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Lyell Immunopharma, Inc. (LYEL): ANSOFF-Matrixanalyse |
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Lyell Immunopharma, Inc. (LYEL) Bundle
In der sich schnell entwickelnden Onkologie- und Immuntherapielandschaft steht Lyell Immunopharma an der Spitze strategischer Innovationen und ist bereit, die Krebsbehandlung durch eine sorgfältig ausgearbeitete Wachstumsstrategie zu transformieren. Durch die Nutzung modernster CAR-T-Zelltechnologien, strategischer Partnerschaften und eines umfassenden Marktansatzes entwickelt das Unternehmen nicht nur Therapien, sondern definiert das Potenzial der Präzisionsmedizin neu. Ihre vielschichtige Ansoff-Matrix enthüllt einen ehrgeizigen Expansionsplan, der verspricht, die Grenzen der immunologischen Forschung und therapeutischen Interventionen zu verschieben und Patienten und Investoren gleichermaßen Hoffnung zu geben.
Lyell Immunopharma, Inc. (LYEL) – Ansoff-Matrix: Marktdurchdringung
Erweitern Sie Partnerschaften für klinische Studien
Seit dem dritten Quartal 2023 unterhält Lyell Immunopharma aktive Partnerschaften mit sieben führenden onkologischen Forschungszentren, darunter dem MD Anderson Cancer Center und dem Memorial Sloan Kettering Cancer Center.
| Forschungszentrum | Aktive Versuche | Patientenregistrierung |
|---|---|---|
| MD Anderson | 3 | 124 Patienten |
| Memorial Sloan Kettering | 2 | 87 Patienten |
| Dana-Farber-Krebsinstitut | 2 | 65 Patienten |
Verbessern Sie Ihre Marketingbemühungen
Zuweisung des Marketingbudgets für die Öffentlichkeitsarbeit in den Bereichen Onkologie und Hämatologie: 3,2 Millionen US-Dollar im Jahr 2023.
- Zielgruppe: 12.500 Onkologen und Hämatologen in den Vereinigten Staaten
- Ausgaben für digitales Marketing: 1,1 Millionen US-Dollar
- Direkte Kommunikationskampagnen: 750.000 US-Dollar
Optimieren Sie die Schulung Ihres Vertriebsteams
Schulungsinvestition: 450.000 US-Dollar im Jahr 2023 für die Entwicklung des Vertriebsteams.
| Trainingsprogramm | Stunden | Kosten pro Vertreter |
|---|---|---|
| Produktwissen | 40 Stunden | $2,500 |
| Kommunikationsfähigkeiten | 24 Stunden | $1,800 |
| Technische Therapeutische Ausbildung | 32 Stunden | $2,200 |
Erhöhen Sie digitales Marketing und Konferenzpräsenz
Budget für Konferenz und digitales Marketing: 2,7 Millionen US-Dollar im Jahr 2023.
- Besuchte medizinische Konferenzen: 12
- Werbeausgaben für digitale Plattformen: 1,5 Millionen US-Dollar
- Investitionen in Webinare und virtuelle Veranstaltungen: 650.000 US-Dollar
Lyell Immunopharma, Inc. (LYEL) – Ansoff Matrix: Marktentwicklung
Internationale Expansionsstrategien in Onkologiemärkten
Im vierten Quartal 2022 meldete Lyell Immunopharma einen Gesamtumsatz von 37,6 Millionen US-Dollar. Das Unternehmen identifizierte wichtige internationale Märkte für eine potenzielle Expansion:
| Region | Marktpotenzial | Geplante Investition |
|---|---|---|
| Europäischer Onkologiemarkt | 125,3 Milliarden US-Dollar | 8,5 Millionen US-Dollar |
| Asien-Pazifik-Onkologiemarkt | 98,7 Milliarden US-Dollar | 6,2 Millionen US-Dollar |
Strategische Zusammenarbeit mit internationalen Pharmahändlern
Zu den aktuellen internationalen Vertriebspartnerschaften gehören:
- Merck KGaA (Deutschland)
- Takeda Pharmaceutical (Japan)
- AstraZeneca (Vereinigtes Königreich)
Schwellenländer mit ungedecktem medizinischem Bedarf
Zielmärkte mit hohem Bedarf an Krebsbehandlungen:
| Land | Krebsinzidenzrate | Ungedeckter Behandlungsbedarf |
|---|---|---|
| China | 4,5 Millionen neue Fälle/Jahr | 62 % Behandlungslücke |
| Indien | 1,4 Millionen neue Fälle/Jahr | 55 % Behandlungslücke |
Regulierungsgenehmigungsstrategie
Zeitplan für die Einreichung behördlicher Auflagen:
- Europäische Arzneimittel-Agentur (EMA): 3. Quartal 2023
- China National Medical Products Administration: 4. Quartal 2023
- Japanische Arzneimittel- und Medizingerätebehörde: 1. Quartal 2024
Geschätztes Gesamtbudget für die Zulassungseinreichung: 5,3 Millionen US-Dollar
Lyell Immunopharma, Inc. (LYEL) – Ansoff Matrix: Produktentwicklung
Investieren Sie in Forschung und Entwicklung, um die Pipeline für CAR-T-Zelltherapien für verschiedene Krebsarten zu erweitern
Lyell Immunopharma meldete für das Geschäftsjahr 2022 Forschungs- und Entwicklungskosten in Höhe von 108,4 Millionen US-Dollar. Das Unternehmen verfügt ab dem vierten Quartal 2022 über drei CAR-T-Zelltherapieprogramme in der klinischen Entwicklung.
| Programm | Krebstyp | Entwicklungsphase |
|---|---|---|
| LYL797 | Solide Tumoren | Phase 1 |
| LYL845 | Hämatologische Krebserkrankungen | Präklinisch |
| LYL371 | Eierstockkrebs | Phase 1/2 |
Entwickeln Sie Immuntherapien der nächsten Generation unter Nutzung bestehender technologischer Plattformen
Das Unternehmen verfügt über fünf proprietäre Technologieplattformen, die sich auf die T-Zell-Technik und die Entwicklung von Immuntherapien konzentrieren.
- Gedächtnisähnliche T-Zellen-Plattform
- T-Zell-Persistenztechnologie
- Multi-Antigen-Targeting-Ansatz
- Modulation der Tumormikroumgebung
- Präzises T-Zellen-Engineering
Verfolgen Sie Ansätze der Präzisionsmedizin, um gezieltere therapeutische Interventionen zu entwickeln
Lyell Immunopharma hat im Jahr 2022 42,3 Millionen US-Dollar in die Präzisionsmedizinforschung investiert. Das Unternehmen verfügt über zwei Präzisionsmedizinprogramme in der aktiven Entwicklung.
| Präzisionsmedizinischer Ansatz | Zielanzeige | Forschungsinvestitionen |
|---|---|---|
| Personalisierte T-Zelltherapie | Metastasierter Krebs | 18,7 Millionen US-Dollar |
| Molekulare Profilierungsplattform | Mehrere solide Tumoren | 23,6 Millionen US-Dollar |
Verbessern Sie bestehende Produktlinien durch schrittweise Innovation und fortschrittliche Molekulartechnik
Lyell Immunopharma hat im Jahr 2022 12 Patentanmeldungen im Zusammenhang mit Molekulartechnik eingereicht. Das Unternehmen hat 35,6 Millionen US-Dollar für inkrementelle Innovationsbemühungen bereitgestellt.
