On March 9, 2023 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Acorda Therapeutics, MAR 9, 2023, View Source [SID1234628404]).

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"Acorda’s operating and financial performance improved throughout the year, meeting our financial guidance for 2022 AMPYRA net revenue, INBRIJA U.S. net revenue, cash, and adjusted OPEX. We also delivered a stream of business successes that have driven shareholder value," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer.

"These successes included a substantial AMPYRA arbitration award and markedly lower cost of goods for AMPYRA going forward, renegotiation of our agreements with Catalent for INBRIJA manufacturing on more favorable terms, the launches of INBRIJA in Germany and Spain, and obtaining an extension from Nasdaq to bring the company’s share price back into compliance with Nasdaq listing requirements," he continued.

"In 2023 we expect to make further progress in reducing operating expenses, increasing INBRIJA’s trajectory, and maintaining the strength of the AMPYRA brand. We are also in active discussions for additional agreements to commercialize INBRIJA in multiple ex-U.S. territories; and we also expect Biopas to launch in Latin America in early 2024."

Fourth Quarter 2022 Financial Results

For the quarter ended December 31, 2022, the Company reported INBRIJA U.S. net revenue of $9 million, a 13.1% decrease compared to the same quarter in 2021. The Company did not report any ex-U.S. INBRIJA sales in the fourth quarter for either period.

For the quarter ended December 31, 2022, the Company reported AMPYRA net revenue of $18.8 million, a 16.6% decrease compared to the same quarter in 2021. Additionally, for the quarter ended December 31, 2022, the Company reported FAMPYRA royalty revenues of $2.7 million, a 25.1% decrease compared to the same quarter in 2021. As previously disclosed, AMPYRA lost its exclusivity and generics entered the market in 2018, and the Company expects AMPYRA revenue to continue to decline. The decline in royalty revenues is largely attributed to the launch of generic competition in the German market in 2022.

Research and development (R&D) expenses for the quarter ended December 31, 2022 were $1.2 million, including negligible share-based compensation expenses, compared to $1.4 million, including $0.1 million of share-based compensation for the same quarter in 2021.

Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2022 were $26.3 million, including $0.2 million of share-based compensation, compared to $28.4 million, including $0.4 million of share-based compensation for the same quarter in 2021.

Provision for income taxes for the quarter ended December 31, 2022 was $2.4 million, compared to a provision for income taxes of $1.7 million for the same quarter in 2021.

The Company reported net income of $19.1 million for the quarter ended December 31, 2022, or $0.79 per basic share and $0.57 per diluted share. Net loss in the same quarter of 2021 was ($20.6) million, or a net loss of ($1.73) per share on both a basic and diluted basis. The increase in net income is primarily driven by recognition of a gain upon extinguishment of debt of a subsidiary of $27.1 million, and receipt of an arbitration award of $18.3 million, reduction in the change in fair value of contingent consideration of $3.1 million, and reduced R&D and SG&A expenses of $2.3 million, partially offset by a one-time contract termination fee of $4 million, and reduced net revenues of $5.5 million.

Full Year Ended December 31, 2022 Financial Results

For the full year ended December 31, 2022, the Company reported INBRIJA global net revenue of $30.9 million, $28 million of which was derived from sales in the U.S., and $2.9 million from ex-U.S. sales, compared to $29.6 million net revenue for the full year 2021, which was derived from U.S. sales only.

For the full year ended December 31, 2022, the Company reported AMPYRA net revenue of $72.9 million, compared to $84.6 million for the full year 2021. Additionally, for the full year ended December 31, 2022, the Company reported FAMPYRA royalty revenues of $11.7 million, compared to $13.8 million for the full year ended 2021. This decline in royalty revenues is largely attributed to the launch of generic competition in the German market in 2022.

Research and development (R&D) expenses in 2022 were $5.8 million, including $0.1 million of share-based compensation, compared to $10.4 million, including $0.7 million of share-based compensation for the full year 2021.

Sales, general and administrative (SG&A) expenses were $106.3 million, including $1.4 million of share-based compensation, compared to $124.4 million, including $2.3 million of share-based compensation, for the full year 2021.

Provision for income taxes was $30.7 million, compared to a benefit from income taxes of $5.1 million for the full year 2021. This change is a result of the elimination of Net Operating Losses ("NOLs") due to a Section 382 change in control due to cumulative changes in the Company’s ownership over the preceding three years, driven by the Company’s interest payment of 2024 convertible senior secured notes in shares in June 2022, which required the write-off $57.9 million of NOLs.

The Company reported net loss of ($65.9) million, or a net loss of ($3.34) per basic and diluted share, compared to a net loss of ($104) million, or a net loss of ($9.79) per basic and diluted share for the full year ended 2021. The decrease in net loss is primarily driven by a gain upon extinguishment of debt of a subsidiary of $27.1 million, reduced R&D and SG&A expenses of $22.8 million, receipt of an arbitration award of $18.3 million, increase of the gain recognized in the change in fair value of contingent consideration of $9.6 million, and reduced cost of sales of $10.5 million, partially offset by an increased provision for income taxes of $35.8 million, lower net revenues of $10.5 million, and a one-time contract termination fee of $4 million.

At December 31, 2022, the Company had cash, cash equivalents, and restricted cash of $44.7 million compared to $65.2 million at year end 2021. Restricted cash includes $6.2 million in escrow related to the 6.00% semi-annual interest portion of the convertible notes.

Early 2023 / 2022 Highlights

In March 2023, Esteve announced that they had launched INBRIJA in Spain.
In February 2023, a Nasdaq Hearings Panel granted an extension until June 20, 2023 to comply with listing requirements and remain listed on the Nasdaq Global Select Market.
In January 2023, Acorda entered into a new long-term, global supply agreement with Catalent to significantly lower minimum purchase requirements for INBRIJA in 2023 and 2024; and beginning in 2025, Acorda will pay a fixed, per-capsule price for INBRIJA.
In December 2022, Acorda obtained waivers from the Finnish government of approximately $27.1 million in loans related to its Biotie subsidiary.
In December 2022, Acorda made a cash interest payment of approximately $6.2 million related to its Convertible Senior Secured Notes Indenture ("2024 Notes").
In November 2022, Acorda stockholders approved a reverse stock split, which can be utilized by the Company to regain compliance with the listing requirements for the Nasdaq Global Select Market.
In October 2022, Acorda was awarded a total of $18.3 million, including interest, through an arbitration involving a dispute with Alkermes over AMPYRA royalties. As a result, Acorda will no longer have to pay Alkermes any royalties on net sales for AMPYRA. In addition, Acorda is free to use alternative sources for supply of AMPYRA which it has secured. The Company estimates that as a result its cost of goods for Ampyra in 2023 will be lower by $10 million – $12 million.
In August 2022, Acorda announced a license agreement with Asieris Pharmaceuticals relating to its preclinical asset, Nepicastat. Acorda received an upfront payment of $0.5 million, and is eligible to receive up to an additional $7 million based on the achievement of regulatory milestones and royalties on future net sales of any product developed.
In June 2022, Acorda met its obligation to HealthCare Royalty Partners and received the full benefit of the royalty payments from Biogen on FAMPYRA sales.
In June 2022, Esteve launched INBRIJA in Germany and Acorda received $2.9 million in revenue related to this launch.
In May 2022, Acorda announced an agreement with Biopas Laboratories to commercialize INBRIJA in the nine largest markets in Latin America, including Brazil and Mexico. Acorda will receive a significant, double-digit, tiered percentage of the selling price of INBRIJA and will also receive sales-based milestones.
2022 Financial Guidance2

For the full year 2022, the Company achieved its guidance targets for INBRIJA U.S. net revenue of $28 million, AMPYRA net revenue of $72.9 million, adjusted OPEX of $112 million, and ending cash balance of $44.7 million.

