On November 7, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended September 30, 2019 (Press release, Corcept Therapeutics, NOV 7, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-third-quarter-2019-financial [SID1234552971]).

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Revenue of $81.5 million, a 26 percent increase from third quarter 2018
GAAP diluted net income of $0.22 per share, compared to $0.14 per share in third quarter 2018
Non-GAAP diluted net income of $0.31 per share, compared to $0.22 per share in third quarter 2018
Cash and investments of $266.9 million, compared to $225.7 million in second quarter 2019
2019 revenue guidance narrowed to $300 – $315 million
Corcept reported quarterly revenue of $81.5 million in the third quarter, compared to $64.4 million in the third quarter of 2018. Third quarter GAAP net income was $26.3 million, compared to $17.7 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the third quarter was $37.8 million, compared to $27.9 million in the third quarter of 2018. A reconciliation of GAAP to non-GAAP net income is included below.

The company narrowed 2019 revenue guidance to $300 – $315 million. Guidance had previously been
$285 – $315 million.

Third quarter operating expenses were $48.5 million, compared to $41.5 million in the third quarter of 2018, primarily due to increased spending to recruit and compensate additional personnel and discover and develop new selective cortisol modulators, as well as increased legal expense. Cash and investments were $266.9 million at September 30, 2019, an increase of $41.2 million from June 30, 2019.

"Our Cushing’s syndrome business had an excellent quarter," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "We expect the number of patients receiving Korlym and physicians prescribing the medication to continue to increase. To reach more doctors, we are expanding our sales force. We expect the clinical specialists we are hiring now to begin contributing to our results next year.

"I am also pleased to announce an important advance in our program to treat serious metabolic disorders. In a double-blind, placebo-controlled trial in healthy subjects, our selective cortisol modulator miricorilant significantly reduced the weight gain caused by the commonly prescribed antipsychotic medication olanzapine (Eli Lily’s drug, Zyprexa). We have already initiated one of two planned Phase 2 trials to further test miricorilant’s activity in this indication."

Cushing’s Syndrome

European sites begin dosing patients in Phase 3 trial ("GRACE") of relacorilant to treat patients with Cushing’s syndrome
Double-blind, placebo-controlled, Phase 3 trial of relacorilant in patients whose Cushing’s syndrome is caused by adrenal adenomas to start in the first quarter of next year
"As of today, 42 of 62 planned sites are recruiting patients for GRACE," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "We expect to open an additional 13 sites by the end of the year. The activation pace of ex-US sites, which we expect will provide the majority of enrollments, has refined our estimate of the trial’s completion date. Our plan is to submit our NDA in the fourth quarter of 2021.

We spent substantial time in Europe in the past quarter helping clinical site activation and speaking to investigators. Most important, our investigators are highly enthusiastic about GRACE1, because of relacorilant’s positive Phase 2 efficacy and side effect profile."

Patients in relacorilant’s Phase 2 trial exhibited meaningful improvements in glucose control and hypertension – two of Cushing’s syndrome’s most common and pernicious symptoms. The trial also met a wide range of secondary endpoints, including weight loss, liver function, coagulopathy, insulin resistance, cognitive function, mood and quality of life. These results were achieved without relacorilant causing Korlym’s significant off-target effects – vaginal bleeding, endometrial thickening and low potassium.2

In addition to GRACE, Corcept plans to start a Phase 3, double-blind, placebo-controlled trial of relacorilant in patients whose Cushing’s syndrome is caused by an adrenal adenoma – a population that has not been rigorously studied. Patients with adrenal Cushing’s syndrome typically experience a slower onset of symptoms, but their ultimate health outcomes are poor. Corcept expects to enroll 130 patients at sites in the United States and Europe in the study. Most of the planned investigators and sites are also participating in GRACE.

Metabolic Disease

Positive top-line results from double-blind, placebo-controlled, Phase 1b trial of miricorilant to reduce antipsychotic-induced weight gain
Recruiting underway in double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent antipsychotic-induced weight gain
"Our program to develop miricorilant as a treatment for metabolic disorders is off to an excellent start," said Dr. Grauer. "Antipsychotic medications such as olanzapine are essential to the health of millions of patients, but the weight gain and other metabolic side effects they cause are life-threatening and often lead patients to discontinue treatment. At the first dose level tested in our Phase 1b trial, healthy subjects given olanzapine plus miricorilant gained less weight than subjects receiving olanzapine plus placebo (see Figure 1). In addition, markers of liver damage that often rise temporarily at the start of olanzapine therapy increased less sharply in subjects receiving miricorilant, suggesting that miricorilant may have protective effects in the liver (see Figure 2). Five subjects in the olanzapine alone group were unable to complete the study due to elevated liver enzymes, while one patient in the miricorilant group experienced this problem."

A photo accompanying this announcement is available at View Source

The Phase 1b trial’s first part enrolled 66 healthy subjects, each of whom received olanzapine (10 mg) and either miricorilant (600 mg) or placebo daily. The trial’s duration was two weeks. The second part of the trial, which is planned to start in December, will test a higher dose of miricorilant (900 mg) in 30 healthy subjects. The study’s full results will be presented at a scientific meeting in 2020.

"These preliminary results are especially encouraging given the short duration of treatment and the low dose of miricorilant. They are consistent with the effects we had previously seen in animal studies. Our plan is to confirm these findings and explore the full breadth of miricorilant’s activity," said Dr. Grauer.

In addition to the second part of its Phase 1b trial, Corcept plans to conduct two double-blind, placebo-controlled Phase 2 trials of miricorilant for the treatment of patients with antipsychotic-induced weight gain. The first trial, which is underway, will test miricorilant’s activity in reversing recent weight gain. It is expected to enroll 100 patients with schizophrenia at 20 sites in the United States. Patients will continue to receive their established antipsychotic medication and will have either miricorilant or placebo added to their regimen for 12 weeks. A second Phase 2 trial is planned to start next year. It will enroll patients with long-standing weight gain. A third Phase 2 trial, testing miricorilant’s activity in preventing antipsychotic-induced weight gain, is under consideration.

Next year, Corcept also plans to start a double-blind, placebo-controlled, Phase 2 trial of miricorilant as a treatment for patients with non-alcoholic steatohepatitis (NASH), a serious liver disorder that afflicts millions of people.

Solid Tumors

European Commission designates relacorilant orphan drug for treatment of pancreatic cancer
Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer to start upon completion of consultations with the U.S. Food and Drug Administration (FDA)
"We are pleased the European Commission (EC) has joined the FDA in designating relacorilant an orphan drug for the treatment of pancreatic cancer," said Dr. Grauer. "The EC based its decision on the European Medicines Agency’s finding that relacorilant has the potential to significantly benefit patients.

"We presented the clinical data reviewed by the EMA at last year’s ASCO (Free ASCO Whitepaper) meeting and it was indeed promising," said Dr. Grauer. "Seven of 25 patients with metastatic pancreatic cancer treated with relacorilant plus nab-paclitaxel (Celgene’s drug, Abraxane) achieved durable disease control, meaning their tumors either shrank or ceased growing for 16 weeks or longer. Tumor response in two patients lasted more than 50 weeks.3 All of these patients’ tumors had progressed during multiple lines of prior therapy, including treatments with nab-paclitaxel or another taxane. That any of them responded is remarkable. We have sought FDA guidance as to the optimum development path in pancreatic cancer and plan to start a Phase 3 trial promptly upon the conclusion of our discussions."

Corcept’s 180-patient, placebo-controlled Phase 2 trial of relacorilant plus nab-paclitaxel in ovarian cancer continues to enroll patients at sites in the United States and the European Union. Dosing also continues in the company’s Phase 1/2 study of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer.

Conference Call

We will hold a conference call on November 7, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-877-260-1479 from the United States or 1-334-323-0522 internationally approximately ten minutes before the start of the call (passcode 8532239). A replay will be available through November 21, 2019 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 8532239).

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

On November 7, 2019 Eisenhower Health reported a revolutionary robot can now detect lung cancer at an early stage allowing for more-accurate diagnosis, changing the prognosis for many now diagnosed with the #1 cancer killer worldwide for both men and women (Press release, Eisenhower Health, NOV 7, 2019, View Source [SID1234550848]). Monarch Platform by Auris Health, Inc. has changed the medical detection landscape by viewing inside the lungs and obtaining a tissue sample for biopsy, enabling earlier and more-accurate analysis of small and hard-to-reach nodules in the periphery of the lung. Renowned Eisenhower Health (View Source) in Rancho Mirage, California is one of the first in the U.S., and one of the first in Southern California to now offer this new innovative and state-of-the-art technology in the fight against lung cancer, the #1 cancer killer today.

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Monarch Platform, recently cleared by the U.S. Food and Drug Administration (FDA), integrates the latest advancements in robotics, software, micro-instrumentation, sensing, data science and endoscopy into one platform to improve outcomes and reduce cost. This technology leverages the power of flexible robotics to enable new possibilities in endoscopy, using small cameras and tools to enter the body through its natural openings. It is intended for diagnostic and therapeutic bronchoscopic procedures.

"Lung cancer is now the leading cause of cancer deaths worldwide, in part because it has no symptoms in it’s early stages. This provides improved reach, vision and control for bronchoscopic procedures and is a very important piece of technology that now provides physicians continuous bronchoscope vision throughout the procedure leading to earlier detection, better outcomes, and a more hopeful future for patients," says Justin Thomas, MD, Board Certified Internal Medicine, Pulmonary Disease and Critical Care Medicine and Director of the Bronchoscopy Laboratory at Eisenhower Health.

News Facts:

Lung cancer is #1 global leading cause of cancer-related deaths for both men and women according to the American Cancer Society
Although the disease is rare among those under the age of 45, more people die from lung cancer than from colon, breast and prostate cancers combined, for both smokers and non-smokers, however, the risks are much greater for smokers
More than 90% of people diagnosed with lung cancer do not survive, often due to detection at an advanced stage
A variety of diagnostic options are currently available for lung cancer but all have limitations in accuracy, safety, or invasiveness. Limitations can lead to false positives, false negatives, or side effects such as pneumothorax (collapsed lung) and hemorrhage, which may increase health care costs and extend hospital stays
Monarch Platform was made possible to Eisenhower Health through a generous donation from Circle of Stars, a group of all female philanthropists established by Eisenhower Health’s Foundation.

On November 7, 2019 To raise awareness of lung cancer—the leading cancer killer of women and men—the American Lung Association and the Ad Council have launched a new phase of work this November during Lung Cancer Awareness Month for their successful "Saved By The Scan" campaign (Press release, American Lung Association, NOV 7, 2019, View Source [SID1234550847]). The campaign, created pro bono by advertising agency Hill Holliday, educates current and former smokers about the low-dose CT scan that can detect lung cancer in the early stages, when the disease is more curable.

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Consider the facts about lung cancer:

Lung cancer kills 422 people every day – approximately 18 deaths each hour, or 1 death every 3.4 minutes.
Early detection can save lives. In fact, survival rates are more than four times higher when lung cancer is detected early, but most cases are not diagnosed until later stages.
If the 8 million Americans considered at high-risk were screened, an estimated 48,000 lives would be saved.
Screening is currently underutilized, with less than 5% of those eligible getting screened.
The television spot features a pair of lungs made of matches, which slowly burn and dissolve as a narrator proclaims, "You quit smoking and thought ‘That’s that.’ But here’s the thing about lung cancer: by the time you see the symptoms, it could be too late." Revealing a room with a CT machine at its center, an uplifting voice is then heard saying, "But now, thanks to a new scan, lung cancer can be detected earlier when it is more curable. If you smoked, get scanned," ultimately encouraging current and former smokers to talk to their doctor and visit SavedByTheScan.org.

