2 unchanged sentences
We are devoting most of our resources to the commercialization of our approved drug and the research and development of our most advanced drug candidates:
−Removed: • We are commercializing INPEFA, an orally-delivered small molecule drug, in the United States to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, or CKD, and other cardiovascular risk factors.
+Added: • We are commercializing INPEFA ® (sotagliflozin), an orally-delivered small molecule drug, in the United States to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease (CKD), and other cardiovascular risk factors.
We are separately pursuing regulatory approval of sotagliflozin as a treatment for type 1 diabetes.
−Removed: Food and Drug Administration, or FDA, issued a complete response letter regarding our New Drug Application, or NDA, for sotagliflozin in type 1 diabetes in March 2019, which we appealed.
−Removed: Following FDA feedback from recent discussions, we are now preparing to resubmit our NDA for patients with type 1 diabetes and CKD.
+Added: We have a pending New Drug Application, or NDA, for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and CKD.
+Added: The NDA is currently under review by the U.S.
+Added: Food and Drug Administration, or FDA, and has been assigned a Prescription Drug User Fee Act, or PDUFA, goal date of December 20, 2024.
We have reported positive results from three Phase 3 clinical trials of sotagliflozin in type 1 diabetes.
−Removed: We are also developing sotagliflozin as a treatment for hypertrophic cardiomyopathy, or HCM, and are preparing to initiate a Phase 3 clinical trial of sotagliflozin in HCM.
+Added: We are also developing sotagliflozin as a treatment for hypertrophic cardiomyopathy, or HCM, and have initiated a Phase 3 clinical trial of sotagliflozin in HCM.
• We are developing LX9211, an orally-delivered small molecule drug candidate, as a treatment for neuropathic pain.
18 unchanged sentences
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.
−Removed: Since our inception, we have incurred significant losses and, as of March 31, 2024, we had an accumulated deficit of $1.8 billion.
+Added: Since our inception, we have incurred significant losses and, as of June 30, 2024, we had an accumulated deficit of $1.9 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.
8 unchanged sentences
Results of Operations
−Removed: Revenues for the three months ended March 31, 2024 were approximately $1.1 million primarily from product revenues recognized from sales of INPEFA following its regulatory approval in May 2023.
+Added: Revenues were approximately $1.6 million and $0.3 million, respectively, for the three months ended June 30, 2024 and 2023 and $2.8 million and $0.3 million, respectively, for the six months ended June 30, 2024 and 2023 primarily from product revenues recognized from sales of INPEFA following its regulatory approval in May 2023.
Cost of Sales
−Removed: Cost of sales during the three months ended March 31, 2024 consist of third-party manufacturing costs and freight associated with sales of INPEFA.
+Added: Cost of sales during the three and six months ended June 30, 2024 consist of third-party manufacturing costs and freight associated with sales of INPEFA.
Prior to receiving regulatory approval on May 26, 2023, we had completed or begun the manufacturing of certain INPEFA raw materials.
2 unchanged sentences
We began capitalizing inventory manufactured subsequent to regulatory approval of INPEFA as the related costs were expected to be recoverable through the commercialization of the product.
−Removed: At March 31, 2024, substantially all of the “zero-cost” INPEFA raw materials remains available to us.
+Added: At June 30, 2024, substantially all of the “zero-cost” INPEFA raw materials remains available to us.
The “zero-cost” inventory is expected to be consumed over approximately the next three years, which will result in a lower average per unit cost of materials during that period;
3 unchanged sentences
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):
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30, Six Months Ended June 30,
+Added: 2024 2023 2024 2023
Total research and development expense $ 17.6 $ 14.5 $ 32.0 $ 26.6
3 unchanged sentences
• Third-party services – Third-party services relate principally to our clinical trial and related development activities, such as preclinical and clinical studies and contract manufacturing.
−Removed: Overall, third-party services for the three months ended March 31, 2024 increased 32% to $7.2 million as compared to the corresponding period in 2023 primarily related to increased external research and development costs.
−Removed: • Personnel – Personnel costs for the three months ended March 31, 2024 increased to $4.2 million from $4.0 million as compared to the corresponding period in 2023.
+Added: Overall, third-party services for the three months ended June 30, 2024 increased 20% to $10.2 million and for the six months ended June 30, 2024 increased 24% to $17.4 million, as compared to the corresponding periods in 2023 primarily related to increased external research and development costs.
+Added: • Personnel – Personnel costs for the three months ended June 30, 2024 increased to $4.3 million from $3.6 million, and for the six months ended June 30, 2024 increased to $8.6 million from $7.5 million as compared to the corresponding periods in 2023.
Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.
−Removed: • Stock-based compensation – Stock-based compensation expenses for the three months ended March 31, 2024 increased 32% to $1.6 million, as compared to the corresponding period in 2023, due to increased headcount.
