On May 8, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that its President and Chief Executive Officer, John P. Butler, will participate in the 2020 RBC Capital Markets Global Healthcare Virtual Conference on Wednesday, May 20 at 10:20 a.m. ET (Press release, Akebia, MAY 8, 2020, View Source [SID1234557413]). A live webcast and replay of Akebia’s presentation will be available on the Company’s website at www.akebia.com.

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On May 8, 2020 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, reported financial results for the first quarter ended March 31, 2020 and highlighted recent activity (Press release, Immunic, MAY 8, 2020, View Source [SID1234557435]).

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"The global coronavirus disease 2019 (COVID-19) pandemic has led to a period of intense, additional focus for Immunic, as we quickly recognized the potential of our lead asset, selective oral DHODH inhibitor, IMU-838, as a possible therapeutic for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, given its already well-recognized, broad-spectrum antiviral effects," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "After performing preclinical testing, we recently announced that, in cellular assays, IMU-838 successfully demonstrated antiviral activity against SARS-CoV-2 at blood concentrations which are well below those associated with IMU-838 dosing regimens studied in our ongoing and previous clinical trials. Based on these positive results, we are preparing a phase 2 clinical development program for IMU-838 as a potential treatment for this devastating disease."

Dr. Vitt continued, "On the heels of this encouraging preclinical data, we were able to bolster our financial position with a successful $15.0 million financing. As a result, we expect to be well funded through key, near-term milestones including top-line data from both our phase 2 trial of IMU-838 for relapsing-remitting multiple sclerosis (RRMS), expected in the third quarter of this year, as well as results from the investigator-sponsored phase 2 trial for IMU-838 in primary sclerosing cholangitis (PSC), expected in early 2021."

First Quarter 2020 and Subsequent Highlights

April 2020: Completed a $15.0 million registered direct offering led by institutional investor, Altium Capital.
April 2020: Announced that lead asset, IMU-838, has successfully demonstrated preclinical activity against clinical isolates of SARS-CoV-2 associated with COVID-19. As a result, the company is now exploring the feasibility of conducting a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 clinical trial in patients with moderate COVID-19.
April 2020: Reported several changes to the company’s executive team, including the resignation of Chief Financial Officer, Sanjay S. Patel, CFA, and the promotion of Glenn Whaley to the position of Vice President Finance, Principal Financial and Accounting Officer. Additionally, announced that Duane Nash, MD, JD, MBA, current Chairman of the Board of Directors, has temporarily assumed the role of Executive Chairman.
January 2020: Exercised option to obtain the exclusive worldwide rights to commercialization of a group of compounds, designated by the company as IMU-856, aimed at restoring intestinal barrier function, from Daiichi Sankyo Co., Ltd.
Anticipated Clinical Milestones

Top-line data from the phase 2 EMPhASIS trial of IMU-838 in RRMS is expected to be available in the third quarter of 2020.
Completion of preclinical and manufacturing activities necessary for initiation of phase 1 clinical studies of IMU-856 are expected during the first half of 2020.
The current, single ascending dose part of the ongoing phase 1 trial of IMU-935, being conducted in Australia, is planned to be followed by a multiple ascending dose (MAD) portion in healthy volunteers and a safety evaluation in patients with mild-to-moderate psoriasis as a third part of this phase 1 trial. Based on the temporary pausing of trials in healthy volunteers imposed by Ethics Committees in Australia due to COVID-19, the MAD portion of the trial is expected to start in the second half of 2020.
Top-line data from the phase 2, investigator-sponsored proof-of-concept clinical trial for IMU-838 in PSC, being conducted at the Mayo Clinic, is expected to be available in early 2021.
Top-line data from the phase 2 CALDOSE-1 trial in ulcerative colitis (UC) is expected to be available during the fourth quarter of 2021.
Upcoming Events

Immunic will host a virtual R&D Day on May 19, 2020. Immunic’s management and invited key opinion leaders, specializing in multiple sclerosis and inflammatory bowel disease, will discuss today’s treatment options for, and the unmet medical needs of, chronic inflammatory and autoimmune diseases, as well as clinical progress of the company’s selective oral immunology programs and their potential advantages over the current treatment landscape. Management will also discuss the company’s COVID-19 program.
Financial and Operating Results

Research and Development (R&D) Expenses were $6.4 million for the three months ended March 31, 2020, as compared to $3.4 million for the same period ended March 31, 2019. The $3.1 million increase was primarily attributable to (i) increased development costs for the phase 2 clinical trials of IMU-838 in RRMS and UC, the IMU-935 phase 1 clinical trial, and preclinical activities with IMU-856, (ii) increased employee costs related to the growth in headcount and (iii) other expenses.
General and Administrative (G&A) Expenses were $2.6 million for the three months ended March 31, 2020, as compared to $1.3 million for the same period ended March 31, 2019. The $1.3 million increase is primarily due to becoming a public company and expanding operations into the United States.
Other Income was $0.5 million for the three months ended March 31, 2020, as compared to $0.3 million for the same period ended March 31, 2019. The $0.2 million increase is primarily attributable to research and development tax incentives for clinical trials in Australia as a result of increased spending on clinical trials in Australia.
Net Loss for the three months ended March 31, 2020 was approximately $8.5 million, or $0.79 per basic and diluted share, based on 10,749,460 weighted average common shares outstanding, compared to a net loss of approximately $4.3 million, or $5.09 per basic and diluted share, based on 846,953 weighted average common shares outstanding for the same period ended March 31, 2019.
Cash and Cash Equivalents, as of March 31, 2020, were $18.6 million. With these funds and the money raised in equity issuances in April 2020, including approximately $13.9 million in net proceeds from the registered direct offering closed on April 27, 2020, and an additional $2.3 million in net proceeds from ATM issuances, the company expects to be able to fund operations beyond twelve months from the date of the issuance of this earnings release.

On May 8, 2020 Luminex Corporation (NASDAQ: LMNX) ("Luminex") reported the pricing of its offering of $260,000,000 aggregate principal amount of 3.00% Convertible Senior Notes due 2025 (the "Convertible Notes") in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") (Press release, Luminex, MAY 8, 2020, View Source;301055557.html [SID1234557434]). The delivery of the Convertible Notes to investors in book-entry form is expected to be made on May 13, 2020, and is expected to result in approximately $218.3 million in net proceeds to Luminex after deducting estimated placement agent’s fees, the net cost of the bond hedge and warrant transactions discussed below, and estimated offering expenses payable by Luminex.

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The Convertible Notes will be general unsecured obligations of Luminex and interest will be paid semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2020. The Convertible Notes will mature on May 15, 2025, unless earlier repurchased, redeemed or converted. Prior to the close of business on the business day immediately preceding November 15, 2024, the Convertible Notes will be convertible at the option of holders only upon the satisfaction of certain conditions and during certain periods. On or after November 15, 2024 until close of business on the second scheduled trading day preceding maturity, the Convertible Notes will be convertible at the option of the holders at any time regardless of these conditions. Conversions of Convertible Notes will be settled in cash, shares of Luminex’s common stock or a combination thereof, at Luminex’s election. The Convertible Notes will not be redeemable prior to maturity.

The initial conversion rate is 22.8918 shares of common stock per $1,000 principal amount of Convertible Notes (equivalent to an initial conversion price of approximately $43.68 per share of Luminex’s common stock). The conversion rate and the corresponding conversion price will be subject to adjustment upon the occurrence of certain events, but will not be adjusted for any accrued and unpaid interest.

If Luminex undergoes a fundamental change (as defined in the indenture governing the Convertible Notes), holders may require Luminex to purchase for cash all or part of their Convertible Notes at a purchase price equal to 100% of the principal amount of the Convertible Notes to be purchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. In addition, if certain make-whole fundamental changes occur, Luminex will, in certain circumstances, increase the conversion rate for any Convertible Notes converted in connection with such make-whole fundamental change.

In addition, in connection with the pricing of the Convertible Notes, Luminex entered into privately negotiated convertible note hedge transactions and warrant transactions with certain dealers (the "Option Counterparties"). The convertible note hedge transactions are expected generally to reduce the potential dilution to Luminex’s common stock upon any conversion of Convertible Notes and/or offset any cash payments Luminex is required to make in excess of the principal amount of converted Convertible Notes, as the case may be, in each case upon conversion of the Convertible Notes. The warrant transactions could separately have a dilutive effect to the extent that the market price per share of Luminex’s common stock exceeds the applicable strike price of the warrants. However, subject to certain conditions, Luminex may elect to settle all or a portion of the warrants in cash. The strike price of the warrant transactions will initially be approximately $69.89 per share, which represents a premium of approximately 80% over the last reported sale price of Luminex’s common stock on May 7, 2020, and is subject to certain adjustments under the terms of the warrant transactions.