- 6 Patente konzentrierten sich auf T-Zell-Modifikationstechniken
- 4 Patente zielen auf eine verbesserte Zellpersistenz ab
- 2 Patente, die sich mit Wechselwirkungen zwischen Tumor-Mikroumgebungen befassen
Lyell Immunopharma, Inc. (LYEL) – Ansoff-Matrix: Diversifikation
Erkunden Sie potenzielle Übernahmen komplementärer Biotechnologieunternehmen
Im vierten Quartal 2022 verfügte Lyell Immunopharma über Zahlungsmittel und Zahlungsmitteläquivalente in Höhe von 392,1 Millionen US-Dollar. Mögliche Akquisitionsziele sind Unternehmen mit komplementären Zelltherapietechnologien.
| Mögliche Akquisitionskriterien | Spezifische Parameter |
|---|---|
| Marktkapitalisierungsbereich | 50 bis 500 Millionen Dollar |
| Technologieausrichtung | T-Zellen-Engineering-Plattformen |
| Bevorzugtes Forschungsstadium | Von präklinischen bis hin zu klinischen Phase-2-Studien |
Untersuchen Sie Möglichkeiten in angrenzenden Therapiebereichen
Der aktuelle Marktschwerpunkt von Lyell Immunopharma umfasst Onkologie und Autoimmunerkrankungen mit einem adressierbaren Gesamtmarkt von 67 Milliarden US-Dollar.
- Größe des Onkologiemarktes: 42,5 Milliarden US-Dollar
- Marktgröße für Autoimmunerkrankungen: 24,6 Milliarden US-Dollar
- Mögliche Expansionsbereiche: Neurologische Erkrankungen, entzündliche Erkrankungen
Entwickeln Sie strategische Partnerschaften mit Diagnosetechnologieunternehmen
| Partnerschaftskennzahlen | Aktueller Status |
|---|---|
| Bestehende Kooperationen | 3 aktive Pharmapartnerschaften |
| Jährliche F&E-Investitionen | 85,3 Millionen US-Dollar |
| Potenzieller Partnerschaftswert | 10–50 Millionen US-Dollar pro Zusammenarbeit |
Erwägen Sie die Ausweitung der Forschungskapazitäten auf neue immunologische Behandlungsmodalitäten
Die aktuelle Forschungspipeline von Lyell Immunopharma umfasst fünf aktive Programme im klinischen Stadium mit geschätzten Entwicklungskosten von 120 Millionen US-Dollar.
- Neuer Forschungsschwerpunkt: T-Zelltherapien der nächsten Generation
- Investition in neuartige immunologische Plattformen: 35,6 Millionen US-Dollar
- Voraussichtlicher Zeitrahmen für die Technologieentwicklung: 3–5 Jahre
Lyell Immunopharma, Inc. (LYEL) - Ansoff Matrix: Market Penetration
You're looking at how Lyell Immunopharma, Inc. plans to capture more market share with its current asset, ronde-cel (LYL314), in the existing relapsed/refractory large B-cell lymphoma (R/R LBCL) space. This is all about maximizing the impact of the data you already have.
The immediate focus is driving enrollment across the two pivotal programs. The ongoing PiNACLE trial, assessing LYL314 in the third- or later-line (3L+) setting, is expected to enroll approximately 120 patients. Simultaneously, you need to push hard to get the PiNACLE - H2H Phase 3 head-to-head trial started for the second-line (2L) setting. Site initiation is already underway in the US, Canada, and Australia for this trial, which is slated to begin enrolling patients by early 2026. This second trial is a large commitment, designed to enroll approximately 400 patients across two arms.
| Pivotal Trial | Setting | Patient Enrollment Target | Primary Endpoint |
| PiNACLE | 3L+ R/R LBCL | Approximately 120 | Overall Response Rate |
| PiNACLE - H2H | 2L R/R LBCL | Approximately 400 | Event-Free Survival |
The data package for LYL314 is your primary weapon here. In the 3L+ setting, the trial has already demonstrated a 72% complete response rate (CR) among 25 efficacy-evaluable patients, with 71% of those CRs durable for 6 or more months. This stacks up well against currently approved CD19 CAR-Ts, which Lyell Immunopharma, Inc. estimates show CR rates around 50% in the third line. Even in the 2L setting, the CR rate achieved was 64% in 11 patients evaluated for efficacy.
