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Post by sla55 on May 1, 2019 15:54:55 GMT -5
United Therapeutics Corporation - FORM 10-Q - For the quarterly period ended March 31, 2019 (page 42)
ir.unither.com/node/25526/htmlWe rely heavily on MannKind for various manufacturing activities related to Treprostinil Technosphere. MannKind has announced that its currently available cash and financing sources are not sufficient to continue to meet its current and anticipated cash requirements, raising substantial doubt about its ability to continue as a going concern. If MannKind is unable to supply us with devices and other components necessary to develop and manufacture Treprostinil Technosphere, the timing and success of this program could be materially adversely impacted. |
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Post by longliner on May 1, 2019 15:57:04 GMT -5
United Therapeutics Corporation - FORM 10-Q - For the quarterly period ended March 31, 2019 (page 42)
ir.unither.com/node/25526/htmlWe rely heavily on MannKind for various manufacturing activities related to Treprostinil Technosphere. MannKind has announced that its currently available cash and financing sources are not sufficient to continue to meet its current and anticipated cash requirements, raising substantial doubt about its ability to continue as a going concern. If MannKind is unable to supply us with devices and other components necessary to develop and manufacture Treprostinil Technosphere, the timing and success of this program could be materially adversely impacted. The kids are digging deep today eh Sla? |
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Post by thekindaguyiyam on May 1, 2019 16:03:12 GMT -5
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Post by goyocafe on May 1, 2019 16:05:09 GMT -5
United Therapeutics Corporation - FORM 10-Q - For the quarterly period ended March 31, 2019 (page 42)
ir.unither.com/node/25526/htmlWe rely heavily on MannKind for various manufacturing activities related to Treprostinil Technosphere. MannKind has announced that its currently available cash and financing sources are not sufficient to continue to meet its current and anticipated cash requirements, raising substantial doubt about its ability to continue as a going concern. If MannKind is unable to supply us with devices and other components necessary to develop and manufacture Treprostinil Technosphere, the timing and success of this program could be materially adversely impacted. Not enough cash to continue operations, but enough for raises and bonuses? Someone help me out here. |
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Post by churchmouse on May 1, 2019 16:12:25 GMT -5
Are you kidding me? "raising substantial doubt about its ability to continue as a going concern." Where are we going to get cash? I just want honest answers from the mgmt.
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Post by mymann on May 1, 2019 16:29:48 GMT -5
They'll probably do another dilution when PPS gets to $1.00.
It like Mannkind Management is a high school football team trying to play in the NFL.
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Post by figglebird on May 1, 2019 16:42:48 GMT -5
I get that many retail investors do not read filings but this is silly.
Wording is UNCHANGED from their last earnings re going concern.
Investing in MANNKIND involves a high degree of risk. They have never been profitable and imply that there is a strong liklihood they may never be profitable.
This is straight forward.
boiler boiler boiler - what is confounding atm is uthrs conflicting dates of phase 3 commencement and 2022 as launch.
I am concerned about when and if we get going w trepostinil ts - but am delighted UTHR trademarked "TREPOSTINIL TECHNOSPHERE"
Obviously Afrezza is not called INSULIN TECHNOSPHERE but the thesis remains that ts is more suited to be a branding agent for DPI mkt than any other.