For the full year 2022, adjusted EBITDA was a loss of ($2.4) million, which fell short of guidance of $5.6 – $5.8 million. The shortfall was primarily due to a non-cash adjustment to the change in fair value of contingent consideration identified through the Company’s year-end procedures. Additionally, the Company recorded inventory write-offs given estimates of future sales compared to inventory to be received under the new global supply agreement with Catalent. There was no impact to cash.

2023 Financial Guidance

For the full year 2023, the Company is targeting INBRIJA U.S. net revenue to be $38 – $42 million.

The Company is targeting 2023 AMPYRA net revenue to be $65 – $70 million. As previously disclosed, AMPYRA lost its exclusivity and generics entered the market in 2018, and the Company expects AMPYRA revenue to continue to decline.

The Company is targeting adjusted OPEX to be $93 – $103 million and ending cash balance to be $43 – $47 million. The 2023 guidance includes the impact of the new global supply agreement with Catalent. Adjusted OPEX is described below under "Non-GAAP Financial Measures." As described below, we are unable to reconcile our adjusted OPEX guidance to GAAP due to the forward-looking nature of the adjustments that are needed to determine this information.

Updated Long-Term Financial Guidance

The financial guidance below includes non-GAAP financial measures. Adjusted OPEX for fiscal years 2024 – 2027 is described below under "Non-GAAP Financial Measures."

Long-term guidance for net revenue, 2024-2027, remains unchanged from previous guidance (other than rounding adjustments).

Long-term guidance for adjusted OPEX increased in 2024 from the previous guidance due to the expected payment of $1.0 million to support the completion of the PSD-7 for INBRIJA manufacture under the new global supply agreement with Catalent. Adjusted OPEX for 2025-2027 remains unchanged.

Guidance Ranges in
U.S.$M

2023

2024

2025

2026

2027

(unaudited)

INBRIJA U.S. net
revenue

$38 – $42

$50 – $56

$59 – $65

$63 – $70

$70 – $78

AMPYRA net revenue

$65 – $70

$62 – $68

$62 – $68

$64 – $71

$62 – $69

Adjusted OPEX

$93 – $103

$92 – $102

$93 – $103

$96 – $106

$99 – $109

Ending Cash Balance

$43 – $47

$51 – $56

$72 – $79

$97 – $107

$124 – $138

Webcast and Conference Call

The Company will host a webcast/conference call in conjunction with its fourth quarter and year end 2022 update and financial results today at 8:30 a.m. ET.

To participate in the Webcast, please use the following registration link:

View Source
If you register for the Webcast, you will have the opportunity to submit a written question for the Q&A portion of the presentation. After you have registered, you will receive a confirmation email with the Webcast details. On the day of the Webcast, you will receive an email 2 hours prior to the start of the Webcast with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on March 9, 2023 until 11:59 p.m. ET on April 8, 2023. To access the replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658 (international); access code 413769. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP) and also certain historical and forward-looking non-GAAP financial measures. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP, and the calculation of the non-GAAP financial measures included herein may differ from similarly titled measures used by other companies. The Company believes that the presentation of these non-GAAP financial measures, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to corporate restructurings not routine to the operation of our business, (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock, and (iii) other items as set forth above that are not ascertainable at the present time. We believe these non-GAAP financial measures help indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding expected operating performance. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and evaluate its performance. In addition, management believes that adjusted OPEX is important in evaluating the administrative costs of operating the Company’s business.

Adjusted OPEX includes (i) research and development expenses and (ii) selling, general, and administrative expenses and excludes (i) costs of goods sold, (ii) amortization of intangible assets, (iii) change in fair value of derivative liability, (iv) change in fair value of acquired contingent liability, and (v) the principal-only portion of an arbitration award less one-time contract termination expenses relating to the new global supply agreement with Catalent. Adjusted EBITDA is GAAP net income (loss) before income taxes less depreciation, amortization, and interest and excluding (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iii) expenses that pertain to corporate restructurings which are not routine to the operation of the business, (iv) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, (v) one-time contract termination expenses relating to the new global supply agreement with Catalent, and (vi) gain on extinguishment of debt of a subsidiary which is a non-cash charge and not related to the operation of the business.

