On November 5, 2019 Allergan plc (NYSE: AGN) reported its third quarter 2019 financial results including GAAP net revenues of $4.05 billion, a 3.6 percent increase from the prior year quarter (Press release, Allergan, NOV 5, 2019, View Source [SID1234550382]).

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Executive Commentary

"The third quarter 2019 results demonstrate our commitment to continued strong operational performance. The core business has grown and has been bolstered by significant pipeline progress, with three new molecular entities currently under regulatory review," said Brent Saunders, Chairman and CEO of Allergan. "VRAYLAR, BOTOX Cosmetic, JUVÉDERM, BOTOX Therapeutic, OZURDEX and Lo LOESTRIN continue to lead the way, with VRAYLAR growing 70 percent and U.S. BOTOX Cosmetic growing 10 percent in the third quarter from the prior year."

Third Quarter 2019 Results

GAAP operating loss in the third quarter of 2019 was $596.6 million compared to GAAP operating income of $257.5 million in the prior year quarter. Non-GAAP operating income in the third quarter of 2019 was $1.76 billion, a decrease of 7.7 percent versus the prior year quarter, partially impacted by divestitures, products that lost or are at risk of losing exclusivity and an increase in operating expenses. GAAP cash flow from operations for the third quarter of 2019 totaled $2.92 billion. Cash flow from operations in the third quarter includes a one-time tax refund of $1.6 billion of capital gains taxes previously paid and attributable to tax losses recorded in prior periods.

Operating Expenses

Total GAAP Selling, General and Administrative (SG&A) Expense was $1.99 billion for the third quarter of 2019, compared to $1.04 billion in the prior year quarter. Total non-GAAP SG&A expense was $1.18 billion for the third quarter of 2019, an increase of 14.3 percent from the prior year quarter, primarily related to an increase in spending to support key products and new product launches. GAAP R&D investment for the third quarter of 2019 was $474.5 million, compared to $424.2 million in the third quarter of 2018. Non-GAAP R&D investment for the third quarter of 2019 was $448.9 million, an increase of 14.0 percent compared to the prior year quarter, due to increased direct project spend to support pipeline advancement and new product launches.

Amortization, Tax and Capitalization

Amortization expense for the third quarter of 2019 was $1.54 billion, compared to $1.59 billion in the third quarter of 2018. The Company’s GAAP tax rate was -2.4 percent in the third quarter of 2019. The Company’s non-GAAP adjusted tax rate was 11.2 percent in the third quarter of 2019. As of September 30, 2019, Allergan had cash and marketable securities of $4.56 billion and outstanding indebtedness of $22.5 billion.

Operating Charges and Impairments

Allergan recorded a pre-tax charge of $750 million in the three months ended September 30, 2019 related to a settlement reached in principle by subsidiaries Forest Laboratories, LLC, Forest Laboratories, Inc. and Forest Laboratories Holdings Ltd. with direct purchasers of Namenda, resolving the class action litigation filed by that class of purchasers in the U.S. District Court for the Southern District of New York. The Company excludes operating charges, asset sales and impairments, net and in-process research and development impairments from its Non-GAAP performance net income attributable to shareholders as well as Adjusted EBITDA and Non-GAAP Operating Income.

THIRD QUARTER 2019 BUSINESS SEGMENT RESULTS

U.S. Specialized Therapeutics

U.S. Specialized Therapeutics net revenues were $1.67 billion in the third quarter of 2019, a decrease of 2.1 percent versus the prior year quarter. Demand growth in BOTOX and JUVÉDERM Collection was offset by a decline in sales of CoolSculpting compared to the prior year quarter and the divestiture of the Company’s Medical Dermatology business on September 20, 2018. Segment gross margin for the third quarter of 2019 was 91.0 percent. Segment contribution for the third quarter of 2019 was $1.08 billion.

