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Last update 12 Aug 2025
Anthrax vaccine adsorbed(Emergent Biodefense)
Last update 12 Aug 2025
Overview
Basic Info
Drug Type Prophylactic vaccine |
Synonyms AVA, BaciThrax, Biothrax |
Target- |
Action stimulants |
Mechanism Immunostimulants |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (12 Nov 1998), |
RegulationOrphan Drug (United States) |
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Related
7
Clinical Trials associated with Anthrax vaccine adsorbed(Emergent Biodefense)IRCT20220706055388N1
The Effect of Ava Therapy on Life Expectancy of Cancer Patients
Start Date07 Jul 2022 |
Sponsor / Collaborator- |
NCT03518125
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 |
NCT02339155
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 |
100 Clinical Results associated with Anthrax vaccine adsorbed(Emergent Biodefense)
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100 Translational Medicine associated with Anthrax vaccine adsorbed(Emergent Biodefense)
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100 Patents (Medical) associated with Anthrax vaccine adsorbed(Emergent Biodefense)
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309
Literatures (Medical) associated with Anthrax vaccine adsorbed(Emergent Biodefense)01 Aug 2025·TRANSPLANTATION
Utility of Non-HLA Autoantibodies in Predicting Graft Survival After Heart Transplantation
Article
Author: Youn, Jong-Chan ; Jung, Sung-Ho ; Cho, Hyun-Jai ; Song, Eun Young ; Kang, Seok-Min ; Jeon, Eun-Seok ; Choi, Jin-Oh ; Kim, Myoung Soo ; Kim, Jae-Joong ; Oh, Jaewon ; Lee, Hae-Young ; Kang, Jeehoon ; Oh, Gyu Chul
Background.:
The presence of antibodies to donor-specific HLAs is a well-known risk factor associated with heart transplantation (HTx) outcomes. Recently, non-HLA antibodies were reported to be associated with HTx outcomes.
Methods.:
We evaluated the association between the presence of non-HLA antibodies with early (≤1 y) and long-term graft failure in 192 patients undergoing HTx in 4 large transplant centers in Korea.
Results.:
Antibodies to vimentin (AVA) and type II collagen (ACA) were associated with a lower rate of 1-y graft survival (78.6% versus 92.6%, log-rank P = 0.006 for AVA+; 72.2% versus 91.1%, log-rank P = 0.015 for ACA+). AVA+ stratified 1-y graft survival in patients with donor-specific antibodies (DSAs+; 45.5% versus 94.1%, log-rank P = 0.002). AVA+ also improved the prediction models based on conventional risk factors derived from Cox regression analysis (integrated discrimination improvement, 9%; P < 0.001; net reclassification index, 24%; P = 0.047). Compared with AVA–/ACA– patients, AVA+/ACA+ patients had poor graft survival both in the early and late periods (all log-rank P < 0.001).
Conclusions.:
In conclusion, the presence of non-HLA antibodies to vimentin and type II collagen was associated with poor graft outcomes in patients undergoing HTx. These findings highlight the need to consider non-HLA antibodies in assessing transplant recipients and tailoring immune modulation strategies.
01 Jun 2025·Zhongguo shi yan xue ye xue za zhi
[The Efficacy of Combination of Avatrombopag and rhIL-11 in Adult Patients of Acute Myeloid Leukemia with Cancer Treatment-Induced Thrombocytopenia].
Article
Author: He, Peng-Cheng ; Zhang, Hai-Tao ; Li, Jing ; Zhao, Si-Jie ; Luo, Min-Na ; Wang, Wen-Juan
OBJECTIVE:
To investigate the safety and efficacy of avatrombopag（AVA） combined with rhIL-11 in treating thrombocytopenia induced by chemotherapy in acute myeloid leukemia.
METHODS:
The clinical information of 8 patients in the real world who received avatrombopag combined with rhIL-11 in cancer treatment-induced thrombocytopenia(CTIT) after AML chemotherapy were retrospectively analyzed, and at the same time, 8 patients who received rhIL-11 only in CTIT after AML chemotherapy served as the control group, A preliminary observation was to summarize and compare the therapeutic efficacy and adverse effects between the two groups.