We are unable to reconcile our guidance for these non-GAAP measures to GAAP due to the forward-looking nature of the adjustments that are needed to determine this information, which includes information regarding future compensation charges, future changes in the market price of our common stock, and changes in the fair value of derivative and contingent liabilities, none of which are available at this time.

On March 9, 2023 XOMA Corporation (NASDAQ: XOMA), the Biotech Royalty Aggregator, reported its full year 2022 financial results and provided an operational update on the Company’s actions to accelerate XOMA’s differentiated biotech royalty and milestone acquisition strategy (Press release, Xoma, MAR 9, 2023, View Source [SID1234628391]).

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"Since joining the Company in January, Brad Sitko and I have continually been impressed by the opportunities in front of XOMA. After having a significant number of royalty and milestone acquisition conversations since January, we are making decisions thoughtfully and rapidly about the opportunities on which we want to transact. We are assessing each potential opportunity with an eye to maximizing shareholder returns," stated Owen Hughes, Executive Chairman of XOMA.

"With cash receipts from Vabysmo (faricimab) and Day One’s public comments regarding filing a New Drug Application for tovorafenib in the first half of 2023, XOMA could be reporting incoming cash from two portfolio assets by the end of 2024. Our economic interests in both these assets were acquired within the past two years. In addition, we have learned from our partners’ public statements there also may be three assets entering Phase 3 development in 2023, which would further increase the value of XOMA’s portfolio. Those are just a few examples of the progression within the more than 70 royalty and milestone assets in our portfolio. With the potential incoming cash receipts from commercialized assets and anticipated milestone payments, we have the ability to accelerate our royalty acquisition strategy and continue to grow XOMA’s portfolio," said Brad Sitko, Chief Investment Officer of XOMA.

Fourth Quarter and Full Year 2022 Financial Results

Revenues for the fourth quarter and year ended December 31, 2022, were $1.5 million and $6.0 million, respectively. For the full year of 2022, XOMA’s reported revenues were related to milestone payments of $2.0 million from Rezolute, $0.8 million from Takeda, $0.8 million from Compugen, and $0.5 million from Sonnet. Revenues in the fourth quarter and year ended December 31, 2021, were $35.9 million and $38.2 million, respectively. For the full year of 2021, XOMA’s reported revenues included milestones of $35.0 million from Novartis, $0.5 million from Compugen, and $0.7 million from Janssen.

The Company’s research and development (R&D) expenses for the quarter and the full year of 2022 were $0.03 million and $0.2 million, respectively, compared to $0.04 million and $0.2 million in the corresponding periods of 2021.

General and administration (G&A) expenses were $7.6 million and $23.2 million for the fourth quarter and year-ended December 31, 2022, respectively. G&A expenses were $5.5 million and $20.5 million for the corresponding periods of 2021. The $2.7 million net increase in 2022, compared with 2021, was primarily due a $2.6 million increase in salaries and related expenses, including the $1.2 million Continuity Incentive accrued in connection with the retirement of Jim Neal, a $0.7 million increase in salaries and wages due to increased headcount and general salary increases, $0.4 million related to bonus payments to Mr. Neal pursuant to his amended employment agreement, and $0.1 million accrued in connection with the employee retention bonus. Additionally, an increase in consulting and legal costs of $2.3 million contributed to the overall increase in 2022. The totality of the increases in 2022 were partially offset by a $2.6 million reduction in stock-based compensation expense for stock options.

In the fourth quarter and full year of 2022, G&A expenses included $1.0 million and $3.6 million, respectively, in non-cash stock-based compensation expense, compared with $1.7 million and $6.2 million for the corresponding periods of 2021. XOMA’s net cash used in operations in the fourth quarter of 2022 was $3.9 million and $12.9 million for the full year of 2022, compared with net cash provided by operations in the fourth quarter of 2021 of $30.7 million and $22.7 million for the full year of 2021.

Net loss for the fourth quarter and year ended December 31, 2022, was $6.0 million and $17.1 million, respectively. Net income for the fourth quarter of 2021 was $29.8 million and $15.8 million for the full year of 2021.

On December 31, 2022, XOMA had cash and cash equivalents of $57.8 million and no debt on its balance sheet. On December 31, 2021, XOMA had cash and restricted cash of $95.4 million. On January 17, 2023, the Company paid cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) equal to $0.53906 per share and cash dividends on the 8.375%

Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO) equal to $0.52344 per depositary share. In February 2023, XOMA received a cash payment from Roche, representing the second commercial payment from XOMA’s 0.5% commercial interest in the sales of Vabysmo. The payment will be reflected in the Company’s condensed consolidated balance sheet as of March 31, 2023, as a reduction of short-term royalty and commercial payment receivables.

"The first year’s commercial performance of Vabysmo has demonstrated the significant impact that even a small percentage of sales from a single multi-billion-dollar product can have on XOMA’s financial outlook. Excluding any additional asset acquisitions, we believe incoming net cash of over $20 million from a combination of milestones that are expected this year together with anticipated royalties should cover our annual base operating and dividend expenses in 2023. Given the nature of our milestone and royalty agreements, we expect cash flows will be uneven on a quarterly basis over the next few years. This reflects the imprecise timing of when milestones occur and assets are commercialized. Looking at 2024, the milestones and royalties we anticipate should continue to contribute significantly towards covering our base operating expenses and dividend obligations," stated Tom Burns, Chief Financial Officer at XOMA.

On March 9, 2023 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the fourth quarter and full-year ended December 31, 2022 and provided business highlights (Press release, Akebia, MAR 9, 2023, View Source [SID1234628390]).

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"We ended our year delivering on our strategic focus, which included a commitment to maximize Auryxia revenue, support vadadustat globally and thoughtfully invest in our pipeline," said John P. Butler, Chief Executive Officer of Akebia. "We believe the work our team executed through the fourth quarter and more broadly in 2022 has put us in a strong position as we prepare for several meaningful upcoming milestones. Building on our positive CHMP opinion for vadadustat in Europe, we anticipate potential Marketing Authorization of Vafseo by the European Commission in May 2023, and we are active in our process to select a partner in Europe to deliver Vafseo to patients with chronic kidney disease (CKD) on dialysis, if approved."

Last month, Akebia announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the European Commission (EC) to approve Vafseo (vadadustat), for the treatment of symptomatic anaemia associated with CKD in adults on chronic maintenance dialysis. If approved, an EC Marketing Authorization of Vafseo would be applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. Akebia is seeking a partner to commercialize vadadustat in Europe.

Additionally, Akebia had an important year with several key milestones in 2022 and into early 2023

Achieved Auryxia revenue of $177.1 million representing 24.5% growth versus 2021

Implemented multiple initiatives to reduce costs and create a clear path to positive cash flows from operations supported by Auryxia revenues

Restructured and simplified the Auryxia supply chain, saving significant anticipated cash over a five-year period

Signed a European license agreement with Averoa SAS for the development and commercialization of Auryxia in Europe

Regained the rights from Otsuka Pharmaceutical Co. Ltd. for vadadustat in the U.S., Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories

Assumed responsibility for vadadustat regulatory filings in EMA and ACCESS Consortium countries: U.K., Switzerland and Australia

Submitted a Formal Dispute Resolution Request (FDRR) to the U.S. Food and Drug Administration (FDA), disputing the Complete Response Letter (CRL) for vadadustat received in March 2022; and

Released data from an investigator-sponsored clinical study with the University of Texas Health Sciences Center, Houston (UT Health), evaluating vadadustat for the prevention and treatment of COVID-19 related acute respiratory distress syndrome (ARDS).

