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Item 7. Management’s Discussion and Analysis

2021-02-25 compared with 2020-02-25 · 119 added, 114 removed, 120 unchanged (66% of the section changed)

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The following discussion of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and notes thereto included in this Annual Report on Form 10-K.

The Company has elected the presentation requirements under Rule 12b-2 of the Exchange Act as a smaller reporting company and have herein included a two year discussion of our financial condition and results of operations.

Please see our Annual Report on Form 10-K filed on February 26, 2019 for similar disclosures on previous years.

We are a biopharmaceutical company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension.

Our only approved product, Afrezza, is an ultra rapid-acting inhaled insulin that was approved by the FDA in June 2014 to improve glycemic control in adult patients with diabetes.

We have elected the presentation requirements under Rule 12b-2 of the Exchange Act as a smaller reporting company and have herein included a two year discussion of our financial condition and results of operations.

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

Our lead product, is Afrezza (insulin human) Inhalation Powder, which was approved by the FDA in June 2014.

Afrezza is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes.

Afrezza became available by prescription in United States retail pharmacies in February 2015.

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

Our partner has disclosed that it intends to submit an NDA for Tyvaso DPI to the FDA in April 2021.

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

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

We continue to manage the risk to our business posed by the global COVID-19 pandemic.

Our sales representatives have resumed in-person sales calls to the extent permitted by state and local public health authorities and by the policies of individual healthcare providers on their call lists.

Our offices in California and Connecticut have remained open for essential personnel and, as public health orders allow, have reopened to non-essential personnel, although many employees continue to work from home for a portion of each workweek.

Although our productivity has been impacted by the global pandemic, we have suitably adapted to the changed business environment that now exists.

The COVID-19 pandemic continues to evolve rapidly and its ultimate impact remains highly uncertain.

We do not yet know the full extent of potential delays or impacts on our business, our collaboration arrangements, commercialization efforts, healthcare systems or to the global economy as a whole.

We expect the COVID-19 pandemic to continue to negatively impact our near-term revenues from Afrezza and believe it has the potential to have additional adverse impacts on our operations.

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

As of December 31, 2020, we had an accumulated deficit of $3.0 billion and a stockholders’ deficit of $180.4 million.

We had net loss of $57.2 million and $51.9 million in the years ended December 31, 2020 and 2019, respectively.

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, and from borrowings under certain loan arrangements.

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, and from borrowings under certain loan arrangements.

As discussed below in “Liquidity and Capital Resources , ” if we are unable to obtain additional funding, there will continue to be substantial doubt about our ability to continue as a going concern.

Our business is subject to significant risks, including but not limited to our need to raise additional capital to fund our operations, our ability to successfully commercialize Afrezza, our ability to manufacture sufficient quantities of Afrezza and competition from other products and technologies.

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

Critical Accounting Policies

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These critical accounting policies are also considered significant accounting policies and are more fully described in Note 2 – Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements included in Part II, Item 8 — Financial Statements and Supplementary Data.

Revenue Recognition – Net Revenue – Commercial Product Sales — On January 1, 2018, we adopted Accounting Standards Codification (“ASC”) Topic 606 - Revenue from Contracts with Customers (“the new revenue guidance”).

We recognize revenue on product sales when a customer obtains control of our product, in an amount that reflects the consideration which we expect to be entitled in exchange for those goods or services.

Product revenues are recorded net of applicable reserves for variable consideration, including discounts, rebates, allowances and fees.

Management estimates related to revenue from commercial products includes estimates for variable consideration, product returns, government and payor rebates, and other incentives.

For further detail refer to Note 2 – Summary of Significant Accounting Policies.

Revenue Recognition – Collaborations and Services — We enter into licensing or research agreements under which we license certain rights to our product candidates to third parties or provide research services to third-parties.

Revenue Recognition – Net Revenue – Commercial Product Sales — We sell Afrezza to a limited number of wholesale distributors and specialty pharmacies in the U.S.

(collectively, its “Customers”).

Wholesale distributors subsequently resell our products to retail pharmacies and certain medical centers or hospitals.

Specialty pharmacies sell directly to patients.

In addition to distribution agreements with Customers, we enter into arrangements with payers that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of our products.

We recognize revenue on product sales when the Customer obtains control of our product, which occurs at delivery for wholesale distributors and generally at delivery for specialty pharmacies.

Product revenues are recorded net of applicable reserves for variable consideration.

Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payers, and other indirect customers relating to the Company’s sale of its products.

These reserves are further detailed under Reserves for Variable Consideration in Note 2 – Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements included in Part II, Item 8 — Financial Statements and Supplementary Data.

The terms of these arrangements may include, but are not limited to, payment to us of one or more of the following:

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development, regulatory, and commercial milestone payments;

payments for manufacturing supply services we provide;

payments for manufacturing commercial and clinical supply services we provide;

and royalties on net sales of licensed products and sublicenses of the rights.

As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract.

We use key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success.

Given that significant estimates depend on the development plan, these estimates could change and impact the revenue recognition.

Consideration received that does not meet the requirements to satisfy the revenue recognition criteria is recorded as deferred revenue in the accompanying consolidated balance sheets based on our best estimate of when such revenue will be recognized.

As part of the accounting for these arrangements, we must develop assumptions that require judgment such as determining the performance obligation in the contract and determining the stand-alone selling price for each performance obligation identified in the contract.

If an arrangement has multiple performance obligations, the allocation of the transaction price is determined from observable market inputs, and we use key assumptions to determine the stand-alone selling price, which may include development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success.

Revenue is recognized based on the measurement of progress as the performance obligation is satisfied and consideration received that does not meet the requirements to satisfy the revenue recognition criteria is recorded as deferred revenue.

Current deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months.

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Inventory Costing and Recoverability — We determine the cost of inventory using the first-in, first-out or FIFO method.

We capitalize inventory costs associated with our products based on judgement that future economic benefits are expected to be realized.

We capitalize inventory costs associated with our products based on judgment that future economic benefits are expected to be realized.

Inventories are stated at the lower of cost or net realizable value.

We analyzed our inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value.

We performed an assessment of projected sales to evaluate the lower of cost or net realizable value and the potential excess inventory on hand at December 31, 2019 and 2018.

As a result of these assessments, we recorded inventory write-offs of $2.2 million in the year ended December 31, 2018.

There were no inventory write-offs in the year ended December 31, 2019.

Recognized Loss on Purchase Commitments — We assess whether losses on long term purchase commitments should be accrued.

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The balance of recognized loss on purchase commitments is primarily associated with insulin purchases.

As of December 31, 2019 and 2018 the balance was $92.0 million and $98.3 million, respectively.

Impairment of Long-Lived Assets — We evaluate long lived assets for impairment at least on a quarterly basis and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.

An impairment loss would be indicated when estimated undiscounted future cash flows from the use and eventual disposition of an asset group, which are identifiable and largely independent of the cash flows of other asset groups, are less than the carrying amount of the asset group.

In connection with our quarterly assessment of impairment indicators, we recorded no impairments for the years ended December 31, 2019 and 2018.

For further information see Note 4 — Property and Equipment of the Notes to Consolidated Financial Statements included in “Part II, Item 8 — Financial Statements and Supplementary Data”.

Mileston e Rights Liability — In July 2013, in conjunction with the execution of a loan agreement (the “Deerfield Credit Facility”) with Deerfield Private Design Fund II, L.P.

An impairment loss would be indicated when

estimated undiscounted future cash flows from the use and eventual disposition of an asset group, which are identifiable and largely independent of the cash flows of other asset groups, are less than the carrying amount of the asset group.

Milestone Rights Liability — In July 2013, in conjunction with the execution of a loan agreement (the “Deerfield Credit Facility”) with Deerfield Private Design Fund II, L.P.

and Deerfield Private Design International II, L.P.

(collectively, “Deerfield”) that expi red following our full satisfaction of our repayment obligations, we issued to Deerfield Private Design Fund II, L.P.

(collectively, “Deerfield”) that expired following our full satisfaction of our repayment obligations, we issued to Deerfield Private Design Fund II, L.P.

and Horizon Santé FLML SÀRL, (the “Milestone Purchasers”) certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and sales milestones, $70.0 million of which remains payable upon achievement of such milestones (the “Milestone Rights”), pursuant to an agreement (the “Milestone Agreement”) that continues beyond the expiration of the loan agreement.

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Upon the achievement of a milestone event, the milestone payment will be allocated between (i) a reduction of the initial liability and (ii) a return on investment and the gain or loss is recognized at the time the milestone event is achieved.

The estimated fair value of the Mile stone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones discounted to present value using a selected market discount rate (Level 3 in the fair value hierarchy).

