10-Q – Quarterly report [Sections 13 or 15(d)]

Syndax has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Syndax, 2017, NOV 8, 2017, View Source [SID1234521729]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

G1 Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, G1 Therapeutics, 2017, NOV 8, 2017, View Source [SID1234521773]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Cellular Biomedicine Group has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Cellular Biomedicine Group, 2017, NOV 8, 2017, View Source [SID1234521809]).

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Evotec AG announces first nine-month 2017 results and corporate update

On November 8, 2017 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first nine months of 2017 (Press release, Evotec, NOV 8, 2017, View Source [SID1234521713]).

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FINANCIAL PERFORMANCE REFLECTS GROWTH PATH

– Group revenues: 42% increase to EUR 170.9 m (9M 2016: EUR 120.6 m);

EVT Execute revenues up 30% to EUR 165.1 m (9M 2016: EUR 126.6 m);
EVT Innovate revenues up 84% to EUR 33.2 m (9M 2016: EUR 17.9 m)

– Adjusted Group EBITDA up 28% to EUR 39.3 m (9M 2016: EUR 30.6 m);

Adjusted EBITDA for EVT Execute of EUR 41.7 m (9M 2016: EUR 41.3 m);
Adjusted EBITDA for EVT Innovate of EUR (2.4) m (9M 2016: EUR (10.7) m)

– R&D expenses at EUR 12.5 m (9M 2016: EUR 12.8 m)

– Strong strategic liquidity position of EUR 88.8 m (after completion of Aptuit acquisition)

EVT EXECUTE – EXPANSION AND GROWTH OF HIGH-QUALITY SERVICES

– Extension of value chain and high-quality development services following Aptuit acquisition

– Cyprotex integration and performance proceeding according to plan

– Multiple new and extended integrated drug discovery alliances, e.g. with Abivax, Blackthorn Therapeutics, Dermira, STORM Therapeutics and Tesaro (after period-end)

– Significant progress within ongoing alliances (e.g. Bayer alliance in endometriosis: Start of second clinical Phase I study)

– Indication extension and initiation of pre-clinical development of existing clinical asset with Bayer in new product franchise (undisclosed)

EVT INNOVATE – VERY GOOD SCIENTIFIC PROGRESS AND IMPORTANT MILESTONES

– Important milestone achievements (Kidney disease alliance with Bayer, iPSC neurodegeneration alliance with Celgene, iPSC diabetes alliance with Sanofi)

– Strong focus on expansion of iPSC platform through new strategic collaborations with Censo Biotechnologies, Fraunhofer IME-SP and Ncardia

– Unique biobank approach through NURTuRE consortium in kidney diseases

– Evotec joins NEPLEX consortium to accelerate the discovery of a novel drug discovery device to test drug candidates in human kidneys (after period-end)

– Expansion of joint venture and strategic investment in Exscientia

– Expansion of CKD Bayer alliance

– Academic BRIDGE model gaining momentum: First North American BRIDGE established with MaRS Innovation in Canada (LAB150); two funding rounds completed in LAB282 projects (Oxford University)

CORPORATE

– Acquisition of Aptuit: $ 300 m in cash (effective 11 August 2017)

– Continued high-value strategic investments and company formations (e.g. Eternygen, Exscientia, Facio Therapies, Forge Therapeutics)

– Loan facility issued by European Investment Bank of up to EUR 75 m to support Innovate R&D strategy

– Novo Holdings A/S new strategic investor in Evotec holding >10%

GUIDANCE 2017 CONFIRMED
All elements of the financial guidance confirmed

1. FINANCIAL PERFORMANCE REFLECTS GROWTH PATH

In the first nine months of 2017, Evotec’s Group revenues grew to EUR 170.9 m, an increase of 42% compared to the same period of 2016 (9M 2016: EUR 120.6 m). This increase was driven primarily by three factors: the strong performance in the base business, contributions from the acquired businesses of Cyprotex (EUR 17.9 m) and Aptuit (EUR 15.0 m), and increased milestone payments. Revenues from milestones, upfronts and licences increased significantly to EUR 21.1 m compared to the same period of the previous year (9M 2016: EUR 15.6 m) including milestones from the collaborations with Bayer in endometriosis and kidney diseases, Celgene in neurodegeneration, and Sanofi in diabetes. The gross margin slightly decreased to 35.1% (9M 2016: 38.5%) due to a different business mix, a higher contribution of the EVT Execute business and the linear amortisation of the Cyprotex intangibles resulting from the purchase price allocation.

R&D investments in strategic areas of first-in-class innovation were according to plan at EUR 12.5 m (9M 2016: EUR 12.8 m). Selling, general and administrative (SG&A) expenses increased substantially by 65% in the first nine months of 2017 to EUR 29.3 m (9M 2016: EUR 17.8 m) and were mainly impacted by expenses of Cyprotex and approx. 1.5 months of Aptuit and M&A-related expenses as well as an increased SG&A headcount (Business development and administrative functions) in response to company growth.

Adjusted Group EBITDA in the first nine months of 2017 increased by 28% to EUR 39.3 m (9M 2016: EUR 30.6 m). Evotec’s operating income in the first nine months of 2017 increased to EUR 25.9 m (9M 2016: EUR 20.4 m).

Liquidity, which includes cash and cash equivalents (EUR 56.8 m) and investments (EUR 32.0 m) amounted to EUR 88.8 m at the end of September 2017 (31 December 2016: EUR 126.3 m). The liquidity position in 2017 was mainly impacted by the proceeds from the capital increase with Novo Holdings A/S and cash used in the acquisition of Aptuit.

Revenues from the EVT Execute segment were EUR 165.1 m in the first nine months of 2017 and significantly increased compared to the prior-year period (9M 2016: EUR 126.6 m). This increase is primarily attributable to a strong performance of the base business and initial contributions from acquisitions. Also included in this amount are EUR 27.4 m of intersegment revenues (9M 2016: EUR 23.9 m). The increase in revenues from the EVT Innovate segment to EUR 33.2 m, which consists entirely of third-party revenues, resulted primarily from the full impact of new partnerships with Celgene and Bayer signed in 2016 as well as milestone achievements from various collaborations. The gross margin for EVT Execute was 29.0% while EVT Innovate generated a gross margin of 46.2%. R&D expenses for the EVT Innovate segment were EUR 15.3 m in the first nine months of 2017 (9M 2016: EUR 17.9 m). In the first nine months of 2017, the adjusted EBITDA of the EVT Execute segment was strong at EUR 41.7 m and slightly improved compared to the prior-year period (9M 2016: EUR 41.3 m). The adjusted EBITDA of EVT Execute in the first nine months of 2017 was affected by one-time M&A and costs associated with the Aptuit acquisition. The EVT Innovate segment reported an adjusted EBITDA of EUR (2.4) m (9M 2016: EUR (10.7) m).

2. EVT EXECUTE & EVT INNOVATE

EVT EXECUTE – EXPANSION AND GROWTH OF HIGH-QUALITY SERVICES

The strong operational performance of the first half of 2017 successfully continued into the third quarter 2017 in the EVT Execute segment. Through the acquisition of Aptuit in August 2017, Evotec extended its value chain offering in early drug discovery to pre-clinical enabling activities ("INDiGO") and high-end CMC. The integration into the Evotec Group is proceeding according to plan. Cyprotex had a very strong start and its integration into the Evotec Group is also proceeding according to plan. Furthermore, Evotec consolidated its US footprint in the first nine months of 2017 to streamline processes and services.

In addition and amongst other highlights, Evotec entered multiple new integrated drug discovery alliances, e.g. with Abivax, Blackthorn Therapeutics, Dermira, STORM Therapeutics and Tesaro (after period-end).

