{ "docId": "019dd923-622c-750b-8b98-e0497bacd3c2", "docSlug": "44aa04154472", "documentTitle": "Align Technology, Inc. (ALGN)", "authorId": "54_Spruce_Point_Capital", "authorName": "Ben Axler", "documentKindSlug": "activist-deck", "documentKindLabel": "Activist deck", "sourceTypeSlug": "short_seller", "sourceTypeLabel": "Short seller", "presentationDate": "2020-04-09 00:00:00", "orientation": "landscape", "aspectRatio": 1.3333334, "pageNumber": 11, "pageCount": 84, "prevPage": 10, "nextPage": 12, "slideType": "expose_contradiction", "function": "expose_gap", "density": "overcrowded", "nDataPoints": 54, "notes": "Includes a screenshot of an FDA database search and a bar chart showing the acceleration of approvals.", "elementsJson": [ "headline_text", "paragraph", "screenshot", "bar_chart_vertical", "callout_box", "quote_block" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b98-e0497bacd3c2/11", "deckHref": "/decks/019dd923-622c-750b-8b98-e0497bacd3c2", "deckJsonHref": "/decks/019dd923-622c-750b-8b98-e0497bacd3c2.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b98-e0497bacd3c2#slide-11", "components": [ { "bbox": { "h": 0.1, "w": 0.16, "x": 0.82, "y": 0.74 }, "kind": "callout", "text": "On pace for ~18 more approvals for remainder of 2020", "attrs": null, "subkind": "primary", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "738da12d-6783-49d7-924d-a3494b2dc73b", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "callout", "text": "Spruce Point believes that, with so many now obtaining FDA approvals, third-party labs are, as a whole, quickly achieving the scale and credibility necessary to pose a serious threat to established clear aligner producers.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-0391-77f4-a9e2-f49867d92666", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.41, "w": 0.53, "x": 0.45, "y": 0.28 }, "kind": "chart", "text": "FDA 510(k) Approvals for Clear Aligner Production", "attrs": null, "subkind": "bar-vertical", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "955e08c7-9802-4cb8-a627-c2b5c609d42b", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.41, "w": 0.42, "x": 0.02, "y": 0.28 }, "kind": "image", "text": "FDA 510(k) Premarket Notification database search results", "attrs": null, "subkind": "screenshot", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "d928f40d-7c6b-4fee-9e49-b4a88f4940df", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "metric", "text": "FDA 510(k) approvals: 33", "attrs": null, "subkind": "primary", "toolName": "Quantification", "toolSlug": "quantification", "confidence": null, "componentId": "019dd953-0391-77f4-a9e2-fca029ae6acb", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.11, "w": 0.96, "x": 0.02, "y": 0.87 }, "kind": "paragraph", "text": "To the extent that investors are at all aware of the presence of third-party 3D printing labs in the clear aligner space, they have likely been conditioned to treat them as extremely minor players with limited scale and/or limited credibility among doctors. Spruce Point believes that, with so many now obtaining FDA approvals, third-party labs are, as a whole, quickly achieving the scale and credibility necessary to pose a serious threat to established clear aligner producers.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "a8454d51-0cea-4819-8271-7f6797f56371", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.11, "w": 0.96, "x": 0.02, "y": 0.16 }, "kind": "paragraph", "text": "More informed investors may have been aware of the presence of third-party 3D printing labs in the clear aligner space in prior years. Until now, however, they have been only very minor players, as only one or two new producers were granted FDA 510(k) approvals for printing clear aligners in most years prior to 2018. However, since 2018, 33 new producers have been approved by the FDA to print clear aligners – more than those cleared in all years leading up to 2018 combined – and we are currently on pace to see more than 18 new approvals through the rest of 2020.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "b3128753-a032-4606-873b-30a95b594c43", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.14, "w": 0.36, "x": 0.45, "y": 0.72 }, "kind": "quote", "text": "We are at the point where we can switch to another clear aligner vendor and we would not have even entertained that two years ago... There are over 100 aligner companies coming out of Asia. Two to three years from now, I don't see how Invisalign will see the same amount of cases that they had in the past.", "attrs": null, "subkind": "testimonial", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "0f2ce84e-fd11-407a-97e5-4a9d27cb17af", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.14, "w": 0.42, "x": 0.02, "y": 0.72 }, "kind": "quote", "text": "You can setup a clear aligner FDA approved lab in less than a year. Your capital equipment costs between buying three [high-volume] 3D printers and thermoforming machines can be less than $100K to get started. If you add in labor, your total costs in your first year will be less than $200K.", "attrs": null, "subkind": "testimonial", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "8a55fd08-9b6d-4928-bf25-0c662f6ae600", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "\"You can setup a clear aligner FDA approved lab in less than a year. Your capital equipment costs between buying three [high-volume] 3D printers and thermoforming machines can be less than $100K to get started. If you add in labor, your total costs in your first year will be less than $200K.\" — Senior Employee, Major Dental Equipment Supplier; \"We are at the point where we can switch to another clear aligner vendor and we would not have even entertained that two years ago... There are over 100 aligner companies coming out of Asia. Two to three years from now, I don't see how Invisalign will see the same amount of cases that they had in the past.\" — Dentist, DSO", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-0391-77f4-a9e2-fabc9b5a63ff", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.08, "w": 0.65, "x": 0.31, "y": 0.03 }, "kind": "title", "text": "FDA Approvals For Clear Aligner Production Are Accelerating Rapidly", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "20e4ffd4-35f9-4d12-a95c-55742b8b5501", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [ { "name": "fraud-exposure", "slug": null, "matchId": "d6bedad2-2cd4-494c-a191-19091c5d69cb", "evidence": "Exposing the contradiction between market perception of minor players and the reality of rapid FDA approval growth.", "confidence": 0.85 } ], "arcBeats": [ { "to": 40, "from": 11, "beatId": "d000155d-5ed4-42d9-a121-e365864b1747", "arcName": "Problem-Agitate-Solution", "arcSlug": "problem-agitate-solution", "beatName": "Agitate (Make it worse)", "beatSlug": "problem-agitate-solution-agitate-make-it-worse", "evidence": "The document presents a detailed analysis of the challenges facing Align Technology, including increasing competition, eroding proprietary advantages, and pandemic-related risks.", "position": 1, "confidence": 0.8, "parentBeatName": "Development", "parentBeatSlug": "development" } ], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }