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Nov. 4, 2020 10:45 PM ET | About: MannKind Corporation (MNKD) Q3: 11-04-20 Earnings Summary Press Release EPS of $-0.05 beats by $0.00 Revenue of $15.35M (5.19% Y/Y) misses by $-0.21M Subscribers Only Earning Call Audio MannKind Corporation (NASDAQ:MNKD) Q3 2020 Results Conference Call November 4, 2020 5:00 AM ET
Michael Castagna - CEO
Steven Binder - CFO
Conference Call Participants
Brandon Folkes - Cantor Fitzgerald
Thomas Smith - SVB Leerink
Robert Hazlett - BTIG
Steven Lichtman - Oppenheimer and Company
Good day, everyone. And welcome to the MannKind Corporation Third Quarter 2020 Earnings Call. As a reminder, this call is being recorded on November 4, 2020, and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call until November 18, 2020.
This call will contain forward-looking statements. Such forward-looking statements are subject to risks and uncertainty, which could cause actual results to differ materially from these stated expectations. For further information on the Company?s risk factors, please see their 10-Q report filed with the Securities and Exchange Commission this afternoon, the earnings release and the slides prepared for this presentation.
Joining us today from MannKind are Chief Executive Officer, Michael Castagna; and Chief Financial Officer, Steven Binder.
I would now like to turn the conference over to Mr. Castagna. Please go ahead, sir.
Thanks. And thank you and thank you everyone for dialing in on what appears to be a hectic election -- post-election day here.
So, as we get into the agenda, we?re going to go through our Q3 highlights, the financial review of Steve and Q4 expectations and then a Q&A.
I just want to remind people about our mission, which is really to give people control of their health and the freedom to live life, and we call it, life more humann.
Our technology really helps provide quick relief of patients? symptoms, such as high sugar, pulmonary hypertension, and migraine, almost at the onset of action and being able to correct that with the quick inhalation using our platform. We?re very excited to continue to expand our technology into other assets as we continue to move R&D forward.
I?d also like to announce recent new addition to our team, Dr. Kevin Kaiserman, who now will be our Head of Medical Affairs and Safety. And new week, we expect to also announce a new head of regulatory. Kevin has 25 years of pediatric endocrinology experience, which we felt was very valuable, given our direction to move further into pediatrics in 2021. He is well-respected as a thought leader. He had private practice here in California and was trained at Children?s Hospital of LA. He?ll be leading our medical affairs, expanded field medical team, our safety and our pediatrics program.
Let me talk about a few of the Q3 highlights. Afrezza third quarter net revenue of $7.3 million with 27% ahead of Q3 of 2019. In the U.S., our total prescription grew 8% and sequentially 3% in quarter two. The market was down 3% over -- year-over-year for rapid-acting analogs, and 2% quarter-over-quarter respectively. So, we?re outpacing the market shrinkage and we?re continuing to grow year-over-year, despite the headwinds that COVID-19 presents.
Access is continuing to open up for our field reps reaching customers in the field. Obviously, certain areas of the country are more difficult than others, but our team has done a very decent job given the difficult circumstances they face.
Our U.S. September year-to-date net revenue is $22.1 million or 31% versus 2019 and our trend is starting to pick up nicely in Q4, as we hope to see scripts [ph] up this Friday.
Our United Therapeutics collaboration with TreT remains on track to complete the critical NDA components here in Q4. And we recently received a $1.2 million purchase order for clinical supplies as we get to Q4 in 2021 and beyond.
Our cash at the end of the quarter was $52.7 million and we used $13.5 million in operating activities. We also reduced our debt by $2.6 million in October by prepaying our December promissory note and at schedule.
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WARUM (?) bekommt Ihr das nicht langsam mal in den Griff mit diesen Schmuddelseiten ? Wollt Ihr nicht o. könnt Ihr nicht ??? Das nimmt langsam ein Ausmaß an was nicht mehr akzeptabel ist !!! Ausserdem schadet es der Reputation von ARIVA auf das Äußerste, aber dies werden Sie ja hoffentlich selbst wissen ? MfG K.H.
Jetzt hat UTHR die Zulassung für DPI Tyvaso eingereicht mit der Mannkind Technosphere Technologie, revenues zwischen 50-100 Millionen jährlich winken. Jetzt scheint die Cooperation mit RLS erste Früchte zu tragen, die Technosphere Technologie ermöglicht medizinisches Cannabinoik megaschnell und megakonzentriert medizinisch hochwirksam an den Mann/die Frau zu bringen, das kann schnell zweistellig werden:
Receptor Life Sciences Announces Poster Presentations at the Respiratory Drug Delivery 2021 Conference April 27, 2021 08:00 AM Eastern Daylight Time
SEATTLE--(BUSINESS WIRE)--Receptor Life Sciences (RLS) today announced the acceptance of two posters for presentation at the Respiratory Drug Delivery (RDD 2021) conference. The posters report Cannabidiol (CBD) pharmacokinetics in healthy volunteers following inhalation of RLS103, an investigational inhaled dry powder CBD. RLS103 is being developed for the treatment of acute panic attack in panic disorder and performance anxiety in social anxiety disorder (SAD).
?An Indirect Pharmacokinetic Comparison of Cannabidiol Formulations: Dry Power Inhaled (DPI) vs Vaporization? Tweet this
This pharmacokinetic study demonstrated that RLS103 facilitates immediate CBD delivery to the bloodstream with peak concentrations at 3.8 minutes that are 71-fold greater than oral CBD on a dose-adjusted basis. The overall systemic exposure, adjusted for dose, was 9-fold greater than that following oral administration because inhalation delivery bypasses hepatic first-pass metabolism. RLS103 delivered CBD with an efficiency 7-fold greater than a vaporizer.
?No immediate-acting treatments for these conditions are currently available, so an inhaled CBD, like RLS103, with an ultra-rapid onset, has the potential to address this need in both disorders,? said Andrea Leone-Bay, PhD, Founder and Chief Scientific Officer of Receptor Life Sciences. RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation.
RDD 2021 is the premier international conference for scientists and drug developers focused on pulmonary and nasal drug delivery. This year, RDD is a virtual conference and Receptor?s poster presentations can be viewed online by conference participants between April 27 and June 20.
?Using Inhalation to Bypass First-Pass Metabolism as a Means of Improving Cannabidiol Bioavailability,? Kelly S. Kraft, Orrin Devinsky, Lorraine Rusch, Melanie Fein, and Andrea Leone-Bay; and ?An Indirect Pharmacokinetic Comparison of Cannabidiol Formulations: Dry Power Inhaled (DPI) vs Vaporization,? Andrea Leone-Bay, Orrin Devinsky, Lorraine Rusch, Melanie Fein, and Kelly S. Kraft.
Receptor Life Sciences is a pharmaceutical company that applies FDA-approved drug delivery technologies to develop innovative therapies to address central nervous system disorders that have few safe and effective treatments. Receptor Life Sciences uses these technologies to produce inhaled and oral cannabinoid products that hold the potential to provide precision, consistency, reliability, and convenience. For more information about Receptor Life Sciences, its patented product candidates and its progress toward FDA approval see www.receptorlife.com.
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