On August 3, 2021 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the second quarter of 2021 (Press release, ChromaDex, AUG 3, 2021, View Source [SID1234585606]).

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Second Quarter 2021 and Recent Highlights

Total net sales were $17.7 million, up 16% from the prior year quarter.
Tru Niagen net sales were $15.4 million, a 31% increase from the prior year quarter.
Gross margin was 61.1%, a 170 basis point increase from the prior year quarter.
Net loss was $(5.6) million or $(0.08) per share, down $0.02 per share from the prior year quarter.
Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a profit of $0.6 million, a $0.1 million improvement from the prior year quarter.
Launched Tru Niagen in 3,800 Walmart stores across the United States in June.
Research on nicotinamide riboside ("NR") continues to expand, with 49 clinical studies currently registered.
"This was an excellent quarter for ChromaDex, financially and strategically," said ChromaDex Chief Executive Officer, Rob Fried. "We delivered strong growth in our core e-Commerce business as well as with existing partners. We launched Tru Niagen in Walmart, our first mass retail launch for the brand and delivered our first shipment of Niagen to a new partner, Ro. We achieved record sales of $17.7 million and positive Adjusted EBITDA excluding legal of $0.6 million. I am very proud of our team’s execution and believe our long-term prospects look stronger than ever."

Results of operations for the three months ended June 30, 2021

For the three months ended June 30, 2021 ("Q2 2021"), ChromaDex reported net sales of $17.7 million, up $2.4 million or 16% compared to the second quarter of 2020 ("Q2 2020"). The increase in Q2 2021 revenues was largely driven by growth in sales of Tru Niagen, partially offset by lower Niagen and other ingredient sales.

Gross margin percentage improved by 170 basis points to 61.1% in Q2 2021 compared to 59.4% in Q2 2020. The improvement in gross margin percentage was driven by the positive impact of increased Tru Niagen consumer product sales and product cost savings initiatives.

Operating expenses increased by $3.6 million to $16.4 million in Q2 2021, compared to $12.8 million in Q2 2020. The increase in operating expenses was driven by $1.3 million of higher selling and marketing expenses and a $2.2 million increase in general and administrative expense. The increase in general and administrative expense was primarily driven by $2.3 million of higher legal expense.

The net loss for Q2 2021 was $(5.6) million or $(0.08) per share as reported compared to a net loss of $(3.7) million or $(0.06) per share for Q2 2020 as reported. Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a profit of $0.6 million for Q2 2021, compared to a profit of $0.5 million for Q2 2020, a $0.1 million improvement. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA excluding total legal expense to net loss, the most directly comparable GAAP measure.

For Q2 2021, the net cash outflow from operating activities was $(7.9) million, compared to $(1.6) million in Q2 2020.

2021 Full Year Outlook

Looking forward, for the full year, the Company expects continued, steady revenue growth driven by its global e-commerce business, as well as growth with existing and new strategic partners. The Company expects slightly better than 60% gross margin and slightly higher general and administrative expense, excluding severance, restructuring and legal expense, for full year 2021. The Company plans to increase investments and resources to drive brand awareness and accelerate its research and development (R&D) pipeline to capitalize on growth in the nicotinamide adenine dinucleotide (NAD+) market globally. Accordingly, the Company expects higher R&D expense and higher selling and marketing expense as a percentage of net sales year-over-year.

Investor Conference Call

A live webcast will be held Tuesday, August 3, 2021 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s second-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source The dial-in information for this call is 1-833-979-2703 (within the U.S.) and 236-714-2223 (outside the U.S.) with Conference ID: 9972229.

The webcast will be recorded, and will be available for replay via the website through 11:59 p.m. Eastern time on August 10, 2021. The replay of the call can also be accessed by dialing 800-585-8367, using the replay ID: 9972229.

On August 3, 2021 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported financial results for the second quarter ended June 30, 2021, including sales of TAVALISSE (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment (Press release, Rigel, AUG 3, 2021, View Source [SID1234585605]).

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"As we begin the second half of 2021, Rigel is well-positioned to execute on several key milestones that have the potential to be important inflection points for the company," said Raul Rodriguez, Rigel’s president and CEO. "TAVALISSE sales are growing as we are able to access more clinicians in-person, and we are expanding our commercial team to allow us to have a greater impact as physicians and patients continue to return to the clinic. Our pipeline programs continue to advance as we wait for a decision on our EUA, with our own Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients rapidly enrolling and our Phase 3 clinical trial of fostamatinib in wAIHA nearing its enrollment goal," continued Mr. Rodriguez.

Business Update
In July, Rigel initiated expansion of its sales force from 39 to 55 territories. Recruiting is underway and it is expected that the team will be fully trained and in the field by the end of September.

In June, Rigel announced that fostamatinib had been selected as part of the National Institutes of Health (NIH) sponsored ACTIV-4 Host Tissue trial. Recruiting is underway and the first patient has been enrolled in the multi-site, randomized, placebo-controlled trial of therapies, including fostamatinib, targeting the host response to COVID-19 in hospitalized patients.

In late-May, Rigel submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for fostamatinib in hospitalized patients diagnosed with COVID-19. The request included data from a NHLBI/NIH-sponsored Phase 2 study, which reported positive topline results in April.

Rigel’s Phase 3 clinical trial evaluating fostamatinib in high-risk patients hospitalized with COVID-19 has enrolled ~150 of the targeted 308 patients, and expects to complete enrollment by year-end 2021.