RESULTS:
D3 and D7 platelet counts were not significantly different between the observation group and the control group after treatment. The platelet counts in the observation group was significantly higher than those of the control group on the 10th day after treatment (P < 0.01). The adverse reactions, such as weakness, abdominal pain, fatigue, nausea and edema after treatment were mild in the observation group and the control group. Except for one patient in the observation group who had a history of cerebral infarction before the onset of the disease and was routinely taking antiplatelet drugs, no thrombosis events occurred in the patients in the observation and control groups during the period of administration of the drug, and the total incidence rate of adverse reactions was not significantly different between the two groups.
CONCLUSION:
The combination of AVA and rhIL-11 can enhance platelet recovery in CTIT of AML patients after chemotherapy. Compared with the rhIL-11 alone group, the platelet recovery time in AVA+rhIL-11 group was significantly shorter, the platelet count on the 10th day after drug administration was significantly higher. No statistically significant difference in the total incidence rate of adverse reactions was observed between rhIL-11 alone group and AVA+rhIL-11 group.
01 Jun 2025·Cureus Journal of Medical Science
Reducing Contrast-Induced Nephropathy Risk in a Murine Model: Role of Avanafil and Vardenafil in Modulating Oxidant/Antioxidant Balance.
Article
Author: Buga, Ana Maria ; Zisis, Ioannis-Erineos ; Tsatsakis, Aristidis ; Docea, Anca Oana ; Mavridis, Charalampos ; Mamoulakis, Charalampos
INTRODUCTION:
Contrast-induced nephropathy (CIN) is a major clinical problem, particularly under conditions of preexisting renal insufficiency and comorbidities. The present study evaluates the potential of phosphodiesterase type 5 inhibitors (PDE5is), avanafil (AVA), and vardenafil (VAR) to prevent CIN by modulating oxidative stress in a murine model.
METHODS:
Two sets of 25 male Wistar rats were allocated into five groups: control, CIN, N-acetylcysteine (NAC), VAR, and AVA. Indomethacin, L-NG-Nitro arginine methyl ester (L-NAME), and iopromide were used to induce CIN. Oxidative stress markers were evaluated, i.e., total antioxidant capacity (TAC), protein carbonyl (PROTC), thiobarbituric acid reactive substances (TBARS), glutathione (GSH), and catalase (CAT) activity.
RESULTS:
In comparison with the control group, TAC, GSH, and CAT activity were reduced, while TBARS and PROTC levels were elevated in the CIN group. Variations in treatment by VAR, AVA, and NAC induced a notable rise in TAC and blood levels of GSH while lowering TBARS in tissue.
CONCLUSION:
The treatment groups with VAR, AVA, and NAC were noted with higher values of TAC, CAT, and GSH, while lower values of TBARS and PROTC indicated a protective effect against oxidative injury. The findings indicate that VAR and AVA effectively control the oxidant/antioxidant status, preventing oxidative stress and the incidence of CIN. Further research would be required to replicate these findings and identify the therapeutic potential of VAR and AVA in clinical conditions.
31
News (Medical) associated with Anthrax vaccine adsorbed(Emergent Biodefense)03 Jul 2025
In April 2025, a series of innovative drugs targeting various disease areas received regulatory approval, ranging from rare diseases such as dystrophic epidermolysis bullosa (DEB) to more prevalent conditions like chronic urticaria, polyarticular juvenile idiopathic arthritis (pJIA), and hospital-acquired pneumonia (HAP). These therapies not only represent the forefront of scientific advancement but also reflect modern medicine’s ongoing pursuit of precision and personalized treatment.
1. Nipocalimab-aahuNipocalimab-aahu (brand name: IMAAVY), developed by Janssen Biotech, a subsidiary of Johnson & Johnson, is a humanized monoclonal antibody targeting the neonatal Fc receptor (FcRn) for the treatment of generalized myasthenia gravis (gMG). It received its first approval in the United States on April 29, 2025, for this indication.
Nipocalimab is an IgG1 monoclonal antibody that selectively binds to and inhibits the interaction between FcRn and IgG, thereby accelerating the degradation of pathogenic IgG antibodies and reducing their concentration in the bloodstream. Under physiological conditions, FcRn binds to the Fc region of IgG, protecting it from lysosomal degradation and prolonging its half-life. However, in autoimmune diseases, this mechanism contributes to the persistence and accumulation of pathogenic IgG. By competitively binding to FcRn, nipocalimab prevents this interaction, leading to the lysosomal degradation of IgG. This targeted mechanism is especially well-suited for diseases driven by IgG-mediated pathogenesis, such as generalized myasthenia gravis and warm autoimmune hemolytic anemia. Compared to traditional immunosuppressants or intravenous immunoglobulin (IVIG), nipocalimab offers effective reduction of pathogenic antibody load without broad immunosuppression, thus providing better safety and tolerability.
