On August 3, 2021 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that it will report financial results and highlights for the quarter ended June 30, 2021 on Tuesday, August 10, 2021, after the U.S. financial markets close.

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The Company will host a conference call and live audio webcast on Tuesday, August 10, 2021 at 5:00 p.m. Eastern Daylight Time to report its second quarter 2021 financial results and provide a corporate update. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 2825907. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode ID 2825907. The webcast and telephone replay will be archived on the Company’s website at www.regulusrx.com following the call.

Wedbush PacGrow Healthcare Conference

Additionally, the Company announced that Jay Hagan, President and Chief Executive Officer, will participate in a panel at the 2021 Wedbush PacGrow Healthcare Conference on Wednesday, August 11, 2021, at 4:05 p.m. E.T.

A live webcast of the panel will be available on the investor relations section of the Company’s website at www.regulusrx.com. A replay of the webcast will be archived for 30 days following the presentation date.

on June 24, 2021, Prothena Corporation plc ("Prothena") reported that Bristol Myers Squibb ("BMS") exercised its option under the terms of the ongoing global neuroscience research and development collaboration (the "Master Collaboration Agreement") to enter into an exclusive U.S. license for PRX005 (Filing, 8-K, Prothena, AUG 3, 2021, View Source [SID1234585612]).

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On July 30, 2021, Prothena entered into a U.S. License Agreement (the "Tau U.S. License Agreement") granting BMS the exclusive license to develop, manufacture and commercialize antibody products in the United States targeting Tau ("Tau Collaboration Products") for any and all uses or purposes with respect to any human or animal disease, disorder or condition.

The Tau U.S. License Agreement includes an upfront payment to Prothena of $80 million. Prothena will be eligible to receive regulatory and sales milestones up to $465 million upon achievement of certain developmental events, including regulatory approval, of a Tau Collaboration Product, and on BMS achieving certain annual net sales thresholds in the United States. Prothena also will be eligible to receive tiered royalties on net sales of Tau Collaboration Products, ranging from high single digit to high teen percentages, on a weighted average basis depending on the achieving of certain net sales thresholds. Such exercise fees, milestones and royalty payments are subject to certain reductions as specified in the Tau U.S. License Agreement.

Prothena is running the Phase 1 clinical study for PRX005. Pursuant to the terms of the Master Collaboration Agreement, BMS may elect to exercise its option to enter into an exclusive global license for PRX005 ("Tau Global Rights") following delivery of the Phase 1 clinical study results. If BMS exercises its Tau Global Rights, BMS would be obligated to pay an additional exercise fee of $55 million. The Tau Global Rights would then replace the regulatory and sales milestones under the Tau U.S. License Agreement, and would increase from $465 million to $562.5 million. The tiered royalties on net sales would remain the same.

Under the Tau U.S. License Agreement, BMS will continue to pay royalties on a product-by-product and country-by-country basis, until the latest of (i) expiration of certain patents covering the Tau Collaboration Products and (ii) an agreed period of time after the first commercial sale of the Tau Collaboration Products in the United States (the "Royalty Term").

The term of the Tau U.S. License Agreement will continue on a product-by-product and country-by-country basis until the expiration of all Royalty Terms with respect to all Tau Collaboration Products. Either party is entitled to terminate the Tau U.S. License Agreement for material breach, bankruptcy or safety reasons. Prothena is entitled to terminate the Tau U.S. License Agreement for a failure by BMS to exercise due diligence with respect to its global rights for the Tau Collaboration Products under the Master Collaboration Agreement, and for certain patent challenges by BMS. The Tau U.S. License Agreement imposes certain post-termination rights and obligations on the parties, which vary based on the reasons giving rise to the termination.

Additionally, under the Master Collaboration Agreement, BMS has options to Prothena’s programs to develop and commercialize antibodies targeting TDP-43 and an undisclosed target. For each such program, BMS may elect to exercise its option to exclusively license rights both in the U.S. and on a global basis. The exercise fees for the remaining programs are, in the aggregate, up to $270 million, and the regulatory and sales milestones are, in the aggregate, up to $1.125 billion.