Rigel’s FORWARD study, a Phase 3 pivotal trial of TAVALISSE in patients with warm autoimmune hemolytic anemia (wAIHA), has enrolled 80 of the targeted 90 patients. If approved, TAVALISSE has the potential to be the first to market therapy for patients with wAIHA.

During the quarter, Rigel received feedback from the FDA supporting its proposed clinical program to evaluate R289, a pro-drug formulation of R835, in low-risk myelodysplastic syndromes (MDS). Planning is now underway on the Phase 1/2 clinical trial.

In June, Rigel entered into a research collaboration with MD Anderson Cancer Center to evaluate Rigel’s novel IRAK1/4 inhibitors in a series of preclinical studies of MDS and chronic myelomonocytic leukemia (CMML). The translational research generated from these studies will add to the body of data generated to date on R835 and R289 and further elucidate the therapeutic potential of targeting deregulated innate immune signaling in MDS and CMML.

Financial Update
For the second quarter of 2021, Rigel reported net loss of $13.8 million, or $0.08 per basic and diluted share, compared to a net loss of $17.6 million, or $0.10 per basic and diluted share, for the same period of 2020.

In the second quarter of 2021, total revenues were $26.3 million, consisting of $17.1 million in TAVALISSE net product sales, $3.7 million in contract revenues from collaborations, and $5.5 million in government contract revenue. TAVALISSE net product sales of $17.1 million in the second quarter of 2021 increased by 14% from $15.0 million for the same period of 2020.

Contract revenues from collaborations of $3.7 million for the second quarter of 2021 consisted of $3.3 million in revenue related to Rigel’s license agreement with Lilly, and $0.4 million in revenue related to the performance of certain research and development services pursuant to its collaboration agreement with Grifols. Government contract revenue was related to the income recognized pursuant to the agreement Rigel entered in January 2021 with the U.S. Department of Defense (DOD) to support Rigel’s ongoing Phase 3 clinical trial of fostamatinib in hospitalized patients with COVID-19.

Rigel reported total costs and expenses of $39.3 million in the second quarter of 2021, compared to $33.4 million for the same period in 2020. The increase in costs and expenses was primarily due to increases in personnel-related costs, stock-based compensation expense, and research and development costs related to Rigel’s various on-going clinical studies.

For the six months ended June 30, 2021, Rigel reported net income of $25.7 million, or $0.15 per basic and diluted share, compared to a net income of $3.7 million, or $0.02 per basic and diluted share, for the same period of 2020.

Rigel reported total revenues of $107.3 million for the six months ended June 30, 2021, consisting of $29.4 million in TAVALISSE net product sales, $69.4 million in contract revenues from collaborations, and $8.5 million in government contract revenues. TAVALISSE net product sales of $29.4 million increased by 6% from $27.7 million for the same period of 2020. Contract revenues from collaborations of $69.4 million for the six months ended June 30, 2021, consisted of $63.9 million in revenue related to Rigel’s license agreement with Lilly, $4.0 million in revenue related to the grant of a non-exclusive license of a certain patent to an unrelated third-party company, and $1.4 million in revenue for the delivery of drug supply, as well as performance of certain research and development services pursuant to its collaboration agreement with Grifols. Government contract revenue of $8.5 million for the six months ended June 30, 2021, was related to the income recognized pursuant to the agreement Rigel entered in January 2021 with the DOD to support Rigel’s ongoing Phase 3 clinical trial of fostamatinib in hospitalized patients with COVID-19.

Total costs and expenses for the six months ended June 30, 2021, were $78.6 million, compared to $68.1 million for the same period in 2020. The increase in costs and expenses was primarily due to increases in personnel-related costs, stock-based compensation expense, and research and development costs related to Rigel’s various on-going clinical studies.

As of June 30, 2021, Rigel had cash, cash equivalents, and short-term investments of $153.4 million, compared to $57.3 million as of December 31, 2020.

Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA
Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that destroy the body’s own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients. Warm antibody AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature.

About COVID-19 & SYK Inhibition
COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.1 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.2

SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology such as pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

For more information on Rigel’s comprehensive clinical program in COVID-19, go to: View Source

About RIP1 Inhibitor, R552
Investigational candidate, R552, is an orally available, potent and selective inhibitor of receptor-interacting serine/threonine-protein kinase 1 (RIP1). RIP1 is believed to play a critical role in necroptosis. Necroptosis is a form of regulated cell death where the rupturing of cells leads to the dispersion of their inner contents, which induces immune responses and enhances inflammation. In preclinical studies, R552 prevented joint and skin inflammation in a RIP1-mediated murine model of inflammation and tissue damage. The safety and efficacy of R552 has not been established by the FDA or any healthcare authority.

About IRAK1/4 Inhibitor R835/R289
Investigational candidates, R835 and its pro-drug, R289 are orally available, potent and selective inhibitors of both IRAK1 and IRAK4. In clinical and preclinical studies, R835 has been shown to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions. R835 treatment demonstrates amelioration of clinical symptoms in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout. The safety and efficacy of R835 or its pro-drug, R289, have not been established by the FDA or any healthcare authority.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSEUSPI.com for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

On August 3, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the second quarter ended June 30, 2021 (Press release, Neurocrine Biosciences, AUG 3, 2021, View Source [SID1234585604]).