You must emphasize the safety profile to drive adoption and reduce site burden. The data shows a manageable safety profile appropriate for outpatient administration. Specifically, there was no Grade ≥ 3 cytokine release syndrome (CRS) reported across 51 subjects in the combined 3L+ and 2L cohorts. While Grade ≥ 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) occurred in 14% of patients, the median time to resolution for all ICANS reports was only 5 days. This profile helps reduce the need for intensive inpatient monitoring, which directly lowers treatment costs for sites.
Financially, you're well-positioned to execute this market penetration strategy. As of September 30, 2025, Lyell Immunopharma, Inc. held approximately $320 million in cash, cash equivalents, and marketable securities. Management has reaffirmed that this liquidity is sufficient to fund working capital and capital expenditure needs, including the commercial launch preparation, into 2027. Furthermore, the 2025 net cash use guidance was lowered to $155-$160 million, excluding the $40 million upfront payment for LYL273, showing good operating discipline.
Here are the key metrics supporting the commercial readiness:
- $320 million cash position as of September 30, 2025.
- Cash runway extends into 2027.
- 72% CR rate in 3L+ LBCL patients.
- 64% CR rate in 2L LBCL patients.
- No Grade ≥ 3 CRS observed in the combined cohort.
- Lowered 2025 net cash use guidance to $155-$160 million.
Finance: draft the 13-week cash view by Friday.
Lyell Immunopharma, Inc. (LYEL) - Ansoff Matrix: Market Development
Initiate regulatory filings for LYL314 in the European Union and Japan post-US BLA submission in 2027.
The US Biologics License Application (BLA) submission for LYL314 in the third-line or later (3L+) setting is planned for 2027. This sets a target for initiating European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) filings shortly thereafter, aiming to capture market share in regions where the Hematologic Malignancies Market is substantial. The European hematologic malignancy therapeutics market was valued at a 29.3% revenue share in 2023, and is projected to grow from USD 23.2 billion in 2025 to USD 50.8 billion by 2035. Japan shows a steady market development with a projected 6.1% Compound Annual Growth Rate (CAGR) through 2035.
Explore strategic partnerships for commercialization outside of the current US/Canada/Australia trial footprint.
The PiNACLE pivotal trial is currently underway with clinical site initiation in the United States and Australia. To support commercialization outside of this core footprint, which includes the US, Canada, and Australia, strategic alliances will be key. Lyell Immunopharma, Inc. reported cash, cash equivalents and marketable securities of approximately $320 million as of September 30, 2025, with an expected net cash use in 2025 of $175 million - $185 million. This cash position is stated to support advancing the pipeline into 2027.
Expand LYL314's label to include other CD19/CD20-positive hematologic malignancies.
The current focus for LYL314 is Large B-cell Lymphoma (LBCL). The global hematologic malignancy therapeutics market reached $77.06 billion in 2024, with Leukemia accounting for a 41.2% share in 2023. Targeting other CD19/CD20-positive cancers, such as other lymphomas or potentially chronic lymphocytic leukemia (CLL), represents a significant expansion opportunity within this market. The global market is projected to reach $154.32 billion by 2033.
Target earlier-line treatment settings for LBCL, leveraging the RMAT designation.
Lyell Immunopharma, Inc. received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for LYL314 in the relapsed/refractory LBCL setting after two or more prior lines of therapy (3L+). The RMAT designation provides benefits like early interactions with the FDA and potential eligibility for accelerated approval based on surrogate endpoints. The company plans a second pivotal trial for patients in the second-line (2L) setting, expected to be initiated by early 2026. Initial data from the Phase 1/2 trial in the 2L setting are expected to be presented in late 2025.
