UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): January 13, 2014
AMAG PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
001-10865 |
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04-2742593 |
(Commission File Number) |
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(IRS Employer Identification No.) |
1100 Winter St. |
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Waltham, Massachusetts |
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02451 |
(Address of principal executive offices) |
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(Zip Code) |
(617) 498-3300
(Registrants telephone number, including area code)
(Former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
The following information and Exhibit 99.1 attached hereto shall not be deemed filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
On January 13, 2014, AMAG Pharmaceuticals, Inc., or the Company, issued a press release providing a business update, including preliminary fourth quarter and annual 2013 financial results. A copy of the Companys press release is furnished herewith as Exhibit 99.1.
Item 7.01. Regulation FD
The following information and Exhibit 99.2 attached hereto shall not be deemed filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
The Company will present further details on the matters noted above at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco on January 15, 2014, which will be accessible by a live audio webcast through the Companys website at www.amagpharma.com on January 15, 2014 at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time). A copy of the Companys presentation slides is furnished herewith as Exhibit 99.2.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The Company hereby furnishes the following exhibits:
Exhibit |
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Description |
99.1 |
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Press release dated January 13, 2014. |
99.2 |
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Copy of Companys presentation slides dated January 2014. |
Forward-looking Statements
This report the materials furnished herewith contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding statements regarding the Companys plans for the J.P. Morgan Healthcare Conference, plans to provide 2014 financial guidance after a decision from the FDA on the Feraheme sNDA, expected revenues for the quarter and year ended December 31, 2013, expected gross margins for the fourth quarter of 2013, expected reductions in operating expenses as compared to fiscal year 2012, the expected year end cash position, the Companys goals and statements regarding the Companys new strategic plan, including its intention to expand its portfolio with additional commercial-stage specialty products, the market growth opportunity and demand for Feraheme® and Rienso, commercial opportunities for Feraheme, including its account base and use by hospitals, growth in Ferahemes current indication, the expected timing for regulatory actions, both in the U.S. and the EU, plans and strategies for MuGard® Mucoadhesive Oral Wound Rinse, the impact of business development transactions on EBITDA, expectations regarding future revenue sources, the Companys ability to optimize after-tax cash flows with business development transactions, expectations that more than 50% of our revenues will be attributable to new products by 2018, statements regarding the potential size and expansion of the U.S. IV iron market opportunity and patient population, and shifting practice patterns in the IV iron market, plans to optimize net revenue per gram, plans to drive MuGard growth across the oral mucositis patient population, the Companys ability to operate the business with financial discipline, identify unique in-license/acquisition candidates and leverage its balance sheet strength, the Companys plans to continue growth of net revenue per gram of Feraheme, the Companys 2014 goals, and the Companys statement that it is well positioned for success in 2014 and beyond are forward-looking statements
which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include: (1) uncertainties regarding the Companys sNDA and the Companys ability to obtain regulatory approval for Feraheme in the broader IDA indication, both in the U.S. and outside of the U.S., including the EU (2) the Companys ability to successfully and timely complete its clinical development programs, (3) uncertainties regarding the Companys and Takeda Pharmaceuticals ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, (4) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (5) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (6) uncertainties relating to the Companys patents and proprietary rights both in the U.S. and outside the U.S., (7) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDAs recently published draft bioequivalence recommendation for ferumoxytol, (8) uncertainties regarding the Companys ability to compete in the oral mucositis market in the U.S. and (9) other risks identified in the Companys filings with the U.S. Securities and Exchange Commission, including the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 and subsequent filings with the Commission. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals and Feraheme are registered trademarks of the Company. MuGard is a registered trademark of Access Pharmaceuticals, Inc. Rienso is a trademark of Takeda Pharmaceutical Company Limited.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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AMAG PHARMACEUTICALS, INC. | |
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By: |
/s/ Scott B. Townsend |
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General Counsel and Senior Vice President of Legal Affairs | |
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Date: January 13, 2014 |
Exhibit 99.1
FOR IMMEDIATE RELEASE
AMAG Pharmaceuticals Announces Preliminary Fourth Quarter and Annual 2013 Financial Results
· Achieves record annual U.S. Feraheme product revenues: approximately 28% growth over 2012
· Generates positive cash flows for second consecutive quarter
· Exceeds cash guidance, ending year with $217 million in cash and investments
WALTHAM, MA (January 13, 2014) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today provided a business update and announced preliminary unaudited fourth quarter and annual 2013 financial results. The company will present further details at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 15, 2014 at 8:00 a.m. Pacific time.
