CytomX Therapeutics to Report Second Quarter 2022 Financial Results on August 4, 2022

On July 28, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported that it will report second quarter 2022 financial results on Thursday, August 4, 2022, after the close of U.S. markets (Press release, CytomX Therapeutics, JUL 28, 2022, View Source [SID1234617061]). Following the announcement, the Company will host a conference call and webcast at 5:00 p.m. ET / 2:00 p.m. PT to discuss the results and provide a corporate update.

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Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website.

Karyopharm to Report Second Quarter 2022 Financial Results on August 4, 2022

On July 28, 2022 Karyopharm Therapeutics Inc. (NASDAQ: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported it will report second quarter 2022 financial results on Thursday, August 4, 2022 (Press release, Karyopharm, JUL 28, 2022, View Source,-2022 [SID1234617060]). Karyopharm’s management team will host a conference call and audio webcast at 8:00 a.m. ET on Thursday, August 4, 2022, to discuss the financial results and other company updates.

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To access the conference call, please dial (888) 349-0102 (local) or (412) 902-4299 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

Athenex Provides Second Quarter 2022 Financial Results and Business Update

On July 28, 2022 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a corporate and financial update for the second quarter ended June 30, 2022 (Press release, Athenex, JUL 28, 2022, View Source [SID1234617059]).

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"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. Johnson Lau, Chief Executive Officer of Athenex. "By monetizing non‑core assets, we have paid down a significant amount of our senior secured debt and extended our cash runway. Athenex remains focused on advancing our NKT cell therapy platform during this transformational period and is highly encouraged by the clinical trial data to date demonstrating the potential of CAR‑NKT cells to offer a more durable, safe, and effective cell therapy option for patients with advanced solid tumors or hematological malignancies."

Second Quarter 2022 and Recent Business Highlights

Business Updates

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 million in June
Entered into an agreement in July to sell China API Business for approximately $19 million
Appointed 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)
Clinical Programs

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 Meetings in 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) (Free ASGCT Whitepaper) 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 1×108 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 (Free ASCO Whitepaper) 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.
Commercial Update

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 UK MHRA for Oral Paclitaxel in advanced breast cancer in UK remain 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: 3×108 cells/m2; DL6: 1×109 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 $25.8 million for the three months ended June 30, 2022, from $20.4 million for the three months ended June 30, 2021, an increase of $5.4 million or 26%. This increase was primarily attributable to an increase in APD specialty product sales, which increased by $4.2 million as the result of increases in shortage product sales and product launches during 2022.

License fees and other revenue for the three months ended June 30, 2022, was $5.7 million, compared to $0.3 million for the same period in 2021, an increase of $5.4 million. This increase was primarily due to the recognition of $5.0 million of license revenue pursuant to the 2017 Almirall License Agreement upon the commencement of a line extension trial for Klisyri in the U.S.

Cost of sales for the three months ended June 30, 2022, totaled $23.1 million, an increase of $4.0 million, or 21%, as compared to $19.1 million for the three months ended June 30, 2021. The increase was primarily due to an increase of $1.3 million in cost of APD product sales and an increase of $2.7 million in cost of 503B product sales.

R&D expenses totaled $13.1 million for the three months ended June 30, 2022, a decrease of $7.6 million, or 37%, as compared to $20.6 million for the three months ended June 30, 2021. This decrease was primarily due to a decrease in Oral Paclitaxel product development and medical affairs costs, costs of clinical and regulatory operations, compensation costs, and costs of preclinical operations.

SG&A expenses totaled $17.2 million for the three months ended June 30, 2022, a decrease of $0.5 million, or 3%, as compared to $17.6 million for the three months ended June 30, 2021. The decrease was primarily due to a $2.5 million decrease of costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and a $0.2 million decrease in compensation related costs. These decreases were partially offset by a $2.2 million increase in operating costs.

Interest expense totaled $4.3 million and $5.6 million, respectively, for the three months ended June 30, 2022, and 2021. Interest expense in both periods was incurred from the Senior Credit Agreement with Oaktree, and the decrease in 2Q 2022 was due to principal repayments made to the Agreement.

Income tax benefit for the three months ended June 30, 2022, amounted to less than $0.1 million, compared to an $11.0 million benefit for the same period in 2021. The income tax benefit in 2Q21 was the result of a taxable temporary difference due to the deferred tax liability recognized for the indefinite lived intangible assets acquired in connection with the acquisition of Kuur’s IPR&D. We did not record a provision for U.S. federal income taxes for the three months ended June 30, 2022, because we expect to generate a loss for the year ending December 31, 2022.

Net loss attributable to Athenex for the three months ended June 30, 2022, was $32.2 million, or ($0.28) per diluted share, as compared to a net loss of $34.3 million, or ($0.33) per diluted share, for the same period in 2021.

For further details on the Company’s financial results, including the results for the three months ended June 30, 2022, refer to the Form 10Q filed with the SEC.

2022 Financial Guidance

Athenex continues to expect product sales from continuing operations growth to be in the range of 20-25% over the prior year period.

Cash Conservation Update

As of June 30, 2022, the Company had cash and cash equivalents, restricted cash, and short-term investments of $37.1 million. The Company is implementing cost savings programs and monetizing non-core assets, and as the Company completes such activities, the Company plans to extend its cash runway into next year.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Thursday, July 28, 2022, at 8:00 a.m. Eastern Time to discuss the financial results and provide a business update.

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 View Source

Deciphera Pharmaceuticals, Inc. to Announce Second Quarter 2022 Financial Results and Host Conference Call and Webcast on August 4, 2022

On July 28, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that it will report its second quarter 2022 financial results on Thursday, August 4, 2022 (Press release, Deciphera Pharmaceuticals, JUL 28, 2022, View Source [SID1234617058]).

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In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 8:00 AM ET on Thursday, August 4, 2022, to discuss the Company’s financial results and provide a corporate update.

The conference call may be accessed via this link: https://register.vevent.com/register/BI14cfe386c5004efcba5c94f8783e2435.

A live webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

Labcorp Announces 2022 Second Quarter Results

On July 28, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported results for the second quarter ended June 30, 2022, and updated full-year guidance (Press release, LabCorp, JUL 28, 2022, View Source [SID1234617057]).

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"Labcorp continued to execute well during the second quarter," said Adam Schechter, chairman and CEO of Labcorp. "We remained dedicated to providing customers with the highest quality science and service while overcoming inflationary and macroeconomic challenges through our accelerated LaunchPad efforts. We also made significant progress against our strategy and reported plans to spin-off our Clinical Development business, resulting in two independent businesses poised for strong, sustainable growth."

Labcorp introduced several innovative diagnostics in the quarter and expanded its drug development capabilities to serve customers in Europe, the Middle East, Africa and Japan. Through Labcorp OnDemand, the company launched at-home collection kits for diabetes, men’s fertility, and for COVID-19, flu and RSV. Labcorp also made available a new skin cancer test for physicians that can also be used during clinical trials. And in July, the company began offering a test to help physicians diagnose conditions including concussions, Alzheimer’s and Parkinson’s.

Furthering its commitment to the fight against COVID-19, Labcorp maintained adequate capacity for current and future testing needs while providing innovations to assist in pandemic response efforts. To help address the monkeypox outbreak, the company collaborated with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration to bring the CDC’s test to doctors and hospitals across the United States.

The company also advanced important strategic partnerships and acquisitions during the quarter, and its previously announced arrangement with Ascension is progressing through normal regulatory approvals.

On July 14, 2022, the company announced a quarterly cash dividend of $0.72 per share of common stock, payable on September 9, 2022, to stockholders of record at the close of business on August 18, 2022.

Spin-Off of the Clinical Development Business

In a separate press release issued this morning, Labcorp announced that its Board of Directors has authorized the company to pursue a spin-off of the company’s wholly owned Clinical Development business to Labcorp shareholders through a tax-free transaction. The spin-off will result in two independent, publicly traded companies, each poised for sustainable growth:

Labcorp: A leading global laboratory services business comprising the company’s routine and esoteric labs, central labs and early development research labs, all of which are leaders with deep scientific expertise, vast health data and insights, and an extensive, advanced global laboratory network.
The Clinical Development Business: A leading, global Contract Research Organization (CRO) providing Phase I-IV clinical trial management, market access and technology solutions to pharmaceutical and biotechnology organizations.
Labcorp is targeting completion of the planned spin-off in the second half of 2023. Labcorp leadership will discuss the planned spin-off in further detail on the company’s conference call today at 9:00 a.m. ET.

Consolidated Results

Second Quarter Results

Revenue for the quarter was $3.70 billion, a decrease of (3.7%) from $3.84 billion in the second quarter of 2021. The decrease was due to organic revenue of (3.4%) and foreign currency translation of (1.1%), partially offset by acquisitions net of divestitures of 0.8%. The (3.4%) decrease in organic revenue was driven by a (4.8%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing), partially offset by a 1.4% increase in the company’s organic Base Business. Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $525.9 million, or 14.2% of revenue, compared to $704.1 million, or 18.3%, in the second quarter of 2021. The company recorded amortization, restructuring charges, and special items, which together totaled $130.2 million in the quarter, compared to $135.8 million during the same period in 2021. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $656.1 million, or 17.7% of revenue, compared to $839.9 million, or 21.9%, in the second quarter of 2021. The decrease in operating income and margin was primarily due to a reduction in COVID-19 Testing, higher personnel expense, and other inflationary costs, partially offset by organic Base Business growth and LaunchPad savings.

Net earnings for the quarter were $358.6 million compared to $467.4 million in the second quarter of 2021. Diluted EPS were $3.87 in the quarter compared to $4.76 during the same period in 2021. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $4.96 in the quarter compared to $6.13 in the second quarter of 2021.

Operating cash flow for the quarter was $572.5 million compared to $487.2 million in the second quarter of 2021. The increase in operating cash flow was due to higher cash earnings and favorable working capital. Capital expenditures totaled $143.3 million compared to $97.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $429.2 million compared to $390.0 million in the second quarter of 2021.

At the end of the quarter, the company’s cash balance and total debt were $1.1 billion and $5.4 billion, respectively. During the quarter, the company invested $99.8 million on acquisitions, paid out $66.7 million in dividends, and repurchased $400.0 million of stock representing approximately 1.7 million shares.

Year-To-Date Results

Revenue was $7.6 billion, a decrease of (5.1)% from $8.0 billion, in the first six months of 2022. The decrease was due to lower organic revenue of (4.9%) and foreign currency translation of (0.7%), partially offset by acquisitions net of divestitures of 0.6%. The (4.9%) decrease in organic revenue was a (7.4%) decrease in COVID-19 Testing, partially offset by a 2.5% increase in the Company’s organic Base Business.

Operating income was $1,213.8 million, or 16.0% of revenue, compared to $1,762.0 million, or 22.0%, in the first six months of 2021. The company recorded amortization, restructuring charges, special items, and impairments, which together totaled $236.3 million in the first six months of 2022 compared to $259.8 million during the same period in 2021. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) was $1,450.1 million, or 19.1% of revenue, compared to $2,021.8 million, or 25.3%, in the first six months of 2021. The decrease in operating income and margin was primarily due to lower COVID-19 Testing and higher personnel costs, partially offset by a recovery in the Base Business.

Net earnings were $850.2 million compared to $1,237.0 million in the first six months of 2021. Diluted EPS were $9.11 in the first six months of 2022 compared to $12.58 during the same period in 2021. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $11.07 in the first six months of 2022 compared to $14.92 during the same period in 2021.

Operating cash flow was $928.5 million compared to $1,644.8 million in the first six months of 2021. The decrease in operating cash flow was due to lower cash earnings and unfavorable working capital. Capital expenditures totaled $260.5 million compared to $192.6 million during the same period in 2021. As a result, free cash flow (operating cash flow less capital expenditures) was $668.0 million compared to $1,452.2 million in the first six months of 2021.

Second Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics

Revenue for the quarter was $2.26 billion, a decrease of (4.7%) from $2.37 billion in the second quarter of 2021. The decrease was primarily due to organic revenue of (5.7%), partially offset by acquisitions of 1.2%. The (5.7%) decrease in organic revenue was due to a (7.8%) decrease in COVID-19 Testing, partially offset by a 2.1% increase in the Base Business. Total Base Business growth compared to the Base Business in the prior year was 3.9%.

Total volume (measured by requisitions) decreased by (2.7%) as organic volume decreased by (3.1%) and acquisition volume contributed 0.4%. Organic volume was impacted by a (5.6%) decrease in COVID-19 Testing, partially offset by a 2.6% increase in Base Business. Price/mix decreased by (2.0%) due to a decrease in COVID-19 Testing of (2.2%) and a decline in organic Base Business of (0.4%), partially offset by acquisitions of 0.8%. Base Business volume was up 3.4% compared to the Base Business last year, while price/mix was up 0.5%.

Adjusted operating income for the quarter was $515.6 million, or 22.9% of revenue, compared to $663.2 million, or 28.0%, in the second quarter of 2021. The decrease in adjusted operating income and adjusted operating margin was primarily due to a reduction in COVID-19 Testing, higher personnel expense, and other inflationary costs, partially offset by organic Base Business growth and LaunchPad savings.

Drug Development

Revenue for the quarter was $1.45 billion, a decrease of (2.9)% from $1.50 billion in the second quarter of 2021. The decrease was due to foreign currency translation of (2.6%) and lower COVID-19 Testing of (0.6%), partially offset by acquisitions net of divestitures of 0.2% and organic Base Business growth of 0.1%. Organic Base Business growth was impacted by reduced COVID-19 related work, the Ukraine/Russia crisis, and lower pass-throughs.

Adjusted operating income for the quarter was $213.3 million, or 14.7% of revenue, compared to $221.1 million, or 14.8%, in the second quarter of 2021. Adjusted operating income and margin decreased primarily due to COVID-19 Testing, a reduction in COVID-19 related work, the Ukraine/Russia crisis, and inflationary costs. These impacts were partially offset by organic Base Business growth and LaunchPad savings. In addition, personnel expense was lower due to cost reduction actions and variable compensation.

Net orders and net book-to-bill during the trailing twelve months were $7.15 billion and 1.23, respectively. Backlog at the end of the quarter was $15.21 billion, an increase of 6.5% compared to last year. The company expects approximately $4.84 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2022

Labcorp is updating 2022 full year guidance to reflect its second quarter performance and full-year outlook. The following guidance assumes foreign exchange rates effective as of June 30, 2022, for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends.

Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by dialing 800-715-9871 (646-307-1963 for international callers). The conference ID is 4124787. A telephone replay of the call will be available through August 11, 2022, and can be heard by dialing 800-770-2030 (609-800-9909 for international callers). The conference ID for the replay is 4124787. A live online broadcast of Labcorp’s quarterly conference call on July 28, 2022, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This online broadcast will be archived and accessible through July 14, 2023.