What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-11-08 compared with 2022-08-09 · 100 added, 79 removed, 116 unchanged (61% of the section changed)

18 unchanged sentences

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

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.

As of September 30, 2022, we had an accumulated deficit of $3.2 billion and a stockholders’ deficit of $237.7 million.

Our net loss was $14.4 million and $69.5 million for the three and nine months ended September 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.

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Trends and Uncertainties

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.

We continue to experience the impact of the COVID-19 pandemic on our sales activities and Biomm’s ability to market Afrezza in Brazil.

In addition, we have increased the safety stock of certain 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.

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 and nine months ended September 30, 2022 and 2021

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

Three Months Ended

September 30,

Net revenue — commercial product sales:

5 unchanged sentences

Revenue — collaborations and services

Royalties — collaborations

Total revenues

Six Months Ended

Nine Months Ended

September 30,

Net revenue — commercial product sales:

5 unchanged sentences

Revenue — collaborations and services

Royalties — collaborations

Total revenues

1 unchanged sentence

* Not meaningful

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.

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 commercial rebates.

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 .

Afrezza — Gross revenue from sales of Afrezza increased by $1.5 million, or 9%, for the three months ended September 30, 2022 compared to the same period in the prior year.

The increase was mainly attributable to increased price (including a more favorable gross-to-net adjustment) and patient demand, partially offset by wholesaler inventory ordering patterns resulting in lower inventory levels for the third quarter of 2022 .

The gross-to-net adjustment was 39.2% of gross revenue for the three months ended September 30, 2022, compared to 40.3% of gross revenue for the same period in the prior year.

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

As a result, net revenue from sales of Afrezza increased by $1.1 million, or 11%, for the three months ended September 30, 2022 compared to the same period in the prior year.

Gross revenue from sales of Afrezza increased by $4.6 million, or 10%, for the nine months ended September 30, 2022 compared to the same period in the prior year.

The increase reflects price (including a more favorable gross-to-net adjustment), higher product demand and a favorable cartridge mix.

The gross-to-net adjustment was 38.8% of gross revenue for the nine months ended September 30, 2022, compared to 40.2% of gross revenue for the same period in the prior year.

As a result, net

revenue from sales of Afrezza increased by $ 3.5 million, or 13 %, for the nine months ended September 3 0, 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 $10.7 million and net revenue of $5.4 million for the three months ended September 30, 2022.

The gross-to-net adjustment of 49.4% of gross revenue was mainly attributable to commercial and government rebates and product distribution fees.

V-Go gross revenue for the nine months ended September 30, 2022 was $14.8 million and net revenue was $7.5 million for the nine months ended September 30, 2022.

The gross-to-net adjustment of 49.4% of gross revenue was mainly attributable to commercial and government rebates and product distribution fees.

Collaborations and Services — Net revenue from collaborations and services decreased by $2.1 million, or 17%, for the three months ended September 30, 2022 and $16.7 million, or 48%, for the nine months ended September 30, 2022 compared to the same periods 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.

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

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 .

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

During the three and nine months ended September 30, 2022, we recognized $9.9 million and $15.8 million, respectively, of revenue under the CSA.

We also recognized royalty revenue of $6.2 million and $6.5 million during the three and nine months ended September 30, 2022, respectively.

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 and six months ended June 30, 2022 and 2021 (dollars in thousands):

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

Three Months Ended

September 30,

Commercial product gross profit:

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Commercial product gross profit

Six Months Ended

Nine Months Ended

September 30,

Commercial product gross profit:

2 unchanged sentences

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.

Afrezza — Commercial product gross profit for Afrezza increased by $2.8 million, or 47%, for the three months ended September 30, 2022, compared to the same period in the prior year.

Gross margin for the three months ended September 30, 2022 was 81% compared to 61% 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 $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.

Cost of goods sold decreased by $1.7 million, or 45%, for the three months ended September 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 decrease in excess capacity costs for Afrezza.

Commercial product gross profit for Afrezza increased by $8.3 million, or 54%, for the nine months ended September 30, 2022, compared to the same period in the prior year.

Gross margin for the nine months ended September 30, 2022 was 75% compared to 55% 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):

Cost of goods sold decreased by $4.8 million, or 38%, for the nine months ended September 30, 2022 compared to the same period in the prior year.

