On November 2, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported that the Company’s third quarter 2021 financial results will be released on Tuesday, November 9, 2021 (Press release, Calithera Biosciences, NOV 2, 2021, View Source [SID1234594122]). Company management will host a conference call on Tuesday, November 9, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 3797324. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

On November 2, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the third quarter ended October 3, 2021 (Press release, PerkinElmer, NOV 2, 2021, View Source [SID1234594121]).

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The Company reported GAAP earnings per share from continuing operations of $1.11, as compared to GAAP earnings per share from continuing operations of $1.57 in the third quarter of 2020. GAAP revenue for the quarter was $1.17 billion, as compared to $964 million in the third quarter of 2020. GAAP operating income from continuing operations for the quarter was $222 million, as compared to $248 million for the same period a year ago. GAAP operating profit margin was 19.0% as a percentage of revenue, as compared to 25.7% in the third quarter of 2020.

Adjusted earnings per share from continuing operations for the quarter was $2.31, as compared to $2.09 in the third quarter of 2020. Adjusted revenue for the quarter was $1.17 billion, as compared to $964 million in the third quarter of 2020. Adjusted operating income from continuing operations for the quarter was $359 million, as compared to $304 million for the same period a year ago. Adjusted operating profit margin was 30.8% as a percentage of adjusted revenue, as compared to 31.6% in the third quarter of 2020.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"I am proud of the team’s tireless efforts to proactively respond to and execute for our customers around the world, driving double digit core growth in all major regions during the third quarter," said Prahlad Singh, president and chief executive officer of PerkinElmer. "Just as importantly, we are embracing new opportunities as we welcome the latest additions to the PerkinElmer family and develop innovative solutions to push the boundaries of what’s possible."

Financial Overview by Reporting Segment for the Third Quarter

Discovery & Analytical Solutions

Third quarter 2021 revenue was $513 million, as compared to $424 million for the third quarter of 2020. Reported revenue increased 21% and organic revenue increased 10% as compared to the third quarter of 2020.
Third quarter 2021 operating income from continuing operations was $7 million, as compared to $43 million for the third quarter of 2020.
Third quarter 2021 adjusted operating income was $95 million, as compared to $62 million for the third quarter of 2020.
Diagnostics

Third quarter 2021 revenue was $654 million, as compared to $540 million for the third quarter of 2020. Reported revenue increased 21% and organic revenue increased 13% as compared to the third quarter of 2020.
Third quarter 2021 operating income from continuing operations was $238 million, as compared to $224 million for the third quarter of 2020.
Third quarter 2021 adjusted operating income was $287 million, as compared to $260 million for the third quarter of 2020.
Initiates Fourth Quarter Guidance and Raises Full Year 2021 Guidance

For the fourth quarter of 2021, the Company forecasts adjusted revenue of approximately $1.2 billion and adjusted earnings per share of $2.05.

For the full year 2021, the Company now forecasts adjusted revenue of $4.9 billion and adjusted earnings per share of $10.81.

Guidance for the fourth quarter and full year is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measures without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items the Company excludes from these non-GAAP measures. The timing and amounts of such events and items could be material to the Company’s results prepared in accordance with GAAP.

Conference Call and Webcast Information

The Company will discuss its third quarter 2021 results and its outlook for business trends during a conference call on November 2, 2021 at 5:00 p.m. Eastern Time. A live audio webcast of the call will be available on the Investors section of the Company’s website, www.perkinelmer.com.

On November 2, 2021 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended September 30, 2021 (Press release, MacroGenics, NOV 2, 2021, View Source [SID1234594120]).

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"In September, we were pleased to present encouraging preliminary results from our ongoing Phase 1 cohort expansion study of MGC018 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting. We look forward to providing additional clinical data updates on this study next year as well as sharing our future development plans for this molecule in the first quarter of next year, after continued engagement with Key Opinion Leaders and regulatory agencies," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Beyond MGC018, we continue to advance our growing pipeline of investigational product candidates for the potential treatment of cancer. Finally, the recent FDA approval to manufacture MARGENZA drug substance at our GMP manufacturing facility is an important achievement for the Company."

Updates on Proprietary Programs

The recent progress and key events related to MacroGenics’ investigational product candidates in clinical development and its approved product, MARGENZA, are highlighted below:

MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. At ESMO (Free ESMO Whitepaper), MacroGenics presented encouraging preliminary clinical results from the ongoing Phase 1 study of MGC018 in patients with solid tumors. The Phase 1 study cohort expansions are ongoing for metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of the head and neck (SCCHN) and triple negative breast cancer (TNBC). The Company expects to present additional data from the ongoing Phase 1 study of MGC018 in the first half of next year. In addition, MacroGenics intends to provide details regarding further development plans in mCRPC in the first quarter of 2022. The Company also intends to initiate a study combining MGC018 with one of its proprietary checkpoint inhibitor molecules in the first half of next year.

Enoblituzumab is an Fc‐engineered, monoclonal antibody that targets B7‐H3. MacroGenics continues to recruit patients into its Phase 2 study of enoblituzumab in a chemotherapy-free regimen in combination with retifanlimab in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative. In September, I-Mab Biopharma announced that an IND to initiate a Phase 2 trial of enoblituzumab in combination with pembrolizumab in patients with select solid tumors was accepted in China, triggering a net $4.5 million milestone payment to MacroGenics. I-Mab has development and commercial rights to enoblituzumab in Greater China.

Bispecific CD123 × CD3 DART molecules:

Flotetuzumab is a bispecific CD123 × CD3 DART molecule being evaluated in patients with refractory acute myeloid leukemia (AML). MacroGenics is conducting a single-arm clinical study to evaluate flotetuzumab in up to 200 patients with refractory AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the composite primary endpoint. The Company anticipates providing further updates on the clinical development of flotetuzumab in 2022.

MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and has an Fc domain to permit intermittent dosing through a longer half-life. MacroGenics submitted an IND application for MGD024 to the FDA in October. The Company intends to present preclinical MGD024 data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.

Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. MacroGenics is evaluating the molecule in patients as monotherapy as well as in combination with other agents. The Company’s partner for this molecule in Greater China, Zai Lab, expanded its Phase 1b/2 study of tebotelimab in combination with the PARP inhibitor niraparib into new indications, including gastric cancer, TNBC and biliary tract cancer. In addition, Zai Lab enrolled the first patient in an endometrial cancer cohort in October 2021.

MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. The Company is conducting a Phase 1 dose expansion study in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), checkpoint-naïve NSCLC, mCRPC and melanoma. The Company anticipates sharing data from its ongoing Phase 1 dose expansion study next year.

IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in multiple solid tumors and has indicated they anticipate disclosing initial data in 2022.

Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells.

MARGENZA Commercial Launch. In March 2021, MacroGenics and its commercial partner, EVERSANA, launched MARGENZA for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. As previously reported, the median overall survival (OS) in the intent-to-treat population was not statistically different between the two arms. A prespecified, non-alpha allocating, exploratory analysis of OS by CD16A genotype in the SOPHIA trial showed a numerical OS advantage in favor of margetuximab in F homozygous patients and a numerical OS advantage in favor of trastuzumab in V homozygous patients. Finally, MacroGenics recently received U.S. FDA approval to manufacture MARGENZA drug substance at its GMP manufacturing facility in Rockville, MD.

MAHOGANY Study. At ESMO (Free ESMO Whitepaper), MacroGenics presented results from Cohort A Part 1 of the Phase 2/3 MAHOGANY study of margetuximab in combination with retifanlimab, an anti-PD-1 molecule the Company licensed to Incyte Corporation, in patients with advanced gastric and gastroesophageal junction cancer. Although the number of confirmed responses by independent review (twenty one of 40 (53%) patients) exceeded the prespecified futility boundary for this chemotherapy-free regimen, MacroGenics has decided to discontinue enrollment of Cohort A based on a number of factors, including the prioritization of its other product candidates given the competition in this indication, and the accelerated approval of combination therapy with pembrolizumab. MacroGenics’ partner for margetuximab in Greater China, Zai Lab, continues to enroll patients in Cohort B.

Zai Lab’s Bridging Study. In October 2021, Zai Lab announced that the bridging study of margetuximab plus chemotherapy in advanced, previously treated HER2-positive breast cancer met its primary endpoint with acceptable safety and tolerability. The study showed that efficacy of the combination in Chinese patients was consistent with that seen in the global population in MacroGenics’ SOPHIA Phase 3 trial. Zai Lab has indicated that it anticipates submitting a BLA in China for pretreated metastatic HER2-positive breast cancer by approximately year-end 2021.
Updates on Partnered Program

Retifanlimab is an investigational anti-PD-1 antibody that MacroGenics licensed to Incyte. Incyte will present clinical results in poster presentations from both a Phase 2 study of retifanlimab in patients with advanced or metastatic Merkel cell carcinoma and a tumor specific expansion cohort study in patients with recurrent MSI-H or deficient mismatch repair (dMMR) recurrent endometrial cancer at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (or SITC (Free SITC Whitepaper)) Virtual Meeting taking place November 10 – 14, 2021.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2021, were $298.9 million, compared to $272.5 million as of December 31, 2020.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $15.7 million for the quarter ended September 30, 2021, compared to total revenue of $18.3 million for the quarter ended September 30, 2020. Revenue for the quarter ended September 30, 2021 included $3.6 million net sales of MARGENZA.
R&D Expenses: Research and development expenses were $49.8 million for the quarter ended September 30, 2021, compared to $44.7 million for the quarter ended September 30, 2020. The increase was primarily related to increased clinical trial and development costs related to the Company’s product candidates, as well as research costs related to preclinical molecules, partially offset by decreased clinical costs and BLA support for margetuximab and decreased development and manufacturing costs related to flotetuzumab.
SG&A Expenses: Selling, general and administrative expenses were $17.2 million for the quarter ended September 30, 2021, compared to $9.7 million for the quarter ended September 30, 2020. The increase was primarily related to MARGENZA launch, as well as labor-related costs and legal expenses.
Net Loss: Net loss was $52.9 million for the quarter ended September 30, 2021, compared to net loss of $36.0 million for the quarter ended September 30, 2020.
Shares Outstanding: Shares outstanding as of September 30, 2021 were 61,254,693.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of September 30, 2021, plus anticipated and potential collaboration payments, should enable it to fund its operations through 2023, assuming the Company’s programs and collaborations advance as currently contemplated.
Conference Call Information

MacroGenics will host a conference call today at 4:30 p.m. (ET) to discuss financial results for the quarter ended September 30, 2021 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 6063045.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On November 2, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended September 30, 2021 (Press release, Bio-Techne, NOV 2, 2021, View Source [SID1234594113]). The quarterly dividend will be payable November 26, 2021 to all common shareholders of record on November 12, 2021. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

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Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $931 million in net sales in fiscal 2021 and has over 2,600 employees worldwide. For more information on Bio-Techne and its brands, please visit www.bio-techne.com.

On November 2, 2021 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2021 (Press release, Integra LifeSciences, NOV 2, 2021, View Source [SID1234594111]).

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"Strength across most of our product portfolio, driven by commercial and operational execution and a contribution from our recently launched CereLink ICP monitor, led to third quarter results near the high end of our guidance range, despite ongoing COVID and supply challenges," said Peter Arduini, Integra’s president and chief executive officer. "Last week we announced Jan De Witte as the next president and CEO of Integra. It has been an honor to serve the many talented Integra colleagues who are so dedicated to fulfilling our mission of improving patients’ lives around the world every day. I am confident that under the leadership of Jan and the strong management team in place, Integra is well-positioned for continued growth and success in the coming years."

Third Quarter 2021 Consolidated Performance

Total reported revenues of $386.9 million increased 4.5% on a reported basis and 6.7% on an organic basis compared to the prior year. Total reported revenues include $16.8 million from the acquisition of ACell, which was completed on January 20, 2021.

The Company reported GAAP gross margin of 62.7%, compared to 63.6% in the third quarter of 2020. Adjusted gross margin was 68.3%, compared to 68.6% in the prior year.

Adjusted EBITDA for the third quarter of 2021 was $104.3 million, or 27.0% of revenue, compared to $103.2 million, or 27.9% of revenue, in the prior year. Adjusted EBITDA benefited from higher revenue, partially offset by higher operating expenses attributable to the gradual return of spending, which was below normal levels in the prior year in response to the global pandemic.

The Company reported GAAP net income of $43.2 million, or $0.51 per diluted share, in the third quarter of 2021, compared to a GAAP net income of $32.3 million, or $0.38 per diluted share, in the prior year.

Adjusted net income for the third quarter of 2021 was $73.1 million, or $0.86 per diluted share, compared to $67.7 million, or $0.80 per diluted share, in the prior year.

Third Quarter 2021 Segment Performance

Codman Specialty Surgical (66% of Revenues)
Total revenues were $256.5 million, representing reported growth of 7.2% and organic growth of 8.0% compared to the third quarter of 2020. Sales in Instruments benefited from a strong recovery in order demand, while the strength in Neurosurgery was broad-based and included sales of our recently launched CereLink ICP Monitor System.
Tissue Technologies (34% of Revenue)
Total revenues were $130.4 million, representing a decrease on a reported basis of (0.4)% and organic growth of 3.7% compared to the third quarter of 2020. Growth in Wound Reconstruction and Care was led by sales in our Integra Dermal Matrices and SurgiMend, and sales in Private Label benefited from continuing recovery in customer orders.
Strategic Initiatives and Key Developments

CEO transition update
On October 28, 2021, the Company’s board of directors announced Jan De Witte as its next president and chief executive officer. Mr. De Witte succeeds Peter Arduini, who previously announced he will step down as chief executive officer to accept the role of president and chief executive officer of GE Healthcare. Mr. De Witte will join Integra prior to the end of the year, at which time he will also be appointed to Integra’s board of directors.
Advancing key products
CereLink, the Company’s next generation intracranial pressure monitor, was launched in the third quarter in both the U.S. and Europe.
Aurora Surgiscope, which is a novel and proprietary minimally invasive surgical solution with integrated visualization and capabilities designed specifically for use in neurosurgery, was released in a phased, limited clinical launch in the third quarter of 2021. During the fourth quarter, the Company expects to further expand its phased launch to generate clinical evidence and gain insights for a broader commercial launch expected in the second half of 2022. We also continued to expand the MIRROR registry to collect data on the use of Aurora for early surgical intervention in the treatment of intracerebral hemorrhage (ICH).

NeuraGen 3D, the Company’s new peripheral nerve repair product, was on display at the recent American Society for Surgery of the Hand meeting. This innovative product is a nerve guide matrix designed to optimize the environment for nerve regeneration and may allow for more complete functional recovery. The Company partnered with leading hand surgeons to provide training and professional education to attendees in anticipation of its planned product launch in early 2022.
The Company submitted a PMA for SurgiMend for a breast reconstruction indication that was the subject of an FDA Advisory Committee meeting on October 20, 2021. At this meeting we gained valuable insights to further inform our submission and we look forward to working with the FDA in the coming months as it completes its review of our PMA.
Balance Sheet, Cash Flow and Capital Allocation

The Company generated cash flow from operations of $82.8 million in the quarter. Net debt at the end of the quarter was $1.1 billion, and the consolidated total leverage ratio was 2.3x.

As of quarter end, the Company had total liquidity of approximately $1.75 billion, including approximately $470 million in cash and the remainder available under the revolving credit facility.

2021 Outlook

The Company is providing forward-looking guidance regarding adjusted earnings per diluted share, but is not providing a reconciliation to GAAP earnings per share, because certain GAAP expense items are highly variable and management is unable to predict them with reasonable certainty and without unreasonable effort. Specifically, the financial impact and timing of divestitures, acquisitions, integrations, structural optimization and efforts to comply with the EU Medical Device Regulation are uncertain, depend on various dynamic factors and are not reasonably ascertainable at this time. These expense items could have a material impact on GAAP results. Adjusted earnings per diluted share also excludes the impact of intangible asset amortization associated with prior business acquisitions, which we expect to be approximately $0.74 per diluted share for the full-year 2021.

In addition, the Company will continue to monitor the ongoing uncertainty around the scope and duration of the pandemic and its impact on financial performance. The Company does not expect the ongoing impact of the pandemic to be uniform across all markets and product lines.

Full-Year 2021 Outlook

Taking into account year-to-date revenue performance, the risk of ongoing effects of the pandemic and unfavorable changes in foreign currency rates, the Company is reaffirming its previous full-year 2021 revenue guidance of $1,540 million to $1,550 million, with an expectation to be at the low end of the range. The Company is increasing its full-year 2021 adjusted earnings per share guidance range from $2.98 to $3.05 to a new range of $3.16 to $3.20.

Fourth Quarter Outlook

Based on our expectations for the full year, we are targeting fourth quarter revenue of $403 million, representing reported growth of approximately 3.5% and organic growth of approximately 6.5%. Adjusted earnings per diluted share are expected to be in a range of $0.82 to $0.86.

In the future, the Company may record, or expects to record, gains or losses, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET today, Tuesday, November 2, 2021, to discuss financial results for the third quarter. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the prepared remarks.

Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.

Access to the live call is available by dialing (888) 394-8218 and using the passcode 7732018. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available until November 12, 2021 by dialing (888) 203-1112 and using the passcode 7732018. The webcast will also be archived on the website.