InterMune Announces First Quarter 2001 Financial Results and Conference Call

Sales of Lead Product Actimmune(R) Increase by 155%



Apr 25, 2001, 01:00 ET from InterMune Pharmaceuticals, Inc.

    BURLINGAME, Calif., April 25 /PRNewswire/ -- InterMune (Nasdaq:   ITMN)
 today announced financial results for the first quarter ended March 31, 2001.
 InterMune reported a pro forma net loss of $10.6 million, or $0.46 per share
 on a pro forma basis, compared to a pro forma net loss of $5.6 million, or
 $0.39 per share on a pro forma basis for the same period in 2000.
     Sales of lead product Actimmune(R) for the first quarter of 2001 were
 $4.9 million, compared to $1.9 million in the first quarter of 2000, an
 increase of 155%.  Total InterMune product sales recorded for the first
 quarter of 2001 were $5.5 million, compared to $106,000 in the first quarter
 of 2000.  InterMune reported only $106,000 of the $1.9 million in Actimmune(R)
 sales in the first quarter of 2000 due to a prior revenue-sharing agreement
 which has since been terminated.  The Company recognized net worldwide sales
 of Amphotec(R) in the first quarter of 2001 totaling $613,000.  The Company
 purchased Amphotec(R), an FDA-approved lipid-complexed form of amphotericin B,
 on January 5, 2001.
     "We are very pleased with the continued growth in sales of Actimmune(R)
 during the first quarter, well in excess of our stated goal of 100% annual
 revenue growth for Actimmune(R)," said W. Scott Harkonen, M.D., President and
 CEO of InterMune.  "Our recent addition of 26 field representatives in
 February, along with heightened physician interest in Actimmune(R), have been
 major drivers of our sales growth.  Looking forward, our new initiatives in
 ovarian cancer, the addition of 22 field representatives in June, and our
 international strategic partnership with Boehringer Ingelheim, should all be
 further drivers of revenue growth."
     "Regarding product development, we have now enrolled over 140 patients in
 our Phase III clinical trial for Actimmune(R) in the treatment of idiopathic
 pulmonary fibrosis.  Our Phase II clinical trial for cryptococcal meningitis
 has completed enrollment and will report data in the fourth quarter of this
 year.  Similarly, our ongoing Phase III trial in tuberculosis and our Phase II
 trials in cystic fibrosis and atypical mycobacterial infections are on track.
 With the initiation of a Phase III trial in ovarian cancer and a Phase II
 trial in liver fibrosis (cirrhosis) in patients with hepatitis C infection,
 both in the second half of this year, investors can look to a steady stream of
 clinical events over the next 18 months," stated Dr. Harkonen.
     Total amortization expenses of $2.1 million were incurred in the first
 quarter of 2001, including $1.9 million relating to product revenue rights to
 Actimmune(R) acquired from Connetics Corporation and $225,000 for the
 acquisition of Amphotec(R) from ALZA Corporation.  Research and development
 expenses were $6.3 million for the first quarter of 2001, compared to
 $4.0 million in the same period in 2000.  The increase was due primarily to
 increased costs of clinical trial expenses for Actimmune(R) in new disease
 indications.  Selling, general and administrative expenses were $5.7 million
 and $1.3 million for the three-month periods ending March 31, 2001 and 2000,
 respectively.  This increase is attributable primarily to increased staffing
 and related expenses necessary to support the expansion of the Company's
 operations.  At March 31, 2001, cash, cash equivalents and available-for-sale
 securities totaled $175.3 million.
 