The exceptional 2013 results we are reporting today including 28 percent revenue growth from Feraheme®, which was launched five years ago reflect the many positive changes we have made at AMAG over the past 18 months, stated William Heiden, president and chief executive officer of AMAG. Along with the commercial success of Feraheme, we achieved many important accomplishments in 2013: in-licensing MuGard, generating positive cash flows in the second half of the year, strengthening our leadership team with key senior hires, and developing a new five-year strategic plan.
Business Highlights and Estimated 2013 Financial Results (unaudited)
· For the fourth quarter of 2013, AMAG expects total revenues of between $21.3 and $21.8 million, including between $18.6 and $19.1 million of U.S. Feraheme net product revenues. AMAG expects 2013 total annual revenues of between $80.5 million and $81.0 million, at the high end of the companys financial guidance, which was revised favorably twice during 2013. U.S. Feraheme net product revenues for 2013 are expected to be between $71.0 million and $71.5 million, including the positive impact of reductions to reserves in the third quarter of 2013. The strong growth in 2013 Feraheme revenues was driven by significant increases in volume as well as increasing net revenue per gram.
· Gross margins for Feraheme improved more than 10% in 2013, increasing from 76% of net product sales for 2012, to an estimated 84% for 2013.
· Total operating expenses for 2013 are expected to be between $79.5 million and $81.0 million, an approximate 7% reduction compared to 2012.
· AMAG generated positive cash flows for the first time in company history in the third quarter of 2013, and again in the fourth quarter. AMAG ended the year with approximately $216.7 million in cash and investments, a $3.2 million increase over the third quarter of 2013.
We achieved or exceeded each financial objective that we set for our business at the beginning of 2013, said Frank Thomas, executive vice president and chief operating officer of AMAG. This puts us in a strong position as we pursue our 2014 goals of building AMAGs product portfolio and growing the base of business that we have established with Feraheme. We plan to provide 2014 financial guidance after a decision from the FDA on the supplemental New Drug Application (sNDA) for Feraheme.
Heiden concluded, We are a company focused on bringing to market therapies that provide clear benefits and improve patients lives. We are proud to know that the 133,000 grams of Feraheme sold in the U.S. in 2013 played an important role in helping to treat the signs and symptoms of iron deficiency anemia in patients with chronic kidney disease.
Webcast Information
A live audio webcast of the companys presentation and the following breakout session, along with the accompanying slide presentation at the 32nd Annual J.P. Morgan Healthcare Conference, will be accessible through the Investors section of the companys website at www.amagpharma.com on January 15, 2014 at 8:00 a.m. P.T. (11:00 a.m. E.T.). Following the conference, the webcast will be archived on the companys website until February 15, 2014.
About AMAG
AMAG Pharmaceuticals, Inc. is a rapidly growing, specialty pharmaceutical company, supported by a talented and passionate workforce. AMAG currently markets Feraheme® (ferumoxytol) Injection and MuGard® Mucoadhesive Oral Wound Rinse in the United States. Along with driving organic growth of its products, AMAG intends to expand its portfolio with additional commercial-stage specialty products. The company is seeking complementary products that leverage the companys commercial footprint and focus on hematology and oncology centers and hospital infusion centers. The companys primary goal is to bring to market therapies that provide clear benefits and improve patients lives. For additional company information, please visit www.amagpharma.com.
About Feraheme® (ferumoxytol)/Rienso
Feraheme (ferumoxytol) Injection for Intravenous (IV) use received marketing approval from the U.S. Food and Drug Administration (FDA) on June 30, 2009 for the treatment of IDA in adult chronic kidney disease patients and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is protected in the U.S. by five issued patents covering the composition and dosage form of the product, and approved method of use. Each issued patent is listed in the FDAs Orange Book. These patents are set to expire in 2020; a request for patent term extension has been filed, which, if granted, may extend the patent term to 2023 for one of the patents.
Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme, and in the European Union in June 2013 and Switzerland in August 2013, where it is marketed by Takeda as Rienso.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding our plans for the J.P. Morgan Healthcare Conference, plans to provide 2014 financial guidance after a decision from the FDA on the Feraheme sNDA, expected revenues for the quarter and year ended December 31, 2013, expected gross margins for the fourth quarter of 2013, expected operating expenses for 2013 and the reduction compared to 2012, the expected year-end cash position and AMAGs goals, including its intention to expand its portfolio with additional commercial-stage specialty products, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include: (1) uncertainties regarding AMAGs sNDA, which seeks approval for a broader indication for Feraheme for the treatment of iron deficiency anemia (IDA) in adult patients who have failed or could not tolerate oral iron, and AMAGs ability to obtain regulatory approval for Feraheme in the U.S. and Canada, and Rienso outside of the U.S. and Canada, in the broader IDA indication, (2) AMAGs ability to successfully and timely complete its clinical development programs, (3) uncertainties regarding AMAGs and Takeda Pharmaceuticals ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, (4) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (5) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (6) uncertainties relating to AMAGs patents and proprietary rights both in the U.S. and outside the U.S., (7) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDAs published draft bioequivalence recommendation for ferumoxytol, (8) uncertainties regarding AMAGs ability to compete in the oral mucositis market in the U.S. and (9) other risks identified in AMAGs filings with the U.S. Securities and Exchange Commission, including AMAGs Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 and subsequent filings with the Commission. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc. MuGard is a registered trademark of Access Pharmaceuticals, Inc. Rienso is a trademark of Takeda Pharmaceutical Company Limited.
AMAG Pharmaceuticals, Inc. Contact:
Amy Sullivan, 617-498-3303
Exhibit 99.2
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AMAG Pharmaceuticals JP Morgan Healthcare Conference January 2014 |
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Forward Looking Statements 1 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to: statements regarding (i) our new strategic plan; (ii) market growth opportunity and demand for Feraheme; (iii) commercial opportunities for Feraheme, including our account base and use by hospitals; (iv) growth in Ferahemes current indication; (v) plans for the broader iron deficiency anemia indication for Feraheme in the U.S. and Rienso in the EU, if approved, and the expected timing of regulatory action; (vi) plans and strategies for MuGard, including its growth opportunity; (vii) our business development goals and opportunities; (viii) the impact of business development transactions on EBITDA; (ix) our ability to optimize after-tax cash flows with business development transactions; (x) expectations that more than 50% of our revenues will be attributable to new products by 2018; (xi) statements regarding the potential size and expansion of the U.S. IV iron market opportunity and patient population, and shifting practice patterns in the IV iron market; (xii) plans to optimize net revenue per gram; (xiii) plans to drive MuGard growth across the oral mucositis patient population; (xiv) our ability to operate the business with financial discipline, identify unique in-license/acquisition candidates and leverage our balance sheet strength; (xv) our expected financial results for 2013, including revenues, operating expenses and cost of goods sold; (xvi) our expected cash and investments balance for 2013; (xvii) our 2014 goals; and (xviii) our statement that AMAG is well positioned for success in 2014 and beyond are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include: (1) uncertainties regarding our sNDA and our ability to obtain regulatory approval for Feraheme in the U.S. and Canada, and Rienso outside of the U.S. and Canada, in the broader IDA indication , (2) our ability to successfully and timely complete clinical development programs, (3) uncertainties regarding our and Takeda Pharmaceuticals ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., including the EU, (4) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (5) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (6) uncertainties relating to our patents and proprietary rights both in the U.S. and outside the U.S., (7) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDAs recently published draft bioequivalence recommendation for ferumoxytol, (8) uncertainties regarding our ability to compete in the oral mucositis market in the U.S. and (9) other risks identified in our filings with the U.S. Securities and Exchange Commission (SEC), including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. |
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Mission: Build a Profitable, Multi-product Specialty Pharmaceutical Company Commercial Infrastructure Focus on Hematology/Oncology, Hospital and Nephrology Strong Balance Sheet Experienced Management Team Feraheme® U.S. CKD Business Feraheme IDA label Expansion* IV Iron Market Expansion Feraheme Geographic Expansion Product #3 2 x MuGard® Product #4 *Pending sNDA Approval |
