Insulin Recombinant Human(MannKind)

SATURDAY, Aug. 31, 2024 -- Insulin can be a critical part of managing diabetes, but patients may not know all of the ins and outs of using the medication effectively. Luckily, the American Diabetes Association (ADA) has plenty of information and tips on using insulin. First, there are different types of insulin, depending on how fast they work, when they peak and how long they last. Insulin is also available in varying strengths and all insulin made in the United States is produced in a lab, the ADA noted. Whether someone needs to take insulin, and how much, varies by patient and the type of diabetes a patient has. In people with type 1 diabetes, the pancreas no longer makes insulin at all. The beta cells have been destroyed, and these patients need insulin shots. With type 2 diabetes, people make insulin but their bodies don't respond well to it. Some people with type 2 diabetes need insulin. Why does insulin have to be given as shots? If taken in pill form, it would be broken down during digestion, so it must be injected into the fat under your skin. In rare cases, insulin can trigger an allergic reaction at the injection site. Talk to your doctor if you believe you are experiencing a reaction, the ADA advised. Depending on a patient's needs, there are several types of insulin available: Premixed insulin can be helpful for those who have poor eyesight or dexterity and it's convenient for people whose diabetes has been stabilized, the ADA added. In 2015, an inhaled insulin product called Afrezza became available in the United States. Afrezza acts rapidly at the beginning of each meal and can be used by adults with type 1 or type 2 diabetes. However, it is not a substitute for long-acting insulin, the ADA noted. Afrezza must be used in combination with injectable long-acting insulin in patients with type 1 diabetes and in type 2 patients who use long-acting insulin. It begins working within 12 to 15 minutes, peaks by 30 minutes, and is out of your system in 180 minutes. Apart from differences in how quickly insulin acts and how long it lasts, there are different strengths of the medication, the ADA noted. The most commonly used strength in the United States is U-100, which means it has 100 units of insulin per milliliter of fluid, though U-500 insulin is available for patients who are extremely insulin-resistant. If you're traveling outside of the United States, be certain to match your insulin strength with the correct size syringe. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Conference Call to Begin Today at 9:00 a.m. (ET)2Q 2024 Total revenues of $72M; +49% vs. 2Q 2023YTD 2024 Total revenues of $139M; +55% vs. YTD 2023YTD 2024 Net income of $9 million; Non-GAAP net income of $29 millionAdvances two orphan lung programs to human studies MNKD-101 Phase 3 clinical trial activities initiatedMNKD-201 Phase 1 clinical trial on schedule to read out 4Q 2024 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 07, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended June 30, 2024. “We achieved our ninth consecutive quarter of revenue growth and are approaching an annual revenue run rate of over $275 million based on the first half of 2024,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We are excited about our future as we move our orphan lung programs into Phase 1 and Phase 3 studies and look forward to the additional Afrezza data read-outs later this year. We believe our diversification strategy of allocating capital towards our pipeline, in-line growth and debt reduction sets us up to deliver sustainable short and long-term value for our shareholders.” Second Quarter 2024 Results Revenue Highlights Three Months Ended June 30, 2024 2023 $ Change % Change (Dollars in thousands) Royalties – collaboration $25,592 $19,055 $6,537 34%Revenue – collaborations and services 26,014 11,211 $14,803 132%Net revenue – Afrezza 16,289 13,527 $2,762 20%Net revenue – V-Go 4,491 4,818 $(327) (7%)Total revenues $72,386 $48,611 $23,775 49% Second quarter royalties for Tyvaso DPI® increased $6.5 million, or 34%, over the same period in prior year due to increased sales by United Therapeutics ("UT"). Collaborations and services revenue increased $14.8 million, or 132%, compared to the same period in 2023 primarily attributable to an increase in manufacturing activities for Tyvaso DPI. Afrezza® net revenue for the second quarter of 2024 increased $2.8 million, or 20%, compared to the same period in 2023 primarily as a result of price (including a decrease in gross-to-net adjustments) and higher demand. V-Go® net revenue for the second quarter of 2024 decreased $0.3 million, or 7%, compared to the same period in 2023 as a result of lower product demand partially offset by increased price. Commercial product gross margin in the second quarter of 2024 was 73% compared to 72% for the same period in 2023. The increase in gross margin was primarily attributable to an increase in Afrezza net revenue. Cost of revenue – collaborations and services for the second quarter of 2024 was $14.8 million compared to $9.0 million for the same period in 2023. The $5.8 million increase was primarily attributable to increased manufacturing volume and related production activities for Tyvaso DPI. Higher manufacturing volumes resulted in efficiencies, which contributed to a lower effective cost per unit. Research and development ("R&D") expenses for the second quarter of 2024 were $11.8 million compared to $6.5 million for the same period in 2023. The $5.4 million increase was primarily attributed to increased costs for development activities for clofazimine inhaled suspension (MNKD-101), an Afrezza pediatric clinical study (INHALE-1), and initiation of a Phase 1 clinical study of a dry-powder formulation of nintedanib (MNKD-201) for treatment of pulmonary fibrotic diseases, partially offset by lower costs for an Afrezza post-marketing clinical study (INHALE-3). Selling expenses were $11.5 million for the second quarter of 2024 compared to $14.0 million for the same period in 2023. The $2.5 million decrease was primarily due to reduced personnel related to a sales force restructuring completed during the first quarter of 2024. General and administrative expenses were $12.6 million for the second quarter of 2024 compared to $11.9 million for the same period in 2023. The $0.7 million increase was primarily attributable to increases in estimated returns associated with sales of V-Go that pre-date our acquisition of the product and personnel costs. Interest income, net, was $3.2 million for the second quarter of 2024 compared to $1.5 million for the same period in 2023. The $1.6 million increase was primarily due to higher yields on our securities portfolio and an increase in the underlying investments from the proceeds of the sale of 1% of our Tyvaso DPI royalties in December 2023. Interest expense on financing liability (related to the sale-leaseback of our Danbury manufacturing facility) was $2.4 million for the second quarter of 2024 and remained consistent with the same period in 2023. Interest expense was $6.1 million for the second quarter of 2024 compared to $6.9 million for the same period in 2023. The decrease of $0.8 million was primarily due to repayment of the MidCap credit facility and Mann Group convertible note in April 2024. Interest expense on liability for sale of future royalties was $4.4 million for the second quarter of 2024 and was attributable to imputed interest and amortization of debt issuance costs on the liability recorded in connection with the sale of 1% of our Tyvaso DPI royalties in December 2023. Loss on available-for-sale securities for the second quarter of 2024 was $1.6 million resulting from the modification of the Thirona note terms. Gain on available-for-sale securities for the same period in 2023 was $0.9 million as a result of the change in fair value of the Thirona investment relating to credit risk. Loss on extinguishment of debt of $7.1 million for the second quarter of 2024 was incurred in connection with the prepayment of the MidCap credit facility and Mann Group convertible note in April 2024. First Half of 2024 Revenue Highlights Six Months Ended June 30, 2024 2023 $ Change % Change (Dollars in thousands) Royalties – collaboration $48,243 $30,733 $17,510 57%Revenue – collaborations and services 50,862 22,597 $28,265 125%Net revenue – Afrezza 30,727 25,951 $4,776 18%Net revenue – V-Go 8,817 9,956 $(1,139) (11%)Total revenues $138,649 $89,237 $49,412 55% Royalties related to Tyvaso DPI for the first half of 2024 increased $17.5 million, or 57%, due to increased sales by UT. Collaborations and services revenue increased $28.3 million, or 125%, compared to the same period in 2023 primarily attributable to an increase in manufacturing activities for Tyvaso DPI. Afrezza net revenue for the first half of 2024 increased $4.8 million, or 18%, compared to the same period in 2023 primarily as a result of price (including a decrease in gross-to-net adjustments) and higher demand. V-Go net revenue for the first half of 2024 decreased $1.1 million, or 11%, compared to the same period in 2023 as a result of lower product demand partially offset by increased price. Commercial product gross margin in the first half of 2024 was 76% compared to 70% for the same period in 2023. The increase in gross margin was primarily attributable to an increase in Afrezza net revenue. Cost of revenue – collaborations and services for the first half of 2024 was $29.6 million compared to $19.7 million for the same period in 2023. The $9.9 million increase was primarily attributable to increased manufacturing volume and related production activities for product sold to UT. R&D expenses for the first half of 2024 were $21.8 million compared to $12.1 million for the same period in 2023. The $9.8 million increase was primarily attributed to increased costs for development activities for MNKD-101, the INHALE-1 study, an Afrezza post-marketing clinical study (INHALE-3) which commenced in the second quarter of 2023, personnel expenses due to increased headcount, and initiation of a Phase 1 study of MNKD-201 for treatment of pulmonary fibrotic diseases. Selling expenses were $23.1 million in the first half of 2024 compared to $27.3 million for the same period in 2023. The $4.2 million decrease was primarily due to reduced personnel and travel expenses related to a sales force restructuring completed during the first quarter of 2024. General and administrative expenses for the first half of 2024 were $23.3 million compared to $22.5 million for the same period in 2023. The $0.9 million increase was primarily attributable to a loss of $1.4 million related to estimated returns associated with sales of V-Go that pre-date our acquisition of the product, partially offset by reduced personnel costs. Interest income, net, was $6.6 million for the first half of 2024 compared to $2.8 million for the same period in 2023. The $3.8 million increase was primarily due to higher yields on our securities portfolio and an increase in the underlying investments from the proceeds of the sale of 1% of our Tyvaso DPI royalties in December 2023. Interest expense on financing liability (related to the sale-leaseback of our Danbury manufacturing facility) was $4.9 million for the first half of 2024 and remained consistent with the same period in 2023. Interest expense was $8.6 million for the first half of 2024 compared to $9.7 million for the same period in 2023. The decrease of $1.0 million was primarily due to repayment of the MidCap credit facility and Mann Group convertible note in April 2024. Interest expense on liability for sale of future royalties was $8.6 million for the first half of 2024 and was attributable to imputed interest and amortization of debt issuance costs on the liability recorded in connection with the sale of 1% of our Tyvaso DPI royalties in December 2023. Loss on available-for-sale securities for the first half of 2024 was $1.6 million resulting from the modification of the Thirona note terms. Gain on available-for-sale securities for the same period in 2023 was $0.9 million as a result of the change in fair value of the Thirona investment relating to credit risk. Loss on extinguishment of debt of $7.1 million for the first half of 2024 was incurred in connection with the prepayment of the MidCap credit facility and the Mann Group convertible note in April 2024. Cash, cash equivalents, restricted cash and investments as of June 30, 2024 were $261.9 million. Non-GAAP Measures To supplement our condensed consolidated financial statements presented under U.S. generally accepted accounting principles ("GAAP"), we are presenting non-GAAP net income (loss) and non-GAAP net income (loss) per share - diluted, which are non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to similarly titled measures used by other companies. The following table reconciles our financial measures for net income (loss) and net income (loss) per share ("EPS") for diluted weighted average shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation. Three Months Six Months Ended June 30, Ended June 