     Highlights From the First Quarter of 2001:
     -- Completed acquisition of Amphotec(R), an FDA-approved lipid-complexed
        form of amphotericin B, from ALZA Corporation.
     -- Appointed James E. Pennington, M.D. to the position of Executive Vice
        President of Medical and Scientific Affairs.
     -- Trained and placed into the field 26 immunology specialists to support
        physicians regarding the safe and appropriate use of Actimmune(R) and
        Amphotec(R).
     -- Commenced enrollment in Phase II clinical trial evaluating the safety
        and efficacy of inhaled Actimmune(R) (Interferon gamma-1b) for the
        treatment of cystic fibrosis.
     -- Formed an international strategic partnership to develop and
        commercialize interferon gamma-1b under Boehringer Ingelheim's trade
        name, Imukin(R), in all countries outside of the United States, Canada
        and Japan.
     -- Nominated Jay Sheppard, Vice President of the Oncology Business Unit at
        ALZA Corporation to the Company's Board of Directors.
     -- Completed enrollment in Phase II clinical trial evaluating the safety
        and efficacy of Actimmune(R) (Interferon gamma-1b) for the treatment of
        cryptococcal meningitis, a life-threatening fungal infection.
     -- Initiated a clinical program in Japan, with plans to develop
        Actimmune(R) (Interferon gamma-1b) for life-threatening diseases, as
        well as chronic granulomatous disease (CGD) and severe, malignant
        osteopetrosis.
     -- Announced plans to develop Actimmune(R) (Interferon gamma-1b) for the
        treatment of liver fibrosis (cirrhosis) associated with hepatitis C.
 
     The Company will hold a conference call with research analysts at
 11:00 a.m. Eastern Time on Thursday, April 26, 2001.  Interested investors and
 others may listen to the call either live or on a replay basis through our
 internet webcast, which may be accessed by visiting our website at
 http://www.intermune.com and clicking on the "Investor Relations" icon.
     InterMune is a biotechnology company dedicated to the development and
 commercialization of innovative products for the treatment of serious
 pulmonary and infectious diseases and cancer.  InterMune currently markets
 Actimmune(R) (Interferon gamma-1b) Injection in the United States for the
 treatment of chronic granulomatous disease (CGD) and severe, malignant
 osteopetrosis and is in Phase III clinical trials for the treatment of
 idiopathic pulmonary fibrosis (IPF) and multidrug-resistant tuberculosis
 (MDR TB).  The Company also markets Amphotec(R), an FDA-approved
 lipid-complexed form of amphotericin B for the treatment of invasive
 aspergillosis, a life-threatening fungal infection.  For more information
 about InterMune and Actimmune(R), please visit InterMune's web sites at
 www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com.
 
     Except for the historical information contained herein, this press release
 contains certain forward-looking statements concerning certain of InterMune's
 financial, business, and clinical development activities and goals, that
 involve risks and uncertainties.  All forward-looking statements and other
 information included in this press release are based on information available
 to InterMune as of the date hereof, and InterMune assumes no obligation to
 update any such forward-looking statements or information.  InterMune's actual
 results could differ materially from those described in InterMune's
 forward-looking statements.  Factors that could cause or contribute to such
 differences include, but are not limited to those discussed under the heading
 "Risk Factors" and the risks and factors discussed in InterMune's most recent
 periodic reports (i.e., 10-K, 10-Q and 8-K) filed with the SEC.  In sum, these
 significant risks include, but are not limited to:  the uncertainty of success
 of InterMune's efforts in research, development, commercialization, product
 acceptance, third-party manufacturing and capital raising; the uncertain,
 lengthy and expensive regulatory process; uncertainties associated with:
 obtaining and enforcing patents important to its business, being an
 early-stage company and relying on third-party payors' reimbursement policies;
 competition from other products; and product liability lawsuits.
 
                          InterMune Pharmaceuticals, Inc.
 