Furthermore, strong progress was achieved in Evotec’s existing alliances. In the first nine months of 2017, a significant pre-clinical milestone was reached in the alliance with Bayer in the field of endometriosis and a clinical milestone was achieved in this collaboration for the progression of the second programme from the alliance portfolio into Phase I clinical development. This collaboration has also been extended a further year until 2018. Additionally, an existing asset progressed into pre-clinical development in a new indication (undisclosed).

EVT INNOVATE -VERY GOOD SCIENTIFIC PROGRESS AND IMPORTANT MILESTONES

The first nine months of 2017 for EVT Innovate were characterised by important achievements in strategic alliances (milestones in the kidney alliance with Bayer, the iPSC neurodegeneration alliance with Celgene, and the iPSC diabetes alliance with Sanofi) and an acceleration of various first-in-class innovations and ventures.

Strong progress was made with the strategic iPSC-based alliance with Celgene in neurodegeneration. This was demonstrated by the achievement of a milestone ($ 5.0 m) for the successful completion of a screening campaign using Evotec’s iPSC-based screening platform. Evotec continues to invest into the further development and expansion of its iPSC platform and entered into new strategic collaborations with Censo Biotechnologies (UK), Fraunhofer IME-SP (Germany) and Ncardia (Belgium/Germany) to strengthen its comprehensive iPSC network.

Evotec joined the NURTuRE (National Unified Renal Translational Research Enterprise) consortium in kidney diseases, expanding its commitment to patient-centric approaches through patient-derived biobanks. After period-end, Evotec announced that it is joining the NEPLEX ("Nephron-on-a-Chip with Cellular and Extracellular Matrix Complexity") consortium to accelerate the discovery of novel drugs to treat kidney diseases. NEPLEX is a strategic collaboration combining microfluidics technology with iPSC technology to develop a functional Nephron-on-a-Chip.

Evotec’s BRIDGE model is gaining significant momentum. In September 2017, Evotec initiated its first North American BRIDGE alliance with MaRS Innovation in Toronto, Canada. The goal of this new partnership ("LAB150") is to significantly shorten the drug discovery timeline and to generate viable start-up companies or high-value licencing arrangements. In its LAB282 BRIDGE alliance with Oxford University, two rounds of funding awards were completed in 2017.

3. CORPORATE

ACQUISITION OF APTUIT

Effective 11 August 2017, Evotec acquired Aptuit, a partner research organisation for integrated outsourced drug discovery and development solutions, for $ 300 m (approx. EUR 256 m; EUR/$ fx rate of 1.17) in cash. This acquisition was financed through a mix of existing cash reserves and an additional new EUR 140 m senior debt bridge facility at highly attractive terms. The one-time transaction costs related to this acquisition amounted to approx. EUR 4 m. The acquisition strengthens Evotec’s position as the leading global player in the external innovation marketplace. Furthermore, it grows Evotec’s business substantially and extends the value chain offering through to IND submission and beyond to integrated drug substance and drug product manufacture.

CONTINUED HIGH-VALUE STRATEGIC INVESTMENTS AND COMPANY FORMATIONS

Alongside its EVT Innovate strategy, Evotec continues to participate in strategic investments and company formations. By doing so, Evotec demonstrates its willingness to accelerate innovation by taking equity stakes in companies. Along these lines, at the end of September 2017, Evotec became the first strategic shareholder in Exscientia Ltd, a UK-based company. Exscientia is the world leader in developing and applying Artificial Intelligence approaches specifically to design new and better therapeutic molecules in a faster and more cost-effective manner. This project is the first to benefit from the European Investment Bank ("EIB") loan facility.

LOAN FACILITY ISSUED BY EUROPEAN INVESTMENT BANK TO SUPPORT INNOVATE R&D STRATEGY

In September 2017, the EIB granted Evotec an unsecured loan facility of up to EUR 75 m to support Evotec’s Innovate R&D strategy. The EIB funding specifically supports Evotec’s Innovate R&D strategy through a unique, innovative and flexible financing structure including a moderate reward-sharing component for the EIB. It is intended to invest the total loan financing of EUR 75 m into EVT Innovate R&D projects over a period of four years. After draw down of respective tranches, these will mature over seven years. The long-term character of this financing reduces substantially the cost of capital for innovation.

4. GUIDANCE 2017 CONFIRMED

On 16 August 2017, Evotec updated its revenue and adjusted Group EBITDA guidance following the acquisition of Aptuit. All elements of the financial guidance are confirmed.

Guidance 2017 Actual 2016
Group revenues More than 40% growth (previously: more than 15%) EUR 164.5 m
Adjusted Group EBITDA1) Improve by more than 50% compared to 2016 (previously: significantly) EUR 36.2 m
R&D expenses Approx. EUR 20 m EUR 18.1 m
1) EBITDA is defined as earnings before interest, taxes, depreciation, and amortisation of intangibles. EBITDA excludes contingent considerations, income from bargain purchase and impairments on goodwill, other intangible and tangible assets as well as the total non-operating result.

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details
Date: Wednesday, 08 November 2017
Time: 02.00 pm CET (01.00 pm GMT/08.00 am EST)

From Germany: +49 69 22 22 29 043
From France: +33 170 750 705
From Italy: +39 02 3601 3806
From UK: +44 20 3009 2452
From USA: +1 855 402 7766
Access Code: 37969784#

A simultaneous slide presentation for participants dialling in via phone is available at http://www.audio-webcast.com/, password: evotec1117.

Webcast details
To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 22 22 33 985 (Germany) or +44 20 3426 2807 (UK) and in the USA by dialling +1 866 535 8030. The access code is 654573#. The on-demand version of the webcast will be available on our website: View Source

Pacira Pharmaceuticals, Inc. Reports Third Quarter 2017 Financial Results

On November 8, 2017 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported consolidated financial results for the third quarter ended September 30, 2017 (Press release, Pacira Pharmaceuticals, NOV 8, 2017, View Source;991.htm [SID1234521758]).

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"We continue to make important progress during 2017 as we advance our strategy to expand the role of EXPAREL as the only long-acting local analgesic capable of providing non-opioid pain control during the most intense period of postsurgical pain," said Dave Stack, chairman and chief executive officer of Pacira. "Recent highlights include the FDA acceptance of our sNDA for nerve block; the publication of new research quantifying the devastating impact of opioids for postsurgical pain; a unique collaboration with Aetna to reduce opioid use associated with impacted wisdom teeth extractions; and the advancement of our important partnership with J&J."

"During the quarter we generated year over year EXPAREL growth despite fewer selling days and the impact of weather in areas of the southern United States representing about 20 percent of our business. From our commercial initiatives and current trends however; we remain confident in the growth potential of EXPAREL and our steadfast commitment to reducing the use of opioids for postsurgical pain."

Recent Highlights


U.S. Food and Drug Administration (FDA) Acceptance of Supplementary New Drug Application for Nerve Block. In October, the FDA accepted the company’s resubmission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL (bupivacaine liposome injectable suspension) label to include administration via nerve block for prolonged regional analgesia. If approved, EXPAREL could help eliminate the need for cumbersome devices like pumps and catheters and shift numerous procedures to an outpatient setting. The expected action date for the FDA under the Prescription Drug User Fee Act (PDUFA) is April 6, 2018.


Provided Invited Testimony at White House Opioid Crisis Commission Meeting. In September, Pacira Chief Executive Officer Dave Stack testified before President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis. The Commission, led

by New Jersey Governor Chris Christie, was created to study ways to combat and treat drug abuse, addiction and the opioid crisis. Stack provided insights into the critical nature of clinician and patient access to non-opioid medications that can effectively manage postsurgical pain while reducing opioid requirements.


