1. WESTLAKE VILLAGE, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will present at the H.C. Wainwright Global Life Sciences Conference which will be available on demand starting on March 9, 2021 at 7:00 am (ET). Interested parties can access a link to the on demand webcast of the presentation from the Events & Presentations section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation

    WESTLAKE VILLAGE, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will present at the H.C. Wainwright Global Life Sciences Conference which will be available on demand starting on March 9, 2021 at 7:00 am (ET). Interested parties can access a link to the on demand webcast of the presentation from the Events & Presentations section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  Afrezza is also available by prescription in Brazil where it is commercialized by the Company's partner Biomm SA. MannKind is headquartered in Westlake Village, California, and has a state-of-the-art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:

    818-661-5000



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  2. WESTLAKE VILLAGE, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced the pricing of $200.0 million aggregate principal amount of 2.50% Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). MannKind also granted the initial purchasers of the notes an option to purchase, within a 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $30.0 million aggregate principal amount of notes. The sale of the notes is expected to close on March 4, 2021, subject to customary closing conditions.

    WESTLAKE VILLAGE, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced the pricing of $200.0 million aggregate principal amount of 2.50% Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). MannKind also granted the initial purchasers of the notes an option to purchase, within a 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $30.0 million aggregate principal amount of notes. The sale of the notes is expected to close on March 4, 2021, subject to customary closing conditions.

    The notes will be general unsecured obligations of MannKind and will accrue interest at a rate of 2.50% per annum, payable semiannually in arrears on March 1 and September 1 of each year, beginning on September 1, 2021. The notes will mature on March 1, 2026, unless earlier converted, redeemed or repurchased.

    Before December 1, 2025, holders will have the right to convert their notes only upon the occurrence of certain events. From and after December 1, 2025, until the close of business on the business day immediately preceding the maturity date, holders will have the right to convert all or any portion of their notes at their election. Upon conversion, MannKind will pay or deliver, as the case may be, cash, shares of MannKind's common stock or a combination of cash and shares of MannKind's common stock, at its election. The initial conversion rate is 191.8281 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $5.21 per share of common stock. The initial conversion price represents a premium of approximately 30% over the last reported sale of $4.01 per share of MannKind's common stock on March 1, 2021. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events.



    MannKind may not redeem the notes prior to March 6, 2024. MannKind may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on or after March 6, 2024 and prior to the 36th scheduled trading day immediately preceding the maturity date, if the last reported sale price of MannKind's common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which MannKind provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

    If a "fundamental change" (as defined in the indenture for the notes) occurs, then, subject to limited exceptions, holders may require MannKind to repurchase their notes for cash. The repurchase price would be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

    MannKind estimates that the net proceeds from the offering will be approximately $193.8 million (or approximately $222.9 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers' discounts and commissions and estimated offering expenses. MannKind intends to use the net proceeds from this offering for working capital and other general corporate purposes, including a Phase 3 clinical trial of Afrezza in pediatric subjects and further development of product candidates in MannKind's pipeline. MannKind may also use a portion of the proceeds from this offering to pay down a portion of existing debt or for acquisitions or strategic investments in complementary businesses or technologies, although MannKind does not currently have any plans for any such debt repayment, acquisitions or investments.



    The notes and any shares of MannKind's common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.



    This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

    About MannKind Corporation 

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  Afrezza is also available by prescription in Brazil where it is commercialized by the Company's partner Biomm SA.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding the anticipated completion and timing of the offering and MannKind's expected use of proceeds from the offering. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, market conditions, whether MannKind will be able to satisfy closing conditions related to the proposed offering, unanticipated uses of capital, and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



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  3. WESTLAKE VILLAGE, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that it intends to offer, subject to market conditions and other factors, $150.0 million aggregate principal amount of Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). MannKind also intends to grant the initial purchasers of the notes an option to purchase, within a 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $22.5 million aggregate principal amount of notes.

    The notes will be general unsecured obligations…

    WESTLAKE VILLAGE, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that it intends to offer, subject to market conditions and other factors, $150.0 million aggregate principal amount of Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). MannKind also intends to grant the initial purchasers of the notes an option to purchase, within a 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $22.5 million aggregate principal amount of notes.

    The notes will be general unsecured obligations of MannKind and will accrue interest payable semiannually in arrears. Upon conversion, MannKind will pay or deliver, as the case may be, cash, shares of MannKind's common stock or a combination of cash and shares of MannKind's common stock, at its election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.



    MannKind intends to use the net proceeds from this offering for working capital and other general corporate purposes, including a Phase 3 clinical trial of Afrezza in pediatric subjects and further development of product candidates in MannKind's pipeline. MannKind may use a portion of the proceeds from this offering to pay down a portion of existing debt or for acquisitions or strategic investments in complementary businesses or technologies, although MannKind does not currently have any plans for any such debt repayment, acquisitions or investments.



    The notes and any shares of MannKind's common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.



    This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

    About MannKind Corporation 

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  Afrezza is also available by prescription in Brazil where it is commercialized by the Company's partner Biomm SA.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding the anticipated terms of the proposed offering and MannKind's expected use of proceeds from the proposed offering. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, market conditions, MannKind's ability to complete the proposed offering on the expected terms, or at all, whether MannKind will be able to satisfy closing conditions related to the proposed offering, unanticipated uses of capital, and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



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  4. Conference Call to Begin Today at 9:00 AM ET

    • 4Q 2020 Afrezza Net Revenue of $10.1 million; +30% vs. 4Q 2019
            Sequential Quarter Growth +38% vs. 3Q 2020
    • 2020 Total Revenues of $65.1 million
           • 2020 Afrezza Net Revenue of $32.3 million; +28% vs. 2019
            2020 Afrezza Gross Profit $17.2 million; 53% Gross Margin
    • $67.2 million of Cash, Cash Equivalents and Restricted Cash at December 31, 2020
    • Acquired QrumPharma Inc. for $12.8 million in cash and stock
    • Entered into an agreement to co-promote Thyquidity beginning 1Q 2021

    WESTLAKE VILLAGE, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the fourth quarter and full year ended December 31, 2020.

    "Our fourth quarter produced…

    Conference Call to Begin Today at 9:00 AM ET

    • 4Q 2020 Afrezza Net Revenue of $10.1 million; +30% vs. 4Q 2019

            Sequential Quarter Growth +38% vs. 3Q 2020
    • 2020 Total Revenues of $65.1 million

           • 2020 Afrezza Net Revenue of $32.3 million; +28% vs. 2019

            2020 Afrezza Gross Profit $17.2 million; 53% Gross Margin
    • $67.2 million of Cash, Cash Equivalents and Restricted Cash at December 31, 2020
    • Acquired QrumPharma Inc. for $12.8 million in cash and stock
    • Entered into an agreement to co-promote Thyquidity beginning 1Q 2021

    WESTLAKE VILLAGE, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the fourth quarter and full year ended December 31, 2020.

    "Our fourth quarter produced exceptional results, with $10.1 million in Afrezza net revenue and positive clinical data for Tyvaso DPI from the BREEZE study conducted by United Therapeutics," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "UT also announced their plan to submit a new drug application for Tyvaso DPI to the FDA in April 2021. During the fourth quarter, we solidified our new direction with the acquisition of QrumPharma, which added a nebulized version of clofazimine to our pipeline of therapies for orphan lung diseases, and we entered into a collaboration agreement with Vertice for the co-promotion of Thyquidity, which is indicated for hyperthyroidism and is expected to expand our reach into endocrine diseases."

    Fourth Quarter 2020 Results

    Total revenues were $18.4 million for the fourth quarter of 2020, reflecting Afrezza net revenue of $10.1 million and collaborations and services revenue of $8.4 million. Afrezza net revenue increased 30% compared to $7.8 million in the fourth quarter of 2019, primarily driven by higher product demand with a more favorable mix of Afrezza cartridges and more favorable gross-to-net deductions. Collaborations and services revenue increased $0.2 million compared to the fourth quarter of 2019.

    Afrezza gross profit for the fourth quarter of 2020 was $6.4 million compared to $3.1 million in the same period of 2019, an increase of $3.3 million, or 105%, that was driven by a combination of increased Afrezza revenue and a reduction in cost of goods sold.

    In-process research and development expense for the fourth quarter of 2020 was $13.2 million, reflecting the acquisition of QrumPharma for approximately $12.8 million in total consideration and approximately $0.4 million in transaction costs. The acquisition of QrumPharma was accounted for as an asset acquisition and expensed on the date of acquisition as substantially all of the fair value of the assets acquired was concentrated in a single asset that consisted of in-process research and development in a pre-clinical development state.

    Research and development expenses for the fourth quarter of 2020 were $1.5 million compared to $2.0 million for the fourth quarter of 2019. This decrease was mainly related to lower clinical trial spending.

    Selling, general and administrative expenses for the fourth quarter of 2020 were $17.1 million compared to $15.7 million for the fourth quarter of 2019. This increase of $1.4 million, or 9%, was primarily attributable to a $1.2 million increase in personnel costs related to the expansion of our sales and medical field force.

    During the fourth quarter of 2020, loss on foreign currency translation for insulin purchase commitments, which are denominated in Euros, was $4.0 million compared to $2.6 million for the fourth quarter of 2019.  The fluctuation was due to a change in the U.S. dollar to Euro foreign exchange rate.

    Interest expense on debt for the fourth quarter of 2020 was $2.4 million compared to $2.3 million for the fourth quarter of 2019.

    The net loss for the fourth quarter of 2020 was $26.4 million, or $0.11 per share, compared to $14.3 million in the fourth quarter of 2019, or $0.07 per share. The increase in the net loss of $12.1 million was primarily due to the write-off of in-process research and development related to the acquisition of QrumPharma. On a non-GAAP basis, excluding the expense incurred for the acquisition of QrumPharma, the net loss for the fourth quarter of 2020 was $13.2 million, or $0.06 per share.

    Twelve Months Ended December 31, 2020

    Total revenues were $65.1 million for the year ended December 31, 2020, reflecting Afrezza net revenue of $32.3 million and collaborations and services revenue of $32.8 million. Afrezza net revenue increased 28% compared to $25.3 million for the year ended December 31, 2019, primarily driven by higher product demand with a more favorable mix of Afrezza cartridges, a price increase and more favorable gross-to-net deductions, all of which was partially offset by a reduction in sales to Biomm (Brazil). Collaborations and services revenue decreased $4.9 million compared to the full year ended December 31, 2019, primarily driven by a $5.8 million decrease in revenue recognized from the UT Research Agreement, which was substantially completed in the second quarter of 2019.

    Afrezza gross profit was $17.2 million for the year ended December 31, 2020, an increase of $12.0 million, or 230%, compared to a gross profit of $5.2 million in the same period in 2019, primarily due higher commercial product sales combined with a reduction in cost of goods sold.



    In-process research and development expense for the year ended December 31, 2020 was $13.2 million, reflecting the research and development acquired and expensed from the acquisition of QrumPharma for approximately $12.8 million in total consideration and approximately $0.4 million in transaction costs.

    Research and development expenses for the year ended December 31, 2020 were $6.2 million compared to $6.9 million for the year ended December 31, 2019. This decrease of $0.7 million, or 9%, was primarily attributable to lower clinical trial spending.

    Selling, general and administrative expenses for the year ended December 31, 2020 were $59.0 million compared to $74.7 million for the year ended December 31, 2019. This decrease of $15.6 million, or 21%, was primarily attributable a $9.3 million decrease in costs for television advertising for Afrezza, a $4.1 million decrease in promotional and marketing activities in response to the COVID-19 pandemic and a $2.5 million decrease in professional fees.

    An impairment of $1.9 million was recognized for the year ended December 31, 2020 on a commitment asset and debt issuance costs related to future funding commitments of the MidCap Credit Facility. There were no asset impairments for the year ended December 31, 2019.

    For the year ended December 31, 2020, foreign currency translation for insulin purchase commitments, which are denominated in Euros, resulted in a loss of $8.0 million compared to a gain of $1.9 million for the year ended December 31, 2019. The fluctuation was due to a change in the U.S. dollar to Euro foreign exchange rate.

    Interest expense on debt for the year ended December 31, 2020 was $9.5 million compared to $10.9 million for the year ended December 31, 2019. This $1.4 million decrease was primarily attributable to a $3.4 million milestone obligation to Deerfield that was achieved in the third quarter of 2019 and a decrease of $0.8 million of interest expense related to the Deerfield Credit Facility, which was extinguished in the third quarter of 2019. This decrease was partially offset by an increase in interest expense from the MidCap Credit Facility of $2.3 million and an increase in interest expense from our Mann Group promissory notes of $0.6 million in 2020.

    The net loss for the year ended December 31, 2020 was $57.2 million, or $0.26 per share, compared to $51.9 million net loss for the year ended December 31, 2019, or $0.27 per share. The higher net loss was mainly attributable to the write-off of in-process research and development related to the acquisition of QrumPharma and a loss on foreign currency translation related to insulin purchase commitments denominated in Euros, offset by a decrease in selling, general and administrative expenses. On a non-GAAP basis, excluding the expense incurred for the acquisition of QrumPharma, the net loss for the year ended December 31, 2020 was $44.0 million, or $0.20 per share.

    Cash, cash equivalents, restricted cash, and short-term investments at December 31, 2020 was $67.2 million compared to $50.2 million at December 31, 2019.

    Debt Reductions Subsequent to December 31, 2020

    Pursuant to the terms of the senior convertible notes, the Company forced the conversion of all $5.0 million in principal of such notes into 1,666,667 shares of the Company's common stock.

    In addition, the Mann Group converted $9.6 million of principal and $0.4 million of accrued interest on its convertible promissory note into 4.0 million shares of the Company's common stock. As of the date hereof, $53.4 million in principal remains outstanding under the promissory notes held by the Mann Group ($18.4 of which is convertible).

    Sale-Leaseback of the Danbury Manufacturing Facility

    Subsequent to December 31, 2020, the Company entered into a non-binding letter of intent ("LOI") with a third party to sell and lease back a portion of the Company's Danbury manufacturing facility and administrative offices. The terms of the LOI include a sales price of approximately $95 million - $105 million, a lease term of 20 years with four 5-year renewal options, and annual rent of approximately $10 million - $11 million at the beginning of the lease. If the transaction is completed, the Company intends to use the proceeds for general corporate purposes, and may also pay down a portion of its senior secured debt. The completion of the transactions contemplated by the LOI is subject to certain conditions, including the negotiation of satisfactory definitive agreements and satisfactory results of the buyer's inspections and other investigations, all of which are anticipated to be completed during the first quarter of 2021.   However, there can be no assurances that this proposed transaction will be completed in the timeframe or on the principal terms set forth above, or at all.

    Non-GAAP Measures

    Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

      Three Months Ended December 31,  Twelve Months Ended December 31, 
      2020  2019  2020  2019 
    Net loss $(26,411) $(14,263) $(57,240) $(51,903)
    GAAP net loss per share — basic and diluted $(0.11) $(0.07) $(0.26) $(0.27)
                     
    Net loss $(26,411) $(14,263) $(57,240) $(51,903)
    Less in-process research and development  13,233      13,233    
    Non-GAAP net loss $(13,178) $(14,263) $(44,007) $(51,903)
    Non-GAAP net loss per share — basic and diluted $(0.06) $(0.07) $(0.20) $(0.27)
                     

    Conference Call

    MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events.  A replay will be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  Afrezza is also available by prescription in Brazil where it is commercialized by the Company's partner Biomm SA.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding MannKind's ability to directly commercialize pharmaceutical products. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability to generate significant product sales for MannKind, MannKind's ability to manage its existing cash resources or raise additional cash resources, stock price volatility and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Tyvaso DPI (formerly known as TreT) is an investigational combination product that is not approved for any use in any country. The Tyvaso DPI tradename is pending final FDA review.

    Company Contact:

    818-661-5000



    MANNKIND CORPORATION AND SUBSIDIARY


    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except share and per share data)

      December 31, 
      2020  2019 
        
    ASSETS        
    Current assets:        
    Cash and cash equivalents $67,005  $29,906 
    Restricted cash  158   316 
    Short-term investments     19,978 
    Accounts receivable, net  4,218   3,513 
    Inventory  4,973   4,155 
    Prepaid expenses and other current assets  3,122   2,889 
    Total current assets  79,476   60,757 
    Property and equipment, net  25,867   26,778 
    Other assets  3,265   6,190 
    Total assets $108,608  $93,725 
             
    LIABILITIES AND STOCKHOLDERS' DEFICIT        
    Current liabilities:        
    Accounts payable $5,582  $4,789 
    Accrued expenses and other current liabilities  19,707   15,904 
    Paycheck Protection Program loan — current  4,061    
    Short-term note payable     5,028 
    Deferred revenue — current  33,275   32,503 
    Recognized loss on purchase commitments — current  11,080   7,394 
    Total current liabilities  73,705   65,618 
    Promissory notes  63,027   70,020 
    Accrued interest — promissory notes  4,150   2,002 
    Long-term Midcap credit facility  49,335   38,851 
    Senior convertible notes  5,000   5,000 
    Recognized loss on purchase commitments — long term  84,208   84,639 
    Operating lease liability  1,202   2,514 
    Deferred revenue — long term  1,662   8,344 
    Milestone rights liability  5,926   7,263 
    Long-term debt - other  812    
    Total liabilities  289,027   284,251 
             
    Stockholders' deficit:        
    Undesignated preferred stock, $0.01 par value — 10,000,000 shares authorized; no shares issued or outstanding at December 31, 2020 and 2019      
    Common stock, $0.01 par value — 400,000,000 and 280,000,000 shares authorized, 242,117,089 and 211,787,573 shares issued and outstanding at December 31, 2020 and 2019, respectively  2,421   2,118 
    Additional paid-in capital  2,866,303   2,799,278 
    Accumulated other comprehensive loss     (19)
    Accumulated deficit  (3,049,143)  (2,991,903)
    Total stockholders' deficit  (180,419)  (190,526)
    Total liabilities and stockholders' deficit $108,608  $93,725 
             



    MANNKIND CORPORATION AND SUBSIDIARY


    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except per share data)

      Three Months Ended December 31,  Twelve Months Ended December 31, 
      2020  2019  2020  2019 
                     
    Revenues:                
    Net revenue — commercial product sales $10,064  $7,761  $32,324  $25,304 
    Revenue — collaborations and services  8,379   8,232   32,820   37,734 
    Total revenues  18,443   15,993   65,144   63,038 
    Expenses:                
    Cost of goods sold  3,652   4,632   15,084   20,078 
    Cost of revenue — collaborations and services  2,631   2,389   9,557   7,901 
    Research and development  1,545   2,021   6,248   6,900 
    Acquired In-Process R&D  13,233      13,233    
    Selling, general and administrative  17,121   15,721   59,040   74,669 
    Impairment of commitment asset        1,889    
    Loss (gain) on foreign currency translation  4,008   2,582   8,006   (1,913)
    Total expenses  42,190   27,345   113,057   107,635 
    Loss from operations  (23,747)  (11,352)  (47,913)  (44,597)
    Other (expense) income:                
    Interest income  2   203   167   997 
    Interest expense on notes  (1,104)  (1,021)  (4,316)  (6,304)
    Interest expense on promissory notes  (1,297)  (1,251)  (5,155)  (4,602)
    (Loss) gain on extinguishment of debt  (264)     (264)  3,529 
    Other expense  (1)  (842)  23   (926)
    Total other expense  (2,664)  (2,911)  (9,545)  (7,306)
    Loss before income tax expense  (26,411)  (14,263)  (57,458)  (51,903)
    Benefit from income taxes        218    
    Net loss $(26,411) $(14,263) $(57,240) $(51,903)
    Net loss per share — basic and diluted $(0.11) $(0.07) $(0.26) $(0.27)
    Shares used to compute net loss per share — basic and diluted  234,575   206,689   222,585   195,584 
                     


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  5. NEW PROVIDENCE, N.J., Feb. 24, 2021 /PRNewswire/ -- Vertice Pharma ("Vertice"), a specialty pharmaceuticals company focused on improving patients' health, today announced the launch of THYQUIDITY. THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.*

    THYQUIDITY is a liquid dosage form of levothyroxine administered by a calibrated oral syringe, and is designed to deliver individualized dosing for patients. THYQUIDITY is a liquid oral solution of levothyroxine sodium containing 100 mcg per 5 mL (20 mcg per…

    NEW PROVIDENCE, N.J., Feb. 24, 2021 /PRNewswire/ -- Vertice Pharma ("Vertice"), a specialty pharmaceuticals company focused on improving patients' health, today announced the launch of THYQUIDITY. THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.*

    THYQUIDITY is a liquid dosage form of levothyroxine administered by a calibrated oral syringe, and is designed to deliver individualized dosing for patients. THYQUIDITY is a liquid oral solution of levothyroxine sodium containing 100 mcg per 5 mL (20 mcg per mL), and it is supplied in a package of two 100 mL bottles.  THYQUIDITY offers broad dosing flexibility for patients, as well as consistent daily dosing. 

