I just discussed. As for the Services segment, revenues were $15,000,000 A significant decrease from the prior year and adjusted gross margin was negative $37,000,000 a decrease versus the prior year driven primarily by declining services revenues related to the COVID-nineteen response, coupled with incremental costs associated with facility remediation efforts and investments in quality and compliance across our manufacturing Moving on to Slide 17, I'll touch on select balance sheet and cash flow highlights. Speaker 400:20:21We ended the Q1 with $430,000,000 in cash, down sequentially from December 31. Operating cash flow was negative in the quarter due primarily to lower MCM and CDMO revenues. As we said previously, we expect the contribution of revenues, earnings and operating cash flow to be weighted to the second half of the year. Capital expenditures in the period were $15,000,000 and as of March 31, our net debt position was $975,000,000 Please turn to slides 18 and 19 for a review of our 2023 forecast and associated assumptions. As announced in our press release this We're updating our guidance for full year 2023 as follows. Speaker 400:21:03Importantly, our revised guidance reflects the impact of the previously announced sale of our Travel Health to the Varian Nordic, which we anticipate to close in the second quarter. Total revenues of $1,100,000,000 to $1,200,000,000 unchanged from prior guidance. Anthrax NCM sales of $260,000,000 to $280,000,000 also unchanged from prior guidance. NARCAN nasal spray sales of $360,000,000 to $380,000,000 an increase over the prior guidance, primarily reflecting robust demand from the U. S. Speaker 400:21:35Public interest channel and the Canadian market. Smallpox MCM sales of $235,000,000 to $255,000,000 unchanged from prior guidance. Other product sales of $120,000,000 to $140,000,000 lower than prior guidance, primarily reflecting the removal of travel health products following the anticipated completion of the divestiture. CDMO Services revenue of $90,000,000 to $110,000,000 A decline from the prior guidance range for the reasons I highlighted earlier. Adjusted net loss of $85,000,000 to $35,000,000 slightly lower versus the prior range, reflecting the impact of higher NARCAN sales and the impact of the Travel Health divestiture, offset by lower CDMO revenues and an increase to our tax valuation allowance. Speaker 400:22:24Adjusted EBITDA of $100,000,000 to $150,000,000 higher than the prior range, primarily reflecting the impact of the Travel Health business divestiture as well as the upward revision to NARCAN, offset by the ongoing process of rebaselining the CDMO business and adjusted gross margin of 39% to 42%, slightly lower than the prior range and reflecting the impact of overall revenue mix. Finally, we are guiding to 2nd quarter revenues of $210,000,000 to 230,000,000 Further emphasizing our anticipation that revenues and profits in 2023 will be more heavily weighted towards the second half of the year. To conclude, please turn to slide 20 for some summary comments. Our results in the Q1 once again reflect a mix of strong performance in certain core areas of our business, offset by ongoing challenges in other aspects of our business. We are committed to sustaining revenue growth and improving profitability, We are addressing near term challenges to our credit profile. Speaker 400:23:21Finally, as always, we remain confident in the impact we are having on patients and customers focused on health security and pandemic preparedness. That completes my prepared remarks. And I'll now turn the call over to the operator so that we can start the question and answer session. Operator? Operator00:23:37Thank you. At this time, we will conduct a question and answer session. Our first question comes from Jessica Fye of JPMorgan, your line is now open. Speaker 500:24:06Hey, guys. This is Nick on for Jess. Thanks for taking our questions. I had a A clarification question on the NARCAN guidance. You guys talked about the increase in that guidance from $290,000,000 to $310,000,000 to $360,000,000 $380,000 Is that I know you talked about some of the push and pulls there and what drove that increase, but can we talk a little bit about how If it's primarily due to an increase in demand from the public interest market, Canadian markets? Speaker 500:24:33Or is there also kind of more When thinking about OTC as well, just thinking about those 3 together, kind of what drove that increase? Speaker 200:24:43Yes, Nick, this is Bob. Thanks for the question and thanks for joining the call. I'll invite in a minute here, Paul, to weigh in. But When as we announced our guidance initially for 2023, we made it clear that Our plans included an OTC switch sometime in Q3 of this year. So the guidance that we initially provided that $290,000,000 to $310,000,000 number already had kind of Consideration for OTC switching it, I think what you see in our upgraded guidance now of $360,000,000 to $380,000,000 is primarily driven by What