Randomized, Active-Comparison, Double-Blind, Phase 2 Study to Assess the Safety and Immunogenicity of Anthrax Vaccine Adsorbed (BioThrax®) Without and With CPG 7909 Adjuvant (AV7909 Anthrax Vaccine), Using a Post-Exposure Prophylaxis Dosing Regimen in Adults 66 Years of Age or Older in Stable Health in Comparison to Adults 18-50 Years of Age in Stable Health

This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.

Start Date09 May 2018

Sponsor / Collaborator

Biomedical Advanced Research and Development Authority (BARDA)

[+1]

NCT02339155 / CompletedPhase 4

A Randomized, Open-label Study to Evaluate the Immunogenicity of Anthrax Vaccine Adsorbed Alone or Concomitantly With Raxibacumab (GSK3068483)

This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is administered alone or concomitantly with raxibacumab. The study is planned to enroll approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be approximately 26 weeks. The dates reflect cohort 1.

Start Date24 Feb 2015

Sponsor / Collaborator

Emergent BioSolutions, Inc.

[+1]

100 Clinical Results associated with Anthrax vaccine adsorbed(Emergent Biodefense)

100 Translational Medicine associated with Anthrax vaccine adsorbed(Emergent Biodefense)

100 Patents (Medical) associated with Anthrax vaccine adsorbed(Emergent Biodefense)

297

Literatures (Medical) associated with Anthrax vaccine adsorbed(Emergent Biodefense)

31 Dec 2024·Annals of Medicine

Cyclosporine plus avatrombopag versus cyclosporine monotherapy for first-line treatment of elderly patients with transfusion-dependent non-severe aplastic anemia: a single center retrospective study

Article

Author: Han, Bing ; Chen, Miao ; Yang, Chen ; Wang, Leyu ; Zhang, Zhuxin ; Hu, Qinglin

BACKGROUNDElderly patients with transfusion-dependent non-severe aplastic anemia (TD-NSAA) face limited treatment options owing to transplantation incompatibility and safety concerns.METHODSData from older patients (≥60 years) newly diagnosed with TD-NSAA and had been treated with either avatrombopag (AVA) + cyclosporine (CsA) or CsA monotherapy at our center were retrospectively collected.RESULTSIn total, 52 patients were enrolled, with 26 receiving AVA + CsA and 26 receiving CsA monotherapy. The overall response (OR) rate was higher in the AVA + CsA group than in the CsA group at the 1^st, 2^nd, 3^rd, 6^th months, and at the end of the follow-up (all p < 0.05). The complete response (CR) rate was higher in the AVA + CsA group than in the CsA group at the 6^th month and at the end of follow-up (p = 0.017 and 0.039). Patients receiving AVA + CsA had a shorter time to achieve the first response (p = 0.008) and CR (p = 0.010) than those receiving CsA monotherapy. Furthermore, patients receiving AVA + CsA exhibited a higher rate of platelet transfusion independence at the 3^rd (p = 0.041), 6^th (p = 0.008) months, and likewise at the end of the follow-up (p = 0.097).CONCLUSIONSThe addition of AVA to CsA can significantly improve the OR or CR rate and platelet levels with acceptable side effects in elderly patients, which implies that the combination is a viable alternative for elderly patients with TD-NSAA.

01 Dec 2024·Experimental Hematology

Efficacy and safety of avatrombopag in combination with standard immunosuppressive therapy for severe aplastic anemia

Article

Author: Yuan, Weiping ; Liang, Weiru ; Shi, Jun ; Ye, Lei ; Peng, Guangxin ; Yang, Yang ; Zhang, Fengkui ; Zhang, Li ; Zhou, Kang ; Jing, Liping ; Zhao, Xin ; Li, Yuan ; Fan, Huihui ; Yang, Wenrui ; Li, Jianping ; Xiong, Youzhen

Severe aplastic anemia (SAA) is a life-threatening bone marrow failure disease. The addition of eltrombopag to immunosuppressive therapy (IST) improves the response rate, but its hepatotoxicity is concerning. Avatrombopag (AVA), a small-molecule thrombopoietin-receptor agonist without hepatotoxicity, has unknown efficacy in SAA treatment. This retrospective study assessed the efficacy and safety of AVA added to IST 42 SAA patients compared to a historical cohort of 84 patients receiving IST alone, using propensity score matching. The median age was 31.5 (6.0-67.0 years) years old in group A and 26 (16.0-45.0 years) years old in group B. At 3 months, group A showed higher complete response (CR) and overall response (OR) rates than group B (CR: 19.0% vs. 4.8%, p = 0.024; OR: 54.8% vs. 39.3%, p = 0.145). Higher CR and OR rates were also found at 6 months in group A than in group B (CR: 31.0% vs. 14.3%, p = 0.145; OR 71.4% vs. 51.2%, p = 0.048). In multivariate analysis of group A, a shorter interval from disease onset to antithymocyte globulin (ATG) treatment (≤6 months) (p = 0.005) predicted better responses rate at 6 months. Event-free survival was also improved in group A (60.7% vs. 49.6%). AVA was well-tolerated, with no hepatic injury observed during treatment, even in those with pre-existing hepatic impairment. The addition of AVA to IST improves both the response rate and response quality in patients with SAA while ensuring safety.

10 Sep 2024·Chinese medical journal

Efficacy and safety of avatrombopag in the treatment of thrombocytopenia after umbilical cord blood transplantation.

Article

Author: Tang, Baolin ; Tu, Meijuan ; Song, Kaidi ; Huang, Aijie ; Cheng, Yaxin ; Wu, Weiwei ; Yao, Wen ; Han, Yongsheng ; Sun, Guangyu ; Zhu, Xiaoyu ; Wu, Yue ; Pan, Tianzhong ; Wan, Xiang

BACKGROUNDDelayed platelet engraftment is a common complication after umbilical cord blood transplantation (UCBT), and there is no standard therapy. Avatrombopag (AVA) is a second-generation thrombopoietin (TPO) receptor agonist (TPO-RA) that has shown efficacy in immune thrombocytopenia (ITP). However, few reports have focused on its efficacy in patients diagnosed with thrombocytopenia after allogeneic hematopoietic stem cell transplantation (allo-HSCT).METHODSWe conducted a retrospective study to evaluate the efficacy of AVA as a first-line TPO-RA in 65 patients after UCBT; these patients were compared with 118 historical controls. Response rates, platelet counts, megakaryocyte counts in bone marrow, bleeding events, adverse events and survival rates were evaluated in this study. Platelet reconstitution differences were compared between different medication groups. Multivariable analysis was used to explore the independent beneficial factors for platelet implantation.RESULTSFifty-two patients were given AVA within 30 days post-UCBT, and the treatment was continued for more than 7 days to promote platelet engraftment (AVA group); the other 13 patients were given AVA for secondary failure of platelet recovery (SFPR group). The median time to platelet engraftment was shorter in the AVA group than in the historical control group (32.5 days vs. 38.0 days, Z = 2.095, P = 0.036). Among the 52 patients in the AVA group, 46 achieved an overall response (OR) (88.5%), and the cumulative incidence of OR was 91.9%. Patients treated with AVA only had a greater 60-day cumulative incidence of platelet engraftment than patients treated with recombinant human thrombopoietin (rhTPO) only or rhTPO combined with AVA (95.2% vs. 84.5% vs. 80.6%, P <0.001). Patients suffering from SFPR had a slightly better cumulative incidence of OR (100%, P = 0.104). Patients who initiated AVA treatment within 14 days post-UCBT had a better 60-day cumulative incidence of platelet engraftment than did those who received AVA after 14 days post-UCBT (96.6% vs. 73.9%, P = 0.003).CONCLUSIONIn summary, compared with those in the historical control group, our results indicate that AVA could effectively promote platelet engraftment and recovery after UCBT, especially when used in the early period (≤14 days post-UCBT).