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"We helped more tardive dyskinesia patients than ever before as our second quarter results reflect sustained growth for INGREZZA. While 8 out of 10 patients still remain undiagnosed, the underlying opportunity to improve the lives of patients with TD remains strong. Therefore, we continue to invest in healthcare provider and patient-focused awareness campaigns to help improve TD diagnosis and treatment rates," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We remain committed to advancing our R&D pipeline and are making steady progress towards initiating 9 mid-to-late-stage clinical trials this year. With significant long-term commercial growth opportunities and a diverse and growing pipeline, we are well positioned to become a leading neuroscience-focused biopharmaceutical company."

Second Quarter Net Product Sales and Commercial Highlights:

INGREZZA net product sales for the second quarter of 2021 were $265 million and $269 million on an inventory adjusted basis
Record total prescriptions achieved during the second quarter 2021 reflecting increased commercial activities
New prescriptions increased throughout the second quarter, reaching their highest levels since March 2020 despite continued significant use of telemedicine within psychiatry
Second quarter refill rates per patient returned to historical normal range versus seasonally low first quarter levels
Financial Highlights:

Second quarter 2021 GAAP net income and diluted earnings per share were approximately $42 million and $0.43, respectively, compared with approximately $80 million and $0.81, respectively, in the second quarter of 2020
Second quarter 2021 non-GAAP net income and diluted earnings per share were approximately $61 million and $0.63, respectively, compared with approximately $139 million and $1.42, respectively, in the second quarter of 2020
Difference between second quarter 2021 GAAP and non-GAAP net income and diluted earnings per share compared with the second quarter of 2020 were driven by:
Increased research and development expense primarily due to increased investment and headcount to support our expanded pipeline programs
Increased selling, general and administrative expense primarily due to increased investment in commercial initiatives including the launch of "TD Spotlight", our INGREZZA direct-to-consumer advertising campaign
Second quarter 2021 provision for income taxes was $15 million, compared with $4 million in the second quarter of 2020. In the first quarter of 2021, the Company began recording a provision for income taxes using an effective tax rate approximating federal and state statutory rates. Due to the Company’s ability to offset its pre-tax income against previously benefited federal net operating losses, no federal cash tax is expected in 2021.
At June 30, 2021, the Company had cash, cash equivalents and debt securities available-for-sale of $1.2 billion
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

Recent Events

In April 2021, Mitsubishi Tanabe Pharma Corporation (MTPC) submitted a Marketing Authorization Application, or MAA, with the Ministry of Health and Welfare in Japan for valbenazine for the treatment of tardive dyskinesia. The MTPC submission of valbenazine triggered a milestone payment of $15 million, which the Company recognized as collaboration revenue in the second quarter of 2021.
In August 2021, the Company announced plans to initiate registrational studies in the second half of 2021 with valbenazine for adjunctive treatment in schizophrenia and for dyskinesia due to cerebral palsy.

GAAP-only guidance includes approximately $130 million of share-based compensation and $5 million of In-Process Research and Development (IPR&D). GAAP-only guidance does not include any potential milestones or IPR&D costs associated with current collaborations or future business development activities.

Conference Call and Webcast Today at 4:30 PM Eastern Time

Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 866-952-8559 (US) or 785-424-1743 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On August 3, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the first quarter ended June 30, 2021 and provided a corporate update (Press release, Deciphera Pharmaceuticals, AUG 3, 2021, View Source [SID1234585603]).

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"We made significant progress against our goals in the first half of the year and we look forward to carrying this momentum through the rest of 2021," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "Building on the successful launch of QINLOCK for fourth-line GIST in the U.S., this best-in-class medicine has now been approved in China and Hong Kong and we expect approval from the European Medicines Agency later this year. In the fourth quarter, we look forward to reporting top-line data from the INTRIGUE Phase 3 study in second-line GIST. In addition, we expect to report updated data from the vimseltinib and rebastinib programs at the upcoming ESMO (Free ESMO Whitepaper) congress as well as finalize pivotal development plans for both programs later this year."

Mr. Hoerter continued, "We also recently achieved a key milestone treating the first patient in our Phase 1 trial of DCC-3116, a first-in-class ULK kinase inhibitor designed to address mutant RAS and RAF cancers through the inhibition of autophagy."

Second Quarter 2021 Highlights and Upcoming Milestones

QINLOCK (ripretinib)
Recorded $22.0 million in QINLOCK net product revenue in the second quarter of 2021, including $20.7 million in U.S. sales of QINLOCK and $1.3 million in ex-U.S. sales of QINLOCK.
Launched commercially in China, via our collaboration with Zai, for the treatment of adult patients with fourth-line GIST.
Presented data for QINLOCK patients undergoing intra-patient dose escalation after disease progression in the INVICTUS Phase 3 study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Expects to announce top-line results from the INTRIGUE Phase 3 study in the fourth quarter of 2021.
Expects potential approval from the European Medicines Agency (EMA) for QINLOCK in the fourth quarter of 2021.
Expects to initiate a Phase 1b/2 study of QINLOCK in combination with binimetinib, a commercially available MEK inhibitor, in post-imatinib GIST patients in the fourth quarter of 2021.
Vimseltinib
Expects to present updated data from the ongoing Phase 1/2 study in patients with TGCT at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 in September.
Plans to finalize the pivotal development plan for vimseltinib in patients with TGCT in the second half of 2021.
Rebastinib
Expects to present updated data from the ongoing Phase 1b/2 study of rebastinib in combination with paclitaxel in the platinum-resistant ovarian cancer cohort at the ESMO (Free ESMO Whitepaper) Congress 2021 in September.
Plans to finalize the pivotal development plan for rebastinib in combination with paclitaxel in the second half of 2021.
DCC-3116
Initiated the Phase 1 study of DCC-3116 in June 2021. The study is evaluating DCC-3116 as a single agent and in combination with trametinib in patients with advanced or metastatic tumors with a mutant RAS or RAF gene. Currently, expansion cohorts are planned in patients with advanced or metastatic pancreatic ductal adenocarcinoma with KRAS or BRAF mutations, non-small cell lung cancer with KRAS, NRAS, or BRAF mutations, colorectal cancer with KRAS, NRAS, or BRAF mutations, and melanoma with NRAS or BRAF mutations.
Expects to present preclinical data on DCC-3116 in combination with approved, targeted oncology agents in multiple tumor models at an upcoming medical meeting in the second half of 2021.
Recent Corporate Updates

