FibroGen to Present at Upcoming Investor Conferences

On November 6, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following healthcare conferences (Press release, FibroGen, NOV 6, 2020, View Source [SID1234570269]):

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

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

                  Schedule Your 30 min Free Demo!

Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020 at 1:20 PM Eastern Time
Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 12:35 PM Eastern Time
A live audio webcast will be available on the "Events & Presentations" section of the FibroGen Investor webpage at View Source A replay will be available for approximately 30 days.

Amyris, Inc. Reports Third Quarter 2020 Financial Results

On November 6, 2020 Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company in Sustainable Health and Clean Beauty markets through its consumer brands and a top supplier of sustainably sourced natural ingredients, reported financial results for its third quarter ended September 30, 2020 (Press release, Amyris Biotechnologies, NOV 6, 2020, View Source [SID1234570237]).

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

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

                  Schedule Your 30 min Free Demo!

John Melo, President and Chief Executive Officer of Amyris said, "The third quarter of 2020 was another strong quarter for our company. Our ability to deliver record Product Revenue in these difficult and uncertain times is a testament to the resiliency of our team, the growing trend of consumers’ commitment to sustainable brands, our products, and the robustness of our business model."

Mr. Melo added, "During the quarter, we continued to execute across the strategic priorities we laid out in the beginning of the year. Our consumer business is growing at over three times 2019 revenue and delivered significantly expanded Gross Margin. We expect the combination of a strong fourth quarter along with the successful completion of strategic transactions to set us up for a profitable 2021."

Q3 2020 Financial Highlights

Sales Revenue: Product Revenue (Consumer & Ingredients) of $31 million was up 58% compared with the prior year quarter, with year-over-year revenue growth in Consumer (+203%) and Ingredients (+21%).
Cash operating expense of $43 million improved $5 million or 10% versus the prior year quarter, mostly due to lower G&A expense.
Adjusted EBITDA of -$33 million improved $10 million year-over-year due to strong revenue growth, improved gross margin and lower operating expense.
Interest expense of $7 million was down $10 million or 61% from Q3 2019 due to lower debt and an improved average interest rate.
Strategic Highlights

1. High growth consumer brands: above-market growth

Recent Progress:
Our wholly owned consumer brands delivered 220% growth on a year-to-date basis. Product Revenue demonstrated three consecutive quarters of >55% YoY growth.
Continued international growth of Biossance.
Upcoming milestone:
Pipette & fast-tracked to launch in China in November.
Biossance Entering China by year end
2. Scientific and commercial collaboration: fast time from lab to industrial scale

Recent Progress:
Executed agreement with the Infectious Disease Research Institute (IDRI) to accelerate development of a mRNA vaccine platform, starting with COVID-19 as first application.
Scaled commercial production of Cannabigerol (CBG), leveraging our fermentation process capability.
Upcoming milestone:
On track to deliver four molecules at scale, surpassing 2020 target of two to three.
Q4 Ingredients revenue to benefit from new products to market.
3. Supply chain optimization: enhanced product margins

Recent Progress:
Year-to-date gross margins improved versus 2019 driven by both Consumer and Ingredients. Consumer margins were 67% year-to-date, well within the 60-70% anticipated target range.
Cosmetics Ingredient Business delivered 49% adjusted EBITDA margin.
Upcoming milestone:
Construction of integrated Brazil ingredients plant on track for Q4 2021 commissioning.
4. Improved balance sheet, earnings and cash flow: financial foundation for success

Recent Progress:
Improved margin profile of consumer brands and ingredients portfolio.
Q3 cash operating expense improved 10%, mostly due to lower G&A.
Q3 interest expense was down 61%. Debt was reduced 41% since the start of 2020.
Q3 reported Total Revenue of $34 million included strong Product Revenue growth compared to the prior year quarter.
Q3 Product Revenue of $31 million increased $11 million or 58% compared with the prior year quarter, with year-over-year revenue growth in Consumer (+203%) and Ingredients (+21%). Q3 marks the third consecutive quarter of tripled year-over-year Consumer Revenue.
YTD Sales Revenue also saw strong growth from Product Revenue, partly offset by lower Collaboration Revenue.
Q3 2020 and Year-to-Date (YTD) Other Key Financials

Q3 Gross margin of 41% was supported by strong improvement in Product margins. Q3 Product gross margin of 35% grew $11 million versus the prior year quarter with a $9 million year-over-year improvement from Consumer and $2 million from Ingredients. YTD Gross margin also reflected a strong improvement in Product margins. Prior year gross margins were helped by higher Collaboration Revenue and a one-off Vitamin E transaction.
Q3 Cash Operating Expense of $43 million improved $5 million or 10% versus the prior year quarter. Improvements in G&A and R&D expense were partly redirected to marketing investments to support Consumer brand growth. T&E expense was down due to COVID-19. Sequential cash operating expense was flat despite continued topline growth. YTD cash operating expense of $130 million was down $6 million or 4%.
Q3 Adjusted EBITDA of -$33 million improved $10 million versus the prior year quarter due to strong revenue growth, improved gross margins and lower expense. YTD adjusted EBITDA of -$101 million improved from -$131 million in the prior year driven by gross margin growth and lower operating expense. Adjusted EBITDA excludes one-time impact from Vitamin E, Lavvan revenue and a one-off credit loss.
Interest Expense of $7 million was down $10 million or 61% from Q3 2019 due to lower debt and an improved average interest rate. Q3 2020 finished with debt of $175m, which compares to $241m at the end of the prior year quarter. YTD interest expense of $42 million improved by $3 million.
Q3 GAAP Net Income of -$23 million compared with -$60 million in 2019. The year-over-year and year-to-date comparisons are impacted by various non-cash adjustments related to fair value of derivatives and debt.
Diluted EPS of -$0.41 compared with -$0.56 for Q3 of 2019. YTD diluted EPS was -$1.46, which compared to -$2.11 for YTD 2019.
Despite strong financial performance in the third quarter, the extent to which the COVID-19 pandemic could affect Amyris’ future financial results and operations is subject to a high degree of uncertainty, and therefore the company is not providing formal guidance at this time.

FINANCIAL RESULTS AND NON-GAAP INFORMATION

To supplement our financial results and guidance presented on a GAAP basis, we use non-GAAP measures that we believe are helpful in understanding our results. These non-GAAP measures are among the factors management uses in planning and forecasting future periods. These non-GAAP financial measures also facilitate management’s internal comparisons to Amyris’s historical performance as well as comparisons to the operating results of other companies. Management believes these non-GAAP financial measures are useful to investors because they allow for greater transparency into the indicators used by management to understand, manage, and evaluate our business and make operating decisions. Our non-GAAP financial measures include the following:

Non-GAAP net income (loss) is calculated as GAAP net income/loss excluding stock-based compensation expense, gains or losses from change in fair value of debt, gains and losses from changes in the fair value of derivatives, losses on debt extinguishment, losses allocated to participating securities, deemed dividends to preferred stockholders, contract asset credit loss reserve, inventory lower of cost or net realizable value adjustments, loss from investment in affiliate and other income/expense.

Adjusted diluted EPS is calculated by dividing Non-GAAP net income (loss) by the weighted average shares, basic and diluted outstanding for the period.

Non-GAAP Gross Margin (Gross Margin) is calculated as GAAP revenues divided by GAAP cost of products sold excluding excess capacity, depreciation and amortization, other costs/provisions and inventory lower of cost or net realizable value adjustments.

Non-GAAP Cash Operating Expense is calculated as GAAP Operating Expense minus non-cash stock-based compensation, depreciation and amortization. In Q3 2020 it also excluded a one-off credit loss.

EBITDA is calculated as GAAP net loss less interest, expense, income tax expense, depreciation and amortization, deemed dividends to preferred stockholders and losses allocated to participating securities.

Adjusted EBITDA is calculated as EBITDA less stock-based compensation expense, gains or losses from change in fair value of debt, gains and losses from changes in the fair value of derivatives, losses on debt extinguishment, other income/expense, net, loss from investment in affiliate, contract asset credit loss reserve and inventory lower of cost or net realizable value adjustments.

Non-GAAP financial information is not prepared under a comprehensive set of accounting rules, and therefore, should only be read in conjunction with financial information reported under U.S. GAAP in order to understand Amyris’s operating performance. A reconciliation of the non-GAAP financial measures presented in this release to the most directly comparable GAAP financial measure, is provided in the tables attached to this press release.

Conference Call
Amyris will host its third quarter 2020 conference call today at 9:00 am ET (6:00 am PT) to discuss its financial results and provide an update on the company’s business. Those who wish to listen to the conference call should dial into (877) 870-4263 (U.S.) or (412)-317-0790 (international) and ask to be joined to the Amyris, Inc. call. A live webcast of the call will be available online on the Amyris website. To listen via live webcast, please visit: View Source

A replay of the webcast will be available on the Investor Relations section of the company’s website approximately two hours after the conclusion of the call. Additional information on Amyris’ third quarter 2020 results can also be found on the Company’s website.

Ampio Pharmaceuticals, Inc. Provides Business Update and Reports Third Quarter 2020 Financial Results

On November 6, 2020 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, reported, at 4:30pm EST, will provide an update and overview of its clinical development pipeline / activities and its financial results for the third quarter ended September 30, 2020 (Press release, Ampio, NOV 6, 2020, View Source [SID1234570228]).

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

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

                  Schedule Your 30 min Free Demo!

Attending the webinar from Ampio will be, Mr. Michael Macaluso (President and CEO), Dr. David Bar-Or (Director and Founder), Ms. Laura Goldberg (Vice President) and Mr. Daniel Stokely (CFO). The key areas of focus will be as follows:

COVID-19 Platform / Pipeline Overview and Update

AP-014 (inhaled) and AP-016 (intravenous) clinical trial update
Possibility of obtaining an Emergency Use Authorization (EUA) from the FDA for inhaled Ampion
Discussion of the differences between Ampion vs. other therapeutic options for COVID-19
OAK Clinical Trial 2020 Timeline / Update

Ampio’s Osteoarthritis of the Knee (OAK) Phase III trial being conducted under a Special Protocol Assessment (SPA) with the FDA has been paused as a result of COVID-19
FDA released "FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic" in April 2020
FDA released "Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency" in June 2020
Ampio harmonizes steps for OAK Phase III trial with the FDA guidance and submitted an SPA amendment to the FDA
Financial Update

As of September 30, 2020, Ampio had $9.4 million of cash and cash equivalents, as compared to cash and cash equivalents of $6.5 million as of December 31, 2019.

For the third quarter of 2020, research and development costs were $1.7 million, down 52% from $3.4 million for the same period in 2019. This decrease was primarily attributable to a decrease in clinical trial and sponsored research costs. Ampio expects clinical trial and sponsored research costs to increase during the fourth quarter of fiscal 2020 due to the AP-014 inhaled Ampion study.

Operations / manufacturing expenses increased $190,000 in the current quarter, when compared to the same period in 2019.

General and administrative costs decreased $98,000, or 5.6%, from $1.7 million for the same period in 2019.

Ampio reported a net loss for the third quarter of $3.4 million compared to a net loss of $7.2 million for the same period in 2019.

To access the webinar, please log in to View Source approximately 10 minutes prior to the start of the call. To ask a question, please dial in to 888-632-3385 (U.S.) or 785-424-1673 (International) and use the Participant Entry Code: 47668. Please note that you can also ask a question through the webinar platform.

A replay of this presentation will be available two hours after the end of the call by dialing 877-481-4010 (U.S.) or 919-882-2331 (International). Replay Passcode: 38512

Eiger BioPharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Business Update

On November 6, 2020 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for third quarter 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, NOV 6, 2020, View Source [SID1234570223]).

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

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

                  Schedule Your 30 min Free Demo!

Recent Highlights and Upcoming Milestones

ZokinvyTM (lonafarnib) in Progeria and Progeroid Laminopathies

New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date November 20, 2020
Lonafarnib in Hepatitis Delta Virus (HDV)

Phase 3 D-LIVR study full enrollment expected in 2021
Peginterferon Lambda (Lambda) in HDV

Phase 2 LIFT (combo with lonafarnib) end-of-study data expected at AASLD 2020
Agreement with FDA and EMA on single, Phase 3 Lambda monotherapy study design
Peginterferon Lambda (Lambda) in COVID-19

Toronto General Hospital, University Health Network (N=60)
Mean baseline viral load: 6.7 log copies/mL
79% (Lambda) vs 38% (placebo) (p=0.013) clear virus by Day 7
> 6 log copies/mL correlates with the threshold for infectivity
Stanford University School of Medicine (N=120)
Mean baseline viral load: < 4 log copies/mL
Median time to cessation of viral shedding was 7 days in both groups
Results of both studies support Lambda activity in high baseline viral load patients
Lambda was well tolerated in both studies with few adverse events, which included minimal elevations of transaminases which self-resolved
Plan to meet with FDA to discuss data and next steps
Third Quarter 2020 Financial Results

Cash, cash equivalents, and short-term investments as of September 30, 2020 totaled $125.3 million.

The Company reported net loss of $15.7 million, or $0.52 per share, for third quarter 2020, as compared to $18.6 million, or $0.76 per share, for third quarter 2019.

Research and Development expenses were $9.8 million for third quarter 2020, as compared to $14.1 million for third quarter 2019. The decrease was primarily due to a decrease in clinical trial related expenses, including clinical trial material costs.

General and Administrative expenses were $5.0 million for third quarter 2020, as compared to $4.2 million for third quarter 2019. The increase was primarily due to an increase in outside consulting, advisory and accounting services and an increase in personnel-related expenses.

Total operating expenses include total non-cash expenses of $1.9 million for third quarter 2020, as compared to $1.8 million for the same period in 2019.

As of September 30, 2020, the Company had 31.9 million of common shares outstanding.

Accelerate Diagnostics Reports Third Quarter 2020 Financial Results

On November 6, 2020 Accelerate Diagnostics, Inc. (Nasdaq: AXDX) reported financial results for the third quarter ended September 30, 2020 (Press release, ACCELERATED MEDICAL DIAGNOSTICS, NOV 6, 2020, View Source [SID1234570213]).

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

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

                  Schedule Your 30 min Free Demo!

"We achieved solid revenue growth in the third quarter, driven by continued steady utilization within our installed base of live Pheno instruments, an improving go-live cadence, and a large capital deal in the U.S.," commented Jack Phillips, President and CEO of Accelerate Diagnostics, Inc. "While COVID-related delays in the go-live process have begun to moderate, our ability to contract new customers continues to be affected by the pandemic. However, we are beginning to see an improvement in customer engagement as our recent product approvals and upcoming product releases are beginning to stimulate new interest in Accelerate Diagnostics. I am very pleased with the efforts put forth by everyone on the Accelerate team during the quarter, as we have continued to make meaningful operational and financial progress in the face of an unprecedented macro-environment."

Third Quarter 2020 Highlights

Added 5 contracted instruments in the quarter and brought 22 instruments live in the U.S.
Ended the third quarter with 223 U.S. live revenue-generating instruments, with another 192 U.S. contracted Pheno instruments not yet live.
Net sales of $3.6 million, compared to $2.3 million in the third quarter of 2019, or 57% growth.
Gross margin was 36% for the quarter, compared to 51% in the third quarter of 2019. This decrease was the result of pandemic-related effects on manufacturing and dilution from the large capital deal in the quarter.
Selling, general, and administrative expenses for the quarter were $11.5 million, compared to $12.7 million in the third quarter of 2019. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows.
Research and development (R&D) costs for the quarter were $5.0 million, compared to $6.1 million in the third quarter of 2019. This decrease was the result of increased efficiencies and lower external study spend.
Net loss was $18.8 million in the third quarter, or $0.33 per share, which included $4.7 million in non-cash stock-based compensation expense.
Net cash used in the quarter was $11.2 million, and the company ended the quarter with total cash, investments, and cash equivalents of $77.5 million.
Received 510k approval for a new suite of product enhancements to the Accelerate Pheno system, which improve performance and expand Pheno’s antimicrobial susceptibility testing (AST) menu for bloodstream infections.
Received FDA Emergency Use Authorization for the MS Fast fully automated chemiluminescence immunoassay analyzer and SARS-CoV-2 tests for the detection of IgG and IgM.
Year to Date 2020 Highlights

Net sales were $8.1 million year-to-date as compared to $5.8 million from the same period in the prior year, or 40% growth.
Gross margin was 41% year-to-date, compared to 50% from the same period in the prior year. This decrease was the result of pandemic related effects on supply chain and dilution from the large capital deal in the quarter.
Selling, general, and administrative expenses were $35.7 million year-to-date, compared to $38.3 million from the same period in the prior year. This decrease was driven by pandemic-related reductions in sales and marketing spend related to travel and trade shows.
Research and development (R&D) costs were $16.2 million year-to-date, compared to $19.1 million from the same period in the prior year. This decrease was the result of increased efficiencies and lower external study spend.
Net loss was $59.3 million year-to-date, or $1.07 per share, which included $12.3 million in non-cash stock-based compensation expense.
Net cash used was $31.0 million year-to-date, and the company ended the quarter with total cash, investments, and cash equivalents of $77.5 million.
Full financial results for the quarter ending September 30, 2020 will be filed on Form 10-Q through the Securities and Exchange Commission’s (SEC) website at View Source

Audio Webcast and Conference Call

The company will host a conference call at 4:30PM ET today to review its third quarter results. To listen to the 2020 third quarter financial results call by phone, dial +1.877.883.0383 and enter the conference ID: 0113821. International participants may dial +1.412.902.6506. Please dial in 10–15 minutes prior to the start of the conference. A replay of the call will be available by telephone at +1.877.344.7529 (U.S.) or +1.412.317.0088 (international) using the replay code 10148610 until November 26, 2020.

This conference call will also be webcast and can be accessed from the "Investors" section of the company’s website at axdx.com/investors. A replay of the audio webcast will be available until November 7, 2020.