+Added: • Stock-based compensation – Stock-based compensation expenses for the three months ended June 30, 2024 increased 29% to $1.7 million, and for the six months ended June 30, 2024 increased 31% to $3.3 million, as compared to the corresponding periods in 2023, due to increased headcount.
• Facilities, equipment, and other – Facilities, equipment, and other costs relate primarily to rent, insurance, travel and training, and software licensing costs.
−Removed: Facilities, equipment, and other costs for the three months ended March 31, 2024 and 2023 were $1.3 million and $1.4 million, respectively.
+Added: Facilities, equipment, and other costs for the three months ended June 30, 2024 and 2023 were $1.4 million and $1.1 million, respectively.
+Added: For the six months ended June 30, 2024 and 2023 these costs were $2.7 million and $2.5 million, respectively.
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):
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30, Six Months Ended June 30,
+Added: 2024 2023 2024 2023
Total selling, general and administrative expense $39.2 $30.0 $71.3 $49.1
2 unchanged sentences
Selling, general and administrative expenses consist primarily of personnel costs to support the commercialization of INPEFA and support of our research and development activities, professional and consulting fees, stock-based compensation expense, and facilities, equipment, and other costs each of which are described further below.
−Removed: • Personnel – Personnel costs for the three months ended March 31, 2024 increased 113% to $16.4 million, as compared to the corresponding period in 2023, primarily due to higher employee salaries and benefit costs as a result of increased headcount during 2024 in conjunction with the commercialization of INPEFA.
+Added: • Personnel – Personnel costs for the three months ended June 30, 2024 increased 20% to $17.2 million, and for the six months ended June 30, 2024 increased 52% to $33.6 million, as compared to the corresponding periods in 2023, primarily due to higher employee salaries and benefit costs as a result of increased headcount in conjunction with the commercialization of INPEFA.
Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.
−Removed: • Professional and consulting fees – Professional and consulting fees for the three months ended March 31, 2024 increased 37% to $9.6 million, as compared to the corresponding period in 2023, primarily due to higher marketing and professional fees in conjunction with the commercialization of INPEFA.
−Removed: • Stock-based compensation – Stock-based compensation expenses for the three months ended March 31, 2024 increased 22% to $2.7 million, as compared to the corresponding period in 2023 due to increased headcount.
−Removed: • Facilities, equipment, and other – Facilities, equipment, and other costs for the three months ended March 31, 2024 and 2023 were $3.3 million and $2.2 million, respectively.
−Removed: The increase of $1.1 million in these costs in 2024 was primarily due to travel in conjunction with the commercialization of INPEFA.
+Added: • Professional and consulting fees – Professional and consulting fees for the three months ended June 30, 2024 increased 48% to $14.6 million, and for the six months ended June 30, 2024 increased 44% to $24.3 million, as
+Added: compared to the corresponding periods in 2023, primarily due to higher marketing and professional fees in conjunction with the commercialization of INPEFA.
+Added: • Stock-based compensation – Stock-based compensation expenses for the three months ended June 30, 2024 increased 27% to $3.2 million, and for the six months ended June 30, 2024 increased 25% to $5.9 million, as compared to the corresponding periods in 2023 due to increased headcount.
+Added: • Facilities, equipment, and other – Facilities, equipment, and other costs for the three months ended June 30, 2024 and 2023 were $4.2 million and $3.3 million, and for the six months ended June 30, 2024 and 2023 were $7.5 million and $5.5 million, respectively.
+Added: The increase was primarily due to travel in conjunction with the commercialization of INPEFA.
Interest and Other Expense
Interest and Other Expense.
−Removed: Interest and other expense was $4.9 million and $1.8 million, respectively, during the three months ended March 31, 2024 and 2023, primarily due to the borrowing of additional $50 million in Oxford debt in June 2023.
+Added: Interest and other expense was $2.2 million and $2.0 million, respectively, during the three months ended June 30, 2024 and 2023, and $7.2 million and $3.8 million, respectively, during the six months ended June 30, 2024 and 2023 reflecting the additional $50 million of Oxford debt borrowed in June 2023.
Interest Income and Other, Net
Interest Income and Other, Net.
−Removed: Interest income and other, net increased to $1.9 million from $1.0 million during the three months ended March 31, 2024 from the corresponding period in 2023.
+Added: Interest income and other, net increased to $4.1 million from $1.3 million during the three months ended June 30, 2024 and increased to $6.0 million from $2.3 million during the six months ended June 30, 2024 from the corresponding periods in 2023 reflecting the increase in cash and investments due to net proceeds received from the March 2024 preferred stock issuance.
Net Loss and Net Loss per Common Share
Net loss and Net loss per Common Share.
−Removed: Net loss was $48.4 million, or $0.20 per share, in the three months ended March 31, 2024 as compared to a net loss of $31.9 million, or $0.17 per share, in the corresponding period in 2023.