                         CONDENSED STATEMENTS OF OPERATIONS
                (unaudited, in thousands, except per share amounts)
 
                                                         Three Months Ended
                                                             March 31,
                                                        2001           2000
     Product sales, net
      Actimmune, net                                   $4,929        $106(A)
 
      Amphotec, net                                       613             --
 
       Total net sales                                  5,542            106
 
 
     Costs and expenses:
      Cost of goods sold                                3,515             56
 
      Amortization of product
       rights                                           2,118             --
 
      Research and development                          6,280          4,037
 
      Selling, general and administrative               5,710          1,295
 
      Deferred compensation                             1,238            758
 
       Total costs and expenses                        18,861          6,146
 
 
     Loss from operations                            (13,319)        (6,040)
 
 
     Interest income, net                               2,750            408
 
 
     Net loss                                        (10,569)        (5,632)
 
     Preferred stock accretion                             --          (269)
 
     Redeemable preferred stock dividend                   --       (27,762)
 
 
     Net loss attributable to
      common stockholders                           $(10,569)      $(33,663)
 
 
     Historical basic and diluted net loss
      per share                                       $(0.46)       $(11.17)
     Shares used in calculating historical
      basic and diluted net loss per
      common share                                     23,032          3,014
 
     Pro forma basic and diluted net loss
      per share                                       $(0.46)        $(2.33)
     Shares used in calculating pro forma
      basic and diluted net loss per
     common share                                      23,032         14,338
 
     Pro forma net loss attributable to
      common stockholders excluding
      preferred stock accretion and
      redeemable preferred stock dividend           $(10,569)       $(5,632)
 
     Pro forma basic and diluted net loss
      per common share attributable to
      common stockholders excluding
      preferred stock accretion and
      redeemable preferred stock dividend             $(0.46)        $(0.39)
 
     (A) Sales of Actimmune(R) up to a contractual threshold of (in thousands)
 $1,827 were reported by Connetics Corporation for the respective period.
 
 
                          InterMune Pharmaceuticals, Inc.
 
                              CONDENSED BALANCE SHEETS
                             (unaudited, in thousands)
 
                                                     March 31,    December 31,
                                                        2001           2000
     Cash, cash equivalents and
      available-for-sale securities                  $175,307       $194,520
 
     Other assets                                      17,321          7,129
 
       Total assets                                  $192,628       $201,649
 
 
     Current liabilities                               $5,849         $5,848
 
     Stockholders' equity                             186,779        195,801
 
       Total liabilities and stockholders' equity    $192,628       $201,649
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X67527022
 
 

SOURCE InterMune Pharmaceuticals, Inc.
    BURLINGAME, Calif., April 25 /PRNewswire/ -- InterMune (Nasdaq:   ITMN)
 today announced financial results for the first quarter ended March 31, 2001.
 InterMune reported a pro forma net loss of $10.6 million, or $0.46 per share
 on a pro forma basis, compared to a pro forma net loss of $5.6 million, or
 $0.39 per share on a pro forma basis for the same period in 2000.
     Sales of lead product Actimmune(R) for the first quarter of 2001 were
 $4.9 million, compared to $1.9 million in the first quarter of 2000, an
 increase of 155%.  Total InterMune product sales recorded for the first
 quarter of 2001 were $5.5 million, compared to $106,000 in the first quarter
 of 2000.  InterMune reported only $106,000 of the $1.9 million in Actimmune(R)
 sales in the first quarter of 2000 due to a prior revenue-sharing agreement
 which has since been terminated.  The Company recognized net worldwide sales
 of Amphotec(R) in the first quarter of 2001 totaling $613,000.  The Company
 purchased Amphotec(R), an FDA-approved lipid-complexed form of amphotericin B,
 on January 5, 2001.
     "We are very pleased with the continued growth in sales of Actimmune(R)
 during the first quarter, well in excess of our stated goal of 100% annual
 revenue growth for Actimmune(R)," said W. Scott Harkonen, M.D., President and
 CEO of InterMune.  "Our recent addition of 26 field representatives in
 February, along with heightened physician interest in Actimmune(R), have been
 major drivers of our sales growth.  Looking forward, our new initiatives in
 ovarian cancer, the addition of 22 field representatives in June, and our
 international strategic partnership with Boehringer Ingelheim, should all be
 further drivers of revenue growth."
     "Regarding product development, we have now enrolled over 140 patients in
 our Phase III clinical trial for Actimmune(R) in the treatment of idiopathic
 pulmonary fibrosis.  Our Phase II clinical trial for cryptococcal meningitis
 has completed enrollment and will report data in the fourth quarter of this
 year.  Similarly, our ongoing Phase III trial in tuberculosis and our Phase II
 trials in cystic fibrosis and atypical mycobacterial infections are on track.
 With the initiation of a Phase III trial in ovarian cancer and a Phase II
 trial in liver fibrosis (cirrhosis) in patients with hepatitis C infection,
 both in the second half of this year, investors can look to a steady stream of
 clinical events over the next 18 months," stated Dr. Harkonen.
     Total amortization expenses of $2.1 million were incurred in the first
 quarter of 2001, including $1.9 million relating to product revenue rights to
 Actimmune(R) acquired from Connetics Corporation and $225,000 for the
 acquisition of Amphotec(R) from ALZA Corporation.  Research and development
 expenses were $6.3 million for the first quarter of 2001, compared to
 $4.0 million in the same period in 2000.  The increase was due primarily to
 increased costs of clinical trial expenses for Actimmune(R) in new disease
 indications.  Selling, general and administrative expenses were $5.7 million
 and $1.3 million for the three-month periods ending March 31, 2001 and 2000,
 respectively.  This increase is attributable primarily to increased staffing
 and related expenses necessary to support the expansion of the Company's
 operations.  At March 31, 2001, cash, cash equivalents and available-for-sale
 securities totaled $175.3 million.
 
