On November 15, 2019 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported that Eiger management will present a corporate update at the Jefferies 2019 London Healthcare Conference on November 20, 2019 from 4:00-4:35 PM GMT in London (Press release, Eiger Biopharmaceuticals, NOV 15, 2019, View Source [SID1234551388]).

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

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

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available on the Eiger BioPharmaceuticals website at www.eigerbio.com under the "Investors" tab. A replay of the webcast will be available approximately one hour following the completion of the live event.

Eiger will also host one-on-one meetings with investors.

On November 15, 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 15, 2019, View Source [SID1234551373]). Bristol-Myers Squibb hereby extends such expiration date from 5:00 p.m., New York City time, on November 15, 2019, to 5:00 p.m., New York City time, on November 20, 2019 (as the same may be further extended, the "Expiration Date").

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, November 5, 2019, November 7, 2019, November 12, 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 14, 2019, the principal amounts of Celgene Notes set forth in the table below had been validly tendered and not validly withdrawn:

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

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

                  Schedule Your 30 min Free Demo!

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, November 5, 2019, November 7, 2019, November 12, 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

This press release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the confidential offering memorandum and consent solicitation statement dated April 17, 2019, 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, November 5, 2019, November 7, 2019, November 12, 2019 and as amended hereby, and the related letter of transmittal and only to such persons and in such jurisdictions as are permitted under applicable law.

The Bristol-Myers Squibb Notes offered in the Exchange Offers have not been registered under the Securities Act of 1933, as amended, or any state securities laws. Therefore, the Bristol-Myers Squibb Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and any applicable state securities laws.

On November 15, 2019 DURECT Corporation (Nasdaq: DRRX) reported that James E. Brown, President and CEO, will be presenting at the Stifel 2019 Health Care Conference, at the Lotte New York Palace Hotel on Tuesday, November 19, 2019 at 3:35 p.m. EST (Press release, DURECT, NOV 15, 2019, View Source [SID1234551389]). Institutional investors and analysts that are attending the conference may request a one-on-one meeting through the conference coordinators.

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

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

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be available by accessing View Source

The live audio webcast of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking on the "Investors" tab. If you are unable to participate during the live webcast, the call will be archived on DURECT’s website in the "Event Calendar" of the "Investors" section.

On November 15, 2019 China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma," the "Company" or "We"), an NYSE American-listed corporation with a fully-integrated specialty pharmaceuticals subsidiary based in China, reported financial results for the quarter ended September 30, 2019 (Press release, North China Pharmaceutical, NOV 15, 2019, View Source [SID1234551390]).

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

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

                  Schedule Your 30 min Free Demo!

Third Quarter Highlights

Revenue increased by 3.4% to $2.4 million in the third quarter 2019 from $2.3 million in the same period of 2018;
Gross margin was 15.7% in the third quarter 2019, compared to 22.3% in the same period of 2018;
Loss from operations was $0.6 million in the third quarter 2019 compared to $1.9 million in the same period of 2018, an improvement of $1.3 million;
Net loss was $0.7 million in the third quarter 2019 compared to $1.9 million in the same period of 2018. Loss per common share was $0.02 per basic and diluted share in the third quarter 2019, compared to $0.04 per basic and diluted share in the same period of 2018.
Ms. Zhilin Li, China Pharma’s Chairman and CEO, commented, "We experienced negative effects on our sales from the strict implementation of the government policy of controlling the proportion of the spending on drugs to the patients’ total expenditures in hospitals in recent quarters. Management endeavors to vigorously promote sales through active participation in recent provincial market openings to solicit new drug tender offers and allow China Pharma to expand its presence in these markets." Ms. Li continued, "In addition, we are experiencing sustained pressure from the more stringent requirements of drug registration standards, consistency evaluations, which has created a challenging environment in our industry during this period. We will continue actively adapting to the state policy guidance and further evaluate market conditions for our current existing products, pipeline products, and competition in the market, in order to optimize our development strategy. We will simultaneously actively implement the launch of our nutrition product."

Third Quarter Results

Revenue increased by 3.4% to $2.4 million for the three months ended September 30, 2019, as compared to $2.3 million for the three months ended September 30, 2018.

Gross profit for the three months ended September 30, 2019 was $0.4 million, as compared to $0.5 million during the same period in 2018. Our gross profit margin in the three months ended September 30, 2019 was 15.7% as compared to 22.3% during the same period in 2018. The decrease in our gross profit margin was mainly due to the increased ratio of fixed cost to revenue.

Our selling expenses for the three months ended September 30, 2019 and 2018 were $0.6 million and $0.9 million, respectively. Selling expenses accounted for 25.8% of the total revenue in the three months ended September 30, 2019, as compared to 40.3% during the same period in 2018.

Our general and administrative expenses were $0.3 million for each of the three months ended September 30, 2019 and 2018. General and administrative expenses accounted for 14.0% and 14.2% of our total revenues in the three months ended September 30, 2019 and 2018, respectively.

Our research and development expenses for the three months ended September 30, 2019 were $0.04 million, as compared to $0.06 million in the same period in 2018. Research and development expenses accounted for 1.7% and 2.7% of our total revenues in the three months ended September 30, 2019 and 2018, respectively. The consistency evaluations discussed under the "Business Overview & Recent Developments" section hereof is expected to have a significant impact on all generic products not only in our pipeline products, but also throughout the existing Chinese market for similar generic products. Because of the continuous introduction of detailed implementation rules under this policy, our pipeline products did not experience any further development in the third quarter of 2019.

Our bad debt expenses for the three months ended September 30, 2019 was $0.03 million, as compared to $1.13 million for the same period in 2018. The decrease of bad debt expenses in this period was mainly due to the decrease in the amount of accounts receivable that is turning to over 2 years old in this period. Our bad debt allowance estimate requires 70% of accounts receivable that are between 365 days and 720 days old, and 100% of accounts receivable that are greater than 720 days old.

Net loss for the three months ended September 30, 2019 was $0.7 million, or $0.02 per basic and diluted common share, as compared to a net loss of $1.9 million, or $0.04 per basic and diluted common share, for the same period a year ago. The decrease in net loss was mainly the result of controls on expenditures outweighed the impact of decrease in gross profit margin.

Nine Months Results

For the nine months ended September 30, 2019, our sales revenue was $7.9 million, which represented a decrease of $1.2 million, or 13.3%, from the $9.1 million in the corresponding period of 2018.

Gross profit for the nine months ended September 30, 2019 was $1.2 million, compared to $2.1 million in the same period of 2018. Gross profit margins for the nine months ended September 30, 2019 and 2018 were 15% and 24%, respectively.

Our net losses for the nine months ended September 30, 2019 and 2018 were $2.0 million and $3.2 million, respectively, which represented an improvement of $1.2 million for the period in 2019. This improvement was mainly due to the decrease of bad debt expenses in this period.

Financial Condition

As of September 30, 2019, the Company had cash and cash equivalents of $0.8 million compared to $1.2 million as of December 31, 2018.

As of September 30, 2019, our net accounts receivable was $0.7 million, compared to $0.9 million as of December 31, 2018.

For the nine months ended September 30, 2019, cash flow from operating activities was $1.4 million, as compared to $1.0 million for the same period in 2018.

On November 15, 2019 Affibody Medical AB (publ) ("Affibody" or "the Company"), a Swedish biotechcompany focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod, reported its Interim Report for the third quarter of 2019 (Press release, Affibody, NOV 15, 2019, View Source [SID1234575700]).

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

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

                  Schedule Your 30 min Free Demo!

Financial Highlights

Revenue for the 3rd Quarter 2019 amounted to SEK 47.6 (25.6) m, and to 297.6 (85.1) m for the nine-month period
Operating result for the quarter amounted to SEK -17.5 (-58.0) m, and to 110.8 (-103.8) m for the nine-month period
Net result for the quarter amounted to SEK -6.0 (-57.7) m, and to 116.9 (-103.4) m for the nine-month period
Cash flow for the quarter amounted to SEK -27.9 (-30.6) m, and to 298.2 (-85.3) m for the nine-month period
Cash and cash equivalents at the end of the period amounted to SEK 389.2 (91.0) m.
Significant Events during the Reporting Period

In September Affibody announced its relocation to Campus Solna
In September a strategic collaboration with GE Healthcare to develop and commercialize Affibody-based PET imaging tracers, with initial focus on HER2 and PD-L1, was announced
In July, 2019 the completion of the planned 12 week interim analysis in the Company’s Phase 2 proof-of-concept study of its bispecific molecule ABY-035 for moderate-to-severe psoriasis ("AFFIRM-35") was announced.
Significant Events during the rest of the Year

The share issue was completed and fully subscribed in May and brought gross proceeds of SEK 147.4 m to the company
In March 2019, a partnership with Alexion Pharmaceuticals, Inc. to co-develop ABY-039, was announced. Under the terms of the agreement, Alexion has provided Affibody with an upfront payment of $25 million, with the potential for additional development- and sales-based milestones of up to $625 million and tiered low double-digit royalty payments. Alexion will lead joint clinical development of ABY-039 and commercialization activities. Affibody has the option to co-promote ABY-039 in the U.S. and will lead clinical development for an undisclosed indication
In February 2019, the Phase 2 proof-of-concept study of ABY-035 for moderate-to-severe psoriasis completed enrollment of patients.