Aldeyra Therapeutics Reports Third-Quarter 2021 Financial Results and Recent Corporate Highlights

On October 28, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, reported recent corporate highlights and financial results for the quarter ended September 30, 2021 (Press release, Aldeyra Therapeutics, OCT 28, 2021, View Source [SID1234592088]).

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"We continue to make important progress in developing safe and effective treatments for ocular and systemic diseases to improve the lives of patients who have significant unmet medical needs," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Among key clinical milestones, we expect to release top-line results from the Phase 3 TRANQUILITY and TRANQUILITY-2 dry eye disease clinical trials in the fourth quarter of this year and are on track to report top-line results from Phase 2 clinical trials of ADX-629 in psoriasis, atopic asthma, and COVID-19 by the end of the year or early 2022. We also look forward to the planned initiation of our Phase 2 clinical trial of ADX-2191 in retinitis pigmentosa this quarter."

Recent Corporate Highlights and Program Updates

Top-Line Results from the Phase 3 TRANQUILITY and TRANQUILITY-2 Trials in Dry Eye Disease Expected in the Fourth Quarter of 2021. Ocular redness is the primary endpoint of the TRANQUILITY trials, which include tear RASP levels, Schirmer’s test, and dry eye disease symptoms as secondary endpoints. In addition, enrollment has completed in a multi-center, double-masked, randomized, vehicle-controlled, parallel-group Phase 2 clinical trial of reproxalap in dry eye disease. The Phase 2 trial was designed to optimize the measurement of tear RASP levels.
Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Scheduled to Initiate in the Fourth Quarter of 2021. The primary endpoint of the trial is the safety and tolerability of ADX-2191 in patients with retinitis pigmentosa. Secondary endpoints are visual acuity, central retinal sensitivity, dark-adapted retinal sensitivity, and retinal morphometry.
Phase 2 Clinical Trial Results from ADX-629, an Orally Administered RASP Inhibitor, Expected in the Fourth Quarter of 2021 or First Quarter of 2022. ADX-629 is in proof-of-concept Phase 2 clinical trials for the treatment of psoriasis, atopic asthma, and COVID-19. ADX-629 represents a first-in-class systems-based therapeutic approach for the potential treatment of many immune-mediated diseases that today are treated with single-target drugs that can lead to toxicity.
Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease Paper Published in Peer-Reviewed Journal. Clinical Ophthalmology published the results of a clinical trial comparing the subjective eye drop experience of patients with dry eye disease over one hour after a single dose of two formulations of reproxalap versus lifitegrast.
Third-Quarter 2021 Financial Results

Cash and cash equivalents as of September 30, 2021 were $241.4 million. Based on Aldeyra’s current operating plan, the company believes that existing cash and cash equivalents will be sufficient to fund currently projected operating expenses through the end of 2023, including potential New Drug Application submissions; initial commercialization of reproxalap, if approved; and continued development of the company’s product candidates in ocular and systemic immune-mediated diseases.

For the quarter ended September 30, 2021, Aldeyra reported a net loss of $15.8 million, compared with a net loss of $8.9 million for the quarter ended September 30, 2020. Net loss per share was $0.27 for the quarter ended September 30, 2021, compared with $0.23 for the same period in 2020. Losses have resulted from the costs of clinical trials and research and development programs, as well as from general and administrative expenses.

Research and development expenses were $12.9 million for the quarter ended September 30, 2021, compared with $6.1 million for the same period in 2020. The increase of $6.8 million is primarily related to increases in our clinical research and development expenditures and consulting costs, partially offset by decreases in personnel related costs, including stock-based compensation, and manufacturing activities.

General and administrative expenses were $2.5 million for the quarter ended September 30, 2021, compared with $2.3 million for the quarter ended September 30, 2020. The increase of $0.2 million is primarily due to an increase in miscellaneous administrative costs.

For the quarter ended September 30, 2021, total operating expenses were $15.4 million, compared with total operating expenses of $8.4 million for the same period in 2020.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET today to discuss third-quarter 2021 financial results and recent corporate highlights. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 8891298. Due to expected high demand, please dial in at least 15 minutes prior to the start time.

A live webcast of the conference call will also be available on the Investor Relations page of the company’s website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

Labcorp Announces 2021 Third Quarter Results

On October 28, 2021 Labcorp (NYSE: LH), a leading life sciences company, reported results for the third quarter ended September 30, 2021, and raised full-year guidance (Press release, LabCorp, OCT 28, 2021, View Source [SID1234592080]).

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"Labcorp delivered another quarter of strong performance as we continue to leverage innovation, science and technology to accelerate our strategy," said Adam Schechter, chairman and CEO of Labcorp. "Our Base Business continued to perform well and grew 14.6%. As a result of our third-quarter performance and improved outlook for the balance of the year, we are raising our full-year financial guidance."

Labcorp’s strong execution against its strategy to improve health care progressed as the company continued its important work to help fight the pandemic. In oncology, Labcorp remained committed to its life-saving work and expanded testing, treatment and clinical trial access for people with cancer. The company intensified its customer focus and made key strides in women’s health, including the acquisition of Ovia Health, a trusted digital health platform providing family planning, pregnancy and parenting support. Additionally, Labcorp maintained its COVID-19 response by addressing testing needs and assisting in the development of vaccines and therapies.

Consolidated Results

Third Quarter Results

Revenue for the quarter was $4.06 billion, an increase of 4.3% over $3.90 billion in the third quarter of 2020. The increase was primarily due to organic growth of 3.4%, acquisitions of 0.4%, and foreign currency translation of 0.5%. The 3.4% increase in organic revenue is driven by a 10.2% increase in the company’s organic Base Business, partially offset by a (6.8%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing). Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $766.9 million, or 18.9% of revenue, compared to $1,047.1 million, or 26.9%, in the third quarter of 2020. The company recorded amortization, restructuring charges, and special items, which together totaled $140.2 million in the quarter, compared to $108.7 million during the same period in 2020. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $907.1 million, or 22.3% of revenue, compared to $1,155.8 million, or 29.7%, in the third quarter of 2020. The decrease in operating income and margin was primarily due to a reduction in COVID-19 Testing and higher personnel costs, partially offset by organic Base Business growth and LaunchPad savings.

Net earnings for the quarter were $587.3 million compared to $703.4 million in the third quarter of 2020. Diluted EPS were $6.05 in the quarter compared to $7.17 during the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $6.82 in the quarter compared to $8.41 in the third quarter of 2020.

Operating cash flow for the quarter was $767.3 million compared to $786.2 million in the third quarter of 2020. The decrease in operating cash flow was due to lower cash earnings, partially offset by favorable working capital. Capital expenditures totaled $117.8 million compared to $77.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $649.5 million compared to $709.0 million in the third quarter of 2020.

At the end of the quarter, the company’s cash balance and total debt were $2.0 billion and $5.4 billion, respectively. During the quarter, the company invested $291.9 million on acquisitions and repurchased $300.0 million of stock representing approximately 1.1 million shares.

Year-To-Date Results

Revenue was $12.06 billion, an increase of 27.1% from $9.49 billion, in the first nine months of 2020. The increase was due to organic growth of 25.2%, acquisitions of 0.8%, and favorable foreign currency translation of 1.2%. The organic revenue increase includes a 18.2% contribution from the company’s organic Base Business and a 7.0% increase in COVID-19 Testing.

Operating income was $2,528.9 million, or 21.0% of revenue, compared to $1,152.2 million, or 12.1%, in the first nine months of 2020. The company recorded amortization, restructuring charges, special items, and impairments, which together totaled $400.0 million in the first nine months of 2021 compared to $750.2 million during the same period in 2020. This decrease was primarily due to the goodwill impairment recorded in the first quarter of 2020. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) was $2,928.9 million, or 24.3% of revenue, compared to $1,902.4 million, or 20.0%, in the first nine months of 2020. The increase in operating income and margin was primarily due to a recovery in the Base Business and higher COVID-19 Testing, partially offset by higher personnel costs.

Net earnings were $1,824.3 million compared to $617.8 million in the first nine months of 2020. Diluted EPS were $18.63 in the first nine months of 2021 compared to $6.31 during the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $21.75 in the first nine months of 2021 compared to $13.36 during the same period in 2020.

Operating cash flow was $2,412.1 million compared to $1,360.7 million in the first nine months of 2020. The increase in operating cash flow was due to higher cash earnings and favorable working capital. Capital expenditures totaled $310.4 million compared to $282.3 million during the same period in 2020. As a result, free cash flow (operating cash flow less capital expenditures) was $2,101.7 million compared to $1,078.4 million in the first nine months of 2020.

Third Quarter Segment Results

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

Diagnostics

Revenue for the quarter was $2.62 billion, a decrease of (3.2%) from $2.70 billion in the third quarter of 2020. The decrease was due to organic revenue of (3.9%), partially offset by acquisitions of 0.4% and favorable foreign currency translation of 0.3%. The decrease in organic revenue was due to a (9.7%) reduction from COVID-19 Testing, partially offset by a 5.8% increase in the Base Business.

Total volume (measured by requisitions) increased by 0.2% as acquisition volume contributed 0.2% and organic volume decreased by (0.1%). Organic volume was impacted by a (5.9%) decrease in COVID-19 Testing, partially offset by a 5.9% increase in Base Business. Price/mix decreased by (3.4%) due to COVID-19 Testing of (3.8%), partially offset by currency of 0.3%, and acquisitions of 0.2%. Organic Base Business volume was up 7.7% compared to last year, while price/mix was up 1.3%.

Adjusted operating income for the quarter was $774.9 million, or 29.6% of revenue, compared to $1,003.9 million, or 37.1%, in the third quarter of 2020. The decrease in adjusted operating income and adjusted operating margin was primarily due to a reduction in COVID-19 Testing and higher personnel costs, partially offset by organic Base Business growth and LaunchPad savings. The company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Drug Development

Revenue for the quarter was $1.46 billion, an increase of 17.5% over $1.24 billion in the third quarter of 2020. The increase was due to organic Base Business growth of 19.9%, acquisitions of 0.4%, and favorable foreign currency translation of 1.0%, partially offset by lower COVID-19 Testing performed through its Central Laboratories business of (3.5%) and divestitures of (0.3%). Drug Development’s Base Business benefited from broad-based growth, including COVID-19 vaccine and therapeutic work.

Adjusted operating income for the quarter was $226.1 million, or 15.5% of revenue, compared to $209.7 million, or 16.9%, in the third quarter of 2020. Adjusted operating income grew primarily due to organic Base Business growth and LaunchPad savings, partially offset by lower COVID-19 Testing and higher personnel costs. The decline in adjusted operating margin was due to the mix impact of lower COVID-19 Testing. For comparability to peers, Drug Development excludes expense related to the Enterprise component of its bonus, which is included in unallocated corporate expense.

Net orders and net book-to-bill during the trailing twelve months were $7.77 billion and 1.34, respectively. Backlog at the end of the quarter was $14.39 billion, an increase of 15.4% compared to last year. The company expects approximately $4.93 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2021

Labcorp is raising 2021 full year guidance to reflect its strong third-quarter performance and improved full-year outlook. The following guidance assumes foreign exchange rates effective as of September 30, 2021, for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions and share repurchases.

(1) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.9%, Previous 2021 Guidance was 1.0%

(2) Enterprise level revenue is presented net of intersegment transaction eliminations, including Drug Development COVID-19 Testing revenue

(3) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.4%, Previous 2021 Guidance was 0.4%

(4) 2021 Updated Guidance includes a benefit from foreign currency translation of 1.7%, Previous 2021 Guidance was 2.0%

(5) Free Cash Flow consists of operating cash flow less capital expenditures

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 877-898-8036 (720-634-2811 for international callers). The conference ID is 4893731. A telephone replay of the call will be available through November 11, 2021, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The conference ID for the replay is 4893731. A live online broadcast of Labcorp’s quarterly conference call on October 28, 2021, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through October 14, 2022.

Jounce Therapeutics to Report Third Quarter 2021 Financial Results and Host Conference Call on Thursday, November 4, 2021

On October 28, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report third quarter 2021 financial results and provide a corporate update before market open on Thursday, November 4, 2021 (Press release, Jounce Therapeutics, OCT 28, 2021, View Source [SID1234592079]). Jounce Therapeutics’ management team will host a live conference call and webcast at 8:00 a.m. E.T.

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Conference Call and Webcast
To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 6873343. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

CytomX Therapeutics to Announce Third Quarter 2021 Financial Results on November 4, 2021

On October 28, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated therapeutics based on its Probody technology platform, reported that it will report third quarter 2021 financial results on Thursday, November 4, 2021, after the close of U.S. markets (Press release, CytomX Therapeutics, OCT 28, 2021, View Source [SID1234592078]). 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 until November 11, 2021.

Q3 Report and presentation

On October 28, 2021 ArcticZymes Technologies (OSE: AZT) reported sales of NOK 25.6 million (19.5) and an EBITDA of NOK 9.0 million (7.1) for the third quarter of 2021 (Press release, Biotec Pharmacon, OCT 28, 2021, View Source [SID1234592076]).

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Highlights from Q3 2021

ArcticZymes Technologies (AZT) had Q3 sales of NOK 25.6 million – an increase of 31% (Q3 2020: NOK 19.5 million)
Coronavirus-related sales are estimated at NOK 2.9 million (Q3 2020: NOK 4.0 million)
Gross profit increased to NOK 24.1 million because of increased sales (Q3 2020: NOK 19.4 million)
AZT generated a positive EBITDA of NOK 9.0 million (Q3 2020: NOK 7.1 million)
Cash-flow for Q3 was positive NOK 9.9 million (Q3 2020: NOK 13.6 million) giving a cash balance of NOK 186.9 million (Q3 2020: NOK 69.7 million)
Four new advanced prototype enzymes were released for customer evaluation
Commercial activities return to normal following the pandemic
CEO Jethro Holter comments:

"ArcticZymes Technologies commercial activities have mostly returning back to normal with customer re-engagement towards pre-pandemic activities. This is reflected in Q3 sales where ArcticZymes Technologies has experienced its second-best quarter for the non-coronavirus-related business achieving NOK 22.7 million. Furthermore, the Company accomplished its highest quarterly performance for sales to the Therapeutics (Biomanufacturing) segment achieving NOK 12.6 million.

AZT continues to uphold its earlier guidance with an annual sales revenue goal of NOK 120 million for 2021."