Medical Aesthetics

Facial Aesthetics
BOTOX Cosmetic net revenues in the third quarter of 2019 were $237.6 million, an increase of 10.0 percent from the prior year quarter.
JUVÉDERM Collection (defined as JUVÉDERM, VOLUMA and other fillers) net revenues in the third quarter of 2019 were $134.8 million, an increase of 6.0 percent versus the prior year quarter.
Regenerative Medicine
ALLODERM net revenues in the third quarter of 2019 were $95.0 million, a decrease of 10.2 percent versus the prior year quarter.
Body Contouring
CoolSculpting net revenues (including both CoolSculpting Systems/Applicators and Consumables) in the third quarter of 2019 were $53.0 million, a decrease of 37.6 percent from the prior year quarter.
Neurosciences & Urology

BOTOX Therapeutic net revenues in the third quarter of 2019 were $431.6 million, an increase of 5.9 percent versus the prior year quarter.
Eye Care

RESTASIS net revenues in the third quarter of 2019 were $286.8 million, a decrease of 3.8 percent versus the prior year quarter.
ALPHAGAN/COMBIGAN net revenues in the third quarter of 2019 were $90.9 million, a decrease of 4.7 percent versus the prior year quarter.
OZURDEX net revenues in the third quarter of 2019 were $33.7 million, an increase of 17.8 percent versus the prior year quarter.
U.S. General Medicine

U.S. General Medicine net revenues in the third quarter of 2019 were $1.52 billion, an increase of 9.9 percent versus the prior year quarter. Demand growth in VRAYLAR, VIIBRYD and Lo LOESTRIN was partially offset by lower revenues from products that lost exclusivity. Segment gross margin for the third quarter of 2019 was 83.9 percent. Segment contribution for the third quarter of 2019 was $967.2 million.

Central Nervous System

VRAYLAR net revenues were $234.6 million in the third quarter of 2019, an increase of 70.0 percent from the prior year quarter.
VIIBRYD/FETZIMA net revenues in the third quarter of 2019 were $105.1 million, an increase of 18.8 percent from the prior year quarter.
Gastrointestinal, Women’s Health & Diversified Brands

LINZESS net revenues in the third quarter of 2019 were $214.7 million, an increase of 4.8 percent versus the prior year quarter.
Lo LOESTRIN net revenues in the third quarter of 2019 were $161.4 million, an increase of 14.1 percent versus the prior year quarter.
BYSTOLIC/BYVALSON net revenues in the third quarter of 2019 were $152.2 million, an increase of 0.7 percent from the prior year quarter.
International

International net revenues in the third quarter of 2019 were $835.1 million, an increase of 5.0 percent versus the prior year quarter excluding foreign exchange impact. Growth in Facial Aesthetics and BOTOX Therapeutic was partially offset by declines in textured breast implants. OZURDEX growth was primarily related to a 2018 recall of OZURDEX in certain international markets. Segment gross margin for the third quarter of 2019 was 82.7 percent. Segment contribution was $437.6 million.

Facial Aesthetics

BOTOX Cosmetic net revenues in the third quarter of 2019 were $165.6 million, an increase of 5.8 percent versus the prior year quarter excluding foreign exchange impact.
JUVÉDERM Collection net revenues in the third quarter of 2019 were $144.7 million, an increase of 7.3 percent versus the prior year quarter excluding foreign exchange impact.
Eye Care

LUMIGAN/GANFORT net revenues in the third quarter of 2019 were $89.7 million, a decrease of 1.4 percent versus the prior year quarter excluding foreign exchange impact.
OZURDEX net revenues in the third quarter of 2019 were $63.8 million, an increase of 159.3 percent versus the prior year quarter excluding foreign exchange impact.
Botox Therapeutic

BOTOX Therapeutic net revenues in the third quarter of 2019 were $93.9 million, an increase of 5.3 percent versus the prior year quarter excluding foreign exchange impact.
PIPELINE UPDATE

Allergan R&D continues to advance its pipeline. During the third quarter of 2019, the Company’s key clinical developments included:

The U.S. Food and Drug Administration (FDA) approved Allergan’s supplemental Biologics License Application (sBLA) to expand the BOTOX (onabotulinumtoxinA) label for the treatment of pediatric patients ages two years and older with lower limb spasticity, excluding spasticity caused by cerebral palsy. This marks the 14th approved indication for BOTOX and BOTOX Cosmetic combined in the U.S., and the 11th BOTOX therapeutic indication. The FDA approved BOTOX (onabotulinumtoxinA) for pediatric upper limb spasticity in the second quarter of 2019.
The FDA accepted a Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD). The FDA is expected to take action on the BLA mid-2020, with launch expected to follow. The European Medicines Agency (EMA) is also reviewing a Marketing Authorisation Application (MAA) for Abicipar in patients with nAMD. A decision from the European Commission is expected in the second half of 2020.
Allergan received FDA approval for the use of Juvéderm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21.
Allergan dosed the first patient in a Phase 2b clinical trial of botulinum neurotoxin serotype E (BoNT/E) EB-001 for the treatment of glabellar frown lines.
Allergan completed enrollment of Part 1 of the Phase 3 AURORA NASH study in adults with stages 2/3 liver fibrosis.
In addition to third quarter 2019 pipeline developments and the anticipated launch of abicipar listed above, Allergan expects three additional significant launches in the next twelve months:

Allergan anticipates a regulatory decision from the FDA in December 2019 for the Company’s New Drug Application (NDA) for ubrogepant, an oral CGRP receptor antagonist for the acute treatment of migraine. Launch is expected to follow in the first half of 2020.
Allergan expects to launch CoolTone, a body contouring device that uses magnetic muscle stimulation, or MMS technology, to strengthen, tone and firm the muscles of the abdomen, buttocks and thighs, in the fourth quarter of 2019, following FDA clearance in the second quarter of 2019.
FDA action is expected in the first half of 2020 on Allergan’s NDA for Bimatoprost Sustained-Release, a biodegradable implant for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Launch is expected to follow in the first half of 2020.
UPDATE ON PROPOSED ABBVIE TRANSACTION

On October 14, 2019, Allergan shareholders voted to approve the proposed acquisition of Allergan by AbbVie. Additionally, both companies received a Request for Additional Information and Documentary Material (Second Request) from the U.S. Federal Trade Commission. Allergan and AbbVie continue to expect to close the transaction in early 2020, subject to customary closing conditions and regulatory approvals.

FULL YEAR 2019 GUIDANCE

(1) GAAP represents EPS for ordinary shareholders. GAAP income per share includes the impact of amortization of approximately $5.9 billion. Non-GAAP represents performance net income per share.

(2) GAAP EPS shares do not include dilution of shares when earnings are a net loss. As such, the dilution impact of outstanding equity awards is not included in the forecasted shares.

(3) The non-GAAP performance net income per share guidance for the twelve months ending December 31, 2019 of >$16.55 represents a "profit forecast" for the purposes of the Irish Takeover Rules. Please see page 7 of this press release for further information in relation to the basis of preparation of, assumptions behind and reports prepared in relation to that profit forecast.

ADDITIONAL THIRD QUARTER DETAILS

Due to the proposed acquisition of Allergan by AbbVie, Allergan is not hosting a conference call to discuss its third quarter results. For additional materials related to Allergan’s third quarter results, please visit Allergan’s Investor Relations website at View Source

On November 5, 2019 DaVita Inc. (NYSE: DVA) reported results for the quarter ended September 30, 2019 (Press release, DaVita, NOV 5, 2019, View Source [SID1234550497]).

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Third quarter 2019 financial and operational highlights:

Consolidated revenues of $2.904 billion.
Operating income of $378 million and adjusted operating income of $462 million.
Cash flows from continuing operations of $648 million.
Entered into a new $5.5 billion senior secured credit agreement and redeemed our 5.75% senior notes.
Repurchased 30,591,750 shares of our common stock at an average cost of $57.14 per share.

For the definitions of non-GAAP financial measures see the note titled "Note on Non-GAAP Financial Measures" and related reconciliations beginning at page 14.