The foregoing description of the Tau U.S. License Agreement is not a complete description thereof, and is qualified in its entirety by reference to the actual agreement that will be filed with the Securities and Exchange Commission as an exhibit to Prothena’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2021.

The foregoing description of the Master Collaboration Agreement is not a complete description thereof, and is qualified in its entirety by reference to the actual agreement that is filed with the Securities and Exchange Commission as Exhibit 10.8 to Prothena’s Annual Report on Form 10-K filed February 26, 2021.

On August 3, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported financial results for the second quarter 2021 (Press release, Alector, AUG 3, 2021, View Source [SID1234585611]). As of June 30, 2021, Alector’s cash, cash equivalents and investments totaled $319.6 million.

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"With the recent presentation of encouraging Phase 2 data for our lead program, AL001 in people with FTD-GRN, at the Alzheimer’s Association International Conference and our announcement of a significant collaboration with GlaxoSmithKline to expand and accelerate the development of AL001 and AL101, we move much closer to realizing the vast potential of our progranulin franchise programs," said Arnon Rosenthal, Ph.D., co-founder and chief executive officer of Alector. "Our earlier-stage pipeline is also steadily progressing and based on our immuno-neurology expertise and insights into human genetics, we continue working to advance new programs to the clinic, all with the aim of halting the degeneration associated with serious neurological disease."

Clinical and Corporate Updates

Progranulin Franchise Portfolio

Twelve-month data from up to twelve patients with frontotemporal dementia with a progranulin mutation (FTD-GRN) from the open-label INFRONT-2 Phase 2 clinical trial of AL001 were presented at the 2021 Alzheimer’s Association International Conference (AAIC).
Once monthly treatment with 60mg/kg of AL001 was shown to have a favorable safety profile and resulted in sustained elevation of progranulin to normal levels for greater than one year.
Clinical outcome assessments of AL001-treated patients showed slowing of clinical progression by 47% compared to a matched control cohort of participants from the Genetic FTD Initiative (GENFI2). Additionally, multiple disease-relevant biomarkers of lysosomal function, complement activation and neuronal health trended toward normalization or remained stable, suggesting that treatment with AL001 may slow disease progression. (1)

Alector and GlaxoSmithKline (GSK) entered into a global collaboration to co-develop and co-commercialize AL001 and AL101 for the treatment of neurodegenerative diseases, including FTD-GRN, as well as other forms of frontotemporal dementia, amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease.
The collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of AL001 and AL101 into large indications.
Under the terms of the agreement, Alector will receive $700 million in upfront payments. Alector will also be eligible for up to $1.5 billion in potential development, regulatory and commercial launch milestone payments, as well as profit-sharing in the U.S. and royalties on any ex-U.S. sales.

Alector is actively enrolling the Phase 3 INFRONT-3 pivotal clinical study of AL001 in at-risk and symptomatic carriers of frontotemporal dementia with a progranulin mutation. An ongoing Phase 2 study in frontotemporal dementia includes a cohort of patients with a C9orf72 mutation, and there are plans to begin testing AL001 in amyotrophic lateral sclerosis (ALS) patients with a C9orf72 mutation in the second half of 2021. AL101, Alector’s second progranulin-elevating monoclonal antibody, is designed to treat people suffering from more prevalent neurodegenerative diseases and is currently in a Phase 1a study in healthy volunteers.
Alzheimer’s Disease Portfolio

Two posters were presented at the 2021 AAIC for Alector’s AL002 program targeting TREM2. TREM2 loss of function is associated with a three-fold increase in the risk of developing Alzheimer’s disease (2). AL002 is Alector’s first-in-class anti-TREM2 monoclonal antibody that is being developed in collaboration with AbbVie in a global Phase 2 study.
The first poster detailed results of the AL002 Phase 1 study in healthy volunteers. AL002 was generally well tolerated and demonstrated dose-dependent and robust target engagement in the brain.
A second poster reviewed the study design of the ongoing Phase 2 INVOKE-2 trial in people with early Alzheimer’s disease. The global, multi-center, double-blind Phase 2 clinical trial is enrolling approximately 265 patients randomized to receive AL002 or placebo. The study is designed to investigate the efficacy and safety of AL002 for the treatment of Alzheimer’s disease.
Data from the Phase 1b study evaluating AL003 in participants with Alzheimer’s disease is expected in the second half of 2021. The AL003 clinical development program is being developed in collaboration with AbbVie.
Second Quarter 2021 Financial Results

Revenue. Collaboration revenue for the quarter ended June 30, 2021, was $6.6 million, compared to $3.2 million for the same period in 2020. Revenue is recognized as the program costs are incurred by measuring actual costs incurred to date compared to the overall total expected costs to satisfy the performance obligation. Changes in estimates for revenue recognized over time are recognized on a cumulative basis.

R&D Expenses. Total research and development expenses for the quarter ended June 30, 2021, were $47.8 million, compared to $34.1 million for the same period in 2020. This change was mainly driven by an increase in expenses to support advancement of several clinical and preclinical programs, as well as in increase in personnel-related expenses

G&A Expenses. Total general and administrative expenses for the quarter ended June 30, 2021, were $14.1 million, compared to $15.7 million for the same period in 2020. This decrease was primarily due to reduced legal fees associated with the conclusion of our arbitration proceedings for certain intellectual property matters.

Net Loss. For the quarter ended June 30, 2021, Alector reported a net loss of $55.1 million, compared to a net loss of $45.3 million for the same period in 2020.

Cash Position. Cash, cash equivalents, and marketable securities were $319.6 million as of June 30, 2021.

Updated Cash guidance. Based on the company’s cash position as of the end of the second quarter, combined with the anticipated net proceeds expected from the GSK collaboration beginning in the third quarter of 2021, Alector anticipates sufficient cash to fund currently planned operations into mid-2024.

On August 3, 2021 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2021 (Press release, Cerus, AUG 3, 2021, View Source [SID1234585610]).

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Recent developments and highlights include:

Second quarter 2021 total revenue of $37.8 million, reflecting a 41% increase over the prior year period. Total revenue was composed of (in thousands, except %):

As of this release, the Company is increasing its 2021 annual product revenue guidance range to $118 million to $122 million (from the prior guidance of $110 million to $114 million), representing an approximately 28% to 33% increase over full year 2020 reported product revenue.
Submitted PMA supplement to U.S. FDA for 7-day storage of INTERCEPT platelets.
Announced collaboration with LifeSouth Community Blood Centers to manufacture INTERCEPT Fibrinogen Complex, expanding the initial launch footprint into the Florida market.
First hospital customer contracts signed in initial launch states for INTERCEPT Fibrinogen Complex.
Announced the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-On Payment (NTAP) for INTERCEPT Fibrinogen Complex.
Submitted fourth and final module (Manufacturing) of CE Mark application for INTERCEPT red blood cells.
Cash, cash equivalents, and short-term investments of $123 million at June 30, 2021.
"The second quarter of 2021 was exceptional for Cerus on numerous fronts. Our record quarterly product revenue of $31.5 million exceeded our expectations and was led by U.S. platelet adoption," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "This strong momentum gives us confidence in delivering significant top-line growth over the balance of the year, and we are raising our full year product revenue guidance accordingly."

"In addition to our strong commercial execution, I am also very proud of several other accomplishments we made as an organization during the second quarter. As planned, we made two important regulatory submissions, with our PMA supplement to the FDA for 7-day storage of INTERCEPT platelets, as well as the fourth and final module of our CE Mark submission for INTERCEPT red blood cells. In addition, for our therapeutics business, we have signed initial customer contracts with hospitals who plan to begin using INTERCEPT Fibrinogen Complex in the second half of 2021, expanded our initial reach into the state of Florida through our collaboration with LifeSouth and received the NTAP from CMS," Greenman continued.

Revenue

Product revenue during the second quarter of 2021 was $31.5 million, compared to $21.5 million during the same period in 2020. Product revenue growth during the quarter benefited from increased demand for INTERCEPT platelet products in the U.S., with broad-based demand from blood centers across the country.

Second quarter government contract revenue was $6.3 million, compared to $5.3 million during the same period in 2020. Second quarter government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Cells as well as sponsored efforts related to the development of next generation pathogen reduction technology to treat whole blood.

Product Gross Profit & Margin

Product gross profit increased $4.4 million over the same period in 2020, however, product gross margins on product revenue during the second quarter of 2021 were 51.3% compared to 54.9% for the second quarter of 2020. The decrease in product gross margin was expected and was tied to increased sales to our U.S. customers, who typically use the Company’s single dose platelet kits, which provide a lower product gross margin percentage compared to our double dose kits that are used more broadly outside of the U.S. Additionally, increased freight costs also contributed to the decrease when compared to the prior year period.

Operating Expenses

Total operating expenses for the second quarter of 2021 were $36.8 million compared to $31.7 million for the same period of the prior year. In general, operating expenses were higher, in part due to the resumption of certain activities that had been suspended due to the effects of the COVID-19 pandemic.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2021 totaled $19.8 million, compared to $16.1 million for the second quarter of 2020. The year-over-year increase in SG&A expenses was tied to incremental expenses associated with the launch of the Company’s INTERCEPT Fibrinogen Complex product, incentive compensation costs, as well as increases in certain vendor fees.

R&D expenses for the second quarter of 2021 were $17.1 million, compared to $15.6 million for the second quarter of 2020. Higher R&D expenses were driven in part by costs associated with the INTERCEPT red blood cell programs in the U.S. and Europe, including the submissions of the third and fourth modules of the Company’s CE Mark application during the quarter. For the most part, U.S. red blood cell efforts are reimbursed and recorded as Government Contract Revenue on the Company’s statement of operations. Additionally, R&D expense during the 2021 period also included elevated costs associated with the development of a next generation, LED-based illuminator.

Net Loss

Net loss for the second quarter of 2021 was $15.4 million, or $0.09 per basic and diluted share, compared to a net loss of $14.9 million, or $0.09 per basic and diluted share, for the second quarter of 2020.

Balance Sheet

At June 30, 2021, the Company had cash, cash equivalents and short-term investments of $122.8 million, compared to $133.6 million at December 31, 2020.

During the quarter, the Company continued its investments in inventory in response to the expected growth of its business. At the same time, the Company continued to manage its accounts receivable, maintaining healthy days sales outstanding and managed cash use from operations down to $8.7 million. The Company continues to have access to additional funds under its loan agreement and, separately, revolving line of credit. During Q2, the Company exercised its option to extend the interest-only duration of its term loans through 2023, in accordance with its loan agreement. At June 30, 2021, the Company had approximately $54.7 million in outstanding term loans and $9.3 million of borrowings under its revolving loan credit agreement, compared to $39.6 and $8.5 million, respectively, at December 31, 2020.

Increasing 2021 Product Revenue Guidance

Based on the strong first half revenue and expectations for the second half of 2021, the Company now expects 2021 product revenue to be in the range of $118 million to $122 million, as compared to the prior range of $110 million to $114 million. The revised guidance range represents approximately 28% to 33% growth compared to 2020 reported product revenue.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 6554004. The replay will be available approximately three hours after the call through August 17, 2021.

On August 3, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the second quarter of 2021 and affirmed non-GAAP adjusted financial guidance for 2021 (Press release, Jazz Pharmaceuticals, AUG 3, 2021, View Source [SID1234585609]).

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"As we enter what we expect to be a period of sustained growth, I have never been more excited about the future for Jazz. The recent approval and launches of Xywav and Rylaze exemplify Jazz today. We are rapidly establishing ourselves as an innovative biopharmaceutical company with expanding R&D capabilities and substantial commercial prowess, underscored by our consistent execution across the business. The addition of the GW cannabinoid platform and related pipeline complement and enhance our own growing R&D capabilities, accelerating our ability to improve the lives of patients," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We have now executed four of five planned product launches since the beginning of 2020 and look forward to our anticipated launch of Xywav in idiopathic hypersomnia later this year, a critical step forward for these underserved patients. With 41% of our second quarter net product sales from recently launched or acquired products, we are well on track to meet our revenue diversification targets while driving significant shareholder value."

Robert Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer, added, "We are excited that Rylaze was recently approved in the United States and is now broadly available to acute lymphoblastic leukemia and lymphoblastic lymphoma patients in critical need. We aim to further leverage our proven R&D capabilities to deliver on the significant value of our pipeline and the GW cannabinoid platform. The shared values and patient-centricity among the Jazz and GW teams, coupled with the successful ongoing integration, will further enhance our ability to innovate and execute, including the planned initiations of a Phase 3 pivotal trial for Epidiolex in epilepsy with myoclonic-atonic seizures and the third Phase 3 nabiximols clinical trial in multiple sclerosis-related spasticity."

Business Updates

Corporate Development

On May 5, 2021, the Company completed the acquisition of GW Pharmaceuticals plc (GW) for a total value of approximately $7.2 billion, or $6.8 billion net of GW cash. The Company secured $5.35 billion of financing to fund the GW transaction. The financing structure supports the Company’s plans for rapid deleveraging to its stated targets while also continuing to make investments to grow the business. The combined company is a leader in neuroscience with a global commercial and operational footprint, well positioned to maximize the value of its diversified portfolio.

Neuroscience

Oxybate (Xyrem and Xywav):

Net product sales for the combined oxybate business increased 3% to $458.3 million in the second quarter of 2021 compared to the same period in 2020.
Average active oxybate patients on therapy were approximately 15,900 in the second quarter of 2021, an increase of approximately 5% compared to the same period in 2020.
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:

Xywav net product sales were $124.2 million in the second quarter of 2021.
There were approximately 5,100 active patients on Xywav exiting the second quarter of 2021.
In June 2021, FDA recognized seven years of Orphan Drug Exclusivity for Xywav.
FDA published its summary of clinical superiority findings for Xywav stating that Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem, and that the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated.
The Company has achieved its goal of obtaining broad payer coverage, having entered into agreements with all three of the largest pharmacy benefit managers.
Xyrem (sodium oxybate) oral solution:

Xyrem net product sales decreased 25% to $334.2 million in the second quarter of 2021 compared to the same period in 2020.
Xywav in Idiopathic Hypersomnia

FDA has granted Priority Review Designation and accepted the supplemental New Drug Application (sNDA) for Xywav in adult patients with idiopathic hypersomnia (IH). The Prescription Drug Fee User Act (PDUFA) target date for an FDA decision has been set for August 12, 2021, which is in line with the Company’s objective of launching in the fourth quarter of 2021 following risk evaluation and mitigation strategy (REMS) implementation.
Epidiolex/Epidyolex (cannabidiol):

Epidiolex/Epidyolex net product sales were $109.5 million in the second quarter of 2021. This includes sales from May 5, 2021, the closing date of the GW Acquisition.
On an unaudited pro forma basis, net product sales in the second quarter of 2021 increased by 32% to $155.9 million compared to the same period in 2020.
The Company expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), also known as Doose syndrome, in the first half of 2022. EMAS represents the fourth target indication for Epidiolex.
Sunosi (solriamfetol):

Sunosi net product sales increased by 41% to $12.1 million in the second quarter of 2021 compared to the same period of 2020.
In the second quarter of 2021, U.S. prescriptions increased by 25% compared to the first quarter of 2021.
Nabiximols:

The Company expects to initiate the third Phase 3 nabiximols clinical trial in multiple sclerosis (MS)-related spasticity this year.
The two ongoing Phase 3 clinical trials in MS-related spasticity continue to progress.
JZP385:

JZP385, a highly selective modulator of T-type calcium channels, is in clinical development for the potential treatment of essential tremor.
The Company expects to initiate a Phase 2b trial in late 2021.
JZP150:

JZP150, a fatty acid amide hydrolase (FAAH) inhibitor, is in clinical development for the potential treatment of post-traumatic stress disorder.
The Company expects to initiate a Phase 2 trial in late 2021.
Oncology

Zepzelca (lurbinectedin):

Zepzelca net product sales were $55.9 million in the second quarter of 2021.
Sequential demand growth over the first two quarters of 2021 was 8% and 9% respectively, offset mainly by reduced inventory holding by distributors.
Robust Zepzelca development program planned:
The Company’s partner, PharmaMar, plans to initiate a confirmatory trial in second-line small cell lung cancer (SCLC) later this year. If positive, this trial would confirm the benefit of Zepzelca in the treatment of SCLC when patients progress following first-line treatment with a platinum-based regimen.
The Company is collaborating with Roche to initiate a Phase 3 pivotal clinical trial in first-line extensive stage SCLC in combination with immunotherapy this year.
The Company expects to initiate a Phase 2 basket trial in early 2022 to explore lurbinectedin monotherapy in patients with select advanced or metastatic solid tumors. Cohorts will include advanced urothelial cancer, large cell neuroendocrine tumor of the lung, and homologous recombinant deficient positive (HRD+) cancers.
The Company has initiated a Phase 4 observational study to collect real world safety and outcome data in adult Zepzelca monotherapy patients with extensive stage small cell lung cancer who progress on or after prior platinum-containing chemotherapy.
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):

On June 30, 2021, FDA approved Rylaze under the Real-Time Oncology Review program for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric patients one month and older and adult patients who have developed hypersensitivity to E. coli-derived asparaginase.
Rylaze was launched and commercially available in the U.S. on July 15, 2021.
Rylaze is the only recombinant Erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment. It was developed by Jazz to address the needs of patients and healthcare providers for an innovative, high-quality Erwinia asparaginase with reliable supply.
Rylaze was granted orphan drug designation for the treatment of ALL/LBL by FDA in June 2021.
The Company will continue to work with FDA and plans to submit additional data in support of a Monday/Wednesday/Friday dosing schedule. Part B of the study is evaluating intravenous administration and is ongoing. The company also plans to submit this data for presentation at a future medical meeting.
The Company anticipates that data from the current development program will support regulatory filings in Europe in 2022 and is currently working with an in-country partner to advance the program for filing, approval and launch in Japan.
Vyxeos (daunorubicin and cytarabine) liposome for injection:

Vyxeos net product sales increased 18% to $31.5 million in the second quarter of 2021 compared to the same period in 2020.
Defitelio (defibrotide sodium) / defibrotide:

Defitelio/defibrotide net product sales increased 13% to $48.1 million in the second quarter of 2021 compared to the same period in 2020.
Erwinaze / Erwinase (asparaginase Erwinia chrysanthemi):

Erwinaze/Erwinase net product sales decreased 13% to $28.3 million in the second quarter of 2021 compared to the same period in 2020.
The Company’s agreement with Porton Biopharma Limited terminated on December 31, 2020. The Company had the right to sell certain Erwinaze inventory post-termination. Sale of this inventory was completed in June 2021.

GAAP net income (loss) for the second quarter of 2021 was ($363.3 million), or ($6.11) per diluted share, compared to $114.8 million, or $2.06 per diluted share, for the second quarter of 2020.

Non-GAAP adjusted net income for the second quarter of 2021 was $240.6 million, or $3.90 per diluted share, compared to $207.3 million, or $3.71 per diluted share, for the second quarter of 2020.

Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total revenues increased 34% in the second quarter of 2021 compared to the same period in 2020.

Products launched or acquired since 2019 accounted for 41% of total net product sales in the second quarter of 2021.
Neuroscience net product sales in the second quarter of 2021 increased 28% to $581.9 million compared to the same period in 2020. Oxybate net product sales increased to $458.3 million led by strong Xywav net product sales of $124.2 million partially offset by a decrease in Xyrem net product sales as a result of the strong adoption of Xywav by existing Xyrem patients. Epidiolex/Epidyolex net product sales from the date of acquisition were $109.5 million.
Oncology net product sales in the second quarter of 2021 increased 61% to $163.8 million compared to the same period in 2020 primarily driven by robust Zepzelca net product sales of $55.9 million. Zepzelca launched in the U.S. in July 2020.
Operating expenses changed over the prior year periods primarily due to the following:

Cost of product sales increased in the second quarter of 2021 compared to the same period in 2020, on a GAAP and non-GAAP adjusted basis, primarily due to increased net product sales as a result of the GW Acquisition. In addition, an acquisition accounting inventory fair value step-up expense of $66.0 million impacted GAAP cost of product sales.
Selling, general and administrative (SG&A) expenses increased in the second quarter of 2021 compared to the same period in 2020, on a GAAP and on a non-GAAP adjusted basis, primarily due to an increase in compensation-related expenses driven by higher headcount as a result of the GW Acquisition, increased investment in sales, marketing and launch activities primarily related to Sunosi, Xywav and Zepzelca in the U.S. and the addition of costs related to Epidiolex. SG&A expenses in the second quarter of 2021 on a GAAP basis also included transaction and integration related expenses of $129.5 million related to the GW Acquisition.
Research and development expenses increased in the second quarter of 2021 compared to the same period in 2020, on a GAAP and on a non-GAAP adjusted basis, primarily due to the addition of costs related to clinical programs for Epidiolex, nabiximols and cannabinoids, an increase in costs for JZP385 and an increase in compensation-related expenses due to higher headcount primarily driven by the GW Acquisition.
On a GAAP basis, our income tax provision for the three months ended June 30, 2021, included an expense of $251.4 million arising on the remeasurement of our U.K. net deferred tax liability, which arose primarily in relation to the GW Acquisition, due to a change in the statutory tax rate in the U.K. following enactment of the UK Finance Act 2021. Due to the impact of this expense, our effective tax rate for the three months ended June 30, 2021, on a GAAP basis is not a meaningful metric.
On a non-GAAP basis, the decrease in the effective tax rate in the second quarter of 2021 compared to the same period in 2020 was primarily due to the impact in 2020 of the disallowance of certain interest deductions, provision for the settlement reached with the French tax authorities, and the impact of the change in income mix.
Cash Flow and Balance Sheet

As of June 30, 2021, cash and cash equivalents were $891.4 million, and the outstanding principal balance of the Company’s long-term debt was $7.1 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500.0 million.

For the six months ended June 30, 2021, the Company generated $326.7 million of cash from operations.

2021 Financial Guidance1

Jazz Pharmaceuticals is reaffirming its previously communicated full year 2021 non-GAAP financial guidance and updating its 2021 GAAP guidance. This guidance reflects the Company’s current and future expected operational performance, including COVID-19 related impacts, the strength of its underlying operations and the prioritization of new and ongoing value creating development projects.

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. IST) to provide a business and financial update and discuss its 2021 second quarter results. The live webcast may be accessed from the Investors section of the Company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 7187077.

A replay of the conference call will be available through August 10, 2021 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 7187077. An archived version of the webcast will be available for at least one week in the Investors section of the Company’s website at www.jazzpharmaceuticals.com.