What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2022-08-09 compared with 2022-05-05 · 118 added, 59 removed, 77 unchanged (70% of the section changed)

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The forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they are made.

We are a biopharmaceutical company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases.

Our lead product is Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, which was approved by the FDA in June 2014 .

We collaborate with a number of third parties to formulate their drugs on our Technosphere drug delivery platform.

Since September 2018, we have been collaborating with United Therapeutics to develop an inhaled formulation of treprostinil known as Tyvaso DPI.

In April 2021, United Therapeutics submitted an NDA to the FDA seeking approval of Tyvaso DPI .

The NDA was resubmitted in December 2021 following a CRL in October 2021.

The FDA is expected to complete its review of the pending NDA for Tyvaso DPI in May 2022.

Our business is subject to significant risks, including but not limited to our ability to commercialize Afrezza successfully and our ability to manufacture sufficient quantities of Afrezza and Tyvaso DPI.

MannKind focuses on the development and commercialization of therapeutic products for patients with endocrine and orphan lung diseases.

We are currently commercializing Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin.

We also collaborate with third parties to formulate their drugs on our Technosphere drug delivery platform.

In May 2022, our partner, United Therapeutics, received approval from the FDA for Tyvaso DPI (treprostinil) inhalation powder, which is indicated for the treatment of pulmonary arterial hypertension and for the treatment of pulmonary hypertension associated with interstitial lung disease.

UT began commercializing Tyvaso DPI in June 2022 and is obligated to pay us a royalty on net sales of the product.

We also receive a margin on supplies of Tyvaso DPI that we manufacture for UT.

Our business is subject to significant risks, including but not limited to our ability to commercialize our products successfully as well as our ability to manufacture sufficient quantities of our products and Tyvaso DPI.

Other significant risks also include the risks inherent in drug development, clinical trials and the regulatory approval process for our product candidates, which in some cases depends upon the efforts of our partners.

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We will continue to monitor the COVID-19 situation closely.

As of March 31, 2022, we had an accumulated deficit of $3.2 billion and a stockholders’ deficit of $231.4 million.

Our net loss was $26.0 million for the three months ended March 31, 2022.

To date, we have funded our operations through the sale of convertible debt securities and equity, from the receipt of upfront and milestone payments from certain collaborations, from borrowings, from sales of Afrezza and from the proceeds of the Sale-Leaseback Transaction.

As of June 30, 2022, we had an accumulated deficit of $3.2 billion and a stockholders’ deficit of $247.1 million.

Our net loss was $29.0 million and $55.0 million for the three and six months ended June 30, 2022.

To date, we have funded our operations through the sale of convertible debt securities and equity, from the receipt of upfront and milestone payments from certain collaborations, from borrowings, from sales of Afrezza and V-Go, and royalties from UT from the sale of Tyvaso DPI and proceeds of the Sale-Leaseback Transaction.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

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Trends and Uncertainties

We continue to experience the impact of the COVID-19 pandemic on our marketing of Afrezza, the accrual rate of our Afrezza pediatrics trial, our Brazil partner’s (Biomm) ability to market Afrezza and delays in the start of our clinical study in India.

COVID-19 has impacted the supply chain for manufacturing Afrezza and Tyvaso DPI where we have increased safety stock of raw materials to mitigate supply chain risk.

We continue to experience the impact of the COVID-19 pandemic on our sales activities, Biomm’s ability to market Afrezza in Brazil and Cipla’s ability to enroll a clinical study in India.

In addition, we have increased the safety stock of raw materials due to concerns that COVID-19 may impact the supply chain for manufacturing Afrezza, V-Go and Tyvaso DPI.

Our manufacturing of Tyvaso DPI may not meet the required demand of our partner, UT.

If we fail as an effective manufacturing organization, we may be unable to support commercialization of Tyvaso DPI, if approved.

Three months ended March 31, 2022 and 2021

The following tables provide a comparison of the revenue categories for the three months ended March 31, 2022 and 2021 (dollars in thousands):

If we fail as an effective manufacturing organization, we may be unable to support commercialization of Tyvaso DPI.

Three and six months ended June 30, 2022 and 2021

The following tables provide a comparison of the revenue categories for the three and six months ended June 30, 2022 and 2021 (dollars in thousands):

Three Months Ended

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Total revenues

Gross revenue from sales of Afrezza increased by $2.4 million, or 18%, for the three months ended March 31, 2022 compared to the same period in the prior year.

The increase reflects wholesaler inventory ordering patterns for the first quarter of 2021, which was adversely impacted as wholesalers decreased inventory levels, and price.

The gross-to-net adjustment was 38.7% of gross revenue, or $6.2 million, for the three months ended March 31, 2022, compared to 40.5% of gross revenue, or $5.5 million, for the same period in the prior year.

The decrease in the gross-to-net percentage was primarily driven by a decrease in wholesaler distribution fees (as a percentage of gross sales) due to an increased mix of specialty and retail pharmacy sales, a decrease in anticipated product returns, and lower co-pay assistance.

As a result, net revenue from sales of Afrezza increased by $1.7 million, or 21%, for the three months ended March 31, 2022 compared to the same period in the prior year.

Net revenue from collaborations and services decreased by $7.2 million, or 77%, for the three months ended March 31, 2022 compared to the same period in the prior year.

The decrease in collaborations and services revenue was primarily attributable to the completion of the R&D Services associated with our collaboration with UT.

Six Months Ended

Net revenue — commercial product sales:

Gross revenue from commercial product sales

Wholesaler distribution fees, rebates and chargebacks,

product returns and other discounts

Net revenue — commercial product sales

Gross-to-net revenue adjustment percentage

Revenue — collaborations and services

Total revenues

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Afrezza — Gross revenue from sales of Afrezza increased by $0.7 million, or 4%, for the three months ended June 30, 2022 compared to the same period in the prior year.

The increase was mainly attributable to increased price and demand, partially offset by wholesaler inventory ordering patterns resulting in lower inventory levels for the second quarter of 2022 .

The gross-to-net adjustment was 38.4% of gross revenue, or $6.7 million, for the three months ended June 30, 2022, compared to 39.8% of gross revenue, or $6.6 million, for the same period in the prior year.

The decrease in the gross-to-net percentage was primarily driven by a decrease in wholesaler distribution fees (as a percentage of gross sales) due to an increased mix of specialty and retail pharmacy sales and a decrease in anticipated product returns, partially offset by higher co-pay assistance.

As a result, net revenue from sales of Afrezza increased by $0.7 million, or 7%, for the three months ended June 30, 2022 compared to the same period in the prior year.

Gross revenue from sales of Afrezza increased by $3.1 million, or 10%, for the six months ended June 30, 2022 compared to the same period in the prior year.

The increase reflects higher product demand, favorable cartridge mix and price.

The gross-to-net adjustment was 38.6% of gross revenue, or $12.9 million, for the six months ended June 30, 2022, compared to 40.1% of gross revenue, or $12.1 million, for the same period in the prior year.

As a result, net revenue from sales of Afrezza increased by $2.4 million, or 13%, for the six months ended June 30, 2022 compared to the same period in the prior year.

V-Go — The acquisition of V-Go on May 31, 2022 resulted in an increase in gross revenue from commercial product sales of $4.1 million and net revenue of $2.1 million for the three and six months ended June 30, 2022.

The gross-to-net adjustment of 49.2% of gross revenue, or $2.0 million, is mainly attributable to commercial and government rebates and product distribution fees.

Collaborations and Services — Net revenue from collaborations and services decreased by $7.4 million, or 56%, for the three months ended June 30, 2022 and $14.6 million, or 65%, for the six months ended June 30, 2022 compared to the same periods in the prior

The decrease in collaborations and services revenue was primarily attribut able to the completion of the R&D Services associated with our collaboration with UT .

In August 2021, we entered into a commercial supply agreement with UT (the “CSA ”).

Revenue associated with the CSA is deferred as of March 31, 2022 and will be recognized over the period when commercial product is sold to UT.