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2013 IN REVIEW |
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2013 Performance Outstanding 2013 financial performance Feraheme revenue +28% vs. 2012 Operating expenses -7% vs. 2012 First positive cash flow in company history in second half (3Q & 4Q) of 2013 Record-breaking Feraheme performance In-market physician demand +20% vs. 2012 Evolution index of 113, gaining share of a growing market Published key data from Feraheme clinical development program First business development deal completed with license of MuGard® Hired key executives to leadership team New heads of Commercial, Development & Regulatory and Medical Affairs Developed 5-year strategic plan Key long-term financial metrics established 4 |
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Feraheme 2013 Performance 5 Net ex-factory sales ($ in millions) |
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Feraheme Demand* Growth by Segment 6 2013 Results 20% increase in Feraheme provider demand 113 evolution index *Source: IMS Health Data. |
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Outstanding Preliminary 2013 Results 7 * Includes the impact of upfront costs of the MuGard licensing transaction; also includes $2.9 million of restricted cash as of 12/31/13. ($ in millions) Original 2013 Guidance 3Q13 Updated Guidance 2013 Preliminary Results (unaudited) U.S. net Feraheme sales $63 - $67 $69 - $71 $71.0 $71.5 Total revenues $73 - $77 $78 - $81 $80.5 $81.0 Feraheme COGS (% of global net sales) 14% - 18% 15% - 17% 15% 17% Operating expenses $78 - $82 $76 - $80 $79.5 $81.0 Cash and investments $206 - $211 $209 - $213 $216.7* |
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Recent Improvement in Net Revenue per Gram of Feraheme 8 Realizing benefit of change to pricing strategy implemented in mid-2012 Reversed historically deteriorating net revenue per gram in 2012 * Net price per gram is calculated by deducting estimated fees, discounts, rebates, and returns from the wholesale acquisition cost (list price) per gram of Feraheme. See AMAGs quarterly filings with the SEC for more information related to the Companys gross to net sales adjustment. Trendline |
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Key Financial Metrics: Positive Trends 2011 - 2013 9 Revenues ($ in millions) Expenses ($ in millions) $130 |
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10 New Strategic Plan GROWING Drive revenue growth by optimizing the performance of Feraheme in CKD Enhance label and expand into new markets |
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Feraheme: 123 11 1 One gram of IV iron is the usual therapeutic course and that which was studied in the Feraheme clinical trials. Feraheme Indication and Contraindications: Feraheme ® (ferumoxytol) Injection for Intravenous (IV) is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components. Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Anaphylactic type reactions, presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical trials, the most commonly occurring adverse reactions for Feraheme-treated patients were diarrhea, nausea, dizziness, hypotension, constipation and peripheral edema. A full list of adverse events can be found in the full prescribing information for Feraheme. For full prescribing information, please visit www.feraheme.com. 1 gram, 2 doses, 3 days apart Attribute Feraheme One-gram Dose Dosing1 Schedule: 2 x 510 mg doses Delivery: Infusion or Rapid IV Injection Regimen (1 g): 2 treatments, 3 to 8 days apart Observation Period: 30 minutes post dosing Infusion option added to Feraheme label, Dec. 23, 2013 |
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U.S. IV Iron Market: Competitive Landscape 12 *Aggregate of Ferrlecit Brand + Generic Ferric Gluconate Source: IMS DDD Data thru week ending 12/20/13 2013 Share of ~860,000 Gram Non-dialysis Market |
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Todays Feraheme Commercial Opportunity 13 Sources: U.S. Census; U.S. Renal Data System, USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES 1998-2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 5761; AMAG estimates market opportunity at $550/gram. 270,000 patients (430,000 grams) + $250 million Feraheme potential Todays Opportunity Hematology/Oncology Strong Feraheme share in CKD Loyal and growing account base Hospitals Adoption and share increasing IDA IDA-CKD |
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Todays Commercial Objective: Increase Share of Current CKD IV Iron Market 14 Sources: U.S. Census; U.S. Renal Data System, USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES 1998-2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 5761; AMAG estimates market opportunity at $550/gram. IDA IDA-CKD ~30% Feraheme Significant growth opportunity in current indication 270,000 patients (430,000 grams) + $250 million Feraheme potential |
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15 Sources: U.S. Census; U.S. Renal Data System, USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES 1998-2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 5761; AMAG estimates market opportunity at $550/gram. 540,000 patients (860,000 grams) + $500 million Feraheme potential IDA IDA-CKD Label Expansion Opportunity* Same call audience: Hematology/Oncology Expand use to all IDA patients in current accounts Convert single IV iron stockers to Feraheme Hospitals Expand use to all IDA patients in current accounts Continue to gain new accounts Planning for Potential Label Expansion*: Gain Additional Share of IV Iron Market *Pending sNDA Approval |