We may need clarity and specifics on trepostinil ta as this deal feels much bigger for us than them atm
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Post by longliner on May 1, 2019 16:47:58 GMT -5
I get that many retail investors do not read filings but this is silly. Wording is UNCHANGED from their last earnings re going concern. Investing in MANNKIND involves a high degree of risk. They have never been profitable and imply that there is a strong liklihood they may never be profitable. This is straight forward. boiler boiler boiler - what is confounding atm is uthrs conflicting dates of phase 3 commencement and 2022 as launch. I am concerned about when and if we get going w trepostinil ts - but am delighted UTHR trademarked "TREPOSTINIL TECHNOSPHERE" Obviously Afrezza is not called INSULIN TECHNOSPHERE but the thesis remains that ts is more suited to be a branding agent for DPI mkt than any other. We may need clarity and specifics on trepostinil ta as this deal feels much bigger for us than them atm yes, but it gives the kids something to feign outrage over.😂 |
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Post by boytroy88 on May 2, 2019 5:02:11 GMT -5
I get that many retail investors do not read filings but this is silly. Wording is UNCHANGED from their last earnings re going concern. Investing in MANNKIND involves a high degree of risk. They have never been profitable and imply that there is a strong liklihood they may never be profitable. This is straight forward. boiler boiler boiler - what is confounding atm is uthrs conflicting dates of phase 3 commencement and 2022 as launch. I am concerned about when and if we get going w trepostinil ts - but am delighted UTHR trademarked "TREPOSTINIL TECHNOSPHERE" Obviously Afrezza is not called INSULIN TECHNOSPHERE but the thesis remains that ts is more suited to be a branding agent for DPI mkt than any other. We may need clarity and specifics on trepostinil ta as this deal feels much bigger for us than them atm yes, but it gives the kids something to feign outrage over.😂 So nothing to worry about atm? Edit: ok.... Old info... Legal boilerplate... |
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Post by Clement on May 2, 2019 8:46:23 GMT -5
United Therapeutics Corporation - FORM 10-Q - For the quarterly period ended March 31, 2019 (page 42)
ir.unither.com/node/25526/htmlWe rely heavily on MannKind for various manufacturing activities related to Treprostinil Technosphere. MannKind has announced that its currently available cash and financing sources are not sufficient to continue to meet its current and anticipated cash requirements, raising substantial doubt about its ability to continue as a going concern. If MannKind is unable to supply us with devices and other components necessary to develop and manufacture Treprostinil Technosphere, the timing and success of this program could be materially adversely impacted. Sla, thanks for all your posts. Below is a cut-and-paste from the 10K for UTHR year ending December 31, 2018. "We rely heavily on MannKind for various manufacturing activities related to Treprostinil Technosphere. MannKind has announced that its currently available cash and financing sources are not sufficient to continue to meet its current and anticipated cash requirements, raising substantial doubt about its ability to continue as a going concern. If MannKind is unable to supply us with devices and other components necessary to develop and manufacture Treprostinil Technosphere, the timing and success of this program could be materially adversely impacted." ir.unither.com/node/25306/html#dk10401_item_1a._risk_factors |
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Post by kite on May 2, 2019 8:59:27 GMT -5
United Therapeutics Corporation - FORM 10-Q - For the quarterly period ended March 31, 2019 (page 42)
ir.unither.com/node/25526/htmlWe rely heavily on MannKind for various manufacturing activities related to Treprostinil Technosphere. MannKind has announced that its currently available cash and financing sources are not sufficient to continue to meet its current and anticipated cash requirements, raising substantial doubt about its ability to continue as a going concern. If MannKind is unable to supply us with devices and other components necessary to develop and manufacture Treprostinil Technosphere, the timing and success of this program could be materially adversely impacted. Sla, thanks for all your posts. Below is a cut-and-paste from the 10K for UTHR year ending December 31, 2018. "We rely heavily on MannKind for various manufacturing activities related to Treprostinil Technosphere. MannKind has announced that its currently available cash and financing sources are not sufficient to continue to meet its current and anticipated cash requirements, raising substantial doubt about its ability to continue as a going concern. If MannKind is unable to supply us with devices and other components necessary to develop and manufacture Treprostinil Technosphere, the timing and success of this program could be materially adversely impacted." ir.unither.com/node/25306/html#dk10401_item_1a._risk_factorsIt looks like nothing to fret about Buy on the dips  |
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Post by MnkdWASmyRtrmntPlan on May 3, 2019 13:31:50 GMT -5
It is ABSOLUTELY nothing to fret about. That section of the SEC filing is about potential disruptions to their business that they have no control over. Things that its commercial success depends upon. As mentioned by others, that section was copy/pasted from last quarter's document. Just look at the paragraphs before and after it. They also worry about Lilly, Medtronic and Medicare and Medicaid:
* The commercial success of our products depends, in part, on the availability of reimbursements by governmental payers such as Medicare and Medicaid
* Patient assistance programs for pharmaceutical products have come under increasing scrutiny by governments, legislative bodies and enforcement agencies. These activities may result in actions that have the effect of reducing prices or demand for our products, harming our business or reputation, or subjecting us to fines or penalties.
