Athenex Provides Second Quarter 2022 Financial Results and Business Update
- Reports 2Q product sales of
$25.8 million, up 26% year-over-year
$85 millionin total transaction value in 2Q for total of $125 millionin proceeds from sales of non-core assets in 1H 2022, and reduced Senior Credit Facility balance from $150 millionto $57.5 million
- Cash used in operating activities for 1H 2022 was reduced 42% over the prior year
- Presented promising early Phase 1 clinical trial data for CD19 and GD2 CAR-NKT cell products at ASTCT/CIBMTR Tandem Meetings and ASGCT annual meeting in 2Q 2022, respectively
- Maintains full-year 2022 product revenue guidance range of 20-25% growth year-over-year
- Management to host conference call and webcast today at
8:00 a.m. EDT
“Our team has made significant progress advancing our new strategy this quarter. I am proud of our operational execution in the first half of 2022 and pleased to say we are continuing this momentum into the second half of the year,” said Dr.
Second Quarter 2022 and Recent Business Highlights
- APD/APS division delivered new product launches and generated 26% growth in product revenues during the second quarter of 2022 versus the prior year
- Announced sale of revenues from
U.S.and European royalty and milestone interests in Klisyri® (tirbanibulin) for a total transaction value of $85 millionin June
- Entered into an agreement in July to sell China API Business for approximately
Darrel P. Cohen, MD, PhD as new Chief Medical Officer of Cell Therapy
- Entered a clinical collaboration with Merck to support the expansion of the Phase 1 clinical trial to evaluate Oral Paclitaxel plus KEYTRUDA® (pembrolizumab) in patients with non-small cell lung cancer (NSCLC)
NKT Cell Therapy
- Presented early Phase 1 ANCHOR dose escalation data for KUR-502, an allogeneic CD19 CAR-NKT therapy at the
American Society of Transplantation and Cellular Therapy(ASTCT)/ Center for International Blood & Marrow Transplant Research (CIBMTR) Tandem Meetingsin April 2022. Data demonstrated a 60% ORR and 6-month CR rate of 40% in 5 patients from the Non-Hodgkin’s Lymphoma (NHL) cohort, including 1 ongoing CR at 34 weeks. Encouraging response rates were observed at low doses, including 2 durable responses in patients who failed prior autologous CAR-T cell therapy. KUR-502 remains well-tolerated without cytokine release syndrome (CRS) in the NHL cohort, immune effector cell-associated neurotoxicity syndrome (ICANS), or graft versus host disease (GvHD).
- Presented early Phase 1 GINAKIT2 dose escalation data for KUR-501, an autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma at the
American Society of Gene & Cell Therapy(ASGCT) annual meeting in May 2022. Study demonstrated expansion of CAR-NKT cells in all patients and dose response, with 2 out of 3 responses observed at the 1x108 cells/m2 dose level, including a durable complete response lasting at least 12 months. Analysis of results found that responses correlated with CD62L+ NKT cell expression as well as CAR‑NKT cell area under the curve (AUC). Treatment remains well-tolerated without any dose-limiting toxicity, no ICANS, and 1 case of Grade 2 CRS.
- Presented pre-clinical data for KUR-503, an allogeneic GPC3 CAR-NKT cell therapy, at the ASCO Annual Meeting in
June 2022. Study demonstrated CAR-NKT cells overexpressing BATF3 enhanced NKT cell proliferation, long-term tumor control, and survival compared to IL-15 CAR-NKT cells.
- Made the strategic decision to deprioritize development of AX-TCRT-001 and plan to close the Phase 1 open-label study of TCRT-ESO-A2 autologous T cells expressing TCR specific for NY-ESO-1 in patients with advanced solid tumors.
Specialty Pharmaceutical Business
- Athenex Pharmaceutical Division (APD) currently markets a total of 31 products with 57 SKUs.
Athenex Pharma Solutions(APS) currently markets 6 products with 16 SKUs.
Key Anticipated Milestones
- Oral Paclitaxel:
- Phase 2 data from I-SPY 2 trial evaluating Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer expected in 2H 2022
- Regulatory interactions with
UKMHRA for Oral Paclitaxel in advanced breast cancer in UKremain on track with responses to questions expected later this quarter
- KUR-501: autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma
- Ongoing enrollment of additional patients in single-institution Phase 1 dose escalation GINAKIT2 study at the 2 highest dose levels (DL5: 3x108 cells/m2; DL6: 1x109 cells/m2)
- Next data update from the ongoing GINAKIT2 study expected in 2023
- KUR-502: allogeneic CD19 CAR-NKT cell therapy for relapsed/refractory B-cell malignancies
- Ongoing multicenter expansion of Phase 1 dose escalation ANCHOR study
- Next clinical trial data update from the ongoing ANCHOR study anticipated in 4Q 2022 or 1Q 2023
- KUR-503: allogeneic GPC3 CAR-NKT cell therapy for hepatocellular carcinoma
- IND filing for KUR-503 in GPC3-expressing hepatocellular carcinoma planned in 2023
Second Quarter 2022 Financial Highlights
Revenues from product sales increased to
License fees and other revenue for the three months ended
Cost of sales for the three months ended
R&D expenses totaled
SG&A expenses totaled
Interest expense totaled
Income tax benefit for the three months ended
Net loss attributable to
For further details on the Company’s financial results, including the results for the three months ended
2022 Financial Guidance
Cash Conservation Update
Conference Call and Webcast Information
To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:
The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under “Events and Presentations”, located at https://ir.athenex.com/investor-calendar.
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation cell therapy drugs for the treatment of cancer. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company’s current clinical pipeline is derived mainly from the following core technologies: (1) Cell therapy, based on NKT cells and (2) Orascovery, based on a P-glycoprotein inhibitor. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active, accessible, and tolerable treatments. For more information, please visit www.athenex.com.
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “continue,” “could,” “expect,” “intend,” “may,” “plan,” “potential,” “strategy” “will,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our ability to complete the sale of our equity interests in our
CONDENSED CONSOLIDATED BALANCE SHEETS
|Selected Balance sheet data:|
|Cash, cash equivalents, and restricted cash||$||35,964||$||51,702|
|Total assets attibutable to discontinued operations||26,542||63,210|
|Royalty financing liability||75,006||—|
|Total liabilities attibutable to discontinued operations||11,164||17,205|
|Total stockholders' (deficit) equity||(5,473||)||34,452|
|(1)working capital: total current assets less total current liabilities
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
|Three Months ended
||Six Months ended
|Product sales, net||$||25,786||$||20,394||54,154||38,881|
|License and other revenue||5,730||304||6,504||20,969|
|Cost of sales||(23,092||)||(19,117||)||(45,613||)||(34,158||)|
|Research and development expenses||(13,094||)||(20,646||)||(27,179||)||(42,390||)|
|Selling, general, and administrative expenses||(17,172||)||(17,641||)||(30,979||)||(36,840||)|
|Gain (loss) on partial extinguishment of debt||2,051||—||(1,450||)||—|
|Income tax benefit (expense)||19||11,035||(8||)||10,881|
|Net loss from continuing operations||(24,033||)||(31,247||)||(53,269||)||(53,134||)|
|Gain (loss) from discontinued operations||(8,341||)||(3,368||)||2,963||(7,084||)|
|Less: net loss attributable to non-controlling interests||(217||)||(341||)||(729||)||(894||)|
|Net loss attributable to
|Net loss per share attributable to
|Weighted-average shares used in computing net loss per share attributable to
Source: Athenex, Inc.