In pivotal clinical trials for gMG, nipocalimab demonstrated significant clinical improvement, particularly in muscle function scores and reduction in exacerbation frequency, outperforming placebo. The treatment showed a rapid onset and durable efficacy. Additionally, its subcutaneous route of administration enhances patient adherence. Even after its approval, Johnson & Johnson plans to continue long-term follow-up studies to assess real-world safety and effectiveness, as well as explore broader applications in other rare autoimmune conditions.
Currently, there are several therapeutic options available for gMG and other IgG-mediated autoimmune diseases, including corticosteroids, immunosuppressants, IVIG, plasma exchange, and newer targeted biologics. For instance, Argenx’s efgartigimod, a recombinant FcRn-targeting fusion protein, has been approved in multiple countries for gMG. While it shares a similar mechanism with nipocalimab, it is not antibody-based. Nipocalimab, as a monoclonal antibody, may offer stronger binding affinity and longer half-life, potentially making it more suitable for long-term maintenance therapy. Other competitors include Soliris (eculizumab) from Alexion and Rituxan (rituximab), which work via complement inhibition and B cell depletion, respectively, but are costly and require frequent infusions.
2. Prademagene zamikeracelPrademagene zamikeracel (EB-101), developed by Abeona Therapeutics, is a gene therapy approved on April 29, 2025, in the United States for the treatment of dystrophic epidermolysis bullosa (DEB).
Prademagene zamikeracel is designed to restore the expression of type VII collagen (COL7) by delivering a functional COL7A1 gene to the patient’s own keratinocytes. DEB is a genetic disorder caused by mutations in the COL7A1 gene, leading to insufficient COL7 production and resulting in extremely fragile skin prone to blistering and wounds. This gene therapy uses a retroviral vector to transfer the functional COL7A1 gene into autologous keratinocytes, enabling these cells to synthesize and secrete normal COL7, which is essential for anchoring fibrils that maintain dermal-epidermal cohesion. The therapy employs a modified retroviral vector that efficiently integrates the gene into the host genome, ensuring long-term and stable gene expression. Its specificity and safety are further enhanced by targeting only the affected skin cells, minimizing off-target effects on other tissues or organs.
Clinical studies have shown that Prademagene zamikeracel significantly improves wound healing and reduces blister formation, thereby enhancing patients' quality of life, without evidence of serious adverse effects or drug interactions. Abeona Therapeutics has employed advanced gene-editing technologies and manufacturing processes to ensure drug stability and bioavailability. Pharmacokinetic studies suggest that its efficacy is comparable or even superior to other gene therapies in development. Post-approval, the company continues to monitor the therapy closely, collecting additional clinical data to optimize its formulation and usage guidelines. A Phase IV clinical trial is planned to explore new indications and long-term outcomes. Preliminary findings suggest potential applicability in other types of inherited skin disorders.
Currently, most treatments for DEB focus on supportive care, such as wound management, infection control, and pain relief, which do not address the underlying genetic cause. In contrast, Prademagene zamikeracel offers a curative approach by directly correcting the disease-causing gene mutation. Competing therapies include beremagene geperpavec (B-VEC) by Krystal Biotech, a gene therapy based on a herpes simplex virus (HSV) vector platform. Although both therapies aim at gene correction, they differ in their vector systems and gene delivery mechanisms.
3. Penpulimab*Penpulimab, developed by Akeso Biopharma Co., Ltd. (Zhongshan, China), was approved by the U.S. FDA on April 23, 2025, under the brand name AK105. It is indicated for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in adult patients who have failed prior first-line therapy. As a fully humanized IgG1 PD-1 monoclonal antibody, Penpulimab features unique structural optimizations and potentially improved safety characteristics.
Penpulimab is a fully human IgG1 subtype monoclonal antibody targeting programmed cell death protein 1 (PD-1). Its mechanism of action centers on modulating T-cell–mediated anti-tumor immune responses. PD-1 is an immune checkpoint molecule expressed on activated T cells; when bound to its ligands (PD-L1/PD-L2), it inhibits T-cell activity, allowing tumors to evade immune surveillance. Penpulimab binds with high affinity to PD-1, blocking its interaction with PD-L1/PD-L2 and restoring the immune system’s ability to recognize and destroy tumor cells. Unlike many other PD-1 antibodies that use the IgG4 subtype, Penpulimab adopts an IgG1 framework, which enables a stronger antibody-dependent cellular cytotoxicity (ADCC) effect, potentially enhancing immune clearance within the tumor microenvironment. Additionally, the Fc region of Penpulimab has been engineered to reduce undesired immune activation, aiming to improve efficacy while minimizing immune-related adverse events.
Penpulimab’s development has focused on nasopharyngeal carcinoma, a malignancy with high prevalence in China and other parts of Asia. In pivotal Phase II clinical trials, Penpulimab demonstrated a notable objective response rate (ORR) and durable disease control in PD-L1–positive patients, with especially pronounced efficacy in Epstein-Barr virus–associated NPC. Data showed that more than 30% of patients achieved tumor reduction, with many experiencing long-lasting responses, and some even achieving complete remission. The FDA approval was granted under Priority Review, recognizing Penpulimab’s clear clinical value in treating this difficult-to-manage cancer. Akeso employed a precision medicine approach in its clinical development by focusing on PD-L1–positive and previously treated advanced NPC patients, thereby improving response rates and optimizing the risk-benefit profile—reflecting the current trend toward individualized cancer immunotherapy.
Currently, several blockbuster PD-1/PD-L1 inhibitors—such as Keytruda (pembrolizumab, Merck), Opdivo (nivolumab, Bristol Myers Squibb), and Tecentriq (atezolizumab, Roche)—have been approved for various solid tumors, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. Some studies have explored their use in NPC. However, Penpulimab is the first PD-1 inhibitor formally approved by the FDA specifically for nasopharyngeal carcinoma, filling a critical gap in treatment. While other PD-1 inhibitors may be used off-label in clinical practice for NPC, they have not yet received regulatory approval for this specific indication.
4. LinvoseltamabLinvoseltamab (brand name: Lynozyfic), developed by Regeneron Pharmaceuticals, is a bispecific T-cell engager approved on April 23, 2025, in the European Union, Iceland, Liechtenstein, and Norway for the treatment of relapsed or refractory multiple myeloma (RRMM).
Linvoseltamab is a bispecific antibody targeting both B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells. It works by simultaneously binding to BCMA-expressing tumor cells and CD3-positive T cells, effectively forming a bridge between them. This interaction leads to the formation of an immunological synapse, activating T cells to release cytotoxic molecules such as perforin and granzymes, which induce direct tumor cell lysis. Beyond cell killing, this bispecific engagement enhances T-cell activation, proliferation, and persistence—amplifying the overall anti-tumor immune response.
Unlike conventional monoclonal antibodies, Linvoseltamab does not rely on endogenous antigen presentation to activate T cells. Its ability to directly stimulate T cells gives it a significant therapeutic advantage in targeting BCMA-positive myeloma cells. Preclinical and clinical data have shown that Linvoseltamab not only suppresses tumor growth but also reduces the risk of relapse, offering a novel and promising treatment strategy for patients with advanced myeloma.
Clinical studies have demonstrated Linvoseltamab’s efficacy in alleviating symptoms, prolonging progression-free survival (PFS) and overall survival (OS), and significantly improving quality of life, with no major adverse events or drug interactions reported. Regeneron has applied advanced bispecific antibody design and manufacturing technologies to ensure drug stability, bioavailability, and consistent pharmacokinetic profiles. Post-marketing, the company is continuing real-world monitoring, collecting further clinical data to optimize formulation and usage, and plans to initiate Phase IV trials to investigate additional indications and long-term benefits. Preliminary research suggests potential activity against other BCMA-positive hematologic malignancies as well.
In the current treatment landscape for RRMM, a variety of therapeutic modalities are available, including monoclonal antibodies, CAR-T cell therapies, and targeted small molecules. For example, Darzalex (daratumumab, Johnson & Johnson) and Blenrep (belantamab mafodotin, GSK) are widely used monoclonal antibodies that target CD38 and BCMA, respectively. While effective, these agents often require combination regimens to maximize their benefit. In contrast, Linvoseltamab as a bispecific T-cell engager offers a standalone, efficient, and simplified treatment approach by directly activating T cells without the need for additional immunomodulatory agents.
Other competitors include Abecma (idecabtagene vicleucel) from bluebird bio, a CAR-T therapy targeting BCMA, which has been approved for relapsed or refractory multiple myeloma. Despite their efficacy, CAR-T therapies are complex and costly, making Linvoseltamab a potentially more accessible and scalable option in this therapeutic area.
5. EbdarokimabEbdarokimab (AK-101), developed by Akeso Biopharma Co., Ltd., is a monoclonal antibody approved in China on April 15, 2025, for the treatment of plaque psoriasis.
Ebdarokimab is a monoclonal antibody specifically targeting the IL-17A/F heterodimer, functioning by binding to and inhibiting this heterodimer to suppress inflammatory responses and prevent tissue damage. IL-17A and IL-17F are pro-inflammatory cytokines that can act individually or as a heterodimer, activating multiple cell types such as keratinocytes, fibroblasts, and endothelial cells. This activation triggers a cascade of inflammatory responses contributing to the pathogenesis of psoriasis and other autoimmune diseases. By binding to the IL-17A/F heterodimer and blocking its interaction with receptors, Ebdarokimab disrupts downstream signaling pathways, reduces the release of inflammatory mediators, and inhibits cell proliferation—thereby alleviating inflammation at affected sites. This targeted mechanism against the heterodimer offers more comprehensive symptom control and potentially fewer side effects.
Moreover, studies suggest that the IL-17A/F heterodimer plays a critical role in ulcerative colitis, providing a theoretical foundation for the potential use of Ebdarokimab in other immune-related diseases.
Clinical data show that Ebdarokimab significantly improves skin lesion scores (e.g., PASI scores), and reduces symptoms such as erythema and scaling, markedly enhancing patient quality of life, with no serious adverse reactions or drug interactions observed. Akeso has employed advanced monoclonal antibody production technologies and process optimization to ensure product stability and bioavailability, and pharmacokinetic studies have demonstrated comparable or superior efficacy to similar agents. Even after approval, the company continues post-marketing surveillance and plans Phase IV clinical trials to explore additional indications and long-term outcomes. Some research suggests Ebdarokimab may also have therapeutic potential in ulcerative colitis.
Currently, the therapeutic landscape for plaque psoriasis includes several important drug classes such as TNF-α inhibitors, IL-17A inhibitors, and other biologics. Cosentyx (secukinumab, Novartis) and Taltz (ixekizumab, Eli Lilly) are widely used IL-17A inhibitors that specifically bind to and neutralize IL-17A to relieve psoriasis symptoms. Although effective, they only target the IL-17A monomer and do not block the IL-17A/F heterodimer. In contrast, Ebdarokimab offers a more comprehensive therapeutic approach by targeting the heterodimer, potentially delivering stronger inflammation control and reducing relapse rates. Other competitors include Stelara (ustekinumab, Johnson & Johnson), an IL-12/23 inhibitor approved for moderate-to-severe plaque psoriasis.
6. Desvenlafaxine BenzoateDesvenlafaxine Benzoate (brand name Desvela, 데스베라서방정), developed by Nexpharm Korea, is a small-molecule antidepressant approved in South Korea on April 9, 2025, for the treatment of major depressive disorder (MDD).
Desvenlafaxine Benzoate is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It works by inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE) into presynaptic neurons, thereby increasing the concentrations of these neurotransmitters in the synaptic cleft, which helps regulate mood and relieve depressive symptoms. By binding to serotonin and norepinephrine transporters, Desvenlafaxine Benzoate prevents their reabsorption into neurons, allowing greater neurotransmitter availability to exert mood-enhancing effects. This dual mechanism of action helps restore neurotransmitter balance in the brain, improving emotional state and reducing symptoms of depression. It also has mild dopamine reuptake inhibition, which may further contribute to its antidepressant efficacy.
Compared to other antidepressants, Desvenlafaxine Benzoate demonstrates a favorable dose-response and safety profile, enabling more effective symptom management with fewer side effects.
Clinical studies have shown that Desvenlafaxine Benzoate significantly improves depressive symptoms and enhances patient quality of life, while reducing the frequency and severity of depressive episodes. Nexpharm Korea has applied advanced drug design and development technologies to ensure drug stability and bioavailability, and pharmacokinetic studies have confirmed comparable or superior efficacy to similar agents. Post-approval, the company continues to monitor the product, collect clinical data, and refine the formulation and usage guidelines. Plans are in place for Phase IV clinical trials to evaluate additional indications and long-term effectiveness.
