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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

On August 3, 2021 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the second quarter ended June 30, 2021 (Press release, Apollo Endosurgery, AUG 3, 2021, View Source [SID1234585608]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights
•Achieved total revenue of $16.6 million, an increase of 194% compared to the second quarter of 2020, and a new revenue record for the Company*
•Increased Endoscopic Suturing System (ESS) revenue 23% and Intragastric Balloon (IGB) revenue 16% on a sequential basis compared to the first quarter of 2021
•Realized gross margin of 55% on favorable product mix
•Continued rollout of X-Tack with now more than 120 active sites, demonstrating excellent product performance, a short learning curve, and utility in a diverse range of upper and lower GI applications
•Reported that the Multi-Center ESG Randomized Interventional Trial (MERIT) study investigators announced successful achievement of the study’s primary efficacy and safety endpoints
•Strengthened the Apollo leadership team with the additions of Kirk Ellis as Vice President of Sales, Steve Bosrock as Vice President of Marketing & Medical Education, and Jeffrey Black as Chief Financial Officer
2021 Outlook
Based on results in the first half of 2021, the Company is increasing its guidance for the full year 2021 and now expects revenue between $61-$63 million, compared to its prior guidance of $55-$57 million.
"In the second quarter, Apollo continued to build momentum by delivering strong financial performance, including record revenue and increased gross margin," said Chas McKhann, Apollo’s Chief Executive Officer. "We also achieved a number of strategic milestones, including sequential growth in our ESS and IGB business lines, positive early indication on MERIT study outcomes and a significant expansion of our X-Tack user base. We believe that these accomplishments plus additions to our leadership team and commercial organization position us well for the future."
Second Quarter Results
Total revenues were $16.6 million for the second quarter of 2021, a new record for the Company’s endoscopy business. Revenue increased $11.0 million or 194% compared to $5.6 million in revenue during the second quarter of 2020 which was impacted by the onset of the COVID-19 pandemic.
Compared to the second quarter of 2020, total ESS product sales increased $7.0 million or 196% and total IGB product sales increased $4.0 million or 220% due to the improvement in demand for our products as the impact of the pandemic continued to dissipate.
Gross margin increased to 55% for the second quarter of 2021 from 43% in the second quarter of 2020 due to higher sales, improved mix of higher variable gross margin products including the new X-Tack device, and unabsorbed overhead costs from reduced production volumes in the prior year quarter as a result of the COVID-19 pandemic.
Total operating expenses increased $7.6 million compared to the second quarter of 2020. The increase was due to the normalization of temporary cost controls that we implemented in response to the pandemic. It also was impacted by higher stock-based compensation expense in the second quarter of 2021.
Net loss for the second quarter of 2021 was $3.0 million compared to $6.3 million for the second quarter of 2020. Excluding the $2.9 million gain on forgiveness of the PPP loan for the second quarter of 2021, and non-cash stock-based compensation expense of $2.5 million and $0.5 million for the second quarter of 2021 and 2020, respectively, net loss for the second quarter of 2021 improved 42% from the second quarter of 2020.
Cash, cash equivalents and restricted cash were $31.2 million as of June 30, 2021, representing a decrease of $1.4 million in cash for the quarter.
* Excluding divested product lines.

Conference Call
Apollo will host a conference call on August 3, 2021 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss Apollo’s operating results for the second quarter ended June 30, 2021. To join the conference call by telephone, please dial +1-973-528-0011. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: ir.apolloendo.com.
A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com following the call.
Non-GAAP Financial Measures
To supplement our financial results, we are providing a non-GAAP financial measure, product sales percentage change in constant currency, which removes the impact of changes in foreign currency exchange rates that affect the comparability and trend of revenues compared to the same period of the prior year. Product sales percentage change in constant currency is calculated by translating current foreign currency sales at last year’s exchange rate. This supplemental measure of our performance is not required by, and is not determined in accordance with GAAP.
We believe the non-GAAP financial measure included herein is helpful in understanding our current financial performance. We use this supplemental non-GAAP financial measure internally to understand, manage and evaluate our business, and make operating decisions. We believe that making non-GAAP financial information available to investors, in addition to GAAP financial information, may facilitate more consistent comparisons between the company’s performance over time with the performance of other companies in the medical device industry, which may use similar financial measures to supplement their GAAP financial information. However, our non-GAAP financial measure is not meant to be considered in isolation or as a substitute for the comparable GAAP metric.

On August 3, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported preliminary financial and operating results for the second quarter ended June 30, 2021 and increases 2021 guide to revenue between $475-$500 million for the year (Press release, Invitae, AUG 3, 2021, View Source [SID1234585607]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Having now served more than 2 million patients, a major milestone for the quarter, we are seeing a clear and steady rise in the rate of adoption of genetics for personalized medicine, and we are sitting at the forefront of making the vision of genetics in mainstream medicine a reality," said Sean George, co-founder and chief executive officer of Invitae. "Years of investment in that reality have delivered yet another strong quarter of growth, and with increased confidence in continuing momentum we are increasing our revenue guidance for the year."

Second Quarter 2021 Financial Results

Generated revenue of $116.3 million in the quarter, a 152% increase compared to $46.2 million in the same period in 2020
Reported billable volume of 287,000 in the quarter, a 154% increase compared to 113,000 in the same period in 2020
Reported preliminary average cost per billable unit of $317 in the quarter compared to $380 average cost per billable unit in the same period in 2020. Non-GAAP average cost per unit was $261 in the quarter
Achieved preliminary gross profit for the second quarter of 2021 of $25.2 million, compared to $3.2 million in the same period in 2020. Non-GAAP gross profit was $41.2 million in the second quarter
Preliminary total operating expense, which excludes cost of revenue, for the second quarter of 2021 was $159.3 million compared to $145.3 million in the same period in 2020. Non-GAAP operating expenses, which excludes cost of revenue, for the quarter was $198.2 million.

Preliminary net loss for the second quarter of 2021 was $129.0 million, or a $0.64 net loss per share, compared to a net loss of $166.4 million, or a $1.29 net loss per share, in the second quarter of 2020. Non-GAAP net loss for the quarter was $170.8 million, or a $0.85 non-GAAP net loss per share.

Cost of revenue, operating expense and net loss and other results as indicated are preliminary and subject to change as we finalize acquisition-related adjustments related to the likelihood of achieving a milestone related to the ArcherDX acquisition which closed in October 2020. These non-cash adjustments are expected to be significant and would be expected to increase the gain and reduce the liability reported in the preliminary financial information contained herein. Any adjustments will be incorporated in Invitae’s Form 10-Q to be filed with the SEC on or before August 9, 2021.

At June 30, 2021, cash, cash equivalents, restricted cash and marketable securities totaled $1.54 billion as compared with $681.9 million as of March 31, 2021. Net increase in cash, cash equivalents and restricted cash for the quarter was $913.5 million. Cash burn was $256.8 million for the quarter. Cash burn for the quarter would have been $136.7 million excluding the cash paid for acquisitions, primarily related to the cash paid to acquire Genosity.

In April, the company announced that a small group of investors, led by SB Management, a subsidiary of Softbank Group Corp., made an investment of $1.2 billion in convertible senior notes to support the company’s future growth initiatives.

Corporate and Scientific Highlights

Acquired digital health AI company Medneon to add their risk assessment tools to Invitae’s education and clinical support offerings to further support cancer patients by making it easier for clinicians to determine who should get testing and how to use genetic information to individualize treatment.
Launched collaborative partnership with the ECOG-ACRIN Cancer Research Group providing genetic testing for the NCI-sponsored, Phase II APOLLO trial (led by Dr. Kim Reiss-Binder, University of Pennsylvania), investigating the effectiveness of PARP inhibitor Olaparib in treating pancreatic cancer patients with mutations in BRCA1, BRCA2 or PALB2 (NCT04858334).
Partnered with Children’s National Hospital to expand the knowledge of Mendelian disorders (conditions that run in families) by identifying novel causes of rare inherited diseases, investigating the mechanisms underlying undiagnosed conditions, and enhancing data sharing across the genomics research community.
Opened early access to its new Personalized Cancer Monitoring (PCM) platform as a laboratory-developed test performed at an Invitae central laboratory.
Presented multiple studies in multiple cancer types at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showing all cancer patients can benefit from germline genetic testing to guide their care, including:
Data from 250 pancreatic cancer patients from the landmark INTERCEPT study conducted at the Mayo Clinic showed that nearly one in six patients with pancreatic cancer showed cancer-linked genetic changes and, importantly, receiving germline testing was associated with improved survival.
The nationwide PROCLAIM study applied a universal genetic testing approach in 615 prostate cancer patients to assess the efficacy of current testing criteria and found, consistent with INTERCEPT, that current testing criteria deprive patients and clinicians of actionable information, particularly among underrepresented populations, showing a significant number of cancer treatment-linked variants were missed if testing was restricted to current NCCN guidelines.
A third study showed simply changing medical policy is not enough to drive changes in clinician adoption. In a review of two independent datasets, including commercially insured and Medicare Advantage enrollees, only 3% of the 55,595 colorectal cancer patients received germline genetic testing, despite medical policy recommending germline genetic testing for all colorectal cancer patients (consistent with the INTERCEPT colorectal cancer study). Of the patients who received testing, 18% had a cancer-linked variant and two thirds, or 67%, of those patients were potentially eligible for precision therapy and/or clinical trials.
Signed 43 biopharma partnership deals in the quarter, including the introduction of a new sponsored testing program to provide no-charge genetic testing to individuals at risk for or suspected of having the most common adult neurodegenerative conditions, including Parkinson’s disease, amyotrophic lateral sclerosis and early-onset Alzheimer’s disease, in the United States, Canada, Australia and Brazil.
Inducement Grants

Invitae reported that it is granting restricted stock units ("RSUs") to new employees who joined Invitae in connection with its recent acquisition of Medneon LLC. The RSUs are being granted under Invitae’s 2015 Stock Incentive Plan, which was amended and restated to increase a pool of shares of Invitae common stock thereunder which is used exclusively for the grant of inducement awards in compliance with New York Stock Exchange Rule 303A.08 ("Rule 303A.08"). The RSUs were approved by the Invitae Board of Directors and are made as an inducement material to each employee entering into employment with Invitae in reliance on the employment inducement exemption under Rule 303A.08. The RSUs cover a total of 114,000 shares of Invitae common stock and will vest in tranches of 25% upon each of the date of grant and the first, second and third anniversaries of such date, subject to acceleration in the event of a termination without cause by Invitae or a termination with good reason by a recipient. A total of 12 recipients will receive these RSUs and the founders of Medneon, Kamal Gogineni and Rakesh Patel, will receive RSUs with respect to 15,000 shares of Invitae common stock each.

Webcast and Conference Call Details
Management will host a conference call and webcast today at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss financial results and recent developments. To access the conference call and webcast, please register at the link below:

View Source

Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

The live webcast of the call and slide deck, may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.