"Lung cancer screening is a powerful tool, but its lifesaving potential will never be fully realized if it’s underutilized," said Harold P. Wimmer, National President and CEO, American Lung Association. "Spreading the word about screening is essential, and the American Lung Association is proud to continue partnering with the Ad Council and Hill Holliday to raise awareness of this lifesaving test."

This iteration of the campaign raises awareness of the benefits of early detection through lung cancer screening and drives current and former smokers to take a lung cancer screening eligibility quiz at SavedByTheScan.org (SalvaTuPulmon.org in Spanish). The site also provides information about lung cancer screening and insurance coverage, and includes a section for people to share their personal stories about how they were "saved by the scan."

In the two years since "Saved By The Scan" was launched, the campaign has been flooded with stories from people who saw the ads and as a result spoke with their doctors, got the scan and caught the disease early – saving their lives.

"I saw the first Saved By The Scan video while I was watching my favorite show one night. I saw a woman climbing a mountain of cigarette butts and learned that I was potentially at high risk for lung cancer," said Milli Wilson, a 62-year-old singer and now a lung cancer screening advocate. "At my next doctor’s visit, I requested the low-dose CT scan. While I had no symptoms, I was diagnosed with early stage lung cancer and my doctor recommended a procedure to remove the mass. Today I’m a living example of how screening can save your life."

"We continue to hear reports from consumers who saw ‘Saved By The Scan’ materials, got the scan and caught the disease early," said Michelle Hillman, Chief Campaign Development Officer of the Ad Council. "When it comes to the power of communications, there’s nothing greater than saving a life and we are eager to share this new round of work, hopefully inspiring more high-risk individuals to talk to their doctors and get the scan if they are eligible."

To extend the campaign’s message further, the American Lung Association and Ad Council are releasing new TV, print, billboard, bus shelter and digital work.

"When smokers hear the words lung cancer, they are rightfully scared. But with this new scanning technology, there’s hope. With the help of our production partner, Psyop, we created a visually arresting film that will let people know lung cancer doesn’t have to be so terrifying. There’s hope," said Lance Jensen, Hill Holliday Chief Creative Officer. "Hill Holliday is proud to work with the American Lung Association and the Ad Council for the second year in a row on this amazing project."

The "Saved By The Scan" campaign has received more than $46 million in donated media support to date and has collaborated on lung cancer screening content with top-tier content platforms, including Facebook Creative Shop, The New York Post, USA Today and WebMD. The lung cancer screening eligibility quiz on SavedByTheScan.org also continues to effectively reach qualified respondents; there have been more than 291,000 quiz completions since the campaign launch, 90,000 people were found to be at high risk and were encouraged to speak with their doctor. Additionally, awareness of the lung cancer screening method has increased 75% since launch and continues to grow year over year.

The campaign targets the estimated 8 million people in the U.S. who are at high risk for lung cancer and should talk to their doctor about getting screened. A person is considered high risk for lung cancer if they: are between 55–80 years old (or between 55–77 years old and on Medicare), have a 30 pack year history of smoking (this means 1 pack a day for 30 years, 2 packs a day for 15 years, etc.), and are a current smoker, or have quit within the last 15 years.

Individuals who may be at high risk are encouraged to visit SavedByTheScan.org (English) or SalvaTuPulmon.org (Spanish), where they can take the lung cancer screening eligibility quiz and find additional information on the campaign and lung cancer.

On November 7, 2019 Eli Lilly and Company (NYSE: LLY) reported the pricing terms of its previously announced cash tender offer for up to $2,000,006,000 aggregate principal amount of its outstanding debt securities (Press release, Eli Lilly, NOV 7, 2019, View Source [SID1234550846]).

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Holders of notes who tendered, and did not validly withdraw, their notes on or before 5:00 p.m., New York City time, on November 6, 2019 (the early tender date), and which are accepted for purchase by Lilly, are eligible to receive the total consideration. The total consideration for each series of notes is based on the applicable reference yield plus a fixed spread, in each case as set forth in the table below, and is payable to holders of the notes listed in the table below who validly tendered and did not validly withdraw their notes on or before the early tender date and which are accepted for purchase by Lilly. The reference yields listed in the table were determined at 10:00 a.m., New York City time, on November 7, 2019. The total consideration for each series of notes includes an early tender premium of $30 per $1,000 principal amount of notes validly tendered and not validly withdrawn by such holders and accepted for purchase by Lilly.