     Highlights From the First Quarter of 2001:
     -- Completed acquisition of Amphotec(R), an FDA-approved lipid-complexed
        form of amphotericin B, from ALZA Corporation.
     -- Appointed James E. Pennington, M.D. to the position of Executive Vice
        President of Medical and Scientific Affairs.
     -- Trained and placed into the field 26 immunology specialists to support
        physicians regarding the safe and appropriate use of Actimmune(R) and
        Amphotec(R).
     -- Commenced enrollment in Phase II clinical trial evaluating the safety
        and efficacy of inhaled Actimmune(R) (Interferon gamma-1b) for the
        treatment of cystic fibrosis.
     -- Formed an international strategic partnership to develop and
        commercialize interferon gamma-1b under Boehringer Ingelheim's trade
        name, Imukin(R), in all countries outside of the United States, Canada
        and Japan.
     -- Nominated Jay Sheppard, Vice President of the Oncology Business Unit at
        ALZA Corporation to the Company's Board of Directors.
     -- Completed enrollment in Phase II clinical trial evaluating the safety
        and efficacy of Actimmune(R) (Interferon gamma-1b) for the treatment of
        cryptococcal meningitis, a life-threatening fungal infection.
     -- Initiated a clinical program in Japan, with plans to develop
        Actimmune(R) (Interferon gamma-1b) for life-threatening diseases, as
        well as chronic granulomatous disease (CGD) and severe, malignant
        osteopetrosis.
     -- Announced plans to develop Actimmune(R) (Interferon gamma-1b) for the
        treatment of liver fibrosis (cirrhosis) associated with hepatitis C.
 
     The Company will hold a conference call with research analysts at
 11:00 a.m. Eastern Time on Thursday, April 26, 2001.  Interested investors and
 others may listen to the call either live or on a replay basis through our
 internet webcast, which may be accessed by visiting our website at
 http://www.intermune.com and clicking on the "Investor Relations" icon.
     InterMune is a biotechnology company dedicated to the development and
 commercialization of innovative products for the treatment of serious
 pulmonary and infectious diseases and cancer.  InterMune currently markets
 Actimmune(R) (Interferon gamma-1b) Injection in the United States for the
 treatment of chronic granulomatous disease (CGD) and severe, malignant
 osteopetrosis and is in Phase III clinical trials for the treatment of
 idiopathic pulmonary fibrosis (IPF) and multidrug-resistant tuberculosis
 (MDR TB).  The Company also markets Amphotec(R), an FDA-approved
 lipid-complexed form of amphotericin B for the treatment of invasive
 aspergillosis, a life-threatening fungal infection.  For more information
 about InterMune and Actimmune(R), please visit InterMune's web sites at
 www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com.
 