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Date Status December 2012 sNDA for broader IDA indication filed September 2013 FDA informed AMAG that they were not ready to enter labeling negotiations due to deficiencies October 2013 FDA extended the PDUFA action date to January 21, 2014 January 7, 2014 FDA informed AMAG that they were actively reviewing the application; label negotiations had not begun Feraheme sNDA Update 16 |
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Opportunity: Grow IV Iron Market 17 IV Iron IDA* IV Iron IDA-CKD 4,000,000 patients diagnosed with IDA placed on oral iron therapy IV Iron IDA-CKD IV Iron IDA* *Pending sNDA Approval Oral Iron IDA* Oral Iron IDA-CKD 4,000,000 patients diagnosed with IDA placed on oral iron therapy Womens Health Rheumatology Oncology Gastroenterology |
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Growth through International Expansion 18 Approved for CKD indication in Europe and Canada Launches began in 4Q12 June 2013 filing for IDA in Europe File action anticipated mid-2014 (milestone payment upon approval) Takeda Deal terms: $60 million up-front payment $186 million in milestones remaining Royalties on sales: tiered, double-digit |
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MuGard: AMAGs Commercial Progress 19 Launched late in 3Q13 by AMAG New marketing materials developed, including HCP brochures, patient materials, reimbursement information and starter kits Conducted comprehensive field training MuGard HCP targets have high overlap with existing Feraheme targets Supplemented by other productive specialties, such as Rad-Oncs AMAG market research indicates: MuGard users are very satisfied with MuGard Once HCPs try MuGard, they intend to prescribe it more MuGard reps are highly valued by the clinicians MuGard demand (bottles) increased 22% from 3Q13 to 4Q13 Sources: IMS NPA, Ex-Factory Sales, Wholesaler/Spec Pharmacy Outflow & Inventory |
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MuGards Road To Success In 2014 20 Strategies Success Factors |
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21 New Strategic Plan GROWING Drive revenue growth by optimizing the performance of Feraheme in CKD Enhance label and expand into new markets BUILDING |
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Build our future by expanding our product portfolio Example: Leverage AMAGs current oncology call-point with cancer supportive care product => MuGard Initial focus on commercial stage products (2-3 additional products by 2018) Example: Acquire commercial gastroenterology (therapeutic area of strategic interest) product and specialty sales force Example: Acquire commercial company with a U.S. hospital product, company HQ based outside the U.S. Opportunistically evaluate late-stage development products Example: License commercial specialty hematology product with label expansion potential New products expected to contribute >50% of revenues by 2018 Example: BUILDING: Business Development Initiatives are a Priority 22 |
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Targeted Business Development 23 Financial Similarly sized (or smaller) specialty company Eliminate overlapping infrastructure and increase EBITDA Examine transactions to optimize after-tax cash flows Bulls-Eye Hem/onc or hospital company or product $10 MM$60 MM/yr. revenue potential IP runway Immediately accretive Strategic Opportunities aligned with Feraheme growth strategy (e.g., GI, Rheum) |
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24 New Strategic Plan AMAG is a rapidly growing, specialty pharmaceutical company, supported by a talented and passionate workforce. Our primary goal is to bring to market therapies that provide clear benefits and improve patients lives. GROWING Drive revenue growth by optimizing the performance of Feraheme in CKD Enhance label and expand into new markets BUILDING Build our future by expanding our product portfolio Initial focus on commercial stage products Opportunistically consider late-stage development products Goal: new products to contribute >50% of revenues by 2018 TOGETHER Leverage infrastructure, maximize impact of employees and build new capabilities when needed Embed new corporate vision and values into culture at AMAG |
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2014 Goals Maximize Feraheme opportunities Drive market share and market growth within current U.S. IDA-CKD indication Optimize net revenue per gram Potential label expansion: IDA (non-CKD) oral iron failures Expected FDA action January 21, 2014 Expected EU action mid-2014 Pursue IV iron market expansion initiatives Drive MuGard growth across oral mucositis patient population Continue to operate the business with financial discipline Execute additional, quality business development transactions Continue to identify unique in-license/acquisition candidates Leverage balance sheet strength to consummate additional business development deals 25 |
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Well positioned for success in 2014. . . and beyond. |
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