On August 4, 2021 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported financial results for the second quarter ended June 30, 2021 and provided recent corporate updates, including new in vivo data from the company’s SNS-VISTA program (Press release, Sensei Biotherapeutics, AUG 4, 2021, View Source [SID1234585731]).

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"The second quarter of 2021 was an important one for Sensei as we advanced our next-generation ImmunoPhage platform technology based on critical learnings from our first generation ImmunoPhage and expanded our R&D footprint and capabilities. We also continue to make important strides toward the clinic with our SNS-VISTA program," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "As we enter the third quarter of 2021, we are in a strong cash position to progress our development programs. By leveraging the synergies of these programs, our goal is to generate tumor-specific T-cells through our ImmunoPhage platform and to unleash the full potential of tumor-specific T-cells through our TMAb platform. We are looking forward to sharing additional data and to announcing new programs."

Sensei also announced today early in vivo data from its SNS-VISTA program. VISTA is recognized as an important immune checkpoint regulator. Disrupting the interaction of VISTA and its receptor on T-cells, known as PSGL1, has been shown to enhance T-cell activation and tumor cell killing. The VISTA-PSGL1 T-cell checkpoint is activated under low pH conditions such as the tumor microenvironment. Sensei’s research team has identified a set of fully-human, highly selective, pH-dependent anti-VISTA antibodies. In a human VISTA knock-in mouse model, these parental antibodies significantly enhanced anti-tumor responses in combination with PD-1 blockade compared to treatment with PD-1 blockade alone. Based on these nonclinical data, the company plans to initiate IND-enabling studies with a lead candidate and present data at a scientific conference by the end of 2021.

"Since the inception of our SNS-VISTA program, we have believed the key to unlocking the power of this immune checkpoint is to design an antibody that selectively binds and blocks VISTA at low pH levels in the tumor microenvironment," said Robert Pierce, MD, chief scientific officer of Sensei Biotherapeutics. "This pH-driven, tumor-selective approach is an important feature of our VISTA platform due to high levels of expression on blood cells at physiologic pH. Thus, blood represents a significant pharmacokinetic sink, which can hinder distribution into the tumor microenvironment. Additionally, we believe that by engineering pH-sensitivity into our VISTA antibody, the safety profile may be improved by limiting on-target and off-tumor binding and activity. We believe these nonclinical data are an important proof point for our platform. We look forward to selecting a lead candidate and moving into IND-enabling studies."

Recent Updates and Second Quarter Highlights:

Strengthened Board of Directors and Immuno-Oncology Advisory Board – In August, Sensei announced that it appointed Kristian Humer as an independent director to its Board. Additionally, in the second quarter, Sensei announced the addition of Jessie English, Ph.D. to its Board of Directors and Maura Gillison, M.D. and Richard Ulevitch, Ph.D. to its Immuno-Oncology Advisory Board.

Prioritized pipeline toward next-generation platform programs – In June, Sensei announced its decision to reprioritize its resources toward its pipeline of next generation product candidates, including: its multi-antigenic next generation ImmunoPhage candidate SNS-401-NG, which uses an optimized antigen linkage technology developed at Sensei; its monoclonal antibody SNS-VISTA (V-set Immunoglobulin Domain Suppressor of T cell Activation) candidate; and complete discovery work for its VSIG4 (V-Set And Immunoglobulin Domain Containing 4) TMAb program. As part of the company’s prioritization, it discontinued development of SNS-301, a first-generation, single-antigen ImmunoPhage that expressed a fragment of the tumor-associated antigen, human aspartate β-hydroxylase (ASPH).

Strengthened TMAb (Tumor Microenvironment Antibody Biologics) platform – In July, Sensei expanded the scope of its collaboration with AdiMab, LLC to include additional antibody campaigns focused on the generation of human monoclonal antibodies for its next generation pH sensitive antibody programs.

Selected Contract manufacturer (CDMO) for SNS-VISTA – In July, Sensei selected a CDMO for the manufacture of GMP-grade material to advance its SNS-VISTA program toward clinical studies.

Expanded Operational Footprint – In June, Sensei expanded its research footprint by adding an additional 5,000 square feet of laboratory space at its 451D Street Boston headquarters. The additional lab space will support the advancement of Sensei technologies used for the discovery of nanobodies used in its ImmunoPhage platform or as standalone therapeutics.

Upcoming Program Milestones:

Sensei is focused on progressing novel product candidates generated from both its ImmunoPhage platform and Phortress Library, and TMAb platform. Sensei’s Phortress Library of Immunophages, derived from antigens found across multiple patient populations and tumor types, enables a personalized, yet off-the-shelf therapeutic option to patients.

TMAb (Tumor Microenvironment Antibody Biologics) Platform

VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint that inhibits anti-tumor immune responses. VISTA may play a role in both intrinsic and acquired PD-1/PD-L1 resistance.

Sensei plans to select a lead product candidate, to present nonclinical data at a scientific conference and to initiate IND-enabling studies by the end of 2021.
VSIG4 (V-Set and Immunoglobulin Domain Containing 4) is a B7-family related protein and a potent inhibitor of T-cell activity, often overexpressed on macrophages within the tumor microenvironment. VSIG4 may play a role in enforcing the immunosuppressive program in macrophage-rich tumors. Inhibition of VSIG4 activity could also enhance T-cell-mediated anti-tumor immune responses.

Sensei plans to select a product candidate from this program in 2023.
ImmunoPhage Platform

SNS-401-NG is a potential first-in-class, multi-antigenic personalized ImmunoPhage candidate being developed in collaboration with the University of Washington. The first clinical application is directed to the treatment of Merkel Cell Carcinoma (MCC), an aggressive form of skin cancer commonly driven by the Merkel Cell Polyoma Virus. Once clinical proof of concept is achieved, Sensei plans to evaluate a broader basket study in patients with head and neck cancer, lung cancer, melanoma, and triple negative breast cancer based on the prevalence of Phortress antigens.

Sensei intends to initiate IND-enabling studies for this product candidate in the second half of 2022.
Second Quarter 2021 Financial Results

Cash Position – Cash, cash equivalents and marketable securities were $162.5 million as of June 30, 2021, as compared to $16.6 million as of December 31, 2020. Sensei expects the current cash balance to fund operations at least into the first half of 2024.

Research and Development (R&D) Expenses – R&D expenses were $5.9 million for the quarter ended June 30, 2021, compared to $2.9 million for the quarter ended June 30, 2020. The increase in R&D expenses was primarily attributable to increased headcount to support Sensei’s research, development, and manufacturing activities.

General and Administrative (G&A) Expenses – G&A expenses were $3.9 million for the quarter ended June 30, 2021, compared to $1.3 million for the quarter ended June 30, 2020. The increase in G&A expenses was primarily attributable to higher personnel costs, including stock-based compensation expense, and costs associated with operating as a public company.

Net Loss – Net loss was $9.8 million, for the quarter ended June 30, 2021, compared to $4.9 million for the quarter ended June 30, 2020.

On August 4, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Wednesday, August 11, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the second quarter ended June 30, 2021 (Press release, Navidea Biopharmaceuticals, AUG 4, 2021, View Source [SID1234585730]).

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Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On August 4, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Wednesday, August 11, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the second quarter ended June 30, 2021 (Press release, Navidea Biopharmaceuticals, AUG 4, 2021, View Source [SID1234585729]).

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Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On August 4, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the Wedbush PacGrow Healthcare Virtual Conference (Press release, Kura Oncology, AUG 4, 2021, View Source [SID1234585728]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a panel titled "Bullseye – Targeted Oncology Part 2" at 10:20 a.m. ET / 7:20 a.m. PT on Wednesday, August 11, 2021.

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A live audio webcast of the panel will be available in the Investors section of Kura’s website at www.kuraoncology.com, with a replay available shortly after the live event.

On August 4, 2021 Horizon Therapeutics plc (Nasdaq: HZNP) reported record second-quarter 2021 financial results and increased both its full-year 2021 net sales and adjusted EBITDA guidance (Press release, Horizon Pharma, AUG 4, 2021, View Source [SID1234585727]).

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"Driving our record second-quarter performance was our highly successful TEPEZZA relaunch, which allowed Thyroid Eye Disease patients to rapidly access therapy and resulted in an increase in our full-year expectations," said Tim Walbert, chairman, president and chief executive officer, Horizon. "Our increased full-year net sales and adjusted EBITDA guidance represents strong double-digit year-over-year growth driven by TEPEZZA, KRYSTEXXA and our other rare disease medicines, where we are seeing continued strong underlying demand given the significant benefits our medicines provide to patients. We also initiated three clinical trials and acquired a biologics drug product manufacturing facility to support our strategy to maximize our key growth drivers, expand our pipeline and build a global presence. Horizon remains one of the fastest-growing biotechnology companies, underscoring our commitment to generate value for patients and our shareholders."

Second Quarter and Recent Company Highlights

Strong TEPEZZA Relaunch Exceeded Expectations: In April, the Company resumed supplying the market with TEPEZZA following a supply disruption that began in December 2020 due to U.S.-government-mandated COVID-19 vaccine orders. Second-quarter net sales of $453.3 million exceeded expectations, and today, the Company increased its TEPEZZA full-year 2021 net sales guidance to greater than $1.550 billion from greater than $1.275 billion on continued strong new patient demand. In May, the Company resumed its unbranded television campaign and launched its first branded TEPEZZA television campaign, which is expected to drive broader reach and awareness of Thyroid Eye Disease (TED) and TEPEZZA, motivating patients to seek treatment more quickly.

Entered into Agreement with Arrowhead to Develop Next-Generation Gout Medicine: In June, the Company entered into an agreement with Arrowhead Pharmaceuticals Inc., for a discovery-stage investigational RNA interference (RNAi) therapeutic targeting xanthine dehydrogenase (XDH) as a potential treatment for people with uncontrolled gout. Gout is a serious and painful form of arthritis that is caused by excess serum uric acid in the blood and XDH represents a clinically validated target that is the primary source of serum uric acid. There are more than nine million gout patients in the United States, and a meaningful portion of the patients treated do not respond sufficiently to conventional therapies.

Acquired Biologics Manufacturing Facility in Waterford, Ireland: In July, the Company completed the acquisition of a biologics drug product manufacturing facility from EirGen Pharma in Waterford, Ireland. The Company intends to use the manufacturing facility to support the growth of the Company’s on-market medicines, including TEPEZZA, KRYSTEXXA and UPLIZNA (inebilizumab-cdon), as well as development-stage biologics.

New Chronic TED Data Published: Data published from two recent independent physician case studies of 40 chronic TED patients who showed benefit after treatment with TEPEZZA were published in Eye, the official journal for the Royal College of Ophthalmologists, and Orbit, the International Journal on Orbital Disorders, Oculoplastic and Lacrimal Surgery. These case studies add to the growing body of evidence supporting the use of TEPEZZA in chronic TED patients.

Initiated Enrollment in Three Clinical Trials:
In May, the first patient was enrolled in an open-label trial to evaluate KRYSTEXXA plus methotrexate in patients who were not complete responders to treatment with KRYSTEXXA monotherapy. Patients who were not complete responders to KRYSTEXXA monotherapy have limited options available to address their uncontrolled gout, which is gout refractory to conventional therapies.

In June, the first patient was enrolled in a Phase 2 randomized, placebo-controlled trial to evaluate HZN-7734 in patients with moderate to severe active systemic lupus erythematosus (SLE), a disease in which the body’s immune system attacks its own tissues and organs.

In July, the first patient was enrolled in a Phase 1 trial to evaluate HZN-1116 in patients with autoimmune diseases.

Hosting Virtual R&D Day in September for Investors and Analysts: The Company will host a virtual R&D Day on Sept. 29, featuring presentations from the Company’s R&D leadership team and key opinion leaders with a focus on the Company’s expanded pipeline.

Presented New UPLIZNA Data at Medical Meetings: The Company participated in several key medical meetings in the quarter, highlighting new UPLIZNA data. In April, new end-of-study data from the open-label extension period of the pivotal Phase 3 trial in patients with neuromyelitis optica spectrum disorder (NMOSD) were presented at the American Academy of Neurology’s 73rd Annual Meeting. The data demonstrated that UPLIZNA was generally well-tolerated for at least four years, and that long-term UPLIZNA treatment provided a sustained reduction in NMOSD attack risk from baseline, regardless of the time of treatment initiation. The Company also presented three oral sessions on UPLIZNA at the 7th Congress of the European Academy of Neurology (EAN) in June. Additionally, a new analysis of the pivotal Phase 3 trial demonstrating that the medicine consistently reduced the risk of worsening disability in people living with NMOSD was published in the May issue of Neurology Neuroimmunology & Neuroinflammation.

Received Multiple Best Workplace Awards: During the second quarter, the Company received four workplace recognitions reflecting the high engagement of its employees. In April, the Company was named one of Fortune’s "100 Best Companies to Work For" in the United States for the first time and was placed on Crain’s Chicago Business’ 2021 "Best Places to Work in Chicago" list for the sixth consecutive year. In May, Great Place to Work named the Company to the "Best Workplaces in Chicago" list for the fifth consecutive year. In July, Fortune and Great Place to Work named the Company to the "Best Workplaces for Millennials" list for the second consecutive year and the Company was the highest ranked biotechnology company on the list.
Key Clinical Development Programs

TEPEZZA, an insulin-like growth factor type 1 receptor (IGF-1R) antagonist monoclonal antibody.
Chronic TED Trial: Phase 4 randomized, placebo-controlled trial to evaluate TEPEZZA in chronic TED expected to initiate in the coming weeks.

