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Post by porkini on Jan 11, 2019 13:21:54 GMT -5
After the peds trial concludes, and Afrezza is approved for peds, the net revenue from scripts will grow exponentially, IMO. They should have started right after approval. Shouldawouldacoulda, c'mon Homer, let it go!
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Post by Thundersnow on Jan 11, 2019 13:24:14 GMT -5
That's true but unfortunately that's a late 2020 event at the earliest.
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Post by mango on Jan 11, 2019 13:33:07 GMT -5
After the peds trial concludes, and Afrezza is approved for peds, the net revenue from scripts will grow exponentially, IMO. They should have started right after approval. Well, their partner Sanofi left them on a deserted island to die. But, good news is is that it's going to wrap up sooner rather than later and it'll all be behind us! đ
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Post by cretin11 on Jan 11, 2019 16:20:14 GMT -5
When is it going to wrap up - Is late 2020 an accurate estimate (doesn't sound like "sooner rather than later")?
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Post by boca1girl on Jan 11, 2019 17:03:22 GMT -5
When is it going to wrap up - Is late 2020 an accurate estimate (doesn't sound like "sooner rather than later")? Yeah, two years away yet. Hopefully early results will be sooooo good, the FDA allows the trials to end early. Hopeium.
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Post by travis1953 on Jan 12, 2019 9:00:38 GMT -5
Is Mannkind still required to do a safety trial for afrezza?
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Post by agedhippie on Jan 12, 2019 11:02:29 GMT -5
Is Mannkind still required to do a safety trial for afrezza? The lung test? Yes.
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Post by sportsrancho on Jan 12, 2019 11:39:30 GMT -5
Is Mannkind still required to do a safety trial for afrezza? The lung test? Yes. But thatâs not likely to happen is it?
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Post by Thundersnow on Jan 12, 2019 13:18:38 GMT -5
I think you're talking about the 5 year Safety Study? I believe the FDA removed that requirement.
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Post by agedhippie on Jan 12, 2019 14:00:43 GMT -5
But thatâs not likely to happen is it? I am not sure. Right now I think that the number of Afrezza users is not high enough for the cost of the trial without it being cost prohibitive. The trial involves tracking 8,000 people and they have to be weighted towards people prone to lung cancer. The same trial also covers the MACE (cardiovascular impact) requirement which is why I think it's unlikely to be waived since all diabetes treatments have a post marketing MACE trial. My suspicion is that the FDA doesn't see this critical, more confirmational, and is letting it slip until there are sufficient patients to make it viable without crippling costs.
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Post by bigchungus91354 on Jan 31, 2019 14:08:08 GMT -5
UTHR Milestones total $50M. 2019 = 2 payments @ $12.5M each 2020 = 2 payments @ $12.5M each Assumption is that payments will be made every 6 months. CJ did not include 2020 payments will get them to Mid 2020. Yes. Mike C. clearly stated in the Jan. 4 conference call that Mannkind is expecting to get $37.5M (which clearly refers to three installments of $12.5M each) in milestone payments from UTHR within the next 18 months (i.e. before mid 2020). Does anyone know what needs to be achieved to receive the 2 2019 UTHR milestones? I have heard people say that they were expected in Q1/Q2, is that from MNKD management or just speculation?
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Post by mnholdem on Jan 31, 2019 18:49:40 GMT -5
The agreement would have this redacted.