The decrease in cost of goods sold was primarily attributable to a $3.8 million decrease in excess capacity costs in the current period and a $2.0 million fee incurred for the amendment of the Insulin Supply Agreement in the prior year period.

V-Go — The acquisition of V-Go on May 31, 2022 resulted in an increase in c ommercial product gross profit of $ 2.5 million and gross margin of 46% for the three months ended September 30, 2022.

Gross profit for V-Go was $3.3 million and gross margin was 44% for the nine months ended September 30, 2022.

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

Three Months Ended

September 30,

Cost of goods sold

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General and administrative

(Gain) loss on foreign currency translation

Loss on purchase commitments

Asset impairment

Gain on foreign currency translation

Total expenses

Six Months Ended

Nine Months Ended

September 30,

Cost of goods sold

2 unchanged sentences

General and administrative

Asset impairment

Gain on foreign currency translation

3 unchanged sentences

* Not meaningful

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.

Cost of revenue — collaborations and services increased by $6.4 million, or 105%, for the three months ended September 30, 2022 and $14.6 million, or 98%, for the nine months ended September 30, 2022 compared to the respective periods in the prior year.

The increase was attributable to an increase in manufacturing activities for commercial product.

Research and development expenses increased by $0.5 million, or 13%, for the three months ended September 30, 2022 compared to the same period in the prior year.

The increase was primarily attributable to personnel costs for headcount hired in the second half of 2021, partially offset by a decrease in the Afrezza pediatrics clinical study (INHALE-1) due to study startup costs incurred in the third quarter of 2021.

Research and development expenses increased by $4.1 million, or 49%, for the nine months ended September 30, 2022 compared to the same period in the prior year.

The increase was primarily attributable to personnel costs for headcount hired in the second half of 2021, development activities on our product pipeline, and the Afrezza pediatrics clinical study (INHALE-1).

Selling expenses increased by $2.7 million, or 25%, for the three months ended September 30, 2022, compared to the same period in the prior year.

The increase was primarily attributable to V-Go promotional efforts, 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 third quarter of 2021), and net impact of personnel-related costs due to Afrezza sales force restructuring.

Selling expenses increased by $10.1 million, or 32%, for the nine months ended September 30, 2022, compared to the same period in the prior year.

be recognized as cost of revenue — collaborations and services in the same period of 2021), V-Go promotional efforts, and net impact of personnel - related costs due to Afrezza sales force restructuring.

General and administrative expenses increased by $2.7 million, or 43%, for the three months ended September 30, 2022, compared to the same period in the prior year.

This increase was primarily attributable to higher stock-based compensation, increased headcount and higher professional fees.

General and administrative expenses increased by $4.5 million, or 20%, for the nine months ended September 30, 2022, compared to the same period in the prior year.

This increase was primarily attributable to higher stock-based compensation, increased headcount, and higher professional and consulting fees.

An impairment of $0.1 million was recognized for the three and nine months ended September 30, 2021 for the contract asset associated with variable consideration for gross profits for sales of Thyquidity under Vertice Pharma’s co-promotion agreement.

See Note 10 – Collaboration, Licensing and Other Arrangements.

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 $ 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.

The foreign currency translation gain was $1.8 million for the three months ended September 30, 2022 compared to $2.1 million for the same period in the prior year.

The foreign currency translation gain was $8.3 million for the nine months ended September 30, 2022 compared to $5.0 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 and six months ended June 30, 2022 and 2021 (dollars in thousands):

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

Three Months Ended

September 30,

Interest income

1 unchanged sentence

Interest expense on notes

Loss on extinguishment of debt

Gain on extinguishment of debt

Other (expense) income

Total other expense

Six Months Ended

Nine Months Ended

September 30,

Interest income

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Loss on extinguishment of debt, net

Other (expense) income

Other expense

Total other expense

1 unchanged sentence

* Not meaningful

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.

Interest income, consisting of interest on investments net of amortization, increased $0.6 million for the three months ended September 30, 2022 and $1.5 million for the nine months ended September 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 $2.5 million for the three months ended September 30, 2022 and $7.3 million for the nine months ended September 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 for the three months ended September 30 , 2022 was comparable to the same period in the prior year .

See Note 9 — Borrowings .

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

Interest expense on notes decreased $ 0.2 million , or 2 %, for the nine months ended September 30, 2022.