     Except for the historical information contained herein, this press release
 contains certain forward-looking statements concerning certain of InterMune's
 financial, business, and clinical development activities and goals, that
 involve risks and uncertainties.  All forward-looking statements and other
 information included in this press release are based on information available
 to InterMune as of the date hereof, and InterMune assumes no obligation to
 update any such forward-looking statements or information.  InterMune's actual
 results could differ materially from those described in InterMune's
 forward-looking statements.  Factors that could cause or contribute to such
 differences include, but are not limited to those discussed under the heading
 "Risk Factors" and the risks and factors discussed in InterMune's most recent
 periodic reports (i.e., 10-K, 10-Q and 8-K) filed with the SEC.  In sum, these
 significant risks include, but are not limited to:  the uncertainty of success
 of InterMune's efforts in research, development, commercialization, product
 acceptance, third-party manufacturing and capital raising; the uncertain,
 lengthy and expensive regulatory process; uncertainties associated with:
 obtaining and enforcing patents important to its business, being an
 early-stage company and relying on third-party payors' reimbursement policies;
 competition from other products; and product liability lawsuits.
 
                          InterMune Pharmaceuticals, Inc.
 
                         CONDENSED STATEMENTS OF OPERATIONS
                (unaudited, in thousands, except per share amounts)
 
                                                         Three Months Ended
                                                             March 31,
                                                        2001           2000
     Product sales, net
      Actimmune, net                                   $4,929        $106(A)
 
      Amphotec, net                                       613             --
 
       Total net sales                                  5,542            106
 
 
     Costs and expenses:
      Cost of goods sold                                3,515             56
 
      Amortization of product
       rights                                           2,118             --
 
      Research and development                          6,280          4,037
 
      Selling, general and administrative               5,710          1,295
 
      Deferred compensation                             1,238            758
 
       Total costs and expenses                        18,861          6,146
 
 
     Loss from operations                            (13,319)        (6,040)
 
 
     Interest income, net                               2,750            408
 
 
     Net loss                                        (10,569)        (5,632)
 
     Preferred stock accretion                             --          (269)
 
     Redeemable preferred stock dividend                   --       (27,762)
 
 
     Net loss attributable to
      common stockholders                           $(10,569)      $(33,663)
 
 
     Historical basic and diluted net loss
      per share                                       $(0.46)       $(11.17)
     Shares used in calculating historical
      basic and diluted net loss per
      common share                                     23,032          3,014
 
     Pro forma basic and diluted net loss
      per share                                       $(0.46)        $(2.33)
     Shares used in calculating pro forma
      basic and diluted net loss per
     common share                                      23,032         14,338
 
     Pro forma net loss attributable to
      common stockholders excluding
      preferred stock accretion and
      redeemable preferred stock dividend           $(10,569)       $(5,632)
 
     Pro forma basic and diluted net loss
      per common share attributable to
      common stockholders excluding
      preferred stock accretion and
      redeemable preferred stock dividend             $(0.46)        $(0.39)
 
     (A) Sales of Actimmune(R) up to a contractual threshold of (in thousands)
 $1,827 were reported by Connetics Corporation for the respective period.
 
 
                          InterMune Pharmaceuticals, Inc.
 
                              CONDENSED BALANCE SHEETS
                             (unaudited, in thousands)
 
                                                     March 31,    December 31,
                                                        2001           2000
     Cash, cash equivalents and
      available-for-sale securities                  $175,307       $194,520
 
     Other assets                                      17,321          7,129
 
       Total assets                                  $192,628       $201,649
 
 
     Current liabilities                               $5,849         $5,848
 
     Stockholders' equity                             186,779        195,801
 
       Total liabilities and stockholders' equity    $192,628       $201,649
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X67527022
 
 SOURCE  InterMune Pharmaceuticals, Inc.