Today announced an agreement with Sprint Bioscience to exclusively in-license worldwide rights to a research-stage program targeting VPS34, a key kinase in the autophagy pathway, strengthening the company’s leading position in the development of regulators of autophagy for the potential treatment of cancer. VPS34 is involved in the endosomal trafficking of cellular cargo targeted for lysosomal degradation in cancer cells. Targeting VPS34 may provide an additional approach to regulating autophagy that is complementary to inhibition of ULK kinase by blocking VPS34-mediated immunosuppression in tumors.
Upcoming Scientific Congress Presentations

ESMO Congress 2021, September 16-21. The following will be e-poster presentations and will be available on-demand via the ESMO (Free ESMO Whitepaper) Congress 2021 website beginning on September 16 at 8:30 AM CEST / 2:30 AM EST.
QINLOCK
Ripretinib as ≥4th-line treatment in patients with advanced gastrointestinal stromal tumor: long-term update from the Phase 3 INVICTUS study.
Phase 1 study of ripretinib, a broad-spectrum KIT and PDGFRA inhibitor, in patients with KIT-mutated or KIT-amplified melanoma.
Vimseltinib
Safety and preliminary efficacy of vimseltinib in tenosynovial giant cell tumor (TGCT).
Rebastinib
A Phase 1b/2 study of rebastinib and paclitaxel in advanced/metastatic platinum-resistant ovarian cancer.
Second Quarter Financial Results

Revenue: Total revenue for the second quarter of 2021 was $23.6 million, which includes $22.0 million of net product revenue from sales of QINLOCK and $1.5 million of collaboration revenue comprised of commercial supply and royalty revenue under our license agreement with Zai Lab. Total revenue for the second quarter of 2020 was $7.1 million, which includes $4.8 million of net product revenue from sales of QINLOCK and $2.3 million of collaboration revenue.
Cost of Sales: Cost of sales was $1.3 million in the second quarter of 2021, which includes $0.4 million in cost of net product revenue for QINLOCK and $0.9 million in cost of collaboration revenue. Cost of sales was less than $0.1 million for the second quarter of 2020. Cost of net product sales is not expected to be significant until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold.
R&D Expenses: Research and development expenses for the second quarter were $60.0 million, compared to $46.1 million for the same period in 2020. The increase was primarily due to personnel and preclinical costs and an increase in clinical trial expenses related to our ongoing Phase 1/2 study of vimseltinib. Non-cash, stock-based compensation was $5.6 million and $5.3 million for the second quarters of 2021 and 2020, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the second quarter of 2021 were $32.8 million, compared to $29.9 million for the same period in 2020. The increase was primarily due to personnel costs as well as external spend related to professional fees, including those associated with establishing a targeted commercial infrastructure in key European markets to support a potential launch of QINLOCK in Europe, if approved. Non-cash, stock-based compensation was $6.8 million and $5.3 million for the first quarters of 2021 and 2020, respectively.
Net Loss: For the second quarter of 2021, Deciphera reported a net loss of $70.4 million, or $1.21 per share, compared with a net loss of $67.2 million, or $1.20 per share, for the same period in 2020. The increase in net loss was primarily a result of increased R&D expenses, as described above, partially offset by a full quarter of product sales during the second quarter of 2021.
Cash Position: As of June 30, 2021, cash, cash equivalents, and marketable securities were $451.0 million, compared to $502.2 million as of March 31, 2021. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product and royalty revenues, excluding any potential future milestone payments or other payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into the first half of 2023.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, August 3, 2021 at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 9943767. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

On August 3, 2021 Amgen (NASDAQ:AMGN) reported financial results for the second quarter of 2021 (Press release, Amgen, AUG 3, 2021, View Source [SID1234585602]). Key results include:

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Total revenues increased 5% to $6.5 billion in comparison to the second quarter of 2020, driven by higher unit demand, partially offset by lower net selling prices.
Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia (denosumab), Repatha (evolocumab) and our biosimilar products MVASI (bevacizumab-awwb) and KANJINTI (trastuzumab-anns).
GAAP earnings per share (EPS) decreased 73% to $0.81 driven by the write-off of $1.5 billion in acquired in-process research & development (acquired IPR&D) associated with our acquisition of Five Prime Therapeutics, partially offset by increased revenues.
GAAP operating income decreased 64% to $0.8 billion and GAAP operating margin decreased 25.8 percentage points to 13.5%.
Non-GAAP EPS increased 4% to $4.38 driven by increased revenues and the impact of fewer weighted average shares outstanding.
Non-GAAP operating income decreased 4% to $3.1 billion and non-GAAP operating margin decreased 4.1 percentage points to 50.9%.
The Company generated $1.7 billion of free cash flow in the second quarter versus $2.7 billion in the second quarter of 2020 driven by a difference in the timing of tax payments.
2021 total revenues guidance reaffirmed at $25.8-$26.6 billion; EPS guidance revised to $8.84-$9.90 on a GAAP basis, and reaffirmed at $16.00-$17.00 on a non-GAAP basis.

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. For comparability of results to the prior year, non-GAAP net income and non-GAAP EPS amounts for 2020 have been revised to reflect the update to our non-GAAP policy that excludes gains and losses on certain equity investments. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

COVID-19 update: Compared to the first quarter of 2021, we have seen gradual recovery from the impacts of the COVID-19 pandemic. Patient visits and lab test procedure trends continued to improve but remained below pre-COVID-19 levels. The cumulative decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business during the second half of the year.

Total product sales increased 3% for the second quarter of 2021 versus the second quarter of 2020. Unit volumes grew 8% while net selling price declined 5%. On a sequential basis, product sales grew 9% quarter-over-quarter, driven by 6% volume growth.

Results for individual products are as follows:

Prolia sales increased 24% year-over-year for the second quarter, driven by 20% volume growth as new and repeat patient volumes continued to recover from the pandemic. With osteoporosis diagnosis rates remaining at approximately 90% of pre-COVID-19 levels in the quarter, we are focused on driving patient growth and are optimistic about Prolia’s continued strength in the second half of the year.
EVENITY (romosozumab-aqqg) sales increased 30% year-over-year for the second quarter, driven by 32% volume growth. U.S. sales nearly doubled year-over-year, driven by 97% volume growth as we continued to focus on new patient activation. Rest of world (ROW) sales decreased 15% year-over-year due in part to the timing of purchases by our partner Astellas during the first half of 2020.
Repatha sales increased 43% year-over-year for the second quarter, driven by 49% volume growth. In the U.S., volumes grew 37% year-over-year, and outside the U.S. volumes grew 66% year-over-year. Volume growth in the quarter was partially offset by lower net selling price as a result of an increase in the number of U.S. Medicare Part D patients receiving Repatha and entering the coverage gap. We expect further reduction in the net selling price on a sequential basis as the number of Medicare Part D patients receiving Repatha increases. Repatha has now been prescribed for more than one million patients.
Aimovig (erenumab-aooe) sales decreased 16% year-over-year for the second quarter. Unit volume growth of 11% was offset by lower net selling price and unfavorable changes to estimated sales deductions. Aimovig retains strong payer coverage and remains the segment leader within the preventive calcitonin gene-related peptide (CGRP) class. To date, more than 500,000 patients worldwide have been prescribed Aimovig for the preventive treatment of migraine.
Otezla (apremilast) sales decreased 5% year-over-year for the second quarter, primarily driven by unfavorable changes to estimated sales deductions and lower net selling price, partially offset by 5% volume growth. In the U.S., Otezla continued to maintain first-line share leadership in psoriasis. New-to-brand prescription (NBRx) volumes grew 10% year-over-year, even as patient visits to dermatologists remained 15% below pre-pandemic levels. The number of new patients that started treatment with Otezla in Q2 was near pre-pandemic levels, but those gains were largely offset by a lower percentage of 90-day prescriptions and lower prescription refill rates. We expect that recovery in the dermatology segment will continue to progress over the coming quarters. Looking forward, we are preparing for the anticipated approval of the mild-to-moderate psoriasis indication in the U.S., and continued geographic expansion, including the launch in China.
Enbrel (etanercept) sales decreased 8% year-over-year for the second quarter, primarily driven by lower net selling price and unfavorable changes in estimated sales deductions. On a year-over-year basis volumes declined 1%. Going forward, we expect net selling price to continue to decline year-over-year.
AMGEVITA (adalimumab) sales increased 73% year-over-year for the second quarter, primarily driven by volume growth. AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.
LUMAKRASTM (sotorasib) has been well received by the oncology community. LUMAKRAS has been added to the National Comprehensive Cancer Network (NCCN) guidelines and unaided awareness among oncologists has increased significantly since launch. KRAS testing of patients with metastatic non-small cell lung cancer (NSCLC) now stands at approximately 70%, driven by increased next generation sequencing (NGS) utilization and KRAS G12C educational efforts, and 46 of the 50 top testing laboratories are now identifying the KRAS G12C mutation as actionable in their lab reports.
KYPROLIS (carfilzomib) sales increased 11% year-over-year for the second quarter, primarily driven by volume growth and net selling price. For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies.
XGEVA (denosumab) sales increased 12% year-over-year for the second quarter, driven by volume growth as the segment recovered from the earlier effects of the pandemic.
Vectibix (panitumumab) sales increased 23% year-over-year for the second quarter, driven by 20% volume growth that benefited from increased shipments to Takeda, our partner in Japan. We expect lower demand from Takeda in the third quarter.
Nplate (romiplostim) sales increased 27% year-over-year for the second quarter, driven by 17% volume growth and higher inventory levels.
BLINCYTO (blinatumomab), our BiTE immunotherapy, sales increased 16% year-over-year for the second quarter, driven by 18% volume growth as we benefited from broader adoption in the community hospital setting.
MVASI sales increased 71% year-over-year for the second quarter, driven by strong volume growth, partially offset by lower net selling price. In the U.S., MVASI continued to hold leading volume share with 50% of the bevacizumab segment in the quarter. Sales were flat quarter-over-quarter as volume growth was offset by unfavorable changes to estimated sales deductions. Going forward on a sequential basis, we expect continued worldwide volume growth to be more than offset by declines in net selling price due to increased competition.
KANJINTI sales increased 27% year-over-year for the second quarter, primarily driven by volume growth, partially offset by lower net selling price. In the U.S., KANJINTI continued to hold leading volume share with 42% of the trastuzumab segment in the quarter. Sales decreased 3% quarter-over-quarter, primarily driven by unfavorable changes to estimated sales deductions. Going forward, we expect sales to decline sequentially in the second half of the year driven by net selling price.
Neulasta (pegfilgrastim) sales decreased 18% year-over-year for the second quarter, driven by declines in both net selling price and volume, partially offset by a $75 million year-over-year benefit from favorable changes in reimbursement mix, resulting from the comparison of a $39 million favorable adjustment to estimated sales deductions in the quarter to a $36 million unfavorable adjustment in the second quarter last year. In the long-acting granulocyte colony-stimulating factor (G-CSF) segment, Neulasta Onpro continued to be the preferred choice for physicians and patients with volume share of 52% in the quarter. The most recent published Average Selling Price for Neulasta in the U.S. declined 35% year-over-year and 12% quarter-over-quarter. Going forward, we expect increased competition to result in further declines in net selling price.
NEUPOGEN (filgrastim) sales increased 4% year-over-year for the second quarter, driven by favorable changes in estimated sales deductions, partially offset by volume declines.
EPOGEN (epoetin alfa) sales decreased 19% year-over-year for the second quarter, driven by volume declines and lower net selling price resulting from our contractual commitment with DaVita.
Aranesp (darbepoetin alfa) sales decreased 5% year-over-year for the second quarter, driven by lower net selling price due to competition.
Parsabiv (etelcalcetide) sales decreased 62% year-over-year for the second quarter, driven by volume declines. With Parsabiv’s inclusion in the U.S. end-stage renal disease (ESRD) bundled payment system, dialysis clinics rapidly implemented new treatment protocols, switching patients from Parsabiv to generic oral cinacalcet. As a result, we expect a 50-60% year-over-year Parsabiv sales decline in 2021. For patients on hemodialysis, Parsabiv is the only IV-administered calcimimetic that treats secondary hyperparathyroidism and provides the opportunity to reduce patient pill burden.
Sensipar/Mimpara (cinacalcet) sales decreased 70% year-over-year for the second quarter, primarily driven by volume declines in response to generic competition.
Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

Total Operating Expenses increased 47% primarily driven by the recent acquisition of Five Prime Therapeutics. Cost of Sales margin increased 1.6 percentage points primarily due to product mix, including COVID-19 antibody shipments to Eli Lilly and Company (Lilly) that began this quarter, profit share and royalties, partially offset by lower amortization expense from acquisition-related assets. Research & Development (R&D) expenses increased 12% primarily due to higher research and early pipeline spend and late-stage development program spend, including our recent business development activities. Acquired IPR&D expenses in 2021 were driven by the Five Prime Therapeutics acquisition. Selling, General & Administrative (SG&A) expenses increased 7% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches.
Operating Margin as a percentage of product sales decreased 25.8 percentage points to 13.5%.
Tax Rate increased 5.6 percentage points primarily driven by the non-deductible acquired IPR&D expense arising from the acquisition of Five Prime Therapeutics.
On a non-GAAP basis:

Total Operating Expenses increased 15%. Cost of Sales margin increased 4.1 percentage points primarily due to product mix, including COVID-19 antibody shipments to Lilly that began this quarter, profit share and royalties. R&D expenses increased 11% primarily due to higher research and early pipeline spend and late-stage development program spend, including our recent business development activities. SG&A expenses increased 6% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches.
Operating Margin as a percentage of product sales decreased 4.1 percentage points to 50.9%.
Tax Rate decreased 1.0 percentage points primarily driven by a prior year change in foreign loss utilization.
Cash Flow and Balance Sheet

The Company generated $1.7 billion of free cash flow in the second quarter of 2021 versus $2.7 billion in the second quarter of 2020, driven by a difference in the timing of tax payments.
The Company’s second quarter 2021 dividend of $1.76 per share was declared on March 3, 2021, and was paid on June 8, 2021, to all stockholders of record as of May 17, 2021, representing a 10% increase from 2020.
During the second quarter, the Company repurchased 6.5 million shares of common stock at a total cost of $1.6 billion. At the end of the second quarter, the Company had $3.9 billion authorization remaining under its stock repurchase program.
Cash and investments totaled $8.1 billion and debt outstanding totaled $32.8 billion as of June 30, 2021.
2021 Guidance

For the full year 2021, the Company now expects:

Total revenues in the range of $25.8 billion to $26.6 billion, unchanged from previous guidance.
On a GAAP basis, EPS in the range of $8.84 to $9.90 and a tax rate in the range of 13.0% to 14.5%.
Previously, the Company expected GAAP EPS in the range of $9.11 to $10.71 and a tax rate in the range of 14.0% to 15.5%.
On a non-GAAP basis, EPS in the range of $16.00 to $17.00, unchanged from previous guidance and a tax rate in the range of 13.5% to 14.5%, also unchanged from previous guidance.
Capital expenditures to be approximately $900 million.
Share repurchases at the upper end of our previous guidance of $3.0 billion to $5.0 billion.
Second Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

LUMAKRAS

In May, the U.S. Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. LUMAKRAS received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Regulatory reviews continue in Europe, Japan and other jurisdictions.
Top-line results from the event-driven confirmatory Phase 3 study comparing LUMAKRAS to docetaxel in patients with KRAS G12C-mutated advanced NSCLC are expected in H1 2022.
Primary results from the Phase 2 monotherapy study in patients with advanced KRAS G12C-mutated colorectal cancer (CRC) have been submitted for publication.
Additional data from the Phase 1/2 CodeBreaK 100 monotherapy study in advanced NSCLC have been accepted for presentation at the World Conference on Lung Cancer in September, including biomarker analyses and post hoc analyses of efficacy and safety in patients with stable brain metastases. Enrollment continues in a cohort of patients with active brain metastases in the CodeBreaK 101 study.
Exploration of LUMAKRAS in multiple Phase 1b combination cohorts continues to progress.
Initial data from LUMAKRAS in combination with Vectibix in patients with advanced KRAS G12C-mutated CRC have been accepted for presentation at the European Society for Medical Oncology Congress in September.
Initial data from LUMAKRAS in combination with a mitogen-activated protein kinase kinase (MEK) inhibitor and LUMAKRAS in combination with an oral EGFR inhibitor are planned to be submitted for presentation at a Q4 2021 medical conference.
The Company is collaborating with Novartis on a LUMAKRAS combination study with their SHP-2 inhibitor TNO155. A cohort is expected to initiate in the CodeBreaK 101 study in Q3 2021. Enrollment continues in a combination cohort with Revolution Medicine’s SHP-2 inhibitor RMC-4630.
Initiation of a Phase 2 study is planned for Q3 2021 in first-line patients with KRAS G12C mutated NSCLC whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutations.
Data from the Phase 2 monotherapy study in patients with KRAS G12C-mutated solid tumors other than NSCLC and CRC are expected in H1 2022.
BLINCYTO

In June, the European Commission approved an expanded indication for the use of BLINCYTO in the treatment of pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukemia as part of the consolidation therapy.
Bemarituzumab

The Company has initiated discussions with regulators on the Phase 3 study design for bemarituzumab, a first-in-class anti-fibroblast growth factor receptor 2b (FGFR2b) antibody for the treatment of patients with human epidermal growth factor receptor 2 (HER2) negative, FGFR2b-positive gastric and gastroesophageal junction cancer. Initiation of the registrational program is planned for Q4 2021.
Bemarituzumab has been granted Breakthrough Therapy Designation by the FDA as first-line treatment for patients with at least 10% FGFR2b overexpression and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin).
Planning is underway for bemarituzumab clinical studies in other solid tumors, including squamous NSCLC.
Acapatamab (AMG 160)

A dose expansion cohort of acapatamab, a half-life extended (HLE) BiTE molecule targeting prostate-specific membrane antigen (PSMA), has completed enrollment of patients with metastatic castrate resistant prostate cancer (mCRPC). Enrollment of acapatamab is ongoing in cohorts with reduced levels of monitoring during cycle one to explore outpatient administration.
An acapatamab dose escalation study has initiated for patients with NSCLC expressing PSMA.
A master protocol evaluating combinations of acapatamab with AMG 404, an anti-programmed cell death 1 (PD-1) antibody, or the novel hormone therapies enzalutamide or abiraterone, continues to enroll patients with earlier-line mCRPC.
Tarlatamab (AMG 757)

The Company has begun planning a potentially pivotal Phase 2 study and will initiate discussions with regulators for tarlatamab, an HLE BiTE molecule targeting delta-like ligand 3 (DLL3), in patients with relapsed or refractory small cell lung cancer.
A Phase 1b study of tarlatamab has begun recruiting patients with neuroendocrine prostate cancer.
A Phase 1b study of tarlatamab in combination with AMG 404 is planned to initiate in Q3 2021 for patients with small cell lung cancer.
Additional Phase 1 Oncology Programs

AMG 509, a bivalent T-cell engager XmAb 2+1 antibody targeting six transmembrane epithelial antigen of the prostate 1 (STEAP1) was recently granted Fast Track designation by the FDA and continues to enroll patients with mCRPC.
Pavurutamab (AMG 701), an HLE BiTE molecule targeting B-cell maturation antigen (BCMA), has resumed enrolling patients with relapsed or refractory multiple myeloma.
AMG 330, a BiTE molecule targeting CD33, continues to enroll patients with acute myeloid leukemia.
Enrollment has been paused in the Phase 1 study of AMG 427, a BiTE molecule targeting fms-like tyrosine kinase 3 (FLT3) for patients with acute myeloid leukemia.
HLE BiTE molecules AMG 199 and AMG 910, targeting mucin 17 (MUC17) and claudin 18.2 (CLDN18.2), respectively, continue to enroll patients with gastric and gastroesophageal junction cancer.
AMG 176, a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1), continues to enroll patients with hematologic malignancies.
AMG 256, a multispecific interleukin-21 receptor agonist, continues to enroll patients with PD-1 positive solid tumors.
Tezepelumab

In July, the FDA accepted the Biologics License Application and granted Priority Review for tezepelumab for the treatment of asthma. Regulatory reviews are also underway in the EU and Japan.
A Phase 3 study has begun enrolling patients with chronic rhinosinusitis with nasal polyps.
A Phase 2b study continues to enroll patients with chronic spontaneous urticaria.
A Phase 2 study continues to enroll patients with chronic obstructive pulmonary disease.
Otezla

In May, the Company announced that the FDA accepted the supplemental New Drug Application for Otezla for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The FDA has assigned a Prescription Drug User Fee Act action date of December 19, 2021.
Phase 3 planning is underway for Otezla for the treatment of Japanese patients with palmoplantar pustulosis.
The Company has stopped enrollment in the Otezla arms of ongoing platform trials designed to evaluate the efficacy and safety of potential treatments for patients hospitalized with COVID-19.
AMG 451 / KHK4083

The Company expects to commence discussions with regulators soon for AMG 451, an anti-OX40 monoclonal antibody, for the treatment of atopic dermatitis, with Phase 3 development anticipated to begin in H1 2022.
Rozibafusp alfa (AMG 570)

A Phase 2b study of rozibafusp alfa, a multispecific antibody-peptide conjugate that simultaneously blocks inducible T-cell costimulatory ligand (ICOSL) and B-cell activating factor (BAFF) activity, continues to enroll patients with systemic lupus erythematosus (SLE).
Efavaleukin alfa (AMG 592)

A Phase 2b study of efavaleukin alfa, an interleukin-2 mutein Fc fusion protein, is enrolling patients with SLE.
Data from a Phase 1b SLE study have been submitted to a Q4 2021 medical conference.
A Phase 2 study of efavaleukin alfa is planned to initiate in H2 2021 for patients with ulcerative colitis.
AMG 714 / PRV-015

A Phase 2b study of AMG 714, a monoclonal antibody that binds interleukin-15, continues to enroll patients with non-responsive celiac disease.
Repatha

A Phase 3 cardiovascular outcomes study (VESALIUS-CV) continues to enroll patients at high cardiovascular risk without prior myocardial infarction or stroke.
Olpasiran (AMG 890)

Results from a Phase 2 study in patients with elevated lipoprotein(a) are expected in H1 2022 with publication expected in H2 2022.
Aimovig

In June, the Japanese Ministry of Health, Labour and Welfare granted marketing approval for Aimovig for the suppression of onset of migraine attacks in adults.
Biosimilars

A Phase 3 study of ABP 654, a biosimilar candidate to STELARA (ustekinumab), has completed enrollment.
A Phase 3 study of ABP 938, a biosimilar candidate to EYLEA (aflibercept) continues to enroll patients.
A Phase 3 study of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), is ongoing.
Amgenpipeline.com

A listing of additional ongoing clinical programs can be found at Amgenpipeline.com
Tezepelumab is being developed in collaboration with AstraZeneca
AMG 451 (also known as KHK4083) is being developed in collaboration with Kyowa Kirin
AMG 714 (also known as PRV-015) is being developed in collaboration with Provention Bio
DARZALEX and STELARA are a registered trademarks of Janssen Pharmaceutica NV
EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.
SOLIRIS is a registered trademark of Alexion Pharmaceuticals, Inc.
XmAb is a registered trademark of Xencor, Inc.

U.S. Manufacturing Facilities

In anticipation of future demand for our medicines, we will invest approximately $1 billion to build two new manufacturing facilities – a packaging plant in Ohio and a drug substance plant in North Carolina. Both of these facilities will be built faster and at a lower cost than traditional plants, and both also will utilize cutting-edge technologies to be more efficient and environmentally friendly than traditional plants.

U.S. Tax Petition

In July 2021, we filed a petition in the U.S. Tax Court to contest notices of deficiencies received from the IRS during the quarter for 2010, 2011 and 2012. These notices seek to increase our U.S. taxable income by an amount that would result in additional federal tax of approximately $3.6 billion, plus interest. Any additional tax that could be imposed would be reduced by up to approximately $900 million of repatriation tax previously accrued on our foreign earnings. We firmly believe that the IRS’s positions in the notices are without merit and we will vigorously contest the notices through the judicial process.

Non-GAAP Financial Measures

In this news release, management has presented its operating results for the second quarters of 2021 and 2020, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2021 EPS and tax rate guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the second quarters of 2021 and 2020. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor’s overall understanding of the financial performance and prospects for the future of the Company’s ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company’s liquidity.

Beginning January 1, 2021, we began to exclude the gains and losses on our investments in equity securities from our non-GAAP measures that are recorded to Other income (expense). This exclusion will not apply to our share of the earnings and losses of our strategic investments in corporations accounted for under the equity method of accounting, such as our investment in BeiGene. The Company will be excluding gains and losses from equity investments for the purpose of calculating the non-GAAP financial measures presented because the Company believes the results of such gains and losses are not representative of our normal business operations. We are making this change beginning in 2021 because, as we have increased our investments in these companies, we recognized that the resulting variability can impede comparability between periods of our financial performance for our ongoing business operations. For comparability of results to the prior year, non-GAAP net income and non-GAAP EPS amounts for 2020 have been revised to reflect the update to our non-GAAP policy that excludes gains and losses on certain equity investments.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.