+Added: Net loss was $53.4 million, or $0.17 per share, in the three months ended June 30, 2024 as compared to a net loss of $44.9 million, or $0.22 per share, in the corresponding period in 2023.
+Added: Net loss was $101.8 million, or $0.37 per share, in the six months ended June 30, 2024 as compared to a net loss of $76.8 million, or $0.39 per share, in the corresponding period in 2023.
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.
4 unchanged sentences
The fifth $25 million tranche is available for draw at our option, subject to Oxford’s consent, at any time prior to the expiration of the 60-month interest-only payment period.
−Removed: The loan and security agreement includes a financial covenant relating to INPEFA net sales and a separate financial covenant which requires us to maintain a minimum cash and investments balance of $10 million until the achievement of specified INPEFA net sales.
−Removed: Upon funding of the fourth tranche, the minimum cash and investments balance will increase to $25 million.
+Added: On June 28, 2024, we entered into a sixth amendment to our Loan Agreement extending the interest-only period with an amortization date of May 1, 2027, extending the maturity date to March 1, 2029, and modifying the exit fee provision and existing financial covenants.
+Added: The loan and security agreement includes a financial covenant relating to net product revenue, which will be effective as of the quarter ending June 30, 2026, and a separate financial covenant which requires us to maintain a minimum unrestricted cash and investments balance of 50% of the outstanding principal amount through June 30, 2026, tested monthly as of the last day of each month.
+Added: In addition, we are separately required to maintain a quarterly minimum unrestricted cash and investments balance of $10 million until the achievement of specified INPEFA net sales (which will be satisfied by meeting the monthly minimum unrestricted cash and investments covenant noted above).
+Added: Upon funding of the fourth tranche, the quarterly minimum unrestricted cash and investments balance requirement will increase to $25 million.
+Added: For additional information, please refer to Note 5 of the Notes to the Condensed Consolidated Financial Statements.
In December 2023, we entered into an Open Market Sale Agreement SM with Jefferies LLC pursuant to which we may offer and sell shares of our common stock having an aggregate sales price of up to $75 million from time to time through Jefferies as sales agent.
−Removed: As of March 31, 2024, the full amount is still available for issuance under this agreement.
+Added: As of June 30, 2024, the full amount is still available for issuance under this agreement.
On March 11, 2024, we entered into an agreement with certain accredited investors pursuant to which we agreed to sell 2,304,147 shares of our Series A Convertible Preferred Stock, at a price of $108.50 per share.
−Removed: We received net proceeds of approximately $242 million, after deducting placement agent fees and offering expenses from the private placement offering.
−Removed: Each share of preferred stock will automatically convert into 50 shares of our common stock upon the filing and acceptance of an amendment to our certificate of incorporation by the Secretary of State of Delaware increasing the number of authorized shares of our common stock to 450,000,000 shares.
+Added: We received net proceeds of $241.4 million, after deducting placement agent fees and offering expenses from the private placement offering.
+Added: On May 10, 2024, each share of preferred stock was converted into 50 shares of our common stock, or an aggregate of 115,207,350 shares.
For additional information on the private placement offering, please refer to Note 8 of the Notes to the Condensed Consolidated Financial Statements.
−Removed: As of March 31, 2024 and December 31, 2023, we had $355.6 million and $170.0 million in cash, cash equivalents and short-term investments, respectively.
−Removed: We used cash of $55.1 million from operations in the three months ended March 31, 2024, largely reflective of the net loss for the period of $48.4 million which included non-cash charges of $4.7 million primarily related to stock-based compensation expense.
−Removed: Investing activities used cash of $110.2 million in the three months ended March 31, 2024, primarily due to net purchases of investments.
+Added: As of June 30, 2024 and December 31, 2023, we had $310.0 million and $170.0 million in cash, cash equivalents and short-term investments, respectively.
+Added: We used cash of $103.7 million from operations in the six months ended June 30, 2024, largely reflective of the net loss for the period of $101.8 million which included non-cash charges of $5.4 million primarily related to stock-based compensation expense.
+Added: Investing activities used cash of $122.5 million in the six months ended June 30, 2024, primarily due to net purchases of investments.
Financing activities provided cash of $239.4 million, primarily from the issuance of sale of 2,304,147 shares of our Series A Convertible Preferred Stock in a private placement at a price of $108.50 per share.
24 unchanged sentences
We are exposed to limited market and credit risk on our cash equivalents which have maturities of three months or less at the time of purchase.
−Removed: We had approximately $355.6 million in cash and cash equivalents and short-term investments as of March 31, 2024.
+Added: We had approximately $310.0 million in cash and cash equivalents and short-term investments as of June 30, 2024.
We maintain a short-term investment portfolio which consists of U.S.
9 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.