Certain items impacting the quarter:

Debt transactions: On August 12, 2019, we entered into a new $5.5 billion senior secured credit agreement consisting of a $1.75 billion senior secured Term Loan A facility with a delayed draw feature, a $2.75 billion senior secured Term Loan B facility and a $1.0 billion senior secured revolving line of credit. As of September 30, 2019, the new Term Loan A and Term Loan B were fully drawn and the new revolving line of credit remained undrawn. We used the proceeds from the new senior secured credit facilities to pay off the remaining balances outstanding on our previous senior secured credit facilities, redeem our 5.75% senior notes due 2022 and pay related redemption fees, and fund our modified "Dutch auction" tender offer (Tender Offer) to purchase shares of our common stock as further described below, as well as to repurchase additional shares of our common stock through open market transactions. The remaining debt borrowings added cash to our balance sheet for potential acquisitions, share repurchases and other general corporate purposes.

As a result of the debt transactions described above, we recorded debt refinancing and redemption charges of $21 million in the third quarter of 2019. These charges consist of write-offs of old debt discount and deferred financing costs, as well as the redemption premium associated with our 5.75% senior notes and professional fees.

Share repurchases: The following table summarizes repurchases of our common stock during the three and nine months ended September 30, 2019.

The amount paid for shares repurchased associated with the Company’s Tender Offer during the three and nine months ended September 30, 2019 includes the clearing price of $56.50 per share plus related fees and expenses of $2 million.

In addition to the share repurchases described above, we have also repurchased 4,283,376 shares of our common stock for $246 million at an average cost of $57.32 per share from October 1, 2019 through November 4, 2019. Effective November 4, 2019, our Board of Directors terminated all remaining prior share repurchase authorizations available to us and approved a new share repurchase authorization of $2 billion.

Non-GAAP adjustments to operating income:

Goodwill impairment charge: During the quarter ended September 30, 2019, we recognized a non-cash goodwill impairment charge of $79 million in our Germany kidney care business as a result of continuing developments in the business and our expected timing and ability to mitigate them. This charge included a $17 million increase to the goodwill impairment charge due to the deferred tax assets that the impairment itself generated. The result was a $79 million goodwill impairment charge to operating income, a $17 million credit to tax expense, and a net $62 million impact on net income. We also recognized a $5 million goodwill impairment charge in our other German health operations.

For the definitions of non-GAAP financial measures see the note titled "Note on Non-GAAP Financial Measures" and related reconciliations beginning at page 14.

Volume: Total U.S. dialysis treatments for the third quarter of 2019 were 7,673,191, or an average of 97,129 treatments per day, representing a per day increase of 2.7% over the third quarter of 2018. Normalized non-acquired treatment growth in the third quarter of 2019 as compared to the third quarter of 2018 was 2.2%.

Effective income tax rate: Our effective income tax rate on income from continuing operations was 23.8% and 24.3% for the three and nine months ended September 30, 2019, respectively. This effective income tax rate was impacted by the amount of third party owners’ income attributable to non-tax paying entities. The effective income tax rate on income from continuing operations attributable to DaVita Inc. was 30.3% and 29.8% for the three and nine months ended September 30, 2019, respectively.

Our effective income tax rate on income from continuing operations attributable to DaVita Inc. for the three and nine months ended September 30, 2019 was further impacted by the write-off of deferred financing costs, other debt costs and goodwill impairment charges. Excluding these items from the three and nine months ended September 30, 2019, our effective income tax rate on adjusted income from continuing operations attributable to DaVita Inc. would have been 27.6% and 28.4% for the three and nine months ended September 30, 2019, respectively.

Center activity: As of September 30, 2019, we provided dialysis services to a total of approximately 233,300 patients at 2,985 outpatient dialysis centers, of which 2,736 centers were located in the United States and 249 centers were located in nine countries outside of the United States. During the third quarter of 2019, we opened a total of 24 new dialysis centers, acquired two dialysis centers and closed 13 dialysis centers in the United States. In addition, we opened one new dialysis center, acquired two dialysis centers and closed two dialysis centers outside of the United States during the third quarter of 2019.

Outlook:

The following forward-looking measures and the underlying assumptions involve significant risks and uncertainties, including those described below, and actual results may vary significantly from these current forward-looking measures. We do not provide guidance for consolidated operating income, diluted net income from continuing operations per share attributable to DaVita Inc. or effective tax rate on income from continuing operations on a GAAP basis nor a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures on a forward-looking basis because we are unable to predict certain items contained in the GAAP measures without unreasonable efforts. These non-GAAP financial measures do not include certain items, including goodwill impairment charges and foreign currency fluctuations, any of which may be significant. The guidance for effective income tax rate on adjusted income from continuing operations attributable to DaVita Inc. also excludes the write-off of deferred financing costs, other debt costs and the amount of third party owners’ income and related taxes attributable to non-tax paying entities.

We will be holding a conference call to discuss our results for the third quarter ended September 30, 2019, on November 5, 2019, at 5:00 p.m. Eastern Time. To join the conference call, please dial (877) 918-6630 from the U.S. or (517) 308-9042 from outside the U.S., and provide the operator the password ‘Earnings’. A replay of the conference call will be available on our website at investors.davita.com for the following 30 days.

On November 5, 2019 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol-Myers Squibb") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "Celgene Notes") issued by Celgene Corporation (NASDAQ:CELG) ("Celgene") for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb Company (the "Bristol-Myers Squibb Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Bristol-Myers Squibb on behalf of Celgene to adopt certain proposed amendments (the "Amendments") to the indentures governing the Celgene Notes (Press release, Bristol-Myers Squibb, NOV 5, 2019, View Source;5 [SID1234550290]). Bristol-Myers Squibb hereby extends such expiration date from 5:00 p.m., New York City time, on November 6, 2019, to 5:00 p.m., New York City time, on November 8, 2019 (as the same may be further extended, the "Expiration Date").

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On the early participation date of May 1, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the Celgene Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal hereby, each as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019 and as amended hereby, and are conditioned upon the closing of Bristol-Myers Squibb’s acquisition of Celgene (the "Merger"), which condition may not be waived by Bristol-Myers Squibb, and certain other conditions that may be waived by Bristol-Myers Squibb.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and on or about the closing date of the Merger. The closing of the Merger is expected to occur by the end of 2019. As a result, the Expiration Date may be further extended one or more times. Bristol-Myers Squibb will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on November 4, 2019, the principal amounts of Celgene Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Celgene Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019, October 30, 2019, November 1, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470 3900 (U.S. toll-free) or (212) 430 3774 (banks and brokers). The eligibility form is available electronically at: View Source

On November 5, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported financial results and a corporate update for the quarter ended September 30, 2019 (Press release, CymaBay Therapeutics, NOV 5, 2019, View Source [SID1234550318]).

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"The third quarter marked one of our most productive periods, culminating in reaching target enrollment in ENHANCE, our global, Phase 3 registration study of seladelpar in PBC, earlier than originally projected," said Sujal Shah, President and CEO of CymaBay. "We expect to complete enrollment in ENHANCE by the end of November and remain on track to report topline data from this 52-week study in early 2021. We also made significant progress in our efforts to expand development of seladelpar into a second rare, cholestatic liver disease with the initiation of our Phase 2 dose-ranging study in PSC. As our development activities advance in the coming months, we look forward to topline data from our completed open-label Phase 2 study in PBC, and topline 52-week biopsy data from our Phase 2b study in NASH, in the first and second quarters of 2020, respectively."