Luminex expects that in connection with establishing their initial hedges of these transactions, the Option Counterparties and/or their respective affiliates will enter into various derivative transactions with respect to Luminex’s common stock and/or purchase Luminex’s common stock in secondary market transactions concurrently with, or shortly after, the pricing of the Convertible Notes. This activity could increase (or reduce the size of any decrease in) the market price of Luminex’s common stock or the Convertible Notes at that time. In addition, Luminex expects that the Option Counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Luminex’s common stock and/or purchasing or selling Luminex’s common stock or other securities of Luminex in secondary market transactions following the pricing of the Convertible Notes and prior to the maturity of the Convertible Notes (and are likely to do so following conversion of the Convertible Notes or during any observation period related to a conversion of Convertible Notes). These activities could also cause or avoid an increase or a decrease in the market price of Luminex’s common stock or the Convertible Notes, which could affect the ability of holders of Convertible notes to convert the Convertible Notes and, to the extent the activities occur following conversion or during any observation period related to a conversion of the Convertible Notes, could affect the amount of cash and/or the number and value of shares of Luminex’s common stock that holders will receive upon conversion of the Convertible Notes.

Luminex intends to use approximately $34.7 million of the net proceeds from the private placement to pay the net cost of the convertible note hedge transactions (after such cost is partially offset by the proceeds to Luminex from the warrant transactions). Luminex intends to use the remaining net proceeds of the offering for working capital and other general corporate purposes.

The private placement is only being made pursuant to Section 4(a)(2) under the Securities Act to purchasers that are both "institutional accredited investors" (as defined in Rule 501 promulgated under the Securities Act) and "qualified institutional buyers" (as defined in Rule 144A under the Securities Act). Neither the Convertible Notes nor any shares of Luminex’s common stock issuable upon conversion of the Convertible Notes have been or are expected to be registered under the Securities Act or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

On May 8, 2020 Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) reported that President Rajiv Malik and Chief Financial Officer Ken Parks will present at the BofA Securities Virtual Health Care Conference 2020 on Thursday, May 14, 2020 at 3:40 p.m. ET (Press release, Mylan, MAY 8, 2020, View Source [SID1234557433]).

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Interested parties can access a live webcast of the presentation via the investor relations section of Mylan’s website at investor.mylan.com. An archived version also will be available following the live presentation and can be accessed at the same location for a limited time.

On May 8, 2020 Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company in Clean Health and Beauty markets through its consumer brands and a top supplier of sustainable and natural ingredients, reported financial results for its first quarter ended March 31, 2020 (Press release, Amyris Biotechnologies, MAY 8, 2020, View Source [SID1234557432]).

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Keeping our people, partners and communities safe and healthy while benefiting from strong product demand has been our number one priority during these unprecedented times with COVID-19.

Management Comments
"COVID-19 has dominated all of our lives with a significant impact both from a health and economic perspective. Keeping our people, our partners and our communities safe and healthy while delivering on very strong product demand from consumers has been our number one priority. This meant that we had to adjust our ways of working across our supply chain, innovation center and offices. Our people have been amazing, and we have continued to deliver on our commitments to our customers," said John Melo, President and Chief Executive Officer. "We play a critical role in helping those who have been impacted by the pandemic. This includes rapidly launching a new hand sanitizer of which we have donated over 20,000 units to frontline healthcare workers. Also, we supply key ingredients for household cleaning and personal care products and are exploring how our science can be further utilized to fight the virus."

Continued Melo, "We are pleased with our first quarter results for what is typically our lowest sales quarter of the year due to seasonality. We have seen limited impact to our business performance from COVID-19. During the month of April we delivered our best single month of consumer product sales. We are experiencing significant demand for our ingredients into cleaning products and personal care products. We are encouraged by the growth in our top and bottom-line performance and see continued opportunity with our strong portfolio of branded consumer products and functional ingredients. Our focus on higher margin product sales and reducing unit costs by adapting our supply chain are delivering strong results. At our current performance we expect to achieve positive operating cash performance by the fourth quarter of this year. We remain committed to our current guidance and will update our view on the year as we get more visibility."

Q1 Financial Highlights

Performance was in line with expectations with Sales Revenue of $29 million up 103% versus the prior year quarter with strong growth seen in Consumer & Ingredients product sales
Gross Margin as a percentage of sales improved to 63% which compares to -33% in Q1 2019 and 56% for the full year 2019. Year-over-year margin growth delivered a $23 million improvement and was driven by improved sales mix from higher consumer brand sales and lower unit cost
Adjusted EBITDA of -$27 million improved $19 million versus the same quarter last year driven by the aforementioned margin improvements
GAAP Net Income of -$87 million was down $23 million. EBITDA improvements of $19 million were offset by non-cash debt related adjustments of $37 million.
Adjusted Net Income of -$44 million improved $15 million versus prior year.
Diluted EPS improved $0.26 or 32% to -$0.56
Adjusted Diluted EPS improved $0.47 or 63% to -$0.28 per share
Debt principal was reduced by $88 million or 30% during the quarter from $297 million to $209 million
Strategic Priorities
At the start of 2020 we set out four strategic priorities to focus our execution on accelerated growth and a clear path to profitability and sustained cash generation:

High growth consumer brands: build on our Clean Beauty market leadership and double sales year over year. Extend offering of clean and safe ingredients and products
Scientific and commercial collaboration: Execute on R&D collaboration programs to scale 3-4 new molecules yearly. Establish market leadership in sustainable Health and Wellness markets
Supply chain optimization: Deliver lower unit costs targeting gross margins >60 of sales. Drive agile and robust supply network to support sales growth
Improved balance sheet, earnings and cash flow: Reduced balance sheet leverage. Be fully funded to deliver growth. Deliver on path to sustained cash generation from operational performance
During the first quarter we made strong progress on each of our strategic priorities:

Consumer brands sales more than doubled; mostly driven by Biossance, our Clean Beauty brand
Launched a new Pipette branded hand sanitizer product responding to COVID-19 needs. We donated first production batches to front-line healthcare workers
Collaboration revenue grew by more than 150%
Gross Margin grew to 63%
Expanded supply and fulfillment network to respond to continued consumer brand growth
Reduced and simplified debt. Delivered much improved earnings both in absolute terms and per diluted share
Q1 2020 Results
Variance $ and Variance % in the following tables and comments may not foot due to rounding

Sales Revenue improved by 103% due to a 92% improvement in Consumer & Ingredients and 158% growth in Collaboration & Grants
Gross Margin as a percentage of sales improved to 63%, and delivered a $23 million improvement driven by a combination of higher margins from consumer brand sales and lower unit costs in ingredients
GAAP Net Income of -$87 million was down $23 million impacted by non-cash adjustments and fair value assessments in debt instruments of $37 million. Adjusted Net Income of -$44 million improved $15 million versus prior year driven by operational improvements from sales mix and lower unit costs
Operating expenses of $44 million were up 5% due to investments in marketing and sales, partly offset by lower R&D expense
Adjusted EBITDA of -$27 million improved $19 million versus the same quarter last year primarily driven by margin improvements
Adjusted Diluted EPS improved $0.47 or 63% to -$0.28 per share
Q1 2020 Category Sales Revenue
Variance $ and Variance % in the following tables and comments may not foot due to rounding

Note: Consumer & Ingredients sales is the total of Renewable Products and Licenses and Royalties

Consumer & Ingredients (C&I) sales grew 92% year over year (price +3%, volume/mix +89%) with growth seen in both direct-to-consumer branded products (+233%) and business-to-business ingredients (+50%). Excluding a $4 million one-off value share C&I sales were up 56%
Collaboration & Grants were up 158% year over year due to higher revenue from several strategic partnership programs
Full Year 2020 Outlook
Our current Sales Revenue guidance is maintained albeit that COVID-19 presents uncertainties to which we do not have full visibility.

Full year Sales Revenue is expected to grow approximately 44% versus 2019 GAAP sales of $153 million. 2020 recurring sales are expected to grow approximately 80% versus 2019 recurring sales of $104 million.

Gross Margin is expected to operate at greater than 60% of sales due to improved sales mix and lower unit costs. Based on sales revenue guidance, Adjusted EBITDA is expected to turn positive during Q4 of this year.

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, and losses allocated to participating securities.

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 and other costs/provisions.

EBITDA is calculated as GAAP net loss less losses allocated to participating securities, interest, tax provision, depreciation and amortization.

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 and other expense, net.

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 first quarter 2020 conference call today May 8, 2020 at 9:00 am ET (6:00 am PT) to discuss its financial results. Those who wish to listen to the conference call should dial into (888) 390-3967 (U.S. and 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

If you are unable to listen to the live call, the webcast will be archived on the Company’s website. 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’ first quarter 2020 results can also be found on the Company’s website.