    "The launch of THYQUIDITY marks our first branded pharmaceutical prescription product and reflects our ongoing mission to deliver high-quality and affordable pharmaceutical products for patients. Vertice is committed to providing branded and specialty generics products and we look forward to building off the momentum of today's launch," said Scott Meyers, Chief Executive Officer of Vertice Pharma.

    Vertice's co-promotion partner is MannKind Corporation (NASDAQ:MNKD). MannKind's sales force will promote THYQUIDITY to adult and pediatric endocrinologists and other U.S. healthcare providers who treat hypothyroidism. 

    "THYQUIDITY fits nicely into our product portfolio of branded and specialty generics and is an exciting launch for the team at Vertice. As we continue to evaluate select opportunities to bring products to market, we are proud to have partnered with MannKind in the launch of this important product," said John Walsh, Head of Specialty Sales and Marketing at Vertice Pharma.

    Hypothyroidism, also called underactive thyroid disease, is a common disorder in which the thyroid gland does not produce enough thyroid hormone to meet the needs of the body. The prevalence of hypothyroidism is 4.6% in the US population.1  Symptoms include fatigue, lethargy, cold intolerance, weight gain, constipation, change in voice, and dry skin.2 Most patients require lifelong therapy to treat their hypothyroidism.3

    Vertice Pharma was founded in 2015 with a unique focus on acquiring specialty pharmaceutical companies and products, including both branded and generic products, to create a durable specialty pharmaceutical business of scale.

    Patient Use and Important Safety Information

    USE

    THYQUIDITYTM (levothyroxine sodium) oral solution is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism. It is meant to replace a hormone that is usually made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life. THYQUIDITY should not be used to treat noncancerous growths or enlargement of the thyroid in patients with normal iodine levels, or in cases of temporary hypothyroidism caused by inflammation of the thyroid gland (thyroiditis).

    IMPORTANT SAFETY INFORMATION

    • Thyroid hormones, including THYQUIDITY, either alone or in combination with other drugs, should not be used for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of THYQUIDITY used daily for hormone replacement are not helpful for weight loss. Larger doses may result in serious or even life-threatening events, especially when used in combination with certain other drugs used to reduce appetite.
    • Do not use THYQUIDITY if you have uncorrected adrenal problems.
    • Tell your doctor about any other medical conditions you may have, especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking THYQUIDITY. If you have diabetes, check your blood sugar levels and/or the glucose in your urine, as ordered by your doctor, and immediately tell your doctor if there are any changes. If you are taking blood thinners, your blood clotting status should be checked often.
    • Taking too much levothyroxine has been associated with increased bone loss, especially in women after menopause.
    • Once your doctor has found your specific THYQUIDITY dose, it is important to have lab tests done, as ordered by your doctor, at least once a year.
    • Foods like soybean flour, cottonseed meal, walnuts, and dietary fiber may cause your body to absorb less THYQUIDITY from the gastrointestinal tract. Grapefruit juice may cause your body to absorb less levothyroxine and may reduce its effect. Let your doctor know if you eat these foods, as your dose of THYQUIDITY may need to be adjusted.
    • Use THYQUIDITY only as ordered by your doctor. Take THYQUIDITY as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.
    • Products such as iron and calcium supplements and antacids can lower your body's ability to absorb levothyroxine, so THYQUIDITY should be taken 4 hours before or after taking these products.
    • Tell your doctor if you are pregnant or breastfeeding or are thinking of becoming pregnant while taking THYQUIDITY. Your dose of THYQUIDITY may need to be increased during your pregnancy.
    • Monitor your baby from birth to 3 months of age for vomiting and/or diarrhea as THYQUIDITY can cause gastrointestinal irritation due to the glycerol component.
    • It may take several weeks before you notice an improvement in your symptoms.
    • Tell your doctor if you are taking any other drugs, including prescription and over-the-counter products.
    • Tell your doctor or dentist that you are taking THYQUIDITY before any surgery.
    • Tell your doctor if you develop any of the following symptoms: rapid or abnormal heartbeat, chest pain, difficulty catching your breath, leg cramps, headache, nervousness, irritability, sleeplessness, shaking, change in appetite, weight gain or loss, vomiting, diarrhea, increased sweating, difficulty tolerating heat, fever, changes in menstrual periods, swollen red bumps on the skin (hives) or skin rash, or any other unusual medical event.
    • Partial hair loss may occur during the first few months you are taking THYQUIDITY.

    This is the most important safety information you should know about THYQUIDITY. For more information, talk with your doctor.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Please see:

    http://www.thyquidity.com/pdf/Prescribing-Information.pdf for full US Prescribing Information including Boxed Warning.

    About Vertice Pharma

    Vertice Pharma is a specialty pharmaceutical company focused on improving patients' health. Vertice Pharma develops, manufactures, markets, and distributes high-quality and affordable pharmaceutical products through its operating companies. Vertice Pharma has global headquarters in the United Kingdom and United States headquarters in New Jersey. For more information visit www.verticepharma.com.

    References

    1. Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW, Spencer CA, Braverman LE. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002 Feb;87(2):489-99. doi: 10.1210/jcem.87.2.8182. PMID: 11836274.
    2. Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017;390(10101):1550-1562. https://pubmed.ncbi.nlm.nih.gov/28336049/
    3. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the Treatment of Hypothyroidism: Prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement. Thyroid. 2014;24(12):1670-1751. https://www.ncbi.nlm.nih.gov/pubmed/25266247.

    * Please see http://www.thyquidity.com/pdf/Prescribing-Information.pdf for full US Prescribing Information including Boxed Warning.

    Company Media Contact:



    Vertice Pharma

    Kimberly Branch

     

    727-530-1633 x276

    THYQUIDITY is a trademark of VistaPharm, Inc. © 2021 VistaPharm, Inc. All rights reserved.

    THQ_0027 0221

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  6. WESTLAKE VILLAGE, Calif., Feb. 18, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the 2021 SVB Leerink Global Healthcare Conference on Thursday, February 25, 2021 at 1:00 pm (ET). Interested parties can access a link to the webcast from the Events & Presentations section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation

    MannKind Corporation (NASDAQ…

    WESTLAKE VILLAGE, Calif., Feb. 18, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the 2021 SVB Leerink Global Healthcare Conference on Thursday, February 25, 2021 at 1:00 pm (ET). Interested parties can access a link to the webcast from the Events & Presentations section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:

    818-661-5000



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  7. WESTLAKE VILLAGE, Calif., Feb. 18, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2020 fourth quarter and full year financial results and its management will host a conference call to discuss the financial results and corporate updates at 9:00 AM (Eastern Time) on Thursday, February 25, 2021.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing…

    WESTLAKE VILLAGE, Calif., Feb. 18, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2020 fourth quarter and full year financial results and its management will host a conference call to discuss the financial results and corporate updates at 9:00 AM (Eastern Time) on Thursday, February 25, 2021.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 7174315#. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil where it is commercialized by the Company's partner Biomm SA. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:

    Phone: (818) 661-5000

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  8. WESTLAKE VILLAGE, Calif., Jan. 04, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the H.C. Wainwright Bioconnect 2021 Conference which will be available on demand starting on January 11, 2021 at 6:00 am (ET). Interested parties can access a link to the on demand webcast of the presentation from the Events & Presentations section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    WESTLAKE VILLAGE, Calif., Jan. 04, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the H.C. Wainwright Bioconnect 2021 Conference which will be available on demand starting on January 11, 2021 at 6:00 am (ET). Interested parties can access a link to the on demand webcast of the presentation from the Events & Presentations section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:

    818-661-5000



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  9. WESTLAKE VILLAGE, Calif. and NEW PROVIDENCE, N.J., Dec. 17, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) and Vertice Pharma today announced that they have entered into a co-promotion agreement for Thyquidity™ (levothyroxine sodium) oral solution through MannKind's specialty sales force. THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. THYQUIDITY is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients or hypothyroidism during the recovery phase of subacute thyroiditis.

    Under the terms of the agreement, MannKind's sales force will promote Thyquidity…

    WESTLAKE VILLAGE, Calif. and NEW PROVIDENCE, N.J., Dec. 17, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) and Vertice Pharma today announced that they have entered into a co-promotion agreement for Thyquidity™ (levothyroxine sodium) oral solution through MannKind's specialty sales force. THYQUIDITY is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. THYQUIDITY is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients or hypothyroidism during the recovery phase of subacute thyroiditis.

    Under the terms of the agreement, MannKind's sales force will promote Thyquidity to adult endocrinologists, pediatric endocrinologists and other US healthcare providers who treat hypothyroidism. Vertice will make a specified quarterly payment to MannKind to defray the costs of the additional promotional activity and will pay MannKind royalties on gross profit resulting from all sales of Thyquidity.

    "We are excited to co-promote Thyquidity with Vertice Pharma," said Michael Castagna, Chief Executive Officer of MannKind. "This arrangement allows us to strengthen our relationships with our current customers, expand into pediatric endocrinology and leverage the talent and capabilities of our sales force and reimbursement support systems."

    "The team at Vertice Pharma is thrilled to be joining forces with MannKind to help launch our product to patients and healthcare providers," said Scott Meyers, Chief Executive Officer of Vertice Pharma. "I look forward to working with MannKind's commercial team to get ready for the launch of Thyquidity in 1Q 2021."

    Hypothyroidism, also called underactive thyroid disease, is a common disorder in which the thyroid gland does not produce enough thyroid hormone. The prevalence of hypothyroidism is 4.6% in the US population.1 Symptoms include fatigue, lethargy, cold intolerance, weight gain, constipation, change in voice, and dry skin.2 Most patients require lifelong therapy to treat their hypothyroidism.3

    INDICATION

    Hypothyroidism

    THYQUIDITY (levothyroxine sodium) oral solution is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

    Pituitary Thyrotropin (Thyroid Stimulating Hormone, TSH) Suppression

    THYQUIDITY is indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

    Limitations of Use

    THYQUIDITY is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients, as there are no clinical benefits and over-treatment with THYQUIDITY may induce hyperthyroidism.

    THYQUIDITY is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

    Important Safety Information

    WARNING: NOT FOR TREATMENT OF OBESITY OR WEIGHT LOSS

    Thyroid hormones, including THYQUIDITY, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

    • THYQUIDITY is contraindicated in patients with uncorrected adrenal insufficiency.
    • In the elderly and in patients with cardiovascular disease, THYQUIDITY should be initiated at lower doses than those recommended in younger individuals or in patients without cardiac disease. If cardiac symptoms develop or worsen, the THYQUIDITY dose should be reduced or withheld for one week and restarted at a lower dose.
    • Patients with coronary artery disease who are receiving THYQUIDITY should be monitored closely during surgical procedures for cardiac arrhythmias. Monitor patients during concomitant administration of THYQUIDITY and sympathomimetic agents for signs and symptoms of coronary insufficiency.
    • Use of oral thyroid hormone is not recommended in myxedema coma. Products formulated for IV administration should be used to treat myxedema coma.
    • Patients with adrenal insufficiency should be treated with replacement glucocorticoids prior to initiating treatment with THYQUIDITY. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated.
    • THYQUIDITY has a narrow therapeutic index. Regardless of the indication for use, careful dosage titration is necessary to avoid the consequences of over- or under-treatment.
    • Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing THYQUIDITY.
    • Increased bone resorption and decreased bone mineral density may occur as a result of levothyroxine over-replacement, particularly in postmenopausal women. To mitigate this risk, patients receiving THYQUIDITY should be given the minimum dose necessary that achieves the desired response.
    • Adverse reactions associated with THYQUIDITY therapy are primarily those of hyperthyroidism due to therapeutic overdosage.
    • Many drugs and some foods affect thyroid hormone pharmacokinetics and metabolism and may alter the therapeutic response to THYQUIDITY. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. Administer at least 4 hours before or after drugs that are known to interfere with absorption. Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. Prescribers should consult appropriate reference sources for additional information on drug or food interactions with THYQUIDITY.
    • Closely monitor patients from birth to 3 months of age receiving THYQUIDITY due to the potential for glycerol- induced gastrointestinal irritation resulting in vomiting and/or osmotic diarrhea.
    • THYQUIDITY should not be discontinued during pregnancy, and hypothyroidism diagnosed during pregnancy should be promptly treated. TSH levels may increase during pregnancy, so TSH should be monitored and THYQUIDITY dose adjusted as needed.

    Please see: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214047s000lbl.pdf] for full US Prescribing Information including Boxed Warning.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, its first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    About Vertice Pharma

    Vertice Pharma is a specialty pharmaceutical company focused on improving patients' health. Vertice Pharma develops, manufactures, markets, and distributes high-quality and affordable pharmaceutical products through its operating companies. Vertice Pharma has global headquarters in the United Kingdom and United States headquarters in New Jersey. For more information visit www.verticepharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    References

    1. Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW, Spencer CA, Braverman LE. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002 Feb;87(2):489-99. doi: 10.1210/jcem.87.2.8182. PMID: 11836274.
    2. Chaker L, Bianco AC, Jonklaas J, Peeters RP. Hypothyroidism. Lancet. 2017;390(10101):1550-1562. https://pubmed.ncbi.nlm.nih.gov/28336049/
    3. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the american thyroid association task force on thyroid hormone replacement. Thyroid. 2014;24(12):1670-1751. https://www.ncbi.nlm.nih.gov/pubmed/25266247.

    Company Contact:



    MannKind Corporation

    818-661-5000

    Vertice Pharma

    Kimberly Branch



    727-530-1633 x276



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  10. WESTLAKE VILLAGE, Calif., Dec. 10, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that James S. Shannon, M.D., MRCP (UK) has been named the new Chairman of the Board of Directors effective December 9, 2020. Kent Kresa, the former Chairman of the Board, will continue to serve on MannKind's Board of Directors and as Chair of the Compensation Committee of the Board.

    "Kent has done an incredible job leading the Board – as Chairman for the last four years and as Lead Independent Director for an additional five years prior to that," said James Shannon. "As Al Mann's successor, Kent helped continue Al's mission of addressing the unmet needs of patients with diabetes and other serious illnesses. Since joining the Board…

    WESTLAKE VILLAGE, Calif., Dec. 10, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that James S. Shannon, M.D., MRCP (UK) has been named the new Chairman of the Board of Directors effective December 9, 2020. Kent Kresa, the former Chairman of the Board, will continue to serve on MannKind's Board of Directors and as Chair of the Compensation Committee of the Board.

    "Kent has done an incredible job leading the Board – as Chairman for the last four years and as Lead Independent Director for an additional five years prior to that," said James Shannon. "As Al Mann's successor, Kent helped continue Al's mission of addressing the unmet needs of patients with diabetes and other serious illnesses. Since joining the Board in 2004, Kent has contributed significantly to the Company's progress and he will certainly continue to do so. We are grateful for his leadership and we look forward to continuing to benefit from his experience."

    Dr. Shannon served on the Board from February 2010 until April 2012 then rejoined the Board in May 2015. Dr. Shannon is a recognized pharmaceutical industry leader with more than 20 years of experience in senior leadership positions. He served as the Chief Medical Officer for GlaxoSmithKline from 2012 -2015 and prior to this, served as Global Head of Pharma Development for Novartis AG based in Basel, Switzerland. Dr. Shannon is trained in Medicine and Cardiology and received his undergraduate and postgraduate degrees at Queen's University of Belfast and is a Member of the Royal College of Physicians (UK). He currently serves on the boards of several companies including Horizon Therapeutics, Kyowa Kirin, Immodulon Therapeutics Limited, ProQR Therapeutics NV, and myTomorrows.

    "I would like to thank Kent for our partnership during my time with MannKind," said Michael Castagna, Chief Executive Officer of MannKind. "He has been a great mentor, for which I will be forever thankful. Having James as Kent's successor speaks to the caliber of our Board. James' keen insight and leadership experience in the pharmaceutical industry will be invaluable as we continue to advance the pipeline and focus on developing innovative medicines for both endocrinology and orphan lung diseases."

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



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  11. WESTLAKE VILLAGE, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that it has acquired QrumPharma, Inc., a privately held pharmaceutical company developing inhalation treatments for severe chronic and recurrent pulmonary infections, including Nontuberculous Mycobacterial (NTM) lung disease.

    "We have focused on building a stronger pipeline to treat unmet needs for orphan lung diseases, an area where we can leverage our experience and technology to create differentiated therapeutic products," said Michael Castagna, Chief Executive Officer of MannKind. "This acquisition brings us a lead program that is expected to enter Phase 1 in late 2021. In addition, our combined capabilities have the potential…

    WESTLAKE VILLAGE, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that it has acquired QrumPharma, Inc., a privately held pharmaceutical company developing inhalation treatments for severe chronic and recurrent pulmonary infections, including Nontuberculous Mycobacterial (NTM) lung disease.

    "We have focused on building a stronger pipeline to treat unmet needs for orphan lung diseases, an area where we can leverage our experience and technology to create differentiated therapeutic products," said Michael Castagna, Chief Executive Officer of MannKind. "This acquisition brings us a lead program that is expected to enter Phase 1 in late 2021. In addition, our combined capabilities have the potential to create a dry powder formulation that will enable patients suffering from NTM to have a much more positive treatment experience. We are also very excited to add the QrumPharma development team to our roster of talent, with their deep expertise of inhaled drug delivery."

    In connection with the acquisition, Thomas Hofmann, M.D., Ph.D. will transition from CEO of QrumPharma to Chief Scientific Officer of MannKind Corporation. Dr. Hofmann has over 20 years of experience in inhaled drug development for cystic fibrosis and anti-infectives, including two FDA-approved drugs. In 2015, Dr. Hofmann was the recipient of the Milton Graub Medical Recognition Award from the Cystic Fibrosis Foundation.

    "My team and I are thrilled to be joining forces with the MannKind development team," said Dr. Thomas Hofmann. "I look forward to leveraging MannKind's best-in-class technology to bring new therapies to patients with orphan lung diseases."

    NTM lung disease is a serious chronic condition associated with a reduction of lung function and quality of life. It is estimated that 75,000-105,000 people in the U.S. were diagnosed in 2018 and the NTM population is growing 8% per year, with women, senior citizens and people with underlying lung conditions at greater risk. QrumPharma's lead program (QRM-003) is focused on an inhaled, nebulized formulation of clofazimine, which would provide several clinical advantages over the current solid oral dosage form. The U.S. Food and Drug Administration has designated QRM-003 as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary nontuberculous Mycobacterial infections.

    MannKind purchased all of the outstanding capital stock of QrumPharma for consideration consisting of $3.5 million in cash and 3,067,179 shares of MannKind common stock, subject to adjustment for cash on hand, unpaid indebtedness, unpaid transaction expenses, net working capital, and other liabilities of QrumPharma. In addition, the selling stockholders of QrumPharma will be entitled to contingent payments in the event that products based on QrumPharma's intellectual property generate net sales that exceed specified thresholds.

    Locust Walk served as an advisor to MannKind.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, its first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



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    • $10 million funded immediately
    • $25 million available upon TreT FDA approval
    • Interest-only period extended to September 2022

    WESTLAKE VILLAGE, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that it and MidCap Financial Trust, as agent, have entered into an amendment to the credit and security agreement dated August 6, 2019 (the "MidCap Credit Facility").

    "We appreciate the unwavering financial support and partnership from MidCap as we progress our three most important business objectives – growing Afrezza to become the standard of care for mealtime insulin, working with our collaboration partner, United Therapeutics, to move Treprostinil Technosphere (TreT) toward an NDA submission with the FDA…

    • $10 million funded immediately
    • $25 million available upon TreT FDA approval
    • Interest-only period extended to September 2022

    WESTLAKE VILLAGE, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that it and MidCap Financial Trust, as agent, have entered into an amendment to the credit and security agreement dated August 6, 2019 (the "MidCap Credit Facility").

    "We appreciate the unwavering financial support and partnership from MidCap as we progress our three most important business objectives – growing Afrezza to become the standard of care for mealtime insulin, working with our collaboration partner, United Therapeutics, to move Treprostinil Technosphere (TreT) toward an NDA submission with the FDA, and developing our pipeline," said Michael Castagna, CEO of MannKind.

    The amendment to the MidCap Credit Facility provides that: (i) Tranche 2 of $10.0 million is made available to the Company and is scheduled to be funded on December 1, 2020, (ii) Tranche 3 of $25.0 million is available to the Company upon the satisfaction of certain conditions, including FDA approval of TreT, (iii) modifications to the financial covenant relating to trailing twelve month minimum Afrezza Net Revenue requirements, (iv) an additional covenant that requires the marketing of TreT if Tranche 3 is funded, (v) an extension of the interest-only period until September 1, 2022 (vi) the minimum cash covenant is increased to $30.0 million at all times, and (vii) amendments to the prepayment fees.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, its first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    About MidCap Financial

    MidCap Financial is a middle market-focused, specialty finance firm that provides senior debt solutions to companies across all industries. MidCap Financial provides management or other services with respect to over $27 billion of commitments as of September, 2020 of which $3.9 billion are managed by MidCap Financial Services Capital Management LLC, a registered investment adviser. MidCap Financial provides a broad array of products intended to finance growth and manage working capital. MidCap Financial is managed by Apollo Capital Management, L.P., a subsidiary of Apollo Global Management, Inc., pursuant to an investment management agreement. Apollo Global Management, Inc. is one of the world's largest asset managers with approximately $414 billion of assets under management (as of June 30, 2020), providing market leading industry expertise, market reach, and financing synergies. Loans to CA residents issued under California Financing Law License No. 60DBO 45424, 60DBO 45427, 60DBO 45431, 60DBO 45435, 60DBO 45439, 60DBO 49531 or 603I389

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



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  12. WESTLAKE VILLAGE, Calif., Nov. 30, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that Sabrina Kay Ed.D. has been appointed to its Board of Directors, effective December 1, 2020. Dr.  Kay will also serve as a member of the Audit Committee of the Board. A serial entrepreneur, tech educator, fashion designer, philanthropist, and public speaker, Dr. Kay brings to MannKind a wealth of experience in marketing, human capital development, finance and executive leadership.

    "We are excited to welcome Dr. Kay and her years of invaluable leadership to our Board of Directors," said Kent Kresa, Chairman of the Board. "Her entrepreneurial vision will be a critical asset for MannKind as the company continues to evolve and…

    WESTLAKE VILLAGE, Calif., Nov. 30, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that Sabrina Kay Ed.D. has been appointed to its Board of Directors, effective December 1, 2020. Dr.  Kay will also serve as a member of the Audit Committee of the Board. A serial entrepreneur, tech educator, fashion designer, philanthropist, and public speaker, Dr. Kay brings to MannKind a wealth of experience in marketing, human capital development, finance and executive leadership.

    "We are excited to welcome Dr. Kay and her years of invaluable leadership to our Board of Directors," said Kent Kresa, Chairman of the Board. "Her entrepreneurial vision will be a critical asset for MannKind as the company continues to evolve and the pipeline expands. Dr. Kay has a successful track record in launching and leading a variety of companies, and will add a fresh and diverse perspective as we continue to pursue our mission to give people control of their health and the freedom to live life." 

    Currently, Dr. Kay serves as Founder and CEO of Fremont Private Investments, where she has led the operations and exits of several companies including The Art Institute of Hollywood (NASDAQ:EDMC), Premier Business Bank (NASDAQ:FFWM), Fashion Umbrella, Fremont College, and Dale Carnegie of Los Angeles.

    In addition to her success in the business world, Dr. Kay is a philanthropist, having served on more than 30 charitable and civic boards. She is chairman of After-School All-Stars Los Angeles, and a board member of the Los Angeles Sports and Entertainment Commission, Petersen Automotive Museum, Portal Schools, the Leadership Council of International Medical Corps Leadership Council, and the Board of Leaders of USC Marshall School. Dr. Kay has also chaired and spoken at numerous tech, education, business, and leadership conferences, and taught entrepreneurship programs at various universities.

    Dr. Kay's achievements have been recognized with numerous awards, including the Education Award from After-School All-Stars and the Humanitarian Award from International Medical Corps. She was named Woman of the Year by the California Legislature, Rising Asian Woman by the World Affairs Council, and was a finalist for Entrepreneur of the Year by Ernst & Young.

    Dr. Kay received her joint doctorate degree in Work-based Learning Leadership from the University of Pennsylvania. She holds an MBA from the University of Southern California and a Master of Science degree in education from the University of Pennsylvania.

    With the addition of Dr. Kay, there are nine members of the MannKind Board of Directors.

    About MannKind Corporation



    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



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  13. WESTLAKE VILLAGE, Calif., Nov. 19, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that it has achieved the final development milestone under its licensing and collaboration agreement with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil.

    Treprostinil Technosphere ("TreT") is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension (PAH). All current clinical trials are now fully enrolled, including the BREEZE study in patients with PAH and a pivotal pharmacokinetics study in healthy subjects, both of which are being conducted by United Therapeutics, as well as a human factors study being…

    WESTLAKE VILLAGE, Calif., Nov. 19, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that it has achieved the final development milestone under its licensing and collaboration agreement with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil.

    Treprostinil Technosphere ("TreT") is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension (PAH). All current clinical trials are now fully enrolled, including the BREEZE study in patients with PAH and a pivotal pharmacokinetics study in healthy subjects, both of which are being conducted by United Therapeutics, as well as a human factors study being conducted by MannKind. In addition, MannKind's stability program for TreT has reached the milestone required for a regulatory filing.

    "We are looking forward to working with United Therapeutics during the first part of 2021 to prepare an FDA submission for TreT," said Michael Castagna, Chief Executive Officer of MannKind.

    MannKind has now received all of the milestone payments that were specified in its agreement with United Therapeutics. MannKind remains entitled to receive low double-digit royalties on net sales of TreT. MannKind will also manufacture supplies of TreT for United Therapeutics and will earn a manufacturing margin.

    About MannKind Corporation



    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



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  14. Conference Call to Begin Today at 5:00 PM ET

    • 3Q 2020 U.S. Afrezza Net Revenue of $7.3 million; +27% vs. 3Q 2019
    • 3Q YTD 2020 U.S. Afrezza Net Revenue of $22.1 million; +31% vs. 3Q YTD 2019
    • Cash and cash equivalents of $52.4 million at September 30, 2020
    • On track to complete Treprostinil Technosphere development activities in 4Q 2020
    • Expanded Afrezza commercial and medical teams
    • YTD Afrezza scientific presentations and publications total 14

    WESTLAKE VILLAGE, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the quarter and nine months ended September 30, 2020.

    "Our employees continue to execute in a tumultuous Covid-19 environment," said Michael Castagna, Chief Executive Officer. "As…

    Conference Call to Begin Today at 5:00 PM ET

    • 3Q 2020 U.S. Afrezza Net Revenue of $7.3 million; +27% vs. 3Q 2019
    • 3Q YTD 2020 U.S. Afrezza Net Revenue of $22.1 million; +31% vs. 3Q YTD 2019
    • Cash and cash equivalents of $52.4 million at September 30, 2020
    • On track to complete Treprostinil Technosphere development activities in 4Q 2020
    • Expanded Afrezza commercial and medical teams
    • YTD Afrezza scientific presentations and publications total 14

    WESTLAKE VILLAGE, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the quarter and nine months ended September 30, 2020.

    "Our employees continue to execute in a tumultuous Covid-19 environment," said Michael Castagna, Chief Executive Officer. "As we head toward year-end, our focus remains on two significant drivers of value for shareholders: enabling healthcare providers to increase their prescribing of Afrezza and supporting United Therapeutics as they move the TreT clinical program to completion, including manufacturing TreT clinical supplies."

    Third Quarter 2020 Results

    Total revenues were $15.4 million for the third quarter of 2020, reflecting Afrezza net revenue of $7.3 million and collaboration and services revenue of $8.1 million. Afrezza U.S net revenue of $7.3 million increased 27% compared to $5.7 million in the third quarter of 2019, driven by higher product demand, a favorable mix of cartridges, and price. The first sale of Afrezza to the Company's marketing partner in Brazil was completed in the third quarter of 2019 for $0.7 million; there were no international sales in the third quarter of 2020. Collaboration and services revenue for the third quarter of 2020 decreased $0.1 million compared to the third quarter of 2019. 

    Afrezza gross profit for the third quarter of 2020 was $3.7 million compared to a loss of $0.7 million in the same period of 2019, an increase of $4.4 million that was driven primarily by higher Afrezza revenue combined with a reduction in cost of goods sold, primarily attributable to a $2.8 million amendment fee associated with our insulin supply agreement in 2019. Non-GAAP gross margin in the third quarter of 2020 increased to 51% from 32% for the same quarter in 2019.

    Selling, general and administrative expenses for the third quarter of 2020 were $13.9 million compared to $16.7 million for the third quarter of 2019. This 17% decrease was primarily due to a $1.2 million reduction in promotional and marketing activities and a $0.8 million decrease in professional costs.

    Interest expense for the third quarter of 2020 was $2.4 million compared to $5.3 million for the third quarter of 2019. This $2.9 million decrease was primarily attributable to a $3.4 million milestone obligation that occurred in the third quarter of 2019, partially offset by interest expense from the MidCap Credit Facility.

    A loss on foreign currency translation for the third quarter of 2020 was $3.9 million compared to a $3.8 million gain for the third quarter of 2019. The fluctuation is related to the change in the U.S. dollar to Euro foreign exchange rate on the recognized loss on insulin purchase commitments, which are denominated in Euros.

    The net loss for the third quarter of 2020 was $11.3 million, or $0.05 per share, compared to a $10.4 million net loss, or $0.05 per share in the third quarter of 2019. The higher net loss was mainly attributable to the change in foreign currency translation from a gain in 2019 to a loss in 2020, partially offset by the reduction in cost of goods sold, selling, general and administrative expenses and interest expense.

    Nine Months Ended September 30, 2020

    Total revenues were $46.7 million for the nine months ended September 30, 2020, reflecting Afrezza net revenue of $22.3 million and collaboration and services revenue of $24.4 million. Afrezza net revenue increased 27% compared to $17.5 million for the nine months ended September 30, 2019, primarily driven by higher product demand, a more favorable mix of cartridges and price, partially offset by a reduction in sales to Biomm (Brazil). Collaboration and services revenue for the nine months ended September 30, 2020 decreased $5.1 million compared to the same period in the prior year, primarily due to a $5.7 million decrease in revenue recognized from the UT Research Agreement, which was substantially completed in 2019.

    Afrezza gross profit for the nine months ended September 30, 2020 was $10.8 million compared to $2.1 million in the same period of 2019, an increase of $8.7 million, or +416%, that was driven primarily by a reduction in cost of goods sold combined with higher commercial product sales. Cost of goods sold decreased by $4.0 million, primarily attributable to a $2.8 million amendment fee associated with our insulin supply agreement in 2019, $0.8 million of increased 2020 manufacturing activities which resulted in a greater amount of costs capitalized to inventory and $1.1 million in reduced 2020 manufacturing-related spending, partially offset by $0.5 million of 2020 inventory write-offs and $0.4 million in costs associated with higher commercial product sales. Non-GAAP gross margin for the nine months ended September 30, 2020 increased to 49% from 28% for the same period in 2019, primarily due to higher Afrezza revenue and lower cost of goods sold.

    Selling, general and administrative expenses for the nine months ended September 30, 2020 were $41.9 million compared to $58.9 million for the same period in 2019. This 29% decrease was primarily due to $9.3 million spent on direct-to-consumer television advertising in 2019 (which was not repeated in 2020), a $4.1 million decrease in promotional and marketing activities, a $1.3 million decrease in consulting costs, and a $1.2 million decrease in personnel and employee related costs.

    The loss on foreign currency translation for the nine months ended September 30, 2020 was $4.0 million compared to a $4.5 million gain for the same period in 2019. The fluctuation is related to the change in the U.S. dollar to Euro foreign exchange rate on the recognized loss on insulin purchase commitments, which are denominated in Euros.

    The net loss for the nine months ended September 30, 2020 was $30.8 million, or $0.14 per share, compared to a $37.6 million net loss, or $0.20 per share for the same period in 2019. The lower net loss was mainly attributable to a decrease selling, general and administrative expenses, partially offset by the change in the foreign currency translation from a gain in 2019 to a loss in 2020. The reduction in the net loss per share was also impacted by a greater number of outstanding shares.

    Cash, cash equivalents and restricted cash at September 30, 2020 was $52.7 million compared to $50.2 million at December 31, 2019, which also included short-term investments of $20.0 million. The increase was primarily due to a milestone payment from United Therapeutics of $12.5 million, $15.2 million of net proceeds received from at-the-market offerings, $11.6 million received from warrant exercises and the origination of a Paycheck Protection Program loan for $4.9 million, offset by non-GAAP net cash used in operating activities of $40.9 million.

    Non-GAAP Measures

    Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis.  Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below.  Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods.  The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

      Three Months Ended September 30, 
      2020  2019  $

    Change
      %

    Change
     
    Net revenue — Afrezza $7,275  $6,402  $873   14%
    Less cost of goods sold (3,591)  (7,099) $(3,508)  (49%)
    GAAP gross profit (loss) — Afrezza  3,684  (697) $4,381   * 
    Exclude Amphastar amendment fee    2,750  $(2,750)  (100%)
    Non-GAAP gross profit — Afrezza $3,684  $2,053  $1,631   79%
    Non-GAAP gross margin  51%  32%        

    * Not meaningful

      Nine Months Ended September 30, 
      2020  2019  $

    Change
      %

    Change
     
    Net revenue — Afrezza $22,260  $17,543  $4,717   27%
    Less cost of goods sold  (11,432)  (15,446) $(4,014)  (26%)
    GAAP gross profit — Afrezza  10,828   2,097  $8,731   416%
    Exclude Amphastar amendment fee    2,750  $(2,750)  (100%)
    Non-GAAP gross profit — Afrezza $10,828  $4,847  $5,981   123%
    Non-GAAP gross margin  49%  28%        



      Nine Months Ended September 30, 
      2020  2019  $

    Change
      %

    Change
     
    Net cash used in operating activities $(28,363) $(83,376) $55,013   66%
    Exclude UT payment received  (12,500)  (12,500) $   %
    Exclude payment-in-kind interest on promissory notes    (32,822) $32,822   100%
    Non-GAAP cash used in operating activities $(40,863) $(128,698) $87,835   68%

    Conference Call

    MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 3965498#. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC, including risks related to the COVID-19 pandemic. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000

    MANNKIND CORPORATION AND SUBSIDIARY

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited)

    (In thousands, except per share data)

      September 30, 2020  December 31, 2019 
    ASSETS        
    Current assets:        
    Cash and cash equivalents $52,398  $29,906 
    Restricted cash  316   316 
    Short-term investments     19,978 
    Accounts receivable, net  4,135   3,513 
    Inventory  4,881   4,155 
    Prepaid expenses and other current assets  4,616   2,889 
    Total current assets  66,346   60,757 
    Property and equipment, net  25,736   26,778 
    Other assets  3,599   6,190 
    Total assets $95,681  $93,725 
             
    LIABILITIES AND STOCKHOLDERS' DEFICIT        
    Current liabilities:        
    Accounts payable $5,797  $4,789 
    Accrued expenses and other current liabilities  15,814   15,904 
    Short-term notes payable  45,379   5,028 
    Deferred revenue — current  28,867   32,503 
    Recognized loss on purchase commitments — current  10,267   7,394 
    Total current liabilities  106,124   65,618 
    Promissory notes  70,025   70,020 
    Accrued interest — promissory notes  5,854   2,002 
    Long-term Midcap credit facility     38,851 
    Senior convertible notes  5,000   5,000 
    Paycheck Protection Program loan — long term  1,421    
    Recognized loss on purchase commitments — long term  84,529   84,639 
    Operating lease liability  1,523   2,514 
    Deferred revenue — long term  1,699   8,344 
    Milestone rights liability  5,926   7,263 
    Total liabilities  282,101   284,251 
             
    Stockholders' deficit:        
    Undesignated preferred stock, $ par value — shares authorized;

        shares issued or outstanding as of September 30, 2020 and December 31, 2019
          
    Common stock, $ par value - 400,000,000 and 280,000,000 shares

    authorized, 230,922,513 and 211,787,573 shares issued and outstanding

    at September 30, 2020 and December 31, 2019, respectively
      2,309   2,118 
    Additional paid-in capital  2,834,003   2,799,278 
    Accumulated other comprehensive loss     (19)
    Accumulated deficit  (3,022,732)  (2,991,903)
    Total stockholders' deficit  (186,420)  (190,526)
    Total liabilities and stockholders' deficit $95,681  $93,725 

    MANNKIND CORPORATION AND SUBSIDIARY

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

    (In thousands, except per share data)

     Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
     2020  2019  2020  2019 
    Revenues:               
    Net revenue — commercial product sales$7,275  $6,402  $22,260  $17,543 
    Revenue — collaborations and services 8,077   8,193   24,441   29,502 
    Total revenues 15,352   14,595   46,701   47,045 
    Expenses:               
    Cost of goods sold 3,591   7,099   11,432   15,446 
    Cost of revenue — collaborations and services 1,581   1,836   6,926   5,512 
    Research and development 1,484   1,580   4,703   4,879 
    Selling, general and administrative 13,899   16,666   41,919   58,948 
    Asset impairment       1,889    
    Loss (gain) on foreign currency translation 3,927   (3,807)  3,998   (4,495)
    Total expenses 24,482   23,374   70,867   80,290 
    Loss from operations (9,130)  (8,779)  (24,166)  (33,245)
    Other (expense) income:               
    Interest income 18   220   165   794 
    Interest expense on notes (1,057)  (4,126)  (3,212)  (5,283)
    Interest expense on promissory notes (1,318)  (1,162)  (3,858)  (3,351)
    Gain on extinguishment of debt    3,529      3,529 
    Other income (expense) 14   (52)  24   (84)
    Total other expense (2,343)  (1,591)  (6,881)  (4,395)
    Loss before provision for income taxes (11,473)  (10,370)  (31,047)  (37,640)
    Benefit for income taxes 218      218    
    Net loss$(11,255) $(10,370) $(30,829) $(37,640)
    Net loss per share - basic and diluted$(0.05) $(0.05) $(0.14) $(0.20)
    Shares used to compute basic and diluted net loss per share 229,668   199,906   218,559   191,786 

     

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  15. WESTLAKE VILLAGE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2020 third quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, November 4, 2020.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921…

    WESTLAKE VILLAGE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2020 third quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, November 4, 2020.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 3965498#. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil where it is commercialized by the Company's partner Biomm SA. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:

    Phone: (818) 661-5000

    Email:

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  16. WESTLAKE VILLAGE, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diabetes and orphan lung diseases, announced today that it will be participating at upcoming conferences. Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD. 

    • H.C. Wainwright 22nd Annual Global Investment Conference - Fireside Chat on Monday, September 14, 2020 at 3:30 pm (EDT)
    • 2020 Cantor Global Virtual Healthcare Conference - Fireside Chat on Tuesday, September 15, 2020 at 8:40 am - 9:10 am (EDT) 
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit – Fireside Chat on Monday, September 21, 2020…

    WESTLAKE VILLAGE, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diabetes and orphan lung diseases, announced today that it will be participating at upcoming conferences. Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD. 

    • H.C. Wainwright 22nd Annual Global Investment Conference - Fireside Chat on Monday, September 14, 2020 at 3:30 pm (EDT)
    • 2020 Cantor Global Virtual Healthcare Conference - Fireside Chat on Tuesday, September 15, 2020 at 8:40 am - 9:10 am (EDT) 
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit – Fireside Chat on Monday, September 21, 2020 at 10:50 am - 11:30 am (EDT)

    Interested parties can access a link to the live webcast of the presentations from the News & Events section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:

    818-661-5000

    Source: MannKind Corporation

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  17. WESTLAKE VILLAGE, Calif., Aug. 31, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that Kevin Kaiserman, MD, has joined the company as Vice President, Medical Affairs and Safety and will assume full responsibility for leading MannKind's medical affairs, field medical activities, safety, and pediatrics initiatives. Dr. Kaiserman will report directly to Michael Castagna, Chief Executive Officer and will be based in MannKind's Westlake Village, California headquarters.

    "As a board-certified pediatric endocrinologist, Kevin brings significant expertise in the field of type 1 diabetes, and is an integral addition to MannKind as we expand our medical affairs capabilities and advance our pediatrics program," said Michael…

    WESTLAKE VILLAGE, Calif., Aug. 31, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that Kevin Kaiserman, MD, has joined the company as Vice President, Medical Affairs and Safety and will assume full responsibility for leading MannKind's medical affairs, field medical activities, safety, and pediatrics initiatives. Dr. Kaiserman will report directly to Michael Castagna, Chief Executive Officer and will be based in MannKind's Westlake Village, California headquarters.

    "As a board-certified pediatric endocrinologist, Kevin brings significant expertise in the field of type 1 diabetes, and is an integral addition to MannKind as we expand our medical affairs capabilities and advance our pediatrics program," said Michael Castagna, Chief Executive Officer of MannKind. "His deep expertise in continuous glucose monitoring and insulin delivery, coupled with his lengthy experience in educating the endocrinology community, will be instrumental in moving our medical initiatives forward and supporting the effort to expand our Afrezza user base."

    Dr. Kaiserman's career includes over 25 years of experience in pediatric endocrinology. For the past 14 years, he has provided clinical management and research for type 1 diabetes patients at his private practice, SoCal Diabetes. Prior to entering private practice, Dr. Kaiserman was a Clinical Associate Professor of Pediatrics and Medical Director of the Clinical Diabetes Program at Children's Hospital Los Angeles and the University of Southern California, Keck School of Medicine. Dr. Kaiserman earned his medical degree from Eastern Virginia Medical School in Norfolk. He completed his internship and residency in the Department of Pediatrics and his fellowship in the Division of Pediatric Endocrinology at the University of California, Los Angeles.

    A renowned speaker and thought leader in the field of diabetes, Dr. Kaiserman has participated in numerous publications and research studies. He is board certified in pediatric endocrinology and is a member of the American Diabetes Association, the Pediatric Endocrine Society, and the Board of Directors of the Los Angeles Chapter of the Juvenile Diabetes Research Foundation. Dr. Kaiserman is the Medical Director of Camp Conrad-Chinnock, a camping program for children and adolescents with diabetes, and serves on the Board of Directors for the international Diabetes Education and Camping Association.

    "I'm thrilled to join MannKind during this exciting time of expansion," said Dr. Kaiserman. "Afrezza is a novel treatment option that provides mealtime control and flexibility for adults living with type 1 and type 2 diabetes. I look forward to working with my colleagues across the country to study this therapy in pediatrics and hope to bring the benefits of Afrezza to children and adolescents living with diabetes. I've seen the rapid rate of innovation around diabetes management over the past decades and am honored to lead the medical team at a company that is changing the way people living with diabetes take control of their health."  

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



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  18. WESTLAKE VILLAGE, Calif., Aug. 07, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diabetes and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the BTIG Virtual Biotechnology Conference 2020 on Tuesday, August 11, 2020 at 2:00 pm (ET). Interested parties can access a link to the live webcast of the presentation from the Events & Presentations section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation

    MannKind Corporation…

    WESTLAKE VILLAGE, Calif., Aug. 07, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diabetes and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the BTIG Virtual Biotechnology Conference 2020 on Tuesday, August 11, 2020 at 2:00 pm (ET). Interested parties can access a link to the live webcast of the presentation from the Events & Presentations section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:

    818-661-5000

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    • 2Q 2020 Afrezza Net Revenue of $7.0 million; +15% vs. 2Q 2019
    • 1H 2020 Afrezza Net Revenue of $15.0 million; +35% vs. 1H 2019
    • Cash and cash equivalents of $63.2 million at June 30, 2020
    • Non-GAAP cash used in operating activities decreased by 37% vs. 1H 2019
    • Chief Commercial Officer, Alejandro Galindo, joined MannKind

    WESTLAKE VILLAGE, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the quarter and six months ended June 30, 2020.

    "I am proud of how our employees pulled together during these uncertain times and innovated as a team to minimize the impact of the COVID-19 pandemic on our business during the second quarter," said Michael Castagna, Chief Executive Officer.  "A small…

    • 2Q 2020 Afrezza Net Revenue of $7.0 million; +15% vs. 2Q 2019

    • 1H 2020 Afrezza Net Revenue of $15.0 million; +35% vs. 1H 2019
    • Cash and cash equivalents of $63.2 million at June 30, 2020
    • Non-GAAP cash used in operating activities decreased by 37% vs. 1H 2019
    • Chief Commercial Officer, Alejandro Galindo, joined MannKind

    WESTLAKE VILLAGE, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the quarter and six months ended June 30, 2020.

    "I am proud of how our employees pulled together during these uncertain times and innovated as a team to minimize the impact of the COVID-19 pandemic on our business during the second quarter," said Michael Castagna, Chief Executive Officer.  "A small 3% reduction in Afrezza TRx compared to the first quarter, when there was a bolus of prescriptions due to patient stockpiling, reflects the successful execution of our commercial plan in a new virtual environment.  We faced many challenges during this quarter, but whether it was production personnel ensuring Afrezza supply through the end of the year, the research team producing clinical supplies for our collaboration partner, United Therapeutics, the field force executing new sales tactics or home office staff adapting to a totally virtual environment, our team exceeded all expectations."

    Second Quarter 2020 Results

    Total revenues were $15.1 million for the second quarter of 2020, reflecting Afrezza net revenue of $7.0 million and collaboration and services revenue of $8.1 million. Afrezza net revenue increased 15% compared to $6.1 million in the second quarter of 2019, primarily driven by price, a favorable mix of cartridges and higher product demand. Collaboration and services revenue for the second quarter of 2020 decreased $0.8 million compared to the second quarter of 2019, primarily due to the substantial completion of the research agreement with United Therapeutics in the second quarter of 2019. 

    Afrezza gross profit for the second quarter of 2020 was $3.3 million vs. $1.7 million in the same period of 2019, a 90% increase that was driven primarily by higher Afrezza revenue combined with a reduction in cost of goods sold. Cost of goods sold decreased by $0.7 million, primarily due to $0.6 million in reduced spending. Gross margin in the second quarter of 2020 increased to 47% from 29% for the same quarter in 2019.

    Selling, general and administrative expenses for the second quarter of 2020 were $13.7 million compared to $16.6 million for the second quarter of 2019. This 18% decrease was primarily due to a $1.9 million reduction in promotional and marketing activities, a $0.5 million decrease in personnel related costs as well as a $0.2 million decrease in professional costs.

    Interest expense for the second quarter of 2020 was $2.4 million compared to $1.7 million for the second quarter of 2019. This $0.7 million increase was primarily attributable to a higher balance of outstanding principal.

    The net loss for the second quarter of 2020 was $10.3 million, or $0.05 per share, compared to a $12.4 million net loss in the second quarter of 2019, or $0.07 per share. The lower net loss is mainly attributable to a decrease in operating expenses of $2.9 million. The reduction in the net loss per share was impacted by both lower operating expenses and a greater number of outstanding shares.

    Six Months Ended June 30, 2020

    Total revenues were $31.3 million for the six months ended June 30, 2020, reflecting Afrezza net revenue of $15.0 million and collaboration and services revenue of $16.4 million. Afrezza net revenue increased 35% compared to $11.1 million for the six months ended June 30, 2019, primarily driven by higher product demand, a more favorable mix of Afrezza cartridges, price and a reduction in wholesaler channel inventory in the six months ended June 30, 2019. Collaboration and services revenue for the six months ended June 30, 2020 decreased $4.9 million compared to the six months ended June 30, 2019, primarily due to a $5.5 million decrease in revenue recognized from the UT Research Agreement, which was substantially completed in the second quarter of 2019, partially offset by a $0.6 million increase in revenue from the UT License Agreement.

    Afrezza gross profit for the six months ended June 30, 2020 was $7.1 million vs. $2.8 million in the same period of 2019, a 156% increase that was driven primarily by higher Afrezza revenue. Cost of goods sold decreased by $0.5 million, primarily attributable to $1.2 million of increased manufacturing activities, which resulted in a greater amount of costs capitalized to inventory and $0.6 million in reduced spending, partially offset by $0.9 million in costs associated with higher commercial product sales and $0.5 million of inventory write-offs. Gross margin for the six months ended June 30, 2020 increased to 48% from 25% for the same period in 2019, primarily due to higher Afrezza revenue.

    Selling, general and administrative expenses for the six months ended June 30, 2020 were $28.0 million compared to $42.3 million for the same period in 2019. This 34% decrease was primarily due to $9.3 million spent on direct-to-consumer television advertising in 2019 (which was not repeated in 2020), a $3.1 million decrease in promotional and marketing activities, a $1.2 million decrease in personnel and employee related costs and a $0.5 million decrease in consulting costs.

    Interest expense for the six months ended June 30, 2020 was $4.7 million compared to $3.3 million for the same period in 2019. This $1.4 million increase was primarily due to the borrowings under the MidCap Credit Facility in August 2019.

    The net loss for the six months ended June 30, 2020 was $19.6 million, or $0.09 per share, compared to a $27.3 million net loss for the same period in 2019, or $0.15 per share. The lower net loss is mainly attributable to a decrease in operating expenses of $10.5 million. The reduction in the net loss per share was impacted by both lower operating expenses and a greater number of outstanding shares.

    Cash, cash equivalents and restricted cash at June 30, 2020 was $63.5 million compared to $50.2 million at December 31, 2019, which also included short-term investments of $20.0 million. The increase was primarily due to the receipt of a $12.5 million United Therapeutics milestone payment, $12.2 million of net proceeds received from the at-the-market offering, $11.6 million received from warrant exercises and the origination of a Paycheck Protection Program loan for $4.9 million, offset by non-GAAP net cash used in operating activities of $27.4 million.

    Chief Commercial Officer

    As previously announced, Alejandro Galindo, M.B.A, M.S., joined the Company on August 4, 2020 as Chief Commercial Officer. Mr. Galindo has an accomplished track-record of over 25 years in the healthcare, energy, and consumer industries. He spent the past six years at Medtronic as Vice President and President of the Advanced Insulin Management Business Unit, where he led a fast-paced, double-digit growth global business within their diabetes division. Prior to Medtronic, Mr. Galindo spent nine years at General Electric (GE) Healthcare in a variety of leadership roles, leading emerging markets, strategic corporate development and global supply chain operations. Prior to joining GE's Healthcare division, he spent eleven years in various global leadership positions for the company's energy and appliance sectors, overseeing advanced manufacturing engineering and product development. Mr. Galindo received a B.Sc. in Industrial & Systems Engineering from Monterrey Institute of Technology, Mexico and M.B.A. and M.S. degrees from Indiana University.

    Non-GAAP Measures

    Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis.  Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below.  Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods.  The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

      Six Months Ended June 30, 
      2020  2019  $ Change  % Change 
    Net cash used in operating activities $(14,903) $(31,325) $(16,422)   (52%)
    Exclude United Therapeutic milestone payment received  (12,500)  (12,500)      0%
    Non-GAAP cash used in operating activities $(27,403) $(43,825) $(16,422)   (37%)

    Conference Call

    MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 7888638#. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC, including risks related to the COVID-19 pandemic. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



    MANNKIND CORPORATION AND SUBSIDIARY

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited)

    (In thousands, except per share data)
     
      
      June 30, 2020  December 31, 2019 
    ASSETS        
    Current assets:        
    Cash and cash equivalents $63,222  $29,906 
    Restricted cash  316   316 
    Short-term investments     19,978 
    Accounts receivable, net  3,366   3,513 
    Inventory  3,823   4,155 
    Prepaid expenses and other current assets  1,856   2,889 
    Total current assets  72,583   60,757 
    Property and equipment, net  26,187   26,778 
    Other assets  4,011   6,190 
    Total assets $102,781  $93,725 
             
    LIABILITIES AND STOCKHOLDERS' DEFICIT        
    Current liabilities:        
    Accounts payable $5,821  $4,789 
    Accrued expenses and other current liabilities  14,706   15,904 
    Short-term notes payable  5,387   5,028 
    Deferred revenue — current  32,184   32,503 
    Recognized loss on purchase commitments — current  9,841   7,394 
    Total current liabilities  67,939   65,618 
    Promissory notes  70,024   70,020 
    Accrued interest — promissory notes  4,538   2,002 
    Long-term Midcap credit facility  39,304   38,851 
    Senior convertible notes  5,000   5,000 
    Paycheck Protection Program loan — long term  2,030    
    Recognized loss on purchase commitments — long term  81,027   84,639 
    Operating lease liability  1,843   2,514 
    Deferred revenue — long term  4,860   8,344 
    Milestone rights liability  5,926   7,263 
    Total liabilities  282,491   284,251 
             
    Stockholders' deficit:        
    Undesignated preferred stock, $0.01 par value — 10,000,000 shares

      authorized; no shares issued or outstanding as of June 30, 2020 and

      December 31, 2019
          
    Common stock, $0.01 par value - 400,000,000 and 280,000,000 shares

      authorized, 228,927,505 and 211,787,573 shares issued and outstanding

      at June 30, 2020 and December 31, 2019, respectively
      2,289   2,118 
    Additional paid-in capital  2,829,478   2,799,278 
    Accumulated other comprehensive loss     (19)
    Accumulated deficit  (3,011,477)  (2,991,903)
    Total stockholders' deficit  (179,710)  (190,526)
    Total liabilities and stockholders' deficit $102,781  $93,725 
             



    MANNKIND CORPORATION AND SUBSIDIARY

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

    (In thousands, except per share data)
     
     Three Months Ended June 30,  Six Months Ended June 30, 
     2020  2019  2020  2019 
    Revenues:               
    Net revenue — commercial product sales$6,985  $6,065  $14,985  $11,141 
    Revenue — collaborations and services 8,129   8,937   16,364   21,309 
    Total revenues 15,114   15,002   31,349   32,450 
    Expenses:               
    Cost of goods sold 3,677   4,327   7,841   8,347 
    Cost of revenue — collaborations and services 1,983   2,139   5,345   3,676 
    Research and development 1,464   1,632   3,219   3,299 
    Selling, general and administrative 13,670   16,609   28,020   42,282 
    Asset impairment 368      1,889    
    Loss (gain) on foreign currency translation 1,867   1,247   71   (688)
    Total expenses 23,029   25,954   46,385   56,916 
    Loss from operations (7,915)  (10,952)  (15,036)  (24,466)
    Other (expense) income:               
    Interest income 14   255   147   573 
    Interest expense on notes (1,084)  (564)  (2,155)  (1,157)
    Interest expense on promissory notes (1,281)  (1,109)  (2,540)  (2,189)
    Other income (expense) 14   (17)  10   (31)
    Total other expense (2,337)  (1,435)  (4,538)  (2,804)
    Loss before provision for income taxes (10,252)  (12,387)  (19,574)  (27,270)
    Provision for income taxes           
    Net loss$(10,252) $(12,387) $(19,574) $(27,270)
    Net loss per share - basic and diluted$(0.05) $(0.07) $(0.09) $(0.15)
    Shares used to compute basic and diluted net loss per

      share
     213,880   188,054   212,943   187,744 
                    

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  19. WESTLAKE VILLAGE, Calif., July 29, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2020 second quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, August 5, 2020.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412…

    WESTLAKE VILLAGE, Calif., July 29, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2020 second quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, August 5, 2020.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 7888638#. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diabetes and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:

    Phone: (818) 661-5000

    Email:

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  20. WESTLAKE VILLAGE, Calif., July 20, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that effective August 4, 2020, Alejandro Galindo, M.B.A, M.S., will be leading MannKind's commercial operations as Chief Commercial Officer. Mr. Galindo will report directly to Michael Castagna, Chief Executive Officer and will serve on the company's executive leadership team.

    "We are excited to welcome Alejandro to MannKind during a critical period of growth. He is an exceptional addition to our executive leadership team and will be a tremendous asset to us as we continue to expand our commercial organization," said Mr. Castagna. "I'm confident that Alejandro's strong leadership skills and extensive experience in product development…

    WESTLAKE VILLAGE, Calif., July 20, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that effective August 4, 2020, Alejandro Galindo, M.B.A, M.S., will be leading MannKind's commercial operations as Chief Commercial Officer. Mr. Galindo will report directly to Michael Castagna, Chief Executive Officer and will serve on the company's executive leadership team.

    "We are excited to welcome Alejandro to MannKind during a critical period of growth. He is an exceptional addition to our executive leadership team and will be a tremendous asset to us as we continue to expand our commercial organization," said Mr. Castagna. "I'm confident that Alejandro's strong leadership skills and extensive experience in product development, global expansion, diabetes, and distribution strategy will help position us for success in the future."

    Mr. Galindo joins MannKind with an accomplished track-record of over 25 years in the healthcare, energy, and consumer industries. He spent the past six years at Medtronic as Vice President and President of the Advanced Insulin Management Business Unit, where he led a fast-paced, double-digit growth global business within their diabetes division. Prior to Medtronic, Mr. Galindo spent nine years at General Electric (GE) Healthcare in a variety of leadership roles, leading emerging markets, strategic corporate development and global supply chain operations. Prior to joining GE's Healthcare division, he spent eleven years in various global leadership positions for the company's energy and appliance sectors, overseeing advanced manufacturing engineering and product development. Mr. Galindo received a B.Sc. in Industrial & Systems Engineering from Monterrey Institute of Technology, Mexico and M.B.A. and M.S. degrees from Indiana University.

    "I'm thrilled to join such an innovative company that is committed to transforming the standard of care for insulin-dependent diabetes and orphan lung diseases," said Mr. Galindo. "I know MannKind has a bright future ahead, and I look forward driving the commercial strategy and expanding access to novel treatment options for patients with unmet medical needs." 

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diabetes and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000



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  21. WESTLAKE VILLAGE, Calif., June 15, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) announced that new data from clinical studies of Afrezza® (insulin human) Inhalation Powder was presented at the American Diabetes Association's 80th Scientific Sessions, June 12-16, 2020.

    The data presented includes:

    • A comprehensive post hoc analysis of four unique studies assessing the safe and effective dosing of Afrezza in patients with type 1 diabetes1 (Poster 1023)
    • An analysis demonstrating treatment with Afrezza is associated with weight loss in patients with type 2 diabetes, compared to weight gain with injected mealtime insulin2 (Poster 1024)
    • An evaluation of a comprehensive two year safety study showing that significant changes in FEV1

    WESTLAKE VILLAGE, Calif., June 15, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) announced that new data from clinical studies of Afrezza® (insulin human) Inhalation Powder was presented at the American Diabetes Association's 80th Scientific Sessions, June 12-16, 2020.

    The data presented includes:

    • A comprehensive post hoc analysis of four unique studies assessing the safe and effective dosing of Afrezza in patients with type 1 diabetes1 (Poster 1023)
    • An analysis demonstrating treatment with Afrezza is associated with weight loss in patients with type 2 diabetes, compared to weight gain with injected mealtime insulin2 (Poster 1024)
    • An evaluation of a comprehensive two year safety study showing that significant changes in FEV1 (as a measure of pulmonary function) during treatment with Afrezza are both uncommon and generally transient in nature3 (Oral Abstract 235)

    "We are pleased to present these clinical studies detailing the safe and effective use of Afrezza at this year's virtual ADA Scientific Sessions," stated David Kendall, MD, Chief Medical Officer MannKind. "These studies provide further support of the effectiveness and clinical safety of Afrezza therapy and offer important insights on effective dosing of Afrezza, the favorable effect of Afrezza on body weight, and the improvement in clinical outcomes possible when converting patients to Afrezza therapy." 

    Highlights of the presentations are described below. See the appendix for presentation details.

    Poster 1023: Dose Titration and Clinical Effects of Inhaled Technosphere® Insulin Compared with Mealtime Subcutaneous (SC) Analog Insulin Therapy in Type 1 Diabetes (T1D)

    • Ultra rapid-acting Afrezza can be safely and effectively dosed at 1.5 to 2.0 times that of injected mealtime insulin
    • This dosing ratio appears to be consistent across a range of A1C responses
    • Afrezza's ultra rapid-acting profile may supersede the perceived precision of injected mealtime insulin dosing and provides patients the ability to flexibly dose based on glycemic response

    Poster 1024: Technosphere® Insulin Added to Basal Insulin Is Associated with Less Weight Gain than Basal Insulin plus Insulin Aspart or Insulin Analog (aspart) 70/30 Mixture in Type 2 DM

    • Patients with type 2 diabetes treated with Afrezza showed modest weight loss while those treated with insulin aspart or insulin aspart mix resulted in weight gain 
    • The weight difference estimate between Afrezza and insulin aspart was 1.83 pounds
    • The weight difference estimate between Afrezza and biaspart insulin was 3.17 pounds
    • The effect on body weight was independent of the magnitude of improvement in glucose control

    Oral Abstract 235: Incidence of Significant Changes in Pulmonary Function during A 2-year Study with Inhaled Technosphere® Insulin

    • Prior clinical studies have shown a modest (~40 ml) difference in mean change in FEV1 over two years when comparing treatment with Afrezza to other diabetes therapies
    • The majority (88%) of individuals treated with Afrezza had no significant change in FEV1 measured at any time
    • Overall, 98% of patients on Afrezza (vs. 99% of usual care) had either no significant change (≥15%) or were observed to have only a transient change in FEV1 over the two years of study

    About Afrezza®

    Available by prescription, Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit www.afrezza.com.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    MannKind Contact:

    Investor Relations

    818-661-5000

    Appendix – Presentation Details

    (1) Poster Presentation: Dose Titration and Clinical Effects of Inhaled Technosphere® Insulin Compared with Mealtime Subcutaneous (SC) Analog Insulin Therapy in Type 1 Diabetes (T1D)

    Presenter: David M. Kendall, M.D.

    Poster No. 1023-P

    Date/Time: Saturday, June 13; 10 AM CT

    (2) Poster Presentation: Technosphere® Insulin Added to Basal Insulin Is Associated with Less Weight Gain than Basal Insulin plus Insulin Aspart or Insulin Analog (aspart) 70/30 Mixture in Type 2 DM

    Presenter: David M. Kendall, M.D.

    Poster No: 1024-P

    Date/Time: Saturday, June 13; 10 AM CT

    (3) Oral Presentation: Incidence of Significant Changes in Pulmonary Function during A 2-year Study with Inhaled Technosphere® Insulin

    Presenter: David M. Kendall, M.D.

    Poster No: 235-OR

    Date/Time: Sunday, June 14; 5:30 PM CT

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  22. WESTLAKE VILLAGE, Calif., June 13, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) announced that data from a new clinical study of Afrezza® (insulin human) Inhalation Powder will be presented at the American Diabetes Association's 80th Scientific Sessions during the ePoster session (Poster 990) on Saturday, June 13, 2020.

    The lead author, Mark Kipnes, MD (Diabetes and Glandular Disease Clinic, San Antonio, Texas) presented clinical data from an investigator-initiated observational "switch" study that evaluated quality of life and glucose control in patients with type 2 diabetes previously treated with injected mealtime insulin. Following conversion to Afrezza, patients were followed for 14 weeks, and glucose control (measured…

    WESTLAKE VILLAGE, Calif., June 13, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) announced that data from a new clinical study of Afrezza® (insulin human) Inhalation Powder will be presented at the American Diabetes Association's 80th Scientific Sessions during the ePoster session (Poster 990) on Saturday, June 13, 2020.

    The lead author, Mark Kipnes, MD (Diabetes and Glandular Disease Clinic, San Antonio, Texas) presented clinical data from an investigator-initiated observational "switch" study that evaluated quality of life and glucose control in patients with type 2 diabetes previously treated with injected mealtime insulin. Following conversion to Afrezza, patients were followed for 14 weeks, and glucose control (measured by both A1C and glucose time in range), rates of hypoglycemia and quality of life were assessed.

    Study subjects experienced a significant (0.8%) reduction in A1C levels at the end of the 14-week treatment period after switching from their injected mealtime insulin to Afrezza. Subjects maintained 66-69% "time in range" (time with glucose values in the range of 70-180 mg/dL) and reduced the time spent with glucose <90 mg/dL. Afrezza therapy resulted in a significant improvement in diabetes quality of life scores. 

    "This study shows that Afrezza treatment—combined with the use of continuous glucose monitoring—can improve overall glucose control while maintaining time in range. Importantly, the study also demonstrates a reduction in blood glucose levels without additional hypoglycemia," stated Dr. Kipnes. "In addition, after switching to Afrezza, these individuals reported an improvement in quality of life measures. This study demonstrates that by rapidly adjusting Afrezza doses, improved clinical outcomes were possible, and patients reported less burden from their diabetes treatment."

    MannKind provided financial support and study product for use in this study. 

    About Afrezza®

    Available by prescription, Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit www.afrezza.com.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    MannKind Contact:

    Investor Relations

    818-661-5000

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  23. Conference Call to Begin Today at 5:00 PM ET

    • 1Q 2020 Afrezza Net Revenue of $8.0 million; +58% vs. 1Q 2019
    • 1Q 2020 Afrezza gross profit 48% vs. 21% in 1Q 2019
    • Non-GAAP Net Cash Used in Operating Activities in 1Q 2020 was $11.2 million; a reduction of 53% vs. 1Q 2019

    WESTLAKE VILLAGE, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the quarter ended March 31, 2020.

    "We are pleased to report first quarter Afrezza net revenue of $8.0 million, which is 58% higher than the same quarter in 2019," said Michael Castagna, Chief Executive Officer of MannKind Corporation.  "We believe that some of the increased revenue this quarter reflects the impact of patients stocking up on extra refills…

    Conference Call to Begin Today at 5:00 PM ET

    • 1Q 2020 Afrezza Net Revenue of $8.0 million; +58% vs. 1Q 2019
    • 1Q 2020 Afrezza gross profit 48% vs. 21% in 1Q 2019
    • Non-GAAP Net Cash Used in Operating Activities in 1Q 2020 was $11.2 million; a reduction of 53% vs. 1Q 2019

    WESTLAKE VILLAGE, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the quarter ended March 31, 2020.

    "We are pleased to report first quarter Afrezza net revenue of $8.0 million, which is 58% higher than the same quarter in 2019," said Michael Castagna, Chief Executive Officer of MannKind Corporation.  "We believe that some of the increased revenue this quarter reflects the impact of patients stocking up on extra refills in advance of the stay-at-home orders that have since been implemented across the country.  In response to the COVID-19 pandemic, we have rapidly implemented digital tools and programs to help our sales force and our Afrezza prescribers navigate this challenging time for our healthcare system.  In addition, our manufacturing and development team in Connecticut remain focused on maintaining supply of Afrezza and meeting our obligations under our collaboration with United Therapeutics."

    Total revenues were $16.2 million for the first quarter of 2020, reflecting Afrezza net revenue of $8.0 million and collaboration and services revenue of $8.2 million. Afrezza net revenue increased 58% compared to $5.1 million in the first quarter of 2019, primarily driven by higher product demand as well as a price increase and a more favorable mix of cartridges. Collaboration and services revenue for the first quarter of 2020 decreased $4.2 million compared to the first quarter of 2019, primarily due to the substantial completion of the research agreement with United Therapeutics in the second quarter of 2019. 

    Afrezza gross profit for the first quarter of 2020 was $3.8 million vs. $1.1 million in the same period of 2019, a 263% increase that was driven primarily by higher Afrezza revenue.  Cost of goods sold increased by $0.1 million which included an increase related to Afrezza unit sales growth and an inventory write-off offset by a greater amount of costs capitalized to inventory due to a higher volume of manufacturing activities in the first quarter of 2020. Gross margin in the first quarter of 2020 increased to 48%, our highest gross margin to date, from 21% for the same quarter in 2019, primarily due to higher Afrezza revenue.

    Selling, general and administrative expenses for the first quarter of 2020 were $14.4 million compared to $25.7 million for the first quarter of 2019. This 44% decrease was primarily due to $9.3 million spent on direct-to-consumer television advertising in 2019, which was not repeated in 2020, a $1.1 million decrease in promotional and marketing activities and $0.8 million decrease in personnel and employee related costs.  

    Net interest expense for the first quarter of 2020 was $2.2 million compared to $1.4 million for the first quarter of 2019. This $0.8 million increase was due to a higher balance of outstanding principal and an increase in the interest rate of certain promissory notes. 

    The net loss for the first quarter of 2020 was $9.3 million, or $0.04 per share, compared to a $14.9 million net loss in the first quarter of 2019, or $0.08 per share. The lower net loss is mainly attributable to a decrease in operating expenses of $7.6 million. The reduction in the net loss per share was impacted by the lower operating expenses and a greater number of outstanding shares.

    Cash, cash equivalents and restricted cash at March 31, 2020 was $39.2 million compared to $50.2 million at December 31, 2019, which also included short-term investments of $20.0 million. The decrease was primarily due to net cash used in operating activities of $11.2 million in the first quarter of 2020. 