News (Medical) associated with Anthrax vaccine adsorbed(Emergent Biodefense)

06 Nov 2024

·www.globenewswire.com

Emergent BioSolutions Reports Third Quarter 2024 Financial Results

Third Quarter 2024 Total Revenues of $293.8 million, increase of 9% versus prior yearThird Quarter 2024 Net Income of $114.8 million, increase of 144% versus prior yearThird Quarter 2024 Adjusted EBITDA of $105.3 million, increase of 432% versus prior yearRaises FY 2024 guidance GAITHERSBURG, Md., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today reported financial results for the third quarter ended September 30, 2024. "Through disciplined execution and steady, measurable progress, Emergent's financial position is the strongest it has been since 2021 as evidenced by our favorable third-quarter results," said CEO Joe Papa. "We have successfully improved efficiencies and refocused our operations related to customer demand, generated value in our core medical countermeasures and NARCAN® Nasal Spray businesses and refinanced our debt leading to increased revenue and cash flow." Papa continued, "Based on the success of our efforts since the beginning of this year, we are officially entering the turnaround phase of our multi-year transformation plan, and we will be focused on driving profitable growth, continued operational improvements and the generation of sustainable value for shareholders. We believe ongoing public health crises like the opioid overdose epidemic and mpox outbreak underscore the need for Emergent's capabilities and expertise. It is not if, but when, the next public health threat emerges, and we believe we are uniquely qualified to help respond to protect, enhance and save lives." FINANCIAL HIGHLIGHTS(1) Q3 2024 vs. Q3 2023 ($ in millions, except per share amounts)Q3 2024Q3 2023% ChangeTotal Revenues$293.8 $270.5 9%Net Income (Loss)$114.8 $(263.4)144%Net Income (Loss) per Diluted Share$2.06 $(5.08)141%Adjusted Net Income (Loss)(2)$76.2 $(56.2)236%Adjusted Net Income (Loss) per Diluted Share(2)$1.37 $(1.09)226%Adjusted EBITDA(2)$105.3 $19.8 432%Total Segment Gross Margin %(2) 57% 33% Total Segment Adjusted Gross Margin %(2) 59% 38% Year to Date (“YTD”) 2024 vs. YTD 2023 ($ in millions, except per share amounts)YTD 2024YTD 2023% ChangeTotal Revenues$848.9 $772.7 10%Net Loss$(159.3)$(711.0)78%Net Loss per Diluted Share$(3.03)$(13.97)78%Adjusted Net Loss(2)$(14.7)$(273.0)95%Adjusted Net Loss per Diluted Share(2)$(0.28)$(5.36)95%Adjusted EBITDA(2)$162.1 $(25.7)731%Total Segment Gross Margin %(2) 32% 31% Total Segment Adjusted Gross Margin %(2) 46% 33% SELECT Q3 2024 BUSINESS UPDATES Secured a new Term Loan for $250 million with OHA Agency, LLC as administrative agent.Closed on a new asset backed loan facility for $100 million with Wells Fargo Bank, National Association.Received $75 million for the sale of our RSDL® (Reactive Skin Decontamination Lotion) product to a subsidiary of SERB Pharmaceuticals ("SERB"), subject to customary adjustments based on inventory value at closingCompleted the sale of the Baltimore-Camden manufacturing site for $35 million, including customary post-closing adjustmentsSold an underutilized warehouse at our Canton, MA facility for $7 millionReceived $50 million in the third quarter related to the resolution of the contractual dispute with Janssen Pharmaceuticals, Inc.Earned $30 million development milestone payments from Bavarian Nordic as part of the sale of the Travel Health Business THIRD QUARTER 2024 FINANCIAL PERFORMANCE(1) Revenues The Company uses the following categories in discussing product/service level revenues: NARCAN® — comprises contributions from NARCAN® Nasal SprayAnthrax MCM — comprises contributions from CYFENDUS®, previously known as AV7909, BioThrax®, Anthrasil® and RaxibacumabSmallpox MCM — comprises contributions from ACAM2000®, VIGIV and TEMBEXA®Other Products — comprises contributions from BAT® and RSDL®Bioservices — comprises service and lease revenues from the Bioservices business ($ in millions)Q3 2024Q3 2023% ChangeProduct sales, net:(3) NARCAN®$95.3$142.1(33)%Anthrax MCM 11.4 32.9(65)%Smallpox MCM 132.7 24.7437%Other Products 30.1 50.1(40)%Total Product sales, net$269.5$249.88% Bioservices: Services$13.9$13.25%Leases 0.4 1.0(60)%Total Bioservices revenues$14.3$14.21% Contracts and grants$10.0$6.554% Total revenues$293.8$270.59% Products Sales, net NARCAN® For Q3 2024, revenues from NARCAN® (naloxone HCl) Nasal Spray decreased $46.8 million, or 33%, as compared with Q3 2023. The decrease was primarily driven by the discontinuation of prescription NARCAN® due to the launch of over-the-counter (“OTC”) NARCAN® in the third quarter of 2023 and lower Canadian retail sales, partially offset by higher sales of OTC NARCAN®. Anthrax MCM For Q3 2024, revenues from Anthrax MCM products decreased $21.5 million, or 65%, as compared with Q3 2023. The decrease reflects the impact of timing of sales related to CYFENDUS® and Anthrasil®, partially offset by an increase in BioThrax® sales, due to timing. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the U.S. government (the “USG”). Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing of USG purchases, the availability of governmental funding and the Company’s delivery of orders that follow. Smallpox MCM For Q3 2024, revenues from Smallpox MCM products increased $108.0 million, or 437%, as compared with Q3 2023. The increase was primarily due to timing of USG purchases of ACAM2000® and VIGIV. Fluctuations in revenues from Smallpox MCM result from the timing of the exercise of annual purchase options in the existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow. Other Products For Q3 2024, revenues from Other Product sales decreased $20.0 million, or 40%, as compared with Q3 2023. The decrease was due to lower product sales of BAT®, due to timing of deliveries, and lower product sales of RSDL®, which was sold to SERB during the third quarter of 2024. Bioservices Revenues Services For Q3 2024, revenues from Bioservices services increased $0.7 million, or 5%, as compared with Q3 2023. The increase was primarily attributable to an increase in production at the Company’s Camden facility, prior to the sale of the facility to Bora, partially offset by lower production at the Company’s Canton and Winnipeg facilities. Leases For Q3 2024, revenues from Bioservices leases decreased $0.6 million, or 60%, as compared with Q3 2023. The decrease was related to the completion of a lease for a Bioservices customer at our Canton facility, partially offset by new lease revenue associated with SERB at our Winnipeg facility. Contracts and Grants For Q3 2024, revenues from contracts and grants increased $3.5 million, or 54%, as compared with Q3 2023. The increase was primarily due to timing of funding as well as an increase related to work under the Ebanga™ program. Operating Expenses ($ in millions)Q3 2024Q3 2023% ChangeCost of Commercial product sales$47.2$60.0(21)%Cost of MCM product sales 54.0 72.5(26)%Cost of Bioservices 21.4 44.3(52)%Research and development (“R&D”) 13.8 15.3(10)%Selling, general and administrative (“SG&A”) 76.6 86.0(11)%Amortization of intangible assets 16.3 16.3—%Goodwill impairment — 218.2(100)%Total operating expenses$229.3$512.6(55)% Cost of Commercial Product Sales For Q3 2024, cost of Commercial Product sales decreased $12.8 million, or 21%, as compared with Q3 2023. The decrease was primarily due to lower prescription NARCAN® unit volume, partially offset by higher OTC NARCAN® unit volume. Cost of MCM Product Sales For Q3 2024, cost of MCM Product sales decreased $18.5 million, or 26%, as compared with Q3 2023. The decrease was primarily due to lower sales of BAT® and CYFENDUS®, coupled with lower allocations to Cost of MCM Product sales at our Bayview facility. This decrease was partially offset by higher sales of BioThrax® and ACAM2000®. Cost of Bioservices For Q3 2024, cost of Bioservices decreased $22.9 million, or 52%, as compared with Q3 2023. The decrease was primarily due to lower overhead and remediation costs related to the sale of the Camden facility, coupled with a decrease in overhead costs at our other Maryland facilities as a result of the announced shutdowns and lower costs at our Canton facility. The decrease was partially offset by an increase in production at our Winnipeg facility. Research and Development Expenses For Q3 2024, R&D expenses decreased $1.5 million, or 10%, as compared with Q3 2023. The decrease was driven by a reduction in spend for certain funded and unfunded projects, excluding Ebanga™. The decrease was partially offset by an increase in funded R&D related to Ebanga™. Selling, General and Administrative Expenses For Q3 2024, SG&A expenses decreased $9.4 million, or 11%, as compared with Q3 2023. The decrease was primarily due to lower employee related expenses and compensation as a result of restructuring initiatives during 2023 and 2024, coupled with a decrease in legal services fees for disputes and other corporate initiatives. This decrease was partially offset by the settlement charge related to the stockholder litigation matter, net of expected insurance proceeds. Goodwill Impairment For Q3 2024, Goodwill impairment decreased $218.2 million as compared with Q3 2023. The decrease was due to the Q3 2023 