we see is increased demand in the 2 channels that we're distributing product today, primarily driven by, again, the public interest market in the United States as well as Canada. Speaker 200:25:37But Paul, weigh in here with some additional color. Speaker 300:25:41Yes. Thanks, Bob. And Nick, Sure. Yes. No, the increase in guidance is directly attributable to both the U. Speaker 300:25:49S. PIP segment as well as the Canadian segment. I think for the The public interest segment in the U. S, obviously, given they serve just the many vulnerable at risk populations with the obviously continued The increase of the opioid crisis, the demand flowing through that channel continues to grow and expand. And similarly, in Canada, we're seeing expanded access to meet the demand in Canada as well. Speaker 300:26:15So obviously, the update in the guidance, I think reflects the trends that we are seeing as we start the year this year. Speaker 500:26:25Great. Thank you. And just maybe a quick follow-up. Could you provide a bit color on some of the conversations you've been having regarding potential insurance coverage for Medicare and Medicaid patients for OTC NARCAN? Speaker 200:26:37Yes. Paul, you want to take that one? Speaker 300:26:40Right. So I think for us access is critical. I think that's what moving NARCAN to over the counter is I think will really help and assist. But I think our conversations and working with whether that's CMS or private payers to understand how they're going to think about Potential coverage for NARCAN OTC continues. I don't think we've landed anywhere with any one particular payer or CMS yet, but we know that this is Top of mind for them, we continue to work with them and other stakeholders to ensure that we're able to balance the access With the affordability as we bring NARCAN OTC to market. Speaker 500:27:21Great. Thanks so much. Operator00:27:24Thank you. Please as a reminder, please limit yourself to one question and one follow-up. One moment for our next question. Our next question comes from Brandon Folkes of Cantor Fitzgerald. Your line is now open. Speaker 600:27:47Hi. Thanks for taking my question and thank you for the update. Maybe just firstly staying on NARCAN, how Speaker 300:27:54How do you think about potential for a Speaker 600:27:55non profit player to come into the OTC market there, both from perhaps the price Ability to supply and satisfaction. And if they do come to market, do you think it's a big Become a bigger player in the retail and first responder market there and then along the line, staying on that line of questioning. What can you say about a 4 milligram naloxone intranasal compared to perhaps a 3 milligram? Any data out there suggesting there are different Speaker 200:28:29Yes. Thanks, Brandon. So again, I'll start and then invite Others to join in there as well. So as it relates to your question about a potential nonprofit Player in the nasal naloxone mix. I'm not going to speculate, Brandon, on Who might be out there and what they might be doing? Speaker 200:28:50Again, our focus continues to be as it has for the last 5 years, Continue to look for opportunities to expand awareness, expand access and as Paul indicated, Continue to work with both public and private insurance companies to make this as affordable as possible. So I think the moves that we're making We'll make a big dent in that. In terms of a non profit, again, I think we won't speculate on what they might do. In terms of the 4 milligram formulation, I don't know that there are any exact studies comparing 3 versus 4 milligram, I think it's pretty widely accepted that again given the work The FDA did on this product to approve it back in February of 2016. The 4 milligram presentation is widely accepted as a very Safe and effective dose. Speaker 200:29:51So Paul, if you want to add some more additional color, please do so. Speaker 300:29:56I think you got that one, Bob. Speaker 600:30:00Great. Thanks. And if we can count that as one question, just one follow-up. So just the intent to procure ACAM2000, can you just and I apologize if you did explain this in the call and pop into the future. What does that mean versus the actual excise of the contract option? Speaker 600:30:19Are there any additional steps between the 2nd to secure and the excise of the contract option? That's it for me. Thank you very much. Speaker 200:30:26Yes. Thanks, Brandon. So the notice of intent to procure is What the government typically uses as the next logical step, so after they do a request for information And after they do a request for a proposal and a contractor responds to that RFP, Then negotiations ensue. And after those negotiations are pretty much done, Brandon, You would typically see a notice of intent to procure. So while the exact details of the potential procurement That we refer to under the notice of intent to procure, we're not detailing now. Speaker 200:31:14They have been pretty much heavily negotiated, And we expect that contract modification to