Third Quarter and Recent Business Highlights

Reached target enrollment of 240 patients in ENHANCE, our global, Phase 3 registration study of seladelpar for the treatment of primary biliary cholangitis (PBC).
The study is expected to be fully enrolled by the end of November 2019 with topline data release anticipated in early 2021.
Initiated a Phase 2 clinical study of seladelpar in primary sclerosing cholangitis (PSC).
The Phase 2 study is a randomized, placebo-controlled, dose-ranging study that will enroll approximately 100 patients at 60 sites globally.
Patients will be randomized to placebo or seladelpar 5, 10 or 25 mg in a 1:1:1:1 randomization.
The study includes an interim assessment of safety and efficacy after approximately 10 patients in each dose group reach 12 weeks of treatment.
Confirmed additional pharmacodynamic effects in the 12-Week interim analysis of the Phase 2b dose-ranging study in NASH.
Dose-dependent decreases of plasma C4 of up to 55% at 50 mg, a key mechanistic marker of hepatocellular bile acid synthesis.
Dose-dependent increases in carnitine and short-chain acyl carnitines of over 35% considered to be plasma markers of increased lipid metabolism.
No significant effects were observed using the ELF panel, a plasma-based marker of fibrosis, or in corrected-T1, an exploratory magnetic resonance imaging method being developed to identify inflammation associated with NASH. These measures will be assessed at additional timepoints as the study continues.
The study remains blinded until the 52-week liver histology endpoint, expected in 2Q 2020.
Announced acceptance of two abstracts for presentation at The Liver Meeting hosted by the American Association for the Study of Liver Diseases (AASLD) in Boston, MA (November 8-12, 2019).
"Pharmacokinetics of Seladelpar in Patients with Primary Biliary Cholangitis, with or without Cirrhosis" (Publication #1328)
"Structural and Biophysical Characterization of the Origins of the Selectivity of Seladelpar and Elafibranor, Peroxisomal Proliferator Activated Receptor (PPAR) Agonists Targeting Inflammatory Liver Diseases" (Publication #2253)
Third Quarter Financial Highlights & Results

Held $218.6 million in cash, cash equivalents and marketable securities at September 30, 2019. Existing cash is expected to fund the current operating plan into 2021.
Research and development expenses were $23.2 million in the third quarter of 2019 as compared to $17.9 million in the same period of 2018. The increase was primarily driven by higher manufacturing costs incurred to support our ongoing clinical trials and registration batches as well as a severance expense incurred due to the departure of an executive.
General and administrative expenses were $4.5 million in the third quarter of 2019 as compared to $3.3 million in the same period of 2018. The increase was driven primarily by higher employee compensation and other administrative expenses as we hired additional personnel to support our expanding operations.
Net loss was $26.3 million, or ($0.38) per diluted share in the third quarter of 2019, as compared to $18.6 million, or ($0.34) per diluted share in the same period of 2018. Net loss was higher primarily due to increased research and development expenses.
Nine Months Ended September 30, 2019 Financial Highlights & Results

Raised $107.7 million in net proceeds through our March public offering of common stock.
Research and development expenses were $62.9 million in the nine months ended September 30, 2019 as compared to $41.7 million in the same period of 2018. The increase was primarily driven by increases in seladelpar-related clinical trial expenses including enrollment activities related to our ENHANCE PBC Phase 3 clinical study, start-up and enrollment activities related to our PSC Phase 2 clinical study, higher manufacturing costs incurred to support our ongoing clinical trials and registration batches, and execution of other NDA-enabling studies.
General and administrative expenses were $14.7 million in the nine months ended September 30, 2019 as compared to $10.2 million in the same period of 2018. The increase was driven primarily by higher employee compensation expense and other administrative expenses as we hired additional personnel to support our expanding operations.
Net loss was $73.4 million, or ($1.10) per diluted share in the nine months ended September 30, 2019 as compared to $53.1 million, or ($0.93) per diluted share in the same period of 2018. Net loss was higher primarily due to increased research and development expenses.
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss third quarter 2019 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13694084. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On November 5, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that the Company will present phase 1 dose-escalation monotherapy data for PRS-343, a 4-1BB/HER2 bispecific for the treatment of HER2-positive solid tumors, in a late-breaking oral presentation session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, Maryland (Press release, Pieris Pharmaceuticals, NOV 5, 2019, View Source [SID1234550334]).

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"We are pleased to have had our abstract accepted as one of the few late-breaking podium presentations at the conference, and we look forward to sharing an updated dataset for the program on November 9th, including safety, PK, biomarker, and clinical response data for patients enrolled in the highest dose cohorts," said Stephen S. Yoder, President and Chief Executive Officer of Pieris.

Presentation Details

Title: A Phase 1 Dose Escalation Study of PRS-343, a HER2/4-1BB Bispecific Molecule, in Patients with HER2-positive Malignancies
Session: 304
Date/Time: Saturday, November 9, 2019, 11:50 AM EST
Location: Potomac Ballroom, Gaylord National Hotel & Convention Center in National Harbor, Maryland

The presentation will be made available on the publications section of the Company’s website at www.pieris.com.