On March 9, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC) reported financial results for the fourth quarter and full year ended December 31, 2016 (Press release, Cascadian Therapeutics, MAR 9, 2017, View Source [SID1234518040]).

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"In 2016, we focused our efforts on the development of tucatinib for late-stage HER2-positive metastatic breast cancer for patients with and without brain metastases and amended our ongoing HER2CLIMB study by increasing the sample size so that, if successful, the trial could serve as a single pivotal trial to support registration," said Scott Myers, President and CEO of Cascadian Therapeutics. "For 2017, we have prioritized our resources on expanding HER2CLIMB globally and exploring the potential utility of tucatinib in additional HER2-positive expressing cancers. With a global development plan underway, clarity on a U.S. regulatory pathway and a solid financial position, we have set the foundation to execute our strategy."

Fourth Quarter and Recent Highlights

Tucatinib — targeted HER2 inhibitor

In December 2016, researchers presented updated data from the Company’s ongoing Phase 1b Triplet combination study (tucatinib with capecitabine and trastuzumab) at the 2016 San Antonio Breast Cancer Symposium. This Triplet combination continued to be well tolerated and showed an updated median progression-free survival of 7.8 months, an overall response rate of 61 percent and a median duration of response of 10 months. Patients treated with the Triplet combination previously received a median of 3 HER2-targeted agents, such as trastuzumab, pertuzumab, lapatinib and T-DM1.

In December 2016, the Company announced that, following a meeting with the U.S. Food and Drug Administration (FDA) and discussions with the Company’s external Steering Committee, the Company amended the HER2CLIMB trial of tucatinib by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support a new drug application.

In October 2016, the Company announced presentation of data from the ongoing Phase 1b Triplet combination study (tucatinib with capecitabine and trastuzumab) at the European Society for Medical Oncology 2016 Congress that showed clinical activity in HER2-positive metastatic lesions to the skin.
CASC-578 — a novel Chk1 cell cycle inhibitor

In December 2016, the Company completed a non-human pharmacology study to evaluate the impact of CASC-578 on multiple cardiovascular endpoints. The results indicate CASC-578 has an acceptable profile at the doses tested and warrants further study of the drug in both single agent and combination settings.
Corporate

In January 2017, the Company strengthened its balance sheet through an underwritten public offering, resulting in net proceeds of approximately $88 million.
Fourth Quarter and Full Year 2016 Financial Results

Cash, cash equivalents and investments totaled $62.8 million as of December 31, 2016, compared to $56.4 million at December 31, 2015, an increase of $6.4 million, or 11.3 percent. The increase was primarily due to the result of net proceeds of $43.3 million from the Company’s June 2016 financing offset by cash used to fund operations of $36.9 million.

Net loss attributable to common stockholders for the three months ended December 31, 2016 was $10.5 million, or $0.47 per share, compared to a net loss attributable to common stockholders of $9.1 million, or $0.58 per share, for the same period in 2015. The $1.4 million increase in net loss attributable to common stockholders for the quarter was primarily due to an increase in research and development expense associated with the development of the Company’s product candidates and an increase in general and administrative expense, which included expenses related to headcount and the Company’s adoption of the Retention Plan in early January 2016.

Net loss attributable to common stockholders for the year ended December 31, 2016 was $60.3 million, or $3.13 per share, compared to a net loss attributable to common stockholders of $32.6 million, or $2.02 per share, for the same period in 2015. The increase in net loss attributable to common stockholders for the year ended December 31, 2016 was primarily due to the intangible asset impairment charge of $19.7 million, which was the result of the mutual termination of the STC.UNM agreement. In addition, the increases in research and development expenses of $4.0 million, due to greater activity related to the development of the Company’s product candidates, and increases in general and administrative expenses of $8.3 million, primarily related to the retirement and separation of the former chief executive officer and other headcount-related expenses, contributed to the year-over-year increase in net loss. The Company also recognized a non-cash $2.6 million deemed dividend due to the beneficial conversion feature on the Series D convertible preferred stock. The increase in the net loss attributable to common stockholders was partially offset by a $6.9 million tax benefit during the year ended December 31, 2016.
2017 Financial Outlook

Cascadian Therapeutics believes the following financial guidance to be correct as of the date provided and is providing the guidance as a convenience to investors and assumes no obligation to update it.

Cascadian Therapeutics expects operating expenses in 2017 to be slightly higher than in 2016, which included a one-time expense associated with the intangible asset impairment. The 2017 increase is due to an increase in activities related to the ongoing HER2CLIMB pivotal trial. Cash used in operations is expected to be approximately $50.0 million to $54.0 million.

On March 9, 2017 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported a corporate update and reported financial results for the fourth quarter and year ended December 31, 2016 (Filing, Q4/Annual, Agenus, 2016, MAR 9, 2017, View Source [SID1234518039]).