The estimated fair value of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones discounted to present value using a selected market discount rate (Level 3 in the fair value hierarchy).

Clinical Trial Expenses — Our clinical trial accrual process seeks to account for expenses resulting from our obligations under contract with vendors, consultants, and clinical site agreements in connection with conducting clinical trials.

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We have elected to account for GILTI in the year the tax is incurred.

On March 27, 2020, the U.S.

government enacted the Coronavirus Aid, Relief, and Economic Security Act, or the CARES Act, a $2 trillion relief package comprising a combination of tax provisions and other stimulus measures.

The CARES Act broadly provides entities tax payment relief and significant business incentives and makes certain technical corrections to the Tax Act.

The tax relief measures for entities include a five-year net operating loss carry back, increased interest expense deduction limits, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property.

The Act also provides other non-income tax benefits, including federal funding for a range of stabilization measures and emergency funding to assist those impacted by the COVID-19 pandemic.

Similar legislation is being enacted in other jurisdictions in which the Company operates.

Accounting Standards Codification Topic 740, Income Taxes , requires the effect of changes in tax rates and laws on deferred tax balances to be recognized in the period in which new legislation is enacted.

The enactment of the CARES Act and similar legislation in other jurisdictions in which the Company operates was not material to the Company’s income tax benefit for the year ended December 31, 2020.

Results of Operations

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Gross revenue from the sales of Afrezza increased by $11.0 million, or 25%, for the year ended December 31, 2020 compared to the prior year.

The increase was primarily driven by higher product demand and price increases, shipments to Biomm (Brazil) as well as a more favorable mix of Afrezza cartridges.

The increase was primarily driven by higher product demand with a more favorable mix of Afrezza cartridges and a price increase, partially offset by a reduction in sales to Biomm (Brazil).

The gross-to-net adjustment was $22.1 million (or 41% of gross revenue) for the year ended December 31, 2020, compared to $18.2 million (or 42% of gross revenue) for the prior year.

The increase of $5.2 million was primarily due to a $1.8 million increase in wholesaler’s fee-for-service, a $1.3 million increase in rebates, chargebacks and patient co-pay assistance programs, and $1.8 million increase in product returns.

Shipments to Biomm (Brazil) of $0.7 million which began in 2019 were not subject to gross-to-net adjustments.

As a result, net revenue from the sales of Afrezza increased by $8.0 million, or 46%, for the year ended December 31, 2019 compared to the prior year.Net revenue from collaborations and services increased by $27.2 million, or 257%, for the year ended December 31, 2019 compared to the prior year.

The increase was primarily driven by $24.8 million in revenue from the UT License Agreement and by $2.3 million in revenue from a separate research agreement with UT that we entered into in the fourth quarter of 2018 (the “UT Research Agreement”).

The increase of $3.9 million was primarily driven by an increase in commercial product sales and a decrease in rebates and wholesaler fees, partially offset by an increase in the utilization of our patient co-pay assistance program.

As a result, net revenue from the sales of Afrezza increased by $7.0 million, or 28%, for the year ended December 31, 2020 compared to the prior year.

The stay-at-home orders implemented around the country in response to the COVID-19 pandemic negatively impacted the sales of Afrezza by limiting the access of our sales force to physicians.

The COVID-19 pandemic is expected to continue to negatively impact our near-term revenues from Afrezza.

Net revenue from collaborations and services decreased by $4.9 million, or 13%, for the year ended December 31, 2020 compared to the prior year.

This was primarily driven by a $5.8 million decrease in revenue recognized from the UT Research Agreement, which was substantially completed in the second quarter of 2019.

During the third quarter of 2020, we sold clinical supplies to UT.

See Note 8 – Collaboration, Licensing and Other Arrangements in the consolidated financial statements included in Part II, Item 8 – Financial Statements and Supplementary Data.

Commercial product gross profit

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Commercial product gross profit (loss):

Commercial product gross profit increased by $7.3 million, or 347%, for the year ended December 31, 2019 from a gross loss of $2.1 million in the prior year.

The increase was primarily attributable to higher commercial product sales.

Non-GAAP Measures

To supplement our consolidated financial statements presented under GAAP, we are presenting certain 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 (dollars in thousands).

Year Ended December 31,

Net revenue — Afrezza

Less cost of goods sold

GAAP gross profit (loss) — Afrezza

Exclude Amphastar amendment fee

Non-GAAP gross profit (loss) — Afrezza

Non-GAAP gross margin

Commercial product gross profit for the year ended December 31, 2020 increased by $12.0 million, or 230%, compared to the prior year.