Subcutaneous (SC) Administration: Phase 1 pharmacokinetic trial underway to explore SC administration of TEPEZZA.

Diffuse Cutaneous Systemic Sclerosis Exploratory Trial: Phase 1 exploratory trial to evaluate TEPEZZA in dcSSc expected to initiate in the third quarter of 2021.

KRYSTEXXA, a recombinant uricase enzyme that converts urate into a water-soluble liquid, allantoin, that can be easily excreted from the body.

MIRROR Randomized Controlled Trial: Phase 4 randomized, placebo-controlled trial underway to evaluate KRYSTEXXA plus methotrexate to increase the complete response rate in patients with uncontrolled gout.

PROTECT Trial: Phase 4 open-label trial underway to evaluate KRYSTEXXA to improve management of uncontrolled gout in kidney transplant patients.

Shorter Infusion Duration Trial: Phase 4 open-label trial underway to evaluate the impact of administering KRYSTEXXA plus methotrexate over a shorter infusion duration in patients with uncontrolled gout.

Monthly Dosing Trial: Phase 4 open-label trial underway to evaluate monthly dosing of KRYSTEXXA plus methotrexate in patients with uncontrolled gout.

Retreatment Trial: Phase 4 open-label trial initiated in May 2021 to evaluate KRYSTEXXA plus methotrexate in patients who were not complete responders to KRYSTEXXA monotherapy.

UPLIZNA, an anti-CD19 humanized monoclonal antibody that depletes B cells, including the pathogenic cells that produce autoantibodies.

Myasthenia Gravis Trial: Phase 3 randomized, placebo-controlled trial underway to evaluate UPLIZNA in patients with myasthenia gravis, a chronic, rare, autoimmune neuromuscular disease that affects voluntary muscles, especially those that control the eyes, mouth, throat and limbs.

IgG4-Related Disease Trial: Phase 3 randomized, placebo-controlled trial underway to evaluate UPLIZNA in patients with IgG4-related disease, which is a group of disorders marked by tumor-like swelling and fibrosis of affected organs, such as the pancreas, salivary glands and kidneys.

Kidney Transplant Desensitization Trial: Phase 2 open-label trial underway to evaluate UPLIZNA, HZN-4920 or both in highly-sensitized patients waiting for a kidney transplant.

HZN-825, an oral lysophosphatidic acid receptor 1 (LPAR1) antagonist that prevents gene activation.

Diffuse Cutaneous Systemic Sclerosis Trial: Pivotal Phase 2b trial to evaluate HZN-825 in diffuse cutaneous systemic sclerosis expected to initiate in the third quarter of 2021.

Interstitial Lung Disease Trial: Pivotal Phase 2b trial to evaluate HZN-825 in idiopathic pulmonary fibrosis, the most common form of interstitial lung disease, expected to initiate in the third quarter of 2021.

HZN-4920, a CD40 ligand antagonist that blocks T cell interaction with the CD40-expressing B cells, disrupting the overactivation of the CD40 ligand co-stimulatory pathway. Several autoimmune diseases are associated with the overactivation of this pathway.

Sjögren’s Syndrome Trial: Phase 2b randomized, placebo-controlled trial underway to evaluate HZN-4920 in patients with Sjögren’s syndrome, a chronic, systemic autoimmune condition that impacts exocrine glands, including the salivary and tear glands.

Rheumatoid Arthritis Trial: Phase 2 randomized, placebo-controlled trial underway to evaluate HZN-4920 in patients with rheumatoid arthritis.

Kidney Transplant Rejection Trial: Phase 2 open-label trial underway to evaluate HZN-4920 in kidney transplant rejection patients.
HZN-7734, an anti-ILT7 human monoclonal antibody that depletes certain dendritic cells. Depleting these cells may interrupt the cycle of inflammation that causes tissue damage in diseases such as lupus, and a variety of other autoimmune conditions.

SLE Trial: Phase 2 randomized, placebo-controlled trial initiated in June 2021 to evaluate HZN-7734 in patients with SLE, a disease in which the body’s immune system attacks its own tissues and organs.

HZN-1116 Autoimmune Disease Trial: Phase 1 trial initiated in July 2021 to evaluate HZN-1116, a monoclonal antibody, in patients with autoimmune diseases.
Second-Quarter Financial Results

Note: For additional detail and reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures, please refer to the tables at the end of this release.

Net Sales: Second-quarter 2021 net sales were $832.5 million, an increase of 80 percent compared to the second quarter of 2020.
Gross Profit: Under U.S. GAAP, the second-quarter 2021 gross profit ratio was 75.9 percent compared to 73.7 percent in the second quarter of 2020. The non-GAAP gross profit ratio in the second quarter of 2021 was 87.7 percent compared to 88.4 percent in the second quarter of 2020.
Operating Expenses: Research and development (R&D) expenses were 16.8 percent of net sales and selling, general and administrative (SG&A) expenses were 42.7 percent of net sales. Non-GAAP R&D expenses were 9.7 percent of net sales, and non-GAAP SG&A expenses were 33.8 percent of net sales.
Income Tax Benefit: In the second quarter of 2021, income tax benefit on a GAAP and non-GAAP basis was $42.5 million and $35.6 million, respectively.
Net Income: On a GAAP basis in the second-quarter of 2021, net income was $158.1 million. Second-quarter 2021 non-GAAP net income was $381.4 million.
Adjusted EBITDA: Second-quarter 2021 adjusted EBITDA was $366.9 million.
Earnings (Loss) per Share: On a GAAP basis, diluted earnings per share in the second quarter of 2021 was $0.67. GAAP loss per share in the second quarter of 2020 was $0.42. Non-GAAP diluted earnings per share in the second quarter of 2021 and 2020 were $1.62 and $0.40, respectively. Weighted average shares outstanding used for calculating GAAP and non-GAAP diluted earnings per share in the second quarter of 2021 were 235.2 million.
Second-Quarter Segment Results

Management uses net sales and segment operating income to evaluate the performance of the Company’s two segments, the orphan segment and the inflammation segment. While segment operating income contains certain adjustments to the directly comparable GAAP figures in the Company’s consolidated financial results, it is considered to be prepared in accordance with GAAP for purposes of presenting the Company’s segment operating results.

Second-quarter 2021 net sales of the orphan segment, the Company’s strategic growth segment, were $746.5 million, an increase of 97 percent over the prior year’s quarter, driven by the strong relaunch execution of TEPEZZA, as well as strong year-over-year growth of KRYSTEXXA, RAVICTI and PROCYSBI. The orphan segment represented 90 percent of total second-quarter net sales.
KRYSTEXXA second-quarter 2021 net sales increased 73 percent year-over-year driven by increased adoption of KRYSTEXXA plus immunomodulation, which now exceeds 40 percent. In addition, the Company continues to see strong uptake of KRYSTEXXA from both rheumatologists and nephrologists.
Second-quarter 2021 orphan segment operating income was $321.2 million, which includes additional investment associated with TEPEZZA, UPLIZNA and the Company’s pipeline programs.
Second-quarter 2021 net sales of the inflammation segment were $86.0 million, and segment operating income was $46.8 million.
Cash Flow Statement and Balance Sheet Highlights

On a GAAP basis, operating cash flow in the second quarter of 2021 was $89.4 million. Non-GAAP operating cash flow was $146.7 million.
As of June 30, 2021, the Company had cash and cash equivalents of $812.3 million.
As of June 30, 2021, the total principal amount of debt outstanding was $2.614 billion, and the gross-debt-to-last-12-months adjusted EBITDA leverage ratio was 2.3 times.

2021 Guidance

The Company now expects full-year 2021 net sales to range between $3.025 billion and $3.125 billion, representing 40 percent growth at the midpoint and an increase from the previous range of $2.75 billion and $2.85 billion. The company now expects TEPEZZA full-year 2021 net sales of greater than $1.550 billion with year-over-year growth of more than 50 percent in the fourth quarter, compared to the previous guidance of greater than $1.275 billion. The Company continues to expect KRYSTEXXA full-year 2021 net sales of greater than $500 million. Full-year 2021 adjusted EBITDA is now expected to range between $1.26 billion and $1.30 billion, representing 28 percent growth at the midpoint and an increase from the previous guidance range of $1.02 billion and $1.06 billion.

Webcast

At 8 a.m. EST / 1 p.m. IST today, the Company will host a live webcast to review its financial and operating results and provide a general business update. The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.