On May 7, 2020 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA to treat serious and life-threatening infections, reported financial results for the first quarter ended March 31, 2020 (Press release, Tetraphase, MAY 7, 2020, View Source [SID1234557284]).

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"In the first quarter, we announced a merger agreement with AcelRx Pharmaceuticals, Inc., an essential step forward for Tetraphase and more importantly, for XERAVA and the patients with serious life threatening infections in need of this treatment," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "In the midst of the ongoing COVID-19 pandemic and the continued rise of antibiotic resistance, our conviction in providing patients with different antibiotic treatment options is stronger than ever, and we believe that together with AcelRx we will be able to more effectively bring XERAVA to patients in healthcare institutions. With an approximate 20% growth in XERAVA net sales in the first quarter compared to the fourth quarter of 2019, we look forward to seeing continued success from the combined Tetraphase and AcelRx teams following the planned close of the acquisition this quarter."

First Quarter and Recent Highlights

Entered into Definitive Merger Agreement with AcelRx Pharmaceuticals, Inc.
In March 2020, the Company announced the execution of a definitive merger agreement pursuant to which AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) would acquire Tetraphase in a stock for stock transaction. Under the terms of the agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, 0.6303 of a share of AcelRx common stock, valued at approximately $14.4 million as of the close of trading on March 13, 2020, and one contingent value right (CVR), which would entitle the holders to receive aggregate payments of up to $12.5 million for the achievement of future XERAVA net sales milestones starting in 2021. The transaction was unanimously approved by both the AcelRx and Tetraphase boards of directors and is expected to close in the second quarter of 2020. Concurrently with signing the merger agreement, Tetraphase and AcelRx entered into a co-promotion agreement to market and promote XERAVA for the treatment of complicated intra-abdominal infections (cIAI) and DSUVIA for the treatment of acute pain in medically supervised settings.

Continued to Progress Launch of XERAVA in U.S. Hospitals With High Antibiotic Usage
The Company continues to see increased formulary uptake, with a 99% success rate for all formulary reviews to date and $1.8 million in XERAVA net sales for the first quarter of 2020, an increase of approximately 20% over the fourth quarter of 2019. Tetraphase’s salesforce is focusing on bringing XERAVA to targeted institutions, which are the highest users of antibiotics defined by days of therapy. The reorder rate for XERAVA continues to be strong, with reorder rates as high as 65% for all accounts and approximately 77% within the Tier 1 account segment. XERAVA is on formulary or available at more than 1,239 accounts. XERAVA continues to outperform all recent IV antibiotic launches anywhere from 3 to 10 fold in patient days of therapy (PDOTs).

Completed Equity Financing Totaling Net Proceeds of $15.9 Million
In January 2020, the Company completed a private placement with Armistice Capital, LLC, a healthcare-focused institutional investor, priced at-the-market, that generated gross proceeds of approximately $10 million. In addition, the Company concurrently completed a registered direct offering with certain healthcare-focused institutional investors, priced at-the-market, that generated gross proceeds of approximately $7.5 million. The net proceeds from the concurrent January 2020 private placement and registered direct offering were approximately $15.9 million. The Company issued warrants in connection with each financing.

First Quarter 2020 Financial Results

As of March 31, 2020, Tetraphase had cash and cash equivalents of $26.1 million and 7.3 million shares outstanding.

For the first quarter of 2020, Tetraphase reported a net loss of $12.1 million, or $1.31 per share, compared to a net loss of $19.5 million, or $7.25 per share, for the same period in 2019, driven by increased product revenues, lower operating expenses and an increase in the weighted-average number of shares outstanding.

Total revenues were $1.8 million for the first quarter of 2020, all of which was from sales of XERAVA, compared to $1.3 million for the same period in 2019, of which $0.3 million was from sales of XERAVA and $0.9 million was government contract revenue.

Research and development (R&D) expenses for the first quarter of 2020 were $1.9 million, compared to $6.7 million for the same period in 2019. The decrease in R&D expenses was driven by the completion of XERAVA development and our corporate reorganization in June 2019, which included the cessation of development of our pipeline candidates.

Selling, general and administrative (SG&A) expenses for the first quarter of 2020 were $10.7 million, compared to $13.3 million for the same period in 2019. The decrease was driven by our 2019 corporate reorganization as well as tight expense control during Q1 2020, offset by increased expenses related to the AcelRX merger transaction announced in March 2020.

About XERAVATM

XERAVA (eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company’s IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

XERAVATM Important Safety Information

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.

XERAVA is not indicated for the treatment of complicated urinary tract infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

On May 7, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the first quarter 2020 (Press release, Y-mAbs Therapeutics, MAY 7, 2020, View Source [SID1234557283]).

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"We are very pleased with our first quarter 2020 financial results, especially seen in conjunction with the completion of our naxitamab BLA submission to the FDA and the notable progress we’ve made on our rolling BLA submission for omburtamab, as well as the continued commercial ramp-up for the potential launch of both compounds. After the balance sheet date, we entered into an exclusive licensing agreement with MSK and MIT for the SADA technology, which we believe may be a potential game changer in therapeutic and diagnostic use of Liquid RadiationTM," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "We have worked hard to complete the submission of the naxitamab BLA in March, and were excited to see the application go in. The omburtamab BLA application process is well underway, and after our recent pre-BLA meeting with the FDA, we have made good progress on that submission. We expect to start submitting a rolling BLA in May, with anticipated completion in June."

First Quarter 2020 and Recent Corporate Developments

·Subsequent to the end of the first quarter, on April 24, 2020, Y-mAbs announced the appointment of Laura J. Hamill to its Board of Directors.

·Also, subsequent to the end of the first quarter, on April 15, 2020, Y-mAbs announced that it has entered into an agreement with Memorial Sloan Kettering Cancer Center and the Massachusetts Institute of Technology for a worldwide exclusive license and research collaboration for the SADA technology, a concept we refer to as Liquid RadiationTM.

·After the close of the first quarter, on April 1, 2020, Y-mAbs announced that the Company completed the submission of its rolling BLA submission to the FDA for naxitamab on March 31, 2020.

·On February 26, 2020, Y-mAbs announced a Pre-BLA meeting with the FDA for omburtamab.

Financial Results

Y-mAbs reported a net loss for the first quarter of 2020 of $26.2 million, or $0.66 per basic and diluted share, compared to a net loss of $15.9 million, or $0.47 per basic and diluted share, reported for the first quarter of 2019.

Operating Expenses

Research and Development

Research and development expenses were $18.6 million for the quarter ended March 31, 2020, compared to $12.5 million for the quarter ended March 31, 2019, an increase of $6.1 million. The increase in research and development expenses primarily reflects the following:

·$2.8 million increase in outsourced research and supplies to support the expansion of our product development activities;
·$2.1 million increase in personnel costs; and
·$0.9 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab.

General and Administration

General and administrative expenses were $8.1 million for the quarter ended March 31, 2020, compared to $3.7 million for the quarter ended March 31, 2019, an increase of $4.4 million. Such increase in general and administrative expenses primarily reflects the following:

·$1.6 million increase in personnel costs; and
·$1.6 million increase in commercial infrastructure costs.

Cash and Cash Equivalents

The Company had approximately $185.8 million in cash and cash equivalents as of March 31, 2020, compared to $207.1 million as of December 31, 2019. The decrease of $21.4 million was primarily attributable to the increased costs of operation as the Company completed its BLA submission for naxitamab and prepared the upcoming submission of the rolling BLA for omburtamab, as wells as build-up of the Company’s commercial infrastructure, and increased personnel costs related to thesse activities.

Webcast and Conference Call

The Company will host a conference call on Friday, May 8, 2020 at 9 am eastern time. To participate in the call, please dial 855-327-6838 (domestic) or 604-235-2082 (international) and reference the access code 10009507. A webcast will be available at: View Source

On May 7, 2020 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the quarter ended March 31, 2020 (Press release, Guardant Health, MAY 7, 2020, View Source [SID1234557282]).
Recent Highlights

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Revenue of $67.5 million for the first quarter of 2020, representing an 84% increase over the corresponding period of 2019

Reported 15,257 tests to clinical customers and 5,266 tests to biopharmaceutical customers in the first quarter of 2020, representing increases of 60% and 40%, respectively, over the first quarter of 2019

Onboarded more than 100 clinical sites for ECLIPSE trial and expanded the target number by 50% to 150 clinical sites

Data published in Nature Cancer demonstrated robust concordance of Guardant360 liquid biopsy with tissue biopsy testing and builds upon the strong clinical evidence from plasmaMATCH for Guardant360’s use in metastatic breast cancer

Strengthened leadership team with the addition of John Saia as Senior Vice President and General Counsel
"During these challenging times, I have even more confidence in the value that liquid biopsy can bring to the cancer treatment paradigm. Cancer treatment is not something that can be delayed for long and we remain unwavering in our commitment to serving patients in the advanced cancer setting," said Helmy Eltoukhy, PhD, co-founder and CEO. "We are operationally, financially, and strategically prepared to navigate through this difficult period and remain focused on the long-term opportunities ahead of us to transform cancer patient care."
"Consistent with our overall belief that earlier detection leads to better outcomes, we are confident that active surveillance testing of COVID-19 would benefit many essential businesses across the country. Given the significant testing gap that currently exists, we are exploring the feasibility of developing our own high throughput diagnostic test for COVID-19 to contribute to this need," continued Dr. Eltoukhy.
First Quarter 2020 Financial Results
Revenue was $67.5 million for the three months ended March 31, 2020, an 84% increase from $36.7 million for the three months ended March 31, 2019. Precision oncology revenue grew 109% driven by increases in testing volume and average selling price. There were 15,257 clinical tests and 5,266 biopharmaceutical tests performed during the first quarter of 2020. Development services revenue decreased 7% primarily related to the timing of achieving project related milestones for companion diagnostic development programs.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services, was $47.0 million for the first quarter of 2020, an increase of $23.9 million from $23.1 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 69.6%, as compared to 63.1% for the corresponding prior year period.
Operating expenses were $81.9 million for the first quarter of 2020, as compared to $46.8 million for the corresponding prior year period, an increase of 75.1%.
Net loss attributable to Guardant Health, Inc. common stockholders was $27.7 million for the first quarter of 2020, as compared to $26.1 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.29 for the first quarter of 2020, as compared to $0.30 for the corresponding prior year period.
Cash, cash equivalents and marketable securities were $758.3 million as of March 31, 2020.
Withdrawal of 2020 Financial Guidance
Given the rapidly changing nature of the COVID-19 pandemic, the ongoing uncertainty it has caused for us, our customers and our community, as well the difficulty in predicting the pandemic’s overall impact on its future financial results, Guardant Health is withdrawing its previously announced annual revenue and net loss guidance for 2020, which was provided on February 24, 2020.
Webcast and Conference Call Information
Guardant Health will host a conference call to discuss the first quarter 2020 financial results after market close on Thursday, May 7, 2020 at 2:00 PM Pacific Time / 5:00 PM Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

On May 7, 2020 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel, small-molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the first quarter ended March 31, 2020 (Press release, Calithera Biosciences, MAY 7, 2020, View Source [SID1234557281]).

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"We continued our positive momentum from 2019 into the first quarter of 2020, further strengthening our cash position and advancing our key clinical development programs," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "This included significant progress toward the initiation of our first clinical trial evaluating telaglenastat in non-small cell lung cancer patients with NRF2/KEAP1 genetic mutations. In addition, we plan to announce top-line results from the randomized CANTATA trial in the fourth quarter."

First Quarter 2020 and Other Recent Program Highlights

CANTATA randomized trial of telaglenastat and cabozantinib in advanced renal cell carcinoma (RCC). The CANTATA trial is a global, randomized, double-blind clinical trial of telaglenastat combined with cabozantinib, in patients with advanced or metastatic RCC who have received one or two prior treatments. The CANTATA trial enrolled 444 patients at multiple centers globally. The primary endpoint is progression-free survival (PFS). In light of delays associated with COVID-19, Calithera plans to report top-line efficacy and safety data from the trial in the fourth quarter of 2020.

KEAPSAKE randomized trial in non-small cell lung cancer (NSCLC) patients with a NRF2/KEAP1 genetic mutation. Mutation of the KEAP1/NRF2 pathway is present in approximately 20% of NSCLC and is associated with poor survival and resistance to standard-of-care therapy. Activation of this pathway leads to reliance upon glutaminase activity and sensitizes cells to glutaminase inhibition with telaglenastat. Given the challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, Calithera expects to begin enrollment of the first patient in the third quarter of 2020. A trial-in-progress abstract describing the study design has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Meeting (ASCO20). Calithera plans to present interim data from this trial in 2021.

Pfizer clinical collaboration with the CDK4/6 inhibitor IBRANCE, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor TALZENNA, each in combination with telaglenastat. In March 2019, Calithera initiated a Phase 1/2 trial of the combination of telaglenastat plus Talzenna in patients with solid tumors including expansion cohorts in renal cell carcinoma and triple-negative breast cancer. In July 2019, the company initiated a Phase 1/2 trial of the combination of telaglenastat plus Ibrance in patients with solid tumors including expansion cohorts in KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer. Dose escalation has been completed for both trials. Dose expansion cohorts have been temporarily paused due to the COVID-19 situation. Calithera expects enrollment to resume in the second quarter of 2020.

INCB001158 program. INCB001158, an internally discovered molecule, is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, in combination with anti-PD-1 immunotherapy, and in multiple chemotherapy regimens. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Clinical trials being conducted by Calithera and Incyte evaluating INCB001158 are ongoing as planned.

CB-280 arginase inhibitor program. Calithera has completed a first-in-human Phase 1 trial evaluating the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers. A Phase 1b clinical study in people with cystic fibrosis (CF), which is expected to start enrollment in the third quarter of 2020, given the challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, will test multiple doses of CB-280 compared to placebo in approximately 30 adults with CF to determine a safe dose range, and evaluate pharmacodynamic effects of arginase inhibition in this population.

Selected First Quarter 2020 Financial Results

Cash, cash equivalents and investments totaled $138.1 million at March 31, 2020. In April 2020, Calithera completed an underwritten public offering of 5,750,000 shares of common stock. Cash, cash equivalents and investments as of March 31, 2020 exclude the approximately $33.5 million in net proceeds from the April offering.

Research and development expenses were $20.1 million for the three months ended March 31, 2020, compared to $20.2 million for the same period in the prior year. The decrease of $0.1 million was primarily due to a $1.2 million decrease in the INCB001158 program and a decrease of $0.8 million for investment in our early stage research programs, partially offset by an increase of $1.4 million in the telaglenastat program and an increase of $0.5 million in our CB-280 program.

General and administrative expenses were $4.9 million for the three months ended March 31, 2020, compared with $4.2 million for the same period in the prior year. The increase of $0.7 million was primarily related to $0.5 million higher professional services costs mainly for legal and consulting services, and $0.2 million in higher facility costs related to the expiration of our sublease in February 2020.

Interest and other income, net was $0.6 million for the three months ended March 31, 2020, compared to $0.7 million for the same period in the prior year.

Net loss for the three months ended March 31, 2020 was $24.4 million, or $0.38 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, May 7, at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 and referring to conference ID 7543049. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On May 7, 2020 PDL BioPharma, Inc. ("PDL" or "the Company") (Nasdaq: PDLI) reported financial results for the three months ended March 31, 2020 and provides a business update (Press release, PDL BioPharma, MAY 7, 2020, View Source [SID1234557280]):

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In March 2020, the Company announced that its Board of Directors (the "Board") approved a Plan of Complete Liquidation and passed a resolution to seek stockholder approval at its next Annual Meeting of Stockholders to dissolve the Company under Delaware state law in the event the Board concludes that the whole Company sale process is unlikely to maximize the value that can be returned to the stockholders. The Company has not set a definitive timeline to file for dissolution and intends to pursue its monetization strategy in a disciplined and cost-effective manner seeking to maximize returns to stockholders. The Company recognizes, however, that accelerating the timeline, while continuing to seek to optimize asset value, could increase returns to stockholders due to reduced general and administrative ("G&A") expenses as well as potentially providing faster returns to stockholders. While the Company cannot provide a definitive timeline for the liquidation process, it has been targeting the end of 2020 for completing the monetization of its key assets. However, the Company recognizes that the duration and extent of the public health issues related to the COVID-19 pandemic make it possible, and perhaps probable, that the timing may be delayed. As announced previously, the Company has engaged financial advisors and initiated processes either to sell these assets separately or to transact the Company as a whole.

"We continue to execute on the strategy of monetizing our assets to unlock the full value of the company for our stockholders," said Dominique Monnet, president and CEO of PDL. "Our plan is to follow a disciplined approach with a focus on maximizing net proceeds. We remain confident in the high quality of our assets, and we believe that they are attractive acquisition targets.

"Earlier this week we announced Board of Director approval for a distribution of all of PDL’s shares of Evofem Biosciences common stock via a special one-time dividend to PDL stockholders as our first distribution under the Plan of Complete Liquidation," he added "We previously stated the ambitious goal of completing the monetization of our key assets by the end of 2020. While we are encouraged by our progress, we recognize that the impact of the COVID-19 pandemic on our assets and the businesses of potential buyers of those assets could cause some delays, which makes it possible, and perhaps probable, that the timing of the sale or sales may be delayed. Again, our intent is to pursue monetization in a disciplined and cost-effective manner and to distribute the net proceeds to stockholders in a tax-efficient manner in the form of share repurchases and dividends, or by other means."

Discontinued Operations Classified as Assets Held for Sale

As a result of these decisions and the actions put in place in the first quarter of 2020, at March 31, 2020 the assets held for sale and discontinued operations criteria were met for the Company’s royalty assets and for Noden Pharma, its pharmaceutical segment. The royalty assets are a component of the Income Generating Assets segment.

During the period in which a component meets the assets held for sale and discontinued operations criteria, an entity must present the assets and liabilities of the discontinued operation separately in the asset and liability sections of the balance sheet for the current and comparative reporting periods. The prior period balance sheet is reclassified for the held for sale items. For statements of operations, the current and prior periods report the results of operations of the component in discontinued operations. While the current period and prior period are presented herein on a comparative basis in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), the presentation has changed from the reporting of GAAP financial results in our fourth quarter 2019 earnings release.

First Quarter Financial Highlights

Total revenues were $6.0 million, consisting primarily of LENSAR product revenue.

LENSAR revenues were $6.0 million, a decrease of 11% over the prior-year period, with procedure volume declining 6%.

Net cash from all royalty rights was $13.6 million, up 8% from $12.6 million for the prior-year period.

U.S. market share for branded Tekturna and the authorized generic of Tekturna of approximately 68% at March 31, 2020 declined from 73% as of December 31, 2019.

GAAP net loss was $31.7 million. Non-GAAP net loss was $6.7 million. A reconciliation of GAAP to non-GAAP financial results can be found in Table 4 at the end of this news release.

Revenue Highlights

Total revenues for the first quarter of 2020 were $6.0 million and consisted primarily of LENSAR product revenue.
◦
Product revenue from LENSAR was $6.0 million, an 11% decrease from the first quarter of 2019. LENSAR procedure volume for the first quarter of 2020 declined 6% from the prior-year period, primarily due to lower system sales and procedures driven by the negative impact of the COVID-19 pandemic and the associated deferral of elective medical procedures, primarily in South Korea and China. While LENSAR U.S. operating results for the first quarter of 2020 were not impacted as significantly by the COVID-19 pandemic, beginning in late March and into the second quarter of 2020 the pandemic resulted in the cancellation of practically all elective cataract surgeries. LENSAR operating results are expected to improve as elective medical procedures gradually open throughout the remainder of 2020.

Operating Expense Highlights

Operating expenses from continuing operations of the Company include G&A expenses for corporate overhead as these costs have historically not been allocated to individual segments.

Operating expenses for the first quarter of 2020 were $37.9 million, a $23.0 million increase from the first quarter of 2019. The increase was primarily a result of an acceleration of equity awards and the accrual for cash severance and retention payments under our wind-down retention plan totaling $18.7 million, and for increased professional service costs. The vesting of equity awards was accelerated when the Board approved a Plan of Complete Liquidation in February 2020 as this action constituted a change in control.

There were decreases in cost of product revenue and sales and marketing expenses in our Medical Devices segment due to a decline in revenue, while G&A and research and development expenses reflected modest increases.

Net loss from continuing operations for the first quarter of 2020 was $31.8 million, a $23.3 million increase from the first quarter of 2019.

Discontinued Operations Highlights

Discontinued operations consist of the following items:

Net royalty revenues from acquired royalty rights, which include cash royalties received and a change in fair value of the royalty rights assets, were $9.4 million compared with $12.3 million in the prior-year period. The decrease is primarily related to the anticipated decrease in fair value of the royalty rights for the Type 2 diabetes products acquired from Assertio Therapeutics. PDL received $13.6 million in net cash from all its royalty rights in the first quarter of 2020, up from $12.6 million in the prior-year period. See Table 3 for a rollforward of royalty assets for the first quarter of 2020 compared with the comparable period in 2019.

The asset held for sale classification requires the Company to record the estimated cost to sell the asset as a deduction to the carrying value of the asset. In the first quarter of 2020, the Company recorded $6.0 million as the estimated cost to sell the royalty assets.
◦
Product revenue from Noden was $15.0 million compared with $20.0 million in the prior-year period. Revenues for the U.S. and the rest of the world were $3.9 million and $11.1 million, respectively, compared with $12.2 million and $7.8 million, respectively, in the prior-year period. The decline in U.S. revenue is primarily a result of the launch of an authorized generic of Tekturna as well as the launch of a third-party generic form of aliskiren in March 2019. U.S. market share for branded Tekturna and authorized generic of Tekturna of approximately 68% declined from the market share of 73% as of December 31, 2019.

In the first quarter of 2020, the Company recorded $1.9 million as the estimated cost to sell Noden.

Net loss from discontinued operations for the first quarter of 2020 was $0.2 million, a $15.3 million decrease from the first quarter of 2019. The decrease was primarily due to the estimated cost to sell the assets classified as held for sale of $7.9 million and the write down of Noden to reflect fair value upon its reclassification as an asset held for sale.

Other Financial Highlights

As of March 31, 2020, the Company’s investment in Evofem had a market value of $82.6 million, a decrease of $13.8 million from December 31, 2019. The Company acquired its investment in Evofem in two tranches in the second quarter of 2019, for a total of $60.0 million.

On a GAAP basis, the net loss attributable to PDL’s stockholders for the first quarter of 2020 was $31.7 million, or $0.26 per share, compared with GAAP net income attributable to PDL’s stockholders of $6.7 million, or $0.05 per diluted share, for the prior-year period. Non-GAAP net loss attributable to PDL’s stockholders was $6.7 million for the first quarter of 2020, compared with non-GAAP net income of $11.9 million for the first quarter of 2019.

PDL had cash and cash equivalents from continuing operations of $125.5 million as of March 31, 2020, compared with $169.0 million as of December 31, 2019.
◦
The $43.5 million reduction was primarily the result of common stock repurchases of $19.2 million, the net cash used for the repurchase of convertible debt of $18.0 million and net cash used in operations of $14.6 million. This reduction was partially offset by the proceeds from royalty rights of $13.6 million.

Stock Repurchase Programs

In January 2020, PDL began repurchasing shares of its common stock in the open market pursuant to the
10b5-1 program entered into in December 2019. In the first quarter of 2020, the Company acquired 6.3 million shares for $20.3 million, at an average cost of $3.20 per share, including commissions.

Under this same program, in the first quarter of 2020, the Company also repurchased $15.9 million par value of convertible notes.

As of April 30, 2020, the Company had approximately 116.5 million shares of common stock outstanding.

Conference Call and Webcast

PDL will hold a conference call to discuss financial results and provide a business update at 4:30 p.m. Eastern time today. Slides to accompany the conference call will be available in the Investor Relations section of View Source

To access the live conference call via phone, please dial 844-535-4071 from the U.S. and Canada or 706-679-2458 internationally. The conference ID is 7238226. A telephone replay will be available for one week beginning approximately one hour after the completion of the call and can be accessed by dialing 855-859-2056 from the U.S. and Canada or 404-537-3406 internationally. The replay passcode is 7238226.