In the MDD treatment landscape, several major drug classes are used, including selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), and other SNRIs. Notable examples include Pristiq (desvenlafaxine, Pfizer) and Effexor XR (venlafaxine extended-release, Wyeth)—both widely used SNRIs that act through similar mechanisms. Pristiq is known for its good tolerability and relatively low incidence of side effects, while Effexor XR is valued for its broad spectrum of indications. In comparison, Desvenlafaxine Benzoate developed by Nexpharm Korea incorporates a benzoate salt structure, offering enhanced stability and bioavailability, improved efficacy, and reduced side effects. Other competitors include Cymbalta (duloxetine, Eli Lilly), a widely used SNRI for depression and chronic pain management.
7. BARYTHRAXBARYTHRAX (GC-1109), a recombinant anthrax vaccine developed by GC Biopharma, was first approved in South Korea on April 8, 2025, for the prevention of anthrax infection.
This recombinant vector-based anthrax vaccine is developed through genetic engineering and is designed to express and deliver the protective antigen (PA) of Bacillus anthracis, stimulating a specific immune response. The vaccine employs recombinant technology to insert the gene encoding the anthrax protective antigen into a viral or bacterial vector. Upon administration, these vectors express and release the PA antigen in the human body, which is then recognized by the host immune system—triggering both humoral and cellular immune responses, generating specific antibodies and memory T cells against Bacillus anthracis. Once the individual is exposed to the pathogen, the primed immune system can rapidly activate, neutralize toxins, and eliminate the bacteria, thus preventing disease onset and progression.
Compared to traditional inactivated or live-attenuated vaccines, this recombinant vaccine offers enhanced safety, as it contains no live pathogens and only expresses selected antigenic components, thereby minimizing the risk of adverse reactions.
Clinical studies have shown that the vaccine induces high-titer antibody responses, significantly enhancing immunity in subjects without serious adverse events. GC Biopharma applied advanced vector design and manufacturing technologies to ensure the vaccine’s stability and immunogenicity and conducted detailed pharmacokinetic and immunological studies demonstrating that the product provides equal or superior performance compared to existing vaccines. The company continues post-marketing surveillance and plans Phase IV trials to further optimize the formulation, usage guidelines, and explore additional indications and long-term efficacy.
Currently, several key vaccine types are available for anthrax prevention, including inactivated, live-attenuated, and recombinant protein vaccines. BioThrax (manufactured by Emergent BioSolutions) is one of the most widely used anthrax vaccines, made from a cell-free extract of Bacillus anthracis PA. Although approved in multiple countries and widely used, BioThrax requires multiple doses and may cause local injection site reactions and mild side effects. In contrast, BARYTHRAX, as a novel recombinant vector vaccine, offers a safer and more effective alternative, potentially requiring fewer doses to establish durable immunity. Competing products include NuThrax (also from Emergent BioSolutions), a next-generation vaccine combining BioThrax with the CpG 7909 adjuvant to enhance the speed and strength of immune responses.
8. Dalnacogene PonparvovecDalnacogene ponparvovec (also known as BBM-H901), developed by Belief BioMed, is an adeno-associated virus (AAV)-based gene therapy approved in China on April 8, 2025, for the treatment of Hemophilia B.
Dalnacogene ponparvovec delivers a functional human coagulation factor IX (FIX) gene into liver cells to correct the coagulation deficiency caused by mutations in the FIX gene. Using an AAV vector carrying an optimized FIX gene sequence, the therapy targets hepatocytes after administration, enabling the integration and expression of the FIX gene within the patient’s cells. This leads to sustained production and secretion of functional FIX protein, restoring coagulation ability.
The therapy incorporates advanced gene engineering and sequence optimization to produce FIX protein with enhanced activity and stability, significantly improving therapeutic outcomes. Unlike traditional FIX replacement therapies, which require regular infusions, Dalnacogene ponparvovec offers a one-time treatment with long-lasting effects, reducing treatment burden and improving quality of life.
Clinical studies have demonstrated that Dalnacogene ponparvovec significantly increases FIX protein levels and reduces bleeding episodes, leading to marked improvements in patients' coagulation function and overall well-being. Belief BioMed has employed cutting-edge AAV vector design and manufacturing technology to ensure product stability and bioavailability, and pharmacokinetic studies confirm comparable or superior efficacy to other gene therapies. Post-approval, the company is maintaining ongoing safety monitoring, gathering additional real-world data, and planning Phase IV clinical trials to explore broader indications and long-term benefits. Preliminary studies suggest the therapy may have potential in treating other inherited disorders.
