Category Archives: Topics

MannKind and Mylan Q1 ’19 Earnings Updates

MannKind and Mylan both hosted their respective Q1 ’19 earnings calls. Of note, Mylan did not discuss its biosimilar insulin programs (including bs-glargine) or bs-glucagon. Below, FENIX provides highlights and insights from the MannKind earnings call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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LY3305677 Lilly’s Oxyntomodulin? New Ph1 Trial Observed

A new Ph1 study of an early Lilly compound has been observed on CT.gov. LY3305677 is believed to be Lilly’s Ph1 injectable oxyntomodulin analog. Recall, in 2016, Lilly opted out of developing the Transition Therapeutics oxyntomodulin analog (TT401; now being developed by OPKO as OPK88003). Below, FENIX provides the rationale for why LY3305677 is likely Lilly’s oxyntomodulin and thoughts on its development in light of tirzepatide (GLP/GIP dual agonist) already moving to Ph3 in both T2DM and obesity.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Novo Q1 ’19 London Earnings Update

Novo Nordisk hosted its post-Q1 ’19 earnings event in London. The session included a brief presentation from management followed by Q&A. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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AZ Triple Combo Approved as Qternmet XR; Qtern Label Update

AstraZeneca announced FDA approval for its triple combination, Qternmet XR (dapagliflozin+saxagliptin+metformin XR), for improvement of glycemic control in patients with T2DM (Qternmet XR FDA label). Additionally, the Qtern label (dapagliflozin+saxagliptin) was updated with 3 notable changes: 1) eGFR cutoff lowered to 45ml/min/1.73m2 which is now consistent with Farxiga, 2) a new 5mg dapa/5mg saxa strength is now available, and 3) the indication no longer requires dapa failure or concurrent use of dapa and saxa. Below, FENIX provides thoughts on the new triple combination FDC and Qtern label updates.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Tresiba Hypo Benefit Over Toujeo; Novo Q1 ’19 Earnings Update

Novo Nordisk hosted its Q1 ’19 earnings call (press release) and provided updates to its diabetes business including the recent oral semaglutide and Ozempic regulatory filings. Of note, Novo reported topline results from the Tresiba vs. Toujeo H2H trial. Below, FENIX provides highlights and insights from the call including thoughts on how the Tresiba vs. Toujeo H2H trial may impact the basal insulin market.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Insulet Q1 ’19 Earnings Update

Insulet hosted its Q1 ’19 earnings call and provided updates to its Omnipod business including the recent launch of the Omnipod Dash PDM as well as development of the Omnipod Horizon hybrid closed-loop. Below are highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Dexcom Q1 ’19 Earnings Update

Dexcom hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, this is believed to be the first time that Dexcom distributed slides as part of an earnings release. Below, FENIX provides highlights and insights from the earnings call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

No Update on Sota CRL Resolution Timeline; Lexicon Q1 ’19 Earnings Update

Lexicon hosted its Q1 ’19 earnings call and briefly discussed the ongoing US regulatory situation for sotagliflozin following the March 22, 2019 CRL. Below, FENIX provides highlights and insights from the call including thoughts on the T2DM submission and approval timeline.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Tandem Q1 ’19 Earnings Update

Tandem hosted its Q1 ’19 earnings call and provided updates to its diabetes business including the Control IQ (hybrid closed-loop) and t:sport (with smartphone control) development programs. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Merck and Pfizer Q1 ’19 Earnings Updates

Merck and Pfizer hosted their respective Q1 ’19 earnings calls. Both companies only briefly discussed their diabetes-related businesses. Below, FENIX provides highlights from the calls.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.