be executed in a fairly reasonable time period. And As such, it's now baked into our smallpox franchise guidance for 2023, which is unchanged from earlier this year. Should we go on to the next question, Jada? Operator00:31:48Yes, of course. Thank you. One moment for Speaker 200:31:53the next question. Operator00:31:59Our next question comes from Boris Peaker of TD Cowen. Your line is now open. Speaker 700:32:05Hi. Thanks for taking the question. This is Nick on for Boris. Just a quick one for me. But how does the closing of the deal with Bavarian affect the income statement? Speaker 700:32:14I know that you guys raised EBITDA guidance without really changing too much else directly affecting it. So I was just wondering how this deal with the variant will Affect that? Speaker 200:32:24Yes. Thanks for the question, Nick. Rich, you want to take that one? Speaker 400:32:28Sure. Happy to. So we have we've incorporated the impacts into Our guidance assuming again a Q2 closing, the main impacts are that the other products revenue will decrease Because the existing VEXCOR and Vivotif products will come out of our sales channel and move to Bavarian Nordic. In addition, there will be a positive impact on adjusted EBITDA driven primarily by lower R and D expense As the Chick program spend will also transition over to Bavarian Nordic as well. So those are the contours Of what the impacts are going to be, we do not disclose the components of adjusted EBITDA below the total company level Or the components of other product revenue, but those are the categories that are impacted. Speaker 700:33:24Got it. Thanks. And then just a quick follow-up on that. So once the if assuming the deal closes in 2Q, well then everything related to ChickVVLP be sent over to them, there will be no more R and D costs from you guys on that? Or will you still have to finish out Phase III trial for on your expense and then Varian takes up from there? Speaker 400:33:44They'll assume responsibility for the trial going forward. Speaker 700:33:49Got it. Thanks very much. Operator00:33:52Thank you. One moment for our next question please. Our next question comes from Christopher Sakai from Singular Research, your line is now open. Speaker 800:34:11Thanks. This is Asim for Chris. I see that you have increased the guidance on NARCAN to 93,000,000 in Win 10,000 to 360,380,000 And maybe coincidentally, there is also a decrease in gross margins, 41, 44 to $239,42,000 And obviously, to an extent, you can give us color, how much Of the decrease in gross margin is due to NARCAN because I also see that another major development Is Travel Health divestment? Speaker 200:34:52Yes. Thanks for the question. Rich, you want to field that one? Speaker 400:34:56Sure. Yes. And you're right, there's several moving parts. I would say, the biggest influence On gross margin guidance change is the change in CDMO revenue guidance and the impact there, As well as, as I referred to on the call, just the impact in the Q1 itself of some of the activities there. So those are really the things that are driving the change to full year adjusted gross margin guidance. Speaker 800:35:26And as a follow-up between now and quarterly call 4th quarter, Depending on your conversations with the different channel partners and pricing and volume variables, It looks like and correct me if I am wrong that your expectations in terms of what You would be able to charge for NARCANZA retail price versus what would be at your end has probably not changed. Do you think that assumption is correct? Speaker 200:36:09So Paul, you want to weigh in on that one? Speaker 300:36:13Sure. So I think as and thanks for the question by the way. Because as we've communicated, we've targeted a consumer out of pocket price for OTC to be slightly less than $50 And I would say that is consistent with the price in the public interest segment as we go forward. So, again, we are in the process of finalizing our Our contracts with our retail partners, I would say stakeholders in this, they're as committed to affordability as we are. And once those contracts are finalized, we can provide specific clarity on where the actual consumer Out of pocket price will end up. Speaker 300:36:58But I think our goals are aligned in terms of affordability. Operator00:37:04Thank you. Thank you. We see no further questions at this time. And I will now turn it back over to the company. Speaker 100:37:15Thank you, Jada. And with that, ladies and gentlemen, we now conclude the call. Thank you for your participation. Please note an archived version of today's webcast as well as PDF version of the slides used during today's call will be available later today and accessible through the Investors landing page on the company website. Once again, thank you, and we look forward to speaking to all of you in the future. Speaker 100:37:34Have a good night. Operator00:37:37Thank you for your participation in today's conference. This does conclude the program. You may nowRead moreRemove AdsPowered by