On August 5, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the second quarter ended June 30, 2021 (Press release, Puma Biotechnology, AUG 5, 2021, View Source [SID1234585882]). Unless otherwise stated, all comparisons are for the second quarter of 2021 compared to the second quarter of 2020.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the second quarter of 2021 was $48.9 million, compared to $48.8 million in the second quarter of 2020. Net NERLYNX revenue in the first six months of 2021 was $94.7 million, compared to $97.4 million in the first six months of 2020.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $5.1 million, or $0.13 per share, for the second quarter of 2021, compared to net income of $3.4 million, or $0.09 per basic share and $0.08 per diluted share, for the second quarter of 2020. Net income for the first six months of 2021 was $11.3 million, or $0.28 per share, compared to a net loss of $13.5 million, or $0.34 per share, for the first six months of 2020.

Non-GAAP adjusted net income was $13.1 million, or $0.32 per share, for the second quarter of 2021, compared to non-GAAP adjusted net income of $14.0 million, or $0.36 per basic share and $0.35 per diluted share, for the second quarter of 2020. Non-GAAP adjusted net income for the first six months of 2021 was $35.4 million, or $0.88 per basic share and $0.87 per diluted share, compared to non-GAAP adjusted net income of $6.0 million, or $0.15 per share, for the first six months of 2020. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income and GAAP net income (loss) per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the second quarter of 2021 was $0.1 million, compared to net cash provided by operating activities of $16.2 million in the second quarter of 2020. Net cash provided by operating activities for the first six months of 2021 was $15.6 million, compared to net cash provided by operating activities of $4.7 million for the first six months of 2020. At June 30, 2021, Puma had cash, cash equivalents and marketable securities of $108.9 million, compared to $93.4 million at December 31, 2020.

"We were pleased to achieve sequential growth in NERLYNX sales in the second quarter of 2021. Importantly, this marks the first quarter that we have shown sequential unit growth since 2019," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We also recently received an important label expansion, which adds dose escalation of NERLYNX for HER2-positive early stage and metastatic breast cancer patients. Utilization of this recommended dosage schedule has shown improved overall tolerability of NERLYNX, thereby enabling patients and physicians to optimize treatment and reduce therapy-related tolerability issues. We look forward to increasing awareness of this within the breast cancer community."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting top line data from the randomized cohort of the Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer that has a HER2 mutation (Q4 2021); (ii) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2-mutated hormone receptor positive breast cancer

(Q4 2021); (iii) reporting data from the Phase II TBCRC-022 trial of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2-2021/H1 2022); (iv) reporting Phase II data from the SUMMIT trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H1-2022); (v) conducting a meeting with the FDA to discuss the potential for an accelerated approval pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have previously been treated with an EGFR tyrosine kinase inhibitor (2022); (vi) reporting Phase II data from the SUMMIT trial of neratinib in cervical cancer patients with HER2 mutations (H1-2022); and (vii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries (2021)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, license revenue and royalty revenue. For the second quarter of 2021, total revenue was $53.4 million, of which $48.9 million was net product revenue, $0.2 million was license revenue received from Puma’s sub-licensees and $4.3 million was royalty revenue. This compares to total revenue of $70.6 million in the second quarter of 2020, of which $48.8 million was net product revenue, $20.7 million was license revenue received from Puma’s sub-licensees and $1.1 million was royalty revenue. For the first six months of 2021, total revenue was $151.6 million, of which $94.7 million was net product revenue, $50.3 million was license revenue received from Puma’s sub-licensees, which included a $50 million upfront payment for providing development, manufacturing and commercial rights to NERLYNX in Greater China to Pierre Fabre, and $6.6 million was royalty revenue. This compares to total revenue for the first six months of 2020 of $121.8 million, of which $97.4 million was net product revenue, $22.7 million was license revenue received from Puma’s sub-licensees, and $1.7 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $70.0 million for the second quarter of 2021, compared to $63.5 million for the second quarter of 2020. Operating costs and expenses for the first six months of 2021 were $148.1 million, compared to $128.9 million for the first six months of 2020.

Cost of Sales

Cost of sales was $12.0 million for the second quarter of 2021, compared to $9.4 million for the second quarter of 2020. Cost of sales was $41.5 million for the first six months of 2021, of which $20.0 million was for a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China, compared to cost of sales of $18.5 million for the first six months of 2020.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $39.4 million for the second quarter of 2021, compared to $29.4 million for the second quarter of 2020. SG&A expenses for the first six months of 2021 were $67.7 million, compared to $60.3 million for the first six months of 2020.

The $7.4 million year-over-year increase for the first six months resulted primarily from an increase in stock-based compensation of approximately $10.9 million, partially offset by decreases in payroll and related costs of approximately $0.8 million, professional fees and expenses of approximately $0.6 million, travel and meetings costs of approximately $0.9 million, and other expenses of approximately $1.2 million.

The $10.9 million increase in stock-based compensation expense consisted of a $13.6 million incremental expense resulting from a modification to the term of Mr. Auerbach’s warrant and an increase of $2.6 million from new grants, partially offset by decreases of approximately $4.2 million for stock awards that have fully vested and $1.1 million from stock awards forfeited.

Research and Development Expenses

Research and development (R&D) expenses were $18.6 million for the second quarter of 2021, compared to $24.7 million for the second quarter of 2020. R&D expenses for the first six months of 2021 were $38.9 million, compared to $50.1 million for the first six months of 2020.

The $11.2 million year-over-year decrease for the first six months resulted primarily from decreases in stock-based compensation expense of approximately $6.3 million, clinical trial expenses of approximately $2.8 million, internal R&D expenses of approximately $1.6 million and consultant and contractors’ costs of approximately $0.5 million.

Total Other Income (Expenses)

Total other income was $11.5 million for the second quarter of 2021 compared to $3.7 million of total other expenses for the second quarter of 2020. Total other income was $7.9 million for the first six months of 2021 compared to total other expenses of $6.4 million for the first six months of 2020. The $14.3 million year-over-year increase for the first six months resulted primarily from a net reduction in accrued legal verdict expense of approximately $14.9 million, partially offset by a decrease in interest income of approximately $0.4 million and other immaterial fluctuations.

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2021 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 5, 2021. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On August 5, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2021 and provided a business update (Press release, Regeneron, AUG 5, 2021, View Source [SID1234585898]).

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"Regeneron had outstanding performance in the second quarter during which we delivered to the U.S. government the entire order for our COVID-19 antibody cocktail and recognized record global sales from our EYLEA and Dupixent franchises," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We continue to advance Dupixent’s potential to help new patient groups, with recent positive Phase 3 data in chronic spontaneous urticaria and additional late-stage read-outs expected later this year in prurigo nodularis, eosinophilic esophagitis, and pediatric atopic dermatitis. With today’s positive Phase 3 results in combination with chemotherapy in non-small cell lung cancer, Libtayo yet again demonstrates its potential to be a leading checkpoint inhibitor. We also progressed our genetics medicines platform, with landmark clinical data alongside our collaborator Intellia using a CRISPR therapeutic and the discovery of a promising new obesity target from the Regeneron Genetics Center."

"Regeneron performed exceptionally well in the second quarter with the core business on a strong growth trajectory as we invest in our diverse and differentiated pipeline for long-term and sustainable growth," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.

Business Highlights

Key Pipeline Progress

Regeneron has approximately 30 product candidates in clinical development, including six marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

EYLEA (aflibercept) Injection

Enrollment in the Phase 3 studies for high-dose formulation in diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD) was completed.
Enrollment in the Phase 3 study for retinopathy of prematurity (ROP) was also completed.
Dupixent (dupilumab)

The Company and Sanofi announced a Phase 3 trial in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks. The trial showed that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naive patients, compared to antihistamines alone in the first of two trials of this clinical program.
In June 2021, the U.S. Food and Drug Administration (FDA) approved a 200 mg single-dose pre-filled pen for Dupixent.
REGEN-COVTM (casirivimab and imdevimab)(2), a dual antibody cocktail to SARS-CoV-2 virus

In the second quarter of 2021, the Company fulfilled its second agreement with the U.S. government to manufacture and deliver 1.25 million doses of REGEN-COV at the lowest treatment dose authorized by the FDA, and recognized $2.59 billion of REGEN-COV sales.
In June 2021, the FDA updated the REGEN-COV EUA by lowering the dose to 1,200 mg and permitting administration by subcutaneous injection when intravenous infusion is not feasible.
In July 2021, based on positive Phase 3 data announced in April 2021 which were recently published in the New England Journal of Medicine, the FDA also expanded the EUA to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and who have been exposed to a SARS-CoV-2 infected individual or are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons). For people who are not expected to mount an adequate immune response to vaccination, REGEN-COV can also now be administered monthly for the duration of ongoing exposure to SARS-CoV-2.
In July 2021, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved the casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19, making Japan the first country to grant a full approval for the antibody cocktail.
Positive results were announced from the Phase 3 UK-based RECOVERY trial in hospitalized COVID-19 patients, demonstrating that adding REGEN-COV to usual care reduced the risk of death by 20% in seronegative patients (patients who had not mounted a natural antibody response on their own against SARS-CoV-2), compared to seronegative patients receiving usual care alone. The Company has requested that the EUA be further expanded to include appropriate hospitalized patients.
Libtayo (cemiplimab)

In June 2021, the European Commission (EC) approved Libtayo for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).
In June 2021, the EC also approved Libtayo for the treatment of metastatic or locally advanced basal cell carcinoma (BCC).
In August 2021, the Company and Sanofi announced that the Phase 3 trial of Libtayo in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival primary endpoint in patients with advanced NSCLC. These data are planned to form the basis of regulatory submissions in the United States and European Union (EU).
Odronextamab, a CD20xCD3 bispecific antibody

The Company is resuming enrollment of patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), following amendment of trial protocols and the FDA’s lifting of the partial clinical hold, in its monotherapy trials of odronextamab.
Fianlimab, an antibody to LAG-3

Positive data from the Phase 1 trial in combination with Libtayo in advanced melanoma were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting; the Company intends to initiate a Phase 3 study in 2022.
REGN1908-1909, a multi-antibody therapy to Fel d 1

The Company initiated a Phase 3 study in cat allergic asthmatics.
Genetics Medicines

Intellia Therapeutics, Inc. and the Company announced positive interim data from the Phase 1 study of NTLA-2001, a CRISPR/Cas9 therapeutic for TTR gene knockout in people living with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). These are the first-ever clinical data supporting safety and efficacy of in vivo CRISPR genome editing in humans and provide proof of concept for the ongoing multi-target collaboration between the companies.
The Regeneron Genetics Center published their discovery of GPR75 gene mutations that protect against obesity. This target is the focus of a small molecule collaboration agreement with AstraZeneca announced in July 2021, under which the companies will equally share research and development costs and any potential future profits.
Corporate Updates

The Company intends to invest approximately $1.8 billion over six years to expand its research, preclinical manufacturing, and support facilities at the Company’s Tarrytown, New York campus.

Second Quarter 2021 Financial Results

Revenues

Total revenues increased by 163% to $5.139 billion in the second quarter of 2021, compared to $1.952 billion in the second quarter of 2020. Total revenues excluding (i) REGEN-COV (casirivimab and imdevimab) net product sales in the United States and (ii) the Company’s share of gross profits in connection with Roche’s sales of casirivimab and imdevimab outside the United States, increased by 22% to $2.379 billion in the second quarter of 2021, compared to the second quarter of 2020(1).

Net product sales of EYLEA in the United States increased in the second quarter of 2021, compared to the second quarter of 2020, primarily due to higher sales volume as well as a favorable comparison given the adverse impact of the COVID-19 pandemic on U.S. EYLEA demand during the second quarter of 2020.

The Company fulfilled its second agreement with the U.S. government and delivered 1.25 million doses of REGEN-COV. Other than $34 million of expected REGEN-COV net product sales in the third quarter of 2021 related to this agreement, the Company does not anticipate recording any additional net product sales of REGEN-COV in the United States during the third quarter of 2021. U.S. net product sales of REGEN-COV in the fourth quarter of 2021 will be dependent upon acceleration of COVID-19 cases and related drug utilization.

Total revenues also include collaboration revenues(3) of $955 million in the second quarter of 2021, compared to $513 million in the second quarter of 2020. Sanofi collaboration revenue increased primarily due to the Company’s share of profits from commercialization of antibodies, which were $328 million in the second quarter of 2021, compared to $172 million in the second quarter of 2020. The change in the Company’s share of profits from commercialization of antibodies was driven by higher Dupixent profits. In the second quarter of 2021, the Company also recorded Roche collaboration revenue of $168 million in connection with the Company’s share of gross profits from Roche’s sales of the casirivimab and imdevimab antibody cocktail outside the United States.

Refer to Table 4 for a summary of collaboration revenue.

Other revenue decreased in the second quarter of 2021, compared to the second quarter of 2020, primarily due to lower amounts recognized in connection with the Company’s agreements with the Biomedical Advanced Research Development Authority (BARDA) related to funding of certain development activities for antibodies for the treatment of COVID-19.

GAAP R&D expenses in the second quarter of 2020 included $85 million in up-front payments in connection with the collaboration agreement with Intellia. The decrease in GAAP R&D expenses in the second quarter of 2021 was offset primarily by higher costs incurred in connection with development activities related to REGEN-COV, which also drove the increase in non-GAAP R&D expenses.
The increase in GAAP and non-GAAP SG&A expenses in the second quarter of 2021 was primarily due to higher headcount-related costs, an increase in commercialization-related expenses for EYLEA and Libtayo, and costs associated with educational campaigns related to COVID-19.
The increase in COGS in the second quarter of 2021 was primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV in the United States. In addition, the Company recognized higher inventory write-offs and reserves in the second quarter of 2021, compared to the second quarter of 2020.
Other operating (income) expense, net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with the Company’s collaborative arrangements.
Other Financial Information

GAAP other income (expense), net, includes the recognition of net unrealized and realized gains on equity securities of $409 million in the second quarter of 2021, compared to $228 million in the second quarter of 2020.

In the second quarter of 2021, the Company’s GAAP effective tax rate was 17.4%, compared to 2.4% in the second quarter of 2020. The increase in the second quarter 2021 GAAP effective tax rate, compared to the second quarter of 2020, was primarily due to the significant positive impact of stock-based compensation in the second quarter of 2020. In the second quarter of 2021, the non-GAAP effective tax rate was 17.0%, compared to 0.9% in the second quarter of 2020.

GAAP net income per diluted share was $27.97 in the second quarter of 2021, compared to GAAP net income per diluted share of $7.61 in the second quarter of 2020. Non-GAAP net income per diluted share was $25.80 in the second quarter of 2021, compared to non-GAAP net income per diluted share of $7.16 in the second quarter of 2020. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

Net cash provided by operating activities in the first half of 2021 was $1.295 billion, compared to $1.641 billion in the first half of 2020, resulting in $1.031 billion in free cash flow for the first half of 2021, compared to $1.341 billion for the first half of 2020. The Company expects a significant increase in free cash flow in the third quarter of 2021 as the Company collected all amounts due from the U.S. government in connection with second quarter 2021 REGEN-COV sales in July 2021.

2021 Financial Guidance(4)

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its second quarter 2021 financial and operating results on Thursday, August 5, 2021, at 8:30 AM Eastern Time. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 9098036. A link to the webcast may be accessed from the "Investors and Media" page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days.

On August 5, 2021 Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, reported financial results for the second quarter ended June 30, 2021, and recent program highlights (Press release, Magenta Therapeutics, AUG 5, 2021, View Source [SID1234585913]).

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"The Magenta team has been hard at work prioritizing the advancement of our program portfolio, now with multiple clinical trials underway, including the two Phase 2 clinical trials of MGTA-145. We plan to initiate a Phase 1/2 trial of MGTA-117 in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), assuming we are successful in resolving the clinical hold on our Investigational New Drug (IND) Application, and we also plan to initiate a Phase 2 clinical trial of MGTA-145 plus plerixafor for mobilization and collection of stem cells in patients with sickle cell disease," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "We remain laser-focused on developing transformative mobilization and conditioning treatments for the many patients who stand to benefit."

Business Highlights:

In Q2 2021, Magenta welcomed three additions to its Executive Team: Caren Deardorf as Chief Commercial Officer; Thomas Beetham as Chief Legal Officer; and David Nichols as Chief Technical Officer.
In May 2021, Magenta closed an $86.4 million private placement financing.
Program Highlights:

MGTA-145 Stem Cell Mobilization and Collection

Recent and Planned Activity:

Enrollment is complete for Phase 2 clinical trial in multiple myeloma. This 25-patient, investigator-initiated, Phase 2 open-label clinical trial, led by Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy at Stanford University School of Medicine, is designed to evaluate the ability of MGTA-145, in combination with plerixafor, to mobilize and collect stem cells for autologous stem cell transplant in patients with multiple myeloma.
Preliminary trial data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 4-8, 2021, showed that all patients (15/15) treated as of the data cut-off date with MGTA-145 and plerixafor met the primary endpoint of sufficient stem cell mobilization and collection for transplant. As of the cut-off date, all patients (12/12) transplanted with MGTA-145 and plerixafor successfully engrafted, and six patients had completed their day-100 follow-up with demonstrated durable engraftment.
This trial has broad and clinically representative inclusion criteria and incorporates patients that represent the general transplant-eligible population of patients with multiple myeloma.
Patients enrolled in this trial included those patients with risk factors that could impact stem cell mobilization and collection, such as myeloma-directed therapies that are known to impact stem cell collection, previous malignancy treated with chemotherapy and/or radiation, and other co-morbid conditions. As indicated previously, mobilization agents may be less effective in patients with multiple risk factors.
Final clinical data from this trial are anticipated in Q4 2021 and are expected to be presented at a scientific congress.
Enrollment is ongoing in the Phase 2 clinical trial in collaboration with the National Marrow Donor Program/Be The Match, evaluating MGTA-145, in combination with plerixafor, in the mobilization and collection of stem cells from allogeneic donors for transplant in patients with AML, acute lymphocytic leukemia (ALL) and MDS. Initial data from this trial are expected in Q4 2021.
Initiation of a Phase 2 clinical trial in sickle cell disease in collaboration with bluebird bio is planned for Q4 2021 to evaluate the utility of MGTA-145, in combination with plerixafor, for the mobilization and collection of stem cells in patients with sickle cell disease where mobilization and collection is difficult and there is a clear unmet medical need.
MGTA-117 Targeted Conditioning

Recent and Planned Activity:

Magenta announced the receipt of a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its IND Application filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with AML and MDS.
The FDA is requiring that Magenta develop an additional bioassay to be used in conjunction with the pharmacokinetics/pharmacodynamics model to inform dose escalation decisions in addition to safety monitoring. This was the only clinical hold item identified by the FDA and is not related to the toxicology or manufacturing of MGTA-117.
Magenta has initiated the development of the bioassay and intends to work closely with the FDA to reach resolution of the clinical hold.
Upon successful resolution of the clinical hold, Magenta anticipates starting the Phase 1/2 dose escalation study and evaluating the safety, pharmacokinetics and pharmacodynamics of MGTA-117 as a single agent with possible anti-tumor therapeutic benefit in a relapsed/refractory AML and MDS patient population. As previously disclosed, Magenta expects to work with the FDA on an ongoing basis to transition the study to targeted conditioning in the primary target population of hematopoietic stem cell transplant-eligible AML and MDS patients after adequate data related to the safety, pharmacokinetics and pharmacodynamics of MGTA-117 have been collected in the relapsed/refractory AML and MDS patient population.
As the program progresses, Magenta also plans to explore MGTA-117 as a targeted conditioning agent prior to the delivery of gene-corrected cells associated with ex vivo gene therapy.
Additional Business Update:

The company also announced today that Mike Bonney resigned from the company’s Board of Directors and its committees, effective August 3, 2021, to focus on his newly expanded role as Executive Chair of Alnylam Pharmaceuticals, Inc. The resignation was not the result of any disagreement with the company nor any of its affiliates on any matter relating to the company’s operations, policies or practices. In connection with Mr. Bonney’s resignation, the size of the Board was reduced from 10 members to nine members and Alison Lawton, currently a member of the Board, was appointed Chair of the Board, and Jeff Albers, also a current member of the Board, was appointed to the Board’s audit committee.

"I would like to thank Mike for his contribution to Magenta’s success through the years," commented Dr. Gardner. "We are grateful for his support and wish him the very best in the future. We are also extremely pleased to announce the expansion of Alison’s role as Chair, bringing us more than 30 years of experience in the biopharmaceutical industry, as an executive and board member, as well as in a wide range of operational roles."

Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2021 were $207.8 million, compared to $148.8 million as of December 31, 2020. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into Q3 2023.

Research and Development Expenses: Research and development expenses were $11.1 million in Q2 2021, compared to $12.6 million in Q2 2020. The decrease was driven primarily by the completion of the GMP manufacturing activities to support the IND Application for MGTA-117 and future clinical trials.

General and Administrative Expenses: General and administrative expenses were $6.5 million for Q2 2021, compared to $7.4 million for Q2 2020.

Net Loss: Net loss was $16.9 million for Q2 2021, compared to net loss of $19.1 million for Q2 2020.

On August 5, 2021 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the fourth quarter ended June 30, 2021 (Press release, Bio-Techne, AUG 5, 2021, View Source [SID1234585929]).

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Fourth Quarter FY2021 Snapshot

Fourth quarter organic revenue increased by 39% (47% reported) to $259.0 million. Full year organic growth of 22% (26% reported) to $931.0 million.
GAAP EPS was $0.37 versus $1.48 one year ago. Delivered adjusted earnings per share (EPS) of $1.87 versus $1.00 one year ago. Full year GAAP EPS was $3.47 vs $5.82 one year ago. Full year adjusted EPS was $6.75 vs $4.55 in the prior year.
Adjusted Operating Margin increased to 38.5% in the fourth quarter of fiscal 2021 compared to 31.1% in the fourth quarter of fiscal 2020.
Excellent commercial execution in both operating segments with Protein Sciences and Diagnostics and Genomics achieving record organic growth of 46% and 22%, respectively.
Delivered record operating cash flow in fiscal 2021 of $352 million.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic growth, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"I am very pleased with the strong finish to fiscal 2021 as the Bio-Techne team delivered 39% organic growth for the fourth quarter and 22% organic growth for the year," said Chuck Kummeth, President and CEO of Bio-Techne. "Last quarter’s 25-year record setting results are only exceeded by this quarter’s results as our team met and conquered amazing challenges. Consistent with our performance all year, the team delivered these results with a continued focus on profitability leading to a 38.5% adjusted operating margin for the quarter."

Kummeth added, "We have discussed the strong momentum in our business these past few quarters and Q4 delivered as promised. Going forward we see continued momentum as we increase our penetration into the life science markets we serve, and our businesses reach and exceed the tipping points in size necessary to accelerate growth. The demand is there, and we are reaching this tipping point across our portfolio of proteomic, genomic, diagnostic and reagent solutions. Our portfolio of products is extremely well positioned for the coming wave of Cell & Gene Therapies, and we are seeing demand across our instrument and reagent portfolio from these customers, which drove 145% growth in our GMP protein business."

Kummeth continued, "Fiscal 2021 was a fantastic year for the Bio-Techne team. As we begin fiscal 2022, I have never felt better about the opportunities in front of the Company."

Fourth Quarter Fiscal 2021

Revenue

Net sales for the fourth quarter increased 47% to $259.0 million. Organic growth was 39% compared to the prior year, with foreign currency exchange having a favorable impact of 4% and acquisitions contributing a favorable impact of 4% to revenue growth. Organic revenue growth was broad based and driven by accelerated momentum of the Company’s long-term growth strategy combined with the non-recurring impact of customer site shutdowns in the comparative period related to the COVID-19 pandemic.

GAAP Earnings Results

GAAP EPS was $0.37 per diluted share, versus $1.48 in the same quarter last year. GAAP EPS was impacted by a non-operating mark-to-market loss on our ChemoCentryx investment. GAAP operating income for the fourth quarter of fiscal 2021 increased 74.5% to $68.6 million, compared to $39.3 million in the fourth quarter of fiscal 2020. GAAP operating margin was 26.5%, compared to 22.4% in the fourth quarter of fiscal 2020. GAAP operating income and operating margin compared to prior year was positively impacted by volume leverage, operational productivity and product mix.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.87 per diluted share, versus $1.00 in the same quarter last year, an increase of 87%. Adjusted EPS increased due to revenue growth. Adjusted operating income for the fourth quarter of fiscal 2021 increased 82.6% compared to the fourth quarter of fiscal 2020. Adjusted operating margin was 38.5%, compared to 31.1 % in the fourth quarter of fiscal 2020. Adjusted operating margin compared to the prior year was favorably impacted by volume leverage, operational productivity, and product mix.

Full Year Fiscal 2021

Revenue

Net sales for the full year fiscal 2021 increased 26% to $931.0 million. Organic growth was 22%, with foreign currency translation and acquisitions having a favorable impact of 3% and 1%, respectively. Organic revenue growth was broad based and driven by accelerated momentum of the Company’s long-term growth strategy.

GAAP Earnings Results

GAAP EPS was $3.47 per diluted share compared to $5.82 per diluted share last fiscal year. GAAP EPS was unfavorably impacted by a non-operating mark-to-market loss of $67 million on our ChemoCentryx investment, compared to a gain on investment of $137 million in the last fiscal year. GAAP operating income for full year fiscal 2021 increased 51% to $237.3 million, compared with $157.4 million in the full year fiscal 2020. GAAP operating margin was 25.5%, compared to 21.3% in the full year fiscal 2020. GAAP operating income and operating margin compared to prior year was positively impacted by both volume leverage and product mix.

Non-GAAP Earnings Results

Adjusted EPS was $6.75 per diluted shares, versus $4.55 in full fiscal year 2020. Adjusted operating margin for full fiscal year 2021 increased to 38.9%, compared with 33.3% in full year fiscal 2020. Adjusted operating margin compared to the prior year was favorably impacted by volume leverage, operational productivity and product mix.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s fourth quarter fiscal 2021 net sales were $192.3 million, an increase of 51% from $127.3 million for the fourth quarter of fiscal 2020. Organic growth for the segment was 46%, with foreign currency exchange having a favorable impact of 5% on revenue growth and acquisitions contributing an immaterial amount to revenue growth. Protein Sciences segment’s operating margin was 46.7% in the fourth quarter of fiscal 2021 compared to 38.9% in the fourth quarter of fiscal 2020. The segment’s operating margin compared to the prior year was positively impacted by volume leverage and operational productivity.

Protein Sciences segment’s full year fiscal 2021 net sales were $704.6 million, an increase of 27% from $555.4 million for fiscal 2020. Organic growth for the segment was 24% for the fiscal year, with currency translation having a positive 3% impact and acquisitions having an immaterial impact on revenue. Protein Sciences segment’s operating margin was 46.7% in fiscal 2021 compared to 42.3% in fiscal 2020. Segment operating margin compared to the prior year was positively impacted by volume leverage, operational productivity and cost management.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s fourth quarter fiscal 2021 net sales were $67.1 million, an increase of 38% from $48.7 million for the fourth quarter of fiscal 2020. Organic growth for the segment was 22% with acquisitions contributing 15% to revenue growth and foreign currency exchange having a 1% favorable impact. The Diagnostics and Genomics segment’s operating margin was 16.7% in the fourth quarter of fiscal 2021 compared to 12.4% in the fourth quarter of fiscal 2020. The segment’s operating margin was favorably impacted by volume leverage, operational productivity and cost management.

The Diagnostics segment’s full year fiscal 2021 net sales were $227.7 million, an increase of 23% from $184.5 million for fiscal 2020. Organic growth for the segment was 18% with acquisitions contributing 4% to revenue growth and currency translation having a positive 1% impact on revenue. The Diagnostics segment’s operating margin was 16.9% in fiscal 2021 compared to 8.1% in fiscal 2020. Fiscal 2021 operating margin was favorably impacted by volume leverage, operational productivity and cost management.

Conference Call

Bio-Techne will host an earnings conference call today, August 5th, 2021 at 8:00 a.m. CDT. To listen, please dial 1-800-289-0438 or 1-323-794-2423 for international callers, and reference conference ID 3330876. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 3330876. The replay will be available from 11:00 a.m. CDT on Thursday, August 5, 2021 until 11:00 p.m. CDT on Sunday, September 5, 2021.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted earnings
Adjusted tax rate
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months as well as the impact of foreign currency. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, acquisition related expenses inclusive of the changes in fair value of contingent consideration, and other non-recurring items including non-recurring costs and gains. The Company excludes amortization of purchased intangible assets, purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses inclusive of the changes in fair value contingent consideration, and other non-recurring items including gains or losses on legal settlements and one-time assessments from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Investors are encouraged to review the reconciliations of adjusted financial measures used in this press release to their most directly comparable GAAP financial measures as provided with the financial statements attached to this press release.

On August 5, 2021 Pillar Biosciences, an innovative next-generation sequencing (NGS) solutions in-vitro diagnostics (IVD) company, reported the U.S. Food and Drug Administration (FDA) has given Premarket Approval (PMA) to its oncoReveal Dx Lung and Colon Cancer Assay, an NGS tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal (CRC) cancer tumors (Press release, Pillar Biosciences, AUG 5, 2021, View Source [SID1234585946]).

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The oncoReveal Dx Lung and Colon Cancer Assay PMA was based on clinically validated data, and allows for the test to be used as a companion diagnostic (CDx) for all FDA approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies for NSCLC targeting EGFR mutations (Exon 19 In Frame Deletions and Exon 21 L858R Substitution Mutations), and KRAS wild-type tumor tissue (absence of mutations in codons 12 and 13) for metastatic colorectal cancer (mCRC) patients, guiding clinicians where targeted treatment with Erbitux (cetuximab) or Vectibix (panitumumab) is warranted. This panel is intended to be used on the Illumina MiSeq Dx instrument, Illumina’s NGS platform for in vitro diagnostic testing.

"We are committed to providing high quality and accurate IVD tests to enable better treatment decisions for cancer patients," said Gang Song, Ph.D., Founder and CEO at Pillar Biosciences. "Our FDA-approved product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients."

"Increasing patient access to content on our Dx instrument fleet through partnerships such as those with Pillar Biosciences speaks to our mission to improve human health by unlocking the power of the genome," said Joydeep Goswami, Chief Strategy and Corporate Development Officer at Illumina. "We are committed to our ongoing partnership with the team at Pillar."

"We believe high quality specialty tests should be provided closest to where a patient resides, especially for a cancer patient. We look forward to accelerating our future development plans and bringing more innovative FDA-approved products to the providers and partners in the community setting," said Zhaohui Wang, Ph.D., Co-founder and Chief Scientific Officer at Pillar Biosciences.