Pipeline Progress Expected in 2023

Obtain potential Marketing Authorization for Vafseo expected in Europe in May 2023

Receive regulatory decision for vadadustat for U.K., Switzerland and Australia

Receive decision on appeal process related to CRL for vadadustat

Present data from the IMPACT investigator-sponsored study evaluating the effect of Auryxia as a phosphate binder on utilization of IV iron and erythropoiesis-stimulating agents on dialysis patients

Present data from the FOCUS study on three times weekly dosing for vadadustat in dialysis patients

Initiate UT Health study of vadadustat for the prevention and treatment of ARDS in a broader population beyond patients with COVID-19

Assess potential regulatory path for vadadustat in other acute treatment indications; and

Advance preclinical development of multiple novel hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor compounds for potential indications of serious unmet need.

"Auryxia revenue continues to fund our business, and we entered 2023 with a robust operating plan, including funding for several compelling pipeline opportunities," said David A. Spellman, Chief Financial Officer of Akebia. "Regarding revenue, we reported nearly 25% net product revenue growth for Auryxia over 2021, which exceeded guidance. The fourth quarter of 2022 included an inventory build of approximately $3M year over year. We have set 2023 net product revenue guidance at $175-180 million as we remain cautious about a phosphate binder market recovery; the market continues to contract modestly due to COVID-19 and dialysis staffing issues. We will continue to be mindful of non-essential spend and work to reduce costs overall."

Financial Results

Revenues: Total revenue was $55.2 million in the fourth quarter of 2022 compared to $59.6 million for the fourth quarter of 2021, and $292.6 million for the full-year 2022 compared to $213.6 million for full-year 2021

Net product revenue was $49.7 million in the fourth quarter of 2022 compared to $42.1 million in the fourth quarter of 2021, an 18.1% increase. Net product revenue was $177.1 million for the full-year 2022 compared to $142.2 million for the full-year 2021, an increase of approximately 24.5%. The increase compared to the fourth quarter and full-year of 2021 is primarily due to pricing and improved payer mix, and a 2022 year-end inventory build by a customer that exceeded 2021. Total units sold decreased year over year

License, collaboration, and other revenue was $5.5 million for the fourth quarter of 2022 compared to $17.5 million for the fourth quarter of 2021, and $115.5 million for the full-year 2022 compared with $71.4 million for the full-year 2021. The increase for the full-year 2022 reflects a nonrefundable and non-creditable payment of $55.0 million that Otsuka paid to Akebia in July 2022 under the terms of a termination and settlement agreement between the companies. In addition, Akebia recognized $15.5 million related to previously deferred revenue as of the date of termination and $9.6 million of non-cash consideration related to Otsuka’s obligations to complete certain agreed upon clinical activities. Additionally, Akebia recognized $19.1 million in collaboration revenue in 2022 from the cost sharing arrangement with Otsuka prior to the termination, compared to $53.0 million for the full-year 2021

Auryxia revenue guidance for 2023 of $175—$180 million assumes, among other things, an increase in realized net price per pill, partially offset by a reduction in total units sold and inventories returning to normal levels

COGS: Cost of goods sold was a benefit of $3.1 million for the fourth quarter of 2022 compared to a cost of $50.4 million for the fourth quarter of 2021. Cost of goods sold was $84.8 million for the full-year 2022, compared with $153.4 million for the full-year 2021. The decrease in both periods compared to the same periods in 2021 was primarily due to a non-cash reduction of our excess purchase commitment liability driven by the reduction in purchase commitments with the restructuring of our supply chain. The decrease was partially offset by contract termination fees and inventory reserves associated with Auryxia drug substance that will not be forward processed

R&D Expenses: Research and development expenses were $31.9 million for the fourth quarter of 2022 compared to $29.6 million for the fourth quarter of 2021, and $129.1 million for the full-year 2022 compared to $147.9 million for the full-year 2021. The increase for the fourth quarter of 2022 compared to the fourth quarter of 2021 was largely due to a one-time credit of $8.6 million representing a reimbursement from Vifor Pharma following the sale of the Priority Review Voucher that occurred in 2021. The decrease for the full-year 2022 compared to the full-year 2021 was primarily due to decreased headcount related costs as a result of the April 2022 reduction in force, decreased consulting costs, and decreased outsourced contract services

