Verrica Pharmaceuticals Reports Second Quarter 2020 Financial Results

On August 5, 2020 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, reported financial results for the second quarter ended June 30, 2020 (Press release, Verrica Pharmaceuticals, AUG 5, 2020, View Source [SID1234563554]).

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"We have made recent key personnel changes that will be important as we work to resubmit the New Drug Application for VP-102, following receipt of a Complete Response Letter from the U.S. Food and Drug Administration. We’re encouraged that the FDA did not raise any clinical safety or efficacy questions, and having recently strengthened leadership in clinical, CMC, and regulatory affairs, we intend to request a Type A meeting with FDA during the third quarter to discuss next steps for resubmission of our NDA. We continue to believe VP-102 can potentially be approved as a safe, effective treatment for molluscum," said Ted White, Verrica’s President and Chief Executive Officer.

Business Highlights and Recent Developments

Verrica received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for VP-102, in which the FDA requested additional information regarding certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process, as well as Human Factors validation. The Agency noted no clinical safety or efficacy deficiencies were identified. Verrica intends to request a Type A meeting with the FDA during the third quarter of 2020, and is committed to working to resubmit the NDA as quickly as possible.

The Company announced changes to its Board of Directors, as well as its CMC, and Regulatory Affairs leadership. Dr. Lawrence Eichenfield, a leading pediatric dermatologist, has been appointed to the Board. Dr. Eichenfield replaces Dr. Gary Goldenberg, who stepped down from the Board to assume the role of Verrica’s Chief Medical Officer. The Company also appointed Dr. Brad Catalone to the newly created position of Head of Drug Development.

Verrica entered into an Option Agreement with Torii Pharmaceutical Co., Ltd. (Torii) for the development and commercialization of Verrica’s product candidates for the treatment of molluscum contagiosum and common warts in Japan, including VP-102. Under the terms of the Option Agreement, Torii will pay Verrica USD $500,000 to secure the exclusive option. Torii may exercise the option to obtain exclusive license rights until the later of six months after the effective date of the Option Agreement, or ten business days after the Company notifies Torii that the FDA has accepted for filing the Company’s resubmission of the NDA for VP-102. If Torii exercises the option, the license agreement would provide for Torii to make an up-front payment of $11.5 million, up to an additional $58 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones, and tiered transfer price payments for supply of product in the percentage range of the mid-30s to the mid-40s of net sales. Torii would be responsible for all development activities and costs in support of obtaining regulatory approval in Japan.

Two new pooled analyses of the Phase 3 CAMP trials of VP-102 in molluscum were presented as online posters at the virtual American Academy of Dermatology 2020 Annual Meeting. A pre-specified exploratory analysis showed VP-102 brought about a statistically significant percentage of patients with complete molluscum lesion clearance across all lesion count quartiles compared to vehicle. An additional post-hoc analysis showed any patient with baseline characteristics matching study protocol may be a candidate for complete lesion clearance after up to four VP-102 treatments.
Second Quarter 2020 Financial Results

Verrica reported a net loss of $9.4 million for the second quarter of 2020, compared to a $7.0 million net loss for the same period in 2019.
Research and development expenses were $3.5 million in the second quarter of 2020, compared to $3.9 million for the same period in 2019. The decrease was primarily attributable to decreased costs related to Verrica’s development of VP-102 for molluscum contagiosum, partially offset by increased compensation costs.
General and administrative expenses were $5.1 million in the second quarter of 2020, compared to $3.6 million for the same period in 2019. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
Year-to-Date June 2020 Financial Results

Verrica reported a net loss of $19.2 million for the six months ended June 30, 2020, compared to a $14.5 million net loss for the same period in 2019.
Research and development expenses were $8.4 million for the six months ended June 30, 2020, compared to $8.4 million for the same period in 2019.
General and administrative expenses were $10.1 million for the six months ended June 30, 2020, compared to $7.1 million for the same period in 2019. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
As of June 30, 2020, Verrica had aggregate cash, cash equivalents, and marketable securities of $79.6 million, which the Company believes will be sufficient to support planned operations at least through the fourth quarter of 2021.

Takeda hustles to prevent cancer drug shortage after FDA warning letter

On August 5, 2020 Takeda reported took a slap from the FDA in June when inspectors slammed its Hikari, Japan, plant in a warning letter (Press release, FiercePharma, AUG 5, 2020, View Source [SID1234563250]). It turns out that fixing those problems helped trigger a local shortage of the chemotherapy drug leuprorelin—and now, the drugmaker is scrambling to shore up supply to keep the shortage from spreading.

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The June warning letter cited Hikari for poor equipment maintenance, faulty documentation and quality shortfalls. Working with the FDA to fix those problems, Takeda had to periodically stop production at the plant for remediation.

"We have a very strong expertise and background in quality," CEO Cristophe Weber said during the company’s quarterly earnings call. "So we know how to resolve this situation. We have a very clear path to … remediate the situation in Hikari."

Production stoppages naturally mean less output, and leuprorelin supply is suffering, the company said during its quarterly earnings presentation Friday. Manufacturing for the Japan market resumed July 20, and the company expects to resupply the drug there in September.

SPECIAL REPORT: The top 15 pharma companies by 2026 sales – Takeda

"We really are aiming to reduce the potential impact, the potential shortage for patients," Weber said during the earnings call. "We gave some guidance to the doctors in Japan to manage as well as possible their patients. So I apologize to the doctors, to the patients, about the inconvenience, but I think we are doing really our best to limit that impact."

Takeda’s earnings presentation said it anticipates a "temporary supply shortage" of leuprorelin in Japan, and "certain regions, including the U.S., may experience periodic shortages." The drug is a synthetic hormone used to fight prostate cancer, breast cancer, endometriosis, uterine fibroids and early puberty.

Listed by the U.S, FDA as leuprolide acetate, the drug is sold by AbbVie—once Takeda’s marketing partner on the drug—under the Lupron brand and Tolmar Pharma as Eligard and Fensolvi. According to the agency’s current catalog of drug shortages, various doses of AbbVie’s version are unavailable or on back order in the U.S.

Takeda said it doesn’t expect a global shortage of leuprorelin; it manufactures the drug for the European market at a plant in Osaka.

RELATED: AbbVie, Amgen and Takeda test anti-inflammatory drugs in joint COVID-19 study

The Hikari plant also produces Takeda’s ulcerative colitis therapy Entyvio, but several other facilities worldwide also turn out the drug, and the company said it does not expect any shortages. The plant was last inspected in 2017 with no problems found.

Meanwhile, Takeda is working with the FDA to fix the problems highlighted in the warning letter. It has brought in external consultants to help fashion a corrective action plan, the presentation slide said.

It will take time, however, as Weber noted on the earnings call. The audit took place in November 2019, Weber said, and typical remediation work takes 12-18 months. "That’s what we are seeing right now at Takeda. We believe that within 12 months, we will be ready for inspection," the CEO said, predicting an inspection-ready status by year’s end. "And we’ll have remediated the issues."

Summary of Consolidated Financial Results for the First Three Months of the Fiscal Year Ending March 31, 2021(PDF?433KB)

On August 5, 2020 Sysmex reported that (Press release, Sysmex, AUG 5, 2020, View Source [SID1234563232])

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1. Results for the First Three Months of the Fiscal Year Ending March 31, 2021

2. Dividend

3. Financial Forecast for the Year Ending March 31, 2021
Our consolidated financial forecast for the fiscal year ending March 31, 2021 is undetermined. Although we are currently investigating the impact of the global novel coronavirus (COVID-19) pandemic on customers’ capital expenditure and demand trends, rationally calculating a financial forecast is problematic at present. We will promptly disclose our financial forecast once calculation becomes possible.

4. Other Information
(1) Changes in significant consolidated subsidiaries (which resulted in changes in scope of consolidation):
No

(2) Changes in accounting policies and accounting estimates
1) Changes in accounting policies required by IFRS: No
2) Other changes in accounting policies: No
3) Changes in accounting estimates: No

(3) Number of outstanding stock (common stock)
1) Number of outstanding stock at the end of each fiscal period (including treasury stock):
209,310,432 shares as of Jun. 30, 2020; 209,266,432 shares as of Mar. 31, 2020
2) Number of treasury stock at the end of each fiscal period:
446,708 shares as of Jun. 30, 2020; 446,680 shares as of Mar. 31, 2020
3) Average number of outstanding stock for each period (cumulative):
208,839,381 shares for the three months ended Jun. 30, 2020
208,723,462 shares for the three months ended Jun. 30, 2019

Note: Quarterly summaries of financial results are excluded from quarterly reviews.
* Explanation regarding the appropriate use of financial forecast and other information
1. Our consolidated financial forecast for the fiscal year ending March 31, 2021 is undetermined.
Although we are currently investigating the impact of the global novel coronavirus (COVID-19) pandemic on customers’ capital expenditure and demand trends, rationally calculating a financial forecast is problematic at present. We will promptly disclose our financial forecast once calculation becomes possible. For details, please refer to "3) Consolidated financial forecast" within "1. Qualitative information on quarterly financial results" on page 5 of the attachment to this
document.

3. Supplementary financial materials (in Japanese and English) will be posted on the Sysmex websit on Wednesday, August 5, 2020.

1. Qualitative information on quarterly financial results
1) Operating performance analysis
Future-related information contained in the text below is based on the judgement as of the end of the fiscal period under review

During the first three months of the fiscal year ending March 31, 2021, in Japan concerns about the spread and prolonged impact of the COVID-19 pandemic are leading to a growing sense of uncertainty about the future, including rapid economic deceleration. Overseas, although economic activity has resumed in China, the COVID-19 pandemic continues to spread. The scale of the global economy is expected to shrink as a result.

On the healthcare front, Japan’s medical and healthcare field is expected to remain robust due to an aging society and increasingly diverse health and medical needs. Looking overseas, the populations of developed countries are aging, while economic growth in emerging markets is causing healthcare demand to increase and prompting higher levels of healthcare quality and service enhancements. These trends are promoting efficient healthcare, with structural changes brought about by artificial intelligence, information and communications technology, and other breaking technologies. However, with the number of COVID-19 cases rising globally, considerations about healthcare systems and public health capable of responding to pandemics like we are currently experiencing are exerting pressure and are likely to cause a major transformation of the healthcare environment itself. Sysmex is also likely to be affected by slowing demand in the short term, with healthcare institutions conducting fewer tests as individual countries introduce measures to prevent
non-essential and non-urgent travel.

Under these conditions, Sysmex launched the CN-6500/CN-3500 automated blood coagulation analyzers in the Japanese market to enhance the workflow efficiency of hemostasis testing. These products offer the same high levels of productivity, reliability, operability, and service as the CN6000/CN-3000 automated blood coagulation analyzers. In addition, they incorporate into a single unit the chemiluminescence enzyme immunoassay (CLEIA) measurement principles used in our HISCL-5000/HISCL-800 automated immunoassay systems. As a result, our new blood
coagulation analyzers allow for flexible measurements in response to a broad range of test orders in the fields of thrombosis and hemostasis, such as molecular markers for blood coagulation measured with CLEIA, in addition to the blood coagulation and platelet aggregation parameters that can be measured by CN-6000/CN-3000 automated blood coagulation analyzers, realizing an efficient testing workflow in a way that caters to needs in healthcare settings. Going forward, we will continue seeking to provide new value by promoting R&D on reagents related to hemostasis and
immunochemistry using CLEIA.

To help the city of Kobe prepare for an increase in infections by strengthening a PCR testing system for COVID-19, the City of Kobe, Sysmex, and SRL, Inc. (a subsidiary of Miraca Holdings Inc. [now H.U. Group Holdings, Inc.]) have configured and begun operating a new PCR testing system at the Sysmex BMA Laboratory, a clinical testing center in the Kobe Biomedical Innovation Cluster. In this initiative, Sysmex will take control of PCR tests. SRL will be in charge of supporting the creation of a testing system, collecting samples and reporting results. We plan to reinforce the PCR testin
implementation system, as necessary. Through this initiative, the three entities aim to reduce the physical and emotional burden of the COVID-19 threat on local residents.

Sysmex also established four antibody measurement technologies that enable detection of the circulating IgG antibody and IgM antibody. These antibodies react specifically to the nucleocapsid protein1 and spike protein2 in SARS-CoV-2, the virus that causes COVID-19. We have begun offering lab assay services using this testing technology for research into the past history of COVID-19 and research and consideration of the clinical significance of the SARS-CoV-2 defense function, as well as in a host of epidemiological studies. Furthermore, we have begun providing a lab assay service for
research on cytokines,3 which have been suggested as a useful indicator in monitoring the risk of increasing severity and treatment effects for SARS-CoV-2. Targeting research institutions, universities, medical institutions and pharmaceutical companies with this assay service, we will provide data that can be used to confirm testing methods suitable to such clinical applications as determining the risk of increasing severity and treatment effect, as well as data that can be used for vaccines, antiviral drugs and other drug discovery research. We aim to contribute to advances in research in amassing broad-ranging clinical evidence, including for epidemiological research, as well
as in drug discovery, to help in the diagnosis and treatment of COVID-19.

1 Nucleocapsid protein (N antigen):
A protein that constitutes the core structure of a virus, significantly affecting virus characteristics.
2 Spike protein (S antigen):
Protein that forms countless protrusions around the virus to bind with cell receptors and generate infection.
3 Cytokine:
This is a general name for proteins secreted by cells and used in intercellular communication.

In Japan, sales of reagents rose in the hematology field, but sales of instruments were down, particularly in the hematology field and in other fields related to laboratory information systems mainly due to the spread of the COVID-19 pandemic. As a result, sales in Japan fell 7.5% year on year, to ¥9,380 million.

Overseas, sales of instruments grew in the urinalysis and life science fields, while reagent sales dropped, centered on the hematology, urinalysis and immunochemistry fields mainly due to the spread of the COVID-19 pandemic. Consequently, overseas sales decreased 12.4% year on year, to ¥51,130 million. The overseas sales ratio fell 0.7 percentage point, to 84.5%.

SG&A expenses fell in all regions mainly due to activity restrictions due to the spread of the COVID-19 pandemic. SG&A expenses were down 8.6% year on year, to ¥18,928 million.

As a result, during the first three months of the fiscal year ending March 31, 2021, the Group recorded consolidated net sales of ¥60,511 million, down 11.7% year on year. Operating profit declined 38.3%, to ¥6,957 million; profit before tax decreased 32.9%, to ¥6,481 million; and profit attributable to owners of the parent fell 33.0%, to ¥4,487 million.

Performance by segment
(1) Japan
In Japan, sales of reagents increased in the hematology field. However, instrument sales declined in the hematology field and in other fields related to laboratory information systems mainly due to the spread of the COVID-19 pandemic. And reagent sales also declined in the immunochemistry field. As a result, segment sale were down 4.1% year on year, to ¥10,513 million.

On the profit front, segment profit (operating profit) fell 10.1%, to ¥6,194 million. The decrease was attributable to lower gross profit, stemming from lower sales and a deteriorating cost of sales ratio, despite lower SG&A and R&D expenses.

(2) Americas
In North America, instrument sales were up in the hemostasis field. However, sales in the region were down due to lower sales of instruments, reagents and maintenance services in the hematology field mainly due to the spread of the COVID-19 pandemic. In Central and South

America, reagent sales fell, mainly in the urinalysis field, but instrument and reagent sales in the hematology field rose, pushing up sales in the region. As a result, overall sales in the Americas were down 12.0% year on year, to ¥12,895 million.

On the profit front, the Americas generated a segment loss (operating loss) of ¥404 million (compared with segment profit of ¥449 million in the first three months of the preceding fiscal year). Profit was affected by lower gross profit, stemming from lower sales and deterioration in the cost of sales ratio, although SG&A expenses fell

(3) EMEA
Sales in the EMEA region declined 6.9% year on year, to ¥18,231 million. Instrument sales rose in the life science field and in other fields in relation to transport systems, but reagent sales were down in the hematology and urinalysis fields mainly due to the spread of the COVID-19 pandemic.

On the profit front, lower sales and deterioration in the cost of sales ratio caused gross profit to decline, while SG&A expenses fell. As a result, segment profit (operating profit) was ¥1,663 million, up 5.9% year on year.

(4) China
In China, sales fell 21.8% year on year, to ¥13,809 million. Instrument sales increased, mainly in the urinalysis and immunochemistry fields, but sales of instruments and reagents were down in the hematology field, as were sales of reagents in the urinalysis and immunochemistry fields mainly due to the spread of the COVID-19 pandemic.

On the profit front, segment profit (operating profit) dropped 84.4%, to ¥287 million as the result of lower gross profit due to falling sales and deterioration of the cost of sales ratio, despite lower SG&A expenses.

(5) Asia Pacific
Instrument sales were up in the hematology field, but regent sales decreased in the hematology and urinalysis fields mainly due to the spread of the COVID-19 pandemic. As a result, sales in the Asia Pacific region decreased 10.7% year on year, to ¥5,062 million.

On the profit front, SG&A expenses decreased, but falling gross profit due to lower sales and deterioration in the cost of sales ratio led to segment profit (operating profit) of ¥284 million, down 53.1% year on year.

2) Financial conditions analysis

(1) Financial conditions
As of June 30, 2020, total assets amounted to ¥368,826 million, down ¥20,465 million from March 31, 2020. As main factors, cash and cash equivalents were down ¥7,857 million, and trade and other receivables (current assets) fell ¥13,906 million, while inventories rose ¥5,128 million.

Meanwhile, total liabilities as of June 30, 2020 were ¥92,523 million, down ¥18,420 million. Principal decreases included trade and other payables, which were down ¥8,075 million; income taxes payable, down ¥3,339 million; accrued bonuses, down ¥2,971 million; and contract liabilities, down ¥2,087 million.

Total equity came to ¥276,302 million, down ¥2,044 million from March 31, 2020. Among principal reasons, retained earnings fell ¥3,030 million, while other components of equity increased ¥517 million. Equity attributable to owners of the parent to total assets rose 3.4 percentage points, from 71.3% on March 31, 2020 to 74.7% on June 30, 2020.

(2) Cash flows
As of June 30, 2020, cash and cash equivalents amounted to ¥48,734 million, down ¥7,857 million from March 31, 2020.
Cash flows from various activities during the first three months of the fiscal year are described in more detail below.

(Cash flows from operating activities)
Net cash provided by operating activities was ¥9,904 million (up ¥2,168 million). As principal factors, profit before tax provided ¥6,481 million (down ¥3,179 million), depreciation and amortization provided ¥6,198 million (up ¥436 million), a decrease in trade receivables provided

¥13,916 million (up ¥9,327 million), an increase in inventories used ¥4,461 million (up ¥823 million), a decrease in trade payables used ¥4,148 million (up ¥2,020 million), and a decrease in consumption taxes receivable provided ¥3,366 million (up ¥424 million).

(Cash flows from investing activities)
Net cash used in investing activities was ¥8,619 million (up ¥8,053 million). Among major factors, purchases of property plant and equipment used ¥1,915 million (down ¥1,342 million), purchases of intangible assets used ¥4,625 million (up ¥2,251 million), payments resulting in an increase in long-term prepaid expenses used ¥1,170 million (up ¥790 million), and proceeds from withdrawal of time deposits decrease ¥7,187 million year on year.

(Cash flows from financing activities)
Net cash used in financing activities was ¥9,085 million (up ¥206 million). This was mainly due to dividends paid of ¥7,517 million (up ¥4 million) and repayment of lease liabilities, which used ¥1,704 million (up ¥263 million).

3) Consolidated financial forecast
Although the COVID-19 pandemic continues to spread around the world, there are signs that economic activity is gradually returning in some countries. Even so, the outlook remains opaque, due to concerns that a second wave could occur and that the impact could be prolonged. Sysmex’s business segment is in the field of healthcare, and over the long term demand in this field is expected to remain high. In the first quarter under review (April to June 2020), demand was down temporarily as the number of hospital tests for items other than COVID-19 decreased, but testing numbers are trending upward. However, the speed of demand recovery differs by country.

Against this backdrop, the degree to which the global COVID-19 pandemic will affect customers’ capital investment and demand trends remains under consideration. As a result, the rational calculation of performance forecasts is problematic at this stage, so our consolidated financial forecast for the fiscal year ending March 31, 2021 remains undetermined. We will promptly discloseour performance forecast once calculation becomes possible.

6) Notes to the condensed quarterly consolidated financial statements
1. Notes related to the going concern assumption
Not applicable
2. Segment information
1) Overview of reportable segments

The Group’s reportable segments are the constituent business units of the Group for which separate financial data are available and that are examined on a regular basis for the purpose of enabling the Managing Board to allocate managerial resources and evaluate results of operations.

The Group is primarily engaged in the manufacture and sale of diagnostic instruments and reagents. These businesses are conducted in Japan by the Company, and in th Americas, EMEA, China and the Asia Pacific by regional headquarters established in those regions. These companies formulate overarching strategies tailored to regional characteristics and conduct business activities accordingly. Regional headquarters and other domestic and overseas subsidiaries are independent management units that handle production and sales for each region.

Accordingly, the Group has five reportable segments comprising geographical segments based on manufacturing and sales systems. These are "Japan," the "Americas," "EMEA," "China," and the "Asia Pacific."

2) Segment profit and operating results
Profit and operating results from continuing operations by reportable segment of the Group are as follows;
Intersegment sales are determined based on market prices or costs of goods manufactured.
Accounting policies of reporting segments are consistent with the Group’s accounting policies indicated in the consolidated financial statements for the previous fiscal year.

1. Segment profit (loss) adjustments of negative ¥78 million include negative ¥132 million for the unrealized gains on inventories and ¥79 million for the unrealized gains on non-current assets.
2. Segment profit (loss) is adjusted to coincide with operating profit in the condensed quarterly consolidated statement of income.

1. Segment profit (loss) adjustments of negative ¥1,068 million include negative ¥1,097 million for the unrealized gains on inventories and ¥110 million for the unrealized gains on non-current assets.
2. Segment profit (loss) is adjusted to coincide with operating profit in the condensed quarterly consolidated statement of income

VistaGen Therapeutics Announces Closing of $12.5 Million Underwritten Public Offering

On August 5, 2020 VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, reported the closing of its previously announced underwritten public offering of 15,625,000 shares of its common stock at a public offering price of $0.80 per share (Press release, VistaGen Therapeutics, AUG 5, 2020, View Source [SID1234563221]). Gross proceeds from the offering were $12.5 million, before underwriting discounts and commissions and estimated offering expenses. In addition, VistaGen granted the underwriter a 45-day option to purchase up to an additional 2,343,750 shares of common stock at the per share public offering price, less discounts and commissions.

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VistaGen currently intends to use the net proceeds from the offering for the continued development of its CNS pipeline programs, general research and development, working capital and general corporate purposes.

Maxim Group LLC acted as sole book-running manager for the offering.

The securities described above were offered by VistaGen pursuant to an effective shelf registration statement on Form S-3 (File No. 333-234025), previously filed with the U.S. Securities and Exchange Commission (SEC) on September 30, 2019 and declared effective on October 7, 2019. The securities were offered by means of a prospectus supplement and accompanying prospectus, forming part of the registration statement. The prospectus supplement and accompanying prospectus relating to this public offering have been filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus relating to the public offering may be obtained by contacting Maxim Group LLC, at 405 Lexington Avenue, 2nd Floor, New York, NY 10174, Attention: Prospectus Department, by telephone at (212) 895-3745, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Natera Reports Second Quarter 2020 Financial Results

On August 5, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported financial results for the second quarter ended June 30, 2020 and provided an update on recent business progress (Press release, Natera, AUG 5, 2020, View Source [SID1234563219]).

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Recent Accomplishments & Highlights

Processed approximately 234,100 tests in the second quarter of 2020 compared to approximately 194,200 tests processed in the second quarter of 2019, an increase of 21%.
Generated total revenues of $86.5 million in the second quarter of 2020 compared to $74.4 million in the second quarter of 2019.
Published Signatera study in Nature Cancer validating ability to monitor tumor response to immune therapy in 25 different types of solid cancer.
Launched the PEDAL study designed to demonstrate Prospera test enhancements at the American Transplant Conference.
Presented four abstracts, including one oral presentation and three poster presentations, at the American Society for Clinical Oncology conference demonstrating the performance of Signatera in areas including colorectal cancer and hepatocellular carcinoma.
Enrolled first patients in both CIRCULATE-Japan and BESPOKE CRC for Signatera in colorectal cancer, and in PROACTIVE for Prospera.
Received positive coverage from Noridian for Prospera; commenced full commercial launch.
Received the Force for Change Illuminator Award from Leading Women Entrepreneurs.
"The business was very resilient in the second quarter," said Steve Chapman, Natera’s Chief Executive Officer. "We posted another very strong volume and revenue result despite the COVID-19 impact, and we achieved major milestones across the oncology and transplant businesses. We are very proud of the team’s performance during this challenging time."

Second Quarter Ended June 30, 2020 Financial Results

Total revenues were $86.5 million in the second quarter of 2020 compared to $74.4 million for the second quarter of 2019. The increase in total revenues was driven primarily by sales of Natera’s Panorama and Horizon tests. Natera processed 234,100 tests in the second quarter of 2020, including approximately 221,600 tests accessioned in its laboratory, compared to 194,200 tests processed in the second quarter of 2019, including approximately 181,600 tests accessioned in its laboratory.

In the three months ended June 30, 2020, Natera recognized revenue on approximately 220,000 tests for which results were reported to customers in the period (tests reported), including approximately 208,400 tests reported in its laboratory, compared to approximately 187,600 tests reported, including approximately 174,800 tests reported in its laboratory, in the second quarter of 2019.

Gross profit* for the three months ended June 30, 2020 and 2019 was $39.5 million and $30.5 million, respectively, representing approximately 46% and 41% gross margin*, respectively. The company was able to achieve higher margins in the second quarter of 2020 primarily because of improved cost of goods sold per test and increased revenues.

Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the second quarter of 2020 were $91.2 million, compared to $59.2 million in the same period of the prior year. The increases were primarily driven by headcount growth to support new product offerings.

Loss from operations for the second quarter of 2020 was $51.6 million compared to $28.6 million for the same period of the prior year.

Net loss for the second quarter of 2020 was $59.6 million, or ($0.75) per diluted share, compared to net loss of $32.4 million, or ($0.48) per diluted share, for the same period in 2019. Weighted average shares outstanding were approximately 79.0 million in the second quarter of 2020.

At June 30, 2020, Natera held $571.2 million in cash, cash equivalents, short-term investments and restricted cash, compared to $441.0 million as of December 31, 2019. As of June 30, 2020, Natera had a total outstanding debt balance of $247.5 million, comprised of $50.1 million with accrued interest under its $50.0 million line of credit with UBS at a variable interest rate of 30-day LIBOR plus 110 bps and a net carrying amount of $197.5 million under its seven-year convertible senior notes. The convertible senior notes were issued in April 2020 for net proceeds of $278.9 million, of which a portion was used to repay the $79.2 million obligations under the company’s 2017 term loan with OrbiMed Advisors. The gross principal balance outstanding for the convertible senior notes was $287.5 million for the second quarter of 2020.

2020 Financial Outlook

Natera anticipates 2020 total revenue of $345 million to $365 million; 2020 cost of revenues to be approximately 51% to 55% of revenues; selling, general and administrative costs to be approximately $260 million to $280 million; research and development costs to be $85 million to $95 million, and net cash burn to be $125 million to $155 million**.

* Gross profit is calculated as GAAP total revenues less GAAP cost of revenues. Gross margin is calculated as gross profit divided by GAAP total revenues.

** Cash burn is calculated as the sum of GAAP net cash used by operating activities (estimated for 2020 to be between $117 million and $147 million) and GAAP net purchases of property and equipment (estimated for 2020 to be approximately $8 million).