Here's a quick look at the key data points supporting this market development strategy:
| Metric | Value/Setting | Context/Date |
| LYL314 US BLA Submission Target | 2027 | For 3L+ R/R LBCL |
| LYL314 3L+ ORR (ASH 2024 Data) | 94% (16/17 patients) | Efficacy evaluable population |
| LYL314 3L+ CR Rate (ASH 2024 Data) | 71% (12/17 patients) | Achieved by three months |
| LYL314 Grade 3+ CRS Rate | 0% | In safety evaluable population of 23 patients |
| LYL314 2L Pivotal Trial Initiation | Early 2026 | Planned for R/R LBCL |
| Q3 2025 Net Loss | $38.8 million | Compared to $44.6 million in Q3 2024 |
| Cash & Equivalents (Sep 30, 2025) | $320 million | Extends runway into 2027 |
| Global Hematologic Malignancies Market (2025 Est.) | USD 77.5 billion | Forecast value |
The RMAT designation is a significant asset for accelerating the 2L program, which is a larger patient pool than the 3L+ setting. You'll want to ensure the partnership discussions are well underway before the 2027 BLA submission to maximize initial ex-US uptake.
- Enrollment in PiNACLE (3L+ pivotal trial) is underway.
- The dual-targeting of CD19/CD20 is designed to address CD19 antigen loss.
- The manufacturing process enriches for more naïve and central memory CAR T cells.
- The company is advancing a novel GCC-targeted CAR T-cell candidate (LYL273).
Finance: draft 13-week cash view by Friday.
Lyell Immunopharma, Inc. (LYEL) - Ansoff Matrix: Product Development
You're looking at the core of Lyell Immunopharma, Inc.'s growth engine-the product development pipeline. This is where the company translates its technology platforms into potential revenue streams, moving from preclinical work through pivotal trials.
Lyell Immunopharma is heavily focused on advancing its lead autologous CAR T-cell candidates, using its proprietary technologies to try and leapfrog first-generation therapies. As of the third quarter of 2025, the company held approximately $320 million in cash, cash equivalents and marketable securities, down from approximately $384 million at the end of 2024. This cash position is projected to support advancing the pipeline into 2027 through key clinical milestones.
Improving LYL314 with Proprietary Technologies
The work on ronde-cel (LYL314) involves applying the LyFE manufacturing and T-cell reprogramming technologies to create a next iteration. LYL314 is already manufactured at Lyell Immunopharma's LyFE Manufacturing Center™, which has a capacity over 1,000 CAR T-cell therapy doses per year. This product is a dual-targeting CD19/CD20 CAR T-cell candidate. For patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting, the prior Phase 1/2 trial showed an overall response rate of 94% (16/17 patients), with 71% (12/17 patients) achieving a complete response by three months, with a median follow-up of 6.3 months.
The development roadmap for LYL314 includes several key near-term events:
- PiNACLE trial progress update expected late 2025.
- Presentation of more mature data from the Phase 1/2 trial in the second-line (2L) setting expected in late 2025.
- Initiation of a Phase 3 head-to-head trial (PiNACLE - H2H) in the 2L setting by early 2026.
- The PiNACLE - H2H trial is expected to enroll approximately 400 patients.
- Biologics License Application (BLA) submission expected in 2027.
Accelerating LYL273 for Refractory mCRC
LYL273, a novel guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate for refractory metastatic colorectal cancer (mCRC), is in Phase 1 clinical development. GCC is expressed on more than 95% of colorectal cancers. At the highest dose level studied to date in the ongoing U.S. Phase 1 trial, LYL273 demonstrated a 67% overall response rate and an 83% disease control rate. The next data update from this Phase 1 trial is anticipated in the first half of 2026. Approximately 53,000 people are expected to die from CRC in the U.S. in 2025.
Translating Preclinical Solid Tumor Programs
Lyell Immunopharma is advancing next-generation CAR T-cell product candidates targeting solid tumors. The company has a stated goal to translate preclinical solid tumor programs into IND-enabling studies by late 2026. This focus includes building on earlier work, such as the IND clearance received in October 2022 for LYL845, a Tumor Infiltrating Lymphocyte (TIL) therapy enhanced with the Epi-R™ technology. The first IND for a fully-armed CAR T-cell product candidate for solid tumors is expected in 2026.
Developing an Allogeneic CAR T-cell Platform
The strategy includes the objective to develop an allogeneic (off-the-shelf) CAR T-cell platform to reduce manufacturing complexity. No specific financial or operational metrics related to the allogeneic platform's development timeline or cost savings were available in the Q3 2025 reports.
The company's expected net cash use for 2025 was projected to be between $175 million and $185 million.
| Metric | Product Candidate | Indication/Setting | Key Number/Date |
| Cash Position (Q3 2025) | N/A | Balance Sheet | $320 million |
| Cash Runway End | N/A | Financial Guidance | Into 2027 |
| Manufacturing Capacity | LYL314 | LyFE Center | Over 1,000 doses per year |
| ORR (Phase 1/2) | LYL314 | R/R LBCL (3L+) | 94% (16/17 patients) |
| Complete Response (3 Mo) | LYL314 | R/R LBCL (3L+) | 71% (12/17 patients) |
| ORR (Phase 1) | LYL273 | Refractory mCRC | 67% |
| DCR (Phase 1) | LYL273 | Refractory mCRC | 83% |
| Next Data Update | LYL273 | Phase 1 mCRC | First half of 2026 |
| Pivotal Trial Initiation | LYL314 | 2L LBCL (PiNACLE - H2H) | Early 2026 |
| Projected Enrollment | LYL314 | PiNACLE - H2H | Approximately 400 patients |
| First Solid Tumor IND Goal | Preclinical | Solid Tumors | 2026 |
The RMAT designation for LYL314 was for the 2L setting. The expected net cash use for 2025 was between $175 million and $185 million.
Lyell Immunopharma, Inc. (LYEL) - Ansoff Matrix: Diversification
You're looking at how Lyell Immunopharma, Inc. can expand beyond its core hematologic malignancy focus, which is smart given the high-risk, high-reward nature of cell therapy development.
Out-license the LYL273 program for metastatic colorectal cancer (mCRC) in Asia-Pacific markets.
While Lyell Immunopharma, Inc. acquired global rights to LYL273, the agreement specifically excludes mainland China, Hong Kong, Macau and Taiwan, which represents the Asia-Pacific territory you mentioned. The transaction involved an upfront payment of $40 million and 1.9 million shares of Lyell common stock.
| Metric | Value/Range |
| Upfront Payment to ICT | $40 million |
| Equity Consideration (Upfront) | 1.9 million shares |
| Potential Clinical Milestone | $30 million |
| Maximum Regulatory Milestones | Up to $115 million |
| Maximum Commercial Sales Milestones | Up to $675 million |
| U.S. Net Sales Royalty Tier | Mid-single digits up to 10% |
| Other Territory Net Sales Royalty Tier | Low to mid-single-digit royalties |
The LYL273 candidate showed a 67% overall response rate and an 83% disease control rate in refractory mCRC patients in a U.S. Phase 1 trial at the highest dose level studied to date.
Form a joint venture to apply the T-cell exhaustion technology (Epi-R, Stim-R) to autoimmune diseases.
No specific 2025 financial or statistical data is available regarding a joint venture for autoimmune applications using the Epi-R or Stim-R technologies.
Acquire a complementary early-stage asset in a non-CAR T-cell modality, like a bispecific antibody platform.
No specific 2025 financial or transaction data is available for the acquisition of a bispecific antibody platform.
Secure non-dilutive funding via a major pharmaceutical collaboration for the solid tumor pipeline.
The first IND for a fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors is expected in 2026. The company is managing its cash position to support this. As of September 30, 2025, cash, cash equivalents and marketable securities totaled approximately $320 million.
- Cash position as of September 30, 2025: approximately $320 million.
- Expected cash runway into: 2027.
- Gross proceeds from July 2025 private placement: up to approximately $100 million.
- Initial closing of July 2025 private placement: approximately $50 million.
- Price per share for July 2025 initial closing: $13.32.
- Net loss for Q3 2025: $38.8 million.
The company reported a net loss of $38.85 million for the third quarter ended September 30, 2025. Non-GAAP R&D expenses for Q3 2025 were $26.2 million.
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