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"Actions we took last year put us on a path to register our lead antibodies that target CTLA-4 and PD-1 in the next four years. We also advanced programs directed at novel targets, such as 4-1BB and TIGIT, and upgraded our Berkeley manufacturing facility," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "As we enter 2017, we have strengthened our balance sheet with our recently announced Incyte transaction resulting in a cash infusion of $80 million and a reduction of our cash burn rate for 2017 and beyond."

Incyte Collaboration

Earlier this year, Agenus amended its collaboration with Incyte, resulting in $80 million of cash to Agenus: $60 million from an equity investment at $6/share plus $20 million in accelerated clinical development milestones for the GITR and OX40 programs. In addition, these programs were converted from co-funded development and profit-share arrangements to royalty-bearing programs at a 15% royalty rate, with Agenus eligible for up to $510 million in future milestones.

UCB Collaboration

Agenus entered into a research collaboration with UCB to advance the development of multi-specific therapeutic antibodies. The collaboration presents a unique opportunity to discover novel therapeutics. This approach has the potential to expedite the development of Agenus’ portfolio of discovery programs focused on the next generation of I-O targets.

2017 Anticipated Milestones:

Start Phase 1 dose-escalation trial for anti-PD-1 antagonist AGEN2034 in H1.
Start Phase 1b combination trial with AGEN1884 (CTLA-4) and AGEN2034 (PD-1) in H2.
Start Phase 1 trial for AutoSynVax in H1.
Start cervical cancer trial for PD-1 monotherapy in H2.
Readouts of AutoSynVax immunogenicity in H2.
Execute additional strategic transactions.
2016 Select Highlights:

Research & Development

Started Phase 1 dose escalation trial of AGEN 1884, Agenus’ proprietary anti-CTLA-4 antibody.
Started Phase 1 trial for INCAGN1876, anti-GITR antibody in partnership with Incyte.
Started Phase 1 trial for INCAGN1949, anti-OX40 antibody in partnership with Incyte.
Advanced collaboration with Merck with the selection of a lead product candidate.
GlaxoSmithKline filed for regulatory approval of Shingrix vaccine containing Agenus’ QS-21 Stimulon.
Leadership

Appointed Ulf Wiinberg to Board of Directors, bringing three decades of leadership experience in the global biopharmaceutical industry to our governance team.
Appointed Dr. Jean-Marie Cuillerot as Vice President and Global Head of Clinical Development, who has since assumed the role of a Chief Medical Officer. Dr. Cuillerot has been integral to the development of Yervoy and Avelumab during his tenure at BMS and Merck Serono.
Fourth Quarter 2016 Financial Results
Cash, cash equivalents and short-term investments were $76.4 million as of December 31, 2016. Subsequent to the end of the year, Agenus received $80 million in cash as part of the amended partnership and stock purchase agreement with Incyte. The increased cash combined with substantially reduced clinical development expense obligations under the prior Incyte agreement, will significantly reduce our cash burn and extend our cash runway through the second quarter of 2018.

For the fourth quarter, Agenus reported a net loss of $26.1 million, or $0.30 per share, compared with a net loss for the fourth quarter of 2015 of $15.6 million, or $0.18 per share. The company’s cash burn for the quarter was approximately $19.0 million compared to approximately $27.9 million during the third quarter.

The increased net loss for the quarter ended December 31, 2016, compared to the same period in 2015, was due primarily to the expansion and growth of the research activities at the Company partially offset by non-cash income for the quarter ended December 31, 2016 of $9.4 million, due to the fair value adjustment of the contingent purchase price considerations compared to $623,000 for the same period in 2015. In addition, during the quarter ended December 31, 2015 we recorded a $5.4 million income tax benefit recognized as a result of our 2015 acquisitions.

For the year ended December 31, 2016, the Company incurred a net loss of $127 million, or $1.46 per share, compared with a net loss of $88 million, or $1.13 per share, in the same period in 2015.

The increase in net loss for the year ended December 31, 2016, compared to the net loss for the same period in 2015, was primarily due to the Company’s growth and to the advancement of our programs, and increased interest expense on our long-term debt partially offset by the decreased non-cash expense for fair value adjustments to our contingent obligations.

On March 9, 2017 Servier, together with Pfizer Inc. (NYSE:PFE) and Cellectis (Alternext: ALCLS; Nasdaq: CLLS), reported that the U.S. Food and Drug Administration (FDA) has granted Servier with an Investigational New Drug (IND) clearance to proceed in the U.S. with the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia (Press release, Cellectis, MAR 9, 2017, View Source [SID1234518037]).

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Servier is sponsoring the CALM Phase 1 study on UCART19. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being co-developed by Servier and Pfizer.

The CALM study was initiated in the UK in August 2016. CALM is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

The allogeneic UCART19 candidate and CALM protocol were reviewed at the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC) meeting on December 14, 2016. Servier submitted an IND application on February 1, 2017, with Pfizer’s support. With this IND clearance, the CALM study will be expanded to include several centers in the U.S., including the MD Anderson Cancer Center in Houston (Texas).

"We are very pleased that Servier’s first IND approval has been granted for such an innovative approach as allogeneic CAR T therapy", said Dr Patrick Thérasse, Director of Clinical Development Oncology at Servier. "B-ALL is a devastating disease and this study is key to gaining greater insight into the efficacy and safety profile of this new immune-oncology approach in patients with B-ALL."

"Pfizer is excited by the potential of this investigational CAR T approach to treating ALL and other B-Cell malignancies," said Barbara Sasu, Vice President, CAR T Research at Pfizer. "We are looking forward to having the opportunity to investigate this approach in the U.S."

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN. UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. The current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology. UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, "off-the-shelf" T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has been granted exclusive rights by Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.

On March 9, 2017 Merck, a leading science and technology company, reported finishing 2016 with record figures and continues to grow profitably (Press release, Merck KGaA, MAR 9, 2017, View Source [SID1234518059]).

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Sales and earnings rose significantly. Major strategic advances were made in all three business sectors.

"2016 was a successful year for Merck. In Healthcare, two of our compounds are in registration. In our Life Science business sector, we made rapid progress with the integration of Sigma-Aldrich. We have moved ahead faster and even better than expected with the realization of synergies. At the same time, the business generated notable organic growth. With its four strong businesses, Performance Materials showed robustness in a challenging market environment. We maintained our strategically important market leadership in display materials and purposefully drove new technologies forward," said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck.
Net sales of the Merck Group increased sharply by 17.0% to € 15.0 billion in 2016 (2015: € 12.8 billion). All regions contributed to organic sales growth of 3.2%. The purchase of Sigma-Aldrich was responsible for an acquisition-related sales increase of 16.4%. By contrast, negative exchange rate effects, which were mainly attributable to Latin American currencies, lowered Group sales by -2.6%.

The operating result (EBIT) rose by 34.6% to € 2.5 billion (2015: € 1.8 billion). EBITDA pre exceptionals, the company’s key earnings indicator, climbed 23.7% to € 4.5 billion. Thanks to the Healthcare and Life Science business sectors, this figure was considerably higher than in the previous year (2015: € 3.6 billion).

Net income rose by 46.1% to € 1.6 billion in 2016 (2015: € 1.1 billion). This positive development was also due to the gain from the return of the rights to Kuvan to BioMarin Pharmaceutical at the beginning of 2016.

Earnings per share pre exceptionals rose by 27.5% to € 6.21 (2015: € 4.87). The proposal to the Annual General Meeting on April 28, 2017 will be to increase the dividend by € 0.15 to € 1.20 per share. Merck will have thus increased its dividend every year since 2009.

The figures for sales, EBITDA pre exceptionals and earnings per share pre exceptionals were within the upgraded target corridor that Merck had most recently announced in its report on the third quarter in November 2016.

Net financial debt, which mainly stems from the Sigma-Aldrich acquisition, decreased to € 11.5 billion at the end of 2016 (December 31, 2015: € 12.7 billion). Merck will resolutely continue along this path. As of December 31, 2016, Merck had 50,414 employees worldwide (December 31, 2015: 49,613).

Healthcare and Life Science drive Group organic sales growth in the fourth quarter
In the fourth quarter of 2016, Group sales rose by 10.6% to € 3.8 billion (Q4 2015: € 3.5 billion). This was driven not only by organic growth attributable to Healthcare and Life Science, but also by strong acquisition-related sales growth from the purchase of Sigma-Aldrich. EBITDA pre exceptionals grew by 15.1% to € 1.1 billion in the fourth quarter of 2016 (Q4 2015: € 933 million). Earnings per share pre exceptionalsincreased significantly by 26.5% in the fourth quarter of 2016 to € 1.43 (Q4 2015: € 1.13).

Healthcare grows organically and makes progress with registrations
Net sales of the Healthcare business sector rose organically by 4.6% in 2016. Organic growth was canceled out by negative exchange rate effects of –4.6%, as well as a negative portfolio effect of -1.1% from the sale of the rights to Kuvan. Consequently, Healthcare sales declined in 2016 by –1.1%, amounting to € 6.9 billion (2015: € 6.9 billion).

Sales of Rebif, which is used to treat relapsing forms of multiple sclerosis, declined organically by only –1.7% in 2016 despite continued competitive pressure from oral formulations. Amid currency headwinds of -1.5%, Rebif sales amounted to € 1.7 billion (2015: € 1.8 billion). In 2016, sales of the oncology drug Erbitux totaled € 880 million (2015: € 899 million). Organic growth of 1.1% was canceled out by negative foreign exchange effects of -3.2%. With Gonal-f, the leading recombinant hormone used in the treatment of infertility, in 2016 Merck generated strong organic sales growth of 12.4%, also benefiting from the competitive environment in the United States. Including negative foreign exchange effects of -2.5%, sales rose to € 753 million (2015: € 685 million).

Despite higher research and development expenses mainly in connection with clinical development projects in immuno-oncology, EBITDA pre exceptionals of Healthcare grew by 6.3% to € 2.1 billion (2015: € 2.0 billion).

Currently, both the multiple sclerosis treatment cladribine tablets and the oncology drug avelumab are in registration.

Life Science delivers strong organic growth despite Sigma-Aldrich integration
In 2016, net sales of the Life Science business sector soared by 68.6% to € 5.7 billion (2015: € 3.4 billion) and profitability rose. At 6.3%, Life Science again delivered strong organic growth, outpacing the market. The acquisition-related increase of 63.1% from the purchase of Sigma-Aldrich had a very strong impact on sales amid slightly negative exchange rate effects of -0.8%. Life Science made good progress with the integration of Sigma-Aldrich, including the realization of synergies. At the end of 2016, annually recurring cost synergies of € 105 million had already been leveraged as compared with the originally planned amount of € 90 million for this period. In addition, thanks to previously unplanned top-line synergies, by the end of 2018 total synergies from the acquisition will amount to € 280 million instead of the originally planned € 260 million per year, as previously announced at Capital Market Day in October 2016.

The Process Solutions business area, which markets products and services for the entire pharmaceutical production value chain, generated organic sales growth of 10.5%. The Research Solutions business area, which focuses on academia and pharmaceutical research institutions, delivered organic sales growth of 1.2%. Sales by Applied Solutions, which serves clinical and diagnostic testing laboratories as well as the food and environmental industries, grew organically by 4.3%.

EBITDA pre exceptionals of Life Science rose in 2016 by 93.0% to € 1.7 billion (2015: € 856 million), reflecting the strong development of the combined Life Science business.

Performance Materials remains robust in a difficult market environment
Net sales by the Performance Materials business sector declined in 2016 by -1.8% to € 2.5 billion (2015: € 2.6 billion). This was mainly due to the -4.7% organic decrease in sales. Acquisition-related growth of 2.7% from the SAFC Hitech business of Sigma-Aldrich acquired in 2015 and exchange rate effects of 0.2% could only partly offset this.

The Display Materials business unit, which comprises the business with liquid crystals and complementary materials, saw a sharp organic decline in sales in 2016 yet still maintained its market leadership position. The decline in sales resulted from a strong previous year as well as destocking by display industry customers. One exception was the energy-saving UB-FFS technology used in the latest generation of smartphones. Here, double-digit growth was achieved along with record sales in the fourth quarter. The Integrated Circuit Materials business unit also showed strong organic sales growth. The Pigments & Functional Materials business unit delivered solid organic sales growth in 2016. Growth in the Advanced Technologies business unit was driven by double-digit sales increases for OLED materials; a new OLED production unit was opened in Darmstadt in September 2016.

EBITDA pre exceptionals of Performance Materials fell by -2.3% to € 1.1 billion (2015: €  1.1 billion).

Sales growth and stable EBITDA pre exceptionals forecast for 2017
For the Group, Merck expects slight to moderate organic sales growth in 2017 in comparison with the previous year. EBITDA pre exceptionals of the Merck Group should remain about stable compared with 2016; this encompasses a slightly positive or negative percentage fluctuation around the previous year’s level.
Merck Group – Key figures
€ million
2016
2015
Change
in %
Q4 2016
Q4 2015
Change
in %
Net sales
15,024
12,845
17.0
3,830
3,464
10.6
Operating result (EBIT)
2,481
1,843
34.6
405
298
36.0
Margin (% of net sales)
16.5
14.3
10.6
8.6
EBITDA
4,415
3,354
31.6
953
803
18.7
Margin (% of net sales)
29.4
26.1
24.9
23.2
EBITDA pre exceptionals
4,490
3,630
23.7
1,075
933
15.1
Margin (% of net sales)
29.9
28.3
28.1
26.9
Earnings per share (€)
3.75
2.56
46.5
0.62
0.29
113.8
Earnings per share pre exceptionals (€)
6.21
4.87
27.5
1.43
1.13
26.5
Net income
1,629
1,115
46.1
269
126
113.8
Dec. 31, 2016
Dec. 31, 2015
Net financial debt
11,513
12,654
– 9.0