On August 11, 2011 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) reported financial results and corporate updates for the first half of 2011 (Press release, Evotec, AUG 11, 2011, View Source;announcements/press-releases/p/evotec-reports-34-revenue-and-profitable-earnings-growth-revenue-guidance-raised-5018 [SID1234538882]).

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!

Strong H1 operational performance
– Discovery alliances revenues +34% to € 33.4 m

– Operating result +169% to € 0.9 m

– Continued strong liquidity of € 56.5 m despite significant acquisitions and technology investments for growth
Expanding portfolio of discovery alliances; good progress and milestone achievements
– Opening the field of biomarker research in strategic partnership with Roche
– New integrated drug discovery alliance with UCB (after period-end)
– Significant milestone achievement with Boehringer Ingelheim:
€ 2 m for clinical Phase I initiation in neuropathic pain in May 2011
– Milestone achieved in alliance with Ono Pharmaceutical; collaboration expanded
Continued expansion of scientific and technology leadership
– Acquisition of Kinaxo (Evotec Munich) completed as of April 2011
– Strengthening integrated innovation service offering through acquisition of Compound Focus (Evotec San Francisco)
– Strategic alliance with PsychoGenics
Development partnerships continue to provide upside potential
– New asset deal with EVT 401 in animal health (after period-end)
– DiaPep277 Phase III programme in diabetes progressing with Andromeda/TEVA
– Phase II of EVT 101 in treatment-resistant depression voluntarily terminated
Revenue guidance for 2011 raised
– Approximately 30% revenue growth expected within core business, leading to revenues of € 70 to 72 m (guidance before: € 68 to 70 m)
– Strategic cash position of Evotec remains strong: liquidity guidance of > € 55 m at year-end confirmed
– Strong order book indicates strong continuing growth
Others
– Roland Oetker and Prof Andreas Pinkwart elected to Evotec Supervisory Board

1. Operational performance

Best first half-year performance in Company history: revenues +34% to € 33.4 m and operating result +169% to € 0.9 m
Evotec reported a strong operational performance for the first half of 2011. Total Group revenues increased by 34% to € 33.4 m (2010:
€ 25.0 m) including € 3.9 m from the acquisitions of DeveloGen, Kinaxo and Compound Focus in H1 2011. Meanwhile R&D expenses increased by € 1.7 m (59%), mainly from the inclusion of DeveloGen and Kinaxo R&D expenses and the strategic build up of Evotec’s beta cell franchise "CureBeta". Despite the acquisitions, SG&A costs declined by 2%. On this basis, Evotec’s operating result for the first half of 2011 was positive at € 0.9 m (2010: € 0.3 m). The Company operates on a strong gross margin of more than 40%.
Liquidity including cash, cash equivalents and investments including long-term financial assets at the end of June 2011 remained strong at € 56.5 m.
Going forward, potential milestone achievements in H2 are expected to further enhance Evotec’s operating financial performance giving a strong basis for increased operating profitability over 2010 (before impairment, if any).
2. Discovery alliances update
Expanding portfolio of discovery alliances leads to significant growth in sales and orders; good progress in collaborations
Evotec’s strategy is to build sustainable, performance-based drug discovery alliances. Consequently, Evotec focuses on high value, revenue generating partnerships with pharmaceutical and biotechnology companies. The Company signed a number of important new contracts, contract extensions and expansions and made good progress in many of its current programmes.
Opening the field of response prediction and biomarker research in strategic partnership with Roche
In June 2011, Evotec announced an important strategic collaboration with Roche in novel protein-activity based biomarkers for oncology drugs in development. Evotec will employ its PhosphoScout platform, to discover protein-phosphorylations that predict favourable dosage and efficacy of targeted cancer drugs in patients. These biomarkers are core to the development of targeted therapeutics for cancer therapy. Roche is responsible for conducting clinical trials as well as assessing the development of companion diagnostics for patient stratification. Under the initial three-year term Evotec and Roche will conduct multiple biomarker programmes for therapeutic antibodies or small molecule inhibitors. Evotec will receive undisclosed up-front and success-based payments for each programme.

New integrated drug discovery alliance with UCB (after period-end)
In July 2011, Evotec entered into a three year integrated drug discovery collaboration with UCB to identify small molecule modulators of important biological targets, selected by UCB, involved in CNS disorders. As part of the collaboration, Evotec will apply their integrated drug discovery expertise and technologies to identify interesting small molecules against the selected targets. The molecules will be further optimised and progressed through lead optimization to preclinical candidates. Evotec will receive a fixed research funding fee over the term of collaboration and will be further rewarded on achieving the goals of the research collaboration with early stage discovery, preclinical and clinical milestones. In addition, Evotec will receive royalties based on net sales of any approved drugs from the collaboration.
Milestone achievements with Boehringer Ingelheim and Ono Pharmaceutical
During the second quarter of 2011, continued strong progress was made in Evotec’s discovery collaboration with Boehringer Ingelheim.
A second back-up compound in this strategic alliance has advanced into clinical trials as a novel treatment for neuropathic pain. With the initiation of the Phase I clinical studies, Evotec earned a milestone payment of € 2.0 m in May 2011. As of 30 June 2011, Evotec achieved in total 13 milestones within this collaboration that was initiated in 2004.

In June, Evotec announced the achievement of specific success criteria in its research collaboration with Ono Pharmaceutical Co., Ltd. and the receipt of a milestone payment. This collaboration was initiated in October 2009 to identify small molecules targeting an ion channel implicated in cardiovascular, CNS and urological diseases and the collaboration has now successfully identified multiple compounds meeting various criteria in activity, selectivity and pharmacokinetic characteristics. Evotec and Ono have agreed to continue this research collaboration until April 2012 and to enter into lead optimisation.

3. Acquisition update
Continued expansion of scientific and technology leadership Evotec focuses on augmenting its technology platform to continuously strengthen its ability to provide integrated drug discovery solutions for customers. At the same time, the Company is developing early assets in highly innovative areas of drug discovery such as beta cell biology and technologies to better understand oncology or metabolic diseases to kick-start new alliances. In line with this strategy, the Company has announced two acquisitions in H1 2011:
Acquisition of Kinaxo (Evotec Munich) completed as of 18 April 2011
During the second quarter of 2011, Evotec completed the acquisition of Kinaxo Biotechnologies GmbH, a Munich-based drug discovery alliance company supporting the development of targeted drugs. The acquisition added proprietary technologies for compound profiling, target deconvolution and response prediction, important for timely decisions on drug efficacy and safety, especially in the key area of oncology. These unique technologies significantly strengthen the Company’s discovery offering to customers.
As a result of the transaction, first announced on 9 February 2011, Kinaxo has become a wholly-owned integrated subsidiary of Evotec.

Strengthening integrated innovation offering through acquisition of Compound Focus (Evotec San Francisco)
Effective 1 June 2011, Evotec acquired Compound Focus, Inc., the compound management business of BioFocus, based in South San Francisco, US. The company’s technologies are focused on automated storage and custom design solutions for small molecule drugs. The current key customer base includes US federal institutes and pharma companies such as Elan, Sunovion Pharmaceuticals (formerly: Sepracor) and Procter & Gamble.
This acquisition allows Evotec to augment its early drug discovery offering substantially and provides critical mass to its existing compound management offering. It will substantially improve the Company’s ability to support its alliance partners in developing and managing their compound libraries and further strengthen its own hit identification capabilities. In addition, the acquisition adds profitable revenues further enhancing Evotec’s earnings profile going forward.

4. Status of clinical and preclinical programmes

Development partnerships continue to provide upside potential
Evotec is focusing on a number of carefully selected core assets, which the Company is progressing towards clinical development and for which it is seeking strategic product development partnerships to fund these developments. To reduce Evotec’s risk profile the Company is not investing in larger clinical trials on its own. The Company’s current clinical stage portfolio comprises several development partnerships.
The following updates can be reported:
New asset deal with EVT 401 in animal health (after period-end)
Evotec has announced that it has entered into a world-wide license and collaboration agreement with a top tier animal health company that intends to develop the proprietary Evotec compound EVT 401, a selective, small molecule P2X7 antagonist, in the companion animal market. Evotec is entitled to receive technology access fees, development and commercial milestone payments, and significant tiered royalties on net sales. Evotec retains all rights to the programme for human therapeutic use.
DiaPep277 Phase III programme in diabetes progressing with Andromeda Biotech/TEVA
DiaPep277, a synthetic peptide in development for the treatment of type 1 diabetes, acquired through the acquisition of DeveloGen, is progressing as planned in Phase III studies conducted by Andromeda Biotech and Teva Pharmaceutical. First Phase III data are expected to be published in 2012.

Phase II of EVT 101 in treatment-resistant depression voluntarily terminated
In May, Evotec and Roche decided to voluntarily terminate the first proof-of-concept study in treatment-resistant depression with their NR2B sub-type selective NMDA antagonist EVT 101. The decision was triggered by difficulties in recruiting patients under the current study protocol, resulting in the possibility of inconclusive results. EVT 101 was generally well tolerated in healthy volunteers and the patients enrolled. Evotec now holds all rights in the EVT 100 series, including the back-up compound EVT 103, and has reinitiated partnering discussions for these assets.
5. Guidance 2011
Revenue guidance for 2011 raised
Based on a strong H1 2011 operational performance, Evotec for the second time in 2011 raised its revenue guidance for the current fiscal year that was published on 24 March and first updated with the acquisition of Compound Focus on 1 June: In 2011, total Group revenues are now expected to grow by approximately 30%, leading to revenues of € 70 to 72 m (March: € 64 to 66 m; June: € 68 to 70 m).
Evotec also confirmed its 2011 year-end liquidity target of > € 55 m at constant year-end 2010 currencies. This target was updated as a result of the Compound Focus acquisition in June 2011 (before: € 65 m) as € 10.25 m of the potential total cash purchase price of € 12.5 m is paid in 2011.
All other financial targets remain unchanged. Focusing on key programmes, especially in the fields of innovation in metabolic diseases and regenerative medicine, the Company expects research & development (R&D) expenses to increase to approximately € 10 m from 2010 levels. On this basis, Evotec’s Group operating result before impairment charges, if any, is expected to be profitable and improve over 2010.

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:

Conference call details:
Date: Thursday, 11 August 2011
Time:
09.30 a.m. CEST
08.30 a.m. BST
03.30 a.m. US time (East Coast)

From Europe:
+49 (0) 6958 999 0805 (Germany)
+44-207-153-2027 (UK)
From the US: +1-480-629-9726

Access Code: 4460055

A simultaneous slide presentation for participants dialing in via phone is available at www.equitystory.com, password: evotec0811.

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 dialing +49 69 58 99 90 568 (Germany) or +44 207 154 2833 (UK) and in the US by dialing +1 303 590 3030. The access code is 4460055#. The on-demand version of the webcast will be available on our website:www.evotec.com/Investors/Financial-Reports-2010-2011/

Second Quarter Report 2011
Key Figures of Condensed Consolidated Interim Income Statements
Evotec AG and Subsidiaries

Euro in thousands except share data and per share data

Six month ended June 30
Six month ended June 30
Change of %
Three months ended June 30
Three months ended June 30
Change of %

On August 20, 2019 Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ: EVTC) reported results and corporate updates for the second quarter 2009 (Press release, Evotec, AUG 20, 2019, View Source;announcements/press-releases/p/evotec-announces-strong-second-quarter-financial-results-4440 [SID1234538881]).

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!

Recent Highlights:
Strong quarterly performance leads to 46% revenue growth and 29% improvement of operating result
Further milestone payment received in drug discovery collaboration with Boehringer Ingelheim (after period-end)
Royalty income earned from DeveloGen
Several new discovery contracts signed
Failure of EVT 302 in smoking cessation; positive Phase I results with EVT 401; alliance with Roche on EVT 100 compound family
Execution of restructuring program "Evotec 2012 – Action Plan to Focus and Grow" yields" first results
Acquisition of Indian RSIPL to strategically leverage Discovery Alliance Business and create a global leader in drug discovery and development services (after period-end)
Revenue guidance increased; all other financial projections confirmed despite the acquisition of RSIPL

1. Operational performance

Strong quarterly performance leads to 46% revenue growth and 29% improvement of operating result
Evotec’s revenues for the second quarter 2009 grew strongly by 46% to EUR 10.5 million (Q2 2008: EUR 7.2 million). This is mainly the result of strong underlying revenues from Evotec’s Discovery Alliances Business, of a portion of the upfront payment for the EVT 100 compound family from Roche (EUR 0.9 million) as well as of license and royalty income totaling EUR 1.8 million from Roche and DeveloGen. Gross margin improved strongly to 38.8% (Q2 2008: 20.8%)
Evotec’s operating loss for the second quarter 2009 improved by 29% to EUR 8.9 million (Q2 2008: EUR 12.5 million) despite restructuring expenses in the amount of EUR 2.7 million. This improvement is a result of the Company’s strong top-line performance and its cost reductions in SG&A and R&D following the implementation of "Evotec 2012 – Action Plan to Focus and Grow".
Net loss for the second quarter 2009 amounted to EUR 8.6 million (Q2 2008: EUR 12.0 million).
Liquidity, which includes cash and cash equivalents (EUR 38.4 million), short-term investments (EUR 25.2 million) and auction rate securities (EUR 9.1 million), at the end of June 2009 amounted to EUR 72.7 million (December 31, 2008: EUR 92.4 million).

Royalty income earned from DeveloGen
The royalty income from DeveloGen was a result of the upfront payment DeveloGen received in its collaboration with Boehringer Ingelheim (published on May 13, 2009) on a target addressing insulin resistance. The target formed part of the Joint Venture between Evotec and DeveloGen which ended in 2005. As part of the agreement, DeveloGen maintained certain IP rights including those for the insulin target, and Evotec retained participation right on all future income DeveloGen might generate from the target. Under the terms of the agreement with Boehringer Ingelheim, DeveloGen received an upfront payment of EUR 7 million, and has the opportunity to earn potential additional milestone payments as well as tiered sales performance payments.

Further milestone payment received in drug discovery collaboration with Boehringer Ingelheim
On July 29, 2009, Evotec announced that a further research milestone, leading to payments to Evotec, has been successfully achieved in its drug discovery collaboration with Boehringer Ingelheim. The milestone was achieved for the identification and selection of a second compound to be advanced into preclinical development within an existing program. This represents the sixth milestone achieved in this multi-year, multi-target collaboration and is the second compound selected for pre-development in the last twelve months.

Several new discovery contracts signed
In July 2009, Evotec announced a significant research collaboration with Cubist Pharmaceuticals utilizing Evotec’s world-leading fragment-based drug discovery platform and a high-throughput screening collaboration with Alios Biopharma. In addition, Evotec-RSIL extended its library synthesis collaboration with Ferrer Grupo.

2. Status of clinical programs and partnering of assets

Failure of EVT 302 in smoking cessation; positive Phase I results with EVT 401; alliance with Roche on EVT 100 compound family
In April 2009, Evotec reported that the Phase II smoking cessation study of its MAO-B inhibitor EVT 302 failed to meet its clinical endpoints and Evotec subsequently stopped the development of the compound in this indication. All other clinical pipeline projects developed on track during the second quarter. On June 29, 2009, Evotec announced the successful completion of the first Phase I study with EVT 401, a potential novel oral treatment for inflammatory conditions such as Rheumatoid Arthritis. The compound was safe and well tolerated and demonstrated the desired pharmacodynamic activity in healthy volunteers. Evotec is now focusing its efforts on optimizing the oral dose formulation, completing the Phase I studies, and preparing for Phase II studies in Rheumatoid Arthritis.
Preparations of the Phase II clinical study for EVT 101 in treatment-resistant depression and a Phase I program for EVT 103 are on track to start in the second half of 2009. In March 2009, Evotec signed a partnership with Roche for the development of the EVT 100 compound family with total potential payments exceeding $300 million.

3. Update on Evotec 2012 Action Plan and cost reductions

Execution of restructuring program "Evotec 2012 – Action Plan to Focus and Grow" yields first results
Based on the "Evotec 2012 – Action Plan to Focus and Grow" Evotec implemented strict restructuring measures during the course of the second quarter. Evotec initiated headcount reductions in administrative functions by 20% and, following the setback in the progress of Evotec’s clinical pipeline, headcount reductions in the clinical development group by approximately 50%. In addition, the Company re-engineered its drug discovery and development operations to more efficiently leverage its research and development infrastructure. All proprietary programs are now managed through Evotec’s European operations and the Company is on course to finally close its US operations in South San Francisco, California, by the end of the third quarter.
As a consequence of these measures, as compared to the prior year, Evotec’s headcount as of June 30, 2009 decreased by 60 people to 370; R&D expenses were down 35% and SG&A expenses were down 11% in the second quarter, despite the fact that in the same quarter last year, the US research and developments programs were consolidated into European operations only after May 2. Expenses are expected to further decline and the full impact of Evotec’s restructuring will be reflected in the financial results for the second half of 2009.

4. Acquisitions

Acquisition of Indian RSIPL to strategically leverage DAB and create a global leader in drug discovery and development services
On August 6, 2009, Evotec announced the acquisition of a controlling majority shareholding of the Indian organization Research Support International Private Limited (RSIPL) for approximately EUR 2.8 million in cash, a portion of which includes a potential earn-out. With this acquisition Evotec expands its chemistry capacity by approximately 160 scientists and delivers on its strategy as described in the "Evotec 2012 – Action Plan to Focus and Grow" to create the global partner of choice for the pharmaceutical and biotechnology industries in discovery and early development services. This transaction adds a complementary drug discovery operation and capability in a cost-effective location to Evotec’s already world-leading discovery platform and efficiently increases its ability to deliver high quality drug discovery and development services to its partners.
On May 7, 2009, Evotec also acquired the zebrafish screening operations of Summit Corporation plc to further strengthen its state-of-the-art technology platform. These strategic technology and capacity additions further validate Evotec’s goal to become the number one global provider of discovery and development services.

5. Guidance

Revenue guidance increased; all other financial targets confirmed despite the acquisition of RSIPL
The Company increases its 2009 revenue guidance to above EUR 40 million (previously above EUR 35 million) and confirms all other financial targets for the fiscal year 2009 published in March despite the acquisition of RSIPL. Liquidity at the end of June 2009 is at EUR 72.7 million. With the contribution of milestone receipts from research collaborations and the full impact of Evotec’s restructuring measures, cash consumption is expected to be reduced considerably in the second half of the year. On this basis, Evotec remains confident to deliver on its liquidity guidance of above EUR 65 million by the end of 2009.

Conference Call
The Company is going to hold a conference call to discuss the results:

Conference call details
Date: Friday, August 7, 2009
Time: 09.30 a.m. CEST
08.30 a.m. BST
03.30 a.m. US time (East Coast)

From Europe: +49.(0)69.5007 1308 (Germany)
+44.(0)20.7806 1956 (UK)
From the US: +1.718.354 1388
Access Code: 8676443

A simultaneous slide presentation for participants dialing in via phone is available at www.equitystory.com, password: evotec0809.

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 dialing +49.(0)69.22222 0418 (Germany) or +44.(0)20.7806 1970 (UK) and in the US by +1.718.354 1112. The access code is 8676443#. The on-demand version of the webcast will be available on our website: www.evotec.com – Investors – Financial Reports.

On August 20, 2019 Delcath Systems, Inc. ("Delcath," the "Company", "we", "our" or "us" (OTCQB: DCTH) reported that it has closed on its previously announced private placement with gross proceeds of $9.5 million at a combined price of $1,000 per Unit (Press release, Delcath Systems, AUG 20, 2019, View Source [SID1234538880]). Each Unit consists of one preferred share initially convertible into 16,667 shares of common stock at an initial conversion price of $0.06 per share and a common stock purchase warrant. Each whole warrant entitles the holder to purchase one share of common stock at an initial exercise price of $0.06 for a period of five years from the date of the Company’s anticipated reverse stock split. The Company has now raised a total of $29.5 million since July 2019.

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!

The offering is being led by fundamental healthcare investors, including Rosalind Advisors and Altium Capital.

Commenting on the announcement, Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath stated, "With this transaction completed, we have a cash runway beyond top line data, a clean capitalization table and the foundation for a possible path to NASDAQ listing. Looking forward, we are positioned for success through multiple value inflection points including full enrollment, top line data and NDA filing – targeted for Q4 2019, 1H 2020 and Q4 2020, respectively, in our registration trial for the treatment of metastatic Ocular Melanoma (mOM). mOM is a devastating disease of high unmet-need for which there is no approved standard-of-care in the United States and for which the Company has orphan drug designation."

Dr. Simpson added, "the management team has laid the foundation for a leading interventional oncology platform company and now has the resources, capital structure and operational resources to move forward its long-term priorities and growth plans, to maximize shareholder value."

The recapitalization enables Delcath to pursue its business plan to:

Develop therapies for cancers of the liver with high unmet medical need and no established standards of care, addressing a multi-billion-dollar opportunity in the United States and Europe;

Expand development of our platform to other indications, chemotherapies and organs; and;

Support our commercial partner medac in Europe (where CHEMOSTAT is approved) to maximize the opportunities set out in our December 2018 commercialization agreement.

The company recently announced the addition of John R. Sylvester to its Board of Directors. Mr. Sylvester is currently Chief Commercial Officer at BTG PLC, an international specialist healthcare company that develops and commercializes products targeting critical care, cancer and other disorders. The quality of BTG’s interventional medicine business played an integral part in its sale to Boston Scientific for $4.2 billion. The Company intends to leverage John’s expertise and experience in the commercialization of new medical technologies as Delcath prepares to enter US and ex-US markets.

Dr. Simpson concluded by stating, "I would like to thank the investors who took the time to assess this incredible opportunity and as a result have recognized the substantial value of Delcath’s assets, technology and clinical programs. Management and the Board are excited to work with our team of clinicians and key opinion leaders to make Melphalan/HDS available as a treatment option to improve patients’ lives and outcomes."

Roth Capital Partners acted as the sole placement agent for the offering. After the placement agent fees and estimated offering expenses payable by the Company, the Company has received net proceeds of approximately $8.6 million. The offering closed on Aug 19, 2019.

The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-1 with the Securities and Exchange Commission by August 21, 2019 for purposes of registering the resale of the shares of common stock issuable upon conversion of the preferred shares and upon exercise of the warrants issued in the private placement.

This notice does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On August 20, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that a license agreement has been reached with Biotheus Inc. ("Biotheus"), a privately held Chinese company based in Zhuhai, Guangdong, China (Press release, Alligator Bioscience, AUG 20, 2019, View Source [SID1234538879]). Under the license agreement, Alligator has granted Biotheus rights in Greater China (including Republic of China, Hongkong, Taiwan and Macau) to an antibody from ALLIGATOR-GOLD for the creation of up to three bispecific molecules. The license agreement includes an option for expanding the license to covering global rights.

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!

The license agreement includes an upfront of USD 1 million where Alligator receives USD 0.5 million upon signing and USD 0.5 million after 6 months of scientific-technical evaluation. Under the agreement Alligator is eligible to receive upfront, milestones and option fees of up to a total of approximately USD 142 million. This sum includes upfront and development milestones amounting to a total of approx. USD 52 million, global option fees up to a total of USD 90 million, plus royalties on future sales and share of sub-license revenue.

"This agreement is a great recognition of our antibody library and our proven expertise in generating high affinity antibodies against TNFR family members, and this collaboration with an up and coming Chinese biotech firm like Biotheus gives us an entrance to the fast advancing life science market in China", said Per Norlén, CEO Alligator Bioscience.

The Tumor Necrosis Factor Receptor super family (TNFR-SF) is a family of related receptors, sharing sequence homology. Several Alligator pipeline programs interact with members of the TNFR super family.

For further information, please contact:
Cecilia Hofvander, Director IR & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact persons set out above, at 4:35 p.m. CEST on August 20, 2019.

On August 20, 2019 Medtronic plc (NYSE:MDT) reported financial results for its first quarter of fiscal year 2020, which ended July 26, 2019 (Press release, Medtronic, AUG 20, 2019, View Source;p=RssLanding&cat=news&id=2406815 [SID1234538876]).

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!

The company reported first quarter worldwide revenue of $7.493 billion, an increase of 1.5 percent as reported or 3.5 percent on a constant currency basis, which adjusts for a $146 million negative impact from foreign currency. As reported, first quarter GAAP net income and diluted EPS were $864 million and $0.64, respectively. As detailed in the financial schedules included through the link at the end of this release, first quarter non-GAAP net income and non-GAAP diluted EPS were $1.703 billion and $1.26, respectively, increases of 6 percent and 8 percent, respectively. Adjusting for a negative 2 cent impact from foreign currency, first quarter non-GAAP diluted EPS increased 9 percent.

First quarter U.S. revenue of $3.918 billion represented 52 percent of company revenue and increased 1.4 percent as reported. Non-U.S. developed market revenue of $2.377 billion represented 32 percent of company revenue and decreased 1.2 percent as reported and increased 2.6 percent on a constant currency basis. Emerging market revenue of $1.198 billion represented 16 percent of company revenue and increased 7.5 percent as reported and 12.5 percent on a constant currency basis.

"Medtronic had a solid first quarter, delivering revenue growth, operating margin expansion, and adjusted EPS growth all ahead of expectations," said Omar Ishrak, Medtronic chairman and chief executive officer. "It’s a good start to our fiscal year."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic, Peripheral & Venous (APV) divisions. CVG first quarter revenue of $2.790 billion decreased 0.7 percent as reported and increased 1.4 percent on a constant currency basis. CVG’s revenue performance was driven by mid-single digit growth in CSH and low-single digit growth in APV, offset by low-single digit declines in CRHF, all on a constant currency basis.

Cardiac Rhythm & Heart Failure first quarter revenue of $1.382 billion decreased 3.1 percent as reported or 1.2 percent on a constant currency basis. Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by mid-single digit growth in Pacemakers, including mid-twenties growth of the Micra transcatheter pacing system, as well as mid-thirties growth of the TYRX absorbable antibacterial envelope, high-single digit growth of the Reveal LINQ insertable cardiac monitoring system, and high-single digit growth in AF Solutions, all on a constant currency basis. Arrhythmia Management growth was offset by low-double digit declines in Heart Failure, including high-forties declines in sales of left ventricular assist devices (LVADs), both on a constant currency basis.

Coronary & Structural Heart first quarter revenue of $941 million increased 2.6 percent as reported or 5.2 percent on a constant currency basis, led by mid-teens constant currency growth in sales of transcatheter aortic valves, reflecting the clinical benefits of the CoreValve Evolut PRO platform. Transcatheter aortic valve growth was offset by low-single digit declines in drug-eluting stents, in-line with the market.

Aortic, Peripheral & Venous first quarter revenue of $467 million decreased 0.2 percent as reported or increased 1.7 percent on a constant currency basis. Venous grew in the high-single digits on a constant currency basis on strong VenaSeal and ClosureFast system growth. Aortic grew in the mid-single digits on a constant currency basis, reflecting strong demand for the Valiant Navion thoracic stent graft system. Peripheral declined in the high-single digits on a constant currency basis, as low-thirties constant currency declines in drug-coated balloons offset growth in other core product segments.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG first quarter revenue of $2.100 billion increased 2.3 percent as reported or 4.8 percent on a constant currency basis. MITG’s revenue performance was driven by balanced growth across both divisions, with mid-single digit constant currency growth in both SI and RGR.

Surgical Innovations first quarter revenue of $1.417 billion increased 1.4 percent as reported or 4.2 percent on a constant currency basis, driven by strong contributions from Advanced Energy and Advanced Stapling. Advanced Energy grew in the high-single digits on continued strength in sales of LigaSure vessel sealing instruments, including the Ligasure Exact dissector, and the Valleylab FT10 energy platform. Advanced Stapling grew in the mid-single digits on a constant currency basis, driven by strong demand for Tri-Staple 2.0 endo stapling specialty reloads and the EEA circular stapler with Tri-Staple technology for colorectal procedures.

Respiratory, Gastrointestinal & Renal first quarter revenue of $683 million increased 4.3 percent as reported or 6.1 percent on a constant currency basis. Respiratory and Patient Monitoring grew in the mid-single digits on a constant currency basis on strong sales of Nellcor pulse oximetry, Microstream capnography, and INVOS cerebral oximetry systems, Puritan Bennett 980 ventilators, and McGRATH MAC video laryngoscopes. GI Solutions grew in the low-double digits on a constant currency basis, with solid growth in PillCam systems, Emprint ablation systems, and Beacon endoscopic ultrasound products. Renal Care Solutions grew mid-single digits on a constant currency basis on strength in renal access products.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Brain Therapies, Spine, Specialty Therapies, and Pain Therapies divisions. RTG first quarter revenue of $2.012 billion increased 3.2 percent as reported or 4.6 percent on a constant currency basis. RTG’s revenue performance was driven by low-double digit growth in Brain Therapies, mid-single digit growth in Specialty Therapies, and low-single digit growth in Spine, offset by mid-single digit declines in Pain Therapies, all on a constant currency basis.

Brain Therapies first quarter revenue of $740 million increased 9.8 percent as reported or 11.4 percent on a constant currency basis, driven by mid-teens constant currency growth in Neurovascular and low-double digit constant currency growth in Neurosurgery. Neurovascular results were broad-based, with high-teens growth in stent retrievers and flow diversion and low-double digit growth in coils, all on a constant currency basis. In addition, the company is seeing rapid adoption of the Riptide aspiration system and React aspiration catheters. Neurosurgery was led by strong, double digit growth of StealthStation S8 surgical navigation systems, O-arm surgical imaging systems, and Mazor X robotic guidance systems.

Spine first quarter revenue of $658 million increased 0.9 percent as reported or 2.0 percent on a constant currency basis. When combined with the company’s sales of enabling technology used in spine surgeries, including robotics, navigation, imaging, and powered surgical instruments that are recognized in the Brain Therapies division, global Spine revenue and U.S. Core Spine revenue both grew in the mid-single digits on a constant currency basis. Cervical spine products grew mid-single digits on a constant currency basis, driven by the continued launch of the Infinity OCT system and solid growth of the Prestige LP cervical disc system. Sales of Infuse bone graft grew in the low-double digits on a constant currency basis.

Specialty Therapies first quarter revenue of $322 million increased 4.2 percent as reported or 5.5 percent on a constant currency basis. ENT grew in the mid-single digits on a constant currency basis, driven by capital equipment sales of the StealthStation ENT surgical navigation system and intraoperative NIM nerve monitoring systems. Pelvic Health grew in the mid-single digits on the strength of InterStim II system sales.

Pain Therapies first quarter revenue of $292 million decreased 7.0 percent as reported or 6.1 percent on a constant currency basis. Pain Stimulation declined in the low-double digits, reflecting channel destocking and the overall slowdown of the spinal cord stimulation market.
Diabetes Group
Diabetes Group first quarter revenue of $592 million increased 3.5 percent as reported or 5.4 percent on a constant currency basis. Diabetes Group revenue performance was led by international markets, which grew 15.3 percent as reported or 19.8 percent on a constant currency basis, driven by the ongoing launch of the MiniMed 670G hybrid closed loop insulin pump system with the Guardian Sensor 3.

Sales of integrated continuous glucose monitoring (CGM) sensors grew in the mid-teens on a constant currency basis, driven by global adoption of sensor-augmented insulin pump systems and the resulting strong sensor attachment rates. The Diabetes Group also continued to see strong adoption of the Guardian Connect Smart CGM system, which grew in the high-eighties.

Guidance
The company today reiterated its revenue growth guidance and raised its EPS guidance for fiscal year 2020.

The company continues to expect revenue growth in its fiscal year 2020 to approximate 4.0 percent on an organic basis. If current exchange rates hold, revenue growth in fiscal year 2020 would be negatively affected by 0.8 to 1.2 percent.

The company increased its fiscal year 2020 diluted non-GAAP EPS guidance from the prior range of $5.44 to $5.50 to the new range of $5.54 to $5.60, including an estimated 10 cent negative impact from foreign exchange based on current rates.

"As a result of our first quarter outperformance and confidence in our outlook, we are raising our full year EPS guidance," said Ishrak. "We’re excited about what lies ahead, as we expect the investments we’ve made in our pipeline to begin to pay off with multiple pipeline catalysts, accelerating revenue growth, and value creation for our shareholders."

Webcast Information
Medtronic will host a webcast today, August 20, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the first quarter financial schedules and non-GAAP reconciliations, click here. To view the first quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.