* We rely on Lilly to manufacture and supply Adcirca for us, and we use Lilly’s pharmaceutical wholesaler network to distribute Adcirca. If Lilly is unable to manufacture or supply Adcirca or its distribution network is disrupted, it could delay, disrupt or prevent us from selling Adcirca. In addition, Lilly has the right to determine the price of Adcirca. Changes in the price of Adcirca set by Lilly could adversely impact demand or reimbursement for Adcirca.
* We rely heavily on Medtronic for the success of our program to develop an implantable pump to deliver intravenous Remodulin (the Implantable System for Remodulin). In particular, Medtronic is entirely responsible for regulatory approvals and all manufacturing and quality systems related to its infusion pump and related components. This includes satisfying FDA-imposed PMA conditions prior to launching the Implantable System for Remodulin. Medtronic entered into a consent decree related to the SynchroMed II implantable infusion pump systems. Medtronic’s failure to comply with the ongoing obligations under the consent decree could adversely impact Medtronic’s ability to manufacture and supply the Implantable System for Remodulin. In the event Medtronic is unwilling or unable to supply the system for any reason, our ability to meet patient demand and generate additional revenues will be materially adversely impacted; any delays in supply could also adversely impact our ability to meet patient demand and generate revenues.
* If any of our internal or third-party manufacturing and supply arrangements are interrupted for compliance issues or other reasons, we may not have sufficient inventory to meet future demand. In addition, any change in suppliers and/or service providers could interrupt the manufacturing of our commercial products and impede the progress of our commercial launch plans and clinical trials.
Additional risks we face with our manufacturing strategy include the following:
· We and our third-party manufacturers are subject to the FDA’s current good manufacturing practices regulations, current good tissue practices, and similar international regulatory standards. Our ability to exercise control over regulatory compliance by our third-party manufacturers is limited;
· We may experience difficulty designing and implementing processes and procedures to ensure compliance with applicable regulations as we develop manufacturing operations for new products;
· Natural and man-made disasters (such as fires, contamination, power loss, hurricanes, earthquakes, flooding, terrorist attacks and acts of war) impacting our internal and third-party manufacturing sites could cause a supply disruption — for example, Medtronic manufactures the Implantable System for Remodulin at its facilities in Puerto Rico, which is vulnerable to hurricanes;
· Even if we and our third-party manufacturers comply with applicable drug manufacturing regulations, the sterility and quality of our products could be substandard and such products could not be sold or used or subject to recalls;
· If we had to replace our own manufacturing operations or a third-party manufacturer, the FDA and its international counterparts would require new testing and compliance inspections. Furthermore, a new manufacturer would have to be familiarized with the processes necessary to manufacture and commercially validate our products, as producing our treprostinil-based and biologic products is complex;
· We may be unable to contract with needed manufacturers on satisfactory terms or at all; and
· The supply of materials and components necessary to manufacture and package our products may become scarce or unavailable, which could delay the manufacturing and subsequent sale of such products. Products manufactured with substituted materials or components must be approved by the FDA and applicable international regulatory agencies before they could be sold.
Jeesh! ... They also face the risk that their CEO may get struck by lightening!
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Post by mike0475 on May 3, 2019 13:44:16 GMT -5
It is ABSOLUTELY nothing to fret about. That section of the SEC filing is about potential disruptions to their business that they have no control over. Things that its commercial success depends upon. As mentioned by others, that section was copy/pasted from last quarter's document. Just look at the paragraphs before and after it. They also worry about Lilly, Medtronic and Medicare and Medicaid: * The commercial success of our products depends, in part, on the availability of reimbursements by governmental payers such as Medicare and Medicaid * Patient assistance programs for pharmaceutical products have come under increasing scrutiny by governments, legislative bodies and enforcement agencies. These activities may result in actions that have the effect of reducing prices or demand for our products, harming our business or reputation, or subjecting us to fines or penalties. * We rely on Lilly to manufacture and supply Adcirca for us, and we use Lilly’s pharmaceutical wholesaler network to distribute Adcirca. If Lilly is unable to manufacture or supply Adcirca or its distribution network is disrupted, it could delay, disrupt or prevent us from selling Adcirca. In addition, Lilly has the right to determine the price of Adcirca. Changes in the price of Adcirca set by Lilly could adversely impact demand or reimbursement for Adcirca. * We rely heavily on Medtronic for the success of our program to develop an implantable pump to deliver intravenous Remodulin (the Implantable System for Remodulin). In particular, Medtronic is entirely responsible for regulatory approvals and all manufacturing and quality systems related to its infusion pump and related components. This includes satisfying FDA-imposed PMA conditions prior to launching the Implantable System for Remodulin. Medtronic entered into a consent decree related to the SynchroMed II implantable infusion pump systems. Medtronic’s failure to comply with the ongoing obligations under the consent decree could adversely impact Medtronic’s ability to manufacture and supply the Implantable System for Remodulin. In the event Medtronic is unwilling or unable to supply the system for any reason, our ability to meet patient demand and generate additional revenues will be materially adversely impacted; any delays in supply could also adversely impact our ability to meet patient demand and generate revenues. * If any of our internal or third-party manufacturing and supply arrangements are interrupted for compliance issues or other reasons, we may not have sufficient inventory to meet future demand. In addition, any change in suppliers and/or service providers could interrupt the manufacturing of our commercial products and impede the progress of our commercial launch plans and clinical trials. Additional risks we face with our manufacturing strategy include the following: · We and our third-party manufacturers are subject to the FDA’s current good manufacturing practices regulations, current good tissue practices, and similar international regulatory standards. Our ability to exercise control over regulatory compliance by our third-party manufacturers is limited; · We may experience difficulty designing and implementing processes and procedures to ensure compliance with applicable regulations as we develop manufacturing operations for new products; · Natural and man-made disasters (such as fires, contamination, power loss, hurricanes, earthquakes, flooding, terrorist attacks and acts of war) impacting our internal and third-party manufacturing sites could cause a supply disruption — for example, Medtronic manufactures the Implantable System for Remodulin at its facilities in Puerto Rico, which is vulnerable to hurricanes; · Even if we and our third-party manufacturers comply with applicable drug manufacturing regulations, the sterility and quality of our products could be substandard and such products could not be sold or used or subject to recalls; · If we had to replace our own manufacturing operations or a third-party manufacturer, the FDA and its international counterparts would require new testing and compliance inspections. Furthermore, a new manufacturer would have to be familiarized with the processes necessary to manufacture and commercially validate our products, as producing our treprostinil-based and biologic products is complex; · We may be unable to contract with needed manufacturers on satisfactory terms or at all; and · The supply of materials and components necessary to manufacture and package our products may become scarce or unavailable, which could delay the manufacturing and subsequent sale of such products. Products manufactured with substituted materials or components must be approved by the FDA and applicable international regulatory agencies before they could be sold. Jeesh! ... They also face the risk that their CEO may get struck by lightening! Or hit by a satelite |
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Post by mytakeonit on May 3, 2019 13:53:57 GMT -5
Did it mention climbing over a guard rail and falling 70 feet into a 300 foot caldera? Better add it in ... because it does happen ... to people visiting Hawaii. Tourist !
But, that's mytakeonit
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Post by liane on May 3, 2019 17:57:20 GMT -5
Did it mention climbing over a guard rail and falling 70 feet into a 300 foot caldera? Better add it in ... because it does happen ... to people visiting Hawaii. Tourist ! But, that's mytakeonit Just saw that on the news. They should have left him to the volcano gods. |
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