SG&A Expenses: Selling, general and administrative expenses were $30.6 million for the fourth quarter of 2022 compared to $44.8 million for the fourth quarter of 2021, and $138.7 million for the full-year 2022 compared to $174.2 million for the full-year 2021. The decrease in both periods compared to the same periods in 2021 was primarily due to decreased headcount related costs as a result of both the April 2022 and November 2022 reductions in force, decreased one-time legal costs, and lower marketing expenses following receipt of the CRL for vadadustat

Net Loss: Net loss was $7.6 million for the fourth quarter of 2022 compared to $70.7 million for the fourth quarter of 2021, and $92.6 million for the full-year 2022 compared to $282.8 million for the full-year 2021. The decrease in net loss for the full-year 2022 compared to the prior year was due primarily to higher revenues, lower cost of goods sold and lower operating expenses, partially offset by restructuring expenses in 2022

Cash Position: Cash and cash equivalents as of December 31, 2022 were $90.5 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan for at least the next twelve months. Akebia’s operating plan assumed certain contractual changes and cost avoidance measures would be executed over the course of 2022, which has now occurred. Akebia’s objective is to fund its current operating plan with existing cash resources and cash from operations for at least the next twelve months. Future decisions by the FDA or other regulatory agencies related to the potential regulatory approval of vadadustat, or Akebia’s ability to generate additional value from vadadustat through partnerships or other transactions, may potentially further extend our cash runway, but are not currently reflected in the operating plan. Akebia also plans to continue to work on initiatives to extend its revenues from Auryxia beyond the anticipated loss of exclusivity in March 2025.

Conference Call

Akebia will host a conference call on Thursday, March 9 at 8:30 a.m. ET to discuss its financial results and recent business highlights. To access the call, please register by clicking on this Registration Link, and then you will be provided with dial in details. To avoid delays, we encourage dialing into the conference call fifteen minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the Investors section of Akebia’s website at: View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.

On March 9, 2023 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies, based on its novel DPX platform, to treat solid and hematologic cancers, reported that it will hold a conference call and webcast on Thursday, March 16, 2023, at 8:00 a.m. ET to discuss the company’s 2022 fourth quarter and fiscal year-end financial and operational results (Press release, IMV, MAR 9, 2023, View Source [SID1234628388]).

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On March 9, 2023 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development, and commercialization of transformative targeted therapies, reported business highlights and reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Theseus Pharmaceuticals, MAR 9, 2023, View Source [SID1234628386]).

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"2022 was a year of significant progress for Theseus across our growing pipeline. We initiated our first-in-human study for our lead candidate, THE-630, in advanced GIST; nominated THE-349 as the development candidate for our fourth-generation EGFR inhibitor program for patients with NSCLC; and made substantial progress across our discovery pipeline, culminating with the recent introduction of our third program, targeting BCR-ABL in patients with CML and Ph+ ALL," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "With a strong cash runway, we are poised to continue executing in 2023 as we anticipate two clinical readouts from the ongoing dose-escalation study of THE-630, the IND filing for THE-349, and continued progress across our preclinical and discovery programs."

Recent Pipeline Highlights and Upcoming Expected Milestones:

THE-630 is a pan-variant tyrosine kinase inhibitor (TKI) of the receptor tyrosine kinase KIT, designed for patients with gastrointestinal stromal tumors (GIST) that have developed resistance to earlier lines of therapy.

● Enrollment is ongoing for the phase 1 portion of the phase 1/2 dose-escalation and expansion clinical trial evaluating THE-630 in patients with advanced GIST, with all seven phase 1 sites open in the U.S. and accruing. Theseus is treating patients in cohort 6 of dose escalation as of March 9, 2022.
● Theseus plans to present preliminary safety, pharmacokinetic (PK), and initial clinical activity data through cohort 6, as well as an analysis of circulating tumor DNA (ctDNA) data up to cohort 5, at a scientific conference in the second quarter of 2023.
● Theseus plans to present follow-up data at a scientific conference in the fourth quarter of 2023, which is expected to include data from additional dose escalation cohorts, including cohorts 7 and 8, where Theseus expects to have reached the target systemic exposure for pan-variant KIT activity of 100 nanomolar (nM) average concentration (Cav).