Published New Research Highlighting Serious Threats Associated with Overprescribing Postsurgical Opioids. Newly published research, conducted by the QuintilesIMS Institute, shows individuals undergoing surgery are at particular risk for long-term opioid use. An overwhelming majority of patients (nine in 10) are exposed to opioids to manage postsurgical pain, and those given prescriptions received an average of 85 pills each. In addition, nearly 3 million individuals who had surgery in 2016 became persistent opioid users, according to the research. This report, The United States for Non-Dependence, represents the most current analysis of national trends in opioid prescribing.


Collaboration with Aetna and the American Association of Oral and Maxillofacial Surgeons to Reduce Opioid Use. In September, Pacira announced a nationwide collaboration with Aetna and the American Association of Oral and Maxillofacial Surgeons (AAOMS) aimed at reducing the number of opioid tablets prescribed to patients undergoing impacted third molar extraction by at least 50 percent through the utilization of EXPAREL to provide prolonged non-opioid postsurgical pain control.


Multiple EXPAREL Data Presentations at the New York School of Regional Anesthesia Annual Fall Symposium. In September, the company presented three posters evaluating the use of EXPAREL administered as a regional nerve block to manage postsurgical pain at the New York School of Regional Anesthesia’s (NYSORA) 16th Annual Symposium on Regional Anesthesia, Pain and Perioperative Medicine.

Third Quarter 2017 Financial Results


EXPAREL net product sales were $66.8 million in the third quarter of 2017, a 3% increase over the $64.9 million reported for the third quarter of 2016. There were two fewer selling days in the third quarter of 2017 compared to the third quarter of 2016.


Total revenues were $67.3 million in the third quarter of 2017, a 1% decrease versus the $68.4 million reported for the third quarter of 2016, primarily related to the discontinuation of DepoCyt(e) and lower collaborative licensing and milestone revenue.


Total operating expenses were $70.9 million in the third quarter of 2017, compared to $89.2 million in the third quarter of 2016.


GAAP net loss was $7.6 million, or $(0.19) per share (basic and diluted), in the third quarter of 2017, compared to a GAAP net loss of $22.2 million, or $(0.59) per share (basic and diluted), in the third quarter of 2016.


Non-GAAP net income was $4.4 million, or $0.11 per share (basic and diluted) in the third quarter of 2017, compared to non-GAAP net income of $8.0 million, or $0.22 per share (basic) and $0.20 per share (diluted), in the third quarter of 2016.


Pacira ended the third quarter of 2017 with cash, cash equivalents, short-term and long-term investments ("cash") of $374.9 million.


Pacira had 40.5 million basic weighted average shares of common stock outstanding in the third quarter of 2017.


For non-GAAP measures, Pacira had 41.4 million diluted weighted average shares of common stock outstanding in the third quarter of 2017.

2017 Outlook

Pacira is updating its full year 2017 sales guidance and reiterating its remaining financial guidance as follows:


EXPAREL net product sales of $280 million to $285 million from its previously guided range of $290 million to $310 million.


Non-GAAP gross margins of approximately 70%.


Non-GAAP research and development (R&D) expense of $50 million to $60 million.


Non-GAAP selling, general and administrative (SG&A) expense of $145 million to $155 million.


Stock-based compensation of $30 million to $35 million.

See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2017 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, November 8, 2017, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 96590192.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 96590192. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income (loss), non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D), non-GAAP selling, general and administrative (SG&A) and non-GAAP product discontinuation expenses, because such measures exclude stock-based compensation, amortization of debt discount, loss on early extinguishment of debt, a contract termination fee with CrossLink BioScience, LLC, or CrossLink, exit costs related to the discontinuation of DepoCyt(e) production and inventory and related reserves from 2016.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D and SG&A outlook for 2017 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2017 financial guidance for gross margins, R&D and SG&A.