Diplomat to Release Third-Quarter 2018 Operating Results, Host Conference Call on Nov. 6

On October 16, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that it will release its third-quarter 2018 operating results after market close Tuesday, Nov. 6, with a conference call to follow at 5 p.m. ET (Press release, Diplomat Speciality Pharmacy, OCT 16, 2018, View Source [SID1234529937]).

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Shareholders and interested participants can listen to a live broadcast by calling 833.286.5805 (647.689.4450 for international callers) and entering participation code 7553049, starting about 15 minutes before the call. A live webcast of the conference call will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. The site will host an audio recording and supplemental investor information for 90 days.

ICYMI…Immunomic Therapeutics Presents at the 2018 BIO Investor Forum…Watch webcast here

On October 16, 2018 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company reported that it will presented at the 2018 BIO Investor Forum held in San Francisco, CA on October 17-18 (Press release, Immunomics, OCT 16, 2018, View Source [SID1234530090]). William Hearl, Ph.D., Immunomic’s Founder and Chief Executive Officer (CEO), presented a company overview and discussed Immunomic’s recently expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM) Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company presented at the 2018 BIO Investor Forum held in San Francisco, CA on October 17-18. William Hearl, Ph.D., Immunomic’s Founder and Chief Executive Officer (CEO), presented a company overview and discussed Immunomic’s recently expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM). Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

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A live webcast of the presentation link is below:

http://www.veracast.com/webcasts/bio/investorforum2018/46203468489.cfm.

Who: William Hearl, Ph.D., Founder and CEO of Immunomic Therapeutics, Inc.

What: Immunomic Therapeutics Takes Aim at Cancer at the BIO Investor Forum

When: Thursday, October 18 at 9:45 a.m. PDT

Where: Westin St. Francis Hotel, Room Elizabethan D, 335 Powell Street, San Francisco, CA 94102

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.. Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

A live webcast of the presentation link is below:

http://www.veracast.com/webcasts/bio/investorforum2018/46203468489.cfm.

Who: William Hearl, Ph.D., Founder and CEO of Immunomic Therapeutics, Inc.

What: Immunomic Therapeutics Takes Aim at Cancer at the BIO Investor Forum

When: Thursday, October 18 at 9:45 a.m. PDT

Where: Westin St. Francis Hotel, Room Elizabethan D, 335 Powell Street, San Francisco, CA 94102

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Third Quarter of 2018

On October 16, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 498 million in the third quarter of 2018 compared to USD 317 million in the third quarter of 2017, an increase of 57% (Press release, Genmab, OCT 16, 2018, View Source [SID1234530344]). The 2018 third quarter net sales were USD 318 million in the U.S. and USD 180 million in the rest of the world.

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Johnson & Johnson reported worldwide operational growth (excluding the impact of foreign currency movements) between the two third quarter periods of 60%.The growth was partially offset by a one-time adjustment outside the U.S. related to accruals for retroactive pricing adjustments which negatively impacted this worldwide operational growth by 16 percentage points.

Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

Fresenius confirms and narrows Group guidance for FY/18 and publishes preliminary results for Q3/18

On October 16, 2018 Fresenius reported that it has confirms and narrows its Group guidance1 for FY/18. Group sales are expected to increase at the low end of the original 5% to 8%2 guidance range (in constant currency) (Press release, Fresenius, OCT 16, 2018, View Source [SID1234530132]). Fresenius expects net income3,4 growth at the low end of the original 6% to 9% guidance range (in constant currency). Excluding expenditures for the further development of the biosimilars business, net income3,5 growth is projected at the low end of the original ~10% to 13% guidance range (in constant currency). Narrowing the Group guidance ranges is due to updated expectations at Fresenius Medical Care, Fresenius Kabi and Fresenius Helios.

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Fresenius Medical Care adjusts its outlook for FY/18 as the business development in Q3/18 was below the company’s expectations. Fresenius Medical Care now expects sales growth of 2% to 3%6 in constant currency (previously: 5% to 7%6). Whilst Fresenius Kabi confirms its guidance of 4% to 7% organic sales growth, it now expects to reach the top end of this range. Fresenius Kabi sees a strong development across all product lines and regions with North America standing out. Fresenius Helios confirms and narrows its FY/18 organic sales growth outlook, and now projects growth at the low end of the original 3% to 6% range. The business development in Germany in Q3/18 was below the company’s expectations mainly due to a decline in admissions and additional catalogue effects. In line with market development in Germany, Fresenius Helios sees a trend towards outpatient treatments leading to fewer admissions in its hospitals.

On a comparable basis8, Fresenius Medical Care now expects FY/18 net income7 to increase by 11% to 12%8 in constant currency (previously: 13% to 15%8). On an adjusted basis9, Fresenius Medical Care now expects FY/18 net income7 to increase by 2% to 3%9 in constant currency (previously: 7% to 9%9). Fresenius Kabi increases its FY/18 EBIT outlook and now expects 1% to 3%10 growth in constant currency (previously: -2% to +1%10). The increase is driven by a strong development across all product lines and regions with North America standing out. FY/18 EBIT excluding expenditures for the further development of the biosimilars business is now expected to grow by ~9% to 11%11 in constant currency (previously: ~6% to 9%11). Fresenius Helios adjusts its FY/18 EBIT outlook and now expects 0% to 2% growth (previously: 5% to 8%), driven by lower sales growth in Germany. Moreover, preparatory structural activities for anticipated regulatory requirements (e.g. clustering), as well as a lack of privatization opportunities in the German market continue to weigh on earnings growth.

Fresenius Vamed confirms its outlook for FY/18 and expects organic sales growth in the range of 5% to 10% and FY/18 EBIT growth of 32% to 37%. The integration of the inpatient post-acute care business acquired from Helios Germany is fully on track.

Q3/2018 preliminary financial results

In Q3/18, Fresenius Group sales increased by ~3%12 (~4%12 in constant currency) to ~€8.2 billion (Q3/2017: €8.297 billion). Group net income3 before special items13 increased by ~8% (~8% in constant currency) to ~€445 million (Q3/2017: €413 million). Fresenius Medical Care has increased the provision for the FCPA (Foreign Corrupt Practices Act) related charge by €75 million (not tax deductible). As in 2017, this charge is treated as a special item. Group net income3 before special items13 and before expenses for the further development of the biosimilars business increased by ~13% (~13% in constant currency) to ~€474 million (Q3/2017: €423 million).

Fresenius will publish its detailed Q3/18 and Q1-Q3/18 financial results on October 30, 2018.

JHL Biotech Announces China Approves Phase I and Phase III Clinical Trial Application for Bevacizumab Biosimilar to Treat Cancer

On October 16, 2018 JHL Biotech reported that the National Medical Products Administration of the PRC (NMPA) has approved JHL’s Phase I and Phase III Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149, to treat several forms of cancer, including advanced non-squamous non-small-cell lung cancer (NSCLC), metastatic colorectal cancer, metastatic kidney cancer, advanced cervical cancer and recurrent ovarian cancer (Press release, JHL Biotech, OCT 16, 2018, View Source [SID1234530227]).

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Racho Jordanov, JHL Biotech, Co-Chairman and CEO stated, "We are very excited for our second biosimilar to be approved for clinical trials by the NMPA. This marks the second NMPA approval we have received in just four months and puts us another step closer to our vision of manufacturing biologics of the highest quality from
China for the world."