Gain on extinguishment of debt of $4.9 million for the three months ended September 30, 2021 consisted of the principal amount and related accrued and unpaid interest for our Paycheck Protection Program (“PPP”) loan, which was forgiven by the SBA in July 2021.

Loss on extinguishment of debt, net of $17.2 million for the nine months ended September 30, 2021 consisted of $22.1 million loss on extinguishment of debt for the amendment to the Mann Group convertible note, which did not result in a change in our financial position, partially offset by a $4.9 million gain on extinguishment of debt as a result of the SBA’s forgiveness of the PPP loan.

Other expense or income for the nine months ended September 30, 2022 and 2021 consisted primarily of the loss associated with a foreign currency hedging transaction which was entered into to mitigate our exposure to foreign currency exchange risks associated with our insulin purchase obligation in 2021 under the Insulin Supply Agreement.

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 V-Go, royalties from UT from the sale of Tyvaso DPI, and proceeds from the Sale-Leaseback transaction.

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 V-Go, royalties and manufacturing revenue from UT as well as proceeds from 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.

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

As of September 30, 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.

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The conversion rate is subject to adjustment under certain circumstances in accordance with the terms of the Indenture.

$40.0 million principal amount under the MidCap credit facility, bearing interest at an annual rate equal to one-month LIBOR plus 6.25%, subject to a one-month LIBOR floor of 1.00%, payable in equal monthly installments beginning in September 2023 through maturity in August 2025.

$40.0 million principal amount under the MidCap credit facility, bearing interest at an annual rate equal to one-month Secured Overnight Financing Rate (“SOFR”) plus 6.25% (cap of 8.25%), subject to a one-month SOFR floor of 1.00%, payable in equal monthly installments beginning in September 2023 through maturity in August 2025.

In August 2022, the Company amended the MidCap credit facility and transitioned the benchmark interest rate from LIBOR to SOFR.

The interest rate prior to the amendment was one-month LIBOR (1% floor) plus 6.25% (cap of 8.25%) .

$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.

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To date, we have been able to timely make our required interest payments, but we cannot guarantee that we will be able to do so in the future.

If we fail to repurchase the Mann Group promissory notes, we will be in default under the applicable instrument for such indebtedness and may also suffer an event of default under the terms of other borrowing arrangements that we may enter into from time to time.

If we fail to repurchase the Mann Group promissory note, we will be in default under the applicable instrument for such indebtedness and may also suffer an event of default under the terms of other borrowing arrangements that we may enter into from time to time.

Any of these events could have a material adverse effect on our business, results of operations and financial condition, up to and including the noteholders initiating bankruptcy proceedings or causing us to cease operations altogether.

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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 as of June 30, 2022.

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

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, $60.0 million of which remains payable upon achievement of such milestones as of September 30, 2022.

A $5.0 million milestone payment was 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 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.

During the nine months ended September 3 0 , 2022 , we used $ 78.3 million of cash for our operating activities , which primarily consisted of $ 59.1 million of selling, general and administrative expenses , $ 5.0 million of cost of goods sold, $ 16.0 million of costs for research and development and $ 12.0 million of cash paid for interest , partially offset by $ 63.0 million of revenue .

During the nine months ended September 30, 2021, we used $49.4 million of cash for our operating activities, which primarily consists of $47.7 million of selling, general and administrative expenses, $25.5 million of cost of goods sold, $7.7 million for research and development and $5.6 million of cash paid for interest, partially offset by $37.6 million of revenue.

Cash used in investing activities of $10.1 million for the nine months ended September 30 , 2022 was primarily due to the purchase of $70.1 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 $2.5 million purchase of property and equipment, partially offset by the maturity of $82.6 million of debt securities.

Cash used in investing activities of $139.0 million for the nine months ended September 30, 2021 was primarily due to the purchase of $238.4 million of debt securities and $6.3 million purchase of property and equipment, partially offset by the sale of $105.7 million of debt securities.

Cash provided by financing activities of $18.6 million for the nine months ended September 30 , 2022 was primarily due to net proceeds from at-the-market offering of $19.4 million, partially offset by the milestone payment of $1.1 million.

Cash provided by financing activities of $172.9 million for the nine months ended September 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

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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.

As of September 30, 2022, we had capital resources of $54.3 million in cash and cash equivalents, $110.7 million in short-term investments, $12.7 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) .

2 unchanged sentences

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