{ "docId": "019dd923-622c-750b-8b9a-648c05e927ed", "docSlug": "ea3395f0d3bd", "documentTitle": "Inspire Medical Systems, Inc. (INSP)", "authorId": "60_Wolfpack_Research", "authorName": "Wolfpack Research", "documentKindSlug": "research-note", "documentKindLabel": "Research note", "sourceTypeSlug": "short_seller", "sourceTypeLabel": "Short seller", "presentationDate": "2020-04-22 00:00:00", "orientation": "portrait", "aspectRatio": 0.77272725, "pageNumber": 9, "pageCount": 57, "prevPage": 8, "nextPage": 10, "slideType": "thesis_headline", "function": "diagnose_problem", "density": "dense", "nDataPoints": 4, "notes": "Uses Germany as a proxy for market maturity to argue against long-term growth potential.", "elementsJson": [ "headline_text", "paragraph", "footnote" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-648c05e927ed/9", "deckHref": "/decks/019dd923-622c-750b-8b9a-648c05e927ed", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-648c05e927ed.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-648c05e927ed#slide-9", "components": [ { "bbox": null, "kind": "callout", "text": "Given it has been available in Germany for nearly a decade, and the extensive service infrastructure Inspire has established there, Germany serves as an excellent example of what a mature market looks like for Inspire.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-5375-7572-b873-211267a09263", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.117, "y": 0.31 }, "kind": "paragraph", "text": "According to Inspire's European website, there are 48 Inspire Sleep Clinics in Germany. The costs of the implant and procedure were covered in 113 hospitals under the NUB process of the German federal reimbursement agency in 2019. Given it has been available in Germany for nearly a decade, and the extensive service infrastructure Inspire has established there, Germany serves as an excellent example of what a mature market looks like for Inspire.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "0acd82c4-05d0-4683-bbc7-758fdc8f0fd6", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.12, "w": 0.78, "x": 0.117, "y": 0.18 }, "kind": "paragraph", "text": "A former Inspire employee told us the company's early business-development strategy focused on Europe, at least in part because the regulatory approval process is less challenging than in the U.S. In Europe, medical devices need a “CE mark” before they can be sold. This designation only proves the device passes certain quality and safety standards, but says nothing about its efficacy. In this sense, it is easier to gain a “CE mark” approval in Europe than an FDA approval in the U.S. Inspire first received a CE mark in Europe in 2011, nearly a decade ago.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "2037814c-b96d-4a48-881c-a237a672a378", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.05, "w": 0.78, "x": 0.117, "y": 0.125 }, "kind": "paragraph", "text": "After nearly a decade of commercial availability in Germany, a wealthy country with a population of 83 million that spends ~9% of its GDP on healthcare, Inspire only sold a meager ~300 units there in 2019.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "f26779af-d3c0-46d4-94a8-3f671ae8becf", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "In Germany, the Institut für das Entgeltsystem im Krankenhaus, the German federal reimbursement agency, has granted the Neue Untersuchungs-und Behandlungsmethoden (\"NUB\") Status 1 coverage for our Inspire system. The NUB process allows for the introduction of new and innovative medical devices prior to reaching reimbursement eligibility and provides for a supplemental payment for new technologies in the German reimbursement system. NUB Status 1 is the highest of four levels and allows for full reimbursement for our Inspire system for the 113 hospitals that applied for therapy in 2019. — INSP 2019 10-K", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-5375-7572-b873-2491dd74d10f", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.15, "w": 0.78, "x": 0.117, "y": 0.805 }, "kind": "source-note", "text": "22 Interview with former Inspire employee in Europe, February 2020\n23 INSP 2019 10-K, p. 12\n24 Inspiresleep.de\n25 INSP 2019 10-K, p. 22: “In Germany, the Institut für das Entgeltsystem im Krankenhaus, the German federal reimbursement agency, has granted the Neue Untersuchungs-und Behandlungsmethoden (\"NUB\") Status 1 coverage for our Inspire system. The NUB process allows for the introduction of new and innovative medical devices prior to reaching reimbursement eligibility and provides for a supplemental payment for new technologies in the German reimbursement system. NUB Status 1 is the highest of four levels and allows for full reimbursement for our Inspire system for the 113 hospitals that applied for therapy in 2019.”", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "ef19c2c6-6733-4034-8483-76bea1606665", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.45, "x": 0.117, "y": 0.093 }, "kind": "title", "text": "Inspire's most mature market shows its future is bleak", "attrs": null, "subkind": "action-title", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "f9d36f7d-6f8d-46c8-9491-58d2f2909cdd", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [ { "to": 20, "from": 6, "beatId": "e9079ce5-c7de-4121-8615-3ae679f7ffcd", "arcName": "Overcoming the Monster", "arcSlug": "overcoming-monster", "beatName": "The Struggle", "beatSlug": "overcoming-monster-the-struggle", "evidence": "The document presents the limitations and side effects of the product", "position": 1, "confidence": 0.8, "parentBeatName": "Development", "parentBeatSlug": "development" } ], "loops": [ { "to": 12, "from": 2, "name": "Pattern Hunter", "slug": "02-pattern-hunter", "bestFor": "Time-pressed audiences, building consensus, when data is strong", "matchId": "6a12c0dc-d6e6-4d39-8050-fac1d309ae4d", "evidence": "The document presents several examples of management's actions contradicting their words", "position": 0, "objective": "To identify patterns in management's actions and words", "structure": "Evidence A -> Evidence B -> Evidence C -> Pattern/Conclusion", "confidence": 0.7, "description": "Group multiple pieces of evidence that together point to a pattern or conclusion" } ], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }