On November 5, 2020 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the three and nine months ended September 30, 2020 and updated its full year 2020 guidance (Press release, Emergent BioSolutions, NOV 5, 2020, View Source [SID1234570054]).

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"Over the last 22 years, Emergent has built a solid business founded on demonstrable strengths in partnering, manufacturing, and integrating value-added M&A," said Robert G. Kramer, president and chief executive officer of Emergent BioSolutions. "The strength of our core business and the accelerated growth of our contract development and manufacturing unit validate our strategy to pursue leadership positions across the public health threat market. Our diverse product and service portfolio gives us continued confidence in executing our strategy, delivering on our commitments to our partners and customers, and creating value for our shareholders."

SELECT Q3 2020 BUSINESS ACCOMPLISHMENTS

Completed an offering of $450 million in aggregate principal amount 3.875% Senior Unsecured Notes due in 2028. The Company utilized the proceeds from the offering to repay $353 million outstanding under its revolving credit facility with the remainder to be utilized for general corporate purposes.

Announced the initiation of a Phase 3 clinical trial sponsored by the National Institutes of Health to evaluate the safety, tolerability, and efficacy of hyperimmune globulin products, including the Company’s COVID-19 Human Immune Globulin (COVID-HIG), as a potential treatment in adult patients hospitalized with COVID-19.

Announced U.S. Food and Drug Administration (FDA) approval of the shelf life extension of NARCAN (naloxone HCl) Nasal Spray from 24 months to 36 months.

Secured approximately $60 million in new business and existing project extensions across development services, drug substance manufacturing, and drug product manufacturing towards the Company’s contract development and manufacturing (CDMO) portfolio.
2020 FINANCIAL PERFORMANCE (unaudited)

(I) Quarter Ended September 30, 2020 (Q3)

Revenues

Total Revenues

For Q3 2020, total revenues were $385.2 million, an increase of $73.4 million as compared to 2019. Total revenues reflect an increase in contract development and manufacturing services revenues partially offset by a decrease in product sales and contracts and grants revenues.

Product Sales

For Q3 2020, product sales were $202.2 million, a decrease of $54.0 million or 21% as compared to 2019. Other product sales increased due to increased sales of BAT[Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] and VIGIV [Vaccinia Immune Globulin Intravenous (Human)] offset by a decline in sales of travel health vaccines.

Contract Development and Manufacturing (CDMO) Services

For Q3 2020, revenue from the Company’s contract development and manufacturing operations was $157.1 million, an increase of $137.1 million as compared to 2019. The increase is largely due to the contribution of arrangements across development, drug substance manufacturing, and drug product manufacturing services with industry and government customers.

Contracts and Grants

For Q3 2020, revenue from the Company’s development-based contracts and grants was $25.9 million, a decrease of $9.7 million as compared to 2019. The decrease primarily reflects the completion of development activities associated with the AV7909 product candidate in 2019, partially offset by recent new development awards related to the Company’s COVID-19 product candidates.

Operating Expenses

Cost of Product Sales and Contract Development and Manufacturing (CDMO) Services

For Q3 2020, cost of product sales and contract development and manufacturing services was $149.0 million, an increase of $41.0 million or 38% as compared to 2019. The increase is primarily due to a charge of $29.9 million associated with contingent consideration liabilities due to the increased expectation that the Company will meet its final sales milestone for NARCAN Nasal Spray, a charge of $13.8 million related to a write-down of inventory balances due to the expected expiration of a portion of the Company’s travel health vaccines, and an increase in volume in CDMO services offset by a decline in volume of product sales.

Research and Development (Gross and Net)

For Q3 2020, gross R&D expenses were $84.4 million, an increase of $31.0 million or 58% as compared to 2019. The increase primarily reflects the impairment of the Company’s in-process research and development (IPR&D) intangible asset of $29.0 million. Excluding this item, research and development expenses were consistent reflecting an increase in costs associated with the Company’s COVID-19 therapeutic product candidates offset by a decrease in costs due to the completion of development activities associated with the Company’s AV7909 product candidate.

For Q3 2020, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue and the impact of the IPR&D intangible asset impairment, was $29.5 million, an increase of $11.7 million or 66% as compared to 2019. The increase is attributable to an increase in costs associated with the Company’s COVID-19 product candidates. The Q3 2020 and Q3 2019 net R&D expense was 8% and 6%, respectively, of adjusted revenue (total revenue less contracts & grants).

Selling, General and Administrative

For Q3 2020, selling, general and administrative expenses were $75.5 million, an increase of $10.5 million or 16% as compared to Q3 2019. The increase primarily reflects an increase in staffing costs to support the Company’s growth.

Amortization of Intangible Assets

For Q3 2020, amortization of intangible assets was $15.0 million, which was consistent with amortization of intangible assets of $14.7 million in Q3 2019.

Income Taxes

For Q3 2020, the income tax provision was $15.5 million as compared to $15.7 million in Q3 2019. The decrease is due to a decrease in income before the provision for income taxes of $3.9 million, an increase in discrete tax benefits of $3.5 million, offset by the impact of non-deductible contingent consideration expense. The Company’s effective quarterly tax rate, excluding discrete adjustments, was 34% and 26%, for Q3 2020 and Q3 2019, respectively. The effective quarterly tax rate, excluding the impact of non-deductible contingent consideration expense was 22% and 26%, for Q3 2020 and Q3 2019, respectively.

Net Income & Adjusted Net Income

For Q3 2020, the Company recorded net income of $39.5 million, or $0.73 per diluted share, versus net income of $43.2 million, or $0.83 per diluted share, in 2019.

For Q3 2020, the Company recorded adjusted net income of $119.0 million, or $2.19 per diluted share, versus adjusted net income of $64.8 million, or $1.24 per diluted share, in 2019. (1)

Adjusted EBITDA

For Q3 2020, the Company recorded adjusted EBITDA of $168.1 million versus $106.4 million in 2019. (1)

(II) Nine months ended September 30, 2020 (unaudited)

Revenues

Total Revenues

For the nine months ended September 30, 2020, total revenues were $972.4 million, an increase of 30% over 2019. Total revenues reflect an increase in product sales and contract development and manufacturing services offset by a decrease in contracts and grants revenues.

Product Sales

For the nine months ended September 30, 2020, product sales were $648.9 million, an increase of $56.2 million or 9% as compared to 2019. Other product sales decreased due to a decline in sales of raxibacumab and travel health vaccines slightly offset by an increase in sales of BAT and VIGIV.

Contract Development and Manufacturing (CDMO) Services

For the nine months ended September 30, 2020, revenue from the Company’s contract development and manufacturing services operations was $251.4 million, an increase of $196.8 million as compared to 2019. The increase is largely due to the contribution of arrangements across development, drug substance manufacturing, and drug product manufacturing services with industry and government customers.

Contracts and Grants

For the nine months ended September 30, 2020, revenue from the Company’s development-based contracts and grants was $72.1 million, a decrease of $26.3 million or 27% as compared to 2019. The decrease primarily reflects the completion of development activities associated with the AV7909 product candidate in 2019, offset by recent new development awards related to the Company’s COVID-19 product candidates.

Operating Expenses

Cost of Product Sales and Contract Development and Manufacturing Services

For the nine months ended September 30, 2020, cost of product sales and contract development and manufacturing services was $355.7 million, an increase of $55.0 million or 18% as compared to 2019. The increase is due primarily to an increase in volume of product sales and CDMO services, charges of $31.3 million related to the Company’s contingent consideration liabilities, a charge of $13.8 million related to a write-down of inventory balances due to the expected expiration of a portion of the Company’s travel health vaccines, and an increase in share-based compensation expense due to a one-time special broad-based, immediately vested equity award to employees.

Research and Development (Gross and Net)

For the nine months ended September 30, 2020, gross R&D expenses were $175.0 million, an increase of $11.6 million compared to 2019. The increase primarily reflects the impact of impairment of the Company’s IPR&D intangible asset of $29.0 million. Excluding this item, gross R&D expense decreased $17.4 million compared to 2019. The decrease primarily reflects a decrease in costs in 2020 due to the completion of development activities associated with the Company’s AV7909 product candidate in 2019. The decrease has been partially offset by an increase in costs associated with the Company’s chikungunya and COVID-19 product candidates.

For the nine months ended September 30, 2020, net R&D expense, which reflects investments made in development programs that are not currently funded in whole or in part by third-party partners and is calculated as gross research and development expenses minus contracts and grants revenue and the impact of the IPR&D intangible asset impairment, was $73.9 million, an increase of $8.9 million or 14% as compared to 2019. The increase primarily reflects an increase in costs associated with the Company’s chikungunya and COVID-19 product candidates offset by a decline in costs associated with the FLU-IGIV product candidate. The 2020 and 2019 net R&D expense was 8% and 10%, respectively, of adjusted revenue (total revenue less contracts & grants).

Selling, General and Administrative

For the nine months ended September 30, 2020, selling, general and administrative expenses were $221.2 million, an increase of $19.9 million or 10% as compared to 2019. The increase primarily reflects an increase in staffing costs to support the Company’s growth and share-based compensation due to a special broad-based, immediately vested equity award to employees during the second quarter of 2020.

Amortization of Intangible Assets

For the nine months ended September 30, 2020, amortization of intangible assets of $44.8 million was consistent with $43.9 million in 2019.

Income Taxes

For the nine months ended September 30, 2020, the income tax provision of $34.7 million increased $36.4 million when compared to 2019. The increase is due to an increase in income before the provision for income taxes of $148.5 million, offset by an increase in discrete tax benefits of $7.0 million in 2020. The Company’s effective tax rate, excluding discrete adjustments, was 29% and 27%, for the nine months ended September 30, 2020 and 2019, respectively. The effective tax rate, excluding the impact of non-deductible contingent consideration expense was 25% and 24%, for the nine months ended September 30, 2020 and 2019, respectively.

Net Income & Adjusted Net Income

For the nine months ended September 30, 2020, the Company recorded net income of $119.7 million, or $2.23 per diluted share, versus net income of $7.6 million, or $0.15 per diluted share, in 2019.

For the nine months ended September 30, 2020, the Company recorded adjusted net income of $225.1 million, or $4.20 per diluted share, versus adjusted net income of $69.6 million, or $1.33 per diluted share, in 2019. (1)

Adjusted EBITDA

For the nine months ended September 30, 2020, the Company recorded adjusted EBITDA of $339.5 million versus $145.4 million in 2019. (1)

2020 FINANCIAL FORECAST

Based upon the Company’s financial performance year to date as well as expectations for the remainder of the year, the Company has updated its full year 2020 financial forecast reflected by the following financial metrics and accompanying operational considerations:

The following operational considerations are incorporated in the Company’s forecast and remain consistent with the previous forecast:

Year over year improvement in gross margin of 400 – 600 basis points driven by improved product mix and increased contribution from the Company’s CDMO business;
The previously announced delay into 2021 of the launch of the Phase 3 clinical study for CHIKV-VLP, the Company’s chikungunya virus virus-like particle vaccine, due to the timing of certain operational factors;
The continued deferral into 2021 of a follow-on procurement contract with the U.S. government for raxibacumab, the Company’s FDA-approved anthrax monoclonal antibody therapeutic, due to the impact of the prioritization of Operation Warp Speed on the Company’s technology transfer activities for the product;
Continued challenges through the end of 2020 in the Company’s travel health business and revenues associated with Vaxchora (Cholera Vaccine, Live, Oral) and Vivotif (Typhoid Vaccine Live Oral Ty21a);
No generic competition in 2020 for NARCAN Nasal Spray.
The Company has assessed the risks to its business associated with the COVID-19 pandemic and has adopted measures to mitigate those risks as they are understood today and accordingly is providing this outlook for 2020. Despite the lack of expected material disruption to the business, the Company’s executive management continues to assess the business and operational implications associated with the pandemic and market conditions on its employees, patients, and customers.

The outlook for 2020 does not include estimates for potential new corporate development or other M&A transactions.

FOOTNOTES

(1) See "Reconciliation of Net Income to Adjusted Net Income and Adjusted EBITDA and Gross Margin and Adjusted Gross Margin" for a definition of terms and the reconciliation tables.

CONFERENCE CALL, PRESENTATION SUPPLEMENT, AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, November 5, 2020, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company’s website or through the followin

On November 5, 2020 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the third quarter and nine months ended September 30, 2020 (Press release, CymaBay Therapeutics, NOV 5, 2020, View Source [SID1234570053]).

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In the third quarter and through early November 2020, CymaBay made significant progress in restarting the development program for seladelpar in primary biliary cholangitis (PBC). Start-up is well underway for RESPONSE, a global phase 3 registration study evaluating seladelpar in patients with PBC and is poised for first patient dosed in the first quarter of next year. Results from the ENHANCE phase 3 study will be featured on November 16 in the late-breaking session of The Liver Meeting 2020 sponsored by the American Association for the Study of Liver Diseases (AASLD). This marks the fourth consecutive year in which data from the seladelpar development program in PBC will be featured in an oral, late-breaking presentation at The Liver Meeting.

Sujal Shah, President and CEO of CymaBay, stated, "We are making great progress towards restarting our seladelpar development program with RESPONSE as we drive to completing late-stage development of seladelpar for patients with PBC. Results from our ENHANCE study to be presented at The Liver Meeting 2020 demonstrate the anti-cholestatic, anti-inflammatory and anti-pruritic effects of seladelpar in patients with PBC and we believe highlight the potential for seladelpar to address key unmet needs for patients suffering from this serious, life-threatening disease. In addition to our core focus in PBC, we continue to evaluate seladelpar and our other early-stage clinical assets for other indications and development opportunities."

Recent Corporate Highlights

Start-up activities initiated for RESPONSE, a 52-week, placebo-controlled, randomized, global, phase 3 registration study evaluating the safety and efficacy of seladelpar in patients with PBC. This study is intended to enroll 180 patients, who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary.

CymaBay has also initiated start-up activities for ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional safety data to support registration. This study is expected to begin enrolling patients in early 2021. The first subjects will consist of patients who have participated in the Company’s prior studies of seladelpar in PBC, including the open-label phase 2 study, ENHANCE and the Company’s long-term safety study. As patients complete RESPONSE, and potentially other future PBC studies with seladelpar, they may also have the opportunity to enroll in ASSURE.

Announced results from two separate studies of seladelpar in patients with PBC and NASH that will be featured at The Liver Meeting 2020 sponsored by the American Association for the Study of Liver Diseases to be held virtually November 13th – 16th

Oral, late-breaking presentation by Professor Gideon Hirschfield, MD, on November 16 highlighting results from ENHANCE, a phase 3 study of seladelpar in patients with PBC
"Poster of Distinction" presentation by Dr. Stephen Harrison, MD, featuring results from a phase 2 paired-liver biopsy study of seladelpar in patients with NASH

In August 2020, CymaBay announced positive topline results from ENHANCE for seladelpar in patients with PBC. Topline data for patients through 3 and 6 months demonstrated anti-cholestatic, anti-inflammatory, and anti-pruritic activity. Notably, 78.2% of patients on seladelpar 10 mg versus 12.5% on placebo achieved the primary composite outcome after only 3 months (p<0.0001). In addition, 27.3% of patients on seladelpar 10 mg versus zero on placebo experienced normalization of ALP by 3 months (p<0.0001). Treatment with seladelpar 10 mg also resulted in a statistically significant improvement in pruritus (p<0.05) for patients with moderate-to-severe itch at baseline versus placebo. Overall, seladelpar appeared to be safe and well-tolerated in this study.

In November 2020, announced a study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes (T1D). Insulin-induced hypoglycemia in diabetes is a significant limiting factor in achieving the desired glucose control and is the cause of significant morbidity. In recent preclinical studies, GPR119 agonists were shown to enhance glucagon secretion in response to low glucose levels and were able to prevent hypoglycemia in animal models. The Phase 2a proof-of-pharmacology study will assess whether MBX-2982 can enhance glucagon secretion during insulin-induced hypoglycemia in subjects with T1D. The study will be led by the AdventHealth Translational Research Institute in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust. CymaBay retains full rights to MBX-2982.

CymaBay held $161.3 million in cash, cash equivalents and short-term investments as of September 30, 2020 and had no outstanding debt. We believe that cash and investments are sufficient to fund CymaBay’s current operating plan into 2022.

Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. To date, these developments have not had a significant impact on CymaBay’s financial condition or its ability to execute its business plan. CymaBay will continue to closely monitor pandemic developments and their associated risks to the business, including the restarting of its clinical development of seladelpar, and will continue to take actions available to mitigate them where possible. Further, all CymaBay’s actions will continue to be guided by a commitment to ensuring the health and safety of its employees as well as patients enrolled in its clinical studies.
Third Quarter and Nine Months Ended September 30, 2020 Financial Results

Research and development expenses for the three months ended September 30, 2020 were $7.7 million, compared to $23.2 million for the three months ended September 30, 2019. Research and development expenses for the nine months ended September 30, 2020 were $25.2 million, compared to $62.9 million for the nine months ended September 30, 2019. Research and development expenses in the first three and nine months of 2020 were significantly lower than the corresponding periods in 2019 primarily due to declining clinical trial activities related to the phase 3 PBC, phase 2b NASH, and phase 2 PSC clinical trials, and other studies, as efforts continued to shut down these studies, which were early-terminated as a result of the FDA’s clinical holds that were placed on the seladelpar program in the fourth quarter of 2019.

General and administrative expenses for the three months ended September 30, 2020 remained flat at $4.5 million when compared to the three months ended September 30, 2019. General and administrative expenses for the nine months ended September 30, 2020 were $12.2 million, compared to $14.7 million for the nine months ended September 30, 2019. General and administrative expenses in the first nine months of 2020 were lower than the corresponding period in 2019 due to lower employee compensation and other administrative expenses incurred as a result of a December 2019 reduction-in-force and restructuring effort that was undertaken to reduce costs after stopping development of seladelpar, while investigating the findings in the NASH phase 2 study.

Net loss for the three months ended September 30, 2020 was $11.4 million, or ($0.17) per diluted share, compared to a net loss of $26.3 million, or ($0.38) per diluted share in the three months ended September 30, 2019. Net loss for the nine months ended September 30, 2020 was $35.2 million, or ($0.51) per diluted share, compared to a net loss of $73.4 million, or ($1.10) per diluted share in the nine months ended September 30, 2019. Net loss was lower in the first three and nine months of 2020 compared to the corresponding periods in 2019 primarily due to a decrease in operating expenses, including clinical trial and labor related expenses, as a result of the early-termination of our seladelpar studies and our cost reduction efforts undertaken after stopping development of seladelpar in the fourth quarter of 2019, while beginning an investigation of the findings in the NASH phase 2 study. Given the FDA’s subsequent lifting of the clinical hold and CymaBay’s restart of the seladelpar program and further exploration of other clinical development opportunities, losses are expected to increase in the future as the Company continues its restarted clinical development activities.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. EST to discuss third quarter 2020 financial results and provide a corporate update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13709641. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On November 5, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that initial analysis of the first in human HMPL-689 Phase I dose escalation study will be presented as a poster at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place on December 5-8, 2020 virtually (Press release, Hutchison China MediTech, NOV 5, 2020, https://www.chi-med.com/chi-med-highlights-hmpl-689-clinical-data-to-be-presented-at-the-62nd-ash-annual-meeting/ [SID1234570052]).

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Further details of the presentation are as follows:

Title: Results from a Phase 1 Dose Escalation Study of HMPL-689, a Selective Oral Phosphoinositide 3-Kinase-Delta Inhibitor, in Chinese Patients with Relapsed/Refractory (R/R) Lymphoma
Lead Author: Junning Cao, Fudan University Cancer Center, Shanghai, China
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma – Clinical Studies: Poster I
Abstract # / Link: #1135 / View Source
Date & Time: Saturday, December 5, 2020, 7:00 AM – 3:30 PM (PT)

About HMPL-689
HMPL-689 is a novel, selective oral inhibitor targeting the isoform PI3Kδ, a component in the B-cell receptor signaling pathway. HMPL-689’s pharmacokinetic ("PK") properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, we therefore anticipate low risk of drug accumulation and drug-to-drug interaction.

Our Phase I/Ib study of HMPL-689 in China has successfully established a Phase II dose and has now expanded into multiple sub-categories of indolent non-Hodgkin’s lymphoma. We have initiated a Phase I/Ib study in the U.S. and Europe, with patient enrollment underway.

Chi-Med currently retain all rights to HMPL-689 worldwide.

On November 5, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported financial results for the third quarter ended September 30, 2020 (Press release, Personalis, NOV 5, 2020, View Source [SID1234570051]).

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Third Quarter Highlights

Reported record revenues of $19.8 million in the third quarter of 2020 versus $17.2 million in the third quarter of 2019, an increase of 15.5%
A total of 39 customers have placed orders for NeXT as of September 30, 2020, with 7 of those customers placing their first orders in the third quarter of 2020
Received a new task order with an approximate value of up to $31 million from U.S. Department of Veterans Affairs Million Veterans Program (VA MVP), increasing the contracted to date value to approximately $175 million
Achieved milestone of completing more than 90,000 whole human genomes sequenced under the VA MVP contract
Completed a follow-on public offering and sold 6.6 million shares of common stock at a price of $19.00 per share; received net proceeds of $117.1 million after discounts, fees, and expenses
"I’m proud to say that we were able to report record revenues once again this quarter, with our team delivering strong execution across both our population sequencing and biopharma businesses, despite the impact from the COVID-19 pandemic. We continued to see strong ordering levels from both our existing and new customers, and year-to-date, our biopharma orders were twice the amount compared with last year," said John West, Chief Executive Officer. "In addition, we further strengthened our balance sheet by raising $117.1 million with an equity financing in the quarter."

Third Quarter 2020 Financial Results

Revenues were $19.8 million in the three months ended September 30, 2020, up 15.5% from $17.2 million in the same period of the prior year. In the third quarter, the VA MVP accounted for $14.1 million of the company’s total revenues, and the remaining $5.7 million was from biopharmaceutical and all other customers.

Gross margin was 26.9% for the three months ended September 30, 2020, compared with 32.8% in the same period of the prior year.

Operating expenses were $15.0 million for the three months ended September 30, 2020, compared with $11.4 million in the same period of the prior year.

Net loss was $9.5 million for the three months ended September 30, 2020 and net loss per share was $0.27 based on a weighted-average basic and diluted share count of 35.5 million, compared with a net loss of $6.9 million and a net loss per share of $0.22 based on a weighted-average basic and diluted share count of 31.1 million in the same period of the prior year.

Cash, cash equivalents, and short-term investments were $206.1 million as of September 30, 2020.

Guidance and COVID-19

Due to continued uncertainty surrounding the COVID-19 pandemic, Personalis will not provide guidance for fiscal 2020 at this time.

Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter financial results after market close on Thursday, November 5, 2020 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using conference ID: 9697771. The live webinar can be accessed at View Source

On November 5, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the third quarter and nine months ended September 30, 2020 (Press release, Coherus Biosciences, NOV 5, 2020, View Source [SID1234570050]).

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"In September, Coherus celebrated its ten year anniversary, and I am thrilled by what we have accomplished at this milestone," said Denny Lanfear, Coherus President and CEO. "Coherus is fully integrated with competencies in research, development, and commercialization, and we are successfully fulfilling our mission to deliver value to patients by providing them access to cost effective drugs that can have a major impact on their lives. Moreover, our Udenyca business is generating significant cash flow, enabling investments in our pipeline of product candidates which, if approved, would expand our addressable market opportunity from $4 billion to $30 billion."

Third Quarter 2020 and Recent Corporate Highlights

Net product revenue for the third quarter of 2020 was $113.6 million, and net income was $27.9 million, or $0.33 per share on a diluted basis.
Non-GAAP income during the third quarter of 2020 was $39.7 million, or $0.47 per share on a diluted basis.
Cash flow from operating activities was $47.4 million for the third quarter of 2020.
Third Quarter 2020 Financial Results

Net product revenue for the third quarter of 2020 was $113.6 million. Cost of goods sold for the third quarter of 2020 was $9.0 million, resulting in a gross profit margin of 92%.

Research and development (R&D) expense for the third quarter of 2020 was $38.9 million, as compared to $21.6 million for the same period in 2019. R&D expense for the nine months ended September 30, 2020 was $98.1 million, as compared to $59.2 million for the same period in 2019. The increase in R&D expense in both periods was primarily due to preparations for the biologics license application (BLA) filing of CHS-1420, Coherus’ biosimilar to Humira (adalimumab), as well as other pipeline activities.

Selling, general and administrative (SG&A) expense for the third quarter of 2020 was $32.0 million, as compared to $31.8 million for the same period in 2019. SG&A expense for the nine months ended September 30, 2020 was $101.4 million, as compared to $101.0 million for the same period in 2019.

Cash, cash equivalents and investments in marketable securities for the third quarter increased to $503.4 as of September 30, 2020, as compared to $456.5 million as of June 30, 2020 and $177.7 million as of December 31, 2019. The increase in the third quarter of 2020 is primarily due to generating $47.4 million in net cash from operating activities.

Net income for the third quarter of 2020 was a $27.9 million, or $0.33 per share on a diluted basis, compared to $47.0 million, or $0.63 per share on a diluted basis for the same period in 2019.

Non-GAAP net income for the third quarter of 2020 was $39.7 million, or $0.47 per share on a diluted basis, compared to non-GAAP income of $55.7 million, or $0.74 per share on a diluted basis for the same period in 2019. See "Non-GAAP Financial Measures" below for a discussion on how the Company calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measures.

Guidance for the Next Twelve Months from September 30, 2020

Coherus will continue to lay the foundation for long-term growth across its three therapeutic areas:

Oncology

Deliver continued unit share growth with UDENYCA against all Neulasta dosage forms, while maintaining average selling price ("ASP") discipline, leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments.
Advance the Company’s biosimilar candidate to Avastin (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, depending on the outcome of the three-way pharmacokinetic ("PK") study, the timing of required interactions with the FDA, as well as completion of analytical similarity exercises.
Ophthalmology

Facilitate Bioeq’s resubmission of a 351(k) BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in 2021.
Advance the Company’s internally developed CHS-2020 biosimilar candidate to Eylea (aflibercept) to a projected Phase 3 clinical trial initiation in 2021, with launch projected in 2025, if approved.
Immunology

Submit the 351(k) BLA for the Company’s internally developed Humira (adalimumab) biosimilar, CHS-1420, by year end 2020, consistent with prior guidance, and continue other activities to advance toward a projected market entry in the United States on or after July 1, 2023, if approved.
Financial Guidance

R&D and SG&A expenses combined for the full fiscal year 2020 are expected to come in at the low end of the previously stated range of $285 million to $310 million, excluding upfront or milestone payments from any potential new collaborations.
Conference Call Information

When: Thursday, November 5, 2020 starting at 4:30 p.m. ET

Webcast: at View Source

The conference call will be broadcast live in listen-only mode on the Company’s investor relations website at View Source If you would like to ask a question, the dial in number for the conference call is 844-452-6826 (Toll-Free U.S. and Canada) or 765-507-2587 (International).

Conference ID: 7079429

Please dial-in 15 minutes early to ensure a timely connection to the call.

Third quarter 2020 financial results are posted on the Coherus website at View Source The webcast will be archived on the Coherus website.