{
  "docId": "019dd923-622c-750b-8b9a-21918ac10c17",
  "docSlug": "f3db2294dcf9",
  "documentTitle": "Harmony Biosciences (HRMY)",
  "authorId": "58_Scorpion_Capital",
  "authorName": "Scorpion Capital",
  "documentKindSlug": "research-note",
  "documentKindLabel": "Research note",
  "sourceTypeSlug": "short_seller",
  "sourceTypeLabel": "Short seller",
  "presentationDate": "2023-03-28 00:00:00",
  "orientation": "landscape",
  "aspectRatio": 1.3333334,
  "pageNumber": 179,
  "pageCount": 366,
  "prevPage": 178,
  "nextPage": 180,
  "slideType": "appendix_methodology",
  "function": "quantify_opportunity",
  "density": "dense",
  "nDataPoints": 12,
  "notes": "The slide uses a 'back-of-the-envelope' calculation to argue that reported adverse events are undercounted.",
  "elementsJson": [
    "paragraph",
    "headline_text",
    "bar_chart_vertical",
    "footnote"
  ],
  "metadataConfidence": 0.95,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/179",
  "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-179",
  "components": [
    {
      "bbox": null,
      "kind": "callout",
      "text": "Nonetheless, despite the imprecise methodology, it would be unusual for the number of case reports to fall sharply in 2021/2022 with patient counts spiking, suggesting the true figure is multiples higher.",
      "attrs": null,
      "subkind": null,
      "toolName": "Visual emphasis",
      "toolSlug": "visual-emphasis",
      "confidence": null,
      "componentId": "019dd953-64d0-7099-9cd7-b0d9cb153c83",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.25,
        "w": 0.61,
        "x": 0.07,
        "y": 0.66
      },
      "kind": "chart",
      "text": "Serious Adverse Events in FDA FAERS Database Counted By \"Event Date\"",
      "attrs": null,
      "subkind": "bar-vertical",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "40448b4d-8aaa-4dbf-b981-d2c1b02f80e5",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "metric",
      "text": "adverse event reports: 1,900",
      "attrs": null,
      "subkind": "primary",
      "toolName": "Quantification",
      "toolSlug": "quantification",
      "confidence": null,
      "componentId": "019dd953-64d0-7099-9cd7-b423cf6ff21a",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.55,
        "w": 0.86,
        "x": 0.07,
        "y": 0.07
      },
      "kind": "paragraph",
      "text": "One can correct and estimate the number of actual adverse event reports in 2021 and 2022 using several methods. For example, total revenue in 2019 and 2020 (almost all in 2020) was ~$165MM. Using an average drug price of $150K/year yields ~1,100 patient years on drug with 415 adverse events during that period. A similar estimate across 2021/2022 yields 4,800 patient years, about 4.5X higher, which would imply 1,900 adverse event reports. The 4.5X factor likely overstates the number, as 2019 included patients in the expanded access program who were presumably not counted as revenue, and some of the events occurred in Europe. Nonetheless, despite the imprecise methodology, it would be unusual for the number of case reports to fall sharply in 2021/2022 with patient counts spiking, suggesting the true figure is multiples higher. We see a similar falloff although not as drastic, regarding the 137 of the 602 adverse events that are classified as serious, indicating that those are too likely substantially higher. We note that we are only estimating case reports to the FDA, not the actual number of adverse events, of which only a small fraction are typically reported.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "cffd7577-c54c-47b9-aea5-7a524df24592",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.05,
        "w": 0.65,
        "x": 0.07,
        "y": 0.93
      },
      "kind": "source-note",
      "text": "Source: FDA FAERS database for Wakix; pitolisant; pitolisant hydrochloride; Scorpion Capital analysis and estimates; for events where event date field is blank, we used the \"initial FDA received date\" as a reasonable proxy",
      "attrs": null,
      "subkind": null,
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "dbbb1f60-f427-451f-a04f-31ed59bce531",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.03,
        "w": 0.55,
        "x": 0.07,
        "y": 0.61
      },
      "kind": "title",
      "text": "Serious adverse events by event date in FDA FAERS database",
      "attrs": null,
      "subkind": "headline",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "14c3f3a2-6d2a-45b7-a347-0795fc6364c8",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [],
  "frameworks": [
    {
      "name": "causal-chain",
      "slug": null,
      "matchId": "a7e0ff34-012d-4624-b54d-2363362d8352",
      "evidence": "The slide links revenue to patient years to adverse event reports to argue for underreporting.",
      "confidence": 0.8
    }
  ],
  "arcBeats": [],
  "loops": [],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}