    Non-GAAP Measures

    Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis.  Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below.  Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods.  The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

        Three Months Ended March 31,  
        2020     2019     $ Change     % Change  
    Net cash used in operating activities   $ (11,219 )   $ (11,597 )   $ (378 )     (3 %)
    Exclude United Therapeutic milestone payment received           (12,500 )     (12,500 )     (100 %)
    Non-GAAP cash used in operating activities   $ (11,219 )   $ (24,097 )   $ (12,878 )     (53 %)

    Conference Call

    MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 7127207#. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC, including risks related to the COVID-19 pandemic. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:

    818-661-5000

    MANNKIND CORPORATION
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (Unaudited)
    (In thousands except share data)

      March 31, 2020     December 31, 2019  
    ASSETS              
    Current assets:              
    Cash and cash equivalents $ 38,868     $ 29,906  
    Restricted cash   316       316  
    Short-term investments         19,978  
    Accounts receivable, net   5,032       3,513  
    Inventory   3,231       4,155  
    Prepaid expenses and other current assets   1,901       2,889  
    Total current assets   49,348       60,757  
    Property and equipment, net   26,517       26,778  
    Other assets   4,347       6,190  
    Total assets $ 80,212     $ 93,725  
                   
    LIABILITIES AND STOCKHOLDERS' DEFICIT              
    Current liabilities:              
    Accounts payable $ 6,731     $ 4,789  
    Accrued expenses and other current liabilities   18,326       15,904  
    Short-term note payable   5,101       5,028  
    Deferred revenue — current   30,840       32,503  
    Recognized loss on purchase commitments — current   7,250       7,394  
    Total current liabilities   68,248       65,618  
    Promissory notes   70,022       70,020  
    Accrued interest — promissory notes   3,259       2,002  
    Long-term Midcap credit facility   38,893       38,851  
    Senior convertible notes   5,000       5,000  
    Recognized loss on purchase commitments — long term   82,987       84,639  
    Operating lease liability   2,155       2,514  
    Deferred revenue  — long term   1,772       8,344  
    Milestone rights liability   5,926       7,263  
    Total liabilities   278,262       284,251  
    Stockholders' deficit:              
    Undesignated preferred stock, $0.01 par value — 10,000,000 shares authorized;
      no shares issued or outstanding as of March 31, 2020 and December 31, 2019
             
    Common stock, $0.01 par value - 280,000,000 shares authorized, 213,137,684 and 211,787,573
      shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
      2,131       2,118  
    Additional paid-in capital   2,801,044       2,799,278  
    Accumulated other comprehensive loss         (19 )
    Accumulated deficit   (3,001,225 )     (2,991,903 )
    Total stockholders' deficit   (198,050 )     (190,526 )
    Total liabilities and stockholders' deficit $ 80,212     $ 93,725  
                   

    MANNKIND CORPORATION
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
    (In thousands, except per share amounts)

      Three Months Ended March 31,  
      2020     2019  
    Revenues:              
    Net revenue — commercial product sales $ 8,000     $ 5,076  
    Revenue — collaborations and services   8,235       12,372  
    Total revenues   16,235       17,448  
    Expenses:              
    Cost of goods sold   4,164       4,020  
    Cost of revenue — collaborations and services   3,362       1,537  
    Research and development   1,755       1,667  
    Selling, general and administrative   14,350       25,673  
    Impairment of commitment asset   1,521        
    Gain on foreign currency translation   (1,796 )     (1,935 )
    Total expenses   23,356       30,962  
    Loss from operations   (7,121 )     (13,514 )
    Other (expense) income:              
    Interest income   133       318  
    Interest expense on notes   (1,071 )     (593 )
    Interest expense on promissory notes   (1,259 )     (1,080 )
    Other expense   (4 )     (14 )
    Total other expense   (2,201 )     (1,369 )
    Loss before provision for income taxes   (9,322 )     (14,883 )
    Provision for income taxes          
    Net loss $ (9,322 )   $ (14,883 )
    Net loss per share - basic and diluted $ (0.04 )   $ (0.08 )
    Shares used to compute basic and diluted net loss per share   212,467       187,434  

     

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  24. WESTLAKE VILLAGE, Calif., April 29, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2020 first quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, May 6, 2020.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671…

    WESTLAKE VILLAGE, Calif., April 29, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2020 first quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, May 6, 2020.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 7127207#. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:
    Phone: (818) 661-5000
    Email:

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  25. WESTLAKE VILLAGE, Calif., March 24, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that Jennifer Grancio has been appointed to its Board of Directors, effective March 23, 2020. Ms. Grancio will also serve as a member of the Audit Committee of the Board. Ms. Grancio brings to MannKind over twenty years of financial services experience and an expertise in creating disruptive business models.

    "We are excited to welcome Ms. Grancio and her years of invaluable leadership to our board of directors," said Kent Kresa, Chairman of the Board. "Her financial services leadership experience will be an essential asset for MannKind as the company continues to grow. We are committed to surrounding ourselves with the best talent…

    WESTLAKE VILLAGE, Calif., March 24, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that Jennifer Grancio has been appointed to its Board of Directors, effective March 23, 2020. Ms. Grancio will also serve as a member of the Audit Committee of the Board. Ms. Grancio brings to MannKind over twenty years of financial services experience and an expertise in creating disruptive business models.

    "We are excited to welcome Ms. Grancio and her years of invaluable leadership to our board of directors," said Kent Kresa, Chairman of the Board. "Her financial services leadership experience will be an essential asset for MannKind as the company continues to grow. We are committed to surrounding ourselves with the best talent available, and the appointment of Ms. Grancio reflects that effort."

    Ms. Grancio served as a founder and executive with BlackRock's iShares business from 1999 to 2018. She spearheaded the distribution of iShares in the United States and Europe and acted as the Global Head of Marketing and Partnerships for BlackRock's indexing service. Through those efforts, Ms. Grancio established herself as a global leader in exchange-traded and mutual funds.

    Since her time at BlackRock, she founded Grancio Capital, where she consults with company leaders on the best ways to expand market reach and how to build effective teams to do so. Previously, she was a senior associate with PricewaterhouseCoopers, a management consulting firm.

    Ms. Grancio has served as a board member for Ethic, a sustainable investing firm, since November 2019. She serves on the board of Harvest Savings & Wealth as of Q1 2020 and is on the advisory boards of Say Technologies and m+ funds. Ms. Grancio is also active as a strategic advisor and speaker to organizations that are committed to developing diverse senior leaders and to developing leadership in young women.

    She earned a bachelor's degree in economics and international relations from Stanford University, and an MBA degree in strategy and finance from Columbia Business School.

    With the addition of Ms. Grancio, there are nine members of the MannKind Board of Directors.

    About MannKind Corporation
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:
    818-661-5000

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  26. WESTLAKE VILLAGE, Calif., March 17, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products, today announced that it is adjusting research and development resources that were reserved for its pipeline of investigational products for treating serious lung diseases, with the goal of prioritizing work on new compounds that may have the potential to address the morbidity and mortality associated with respiratory viral infections, such as COVID-19.  

    Specifically, MannKind has initiated a collaboration with Immix Biopharma, Inc. to prepare a dry powder formulation of a compound with the potential to treat acute respiratory distress syndrome, a complication…

    WESTLAKE VILLAGE, Calif., March 17, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products, today announced that it is adjusting research and development resources that were reserved for its pipeline of investigational products for treating serious lung diseases, with the goal of prioritizing work on new compounds that may have the potential to address the morbidity and mortality associated with respiratory viral infections, such as COVID-19.  

    Specifically, MannKind has initiated a collaboration with Immix Biopharma, Inc. to prepare a dry powder formulation of a compound with the potential to treat acute respiratory distress syndrome, a complication of COVID-19.  The immediate focus of this effort is to rapidly develop prototype powders, which will then be assessed for their potential to be used therapeutically.  Other collaborations are being actively explored at this time.

    MannKind is committed to joining the global effort to overcome the COVID-19 crisis.  MannKind's formulation and drug development expertise as well as its excess manufacturing capacity will be deployed as necessary to help protect humankind from this global health crisis. 

    Formulations for Pulmonary Delivery
    MannKind's Technosphere® technology is an innovative, dry-powder formulation technology that allows medication to be delivered to the lungs.  MannKind has successfully prepared Technosphere formulations of anionic and cationic drugs, hydrophobic and hydrophilic drugs, proteins, peptides and small molecules. Technosphere powders are based on a proprietary excipient, fumaryl diketopiperazine (FDKP), which is a pH-sensitive organic molecule that self-assembles into small particles under acidic conditions. Active pharmaceutical ingredients can be loaded onto these particles, which are then dried to powder form. The resulting powder has a consistent and narrow range of particle sizes with good aerodynamic properties that enable efficient delivery deep into the lungs. Technosphere powders dissolve quickly when the particles contact the moist lung surface with its neutral pH, releasing the drug molecules to diffuse across a thin layer of cells into the arterial circulation, bypassing the liver to provide excellent systemic exposure. 

    Drug Delivery Devices
    MannKind has also created an innovative line of breath-powered, dry powder inhalers. Its inhalers are easy to use, cost-effective and can be produced in both a reusable (chronic treatment) and a single-use (acute treatment) format. Both the reusable and single-use inhaler formats use the same internal air-flow design. Being breath-powered, our inhalers require only the patient's inhalation effort to deliver the powder. The inhalers are engineered to produce an aggressive airstream that de-agglomerates the powder while keeping the powder moving relatively slowly. This slow-moving powder effectively navigates the patient's airways to reach the deep lung with minimal deposition at the back of the throat. MannKind's inhalers show very little change in performance (i.e., efficient cartridge emptying) over a wide range of inhalation efforts.

    Manufacturing Capability
    MannKind's 328,000 square foot R&D and manufacturing facility is located in Danbury, Connecticut and has a full range of development and manufacturing capabilities, including analytical, chemical, formulation, filling and packaging.  The facility houses two 61 square meter lyophilizers and has sufficient filling capacity to produce more than 300 million cartridges of inhaled drug annually.  The quality management systems of the facility have been certified to be in conformance with the ISO 13485 and MD-SAP standards and was inspected most recently by the U.S. Food and Drug Administration in June 2018, at which time there were no inspectional observations. 

    About Immix Biopharma
    Immix Biopharma, Inc. is a privately-held, biopharmaceutical firm focused on developing safe and effective therapies for cancer patients. The company was founded by Vladimir Torchilin, Ph.D., D.Sc., Director of the Center for Pharmaceutical Biotechnology and Nanomedicine at Northeastern University; physician-scientist and clinical researcher Ilya Rachman, MD, PhD, MBA; and Sean D. Senn, JD, MSc., MBA, a senior biotechnology patent attorney. Immix is focused on harnessing scientific advances in order to engineer transformative and effective cancer treatments. For more information visit www.immixbio.com.

    About MannKind
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    MannKind Contacts:
    Investor Relations
    818-661-5000

    Collaborations
    (818) 661-5001
    B

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    • 2019 Total Revenue of $63.0 million

    ° 2019 Afrezza Net Revenue of $25.3 million; +46% vs. 2018
    ° 2019 Collaborations and Services Revenue of $37.7 million; +257% vs. 2018

    • 4Q 2019 Total Revenue of $16.0 million

    ° 4Q 2019 Afrezza Net Revenue of $7.8 million; +35% vs. 4Q 2018

    ▪ 4Q 2019 Afrezza Net Revenue grew 22% vs. 3Q 2019
    ▪ 4Q 2019 Afrezza Gross Profit $3.1 million; 40% Gross Margin

    ° 4Q 2019 Collaborations and Services Revenue of $8.2 million; -20% vs. 4Q 2018

    • $50.2 million of Cash, Cash Equivalents, Restricted Cash, and Short-term Investments at December 31, 2019

    WESTLAKE VILLAGE, Calif., Feb. 25, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the fourth quarter and full year ended December…

    • 2019 Total Revenue of $63.0 million

    ° 2019 Afrezza Net Revenue of $25.3 million; +46% vs. 2018
    ° 2019 Collaborations and Services Revenue of $37.7 million; +257% vs. 2018

    • 4Q 2019 Total Revenue of $16.0 million

    ° 4Q 2019 Afrezza Net Revenue of $7.8 million; +35% vs. 4Q 2018

    ▪ 4Q 2019 Afrezza Net Revenue grew 22% vs. 3Q 2019
    ▪ 4Q 2019 Afrezza Gross Profit $3.1 million; 40% Gross Margin

    ° 4Q 2019 Collaborations and Services Revenue of $8.2 million; -20% vs. 4Q 2018

    • $50.2 million of Cash, Cash Equivalents, Restricted Cash, and Short-term Investments at December 31, 2019

    WESTLAKE VILLAGE, Calif., Feb. 25, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported financial results for the fourth quarter and full year ended December 31, 2019.

    "We ended 2019 on a strong note with fourth quarter 2019 Afrezza net revenue of $7.8 million, our best quarter to date," said Michael Castagna, Chief Executive Officer of MannKind Corporation. He also noted, "Our collaboration with United Therapeutics on TreT continues to make progress along the clinical and commercial pathways that are expected to set up a filing with the FDA within 12 months."

    Fourth Quarter 2019 Results

    Total revenues were $16.0 million for the fourth quarter of 2019, reflecting Afrezza net revenue of $7.8 million and collaborations and services revenue of $8.2 million. Afrezza net revenue increased 35% compared to $5.7 million in the fourth quarter of 2018, primarily driven by higher product demand and price.  Collaborations and services revenue decreased $2.1 million compared to the fourth quarter of 2018, primarily due to lower revenue from the United Therapeutics research agreement, which was substantially completed by the second quarter of 2019.

    On a GAAP basis, Afrezza gross profit was $3.1 million for the fourth quarter of 2019 compared to $0.7 million in the same period in 2018.  Afrezza cost of goods sold for the fourth quarter of 2018 included a fee of $2.0 million recorded in connection with the amendment of our insulin supply agreement with Amphastar. As a result, on a non-GAAP basis, gross profit was $2.7 million or 48% gross margin for the fourth quarter of 2018, compared to a GAAP basis gross margin of 40% for the fourth quarter of 2019.

    Research and development (R&D) expenses for the fourth quarter of 2019 were $2.0 million compared to $1.1 million for the fourth quarter of 2018. This 82% increase was primarily attributable to an increase of $0.6 million in personnel costs associated with the United Therapeutics research agreement, which was classified as a cost of collaborations and services revenue in 2018, and to an increase of $0.3 million in maintenance costs for our research facility in Danbury, Connecticut.

    Selling, general and administrative (SG&A) expenses for the fourth quarter of 2019 were $15.7 million compared to $18.0 million for the fourth quarter of 2018. This decrease of $2.3 million, or 13%, was primarily attributable to a $1.7 million decrease in personnel related costs and a $1.1 million decrease in Afrezza marketing costs, partially offset by an increase of $0.5 million in consulting and professional services costs.

    Interest expense on debt for the fourth quarter of 2019 was $2.3 million compared to $1.7 million for the fourth quarter of 2018. This $0.6 million increase, or 35%, was primarily attributable to the net increase in our debt balance as a result of our debt restructuring in the third quarter of 2019.

    The net loss for the fourth quarter of 2019 was $14.3 million, or $0.07 per share compared to a $9.8 million net loss in the fourth quarter of 2018 or $0.06 per share. The increase in the net loss of $4.5 million was primarily the result of an increased loss on foreign currency translation of $4.0 million associated with our insulin supply agreement denominated in Euros and of an increase of $0.6 million in interest expense.

    Twelve Months Ended December 31, 2019 

    Total revenues were $63.0 million for the year ended December 31, 2019, reflecting Afrezza net revenue of $25.3 million and collaborations and services revenue of $37.7 million. Afrezza net revenue increased 46% compared to $17.3 million for the year ended December 31, 2018, primarily due to higher product demand, the first sale of Afrezza to our marketing partner in Brazil (Biomm), price increases as well as a more favorable mix of Afrezza cartridges. Collaborations and services revenue increased $27.2 million compared to the full year ended December 31, 2018, which was primarily attributed to the licensing and research agreements with United Therapeutics, both of which began in the fourth quarter of 2018.

    On a GAAP basis, Afrezza gross profit was $5.2 million for the year ended December 31, 2019, an improvement of $7.3 million or 347% compared to a gross loss of $2.1 million in the same period in 2018, primarily due to an increase of $8.0 million in net revenue and a $2.2 million decrease in inventory write-offs, partially offset by increased costs due to higher sales and an increase of $0.8 million in fees paid to Amphastar for amendments to our insulin supply agreement. As a result, on a non-GAAP basis, gross profit was $8.0 million, or 32%, for the year ended December 31, 2019 compared to a gross loss of $0.1 million, or 1%, for the full year ended December 31, 2018.

    R&D expenses for the year ended December 31, 2019 were $6.9 million compared to $8.7 million for the year ended December 31, 2018. This decrease of $1.8 million, or 21%, was primarily attributable to a $1.7 million decrease in personnel related costs and a $0.9 million decrease in clinical trial spending, partially offset by increased expenses of $0.2 million related to the development of our BluHale inhalation profiling apparatus and increased facility maintenance and equipment repair costs of $0.5 million.

    SG&A expenses for the year ended December 31, 2019 were $74.7 million compared to $79.7 million for the year ended December 31, 2018. This decrease of $5.0 million, or 6%, was primarily attributable to a $6.6 million decrease in personnel and employee related costs, decreased consulting costs of $2.5 million and a $1.2 million decrease in stock-based compensation costs, which was partially offset by a $5.6 million increase in costs for television advertising for Afrezza.

    Interest income increased by $0.5 million, or 99%, for the year ended December 31, 2019 compared to the year ended December 31, 2018, primarily due to a higher average balance on money market funds and short-term investments.

    Interest expense on debt for the year ended December 31, 2019 was $10.9 million compared to $9.4 million for the year ended December 31, 2018. This $1.5 million increase was primarily attributable to a $3.4 million charge realized as a result of achieving a sales milestone in the third quarter of 2019 under our milestone agreement with Deerfield, partially offset by lower interest as a result of the repayment of the Deerfield credit facility.  

    The net loss for the year ended December 31, 2019 was $51.9 million, or $0.27 per share, compared to $87.0 million net loss for the year ended December 31, 2018, or $0.60 per share. The lower net loss was mainly attributable to a $35.2 million increase in total revenues.

    Cash, Cash Equivalents, Restricted Cash and Short Term Investments

    Cash, cash equivalents, restricted cash, and short-term investments at December 31, 2019 was $50.2 million compared to $71.7 million at December 31, 2018.

    Non-GAAP Measures

    Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis.  Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below.  Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods.  The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

        Three Months Ended December 31,  
        2019     2018     $ Change     % Change  
    Net revenue — Afrezza   $ 7,761     $ 5,734     $ 2,027       35 %
    Less cost of goods sold     (4,632 )     (4,986 )   $ (354 )     (7 %)
    GAAP gross profit  — Afrezza     3,129       748     $ 2,381       318 %
    Exclude Amphastar amendment fee           2,000     $ (2,000 )     (100 %)
    Non-GAAP gross profit  — Afrezza   $ 3,129     $ 2,748     $ 381       14 %
    Non-GAAP gross margin     40 %     48 %                
                                     
        Twelve Months Ended December 31,  
        2019     2018     $ Change     % Change  
    Net revenue — Afrezza   $ 25,304     $ 17,276     $ 8,028       46 %
    Less cost of goods sold     (20,078 )     (19,392 )   $ 686       4 %
    GAAP gross profit (loss)  — Afrezza     5,226       (2,116 )   $ 7,342       347 %
    Exclude Amphastar amendment fee     2,750       2,000     $ 750       38 %
    Non-GAAP gross profit (loss)  — Afrezza   $ 7,976     $ (116 )   $ 8,092       6,976 %
    Non-GAAP gross margin     32 %     (1 %)                


    Conference Call

    MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. To participate in the live call by telephone, please dial (800) 289-0438 or (323) 794-2423 and use the participant passcode: 1233728. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 1233728. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.  

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding MannKind's ability to directly commercialize pharmaceutical products. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability to generate significant product sales for MannKind, MannKind's ability to manage its existing cash resources or raise additional cash resources, stock price volatility and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:
    818-661-5000

    MANNKIND CORPORATION AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
    (In thousands, except per share data)

         Three Months Ended December 31,     Twelve Months Ended December 31,  
        2019     2018     2019     2018  
                                     
    Revenues:                                
    Net revenue — commercial product sales   $ 7,761     $ 5,734     $ 25,304     $ 17,276  
    Revenue — collaborations and services     8,232       10,351       37,734       10,583  
    Revenue — other           (53 )            
    Total revenues     15,993       16,032       63,038       27,859  
    Expenses:                                
    Cost of goods sold     4,632       4,986       20,078       19,392  
    Cost of revenue — collaborations and services     2,389       1,077       7,901       1,077  
    Research and development     2,021       1,084       6,900       8,737  
    Selling, general and administrative     15,721       17,976       74,669       79,716  
    Loss (gain) on foreign currency translation     2,582       (1,361 )     (1,913 )     (4,468 )
    Total expenses     27,345       23,762       107,635       104,454  
    Loss from operations     (11,352 )     (7,730 )     (44,597 )     (76,595 )
    Other (expense) income:                                
    Interest income     204       196       997       501  
    Interest expense on notes     (1,021 )     (620 )     (6,304 )     (5,116 )
    Interest expense on promissory notes     (1,251 )     (1,089 )     (4,602 )     (4,323 )
    Gain (loss) on extinguishment of debt                 3,529       (765 )
    Other expense     (843 )     (508 )     (926 )     (437 )
    Total other expense     (2,911 )     (2,021 )     (7,306 )     (10,140 )
    Loss before income tax expense     (14,263 )     (9,751 )     (51,903 )     (86,735 )
    Provision for income taxes                       240  
    Net loss   $ (14,263 )   $ (9,751 )   $ (51,903 )   $ (86,975 )
    Net loss per share — basic and diluted   $ (0.07 )   $ (0.06 )   $ (0.27 )   $ (0.60 )
    Shares used to compute net loss per share — basic and diluted     206,689       161,397       195,584       144,136  


    MANNKIND CORPORATION AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (Unaudited)
    (In thousands, except per share data)

        December 31,  
        2019     2018  
                 
        (In thousands except per share data)  
    ASSETS                
    Current assets:                
    Cash and cash equivalents   $ 29,906     $ 71,157  
    Restricted cash     316       527  
    Short-term investments     19,978        
    Accounts receivable, net     3,513       4,017  
    Inventory     4,155       3,597  
    Prepaid expenses and other current assets     2,889       2,556  
    Total current assets     60,757       81,854  
    Property and equipment, net     26,778       25,602  
    Other assets     6,190       249  
    Total assets   $ 93,725     $ 107,705  
                     
    LIABILITIES AND STOCKHOLDERS' DEFICIT                
    Current liabilities:                
    Accounts payable   $ 4,789     $ 5,379  
    Accrued expenses and other current liabilities     15,904       15,022  
    Facility financing obligation           11,298  
    Short-term note payable     5,028        
    Deferred revenue — current     32,503       36,885  
    Recognized loss on purchase commitments — current     7,394       6,657  
    Total current liabilities     65,618       75,241  
    Promissory notes     70,020       72,089  
    Accrued interest — promissory notes     2,002       6,835  
    Long-term Midcap credit facility     38,851        
    Senior convertible notes     5,000       19,099  
    Recognized loss on purchase commitments — long term     84,639       91,642  
    Operating lease liability     2,514        
    Deferred revenue  — long term     8,344       10,680  
    Milestone rights liability     7,263       7,201  
    Total liabilities     284,251       282,787  
    Commitments and contingencies                
    Stockholders' deficit:                
    Undesignated preferred stock, $0.01 par value — 10,000,000 shares authorized;
      no shares issued or outstanding at December 31, 2019 and 2018
               
    Common stock, $0.01 par value — 280,000,000 shares authorized,
      211,787,573 and 187,029,967 shares issued and outstanding at December 31, 2019
      and 2018, respectively
        2,118       1,870  
    Additional paid-in capital     2,799,278       2,763,067  
    Accumulated other comprehensive loss     (19 )     (19 )
    Accumulated deficit     (2,991,903 )     (2,940,000 )
    Total stockholders' deficit     (190,526 )     (175,082 )
    Total liabilities and stockholders' deficit   $ 93,725     $ 107,705  

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  27. WESTLAKE VILLAGE, Calif., Feb. 24, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, announced today that it will be featured as a presenting company at the 9th Annual SVB Leerink Global Healthcare Conference on Thursday, February 27, 2020 at 9:30 am (ET) at the Lotte New York Palace Hotel in New York, NY. Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD. Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company's website at http://www.mannkindcorp.com. The…

    WESTLAKE VILLAGE, Calif., Feb. 24, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, announced today that it will be featured as a presenting company at the 9th Annual SVB Leerink Global Healthcare Conference on Thursday, February 27, 2020 at 9:30 am (ET) at the Lotte New York Palace Hotel in New York, NY. Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD. Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:
    818-661-5000
     

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  28. WESTLAKE VILLAGE, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKDtoday announced the presentation of results from multiple clinical studies of Afrezza® (insulin human) Inhalation Powder and MannKind's BluHale® technology system. These data are being presented in both oral and poster presentations during the 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020) in Madrid Spain, February 20-22, 2020. 

    "We are very pleased to have the opportunity to highlight these positive results during this year's ATTD," stated Dr. David Kendall, Chief Medical Officer of MannKind. "These presentations highlight original studies of Afrezza in individuals with both type 1 and type 2 diabetes…

    WESTLAKE VILLAGE, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKDtoday announced the presentation of results from multiple clinical studies of Afrezza® (insulin human) Inhalation Powder and MannKind's BluHale® technology system. These data are being presented in both oral and poster presentations during the 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020) in Madrid Spain, February 20-22, 2020. 

    "We are very pleased to have the opportunity to highlight these positive results during this year's ATTD," stated Dr. David Kendall, Chief Medical Officer of MannKind. "These presentations highlight original studies of Afrezza in individuals with both type 1 and type 2 diabetes, and include initial studies of Afrezza in pediatric patients. In addition to the results of clinical studies, we are pleased to disclose novel data on the use of BluHale, our Bluetooth-enabled technology for real-time profiling of inhalation effort and other parameters associated with the use of our inhaler. Collectively, these data further expand our understanding of the unique clinical profile of Afrezza, and highlight the potential use of Afrezza in children and adolescents, as well as advancing the opportunity to create connected technology for our drug delivery system." 

    Highlights of the original scientific disclosures:

    • Preliminary data from an independent, investigator initiated study of Afrezza on the background of closed loop pump insulin delivery by means of an "artificial pancreas" system showed that pulmonary dosing allows for titration to higher unit doses in individuals with type 1 diabetes (presented by Alfonso Galderisi MD, PhD from Yale University).
    • Clinical use of Afrezza in adults with uncontrolled type 2 diabetes on two or more glucose lowering therapies resulted in a significant (1.6%) drop in A1c levels and a significant increase in time in range (presented by Dr. Philip Levin MD, Endocrinology, MODEL Clinical Research).
    • Pharmacokinetics (and pharmacodynamics) of Technosphere insulin in children and adolescents ages 8-17 with type 1 diabetes showed that the ultra rapid rise in insulin concentrations corresponded with early post-prandial glucose control within the first hour post-dose, similar to what has been observed in adult patients.
    • Two poster presentations highlighting the use of MannKind's unique Bluetooth enabled technology for enhanced instruction on use of the Afrezza inhaler and as a tool to provide connected dose information on top of continuous glucose monitoring data. 

    Dr. Phillip Levin, Principal Investigator from MODEL Clinical Research in Baltimore, MD and lead author on the study of uncontrolled type 2 diabetes patients, noted that "the addition and rapid titration of Afrezza in patients with type 2 diabetes not currently at goal using two or more glucose lowering therapies, resulted in a 1.6% reduction in A1C and significantly increased time in range as measured by CGM. Our study provides additional clarity on both dose requirements and the clinical impact of adding ultra rapid-acting Afrezza therapy in uncontrolled type 2 diabetes."

    In addition to the original scientific disclosure presented at this year's ATTD meeting, Dr. Kendall will participate as faculty in the "Ultra-rapid Insulin Analogues" session on Saturday, February 22, during which he will provide a current perspective on the clinical use of Afrezza, including evidence that ultra rapid-acting Afrezza can be safely and effectively titrated in fixed dose increments and that speed of insulin action may supersede dose precision for achieving post-prandial glucose control.

    The full title of each of the presentations, presenting author, and the date and time of each disclosure are provided below.

    ORAL PRESENTATION HIGHLIGHTS
       
    Title:  Technosphere® Insulin Provides Better Early Postprandial Glucose Control Than Subcutaneous Rapid-Acting Analogue
    (ATTD 2020 - Saturday February 22, 2020; 8:50 – 9:00 a.m. – Berlin Room)
       
    Presenter: David Kendall, MD, MannKind Corporation
       
    ELECTRONIC POSTER PRESENTATION HIGHLIGHTS
       
    Title: Patient Trainer Experience with BluHale® V1.0 for Proper Technosphere® Insulin Administration
    (ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
       
    Presenter: Nadia Zaveri, PharmD, MannKind Corporation
       
       
    Title: Safety and Pharmacokinetics of Technosphere® Insulin in Pediatric Patients
    (ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
       
    Presenter: David Kendall, MD, MannKind Corporation
       
       
    Title: Insights to Improve Use of Technosphere® Insulin Provided By BluHale®, a Digital Diabetes Tool
    (ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
       
    Presenter: Benoit Adamo, MannKind Corporation
       
       
    Title: Effective Treatment of Patients with Uncontrolled Type 2 Diabetes On Multiple Diabetes Medications By Adding Mealtime Ultra-rapid Technosphere® Insulin
    (ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
       
    Presenter: Philip Levin, MD, Endocrinology, MODEL Clinical Research
       
       
    Title: Afrezza® Pre-meal Bolus Reduces Early Glycemic Excursion During Hybrid Closed Loop Treatment
    (ATTD 2020 – Saturday, February 22, 2020; 8:30 a.m.)
       
    Presenter: Alfonso Galderisi, MD, PhD, Yale University

    About ATTD Annual Meeting
    The ATTD is a scientific program that brings leading international experts together to discuss breakthroughs in diabetes treatments, technological innovations and showcase the latest developments in new insulin analogues, delivery systems, pumps, glucose sensors, closed-loop systems and much more.

    About Afrezza®
    Available by prescription, Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.

    About MannKind
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's quarterly report on Form 10-Q for the quarter ended September 30, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    MannKind Contact:
    818-661-5000

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  29. WESTLAKE VILLAGE, Calif., Feb. 18, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2019 fourth quarter and full year financial results and its management will host a conference call to discuss the financial results and corporate updates at 9:00 AM (Eastern Time) on Tuesday, February 25, 2020.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder. 

    To participate in the live call by telephone, please dial (800) 289-0438 or (323) 794-2423 and use the participant passcode: 1233728. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events…

    WESTLAKE VILLAGE, Calif., Feb. 18, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2019 fourth quarter and full year financial results and its management will host a conference call to discuss the financial results and corporate updates at 9:00 AM (Eastern Time) on Tuesday, February 25, 2020.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder. 

    To participate in the live call by telephone, please dial (800) 289-0438 or (323) 794-2423 and use the participant passcode: 1233728. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 1233728. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.  

    Company Contact:
    Phone:  (818) 661-5000 
    Email: 

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  30. WESTLAKE VILLAGE, Calif., Jan. 06, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKDannounced today that its Brazilian partner, Biomm S.A., has received written notice from the Chamber of Regulation of the Medicines Market (CMED) approving the proposed price of Afrezza in Brazil. Biomm intends to commence marketing and distributing Afrezza throughout Brazil, beginning the week of January 13, 2020.

    About Afrezza®
    Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of…

    WESTLAKE VILLAGE, Calif., Jan. 06, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKDannounced today that its Brazilian partner, Biomm S.A., has received written notice from the Chamber of Regulation of the Medicines Market (CMED) approving the proposed price of Afrezza in Brazil. Biomm intends to commence marketing and distributing Afrezza throughout Brazil, beginning the week of January 13, 2020.

    About Afrezza®
    Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit www.afrezza.com.

    About MannKind Corporation
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only orally inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's quarterly report on Form 10-Q for the quarter ended September 30, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    MannKind Contact:
    818-661-5000

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  31. WESTLAKE VILLAGE, Calif., Dec. 20, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKDannounced today that Hypoglycemia is reduced with use of inhaled Technosphere® Insulin relative to insulin aspart in type 1 diabetes mellitus has been published online in DIABETICMedicine.

    This post-hoc analysis was designed to further evaluate the risk of hypoglycemia observed in adults with type 1 diabetes who were treated with inhaled Technosphere Insulin (Afrezza®) or subcutaneous insulin aspart.  Specifically, the research controlled for the level of any HbA1c achieved on the incidence rates of hypoglycemia (low levels of sugar in the blood) in 375 adults with type 1 diabetes. The data demonstrated the following:

    • Participants treated with Afrezza…

    WESTLAKE VILLAGE, Calif., Dec. 20, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKDannounced today that Hypoglycemia is reduced with use of inhaled Technosphere® Insulin relative to insulin aspart in type 1 diabetes mellitus has been published online in DIABETICMedicine.

    This post-hoc analysis was designed to further evaluate the risk of hypoglycemia observed in adults with type 1 diabetes who were treated with inhaled Technosphere Insulin (Afrezza®) or subcutaneous insulin aspart.  Specifically, the research controlled for the level of any HbA1c achieved on the incidence rates of hypoglycemia (low levels of sugar in the blood) in 375 adults with type 1 diabetes. The data demonstrated the following:

    • Participants treated with Afrezza experienced statistically significantly lower rates of level 1 (blood glucose ≤ 3.9 mmol/L or 70 mg/dL) and level 2 (blood glucose ≤ 3.0 mmol/L or 54 mg/dL) hypoglycemic events. There was also a trend towards lower rates of level 3 hypoglycemia (requiring external assistance for recovery) than participants treated with insulin aspart.
    • The lower rate of hypoglycemia with Afrezza was observed across the range of end-of-treatment A1c levels.
    • Due to its unique pharmacokinetic/pharmacodynamic profile, Afrezza was associated with higher rates of hypoglycemia 30–60 minutes after meals but significantly lower rates 2–6 hours after meals.

    These data indicate that participants using Afrezza experienced clinically non-inferior glycemic control and lower hypoglycemia rates across a range of A1c levels compared with participants receiving insulin aspart.

    Hypoglycemia and fear of hypoglycemia are barriers to effective insulin therapy and may prevent people with diabetes from achieving glycemic targets. Potential risks associated with hypoglycemia include, but are not limited to, treatment costs, limiting the individual patient's capacity to intensify diabetes control, individual patient rates of productivity, as well as many other debilitating effects.

    The published research can be found online at https://onlinelibrary.wiley.com/doi/abs/10.1111/dme.14202

    About Afrezza®

    Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit www.afrezza.com.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only orally inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    MannKind Contact:
    818-661-5000

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  32. WESTLAKE VILLAGE, Calif., Nov. 29, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, announced today that it will be featured as a presenting company at the Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 3:30 p.m. (ET) at the Lotte New York Palace in New York City. Presenting from the Company will be its Chief Executive Officer, Michael Castagna.
     
    The presentation will be webcast live. Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company's website at http://www.mannkindcorp.com

    WESTLAKE VILLAGE, Calif., Nov. 29, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, announced today that it will be featured as a presenting company at the Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 3:30 p.m. (ET) at the Lotte New York Palace in New York City. Presenting from the Company will be its Chief Executive Officer, Michael Castagna.
     
    The presentation will be webcast live. Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only orally inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:
    818-661-5000
    ir@mannkindcorp.com

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  33. WESTLAKE VILLAGE, Calif., Nov. 21, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that Anthony Hooper will join its Board of Directors, effective January 1, 2020.  Mr. Hooper will also serve as a member of the Audit Committee of the Board. Mr. Hooper brings 35 years of experience in the pharmaceutical industry to the MannKind Board of Directors.

    "Tony will be a terrific addition to our board of directors," said Kent Kresa, Chairman of the Board of MannKind Corporation. "His commercial operations experience and his deep knowledge of the pharmaceutical industry will be invaluable to MannKind as we look to grow our company for the future."

    Mr. Hooper served as executive vice president of Global Commercial Operations…

    WESTLAKE VILLAGE, Calif., Nov. 21, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that Anthony Hooper will join its Board of Directors, effective January 1, 2020.  Mr. Hooper will also serve as a member of the Audit Committee of the Board. Mr. Hooper brings 35 years of experience in the pharmaceutical industry to the MannKind Board of Directors.

    "Tony will be a terrific addition to our board of directors," said Kent Kresa, Chairman of the Board of MannKind Corporation. "His commercial operations experience and his deep knowledge of the pharmaceutical industry will be invaluable to MannKind as we look to grow our company for the future."

    Mr. Hooper served as executive vice president of Global Commercial Operations for Amgen Inc. from Oct 2011 until August 2018. During his tenure, he led the transformation of Amgen's commercial organization, placing a relentless focus on putting patients at the center of all the company's activities. Under his leadership, Amgen grew revenue by 50 percent, launched six new first-in-class medicines for serious diseases, more than doubled the global footprint by expanding into 50 new countries, and established a new biosimilars business.  Prior to joining Amgen, Hooper spent more than 15 years at Bristol-Myers Squibb. His last role there was senior vice president, Global Commercial Operations and president of the company's $15 billion pharmaceutical business in the Americas, Japan and Intercontinental regions. Previously, he was assistant vice president of Global Marketing for Wyeth Laboratories and led the international marketing group for Lederle International.  Mr. Hooper earned law and MBA degrees from the University of South Africa.

    The addition of Mr. Hooper will bring the total number of MannKind Board members to eight.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com. 

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding MannKind's ability to directly commercialize pharmaceutical products. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These

    forward-looking statements are based upon the MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability to generate significant product sales for MannKind, MannKind's ability to manage its existing cash resources or raise additional cash resources, stock price volatility and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2018 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:
    818-661-5000

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    • 3Q 2019 Total Revenues of $14.6 million; +227% vs. 3Q 2018
      °  3Q 2019 Afrezza Net Revenue was $6.4 million; +46% vs. 3Q 2018
         •  Afrezza sold to our marketing partner in Brazil for launch was $0.7 million
      °  3Q 2019 Collaborations and Services Revenue was $8.2 million
    • Debt financing completed providing up to $75.0 million in non-dilutive capital
    • Received second $12.5 million milestone payment from United Therapeutics in November 2019
    • Advanced Technosphere® formulations of sumatriptan and tadalafil into nonclinical pharmacology studies

    WESTLAKE VILLAGE, Calif., Nov. 06, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported preliminary financial results for the quarter and nine months ended September 30, 2019.

