Tag Archives: Lilly

Lilly Q3 ’19 Earnings Update; Conterno to Retire

Lilly hosted its Q3 ’19 earnings call (press release) and provided updates across its diabetes business. In a separate press release, Lilly disclosed that its current senior vice president of Lilly and president of Lilly Diabetes and Lilly USA, Enrique Conterno, will be retiring at the end of the year. Mike Mason, current SVP of Connected Care and Insulins, will succeed Conterno. During the earnings call, Lilly also highlighted Ph1 development of its triple-agonist and oral GLP-1 non-peptide agonist, Jardiance LCM, the recent positive CHMP opinion for Baqsimi, and Trulicity pricing dynamics. Below, FENIX provides context and insights from the call.

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Jardiance T1DM Adcom Scheduled for Nov 13

FDA has requested an advisory committee on November 13, 2019 to discuss the use of empagliflozin in T1DM. Of note, the empa T1DM adcom appears to be part of a 2-day adcom with Amarin’s REDUCE-IT which is scheduled for November 14. As always, FENIX will provide full coverage and analysis of the adcom. Below, FENIX provides brief thoughts on the empa T1DM adcom including hypotheses as to why the empa T1DM review has progressed to an adcom while Lexicon and AZ received CRLs for sota and dapa, respectively.

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REWIND Receives Positive CHMP Opinion

Lilly announced that CHMP issued a positive opinion for a Trulicity CV indication based on results from the REWIND CVOT. Below, FENIX provides thoughts on the impending Trulicity EU label update as well as potential readthrough to the ongoing FDA regulatory review.

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Xeris Glucagon Approved by FDA; Investors Appear Unimpressed

Xeris Pharmaceuticals announced FDA approval of its Gvoke pre-filled syringe (PFS) and auto-injector for hypoglycemia rescue in patients 2 years of age and older. Xeris held an associated call with investors following the approval announcement. The approval comes exactly 3-months after the PDUFA delay imposed by FDA. Below, FENIX provides an in-depth Gvoke label analysis in the context of the recent approval of Lilly’s nasal glucagon, Baqsimi.

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New Novo Insulin Savings Program

Novo Nordisk announced plans to initiate a new US insulin savings program starting on January 2, 2020. Under the new plan, Novo will offer a $99 Cash Card Program for a select volume of any of its insulin analog products as well as the launch of NovoLog and NovoLog Mix Authorized Generics (AG). Below, FENIX provides thoughts on the New Novo insulin program in the context of similar programs by Lilly and Sanofi.

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More Thoughts from DAPA-HF… Could Novo+Lexicon Really Happen?

With the historic results of DAPA-HF recently presented at ESC 2019, FENIX provided some initial reaction. Today, FENIX continues to think about additional market possibilities and implications inside and outside SGLT2i dynamics in a winners-and-losers analysis format.

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Lilly Wins in Arbitration with Adocia

Lilly announced that an arbitration panel ruled in favor of Lilly with regard to a claim filed by Adocia over the former partnership between the two companies. The panel decided that Lilly is not liable to pay damages. Adocia issued its own statement and held a subsequent call with investors in which it disagreed with the findings of the panel. Below, FENIX provides additional commentary from Adocia and insights into the future potential of the Adocia’s BioChaperone franchise.

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Final Tirzepatide Pivotal Trial Initiated (SURPASS-5 add-on to basal insulin)

Lilly has initiated SURPASS-5 (add-on to glargine) which is the 5th and final tirzepatide pivotal Ph3 trial for T2DM. Below, FENIX provides an overview of SURPASS-5 as well as insight into why the study is likely using background glargine U100 and not all basal insulins as well as a high-level comparison between SURPASS-5 and the Trulicity AWARD-9 study.

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