In the treatment landscape for Hemophilia B, current options include recombinant FIX protein replacement therapies, non-replacement therapies, and other gene therapies. Alprolix (a recombinant FIX-Fc fusion protein by Bioverativ) and BeneFIX (recombinant FIX by Pfizer) are widely used replacements that supplement exogenous FIX to correct coagulation deficits but require frequent infusions, which can be inconvenient. By contrast, Dalnacogene ponparvovec, as a single-administration AAV-based gene therapy, offers a long-term solution with sustained FIX expression and reduced treatment frequency.
Other competitors include Valoctocogene roxaparvovec (BioMarin), an AAV gene therapy for Hemophilia A. Although targeting a different clotting factor, its clinical development has provided valuable insights applicable to the advancement of Dalnacogene ponparvovec.
9. Sitagliptin Phosphate Hydrate / Empagliflozin L-ProlineSitagliptin Phosphate Hydrate / Empagliflozin L-Proline (brand name: Empamax, 엠파맥스에스정), developed by Chong Kun Dang Pharmaceutical Corp., is a small-molecule combination drug for the treatment of type 2 diabetes mellitus (T2DM). It was first approved in South Korea on April 7, 2025.
Sitagliptin phosphate is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by blocking the enzymatic degradation of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby prolonging the action of these incretin hormones. GLP-1 and GIP enhance insulin secretion and suppress glucagon release, leading to improved glycemic control. Sitagliptin also helps preserve β-cell function and slows the progression of T2DM.
Empagliflozin, on the other hand, is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that lowers blood glucose levels by inhibiting glucose reabsorption in the kidneys and increasing urinary glucose excretion. The combination of a DPP-4 inhibitor and an SGLT2 inhibitor offers a dual mechanism of action that not only improves glycemic control but also provides additional cardiovascular and weight management benefits. Empagliflozin promotes weight loss through glucosuria, while sitagliptin preserves β-cell function—making this fixed-dose combination particularly effective for comprehensive T2DM management.
Clinical results demonstrate that Sitagliptin Phosphate Hydrate / Empagliflozin L-Proline significantly reduces HbA1c, improves glycemic control, and lowers the incidence of hypoglycemia, while also supporting weight loss. Chong Kun Dang utilized advanced formulation and drug development technologies to ensure the drug’s stability and bioavailability, supported by detailed pharmacokinetic studies showing equal or superior efficacy compared to individual agents. The company continues post-marketing surveillance and plans Phase IV clinical trials to further optimize dosing, explore long-term outcomes, and evaluate additional indications—such as cardiovascular protection, which has been suggested by emerging data.
Currently, the T2DM treatment landscape includes various key drug classes such as DPP-4 inhibitors, SGLT2 inhibitors, and other oral hypoglycemic agents. Januvia (Merck) and Jardiance (Boehringer Ingelheim) are two widely used monotherapies that lower blood glucose via different mechanisms. Januvia is known for its tolerability and low risk of hypoglycemia, while Jardiance is favored for its cardiovascular benefits. Compared with these monotherapies, Chong Kun Dang’s fixed-dose combination offers a more comprehensive therapeutic option, especially for patients requiring simultaneous glycemic control and weight management. Competing products include Farxiga (AstraZeneca, an SGLT2 inhibitor) and Trulicity (Eli Lilly, a GLP-1 receptor agonist), both of which use different mechanisms to support glycemic control.
10. AtrasentanAtrasentan, marketed under the brand name Vanrafia, is an innovative small-molecule drug developed by Novartis Pharmaceuticals for the treatment of various kidney diseases. It received its first approval in the United States on April 2, 2025, for the treatment of IgA nephropathy (IgAN). As a selective endothelin receptor antagonist, Atrasentan offers patients a more effective and targeted therapeutic option, with the potential for global adoption to further improve treatment outcomes and quality of life.