    "I am excited…

    • 3Q 2019 Total Revenues of $14.6 million; +227% vs. 3Q 2018
      °  3Q 2019 Afrezza Net Revenue was $6.4 million; +46% vs. 3Q 2018
         •  Afrezza sold to our marketing partner in Brazil for launch was $0.7 million
      °  3Q 2019 Collaborations and Services Revenue was $8.2 million
    • Debt financing completed providing up to $75.0 million in non-dilutive capital
    • Received second $12.5 million milestone payment from United Therapeutics in November 2019
    • Advanced Technosphere® formulations of sumatriptan and tadalafil into nonclinical pharmacology studies

    WESTLAKE VILLAGE, Calif., Nov. 06, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today reported preliminary financial results for the quarter and nine months ended September 30, 2019.

    "I am excited to see MannKind continue its transformation, with another quarter of double-digit growth in Afrezza revenue, year over year, and aggregate net revenue of $14.6 million," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "In the third quarter, we completed our recapitalization and achieved several key milestones, such as booking our first international sale of Afrezza to Brazil, seeing the first PAH patient dosed with TreT and progressing two pipeline compounds into nonclinical testing."

    Third Quarter 2019 Results

    Net revenues were $14.6 million for the third quarter of 2019, reflecting Afrezza net revenue of $6.4 million and collaborations and services revenue of $8.2 million. Afrezza net revenue increased 46% compared to $4.4 million in the third quarter of 2018, primarily driven by higher product demand (including the first shipment to Brazil), a more favorable mix of Afrezza cartridges and price.

    Collaborations and services revenue increased $8.1 million compared to the third quarter of 2018, primarily driven by the license agreement with United Therapeutics, which began in the fourth quarter of 2018.

    On a GAAP basis, Afrezza gross loss was $0.7 million for the third quarter of 2019 compared to a gross loss of $0.9 million in the same period in 2018. Afrezza cost of goods sold for the third quarter of 2019 included a one-time fee of $2.75 million recorded in connection with the amendment of the Company's insulin supply agreement with Amphastar in August 2019. As a result, on a non-GAAP basis, gross profit was $2.1 million or 33% for the third quarter of 2019.

    Research and development (R&D) expenses for the third quarter of 2019 were $1.6 million compared to $2.0 million for the third quarter of 2018. This 23% decrease was primarily attributable to a $0.4 million decrease in clinical trial spending. 

    Selling, general and administrative (SG&A) expenses for the third quarter of 2019 were $16.7 million compared to $19.4 million for the third quarter of 2018. This decrease of $2.7 million, or 14%, was primarily attributable to a $0.8 million decrease in personnel-related costs and a $1.9 million decrease in Afrezza marketing costs. 

    Interest expense on notes for the third quarter of 2019 was $4.1 million compared to $1.0 million for the third quarter of 2018. This $3.1 million increase or 316% was primarily attributable to a $3.4 million charge realized as a result of achieving of a sales milestone in the third quarter of 2019 under the Company's milestone agreement with Deerfield.

    The net loss for the third quarter of 2019 was $10.4 million, or $0.05 per share compared to a $24.2 million net loss in the third quarter of 2018 or $0.16 per share. The decrease was primarily the result of increased total revenues from higher Afrezza commercial demand and from the licensing and research agreements with United Therapeutics.

    Nine Months Ended September 30, 2019 

    Net revenues were $47.0 million for the nine months ended September 30, 2019, reflecting Afrezza net revenue of $17.5 million and collaborations and services revenue of $29.5 million. Afrezza net revenue increased 52% compared to $11.5 million for the nine months ended September 30, 2018, primarily due to higher product demand (including the first shipment to Brazil), a more favorable mix of Afrezza cartridges and price. Collaborations and services revenue increased $29.3 million compared to the nine months ended September 30, 2018, which was primarily attributed to the licensing agreement ($23.3 million) and research agreement ($5.9 million) with United Therapeutics, both of which began in the fourth quarter of 2018.

    On a GAAP basis, Afrezza gross profit was $2.1 million for the nine months ended September 30, 2019, an improvement of $5.0 million or 173% compared to a gross loss of $2.9 million in the same period in 2018, primarily due to an increase of $6.0 million in net revenue, a $1.8 million decrease in inventory write-offs, partially offset by increased costs due to higher sales and the Amphastar one-time amendment fee of $2.75 million in the third quarter of 2019. As a result, on a non-GAAP basis, gross profit was $4.9 million or 28% for the nine months ended September 30, 2019.

    R&D expenses for the nine months ended September 30, 2019 were $4.9 million compared to $7.7 million for the nine months ended September 30, 2018. This $2.8 million or 36% decrease was primarily attributable to a $1.0 million decrease in personnel-related costs and a $1.1 million decrease in clinical trial spending.

    SG&A expenses for the nine months ended September 30, 2019 were $58.9 million compared to $61.7 million for the nine months ended September 30, 2018. This decrease of $2.7 million or 5% was primarily attributable to a $6.1 million decrease in personnel related costs, $1.9 million decrease in professional fees, a $1.0 million decrease in stock-based compensation costs offset by a $6.8 million increase in costs for a television campaign for Afrezza.

    Interest income increased by $0.5 million or 160% for the nine months ended September 30, 2019 primarily attributable to a higher balance on money market funds and other short-term investments.

    Interest expense on notes for the nine months ended September 30, 2019 was $5.3 million compared to $4.5 million for the nine months ended September 30, 2018. This $0.8 million increase was primarily attributable to a $3.4 million charge realized as a result of achieving of a sales milestone in the third quarter of 2019 under the Company's milestone agreement with Deerfield, partially offset by a reduction in debt principal balances.

    The net loss for the nine months ended September 30, 2019 was $37.6 million, or $0.20 per share compared to a $77.2 million net loss for the nine months ended September 30, 2018 or $0.56 per share. The lower net loss was mainly attributable to a $35.2 million increase in total revenues. 

    Cash, Cash Equivalents, Restricted Cash and Short Term Investments

    Cash, cash equivalents, restricted cash, and short-term investments at September 30, 2019 was $50.4 million compared to $71.7 million at December 31, 2018.

    Non-GAAP Measures

    Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a non-GAAP basis. Reported results were prepared in accordance with GAAP whereas non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

       
      Three Months Ended September 30,
    ($ in million) 2019
      2018
       $ Chg
       % Chg 
    Net Revenue - Afrezza $ 6.4     $ 4.4     $ 2.0     45 %
    Cost of Goods Sold   (7.1 )     (5.3 )     (1.8 )   -34 %
     GAAP Gross Profit (Loss) - Afrezza $ (0.7 )   $ (0.9 )     0.2     22 %
    Exclude Amphastar Amendment Fee   2.8             2.8      
     Non-GAAP Gross Profit (Loss) - Afrezza $ 2.1     $ (0.9 )   $ 3.0     333 %
     Non-GAAP Gross Margin   33 %     -20 %      
                         


       
      Nine Months Ended September 30,
    ($ in million)  2019    2018    $ Chg
       % Chg 
    Net Revenue - Afrezza $ 17.5     $ 11.5     $ 6.0     52 %
    Cost of Goods Sold   (15.4 )     (14.4 )     (1.0 )   -7 %
     GAAP Gross Profit (Loss) - Afrezza $ 2.1     $ (2.9 )     5.0     172 %
    Exclude Amphastar Amendment Fee   2.8             2.8      
     Non-GAAP Gross Profit (Loss) - Afrezza $ 4.9     $ (2.9 )   $ 7.8     269 %
     Non-GAAP Gross Margin   28 %     -25 %      
                         

    Conference Call

    MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. To participate in the live call by telephone, please dial (866) 548-4713 or (323) 794-2093 and use the participant passcode: 8987532. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 8987532. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding MannKind's ability to directly commercialize pharmaceutical products. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability to generate significant product sales for MannKind, MannKind's ability to manage its existing cash resources or raise additional cash resources, stock price volatility and other risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2018 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    Company Contact:
    818-661-5000


    MANNKIND CORPORATION AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
    (In thousands, except per share data)

        Three Months Ended September 30,     Nine Months Ended September 30,  
        2019     2018     2019     2018  
    Revenues:                                
    Net revenue - commercial product sales   $ 6,402     $ 4,387     $ 17,543     $ 11,542  
    Revenue - collaborations and services     8,193       82       29,502       232  
    Revenue - other                       53  
    Total revenues     14,595       4,469       47,045       11,827  
    Expenses:                                
    Cost of goods sold     7,099       5,303       15,446       14,406  
    Cost of revenue - collaborations and services     1,836             5,512        
    Research and development     1,580       2,043       4,879       7,653  
    Selling, general and administrative     16,666       19,394       58,948       61,740  
    Gain on foreign currency translation     (3,807 )     (728 )     (4,495 )     (3,107 )
    Total expenses     23,374       26,012       80,290       80,692  
    Loss from operations     (8,779 )     (21,543 )     (33,245 )     (68,865 )
    Other (expense) income:                                
    Interest income     220       144       794       305  
    Interest expense on notes     (4,126 )     (993 )     (5,283 )     (4,496 )
    Interest expense on promissory notes     (1,162 )     (1,074 )     (3,351 )     (3,234 )
    Gain (loss) on extinguishment of debt     3,529       (712 )     3,529       (765 )
    Other income (expense)     (52 )     10       (84 )     71  
    Total other expense     (1,591 )     (2,625 )     (4,395 )     (8,119 )
    Loss before provision for income taxes     (10,370 )     (24,168 )     (37,640 )     (76,984 )
    Provision for income taxes                       (240 )
    Net loss   $ (10,370 )   $ (24,168 )   $ (37,640 )   $ (77,224 )
    Net loss per share - basic and diluted   $ (0.05 )   $ (0.16 )   $ (0.20 )   $ (0.56 )
    Shares used to compute basic and diluted net loss per share     199,906       153,597       191,786       138,307  


    MANNKIND CORPORATION AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS
    (Unaudited)
    (In thousands, except per share data)

        September 30, 2019     December 31, 2018  
    ASSETS                
    Current assets:                
    Cash and cash equivalents   $ 30,173     $ 71,157  
    Restricted cash     316       527  
    Short-term investments     19,885        
    Accounts receivable, net     4,093       4,017  
    Inventory     3,692       3,597  
    Prepaid expenses and other current assets     3,584       2,556  
    Total current assets     61,743       81,854  
    Property and equipment, net     27,126       25,602  
    Right-of-use and other assets     6,271       249  
    Total assets   $ 95,140     $ 107,705  
                     
    LIABILITIES AND STOCKHOLDERS' DEFICIT                
    Current liabilities:                
    Accounts payable   $ 11,664     $ 5,379  
    Accrued expenses and other current liabilities     14,298       15,022  
    Facility financing obligation           11,298  
    Senior convertible notes - current     2,520        
    Deferred revenue - current     32,212       36,885  
    Recognized loss on purchase commitments - current     3,593       6,657  
    Total current liabilities   $ 64,287     $ 75,241  
    Senior convertible notes     7,437       19,099  
    Credit facility     38,798      
    Promissory notes     70,019       72,089  
    Accrued interest - promissory notes     807       6,835  
    Recognized loss on purchase commitments - long term     85,858       91,642  
    Deferred revenue - long term     2,631       10,680  
    Milestone rights liability     7,263       7,201  
    Operating lease liabilities     2,746        
    Total liabilities   $ 279,846     $ 282,787  
    Commitments and contingencies                
    Stockholders' deficit:                
    Common stock, $0.01 par value - 280,000,000 shares authorized,
      206,407,551 and 187,029,967 shares issued and outstanding at
      September 30, 2019 and December 31, 2018, respectively
      $ 2,064     $ 1,870  
    Additional paid-in capital     2,790,890       2,763,067  
    Accumulated other comprehensive loss     (20 )     (19 )
    Accumulated deficit     (2,977,640 )     (2,940,000 )
    Total stockholders' deficit   $ (184,706 )   $ (175,082 )
    Total liabilities and stockholders' deficit   $ 95,140     $ 107,705  

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  34. WESTLAKE VILLAGE, Calif., Nov. 04, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that it has achieved the second of four specified development milestones under its licensing and collaboration agreement with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil.  Treprostinil Technosphere ("TreT") is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension.  Pursuant to the agreement, MannKind is eligible to earn additional milestone payments up to $25 million upon the achievement of other defined development milestones.  MannKind will also be entitled to receive low double-digit royalties on…

    WESTLAKE VILLAGE, Calif., Nov. 04, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced that it has achieved the second of four specified development milestones under its licensing and collaboration agreement with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil.  Treprostinil Technosphere ("TreT") is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension.  Pursuant to the agreement, MannKind is eligible to earn additional milestone payments up to $25 million upon the achievement of other defined development milestones.  MannKind will also be entitled to receive low double-digit royalties on net sales of TreT.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S.

    For further information, visit www.mannkindcorp.com.

    Company Contact:
    818.661.5000

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  35. WESTLAKE VILLAGE, Calif., Oct. 30, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2019 third quarter and year-to-date financial results and its management will host a conference call to discuss the financial results and corporate updates at 9:00 AM (Eastern Time) on Wednesday, November 6, 2019.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder. 

    To participate in the live call by telephone, please dial (866) 548-4713 or (323) 794-2093 and use the participant passcode: 8987532. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News…

    WESTLAKE VILLAGE, Calif., Oct. 30, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2019 third quarter and year-to-date financial results and its management will host a conference call to discuss the financial results and corporate updates at 9:00 AM (Eastern Time) on Wednesday, November 6, 2019.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder. 

    To participate in the live call by telephone, please dial (866) 548-4713 or (323) 794-2093 and use the participant passcode: 8987532. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com under News & Events. 

    A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 8987532. A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.  

    Company Contact:
    Phone:  (818) 661-5000 
    Email: 

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  36. WESTLAKE VILLAGE, Calif., Sept. 26, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, announced today that it will be featured as a presenting company at the 2019 Cantor Global Healthcare Conference on Thursday, October 3, 2019 at 9:30 am (ET) at the InterContinental New York Barclay Hotel in New York City. Presenting from the Company will be its Chief Executive Officer, Michael Castagna.

    The presentation will be webcast live. Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company's website at…

    WESTLAKE VILLAGE, Calif., Sept. 26, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, announced today that it will be featured as a presenting company at the 2019 Cantor Global Healthcare Conference on Thursday, October 3, 2019 at 9:30 am (ET) at the InterContinental New York Barclay Hotel in New York City. Presenting from the Company will be its Chief Executive Officer, Michael Castagna.

    The presentation will be webcast live. Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company's website at http://www.mannkindcorp.com. The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only orally inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:
    Rose Alinaya
    Investor Relations
    818-661-5000

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  37. WESTLAKE VILLAGE, Calif., Sept. 19, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) announced that data from a one-year study of Afrezza® (insulin human) Inhalation Powder was presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.

    Oral Abstract 183: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog

    MannKind investigators reported data1 from more than 500 patients with type 1 diabetes comparing Afrezza to rapid-acting injected insulin analog (insulin aspart) therapy to assess glucose control, mealtime glucose changes, Afrezza dosing, and rates of hypoglycemia over a one-year period.

    Oral Abstract Presentation

    WESTLAKE VILLAGE, Calif., Sept. 19, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) announced that data from a one-year study of Afrezza® (insulin human) Inhalation Powder was presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.

    Oral Abstract 183: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog

    MannKind investigators reported data1 from more than 500 patients with type 1 diabetes comparing Afrezza to rapid-acting injected insulin analog (insulin aspart) therapy to assess glucose control, mealtime glucose changes, Afrezza dosing, and rates of hypoglycemia over a one-year period.

    Oral Abstract Presentation Highlights:

    • When compared to injected insulin aspart, Afrezza provided significantly better glucose control in the first two hours following a standardized meal.
    • Titration of Afrezza to approximately 1.5 to 2 times the unit dose of injected insulin aspart resulted in significantly lower post-meal glucose excursions and was associated with lower rates of overall and level 2 hypoglycemia—an observation that was particularly evident in the late (>2 hour) post-meal period.

    Dr. Anne Peters, Clinical Professor of Medicine at the Keck School of Medicine at USC and Director of the USC Westside Center for Diabetes Care noted that "the improved post-meal glucose levels and lower rates of low blood sugars seen in this study of individuals with type 1 diabetes support my growing clinical experience. The presentation of these data provides further evidence that proper dosing of Afrezza has the potential to safely and effectively keep more patients within the target glucose range at meal times."

    These data provide additional evidence supporting the safe and effective use of Afrezza in type 1 diabetes patients and offer insight into the dosing of this ultra rapid-acting insulin as compared to a traditional rapid-acting injected insulin analog.

    About Afrezza®
    Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit www.afrezza.com.

    About MannKind Corporation
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only orally inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Forward-Looking Statements
    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind's quarterly report on Form 10-Q for the quarter ended June 30, 2019 as well as MannKind's other filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    MannKind Contact:
    Rose Alinaya
    Investor Relations
    818-661-5000

    Appendix – Presentation Information
    (1) Oral Presentation: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog
    Presenter: David M. Kendall, M.D.
    Presentation No: 183
    Date/Time: Thursday, September 19, 2019; 2:30 PM

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  38. WESTLAKE VILLAGE, Calif., Aug. 30, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, announced today that it will be featured as a presenting company at the H.C. Wainwright 21st Annual Global Investment Conference on Monday, September 9, 2019 at 12:05 pm (ET) at the Lotte New York Palace Hotel in New York City. 

    Michael Castagna, Chief Executive Officer, of MannKind Corporation, will provide an overview of the Company's business during the live presentation.  Steven B. Binder, Chief Financial Officer, will participate in one-on-one meetings with investors who…

    WESTLAKE VILLAGE, Calif., Aug. 30, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, announced today that it will be featured as a presenting company at the H.C. Wainwright 21st Annual Global Investment Conference on Monday, September 9, 2019 at 12:05 pm (ET) at the Lotte New York Palace Hotel in New York City. 

    Michael Castagna, Chief Executive Officer, of MannKind Corporation, will provide an overview of the Company's business during the live presentation.  Steven B. Binder, Chief Financial Officer, will participate in one-on-one meetings with investors who are registered to attend the conference. 

    The presentation will be webcast live.  Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company's website at http://www.mannkindcorp.com.  The webcast replay will remain available for 14 days following the live presentation.

    About MannKind Corporation
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only orally inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

    Company Contact:
    Rose Alinaya
    Investor Relations
    818-661-5000

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