THE-349 is a fourth-generation (4G) epidermal growth factor receptor (EGFR) TKI development candidate with activity against single-, double-, and triple-mutant EGFR variants, including T790M and C797X, found in EGFR-mutant non-small cell lung cancer (NSCLC) that has developed resistance to first- or later-line osimertinib.

● In the third quarter of 2022, Theseus announced the nomination of THE-349 as the development candidate for its second development program, targeting EGFR-mutant NSCLC.
● Preclinical data demonstrate THE-349 can potently inhibit all major classes of EGFR activating and resistance mutations observed in a post-first- or later-line osimertinib setting, possesses kinome and wild-type EGFR selectivity, and has central nervous system (CNS) activity.
● Theseus expects to submit an Investigational New Drug Application (IND) for THE-349 to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023 and to initiate the clinical program as soon as possible thereafter, subject to clearance of the IND by the FDA.

BCR-ABL Program: Theseus is aiming to develop a potent and selective, next-generation, pan-variant BCR-ABL TKI candidate that optimizes the balance of safety and efficacy for patients with relapsed/refractory chronic myelogenous leukemia (CML) and patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

● In January 2023, Theseus announced the prioritization of a new TKI program targeting BCR-ABL in patients with relapsed/refractory CML and newly diagnosed Ph+ ALL.
● Preclinically, Theseus lead molecules have shown a high degree of potency against BCR-ABL and clinically relevant resistance mutations, such as the T315I gatekeeper mutation, and substantial kinome selectivity.
● Theseus expects to nominate a development candidate for this program by early 2024, with the goal of pursuing clinical development in patients with CML who have been previously treated with a second-generation (2G) TKI or have the T315I mutation, and in newly diagnosed patients with Ph+ ALL.

Business Highlights:

● Theseus recently appointed three leaders to key positions, including Ron Knickerbocker, Ph.D., as Senior Vice President, Biometrics and Clinical Development Strategy; Shouryadeep "Deep" Srivastava, M.D., Ph.D., as Vice President, Clinical Development; and Ben Enerson as Vice President, Legal Affairs.

Fourth Quarter and Full Year Financial Results:

Cash Position: As of December 31, 2022, Theseus had cash, cash equivalents, and marketable securities of $211.8 million, as compared to $244.7 million as of December 31, 2021. Theseus expects its current cash, cash equivalents, and marketable securities to fund operations and capital expenditures into the third quarter of 2025 based on its current operating plan.

R&D Expenses: Research and development expenses were $10.4 million for the fourth quarter of 2022 and $35.7 million for the year ended December 31, 2022, as compared to $5.0 million for the fourth quarter of 2021 and $18.3 million for the year ended December 31, 2021. This year-over-year increase was primarily due to $9.6 million of increased employee-related costs driven by an increase in headcount, and $3.8 million of increased expenses for clinical and preclinical studies as Theseus continued to advance THE-630 and THE-349 in clinical and preclinical studies, respectively, as well as $2.8 million of increased expense for its discovery programs.

G&A Expenses: General and administrative expenses were $5.1 million for the fourth quarter of 2022 and $18.4 million for the year ended December 31, 2022, as compared to $3.6 million for the fourth quarter of 2021 and $9.0 million for the year ended December 31, 2021. This year-over-year increase was primarily due to $5.6 million of increased employee-related costs driven by an increase in headcount, as well as $3.8 million of increased professional fees and other general expenses driven by costs associated with operating as a growing public company.

Net Loss: Net loss was $13.7 million for the fourth quarter of 2022, as compared to a net loss of $8.7 million for the fourth quarter of 2021. Net loss was $50.6 million for the full year 2022, or a net loss per share of $1.31, as compared to a net loss of $27.3 million for the full year 2021, or a net loss per share of $2.84.