Atrasentan is a selective endothelin A (ETA) receptor antagonist that functions primarily by blocking the binding of endothelin-1 (ET-1) to the ETA receptor, thereby reducing vasoconstriction and inflammatory responses. ET-1 is a potent vasoconstrictor involved in regulating blood pressure and fluid-electrolyte balance. Under pathological conditions such as kidney disease, ET-1 contributes to excessive vasoconstriction and tissue damage. By selectively antagonizing ETA receptors, Atrasentan significantly lowers intraglomerular hypertension, reduces proteinuria, and helps preserve renal function. Additionally, Atrasentan suppresses the release of inflammatory mediators and mitigates renal fibrosis, thereby slowing disease progression. This dual mechanism of action allows Atrasentan to effectively slow the decline in kidney function and improve long-term outcomes in patients with IgA nephropathy and other glomerular diseases.
Clinical studies have demonstrated that Atrasentan excels in reducing proteinuria and preserving renal function, significantly lowering the risk of kidney function deterioration. Novartis applied advanced drug design and development technologies to ensure drug stability and bioavailability, and conducted detailed pharmacokinetic studies, confirming that Atrasentan offers comparable or superior efficacy relative to similar therapies. Even after market launch, the company continues post-marketing surveillance to collect real-world clinical data, with plans to initiate Phase IV clinical trials to explore additional indications and long-term benefits. Notably, current research suggests that Atrasentan may also be effective in treating other glomerular diseases, such as focal segmental glomerulosclerosis (FSGS) and Alport syndrome.
Currently, several important drug classes are available for the treatment of IgA nephropathy and other kidney diseases, including but not limited to angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), glucocorticoids, and immunosuppressants. For example, ACE inhibitors and ARBs are widely used to control hypertension and reduce proteinuria, but their mechanisms primarily focus on modulating the renin-angiotensin system, without directly targeting ET-1-mediated pathways. In contrast, Atrasentan, as a selective ETA receptor antagonist, provides a novel therapeutic approach by more effectively addressing glomerular hypertension and inflammatory responses. Other competing therapies include immunosuppressants such as cyclophosphamide and mycophenolate mofetil, which are commonly used to treat severe glomerular diseases but are often associated with significant adverse effects.
Conclusion
The wave of new drug approvals in April 2025 not only reflects the current advancements in pharmaceutical science and technology but also serves as a critical indicator of the future direction of medical innovation. Increasingly, targeted therapies and biologics are being developed to treat complex and difficult-to-cure diseases. This trend marks the gradual mainstream adoption of personalized medicine, which aims to deliver more effective and less toxic treatments by precisely targeting the key mechanisms of disease pathogenesis.
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06 Nov 2024
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
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)
100 Deals associated with Anthrax vaccine adsorbed(Emergent Biodefense)
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Anthrax | United States | 12 Nov 1998 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2 | 305 | (Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)) | xftzeeuhmk = irjuwfglkb bobdxkkkeo (snuxfwsgti, tweukmoczf - sgbjzviczf) View more | - | 09 Jun 2020 | ||
(Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)) | xftzeeuhmk = duesydtxpx bobdxkkkeo (snuxfwsgti, ormrampmrl - iavziehshj) View more | ||||||
Phase 4 | 573 | (AVA Alone) | igqrqrbpir(tzixmaltxv) = amifaflkck jfuxdydxum (bnerekiwzl, dlwaciwgyp - dxwisahenl) View more | - | 09 Jan 2018 | ||
(AVA+Raxibacumab) | igqrqrbpir(tzixmaltxv) = yoyfacrurv jfuxdydxum (bnerekiwzl, ndcyfcvvrg - mapbunjvhs) View more | ||||||
Phase 2 | 154 | (BioThrax + Ciprofloxacin PK) | pgocwhuiub(shsrrskjyn) = xihrwtjffw apejpedzbu (deqxtneava, phoidmyndc - fbewxmktvo) View more | - | 19 Nov 2014 | ||
(BioThrax + Ciprofloxacin no PK) | pgocwhuiub(shsrrskjyn) = yqyfnratfy apejpedzbu (deqxtneava, xxfiymbsjg - kqvkdojgru) View more | ||||||
Phase 4 | 328 | (Arm A: 0.50mL BioThrax, Days 0, 14) | owfoslauvs = pznridvoke yjmsakgwfr (znrpgfjrdx, qyryetdgvj - oefommjczo) View more | - | 28 May 2014 | ||
(Arm B: 0.50mL BioThrax, Days 0, 28) | owfoslauvs = hvuywjipfn yjmsakgwfr (znrpgfjrdx, yawimyjeat - jmjsuhnwzl) View more |
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