Revenue associated with the CSA wa s deferred until we began manufacturing and subsequently selling Tyvaso DPI in June 2022 .

During the three and six months ended June 30, 2022, we recognized $ 4 .

7 million and $ 5 .

9 million, respectively, of revenue under the CSA .

We also recognized royalty revenue of $0.3 million during the three and six months ended June 30, 2022 .

See Note 10 – Collaboration, Licensing and Other Arrangements .

Commercial product gross profit

The following tables provide a comparison of the commercial product gross profit categories for the three months ended March 31, 2022 and 2021 (dollars in thousands):

The following tables provide a comparison of the commercial product gross profit categories for the three and six months ended June 30, 2022 and 2021 (dollars in thousands):

Three Months Ended

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Commercial product gross profit

Commercial product gross profit for the three months ended March 31, 2022 increased by $3.8 million, or 99%, compared to the same period in the prior year.

Gross margin for the three months ended March 31, 2022 was 77% compared to 47% for the same period in the prior year.

Six Months Ended

Commercial product gross profit:

Net revenue — commercial product sales

cost of goods sold

Commercial product gross profit

Afrezza — Commercial product gross profit for Afrezza increased by $1.7 million, or 31%, for the three months ended June 30, 2022, compared to the same period in the prior year.

Gross margin for the three months ended June 30, 2022 was 68% compared to 56% for the same period in the prior year.

The increase in gross profit and gross margin was attributable to an increase in Afrezza sales as well as a decrease in cost of goods sold.

Cost of goods sold decreased by $2.0 million, or 47%, for the three months ended March 31, 2022 compared to the same period in the prior year.

The decrease in cost of goods sold was primarily attributable to a decrease of $2.3 million in manufacturing-related spending on Afrezza as a result of the absorption of manufacturing-related costs due to the manufacturing of a second product.

The following tables provide a comparison of the expense categories for the three months ended March 31, 2022 and 2021 (dollars in thousands):

Cost of goods sold decreased by $1.0 million, or 24%, for the three months ended June 30, 2022 compared to the same period in the prior year.

The decrease in cost of goods sold was primarily attributable to a $2.0 million fee incurred for the amendment of the Insulin Supply Agreement in the prior year period and a $0.4 million decrease in manufacturing-related spending in the current period, partially offset by a $1.1 million increase in cost of goods sold due to lower manufacturing activities for Afrezza.

Commercial product gross profit for Afrezza increased by $5.4 million, or 58%, for the six months ended June 30, 2022, compared to the same period in the prior year.

Gross margin for the six months ended June 30, 2022 was 72% compared to 52% for the same period in the prior year.

The increase in gross profit and gross margin was attributable to an increase in Afrezza sales as well as a decrease in cost of goods sold.

Cost of goods sold decreased by $3.1 million, or 35%, for the six months ended June 30, 2022 compared to the same period in the prior year.

The decrease in cost of goods sold was primarily attributable to a $2.6 million decrease in manufacturing-related spending in the current period and a $2.0 million fee incurred for the amendment of the Insulin Supply Agreement in the prior year period, partially offset by a $0.9 million increase in cost of goods sold due to lower manufacturing activities for Afrezza.

V-Go — The acquisition of V-Go on May 31, 2022 resulted in an increase in c ommercial product gross profit of $0.8 million for the three and six months ended June 30, 2022.

Gross margin for V-Go for the three and six months ended June 30, 2022 was 40%.

The following tables provide a comparison of the expense categories for the three and six months ended June 30, 2022 and 2021 (dollars in thousands):

Three Months Ended

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General and administrative

(Gain) loss on foreign currency translation

Loss on purchase commitments

Total expenses

Six Months Ended

Cost of goods sold

Cost of revenue — collaborations and services

Research and development

General and administrative

Gain on foreign currency translation

Loss on purchase commitments

Total expenses

Cost of revenue — collaborations and services increased by $5.4 million, or 164%, for the three months ended March 31, 2022 compared to the same period in the prior year.

The increase was attributable to an increase in costs for the UT CSA, specifically an increase in manufacturing activities in preparation for supplying commercial product to UT.

Research and development expenses increased by $1.1 million, or 45%, for the three months ended March 31, 2022 compared to the same period in the prior year.

The increase was primarily attributable to costs incurred for research and development activities in our product pipeline, including the Phase 1 clinical trial for clofazimine.

Selling expenses increased by $3.1 million, or 32%, for the three months ended March 31, 2022 compared to the same period in the prior year.

The increase was primarily attributable to an enhanced primary care physician-focused promotional campaign that began in the fourth quarter of 2021, Afrezza territory restructuring costs, as well as promotional expenses and patient support services expenses to support Afrezza sales growth.

General and administrative expenses increased by $0.2 million, or 2%, for the three months ended March 31, 2022 compared to the same period in the prior year .

The increase was primarily attributable to increased stock-based compensation and headcount.

This increase was partially offset by lower legal fees and business development expenses.

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Cost of revenue — collaborations and services increased by $2.8 million, or 50%, for the three months ended June 30, 2022 and $8.2 million, or 93%, for the six months ended June 30, 2022 compared to the respective periods in the prior year.

The increase was attributable to an increase in manufacturing activities leading up to commercial product manufacturing in the second quarter of 2022 and subsequent sale to UT.

Research and development expenses increased by $2.6 million, or 110%, for the three months ended June 30, 2022 and $3.7 million, or 77%, for the six months ended June 30, 2022 compared to the respective periods in the prior year.

The increase was primarily attributable to costs incurred for development activities on our product pipeline and the Afrezza pediatrics clinical study (INHALE-1).

Selling expenses increased by $4.3 million, or 38%, for the three months ended June 30, 2022, compared to the same period in the prior year.

The increase was primarily attributable to a pilot promotional effort aimed at primary care physicians that began in the fourth quarter of 2021, elimination of the Thyquidity co-promotion (which permitted some expenses associated with the sales force to be recognized as cost of revenue — collaborations and services in the second quarter of 2021), promotional expenses to support Afrezza growth, and V-Go promotional efforts, partially offset by lower personnel related costs due to Afrezza territory restructuring.

Selling expenses increased by $7.4 million, or 35%, for the six months ended June 30, 2022, compared to the same period in the prior year.

General and administrative expenses increased by $1.7 million, or 19%, for the three months ended June 30, 2022, compared to the same period in the prior year.

This increase was primarily attributable to higher stock-based compensation, increased salaries, increased headcount, and legal fees due to the acquisition of V-Go.

General and administrative expenses increased by $1.8 million, or 11%, for the six months ended June 30, 2022, compared to the same period in the prior year.

This increase was primarily attributable to higher stock-based compensation and other compensation.

Under the Insulin Supply Agreement with Amphastar, payment obligations are denominated in Euros.

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dollar to Euro exchange rate associated with the recognized gain or loss on purchase commitments.

The foreign currency translation gain was $2.0 million for the three months ended March 31, 2022 compared to $3.8 million for the same period in the prior year.

The foreign currency translation gain was $ 4.5 million for the three months ended June 30 , 2022 compared to a loss of $ 0.9 million for the same period in the prior year.

The foreign currency translation gain was $ 6.5 million for the six months ended June 30, 2022 compared to $ 2.9 million for the same period in the prior year.

Other Income (Expense)

The following tables provide a comparison of the other income (expense) categories for the three months ended March 31, 2022 and 2021 (dollars in thousands):

The following tables provide a comparison of the other income (expense) categories for the three and six months ended June 30, 2022 and 2021 (dollars in thousands):

Three Months Ended

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Interest expense on notes

Loss on extinguishment of debt

Total other expense

Six Months Ended

Interest income

Interest expense on financing liability

Interest expense on notes

Loss on extinguishment of debt, net

Other (expense) income

Total other expense

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Interest expense on financing liability was $2.4 million for the three months ended March 31, 2022 and represented interest incurred on the Sale Leaseback transaction for our manufacturing facility in Danbury, CT, which closed in the fourth quarter of 2021.

Interest expense on notes de creased by $ 3 .7 million, or 57 %, for the three months ended March 31, 2022 compared to the same period in the prior year.

The decrease was primarily due to a $3.7 million milestone obligation that was achieved during the first quarter of 2021, partially offset by an increase in interest expense on the Senior convertible notes .

Interest income, consisting of interest on investments net of amortization, increased $0.5 million for the three months ended June 30, 2022 and $0.9 million for the six months ended June 30, 2022 compared to the same periods in the prior year primarily due to higher yields on our marketable securities and money market funds.

Interest expense on financing liability was $2.4 million for the three months ended June 30, 2022 and $4.8 million for the six months ended June 30, 2022 and represented interest incurred on the Sale-Leaseback Transaction for our manufacturing facility in Danbury, CT, which closed in the fourth quarter of 2021.

Interest expense on notes increased by $3.5 million, or 109%, for the three months ended June 30 , 2022 compared to the same period in the prior year.

The increase was primarily due to a $3.9 million increase for the achievement of a milestone under the milestone rights obligation that was achieved during the second quarter of 2022.

See Note 9 — Borrowings .

Interest expense on notes decreased $0.2 million, or 3%, for the six months ended June 30, 2022.

LIQUIDITY AND CAPITAL RESOURCES

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Our primary uses of cash include the development of our product pipeline, the manufacturing and marketing of Afrezza, the funding of general and administrative expenses, and interest expense on our financing liability and debt.

To date, we have funded our operations through the sale of equity and convertible debt securities, from the receipt of upfront and milestone payments from certain collaborations, from borrowings, from sales of Afrezza and the Sale Leaseback transaction.

We believe we will be able to meet our liquidity needs over the next twelve months based on the balance of cash, cash equivalents and investments on hand.

We believe we will meet longer-term expected future cash requirements and obligations, through a combination of cash and investments on hand, operating activities including manufacturing revenue and royalties from the production and sale of Tyvaso DPI, if approved, to UT, and available credit from our Midcap credit facility.

As of March 31, 2022, we had $288.4 million principal amount of outstanding debt, consisting of:

$230.0 million aggregate principal amount of Senior convertible notes bearing interest at 2.50% payable semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2021 and will mature on March 1, 2026, unless earlier converted, redeemed or repurchased.

As of June 3 0 , 2022 , we had $ 278.8 million principal amount of outstanding debt , consisting of:

$230.0 million aggregate principal amount of Senior convertible notes bearing interest at 2.50% payable semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2021 and maturing on March 1, 2026, unless earlier converted, redeemed or repurchased.

The Senior convertible notes are convertible at an initial conversion price of approximately $5.21 per share of common stock.

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$8.8 million principal amount of indebtedness under the Mann Group convertible note bearing interest at a fixed rate of 2.50% per annum compounded quarterly and maturing in December 2025, which is convertible into shares of our common stock at the option of Mann Group at a conversion price of $2.50 per share.

Interest is paid-in-kind from August 2019 until the end of 2020, after which we have the option to pay interest in-kind or in shares.

Interest was paid-in-kind from August 2019 until the end of 2020, after which we have the option to pay interest in-kind or in shares.

There can be no assurance that we will have sufficient resources to make any required repayments of principal under the Senior convertible notes, the MidCap credit facility or the Mann Group convertible note.

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The Milestone Rights were subsequently assigned the Milestone Purchasers.

The Milestone Rights provide the Milestone Purchasers certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and sales milestones, $65.0 million of which remains payable upon achievement of such milestones.

A $5.0 million milestone payment will be made in the third quarter of 2022.

See Note 15 – Commitments and Contingencies and Note 9 – Borrowings for further information related to the Milestone Rights.

During the three months ended March 31, 2022, we used $18.2 million of cash for our operating activities, which primarily consisted of $16.3 million of selling, general and administrative expenses, $9.0 million of cost of goods sold, $5.1 million of costs for research and development and $3.6 million of cash paid for interest, partially offset by $15.7 million of revenue.

During the three months ended March 31, 2021, we used $12.7 million of cash for our operating activities as a result of our net loss of $12.9 million.

The net change in operating asset and liabilities was primarily a result of the recognition of amortization of deferred revenue of $9.0 million, partially offset by an increase in accrued expenses and other current liabilities of $8.3 million.

Cash used in investing activities of $ 39.5 million for the three months ended March 31, 2022 was primarily due to the purchase of $ 56.0 million of debt securities and $ 5.0 million purchase of available-for-sale securities , and $5.1 million purchase of property and equipment , partially offset by the maturity of $ 26.5 million of debt securities .

Cash used in investing activities of $31.4 million for the three months ended March 31, 2021 was primarily due to the purchase of debt securities.

Cash provided by financing activities of $0.8 million for the three months ended March 31, 2022 was primarily due to proceeds from the market price stock purchase plan of $0.7 million.

Cash provided by financing activities of $225.0 million for the three months ended March 31, 2021 was primarily due to net proceeds from the offering of Senior convertible notes of $222.9 million.

During the six months ended June 30, 2022, we used $50.2 million of cash for our operating activities, which primarily consisted of $38.6 million of selling, general and administrative expenses, $21.5 million of cost of goods sold, $10.9 million of costs for research and development and $5.8 million of cash paid for interest, partially offset by $31.7 million of revenue.

During the six months ended June 30, 2021, we used $34.2 million of cash for our operating activities as a result of our net loss of $48.4 million, partially offset by non-cash charges of $32.5 million of which $22.1 million was a loss on extinguishment of debt related to the first amendment of the Mann Group convertible note.

The net change in operating asset and liabilities was primarily a result of the amortization of deferred revenue of $21.2 million and the payment of the Mann Group promissory note interest of $4.9 million, partially offset by the receipt of $5.3 million in customer deposits from UT for expansion equipment as well as other pass- through payments, and an increase in operating payables and accrued expenses.

Cash used in investing activities of $37.5 million for the six months ended June 30 , 2022 was primarily due to the purchase of $68.5 million of debt securities, the up-front consideration of $15.1 million for certain assets and assumed liabilities related to V-Go and $5.0 million purchase of available-for-sale securities, and $2.2 million purchase of property and equipment, partially offset by the maturity of $53.3 million of debt securities.

Cash used in investing activities of $144.0 million for the six months ended June 30, 2021 was primarily due to the purchase of $138.9 million of debt securities and $3.0 million of Thirona convertible notes that was recognized as an available-for-sale investment.

Cash used in financing activities of $1.0 million for the six months ended June 30 , 2022 was primarily due to the payments on our financing liability of $1.4 million.

Cash provided by financing activities of $173.5 million for the six months ended June 30, 2021 was primarily due to net proceeds from the offering of Senior convertible notes of $222.7 million, partially offset by the repayment of $35.1 million of Mann Group non-convertible notes and related unpaid accrued interest and the repayment of $10.0 million of principal and $1.0 million prepayment penalty for the MidCap credit facility.

Future Liquidity Needs

We are not currently profitable and have rarely generated positive net cash flow from operations.

In addition, we expect to continue to incur significant expenditures for the foreseeable future in support of our manufacturing operations, sales and marketing costs for Afrezza, and development costs for other product candidates in our pipeline.

As of March 31, 2022, we had capital resources of $67.2 million in cash and cash equivalents, $95.2 million in short-term investments, $70.5 million in long-term investments, and total principal amount of outstanding borrowings of $288.4 million.

In addition, we expect to continue to incur significant expenditures for the foreseeable future in support of our manufacturing operations, sales and marketing costs for our products, and development costs for other product candidates in our pipeline.

As of June 30, 2022, we had capital resources of $154.2 million in cash, cash equivalents and short-term investments, $32.6 million in long-term investments, and total principal amount of outstanding borrowings of $278.8 million.

We believe our resources will be sufficient to fund our operations for beyond the next twelve months from the date of issuance of our condensed consolidated financial statements included in Part I – Financial Statements (Unaudited) .

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis