On February 14, 2020 AstraZeneca reported a year of strong revenue growth, supported by the launch of new medicines1 and further good progress on its pipeline, with several approvals and data readouts (Press release, AstraZeneca, FEB 14, 2020, View Source [SID1234554348]). These trends are set to continue in 2020, accompanied by growth in earnings and cash. In maintaining its focus on patients and science, the Company remains on track to deliver its strategic ambitions.

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Full-year Product Sales growth of 12% (15% at CER2) to $23,565m included fourth-quarter Product Sales of $6,250m (+8%, +9% at CER).
All three therapy areas and every sales region grew at CER in the quarter and over the full year.

Highlights for the year included:-

Sales of new medicines increased by 59% (62% at CER) to $9,906m, including new-medicine growth in Emerging Markets of 75% (84% at CER) to $1,865m. New medicines represented 42% of total Product Sales (FY 2018: 30%)-Sales growth across the therapy areas: Oncology +44% (+47% at CER) to $8,667m, New CVRM3 +9% (+12% at CER) to $4,376m and Respiratory +10% (+13% at CER) to $5,391m-For the first time, around half of Product Sales in the year were within the specialty-care4 setting-Sales growth across regions: total Emerging Markets sales increased by 18% (24% at CER) to $8,165m, with China sales growth of 29% (35% at CER); China sales in the quarter increased by 25% (28% at CER) to $1,189m. US sales increased by 13% in the year to $7,747m; Europe sales declined by 2% in the year (up by 2% at CER) to $4,350m; Japan sales increased by 27% (26% at CER) to $2,548m FY 2019 Q4 2019 Pascal Soriot, Chief Executive Officer, commenting on the results said: "In the first full year of our return to growth, we made good progress in line with our strategy.

Results from our new medicines and Emerging Markets accompanied positive news for patients, most recently including regulatory approvals of Enhertu in breast cancer and Calquence in leukaemia. Our collaborations also progressed at pace, including that with Daiichi Sankyo, while there were several regulatory approvals for new medicines in China at the end of the year, such as Lynparza in first-line ovarian cancer. Driven by a strong team, 2020 is anticipated to be another year of progress for AstraZeneca. We are becoming a better-balanced business, both regionally and through our medicines. This transition is a further step towards improving operating leverage and cash generation. As we accelerate our commitments to achieving our longterm climate-change and decarbonisation targets, we will maintain our focus on executing a strategy centred on science and patients."

2 Guidance The Company provides guidance for FY 2020 at CER; Company guidance is on:-Total Revenue, comprising Product Sales and Collaboration Revenue-Core EPS Prior guidance was on Product Sales and Core EPS. The change to guiding on Total Revenue and Core EPS reflects the changing nature and growing strategic impact of Collaboration Revenue, which will primarily comprise potential income from existing collaborations as follows:-

A share of gross profits derived from sales of Enhertu (trastuzumab deruxtecan) in several markets, where those sales are recorded by Daiichi Sankyo Company, Limited (Daiichi Sankyo)-A share of gross profits derived from sales of roxadustat in China, recorded by FibroGen Inc. (FibroGen)8-Milestone revenue from the MSD9 collaboration on Lynparza and selumetinib-Smaller amounts of milestone and royalty revenue from other marketed and pipeline medicines All guidance assumes an unfavourable impact from China lasting up to a few months as a result of the recent novel coronavirus (Covid-19) outbreak. The Company will monitor closely the development of the epidemic and anticipates providing an update at the time of the Q1 2020 results.

Depending on the impact of the Covid-19 epidemic, Total Revenue is expected to increase by a high single-digit to a low double-digit percentage and Core EPS is expected to increase by a mid-to high-teens percentage. Variations in performance between quarters can be expected to continue. The Company is unable to provide guidance and indications on a Reported basis because the Company cannot reliably forecast material elements of the Reported result, including any fair-value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal-settlement provisions. Please refer to the section Cautionary Statements Regarding Forward-Looking Statements at the end of this announcement. Indications The Company provides indications for FY 2020 at CER:-

The Company is focused on improving operating leverage-A Core Tax Rate of 18-22%. Variations in the Core Tax Rate between quarters are anticipated to continue-Capital Expenditure is expected to be broadly stable versus the prior year Currency impact If foreign-exchange rates for February to December 2020 were to remain at the average of rates seen in January 2020, it is anticipated that there would be a neutral impact on Total Revenue and a low single-digit adverse impact on Core EPS, versus the prior year. In addition, the Company’s foreign-exchange rate sensitivity analysis is contained within the operating and financial review. Financial summary-Product Sales increased by 12% in the year (15% at CER) to $23,565m, driven by the performances of new medicines and Emerging Markets-The Reported Gross Profit Margin increased by three percentage points in the year (two at CER) to 79%, partly reflecting the mix of sales; the Core Gross Profit Margin was stable at 80%.

The performance came despite the impact of a provision regarding Epanova for inventory and supply-related costs of $115m, recorded in Reported and Core Cost of Sales-Reported Operating Expense increased by 11% in the year (14% at CER) to $18,080m and represented 74% of Total Revenue (FY 2018: 74%); part of the rise reflected an increased level of intangible asset impairments. Core Operating Expense increased by 4% (7% at CER) to $14,748m and represented 60% of 3 Total Revenue (FY 2018: 64%); the increase was driven by investment in the launches of new medicines and in Emerging Markets-The Reported Operating Profit Margin declined in the year by three percentage points (four at CER) to 12%; the Core Operating Profit Margin increased by one percentage point (stable at CER) to 26%-Reported EPS of $1.03 in the year, based on a weighted-average number of shares of 1,301m, represented a decline of 40% (44% at CER); Core EPS increased by 1% (stable at CER) to $3.50-The Board has reaffirmed its commitment to the progressive dividend policy; a second interim dividend of $1.90 per share has been declared, taking the unchanged full-year dividend per share to $2.80

The strong Oncology performance continued to benefit from new medicines such as Tagrisso, Lynparza and Imfinzi. The full impact of recent regulatory approvals for Calquence and Enhertu is anticipated to favourably affect Total Revenue growth in 2020. The performance from legacy Oncology medicines in the year included a decline in Faslodex sales of 13% (11% at CER) to $892m; the fall in the fourth quarter of 39% (38% at CER) led to sales of Faslodex of $166m. These declines reflected the 2019 launch of multiple generic Faslodex medicines in the US. Iressa sales also declined in the year by 18% (15% at CER) to $423m and in the quarter by 29% (28% at CER) to $80m; Iressa continued to be included on the China volume-based procurement programme in the year. The Company anticipates continued declines for both medicines. Oncology sales increased in Emerging Markets by 45% (52% at CER) to $2,211m. Recent developments and progress against the Company’s sustainability priorities are reported below:-Access to healthcare: the Company announced that the Young Health Programme (YHP) will partner with UNICEF10 to prevent non-communicable diseases among young people. AstraZeneca and UNICEF will collaborate on initiatives that will reach more than five million young people, train c.1,000 youth advocates, and potentially help to shape public policy around the world over the next six years-Environmental protection: AstraZeneca recently unveiled an ambitious programme for zero-carbon emissions from its global operations by 2025 and a carbon-negative value chain by 2030. The strategy brings forward decarbonisation plans by more than a decade. In 2019, the Company was ranked 56th overall, as 5 one of the world’s one hundred most sustainable companies by environmental research and media group, Corporate Knights, and second for biopharmaceutical companies-Ethics and transparency: the Hampton-Alexander independent review body, which works to support improvements in women’s representation at board level and in leadership roles two layers below the board, recently published its latest review. In the reviews FTSE 100 ranking, AstraZeneca moved up from seventh place in 2018 to sixth in 2019 for women represented in the top-three layers of management A more extensive sustainability update is provided later in this announcement.

Notes These notes refer to pages one to five.

1. Tagrisso, Imfinzi, Lynparza, Calquence, Farxiga, Brilinta, Lokelma, Fasenra, Bevespi and Breztri. These new medicines are pillars in the main therapy areas and are important platforms for future growth. Over time, Enhertu and roxadustat will be added to this list.

2. Constant exchange rates. These are financial measures that are not accounted for according to generallyaccepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results.

3. New Cardiovascular (CV), Renal & Metabolism comprises Diabetes medicines, Brilinta and Lokelma. Over time, roxadustat will be added to this list.

4. Specialty-care medicines comprise all Oncology medicines, Brilinta, Lokelma and Fasenra.

5. Reported financial measures are the financial results presented in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board and adopted by the EU. The UK is yet to announce its IFRS endorsement process and is anticipated to continue to follow the EU endorsement process for the foreseeable future.

6. Core financial measures.
These are non-GAAP financial measures because, unlike Reported performance, they cannot be derived directly from the information in the Group’s Financial Statements. See the operating and financial review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.

7. Earnings per share.

8. FibroGen and AstraZeneca are collaborating on the development and commercialisation of roxadustat in the US, China, and other global markets. FibroGen and Astellas Pharma Inc. (Astellas) are collaborating on the development and commercialisation of roxadustat in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. 9. Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada. 10. United Nations International Children’s Emergency Fund.

Conference call
A conference call and webcast for investors and analysts will begin at 12pm UK time today. Details can be accessed via astrazeneca.com.

Reporting calendar
The Company intends to publish its first quarter financial results on 29 April 2020.

On February 14, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported that rights offering to raise gross proceeds of approximately $60.0 million (the "Rights Offering") (Press release, CTI BioPharma, FEB 14, 2020, View Source [SID1234554369]). Under the terms of the Rights Offering, the holders, as of 5:00 p.m., New York time, on February 13, 2020, of CTI BioPharma’s common stock (the "Common Stock") and series O convertible preferred stock (the "Series O Preferred"), are entitled to exercise their subscription rights to purchase their pro rata share (assuming full conversion of the Series O Preferred into shares of Common Stock) of the $60.0 million offering amount, as more fully described in the prospectus supplement (and accompanying prospectus), dated February 14, 2020, relating to the Rights Offering (the "Prospectus"). Each subscription right may be exercised to purchase a share of Common Stock at a subscription price equal to $1.00 per share of Common Stock or, in lieu of Common Stock, an equivalent number of shares of non-voting series X convertible preferred stock (the "Series X Preferred") at a purchase price equal to $10,000 per share of Series X Preferred. The subscription rights may be exercised at any time during the subscription period of February 14, 2020 through 5:00 p.m., New York time, on March 2, 2020.

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The Rights Offering will be fully backstopped by BVF Partners L.P., Stonepine Capital, L.P., OrbiMed Private Investments VI, LP and New Enterprise Associates, Inc. (the "Backstop Investors") each of which have agreed to purchase its respective as-converted pro rata share of the offering amount, plus an additional amount of Common Stock or Series X Preferred that are not subscribed for by other purchasers in the Rights Offering, for a total of up to $60.0 million.

CTI BioPharma reserves the right to modify, extend, postpone or cancel the Rights Offering at any time prior to the closing of the sale of the securities offered in the Rights Offering. CTI BioPharma has engaged Georgeson LLC to act as information agent with respect to the Rights Offering. For questions regarding the Rights Offering, or to obtain copies of the Prospectus and any related materials, please contact Georgeson LLC by telephone at 888-613-9988.

CTI BioPharma has filed a shelf registration statement (including a prospectus supplement) with the Securities and Exchange Commission (the "SEC"). Before you invest, you should read the Prospectus and the other documents CTI BioPharma has filed with the SEC for more complete information about CTI BioPharma and the Rights Offering. This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities in any jurisdiction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

On February 14, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter and year ended December 31, 2019 (Press release, ImmunoGen, FEB 14, 2020, View Source [SID1234554349]).

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"Following the results of FORWARD I, we moved decisively to restructure the business to reduce our costs, prioritized our portfolio to focus on our most promising programs, and worked constructively with FDA to define an accelerated path to approval for mirvetuximab," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "With the benefit of these steps, we have emerged from a challenging year with significant momentum driven by the start of our registration program for mirvetuximab in platinum-resistant ovarian cancer and continued progress with our portfolio of early-stage products. In particular, we have enrolled the first patient in the confirmatory MIRASOL Phase 3 trial for mirvetuximab, presented clinical data at ASH (Free ASH Whitepaper) in December demonstrating IMGN632’s encouraging anti-tumor activity and favorable tolerability in patients with AML and BPDCN, and, most recently, raised roughly $98 million in a follow-on offering to strengthen our balance sheet."

Enyedy added, "We enter 2020 with a number of important upcoming milestones to drive value in the business. For mirvetuximab, these include opening our pivotal SORAYA trial in the first quarter, continuing to enroll MIRASOL, initiating an additional combination study in platinum-sensitive disease, and presenting data from our platinum-agnostic and platinum-sensitive combination studies. Building upon the encouraging data we reported in 2019, we will continue to advance IMGN632 in the clinic and look forward to presenting BPDCN and MRD+ monotherapy and AML combination data this year. In addition, we expect the IND for IMGC936, our novel ADAM9-targeting ADC, to be filed during the first half of the year. With these catalysts ahead, we look forward to a productive next twelve months."

RECENT PROGRESS

Received guidance from the U.S. Food and Drug Administration (FDA) that SORAYA, a new single-arm study in platinum-resistant ovarian cancer, could support accelerated approval for mirvetuximab.

Enrolled the first patient in our confirmatory Phase 3 MIRASOL trial.

Presented preclinical combination data and updated clinical monotherapy data for IMGN632 with additional patients enrolled in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) expansion cohorts at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.

Continued enrollment for IMGN632 monotherapy in Phase 1 expansion cohorts in patients with AML, BPDCN, relapsed acute lymphocytic leukemia (ALL), and minimal residual disease positive (MRD+) AML patients following frontline induction therapy.

Advanced IMGN632 combination therapy studies with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory unfit AML patients.

Progressed investigational new drug (IND)-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.

Outlicensed our epithelial cell adhesion molecule (EpCAM)-targeting Probody-drug conjugate to CytomX in exchange for an upfront fee and milestone and royalty payments.

Raised $97.6 million in a follow-on offering completed in January.

ANTICIPATED 2020 EVENTS

Initiate pivotal SORAYA trial in the first quarter of 2020 and continue enrollment in the confirmatory Phase 3 MIRASOL trial.

Open an additional platinum-sensitive investigator sponsored trial evaluating mirvetuximab in combination with carboplatin.

Present initial data from the Phase 1b FORWARD II platinum-agnostic doublet cohort evaluating mirvetuximab in combination with Avastin (bevacizumab) in mid-2020 and updated data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and bevacizumab in the fall of 2020.

Continue enrollment with IMGN632 monotherapy in relapsed AML, ALL, BPDCN, and MRD+ AML expansion cohorts and in combinations in AML.

Present IMGN632 BPDCN and AML combination and MRD+ monotherapy data at ASH (Free ASH Whitepaper) in December.

File IND for IMGC936 in the first half of 2020.

Transition next generation anti-folate receptor alpha (FRα) ADC, IMGN151, to pre-clinical development in mid-2020.

FINANCIAL RESULTS

Total revenues in the fourth quarter and year ended December 31, 2019 increased to $44.9 million and $82.3 million, respectively, compared to $13.4 million and $53.4 million for the same periods in 2018. Revenues are comprised of the following components:

License and milestone fees: License and milestone fees of $34.8 million for the year ended 2019, of which $29.6 million was recorded in the fourth quarter, included $14.5 million in amortization of a $75 million upfront fee previously received under the Company’s collaboration agreement with Jazz, $7.3 million of a $7.5 million fee recognized pursuant to a license agreement executed with CytomX in December 2019, and $12.7 million in partner milestones. Of these amounts noted, $15.2 million of related cash will be received in 2020. License and milestone fees of $15.3 million for 2018 included $13.8 million of recognized upfront fees previously received from partners and $1.5 million in partner milestone payments.

Non-cash royalty revenue: Non-cash royalty revenue in the fourth quarter and year ended December 31, 2019 increased to $15.3 million and $47.4 million, respectively, compared to $9.3 million and $32.2 million for the same periods in 2018.

Research and development expenses were $26.1 million for the quarter ended December 31, 2019 compared to $43.7 million for the quarter ended December 31, 2018, and $114.5 million for the year ended December 31, 2019 compared to $174.5 million for the year ended December 31, 2018. The decreases in both periods are primarily due to: (i) lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019 and the closing of our manufacturing facility at the end of 2018, including decreases in personnel, facility, and third-party research expenses; (ii) lower external manufacturing costs driven by activity to support commercial validation of mirvetuximab in the prior year periods; and, (iii) decreased clinical trial expenses for the year ended December 31, 2019 driven by lower activity in the FORWARD I Phase 3 clinical trial; however, clinical trial expenses for the fourth quarter of 2019 increased compared to the fourth quarter of 2018 driven by expenses incurred to initiate the MIRASOL and IMGN632 combination studies.

General and administrative expenses were flat at $9.8 million for the fourth quarter of 2019 and 2018, and $38.5 million for the year ended December 31, 2019 compared to $36.7 million for the year ended December 31, 2018. The increase year over year is primarily due to a higher allocation of facility-related expenses for excess laboratory and office space, partially offset by lower personnel expenses resulting from the restructuring of the business. Similar variances occurred quarter over quarter, but were further offset by lower stock compensation expense driven largely by stock options forfeited in the fourth quarter of 2019.

Restructuring charge of $0.5 million and $21.4 million recorded in the fourth quarter and year ended December 31, 2019, respectively, related to the restructuring of the business at the end of the second quarter of 2019, compared to $0.4 million and $3.7 million recorded in the same periods in 2018 related to the decommissioning of the Norwood facility.

Net income for the fourth quarter of 2019 was $4.8 million, or $0.03 per basic and diluted share, compared to a net loss of $(41.8) million, or $(0.28) per basic and diluted share, for the fourth quarter of 2018. Net loss for the year ended December 31, 2019 was $(104.1) million, or $(0.70) per basic and diluted share, compared to a net loss of $(168.8) million, or $(1.21) per basic and diluted share.

ImmunoGen had $176.2 million in cash and cash equivalents as of December 31, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $88.4 million for the year ended December 31, 2019, compared with cash used in operations of $166.4 million for the year ended December 31, 2018. The current year benefited from $65.2 million of net proceeds generated from the sale of the Company’s residual rights to Kadcyla (ado-trastuzumab emtasine) royalties in January 2019. Capital expenditures, net of proceeds from the sale of equipment, were $0.5 million and $5.2 million for 2019 and 2018, respectively.

In January 2020, pursuant to a public offering, the Company sold an aggregate of 24,523,750 shares of its common stock, with net proceeds to the Company of $97.6 million, after deducting underwriting discounts and estimated offering expenses.

FINANCIAL GUIDANCE

For 2020, ImmunoGen expects:

revenues between $60 million and $65 million;

operating expenses between $165 million and $170 million; and

cash and cash equivalents at December 31, 2020 to be between $170 million and $175 million.

ImmunoGen expects that its current cash, inclusive of the proceeds generated from the recent public offering and anticipated cash receipts from partners, will fund operations into the second half of 2022.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 3989656. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

On February 14, 2020 CollPlant (NASDAQ: CLGN) (the "Company"), a regenerative and aesthetic medicine company, reported it has entered into definitive agreements for up to $4.45 million (Press release, CollPlant, FEB 14, 2020, View Source [SID1234554370]). The capital raise is by way of a non-brokered private placement with U.S. accredited investors who have many years of deep experience in medical and 3D printing.

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In connection with the offering, the Company will issue 445,000 American Depositary Shares (ADSs) of the Company at a price of $10.00 per ADS. The transaction does not include any warrants. The closing of the offering is expected to take place within seven business days, subject to the satisfaction of customary closing conditions.

"We are proud to welcome U.S. investors who have substantial knowledge of the primary activity areas of CollPlant and are in alignment with our corporate strategy," stated Yehiel Tal, the Chief Executive Officer of CollPlant. "We intend to use these funds to continue to develop groundbreaking treatment options for patients through our recombinant human collagen (rhCollagen) technology platform. We look forward to sharing additional company updates on our clinical development programs and strategic partnerships in future announcements."

The securities described above are being offered and sold in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended and Regulation D promulgated thereunder, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 14, 2020 The Board of Oasmia Pharmaceutical reported that has appointed Francois Martelet as the new CEO (Press release, Oasmia, FEB 14, 2020, View Source [SID1234556575]). Dr Martelet has extensive international experience of leading pharmaceutical companies. He replaces Sven Rohmann, who has been acting CEO during a crucial transition period. Mr Rohmann remains in his position as Board member and will continue to play an active role in the company’s commercialization strategy going forward.

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Francois Martelet is an experienced Pharma executive with a proven track record of shaping companies and turning around underperforming units. He has held three CEO positions in the last 12 years. He has spent most of his career in the oncology field, as CEO of Avax and Topotarget, as well as in executive roles at senior level at Roche, Eli Lilly, Novartis and MSD. He has been based in six countries in Europe (including Sweden) and in the US. Francois Martelet is a French Medical Doctor, with a Masters Degree in Business. He speaks four languages, among them Swedish. Dr Martelet will take up his position on March 15, 2020.