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Post by lakers on Feb 2, 2019 11:24:51 GMT -5
United licensed MannKind's dry powder formulation of treprostinil, and has the option to collaborate on additional active pharmaceutical ingredients. United licensed Arena's ralinepag for $950 million, and has the option to create an inhalable formulation for an additional $250 million using MannKindâs Technosphere. MannKind's drug delivery platform will likely be applied to Unitedâs currently approved medications, and compounds in development generating revenues for both companies. www.google.com/amp/s/seekingalpha.com/amp/article/4223623-closer-inspection-collaboration-mannkind-united-therapeuticsOn September 3, 2018, MannKind and United Therapeutics also entered into a research agreement (the âResearch Agreementâ) for the conduct of research by MannKind in connection with multiple potential products, including evaluating the feasibility of preparing a dry powder formulation of a compound within additional classes of active ingredients (outside the scope of the License Agreement) for the treatment of pulmonary hypertension. MannKind received an upfront payment of $10 million in consideration for its performance under the Research Agreement. In addition, United Therapeutics, at its option, may obtain a license to develop, manufacture and commercialize products based on specified compounds within the drug classes covered by the Research Agreement (the âOptionâ). Each specified compound advanced into development and commercialization under such a license would be subject to the payment to MannKind of additional milestone payments of up to $30 million and a low double-digit royalty on net sales of such products. The Research Agreement will terminate in the event that United Therapeutics does not exercise the Option within five years following the date of the Research Agreement, or in the event United Therapeutics exercises the Option and the parties enter into a separate license agreement as contemplated by the Option. United Therapeutics may terminate the Research Agreement without cause upon 30 daysâ prior written notice to MannKind, and either party may terminate the Research Agreement in the event of liquidation, bankruptcy or insolvency of the other party. secfilings.nasdaq.com/filingFrameset.asp?FilingID=12951922&RcvdDate=9/6/2018&CoName=MANNKIND%20CORP&FormType=8-K&View=htmlMilestone A is $12.5 million Milestone B is $12.5 million Milestone C is $12.5 million Milestone D is $12.5 million Milestone E is $15 million Milestone F is $15 million Milestone Payments (A) through (D) shall be made no more than once (and each only upon the first achievement of the corresponding milestone), irrespective of how many Products achieve the corresponding milestone. Milestone Payments (E) and (F) above may be paid more than once (i.e., if there are multiple Optioned Agents), but each shall be paid only once for the first Optioned Product for each Optioned Agent that reaches the corresponding milestone. No unachieved Milestone Payments shall accrue and be due if notice has been given by United Therapeutics for termination of the Agreement seekingalpha.com/article/4218970 A+B+C+D = $50M for Trep-T which may have multiple products. E+F = $30M per first Optioned Product for each Optioned Agent which may spawn multiple products. MC mentioned $37.5 M over 18 mos refered to A+B+C.
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Post by bigchungus91354 on Feb 5, 2019 11:21:11 GMT -5
How? +70m ( current cash) +37.5m (3 uthr milestones) +30m (new uthr molecule) -10m ( r and d for new molecule) -14.2m (2019 amphastar insulin) -13.5m ( 2019 Deerfield debt) -5m ( afrezza milestone to Deerfield). The amph insulin contract needs to be changed. Mike alluded to this in the call. Some of the Deerfield debt needs to be paid down with shares if the stock is trading higher. 2018 Guidance for Net cash used in operating activities was 90m-100m. How much of this do we currently have, and how much are we waiting on receiving? +37.5m (3 uthr milestones) +30m (new uthr molecule) We could also estimate net sales revs of ?? +$400K/week? - ad campaign = ?? $150K/week - burn = $9M/month?
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Post by cjm18 on Feb 5, 2019 12:35:03 GMT -5
How? +70m ( current cash) +37.5m (3 uthr milestones) +30m (new uthr molecule) -10m ( r and d for new molecule) -14.2m (2019 amphastar insulin) -13.5m ( 2019 Deerfield debt) -5m ( afrezza milestone to Deerfield). The amph insulin contract needs to be changed. Mike alluded to this in the call. Some of the Deerfield debt needs to be paid down with shares if the stock is trading higher. 2018 Guidance for Net cash used in operating activities was 90m-100m. How much of this do we currently have, and how much are we waiting on receiving? +37.5m (3 uthr milestones) +30m (new uthr molecule) Â We could also estimate net sales revs of ?? +$400K/week? - ad campaign = ?? $150K/week - burn = $9M/month? We havenât received any of those items in blue. Spencerâs latest article projects we donât make it to next year. It does not include the 30m nor one of the milestone payments.
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