Gross margin for the year ended December 31, 2020 increased to 53% from 21% for the prior year.

The increase in gross profit and gross margin was attributable to higher commercial product sales combined with a reduction in cost of goods sold.

Cost of goods sold decreased by $5.0 million, or 25%, for the year ended December 31, 2020 compared to the prior year.

The reduction in cost of goods sold was primarily attributable to a $2.8 million amendment fee associated with our Insulin Supply Agreement with Amphastar in 2019, $1.7 million in reduced manufacturing-related spending and $1.0 million of increased manufacturing activities, which resulted in a greater amount of costs capitalized to inventory, partially offset by $0.5 million of inventory write-offs.

The following table provides a comparison of the expense categories for the years ended December 31, 2020 and 2019 (dollars in thousands):

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Cost of revenue — collaborations and services

In-process research and development

Research and development

General and administrative

Gain on foreign currency translation

Impairment of commitment asset

Loss (gain) on foreign currency translation

Total expenses

Cost of goods sold increased by $ 0.7 million, or 4 %, for the year ended December 31, 2019 compared to the prior year .

The increase was primarily attributable to higher cost of Afrezza sales of $2.1 million corresponding to higher Afrezza gross sales of $13.3 million and an increase of $0.8 million in fees paid for amendments to our Insulin Supply Agreement in 2018 and 2019, partially offset by a $2.2 million decrease in inventory write-offs as there were no inventory write-offs in 2019 .

Cost of goods sold includes the fees incurred to amend our Insulin Supply Agreement, which consisted of approximately $2.8 million and $2.0 million for the years ended December 31, 2019 and 2018, respectively.

Cost of revenue - collaborations and services increased by $1.7 million, or 21 %, for the year ended December 31, 2020 compared to the prior year .

The increase was attributable to resource costs related to conducting activities under the UT License Agreement and UT Research Agreement, which began in the fourth quarter of 2018.

The increase was attributable to resource costs related to conducting activities for our collaboration partner, UT, in addition to the cost of clinical supplies.

In-process research and development expense of $13.2 million for the year ended December 31, 2020 related to the acquisition of QrumPharma for total consideration of approximately $12.7 million and transaction costs of approximately $0.5 million.

The acquisition of QrumPharma was accounted for as an asset acquisition and expensed on the date of acquisition as substantially all of the fair value of the assets acquired was concentrated in a single asset that consisted of in-process research and development in a pre-clinical development state.

See Note 3 – Acquisition in the consolidated financial statements included in Part II, Item 8 – Financial Statements and Supplementary Data.

Research and development expenses decreased by $0.7 million, or 9%, for the year ended December 31, 2020 compared to the prior year .

The decrease was primarily attributable to a $1.7 million decrease in personnel related costs and a $0.9 million decrease in clinical trial spending, partially offset by increased expenses of $0.2 million related to the development of our BluHale inhalation profiling apparatus and increased facility remediation and equipment repair costs of $0.5 million.

The decrease was mainly attributable to lower clinical trial spending.

Selling expenses decreased by $12.0 million, or 26 %, for the year ended December 31, 2020 compared to the prior year .

The decrease was primarily attributable to a $6.0 million decrease in personnel related costs, a $0.3 million decrease in sponsorships and decreased consulting costs of $0.3 million in 2019, partially offset by a $5.6 million increase in costs for television advertising for Afrezza in 2019.

The decrease was primarily attributable to a $9.3 million decrease in costs for television advertising for Afrezza and a $4.1 million decrease from a reduction in promotional and marketing activities in response to the COVID-19 pandemic, partially offset by a $0.8 million increase in personnel-related costs and a $0.5 million increase in costs associated with AfrezzaAssist, our new patient support platform.

General and administrative expenses decreased by $3.6 million, or 13 %, for the year ended December 31, 2020 compared to the prior year .

This decrease was primarily attributable to a $0.6 million decrease in personnel and employee related costs, a $2.2 million net decrease in consulting and professional costs and a $1.2 million decrease in stock-based compensation costs.

This decrease was primarily attributable to a $2.5 million decrease in professional fees, $0.6 million decrease in personnel and employee-related costs and a $0.2 million reduction in property taxes.

During the year ended December 31, 2020, an impairment of $1.9 million was recognized for a commitment asset and debt issuance costs related to the future funding commitments of the MidCap Credit Facility (see Note 1 – Description of Business and Note 7 – Borrowings in the consolidated financial statements included in Part II, Item 8 – Financial Statements and Supplementary Data.

There were no asset impairments for the year ended December 31, 2019.

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

We are required to record the foreign currency translation impact of the U.S.

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

The gain on foreign currency translation decreased $2.6 million, or 57%, for the year ended December 31, 2019 due to the translation impact of the U.S.

dollar to Euro exchange rates resulting in a lower gain in 2019 when compared to 2018.

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

The foreign currency translation resulted in a loss of $8.0 million for the year ended December 31, 2020 compared to a gain of $1.9 million for the prior year .

This impact was due to the translation of the U.S.

dollar to Euro exchange rates.

Other Income (Expense)

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Interest expense on notes

Interest expense on Mann Group promissory notes

Gain (loss) on extinguishment of debt

Interest expense on promissory notes

(Loss) gain on extinguishment of debt

Other expense

Total other expense

Interest income increased by $ 0.5 million , or 99%, for the year ended December 31, 2019 compared to the prior year .

This increase was primarily attributable to a higher average balance on our money market funds and short-term investments .

Interest expense on notes, which included the MidCap Credit Facility, our previously outstanding $18.7 million aggregate principal amount of 5.75% Convertible Senior Subordinated Exchange Notes due 2021 (the “2021 notes”), our 2024 convertible notes, the Deerfield Credit Facility and the Milestone Rights, increased by $1.2 million, or 23%, for the year ended December 31, 2019 compared to the prior year.

The increase was primarily attributable to additional interest of $3.4 million related to our milestone obligation under the Milestone Rights achieved in the third quarter of 2019, partially offset by lower interest as a result of the repayment of the Deerfield Credit Facility, which had an interest rate of 9.75%.

The gain on extinguishment of debt for the year ended December 31, 2019 was primarily due to the cancellation of the 2021 notes in exchange for cash, common stock, 2024 convertible notes and non-interest bearing notes in August 2019 pursuant to an exchange agreement.

The loss on extinguishment of debt for the year ended December 31, 2018 was primarily attributable to conversions of convertible debt to common stock under the Deerfield Credit Facility in September 2018.

Other expense increased by $0.5 million, or 112%, for the year ended December 31, 2019 compared to the prior year.

Other expense of $0.9 million incurred during 2019 was primarily due to expense recognized for the incremental fair value of warrants issued in December 2018 that were amended in December 2019.

Other expense of $0.4 million incurred during 2018 primarily related to a currency loss realized in connection with a foreign exchange contract for purchases under the Insulin Supply Agreement.

Interest income decreased by $0.8 million, or 83%, for the year ended December 31, 2020 compared to the prior year primarily due to lower short-term interest rates.

Interest expense on notes decreased $2.0 million, or 32%, for the year ended December 31, 2020 compared to the prior year.

The decrease was primarily due to a $3.4 million milestone obligation that was achieved in the third quarter of 2019 and a decrease of $0.8 million of interest expense related to the Deerfield Credit Facility, which was extinguished in the third quarter of 2019, partially offset by an increase in interest expense from the MidCap Credit Facility of $2.3 million in 2020.

The loss on extinguishment of debt for the year ended December 31, 2020 was primarily due to the third amendment to the MidCap Credit Facility, in addition to the prepayment of the 2020 notes.

Liquidity and Capital Resources

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As of December 31, 2020, we had $122.9 million principal amount of outstanding debt, consisting of:

$40.0 million principal amount under the MidCap Credit Facility, bearing interest at an annual rate equal to one-month LIBOR plus 6.75%, subject to a one-month LIBOR floor of 2.00%, and maturing in August 2024;

$5.0 million principal amount of 2024 convertible notes bearing interest at 5.75% per annum, with interest payable in cash or equity semiannually in arrears on February 15 and August 15 of each year, and maturing in November 2024, all of which is convertible into shares of our common stock at the option of the holder at a conversion price of $3.00 per share;

$ 5.2 million principal amount of 2020 notes , half of which mature in June 2020 and half of which mature in December 2020;

$50.0 million principal amount under the MidCap Credit Facility, bearing interest at an annual rate equal to one-month LIBOR plus 6.75%, subject to a one-month LIBOR floor of 2.00%, payable in equal monthly installments beginning in September 2022 through maturity in August 2024;

$5.0 million principal amount of 2024 convertible notes, with interest payable in cash or equity semiannually in arrears on February 15 and August 15 of each year, and maturing in November 2024, all of which was convertible into shares of our common stock at the option of the holder at a conversion price of $3.00 per share.

The 2024 convertible notes provided that, under certain circumstances, at our option, we may elect to cause all or any portion of the 2024 convertible notes to be mandatorily converted;

$63.0 million principal amount of indebtedness under the Mann Group promissory notes bearing interest at a fixed rate of 7.00% per annum compounded quarterly and maturing in November 2024, $28.0 million of which is convertible into shares of our common stock at the option of the 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 either 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 MidCap Credit Facility, the 2024 convertible notes, the 2020 notes or the Mann Group promissory notes when required.

Further, if we undergo a fundamental change, as that term is defined in the indentures governing the terms of the 2024 convertible notes, the holders of such debt securities will have the option to require us to repurchase all or any portion of such debt securities at a repurchase price of 100% of the principal amount of such debt securities to be repurchased plus accrued and unpaid interest, if any.

The 2024 convertible notes and the Mann Group convertible note are fully convertible at any time prior to maturity as further disclosed in Note 7 – Borrowings.

$4.9 million from a loan under the Paycheck Protection Program of the CARES Act, all or a portion of which may be forgiven.

The PPP Loan matures in April 2022 and bears interest at a rate of 0.98% per annum.

Principal and interest payments can be deferred up to ten months after the end of a 24 week covered period unless we are is notified earlier of our loan forgiveness status.

In the event the SBA does not authorize loan forgiveness, the deferred principal and interest will be payable to the lender and we will then make equal monthly payments as required to fully amortize the remaining principal amount by April 9, 2022.

In February 2021, we elected to convert the $5.0 million principal amount of 2024 convertible notes into 1,666,667 shares of our common stock in accordance with the terms of the 2024 convertible notes.

There can be no assurance that we will have sufficient resources to make any required repayments of principal under the MidCap Credit Facility, the Mann Group promissory notes, or unforgiven amounts of the PPP Loan .

The Mann Group convertible note is fully convertible at any time prior to maturity as further disclosed in Note 7 – Borrowings.

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 pay interest on the 2024 convertible notes or under the MidCap Credit Facility, or if we fail to repay or repurchase the 2024 convertible notes, the 2020 notes, Mann Group promissory notes or borrowings under the MidCap Credit Facility, 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 pay interest under the MidCap Credit Facility, or if we fail to repay the Mann Group promissory notes, borrowings under the MidCap Credit Facility or unforgiven amounts of the PPP Loan, 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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See Note 13 — Commitments and Contingencies and Note 7 — Borrowings for further information related to the Milestone Rights.

These factors raise substantial doubt about our ability to continue as a going concern.

These liabilities and other factors raise substantial doubt about our ability to continue as a going concern.

Our financial statements and related notes thereto included elsewhere in this report do not include adjustments that might result from any unfavorable outcome of this uncertainty.

During the year ended December 31, 2020, we used $28.1 million of cash for our operating activities, which reflects our net loss of $57.2 million, partially offset by non-cash charges of $38.9 million (including $13.2 million for the write-off of in-process research and development related to the acquisition of QrumPharma).

The net change in operating asset and liabilities was primarily a result of the recognition of deferred revenue of $32.8 million, which was partially offset by the receipt of milestone payments from UT of $25.0 million and pass-through payments of $1.9 million.

During the year ended December 31, 2019, we used $88.5 million of cash for our operating activities mainly as a result of our net loss of $51.9 million as well as paid-in-kind interest on the Mann Group promissory notes of $32.8 million and a decrease in deferred revenue of $6.7 million.

During the year ended December 31, 2018, we used $37.7 million of cash for our operating activities mainly as a result of our net loss of $87.0 million, partially offset by a decrease in operating assets and liabilities primarily attributable to our receipt of $57.2 million in cash from

collaboration agreements (revenue recognition of $46.8 million was deferred to future periods .

See Note 8 — Collaboration s and Licensing Arrangements).

Cash used in investing activities was $22.8 million for the year ended December 31, 2019 compared to cash used in investing activities of $0.2 million for the year ended December 31, 2018.

The difference was primarily due to a purchase of treasury bills of $45.0 million, partially offset by proceeds from sales of treasury bills of $25.0 million in 2019.

There was no investment in treasury bills for the year ended December 31, 2018.

Cash provided by investing activities of $15.2 million for the year ended December 31, 2020 was primarily due to the proceeds from the sale of treasury bills of $20.0 million, partially offset by $4.0 million of cash consideration paid for the acquisition of QrumPharma, net of $0.2 million of cash acquired, in addition to $0.5 million of related transaction costs.

Cash used in investing activities was $22.8 million for the year ended December 31, 2019, which consisted of a purchase of treasury bills of $45.0 million, partially offset by proceeds from sales of treasury bills of $25.0 million.

Cash provided by financing activities of $49.9 million for the year ended December 31, 2020 was primarily due to the receipt of $23.5 million in gross proceeds from at the market offerings, the exercise of outstanding warrants to purchase shares of our common stock of $11.6 million, proceeds from the MidCap Credit Facility of $10.0 million and proceeds from the PPP Loan of $4.9 million.

Cash provided by financing activities was $ 69.9 million for the year ended December 31, 2019, primarily due to $39.1 million of net proceeds from the Midcap Credit Facility, $31.8 million of net proceeds from the exchange of the Mann Group promissory notes, $9.9 million of net proceeds from the exchange of the senior convertible notes, in addition to proceeds received from the issuance of our common stock associated with the exercise of warrants for $5.9 million and our at-the-market offering for $3.2 million.

These net proceeds were partially offset by net payments of $11.1 million for the 2021 notes and $6.9 million for the Deerfield Credit Facility.

Cash provided from financing activities was $61.3 million for the year ended December 31, 2018 primarily related to an aggregate proceeds of $68.0 million in a public offering and a direct placement of common stock and $2.0 million in at-the-market issuance of common stock offset by $5.0 million of principal payment on Facility Financing Obligation and $4.1 million costs associated with the offering and direct placement of common stock.

Future Liquidity Needs

Future Liquidity Needs and Going Concern

We are not currently profitable and have rarely generated positive net cash flows 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 collaboration and development costs for product candidates in our pipeline.

As of December 31, 2019, we had an accumulated deficit of $3.0 billion and $120.3 million of total principal amount of outstanding borrowings, with limited capital resources of $29.9 million in cash and cash equivalents and $20.0 million in short-term investments.

As of December 31, 2020, we had an accumulated deficit of $3.0 billion and $122.9 million of total principal amount of outstanding borrowings, with limited capital resources of $67.0 million in cash and cash equivalents.

These financial conditions raise substantial doubt about our ability to continue as a going concern.

Our capital resources may not be sufficient to continue to meet our current and anticipated obligations over the next twelve months if we cannot increase our operating cash inflows by growing our prescription and revenue base and/or obtain access to the remaining $35.0 million borrowings that may become available under the MidCap Credit Facility.

In the event these capital resources are not sufficient, we may need to raise additional capital by selling equity or debt securities, entering into strategic business collaboration agreements with other companies, seeking other funding facilities or licensing arrangements, selling assets or by other means.

Our capital resources may not be sufficient to continue to meet our current and anticipated obligations over the next twelve months if we cannot increase our operating cash inflows by growing our prescription and revenue base and/or obtain access to the remaining $25.0 million borrowings that may become available under the MidCap Credit Facility (which, in turn, requires us to grow Afrezza revenue before we can access such funds).

The various stay-at-home orders implemented around the country in response to the COVID-19 pandemic have negatively impacted the sales of Afrezza by limiting the access of our sales force to physicians.

The COVID-19 pandemic is expected to continue to negatively impact our near-term revenues from Afrezza.

Our ability to draw the $25.0 million Tranche 3 of the MidCap Credit Facility depends on the satisfaction of certain milestone conditions associated with Tyvaso DPI and other financial covenants.

In the event the milestone conditions are not achieved or our capital resources are not sufficient, we may need to raise additional capital by either selling equity or debt securities, entering into strategic business collaboration agreements with other companies, seeking other funding facilities or licensing arrangements, selling assets or by other means.

However, we cannot provide assurances that additional capital will be available on acceptable terms or at all.

In addition, the COVID-19 pandemic continues to have the potential for disruption of global financial markets.

This disruption, if it occurs, could prevent us or make it more difficult for us to access capital or make it difficult to comply with the covenants contained in the MidCap Credit Facility, which could negatively affect our liquidity.

Issuances of debt or additional equity could impact the rights of our existing stockholders, dilute the ownership percentages of our existing stockholders and may impose restrictions on our operations.