non-cash impairment charge to Goodwill in the MCM Products reporting unit, which reduced the reporting unit’s goodwill balance to zero. ADDITIONAL FINANCIAL INFORMATION(1) Capital Expenditures ($ in millions)Q3 2024Q3 2023% ChangeCapital expenditures$5.8 $12.6 (54)%Capital expenditures as a % of total revenues 2% 5% For Q3 2024, capital expenditures decreased largely due to lower product development activities across the Company’s facilities. SEGMENT INFORMATION The Company manages the business with a focus on three reportable segments: (1) the Commercial Products segment consisting of our NARCAN® and other commercial products that were sold as part of our travel health business in the second quarter of 2023; (2) the MCM Products segment consisting of the Anthrax - MCM, Smallpox - MCM and Other products and (3) the services segment (“Services”) consisting of our Bioservices business. The Company evaluates the performance of these reportable segments based on revenues and segment adjusted gross margin, which is a non-GAAP financial measure. Segment revenue includes external customer sales, but does not include inter-segment services. The Company does not allocate contracts and grants revenue, R&D, SG&A, amortization of intangible assets, interest and other income (expense) or taxes to its evaluation of the performance of these segments. THIRD QUARTER 2024 SEGMENT RESULTS ($ in millions)Commercial ProductsQuarter Ended September 30, 2024 2023 $ Change% ChangeRevenues$95.3 $142.1 $(46.8)(33)%Cost of sales 47.2 60.0 (12.8)(21)%Gross margin**$48.1 $82.1 $(34.0)(41)%Gross margin %** 50% 58% Segment adjusted gross margin(2)$48.1 $82.1 $(34.0)(41)%Segment adjusted gross margin %(2) 50% 58% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues. Commercial Products gross margin decreased $34.0 million, or 41%, to $48.1 million in the quarter, as compared with $82.1 million in the prior year quarter. Commercial Products gross margin percentage decreased seven percentage points to 50% for the quarter ended September 30, 2024. The decrease was largely due to an unfavorable price and volume mix in 2024 for NARCAN® products. Commercial Products segment adjusted gross margin is consistent with gross margin. ($ in millions)MCM ProductsQuarter Ended September 30, 2024 2023 $ Change% ChangeRevenues$174.2 $107.7 $66.5 62%Cost of sales 54.0 72.5 (18.5)(26)%Gross margin**$120.2 $35.2 $85.0 241%Gross margin %** 69% 33% Add back: Changes in fair value of financial instruments$— $(1.1)$1.1 100%Restructuring costs 4.9 5.0 (0.1)(2)%Inventory step-up provision 1.2 — 1.2 NMSegment adjusted gross margin(2)$126.3 $39.1 $87.2 223%Segment adjusted gross margin %(2) 73% 36% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues.NM - Not Meaningful MCM Products gross margin increased $85.0 million, or 241%, to $120.2 million in the quarter, as compared with $35.2 million in the prior year quarter. MCM Products gross margin percentage increased 36 percentage points to 69% for the quarter ended September 30, 2024. The increase was largely due to overall higher sales volumes with a favorable product mix weighted more heavily to higher margin products coupled with lower allocations to cost of MCM Product sales at our Bayview facility and overall lower shutdown and overhead costs across our facilities. MCM Product segment adjusted gross margin in the current year period excludes the impact of non-cash items related to the impact of restructuring costs of $4.9 million and inventory step-up provision of $1.2 million. ($ in millions)ServicesQuarter Ended September 30, 2024 2023 $ Change% ChangeRevenues$14.3 $14.2 $0.1 1%Cost of services 21.4 44.3 (22.9)(52)%Gross margin**$(7.1)$(30.1)$23.0 76%Gross margin %**(50)%(212)% Add back: Restructuring costs 0.1 8.1 (8.0)(99)%Segment adjusted gross margin(2)$(7.0)$(22.0)$15.0 68%Segment adjusted gross margin %(2)(49)%(155)% ** Gross margin is calculated as revenues less cost of services. Gross margin % is calculated as gross margin divided by revenues. Services gross margin increased $23.0 million, or 76%, to $(7.1) million in the quarter, as compared with $(30.1) million in the prior year quarter. Services gross margin percentage increased 162 percentage points to (50)% for the quarter ended September 30, 2024. The increase was primarily due to lower overhead and remediation costs related to the sale of the Camden facility coupled with lower costs at our Bayview facility. Services segment adjusted gross margin in the current year period excludes the impact of restructuring costs of $0.1 million. YTD 2024 SEGMENT RESULTS Commercial Products Nine Months Ended September 30, 2024 2023 $ Change % Change Revenues$333.8 $386.2 $(52.4)(14)%Cost of sales 152.7 160.2 (7.5)(5)%Gross margin**$181.1 $226.0 $(44.9)(20)%Gross margin %** 54% 59% Segment adjusted gross margin(2)$181.1 $226.0 $(44.9)(20)%Segment adjusted gross margin %(2) 54% 59% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues. Commercial Products gross margin decreased $44.9 million, or 20%, to $181.1 million for the nine months ended September 30, 2024, as compared with $226.0 million for the nine months ended September 30, 2023. Commercial Products gross margin percentage decreased five percentage points to 54% in 2024. The decrease was largely due to an unfavorable price and volume mix in 2024 for NARCAN® products, partially offset by the sale of the products associated with our travel health business to Bavarian Nordic. Commercial Products segment adjusted gross margin is consistent with gross margin. ($ in millions)MCM ProductsNine Months Ended September 30, 2024 2023 $ Change% ChangeRevenues$393.0 $309.2 $83.8 27%Cost of sales 147.3 208.4 (61.1)(29)%Gross margin**$245.7 $100.8 $144.9 144%Gross margin %** 63% 33% Add back: Changes in fair value of financial instruments$0.6 $(0.4)$1.0 250%Inventory step-up provision 1.2 1.9 (0.7)(37)%Restructuring costs 7.5 7.0 0.5 7%Segment adjusted gross margin(2)$255.0 $109.3 $145.7 133%Segment adjusted gross margin %(2) 65% 35% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues.NM - Not Meaningful MCM Products gross margin increased $144.9 million, or 144%, to $245.7 million for the nine months ended September 30, 2024, as compared with $100.8 million for the nine months ended September 30, 2023. MCM Products gross margin percentage increased 29 percentage points to 63% for the nine months ended September 30, 2024. The increase was largely due to overall higher sales volumes with a favorable product mix weighted more heavily to higher margin products coupled with lower allocations to Cost of MCM Product sales at our Bayview facility and lower shutdown related costs, a reduction in Trobigard® related costs, due to the Trobigard® revocation, and realization of previously adjusted inventory values. MCM Product segment adjusted gross margin excludes the impact of restructuring costs of $7.5 million, inventory step-up provision of $1.2 million and changes in fair value of financial instruments of $0.6 million. ($ in millions)ServicesNine Months Ended September 30, 2024 2023 $ Change% ChangeRevenues$97.5 $57.7 $39.8 69%Cost of services 263.3 151.7 111.6 74%Gross margin**$(165.8)$(94.0)$(71.8)(76)%Gross margin %**(170)%(163)% Add back: Settlement charges, net$110.2 $— $110.2 NMRestructuring costs 0.3 8.1 (7.8)(96)%Segment adjusted gross margin(2)$(55.3)$(85.9)$30.6 36%Segment adjusted gross margin %(2)(57)%(149)% ** Gross margin is calculated as revenues less cost of sales. Gross margin % is calculated as gross margin divided by revenues.NM - Not Meaningful Services gross margin decreased $71.8 million, or 76%, to $(165.8) million for the nine months ended September 30, 2024, as compared with $(94.0) million for the nine months ended September 30, 2023. Services gross margin percentage decreased 7 percentage points to (170)% for the nine months ended September 30, 2024. The decrease was primarily due to the Settlement Agreement with Janssen and resulting revenue and write-down of related assets to net realizable value, coupled with lower production at the Company's Canton facility. This decrease was partially offset by an increase in production at the Camden facility prior to the sale of the facility to Bora and a decrease in overhead costs at our other Maryland facilities. Services segment adjusted gross margin in the current year period excludes the impact of segment settlement charge, net of $110.2 million and restructuring costs of $0.3 million. 2024 FINANCIAL FORECAST The Company provides the following updated financial forecast for full year 2024, reflecting management's expectations based on the most current information available. Full Year 2024 METRIC($ in millions)Updated Range(as of 11/6/2024)Previous Range(as of 08/06/2024)Previous Range(as of 05/01/2024)Previous Range(as of 03/06/2024)Total revenues$1,065 - $1,125$1,050 - $1,125$1,000 - $1,100$900 - $1,100Net loss$(203) - $(183)$(314) - $(274)$(148) - $(98)$(183) - $(133)Adjusted net loss(2)$(50) - $(30)$(115) - $(75)$(65) - $(15)$(130) - $(80)Adjusted EBITDA(2)$180 - $200$140 - $180$125 - $175$50 - $100Total segment adjusted gross margin %(2)43% - 45%42% - 45%44% - 47%40% - 45% Segment Level Revenue(4) Commercial Products$420 - $430$450 - $480$460 - $500$460 - $500MCM Products$510 - $550$455 - $490$440 - $490$340 - $490Services(5)$105 - $110$120 - $130$70 - $80$70 - $80 Key Assumptions($ and shares in millions)Updated Range(as of 11/6/2024) Interest expense~$75 R&D~7% of Revenue Weighted avg. fully diluted share count~53 Capex~$25 Depreciation & amortization~$109 FOOTNOTES (1) All financial information included in this release is unaudited. (2) See “Non-GAAP Financial Measures” and the "Reconciliation of Non-GAAP Financial Measures" tables for the definitions and reconciliations of these non-GAAP financial measures to the most closely related GAAP financial measures. (3) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts in accordance with U.S. generally accepted accounting principles. (4) Our Commercial Products forecast consists solely of NARCAN® Nasal Spray, as our Other Commercial Products, including Vivotif® and Vaxchora®, were sold to Bavarian Nordic as part of our travel health business in May 2023. (5) Our Services revenue forecast includes $50.0 million related to the Settlement Agreement with Janssen and excludes revenues related to the Baltimore-Camden Facility after August 20, 2024. CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION Company management will host a conference call at 5:00 pm eastern time today, November 6, 2024, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company's website or through the following: By phoneTo join via telephone, please use the following dial-in details:U.S. / New York: +1-646-968-2525U.S. & Canada (Toll Free): +1-888-596-4144Conference ID: 5259189 By webcast Visit https://edge.media-server.com/mmc/p/nm3oj8g9A replay of the call can be accessed from the Emergent website. ABOUT EMERGENT BIOSOLUTIONS INC. At Emergent, our mission is to protect and enhance life. We develop, manufacture, and deliver protections against public health threats through a pipeline of innovative vaccines and therapeutics. For over 25 years, we have been at work defending people from things we hope will never happen—so that we are prepared just in case they ever do. We do what we do because we see the opportunity to create a better, more secure world. One where preparedness empowers protection from the threats we face. And peace of mind prevails. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information, visit our website and follow us on LinkedIn, Twitter, and Instagram. NON-GAAP FINANCIAL MEASURES In the accompanying analysis of financial information, we sometimes use information derived from consolidated and segment financial information that may not be presented in our financial statements or prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Certain of these financial measures are considered not in conformity with GAAP (“non-GAAP financial measures”) under the United States Securities and Exchange Commission (“SEC”) rules. Specifically, we have referred to the following non-GAAP financial measures: Adjusted Net Income (Loss)Adjusted Net Income (Loss) per Diluted ShareAdjusted EBITDATotal Segment RevenuesTotal Segment Gross MarginTotal Segment Gross Margin %Total Segment Adjusted Gross MarginTotal Segment Adjusted Gross Margin %Segment Adjusted Gross MarginSegment Adjusted Gross Margin % We define Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per Diluted Share, which are non-GAAP financial measures, as net income (loss) and net income (loss) per diluted share, respectively, excluding the impact of changes in fair value of financial instruments, acquisition and divestiture-related costs, severance and restructuring costs, settlement charges, net, exit and disposal costs, impairment charges, gain (loss) on sale of business, non-cash amortization charges, contingent consideration milestones, and other income (expense) items. We use Adjusted Net Income (Loss) for the purpose of calculating Adjusted Net Income (Loss) per Diluted Share. Management uses Adjusted Net Income (Loss) per Diluted Share to assess total Company operating performance on a consistent basis. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results and GAAP financial measures, provide management and investors with an additional understanding of our business operating results, including underlying trends. We define Adjusted EBITDA, which is a non-GAAP financial measure, as consolidated net income (loss) before income tax provision (benefit), interest expense, net, depreciation, amortization of intangible assets, excluding the impact of changes in fair value of financial instruments, acquisition and divestiture-related costs, severance and restructuring costs, settlement charges, net, exit and disposal costs, impairment charges, gain (loss) on sale of business, non-cash amortization charges, contingent consideration milestones and other income (expense) items. We believe that this non-GAAP financial measure, when considered together with our GAAP financial results and GAAP financial measures, provides management and investors with a more complete understanding of our operating results, including underlying trends. In addition, EBITDA is a common alternative measure of operating performance used by many of our competitors. It is used by investors, financial analysts, rating agencies and others to value and compare the financial performance of companies in our industry, although it may be defined differently by different companies. Therefore, we also believe that this non-GAAP financial measure, considered along with corresponding GAAP financial measures, provides management and investors with additional information for comparison of our operating results with the operating results of other companies. We have included the definitions of Segment Gross Margin and Segment Gross Margin %, which are GAAP financial measures, below in order to more fully define the components of certain non-GAAP financial measures presented in this press release. We define Segment Gross Margin, as a segment's revenues, less a segment's cost of sales or services. We define Segment Gross Margin %, as Segment Gross Margin as a percentage of a segments revenues. We define Segment Adjusted Gross Margin, which is a non-GAAP financial measure as Segment Gross Margin excluding the impact of restructuring costs, changes in the fair value of financial instruments, settlement charges, net and inventory step-up provision. We define Segment Adjusted Gross Margin %, which is a non-GAAP financial measure, as Segment Adjusted Gross Margin as a percentage of a segment's revenues. We define Total Segment Revenues, which is a non-GAAP financial measure, as our Total Revenues, less contracts and grants revenue, which is also equal to the sum of the revenues of our reportable operating segments. We define Total Segment Gross Margin, which is a non-GAAP financial measure, as Total Segment Revenues less our aggregate cost of sales or services. We define Total Segment Gross Margin %, which is a non-GAAP financial measure, as Total Segment Gross Margin as a percentage of Total Segment Revenues. We define Total Segment Adjusted Gross Margin, which is a non-GAAP financial measure, as Total Segment Gross Margin, excluding the impact of restructuring costs, settlement charges, net, changes in the fair value of financial instruments and inventory step-up provision. We define Total Segment Adjusted Gross Margin %, which is a non-GAAP financial measure, as Total Segment Adjusted Gross Margin as a percentage of Total Segment Revenues. Non-GAAP financial measures are not defined in the same manner by all companies and may not be comparable with other similarly titled measures of other companies. The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Non-GAAP financial measures should be considered in addition to, but not as a substitute for or superior to, the information contained in our Consolidated Statements of Operations and Consolidated Statements of Cash Flows. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial tables accompanying this press release. SAFE HARBOR STATEMENT This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the future performance of the Company or any of our businesses, our business strategy, future operations, future financial position, future revenues and earnings, our ability to achieve the objectives of our restructuring initiatives and divestitures, including our future results, projected costs, prospects, plans and objectives of management, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “may,” “plan,” “position,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs, assumptions and expectations regarding future events based on information that is currently available. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement contained herein. Any such forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake any obligation to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including, among others, the availability of USG funding for contracts related to procurement of our medical countermeasure ("MCM") products, including CYFENDUS® (Anthrax Vaccine Adsorbed (AVA) Adjuvanted), previously known as AV7909, BioThrax® (Anthrax Vaccine Adsorbed), and ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) among others, as well as contracts related to development of medical countermeasures; the availability of government funding for our other commercialized products, including Ebanga™ (ansuvimab-zykl) and BAT® (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)); our ability to meet our commitments to quality and compliance in all of our manufacturing operations; our ability to negotiate additional USG procurement or follow-on contracts for our MCM products that have expired or will be expiring; the commercial availability and acceptance of over-the-counter NARCAN® (naloxone HCl) Nasal Spray; the impact of a generic and competitive marketplace on NARCAN® Nasal Spray and future NARCAN® Nasal Spray sales; our ability to perform under our contracts with the USG, including the timing of and specifications relating to deliveries; our ability to provide Bioservices (as defined below) for the development and/or manufacture of product and/or product candidates of our customers at required levels and on required timelines; the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices and other regulatory obligations; our ability to negotiate further commitments related to the collaboration and deployment of capacity toward future commercial manufacturing under our existing Bioservices contracts; our ability to collect reimbursement for raw materials and payment of service fees from our Bioservices customers; the results of pending government investigations and their potential impact on our business; our ability to obtain final court approval of the proposed settlement agreement relating to the stockholder litigation, including our ability to satisfy the conditions of the proposed settlement, and the source of funds to be used to resolve the litigation, and the potential impact of the settlement agreement, if approved, on our business; our ability to comply with the operating and financial covenants required by our term loan facility under a credit agreement, dated August 30, 2024, our revolving credit facility under a credit agreement, dated September 30, 2024, and our 3.875% Senior Unsecured Notes due 2028; our ability to maintain adequate internal control over financial reporting and to prepare accurate financial statements in a timely manner; our ability to successfully manage our liquidity in order to continue as a going concern; the procurement of our product candidates by USG entities under regulatory authorities that permit government procurement of certain medical products prior to FDA marketing authorization, and corresponding procurement by government entities outside the United States; our ability to realize the expected benefits of the sale of our travel health business to Bavarian Nordic, the sale of RSDL® to SERB Pharmaceuticals and the sale of our drug product facility in Baltimore-Camden to Bora Pharmaceuticals Injectables Inc.; the impact of the organizational changes we announced in January 2023, August 2023, May 2024 and August 2024; our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria; the impact of cyber security incidents, including the risks from the unauthorized access, interruption, failure or compromise of our information systems or those of our business partners, collaborators or other third parties; the success of our commercialization, marketing and manufacturing capabilities and strategy; and the accuracy of our estimates regarding future revenues, expenses, capital requirements and need for additional financing. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Readers should consider this cautionary statement, as well as the risks identified in our periodic reports filed with the Securities and Exchange Commission, when evaluating our forward-looking statements. Trademarks Emergent®, BioThrax®, BaciThrax®, BAT®, Trobigard®, Anthrasil®, CNJ-016®, ACAM2000®, NARCAN®, CYFENDUS®, TEMBEXA® and any and all Emergent BioSolutions Inc. brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All other brands, products, services and feature names or trademarks are the property of their respective owners, including RSDL® (Reactive Skin Decontamination Lotion), which was acquired by SERB on July 31, 2024. Investor ContactRich LindahlExecutive Vice President, Chief Financial Officerlindahlr@ebsi.comMedia ContactAssal HellmerVice President, Communicationsmediarelations@ebsi.com Emergent BioSolutions Inc. Consolidated Balance Sheets(unaudited, in millions, except per share data) September 30, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents$149.9 $111.7 Restricted cash 6.5 — Accounts receivable, net 121.3 191.0 Inventories, net 322.7 328.9 Prepaid expenses and other current assets 61.0 47.9 Total current assets 661.4 679.5 Property, plant and equipment, net 278.1 382.8 Intangible assets, net 517.8 566.6 Other assets 20.5 194.3 Total assets$1,477.8 $1,823.2 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$82.1 $112.2 Accrued expenses 16.1 18.6 Accrued compensation 63.3 74.1 Debt, current portion 0.8 413.7 Other current liabilities 67.6 32.7 Total current liabilities 229.9 651.3 Debt, net of current portion 661.8 446.5 Deferred tax liability 41.9 47.2 Other liabilities 35.8 28.9 Total liabilities$969.4 $1,173.9 Stockholders’ equity: Preferred stock, $0.001 par value per share; 15.0 shares authorized, no shares issued and outstanding — — Common stock, $0.001 par value per share; 200.0 shares authorized, 59.7 and 57.8 shares issued; 54.1 and 52.2 shares outstanding, respectively. 0.1 0.1 Treasury stock, at cost, 5.6 and 5.6 common shares, respectively (227.7) (227.7)Additional paid-in capital 924.4 904.4 Accumulated other comprehensive loss, net (7.3) (5.7)Accumulated deficit (181.1) (21.8)Total stockholders’ equity$508.4 $649.3 Total liabilities and stockholders’ equity$1,477.8 $1,823.2 Emergent BioSolutions Inc. Consolidated Statements of Operations(unaudited, in millions, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues: Commercial Product sales$95.3 $142.1 $333.8 $386.2 MCM Product sales 174.2 107.7 393.0 309.2 Total Product sales, net 269.5 249.8 726.8 695.4 Bioservices: Services 13.9 13.2 96.7 52.2 Leases 0.4 1.0 0.8 5.5 Total Bioservices revenues 14.3 14.2 97.5 57.7 Contracts and grants 10.0 6.5 24.6 19.6 Total revenues 293.8 270.5 848.9 772.7 Operating expenses: Cost of Commercial Product sales 47.2 60.0 152.7 160.2 Cost of MCM Product sales 54.0 72.5 147.3 208.4 Cost of Bioservices 21.4 44.3 263.3 151.7 Research and development 13.8 15.3 61.6 82.0 Selling, general and administrative 76.6 86.0 247.2 278.7 Amortization of intangible assets 16.3 16.3 48.8 49.4 Goodwill impairment — 218.2 — 218.2 Impairment of long-lived assets — — 27.2 306.7 Total operating expenses 229.3 512.6 948.1 1,455.3 Income (loss) from operations 64.5 (242.1) (99.2) (682.6) Other income (expense): Interest expense (8.3) (19.7) (56.2) (66.2)Gain (loss) on sale of business 64.3 (0.7) 24.3 74.2 Other, net 21.9 (3.4) 15.8 (2.1)Total other income (expense), net 77.9 (23.8) (16.1) 5.9 Income (loss) before income taxes 142.4 (265.9) (115.3) (676.7)Income tax provision (benefit) 27.6 (2.5) 44.0 34.3 Net income (loss)$114.8 $(263.4) $(159.3) $(711.0) Earnings (loss) per common share Basic$2.16 $(5.08) $(3.03) $(13.97)Diluted$2.06 $(5.08) $(3.03) $(13.97) Shares used in computing earnings (loss) per common share Basic 53.1 51.8 52.6 50.9 Diluted 55.6 51.8 52.6 50.9 Nine Months Ended September 30, 2024 2023 Operating Activities Net loss$(159.3) $(711.0)Adjustments to reconcile net loss to net cash provided by (used in) operating activities: Share-based compensation expense 13.7 19.1 Depreciation and amortization 82.8 95.5 Change in fair value of contingent obligations, net 0.6 (0.4)Amortization of deferred financing costs 5.2 15.6 Deferred income taxes (5.1) (3.7)Noncash gain on sale of business (32.2) (74.2)Change in fair value of warrant and forward liabilities (1.1) — Goodwill impairment — 218.2 Impairment of long-lived assets 27.2 306.7 Loss on disposal of assets 28.9 13.9 Other 3.9 (5.0)Changes in operating assets and liabilities: Accounts receivable 52.7 (58.5)Inventories (35.5) (25.0)Prepaid expenses and other assets 146.3 (18.3)Accounts payable (22.8) 17.7 Accrued expenses and other liabilities 32.9 (30.2)Long-term incentive plan accrual 2.5 3.7 Accrued compensation (9.9) (0.8)Income taxes receivable and payable, net 26.6 (3.5)Contract liabilities (18.8) 1.8 Net cash provided by (used in) operating activities 138.6 (238.4)Investing Activities Purchases of property, plant and equipment (21.2) (40.2)Proceeds from sale of property, plant and equipment 7.6 — Milestone payment from prior asset acquisition — (6.3)Proceeds from sale of business 110.2 270.2 Net cash provided by investing activities 96.6 223.7 Financing Activities Proceeds from the issuance of debt, net of lender fees 219.0 — Proceeds allocated to warrants issued in conjunction with debt 13.4 — Proceeds allocated to common stock issued in conjunction with debt 9.3 — Principal payments on term loan facility (198.2) (160.7)Proceeds from revolving credit facility 65.0 — Principal payments on revolving credit facility (284.2) (386.8)Debt issuance costs (14.6) — Proceeds from share-based compensation activity 0.7 1.3 Taxes paid for share-based compensation activity (0.9) (2.4)Proceeds from at-the-market sale of stock, net of commissions and expenses — 8.2 Net cash used in financing activities: (190.5) (540.4)Effect of exchange rate changes on cash, cash equivalents and restricted cash — 0.3 Net change in cash, cash equivalents and restricted cash 44.7 (554.8)Cash, cash equivalents and restricted cash, beginning of period 111.7 642.6 Cash, cash equivalents and restricted cash, end of period$156.4 $87.8 Supplemental cash flow disclosures: Cash paid for interest$55.8 $56.5 Cash paid for income taxes$35.5 $38.3 Non-cash investing and financing activities: Purchases of property, plant and equipment unpaid at period end$1.6 $9.2 Gain on extinguishments of debt$0.6 $— Issuance of common stock in conjunction with debt 7.7 — Reconciliation of cash and cash equivalents and restricted cash: Cash and cash equivalents$149.9 $87.8 Restricted cash 6.5 — Total$156.4 $87.8 Emergent BioSolutions, Inc.Reconciliation of Non-GAAP Financial MeasuresReconciliation of Net Income (Loss) and Net Income (Loss) per Diluted Share to Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per Diluted Share(1) ($ in millions, except per share data)Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 SourceNet income (loss)$114.8 $(263.4) $(159.3)$(711.0) Adjustments: Non-cash amortization charges$9.7 $21.9 $54.0 $65.0 Amortization of intangible assets (IA), Other IncomeImpairments — 218.2 27.2 524.9 Impairment of long-lived assets and goodwillSeverance and restructuring costs 6.3 20.6 22.9 34.5 Cost of MCM Products, Cost of Services, SG&A and R&DInventory step-up provision 1.2 — 1.2 1.9 Cost of MCM ProductsAcquisition and divestiture costs — — — 2.8 SG&AExit and disposal costs — — 13.3 6.1 R&DLoss (gain) on sale of business (64.3) 0.7 (24.3) (74.2)Other Income (Expense)Settlement charges, net 10.0 — 120.2 — Cost of Services and SG&AContingent consideration milestones (30.0) — (30.0) — Other Income (Expense)Changes in fair value of financial instruments (1.1) (1.1) (0.5) (0.4)Cost of MCM Products and Other Income (Expense)Other expense (income), net items 6.7 — 9.8 — Other Income (Expense)Tax effect 22.9 (53.1) (49.2) (122.6) Total adjustments:$(38.6)$207.2 $144.6 $438.0 Adjusted net income (loss)$76.2 $(56.2) $(14.7)$(273.0) Net income (loss) per diluted share$2.06 $(5.08) $(3.03)$(13.97) Adjustments: Non-cash amortization charges$0.17 $0.42 $1.03 $1.28 Amortization of IA, Other Income (Expense)Impairments — 4.21 0.52 10.31 Impairment of long-lived assetsSeverance and restructuring costs 0.12 0.40 0.44 0.68 Cost of MCM Products, Cost of Services, SG&A and R&DInventory step-up provision 0.02 — 0.02 0.04 Cost of MCM ProductsAcquisition and divestiture costs — — — 0.06 SG&AExit and disposal costs — — 0.25 0.12 R&DLoss (gain) on sale of business (1.16) 0.01 (0.46) (1.46)Other Income (Expense)Settlement charges, net 0.18 — 2.29 — Cost of Services and SG&AContingent consideration milestones (0.54) — (0.57) — Other Income (Expense)Changes in fair value of financial instruments (0.02) (0.02) (0.01) (0.01)Cost of MCM Products and Other Income (Expense)Other expense (income), net items 0.12 — 0.19 — Other Income (Expense)Tax effect 0.42 (1.03) (0.95) (2.41) Total adjustments:$(0.69)$3.99 $2.75 $8.61 Adjusted net income (loss) per diluted share$1.37 $(1.09) $(0.28)$(5.36) Diluted shares used in computing Adjusted net income (loss) per diluted share 55.6 51.8 52.6 50.9 Emergent BioSolutions, Inc.Reconciliation of Net Income (Loss) to Adjusted EBITDA(1) ($ in millions)Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Net income (loss)$114.8 $(263.4) $(159.3)$(711.0)Adjustments: Depreciation & amortization$26.4 $27.9 $82.8 $95.5 Income taxes 27.6 (2.5) 44.0 34.3 Total interest expense, net 7.7 19.4 54.8 59.9 Impairments — 218.2 27.2 524.9 Inventory step-up provision 1.2 — 1.2 1.9 Changes in fair value of financial instruments (1.1) (1.1) (0.5) (0.4)Severance and restructuring costs 6.3 20.6 22.9 34.5 Exit and disposal costs — — 13.3 6.1 Acquisition and divestiture costs — — — 2.8 Loss (gain) on sale of business (64.3) 0.7 (24.3) (74.2)Settlement charges, net 10.0 — 120.2 — Contingent consideration milestones (30.0) — (30.0) — Other expense (income), net items 6.7 — 9.8 — Total adjustments$(9.5)$283.2 $321.4 $685.3 Adjusted EBITDA$105.3 $19.8 $162.1 $(25.7) Emergent BioSolutions, Inc.Reconciliations of Total Revenues to Total Segment Revenues and of Segment and Total Segment Gross Margin and Gross Margin % to Segment and Total Segment Adjusted Gross Margin and Adjusted Gross Margin %(1) Three Months Ended September 30, 2024(unaudited, in millions)Commercial ProductsMCM ProductsServices Total Segment Contracts & Grants Total RevenuesRevenues$95.3 $174.2 $14.3 $283.8 $10.0$293.8 Cost of sales or services 47.2 54.0 21.4 122.6 Gross margin$48.1 $120.2 $(7.1) $161.2 Gross margin % 50% 69%(50)% 57% Add back: Inventory step-up provision$— $1.2 $— $1.2 Restructuring costs — 4.9 0.1 5.0 Adjusted gross margin$48.1 $126.3 $(7.0) $167.4 Adjusted gross margin % 50% 73%(49)% 59% Three Months Ended September 30, 2023(unaudited, in millions)Commercial ProductsMCM ProductsServices Total SegmentContracts & Grants Total RevenuesRevenues$142.1 $107.7 $14.2 $264.0 $6.5$270.5 Cost of sales or services 60.0 72.5 44.3 176.8 Gross margin$82.1 $35.2 $(30.1) $87.2 Gross margin % 58% 33%(212)% 33% Add back: Changes in fair value of financial instruments$— $(1.1)$— $(1.1) Restructuring costs — 5.0 8.1 13.1 Adjusted gross margin$82.1 $39.1 $(22.0) $99.2 Adjusted gross margin % 58% 36%(155)% 38% Emergent BioSolutions, Inc.Reconciliations of Total Revenues to Total Segment Revenues and of Segment and Total Segment Gross Margin and Gross Margin % to Segment and Total Segment Adjusted Gross Margin and Adjusted Gross Margin %(1) Nine Months Ended September 30, 2024(unaudited, in millions)Commercial ProductsMCM ProductsServices1 Total SegmentContracts & Grants Total RevenuesRevenues$333.8 $393.0 $97.5 $824.3 $24.6$848.9 Cost of sales or services 152.7 147.3 263.3 563.3 Gross margin$181.1 $245.7 $(165.8) $261.0 Gross margin % 54% 63%(170)% 32% Add back: Changes in fair value of financial instruments$— $0.6 $— $0.6 Inventory step-up provision — 1.2 — 1.2 Settlement charges, net — — 110.2 110.2 Restructuring costs — 7.5 0.3 7.8 Adjusted gross margin$181.1 $255.0 $(55.3) $380.8 Adjusted gross margin %(1) 54% 65%(57)% 46% (1) Total Segment results for the nine months ended September 30, 2024 includes $50.0 million attributable to the Settlement Agreement with Janssen. The revenue and cost of services is related to raw materials purchased for the Janssen Agreement which Janssen had not reimbursed. Excluding the impacts of the Settlement Agreement, Total Segment Adjusted Gross Margin % would have been 3% higher for the nine months ended September 30, 2024. Nine Months Ended September 30, 2023(in millions)Commercial ProductsMCM ProductsServices Total SegmentContracts & Grants Total RevenuesRevenues$386.2 $309.2 $57.7 $753.1 $19.6$772.7 Cost of sales or services 160.2 208.4 151.7 520.3 Gross margin$226.0 $100.8 $(94.0) $232.8 Gross margin % 59% 33%(163)% 31% Add back: Changes in fair value of financial instruments$— $(0.4)$— $(0.4) Inventory step-up provision — 1.9 — 1.9 Restructuring costs — 7.0 8.1 15.1 Adjusted gross margin$226.0 $109.3 $(85.9) $249.4 Adjusted gross margin % 59% 35%(149)% 33% Emergent BioSolutions, Inc.Reconciliation of Net Loss Forecast to Adjusted Net Income (Loss) Forecast ($ in millions)2024 Full Year ForecastSourceNet loss$(203) - $(183) Adjustments: Non-cash amortization charges$65Amortization of intangible assets and Other Income (Expense)Changes in fair value of financial instruments(1)Other Income (Expense)Impairments27Impairment of long-lived assetsSeverance and restructuring costs23Cost of MCM Products, Cost of Services, SG&A and R&DInventory step-up provision1Cost of MCM ProductsExit and disposal costs13R&DLoss (gain) on sale of business(24)Other Income (Expense)Settlement charges, net120Cost of Services and SG&AContingent consideration milestones(30)Other Income (Expense)Other expense (income), net items10Other Income (Expense)Tax effect(51) Total adjustments:$153 Adjusted net loss$(50) - $(30) Reconciliation of Net Loss Forecast to Adjusted EBITDA Forecast ($ in millions)2024 Full Year ForecastNet loss$(203) - $(183)Adjustments: Depreciation & amortization$109Income taxes60Total interest expense, net75Impairments27Inventory step-up provision1Changes in fair value of financial instruments(1)Severance and restructuring costs23Exit and disposal costs13Loss (gain) on sale of business(24)Settlement charges, net120Contingent consideration milestones(30)Other expense (income), net items10Total adjustments$383Adjusted EBITDA$180 - $200 Reconciliations of Forecasted Total Revenues to Forecasted Total Segment Revenues and of Forecasted Segment and Total Segment Gross Margin and Gross Margin % to Forecasted Segment and Total Segment Adjusted Gross Margin and Adjusted Gross Margin %(1) (in millions)2024 Full Year Forecast Total revenues$1,065 - $1,125Contracts & Grants(30) - (35)Total segment revenues$1,035 - $1,090 Cost of sales or services$710 - $719Total segment gross margin$325 - $371Total segment gross margin %31% - 34%Add back: Changes in fair value of financial instruments$1Inventory step-up provision1Settlement charges, net110Restructuring costs8Total segment adjusted gross margin$445 - $491Total segment adjusted gross margin %43% - 45%