(1) Per $1,000 principal amount of notes that are tendered and accepted for purchase.

(2) The total consideration includes the early tender premium of $30 per $1,000 principal amount of notes.

(3) The maximum principal amount of 3.950% Notes due 2049 that will be purchased by Lilly is $200,000,000.

(4) The maximum principal amount of 4.150% Notes due 2059 that will be purchased by Lilly is $200,000,000.

(5)The maximum principal amount of 2.350% Notes due 2022 that will be purchased by Lilly is $250,000,000.

All payments for notes purchased in connection with the early tender date will also include accrued and unpaid interest on the principal amount of notes tendered up to, but not including, the initial settlement date, which is currently expected to be November 8, 2019.

Holders of notes who validly tender their notes after the early tender date will, if such notes are accepted by Lilly, receive the tender consideration, which is equal to the total consideration minus $30 per $1,000 principal amount of notes tendered by such holders and accepted for purchase by Lilly. Accrued and unpaid interest up to, but excluding, the applicable settlement date will be paid in cash on all validly tendered notes accepted and purchased by Lilly in the tender offer.

The tender offer is scheduled to expire at 11:59 p.m., New York City time, on November 21, 2019, unless extended or earlier terminated.

In accordance with the terms of the tender offer, the withdrawal date was 5:00 p.m., New York City time, on November 6, 2019. As a result, tendered notes may no longer be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

The tender offer is being conducted upon the terms and subject to the conditions set forth in the Offer to Purchase, dated October 24, 2019, and the related Letter of Transmittal, each as supplemented by the press release dated November 7, 2019 that increased the size of the tender cap.

Lilly has retained Citigroup Global Markets Inc. and Morgan Stanley & Co. LLC to serve as lead dealer managers for the tender offer and BNP Paribas Securities Corp. and J.P. Morgan Securities LLC to serve as co-dealer managers. Lilly has retained Global Bondholder Services Corporation to serve as tender agent and information agent for the tender offer.

Requests for documents relating to the tender offer may be directed to Global Bondholder Services Corporation by telephone at (866) 470-3900, by email at [email protected] or in writing at 65 Broadway, Suite 404, New York, NY 10006. Questions regarding the tender offer may be directed to Citigroup Global Markets Inc. at (212) 723-6106 or to Morgan Stanley & Co. LLC at (800) 624-1808.

On November 7, 2019 Amyris, Inc. (Nasdaq:AMRS), a leader in the development and production of sustainable ingredients for the Health & Wellness, Clean Beauty and Flavors & Fragrances markets, reported preliminary unaudited financial results for the third quarter ended September 30, 2019 (Press release, Amyris Biotechnologies, NOV 7, 2019, View Source [SID1234550845]).

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"We are pleased with our Q3 results," said John Melo, President and CEO of Amyris. "We are continuing to double our product revenue year over year and we are on track to exceed our $150 million in revenue guidance for 2019. While capital constraints proved challenging, we were able to carefully manage the business to deliver on significant demand across most of our core products. These capital constraints should be lessened as a result of having achieved SEC filing and Nasdaq compliance, resolving our CVI Heights debt, expanding our gross margin, and continuing the revenue growth of our business over the coming quarters."

Continued Melo, "Our Biossance brand is redefining consumer expectations for high performing, clean and sustainable skin care. Purecane sweetener and Pipette baby care are experiencing excellent early engagement with consumers and the early consumer product ratings for both of these new brands are outstanding. These brands provide clean, sustainable and highly effective products with ingredients produced by Amyris. Products such as these that deliver the best performance in their respective categories is where we excel and where we are capturing a market leadership position. Our fourth quarter has started strong and we are on track for a great finish to 2019.

"Our cannabinoids development program is advancing at a much better rate than we expected, and we will have product available for sampling and early formulation development early in 2020. We remain confident in our ability to commercially launch these cannabinoids in 2020, assuming regulatory conditions have been met. Upon commercial scale, this program should generate significant product revenue as well as royalties to Amyris."

Key Highlights

Other operating and development highlights included:

Successfully launched Pipette brand, the new standard in clean baby care with better-performing, safer products for moms and babies using ingredients from the purest sources.
Biossance clean skin care brand has entered the Australian and New Zealand markets as global expansion continues. Biossance revenue growth is escalating based on growing geographic footprint and number of Sephora stores (now 219 out of 480 total North American stores carrying the full end cap of all product SKUs at quarter end). More recently, Sephora introduced Biossance to the South Korea and Thailand markets furthering the brand’s continued geographic expansion and growth opportunity.
Cannabinoids development progressing better than expected with CBD ahead of target delivery with anticipated commercialization of both CBD and a second unnamed (due to partner’s competitive considerations) cannabinoid molecule, subject to regulatory clearance, available for commercialization in 2020.
Significantly expanded collaboration agreement with Yifan of China.
Closed on financings to support working capital and revenue growth as well as agreement to resolve the CVI Heights unsecured convertible senior notes debt.
Financial Performance (preliminary unaudited)

Third Quarter 2019

GAAP revenue for the third quarter of 2019 was $35.0 million, compared with $14.3 million for the third quarter of 2018. Renewable products revenue (including royalties connected to renewable products we produced and shipped) for the quarter was $19.7 million compared with $9.8 million for the same period a year ago. Grants and collaborations revenue was $15.3 million for the third quarter of 2019 compared with $4.5 million for the year-ago period.
Sales, general and administrative expenses were $33.3 million for the third quarter of 2019 compared with $27.2 million for year-ago period, primarily reflecting Biossance growth and an increase in headcount as well as certain one-time expenses. Research and development expenses of $19.0 million for the quarter were up from $16.4 million for the third quarter of 2018 due to increased R&D costs for product development connected to the increase in collaboration revenue over 2018.
GAAP net loss attributable to Amyris common stockholders for the third quarter of 2019 was $53.2 million, or $0.51 per basic and diluted share, compared with a GAAP net loss attributable to Amyris common stockholders for the third quarter of 2018 of $76.8 million, or $1.26 per basic and diluted share.
Non-GAAP net loss for the third quarter of 2019 was $46.4 million, or $0.45 per basic share. This compared with a non-GAAP net loss of $46.7 million, or $0.77 per basic share for the third quarter of 2018.
Nine Months Ended September 30, 2019

GAAP revenue for the first nine months ended September 30, 2019 was $112.0 million, compared with $47.2 million for the same period of 2018. Product revenue (including royalties connected to renewable products we produced and shipped) more than doubled for the 2019 period versus the prior year period.
GAAP net loss attributable to Amyris common stockholders for first nine months of 2019 was $188.0 million, or $2.06 per basic and diluted share. This compared to a net loss of $175.7 million, or $3.15 per basic and diluted share for the first nine months of 2018.
Non-GAAP net loss for the first nine months of 2019, excluding the non-cash items mentioned, was $119.4 million, or $1.31 per basic share, compared to a non-GAAP net loss for the first nine months of 2018 of $114.3 million, or $2.05 per basic share.
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 impairment, stock-based compensation expense, gain on divestitures, gains and losses from changes in the fair value of derivatives, debt extinguishment costs, and depreciation and amortization.

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, including non-GAAP net income (loss), to the most directly comparable GAAP financial measure, is provided in the tables attached to this press release.

QUARTERLY CONFERENCE CALL TODAY

Amyris will discuss these results and provide a business update in a conference call scheduled for 4:30 p.m. ET (1:30 p.m. PT) today. Investors may access the call by dialing (877) 870-4263. Participants should ask to be joined to the Amyris, Inc. call.

A live audio webcast of this conference call and accompanying presentation is also available by visiting the investor relations section of the company’s website at View Source A replay of the webcast will be available at the investor relations section of the company’s website approximately two hours after the conclusion of the call.