Genprex, Inc. Prices $17,500,000 Common Stock Offering Priced At-The-Market and Without Warrants

On February 19, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical stage gene therapy company developing a new and potentially life-saving approach to treating some of the world’s most deadly cancers based upon a novel proprietary technology platform, reported it has entered into securities purchase agreements with institutional investors for the purchase and sale of 5,000,000 shares of common stock, par value $0.001 per share, at an offering price of $3.50 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules (Press release, Genprex, FEB 19, 2020, View Source [SID1234554501]). There are no warrants in the offering. The gross proceeds of the offering will be approximately $17,500,000 before deducting fees and other estimated offering expenses. The Company intends to use the net proceeds to advance its lead clinical programs in non-small cell lung cancer (NSCLC) and for working capital and general corporate purposes. The closing of the registered direct offering is expected to take place on or about February 21, 2020, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as lead placement agent for the offering.

Joseph Gunnar & Co., LLC is acting as co-placement agent for the offering.This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233774) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and an additional registration statement on Form S-3 filed pursuant to Rule 462(b) under the Securities Act 1933, as amended, filed with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by Genprex with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, New York 10022 or by email at [email protected]. Joseph Gunnar & Co. LLC, 30 Broad Street, 11th Floor, New York, New York 10004 or by email at [email protected].

Corporate Presentation

On February 19, 2020 Genmab Presented the Corporate Presentation (Presentation, Genmab, FEB 19, 2020, View Source [SID1234554500]).

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Genmab Publishes 2019 Annual Report

On February 19, 2020 Genmab A/S (Nasdaq: GMAB) reported the publication of its Annual Report for 2019 (Press release, Genmab, FEB 19, 2020, View Source [SID1234554499]). Below is a summary of business progress in 2019, financial performance for the year and the financial outlook for 2020. The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com. An online summary of the report is available at View Source

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Conference Call
Genmab will hold a conference call in English to discuss the full year results for 2019 today, February 19, 2020 at 6:00 pm CET, 5:00 pm GMT or noon EST. To join the call dial +1 631 510 7495 (US participants) or +44 2071 928000 (international participants) and provide conference code 4887886.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

2019 ACHIEVEMENTS

Business Progress
Daratumumab

U.S. FDA decision on Phase III MAIA multiple myeloma (MM) submission – achieved
U.S. FDA decision on Phase III CASSIOPEIA MM submission – achieved
Phase III COLUMBA MM subcutaneous daratumumab safety and efficacy analysis – achieved

Ofatumumab
·Phase III ASCLEPIOS I & II relapsing multiple sclerosis SubQ ofatumumab study completion and reporting – achieved

Tisotumab vedotin
·Phase II innovaTV 204 tisotumab vedotin recurrent / metastatic cervical cancer study enrollment complete by mid-year – achieved

Innovative Pipeline

Phase II enapotamab vedotin expansion cohort efficacy analysis – achieved
Phase I/II HexaBody-DR5/DR5 initial clinical data – initial data now anticipated in 2020
Phase I/II epcoritamab (DuoBody-CD3xCD20) clinical data dose escalation cohorts – achieved
File INDs and/or CTAs for 3 new product candidates – achieved
U.S. IPO

Genmab successfully completed an initial public offering (IPO) of American Depositary Shares (ADSs) on the Nasdaq Global Select Market
Achievement made Genmab a dual-listed company listed on both the Nasdaq Copenhagen in Denmark and the Nasdaq Global Select Market in the U.S.
Financial Performance

Revenue was DKK 5,366 million in 2019 compared to DKK 3,025 million in 2018. The increase of DKK 2,341 million, or 77%, was mainly driven by higher DARZALEX royalties and milestones achieved under our daratumumab collaboration with Janssen.
Operating expenses increased by DKK 1,083 million, or 66%, from DKK 1,645 million in 2018 to DKK 2,728 million in 2019 driven by the advancement of tisotumab vedotin and enapotamab vedotin, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
Operating income was DKK 2,638 million in 2019 compared to DKK 1,380 million in 2018. The improvement of DKK 1,258 million, or 91%, was driven by higher revenue, which was partly offset by increased operating expenses.
2019 year-end cash position of DKK 10,971 million, an increase of DKK 4,865 million, or 80%, from DKK 6,106 million as of December 31, 2018.
2020 OUTLOOK

Revenue
We expect our 2020 revenue to be in the range of DKK 4,750 – 5,150 million, compared to DKK 5,366 million in 2019. Our revenue in 2019 included DKK 1,684 million related to one-time sales milestones for DARZALEX net sales exceeding USD 2.5 billion and 3.0 billion in a calendar year.

Our projected revenue for 2020 primarily consists of DARZALEX royalties of DKK 4,075 – 4,475 million. Our 2020 guidance for DARZALEX royalties represents a 30% to 43% increase compared to 2019. Such royalties are based on estimated DARZALEX net sales of USD 3.9 – 4.2 billion. We project cost reimbursement income of approximately DKK 475 million which is related to our collaborations with Seattle Genetics and BioNTech. The remainder of our revenue is approximately DKK 200 million and consists of milestones and other royalties.

Operating Expenses
We anticipate our 2020 operating expenses to be in the range of DKK 3,850 – 3,950 million, compared to DKK 2,728 million in 2019. The increase is driven by the advancement of our clinical programs, particularly epcoritamab (DuoBody-CD3x-CD20) and DuoBody-PD-L1x4-1BB.

Operating Result
We expect our operating income to be in the range of DKK 850 – 1,250 million in 2020 compared to DKK 2,638 million in 2019.

Fresenius Medical Care achieves 2019 guidance and confirms 2020 outlook of sustainable, profitable growth

On February 19, 2020 Fresenius Medical reported that Care achieves 2019 guidance and confirms 2020 outlook of sustainable, profitable growth (Press release, Fresenius, FEB 19, 2020, View Source [SID1234554498])

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Rice Powell, Chief Executive Officer of Fresenius Medical Care, said: "2019 was a successful year for Fresenius Medical Care. We achieved our revenue and net income targets and are therefore proposing our 23rd consecutive dividend increase. Last year we also invested more strongly in our future growth, particularly in the area of home dialysis and in developing economies. In addition, our measures to increase efficiency and optimize our cost base are progressing according to plan. As a consequence, we expect growth to accelerate, and confirm the 2020 outlook that we issued early last year."

2020 guidance confirmed: mid to high single digit growth rates
Fresenius Medical Care expects both revenue and net income to grow at a mid to high single digit rate in 2020. These targets are in constant currency and exclude special items3 and are based on the adjusted results 2019 including the effects of the operations of the NxStage acquisition and the IFRS 16 implementation.

Investment year 2019
The continued expansion of home dialysis in the U.S. is a key growth area for Fresenius Medical Care. As announced at the beginning of 2019, our investments focused on home training facilities, educational staff and materials along with scaling the distribution infrastructure to support both products and services. The closing of the acquisition of NxStage Medical, Inc. in February 2019 marked a milestone in our home dialysis strategy. In 2019, Fresenius Medical Care reported record growth with more than 25,000 patients being treated at home in North America.

The second major focus of investment were developing economies. In China, the world’s fastest-growing dialysis market, Fresenius Medical Care invested in expanding production capacities, research and development activities as well as in strengthening its services business, that has almost doubled with now 11 clinics. In September 2019, we launched the 4008A dialysis machine in China, laying an important foundation for the further development of the market.

In addition, Fresenius Medical Care invested EUR 91 million (EUR 83 million in North America) to sustainably improve the cost base of our clinical infrastructure. This 2019 cost optimization program is expected to be accretive to net income from the current financial year onwards. In 2019, we achieved further sustained cost improvements as part of our Global Efficiency Program (GEP II), in line with the originally anticipated contribution.

Creating shareholder value
Based on the solid results for 2019, the General Partner and the Supervisory Board will propose a new record dividend of EUR 1.20 per share, corresponding to a total payout of EUR 358 million, to the Annual General Meeting in May 2020. This proposal would result in the 23rd consecutive dividend increase.

In order to create additional shareholder value, Fresenius Medical Care launched a share buy-back program in 2019. Between March and December 2019, 8.9 million own shares were bought back at a total purchase price of EUR 600 million. The Company intends to use its residual authorization of EUR 400 million over the course of 2020.

Patients, Clinics and Employees
As of December 31, 2019, Fresenius Medical Care treated 345,096 patients in 3,994 dialysis clinics worldwide. At the end of 2019, Fresenius Medical Care had 120,659 employees (full-time equivalents) worldwide, compared to 112,658 employees as of December 31, 2018.

Strong organic revenue growth continued
Revenue for the fourth quarter of 2019 increased by 7% (+4% at constant currency) to EUR 4,580 million. Organic growth remained strong at 5%4. Adjusted revenue increased by 6% (+4% at constant currency) to EUR 4,546 million. For a detailed reconciliation, please refer to the table at the end of the press release.

Health Care Services revenue rose by 6% to EUR 3,607 million (+3% at constant currency), while Health Care Products revenue grew by 10% to EUR 973 million (+8% at constant currency). This includes the negative effect from a revenue recognition adjustment of EUR 86 million (FY 2019: EUR 170 million) for accounts receivable in legal dispute in North America.

Revenue for the full year 2019 rose by 6% to EUR 17,477 million (+2% at constant currency). Organic growth amounted to 5%. Adjusted revenue increased by 8% (+5% at constant currency) to EUR 17,329 million. Health Care Services revenue grew by 5% (+1% at constant currency) to EUR 13,872 million. Growth in same market treatments, contributions from acquisitions and increases in organic revenue per treatment were partly offset by decreases attributable to prior year revenue from divested activities of Sound Physicians and closed or sold clinics. Health Care Products revenue for the full year 2019 rose by 10% to EUR 3,605 million (+8% at constant currency). This increase was mainly driven by higher sales of home dialysis products as a result of the NxStage acquisition and by higher sales of dialyzers. This was partially offset by lower sales of machines as a result of changes in the accounting treatment for sale-leaseback transactions due to the IFRS 16 implementation.

In the fourth quarter operating income increased by 1% to EUR 616 million (-2% at constant currency), resulting in a margin of 13.5% (Q4 2018: 14.3%). Adjusted operating income grew by 3% to EUR 655 million (stable at constant currency), resulting in a margin of 14.4% (Q4 2018: 14.8%). The included negative effect from a revenue recognition adjustment for accounts receivable in legal dispute in North America is EUR 86 million (FY 2019: EUR 170 million). For a detailed reconciliation, please refer to the table at the end of the press release.

Operating income for the full year decreased by 25% to EUR 2,270 million (-28% at constant currency), resulting in a margin of 13.0% (FY 2018: 18.4%). The 2018 basis includes the gain from the divestiture of Care Coordination activities including Sound Physicians. On an adjusted basis, operating income remained stable at EUR 2,296 million (-4% at constant currency), resulting in a margin of 13.2% (FY 2018: 14.3%).

Net income2 for the fourth quarter decreased by 19% to EUR 343 million (-21% at constant currency). Adjusted net income2 increased by 3% to EUR 408 million (+0% at constant currency). For a detailed reconciliation, please refer to the table at the end of the press release. Basic earnings per share (EPS) decreased by 17% to EUR 1.14 (-20% at constant currency). On an adjusted basis, EPS increased by 6% to EUR 1.36 (+3% at constant currency).

For the full year, net income decreased by 39% to EUR 1,200 million (-42% at constant currency). EPS decreased by 39% to EUR 3.96 (-41% at constant currency). Here, too, the 2018 basis includes the gain from the divestiture of Care Coordination activities including Sound Physicians. On an adjusted basis, net income grew by 2% to EUR 1,369 million (-2% at constant currency). This resulted in a 3% increase in adjusted EPS to EUR 4.52 (-1% at constant currency).

Strong Cash-flow development
In the fourth quarter, Fresenius Medical Care generated EUR 771 million of operating cash flow (Q4 2018: EUR 698 million) resulting in a margin of 16.8% (Q4 2018: 16.2%). The increase was largely driven by the IFRS 16 implementation. Free cash flow (net cash used in operating activities, after capital expenditures, before acquisitions and investments) amounted to EUR 434 million (Q4 2018: EUR 397 million) resulting in a margin of 9.5% (Q4 2018: 9.2%).

In the full year, we generated operating cash flow of EUR 2,567 million resulting in a margin of 14.7% (FY 2018: EUR 2,062 million, 12.5%). The increase was mainly due to the IFRS 16 implementation. Free cash flow for the full year 2019 amounted to EUR 1,454 million resulting in a margin of 8.3% (FY 2018: EUR 1,059 million, 6.4%).

Regional developments
In North America, revenue in the fourth quarter of 2019 increased by 6% to EUR 3,174 million (+3% at constant currency, +5% organic growth). For the full year 2019, North America revenue rose by 5% to EUR 12,195 million (stable at constant currency, +4% organic).

Operating income for the fourth quarter grew by 5% to EUR 515 million (+2% at constant currency). For the full year, operating income decreased by 33% to EUR 1,794 million (-36% at constant currency). The 2018 basis includes the gain from the divestiture of Care Coordination activities including Sound Physicians.

In EMEA, revenue in the fourth quarter increased by 4% to EUR 709 million (+4% at constant currency, +3% organic). For the full year, EMEA revenue rose by 4% to EUR 2,693 million (+4% at constant currency, +4% organic).

Operating income for the fourth quarter rose by 17% to EUR 114 million (+17% at constant currency). For the full year, operating income grew by 12% to EUR 448 million (+13% at constant currency) resulting in a margin of 16.6% (FY 2018: 15.4%). This improvement was mainly driven by a reduction of a contingent consideration liability related to Xenios and a positive impact from the IFRS 16 implementation.

In Asia-Pacific, revenue in the fourth quarter 2019 grew by 10% to EUR 499 million (+7% at constant currency, +6% organic). For the full year, revenue increased by 10% to EUR 1,859 million (+7% at constant currency, +7% organic).

Operating income for the fourth quarter decreased by 13% to EUR 75 million (-14% at constant currency). The decline in margin in the fourth quarter was mainly due to investments in business growth and expenses for the cost optimization program. For the full year, operating income grew by 8% to EUR 329 million (+6% at constant currency).

Regarding the coronavirus (nCoV) outbreak the first priority is to ensure continuation of treatments for our patients and the safety of our employees. It is too early to quantify the potential impact to our Asia-Pacific operations.

In Latin America, revenue for the fourth quarter increased by 6% to EUR 193 million (+24% at constant currency, +19% organic). For the full year, Latin America revenue increased by 3% (+21% at constant currency, +17% organic) to EUR 709 million.

Operating income for the fourth quarter increased by 189% to EUR 15 million (+201% at constant currency). For the full year, operating income increased by 47% to EUR 43 million (+35% at constant currency). The improved margin was mainly due to favorable foreign currency transaction effects.

1 For a detailed reconciliation, please refer to the table at the end of the press release.
2 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
3 Special items are effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.
4 Definition of organic growth excludes effects such as out of period adjustments or effects from IFRS 16 implementation.

Press conference
Fresenius Medical Care will hold a press conference at its headquarters in Bad Homburg, Germany to discuss the results of the fourth quarter and full year tomorrow on Thursday, February 20, 2020, at 10:00 a.m. CET / 4:00a.m. EST. The press conference will be webcasted on the company’s website www.freseniusmedicalcare.com in the "Media" section. A replay will be available shortly after the conference.

Conference call
We will also host a conference call to discuss the results of the fourth quarter tomorrow on Thursday, February 20, 2020, at 3:30 p.m. CET / 09:30 a.m. EST. Details will be available on the company’s website www.freseniusmedicalcare.com in the "Investors" section. A replay will be available shortly after the call.

Five Prime Therapeutics Licenses Antibodies to Seattle Genetics for Use in Novel Antibody Drug Conjugate (ADC) Programs

On February 19, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported a global license agreement with Seattle Genetics, Inc. to develop and commercialize novel antibody-drug conjugate (ADC) therapies using monoclonal antibodies developed by Five Prime (Press release, Five Prime Therapeutics, FEB 19, 2020, View Source [SID1234554497]). ADCs harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.

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Under the terms of the agreement, Five Prime granted Seattle Genetics an exclusive worldwide license to a family of monoclonal antibodies that are directed to a single target and Seattle Genetics will be responsible for research, development, manufacturing and commercialization of ADC products based on these antibodies. For the multi-product deal, Five Prime will receive a $5 million upfront payment and is eligible to receive progress-dependent development and regulatory milestone payments as well as cumulative commercial milestone payments. Cumulative milestones may reach up to $295 million for the first ADC product that is developed and commercialized. Five Prime will additionally receive tiered mid-single digit royalties on net product sales.

"We are pleased to enter into this license agreement with Seattle Genetics, a global leader that develops and commercializes transformative targeted cancer therapies that utilize its industry-leading ADC technology," said William Ringo, Chairman and interim Chief Executive Officer of Five Prime Therapeutics. "This agreement allows Five Prime to realize value from our pre-clinical pipeline while prioritizing our clinical investments based on upcoming data readouts for our programs. Looking to the future, we will continue to seek strategic partnerships that allow us to maximize the value of our assets and the long-term potential of the company."