Financial StatementVaccine

29 Aug 2024

·www.globenewswire.com

Alignment Health Plan Ranks No. 2 in Customer Satisfaction Among Medicare Advantage Plans in California in J.D. Power Study

ORANGE, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Alignment Health, the consumer brand name for Alignment Healthcare (NASDAQ: ALHC), today announced Alignment Health Plan has ranked No. 2 in customer satisfaction in California, according to the J.D. Power 2024 U.S. Medicare Advantage Study, an annual analysis of members of MA plans on eight factors across 10 different states. Roughly 32.8 million in the U.S. are enrolled in a Medicare Advantage plan, accounting for more than half (54%) of eligible Medicare beneficiaries.1 As a state, California has the highest number of seniors with more than 5.9 million people ages 65 years-or-older, which accounts for more than 10% of the total U.S. population of 55 million Americans ages 65 years-or-older, according to the U.S. Census. “We’re proud of the personalized care, service and experience we provide, treating each member as if they were our own mom or dad,” said John Kao, founder and CEO, Alignment Health. “Our entire team at Alignment is focused on delivering high-quality care at an affordable cost. We are honored by the love we receive from our members, and we are committed to upholding our approach to Medicare Advantage done right.” This recognition builds upon Alignment’s accolades in 2024 that demonstrate the company’s commitment to seniors, including: Achieving a 5- out of 5-star rating from the Centers for Medicare & Medicaid Services (CMS) for its H5296 Medicare Advantage HMO contract in North Carolina and Nevada;Earning a 4- out of 5-star rating from CMS for its California HMO, marking its seventh consecutive year as a 4-star or greater plan; andBeing named a 2024 Best Insurance Company for Medicare Advantage by U.S. News & World Report for the second consecutive year for its North Carolina plan. “Meeting our members where and when they need care makes a difference in both their quality of care and their quality of life,” said Dawn Maroney, CEO of Alignment Health Plan. “Regardless of where they live or their social backgrounds, all seniors deserve high-quality, affordable care, and we have stepped up to the plate by consistently offering a diverse portfolio of plans with enriched benefits and a dedicated concierge team that is available 24/7 to help them with their health needs.” The J.D. Power U.S. Medicare Advantage Study measures member satisfaction with Medicare Advantage plans across eight factors (in order of importance): level of trust; able to get health services how/when I want; helping to save me time or money; product/coverage offerings meet my needs; ease of doing business; people –representatives, call center agents; resolving problems or complaints; and digital channels. This year’s study noted that ease of finding care, low out-of-pocket costs and provider choice were the top factors driving customer satisfaction with MA plans. For more information about Alignment’s award-winning product offerings, benefits and services, visit www.alignmenthealthplan.com. About Alignment HealthAlignment Health is championing a new path in senior care that empowers members to age well and live their most vibrant lives. A consumer brand name of Alignment Healthcare (NASDAQ: ALHC), Alignment Health offers more than 50 benefits-rich, value-driven Medicare Advantage plans that serve 53 counties across six states. The company partners with nationally recognized and trusted local providers to deliver coordinated care, powered by its customized care model, 24/7 concierge care team and purpose-built technology, AVAⓇ. Based in California, the company’s mission-focused team makes high-quality, low-cost care a reality for members every day. As it expands its offerings and grows its national footprint, Alignment upholds its core values of leading with a serving heart and putting the senior first. For more information, visit www.alignmenthealth.com. About J.D. PowerJ.D. Power is a global leader in consumer insights, advisory services, and data and analytics. A pioneer in the use of big data, artificial intelligence (AI) and algorithmic modeling capabilities to understand consumer behavior, J.D. Power has been delivering incisive industry intelligence on customer interactions with brands and products for more than 55 years. The world's leading businesses across major industries rely on J.D. Power to guide their customer-facing strategies. J.D. Power has offices in North America, Europe and Asia Pacific. To learn more about the company's business offerings, visit JDPower.com/business. The J.D. Power auto-shopping tool can be found at JDPower.com. Media Contacts For Alignment HealthPriya Shahalignment@mpublicrelations.com For J.D. PowerGeno Effler, J.D. Power; West Coast; 714-621-6224; media.relations@jdpa.com John Roderick; East Coast; 631-584-2200; john@jroderick.com 1 Medicare Advantage in 2024: Enrollment Update and Key Trends (KFF, Aug. 8, 2024)

22 Aug 2024

·pipelinereview.com

BioVaxys DPX-Based Vaccines Exhibit Robust Efficacy Across Multiple Infectious Diseases

