1、M IdeaHims&Hers Health Inc|North AmericaMapping the legal landscape for Compounding Pharmacies post GLP-1 shortageFollowing the partnership termination by Novo,a bear-case narrative for HIMS has resurfaced.We map the legal landscape spearheaded by Eli Lilly against compounders and provide insight fr

2、om the Allergan vs.Imprimis ruling.Expect these developments to be an overhang on the stock into Q2 earnings.Post the tirzepatide shortage,Lilly has initiated a flurry of lawsuits against compounders who claim to offer personalized tirzepatide under 503A.As shown in Exhibit 1,the causes of action fo

3、r these lawsuits are largely the same or substantially similar,and they involve both state law and the Federal law.In addition,the remedy requests are largely the same or substantially similar,involving preliminary and permanent injunctions,as well as monetary damages(e.g.,profits,compensatory damag

4、es).Furthermore,these lawsuits have been filed in only three jurisdictions:Delaware,New Jersey and California.Presently,the compounders are asking the Court to dismiss the cases,but we think it is more important to watch whether Lilly will file a request for preliminary injunction.As we discussed in

5、 a prior note HERE,Section 503A of the Food,Drug&Cosmetic Act(FDC Act)permits personalized compounding when a drug is not on FDAs shortage list,but there are constraints.These lawsuits should help to define the size of personalized GLP1 compounding market.As a countermeasure,Empower seeks to invalid

6、ate tirzepatides composition-of-matter patent(US9,474,780)at the Patent Trial and Appeal Board(PTAB).We note Empower has not challenged the other Orange Book patents for LLYs Mounjaro/Zepbound.For background,the PTAB is akin to a quality control unit within the United States Patent and Trademark Off