30, 2024 2023 2024 2023 Net Income (Loss) Basic EPS Net Loss Basic EPS Net Income Basic EPS Net Loss Basic EPS (In thousands except per share data) GAAP reported net income (loss)$(2,014) $(0.01) $(5,265) $(0.02) $8,616 $0.03 $(15,060) $(0.06)Non-GAAP adjustments: Sold portion of royalty revenue (1) (2,559) (0.01) — — (4,824) (0.02) — — Interest expense on liability for sale of future royalties 4,383 0.02 — — 8,631 0.03 — — Stock compensation 6,428 0.02 5,580 0.02 10,313 0.04 9,235 0.04 (Gain) loss on foreign currency transaction (529) — 251 — (1,928) (0.01) 1,205 — Loss (gain) on available-for-sale securities 1,550 0.01 (932) — 1,550 0.01 (932) — Loss on extinguishment of debt 7,050 0.02 — — 7,050 0.03 — — Non-GAAP adjusted net income (loss)$14,309 $0.05 $(366) $— $29,408 $0.11 $(5,552) $(0.02)Weighted average shares used to compute net income (loss) per share – basic 273,056 $0.05 265,626 $(0.00) 271,706 $0.11 264,802 $(0.02) __________________________(1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the periods presented which is remitted to the royalty purchaser and recognized as royalties – collaboration in our consolidated statements of operations. Our revenues from royalties – collaboration during 2Q 2024 and the first half of 2024 totaled $25.6 million and $48.2 million, respectively, of which $2.6 million and $4.8 million, respectively, were attributed to the royalty purchaser. Clinical Development Update Afrezza INHALE-3 (T1DM, Afrezza vs. standard of care; phase 4 clinical trial) First meal dosing data published online in Diabetes Care in July 2024Randomized treatment phase top-line data/primary endpoints presented at American Diabetes Association conference in June 2024 Inhaled insulin improved the ability to achieve target A1c (<7%) by 76% over the standard of care (30% of Afrezza participants vs. 17% on standard of care)24% of Afrezza vs. 13% on standard of care met time-in-range > 70% with no increased hypoglycemia by continuous glucose monitoringOver 50% of subjects at the end of the study expressed interest in continuing AfrezzaMet 17-week primary endpoint; full 30-week data expected to read out later this year Additional data to be presented at Association of Diabetes Care and Education Specialists conference in August 2024 Afrezza INHALE-1 (pediatric phase 3 clinical trial) Upcoming expected data read-outs and planned U.S. Food and Drug Administration ("FDA") submission: Primary endpoint analysis in 4Q 2024Full results in 1H 2025FDA submission for label expansion in 2025 MNKD-101 (clofazimine inhalation suspension) Phase 3 clinical trial activities initiated and site activation commenced in 2Q 2024Co-primary endpoints of sputum conversion and patient-reported outcomesUp to 120 global sites with 180 patients expected to be evaluated MNKD-201 (nintedanib DPI) Phase 1 trial in healthy volunteers underway with first participant dosed in 2Q 2024Chronic toxicology and Phase 1 results expected in 4Q 2024 Conference Call MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. The webcast will be accessible via a link on MannKind’s website at https://investors.mannkindcorp.com/events-and-presentations. A replay will also be available in the same location within 24 hours following the call and be accessible for approximately 90 days. About MannKind MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking Statements Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding MannKind's annual revenue run rate; MannKind's ability to deliver sustainable short and long-term value for its shareholders; the expected timing of patient enrollment and dosing in clinical studies of MNKD-101; expected timing for data read-outs for clinical studies of MNKD-201 and Afrezza; and the timing of planned FDA submissions for Afrezza. 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 various risks and uncertainties, which include, without limitation, risks associated with manufacturing and supply; risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of progressing clinical trials and reporting data; risks associated with safety and other complications of our products and product candidates; risks associated with the regulatory review process; and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 27, 2024, and subsequent periodic reports on Form 10-Q. 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 is a trademark of United Therapeutics Corporation. AFREZZA, MANNKIND, and V-GO are registered trademarks of MannKind Corporation. MANNKIND CORPORATION AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 (In thousands except per share data) Revenues: Net revenue – commercial product sales $20,780 $18,345 $39,544 $35,907 Revenue – collaborations and services 26,014 11,211 50,862 22,597 Royalties – collaboration 25,592 19,055 48,243 30,733 Total revenues 72,386 48,611 138,649 89,237 Expenses: Cost of goods sold 5,605 5,224 9,424 10,754 Cost of revenue – collaborations and services 14,772 9,013 29,551 19,696 Research and development 11,816 6,453 21,829 12,058 Selling 11,495 14,002 23,096 27,312 General and administrative 12,617 11,947 23,345 22,489 (Gain) loss on foreign currency transaction (529) 251 (1,928) 1,205 Total expenses 55,776 46,890 105,317 93,514 Income (loss) from operations 16,610 1,721 33,332 (4,277)Other income (expense): Interest income, net 3,177 1,547 6,611 2,849 Interest expense on financing liability (2,444) (2,449) (4,891) (4,873)Interest expense (6,051) (6,873) (8,618) (9,659)Interest expense on liability for sale of future royalties (4,383) — (8,631) — (Loss) gain on available-for-sale securities (1,550) 932 (1,550) 932 Loss on extinguishment of debt (7,050) — (7,050) — Other expense — (143) — (32)Total other expense (18,301) (6,986) (24,129) (10,783)Income (loss) before income tax expense (1,691) (5,265) 9,203 (15,060)Income tax expense 323 — 587 — Net income (loss) $(2,014) $(5,265) $8,616 $(15,060)Net income (loss) per share – basic $(0.01) $(0.02) $0.03 $(0.06)Weighted average shares used to compute net income (loss) per share – basic 273,056 265,626 271,706 264,802 Net income (loss) per share – diluted $(0.01) $(0.02) $0.03 $(0.06)Weighted average shares used to compute net income (loss) per share – diluted 273,056 265,626 279,358 (1) 264,802 __________________________ (1) Diluted weighted average shares ("DWAS") differs from basic due to the weighted average number of shares that would be outstanding upon conversion of convertible notes and exercise or vesting of outstanding share-based payments to employees. For the six months ended June 30, 2024, DWAS included 7,652 shares of outstanding share-based payments. 44,120 shares issuable upon conversion of our Senior convertible notes were excluded as their effect would be antidilutive. MANNKIND CORPORATION AND SUBSIDIARY CONDENSED CONSOLIDATED BALANCE SHEETS June 30, 2024 December 31, 2023 (In thousands except share and per share data) ASSETS Current assets: Cash and cash equivalents $96,643 $238,480 Short-term investments 151,118 56,619 Accounts receivable, net 23,346 14,901 Inventory 24,753 28,545 Prepaid expenses and other current assets 30,080 34,848 Total current assets 325,940 373,393 Restricted cash 732 — Long-term investments 13,398 7,155 Property and equipment, net 85,144 84,220 Goodwill 1,931 1,931 Other intangible asset 1,033 1,073 Other assets 15,658 7,426 Total assets $443,836 $475,198 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $9,556 $9,580 Accrued expenses and other current liabilities 40,952 42,036 Liability for sale of future royalties – current 12,149 9,756 Financing liability – current 9,935 9,809 Deferred revenue – current 7,420 9,085 Recognized loss on purchase commitments – current — 3,859 Midcap credit facility – current — 20,000 Total current liabilities 80,012 104,125 Senior convertible notes 227,577 226,851 Liability for sale of future royalties – long term 135,365 136,054 Financing liability – long term 94,094 94,319 Deferred revenue – long term 66,116 69,794 Recognized loss on purchase commitments – long term 60,183 60,942 Operating lease liability 3,272 3,925 Financing lease liability 184 — Milestone liabilities 2,813 3,452 Mann Group convertible note — 8,829 Accrued interest – Mann Group convertible note — 56 Midcap credit facility – long term — 13,019 Total liabilities 669,616 721,366 Stockholders' deficit: Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2024 or December 31, 2023 — — Common stock, $0.01 par value – 800,000,000 shares authorized; 274,467,247 and 270,034,495 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 2,740 2,700 Additional paid-in capital 2,992,271 2,980,539 Accumulated deficit (3,220,791) (3,229,407)Total stockholders' deficit (225,780) (246,168)Total liabilities and stockholders' deficit $443,836 $475,198