VANCOUVER, Canada I August 22, 2024 I BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF ) (“BioVaxys” or the “Company”) highlights the potential of its novel lipid-in-oil delivery platform, DPX™, across multiple infectious disease studies and announces its plans for partnering and further development. BioVaxys’ DPX™ technology (“DPX”) is a patented delivery platform that can incorporate a range of bioactive molecules to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease. Key findings demonstrated in completed infectious disease studies, which are discussed in more detail below include: BioVaxys President and Chief Operating Officer Kenneth Kovan says “With data so compelling and supportive of the value of DPX-based vaccines for infectious diseases, we are seeking various off-balance sheet avenues to support development. The significant cargo capacity of DPX and the proven ability to package diverse antigens such as that shown with our DPX-SurMAGE multi-antigen cancer vaccine, could also greatly benefit potential partnerships for developing more effective viral vaccines, such as a multivalent mRNA DTP vaccine to address the recognized problem of immunity to the Bordetella pertussis waning over time, or for emerging global diseases such as MPox, where a DPX-mRNA formulation could have significant advantage. This fits well with our strategy of expanding development partnerships with DPX beyond oncology.” 100% of Subjects in a Phase 1 Study Treated with a DPX-based RSV Vaccine Developed Antibodies with Persistent Immune Response DPX™+RSV(A) “DPX-RSV” is BioVaxys’ vaccine candidate targeting the respiratory syncytial virus (RSV) based on a DPX formulation of the SHe peptide of group A RSV. Results of a Phase 1 study showed that more than nine months after the last vaccination, 15 of 16 participants (93%) who received DPX-RSV demonstrated antigen-specific immune responses. This study evaluated the safety and immune response profile of two doses of DPX-RSV in 40 healthy older adult volunteers (aged 50-64 years) and was well tolerated amongst all study participants, with no SAEs reported. One of the two doses of DPX+RSV(A) was tested out to one year and 100% of older adults (7/7 immune responders) maintained antigen-specific immune responses one year after receiving a booster dose. After one year, their antibody levels measured were still at peak with no sign of decrease. RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older. Currently available RSV vaccines including GSK’s Arexvy, Moderna’s mResvia, and Pfizer’s Abrysvo target either the F or G proteins of the virus and provide protection by neutralizing the RSV virus. Clinical measures of efficacy focus on the amount of neutralizing antibodies in the bloodstream. DPX-RSV works differently; it targets the SH viral ectodomain of the RSV virus and, instead of neutralizing the virus, it enables the immune system to recognize and destroy infected cells. BioVaxys has exclusive worldwide licenses on applications that target the SH ectodomain antigen in RSV. The Company is exploring opportunities to out-license this product to potential partners. Animal challenge studies with DPX-Based Anthrax Vaccine Demonstrated 100% Immunity from Single Injection The promise and versatility of the DPX platform for infectious disease applications has been additionally supported by in vivo studies of a DPX formulation targeting anthrax, with a DPX Anthrax vaccine formulation exhibiting 100% immunity following a single injection. In a preclinical study led by the National Institutes of Health, a single intramuscular injection of recombinant B. anthracis -protective antigen (rPA) formulated in the Company’s DPX platform (“DPX-rPA”) was compared in animal models to rPA in alum, and to Biothrax® (anthrax vaccine adsorbed (AVA)), a US Food and Drug Administration approved vaccine that requires five administrations over 12 months with annual boosting to maintain pre-exposure prophylaxis. Serological analysis of anti-rPA immunoglobulin G and toxin neutralization activity demonstrated higher responses induced by DPX-rPA when compared to rPA in alum. In rabbit and non-human primate (“NHP”) studies, the DPX-rPA formulation generated an immune response in as little as 14 days after a single immunization, whereas AVA required two immunizations. In the rabbit study, a single injection of DPX-rPA or two injections of AVA conferred 100% protection from a lethal anthrax challenge. Furthermore, in the NHP study, single-dose DPX-rPA was 100% protective against challenge, whereas one primate in the two-dose AVA group and all saline-administered animals succumbed to infection. Anthrax, caused by exposure to aerosolized spores of Bacillus anthracis , remains a very serious biological threat, and is categorized by the Centers for Disease Control and Prevention (CDC) as a Category A biothreat agent, along with botulism, plague, smallpox, tularemia, and viral hemorrhagic fevers posing the greatest risk to national security. At-risk populations for non-weaponized occupational exposure include those working with infected animals, contaminated animal products or environments such as farmers, veterinarians, livestock handlers, diagnostic laboratory workers, agriculture and wildlife workers, and workers who butcher animals or process meat, hides, hair and wool. The ideal anthrax vaccine would provide rapid protection with a single dose, generate a durable immune response, and have enhanced stability for stockpiling purposes. An anthrax vaccine formulated in DPX™ is expected to provide these characteristics. There are currently no approved anthrax vaccines that can provide single dose, rapid protection. Currently approved anthrax vaccines include Biothrax, which requires multiple doses over the span of a year, and more recently, Cyfendus, which is intended for people with suspected or confirmed inhalational exposure to anthrax and is given in two intramuscular doses over two weeks and must be given together with antibiotics. As the efficacy of Cyfendus for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax, BioVaxys is exploring potential advancement of DPX-rPA with its current preclinical data with the US Dept of Defense, Battelle and other organizations. DPX-rHA for Influenza Achieves Higher Antibody Levels than Alum rHA Vaccine and Protects Against Multiple Flu Strains Most recently, in preclinical influenza studies in a murine model, a single dose of DPX formulated with recombinant hemagglutinin (rHA) was shown to exhibit higher and more durable levels of HA antibodies than Alum+rHA. Alum is the market-standard adjuvant that can increase the immunogenicity of recombinant hemagglutinin (rHA) in influenza vaccines. When combined with rHA, alum can generate anti-HA titers that are 10 times higher than without the alum adjuvant. Additional in vivo studies compared two different strains (Puerto Rico H1N1 and Hong Kong H3N2) of heat inactivated whole influenza virus packaged in DPX (DPX+FLU) compared to Alum + heat inactivated whole influenza virus (Alum+FLU). One month post vaccination the mice were challenged with both live influenza strains, with the animals that received DPX+FLU having an almost 100% survival 10 days post challenge to both the Puerto Rico H1N1 and Hong Kong H3N2 strains, compared to ~70% survival for mice challenged with Puerto Rico H1N1and receiving Alum+FLU, and <20% survival for mice challenged with Hong Kong H3N2 strain and receiving Alum+FLU. BioVaxys is planning further preclinical studies to evaluate a quadrivalent (four flu strains) DPX formulation. BioVaxys Technology Corp . ( www.biovaxys.com ), registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© “neoantigen” tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological diseases. Through a differentiated mechanism of action, the DPX™ platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. The Company’s clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX™ platform, and is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX™+SurMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX™-RSV for Respiratory Syncytial Virus, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© “neoantigen” tumor cell construct platform for refractive late-stage ovarian cancer. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF ). For more information, visit www.biovaxys.com and connect with us on X and LinkedIn. SOURCE: BioVaxys Technology

VaccinePhase 1ImmunotherapyClinical ResultPhase 2

100 Deals associated with Anthrax vaccine adsorbed(Emergent Biodefense)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07AC01	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Anthrax	US	Emergent Biodefense Operations Lansing LLC	12 Nov 1998

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03518125 (B-SAFE, CTgov)	Phase 2	Anthrax	305	BioThrax (Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29))	nyanbgtuzz(oaordwctwd) = ascmjpwbwf qefbnenrrc (njnawaxbrg, eklukdpwjs - whsayyubvg) View more	-	09 Jun 2020
				AV7909 (Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29))	nyanbgtuzz(oaordwctwd) = qbornfsxwo qefbnenrrc (njnawaxbrg, tvhbytvyvt - nemvwfhvls) View more
NCT02339155 (CTgov)	Phase 4	Bacterial Infections	573	AVA (AVA Alone)	cqroxopuho(xaozbpjtxd) = lrcwtwaeaa nschzpuhvv (mprklhdmvp, hveporgkag - axhhlzxxxc) View more	-	09 Jan 2018
				AVA+Raxibacumab (AVA+Raxibacumab)	cqroxopuho(xaozbpjtxd) = tjfkhdfpjd nschzpuhvv (mprklhdmvp, iaqnowzqti - levbtofomp) View more
NCT01753115 (CTgov)	Phase 2	Anthrax	154	BioThrax+Ciprofloxacin (BioThrax + Ciprofloxacin PK)	wgqjvsjyhp(hdvqbqrtqb) = xndkdtlhru vjqkoxsufn (nekrezxqsf, poimkvkwjx - nzwrqprxfj) View more	-	19 Nov 2014
				BioThrax+Ciprofloxacin (BioThrax + Ciprofloxacin no PK)	wgqjvsjyhp(hdvqbqrtqb) = amfxbtfttx vjqkoxsufn (nekrezxqsf, jabrmlaibo - qltlidgnzs) View more
NCT01641991 (CTgov)	Phase 4	Anthrax	328	BioThrax (Arm A: 0.50mL BioThrax, Days 0, 14)	gdzommvkww(jkpdowzyut) = fhfjivvowh ywpmtuqmlq (tzfykdlzpr, dwgulpsujj - xobjedxtqb) View more	-	28 May 2014
				BioThrax (Arm B: 0.50mL BioThrax, Days 0, 28)	gdzommvkww(jkpdowzyut) = qzozxdkrwq ywpmtuqmlq (tzfykdlzpr, fvfvdfvqbq - ckoskwcnbx) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Anthrax vaccine adsorbed(Emergent Biodefense)

Overview

Basic Info

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation