What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-05-05 compared with 2021-11-09 · 58 added, 86 removed, 71 unchanged (67% of the section changed)

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We are a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives.

We are devoting most of our resources to the research and development of our most advanced drug candidates:

We are devoting most of our resources to the research, development and preparation for commercialization of our most advanced drug candidates:

• We are developing sotagliflozin, an orally-delivered small molecule drug candidate, as a treatment for heart failure and type 1 diabetes.

We have reported positive results from two Phase 3 clinical trials evaluating the effect of sotagliflozin on long-term outcomes related to cardiovascular death and heart failure in approximately 10,500 and 1,200 patients, respectively.

We are now preparing an application for regulatory approval to market sotagliflozin for heart failure in the United States and, if approved, for the commercial launch of sotagliflozin in the United States.

We are now preparing a resubmission of our application for regulatory approval to market sotagliflozin in the United States for heart failure after voluntarily withdrawing our initial application to correct a technical issue with the initial submission.

We have reported positive results from three Phase 3 clinical trials evaluating the effect of sotagliflozin on type 1 diabetes in approximately 800, 800 and 1,400 patients, respectively.

The FDA issued a complete response letter regarding our application for regulatory approval to market sotagliflozin for type 1 diabetes in the United States and, at our request, has issued a public Notice of Opportunity for Hearing on whether there are grounds for denying approval of our application.

The Office of the FDA Commissioner has granted our joint request with the FDA’s Center for Drug Evaluation and Research to extend the previously granted abeyance of such proceedings until November 26, 2021 to allow for the continuation of good faith discussions between the parties.

Sotagliflozin has been approved in the European Union for use as an adjunct to insulin therapy in the treatment of type 1 diabetes, but has not yet been commercially launched.

Food and Drug Administration, or FDA, issued a complete response letter regarding our application for regulatory approval to market sotagliflozin for type 1 diabetes in the United States.

At our request, the FDA has issued a public Notice of Opportunity for Hearing on whether there are grounds for denying approval of our application and the hearing process is ongoing.

• We are developing LX9211, an orally-delivered small molecule drug candidate, as a treatment for neuropathic pain.

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We seek to collaborate with other pharmaceutical and biotechnology companies with respect to drug discovery or the development and commercialization of certain of our drug candidates, particularly with respect to commercialization in territories outside the United States or commercialization in the United States for indications treated by primary care physicians, or when the collaboration may otherwise provide us with access to expertise and resources that we do not possess internally or are complementary to our own.

Our collaborations and strategic alliances include arrangements with TerSera Therapeutics LLC, under which we are eligible to receive milestone and royalty payments relating to XERMELO in biliary tract cancer, and with Genentech, Inc., under which we are eligible to receive milestone and royalty payments relating to its UTTR1147a (IL-22 Fc) biotherapeutic drug candidate.

We have derived substantially all of our revenues from strategic collaborations and other research and development collaborations and technology licenses, as well as from commercial sales of XERMELO following our commercial launch of the product in February 2017 until our sale of XERMELO and related assets to TerSera in September 2020.

We have derived substantially all of our revenues from strategic collaborations and other research and development collaborations and technology licenses, as well as from commercial sales of our XERMELO product following its commercial launch in February 2017 until our sale of XERMELO and related assets to TerSera Therapeutics, LLC in September 2020.

To date, we have generated a substantial portion of our revenues from a limited number of sources.

Our operating results and, in particular, our ability to generate additional revenues are dependent on many factors, including the success of our ongoing nonclinical and clinical development efforts and ability to obtain necessary regulatory approvals of the drug candidates which are the subject of such efforts;

the ability of our collaborators and licensees to successfully develop and commercialize products and our receipt of milestone payments and royalties from such efforts;

success in establishing new collaborations and licenses, particularly for the commercialization of sotagliflozin for heart failure;

and general and industry-specific economic conditions which may affect research and development expenditures.

Future revenues from our collaborations and strategic licenses are uncertain because they depend on the achievement of milestones and payment of royalties we earn from the development and commercialization efforts of our collaborators and licensees.

Our operating results and, in particular, our ability to generate additional revenues are dependent on many factors, including the success of our ongoing nonclinical and clinical development efforts and the ability to obtain necessary regulatory approvals of the drug candidates which are the subject of such efforts;

our success in establishing new collaborations and licenses and our receipt of milestones, royalties and other payments under such arrangements;

and general and industry-specific economic conditions which may affect research, development and commercialization expenditures.

Our ability to secure future revenue-generating agreements will depend upon our ability to address the needs of our potential future collaborators and licensees, and to negotiate agreements that we believe are in our long-term best interests.

We may determine, as we have with certain of our drug candidates, that our interests are better served by retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which could limit our near-term revenues and increase expenses.

may determine, as we have with certain of our drug candidates, that our interests are better served by retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which could limit our near-term revenues and increase expenses.

Because of these and other factors, our operating results have fluctuated in the past and are likely to do so in the future, and we do not believe that period-to-period comparisons of our operating results are a good indication of our future performance.

Since our inception, we have incurred significant losses and, as of September 30, 2021, we had an accumulated deficit of $1.5 billion.

Since our inception, we have incurred significant losses and, as of March 31, 2022, we had an accumulated deficit of $1.5 billion.

Our losses have resulted principally from costs incurred in research and development, selling, general and administrative costs associated with our operations, and non-cash stock-based compensation expenses associated with stock options and restricted stock units granted to employees and consultants.

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Selling, general and administrative expenses consist primarily of salaries and related expenses for executive, sales and marketing, and administrative personnel, professional fees and other corporate expenses, including information technology, facilities costs and general legal activities.

We expect to continue to incur significant research and development costs in connection with the continuing development of our drug candidates.

We expect to continue to incur significant research and development costs in connection with the continuing research and development of our drug candidates.

As a result, we will need to generate significantly higher revenues to achieve profitability.

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Recent Accounting Pronouncements

There are no recent accounting pronouncements that could have a material impact to our condensed consolidated financial statements.

In December 2019, the FASB issued ASU No.

2019-12, Income Taxes (Topic 740) Simplifying Accounting for Income Taxes, as part of its initiative to reduce complexity in the accounting standards.

The guidance amended certain disclosure requirements that had become redundant, outdated or superseded.

Additionally, this guidance amends accounting for the interim period effects of changes in tax laws or rates, and simplifies aspects of the accounting for franchise taxes.

The guidance is effective for annual periods beginning after December 15, 2020, including interim periods therein.

The adoption of ASU 2019-12 in the first quarter of 2021 did not have a material impact on our condensed consolidated financial statements.

In August 2020, the FASB issued ASU No.

2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40), which removes the separation models for convertible debt with cash conversion or beneficial conversion features.

ASU 2020-06 also requires the application of the if-converted method for calculating earnings per diluted share, as the treasury stock method will no longer be permitted for convertible instruments.

The adoption of ASU 2020-06 during the first quarter of 2022 did not have a material impact on our condensed consolidated financial statements.

Results of Operations

Total revenues and dollar and percentage changes as compared to the corresponding periods in the prior year are as follows (dollar amounts are presented in millions):

Three Months Ended September 30, Nine Months Ended September 30,

2021 2020 2021 2020

Total revenues $ — $ 6.6 $ 0.3 $ 23.8

Dollar decrease $ (6.6) $ (23.5)

Percentage decrease (100) % (99) %

• Net product revenue – Net product revenue for the three months ended September 30, 2020 was $6.5 million, and for the nine months ended September 30, 2020 was $23.4 million.

We sold XERMELO and related assets to TerSera on September 8, 2020.

Product revenues were recorded net of estimated product returns, pricing discounts including rebates offered pursuant to mandatory federal and state government programs and chargebacks, prompt pay discounts and distribution fees and co-pay assistance.

Revenue recognition policies require estimates of the aforementioned sales allowances each period.

• Royalties and other revenue – Royalties and other revenues for the nine months ended September 30, 2021 decreased 21% to $0.3 million as compared to the corresponding period in 2020.

Cost of Sales

Cost of sales consists of third-party manufacturing costs, freight and indirect overhead costs associated with sales of XERMELO.

Cost of sales was $0.6 million and $1.9 million for the three and nine monthly periods ended September 30, 2020, respectively, and included $0.3 million and $1.2 million, respectively, of amortization of intangible assets relating to XERMELO.

Research and Development Expenses

Research and development expenses and dollar and percentage changes as compared to the corresponding periods in the prior year are as follows (dollar amounts are presented in millions):

Three Months Ended September 30, Nine Months Ended September 30,

2021 2020 2021 2020

Research and development expenses and dollar and percentage changes as compared to the corresponding period in the prior year are as follows (dollar amounts are presented in millions):

Three Months Ended March 31,

Total research and development expense $ 14.9 $ 12.6

Dollar decrease $ (24.4) $ (114.1)

Percentage decrease (61) % (75) %

Dollar increase $ 2.3

Percentage increase 18 %

Research and development expenses consist primarily of third-party and other services principally related to nonclinical and clinical development activities, salaries and other personnel-related expenses, stock-based compensation expense, and facility and equipment costs.

• Third-party and other services – Third-party and other services for the three months ended September 30, 2021 decreased 66% to $10.7 million, and for the nine months ended September 30, 2021 decreased 81% to $23.4 million, as compared to the corresponding periods in 2020 primarily due to decreases in external clinical development costs relating to sotagliflozin subsequent to the wind down of the activities beginning in March 2020.

• Third-party and other services – Third-party and other services for the three months ended March 31, 2022 increased 32% to $9.5 million, as compared to the corresponding period in 2021 primarily due to increases in professional and consulting fees relating to preparations for the resubmission of our application for regulatory approval to market sotagliflozin in the United States for heart failure.

Third-party and other services relate principally to our clinical trial and related development activities, such as nonclinical and clinical studies and contract manufacturing.

• Personnel – Personnel costs for the three months ended September 30, 2021 decreased 55% to $2.5 million, and for the nine months ended September 30, 2021 decreased 51% to $7.6 million, as compared to the corresponding periods in 2020, primarily due to lower employee salaries and benefit costs as a result of the reduction in force of our

personnel in September 2020.

• Personnel – Personnel costs for the three months ended March 31, 2022 increased 10% to $3.2 million, as compared to the corresponding period in 2021, primarily due to higher employee salaries and benefit costs as a result of increasing headcount during 2022 in preparation for commercialization of sotagliflozin.

Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.

• Stock-based compensation – Stock-based compensation expenses for the three months ended September 30, 2021 increased 11% to $1.1 million, and for the nine months ended September 30, 2021 decreased 30% to $3.6 million, as compared to the corresponding periods in 2020, primarily due to cancellation of unvested share-based awards as a result of the reduction in force of our personnel in September 2020.

• Facilities and equipment – Facilities and equipment costs for the three months ended September 30, 2021 decreased 33% to $0.4 million, and for the nine months ended September 30, 2021 decreased 41% to $1.2 million, as compared to the corresponding periods in 2020, primarily due to lower depreciation expense subsequent to the sale of our facilities in December 2020.

• Other – Other costs for the three months ended September 30, 2021 decreased 25% to $0.9 million, and for the nine months ended September 30, 2021 decreased 30% to $2.8 million, as compared to the corresponding periods in 2020, primarily due to lower insurance and software license expenses.

• Stock-based compensation – Stock-based compensation expenses for the three months ended March 31, 2022 decreased 20% to $1.0 million, as compared to the corresponding period in 2021, primarily due to cancellation of unvested share-based awards during 2021.

• Facilities and equipment – Facilities and equipment costs for each of the three months ended March 31, 2022 and 2021 were $0.3 million.

• Other – Other costs for each of the three months ended March 31, 2022 and 2021 were $0.9 million.

Selling, General and Administrative Expenses

Selling, general and administrative expenses and dollar and percentage changes as compared to the corresponding periods in the prior year are as follows (dollar amounts are presented in millions):

Three Months Ended September 30, Nine Months Ended September 30,

2021 2020 2021 2020

Three Months Ended March 31,

Total selling, general and administrative expense $ 8.5 $ 8.3

Dollar decrease $ (4.7) $ (17.3)

Percentage decrease (39) % (42) %

Dollar increase $ 0.2

Percentage increase 3 %

Selling, general and administrative expenses consist primarily of personnel costs to support our research and development activities, professional and consulting fees, stock-based compensation expense, and facility and equipment costs.

• Personnel – Personnel costs for the three months ended September 30, 2021 decreased 69% to $2.4 million, and for the nine months ended September 30, 2021 decreased 64% to $7.9 million, as compared to the corresponding periods in 2020, primarily due to lower employee salaries and benefit costs as a result of the reduction in force of our personnel in September 2020.

• Personnel – Personnel costs for the three months ended March 31, 2022 increased 5% to $3.3 million, as compared to the corresponding period in 2021, primarily due to higher employee salaries and benefit costs as a result of increasing headcount during 2022 in preparation for commercialization of sotagliflozin.

Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.

• Professional and consulting fees – Professional and consulting fees for the three months ended September 30, 2021 increased 11% to $2.2 million, primarily as a result of higher legal fees, partially offset by lower marketing expenses.

Professional and consulting fees for the nine months ended September 30, 2021 decreased 8% to $7.4 million, as compared to the corresponding periods in 2020, primarily due to lower marketing expenses and professional and consulting fees, partially offset by higher legal fees.

• Stock-based compensation – Stock-based compensation expenses for the three months ended September 30, 2021 increased 80% to $1.6 million, and for the nine months ended September 30, 2021 decreased 13% to $4.7 million, as compared to the corresponding periods in 2020, primarily due to cancellation of unvested share-based awards as a result of the reduction in force of our personnel in September 2020.

• Facilities and equipment – Facilities and equipment costs for the three months ended September 30, 2021 decreased 18% to $0.4 million, and for the nine months ended September 30, 2021 decreased 23% to $1.1 million, as compared to the corresponding periods in 2020, primarily due to lower property taxes and depreciation expense subsequent to the sale of our facilities in December 2020.

• Other – Other costs for the three months ended September 30, 2021 decreased 26% to $0.7 million, and for the nine months ended September 30, 2021 decreased 41% to $2.3 million, as compared to the corresponding periods in 2020, primarily due to decreases in travel due to the COVID-19 pandemic and software license expense.

Impairment Loss on Buildings

In July 2020, our subsidiary, Lex-Gen Woodlands, L.P., entered into a real estate purchase and sale agreement to sell our facilities in the Woodlands, Texas.

We recognized an impairment loss of $1.6 million as a result of writing down the buildings to the estimated net selling price.

Gain on the sale of XERMELO

In September 2020, a gain of $132.8 million was recognized in connection with the sale of XERMELO and related assets to TerSera.

Loss on Debt Extinguishments, Net

Immediately following the closing of the sale of XERMELO and related assets to TerSera in September 2020, we repaid term borrowings of $150.0 million to BioPharma Credit PLC and BioPharma Credit Investments IV Sub LP.

A debt extinguishment loss of $8.6 million was recognized.

In September 2020, we entered into separate, privately negotiated exchange agreements to exchange $67.1 million aggregate principal amount of its 5.25% Convertible Senior Notes due 2021, or the Convertible Notes.

As a result, a debt extinguishment gain of $8.4 million was recognized.

Interest Expense and Interest and Other Income, Net

Interest Expense .

Interest expense for the three and nine months ended September 30, 2021 decreased 96% to $0.2 million, and $0.5 million, respectively, as compared to the corresponding periods in 2020, primarily due to our repayment of our $150 million BioPharma term loan in September 2020 and our exchange of $75.8 million in aggregate principal amount of Convertible Notes in September and October 2020.

Interest and Other Income, Net.

Interest and other income, net for the three and nine months ended September 30, 2021 was $0.01 million and $0.1 million, respectively, and for the three and nine months ended September 30, 2020 was $0.3 million and $1.9 million, respectively.

Net Income (Loss) and Net Income (Loss) per Common Share

Net income (loss) and Net income (loss) per Common Share.

Net loss was $23.1 million, or $0.16 per share, in the three months ended September 30, 2021 as compared to net income of $82.6 million, or $0.71 per diluted share, in the corresponding period in 2020.

Net loss was $62.1 million, or $0.43 per share, in the nine months ended September 30, 2021 as compared to $53.1 million, or $0.50 per share, in the corresponding period in 2020.

• Professional and consulting fees – Professional and consulting fees for the three months ended March 31, 2022 decreased 5% to $2.3 million, as compared to the corresponding period in 2021, primarily due to lower legal fees, partially offset by higher marketing and professional fees.

• Stock-based compensation – Stock-based compensation expenses for the three months ended March 31, 2022 increased 11% to $1.7 million, as compared to the corresponding period in 2021.

• Facilities and equipment – Facilities and equipment costs for each of the three months ended March 31, 2022 and 2021 were $0.3 million.

• Other – Other costs for the three months ended March 31, 2022 and 2021 were $0.9 million and $0.8 million, respectively.

Net Loss and Net Loss per Common Share

Net loss and Net loss per Common Share.

Net loss was $23.5 million, or $0.16 per share, in the three months ended March 31, 2022 as compared to a net loss of $21.0 million, or $0.15 per share, in the corresponding period in 2021.

Our quarterly operating results have fluctuated in the past and are likely to do so in the future, and we believe that quarter-to-quarter comparisons of our operating results are not a good indication of our future performance.

Liquidity and Capital Resources

We have financed our operations from inception primarily through sales of common and preferred stock, contract and milestone payments we received under our collaborations and strategic licenses, target validation, database subscription and technology license agreements, product sales, government grants and contracts, and financing under debt and lease arrangements, as well as from commercial sales of our XERMELO product following its commercial launch in February 2017 until our sale of XERMELO and related assets to TerSera Therapeutics, LLC in September 2020.

We have also financed certain of our research and development activities under financing arrangements with Symphony Icon, Inc.

As of September 30, 2021, we had $120.9 million in cash, cash equivalents and short-term investments.

In March 2022, we entered into a loan and security agreement with Oxford Finance LLC that provides up to $150 million in borrowing capacity, available in four tranches, under which $25 million has been funded.

As of March 31, 2022, we had $86.5 million in cash, cash equivalents and short-term investments.

As of December 31, 2021, we had $86.7 million in cash, cash equivalents and short-term investments.

We used cash of $64.2 million from operations in the nine months ended September 30, 2021.

We used cash of $23.4 million from operations in the three months ended March 31, 2022.

This consisted primarily of the net loss for the period of $23.5 million and a net decrease in operating liabilities net of assets of $2.9 million, partially offset by non-cash charges of $2.8 million related to stock-based compensation expense.

Investing activities used cash of $4.0 million in the nine months ended September 30, 2021, primarily due to net purchases of investments of $2.8 million and $1.2 million of asset purchases.

Financing activities provided cash of $34.0 million, primarily as a result of $36.7 million net proceeds from the sales of common stock during January, August and September of 2021 under our Open Market Sale Agreement SM with Jefferies LLC which was partially offset by $2.7 million used to repurchase common stock.

Investing activities used cash of $4.4 million in the three months ended March 31, 2022, primarily due to net purchases of investments.

Financing activities provided cash of $23.3 million primarily from $24.2 million of net proceeds from the Oxford debt financing during March 2022, which was partially offset by

$0.9 million used to repurchase common stock by retaining shares in substitution of the tax withholding obligations of recipients of restricted stock units granted under our 2017 Equity Incentive Plan with respect to the vesting of such restricted stock units.

Other commitments.

In April 2019, sotagliflozin was approved in the European Union for use as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes and a body mass index ≥ 27 kg/m 2 , who could not achieve adequate glycemic control despite optimal insulin therapy.

Upon the achievement of certain European regulatory pricing approvals, we will be required to make certain royalty payments, totaling $4.5 million, in three equal annual installments of $1.5 million.

In December 2020, our subsidiary, Lex-Gen Woodlands, L.P., sold our facilities in The Woodlands, Texas for $11.9 million.

Concurrent with such sale, we entered into a leaseback agreement with respect to 38,000 square feet of such facilities for a period of up to six months, with monthly gross rent payments of $101,000, which ended on June 15, 2021.

In February 2021, we leased a 25,000 square-foot office space in The Woodlands, Texas and in June 2021, we relocated our corporate offices.

In March 2022, we filed an application for withdrawal of such approval for business reasons, which request was granted by the European Commission.

Upon the achievement of certain European regulatory pricing approvals, we would have been required to make certain royalty payments, totaling $4.5 million, in three equal annual installments of $1.5 million.

In February 2021, we leased a 25,000 square-foot office space in The Woodlands, Texas.

The term of the sublease extends from March 1, 2021 through August 31, 2025, and provides for escalating yearly base rent payments starting at $506,000 and increasing to $557,000 in the final year of the lease.

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Our future capital requirements will be substantial and will depend on many factors, including the success of our ongoing nonclinical and clinical development efforts and the ability to obtain necessary regulatory approvals of the drug candidates which are the subject of such efforts;

the ability of our collaborators and licensees to successfully develop and commercialize products and our receipt of milestone payments and royalties from such efforts;

our success in establishing new collaborations and licenses, particularly for the commercialization of sotagliflozin for heart failure;

our success in establishing new collaborations and licenses and our receipt of milestones, royalties and other payments under such arrangements;

the amount and timing of our research, development and commercialization expenditures;

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Our capital requirements will also be affected by any expenditures we make in connection with license agreements and acquisitions of and investments in complementary technologies and businesses.

We expect to continue to devote substantial capital resources to successfully complete our nonclinical and clinical development efforts with respect to sotagliflozin, LX9211 and our other drug candidates;

We expect to continue to devote substantial capital resources to prepare for the commercialization of sotagliflozin, if approved;

successfully complete our nonclinical and clinical development efforts with respect to sotagliflozin, LX9211 and our other drug candidates;

and for other general corporate activities.

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The sale of additional equity or convertible debt securities may result in additional dilution to our stockholders.

From time to time, our board of directors may authorize us to repurchase shares of our common stock, repurchase, in cash or common stock, our outstanding convertible notes, or make a cash payment to holders of our convertible notes to induce conversion pursuant to the terms of the convertible notes, in each case, in privately negotiated transactions, publicly announced programs or otherwise.

From time to time, our board of directors may authorize us to repurchase shares of our common stock.

If and when our board of directors should determine to authorize any such action, it would be on terms and under market conditions that our board of directors determines are in the best interest of us and our stockholders.

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We currently do not hedge interest rate exposure or hold any derivative financial instruments in our investment portfolio.

We had approximately $120.9 million in cash and cash equivalents and short-term investments as of September 30, 2021.

We had approximately $86.5 million in cash and cash equivalents and short-term investments as of March 31, 2022.

We believe that the working capital available to us will be sufficient to meet our cash requirements for at least the next 12 months.

We are not subject to interest rate sensitivity on our outstanding Convertible Notes as they generally have a fixed rate of 5.25% per annum.

The Convertible Notes interest is payable in cash semi-annually in arrears and matures in December 2021, unless earlier converted or repurchased in accordance with their terms.

We are subject to interest rate sensitivity on our outstanding Oxford Term Loans as they contain a floating rate tied to the 30-day LIBOR rate.

The Oxford Term Loans interest is payable in cash monthly and matures in March 2027, unless earlier repaid in accordance with their terms.

We have operated primarily in the United States and substantially all sales to date have been made in U.S.

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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