These restrictions could include limitations on additional borrowing, specific restrictions on the use of our assets as well as prohibitions on our ability to create liens, pay dividends, redeem our stock or make investments.

The impact of the COVID-19 pandemic on Afrezza sales also increased the risk of non-compliance with a covenant relating to trailing twelve-month minimum Afrezza net revenue, tested on a monthly basis, which is set forth in the MidCap Credit Facility Agreement, as amended.

In November 2020, we entered into an amendment to the MidCap Credit Facility, pursuant to which the minimum cash requirement was increased to $30.0 million .

I f we fail to meet the minimum Afrezza net revenue covenant, any outstanding borrowings, together with accrued interest, under the MidCap Credit Facility could be declared immediately due and payable.

If we default under our obligations under the MidCap Credit Facility, the lender could proceed against the collateral granted to them to secure our indebtedness or declare all obligations under the MidCap Credit Facility to be due and payable.

In certain circumstances, procedures by the lender could result in a loss by us of all of our equipment and inventory, which are included in the collateral granted to the lender.

We may not have sufficient resources to make any required repayments of principal under the terms of our indebtedness when required.

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

If we fail to pay interest on the MidCap Term Loan, or if we fail to repay or repurchase the MidCap Term Loan, PPP Loan or borrowings under the Mann Group promissory notes when required, we will be in default under the instrument for such debt securities or loans, 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 note holders initiating bankruptcy proceedings or causing us to cease operations altogether.

If we are unable to meet our current and anticipated obligations over the next twelve months through our existing capital resources, or obtain new sources of capital when needed, we may have to delay or reduce the scope of our manufacturing operations, reduce or eliminate one or more of our development programs, or make significant changes to our operating plan.

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See Note 2 — Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements included in Part II, Item 8 — Financial Statements and Supplementary Data for information regarding accounting standards we adopted in 2020 and other new accounting standards that have been issued by the FASB but are not effective until after December 31, 2020.

Quantitative and Qualitat ive Disclosures about Market Risk

Interest Rate Risk

Interest on borrowings under the MidCap Credit Facility is determined, for any one-month period, on the basis of one-month LIBOR in effect at the beginning of such period plus 6.75%, subject to a one-month LIBOR floor of 2.00%.

Accordingly, our interest expense under the MidCap Credit Facility is subject to changes in the one-month LIBOR rate.

All other debt has fixed interest rates, so the interest expense associated with such debt is not exposed to changes in market interest rates.

Specifically, the interest rate on amounts borrowed under the Mann Group promissory notes is fixed at 7.00% and the interest rate under the 2024 convertible notes is fixed at 5.75%.

See Note 7 – Borrowings for information about the principal amount of outstanding debt.

If a change in the one-month LIBOR interest rate equal to 10% of the one-month LIBOR interest rate on December 31, 2019 were to have occurred, this change would not have a material effect on our interest payment obligation.

Our current policy requires us to maintain a highly liquid short-term investment portfolio consisting mainly of U.S.

money market funds, U.S.

Treasury bills or notes and investment-grade corporate, government and municipal debt.

None of these investments are entered into for trading purposes.

Our cash is deposited in and invested through highly rated financial institutions in North America.

If a change in interest rates equal to 10% of the interest rates on December 31, 2019 were to have occurred, this change would not have had a material effect on the value of our short-term investment portfolio.

Foreign Currency Exchange Risk

We incur and will continue to incur significant expenditures for insulin supply obligations under our Insulin Supply Agreement with Amphastar.

Such obligations are denominated in Euros.

At the end of each reporting period, the recognized gain or loss on purchase commitment is converted to U.S.

dollars at the then-applicable foreign exchange rate.

As a result, our business is affected by fluctuations in exchange rates between the U.S.

dollar and the Euro.

In 2019, we entered into two 90-day foreign currency hedging transactions to mitigate our exposure to foreign currency exchange risks associated with then-existing insulin purchase commitments.

We realized a de minimis currency loss for these transactions, which we recorded in other income and expense.

Exchange rate fluctuations may adversely affect our expenses, results of operations, financial position and cash flows.

If a change in the U.S.

dollar to Euro exchange rate equal to 10% of the U.S.

dollar to Euro exchange rate on December 31, 2019 were to have occurred, this change would have resulted in a foreign currency impact to our pre-tax loss of approximately $9.2 million.

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What changed 10-K

Item 7. Management’s Discussion and Analysis